[Federal Register Volume 68, Number 133 (Friday, July 11, 2003)]
[Rules and Regulations]
[Pages 41434-41506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17525]
[[Page 41433]]
-----------------------------------------------------------------------
Part III
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
-----------------------------------------------------------------------
21 CFR Part 101
Food Labeling; Trans Fatty Acids in Nutrition Labeling; Consumer
Research to Consider Nutrient Content and Health Claims and Possible
Footnote or Disclosure Statements; Final Rule and Proposed Rule
Federal Register / Vol. 68, No. 133 / Friday, July 11, 2003 / Rules
and Regulations
[[Page 41434]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 94P-0036]
RIN 0910-AB66
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient
Content Claims, and Health Claims
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations on nutrition labeling to require that trans fatty acids be
declared in the nutrition label of conventional foods and dietary
supplements on a separate line immediately under the line for the
declaration of saturated fatty acids. This action responds, in part, to
a citizen petition from the Center for Science in the Public Interest
(CSPI). This rule is intended to provide information to assist
consumers in maintaining healthy dietary practices. Those sections of
the proposed rule pertaining to the definition of nutrient content
claims for the ``free'' level of trans fatty acids and to limits on the
amounts of trans fatty acids wherever saturated fatty acid limits are
placed on nutrient content claims, health claims, and disclosure and
disqualifying levels are being withdrawn. Further, the agency is
withdrawing the proposed requirement to include a footnote stating:
``Intake of trans fat should be as low as possible.'' Issues related to
the possible use of a footnote statement in conjunction with the trans
fat label declaration or in the context of certain nutrient content and
health claims that contain messages about cholesterol-raising fats in
the diet are now the subject of an advance notice of proposed
rulemaking (ANPRM) which is published elsewhere in this issue of the
Federal Register.
DATES: This rule is effective January 1, 2006.
FOR FURTHER INFORMATION CONTACT: Julie Schrimpf, Center for Food Safety
and Applied Nutrition (HFS-832), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-2373.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Nutrition Labeling
B. Nutrient Content and Health Claims
C. Comments
II. Highlights of the Final Rule
III. Legal Authority
A. Statutory Authority
B. The First Amendment
IV. Review of the Science
A. Reviews by the Federal Government and the Institute of Medicine
(IOM/National Academy of Science (NAS)
B. Published Studies
V. Nutrition Labeling of Trans Fat
A. Voluntary v. Mandatory Declaration of Trans Fatty Acids in
Nutrition Labeling
B. Format, Including Percent of Daily Value (% DV), for Nutrition
Labeling of Trans Fat
C. Definition of Trans Fatty Acids
D. Methodology
VI. Nutrient Content Claims, Health Claims, Disclosure and
Disqualifying Levels
VII. Other Issues
VIII. Effective Date
IX. Final Regulatory Impact Analysis
A. The Current Situation and the Need for This Regulation
B. Regulatory Alternatives
C. Changes Resulting From This Rule
X. Final Regulatory Flexibility Analysis
A. Introduction
B. Economic Effects on Small Entities
C. Regulatory Options
D. Recordkeeping and Reporting Requirements
E. Summary
XI. Unfunded Mandates
A. Future Costs
B. Particular Regions, Communities, or Industrial Sectors
C. National Productivity and Economic Growth
D. Full Employment and Job Creation
E. Exports
XII. Environmental Impact
XIII. Paperwork Reduction Act
XIV. Federalism
XV. References
I. Background
A. Nutrition Labeling
The Nutrition Labeling and Education Act of 1990 (the 1990
amendments) (Public Law 101-535) amended the Federal Food, Drug, and
Cosmetic Act (the act) to provide, among other things, that certain
nutrients and food components be included in nutrition labeling.
Section 403(q)(2)(A) and (q)(2)(B) (21 U.S.C. 343(q)(2)(A) and
(q)(2)(B)) of the act state that the Secretary of Health and Human
Services (the Secretary) (and, by delegation, FDA) can, by regulation,
add or delete nutrients included in the food label or labeling if he or
she finds such action necessary to assist consumers in maintaining
healthy dietary practices.
In response to these provisions, in the Federal Register of
November 27, 1991 (56 FR 60366), FDA published a proposed rule entitled
``Food Labeling; Reference Daily Intakes and Daily Reference Values;
Mandatory Status of Nutrition Labeling and Nutrient Content Revision.''
In that document, the agency proposed to require that foods bear
nutrition labeling listing certain nutrients and the amount of those
nutrients in a serving of the food. Given the scientific knowledge
about trans fatty acids at the time, FDA did not propose to require
that trans fatty acids be listed. However, FDA requested comments on
whether the listing of trans fatty acids should be voluntary (56 FR
60366 at 60371). (Note: throughout this preamble, FDA has used the term
``trans fatty acids'' and ``trans fat'' interchangeably; likewise, for
the terms ``saturated fatty acids,'' and ``saturated fat'').
In the Federal Register of January 6, 1993 (58 FR 2079), FDA issued
a final rule implementing the 1990 amendments entitled ``Food Labeling;
Mandatory Status of Nutrition Labeling and Nutrient Content Revision,
Format for Nutrition Label'' that prescribes how nutrition labeling is
to be provided on foods that are regulated by the agency. In that
document, the agency required the declaration of total fat and
saturated fat in the nutrition label, with the declaration of both
monounsaturated fat and polyunsaturated fat (both defined as the cis
isomers only) required, when claims are made about fatty acids and
cholesterol. Based on its review of the comments, the agency stated
that it was premature to include trans fatty acids in nutrition
labeling because of a lack of agreement on the dietary implications of
trans fatty acid intake. However, the agency acknowledged that it might
be necessary to revisit the labeling of trans fatty acids in the future
(58 FR 2079 at 2090-2092).
FDA received a citizen petition, dated February 14, 1994, from CSPI
(docket number 94P-0036/CP1) stating that an increasing body of
evidence suggests that dietary trans fatty acids raise blood
cholesterol levels, thereby increasing the risk of coronary heart
disease (CHD). The petitioner argued that the 1993 final rules
implementing the 1990 amendments do not adequately reflect the effect
of dietary trans fatty acids on CHD and that label values for saturated
fat underestimate the total amount of ``heart-unhealthy'' fats because
trans fatty acids are not declared. CSPI requested that FDA amend the
definition of saturated fat in
[[Page 41435]]
Sec. 101.9(c)(2)(i) (21 CFR 101.9(c)(2)(i)) to include trans fatty
acids so that the declaration of saturated fat on the nutrition label
would provide consumers with complete information on all ``heart-
unhealthy'' fatty acids. In addition, the petitioner requested that all
saturated fat claims in Sec. 101.62(c) (21 CFR 101.62(c)), the
saturated fat threshold on all cholesterol claims in Sec. 101.62(d),
the claims for ``lean'' and ``extra lean'' in Sec. 101.62(e), and
disqualification and disclosure levels for health and nutrient content
claims be amended to reflect the combined levels of saturated and trans
fatty acids. Further, CSPI requested that FDA: (1) Limit ``vegetable
oil'' claims (e.g., ``made with vegetable oil'') to foods that are low
in both saturated and trans fatty acids, and (2) require that
``partially hydrogenated'' fat be listed on food labels as ``partially
saturated.''
On July 13, 1998, CSPI amended its petition in a way that would
maintain the definition of saturated fat in Sec. 101.9(c)(2)(i), yet
provide consumers with information on the trans fatty acid content of
the food. Specifically, CSPI suggested that FDA either: (1) Disclose
the sum of trans and saturated fats next to the term ``saturated fat*''
with an asterisk at the bottom of the label that states ``contains ----
-- grams of trans fat,'' or (2) disclose the sum of trans and saturated
fats next to the term ``saturated + trans fat'' when trans fat was
present.
In response to CSPI's petition, FDA issued a proposed rule in the
Federal Register of November 17, 1999 (64 FR 62746), entitled ``Food
Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content
Claims, and Health Claims'' (hereinafter identified as ``the November
1999 proposal''). In that document, FDA proposed to amend its nutrition
labeling regulations to require that the amount of trans fatty acids in
a food, including dietary supplements, be included in the amount and
percent Daily Value (%DV) declared for saturated fatty acids, with a
footnote indicating the amount of trans fatty acids in a serving of the
product, when the product contains 0.5 or more grams (g) trans fatty
acids per serving. FDA reviewed recent research that showed that
consumption of diets containing trans fatty acids, like diets
containing saturated fats, results in increased serum low-density
lipoprotein cholesterol (LDL-C), a major risk factor for CHD. The
proposed rule was issued to assist consumers in maintaining healthy
dietary practices (64 FR 62746 at 62754).
B. Nutrient Content and Health Claims
In the Federal Register of November 27, 1991 ( 56 FR 60478), FDA
also published a proposed rule entitled ``Food Labeling: Definitions of
Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol
Content of Food.'' Although the agency proposed definitions for fat,
fatty acid, and cholesterol nutrient content claims, it did not propose
a definition for the nutrient content claim ``saturated fat free.''
However, the comments in response to that proposal recommended that FDA
define the claim ``saturated fat free.''
In the Federal Register of January 6, 1993 (58 FR 2302), FDA issued
a final rule entitled ``Food Labeling: Nutrient Content Claims, General
Principles, Petitions, Definition of Terms; Definition of Nutrient
Content Claims for the Fat, Fatty Acid, and Cholesterol Content of
Food,'' (hereinafter the ``nutrient content claims final rule''). In
that rule, the agency stated that it did not set a trans fat criterion
for most claims because the evidence suggesting that trans fatty acids
raise serum cholesterol was inconclusive at that time (58 FR 2302 at
2332 and 2340). However, FDA did set a trans fat criterion for the
``saturated fat free'' claim stating that ``because of the uncertainty
regarding this issue, the fact that consumers would expect a food
bearing a `saturated fat free' claim to be free of saturated fat and
other components that significantly raise serum cholesterol, and the
potential importance of a saturated fat free claim, the agency believes
that it would be misleading for products that contain measurable
amounts of trans fatty acids to bear a `saturated fat free' claim'' (58
FR 2302 at 2332). The trans fat criterion for the claim ``saturated fat
free'' was set at a level not to exceed 1 percent of total fat in the
food (58 FR 2302 at 2419). The agency stated that 1 percent was the
appropriate threshold because analytical methods for measuring trans
fatty acids below that level were not reliable (58 FR 2302 at 2332).
This action was taken under the authority of section 403(r)(2)(A)(vi)
of the act, which prohibits a claim if it is misleading in light of the
level of another nutrient in the food.
Some comments that FDA received after publication of the nutrient
content claims final rule objected to the 1 percent criterion for trans
fatty acids in the definition of ``saturated fat free.'' One comment
pointed out that a cookie containing 1.5 g of total fat would be
allowed to have only 0.015 g of trans fatty acids, an amount that could
not be accurately measured. In response to these comments, in the
Federal Register of August 18, 1993 (58 FR 44020 at 44032), the agency
amended the definition of ``saturated fat free'' to require that a food
contain less than 0.5 g of trans fatty acids in addition to less than
0.5 g of saturated fat per reference amount customarily consumed
(hereinafter referred to as ``reference amount'') and per labeled
serving to be eligible to bear the claim.
In the November 1999 proposal, FDA concluded that dietary trans
fatty acids have adverse effects on blood cholesterol measures that are
predictive of CHD risk (64 FR 62746 at 62754). Consequently, to avoid
misleading claims, the agency proposed that the amount of trans fatty
acids be limited wherever saturated fat limits are placed on nutrient
content claims, health claims, or disclosure and disqualifying levels.
In the November 1999 proposal, the agency did not propose to take
action requested by CSPI to amend Sec. 101.65(c)(3) (21 CFR
101.65(c)(3)) to state that ``made with vegetable oil'' is an implied
claim that the product is low in saturated fat and trans fats combined
(64 FR 62746 at 62762) because the agency proposed to amend nutrient
content claims for saturated fat to include a trans fatty acid
criterion. The agency stated that the proposed amendments to nutrient
content claims and the requirements for implied nutrient content claims
in Sec. 101.65(c)(3) adequately addressed the petitioner's request.
In addition, in the November 1999 proposal, FDA requested comment
on whether ``trans fat free'' claims would help consumers maintain
healthy dietary practices and whether they would provide incentive to
the food industry to reduce the amount of trans fat in the food supply
(64 FR 62746 at 62759). FDA proposed a definition for the trans fat
free claim. FDA concluded that there was no basis for defining ``low
trans fat'' without quantitative recommendations for daily intake of
trans fat. Further, FDA did not define a ``reduced trans fat'' claim
because it was concerned that a reduced trans fat claim would detract
from educational messages that emphasize lower intakes of saturated
fat. Persons who believed that a ``reduced trans fat'' claim would be
useful were advised to submit a petition under Sec. 101.69 (21 CFR
101.69).
In the November 1999 proposal, FDA proposed to deny CSPI's request
that the agency require that ``partially hydrogenated'' fat be listed
as ``partially saturated'' fat (64 FR 62746 at 62762). Among other
reasons, the agency stated that ``hydrogenated'' and ``partially
[[Page 41436]]
hydrogenated'' are not intended to describe the nutritional properties
of the fat or oil. It explained that the purpose of the ingredient
statement is to identify the ingredients in a food by listing the
common or usual names of each ingredient (64 FR 62746 at 62762-62763).
Comments to the November 1999 proposal requested that the final
rule define the nutrient content claim ``reduced trans fat.'' Other
comments suggested a ``reduced saturated fat'' claim that would be
defined as a reduction of saturated and trans fats combined. The agency
considered these comments and determined that all interested parties
should have an opportunity to comment on whether the final rule should
define claims that address reduced levels of trans fat. Therefore, FDA
reopened the comment period for the November 1999 proposal on December
5, 2000, for a period of 45 days (65 FR 75887) stating that it would
consider only comments that addressed ``reduced trans fat'' and
``reduced saturated and trans fat'' claims.
Subsequent to FDA's November 1999 proposal, the Institute of
Medicine of the National Academy of Sciences (IOM/NAS) issued a report
entitled ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber,
Fat, Fatty Acids, Cholesterol, Protein and Amino Acids'' (the IOM/NAS
macronutrient report) (Ref. 140) and found, similar to the effect of
saturated fat, ``a positive linear trend'' between trans fatty acid
intake and total and LDL-C concentrations, and therefore increased risk
of CHD. Because trans fats are unavoidable in ordinary diets, the IOM/
NAS report recommended that ``trans fat consumption be as low as
possible while consuming a nutritionally adequate diet.'' Likewise, the
conclusions in two other scientific reports, which became available
subsequent to the November 1999 proposal, i.e., the Dietary Guidelines
for Americans, 2000 (Ref. 88) and guidelines from the National
Cholesterol Education Program (NCEP) (Ref. 89), were similar with
recommendations to limit trans fat intake in the diet. Although the
IOM/NAS report (Ref. 140) underscored the relationship between the
intake of trans fat and the increased risk for heart disease and
emphasized that consumers need to limit trans fat in their diets, it
did not provide a Dietary Reference Intake (DRI) value for trans fat or
information that FDA believes is sufficient to support the agency's
establishing a Daily Reference Value (DRV) or other information on the
label, such as a %DV, for trans fat.
In response to the recommendations of the new scientific reports to
limit the intake of trans fat and to provide consumers with label
information that may better assist them in understanding the
quantitative declaration of trans fat in the context of a total daily
diet, FDA reopened the comment period of the November 1999 proposal for
a period of 30 days (67 FR 69171, November 15, 2002). In that document
the agency proposed to require an asterisk (or other symbol) in the %DV
column for trans fat, when it is listed, that is tied to a similar
symbol at the bottom of the Nutrition Facts box that is followed by the
statement ``Intake of trans fat should be as low as possible.'' The
agency stated that the statement is taken from the IOM/NAS
macronutrient report and is consistent with the dietary guidance in the
other recent scientific reports identified in that document (67 FR
69171 at 69172).
In the November 15, 2002, Federal Register document to reopen the
comment period the agency also stated that it would consider the
exercise of its enforcement discretion for those manufacturers who
wanted to begin labeling the trans fat content of food products prior
to publication of the final rule (67 FR 69171 at 69172). The agency
cautioned manufacturers that the trans fat final rule may differ from
what was being proposed in the November 15, 2002, document to reopen
the comment period and that manufacturers would then be required to
change their labels to conform to the final rule.
C. Comments
FDA received over 1,650 letters in response to the November 1999
proposal, over 45 letters in response to the December 5, 2000, notice
reopening the comment period, and over 25 letters in response to the
November 15, 2002, proposal and notice to reopen the comment period.
Each of these letters contained one or more comments. Responses were
received from industry, trade associations, consumers, consumer
advocacy organizations, academia, health care professionals,
professional societies, city and State governments, other Federal
agencies, and other countries. Some of the comments supported the
proposal generally or supported aspects of the proposal. Other comments
objected to specific provisions and requested revisions. Some comments
requested that the proposal be withdrawn or reproposed. A few comments
addressed issues outside the scope of the proposal and will not be
discussed here. On September 18, 2001, the Office of Information and
Regulatory Affairs (OIRA), Office of Management and Budget, sent to the
Secretary of the Health and Human Services (the Secretary) a letter
requesting that the Secretary and FDA consider giving greater priority
to the November 1999 proposal (Ref. 156) in light of the growing body
of scientific evidence suggesting that consumption of trans fatty acids
in foods increases the consumer's risk of developing CHD. The estimated
public health benefits from increased consumer awareness of trans fat
content in foods that were described in FDA's preliminary Regulatory
Impact Analysis in the November 1999 proposal, and the subsequent
evidence found in more recent studies, strongly support the interests
of the Government to lower the incidence of and economic burden of CHD
in the United States. This final rule summarizes the relevant comments
that were received in response to the November 1999 proposal and
provides the agency's conclusions regarding the labeling of trans fat
on the Nutrition Facts panel.
A summary of the relevant comments that pertain to nutrition
labeling of trans fat, the agency's responses to the comments, and a
discussion of the agency's conclusions follow.
II. Highlights of the Final Rule
In this final rule and given the current state of scientific
knowledge, FDA is requiring the mandatory declaration in the nutrition
label of the amount of trans fatty acids present in foods, including
dietary supplements. The declaration of this nutrient must be on a
separate line immediately under the declaration for saturated fat but
it will not include a %DV that is required for some of the other
mandatory nutrients, such as saturated fat. In addition, the agency is
withdrawing those sections of the proposed rule pertaining to the
definition of nutrient content claims for ``free'' and for ``reduced''
levels of trans fatty acids, and limits on the amounts of trans fatty
acids, wherever saturated fatty acid limits are placed on nutrient
content claims, health claims, and disclosure and disqualifying levels.
Further, the agency is withdrawing the proposed requirement to include
a footnote stating: ``Intake of trans fat should be as low as
possible.''
The action the agency is taking in this final rule is based on its
evaluation of comments received in response to the November 1999
proposal, the reopening of the comment period on November 15, 2002, and
on scientific evidence that shows that consumption of trans fatty acids
increases LDL-C, a primary risk factor for CHD. The scientific evidence
includes current authoritative reports,
[[Page 41437]]
such as Dietary Guidelines 2000 (Ref. 87), that recommend that
Americans cut back on trans fats when reducing fat intake. The agency
concludes that the declaration of this nutrient on a separate line,
will help consumers understand that trans fat is chemically distinct
from saturated fat and will assist them in maintaining healthy dietary
practices. The agency intends to promote consumer awareness and
understanding of the health effects of trans fat as part of an
educational program. FDA is issuing an ANPRM elsewhere in this issue of
the Federal Register that will solicit comment and additional consumer
research that potentially could be used to establish new nutrient
content claims about trans fat, to establish qualifying criteria for
trans fat in certain nutrient content claims and health claims, and to
establish disclosure and disqualifying criteria for trans fat. In
addition, the ANPRM is soliciting comment on whether it should consider
statements about trans fat, either alone or in combination with
saturated fat and cholesterol, as a footnote in the Nutrition Facts
panel or as a disclosure statement in conjunction with claims to
enhance consumer's understanding about cholesterol-raising lipids.
III. Legal Authority
General Comments
FDA received a number of comments from trade associations and
others in industry asserting that FDA did not meet its burden under the
first amendment in proposing to mandate nutrition labeling of trans
fat. Further, the comments asserted that FDA did not meet its first
amendment burden for establishing restrictions on specific claims by
virtue of how FDA defined nutrient content claims or established
disqualifying and disclosure levels, including the effects that those
actions would have on restricting certain health claims on food. In
addition, comments raised questions about whether the agency's proposed
action was consistent with the Administrative Procedure Act (APA) and
whether the agency was acting consistent with its authority under the
act.
As stated in section VI of this document, FDA is withdrawing those
sections of the rule pertaining to the definition for nutrient content
claims that were proposed, and to limits on the amounts of trans fatty
acids wherever saturated fatty acid limits are placed on nutrient
content claims, health claims, and disclosure and disqualifying levels.
Further, the agency is withdrawing the proposed requirement to include
a footnote stating ``Intake of trans fat should be as low as
possible.'' The agency provides an overview of comments received on
these withdrawn sections in section VI of this document, and therefore,
is not addressing those comments here. Thus, the agency is addressing
only those comments that pertain to legal issues about the agency's
action to require mandatory trans fat labeling.
A. Statutory Authority
Several comments question whether the agency's proposed requirement
for mandatory trans fat labeling would prevent consumer deception or
would assist consumers in maintaining healthy dietary practices. The
comments suggest that the data do not support mandatory trans fat
labeling, unless the label contains a nutrient content or health claim
related to fat or cholesterol or unless polyunsaturated fat or
monounsaturated fat is voluntarily declared on the label. Specifically,
the comments assert that mandatory trans fat labeling in the absence of
claims, or statements about other fats, would not assist consumers in
following healthy dietary practices or would not prevent consumer
deception.
A few comments suggest that there was no basis for concluding any
health benefit can be expected from disclosure of trans fat levels on
foods when present in amounts that have not been clinically shown to
have a material impact on human health or disclosure on foods with a
trivial contribution of fat.
Another comment argues that the agency could only require mandatory
labeling of trans fat under the statute where the absence of such
labeling constitutes the omission of a material fact under section
201(n) of the act (21 U.S.C. 321(n)), such as when nutrient content
claims are made about cholesterol or fatty acids, or when
polyunsaturated and monounsaturated fats are voluntary listed. A
related comment suggests that trans fat labeling would be appropriate
where the declaration of ``total fat'' and ``saturated fat,'' that did
not explicitly include trans fat, were established as misleading under
section 201(n) of the act (without trans fat listed). The comment seems
to suggest that the declaration of ``total fat'' and ``saturated fat''
in that situation would be misleading if the actual nutrition
contribution from trans fat that such products make to the diet was
greater in comparison to other products. In addition, one comment
suggests that mandatory nutrition labeling of trans fat can only be
``material'' where there is sufficient trans fat present in the food to
significantly impact the overall fatty acid contribution that the food
makes to the diet, such that only having total fat and saturated fat on
the label would misrepresent the nutritional value of the product in a
material way.
FDA believes it has adequate authority to adopt this rule. FDA's
authority under the act to require trans fat labeling includes sections
201(n), 403(a)(1) and (q), and 701(a) of the act (21 U.S.C. 371(a)).
FDA has authority under section 701(a) of the act to issue regulations
for the efficient enforcement of the act. FDA can require labeling of
certain facts that are material in light of representations made in the
labeling or with respect to consequences which may result from the use
of the article in order for a product not to be misbranded under
sections 201(n) and 403(a) of the act. Further, under section
403(q)(2)(A) of the act, the Secretary (and FDA, by delegation) may
require that information relating to a nutrient be in the labeling of
food for the purpose of ``providing information regarding the
nutritional value of such food that will assist consumers in
maintaining healthy dietary practices.''
The agency believes that the data in the record supports mandatory
trans fat labeling to ensure that consumers are not misled and are
adequately informed about the product's attributes. Accordingly, FDA
believes that mandatory trans fat labeling is necessary for foods not
to be misbranded under section 403(a) of the act. The absence of
information about the content of trans fat in foods that are subject to
mandatory labeling would constitute an omission of a material fact
under section 201(n) of the act.
Under the act, the agency has the mandate to ensure that labeling
provides truthful and nonmisleading information to consumers. Thus, the
law provides the agency with authority to require specific label
statements when needed for reasons other than to ensure the safe use of
food. Under section 403(a)(1) of the act, a food is misbranded if its
labeling is false or misleading in any particular. Section 201(n) of
the act amplifies what is meant by ``misleading'' in section 403(a)(1)
of the act. Section 201(n) of the act states that, in determining
whether labeling is misleading, the agency shall take into account not
only representations made about the product, but also the extent to
which the labeling fails to reveal facts material in light of such
representations made or suggested in the labeling or material with
respect to consequences which may result from use of the article to
which the labeling relates under the conditions of use prescribed in
the labeling or under such
[[Page 41438]]
conditions of use as are customary or usual (see Sec. 1.21 (21 CFR
1.21)). Thus, the omission of certain material facts from the label or
labeling of a food causes the product to be misbranded within the
meaning of 21 U.S.C. 343(a)(1) and 321(n).
In general, the agency believes the concept of ``material fact'' is
one that must be applied on a case-by-case basis. The agency has
required special labeling in cases where information is necessary to
ensure that consumers are aware of special health risks associated with
consumption of a particular product. For example, although protein
products intended for use in weight reduction are not inherently
unsafe, FDA requires a warning statement for such products that states,
in part, that very low calorie protein diets may cause serious illness
or death. Another example of required information is the use of the
term ``milk derivative'' following the ingredient declaration of sodium
caseinate when used in a product labeled ``non dairy'' (21 CFR
101.4(d)).\1\
---------------------------------------------------------------------------
\1\ FDA's regulation regarding the failure to reveal material
facts (Sec. 1.21) states that ``affirmative disclosure of material
facts * * * may be required, among other appropriate regulatory
procedures, by * * * regulations in this chapter promulgated
pursuant to section 701(a) of the act; or direct court enforcement
action (emphasis added).'' Thus, establishing a requirement for
mandatory trans fat labeling is consistent with Sec. 1.21.
---------------------------------------------------------------------------
Consumption of trans fat results in consequences to the consumer.
Consumers may increase or decrease their risk of CHD based on the level
of trans fat in their diets. Thus, the presence or absence of trans fat
in a food product is a material fact under section 201(n) of the act.
Consumers must know--and the agency believes is material
information that the reasonable consumer should know--the amount of
trans fat in food products that they select as part of their total
daily diet to choose products that would allow them to reduce their
intake of trans fat, and thus, reduce the risk of CHD. Section IV of
this document discusses the scientific evidence for why trans fat
consumption places consumers at risk for CHD. Absent mandatory
labeling, consumers would not be able to understand the relative
contribution that foods make to their total daily intake of trans fat.
First, because polyunsaturated and monounsaturated fats are not subject
to mandatory labeling, simply including trans fat as part of the total
fat contribution would not allow consumers to calculate the trans fat
content by finding the difference between the sum total of all the
mandatory fats listed on the label and the total fat content. Second,
even if all component fats were required to be listed, it would not be
realistic to expect consumers to do such calculations on each product
to compare the relative trans fat contribution of each. Further, the
fact that an individual food product may contain zero gram trans fat is
still a ``material fact'' for that food. In the context of mandatory
labeling of nutrients in a nutrition facts panel, the relative
contribution of various food products to the total day's consumption of
a heart unhealthy fat is important for consumers ``to readily observe
and comprehend the information and to understand the relative
significance of that information in the context of the total daily
diet'' (section 2(b)(1)(A) of Public Law 101-535). Further, foods in
which trans fat has replaced saturated fat would appear to be heart
healthy based on the saturated fat grams listed on the nutrition facts
panel, when, in fact, such foods may not be heart healthy due to the
large contribution of trans fat to the total fat content. Consumers
would be misled without having trans fat information available on the
label. Thus, for the reasons set forth previously, FDA concludes that
it is acting within its statutory authority under the act to require
trans fat labeling.
Moreover, Congress provided the agency with the express authority
to add to the list of nutrients on the label under section 403(q)(2)(A)
of the act. As stated in section V.A of this document, section
403(q)(2)(A) gives FDA the authority to require that information on
additional nutrients be included in nutrition labels if FDA determines
that providing such information will assist consumers to maintain
healthy dietary practices. Section IV of this document provides ample
evidence of the heart unhealthy effects from consumption of trans fat
over a range of intakes, information the agency believes is material
information that the reasonable consumer should know. When scientific
evidence supports such labeling, the agency has discretion to determine
whether to require the addition of a particular nutrient to the label
of food products. Thus, the agency is well within its statutory
authority for requiring mandatory labeling of trans fat and is not
limited to requiring such information only when certain claims are made
or only when other fats are listed on the label.
Further, the agency disagrees with the comments that assert that
mandatory trans fat labeling would not assist consumers to maintain
healthy dietary practices, unless the label also carries a nutrient
content or health claim or information about other fats. The agency
also disagrees with comments suggesting that there is no basis for
concluding any health benefit can be expected from disclosure of trans
fat if foods contain a trivial amount of trans fat or if trans fat is
not present in amounts that have not been clinically shown to adversely
affect human health.
The agency is exercising the discretion that Congress gave it in
the 1990 amendments to include trans fat as a mandatory nutrient in
food labeling, based on the state of the scientific evidence on the
increased LDL-C levels from intake of trans fat (see section IV of this
document). The scheme that Congress established would require all
mandatory nutrients be listed on the food label, including those that
the agency determines are necessary under section 403(q)(2)(A) of the
act. Congress wanted one uniform statutory scheme for food labeling and
discussed the importance of maintaining consistency in the format and
content of the food label to ``help all consumers to better understand
and improve their eating habits by providing uniform information in a
coherent and understandable format.'' (136 Cong. Rec. S 16607 at 16609
(statement of Senator Metzenbaum)). The statute does not require other
mandatory nutrients to be listed, for example, saturated fat, only when
monounsaturated and polyunsaturated fat are voluntarily listed.
Mandatory nutrients are listed for each food that bears a nutrition
facts panel. Food that bears a nutrition label must contain certain
required nutrients as part of that label to not be misbranded.
Further, section 403(q)(2)(A) provides that mandatory labeling
would be appropriate when information about a nutrient would assist
consumers to maintain healthy dietary practices. Information on the
trans fat content of food would assist consumers in this way. Consumers
need the information on trans fat content of all foods that they
consume so that they can reduce their intake of trans fat. The fact
that a food may have no trans fat or a small amount of trans fat is
useful information to the consumer so that food choices can be made and
the consumer can put that product, along with many other products
consumed as part of the daily diet, into the context of the total daily
diet to maintain healthy dietary practices. Consumers would have
information on the amount of trans fat in a product, along with other
information about the amount of saturated fat and cholesterol.
Consumers could use information about all three fats, not just
saturated fat and
[[Page 41439]]
cholesterol, to incorporate nutrition education information about
recommended contributions for all three fats to the diet when making
healthier food choices. There is ample discussion in section IV of this
document about the heart unhealthy effects of consuming trans fat and
there is a new and strong consensus among the scientific community for
reducing trans fat intake. Thus, the agency believes it is within the
bounds of its statutory authority under section 403(q)(2)(A) of the act
to require the listing of trans fat on the food label, which listing is
not dependent on the presence of claims or other voluntary fat
information.
B. The First Amendment
Several general comments were received asserting that the agency's
action to mandate labeling is subject to review under the first
amendment. The comments assert that mandatory labeling of trans fat is
commercial speech, and thus, such speech is entitled to the full range
of first amendment protections as all commercial speech (citing to
Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)). The comments
further assert that ``compelled speech'' is entitled to the same
protections as speech ``bans,'' (citing to Central Hudson Gas & Elec.
Corp. v. Public Service Comm'n of New York, 477 U.S. 557 at 566
(1980)). One comment explained that the court in Pearson emphasized
that the first amendment does not allow FDA to restrict truthful,
nonmisleading information as a ``paternalistic'' means of directing
consumer food choices (164 F.3d at 656 (citing Bates v. State Bar of
Arizona, 433 U.S. 350 at 377(1977) (``[W]e view as dubious any
justification that is based on the benefits of public ignorance.''));
44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (opinion
of Stevens, J. joined by Kennedy, J., and Ginsburg, J.) (``The First
Amendment directs us to be especially skeptical of regulations that
seek to keep people in the dark for what the government perceives to be
their own good.''). The comment further cited several cases for the
proposition that the government cannot compel speech when disclosures
are not necessary to materially alleviate real consumer harm (citing to
IDFA v. Amestoy, 92 F.3d 67, 73 (2nd Cir. 1996); Ibanez v. Florida
Dep't of Business and Prof'l Regulation, 512 U.S. 136 (1994); and
Edenfield v. Fane, 507 U.S. 761 (1993)). Another comment suggests that
the agency needed to consider the limitations imposed by the first
amendment to avoid unjustified burdens and costs on food labeling where
there is no genuine public health benefit from a rule that does not
materially alleviate a genuine harm of potential consumer deception.
Some comments assert that FDA's proposal to mandate trans fat
labeling does not remedy a concrete harm as required by the first
amendment. One comment suggests that a trans fat labeling rule could be
supported if carefully crafted to remedy consumer deception but not
where risk of consumer deception cannot be established as a genuine
harm. Other comments state that FDA did not tailor its approach to
labeling and would be requiring mandatory labeling of trans fat for
foods containing as little as 0.5 g trans fat, which would not
alleviate a genuine harm. The comment seems to further suggest that
including trans fat in the total fat content on the label would be
sufficiently tailored to alleviate a genuine harm. Another comment
states that there is mere speculation in the record that providing
information on trans fat would assist consumers to maintain healthy
dietary practices, and thus, is not narrowly tailored to materially
alleviate a genuine harm.
A few comments state that treating trans fats the same as saturated
fat on labeling would be the same as proposing to require false
information on labels. Such an outcome, the comments state, would be
indefensible on Constitutional grounds. One comment states that
mandatory declaration of trans fat can only be justified under
constitutional provisions when the absence of such declaration would
constitute an omission of a material fact.
FDA believes that this regulation is consistent with the first
amendment. As noted previously, the failure to disclose the amount of
trans fat in a product is an omission of material fact. When a
manufacturer makes explicit or implicit health claims, the failure to
provide trans fat information is likely to mislead the consumer.
Moreover, the reasonable consumer would expect that the information on
the label would give them the most important nutrition information
relative to the healthfulness of a product. Yet the omission of trans
fat runs counter to that expectation, impeding rational consumer
choice. As the agency has explained earlier, consumers need information
about trans fat on all foods, not just those that contain a certain
threshold level of trans fat, to reduce overall intake of trans fat in
the diet. Consumers can use that information to compare products and
make selections that can reduce their risk of CHD.
Accordingly, FDA believes that this final rule passes muster under
the four-part test in Central Hudson primarily because, as discussed
previously, requiring the factual information on the amount of trans
fat in labeling ensures that the label is not false or misleading.
Under the first prong of Central Hudson, commercial speech must be
related to lawful activity and not be misleading. Speech that is false
or misleading is not protected and may be prohibited (Central Hudson,
447 U.S. 557 at 563-564).\2\
---------------------------------------------------------------------------
\2\ The agency does not need to address the comments that
asserted that proposing to treat trans fat the same as saturated fat
in the November 1999 proposal would be the same as requiring false
labeling. Since the agency is requiring separate line labeling in
this final rule, those comments are moot.
---------------------------------------------------------------------------
Given this determination, arguably the agency need not address the
other three parts of the Central Hudson test at all. Nonetheless, and
particularly in light of FDA's showing that such information is
important to ensuring that consumers are adequately informed about the
products they are buying, the proposed requirement satisfies the next
three prongs. Turning to the second prong, the asserted governmental
interest must be substantial. FDA's interest is clearly substantial,
for at least two reasons. As noted previously, the FDA has a
substantial interest in protecting and promoting public health and in
preventing consumer deception by ensuring the accuracy and completeness
of trans fat information in labeling. (See Pearson, 164 F.3d at 656.)
The food labeling regulations seek to ensure that consumers have access
to information about food that is scientifically valid, truthful,
reliable, and not misleading. (58 Fed. Reg. 2478, 2526 (1993)).
Consumers have a first amendment interest in obtaining information on
which to base a decision, particularly one that has health
consequences, regarding whether to buy a product, and this interest is
``served by insuring that the information is not false or deceptive.''
(National Comm'n on Egg Nutrition v. FTC, 570 F.2d 157, 162 (7th Cir.
1977), cert. denied, 439 U.S. 821 (1978)).
Moreover, FDA has a substantial governmental interest in assisting
consumers to maintain healthy dietary practices. Such interest is
consistent with the purpose of section 403(q)(2)(A) of the act; to
provide information to consumers on nutrients (trans fat content of
food) when such information is of public health importance. The
government is not confined to asserting a substantial government
interest in preventing consumer deception for a regulation before that
regulation can sustain a first amendment review (Rubin v. Coors Brewing
Co., 514 U.S.476, 484-
[[Page 41440]]
85 (1995) (finding that the protection of the health, safety, and
welfare of citizens is a substantial government interest)). In fact,
FDA's interest in this rule includes an interest in ensuring consumers
have information they need to help them maintain healthy dietary
practices by providing factual information to consumers on food labels
so that they can reduce CHD risk.
Under the third prong of Central Hudson, the regulation must
directly advance the government's interest asserted (Central Hudson 447
U.S. 557 at 566). Requiring mandatory trans fat labeling on food
products directly advances the government interest. As stated in
section V.A of this document, analyses of survey data show that
consumers rely on the Nutrition Facts label as a guide to choosing
foods that meet their dietary objectives. The most frequently reported
label use and the one that increased the most following the
implementation of the 1990 amendments was to see how high the food was
in nutrients such as fat. Mandatory trans fat labeling would help
consumers maintain healthy dietary practices because it would provide
needed information about the amount of trans fat in a given product so
that consumers could plan a daily diet in a way that would reduce their
intake of trans fat. Further, as stated in section V.A of this
document, consumers need to be able to see the trans fat content of all
foods subject to mandatory labeling so that they can compare the
relative contribution of trans fat from each and make purchasing
decisions accordingly.
Finally, under the fourth prong of Central Hudson, the regulation
must be no more extensive than necessary to serve the government
interest (Central Hudson 447 U.S. 557 at 566). That is the case here.
Given, as stated in section V.A, that consumers need to understand the
relative contribution of trans fat from all foods subject to mandatory
labeling to make choices among products that will reduce their intake
of trans fat, there are not ``numerous and obvious less-burdensome
alternatives'' (Cincinnati v. Discovery Network, 507 U.S. 410, 418 n.13
(1993)) than the requirement imposed here. Imparting truthful, factual,
noncontroversial information about the presence or absence and amount
of trans fat in food products on the label will provide consumers with
information to help them to reduce their risk of CHD. Thus, the
agency's action to require factual information be imparted to consumers
about trans fat content of foods by requiring such information in
labeling is sufficiently narrowly tailored to meet the fourth prong of
Central Hudson. The ``government is not required to employ the least
restrictive means conceivable'' rather it is required to have ```a fit
that is not necessarily perfect, but reasonable; that represents not
necessarily the single best disposition but one whose scope is in
proportion to the interest served''' (Greater New Orleans Broadcasting
Ass'n, Inc. v. U.S., 527 U.S. 173 at 177 (citing Board of Trustees of
State Univ. of N.Y. v. Fox, 492 U.S. 469, 480 (1989))). Requiring
disclosure of trans fat content would assist consumers to maintain
healthy dietary practices, provide complete, factual information on a
food label to help them to reduce trans fat intake and thereby reduce
their risk of CHD. Further, it would prevent them from being misled by
providing information on trans fat that can help them make product
comparisons and choose products that are heart healthy.
The agency disagrees with the suggestion that narrow tailoring
under the fourth prong of Central Hudson requires that trans fat
content be included in the figure for total fat content. Such an
approach would not provide consumers with labeling information on the
amount of trans fat in a product. To provide consumers with a way to
calculate the amount of trans fat in a product, all other fats
(including monounsaturated and polyunsaturated fats) would be required
to be on the label. The comment provided no basis for why
monounsaturated fat and polyunsaturated fat should be made mandatory,
why it would make sense for consumers to have to calculate the value
for trans fat content from each label under the statutory scheme in
section 403(q)(2)(A) of the act, and why such an approach would be less
burdensome under the fourth prong of Central Hudson to support its
assertion.
Moreover, there is a substantial argument that the agency need not
satisfy the Central Hudson test because that test applies to
prohibitions on speech, and not compelled commercial speech, which is
at issue here. Although consumer curiosity alone is an insufficient
interest to compel factual speech (International Dairy Foods Ass'n v.
Amestoy, 92 F. 3d 67, 74 (2nd Cir. 1996)), the government can compel
manufacturers to disclose information that ``bears on a reasonable
concern for human health or safety or some other sufficiently
substantial government concern.'' Id. FDA's rule to require mandatory
trans fat labeling is one that would require manufacturers to disclose
such information.
Further, the U.S. Court of Appeals for the second circuit upheld a
regulation compelling speech where the goal of the statute was to
reduce the amount of mercury released into the environment; a goal that
was ``inextricably intertwined with the goal of increasing consumer
awareness of the presence of mercury in a variety of products''
(National Electrical Manufacturer's Ass'n v. Sorrell, 272 F. 3d 104,
115 (2d Cir. 2001)). FDA is providing information that will assist
consumers to maintain healthy dietary practices and prevent consumers
from being misled if incomplete nutrition information on trans fat were
provided on the food label, i.e., information that did not include the
presence or amount of trans fat in foods. Similar to the goal the State
of Vermont has in increasing awareness of consumers to prevent the
harmful consequences of mercury containing products entering the
environment, FDA wants to prevent the harmful consequences (increased
risk of CHD) to consumers from trans fats. Thus, the agency's action to
require trans fat labeling in this rule comports with similar actions
in other compelled commercial speech cases which have been upheld under
the first amendment.
For all of the foregoing reasons, the agency believes it has
complied with its burdens under the first amendment to support
mandatory disclosure of the amount of trans fat in food labeling. The
information that FDA is requiring in food labeling for trans fat, i.e.,
the amount of trans fat listed in grams or an optional footnote stating
``Not a significant source of trans fat'' if zero grams are present, is
purely factual information. FDA's action to compel trans fat labeling
does not ``prescribe what shall be orthodox in politics, nationalism,
religion, or other matters of opinion or force citizens to confess by
word or act their faith therein.'' Rather, it simply provides for
factual and uncontroversial information that can be supported if such
labeling is reasonably related to FDA's government interests (Zauderer,
471 U.S. at 650-51 (distinguishing between the level of review
necessary under the first amendment where factual and uncontroversial
information is required and recognizing that the constitutionally
protected interest in not providing such information is minimal); see
also Glickman v. Wileman Brothers & Elliott, Inc., 521 U.S. 457, 472
(1997) (distinguishing compelled financial contributions that promote
speech to encourage consumer purchases from speech in which the content
of the message focuses on political or ideological differences). FDA's
interests in requiring mandatory trans fat labeling
[[Page 41441]]
is to protect the public health by providing consumers with information
that will assist them in maintaining healthy dietary practices and by
preventing misleading labeling by providing factual, truthful, and
noncontroversial information.
Providing information to consumers about the trans fat content of
foods on food labeling is reasonably related to the agency's interest
of assisting consumers to maintain healthy dietary practices. As
explained in section IV of this document, there is a relationship
between the level of trans fat in the diet and risk of CHD. To reduce
this risk, consumers need information about the level of trans fat in
food products. The agency has evidence that consumers refer to product
labels when purchasing food products and use labels to determine how
much fat is in a product (Ref. 96). Thus, by requiring that trans fat
information be on a food label, the agency will be assisting consumers
in making food purchasing decisions that can result in a reduction in
trans fat intake so that they can reduce their risk of CHD. Moreover,
because the presence or absence of trans fat is a material fact under
section 201(n) of the act, as explained earlier, mandatory labeling
that provides information about the presence or absence of trans fat,
and if present, at what levels, is a reasonable means for imparting
full, factual information to consumers so that they will not be misled
in purchasing decisions because they have no information about trans
fat content and may not even be able to calculate it based on
information on other fats on the label.
The agency has carefully considered the limitations imposed by the
first amendment to avoid unjustified burdens and costs of food labeling
where there is no genuine public health benefit from the rule that does
not alleviate a harm of potential consumer deception. The agency did
carefully calculate the costs and benefits of food labeling (see
section IX of this document) and determined that the scope of mandatory
trans fat labeling was in proportion to the government interest served.
Cincinnati v. Discovery Network, Inc., 507 U.S. 410 (1993) (stating
that a regulation ``should indicate that its proponent `carefully
calculated' the costs and benefits associated with the burden on speech
imposed by its prohibition'' (quoting Fox, 492 U.S. at 480)). Moreover,
the agency has documented that there is a public health benefit to the
final rule. To the extent that those who commented ``believe that their
money is not being well spent, `does not mean that they have first
amendment complaint.''' Glickman, 521 U.S. at 472.
Administrative Procedure Act
One comment asserts that FDA must adopt regulations that are
supported by the rulemaking record and that are not otherwise arbitrary
and capricious in light of the statutory limitations on the agency's
authority. This comment and another assert that the data do not support
a basis for treating trans fat and saturated fat the same either
chemically or for purposes of one's health, and that therefore, FDA is
proposing to require food labels that provide false information. One
comment said that to equate trans fat and saturated fat on the existing
body of evidence would be arbitrary and capricious in violation of the
APA. Another comment asserts that FDA did not account for legal and
policy considerations that are necessary to construct an appropriate
trans fat regulatory framework and thus, does not have a rulemaking
record that satisfies the agency's burden of proof under the APA. The
comment seemed to relate deficiencies in the record necessary to
satisfy first amendment requirements to a failure to satisfy APA
requirements. One comment asserts that the rulemaking record for FDA's
proposal does not support the expansive scope of the mandatory trans
fat labeling proposal, and therefore, fails to satisfy the requirements
of the APA. The comment states that the body of scientific evidence did
not establish a genuine ``harm'' from trans fat consumed at ordinary
intake levels from foods that would be subject to the mandatory
labeling requirements.
To the extent that comments were raising concerns about the agency
going to a final rule based on including trans fat in the amount and %
DV for saturated fat and that doing so would be the same as requiring
false information on labels, those comments are now moot since the
agency is requiring a separate line for labeling trans fat. FDA
disagrees with the comment that suggests that FDA did not account for
legal and policy considerations necessary to construct an appropriate
trans fat regulatory framework, and that the rulemaking record does not
support the scope of this rule. As stated previously, the agency is
using the statutory framework that Congress provided in section
403(q)(2)(A) of the act to require mandatory trans fat labeling.
Further, the agency has explained its rationale, based on the science,
for why it believes that it is necessary for consumers to have
information on the trans fat content of foods to maintain healthy
dietary practices. To the extent that the comments assert that the body
of scientific evidence did not establish a ``harm'' from trans fat
consumed at ordinary intake levels from foods, and thus, would preclude
the agency from requiring mandatory trans fat labeling under the APA,
the agency disagrees. The science supports adverse health effects from
consumption of trans fat among a range of intakes that includes intakes
at average intake levels among the U.S. population (see section IV of
this document). That said, mandating the disclosure of this information
does not require FDA to find that trans fatty acids actually cause CHD.
In mandating the disclosure of this information, FDA need not meet the
standard of proof required to establish causation in a private tort
action (Glastetter v. Novartis Pharmaceutical Corp., 252 F.3d 986, 991
(8th Cir. 2001)).
``The distinction between avoidance of risk through regulation
and compensation for injuries after the fact is a fundamental one.
In the former, risk assessments may lead to control of a toxic
substance even though the probability of harm to any individual is
small and the studies necessary to assess the risk are incomplete;
society as a whole is willing to pay the price as a matter of
policy. In the latter, a far higher probability (greater than 50
percent) is required since the law believes it is unfair to require
an individual to pay for another's tragedy unless it is shown that
it is more likely than not that he caused it * * *.''
In re ``Agent Orange'' Product Liability Litigation, 597 F. Supp. 740,
781 (E.D.N.Y.) 1984), aff'd 818 F. 2d 145 (2d. Cir. 1987). In making
its decision, the agency follows ``the preventive perspective that
agencies adopt in order to reduce public exposure to harmful
substances.'' Glastetter, 252 F. 3d at 991, quoting Hollander v. Sandoz
Pharmaceuticals Corp., 95 F. Supp. 2d 1230, 1234 n.9 (W.D. Okla. 2000).
Accordingly, so long as we conclude that the consumer would reasonably
expect this information to be disclosed and that it is scientifically
justifiable to require its disclosure, we are justified in taking this
action.
The agency has determined, based on this scientific evidence, that
consumers need this information to maintain healthy dietary practices.
Thus, the agency is not precluded under the APA, as the comment
suggests, from issuing this final rule. In addition, the agency has
discussed why it believes that this final rule comports with the first
amendment, and thus, disagrees with the comment that suggests that
because it did not meet its burdens under the first amendment, it did
not satisfy the APA requirements.
[[Page 41442]]
IV. Review of the Science
A. Reviews by the Federal Government and the Institute of Medicine
(IOM)/National Academy of Sciences (NAS)
In the November 1999 proposal, FDA reviewed reports published by
the U.S. Federal government and the IOM/NAS. These reports, which were
published between 1988 and 1995, showed that conclusions about the role
of trans fat in raising LDL-C, the primary risk factor for CHD, and
dietary recommendations were evolving as results from new studies
became available (64 FR 62746 at 62749). For example, the 1988 Surgeon
General's Report (Ref. 2) and the 1989 IOM/NAS Report (Ref. 4) found no
adverse effects of trans fat. Later, the 1993 publication from the NCEP
stated that ``trans fatty acids raise LDL-C levels nearly as much as do
cholesterol-raising saturated fatty acids'' (Ref. 5). The fourth
edition of Dietary Guidelines for Americans, a joint 1995 publication
from the U.S. Department of Health and Human Services and the U.S.
Department of Agriculture (USDA) stated that, ``Partially hydrogenated
vegetable oils, such as those used in many margarines and shortenings,
contain a particular form of unsaturated fat known as trans-fatty acids
that may raise blood cholesterol levels, although not as much as
saturated fat'' (Ref. 6).
Subsequent to the November 1999 proposal, new expert panels have
been convened to update, in light of new scientific evidence, the
conclusions and recommendations in the reports discussed previously.
FDA has reviewed these new reports to evaluate whether their updated
conclusions reversed or significantly altered its earlier conclusions.
The Dietary Guidelines 2000 (Ref. 87) makes the following
statements regarding trans fatty acids and food sources of trans fat:
Foods high in trans fatty acids tend to raise blood cholesterol.
These foods include those high in partially hydrogenated vegetable
oils, such as many hard margarines and shortenings. Foods with a
high amount of these ingredients include some commercially fried
foods and some bakery goods. (Ref. 87, p. 28);
Aim for a total fat intake of no more than 30 percent of
calories, as recommended in previous editions of the Guidelines. If
you need to reduce your fat intake to achieve this level, do so
primarily by cutting back on saturated and trans fats. (Ref. 87, p.
30);
Limit use of solid fats, such as ... hard margarines, ... and
partially hydrogenated shortenings. Use vegetable oil as a
substitute. (Ref. 87, p. 30).
In the report describing the basis for its recommendations, the
Advisory Committee on Dietary Guidelines 2000 (Ref. 88) suggested that
information be provided to help the reader of the Dietary Guidelines
2000 distinguish among the different kinds of fats--saturated, trans,
and unsaturated. The advisory committee summarized the scientific
evidence on trans fatty acids as follows:
Trans fatty acids are included because a definitive body of
recent experimental evidence indicates that trans fatty acids raise
the concentration of the most dangerous form of serum cholesterol
(LDL-cholesterol).
The advisory committee further states:
Trans fatty acids also tend to lower a protective form of serum
cholesterol (HDL-cholesterol). Prospective epidemiological studies
further note that higher intakes of trans fatty acids are associated
with a higher incidence of coronary heart disease. (Ref. 88, p. 37).
Recent guidelines from the National Cholesterol Education Program
(NCEP) (Ref. 89) provide an update to the 1993 NCEP report (Ref. 5).
The 2001 NCEP report is an evidence-based report that extensively
references the scientific literature. The expert panel concluded that:
Trans fatty acids raise serum LDL-cholesterol levels. Through
this mechanism, higher intakes of trans fatty acids thus should
increase risk for CHD. Prospective studies support an association
between higher intakes of trans fatty acids and CHD incidence. (Ref.
89, p. V-15).
Based on these conclusions, the Expert Panel recommended for
individuals at increased risk for CHD that:
Intakes of trans fatty acids should be kept low. The use of
liquid vegetable oil, soft margarine, and trans fatty acid-free
margarine are encouraged instead of butter, stick margarine, and
shortening. (Ref. 89, p. V-15).
Lastly, a recent report of the IOM/NAS found ``a positive linear
trend between trans fatty acid intake and LDL cholesterol
concentration, and therefore increased risk of CHD'' (Ref. 140). The
report summarized that this would suggest a Tolerable Upper Intake
Level (UL) of zero, but because trans fats are unavoidable in ordinary
diets and achieving such a UL would require extraordinary changes in
dietary intake patterns that might introduce other undesirable effects
and unknown health risks, a UL was not proposed. Instead, the report
recommended ``that trans fat consumption be as low as possible while
consuming a nutritionally adequate diet.''
In summary, the recently updated Dietary Guidelines (Ref. 87 ),
NCEP (Ref. 89), and IOM/NAS (Ref. 140) reports, based on current
scientific evidence, consistently find that trans fatty acids are
associated with increased LDL-C levels and, therefore, that lower
intakes of both saturated and trans fatty acids are important dietary
factors in reducing the risk of CHD in the general population and for
those at increased risk for CHD. In addition, these new reports (Refs.
87, 89, and 140) either reversed previous scientific conclusions of no
deleterious effects of trans fatty acids (Refs. 2 and 4), or
strengthened previous scientific conclusions of an adverse effect of
trans fat intakes on CHD risk (Refs. 5 and 6). Thus, based on the
current body of scientific evidence, there is strong agreement among
the expert panels that the available evidence is sufficiently
compelling to conclude that trans fat intakes increase CHD risk.
Accordingly, these expert panels recommended, in addition to their
longstanding recommendations that Americans consume diets limited in
saturated fat, that consumers also select food products that are low in
trans fat. Although the expert panels' primary emphases remain on
limiting intakes of saturated fat (which contributes on average about
11-12 percent of calories in U.S. diets), they also have recommended
limiting intakes of trans fats (which contribute, on average, about 3
percent of calories in U.S. diets). These recommendations are made for
the general population (Refs. 87 and 140) and persons at increased risk
for CHD whose LDL-C is above goal levels (Ref. 89).
(Comment 1) Several comments on the November 1999 proposal
questioned whether the conclusions regarding trans fat would be
supported by pending scientific reviews. Some of these comments
recommended that FDA not issue a final rule until after publication of
Dietary Guidelines 2000. Other comments recommended waiting until the
IOM/NAS completes work on a review of dietary reference values for
macronutrients.
The Dietary Guidelines 2000 have been published (Refs. 87 and 88).
While they do not mention trans fat in its broad guideline, ``Choose a
diet that is low in saturated fat and cholesterol and moderate in total
fat,'' the recommendations from the Dietary Guidelines 2000 and the
accompanying advisory committee review clearly state that foods high in
trans fatty acids tend to raise blood LDL-C which increases the risk of
CHD. Reductions in intakes of both saturated and trans fats are
suggested for maintaining total fat to no more than 30 percent of
calories. Substitutions of foods low in trans and saturated fatty acids
(e.g., vegetable oils) for foods with higher levels of trans fatty
acids (e.g., hard margarines, partially hydrogenated shortenings) are
also recommended. Thus, in the Dietary Guidelines 2000, the
recommendations to reduce trans fat intake are definitive,
[[Page 41443]]
not tentative. Additionally, the recommendations in the Dietary
Guidelines 2000 are reinforced by similar findings and recommendations
from other recent expert panels (Refs. 89 through 91, and 140),
including those of the IOM/NAS report on macronutrients (Ref. 140),
which has also been published. The IOM/NAS report recommends that
``trans fat consumption be as low as possible while consuming a
nutritionally adequate diet.''
(Comment 2) One comment suggested that trans fat is a healthier
choice than saturated fat, quoting 1994 and 1998 statements that it
attributed to the American Heart Association (AHA) recommending that
margarine be used instead of butter and that trans fats displace
saturated fats in the diet. The comment suggested that, if AHA or
others in the scientific community recommend margarine be used instead
of butter, this establishes that hydrogenated vegetable oils and trans
fat have health benefits, at least in comparison to saturated fatty
acids. Several other comments stated that trans fats displace saturated
fats in the diet, thus implying that they are healthful alternatives to
saturated fats.
FDA disagrees with the comments' conclusions that the
recommendations of the AHA and other scientific bodies that margarine
be substituted for butter provides a basis for concluding that trans
fat has health benefits or is a healthier choice than saturated fats.
The recently updated 2000 AHA Guidelines (Ref. 91) recommend that
intakes of foods with a high content of cholesterol-raising fatty acids
(i.e., trans and saturated fats) be limited because both raise serum
LDL-C levels, and consequently, increase CHD risk. Specifically, the
AHA recommends limiting the intake of: (1) Foods rich in saturated
fatty acids (e.g., full-fat dairy products, fatty meats, tropical
oils), and (2) trans-fatty acids, the major contributor of which is
hydrogenated fat (Ref. 91). Relative to trans fat, the 2000 AHA
guidelines state that, ``It has been established that dietary trans-
unsaturated fatty acids can increase LDL cholesterol and reduce HDL
cholesterol'' (Ref. 91). Moreover, the AHA recommendations are
consistent with the recommendations of the other scientific bodies
described earlier in this document. All of these reports recommend
substituting vegetable oils for animal fats; and, within the vegetable
oil category, recommend selecting those products that are lower in or
free of trans fat (e.g., liquid vegetable oils, soft margarines, and
trans-free margarines) in place of more hydrogenated oil products
(e.g., stick margarines and shortenings). More recently, the IOM/NAS
concluded that there is no evidence of health benefits associated with
trans fat intakes, but that trans fat does increase LDL-C and,
therefore, the risk of CHD (Ref. 140). Thus, the comment's premise that
the current recommendations of the AHA and other scientific bodies
support the conclusion that trans fat is a healthful alternative to
butter and animal fats is not consistent with, nor supported by, the
full context and intent of recommendations by the AHA and other
scientific bodies.
Those comments that said trans fat is a healthful alternative to
saturated fat also are not consistent with the recommendations of the
AHA and other scientific bodies. These expert bodies all concluded that
both trans and saturated fatty acids increase the risk of CHD by
increasing serum LDL-C levels and, therefore, they recommended limiting
intakes of both trans and saturated fatty acids.
It should be noted that recommendations to consume margarine
instead of butter are based on the fact that the combined amount of
cholesterol-raising lipids (trans and saturated fats) are lower in
margarines than in butter (Ref. 92). Additionally, butter, unlike
margarine, contains dietary cholesterol which also has cholesterol-
raising effects (Ref. 139).
B. Published Studies
To evaluate the evidence that dietary trans fat increases the risk
of CHD, FDA reviewed the scientific evidence cited in the petition and
recent human studies from its own literature search. In the November
1999 proposal, FDA summarized its review of the findings of
intervention and observational studies on the relationship between
intakes of trans fatty acids and CHD (64 FR 62746 at 62749-62754). FDA
considered the findings from human studies to constitute evidence that
is more directly relevant and persuasive than findings from animal
studies. FDA gave greater weight to results from dietary intervention
studies than to observational (epidemiological) studies because of an
intervention study's ability to provide evidence for a cause-effect
relationship. FDA regarded results from observational studies as
indirect evidence for a relationship between trans fatty acid intake
and CHD risk. FDA also reviewed estimates of dietary intakes of trans
fatty acids in the U.S. population (64 FR 62746 at 62752-62753).
In the November 1999 proposal, FDA evaluated results of 12 dietary
intervention studies (Refs. 7 through 15, 34, 36, and 82). FDA focused
on the physiological measures of serum and plasma LDL-C concentrations
to evaluate whether trans fatty acid intakes influence the risk of CHD
because such measures are recognized as valid predictors of increased
risk for CHD (Ref. 5). FDA concluded that controlled intervention
studies, in different population groups in the United States and other
countries, consistently indicate that consumption of diets containing
trans fatty acids, like diets containing saturated fats, results in
increased serum LDL-C (a major risk factor for CHD) compared with
consumption of diets containing cis-monounsaturated or cis-
polyunsaturated fat sources (64 FR 62746 at 62753). The agency also
compiled reports of changes in serum total and high density lipoprotein
cholesterol (HDL-C) and serum lipoproteins to present a more complete
picture of serum lipid changes (64 FR 62746 at 62799-62821).
In the November 1999 proposal, FDA also reviewed nine publications
that examined associations between trans fatty acids, serum lipids and
CHD endpoints: Four publications describing three prospective cohort
studies (Refs. 19 through 21 and 38), one publication describing an
inter-cohort study (Ref. 22), three publications describing case
control studies (Refs. 16 through 18), and one publication describing a
cross-sectional study (Ref. 23). FDA stated that these epidemiological
investigations of associations between dietary trans fatty acids and
risk of CHD must be interpreted cautiously because of the imprecision
associated with the dietary collection methodologies used, the
difficulty of eliminating confounding factors, and because no dose-
response relationship has been demonstrated in the studies (64 FR 62746
at 62752). FDA also stated that despite these generally recognized
deficiencies in the observational studies, the repeated and consistent
findings from these studies show that consumption of trans fatty acids
is associated with adverse effects on CHD risk in humans, which
supports the findings from intervention studies (64 FR 62746 at 62752).
Thus, in the November 1999 proposal, FDA concluded that controlled
intervention studies in different population groups in the United
States and other countries consistently indicate that consumption of
diets containing trans fatty acids, like diets containing saturated
fats, results in increased serum LDL-C compared with consumption of
diets containing cis-monounsaturated or cis-polyunsaturated
[[Page 41444]]
fat sources (64 FR 62746 at 62753). FDA also concluded that these
findings are consonant with findings from observational studies among
free-living persons in the United States and other countries (64 FR
62746 at 62753).
In the November 1999 proposal, FDA also summarized the results of
estimates of dietary intake of trans fatty acids in the U.S. population
(64 FR 62746 at 62752). FDA noted that estimates of mean consumption of
trans fatty acids in the United States ranged from about 3 g/day to
about 13 g/day. Based on national food disappearance data, estimated
mean values for the daily per capita consumption of total trans fatty
acids were variable: 12.8 g/day (Ref. 24), 10.2 g/day (Ref. 39), and
8.1 g/day (Ref. 25). Based on a nationally representative sample of the
U.S. population, the estimated mean intake of trans fatty acids was 5.3
g/day (2.6 percent of calories) and the 90th percentile intake was 9.4
g/day for individuals 3 years of age and older in the U.S. population
(Ref. 12). Estimates of mean trans fatty acids intake were 4.4 g/day
for men and 3.6 g/day for women in one observational study in the
United States (Ref. 18) and 3.4 g/day for men in another (Ref. 23).
Some studies presented mean or median intakes for quintiles of the
population studied. Median intakes were 3.1 g/day for men and 3.0 g/day
for women in the lowest quintile and 6.7 g/day for men and 6.8 g/day
for women in the highest quintile (Ref. 18). Another study reported
intakes of 1.5 g/day and 5.3 g/day, respectively, for the lowest and
highest quintiles of male health professionals (Ref. 19). For female
nurses in the United States, mean energy-adjusted intakes of trans
fatty acids were 2.4 and 5.7 g/day, respectively for the lowest and
highest quintiles of trans fatty acid intakes (Ref. 21). FDA concluded
that, overall, the estimates of mean trans fatty acids intakes are
similar to intakes of trans fatty acids in the U.S. intervention
studies (the selected intervention studies used in this comparison were
those in which trans fatty acid contents were determined by chemical
analysis of duplicate portions of the diets and for which statistically
significant increases in serum LDL-C were reported compared to diets
containing cis-polyunsaturated fatty acids (Refs. 13, 34, and 82) or
cis-monounsaturated fatty acids (Ref. 12)). The intakes of trans fatty
acids for which the increases in serum LDL-C were statistically
significant in the intervention studies ranged from 7.6 g/day to 13 g/
day (Refs. 12, 13, 34, and 82). FDA stated that these levels are very
similar to the estimated intakes of the many individuals in the United
States whose trans fatty acid intake is greater than the mean of 5.3 g/
day (64 FR 62746 at 62753).
Subsequent to the November 1999 proposal, additional studies on the
topic of trans fatty acid intakes and CHD risk have been published
(Refs. 98 through 102). FDA reviewed the findings from these new
studies to evaluate whether they differ significantly from the findings
of studies included in the proposed rule. In general, the results from
these recently published intervention and prospective studies are
consistent with the results from the studies included in the November
1999 proposal in that they also found that diets containing trans fat
increased LDL-C, and therefore, CHD risk (Refs. 98 to 101) and that, in
free-living populations, consumption of trans fat was associated with
increased risk of heart attack and death from CHD (Ref. 102). In
addition, a cross-sectional observational study has been published
(Ref. 93). This study, which was the subject of several comments,
suggests no relationship between current intakes of trans fat in
European countries and CHD risk. FDA has addressed this study in
Comment 4 of this document.
(Comment 3) Many comments discussed the strength of the scientific
evidence for establishing whether trans fatty acids adversely affect
CHD risk by raising LDL-C levels. A number of comments found the
evidence to be strong and supportive of trans fatty acid labeling on
foods. Other comments questioned whether there was sufficient evidence
to warrant labeling of trans fat content. Several comments stated that
the health impact of the intake levels reported in population-based
surveys and observational studies was minimal.
A few comments to the November 15, 2002, proposal to reopen the
trans fat comment period questioned the scientific validity of the IOM/
NAS report based on the underlying science and regression equations
relied upon. The comments argued that one of the articles relied upon
(Ref. 83) was an opinion essay and was not peer-reviewed by the New
England Journal of Medicine (NEJM) where it was published.
Based on an evaluation of the scientific evidence, FDA concludes
that the scientific evidence is sufficient to require nutrition
labeling of trans fat. In the November 1999 proposal, FDA
systematically summarized and reviewed the available individual human
studies (64 FR at 62749-62754 and 62798 to 62821). In re-examining this
review in light of the comments, FDA finds no basis to alter its
earlier conclusion that, in general, there is consistency in finding
adverse effects of trans fat on CHD risk. Controlled intervention
studies in different population groups in the United States and other
countries consistently indicated that consumption of diets containing
trans fat results in elevations of LDL-C, and therefore, increased risk
of CHD (Refs. 7 to 15, 34, 36, and 82). In addition, positive
statistical associations are consistently reported in observational
studies between estimated trans fat intake in free-living populations
and incidence of CHD manifested as heart attack or death from CHD
(Refs. 16 to 22, and 38) or increased risk of CHD as assessed by higher
levels of LDL-C (Ref. 23) (64 FR 62751 to 62753). Thus, FDA continues
to find that a large body of the most persuasive types of evidence
(i.e., intervention trials and prospective cohort observational
studies) consistently show that trans fat intakes adversely affect CHD
risk under both controlled trial conditions and in free-living
populations following their usual dietary patterns. This consistency
was seen across studies done: (1) In the United States and several
European countries, (2) using a variety of test and control products
and study designs, (3) using a range of intake levels for trans fatty
acids (less than (<) 1 percent to 7 percent of calories), (4) by
different investigators and research groups, (5) with different
populations and selection/exclusion criteria, and (6) within different
total dietary contexts. This relationship was also consistently found
in comparisons of high vs. low consumers of trans fats in free-living
U.S. populations consuming their normal diets. Thus, whether controlled
intervention trials or among free-living U.S. populations consuming
their usual diets, the adverse effects of trans fat intakes on CHD risk
were consistently observed.
Moreover, FDA's conclusions were consistent with those of
independent Federal Government expert panels that published dietary
recommendations for U.S. population groups subsequent to publication of
the November 1999 proposal (Refs. 87 and 89 through 91) that were cited
in the Federal Register to reopen the comment period on November 15,
2002. These expert panels, reviewing the same scientific evidence as
FDA described in the proposed rule, and given their knowledge of U.S.
dietary patterns, consistently concluded that trans fat intakes are
associated with increased CHD risk and recommended that U.S.
[[Page 41445]]
consumers and those who need to lower their LDL-C level minimize their
intakes of trans fat to reduce their risk of CHD. For example, the IOM/
NAS noted ``a positive linear trend between trans fatty acid intake and
total and LDL-C concentrations, and therefore, increased risk of CHD,
thus suggesting an upper limit of zero'' (Ref. 90). However, they
further stated that, because trans fatty acids are unavoidable in
ordinary diets, a complete avoidance of these fats is not possible
without extraordinary changes in patterns of dietary intake. Such
extraordinary adjustments may introduce other undesirable effects
(e.g., elimination of foods such as diary products and meats that
contain trans fatty acids may result in inadequate intakes of protein
and certain micronutrients). For these reasons, the IOM/NAS recommended
that trans fatty acid consumption be as low as possible while consuming
a nutritionally adequate diet. In response to the comments about the
scientific validity of an article used in the IOM/NAS report, FDA notes
that the paper by Ascherio and coworkers (Ref. 83) is not the only
information that the IOM/NAS relied on to conclude that trans fatty
acid consumption should be as low as possible relative to CHD risk.
Moreover, FDA did not find the LDL/HDL cholesterol ratio used in the
Ascherio et al. analysis to be a useful endpoint for purposes of the
trans fatty acid rule-making (see Comment 10). Additionally, FDA's
independent evaluation of the scientific evidence concluded that there
is consistency in finding adverse effects of trans fat on risk of CHD.
Therefore, even though the independent reviews of FDA and the other
expert panels differed to some degree in how they used the available
scientific evidence, the resultant consistency of the conclusions
across these reviews provides strong credence to the finding that trans
fatty acid consumption increases CHD risk via increases in LDL-C.
In summary, based on the consistent results across a number of the
most persuasive types of study designs (i.e., intervention trials and
prospective cohort studies) that were conducted using a range of test
conditions and across different geographical regions and populations,
the agency now agrees with the comments that stated that the available
evidence for an adverse relationship between trans fat intakes and CHD
risk is strong. FDA also finds the results from the large prospective
cohort studies among free-living U.S. population groups to be
persuasive evidence that the trans fat intakes associated with U.S.
dietary patterns can have a significant adverse effect on CHD risk for
U.S. consumers. The scientific agreement for this relationship among
the various expert groups and consensus among these expert groups in
recommending that U.S. consumers limit their intakes of saturated and
trans fats now provide further evidence of the strength of the science
and the public health importance of lowering trans fat intakes for U.S.
consumers. Therefore, the comments do not persuade FDA to change its
position in the proposed rule that labeling of trans fatty acids is
warranted based on: (1) The scientific evidence; and (2) the public
health importance of the guidelines recommending that consumers limit
their intakes of both of the LDL-C-raising fats: trans and saturated
fats. Thus, FDA concludes that its tentative conclusion in the proposed
rule that ``under conditions of use in the United States, consumption
of trans fatty acids contributes to increased serum LDL-C levels, which
increases the risk of CHD'' (64 FR 62746 at 62754) is no longer
tentative. FDA continues to find the overall weight of scientific
evidence in support of this conclusion to be sufficiently compelling to
now warrant trans fatty acid labeling.
(Comment 4) Several comments stated that a new observational study
by van de Vijver et al., ``Association between trans fatty acid intake
and cardiovascular risk factors in Europe: The transFAIR Study'' (Ref.
93) showed no association between average total trans fat intake in
Europe and LDL-C or HDL-C so that average trans fat intake in the
United States is probably not detrimental to human health.
FDA disagrees with the comments. The transFAIR study had a cross-
sectional design, measuring trans fatty acid intake and serum lipids in
327 men and 299 women, ages 50 to 65 years, in 8 European countries
from approximately 1997 to 1999. The study reported no statistically
significant association between total trans fat intake and serum LDL-C.
The habitual intake of trans fat was estimated to be about 2 g/day
(e.g., approximately 1 percent of calories).
FDA notes that cross-sectional designs, such as the one used by van
de Vijver et al., are relatively weak designs for showing associations
between diet and serum lipids (Ref. 93). As an observational study,
they are generally considered to be less persuasive than intervention
trials. Moreover, compared with other types of observational studies
(e.g., prospective (cohort) observational studies and retrospective
(case-control) studies), they are considered particularly weak.
Considering the weaknesses of the cross-sectional design used in the
transFAIR study compared with the much larger body of evidence from
more persuasive types of studies (i.e., intervention trials and
prospective observational studies) that consistently demonstrate an
adverse effect of trans fat intakes on LDL-C, FDA does not find the
transFAIR study to be sufficiently compelling to override the overall
weight of the scientific evidence reviewed in the November 1999
proposal or to override the independent conclusions of recent expert
panels convened by the Federal Government (Refs. 87 and 89), the IOM/
NAS (Ref. 90), and the AHA (Ref. 91).
For the reasons cited previously, FDA disagrees with the comments
that a lack of association between trans fat intake and serum lipids in
the European transFAIR study indicates that average trans fat intake in
the United States is probably not detrimental to human health.
(Comment 5) Many comments emphasized the inadequacies in the
assessment of intakes of trans fatty acids by the U.S. population and
noted that the current data are insufficient in regard to the trans
fatty acid content of foods. One comment noted that USDA's data for the
trans fatty acid content of foods are limited to a few foods with a
small number of samples. Thus, the comment concluded that extrapolation
of trans fatty acid content from a few foods must be used to estimate
the content of trans fat in the large number of foods that make up the
total diets of the U.S. population. This extrapolation results in
intake estimate errors with unknown effects. Some comments assert that
the data are an over-estimate of the U.S. population's trans fatty acid
intake and other comments assert that the data are an under-estimate.
FDA agrees that estimates of dietary intakes of trans fat, as with
all intake estimates based on participant reports and limitations in
compositional data bases, are subject to multiple sources of error. In
the November 1999 proposal, the agency reviewed intake estimates from
three different types of data: (1) National food consumption survey,
(2) national disappearance data, and (3) observational studies done in
U.S. population groups. By examining results from multiple methods of
estimating intakes, the agency was able to assess some, but not all, of
the uncertainties in current intake estimates. In discussing these
data, FDA noted the very limited composition data available for the
trans fatty acid composition of foods and the difficulties in
determining the accuracy
[[Page 41446]]
of reported trans intakes with current knowledge and methods (64 FR at
62752-62753).
In the November 1999 proposal, FDA reviewed an analysis that used
the results of the 1989-1991 Continuing Survey of Food Intakes by
Individuals (CSFII), a national food consumption survey of the U.S.
population conducted by the USDA (Ref. 26). This study reported a mean
trans fatty acid intake of 5.3 g/day (2.6 percent of calories) for
persons 3 years and older. One way to evaluate the accuracy of survey
intake estimates is to compare the reported caloric intakes to known
requirements, or to levels from intervention trials that have been
shown to maintain body weight for some period of time. The authors of
this study stated that these reported caloric intakes were 20-40
percent below known physiologic requirements, suggesting significant
under-reporting of intakes (Ref. 26). The reported caloric intakes in
the CSFII were also approximately 265 to 1,000 calories/day below
levels required to maintain body weights for U.S. subjects in
intervention trials (Ref. 26). Therefore, the estimates of intakes from
the CSFII survey data are likely significantly under-reported,
particularly when expressed on a gram per day basis.
The second type of trans fatty acid intake estimate considered in
the November 1999 proposal was derived from estimates of trans fatty
acids available in the U.S. food supply calculated from USDA-Economic
Research Service fats and oils production figures and food
disappearance data for fats and oils. Three studies provided daily per
capita estimates of trans fatty intakes of 12.8 g, 10.2 g, and 8.1 g.
(Refs. 24, 39, and 25, respectively). Although all three estimates were
``corrected'' for losses due to waste in processing and use, per capita
intake estimates based on disappearance data generally overestimate
intakes (Ref. 4).
Finally, observational studies conducted in U.S. populations also
can provide intake estimates. In the November 1999 proposal, FDA
reviewed several observational studies, including several prospective
cohort studies conducted in U.S. populations who were healthy at the
time of enrollment (Refs. 19, 21, and 38). Estimates of daily trans
intakes ranged from 1.3 to 3.2 percent of calories and from 1.5 to 6.4
g/day for adult participants in these studies. These ranges of intake
estimates are somewhat lower than those in the CSFII survey so are
therefore also likely underestimated. However, even with these
relatively low intake estimates, these studies found that among free-
living adults, those adults consuming trans fatty acids at the highest
quintiles of intake had increased relative risk of CHD as compared to
adults consuming trans fatty acids at the lowest quintiles of intake.
In summary, the different types of studies, and different studies
within a study type, estimated different intake levels for the U.S.
population. The estimates from the food disappearance data are likely
overestimated. The estimates from the observational studies and the
national food consumption survey are likely underestimated. All
estimates used the same compositional data base which, as noted above,
has very limited data on the trans fat content of foods. Although we
have no external ``gold standard'' against which to determine which
estimate is most accurate, the available intake estimates suggest that
average intakes of U.S. consumers probably fall within the range of 1.3
g to 12.8 g/day.
Because of the multiple sources of uncertainty in intake estimates,
caution must be exercised to avoid over-interpretation of the available
dietary intake estimates and their relationship to the trans fat levels
used in the intervention trials. It is important to note, however, that
the agency's determination of the scientific basis for and public
health importance of trans fat labeling was based on the totality of
the scientific evidence. In this evaluation, FDA weighted the results
of the intervention trials most heavily. The intervention trials
clearly demonstrate, in a cause and effect manner, an adverse effect of
trans fat intakes on LDL-C levels, and therefore on CHD risk, across a
broad range of intakes (less than 1 percent to 7 percent of calories),
dietary patterns, and population groups. For the purposes of
determining that the scientific evidence was sufficient to conclude
that trans fat labeling was warranted from a public health perspective,
FDA finds that the intervention and observational studies provided
strong evidence of both a causal relationship between trans fat intake
and risk of CHD and applicability to the general U.S. population.
Therefore, FDA does not need to rely solely on dietary intake estimates
to make this determination.
Because of the serious public health consequences of CHD in the
U.S. population, prudent public health dictates that we help consumers
control those risk factors which they can alter directly through their
own behavior. Heart-healthy diets that limit the intakes of both
saturated and trans fats can serve this purpose as is evidenced by
recommendations in the recent expert panel reports (Refs. 87, 89
through 91, and 140).
(Comment 6) Many comments addressed the issue of the relevance of
intervention study intakes to usual conditions of use in the United
States. Some comments expressed concern that FDA's conclusions relied
on intervention studies in which the intakes of trans fatty acids were
very high and not representative of U.S. intakes of about 5.3 g/day (3
percent of calories).
FDA disagrees with the comments that it relied heavily on
intervention trials with high trans fat intake. A range of fatty acid
intakes was included in the dietary intervention assessments. For
example, the four U.S. research investigations with chemical analyses
of the diets included a total of 15 study diets (Refs. 12, 13, 34, and
82). These studies included diets with little or no trans fat (e.g.,
0.4 to 0.6 percent of calories), diets that contained moderate levels
of trans fat (e.g., 3 to 4 percent of calories), as well as diets with
a higher intake of trans fat (e.g., 6 to 7 percent of calories). FDA
relied on the totality of the evidence, i.e., intervention studies that
had trans fat intakes that ranged from very low levels (less than 1
percent of calories) to intakes up to 6 to 7 percent of calories and on
findings from observational studies that showed an adverse relationship
between trans fat intakes and CHD risk among U.S. population groups
consuming their usual diets.
Thus, in the aggregate, the U.S. intervention studies included an
assessment of the effect of a wide range of trans fatty acid levels
that overlap the range of intake estimates for the U.S. population. As
noted in FDA's response to Comment 5, the relevance of the findings
from the intervention studies for the U.S. population are shown by the
consistent findings of an adverse relationship between trans fat and
CHD risk in the prospective studies of free-living U.S. population
groups. Thus, the relevance of the trans intakes used in the
intervention studies for the U.S. population was confirmed by the
consistent findings in the prospective studies that showed an adverse
association between trans intake and CHD risk among free-living U.S.
population groups. The recommendations of recent expert panels that
Americans limit their intakes of trans fat shows that a broad-based
scientific agreement exists as to the public health merits of trans fat
labeling for the U.S. population within the context of current dietary
intakes.
[[Page 41447]]
(Comment 7) Other comments suggested that the study populations
were not representative of the U.S. population. For example, one
comment said that the intervention studies included individuals at high
risk with serum cholesterol levels greater than () 320
milligrams (mg)/deciliter (dL) or LDL-C 130 mg/dL. Another
comment stated that the agency failed to reflect that relative risk
will depend on the base risk of the population used for comparisons
with the U.S. general population.
FDA disagrees with these comments. Of the 512 subjects included in
the dietary intervention studies cited in the November 1999 proposal,
48 percent of the dietary intervention population had an LDL-C level of
100 to 120 mg/dL that is categorized as near or above optimal level
according to the NCEP lipid classification scheme (Ref. 89). Thirty-
eight percent had an LDL-C of 130 to 159 mg/dL, categorized as
borderline high; and 14 percent had a LDL-C of greater than or equal to
(=)160 mg/dL, categorized as high. Only 5 percent of the
participants had a low HDL-C level, < 40 mg/dL; and another 7 percent
had a high HDL-C level, =60 mg/dL. Most (88 percent) had
mean HDL-C levels in the range of 41 to 59 mg/dL. Also, 73 percent of
the population was in the age group where the CHD risk is lower, e.g.,
men <45 years of age and women <55 years of age. The study populations
were described as participants who had normal cardiac, kidney and liver
function, and were not taking medications that affect lipid levels.
Many participants had near or optimal LDL-C levels and most had HDL-C
levels that were neither high nor low by the NCEP criteria. The data
that FDA relied on included a dietary intervention population that is
representative of the U.S. general population.
(Comment 8) Some comments suggested that the test products were not
representative of available commercial products in the U.S.
marketplace. One comment suggested that several studies were designed
to study the effects of different food oil sources and not designed to
specifically study the effect of trans fat on blood lipid levels.
FDA disagrees with these comments. In general, the test products
used in studies done by U.S. research groups were either commercially
available products or were produced specifically for a study by U.S.
manufacturers using oil sources commonly used in the U.S. market (Refs.
12 through 15, 34, and 82). However, regardless of whether studies used
products typical of those commercially available in other countries,
products commercially available in the United States, or products
developed specifically for the study at hand, results were generally
consistent across all these studies and consistent with the larger body
of evidence that included studies done in Europe and with European
oils. That is, there was consistency across studies in finding that
higher intakes of trans fat resulted in increased levels of LDL-C and,
therefore, in increased risk of CHD. Moreover, the observational
studies in U.S. populations, where participants were consuming products
commercially available in the U.S. marketplace, also consistently
showed that higher intakes of trans fat were associated with adverse
effects on CHD risk (Refs. 19, 21, and 38).
FDA also recognizes that the intervention studies were designed
with a variety of objectives in mind. Some were designed to compare two
different sources of hydrogenated oils (e.g., Refs. 9, 14, 15, and 36).
Many were designed to compare the effects of different types of fatty
acids by varying the source oils to achieve the desired fatty acid
types and levels (e.g., Refs. 7, 8, 10, 11 through 13, and 34). The
study designs also varied significantly in how they identified controls
for the comparisons of interest. Despite these differences in
objectives and study design, the general consistency across studies in
finding that trans intakes are adversely related to CHD risk provides
evidence that the relationship is likely real and not simply an
artifact of a particular type of study design (Ref. 94).
Thus, most of the intervention trials provide enough information
about test products, study population, and study diets to evaluate
their relevance to the U.S. general population. The wide range of trans
fatty acid intakes, products, and population characteristics in these
studies overlaps with those found for U.S. consumers in the general
population. Important, however, is that there is remarkable consistency
across the intervention studies, regardless of population, products and
diets used, in finding that higher intakes of trans fatty acids are
associated with increased levels of serum LDL-C, a major risk factor
for CHD. Thus, the available intervention studies show consistent
results across a broad range of use conditions and population
characteristics. FDA, therefore, disagrees with comments that suggest
that the test products used in intervention studies are not applicable
to the U.S. marketplace, or the study designs are not applicable to
evaluating the relationship of trans fat to CHD risk in the U.S.
population.
(Comment 9) Many comments questioned whether the scientific
evidence shows that the physiological effects of trans fat on CHD risk
are equivalent to, greater than, or less than those of saturated fat on
a gram-for-gram basis. Some comments noted that the intervention
studies show that the increase in LDL-C levels associated with trans
fat is greater than that from unsaturated fats but less than that from
saturated fat. Some comments noted that in the review of science for
the November 1999 proposal, FDA concluded that the available studies do
not provide a definitive answer to the question of whether trans fatty
acids have an effect on LDL-C and CHD risk equivalent to saturated fats
on a gram-for-gram basis, but in the preliminary regulatory impact
analysis, FDA estimated that the effects of saturated and trans fatty
acids on LDL-C levels are about equivalent.
FDA notes that the intervention studies demonstrate that the net
physiologic effect of a particular fatty acid or category of fatty
acids is dependent upon the composition of both the intervention diet
and the comparison diet. In the dietary intervention research reviewed,
the study investigators used a variety of study designs to assess the
effect of a defined quantity of trans fatty acids (provided by food
sources of hydrogenated oil) on levels of serum or plasma lipids. The
best study designs controlled the variation in the ranges of protein,
fat, cholesterol, and carbohydrate with particular attention given to
the fatty acids. The effect of trans fat study diets were compared by
replacement with food sources of: (1) Cis-unsaturated fatty acids, (2)
monounsaturated (oleic) fatty acids, and (3) saturated fatty acids. As
FDA stated in the November 1999 proposal (64 FR 62745 at 62750), the
intervention study data showed the following: (1) Trans fatty acids
increased LDL-C in comparison with cis-polyunsaturated fatty acids
(Refs. 8, 13, 15, and 82); (2) trans fatty acids increased LDL-C levels
in comparison with cis-monounsaturated fatty acids (Refs. 7, 11 and
12); and (3) trans fatty acids increased LDL-C, or there was no
significant difference, in comparison with saturated fatty acids (Refs.
7 through 12). Based on these results, FDA concluded in the science
review section of the November 1999 proposal that the available studies
do not provide a definitive answer to the question of whether trans
fatty acids have an effect on LDL-C and CHD risk equivalent to
[[Page 41448]]
saturated fats on a gram-for-gram basis. However, FDA also stated that
the studies that compared a saturated fat diet with a diet in which
some of the saturated fat was replaced with trans fat showed that trans
fat, like saturated fat, increases LDL-C.
For purposes of its regulatory impact analysis in the proposal, FDA
needed a basis for quantifying its estimates of the compliance costs
and benefits associated with given changes in trans fat intakes and the
associated changes in CHD risk. The available evidence always presents
some uncertainty for these types of analyses, as there is with other
inputs into regulatory decisions. Given these caveats, FDA, in order to
develop the tools required for a quantitative evaluation of benefits
and costs, reviewed a meta analysis of five intervention trials that
included six levels of trans fat intakes (Refs. 62 and 69). Using
multiple regression to statistically control for differences in other
fatty acids between trans-enriched diets and reference diets, the
authors projected linear increases in LDL-C as a function of level of
increasing trans fat intake. According to the regression equations,
each additional percent of energy from trans fat, when substituted for
the same percent of calories from cis-monounsaturated fatty acids, was
predicted to increase LDL-C by 1.5 mg/dL. This relationship was then
used as the basis for estimating the benefits and costs of the proposed
rule and not for purposes of establishing whether there is a gram-for-
gram relationship between trans and saturated fatty acids on LDL-C
levels and CHD risk. FDA notes that, in rulemaking to implement the
1990 amendments, the agency also found it necessary to use coefficients
derived from regression equations to estimate the benefits and costs of
various regulations (56 FR 60856, November 27, 1991; 58 FR 2927,
January 6, 1993). In one such analysis, FDA used the equation of
Hegsted and Keys to predict how changes in total serum cholesterol
would be affected by projected changes in saturated fat intake (56 FR
60856 at 60869, November 27, 1991). Because the Hegsted and Keys
equations did not include coefficients for trans fat or information on
components of total cholesterol (e.g., LDL-C), FDA found it necessary
to find regression equations that included trans fat intakes and LDL-C
levels. The equations of Katan et al. and Zock et al. (Refs. 62 and
69), together with the equations of Mensink and Katan (Ref. 65), which
summarized the results of 27 clinical trials, were available to meet
this need for a quantitative basis on which to estimate the benefits
and costs of the proposed rule.
In estimating the benefits and costs, FDA also recognized that the
type of macronutrient substituted for trans fat in the diet would
affect the magnitude and nature of the changes in LDL-C in response to
decreases in trans fatty acid intakes. Thus, FDA also estimated how the
benefits and costs would be altered if saturated fat, cis-
polyunsaturated fat or carbohydrate, rather than cis-monounsaturated
fat, were used to replace some of the trans fat in the diet. In this
analysis an intermediate step in the calculation showed that when
saturated fat was substituted for cis-monounsaturated fat, LDL-C was
raised by 1.52 mg/dL, an amount similar to that found when trans fat
was substituted for cis-monounsaturated fat (1.50 mg/dL).
Regardless of whether FDA reviewed the effects of saturated fat and
trans fat on LDL-C and CHD risk for the science section or the
regulatory impact section, the conclusion about those effects is the
same. That is, both trans fatty acids and saturated fatty acids raise
LDL-C levels, a major risk factor for CHD risk. Consumers need to
minimize their intakes of both types of fatty acids within a moderate
fat intake to implement dietary guidelines for healthful diets. These
conclusions are consistent with those reached independently by expert
panels (Refs. 87, 89, 90 and 91).
(Comment 10) Many comments addressed the issue of the potential
adverse effects of trans fat on HDL-C levels. Some comments suggested
that trans fat has more adverse health effects than saturated fat
because trans fat, in addition to raising LDL-C, also lowers HDL-C, the
so-called ``good'' cholesterol, whereas saturated fat raises HDL-C.
Some comments noted that trans fat raises the LDL/HDL ratio
approximately twice as much as saturated fat. Other comments stated
that, in the prospective studies, the risk of CHD associated with trans
fat intake was much greater than the risk associated with saturated
fat, and much greater than would be predicted based on the effect on
serum lipids. In contrast, one comment stated that it is premature to
conclude that trans fat intake lowers HDL-C because many intervention
studies showed that trans fat intake causes only a small decrease or
has no effect on HDL-C.
Based on the recommendations of the 1993 NCEP Expert Panel (Ref.
5), in the November 1999 proposal, FDA concluded that an examination of
the effects of trans fatty acids on serum LDL-C would provide the
strongest evidence, and should be the primary criterion, to evaluate
whether trans fatty acids influence CHD risk. In the November 1999
proposal, FDA tentatively concluded that the available evidence
demonstrated that under conditions of use in the United States,
consumption of trans fatty acids contributes to increased serum LDL-C
levels, which increases the risk of CHD. The evidence for this
relationship alone was sufficient for the agency to tentatively
conclude that addressing trans fatty acids in nutrition labeling is
important to public health.
FDA's review of the intervention trials showed that HDL-C decreased
when trans fats replaced saturated fats. Further, Federal Government
advisory groups (Refs. 88 through 90, and 140) and an advisory group of
health professionals (Ref. 91) have stated that substitution of trans
fat for saturated fat lowers HDL-C.
To date, lowered HDL-C levels have been shown to be a useful
predictor of heart disease risk because of its correlation with CHD
risk. However, it is not known whether lowering HDL-C is related to CHD
risk in a cause and effect manner. Until this relationship is confirmed
by appropriate study designs, the use of HDL-C as a surrogate biomarker
for CHD risk must be done with caution and clear recognition of the
uncertainty surrounding this use. For example, FDA notes that the NCEP
2001 Report (Ref. 89) makes several statements that both recognize and
qualify the relationship between trans fatty acids, HDL-C, and CHD
risk. While the NCEP Report states that a low HDL-C level is strongly
and inversely associated with risk for CHD, the NCEP Report also states
that, because of the association of low HDL levels with other
atherogenic factors, a low HDL-C is not as strongly independent in its
prediction as suggested by usual multivariate analysis.
Therefore, while FDA did not place primary reliance upon the
relationships among trans fat intakes and adverse effects on HDL-C and
CHD risk in deciding that nutrition labeling was warranted, FDA also
recognizes this possible relationship, so concerns about possible
adverse effects cannot be ignored (64 FR 62746 at 62798 to 62821). For
this reason, FDA included information on the effects of trans fatty
acids on HDL-C levels when reviewing the available human studies in the
science review section. Additionally, because of the possibility of an
adverse effect on HDL-C levels from trans fat intake and a correlation
between such an effect with CHD risk, the possible impact on HDL-C
levels from trans fat
[[Page 41449]]
intake was used in the regulatory impact section as one of several
possible approaches for determining cost benefit ratios of trans fat
labeling. The agency would have been remiss in evaluating the full
range of possible cost/benefit relationships if it had failed to
include this potential adverse effect from trans fatty acid intakes to
CHD risk in these analyses.
The question of interpretation of LDL/HDL ratios is more difficult.
For example, concurrent small changes in both LDL-C and HDL-C could
result in a similar LDL/HDL ratio as would concurrent large changes in
both LDL-C and HDL-C assuming the changes are in the same direction.
Or, large changes in HDL-C with moderate changes in LDL-C could give
similar LDL/HDL ratios as would moderate changes in HDL and small
changes in LDL. However, it is likely that the magnitude of the change
in the individual blood cholesterol levels is as, or more, important
than is a change in the ratio of the two. Thus, interpretation of the
LDL/HDL ratio is unclear and until there is evidence by which its
meaning can be more precisely defined, use of this ratio requires
considerable caution. However, even with these caveats, regardless of
whether results are expressed as increased levels of LDL-C or as
increases in LDL/HDL ratios, the conclusion is the same: trans fat
intakes increase CHD risk.
(Comment 11) A number of comments emphasized that, in addition to
HDL-C, trans fat has other adverse effects that may contribute to CHD
risk but saturated fat does not. The comments mentioned that trans fat
has adverse effects on various CHD risk factors including serum
lipoprotein(a), serum triglycerides, insulin resistance and diabetes
risk. These comments also stated that trans fat has adverse effects on
aspects of lipid metabolism that may cause increased CHD risk, such as
interference with metabolism of omega-3 fatty acids, interference with
enzymes such as delta-6-desaturase, promotion of essential fatty acid
insufficiency, and increase in free radical formation. Several of the
comments argued that some of these CHD risk factors represent
additional biological mechanisms related to trans fat that could
account for the amount of CHD risk observed in prospective studies
beyond that explained by changes in LDL-C and HDL-C.
Some comments stated that trans fat may have adverse effects on
other health conditions, besides CHD. One of these comments requested
that, in order to provide the full picture of health issues involved
with trans fats, FDA review trans fat effects on cancer, obesity,
immunity, reproduction, development, and diabetes when publishing the
final rule. Another comment characterized trans fatty acids as being
atypical fatty acids with an insidious nature in disrupting lipid
metabolism. Some comments identified potential adverse effects of trans
fat on lowered birth weights and decreased visual acuity in infants
exposed to high levels of trans fatty acids in utero or via breast
milk. The comments suggested that FDA advise pregnant and lactating
women to limit their trans fat intake.
FDA recognizes that the relationship of biomarkers, other than LDL-
C, and to a lesser degree, HDL-C, with CHD risk is less well
established and difficult to interpret. Moreover, at this time, the
findings suggesting effects of trans fat on non-heart disease risks are
preliminary. Therefore, FDA finds that its focus on LDL-C provides a
sufficient basis for concluding that the labeling of trans fat levels
in food products is warranted.
V. Nutrition Labeling of Trans Fats
In the November 1999 proposal, FDA proposed that when trans fats
are present in a food, including dietary supplements, the declaration
of saturated fat must include the combined quantitative amount by
weight of both saturated and trans fats. Further, FDA proposed that
when 0.5 or more grams per serving of trans fats are present, the
declaration be followed by a symbol that refers to a footnote at the
bottom of the nutrition label stating the number of grams of trans fat
present in a serving of the product, i.e., ``Includes ------ g trans
fat.'' The agency also had discussed, in addition to the one proposed,
several other options for declaring trans fat in the Nutrition Facts
panel. These included: (1) Declaring the combined amount of both
saturated fat and trans fat as ``Saturated fat'' without identifying
the amount of trans fat, (2) declaring the combined amount of both
saturated fat and trans fat as ``Saturated + trans fats'' without
identifying the amount of trans fat, (3) declaring the combined amount
of both saturated fat and trans fat as ``Saturated + trans fats'' with
an explanatory footnote stating the amount of each fat separately, and
(4) declaring the amount of trans fat as a separate line item under
saturated fat. The agency proposed that with all of these options the
term ``trans fatty acids'' and ``trans fat'' could be used
interchangeably.
A. Voluntary v. Mandatory Declaration of Trans Fatty Acids in Nutrition
Labeling
(Comment 12) The majority of the comments supported the November
1999 proposal, which required the mandatory declaration of trans fat in
nutrition labeling when it is present in a food, including dietary
supplements. An overwhelming majority of comments supporting the
mandatory declaration of trans fat did so because of public health
concerns. Some comments stated that the scientific evidence clearly
demonstrates that consumption of trans fat contributes to increased
LDL-C and, hence, increased risk of CHD. Several comments noted that
consumers are increasingly aware of the relationship between dietary
fat and chronic disease, especially CHD, and look to the nutrition
label for information about ``heart-unhealthy'' fat. A few comments
noted that another benefit of mandatory labeling of trans fat is that
it may provide an incentive to manufacturers to reduce the trans fat
content of their foods.
A few comments stated that mandatory labeling of trans fat was not
warranted because the scientific data linking trans fat to CHD is weak
and because the average intake of trans fat, estimated as 2.91 percent
of energy in the proposal, is minimal. Other comments also opposed
mandatory labeling stating that the effect of trans fat on LDL-C or CHD
risk was not sufficient to establish public health risk at ordinary
levels of intake.
Some comments stated that, although mandatory labeling of trans fat
was not warranted, a requirement for label declaration of trans fat
could be justified in certain circumstances. Several of these comments
stated that required label declaration of trans fat was justified if it
was needed to prevent the label from being misleading because of the
level of trans fat in light of other information on the label about
total fat or fatty acids. Several comments that opposed mandatory
declaration of trans fat suggested that, in order to prevent consumer
deception, trans fat declaration should be required when nutrient
content claims or health claims are made about fatty acids or dietary
cholesterol or when there is label declaration of monounsaturated and
polyunsaturated fats. One comment stated that there is no evidence that
trans fat declaration would assist consumers in following healthy
dietary practices unless certain claims are made or unless
monounsaturated and polyunsaturated fats are declared on the label. One
comment stated that the
[[Page 41450]]
amount of trans fat is ``material'' only when trans fat is present at
greater than 1 g per serving because it would then significantly impact
the overall fatty acid contribution to the diet. Another comment stated
that trans fat declaration should be required only when trans fat is
present at greater than 2 g per serving because that threshold would
capture the food categories that contribute the vast majority of trans
fat to the diet but would exclude products that contain only a trivial
amount of trans fat. This comment stated that mandatory trans fat
labeling of products with 2 g trans fat or less per serving would have
a significant labeling burden although the foods make little overall
contribution to trans fat in a mixed diet and have not been shown to
have any public health impact. Another comment suggested that, if no
claims are made, trans fat declaration should be voluntary if trans fat
is present at 0.5 g or less per serving. One comment suggested that, if
there are no claims about fatty acids or cholesterol, trans fat
declaration should not be required when the food is ``low'' in total
fat. The comment stated that a food ``low'' in total fat conforms with
dietary recommendations; that no material improvement in food choices
can be made from knowledge of the specific trans fat level in a ``low
fat'' food; and that the level of trans fat in a ``low fat'' food is
not enough to have any adverse impact on public health.
One comment stated that trans fat declaration should be optional
because consumers prefer simplicity and clarity in nutrition labeling
and consumers are unlikely to benefit from added verbiage about a
nutrient that is not familiar to them. One comment suggested that trans
fat declaration should be voluntary, but should be required under the
same conditions that declaration of monounsaturated and polyunsaturated
fat is required. The comment stated that trans fat declaration would
then be required when fatty acid or cholesterol claims are made, and
this would be the case for important food sources of trans fat, such as
margarines, which often make such claims. According to the comment,
although not all foods would choose or be required to disclose trans
fat, the foods that are predicted to reformulate and that generate the
expected health benefits of trans fat labeling would do so. After the
initial disclosure of trans fat by these foods, additional foods would
disclose trans fat due to competitive pressure (described by the
comment as ``the unfolding principle''). The comment stated that market
incentives and facilitation of information flow, rather than mandatory
disclosure, are the best ways to achieve trans fat disclosure.
FDA disagrees with comments opposed to mandatory declaration of
trans fat. The 1990 amendments mandated nutrition labeling on most
foods to provide consumers with information about specified nutrients
that would help them maintain healthy dietary practices, as well as to
create an incentive to food companies to improve the nutritional
qualities of their products. Section 403(a) requires that food be
adequately labeled and that material facts about a food's
characteristics be disclosed to consumers. Section 403(q)(2)(A) of the
act gives the Secretary (as delegated to FDA in Sec. 5.10 (21 CFR
5.10)) the authority to require that information on additional
nutrients be included in nutrition labels, if the Secretary determines
that providing such information will assist consumers to maintain
healthy dietary practices. In the legislative history of the 1990
amendments, Congress noted that ``Scientific evidence has clearly
linked dietary habits to good health. For this reason, it is important
for FDA to provide consumers with better information about the foods
they eat.'' (Ref. 141). As described in section IV of this document,
scientific studies have demonstrated consistently that consumption of
trans fat increases LDL-C, a major risk factor for CHD.
New studies and recent expert reports (Refs. 87, 90, 95, and 140)
have been published and confirm the relationship between trans fat
intake and risk of CHD. These studies' reports corroborate the agency's
earlier finding in the proposed rule that information on trans fat on
the nutrition label will assist consumers to maintain healthy dietary
practices. Dietary Guidelines 2000 cautions consumers that foods high
in trans fatty acids tend to raise blood cholesterol and gives examples
of food sources of trans fat (Ref. 87). The Guidelines advise Americans
who need to reduce fat intake to ``do so primarily by cutting back on
saturated and trans fats'' (Ref. 87). Likewise, the Executive Summary
of the NCEP 2001 report urges primary prevention of CHD in the United
States through lifestyle changes (Ref. 95). The NCEP's Therapeutic
Lifestyle Changes Diet recommends that those who wish to lower their
LDL-C level reduce their intake of saturated fat and keep consumption
of trans fat low (Ref. 89). Similarly, the IOM/NAS report recommends
``that trans fat consumption be as low as possible while consuming a
nutritionally adequate diet'' (Ref. 90). It is clear that persons
interested in following these recommendations and maintaining optimal
LDL-C levels must be able to determine levels of both saturated and
trans fats in individual food products. This information provides
consumers with the ability to maintain healthy dietary practices.
Information on saturated fat content is already available in Nutrition
Facts panels on food labels. The practical way to inform consumers of
the level of trans fat in individual food products is for the
information also to be included in the Nutrition Facts panel.
Government and industry surveys consistently find that a majority
of American consumers report looking at the nutrition label the first
time they purchase a food product (e.g., about 75 percent according to
FDA surveys (Ref. 96) and 51 percent according to a 1997 industry
survey (Ref. 97). According to the FDA surveys, the most frequently
reported label use and the one which increased most following the
implementation of the 1990 amendments was ``to see how high or low the
food is in things like calories, salt, vitamins, fat, etc.'' (70
percent in 1995, up 12 percent from 1994) (Ref. 96, table 16.1).
These survey data show that consumers rely on the Nutrition Facts
label as a guide to choosing foods that meet their dietary objectives.
As consumers learn more about the dietary significance of trans fat and
the dietary advice to limit its consumption, the Nutrition Facts panel
is where label users will expect and want to find this information. If
they cannot find information on trans fat content there or if it is
only there when claims are made about fatty acids or cholesterol, they
will be hampered in their ability to implement the most recent dietary
guidance, and are likely to be misled about a food's basic
characteristics.
Therefore, FDA, as delegated by the Secretary, has concluded that
trans fat is a material fact which cannot be omitted from the label. In
addition, information on the trans fat content of food will assist
consumers in maintaining healthy dietary practices. As such, FDA is
acting in accordance with section 403(a) and (q)(2)(A) of the act to
require that information on trans fat content be included in nutrition
labeling. Including trans fat as a mandatory component of nutrition
labeling will allow consumers to choose foods that will reduce their
intake of trans fat, along with saturated fat, within the recommended
intake level for total fat in a manner that is consistent with the most
recent dietary guidance.
[[Page 41451]]
FDA disagrees with the comments that stated that mandatory labeling
of trans fat is not warranted because average trans fat intake is
minimal or because trans fat consumption is not a matter of public
health risk at ordinary levels of intake. As described in section IV of
this document, subjects in intervention studies showing that trans fat
intake raises LDL-C levels had a wide range of trans fat intake levels,
including levels that overlap the range of intake estimates for the
U.S. population. The findings from intervention studies are supported
by findings of a positive association between trans fat intake and
increased CHD risk in the prospective observational studies, among
free-living subjects consuming ordinary diets. Taken together, these
studies demonstrate that trans fat consumption in the United States is
a matter of public health concern at ordinary levels of intake.
FDA disagrees with the comments that suggested that the nutrition
label would not be misleading if grams of trans fat were not listed,
except where claims about fatty acids or cholesterol were made,
monounsaturated fats and polyunsaturated fats were declared, or where
trans fats were present at less than 2 g, 1g or 0.5 g per serving. The
agency believes that the absence of information of the amount of trans
fat in a product, when labeling of trans fat as a mandatory nutrient is
required, even where trans fat is present at less than 0.5 g, would be
misleading. The presence or absence of trans fat in a product is a
material fact as to the consequences that may result from the use of
the product. Consumers need to know when a product contains less than
0.5 g trans fat just as much as they need to know when a product
contains 1, 2, or more grams of trans fat in order to understand how
each product impacts their overall dietary intake of trans fat. Such
need is not based solely on the presence or absence of claims, levels
of other fats, or declaration of other fats on the label. Consumers
need to understand how each product contributes to their overall intake
of trans fat in order to maintain healthy dietary practices which call
for reducing trans fat intake as low as possible while consuming a
nutritionally adequate diet. Consumption of several foods, each with
0.5 to 1 g trans fat per serving, over the course of a day may result
in a significant overall trans fat intake for the day. The association
between the intake of trans fat over a range of intakes and the risk of
CHD are discussed in section IV of this document. Because low levels of
trans fats may have significant impacts on increased CHD risk, there
are important public health reasons for excluding foods high in trans
fat intake and for including foods lower in trans fat intake. Consumers
need the trans fat information on products in order to determine how
each product fits into their individual health goal for reducing trans
fat intake in the context of their total daily diet. Thus, the agency
is requiring trans fat labeling, regardless of whether claims are made
or the levels of other fats are declared, to prevent products from
being misleading under sections 403(a)(1) and 201(n) of the act.
Therefore, as described in section III of this document, in this
rulemaking FDA is relying on its authority under those sections as well
as its authority under section 403(q)(2)(A) of the act to require that
information on trans fat be included in nutrition labeling to assist
consumers in maintaining healthy dietary practices. Requiring such
information on labels, whether or not voluntary nutrients are listed or
claims are made about fatty acids or cholesterol, is consistent with
statutory directives for nutrition labeling in section 403(q)(1) of the
act, where amounts of nutrients of public health significance are
required to be listed, regardless of other information on the label.
FDA also disagrees with the comments that stated that trans fat
declaration would assist consumers in maintaining healthy dietary
practices only under certain circumstances, such as when certain claims
are made, when monounsaturated and polyunsaturated fats are declared on
the label, when trans fat is present at greater than 0.5 g, 1 or 2 g
per serving or when the food is not ``low'' in total fat (i.e., more
than 3 g fat/reference amount). As described previously, consumers need
information on both saturated and trans fats in individual food
products so that they can follow current dietary recommendations and
maintain optimal LDL levels. It is the provision of trans fat
information on foods consumed throughout the day that can assist
consumers in maintaining healthy dietary practices, and the usefulness
of this information is not limited to foods with certain nutritional
characteristics. In addition, the consumption of several foods with 0.5
or 1 g of trans fat per day that may provide a total of 8 g of trans
fat to the diet would be expected to have the same effect on LDL-C
levels as consumption of one food with 8 g trans fat. Requiring trans
fat to be declared only when present at a specified level would be
inconsistent with statutory directives for nutrition labeling in
section 403(q)(1) of the act, where amounts of nutrients of public
health significance are required to be listed, regardless of the amount
present.
Similarly, tying mandatory declaration of trans fat to the
declaration of monounsaturated and polyunsaturated fats overlooks the
difference in health effects of these fatty acids and the basic premise
of section 403(q) of the act that requires the listing of nutrient
information necessary to assist consumers in maintaining healthy
dietary practices. Unlike information on trans fat, FDA has not
determined that information on monounsaturated and polyunsaturated fat
is necessary to assist consumers in maintaining healthy dietary
practices. Accordingly, the declaration of those fatty acids is not
mandatory. Rather, unless claims are made about fatty acids or
cholesterol, the agency provides that their listing is voluntary (Sec.
101.9(c)(2)(ii), (c)(2)(iii), and (c)(3)), consistent with the
authority in section 2(b)(1)(C) of the 1990 amendments that stipulates
that regulations shall ``permit the label or labeling of food to
include nutrition information which is in addition to the information
required by such section 403(q) and which is of the type described in
subparagraph (1) or (2) of such section * * *.''
Regarding the comment that consumers prefer simplicity and clarity
in labels, FDA does not agree that providing a listing of the amount of
trans fat on a label is not simple or clear nor did the comment provide
any rationale for its assertion. Further, FDA does not agree that trans
fat listing on a label would be ``added verbiage'' about an unfamiliar
nutrient that likely will not benefit consumers. The comment presented
no information to support its assertion. The addition of trans fat as a
mandatory nutrient on a separate line will not significantly change the
appearance of the nutrition information that consumers are already
familiar with. Having consistent information about trans fat present on
all food labels will facilitate consumer education efforts about trans
fat, as discussed later in this document (see Comment 28).
FDA is not persuaded by the comment that it is not necessary to
make trans fat labeling mandatory because, after an initial disclosure
of trans fat by certain foods, additional foods would disclose trans
fat due to competitive pressure (unfolding principle). Although some
disclosure of trans fat under competitive pressure might occur, the
overall extent of such voluntary disclosure is not certain. Before the
1990 amendments
[[Page 41452]]
were enacted, provision of nutrition labeling information was voluntary
except in certain circumstances. At the time when nutrition labeling
was voluntary, many foods did not provide nutrition labeling,
demonstrating that the disclosure suggested by the ``unfolding
principle'' was incomplete. To remedy this situation, Congress enacted
the 1990 amendments, mandating that nutrients of public health
significance be declared on food labels under section 403(q) of the
act.
As mentioned earlier, section 403(q)(2)(A) of the act provides for
the inclusion of an additional nutrient(s) if the Secretary (as
delegated to FDA in Sec. 5.10) determines that it should be included
in nutrition labeling to assist consumers in maintaining healthy
dietary practices. FDA is not asserting, as its basis for mandatory
trans fat nutrition labeling, a rationale that is different from that
which Congress declared by statute for such mandatory labeling. Lacking
any congressional direction to do otherwise, the agency considers it
implicit that any such added nutrients would be listed in a similar
manner to those specified in section 403(q)(1) of the act. Accordingly,
the agency is amending Sec. 101.9 Nutrition Labeling of Food, to add
trans fat as a mandatory component of nutrition labeling on all foods
in accordance with section 403(q)(2)(A) of the act.
B. Format, Including Percent of Daily Value (% DV), for Nutrition
Labeling of Trans Fat
FDA received many comments regarding the proposed option for
nutrition labeling of trans fatty acids and other options discussed in
the preamble. In addition, comments were received suggesting that trans
fat be listed in conjunction with the listing of total fat.
The agency did not receive comments supporting either of the two
options that would declare only the combined amount of saturated fat
and trans fat rather than the individual amounts present. In light of
the lack of support for these two options and the fact that these
options do not allow consumers to determine the individual amounts of
saturated fat and trans fat, the agency is not considering them
further.
FDA also received a few comments that supported the proposed
footnote statement ``Intake of trans fat should be as low as possible''
or a modification of it. However, the overwhelming majority of comments
opposed the use of the footnote.
1. Proposed Option
(Comment 13) Many comments supported the proposed option of having
the amount of trans fat included in the amount declared for ``Saturated
Fat'' and in the calculation of the corresponding % DV with a footnote
stating ``Includes ------ g trans fat'' when the food contains trans
fat. Comments stated that combining both saturated and trans fat in the
declaration of saturated fat maintains a consistent public health
message and provides consumers with a less confusing means to identify
``heart-unhealthy'' fats in one place on the label. Comments suggested
that, to assist consumers, trans fat should be included with saturated
fat because saturated and trans fats have similar physiological and
functional properties and because there is no DV for trans fat.
Comments suggested that combining saturated and trans fats will
decrease the likelihood that consumers would look only at the declared
level for trans fat and choose a food because it has little or no trans
fat, even though it contains a high amount of saturated fat.
Furthermore, the comments suggested that combining trans with saturated
fats would create an incentive for manufacturers to decrease ``heart-
unhealthy'' fats in foods.
Comments supporting inclusion of trans fat in the calculation of
the % DV for saturated fat stated that such action is reasonable for
purposes of consumer information. One of these comments argued that
trans fats are already included in recommendations to limit total fat
to 30 percent of calories, a number that should not be increased, and
are excluded from definitions of unsaturated fats for labeling purposes
(i.e., Sec. 101.9(c)(2)(ii) and (c)(2)(iii)). This comment
acknowledged that including trans fat would in effect lower the
reference value for saturated fat. The comment argued that this would
help Americans reduce their risk of heart disease, quoting from the
IOM/NAS report ``Diet and Health'' which states that ``saturated fatty
acid intake [should] be maintained at less than 10 percent of total
calories by individuals,'' but that ``further reduction, to 8 or 7
percent of calories or lower, would confer greater health benefits.''
The comment said that including trans fat in the % DV would help
Americans follow this advice.
However, many comments opposed this option of including trans fat
with saturated fat, arguing that including trans fat with saturated fat
is scientifically inaccurate and misleading because trans and saturated
fats are chemically, functionally, and physiologically different.
Comments pointed out that chemically trans fats are unsaturated fatty
acids that contain one or more double bonds in a trans configuration
while saturated fats do not contain double bonds. Moreover, comments
stated that trans fatty acids do not have the same functional
characteristics as saturated fats because their melting and
crystallization kinetics are quite different. Comments also pointed out
that trans fat is physiologically distinct from saturated fat, stating
that trans fat decreases HDL-C levels and that saturated fat does not.
In addition, there were comments suggesting that trans fat adversely
affects other factors that contribute to CHD, such as lipoprotein(a),
and may cause adverse effects unrelated to CHD. For these reasons, the
comments were adamant that trans fat should not be treated as though it
is ``bioequivalent'' to saturated fat and, consequently, the listing of
trans fat should be disassociated from the listing of saturated fat.
In addition, several comments objected to combining both trans and
saturated fats on the grounds that it is inconsistent with FDA's
regulatory precedent of classifying nutrients based on their chemical
definition or structure, rather than their physiological effect.
Specifically, the comments cited FDA's decision when implementing the
1990 amendments to establish a chemical definition for saturated fat
rather than a physiological definition (58 FR 2079 at 2089).
A few comments expressed concern that by including trans fat with
saturated fat, FDA is creating a category of ``bad'' or ``cholesterol-
raising'' fat that is inconsistent with the current nutrition label,
which provides consumers with information about the nutrient profile of
a product rather than providing information about perceived health
effects. Other comments stated that FDA's proposal to combine trans fat
and saturated fat may mislead consumers, albeit misleading them for
their own good, by causing them to misclassify trans fats as saturated
fats or causing them to assume that the DV for saturated fat has been
reduced (the effect of combining the quantitative amounts of trans and
saturated fats and determining the % DV using the established DV for
saturated fat). Further, several comments stated that adding trans fat
to the amount of saturated fat declared may mislead and confuse
consumers by leading them to incorrectly conclude that the amount of
saturated fat has increased.
Other comments stated that, because of the magnitude of CHD risk in
the prospective studies, trans fat should be
[[Page 41453]]
labeled more prominently than proposed in the November 1999 proposal.
These comments argued that listing the amount of trans fat in a
footnote is more confusing and implies that it is unimportant. In
addition, comments stated that footnotes, which can use smaller type
size, are more difficult to read. One comment stated that it was not
surprising that consumers were unfamiliar with the term since it was
not allowed to appear on Nutrition Facts labels. This comment suggested
that consumer knowledge about trans fat would improve as more dietary
recommendations are made for limiting trans fats and as they are listed
in food labeling.
Other comments objected to including trans fats when calculating
the % DV for saturated fat stating that the effects of trans fat on
LDL-C have not been proven to equal the effects of saturated fat on
LDL-C, so they should not be held to the same standard. These comments
argued that including trans fat in the calculation of % DV assumes that
trans fat is equivalent to saturated fat on a gram-for-gram basis,
whereas the agency admitted in the proposal that available studies do
not allow for such a conclusion. The comments stated that no
authoritative bodies have recommended that trans fat be considered as a
part of the dietary recommendation for saturated fat. Also, they stated
that including trans fat, in effect, lowers the DRV for saturated fat
and there is no new data on saturated fat that supports this action,
i.e., that there is no basis for concluding that saturated fats are now
sufficiently worse than previously believed to justify an apparent
reduction in recommended intakes. One comment also argued that if the
declaration of % DV changed on a product as a result of including trans
fat with saturated fat, consumers may incorrectly assume a change has
been made which made the product less healthy when, in fact, no such
change had occurred.
One comment said that FDA should not include trans fat in the
calculation of % DV unless the DRV for saturated fat is increased to 22
g since the agency had actually rounded down the DRV for saturated fat
from 22.2 g (equivalent to 10 percent of calories from a 2,000 calorie
diet) to 20 g when implementing the 1990 amendments (see 58 FR 2206 at
2219). Another comment objected to the idea of increasing the DRV for
saturated fat because products that do not contain trans fat would
appear healthier (i.e., have a lower % DV) even though the amount of
saturated fat in the product would remain the same.
Based on comments received, FDA is persuaded that there are
inherent weaknesses and inconsistencies in its proposed option.
Therefore, the agency has reconsidered its proposal to include trans
fats in the declaration of saturated fat with a footnote indicating the
amount of trans fat. The agency acknowledges that declaring the amount
of saturated fat and trans fat together, even with the proposed
footnote, could lead some consumers to believe that the two types of
fatty acids are chemically and physiologically the same. Clearly, trans
fats contain double bonds and thus, are chemically distinct from
saturated fat. Likewise, although both saturated and trans fats do
raise LDL-C levels, physiologic distinctions between the two types of
fatty acids do exist as discussed previously in Comments 10 and 11.
While findings on some of these distinctions are preliminary, they do
not support the position which the agency took in the November 1999
proposal that the two fatty acids should be declared as one combined
entity because of similar physiological effects.
The agency re-evaluated its position, noted in the final rules
implementing the 1990 amendments, that there is insufficient knowledge
about the physiological effects of particular fatty acids to use
anything other than a chemical definition for saturated fats (58 FR
2079 at 2089). In that rulemaking, FDA reconsidered its regulatory
position in place since 1973 (38 FR 2132 at 2134, January 19, 1973) of
linking the definition of saturated fatty acids to effects of
particular fatty acids on blood total and LDL-C and determined that a
chemical definition was a more appropriate approach. The agency stated
that a chemical definition avoids much of the controversy regarding
blood cholesterol effects of short to medium and certain very long
chain fatty acids because the definition is not subject to changes in
knowledge about the physiological effects of a particular fatty acid.
In addition, the agency stated that a chemical definition approach to
labeling fatty acids avoids the uncertainty about physiological effects
other than those related to CHD (58 FR 2079 at 2089). Based on its re-
review of the position noted in the final rules implementing the 1990
amendments, the comments received on proposed rule opposing a contrary
position, and current science on trans fat, the agency is persuaded
that it would be important to approach trans fat labeling on the basis
of using a chemical definition and not based on physiological effects.
Accordingly, the agency concludes that it is necessary to disassociate
saturated and trans fats on the nutrition label so that consumers do
not misinterpret the declaration of saturated fat by thinking that
trans fats are included in that definition.
The agency also acknowledges the concerns expressed in comments
about the prominence given to the information on trans fat. Current
food labeling regulations do allow for a smaller type size for
footnotes (Sec. 101.9(d)(1)(iii)) and limit the declaration of amounts
in footnotes to statements saying that the food is not a significant
source of specified nutrients (e.g., Sec. 101.9(c)(3)). Consequently,
consumers may overlook quantitative information on trans fat content
placed there.
In the November 1999 proposal, FDA expressed concern that consumers
may not yet know what trans fats are or know about their impact on
health (64 FR 62746 at 62755). The agency agrees with the comment that
suggested that consumer knowledge would improve as more dietary
recommendations are made for limiting trans fats and as they are listed
in nutrition labeling. In addition, the agency notes that media
attention to trans fat has been widespread since publication of the
November 1999 proposal. For example, public awareness about trans fats
was increased as reports of the IOM/NAS report on trans fatty acids
were issued (Ref. 140), as consumer and health groups issue press
releases and reports about trans fats (Refs. 147 and 148), as food
manufacturers add information about the trans fat content of products
to labels, and as industry announcements are made about the trans fat
content of packaged and restaurant foods (Refs. 149 and 150). In
addition, the agency is planning a consumer education program discussed
later in Comment 28 to further heighten consumers' knowledge of what
trans fats are and their impact on health. Thus, the agency no longer
believes that its prior reasoning, i.e., that trans fat would need to
be included in the declaration of saturated fats in order for consumers
to understand that trans fats are heart unhealthy is necessarily true.
Consumers should be more aware of trans fat based on the public
exposure to information on trans fat over the past years and FDA
efforts before the rule becomes effective.
In the November 1999 proposal, FDA tentatively concluded that, in
the absence of dietary recommendations for trans fats, it was
reasonable to include trans fats in the % DV for saturated fat (46 FR
62746 at 62756). Consequently, FDA proposed that the % DV be calculated
by combining the amount of
[[Page 41454]]
saturated fat and trans fat in a food and dividing by the DRV for
saturated fat (20 g). In effect, this is equivalent to having a
combined DRV for saturated and trans fat of 20 g. FDA agrees with the
comments that suggest that this approach is problematic in that by
displacing the DV for saturated fat with trans fat, the DV, in essence,
is lowered for saturated fat. However, the DV for saturated fat has not
changed. Therefore, it would be scientifically more accurate to keep
the DV for saturated fat intact, without displacing it with trans fat.
This approach would be consistent with the recent IOM/NAS macronutrient
report (Ref. 140) that does not treat saturated and trans fats
together. FDA concludes that there is an insufficient scientific basis
at this time for combining the declared amounts of trans and saturated
fats and calculating the % DV. Additionally, FDA is persuaded by the
arguments discussed previously that point to the differences between
saturated fat and trans fat that it is inappropriate to do so.
Accordingly, the agency concludes that other options that
disassociate trans fat from the listing of saturated fat would be
preferable to the proposed option. The other options identified in the
proposal and those suggested in comments are discussed later.
2. Option to List Saturated and Trans Fat on Same Line
(Comment 14) Several comments preferred the option identified in
the November 1999 proposal that would list ``Saturated + trans fat''
with the amount in grams and the % DV based on the combined value, and
the individual amounts of both saturated and trans fats in a footnote.
One comment suggested that the footnote declare the specific amount of
trans fat only, while another suggested that the individual amounts be
listed in separate lines immediately below the combined amount rather
than in a footnote. These comments stated that this type of declaration
shows that: (1) There are two different fatty acid categories, thereby
maintaining the chemical definitions of trans fat and saturated fat and
indicating equal importance to health; (2) gives them equal prominence
with poly- and monounsaturated fats; (3) suggests to consumers that
trans fats have similar cholesterol-raising properties as saturated
fats; and (4) provides an easy method for comparing the ``heart-
unhealthy'' fat content of foods. The comments also argued that this
type of declaration indicates the combined total amount of saturated
and trans fats, a number that would stay constant when saturated and
trans fats are substituted for each other, and it was therefore clearer
to declare the sum of both.
Alternatively, a few comments recommended declaring the individual
amounts for saturated fat and trans fat on one line in the nutrition
label, i.e.,. ``Saturated fat ----g + trans fat ----g.'' These comments
pointed out that declaring saturated and trans fats in this way would
be consistent with the chemical definitions for each type of fatty acid
and would help consumers see that trans fats are different from
saturated fats. The comments argued that research may elucidate new
properties or biological effects of both saturated and trans fatty
acids, warranting this distinction between them. From a consumer
perspective, one of the comments also argued that, if FDA begins to
mandate the placement of nutrient content information in locations
other than the current nutrient list, consumers may become increasingly
confused about where on the food label to locate information that they
need.
Two comments urged the agency to harmonize its trans fat labeling
policy internationally, noting that this format, i.e., ``Saturated fat
-- g + trans fat --g,'' was proposed by Canada in June 2001, for use in
mandatory nutrition labeling in that country (Ref. 103).
Other comments did not favor listing saturated and trans fats on
the same line as ``Saturated + trans fat'' for the same reasons
expressed in opposition to the proposed option, namely because trans
and saturated fats are chemically different, because they have
different effects on HDL-C, and because, according to preliminary data,
trans fat may have effects on non-heart disease risks that saturated
fats are not reported to have. In addition to concerns about the
chemical and physiological differences between trans and saturated
fats, some comments expressed opposition to labeling the two on the
same line because public health and scientific organizations that are
instrumental in establishing daily reference intake values have not yet
established a DV for trans fat. Many other comments objected to having
saturated and trans fats on one line, in any manner, if it resulted in
trans fat being included in the calculation of the % DV for saturated
fat. Specific arguments against including trans fat when calculating
the % DV for saturated fat are discussed in the preceding comment.
The agency is not persuaded by comments supporting this option.
While this option does indicate more clearly than the proposed rule
that saturated and trans fats represent two different categories of
fat, it would still necessitate a displacement of the % DV for
saturated fat by trans fat and would not disassociate the two fats in
terms of potential physiologic effects. Based on the reasons set forth
in response to Comment 13, we believe that it would be scientifically
more accurate to not displace the % DV for saturated fat with trans
fat. In addition, this option would not be consistent with our
rationale, as explained in the response to Comment 13, for why a
chemical definition approach to labeling is preferred. Such an approach
avoids the uncertainty about physiological effects now or in the
future. While the two fatty acids do both lead to increased LDL-C,
advisory groups (as noted in comment 10 of this document) have stated
that substitution of trans fat for saturated fat lowers HDL-C. Low
levels of HDL-C can be a predictor of CHD. While evidence concerning
the differing effects of saturated fat and trans fat on other disease
risk factors is preliminary, FDA is convinced by comments that it is
preferable to disassociate the two fatty acids and maintain a chemical
definition approach to labeling. Accordingly, the agency finds this
option unacceptable.
Those comments stating that saturated and trans fat are substituted
for each other recognized that the two types of fats have some
functional similarities. However, comments were not unanimous in
stating that the combined total amount of saturated and trans fats
would stay constant when one of the two fatty acids was raised or
lowered. Some comments indicated that trans fats could be reduced
significantly with a smaller concomitant increase in saturated fat. In
addition, FDA points out that the intent of this rulemaking is not to
make such substitutions easier from a labeling perspective but to
encourage the reduction of both types of fats to assist consumers in
maintaining healthy dietary practices.
FDA recognizes that Canada has issued final rules on nutrition
labeling that declare saturated fat and trans fat on one line. However,
FDA has determined, based on comments to this final rule, that such
declaration would not be an appropriate approach for the agency at this
time. Such an option would not account for the chemical and
physiological differences between saturated and trans fat, and thus,
would be inconsistent with the agency's past approach to labeling that
is based on chemical differences. Further, there are additional
differences between Canada's new nutrition labeling rule and existing
U.S. regulations, under Sec. 101.9, that will need to be reviewed by
both countries.
[[Page 41455]]
After further review and discussion, the United States and Canada can
consider the possibility of mutual recognition of nutrition labels.
3. Option to Include Trans Fat as a Part of Total Fat
(Comment 15) Several comments recommended a new option that would
place an asterisk (or other symbol) after the declaration of total fat
(i.e., ``Total Fat*'') that references a footnote stating the number of
grams of trans fat included in the total fat declaration (e.g.,
``*Includes------g trans fat''). A few comments proposed an alternative
to this option that would declare trans fat in a parenthetical
statement on the same line with ``total fat'' (i.e., ``Total Fat ---- g
(includes---- g trans fat)'').
Some of these comments suggested that declaring trans fat as a part
of total fat alleviates many of the concerns voiced about the proposed
option. The comments stated that this option discloses the amount of
trans fat in scientifically accurate terms and is consistent with
current regulations that include the quantity of trans fat within the
amount declared for total fat. A comment said that this option should
be used until a DRV is established for trans fat. Another comment
suggested that the DRV for total fat should be increased to accommodate
trans fat. Other comments stated that current dietary guidelines
recommend monitoring both total fat and saturated fat intake,
especially for consumers concerned about their heart health, and that
the AHA recommends focusing on the total amount of fat consumed to
address concerns about trans fat consumption.
The comments stated that placing the asterisk beside ``total fat''
has advantages for consumers. At least one comment stated that this
type of listing may be more readily seen by consumers since it gives
greater prominence to the trans fat information. Other comments stated
that including trans fat as a part of total fat avoids the confusion
that consumers would experience with FDA's proposed option when amounts
declared for saturated fat would appear to have increased.
The agency disagrees with those comments suggesting that concerns
about trans fat consumption can be addressed by focusing on the total
amount of fat consumed. FDA agrees that trans fats are chemically a
component of total fat; however, that is also true for saturated,
polyunsaturated, and monounsaturated fatty acids that are listed as
subcomponents of total fat in many food labels. Therefore, the agency
does not agree that trans fatty acids should be listed only as a part
of total fat until there is an established DRV for trans fatty acids,
particularly since DRVs also have not been established for poly- or
monounsaturated fatty acids. The agency also points out that the
current DRV for total fat includes all fatty acids, so does not need to
be increased to accommodate trans fatty acids.
Further, placing an asterisk after ``Total Fat'' on the label with
a footnote stating the grams of trans fat, or a statement of the grams
of trans fat beside the total fat on the label likely would lead to the
same types of objections that were raised when that approach was
considered for saturated fat. Moreover, previous comments in comment 13
raised concerns about consumers overlooking quantitative information in
a footnote. Further, comments raised concern about not maintaining the
chemical distinction for individual fatty acids, as has been the past
agency practice. Placing trans fat on the same line of total fat may
raise questions about how trans fat is to fit within the % DV for total
fat. The agency is not persuaded by any the comments that the problems
with this option would be any different than those with the option to
label trans fat on the same line as saturated fat. Thus, the agency is
not persuaded that the nutrition label should identify levels of trans
fat in the total fat declaration through the addition of a footnote or
parenthetical listing.
Moreover, while total fat in the diet is important, the composition
of that total fat intake is at least equally, if not more, important.
Recent recommendations from the Dietary Guidelines 2000 (Ref. 87) and
the Dietary Guidelines Advisory Committee (Ref. 88) have emphasized
reducing intake of both saturated and trans fats while placing less
emphasis on reducing total fat intake. For example, while the 1995
edition of the Dietary Guidelines recommended that Americans choose a
diet ``low'' in fat and saturated fat (Ref. 6), the 2000 edition now
recommends ``moderate'' total fat (Ref. 87) with guidance that
consumers needing to reduce their total fat intake do so by cutting
back on saturated and trans fats. Similarly, the 2000 AHA Guidelines
specifically recommend limiting ``intake of foods with high content of
cholesterol-raising fatty acids'' (i.e., saturated and trans fatty
acids) rather than total fat (Ref. 91). The 2001 NCEP report increased
the recommendation for individuals with elevated LDL-C for total fat
intake from 30 to 35 percent of calories provided that saturated and
trans fats be kept low (Ref. 89).
The comments suggesting that trans fat information would have
greater prominence and be more readily seen when related to total fat
rather than saturated fat did not provide any data to support this
position. While doing so would move trans fat up one line in the
Nutrition Facts label, FDA has no basis to conclude that this would
make it more prominent to consumers.
The agency acknowledges that the options of using an asterisk next
to total fat with a footnote listing trans fat or listing trans fat
parenthetically next to total fat would avoid any possible confusion
experienced by consumers as a result of the proposed option if levels
of saturated fat appeared to have increased when, instead, amounts of
trans fat were added to the amount of saturated fat. However, other
options, such as the option of declaring trans fat on a separate line
would also avoid the possibility of such confusion and, at the same
time, would more clearly identify trans fat as a separate subcomponent
of total fat, in a manner similar to the other subcomponents, i.e.,
saturated, poly- and monounsaturated fats.
For the reasons noted previously, the agency is not persuaded that
the nutrition label should identify levels of trans fat in the total
fat declaration through the addition of a footnote or parenthetical
listing.
4. Option to Include a Separate Line for Trans Fats
(Comment 16) Many comments recommended that trans fat content be
declared on a separate line on the Nutrition Facts panel because of the
problems ascribed to the proposed option. In general, these comments
stated that there is no scientific evidence to support FDA's proposal
to combine saturated and trans fatty acids because both of these fatty
acids have different chemical structures and physiological effects.
They asserted that a separate line on the nutrition label for trans
fats would fully inform consumers about the kind of fats that are in
the foods they select and consume. These comments urged the agency to
list trans fat in the same way as other subcomponents of total fat,
i.e., saturated and poly- and monounsaturated fats. They stated that
doing so would clarify the chemical differences between the fatty
acids, including saturated fatty acids, and would be easier for
consumers to understand since it eliminates the need for a footnote.
Comments also noted that adding a separate line for trans fat would be
consistent with FDA's regulatory precedent, which was established with
the 1993 mandatory
[[Page 41456]]
nutrition labeling regulations, of classifying nutrients based on their
chemical definition or structure, rather than their physiological
effect (58 FR 2079 at 2089). Moreover, the comments argued that listing
trans fat on a separate line now would avoid having to do it later if
future scientific research shows that the effects of trans fat
consumption are significantly different from the effects of saturated
fat consumption.
Several comments argued that by providing a separate line for trans
fat, consumers can be educated more easily about the health effects of
trans fatty acids. These comments disagreed with FDA's position in its
November 1999 proposal that trans fat should be combined with saturated
fat because consumers lack knowledge about trans fat information and do
not understand the term trans fat. Also, some comments stated that
FDA's rationale for not listing trans fat more prominently (i.e., that
consumers are not familiar with the term ``trans fat'') is not
justified since consumers do not generally know much about mono- or
polyunsaturated fats yet quantitative information may be provided for
them in nutrition labeling and must be provided when claims are made
about fatty acids or cholesterol. A few comments also stated that
creating a separate line for trans fat establishes a basis for current
and future consumer education about the health risks and benefits of a
variety of fatty acids that affect LDL-C and HDL-C levels.
A few comments in favor of a separate line for trans fat in
nutrition labeling specifically addressed the need to establish a DRV
for trans fat. One comment stated that FDA could establish a DRV for
trans fat based on international recommendations for trans fat
consumption. Another comment indicated that a DRV for trans fat could
be established at a level equal to or below the average daily intake of
trans fat. One other comment stated that the only basis for
establishing a daily value would be the amount of naturally-occurring
trans fat in ruminant (dairy) products since they have not been shown
to be associated with increased risk of CHD; otherwise, the DRV for
trans fats formed through partial hydrogenation should be zero.
However, the majority of those commenting stated that scientific
evidence is not sufficient to support the establishment of a DRV for
trans fat because no public health or scientific organization has
proposed guidelines for dietary intake levels of trans fat at this
time. Some of these comments said that trans fat should be treated in a
manner consistent with poly- and monounsaturated fats, i.e., without a
% DV, until such time as there is a basis for establishing a DRV for
trans fat. A few comments suggested waiting until the IOM/NAS completes
its report on DRIs for macronutrients. A few comments noted that
listing trans fat on a separate line with no % DV would be less useful
to consumers because they would not be able to determine if the amount
were high or low in the context of the daily diet. One comment stated
that if there is enough scientific evidence to require the mandatory
labeling of trans fat, the agency should provide the information that
will help consumers to interpret the magnitude of the amount in the
food. Additionally, other comments stressed the importance in helping
consumers understand the relevance of the nutrient amount in the
context of the total diet.
One comment objected to the option of having a separate line for
trans fat on the basis of consumer confusion. It said that adding a
fourth line of fatty acid information would confuse consumers because
they would have to look at several separate values when comparing food
products. This comment also was concerned that the use of a separate
line would not encourage the food industry to reduce ``heart-
unhealthy'' fat in the food product.
FDA agrees with comments that point out that there are chemical
differences between saturated and trans fatty acids. The agency noted
these differences in its November 1999 proposal when it proposed to
include the amount of trans fat in the declaration of saturated fat.
The intent was to assist consumers in understanding the cholesterol-
raising properties of the food by declaring the two fatty acids under
the name ``saturated fat'' without changing the definition of saturated
fat, but FDA acknowledged that this action ``may confuse consumers and
lead some to misclassify trans fatty acids as saturated fats'' (64 FR
at 62746 62755). The agency is persuaded by the large number of
comments on this issue that the proposed action was, in fact,
interpreted by many as incorrectly classifying the two different fatty
acids as ``saturated fat'' and that it is necessary to disassociate
trans fat from saturated fat to prevent misleading consumers in this
way.
FDA also acknowledges that while the two types of fatty acids have
similar effects on LDL-C, there are other physiological distinctions
between them. Because the overall weight of scientific evidence in
support of the finding that consumption of trans fat, like saturated
fat, contributes to increased LDL-C levels increasing the risk of CHD,
was sufficiently compelling to warrant trans fat labeling, the agency
did not focus on other physiological effects of trans fat. While
studies on a variety of physiological effects of trans fat are ongoing
and results preliminary, the agency is persuaded by comments that the
declaration of trans fat on a separate line will best accommodate
future scientific development. This will be helpful if future research
more clearly elucidates the physiological mechanisms of each and
confirms that trans fat does have adverse effects on other CHD risk
factors or health conditions that differ significantly from saturated
fat.
As pointed out by comments, doing so has the advantage of being
consistent with: (1) The format used to list the other subcomponents of
total fat, namely saturated, polyunsaturated and monounsaturated fats;
(2) the declaration of quantitative amounts contiguous to the listing
of the nutrient rather than in a footnote; and (3) the agency's
regulatory precedent of classifying nutrients based on their chemical
definition or structure. Consistency with the existing format can be
expected to assist consumers in recognizing trans fat as a subcomponent
of total fat. It will also be responsive to consumer interest in
knowing the full breakout of fatty acids since, when poly- and
monounsaturated fats are declared, the amounts for saturated, trans,
polyunsaturated, and monounsaturated fats will add up to the amount of
total fat except for minor deviations that may result from application
of rounding rules in Sec. 101.9(c)(2).
The agency agrees with the majority of the comments that the
scientific evidence is not sufficient to support the establishment of a
DRV for trans fat at this time. The comments that attempted to suggest
a basis for doing so did not suggest particular values or submit
scientific evidence to justify the establishment of such values. FDA
emphasizes that existing DRVs are based on quantitative dietary intake
recommendations developed from extensive scientific evidence that
establishes values that will promote public health (58 FR 2206 at
2217). DRVs have not been based on international recommendations, which
may not be germane in the United States, or on average dietary intake
levels, which may not represent healthy dietary consumption patterns.
The FDA is not aware of any international recommendations that it could
rely on, nor did the comment provide any such specific recommendations.
The agency has relied extensively on reports from the IOM/NAS in
developing the current Reference Dietary Intake (RDIs) and DRVs.
However, the recent IOM/NAS
[[Page 41457]]
report on DRIs for macronutrients (Ref. 140) did not make quantitative
recommendations for trans fat for establishing a DRV. Accordingly, in
the absence of a scientific basis or recommendation by an authoritative
body, FDA is not establishing a DRV for trans fat. FDA intends to
revisit this issue when there is more scientific information that the
agency can use to establish an appropriate reference level for trans
fat intake.
The agency recognizes that the absence of a DRV, and thus, the
absence of a % DV for trans fat on food labels, nutrition educators
will need to direct efforts at educating consumers further about the
effects of trans fat on LDL-C levels and CHD risk. However, because of
the public health impact of CHD in the United States, the agency
believes it is necessary to proceed at this time with this final rule
to list trans fat in nutrition labeling so that consumers will have
quantitative information to use in implementing dietary guidelines to
cut back on trans fat. By adding quantitative information on trans fat
content, consumers will have information to use in comparing products
and making diet selections that will reduce their intake of trans fat
in the context of their daily diet by substituting lower trans fat
products for those previously consumed that were higher in trans fat.
The agency does not believe it would be any more difficult for
consumers to look at a separate line for information on trans fats than
it has been for any other separate fat listing. Listing them separately
will allow consumers to readily see levels of each in food products and
make decisions accordingly. In addition, the agency stated earlier that
it believes public awareness about trans fat has increased since
publication of the November 1999 proposal as a result of media
attention, press releases, label statements, and industry
announcements. FDA concludes that this increased awareness, in
conjunction with an education program about the change, will allow
consumers to use this new information to help maintain healthy dietary
practices and will minimize any confusion caused by the change. To
maximize the impact of declaring trans fat in the Nutrition Facts
panel, a coordinated educational effort among public health
professionals and organizations focusing on all three cholesterol-
raising dietary components, i.e., saturated fat, trans fat, and
cholesterol, will be required. Such a program is discussed in Comment
28 below.
The comment that was concerned that use of a separate line for
trans fat would not encourage industry to reduce ``heart-unhealthy''
fats did not present any data to show the effectiveness of the various
options in achieving this goal. Following implementation of mandatory
nutrition labeling rules in 1993, the industry reformulated many foods
products to reduce levels of nutrients about which consumers were
concerned (Ref. 96). Accordingly, FDA believes that the required
addition of information on trans fat content to nutrition labels,
coupled with a consumer education program on the health effects of
dietary trans fat, will provide incentive to the food industry to
minimize the level of trans fat present in individual food products.
Some parts of the food industry have responded to consumer concerns,
e.g., levels of trans fat in margarine products have been lowered (Ref.
104), and companies have announced plans to use reformulated fats that
are lower in trans fat (Refs. 149 and 150). The agency believes that
requiring trans fat labeling will prompt others in the food industry to
reformulate some of their products to offer lower trans fat
alternatives.
Accordingly, FDA is revising Sec. 101.9(c) by adding paragraph
Sec. 101.9(c)(2)(ii) to require the quantitative declaration of trans
fat in the Nutrition Facts panel. This new paragraph requires the
listing of trans fat on a separate line under the statement for
saturated fat. As is the case for all subcomponents of total fat, it is
to be indented and separated by a hairline, with the amount expressed
as grams per serving to the nearest 0.5 g increment below 5 g and to
the nearest gram increment above 5 g. If the serving contains less than
0.5 g, the content must be expressed as 0, except when the statement
``Not a significant source of trans fat'' is used. In addition, the
agency is clarifying that the word ``trans'' may be italicized to
indicate its Latin origin. This provision to allow for italics provides
an exception to Sec. 101.9(d)(1)(ii)(A) that requires that a single
easy-to-read type style be used throughout the nutrition label.
Therefore, paragraph (d)(1)(ii)(A) is being revised to state that
``except as provided for in paragraph (c)(2)(ii) of this section,'' a
single easy-to-read type style is to be used throughout the nutrition
label.
As a result of adding paragraph (c)(2)(ii) for trans fat, the
agency is redesignating current paragraph (c)(2)(ii) (polyunsaturated
fat) as paragraph (c)(2)(iii) and current paragraph (c)(2)(iii)
(monounsaturated fat) as (c)(2)(iv).
(Comment 17) In response to the November 2002 reopening of the
comment period on the November 1999 proposal to require a footnote
stating ``Intake of trans fat should be as low as possible'' when trans
fat is listed, FDA received some comments that supported the proposed
footnote statement. A few comments noted that the proposed footnote was
needed to raise consumer awareness and understanding about the
relevance of trans fat in the diet and to assist them in making healthy
food choices. Another comment stated that the footnote is consistent
with the IOM/NAS report on macronutrients. Two of the comments strongly
recommended that the footnote be modified to state that ``Combined
total intake of saturated and trans fats should be as low as
possible.'' The comments argued that the footnote proposed by FDA gives
undue emphasis to trans fat and will cause some consumers to evaluate
products based on the content of trans fat instead of on the content of
both trans and saturated fats, as is recommended in dietary guidance.
One of the comments included the results of a national online survey
that tested the communication effectiveness of the proposed footnote
relative to no footnote and to the alternative footnote ``Combined
total intake of saturated and trans fats should be as low as
possible.'' Respondents were faced with a food comparison that required
them to take both saturated fat and trans fat into account to correctly
identify the ``more healthful'' of two food products, described by the
comment as the product with the lowest total amount of saturated and
trans fats combined. The two foods being compared were both high in
saturated fat (70% DV (14 g) and 35% DV (7 g) saturated fat) but the
food highest in saturated fat (14 g) had no trans fat (food 1) while
the one with half as much saturated fat (7 g) had 2g of trans fat (food
2). With no footnote, over half of the respondents who identified a
product as more healthful (57 percent) correctly identified the more
healthful food (food 2) and 12 percent chose food 1. In the presence of
the FDA proposed footnote, 39 percent of the respondents who identified
a product as more healthful incorrectly chose food 1 as more healthful,
presumably focusing on the zero trans fat content in the higher fat
food, with only 45 percent choosing the food with the lowest total
amount of saturated and trans fats combined. In the presence of the
alternative footnote, which mentioned the need to keep the intake of
both saturated and trans fats low a majority of respondents again
correctly chose food 2 (69 percent) as
[[Page 41458]]
more healthful, with 17 percent choosing food 1.
The majority of the comments strongly opposed the proposed footnote
statement and recommended that FDA drop the footnote and finalize the
quantitative (grams per serving) label declaration of trans fat on a
separate line below saturated fat with no % DV. Several comments stated
that the proposed footnote statement is inconsistent with the IOM/NAS
macronutrient report and incorrectly establishes a de facto DV or UL of
zero for trans fat intake that the IOM/NAS never intended to establish.
Some of these comments explained that the proposed footnote statement
takes into consideration part of the recommendation from the IOM/NAS
report that recommends the intake of trans fat be as low as possible,
while ignoring the part that states ``* * * while consuming a
nutritionally adequate diet.'' The comments claimed that the omission
of the latter part of the recommendation significantly changes the
meaning of the statement and the recommendation of the IOM/NAS, namely
that the IOM did not intend to recommend that trans fat be totally
eliminated from the daily diet. These comments noted that the IOM/NAS
report did not establish an UL for trans fat despite the relationship
between intake of trans fat and CHD stating that trans fatty acids are
unavoidable in ordinary, nonvegan diets, and to attempt to eliminate
them would require significant changes in dietary intake patterns which
may result in unknown and unquantifiable health risks. The comments
went on to say that the IOM committee indicated that ``[I]t is possible
to consume a diet low in trans fatty acids by following the dietary
guidance provided in Chapter 11'' of their report. The comments
concluded that the proposed footnote statement is inconsistent with the
IOM/NAS report and could mislead consumers into substituting more foods
with saturated fat in an effort to avoid foods containing trans fat.
Similarly, several comments described the proposed footnote
statement as an unjustified warning statement on the label of foods
that contain trans fat. Some of these comments stated that consumers
will perceive the footnote as a de facto % DV of zero and will not
understand the meaning of the portion of the proposed footnote
statement ``as low as possible;'' consumers will perceive it as a
warning to avoid trans fat-containing foods at all costs. Several
comments stated that the footnote would be misleading because consumers
would be confused about the relative impact of saturated fat (by
thinking up to 20 g, i.e., the DV for saturated fat, is heart healthy)
compared to trans fat (thinking trans fat intake must be kept to zero
to be heart healthy). Some of these comments mentioned that the dietary
recommendation to reduce saturated fat is a well established goal of
federal agencies and other health organizations and that Americans
consume much more saturated fat than trans fat. The comments stressed,
therefore, that any footnote statement on the nutrition label about
trans fat should not undermine the important health message consumers
have learned over the years about limiting saturated fat intake.
Comments also criticized the proposed footnote for being more
prescriptive than, and inconsistent with, other Federal Government
dietary recommendations, such as the Dietary Guidelines for Americans
2000 and the NCEP Adult Treatment Panel III Report, 2001. According to
the comments, the recommendations of these reports support the need for
Americans to choose diets that are low in saturated fat and cholesterol
and moderate in fat while reducing, not eliminating, dietary
consumption of trans fat.
Comments also pointed out that the IOM/NAS report gives essentially
identical advice for saturated fat and cholesterol as it gives for
trans fat, yet FDA's proposed footnote singled out only their
recommendation for trans fat. The comments argued that this placed
undue emphasis on the role of trans fat in heart health.
Many of the comments expressed concern that the proposed footnote
statement is potentially misleading to consumers and will undermine the
key goals of this rulemaking. To that end, the comments strongly
recommended that FDA drop the proposed footnote statement from the
final rule and take time to conduct consumer research to determine the
impact of the proposed footnote statement on consumers' understanding
and comprehension. A few comments cited FDA's obligation under the 1990
amendments (paragraph 2(b)(1)(A)) to ensure that nutrition labeling is
``conveyed to the public in a manner which enables the public to
readily observe and comprehend such information and to understand its
relative significance in the context of a total daily diet.'' The
comments argued that the proposed footnote statement should be consumer
tested to ensure that the nutrition information provides meaningful
guidance to consumers and drives the market in a nutritionally
beneficial direction. The majority of comments that opposed the
proposed footnote statement commented that even in the absence of a DV,
consumers can still find quantitative information useful (similar to
the listing of monounsaturated and polyunsaturated fats on the
nutrition label).
Many of the comments recommended that FDA not move forward with the
proposed footnote until the IOM/NAS completes a study, which is
underway, of the uses of DRIs in nutrition labeling. The comments noted
that the IOM is under contract with FDA, USDA and Health Canada to
assess the objectives, rationale, and recommendations for the
methodology for selecting reference values for nutrition labeling of
foods based on DRIs and will identify guiding principles for use in
setting reference values for nutrients on the food label. The comments
also noted that the IOM committee is expected to complete its work on
this project in mid-2003 and to issue a report in September 2003.
One comment stated that the prescriptive nature of the proposed
footnote may also violate international obligations of the United
States under the World Trade Organization (WTO). The comment stated
that WTO's Agreement on the Sanitary and Phytosanitary (SPS) Measures
requires that SPS measures intended to protect human health be based
upon sound science. The comment questions this regarding the proposed
footnote statement because it implies a benefit to consumers who avoid
consuming trans fat foods when the IOM/NAS suggests that eliminating
trans fats entirely in the diet would lead to greater harm by impeding
dietary intake of essential nutrients. The comment also stated that if
the proposed footnote statement was not a SPS measure, it would violate
WTO's Agreement on Technical Barriers to Trade, which requires that
``technical'' regulations fulfill a legitimate purpose and be no more
trade restrictive than necessary. The comment expressed the opinion
that the proposed footnote statement oversimplifies and misrepresents
the IOM/NAS report on which it is based and that the statement is more
trade restrictive than necessary because alternatives to such a
footnote statement, such as a consumer education program, are available
to assist consumers in understanding the quantitative trans fat
labeling in the absence of a DV.
Some comments expressed concern that the proposed footnote
statement would provide a disincentive to the industry such that many
foods would be reformulated to reduce or remove trans fat but, as a
result, saturated fat content would be increased. Other comments
expressed concern about the lack of
[[Page 41459]]
label space for the proposed footnote statement. One comment stated
that the Nutrition Facts panel would no longer be simple and
uncluttered and, as a result, consumers would be discouraged from
reading the label. Other comments complained that the 30-day comment
period for the November 2002 proposal was inadequate to address
footnote issues and to conduct needed consumer research.
Many of the comments stated that FDA did not carry its burden under
the first amendment. The comments argued that the proposed footnote
statement fails to serve a substantial government interest in
alleviating a genuine public harm, does not directly advance that
interest and is not narrowly tailored. Several comments stated that the
footnote statement is tantamount to a warning statement and is
misleading.
Some comments stated that the use of the footnote statement would
be establishing a new precedent by providing guidance, not just
quantitative information on the Nutrition Facts panel. They argued that
there were no consumer data to show that the footnote will help
consumers understand the information. Comments stated that the agency
had such data when it decided on the Nutrition Facts panel labeling
format that only included quantitative information and should have
consumer data here, where a new precedent is being considered.
Lastly, a few comments opposed FDA's offer to consider exercising
our enforcement discretion to allow products to begin declaring trans
fat and include the proposed footnote statement prior to publication of
the final rule. One comment stated that the agency should publish a
``clarification notice'' to stop companies that are changing their
labels now.
The agency is persuaded by comments that the statement it proposed
may have unintended consequences. It was not FDA's intent to distract
consumers from dietary guidance to minimize intake of saturated fat,
but rather, in the absence of a DV for trans fat, to inform consumers
of recommendations concerning its consumption.
While the online survey was small, its results support concerns
expressed by the food industry that some consumers would interpret the
footnote as a de facto DV of zero or as a warning statement that they
should avoid all trans fat. The agency agrees with comments that this
interpretation is inconsistent with dietary guidance given in the IOM/
NAS report to keep intake of trans fat ``as low as possible while
consuming a nutritionally adequate diet'' (Ref. 140), as well as
guidance in the Dietary Guidelines 2000 to cut back on saturated and
trans fats when reducing total fat intake (Ref. 87) or in the 2001 NCEP
report to keep the intake of trans fatty acids low (Ref. 89). FDA also
agrees that these scientific reviews have similar dietary
recommendations for the intake of saturated fat and cholesterol that
are important for consumers to take into consideration when making
decisions about heart-healthy dietary choices. The agency addressed
only trans fat in the footnote statement, not because saturated fat or
cholesterol had different recommendations or were less important, but
because they have established DVs from which to determine the % DV for
nutrition labeling purposes.
The agency agrees with comments that support consumer testing to
ensure that information on the food label provides meaningful guidance
to consumers and drives the market in a nutritionally beneficial
direction. FDA concludes, therefore, that based on arguments presented
in the comments, that while the footnote would provide guidance on
dietary recommendations for trans fat, it is premature to require the
use of the proposed footnote statement in the nutrition label without
further research. Consumer research would likely need to provide
information on the impact of the statement in a footnote on consumers'
food selections.
Accordingly, as a result of concerns expressed in the comments,
asserting that consumers may place undue emphasis on trans fat
information relative to other heart-unhealthy fats from the presence of
the trans fat proposed footnote, the agency is not proceeding at this
time to incorporate a requirement for a footnote statement in this
final rule. Instead, FDA is issuing an ANPRM elsewhere in this issue of
the Federal Register that will solicit comment and additional consumer
research on the use of a footnote and the language that may be used in
a footnote to better reflect the dietary recommendations given in the
previously-mentioned scientific reviews. The ANPRM will also solicit
information and data that potentially could be used to establish new
nutrient content claims about trans fat, to establish qualifying
criteria for trans fat in current nutrient content claims for saturated
fat and cholesterol, lean and extra lean claims, and health claims that
contain a message about cholesterol raising fats, and to establish
disclosure and disqualifying criteria for trans fat.
The agency is also requesting comments on whether it should
consider statements about trans fat, either alone or in combination
with saturated fat and cholesterol, as a footnote in the Nutrition
Facts panel or as a disclosure statement in conjunction with claims to
enhance consumer's understanding about cholesterol-raising lipids. In
light of the need for consumer research to evaluate consumers'
understanding of the totality of dietary recommendations that address
the selection of foods for a heart-healthy diet, the agency notes in
the ANPRM that it intends to conduct such research and looks forward to
receiving additional research from other interested parties.
In the meantime, as noted in the preceding comment, FDA is issuing
this final rule to require the quantitative declaration of trans fat in
the Nutrition Facts panel. To help consumers understand more about this
heart-unhealthy fat, the agency plans to initiate consumer education
programs about this final rule following publication (see Comment 28).
As noted earlier, most comments that opposed the proposed footnote
stated a belief that even in the absence of a DV, consumers can still
find quantitative information useful, and pointed to current labeling
of mono- and polyunsaturated fats. In light of previous research that
shows that consumers often use information on the Nutrition Facts panel
to compare levels of nutrients in two or more foods, FDA concludes that
it is important to proceed to list the quantitative information on
trans fat at this time so that consumers will have information to use
in comparing products and making dietary selections to reduce their
intake of trans fat. The agency believes a footnote or other labeling
approach about saturated fat, cholesterol, and trans fat may provide
additional assistance to convey the relative importance of each of
these fats to consumers in a manner which enables them to understand
their relative significance, to each other and in the context of a
total daily diet. However, because of the public health impact of CHD
in the United States and the additional time it will take to conduct
the necessary consumer research, the agency concludes that it is
essential to proceed at this time to mandate the listing of the
quantitative information on trans fat so that consumers will be able to
use that information to help maintain healthy dietary practices and to
address an added footnote statement at a later time.
FDA acknowledges concerns, expressed in response to the November
[[Page 41460]]
2002 notice (67 FR 69171) to reopen the comment period, about the
shortness of the comment period and requests to extend the comment
period. However due to the high level of interest in the public health
and economic aspects of this rule, the agency did not believe it was in
the public interest to provide for additional time for comment. A
longer comment period, however, will be provided for the ANPRM being
published elsewhere in this issue of the Federal Register.
(Comment 18) A few comments requested that the term ``trans fatty
acids'' not be used interchangeably with ``trans fat'' as proposed in
Sec. 101.9(c)(2)(i)(B) in the November 1999 proposal. These comments
stated that the term ``fatty acid'' would be confusing to consumers and
is inconsistent with the terminology used in nutrition labeling and
claims for other fatty acids, i.e., ``saturated fat,''
``polyunsaturated fat,'' and ``monounsaturated fat.'' The comments
stated that while ``fatty acid'' is technically correct, labels should
use the easier term to understand, i.e., ``trans fat.''
The agency agrees that there should be consistent terminology used
on the food label and notes that proposed Sec. 101.9(c)(2)(i)(B),
which dealt primarily with the proposed footnote about trans fat
content, is deleted from this final rule. The agency did not move the
sentence providing for the use of the term ``trans fatty acids'' to new
Sec. 101.9(c)(2)(ii). Therefore, the term ``fatty acids'' is not to be
used on the Nutrition Facts panel.
Conforming Amendments
Because this final rule is making trans fat a mandatory nutrient to
be placed on a separate line in nutrition labeling, there are a number
of conforming amendments throughout Sec. 101.9 that must be made.
Section 101.9(c) requires that information on mandatory nutrients, such
as saturated fat and trans fat, be included in all nutrition labeling
unless otherwise excepted from such labeling as provided for in
specified paragraphs.
Special provisions within Sec. 101.9(c) allow for shortened
formats that provide manufacturers flexibility to omit noncore
nutrients (i.e., mandatory nutrients other than calories, total fat,
sodium, total carbohydrate, and protein) that are present in
insignificant amounts from the list of nutrients and group them in a
summary statement at the bottom of the label that states ``Not a
significant source of ------------'' (see 58 FR 2079 at 2083, Comment
8, January 6, 1993). These special provisions are found in Sec.
101.9(c)(1)(ii) for calories from fat, Sec. 101.9(c)(2)(i) for
saturated fat, Sec. 101.9(c)(3) for cholesterol, Sec. 101.9(c)(6)(i)
for dietary fiber, Sec. 101.9(c)(6)(ii) for sugars, and Sec.
101.9(c)(8)(iii) for vitamin A, vitamin C, calcium, or iron. For
consistency with the labeling scheme for these other noncore mandatory
nutrients, new Sec. 101.9(c)(2)(ii) provides that if the trans fat
content is not required and, as a result, not declared, the statement
``Not a significant source of trans fat'' must be placed at the bottom
of the table of nutrient values. Also, for added consistency, new Sec.
101.9(c)(2)(ii) will point to an exception to this requirement under
Sec. 101.9(f). Section 101.9(f) provides for a simplified format to be
used on labels of products containing insignificant amounts of more
than half the nutrients required to be in the Nutrition Facts label.
Except as specified in Sec. 101.9(f)(4), products that qualify for the
simplified format do not have to use the statement ``Not a significant
source of ------------'' for noncore nutrients that are omitted from
the label under Sec. 101.9(c). An example of such an exception would
include when nutrition claims are made for the product.
Current Sec. 101.9(c)(2)(i) requires label declaration of
saturated fat content information on a separate line (the ``Not a
significant source of --------'' statement would not be an option), if
claims are made about fat or cholesterol and if ``calories from
saturated fat'' is declared. In the November 1999 proposal, Sec.
101.9(c)(2)(i) was amended to also require label declaration of
saturated fat content information when claims are made about fatty
acids. Current Sec. 101.9(c)(2)(i) did not include claims about fatty
acids because at the time that regulation was proposed (56 FR 60478,
November 27, 1991), it was thought unnecessary since no claims were
proposed for fatty acids that were present at less than 0.5 g per
reference amount. However, when the ``saturated fat free'' claim was
established in the final rules (58 FR 2302 at 2331), FDA inadvertently
did not amend Sec. 101.9(c)(2)(i) to require the declaration of
saturated fat content on a separate line when fatty acid claims were
made. As a result, the declaration of saturated fat content was not
required when ``saturated fat free'' claims were made. This is
inconsistent with regulations governing claims for all other nutrients
that require the listing of the nutrient that is the subject of the
claim within the Nutrition Facts panel so that consumers can easily
find quantitative information supporting claims made for a product.
Because no comments objected to the proposed requirement in the
November 1999 proposal for a label declaration of saturated fat content
when fatty acid claims are made, which would require that saturated fat
content be listed when a ``saturated fat free'' claim is used, FDA is
finalizing this part of the regulation as proposed. Similarly, new
Sec. 101.9(c)(2)(ii) also requires label declaration of trans fat
content information if claims are made about fat, fatty acids, or
cholesterol.
In reference to the statement ``Not a significant source of ------
------'' that is to be placed at the bottom of the list of nutrient
values, the agency proposed in the November 1999 proposal (64 FR 62746
at 62757) to remove the phrase ``in the same type size'' in Sec.
101.9(c)(2)(i) where it refers to the size of the statement. This
action was intended to correct a technical error in the regulations
caused by the fact that current Sec. 101.9(d)(1)(iii) allows the
statement, along with all footnotes, to be in type size no smaller than
6 point type while it requires the listing of nutrient values to be in
type size no smaller than 8 point type. Accordingly, the phrase ``in
the same type size'' in Sec. 101.9(c)(2)(i) would require the ``Not a
significant source of --------'' statement to be in 8 point type,
conflicting with Sec. 101.9(d)(1)(iii). This technical error was
addressed in amendments published on August 18, 1993 (58 FR 44063 at
44065-66). To correct the problem, FDA stated at that time (58 FR 44063
at 44065-66) that it was removing the sentence from Sec.
101.9(c)(8)(iii) that required the ``Not a significant source of ------
'' statement to be in the same type size as nutrients listed in the
Nutrition Facts panel. However, the agency failed to notice the same
error in Sec. 101.9(c)(2)(i), (c)(3), (c)(6)(i), and (c)(6)(ii).
Inadvertently, the conflicting sentence was never removed from Sec.
101.9(c)(8)(iii), nor were the statements requiring ``in the same type
size'' removed from any of the other paragraphs. In this final rule,
FDA is making the correction in Sec. 101.9(c)(2)(i) and in new Sec.
101.9(c)(2)(ii). The agency intends to remove the phrase ``in the same
type size'' from the remaining sections of Sec. 101.9(c) in the
future.
In addition, current nutrition labeling rules provide exemptions
for select nutrients when food products qualify for simplified formats
(see Sec. 101.9(f)).
FDA is revising Sec. 101.9(f) that pertains to the use of a
simplified format when a food product contains insignificant amounts of
seven or more of the mandatory nutrients. This section implements
section 403(q)(5)(C) of the act, which states that ``If a food contains
[[Page 41461]]
insignificant amounts ... of more than one-half the nutrients required
* * * to be in the label or labeling of the food, the Secretary shall
require the amounts of such nutrients to be stated in a simplified form
prescribed by the Secretary.'' Current regulations considered 13
required nutrients (calories, total fat, saturated fat, cholesterol,
sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A,
vitamin C, calcium, and iron) and calculated ``more than one-half'' to
mean that seven or more nutrients must be at insignificant levels for a
product to use the simplified format (58 FR 2709 at 2140, comment 173).
Accordingly, in conformance with the statutory requirements, the
inclusion of trans fat as a mandatory nutrient results in a total of 14
required nutrients. This new total necessitates changing the number of
nutrients that must be present in insignificant amounts in Sec.
101.9(f) from seven to eight to qualify a food for the simplified
format. Therefore, FDA is revising Sec. 101.9(f) to state ``The
declaration of nutrition information may be presented in the simplified
format set forth herein when a food product contains insignificant
amounts of eight or more of the following: Calories, total fat,
saturated fat, trans fat, cholesterol, sodium, total carbohydrate,
dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron
* * *''
FDA is modifying sample labels throughout Sec. 101.9 to be
consistent with the revisions described previously. The citations for
the sample labels that have been modified are as follows: Sec.
101.9(d)(11)(iii) (the tabular display of the nutrition label),
paragraph (d)(12) (the full nutrition label), paragraph (d)(13)(ii) (an
example of an aggregate nutrition label), and paragraph (e)(5)
(nutrition information presented for a food ``as purchased'' and ``as
prepared''). Likewise, the sample labels in Sec.
101.9(j)(13)(ii)(A)(1) and (j)(13)(ii)(A)(2) (tabular display and
linear displays, respectively, of nutrition labels for foods in
packages with a total surface area available to bear labeling of 40 or
less square inches) are also being revised to include trans fat.
Other conforming amendments to Sec. 101.9 that are required as a
result of this rulemaking include revisions to paragraphs (g)(5) and
(g)(6) that inform the industry of how FDA will determine compliance
with this section. Paragraph (g)(5) addresses those nutrients for which
dietary guidance generally recommends limitations on intake.
Accordingly, FDA will include trans fat as one of the nutrients that
are deemed to be misbranded under section 403(a) of the act if the
nutrient content of the composite sample is greater than 20 percent in
excess of the value for that nutrient declared on the label. Likewise,
Sec. 101.9(g)(6) is being revised to state that reasonable
deficiencies in a food of calories and specified nutrients, including
trans fat, under labeled amounts are acceptable within current good
manufacturing practice.
Section 403(q)(5)(F) of the act specifies that dietary supplement
products shall bear nutrition labeling ``in a manner which is
appropriate for the product and which is specified in regulations...
.'' Accordingly, FDA issued regulations in Sec. 101.36 that specify
the nutrition information that must be on the label or labeling of
dietary supplements (62 FR 49826, September 23, 1997). In the November
1999 proposal, FDA proposed to amend Sec. 101.36 to maintain
consistency in the nutrition labeling of conventional foods and of
dietary supplements. Comments unanimously supported revising Sec.
101.36 to be consistent with Sec. 101.9 as it pertains to the
provisions for trans fat. Accordingly, FDA is revising paragraph Sec.
101.36(b)(2)(i) to provide for trans fats in the nutrition labeling of
dietary supplements.
This final rule also impacts on the voluntary nutrition labeling
program of raw fruits, vegetables, and fish in that Sec. 101.45(a)(2)
requires that nutrients be declared in accordance with Sec. 101.9.
However, because section 403(q)(4)(A) of the act requires the
Secretary, and by delegation FDA, to furnish nutrition information for
that program and the agency has proposed to update those values (67 FR
12918, March 20, 2002), the agency is deferring action on Sec. 101.45
until a final rule is published on that rulemaking.
C. Definition of Trans Fatty Acids
In the November 1999 proposal, FDA defined trans fatty acids as
``unsaturated fatty acids that contain one or more isolated (i.e.,
nonconjugated) double bonds in a trans configuration (64 FR 62746 at
62757).
(Comment 19) Most of the comments on the definition of trans fat
supported the proposed definition that excludes fatty acids with
conjugated bonds, stating that trans fatty acids with conjugated bonds
are metabolized differently than those with nonconjugated bonds and
that this definition adequately identifies the fatty acids intended to
be covered by the rule. A few comments recommended that trans fatty
acid precursors of conjugated linoleic acid (CLA) should also be
excluded from the definition. These comments noted that trans-vaccenic
acid (trans-11 18:1), which is the dominant trans fatty acid in
products of ruminant origin (e.g., cows' milk), can be desaturated in
the body and converted to CLA. For this reason, the comments
recommended that trans fatty acids of ruminant origin not be included
in the definition of trans fatty acids.
Other comments stated that trans fatty acids with conjugated bonds
should be included in the definition of ``trans fatty acids.''
Another comment requested that FDA explicitly state that the rules
on the labeling and claims for trans fatty acids apply equally to
naturally occurring trans fats.
FDA notes that the comments requesting that trans vaccenic acid and
other trans fatty acids of ruminant origin be excluded from the
definition of trans fatty acids and that fatty acids with conjugated
bonds be included focused on functional or metabolic aspects of these
compounds (e.g., their metabolic transformations to other types of
fatty acids) rather than on their actual chemical structures. Since
most of the comments agreed with the proposed definition, which
identifies trans fatty acids by their chemical structures, the agency
is taking no action in response to suggestions to define trans fatty
acids by their functional attributes. Thus for the purposes of this
rule, the origin of the trans fatty acid does not matter. Trans
vaccenic acid, a trans fatty acid with a single double bond, and other
trans fatty acids of ruminant origin with either a single double bond
or nonconjugated double bonds are included in this chemical definition
of trans fatty acids. Trans fatty acids with conjugated bonds will not
be included because they do not meet the Agency's regulatory chemical
definition of trans fatty acids which is ``all unsaturated fatty acids
that contain one or more isolated double bonds in a trans
configuration.'' FDA notes also that while the proposal combined
saturated fat and trans fatty acids on a single line, this final rule
provides for a separate line for trans fat. The declarations of
saturated fat and trans fat will now be separate and both declarations
will be based on chemical definitions of these components. Again, trans
fatty acids, regardless of origin, that meet the above definition are
to be included in the label declaration of trans fat.
FDA notes that, in classifying fatty acids, the IOM report on
macronutrients uses a chemical definition of trans fatty acids that
differs from FDA's regulatory chemical definition. The IOM report
includes all fatty acids with a double bond in the trans configuration
in the broad category of trans fatty acids (Ref.
[[Page 41462]]
140). Thus, the IOM definition includes both conjugated and non-
conjugated double bonds in the trans configuration, whereas FDA's
definition only includes trans fatty acids with nonconjugated double
bonds. In addition, the IOM report considers conjugated linoleic acid
as a collective term for geometric and positional fatty acids in which
the double bonds (trans and/or cis) are conjugated. In the IOM report,
the categories, trans fatty acids and conjugated linoleic acid,
overlap. Under FDA's definition, conjugated linoleic acid would be
excluded from the definition of trans fat. Thus, using FDA's regulatory
chemical definition, the categories ``trans fatty acids'' and
``conjugated fatty acids'' are mutually exclusive. The definition of
trans fatty acids, excluding fatty acids with conjugated double bonds,
is consistent with the way that cis isomers of polyunsaturated fatty
acids are defined in redesignated Sec. 101.9(c)(2)(iii).
D. Methodology
(Comment 20) One comment asked whether the Association of Official
Analytical Chemists (AOAC) Official Method 996.01 can be used for
measuring trans fat in foods. The comment noted that, at present, AOAC
Official Method 996.01 is the ideal method for the measurement of total
fat, saturated fat, and mono- and polyunsaturated fat in foods. The
comment noted further that AOAC Official Method 996.01 was originally
intended for cereal products containing 0.5-13 percent total fat and
that recently, a study by Ali et al. (Ref. 30) demonstrated its
applicability to all types of food matrices with fat contents ranging
from 0.7 to 97.5 g/100 g food. The comment noted that the method of Ali
et al. (Ref. 30) used an SP-2560 fused silica capillary column (100
meters (m) x 0.25 millimeter (mm)) and can be used for the accurate
determination of trans fatty acids. The comment noted that if
appropriate gas chromatography (GC) operating conditions are selected,
the SP-2560 column as well as columns of similar polarity give a very
good separation of cis and trans isomers.
FDA notes that, as currently written, AOAC Official Method 996.01
is not suitable for quantifying trans fatty acids for food labeling
purposes because the capillary column specified (i.e., 30 m x 0.25 mm
id., 0.2 microm film, non-bonded 90 percent cyanopropyl, 10 percent
phenyl siloxane) is not sufficiently long to obtain adequate separation
of the cis and trans fatty acids. Ali et al., (Ref. 30) modified the
method and used a 100 m flexible fused silica column (SP-2560, 100 m x
0.25 mm id., 0.20 microm film thickness) to obtain better separation of
isomers in food samples. Specifically, better resolution in the complex
18:1 and 18:2 regions was obtained with the longer column. FDA has
found that when appropriate operating conditions are selected, the SP-
2560 column and other columns of similar polarity give a very good
separation of cis and trans isomers. We point out, however, that the
modification described by Ali et al., (Ref. 30) has not been subjected
to a collaborative study and is not an official method.
It is important to note that FDA regulations do not specify the
methodology that firms are to use in obtaining values for nutrition
labeling purposes. Rather, under Sec. 101.9(g)(2), FDA determines
compliance with nutrition labeling rules by using appropriate
analytical methods ``as given in the `Official Methods of Analysis of
the AOAC International' 15th Ed. (1990) or, if no AOAC method is
available or appropriate, by other reliable and appropriate analytical
procedures.'' Firms may choose to use a method other than that which
the agency uses to determine compliance, but the firm would be subject
to, for compliance purposes, a method the agency considers appropriate
under Sec. 101.9(g). With respect to analysis of fats (including trans
fat), FDA laboratories utilize the most recent editions (including
revisions of methods from the Association of Official Analytical
Chemists International (AOACI; Official Methods of Analysis of AOAC
International, 17th edition, Revision 1, 2002; AOAC International,
Gaithersburg, MD) (Ref. 143) and the American Oil Chemists Society
(AOCS; Official Methods and Recommended Practices of the AOCS, 2002-
2003 Methods-Additions and Revisions, AOCS Press, Champaign, IL) (Ref.
144)).
(Comment 21) Several comments asked that FDA recognize AOAC Method
996.06 as modified in the Journal of the Association of Official
Analytical Chemists in January 2000, as a suitable method for the
analysis of trans fatty acids for food labeling purposes.
FDA points out that recommendations for the modification of AOAC
Official Method 996.06 (Ref. 105) were published in the Journal of the
Association of Official Analytical Chemists (Ref. 106). The
recommendations are based on the work of DeVries et al. 1999 (Ref.
107). DeVries and coworkers report that while quantitation of fat in
foods has been performed successfully with AOAC Official Method 996.06,
a number of situations have been encountered that render the following
method note inaccurate: ``For any unknown or uncalibrated peaks, use
the nearest calibrated fatty acid response factors and conversion
factors'' (Ref. 107). Specifically, the identification of extraneous
compounds and availability of additional standard fatty acid methyl
esters combined with mass spectral data led to the recommendation of
modifications in AOAC Official Method 996.06.
Specific recommendations for modifications include recommendations
that the column requirements for the method be changed to a
performance-based specification such that a capillary column capable of
separating adjacent peaks of C18:3 and 20:1 and the fatty acid methyl
ester trio of adjacent peaks of C22:1, C20:3 and C20:4 with a
resolution of 1 or greater be used. Column SP-2560, 100 m x 0.25 mm
with a 0.20 microm film was identified as a suitable column.
The recommendations referenced in the paragraph above have now been
incorporated into AOAC Method 996.06 (Official Methods of Analysis of
AOAC International, 17th edition, Revision 1, 2002; chapter 41.1.28A)
(Ref. 105). This method is suitable for use in a wide range of food
matrices for measuring trans fat for labeling purposes.
AOAC Method 996.06 cited above for trans fat analysis is the most
current AOAC gas chromatography method available and FDA will consider
it an appropriate method under Sec. 101.9(g)(2) for determining
compliance with nutrition labeling provisions for trans fat. AOAC
Method 996.06 is not included in the 15th edition (1990) of Official
Methods of Analysis of AOAC International (which is incorporated by
reference in Sec. 101.9(g)(2)) because the process of development and
validation of this method was not completed until 1996. Therefore, AOAC
Method 996.06 as it is reported in Revision 1, 2002 of the 17th edition
of Official Methods of Analysis of AOAC International (Ref. 105) may be
used as an ``other reliable and appropriate analytical procedure'' as
provided for in Sec. 101.9(g)(2). FDA intends to propose amendments in
the future on the edition of the AOAC method listed in Sec.
101.9(g)(2) and other needed revisions of Sec. 101.9.
(Comment 22) One comment noted that detection methodology is not
sophisticated enough to accurately measure trans fat in all food
products. The comment stated that significant work is needed to
validate the AOCS methods for food matrices other than fat and oils.
[[Page 41463]]
FDA disagrees with this statement. While the agency recognizes that
AOCS methods have not been extended to cover matrices other than fats
and oils, the AOAC method 996.06 (Official Methods of Analysis of AOAC
International, 17th edition, Revision 1, 2002) (Ref. 105) is suitable
for the analysis of trans fat in a wide range of foods of varying fat
content. As noted in comment 19, above, AOAC Method 996.01 is not
suitable for quantifying trans fatty acids for food labeling purposes
because the capillary column specified is not sufficiently long to
obtain adequate separation of the cis and trans fatty acids.
(Comment 23) A few comments recommended that FDA consider listing
amounts of trans fat to the nearest tenth or hundredth of a gram,
rather than to the nearest 0.5 g. One of these comments stated that
Canada has established a rounding limit of 0.1 g for food labeling
indicating that analytical methods are capable of detecting that
amount.
FDA disagrees with these recommendations. FDA notes that while
these recommended levels might be quantifiable by laboratories using GC
methodology such as that described in AOAC method 996.06 (Official
Methods of Analysis of AOAC International, 17th edition, Revision 1,
2002) (Ref. 105), they will pose a problem for laboratories that are
set up to quantify trans fatty acids by infrared spectroscopy (IR)
methodology because the detection limits of the currently available IR
methods are higher than those of the GC methods. More importantly,
however, there are no unambiguous methods for confirming the very low
levels suggested by the comment.
Moreover, FDA notes that the increment for listing trans fat is
consistent with increments used for listing total fat and saturated
fat. Therefore, the agency is finalizing Sec. 101.9(c)(2)(ii) to state
that trans fat shall be expressed, as proposed, to the nearest 0.5 g
increment below 5 g and to the nearest gram increment above 5 g.
(Comment 24) One comment noted that the IR method of choice in the
November 1999 proposal, AOCS Recommended Practice Cd 14d-96 (Ref. 45),
generally overestimates trans fat at low levels because of
interferences and issues with both accuracy and detection limits. The
comment noted further that the AOCS GC method Ce 1f-96 (Ref. 46) has
better sensitivity, but has not been validated for many types of food
products and that significant work is needed to validate this method
for other food matrices.
FDA agrees that the detection limits of the AOCS GC method (Ce 1f-
96) (Revised 2002, Ref. 146) are lower than those of the AOCS IR
recommended practice (Cd 14d-96) (Revised 1999, Ref. 145). FDA notes
that AOCS Recommended Practice Cd-14d-96 is applicable to the
determination of isolated trans double bonds in natural or processed
oils and fats with trans levels equal or greater than about 0.8
percent. The lower limit of quantitation for this IR recommended
practice may be higher (i.e., the method may be less accurate for
determination of low levels of trans fat) for complex systems such as
commercial food products (Ref. 145).
The AOCS Official Method Ce 1f-96 (Ref. 146) is designed to
evaluate the level of trans isomers formed during refining or during
hydrogenation of vegetable oils or fats and the scope of the method
does not extend beyond these matrices. FDA notes that the recent
improvements in AOAC Official Method 996.06 as referenced in Revision
1, 2002 (Ref. 105), have resulted in the applicability of this GC
method to a wide range of food products.
(Comment 25) One comment asked if trans fat values below 0.5 g are
to be declared as ``0,'' how FDA will address the labeling of foods
like butter, where trans fat content fluctuates seasonally above and
below 0.5 g per serving. The comment stated that FDA should err on the
side of conservatism and require that labeling be based on the highest
levels found in such products over the entire year.
FDA has long recognized that variations occur naturally in the
nutrient content of foods. The compliance procedures that FDA follows,
which are found in Sec. 101.9(g)(2), provide that a sample for
nutrient analysis must consist of a composite of 12 subsamples, taken
one from each of 12 randomly chosen shipping cases. FDA will then
analyze the nutrient content of this composite test sample. Upon
determination of the laboratory analyses, FDA uses the compliance
procedures set forth in Sec. 101.9(g)(5) and (g)(6) to determine if
the values declared for those nutrients that have recommended dietary
limits, such as saturated fat and cholesterol, misbrand the label. The
content of a sample composite of these nutrients is in compliance if
the analyzed value is no more than 20 percent greater than the value
declared on the label. Stated another way, for nutrients listed in
Sec. 101.9(g)(5), the ratio between the nutrient level obtained by
laboratory analysis and the product's label value, multiplied by 100,
cannot be greater than 120 percent for the product to be in compliance.
For example, if the laboratory value is 4 grams, and a product's label
value is 2 gram, the ratio (4/2) x 100 = 200 percent. This value is
greater than 120 percent, hence, the product is out of compliance.
FDA did not address this issue in the proposal because the
declaration of ``saturated fat'' included trans fats, and saturated
fats are addressed in Sec. 101.9(g)(5) and (g)(6). Now that FDA is
requiring that trans fat be declared in the main body of the nutrition
label (i.e., the amount of trans fat is not in a footnote), FDA is
making a conforming amendment to Sec. 101.9(g)(5) and (g)(6) to
include trans fatty acids.
FDA's policy since the 1970s assigns the manufacturer the
responsibility for assuring the validity of a product label's stated
nutrient values (Ref. 108). Accordingly, the source of the data used to
calculate nutrition labeling values is the manufacturer's prerogative,
but FDA's policy recommends that the nutrient values for labeling be
based on product composition, as determined by laboratory analysis of
each nutrient. If a manufacturer knows that a nutrient is likely to
vary over seasons or due to other factors (e.g., location, growing
conditions, product transport, or processing practices), in order to
assure compliance, the manufacturer should analyze samples of the
product over the various seasons or relative to other factors to
account for variability of nutrient content.
To ensure that label values will accurately represent the nutrient
content of food products to consumers and also have a high probability
of being in compliance with nutrition labeling regulations, FDA
recommends the calculation of a one-sided 95 percent prediction
interval as the most appropriate and the preferred method to use in
computing label values (Ref. 108).
Prediction intervals take into account the variability of a
nutrient. Mean values do not. A manufacturer of a product, like butter,
whose trans fat content fluctuates seasonally, would want to analyze
samples of trans fat during each season and statistically consider
using 95 percent prediction intervals to calculate the nutrition label
value for trans fat. A predicted value on a nutrition label may
sometimes indicate a level of a nutrient such as saturated fat at a
higher level than is actually in the product, but it will never show a
lower level than the product contains. While sometimes predicted values
and mean values round to the same nutrient level, products bearing mean
values on their nutrition labels
[[Page 41464]]
have a lower probability of meeting FDA compliance requirements.
VI. Nutrient Content Claims, Health Claims, Disclosure and
Disqualifying Levels
In its November 1999 proposal, FDA proposed a definition for the
nutrient content claim ``trans fat free'' and proposed limits on the
amounts of trans fat wherever saturated fat limits are placed on
nutrient content claims, health claims, or disclosure and disqualifying
levels. Several comments to that proposal requested that the final rule
define the claim ``reduced trans fat'' or amend the claim ``reduced
saturated fat'' to require a reduction of saturated and trans fats
combined. To address this issue, the agency reopened the comment period
(65 FR 75887) to consider ``reduced trans fat'' and ``reduced saturated
and trans fat'' claims.
With regard to the specific definitions, FDA proposed that ``trans
fat free'' and ``saturated fat free'' should be defined as less than
0.5 g trans fat and less than 0.5 g saturated fat per reference amount
and per labeled serving; ``low saturated fat'' as 1 g or less of
saturated fat and less than 0.5 g of trans fat per reference amount and
not more than 15 percent of calories from saturated fat and trans fat
combined; ``reduced saturated fat'' as at least 25 percent less
saturated fat and at least 25 percent less saturated fat and trans fat
combined; ``lean'' as 4.5 g or less of saturated fat and trans fat
combined; and ``extra lean'' as less than 2 g of saturated fat and
trans fat combined. In addition, cholesterol claims were allowed only
on foods containing 2 g or less of saturated fat and trans fat
combined, and disqualifying and disclosure levels were set at 4 g or
less of saturated fat and trans fat combined. FDA did not propose to
define ``low trans fat.''
The comments relating to claims were very diverse and indicated
strongly opposing views. With regard to the ``trans fat free'' claim,
some comments favored the proposed definition, while other comments
suggested increasing the saturated fat limit, eliminating the saturated
fat limit , or not defining this claim. Similarly, some comments
supported the ``saturated fat free'' claim, while other comments
recommended that the trans limit be increased to 2 g. For ``low
saturated fat'' some comments favored the proposed definition, while
others suggested increasing the trans fat limit as high as 2 g. One
comment recommended that this claim be less than or equal to 1.5 g of
saturated and trans fats combined.
A number of comments supported having a ``reduced trans fat'' claim
and others were against it. The vast majority of the comments in favor
of this claim suggested that trans fat be reduced by at least 25
percent, but there was little agreement on the secondary saturated fat
criterion. The comments ranged from no limit on saturated fat, to no
increase in the level of saturated fat, a limit of less than or equal
to 2 g, or at least a 25 percent reduction. The comments on ``reduced
saturated'' fat were similar to the comments on ``reduced trans fat''
in that there was no agreement on the level of the secondary criterion,
i.e., trans fat for this claim. In addition, some comments recommended
having the claim ``reduced saturated and trans fats'' for greater
flexibility, while others opposed such a claim. Of those in favor, some
comments recommended a reduction of at least 25 percent in saturated
and trans fats combined, one comment favored a 33 to 50 percent in
saturated and trans fats combined, and one comment wanted a 25 percent
reduction in saturated fat and a 25 percent reduction in trans fat.
Finally, the comments on disclosure and disqualifying levels were
equally divergent. Some comments favored the proposed criterion of 4 g
or less of saturated and trans fats combined, while others recommended
a limit of 4 g of saturated fat and 4 g of trans fat, or believed that
there should be no limit on trans fat. One comment stated that trans
fat thresholds should be incorporated into the criteria defining
nutrient content claims and health claims only to the extent that such
criteria are necessary to prevent the claim from misleading consumers.
The comment stated that this is the approach FDA applied in
establishing the saturated fat thresholds for cholesterol content
claims in Sec. 101.62(d) and is an appropriate construct for nutrient
content claims about trans fat.
The objections in the comments against the proposed definitions
were generally based on scientific, legal, or economic arguments. Some
of the comments believed that the agency is acting in advance of
sufficient scientific justification, while others stated that the
agency should have acted sooner. There was disagreement as to whether
the adverse effects of trans fat are comparable to that of saturated
fat. Some of the comments stated that the proposed definitions assume
that trans fat and saturated fat are ``bioequivalent.'' These comments
particularly objected to changing the disclosure and disqualifying
level of 4 g of saturated fat to 4 g of saturated and trans fat
combined (i.e, holding the current level constant and including trans
fat). These comments argued that the effects of saturated fat and trans
fat have not been proven to be the same on a gram-for-gram basis and,
therefore, should not be treated interchangeably. Other comments stated
that there is no scientific evidence showing any adverse effects on
serum cholesterol levels or cardiovascular health from trans fat in a
mixed diet to support FDA's proposed definitions for nutrient content
claims.
Other comments argued that the proposed claims should be included
in the final rule for public health reasons, while others argued that
less restrictive claims would benefit the public health to a greater
extent because they would encourage more reformulation. Some of these
comments pointed out that the ``trans fat free'' claim, in particular,
is not meaningful because very few foods could meet the proposed
criteria and therefore would not be used enough to be helpful.
Several comments asserted that FDA did not meet its burden under
the first amendment because the threshold levels proposed by FDA for
trans fat for certain nutrient content and health claims, which, if
exceeded, would prohibit the use of the claims on food and have the
effect of restricting the use of specific claims that would be truthful
and not misleading. The comments reasoned that FDA could only limit
claims where the level of trans fat in a food product would make the
claim misleading. Further, the comments reasoned that, before FDA could
prohibit a claim, FDA would need to establish that the use of a
disclaimer on the label or the disclosure of trans fat on the label
could not prevent the claim from being potentially misleading.
Economic concerns regarding the proposed nutrient content claims
are discussed in section IX of this document.
FDA has carefully reviewed the comments and finds that it has
insufficient scientific information at this point in time to support a
decision on the appropriate definition for the nutrient content claims
discussed in the November 1999 proposal and the December 5, 2000,
notice to reopen the comment period. The comments that expressed a
preference for a specific threshold level of trans fat for various
claims did not provide a scientific rationale to support the level. In
the past, the development of definitions for nutrient content claims
and the establishment of disclosure and disqualifying levels generally
have been dependent upon scientific agreement of appropriate
quantitative reference values for daily consumption of the
[[Page 41465]]
nutrient that is the subject of the claim. In proposing nutrient
content claims, the agency stated that ``With the exception of the term
``sugar free'' and terms related to caloric levels in foods, the agency
has limited the proposed definitions to nutrients for which there are
proposed DRVs or RDIs'' (56 FR 60421 at 60429, November 27, 1991). The
approach of having an appropriate reference value for daily consumption
provides a consistent and quantitative basis for defining claims. As
stated in section V of this document, in the absence of the type of
quantitative information from authoritative scientific groups on which
the agency could support the establishment of a DRV for trans fat, the
agency is providing for mandatory trans fat labeling, without a %DV.
The agency does not believe that the current level of scientific
evidence supports the establishment of such a value for trans fat at
this time. Many comments supported this position. As a result of the
absence of an appropriate reference value for trans fat, the agency has
been hampered in developing an integrated approach that responds to the
issues raised in the comments. Accordingly, the agency is withdrawing
those sections of the November 1999 proposal pertaining to the
establishment of a definition for ``trans fat free,'' consideration of
``reduced trans fat'' and ``reduced saturated and trans fat'' claims
and limits on the amounts of trans fatty acids wherever saturated fatty
acid limits are placed on nutrient content claims, health claims, or
disclosure and disqualifying levels. FDA plans to continue to evaluate
the evolving science and, when the science has evolved to a point where
the agency believes it can proceed with scientifically-based
definitions and levels for these claims, it will proceed to do so
through a new rulemaking. FDA will seek to ensure that it acts
consistent with its obligations under the first amendment to allow
truthful and nonmisleading speech.
As discussed under comment 17, FDA is issuing an ANPRM elsewhere in
this issue of the Federal Register that will solicit comment and data
that potentially could be used to establish new nutrient content claims
about trans fat, to establish qualifying criteria for trans fat in
current nutrient content claims for saturated fat and cholesterol, lean
and extra lean claims, and health claims that contain a message about
cholesterol raising fats, and to establish disclosure and disqualifying
criteria for trans fat.
VII. Other Issues
(Comment 26) Several comments requested that FDA defer rulemaking
on trans fat labeling until both FDA and USDA are able to concurrently
take this action.
FDA consulted with USDA and both agencies agree that it is
important that nutrition labeling rules for both agencies be consistent
and that labeling of trans fat is necessary to assist consumers in
maintaining healthy dietary practices. USDA is considering a similar
policy for trans fat labeling based on the view that the approach to
nutrition labeling should be consistent, but currently does not have a
rulemaking on trans fat labeling on its regulatory agenda. Because
trans fat levels are expected to be higher in foods regulated by FDA,
as compared to foods under USDA jurisdiction, and because FDA has a
citizen petition on the labeling of trans fat, FDA has determined that
it is necessary to proceed with this final rule based on the public
health interest. FDA notes that it is committed to cooperating with
USDA, as needed, on trans fat labeling in any future action that USDA
may consider.
(Comment 27) Some comments requested that trans fat not be used in
restaurant food or its use be reduced.
These comments are outside the scope of this rule on the
nutritional labeling of trans fat. This rulemaking is about trans fat
labeling and not about whether or not trans fat is used in food
generally or in particular food products. Although restaurant foods are
not required to provide full nutrition labeling, they are required
under Sec. 101.10 (21 CFR 101.10), ``Nutrition Labeling of Restaurant
Foods,'' to provide information on nutrients that are relevant to any
nutrient content claims made. Further guidance on labeling of
restaurant foods may be found in ``Questions and Answers Volume II, A
Guide for Restaurants and Other Retail Establishments'' (Ref. 111).
(Comment 28) A number of comments to the November 1999 proposal and
the November 2002 notice reopening the comment period of the November
1999 proposal stated that there is a great need for consumer education
about trans fatty acids and the nutrition label.
FDA agrees that consumer education will be needed as a result of
this final rule so that consumers are better able to utilize the new
trans fat labeling information to assist them in maintaining healthy
dietary practices. Since the first edition of ``Dietary Guidelines for
Americans'' in 1980 (Ref. 112), Americans have been advised to avoid
too much saturated fat to reduce the risk of heart disease. This
message has also been a major factor in the National Cholesterol
Education Program, which has been in existence since 1985 (http://www.nhlbi.nih.gov/about/ncep/index.htm) that focuses on individuals at
higher risk for CHD. Some success of these educational programs was
demonstrated by the third National Health and Nutrition Examination
Survey (Ref. 89) conducted during 1988-94, that showed that the
public's intake of saturated fat has declined since the previous survey
conducted from 1976-80 (Ref. 113). Also, the 1994-96 CSFII showed a
decline in the public's intake of saturated fat since a previous survey
conducted in 1989-91 (Ref. 142). Therefore, in introducing new messages
about trans fatty acids, FDA intends to work with existing public
health programs to build upon the extensive work done by them to
educate consumers about saturated fatty acids and cholesterol and their
relationship to heart health.
The agency also plans to initiate a variety of outreach and
consumer education programs about this final rule following
publication. Electronic dissemination of this information will be
provided at FDA's Web site and briefings will be provided to
representatives of a variety of health professionals, government
agencies, industry representatives, trade associations, and press and
consumer groups so that they can communicate trans fat information to
their constituencies. To assist in this effort, education and press
materials will be developed to facilitate communication to consumers
about changes they will see as trans fat is added to the nutrition
label and how they can use that information in their efforts to
maintain a healthy diet.
(Comment 29) A few comments suggested using color coding to help
consumers quickly recognize unhealthy products, including those
containing trans fat. One of the comments mentioned applying this
technique to ingredient listing and another comment said that a graphic
could show the proportion of saturated, trans, polyunsaturated, and
monounsaturated fats. The latter comment noted that horizontal color
bars were used quite successfully in the introduction of canola oil in
the United States.
These comments are outside the scope of this final rule on the
nutrition labeling of trans fatty acids. The agency notes that
manufacturers are free to use color bars on the product label outside
of the Nutrition Facts panel (i.e., the box), to illustrate the kinds
of fatty acids
[[Page 41466]]
in their products, provided it is done in a manner that is not
misleading, but the panel itself is to be in compliance with this final
rule.
(Comment 30) FDA received only one comment in response to the
November 1999 proposal to deny the petitioner's request to require that
``partially hydrogenated'' fat be listed on food labels as ``partially
saturated'' fat (64 FR 62746 at 62762). The comment concurred with the
agency's tentative conclusion to deny the request stating that
``partially hydrogenated'' fat is the most appropriate terminology for
use on food label ingredient statements.
The agency concurs with the comment and, accordingly, is denying
this request.
(Comment 31) Although a great many comments supported CSPI's
petition in general, these comments did not specifically address the
petitioner's request to limit ``vegetable oil'' claims to foods that
are low in saturated and trans fats combined.
In the November 1999 proposal, the agency referred to Sec.
101.65(c)(3), which states, in part, that a claim ``that a food is made
only with vegetable oil is a claim that the food is low in saturated
fat,'' and tentatively concluded that the petitioner's request was
being addressed by the action taken in the proposed rule to limit the
amount of trans fat in foods bearing ``low in saturated fat'' claims
(64 FR 62746 at 62762). However, in this final regulation those
sections of the proposed rule pertaining to limiting the amount of
trans fat in foods making a ``low in saturated fat'' claim are being
withdrawn. Therefore, the agency is not restricting ``vegetable oil''
claims as proposed or as petitioned at this time.
As discussed in section VI of this document, FDA plans to proceed
with a new rulemaking pertaining to limits on the amount of trans fat
in claims relating to saturated fat when the science on trans fat has
evolved to a point where the agency believes it can proceed with
scientifically-based definitions and levels for these claims.
VIII. Effective Date
In the November 1999 proposal, the agency proposed that any final
rule that may issue based upon the proposal become effective in
accordance with the uniform effective date for compliance with food
labeling requirements that is announced by notice in the Federal
Register and that it not be sooner than 1 year following publication of
any final rule based on the proposal. Also, the agency said it will not
object to voluntary compliance immediately upon publication of the
final rule.
(Comment 32) FDA received several comments about the effective date
for a final rule. One comment stated that the proposed effective date
was appropriate while a few other comments recommended that it be
sooner than proposed. Several comments suggested that the effective
date be 24 months after publication of the final rule or January 1,
2004, whichever comes later. Some comments, however, requested that the
effective date be extended several years (e.g., 4 to 7 years) for small
businesses. These comments stated that it was important for small
businesses to be able to phase in the cost associated with the new
label requirements so that they have extra time to absorb the costs of
these changes. Many small manufacturers reported that they have
significant inventories of labels. Also, smaller manufacturers
indicated that they would incur costs including loss and disposal of
obsolete packaging inventories, product in obsolete packages, and new
printing plates. These small businesses believe that a longer
compliance period would allow these companies to more easily manage
their inventories and phase in the trans fat labeling requirements
along with other scheduled labeling revisions. This will help minimize
unnecessary labeling costs and costs passed on to consumers. At least
one comment requested that the effective date be one year after
establishment of an official AOAC method for measuring trans fatty
acids in complex food matrices.
To minimize the need for multiple labeling changes and to provide
additional time for compliance by small businesses to allow them to use
current label inventories and phase in label changes, the agency is
setting the effective date at January 1, 2006, the next uniform
effective date following publication of this rule. This allows firms
more than 2 years to implement this final rule providing some
regulatory relief and economic savings for small businesses. Extending
the effective date for products containing trans fat would delay the
benefits of this rule to the public health.
The agency notes that there are several methods for measuring the
amounts of trans fat in food products including but not limited to AOAC
Method 996.06, as modified (17th edition of the ``Official Methods of
Analysis of the AOAC International'') (Refs. 105 and 106).
Consequently, the agency does not believe that there is any need to
extend the effective date because of the lack of appropriate
methodology.
Although the effective date of the final rule is some time away,
FDA encourages manufacturers to have new labels printed that are in
compliance with these final rules so they may be used as soon as
current inventories are exhausted to ensure a smooth and timely
changeover. The agency will not object to voluntary compliance
immediately upon publication of the final rule.
IX. Final Regulatory Impact Analysis
FDA has examined the economic implications of this final rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including: Having an annual effect on the economy of $100
million, adversely affecting a sector of the economy in a material way,
adversely affecting competition, or adversely affecting jobs. A
regulation is also considered a significant regulatory action if it
raises novel legal or policy issues. FDA has determined that this final
rule is a significant regulatory action as defined by Executive Order
12866.
The Small Business Regulatory Enforcement Fairness Act of 1996
(Public Law 104-121) defines a major rule for the purpose of
congressional review as having caused or being likely to cause one or
more of the following: An annual effect on the economy of $100 million;
a major increase in costs or prices; significant adverse effects on
competition, employment, productivity, or innovation; or significant
adverse effects on the ability of U.S.-based enterprises to compete
with foreign-based enterprises in domestic or export markets. In
accordance with the Small Business Regulatory Enforcement Fairness Act,
Office of Management and Budget (OMB) has determined that this final
rule is a major rule for the purpose of congressional review.
A. The Current Situation and the Need for This Regulation
Current nutrition labeling regulations do not allow manufacturers
to disclose information about trans fat content of their products in
the Nutrition Facts panel of product labels. The regulation, in Sec.
101.9(c) reads, in part, ``No nutrients or food components other than
those listed in this paragraph as either mandatory or voluntary may be
[[Page 41467]]
included within the nutrition label.'' Some of the nutrients listed are
total fat, saturated fat, polyunsaturated fat (voluntary), and
monounsaturated fat (voluntary). Prior to publication of this final
rule trans fat was not included as either mandatory or voluntary, and
therefore, no information about trans fat could have been included in
the Nutrition Facts panel.
As explained in the November 1999 proposal and in section IV of
this document, there is a scientifically established link between the
consumption of trans fat and CHD. As described in table 1 of this
document, for purposes of economic analysis, FDA estimated trans fat
intake based on dietary intakes reported in a national food consumption
survey. FDA estimates that average trans fat intake from partially
hydrogenated fat is about 2.03 percent of energy, and average total
trans fat intake, including trans fat of ruminant origin, is about 2.55
percent of energy. Because trans fat increases serum LDL-C (``bad''
cholesterol), reducing trans fat intake reduces CHD risk. The amount of
risk reduction depends on what replaces trans fat in the diet (64 FR
62746 at 62768 to 62770). For example, as shown later in this section,
reducing trans fat intake by 0.1 percent reduces CHD risk by 0.072 to
0.163 percent.\1\ CHD is a common disease in the general U.S.
population, with about 1.1 million heart attacks annually, 40 percent
of them fatal (Ref. 134). Therefore, a small decrease in risk
corresponds to a large number of heart attacks and deaths prevented.
Thus, as shown later in this section, reducing trans fat intake by
about 0.04 percent of energy (projected to decrease CHD risk by about
0.05 percent), prevents approximately 600 heart attacks per year,
including 200 fatal heart attacks. Preventing these heart attacks is
valued at $4.1 billion per year (present value discounted at 7
percent).
---------------------------------------------------------------------------
\1\ Using Method 1 (LDL-C), described later in section IX.E, and
the factors shown in tables 8 and 9 below, replacement of 0.1
percent of energy from trans fat would decrease CHD risk by 0.072
percent when replaced with the same percent of energy from half cis-
monounsaturated fat and half saturated fat (-0.1 x 0.74 x 0.7 x 1.4
= -0.072) and by 0.163 when replaced with half cis-monounsaturated
fat and half cis-polyunsaturated fat (-0.1 x 1.66 x 0.7 x 1.4 = -
0.163).
---------------------------------------------------------------------------
Although the effect of trans fat on LDL-C and CHD risk is the
primary basis for trans fat labeling, trans fat may also increase CHD
risk by lowering high-density lipoprotein cholesterol (HDL-C) (``good''
cholesterol). In a second method for estimating the health benefits of
trans fat labeling, the expected changes in LDL-C and HDL-C can be
considered together (64 FR 62746 at 62768 to 62770). For example, as
shown later in this section, each 0.1 percent of energy decrease in
trans fat intake reduces CHD risk by 0.237 to 0.293 percent.\2\ Thus,
as shown later in this section, reducing trans fat intake by about 0.04
percent of energy (projected to decrease CHD risk by about 0.1
percent), prevents approximately 1,200 heart attacks, including 480
fatal heart attacks, annually, valued at $8.3 billion per year (present
value discounted at 7 percent).
---------------------------------------------------------------------------
\2\ Using Method 2 (LDL-C and HDL-C), replacement of 0.1 percent
of energy from trans fat would decrease CHD risk by 0.237 percent
when replaced with the same percent of energy from half cis-
monounsaturated fat and half saturated fat (-0.1 x -0.47 x -2.5 x
1.4 = -0.165 and -0.072 plus -0.165 = 0.237) and by 0.293 when
replaced with half cis-monounsaturated fat and half cis-
polyunsaturated fat (-0.1 x -0.37 x -2.5 x 1.4 = -0.130 and -0.163
plus -0.130 = -0.293).
---------------------------------------------------------------------------
This final regulation is needed to amend existing regulations so
that manufacturers will be able to provide important health-related
information to consumers regarding the amount of trans fat in food
products.
FDA believes that the requirements of this final rule will provide
consumers with information they need so that they may consider the
amount of trans fat in products in their food purchasing decisions.
Increased consumer attention to trans fat content because of nutrition
labeling may also provide an incentive to food manufacturers to reduce
the amount of trans fat in their products.
B. Regulatory Alternatives
In the analysis of the proposed rule, FDA listed a number of
regulatory alternatives regarding trans fat, including: (1) Take no new
regulatory action; (2) take the proposed regulatory action; (3) propose
to permit the voluntary labeling of trans fat and to permit trans fat
nutrient content claims; (4) alter the proposed regulatory action--
propose reporting of trans fat on a separate line below saturated fat;
(5) alter the proposed regulatory action--propose to report trans fat
differently than in the proposal; (6) expand the proposed regulatory
action--propose ``low trans fat'' and ``reduced trans fat'' claims; (7)
expand the proposed regulatory action--propose labeling at food service
establishments. We evaluated these regulatory alternatives in the
economic discussion of the proposed rule, although we lacked sufficient
data to evaluate all of the options quantitatively. FDA received no
comments on the economic discussion of these alternatives, so we do not
include them in this document. In addition to the alternatives
described in the proposed rule, FDA considered and asked for comments
on a proposed required footnote. Because the agency is withdrawing the
proposed requirement for a footnote and intends to ask for comments in
an ANPRM published elsewhere in this issue of the Federal Register, we
will not estimate the costs and benefits of that option in this
document.
C. Changes Resulting From This Rule
As stated in the analysis to the proposed rule (64 FR 62746 at
62764), to estimate the impacts of this rule, FDA is following the
general approach used to estimate the health benefits for the
implementation of the 1990 amendments (56 FR 60856 at 60869, November
27, 1991). Accordingly, FDA is estimating: (1) The changes in trans fat
intakes that would result from labeling changes; (2) the changes in
health states that would result from changes in trans fat intakes; and
(3) the value of changes in health states in terms of life-years
gained, number of cases or deaths avoided, and dollar value of such
benefits.
1. Changes in Existing Labeling Regulations
This final rule requires the mandatory declaration in the nutrition
label of the amount of trans fat present in foods. According to this
final rule, the amount of trans fat must be on a separate line
immediately under the amount of saturated fat, but it will not include
a % DV that is required for some of the other mandatory nutrients, such
as saturated fat. These changes must be made within a period of 30
months. This change to the existing regulations will increase the
information available to consumers that they can use to maintain a
healthy diet. It will also change the constraints and incentives faced
by producers of food.
The final rule will increase the information provided to consumers
on food packages. This change in the nutrition label will reduce the
cost to consumers of obtaining information on the trans fat content of
food. FDA anticipates that, once the rule takes effect, consumers will
use information on the Nutrition Facts panel to adjust their purchasing
practices among foods, consistent with their consumption preferences.
The final rule will also change the incentives and constraints that
food producers face in manufacturing and marketing their products.
Because these provisions will not be effective until months after
publication of the final rule, food manufacturers can use the time
between publication of the final rule and its effective date to study
the requirements of the rule and the
[[Page 41468]]
composition of their products, to anticipate the response of consumers
and competitors to the new information, to change the labeling, and
possibly to change the composition of their existing food products.
Even after the effective date of the rule, food manufacturers will
observe the response of consumers to the information on trans fat, and
some may develop and market new products with less trans fat than
similar existing products.
FDA assumes that producers will decide whether or not to change the
composition of existing products on a product-by-product basis,
depending on expected private returns. They will choose to reformulate
the existing products when the expected private benefits exceed the
expected private costs of reformulating the products. In other words,
if a product is expected to lose market share without reformulation
because of the new disclosure, then manufacturers will compare the
private costs from decreased sales to the cost of reformulation.
2. Anticipated Changes in Trans Fat Intake
FDA anticipates that, taken together, changes in food purchases by
consumers and reformulation by producers in response to this rule will
result in an overall decrease in trans fat intake in the U.S.
population. In the November 1999 proposal, FDA developed four scenarios
to demonstrate potential quantitative changes in trans fat intake (64
FR 62746 at 62767). FDA also estimated the current trans fat intake of
the population as a starting point for its scenarios for projected
intake changes.
a. Revised estimate of current trans fat intake. In section IV of
this document, FDA discussed the uncertainties associated with
estimates of trans fat intake from: (1) National food consumption
survey, (2) national disappearance data, and (3) food frequency
questionnaires done in observational studies of U.S. population groups.
Although there are uncertainties associated with each type of estimate,
FDA chose estimation of trans fat intake based on a national food
consumption survey as most suitable for use in this economic analysis.
Estimates of intake based on national disappearance data generally
overestimate intake dues to losses in processing and use, and food
groups derived from disappearance data correspond to commodities rather
than to foods as consumed. Therefore, an estimate based on a national
food consumption survey was better suited to the present analysis than
was an estimate based on national disappearance data. Estimates of
trans fat intake based on food frequency questionnaires may have the
advantage of having been validated versus biomarkers such as trans fat
content of adipose tissue. Such estimates are suitable for their
intended use in ranking and classifying trans fat intake of subjects in
observation studies. However, food frequency questionnaires are not
necessarily designed to provide accurate absolute (numerical) intake
estimates. As described in the November 1999 proposal (64 FR 62746 at
62753), estimates of nutrient intakes based on food frequency data may
be subject to systematic bias toward either over- or underestimation of
intake, depending on the design of the food frequency questionnaire
(Ref. 27). Available estimates of trans fat intake from food frequency
questionnaires in observational studies are lower than estimates of
trans fat intake from a national food consumption survey (Ref. 26), as
summarized in the November 1999 proposal (64 FR 62746 at 62752 to
62753) and in section IV of this document. Additionally, the available
food frequency results pertain to the intake of specific U.S.
population groups in the observation studies, not to the overall U.S.
population. Therefore, an estimate based on a national food consumption
survey was better suited to the present analysis than was an estimate
based on food frequency questionnaires done in observational studies.
One disadvantage of an estimate based on a national food consumption
survey is that, as described in section IV, food intake is generally
under-reported in consumption surveys (Ref. 26). Therefore, intake of
trans fat, in grams, estimated from a national consumption survey is
likely to underestimate actual intake. However, intake of trans fat
from national consumption survey data is likely to underestimate actual
intake to a lesser extent than does the lower reported intake of trans
fat from food frequencies done in observation studies. Additionally,
intake of trans fat, as a percent of total energy, from a national
consumption survey is more likely to be an unbiased estimate (Ref. 26).
As described in the November 1999 proposal (64 FR 62746 at 62765),
information on trans fat content of foods is limited, and there have
been few estimates of trans fat intake based on national dietary
surveys using food records or recalls. As described in section IV of
this document and in the November 1999 proposal (64 FR 62746 at 62752
and 62765), an available estimate by Allison et al. (Ref. 26), based on
CSFII 1989-91, reported mean trans fat intake of 5.3 g/day (d) (2.6
percent of energy). However, for the purposes of economic analysis, FDA
needed to estimate the mean intake of trans fat from specific food
groups. Therefore, in the November 1999 proposal, FDA indirectly
estimated trans fat intake based on a report from the Research Triangle
Institute (RTI) (Ref. 73). The RTI report used a special 1995 USDA
database of trans fat content of foods (Ref. 40), together with the
mean intake of food groups from USDA's CSFII 1994-96, and matched the
CSFII 1994-96 food groups with Standard Industrial Classification (SIC)
Codes for food product categories. FDA limited its estimate to foods
with trans fat from partially hydrogenated fats and oils (64 FR 62746
at 62765). (Although trans fat does occur naturally in dairy foods, it
is generally present in dairy products at less than 0.5 g trans fat per
serving, and therefore most dairy products would not have been affected
by the November 1999 proposal (64 FR 62746 at 62775)).
In the November 1999 proposal, FDA estimated that current average
trans fat intake from hydrogenated fat was 2.91 percent of energy
(calories) for adults, which is about 7.62 g/d for men and 5.54 g/d for
women (Ref. 73 and 64 FR 62746 at 62765). Among food product
categories, average trans fat intake of adults, as a percent of energy,
was: margarine, 0.39 percent; bread/cake, 0.67 percent; cookies/
crackers, 0.98 percent; other food groups, 0.87 percent. The estimated
intake of trans fat from margarine included FDA's adjustment based on
the assumption that approximately 30 percent of margarines currently on
the market had already been reformulated to remove trans fat.
(Comment 33) Comments generally agreed that FDA's estimate of
current trans fat intake was reasonable and in the range of other
estimates of trans fat intake. Comments from the margarine industry
agreed with FDA's overall estimate of trans fat intake from margarine
but stated that FDA had overestimated the percent of margarines (30
percent) that had already been reformulated to remove trans fat. One
comment indicated that the proportion of margarines with less than 0.5
g trans fat per serving is about half of FDA's estimate, or 15 percent
of margarines. Some comments pointed out the importance of trans fat
intake from food groups that were not itemized separately in FDA's
summary table, including chips and snacks and French fried potatoes.
Because FDA had restricted its estimate to trans fat intake from
partially hydrogenated fats and oils, some comments requested
clarification
[[Page 41469]]
regarding whether naturally-occurring trans fat of ruminant origin
would be regulated by the provisions of the proposed rule. One comment
from a manufacturer agreed with FDA that the USDA trans fatty acid
database contains relatively few foods. This comment recommended that a
large database be developed of trans fat food values that have been
analyzed using standardized methods, and that the database be used to
establish reference or ``normative'' intake data on trans fat in the
U.S. population. The comment stated that this information would be
helpful in developing a Daily Value for trans fat intake. A comment
from the dressings and sauces industry disagreed with FDA's statement
that ``some salad dressings contain substantial amounts of trans fatty
acids'' (64 FR 62746 at 62752). The comment stated that the oils used
in dressing and sauce products contain less than one percent trans
fatty acids. Additionally, according to the comment, the contribution
of trans fat of ruminant origin is negligible in dressings and sauces
that contain dairy products, as demonstrated in the reference cited by
FDA regarding trans fat in salad dressings (Refs. 29 and 30).
FDA's original estimate that about 30 percent of margarine had been
reformulated to remove trans fat was based on an informal market survey
in the Washington, DC area (Ref. 80 and 64 FR 62746 at 62781). FDA
accepts the comment's estimate that 15 percent of margarines currently
on the market contain less than 0.5 g per serving. In its own estimate
of total intake, FDA did include the contribution to average trans fat
intake of other food groups containing partially hydrogenated fat, such
as chips and French fried potatoes. These food groups were itemized in
the RTI report (Ref. 73) but FDA summarized them under ``All other'' in
the November 1999 proposal.
In response to the comments requesting clarification about whether
naturally-ocurring trans fat of ruminant origin would be regulated by
this rule, FDA reiterates that this final rule applies to all FDA-
regulated foods and covers all fatty acids that meet the regulatory
definition of ``trans fatty acids,'' regardless of origin. Naturally
occurring trans fat in dairy products and in ruminant meat (e.g., meat
from cows and sheep) present in FDA-regulated food products will be
subject to this rule. FDA did not include trans fat of ruminant origin
in its original intake estimate in the November 1999 proposal because,
in these products, trans fat is generally present at less than 0.5 g
per serving and declaration of the amount of trans fat in these
products would not have been required by the November 1999 proposal. As
noted later in this section, we have revised our estimate of trans fat
intake and extended our revised estimate to include trans fat of
ruminant origin. Although FDA agrees with the comment stating that
development of a large database of trans fat food values would be
beneficial, database development is beyond the scope of the present
rulemaking. FDA agrees with the comment regarding the trans fat content
of dressing and sauces and acknowledges that FDA's earlier statement
about trans fat in salad dressings (64 FR 62746 at 62752) was
inaccurate. However FDA's earlier statement was part of a general
summary of possible limitations of data regarding trans fat intake of
the population, and was not incorporated into FDA's estimates of trans
fat intake in the November 1999 proposal. As noted previously, FDA
based its estimates of trans fat intake on the special 1995 USDA
database of trans fat content of selected foods.
As described previously in this section, although there are
uncertainties associated with each type of estimate, FDA chose
estimation of trans fat intake based on a national food consumption
survey as most suitable for use in this economic analysis. In
reevaluating its November 1999 trans fat intake estimate based on a
national survey, CSFII 1994-96, FDA notes that the CSFII 1994-96 food
group categories used to generate the estimate were very broad (Refs.
73 and 114) and the match between the broad CSFII food group categories
and the SIC Codes was not always exact. Recently, USDA has published
more detailed tables of food group intake for CSFII 1994-96 (Ref. 115).
FDA has used the new tables to recalculate its estimate of average
trans fat intake in the United States. For clarity, FDA now includes
the itemized trans fat intake for the various food groups rather than
creating a summary category for ``All other.'' FDA has also extended
its estimate to incorporate trans fat of ruminant origin. FDA has
estimated the intake of trans fat from margarine from the USDA intake
data, without assumptions regarding the percent of margarine that may
have been reformulated to remove trans fat. We will describe our
assumptions about current margarine reformulation in later sections of
this document.
The revised estimate of average trans fat intake of adults in the
United States for this economic analysis is shown in table 1 of this
document. The revised estimate is slightly lower than that in the
November 1999 proposal. Table 1 shows that average trans fat intake
from partially hydrogenated vegetable oils is about 5.36 g/d for men
and 3.89 g/d for women, or about 2.03 percent of energy. Adding the
trans fat of ruminant origin gives an overall total trans fat intake of
6.86 g/d for men and 4.78 g/d for women, about 2.55 percent of energy.
Major sources of trans fat intake as a percent of energy include
margarine, 0.42 percent; cake and related products, 0.61 percent;
cookies and crackers, 0.25 percent; fried potatoes, 0.21 percent; chips
and snacks, 0.12 percent; and household shortening, 0.11 percent.
Table 1.--Average Trans Fat Intake of U.S. Adults From Food Groups
----------------------------------------------------------------------------------------------------------------
CSFII 94-96\1\ Men Women All All
----------------------------------------------------------------------------------------------------------------
Mean daily energy intake, kcal\2\....................... 2455 1646 2058 ............
----------------------------------------------------------------------------------------------------------------
Mean daily trans fat intake\3 4\................................................................................
----------------------------------------------------------------------------------------------------------------
Food group............................................ Grams Grams Grams % of energy
----------------------------------------------------------------------------------------------------------------
Hydrogenated products.......................................................................................
Total yeast bread................................. 0.475 0.330 0.404 0.177%
Cakes, pies, doughnuts, sweet rolls, biscuits, 1.607 1.163 1.391 0.607%
muffins, quick breads, pancakes, waffles,
tortillas........................................
Cookies, crackers................................. 0.624 0.515 0.571 0.249%
Ready to eat breakfast cereal..................... 0.093 0.074 0.084 0.037%
French-fried, home-fried potatoes................. 0.635 0.332 0.486 0.213%
Potato chips, corn chips, popcorn................. 0.345 0.215 0.281 0.123%
[[Page 41470]]
Pourable and mayo type salad dressing............. 0.181 0.136 0.159 0.069%
Total candy containing chocolate.................. 0.048 0.040 0.044 0.019%
Total margarine................................... 1.072 0.859 0.967 0.423%
Household shortening.............................. 0.277 0.222 0.250 0.109%
Total hydrogenated products....................... 5.357 3.886 4.637 2.026%
Animal products.............................................................................................
Total milk, including on cereal................... 0.125 0.085 0.105 0.046%
Ice cream and ice milk............................ 0.092 0.057 0.075 0.033%
Total cheese and cottage cheese................... 0.227 0.148 0.188 0.083%
Total beef, ground and not ground................. 0.569 0.319 0.447 0.195%
Total frankfurter and lunch meat.................. 0.360 0.188 0.276 0.121%
Total fluid and sour cream........................ 0.061 0.044 0.052 0.023%
Total butter...................................... 0.071 0.049 0.060 0.026%
Total animal products............................. 1.505 0.890 1.203 0.527%
----------------------------------------------------------------------------------------------------------------
Total all products.................................... 6.862 4.776 5.840 2.553%
----------------------------------------------------------------------------------------------------------------
\1\ Continuing Survey of Food Intakes of Individuals, 1994-1996
\2\ kcal: kilocalories
\3\ Source of trans fat content of foods: Ref. 40.
\4\ Source of food intake data: Smiciklas-Wright H., D.C. Mitchell, S.J. Mickle, A.J. Cook and J.D. Goldman.
Foods Commonly Eaten in the United States. Quantities per Eating Occasion and in a Day, 1994-1996. U.S.
Department of Agriculture NFS Report No 96-5, pre-publication version, 2002. www.barc.usda.gov/bhnrc/food
survey/Products 9496.html.
The revised estimate of trans fat intake based on CSFII 1994-96 and
shown in table 1 is slightly lower than the estimate in the November
1999 proposal (64 FR 62746 at 62765). Table 1 shows that average trans
fat intake from partially hydrogenated vegetable oils is about 5.36 g/d
for men and 3.89 g/d for women, or about 2.03 percent of energy. Adding
the trans fat of ruminant origin gives an overall total trans fat
intake of 6.86 g/d for men and 4.78 g/d for women, about 2.55 percent
of energy. For comparison, FDA also calculated the trans fat intake
based on CSFII 1989-91, using the same method as for the estimate based
on CSFII 1994-96 (Ref. 116 and 117). The overall total trans fat intake
from CSFII 1989-91 is 6.47 g/d for men, 4.51 g/d for women and 5.32 g/d
for all adults, or 2.71 percent of energy (not shown in table 1), very
similar to the 6.86 g/d for men and 4.78 g/d for women and 5.84 g/d for
all adults, or 2.55 percent of energy intake based on CSFII 1994-96
(table 1 of this document) (Ref. 116). FDA's estimates of 2.55 percent
of energy from trans fat based on CSFII 1994-96 and 2.71 percent of
energy based on CSFII 1989-91 can be compared with other available
estimates from national food consumption surveys. FDA's estimates are
very similar to the intake estimated by Allison et al. based on CSFII
1989-91 (Ref. 26), using a different method. As described in the
November 1999 proposal, Allison et al. reported that average trans fat
intake for persons age 3 and older was 2.6 percent of energy, or 5.3 g/
d (64 FR 62746 at 62752 and 62765).
Allison et al. linked the special 1995 USDA database of trans fat
content of foods to the food intake reported by each individual in
CSFII 1989-91 (Ref. 26). They also separated the ingredients in food
mixtures, so that the trans fat content of the ingredients could be
included in the total intake. These researchers reported the trans fat
intake for various age and gender groups in the United States, but did
not report the amount of trans fat contributed by various foods and
food groups. To make its estimate, FDA began with USDA reports of
average intake of food groups in CSFII 1989-91 and 1994-96 (Refs. 115
and 117). In its reports, USDA also separated the ingredients in food
mixtures. For example, in CSFII 1994-96, USDA found that the average
intake of margarine reported separately by survey participants was 2.8
g/d. However, when margarine, used as an ingredient in other foods, was
added to the total, the average margarine intake rose to 7.0 g/d. FDA
then linked the average intake of the food groups with the trans fat
content of foods from the special 1995 USDA database (Ref. 40) to give
the trans fat intake estimate in table 1 of this document. The
similarity of the estimates of FDA and of Allison et al. can be
explained by use of common data--the CSFII intake report and the 1995
USDA trans fat database. Linking the two data sets resulted in
comparable overall trans intake, whether linked at the level of each
individual's intake by Allison et al., or linked at the level of
average intake of food groups by FDA.
FDA's estimates are also similar to a recently-published estimate
from another national food consumption survey, the National Health and
Nutrition Examination Survey III (NHANES III), 1988-94 (Refs. 152 and
153). The estimate from NHANES III for mean trans fat intake for age 20
to 59 was 5.6 g/d or 2.2 percent of energy (mean energy intake was
2,325 kcal/d, and (5.6 g/d x 9 kcal/g x 100)/2,325 kcal = 2.2 percent
of energy).
b. Projected change in trans fat intake. In the November 1999
proposal, we developed four scenarios of projected changes in trans fat
intake due to labeling. Scenario 1 demonstrated the effect of the
hypothetical removal of all of the trans fat originating from partially
hydrogenated fats and oils, corresponding to a decrease of 2.91 percent
of energy from trans fat. Scenarios 2 through 4 predicted three
possible levels of product reformulation, together with an estimate of
consumer behavior. We estimated that trans fat intake would have
decreased by 0.58 percent of energy, 0.50 percent of energy and 0.42
percent of energy in Scenarios 2, 3 and 4, respectively (64 FR 62746 at
62767). For each scenario, the full health benefits would have been
realized years after the rule took effect: 10, 8, and 3 years after the
effective date for Scenarios 2, 3, and 4. These time periods included
the time for reformulation and the 3 years that would have passed
before changes in diet would have begun to reduce the risk of CHD.
Consumer awareness
(Comment 34) Several comments suggested that FDA overstated
consumer response to the proposed change to food labeling. Some
comments said that a
[[Page 41471]]
footnote might be ignored. Some comments said that consumers rarely
look at any nutrition information beyond calories and total fat and
that consumer concerns about fat have dwindled. One comment argued that
consumers have not significantly altered their dietary habits because
of the implementation of the 1990 amendments. One comment stated that
educated consumers probably already know enough to look for and avoid
trans fat. There was also one comment arguing that shelf labeling is
more likely to attract consumer attention than are product labels, and
the use of shelf labeling is probably more prevalent than that of
product labels. One comment stated that FDA has underestimated consumer
awareness of trans fatty acids. Another comment stated that consumer
awareness is likely to increase as trans fat dietary recommendations
accumulate and consumer education devotes more attention to trans fat.
FDA is not going forward with the proposed asterisk for saturated
fat and footnote listing the amount of trans fat. Instead, this final
rule requires trans fat to be listed on a separate line immediately
below saturated fat. Consumers who look at the Nutrition Facts panel
for information on total fat and its fatty acid subcomponents are
likely to notice the information on trans fat.
In the November 1999 proposal, FDA used results of earlier research
and estimated that direct consumer choice in response to trans fat
labeling would result in a 1 percent decrease in trans fat intake (64
FR 62746 at 62766). This final rule requires that the amount of trans
fat be declared in nutrition labels on a separate line immediately
under the line for saturated fat. This placement of trans fat is more
prominent than the footnote specified in the November 1999 proposal and
may be more readily noticed by consumers. In the November 1999
proposal, the amount of trans fat was to be included in the amount and
% DV declared for saturated fat. This association of trans fat with
saturated fat, which also may have assisted consumers in using the
information on trans fat, is absent in this final rule. Also, as a
result of this final rule, consumer response to trans fat information
will be based solely on the declaration of the amount of trans fat in
grams. As discussed in section V of this document, there will not be
information on a % DV for trans fat. In the November 1999 proposal, the
agency proposed to define the nutrient content claim for ``trans fat
free'' and also proposed that the amount of trans fat be limited
wherever saturated fat limits are placed on nutrient content claims,
health claims, or disclosure and disqualifying levels. As explained in
sections V and VI of this document, this final rule does not establish
definitions for nutrient content claims about trans fat and does not
place trans fat limits on claims regarding saturated fat, cholesterol
or other nutrients. In summary, the declaration of trans fat in this
final rule is prominent and straightforward. This feature of the final
rule may tend to increase the magnitude of consumer response to the
trans fat information. However, the provisions of this final rule also
do not link trans fat with saturated fat or with a % DV for trans fat
and do not change existing regulations regarding claims. The absence of
these features in the final rule may tend to decrease the magnitude of
consumer response to the trans fat information.
Based on previous research, the November 1999 proposal projected a
1 percent decrease in trans fat intake from direct consumer choice in
response to trans fat labeling (64 FR 62746 at 62766). This overall 1
percent decrease in trans fat intake could be thought of as a 2.2
percent decrease in trans fat intake by the 45 percent of consumers
shown in previous research to use food labels to make purchase
decisions (Refs. 68 and 74) (64 FR 62746 at 62766).
In the process of evaluating these comments about consumer
awareness, FDA has identified additional data relevant to these issues.
In the 1999 Discovery Health survey, 66 percent of those responding to
the survey knew that saturated fat was related to disease and 31
percent knew that partially hydrogenated fat was related to disease
(Ref. 118). In the 2001-2002 Consumer Attitudes About Nutrition survey,
83 percent of respondents reported that saturated fat is unhealthy, 46
percent reported that trans fat is unhealthy and 44 percent reported
that hydrogenated fat is unhealthy (Ref. 135). These results indicate
that survey respondents were about half as likely to know that
partially hydrogenated fat was ``unhealthy'' or related to disease as
to know that saturated fat was related to disease. If these surveys are
representative of the population, this indicates a significant level of
awareness of the health effect of partially hydrogenated fat, and its
component, trans fat, even though consumers have very little easily
obtainable information on trans fat and even though nutrition education
efforts, until very recently, have focused on saturated fat to the
exclusion of trans fat. Once nutrition education efforts include trans
fat in their messages and once consumers have information on nutrition
labels about trans fat content, consumer awareness of the relationship
between saturated fat, trans fat, and cholesterol and heart disease
will increase. Another recent study, by Kim et al., estimated that food
label use has a large effect on nutrient intake. (Ref. 119) This study
reported that 73 percent of individuals surveyed use nutrition labels
and look for information on saturated fat.
In the study by Kim et al., 73 percent of individuals surveyed who
use nutrition labels and look for information on saturated fat had 15
percent lower saturated fat intake than those who did not use nutrition
labels. This corresponds with an overall 11 percent decrease (0.15 x 73
percent = 11 percent) in saturated fat intake because of nutrition
labeling. Thus, the study by Kim et al. gave a high estimate of an 11
percent decrease in saturated fat intake because of nutrition labeling
and FDA's earlier research gave a low estimate of a 1 percent decrease
in saturated fat intake.
The Discovery Health study and the Consumer Attitudes About
Nutrition survey indicated that consumer awareness of a nutrient-
disease relationship involving trans fat was about half as prevalent as
consumer awareness of a nutrient-disease relationship involving
saturated fat. Accounting for the lower prevalence of awareness of the
nutrient-disease relationship for trans fat, would reduce, by about
one-half, the estimates for decreases in saturated fat intake. This
would give a high estimate of a 5.5 percent decrease and a low estimate
of a 0.5 percent decrease in trans fat intake because of labeling.
The estimates for decreases in trans fat intake due to nutrition
labeling may also be affected by the features of this final rule. As
noted previously, the prominence of the declaration of trans fat in
this final rule may tend to increase the magnitude of consumer response
to the trans fat information. However, the magnitude of consumer
response to the trans fat information may decrease because there is no
link with saturated fat or with a % DV and there are no changes in
existing regulations regarding claims. Recognizing that different
features of this final rule may tend to either increase or decrease
consumer response to the trans fat information, FDA acknowledges
considerable uncertainty in incorporating the features of this final
rule into its estimate of the consumer response to trans fat labeling.
One possibility is that the increased and decreased responses related
to features
[[Page 41472]]
of the rule will be about equal and will cancel each other out. This
would leave a high estimate of 5.5 percent decrease and a low estimate
of a 0.5 percent decrease in trans fat intake as discussed above.
However, for the purpose of this final analysis, FDA has chosen a very
low estimate of consumer response to the new label. FDA is using an
estimate even lower than the low estimate above: a decrease of 0.1
percent of trans fat intake. The actual change that occurs may be
larger. However, FDA chose this amount so as not to overestimate
benefits of this rule. To the extent that actual consumer response is
higher than FDA's estimate, this analysis will underestimate the
benefits of trans fat labeling.
i. Margarine reformulation. In the November 1999 proposal, in
scenarios 2 through 4, FDA estimated that 30 percent of margarine
products had already been reformulated to eliminate trans fat, and that
all of the remaining margarine products would be reformulated to remove
trans fat by the effective date for trans fat labeling.
(Comment 35) A comment stated that FDA had overestimated the
proportion of margarine that had already been reformulated and said
that the actual amount was about 15 percent of margarine products.
Several comments disagreed with FDA's estimate that all margarine would
reformulate by the effective date for trans fat labeling. These
comments noted that reformulation is very expensive, requires a long
time to accomplish, and would, under certain circumstances, require the
use of more expensive inputs. Other comments stated that private
benefits of reformulating margarine products would not exceed the
private costs for manufacturers unless the margarine products could
make nutrient content claims. These comments gave a number of examples
to demonstrate that even reformulated margarines were not likely to be
able to comply with the proposed definitions for nutrient content
claims.
FDA accepts the comment about current margarine products. For this
analysis, FDA estimates that about 15 percent of margarine has already
been reformulated to remove trans fat. In response to the comments
about projected margarine reformulation, FDA notes that the analysis
for the November 1999 proposal did include the cost of reformulation
and the time needed for reformulation. In that analysis, FDA did not
include higher ingredient costs for margarine reformulation, because
the price of reformulated margarine products that are already on the
market is no higher than the price of margarine products containing 0.5
g or more per serving of trans fat. The different ingredients used in
the products appear to have had no impact on the cost of production.
However, in response to the comments, FDA acknowledges that, as greater
numbers of products are reformulated, the increased demand for the
substitute ingredients may increase costs.
As noted earlier regarding consumer response to trans fat labeling,
the declaration of trans fat in this final rule is prominent and
straightforward. This feature may tend to increase the incentives for
manufacturers to reformulate their products to be lower in trans fat.
However, the provisions of this final rule also do not link trans fat
with saturated fat or with a % DV for trans fat and do not change
existing regulations regarding claims. The absence of these features
may tend to decrease the incentives for manufacturers to reformulate
their products to be lower in trans fat in comparison to the incentive
that would have been introduced by the proposed rule. Therefore, in
response to the comments regarding projected margarine reformulation,
FDA recognizes that different features of this final rule may tend to
either increase or decrease the incentive for reformulation in
comparison to the incentive that would have been introduced by the
proposed rule.
Although FDA acknowledges considerable uncertainty in the
likelihood of additional margarine reformulation, FDA is aware of
evidence suggesting that at least some margarine products are likely to
reformulate in response to trans fat labeling. As stated in the
analysis for the proposed rule, in several European countries, the
actual, demonstrated market response to consumer concern about trans
fat is that margarine products have been reformulated to reduce or
eliminate trans fat (64 FR 62746 at 62781) (Refs. 102, 124, 125, and
127). Also, many people who now consume margarine products do so in
order to consume a more heart-healthy product than butter. Because the
rule would require the prominent declaration of the amount of trans fat
on a separate line below saturated fat, these margarine consumers are
likely to search for margarine products with lower levels of both
saturated fat and trans fat. Additionally, publicity generated about
the issue by consumer groups and the media has highlighted margarine as
a source of trans fat and has given prominent attention to reformulated
margarine products. As more margarine products are reformulated,
consumer groups may shift their focus to those remaining margarine
products that have not reformulated. This suggests that with sufficient
information on trans fat content consumers are likely to pressure
margarine producers to reduce trans fat. This consumer pressure will
generate some competitive pressures among margarine producers to reduce
trans fat content even in the absence of nutrient content claims.
In response to comments received, because of the absence of trans
fat claims in this rule, and recognizing the uncertainty, FDA is using
a low estimate of margarine reformulation in this final rule. FDA
estimates that reformulation will reduce the trans fat content of
margarines as a whole by 10 percent due to trans fat labeling. Because
the trans fat in margarine accounts for about 0.36 percent of energy
intake, this reduction corresponds to a decrease in trans fat intake of
0.036 percent of energy. The actual decrease may be larger, but FDA
chose this lower amount so as not to overestimate benefits of this
rule. The additional 10 percent margarine reformulation will mean that,
including previous reformulations, about 23 percent of trans fat will
have been removed from margarine. This estimated reduction is far lower
than the 100 percent reduction seen in several European countries. The
estimated 10 percent reformulation has the advantage of being an
underestimate. To the extent that more trans fat is removed from
margarine than FDA's estimate, this analysis will underestimate the
benefits of trans fat labeling.
ii. Reformulation of other products. In two scenarios in the
November 1999 proposal, FDA projected that some baked products would be
reformulated to remove trans fat (64 FR 62746 at 62767). In that
analysis, the baked products were separated into two categories
corresponding to SIC codes: breads, cakes and similar products (SIC
code 2051) and cookies and crackers (SIC code 2052). Considering the
trans fat contributions of the two categories of baked goods (64 FR
62746 at 62765), the overall projected reformulation of baked goods
corresponded to a 5 percent reduction in trans fat intake in scenario 3
and a 10 percent reduction in scenario 2.
(Comment 36) A number of comments stated that FDA had overestimated
the proportion of baked goods products that would reformulate or the
proportion of trans fat that could realistically be removed from baked
goods by reformulation. Some comments noted that reformulation was very
expensive, required a long time to accomplish, and would under certain
circumstances
[[Page 41473]]
require the use of more expensive inputs. Some of these comments, from
the shortening or baked products industries, gave examples of recently
developed commercial shortenings that were lower in trans fat than
currently used shortenings. Several comments stated that, although
alternative shortenings exist, they may not be a practical solution for
reformulation because of expense or limited supply of the alternative
shortenings and because time and expense for product development for
reformulation would still be needed. Other comments stated that the
private benefits of reformulation would not exceed private costs unless
the declaration of trans fat on the food label was on a separate line
on the Nutrition Facts panel or was in some way more prominent than in
the November 1999 proposal. Some comments emphasized the disadvantages
of reformulation for the cookies and crackers category, stating that
FDA's estimate of 15 percent reduction in trans fat from those products
was an overestimate.
In response to the comments about difficulties of reformulation,
FDA notes that the analysis for the November 1999 proposal did include
the cost of reformulation and the time needed for reformulation, but
did not include higher ingredient costs for reformulation. In the long
run, ingredient costs may not actually increase, because of increased
industrial capacity to produce ingredients made with new technologies.
In response to the comments about the cookies and crackers category,
FDA acknowledges that its own projection of much higher reformulation
for this category than for other baked products may have been
unrealistic. Also in response to the comments, FDA notes that the
emergence of commercial shortenings with lower trans fat content
indicates that the reformulation of some baked products is feasible.
Moreover, within these baked product categories there is a significant
variation in trans fat content. Therefore, products with significantly
higher than average amounts of trans fat compared with competing
products will face competitive pressures to reduce the amount of trans
fat in their products. In response to the comment about prominence of
trans fat on the nutrition label, FDA notes that, in this final rule,
the declaration of trans fat is prominent and straightforward, on a
separate line below trans fat.
After consideration of the comments and our own re-evaluation, we
continue to believe that, ultimately, some proportion of baked products
will be reformulated in most subcategories: Crackers, cookies,
biscuits, tortillas, quick breads and muffins, doughnuts and sweet
rolls, cakes, pies, pancakes and waffles. (In the categories of yeast
breads and rolls, it is unlikely that reformulation will occur because
yeast breads are relatively low in fat and typically contain less than
0.5 g trans fat per labeled serving.) However, there were disparate
views among the comments regarding the availability of reformulated
shortenings and the technical difficulty of baked product
reformulation. Therefore, because of this uncertainty, we have opted
for a more conservative approach and are not including a quantitative
estimate of reformulation of baked goods in the analysis of the
benefits and cost of trans fat labeling. We chose not to include a
quantitative estimate of reformulation of baked goods so as not to
overestimate the benefits of this rule. To the extent that
reformulation of baked goods does occur, this analysis will
underestimate the benefits of trans fat labeling.
Because of the existence of commercial shortenings with lower trans
fat content, as pointed out in comments, FDA evaluated whether trans
fat labeling might also result in reformulation of household
shortenings to be lower in trans fat. Current household shortenings are
lower in trans fat than current commercial shortenings, with some
household products having only about half as much trans fat as some
commercial products. This fact suggests that the potential for lowering
the trans fat content of household shortening is not as great as the
potential for lowering the trans fat in current commercial shortenings.
However, some household shortenings are currently making comparative
saturated fat claims related to butter, and household shortenings may
experience competitive pressure from some reformulated stick margarines
due to trans fat labeling. Because of the uncertainty, FDA chose not to
include a quantitative estimate of reformulation of household
shortening so as not to overestimate benefits of this rule. To the
extent that reformulation of household shortening does occur, this
analysis will underestimate the benefits of trans fat labeling.
(Comment 37) Some comments discussed reformulation of other
products, including potato chips, corn chips and similar snacks,
microwave popcorn, and candy. Several of these comments emphasized the
difficulty of reformulating products in these categories because of the
expense, the time required, and the need for costly ingredients. Some
of the comments suggested that, because of the difficulties of
reformulation, trans fat labeling would put these categories of
products at a competitive disadvantage. Other comments suggested that
FDA's projected decrease in trans fat intake was an overestimate
because trans fat labeling would not apply to a major source of trans
fat: foods eaten at restaurants, especially French fried potatoes.
FDA did not project quantitative decreases in trans fat intake due
to reformulation of other products, such as chips, microwave popcorn
and candy, because these products contribute a smaller proportion of
trans fat intake and because FDA did not have enough information to
make quantitative reformulation estimates for these product categories.
FDA is aware of the development of stable frying oils low in trans fat
and suitable for chips, and notes that there is interest in development
of fats and oils lower in trans fat for many product categories (Refs.
120 to 122 and 151). At least one manufacturer has announced the
reformulation of its snacks and chips to decrease trans fat (Ref. 150).
To the extent that these product categories reformulate to decrease
trans fat, the decrease in trans fat intake projected in this analysis
will be an underestimate.
FDA acknowledges that a large proportion of the U.S. French fried
potato intake is consumed in restaurants. Foods typically consumed in
restaurants also include other food sources of trans fat. Restaurant
food is not subject to mandatory nutrition labeling requirements,
unless a nutrition-related claim is made. In its estimate of
reformulation, FDA did not project reformulation of French fries or of
baked goods. Therefore, FDA's estimate did not assume reformulation of
restaurant foods. However, FDA is aware of some interest by restaurants
in using the absence of trans fat as a marketing device to gain
competitive advantage (Ref. 123). If, as seems possible, frying oils
and shortenings are developed for reformulation of packaged foods and
become available in the market, they may become competitive choices
with traditional fats and oils, even for restaurants that do not wish
to use absence of trans fat for competitive advantage. To the extent
that restaurants adopt reformulated baking and frying oils and purchase
other products reformulated to be lower in trans fat, the decrease in
trans fat intake projected in this analysis will be an underestimate.
iii. Quantitative decrease in intake. Table 2 of this document
summarizes FDA's revised estimate of projected decreases in trans fat
intake due to
[[Page 41474]]
labeling. In table 2, current trans fat intake from margarine is 0.359
percent of energy, reduced 15 percent from the 0.423 percent of energy
intake in table 1 of this document to adjust for the estimated 15
percent of margarine that has already been reformulated to remove trans
fat. This adjustment reduces the total trans fat intake from
hydrogenated products to 1.96 percent of energy in table 2, compared
with 2.03 percent of energy in table 1. Table 2 shows that, by the
effective date of the rule, FDA projects that trans fat intake will
decrease by 0.0378 percent of energy. This decrease will be composed of
0.0359 percent of energy due to removal of 10 percent of trans fat from
margarine by reformulation, and an additional 0.0019 percent of energy
due to direct consumer choice. The additional 0.0019 percent of energy
represents 0.1 percent of all remaining trans fat from hydrogenated fat
after margarine reformulation (1.964 percent - 0.0359 percent = 1.928
percent; 0.1 percent x 1.928 percent = 0.0019 percent).
Table 2.--Estimated Decreases in Trans Fat Intake and Contribution From
Food Groups Due to Labeling, at Effective Date of Rule
------------------------------------------------------------------------
Before Change at
Effective Date Effective Date ----------------
of Rule of Rule Decrease in
--------------------------------- trans fat
Mean daily Decrease in intake
trans intake\1\ trans fat ----------------
Food group ----------------- contribution
from food
group Decrease in
Percent of ---------------- percent of
energy from Percent energy from
trans fat decrease in trans fat
trans fat
------------------------------------------------------------------------
Total Margarine 0.359%\2\ 10% 0.0359%
------------------------------------------------------------------------
Other food groups with 1.605% none ...............
partially
hydrogenated fats and
oils
------------------------------------------------------------------------
Total from 1.964% .............. ...............
hydrogenated products
------------------------------------------------------------------------
Total decrease due to reformulation 0.0359%
--------------------------------------------------------
Additional decrease due to consumer choice 0.0019%\3\
--------------------------------------------------------
Total decrease 0.0378%
------------------------------------------------------------------------
\1\ Trans fat intake for men and women age 20 and over from CSFII 1994-
96, see table 1 of this document.
\2\ Trans fat intake from margarine, 0.359 percent of energy, already
decreased by 15 percent from intake in table 1, to account for
margarine that has already been reformulated to decrease trans fat.
\3\ Estimated decrease due to consumer choice at effective date is 0.1
percent of all remaining trans fat from hydrogenated fat after
margarine reformulation.
iv. Substitutions for trans fat. In the November 1999 proposal, FDA
assumed that manufacturers would most likely replace trans fat in
margarine with: (1) Cis-monounsaturated fat, (2) 50 percent cis-
monounsaturated fat and 50 percent cis-polyunsaturated fat, or (3) 50
percent cis-monounsaturated fat and 50 percent saturated fat, and that
they would most likely replace trans fat in baked products with 50
percent cis-monounsaturated fat and 50 percent saturated fat (64 FR
62746 at 62771). In making these assumptions, FDA relied, in part, on a
report from RTI estimating that current food technology would require
the incorporation of about 0.5 g saturated fat for every 1 g trans fat
removed by reformulation (64 FR 62746 at 62767).
(Comment 38) Some comments stated that FDA had ignored the question
of macronutrient substitutions, or had assumed that reformulation would
replace trans fat with 100 percent cis-monounsaturated fat. According
to the comments, functional requirements for margarines, shortenings
and baked products would require that some trans fat be replaced by
saturated fat, and this requirement was not accounted for in FDA's
projections for reformulation. Other comments noted FDA's assumptions
regarding macronutrient substitutions, but stated that FDA had
overestimated the extent to which trans fat could be replaced by cis-
unsaturated fat, because of functional and cost requirements of various
products. These comments generally implied that FDA had overestimated
the expected amount of reformulation because saturated fat would need
to replace trans fat in any reformulation. Comments pointed out that
the amount of saturated fat, a cholesterol-raising fat, is already
declared on the nutrition label. Therefore, according to the comments,
replacement of trans fat with saturated fat would not provide a
competitive advantage or an incentive to reformulate and, with higher
total saturated fat, the reformulated product might not meet the
criteria for proposed defined nutrient content claims.
In response to the comments, FDA notes that it did consider the
type of macronutrients substituted for trans fat, and these were
accounted for in the mathematical model used to calculate the health
benefits (64 FR 62746 at 62771). FDA is aware that there is a range of
functional requirements for margarines and spreads, including tub and
stick forms and regular and lower fat varieties. Therefore, FDA assumed
a range of ingredient substitutions for margarines and spreads,
including both saturated and cis-unsaturated fat. Replacement of trans
fat with a range of combinations of saturated and cis-unsaturated fat
in margarines and spreads is consistent with reports from North America
and Europe (Refs. 104, 124, 125, 126, 127, and 128). In a survey of
U.S. margarines, tub margarines with trans fat less than 0.5 g per
serving did not have increased saturated fat compared with other tub
margarines (Ref. 104). In the U.S. study, a stick margarine with less
than 0.5 g trans fat per serving had higher saturated fat than other
stick margarines with comparable fat content, but had lower saturated
fat plus trans fat than the other stick margarines (Ref. 104). FDA is
aware that the functional requirements for baked
[[Page 41475]]
products and shortenings may not allow the wide range of substitutions
possible in margarines and spreads. Rather, the functional requirements
for baked products will likely require replacement of at least some of
the trans fat with saturated fat. This partial replacement of trans
with saturated fat is consistent with reports by industry observers
(Refs. 121 and 122) and with the examples of the alternative commercial
shortenings described in several of the comments. In these examples,
the shortenings reformulated to be lower in trans fat were higher in
saturated fat but were lower in total saturated fat plus trans fat than
were the traditional, nonreformulated shortenings. Under this final
rule, products lower in both saturated fat and trans fat will have a
competitive advantage because the rule requires prominent declaration
of both types of fat on the label.
Based on its consideration of the comments and its own evaluation,
FDA continues to believe that the likely substitutions for trans fat
for margarines will be as described in the November 1999 proposal (64
FR 62746 at 62771). FDA does not have enough information to project the
substitutions for trans fat due to direct consumer choice, and
therefore assumes (for simplicity) that direct consumer choice will
show the same range of substitutions as does margarine reformulation.
We will describe the effects of these substitutions for trans fat on
the health benefits of trans fat labeling in section VI.E of this
document.
Because of the functional requirements for baked products, FDA
continues to believe that the most plausible replacement for trans fat
in baked products is 50 percent cis-monounsaturated fat and 50 percent
saturated fat. However, because of the uncertainty in quantitative
estimation of baked product reformulation, FDA is not including baked
product reformulation in its quantitative estimate of benefits and
costs of trans fat labeling. As note earlier, to the extent that baked
products are reformulated, this analysis will be an underestimate of
the actual benefits of this rule.
D. Costs
The costs of this rule are the activities that change as a result
of this rule. The total cost of these regulations is the sum of the
total testing costs, total relabeling costs, and total reformulation
costs. All labels must be in compliance with this final rule by a
single effective date. All costs are estimated at the effective date,
taken to be 30 months from the publication date of this final rule. If
the effective date is more than 30 months from the date of publication,
then the actual costs of this rule will be lower than estimated here.
1. Products Affected
This final rule covers all food and dietary supplement labeling
within FDA's jurisdiction. With a few exceptions, labeling for all FDA
regulated foods and dietary supplements will have to be changed by the
next uniform effective date following publication of this rule, or
about 2 to 3 years after the date of publication. One exception is for
products with less than 0.5 g trans fat per serving that also use the
``simplified format'' for labeling and that do not make nutrition
claims or declare vitamins or minerals. The labeling for these products
will not have to be changed. FDA does not have data to estimate how
many products fall into this category, so the cost estimate does not
reflect this exception and is therefore an overestimate of the actual
cost of the rule. The other exception is for products that sell less
than 100,000 units per year in the United States, that are made by
firms that have fewer than 100 employees, that do not make nutrition or
health claims, and that have filed a notification with FDA in
accordance with Sec. 101.9(j)(18). These products are not required to
display the Nutrition Facts panel that is being amended by this rule.
Again, FDA does not have data to estimate how many products fall into
this category, so the cost estimate does not reflect this exception and
is therefore an overestimate of the actual cost of the rule.
To estimate the costs of this rule, FDA has used the FDA Labeling
Cost Model developed for FDA under contract by RTI International in
April 2002 (Ref. 129). This labeling model has more current data than
the previous labeling cost model developed for the implementing rules
of the 1990 amendments (Ref. 74). The model indicates that there are
approximately 308,000 food and dietary supplement stock keeping units
(SKUs) sold in the United States in categories for which some products
will need to be relabeled. A SKU is a specific product sold in a
specific size. For example, there is one SKU for 16 ounce (oz)
containers of Brand X Diet Peach Tea. The same brand and flavor of tea
(a product) in a 12 oz container would be another SKU, and a 12 oz
container of the same brand but different flavor of tea would be still
another SKU. The model also indicates that there are about 154,000
products potentially affected by this rule. Table 3 of this document
shows the data on the number of SKUs and products affected. From the
categories listed in table 3 as ``Selected Baking Ingredients,''
``Selected Candy,'' ``Selected Condiments, Dips and Spreads,'' and
``Selected Dressings and Sauces,'' FDA excluded products, such as
baking powder, bottled water, gum, jam, and vinegar, that qualify for
the ``simplified'' format and are certain not to be affected by this
rule. Even with these products removed, this estimate is still certain
to be an overestimate of the actual SKUs and products affected by this
rule because FDA has imputed costs to all products and SKUs within
these broad product categories. Labels on many products categories such
as ``Selected Beverages'' and ``Dietary Supplements'' are not likely to
need to be changed. However, FDA has no basis to make better estimates
of the actual number of products and SKUs affected by this rule.
Table 3.--Number of SKUs and Products Affected by Product Category
----------------------------------------------------------------------------------------------------------------
Product Categories Number of SKUs Number of Products
----------------------------------------------------------------------------------------------------------------
Baked Goods 47,200 29,600
----------------------------------------------------------------------------------------------------------------
Selected Baking Ingredients 7,700 3,300
----------------------------------------------------------------------------------------------------------------
Baby Foods 1,100 800
----------------------------------------------------------------------------------------------------------------
Selected Beverages 32,100 8,400
----------------------------------------------------------------------------------------------------------------
Breakfast Foods 3,600 2,400
----------------------------------------------------------------------------------------------------------------
[[Page 41476]]
Selected Candy 20,600 12,200
----------------------------------------------------------------------------------------------------------------
Selected Condiments, Dips and Spreads 15,200 2,300
----------------------------------------------------------------------------------------------------------------
Dairy Foods 33,800 22,100
----------------------------------------------------------------------------------------------------------------
Desserts 10,700 7,200
----------------------------------------------------------------------------------------------------------------
Dietary Supplements 29,500 9,800
----------------------------------------------------------------------------------------------------------------
Selected Dressings and Sauces 14,200 11,300
----------------------------------------------------------------------------------------------------------------
Eggs 5,800 1,800
----------------------------------------------------------------------------------------------------------------
Entrees 10,300 7,900
----------------------------------------------------------------------------------------------------------------
Fats and Oils 3,100 1,900
----------------------------------------------------------------------------------------------------------------
Fruits and Vegetables 25,100 2,500
----------------------------------------------------------------------------------------------------------------
Seafood 6,800 4,200
----------------------------------------------------------------------------------------------------------------
Side Dishes and Starches 18,000 13,200
----------------------------------------------------------------------------------------------------------------
Snack Foods 17,800 10,000
----------------------------------------------------------------------------------------------------------------
Soups 3,700 2,800
----------------------------------------------------------------------------------------------------------------
Weight Control Foods 1,300 700
----------------------------------------------------------------------------------------------------------------
Total 307,600 154,400
----------------------------------------------------------------------------------------------------------------
2. Testing Costs
In the proposed analysis, FDA assumed that all product formulations
that include partially hydrogenated oil as an ingredient would be
tested to determine the quantity of trans fat (except for margarine
products, which were all expected to reformulate). Some comments stated
that FDA's estimate of the number of products that would need to be
tested was too low because products in other categories than those
acknowledged by FDA could potentially contain a reportable amount of
trans fat. Indeed, other comments stated that all products would have
to be tested for trans content. FDA disagrees with the comment that all
products need to be tested because manufacturers will know that some
products do not contain trans fat, but does agree that more products
need to be tested than previously estimated. In the proposed analysis,
FDA estimated costs for testing only for the estimated portion of
products containing partially hydrogenated oil in several categories of
foods anticipated to be most affected by the rule (an estimated 42,000
products). In this final analysis, based on information in the FDA
Labeling Cost Model (Ref. 129), FDA estimates that about 154,000 food
products in categories that could possibly include trans fat will be
tested for trans fat content as a result of this rulemaking.
In the proposed rule, FDA used a per product cost of testing for
trans fat of $200. Some comments stated that this estimate is too low.
They stated that tests had to be calibrated for each type of food to
demonstrate accuracy of the test in the food matrix. FDA notes that
manufacturers of many different types of foods have already had their
products tested, so that much of the calibration has already been done.
The new Labeling Cost Model includes data on the cost of testing for
trans fat. Included in the analytical testing estimate is the cost of
testing two samples of the product, one hour of labor to prepare and
package the product (at $14.73 per hour) and delivery charges for one
two-pound package delivered overnight (at $26.30). The labor cost
estimate was based on the average total compensation (wages and
benefits) for handlers, equipment cleaners, helpers, and laborers in
manufacturing industries. Overhead beyond benefits on the time to
prepare a sample for testing is negligible. The model reports a range
of testing costs for trans fat given in table 4.
Table 4.--Range of Per Product and Total Testing Costs
----------------------------------------------------------------------------------------------------------------
Low Medium High
----------------------------------------------------------------------------------------------------------------
Cost per Product $261 $291 $371
----------------------------------------------------------------------------------------------------------------
Total Testing Cost $40,298,000 $44,930,000 $57,282,000
----------------------------------------------------------------------------------------------------------------
One comment suggested that butter and other products with high
butter fat contents, such as some ice cream, would contain a reportable
amount of naturally occurring trans fat, and that therefore, FDA had
underestimated the costs of testing these products. In this final
analysis, FDA has included testing and relabeling costs for all dairy
products
[[Page 41477]]
including butter and other products that are high in butter fat.
3. Relabeling Costs
In the analysis of the proposed rule, FDA estimated that 39,000
SKUs were associated with the 32,000 products that would change their
information panels at a cost of $30 million. During the comment period
reopened November 2002, FDA received comments that we would have to
reestimate the relabeling costs for the final rule. Under this final
rule many more labels will have to be changed than under the proposed
rule. FDA has used the new Labeling Cost Model to reestimate the
relabeling costs of this final rule. Based on information in the model,
three-quarters of the labels normally will be scheduled to be changed
during the 30 month compliance period. FDA estimates that about 78,000
(25 percent) of the almost 308,000 SKUs will have to be changed earlier
than would have been planned without this rule. Included in the cost of
relabeling are administrative, graphic design, pre-press preparation,
printing and engraving, and the lost value of discarded labels. Across
product categories, the average low relabeling cost per SKU is about
$1,100 and the average high relabeling cost per SKU is $2,600. The
reported estimated costs of changing labels varies within a product
category because different packaging converters and food manufacturers
reported different costs to RTI International. Table 5 shows the total
SKUs changed earlier than planned and the total estimated costs of
relabeling per product category and for the entire industry.
Table 5.--Range of Relabeling Costs by Product Category
----------------------------------------------------------------------------------------------------------------
Product Categories SKUs Changed Low Medium High
----------------------------------------------------------------------------------------------------------------
Baked Goods 12,500 $10,941,000 $16,137,000 $27,231,000
----------------------------------------------------------------------------------------------------------------
Baking Ingredients 1,700 $1,615,000 $2,380,000 $3,899,000
----------------------------------------------------------------------------------------------------------------
Baby Foods 200 $164,000 $249,000 $404,000
----------------------------------------------------------------------------------------------------------------
Selected Beverages 9,000 $11,871,000 $16,659,000 $25,437,000
----------------------------------------------------------------------------------------------------------------
Breakfast Foods 1,000 $801,000 $1,237,000 $2,044,000
----------------------------------------------------------------------------------------------------------------
Selected Candy 4,100 $4,801,000 $6,974,000 $10,846,000
----------------------------------------------------------------------------------------------------------------
Selected Condiments, Dips 3,700 $4,026,000 $5,970,000 $9,283,000
and Spreads
----------------------------------------------------------------------------------------------------------------
Dairy Foods 8,700 $10,744,000 $16,025,000 $25,032,000
----------------------------------------------------------------------------------------------------------------
Desserts 3,500 $2,762,000 $4,263,000 $7,042,000
----------------------------------------------------------------------------------------------------------------
Dietary Supplements 8,100 $13,449,000 $20,110,000 $34,041,000
----------------------------------------------------------------------------------------------------------------
Selected Dressings and 2,800 $2,908,000 $4,352,000 $6,757,000
Sauces
----------------------------------------------------------------------------------------------------------------
Eggs 2,400 $1,983,000 $2,896,000 $5,086,000
----------------------------------------------------------------------------------------------------------------
Entrees 2,400 $2,012,000 $3,078,000 $5,032,000
----------------------------------------------------------------------------------------------------------------
Fats and Oils 800 $759,000 $1,160,000 $1,848,000
----------------------------------------------------------------------------------------------------------------
Fruits and Vegetables 7,500 $7,426,000 $10,915,000 $17,882,000
----------------------------------------------------------------------------------------------------------------
Seafood 1,400 $1,732,000 $2,541,000 $3,786,000
----------------------------------------------------------------------------------------------------------------
Side Dishes and Starches 4,100 $3,361,000 $5,124,000 $8,494,000
----------------------------------------------------------------------------------------------------------------
Snack Foods 3,600 $3,604,000 $5,288,000 $8,499,000
----------------------------------------------------------------------------------------------------------------
Soups 700 $809,000 $1,194,000 $1,854,000
----------------------------------------------------------------------------------------------------------------
Weight Control Foods 200 $196,000 $283,000 $489,000
----------------------------------------------------------------------------------------------------------------
Total 78,400 $85,964,000 $126,835,000 $204,986,000
----------------------------------------------------------------------------------------------------------------
4. Margarine Reformulation Costs
One consequence of this regulation will be the reformulation of
some foods to reduce levels of trans fat. Because those changes in food
composition are attributable to this rule, the costs of reformulation
are counted here. The benefits to consumers of being able to choose
reformulated foods containing less trans fat will be counted in section
VI.E of this document. In the analysis of the proposed rule, FDA
estimated the average reformulation would cost $440,000 per product and
would take a full year. Some comments stated that reformulation was
very expensive, required a long time to accomplish and would, under
certain circumstances, require the use of more expensive inputs. No
comments contradicted FDA's estimate of the per product cost of
reformulation or provided information to change that estimate, so FDA
will continue to use a per product reformulation cost of $440,000. In
the proposed analysis FDA assumed that only large firms would
reformulate. There was no controversy over this assumption.
As mentioned previously, based on comments, FDA estimates that 15
percent of margarine products have
[[Page 41478]]
already been reformulated to eliminate trans fat. For margarine
reformulation, FDA has estimated no increase in ingredient costs,
because the price of reformulated margarine products that are already
on the market is no higher than the price of margarine products
containing 0.5 g or more per serving of trans fat. The different
ingredients used in the products appear to have had no impact on the
cost of production. However, as greater numbers of products are
reformulated, the increased demand for the substitute ingredients may
increase costs. However, given that increases in costs of inputs, if
any, have not been passed on with a change in 15 percent of margarine
products, it seems quite reasonable that an additional smaller change
(10 percent) will not result in significant increases in ingredient
costs.
Therefore, FDA estimates that 10 percent of the margarine products
that have not yet been reformulated will be reformulated to reduce
trans fat content to less than 0.5 g per serving. We assume that
reformulating 10 percent of margarine products will result in a 10
percent reduction in the average trans fat content of margarine as a
product category. The reformulation will therefore reduce the trans fat
content of margarines as a whole by 10 percent. In the analysis for the
proposed rule, FDA estimated that there were 820 margarine products.
Data in the new Labeling Cost Model indicate only 300 margarine
products. The new data was used to estimate that 30 margarine products
will reformulate as the result of this rule from 8 (10 percent of 84)
to 82 (10 percent of 820), if 10 percent of the total number of
margarine products are reformulated. Table 6 shows the cost of
margarine reformulation.
Table 6.--Cost of Margarine Reformulation
Cost of Reformulating per Product $440,000
----------------------------------------------------------------------------------------------------------------
Products Reformulating 30
----------------------------------------------------------------------------------------------------------------
Total Cost $13,200,000
----------------------------------------------------------------------------------------------------------------
FDA has not attempted to estimate the ongoing increased cost of
substitutes for partially hydrogenated oil. Competition provides
producers with incentives to use the least expensive ingredients that
are acceptable for the quality of product they are making. Therefore,
in general, any change in existing formulations (such as is expected to
occur as a result of this rule) can increase the cost of ingredients.
Even a very small increase in the price of a minor ingredient can
amount to an increase in production costs of millions of dollars when
multiplied by millions of units. However, there is good reason to
believe that, in the long run, ingredient costs may not increase. To
the extent that producers rely on newly formulated ingredients made
with new technologies, the price of these ingredients largely depends
on the industrial capacity to produce them. As the demand for such
ingredients increases, producers will have more incentive to increase
capacity and the prices of these ingredients will fall. In the case
where producers make use of different mixes of oils, agricultural
inputs are well known for being able to be supplied in greater and
greater quantities without an increase in price. FDA does not have
sufficient information on the types of substitutes that will be used,
on the volume of substitutes that will be needed, or on the future
price of the substitutes at the time that reformulation is completed.
5. Cost Summary
Costs for testing, relabeling, and reformulation are all expected
to occur by the first effective date of the final rule, or about 2 to 3
years after publication. Table 7 shows the estimates of total cost.
Table 7.--Range of Costs by Category and Total Cost
----------------------------------------------------------------------------------------------------------------
Cost Category Low Medium High
----------------------------------------------------------------------------------------------------------------
Testing $40,298,000 $44,930,000 $59,282,000
----------------------------------------------------------------------------------------------------------------
Relabeling $85,964,000 $126,835,000 $204,986,000
----------------------------------------------------------------------------------------------------------------
Reformulation $13,200,000 $13,200,000 $13,200,000
----------------------------------------------------------------------------------------------------------------
Total $139,000,000 $185,000,000 $275,000,000
----------------------------------------------------------------------------------------------------------------
FDA acknowledges that there is a significant degree of uncertainty
in the cost estimates provided here. The most significant source of
potential divergence from the reported estimates would be an ongoing
increased cost of substitutes for partially hydrogenated oil for
producers of reformulated products. FDA has not included any costs for
this item in this analysis, so that, if substitute oils do cost more,
the costs here are underestimates.
Reformulation is a second significant area of uncertainty. The
unknowns include the number of products that will be reformulated, the
cost of reformulation, the number of abandoned attempts at
reformulation, the length of time actually needed to reformulate
products, and the degree to which the reformulation of some products
reduces the cost of reformulating other products of the same or
different type. The estimates that are provided in this analysis might
be either over- or underestimates of the actual costs of reformulation.
A third major area of uncertainty includes the number of labels
that will be changed. Actual costs are likely to be lower than those
estimated here because this analysis estimated costs based on broad
categories of products some of which will not have to change their
labels.
E. Benefits
To estimate the health benefits of trans fat labeling in the
November 1999 proposal, FDA followed the general approach used to
estimate the health
[[Page 41479]]
benefits for the implementation of the 1990 amendments (56 FR 60856 at
60869, November 27, 1991). Accordingly, FDA estimated: (1) The changes
in trans fat intake that would result from labeling changes; (2) the
changes in health states that would result from changes in trans fat
intakes; and (3) the value of changes in health states in terms of
life-years gained, number of cases or deaths avoided and dollar value
of such benefits. The rule may generate other benefits, but we do not
quantify them. For example, consumers who are aware of the risks
associated with trans fat will more readily find information on the
trans fat content of various foods. The value of the reduction in
search time for those consumers is an additional benefit of this final
rule.
1. Changes in Trans Fat Intake
FDA has estimated the current trans fat intake of the population
and the estimated changes in trans fat intake. Based on comments
received and on its own reevaluation, FDA revised its estimate of
current trans fat intake, shown in table 1 (section IX.C) and its
projected estimate for changes in trans fat intake due to labeling
(table 2, section IX.C). The estimate projects quantitative decreases
in trans fat intake with implementation of the final rule, and
discusses the qualitative replacement of trans fat by other types of
fat.
2. Changes in Health States
In the November 1999 proposal, FDA used two methods to estimate the
potential decrease in CHD likely to result from decreased intake of
trans fat in response to the labeling change.
a. Method 1. Decrease in CHD risk due to decreased serum
concentrations of LDL-C.
b. Method 2. Decrease in CHD risk due to decreased serum
concentrations of LDL-C and increased serum concentrations of HDL-C.
FDA also reviewed the association of CHD risk with trans fat intake
found in large prospective observational cohort studies.
As described in section IV of this document, in the November 1999
proposal FDA concluded that the effects of trans fatty acids on serum
LDL-C should be the primary criterion for whether trans fatty acids
influence CHD risk. In Method 1, FDA used changes in the primary
criterion, serum LDL-C, to evaluate the effects of trans fat intake on
CHD risk (64 FR 62746 at 62768). Additionally, as described in section
IV of this document, although FDA did not place primary reliance upon
the relationships among trans fat intakes and adverse effects on HDL-C
and CHD risk in deciding that nutrition labeling was warranted, FDA
also recognizes this possible relationship, so concerns about possible
adverse effects cannot be ignored. Therefore, the economic analysis
used changes in both HDL-C and LDL-C as a second method to quantify the
effects of trans fat intake on CHD risk, with the noted qualification
that the primary basis for the rule was the effect of trans fat on LDL-
C (64 FR 62746 at 62769).
Section IV of this document notes that observational
epidemiological studies can provide evidence of an association between
a risk factor and a disease, but cannot establish direct cause and
effect. Therefore, FDA considered the evidence from observational
epidemiological studies, including large prospective (cohort) studies,
as indirect evidence for a relationship between trans fat intake and
CHD risk. In the November 1999 proposal, FDA found that the prospective
studies of trans fat intake and CHD risk consistently reported a
greater risk of CHD attributable to trans fat intake than would be
accounted for by either Method 1 (changes in LDL-C) or by Method 2
(changes in both LDL-C and HDL-C) (64 FR 62746 at 62770 to 62771). The
estimates in Method 1 and Method 2 are calculated using factors from
regression equations summarizing the results of short-term feeding
trials (intervention studies). In the intervention studies, trans fat
is fed to people for a few weeks, changes in serum lipids are measured,
and it is assumed that the CHD risk associated with trans fat intake
occurs through the mechanism of changes in LDL-C and possibly HDL-C. In
contrast, the prospective studies measure actual CHD occurrence in a
large group of people over a period of years, and describe all CHD risk
associated with trans fat intake, regardless of the mechanism of action
by which trans fat intake may be associated with CHD. Thus, the results
of the prospective studies suggest that there may be additional
mechanisms by which trans fat contributes to CHD risk. Because
prospective studies do not show direct cause and effect, and because
the relative risks determined in observational studies are imprecise,
FDA did not use the results of the prospective studies in quantitative
estimates of changes in trans fat intake and CHD risk. However, FDA
noted that, if there are additional mechanisms by which trans fat
contributes to CHD risk, as suggested by the prospective studies, then
the actual benefits may be greater than estimated using either Method 1
(changes in LDL-C) or Method 2 (changes in LDL-C and HDL-C) (64 FR
62746 at 62771).
As described in the November 1999 proposal (64 FR 62746 at 62768
and 62769), the regression equations of Katan et al. (Ref. 62) and Zock
et al. (Ref. 69) were based on five intervention studies that made, in
total, six dietary comparisons between consumption of trans fat and
cis-unsaturated fat (Refs. 7, 8, and 11 through 13). The regression
equation for LDL-C showed that each additional percent of energy from
trans fat was predicted to increase LDL-C by 1.5 mg/deciliter (dL)
(0.040 millimol/liter) (R\2\ = 0.86, p = 0.0028) when substituted for
the same percent of energy from cis-monounsaturated fat, holding total
energy intake constant. The regression equation for HDL-C showed that
each additional percent of energy from trans fat was predicted to
decrease HDL-C by 0.4 mg/dL (0.013 millimol/liter) (R\2\ = 0.88, p =
0.0019), when substituted for the same percent of energy from cis-
monounsaturated fat. The regression lines were forced through the
origin because a zero change in intake will produce a zero change in
lipoprotein concentrations (Refs. 62, 69, and 154). In carrying out the
regression, differences between diets in fatty acids other than trans
fat and cis-monounsaturated fat were adjusted for by using regression
coefficients from a previous meta-analysis of 27 intervention studies
(Ref. 65).
Sample calculations using Method 1 and Method 2 are summarized in
table 8 in this document. The table illustrates a decrease in trans fat
intake of 0.1 percent of energy (calories) and shows the factors FDA
used to relate a given decrease in trans fat intake to a corresponding
change in CHD risk. To estimate the change in CHD risk with change in
trans fat intake, for each type of serum lipid, LDL-C and HDL-C, we
multiplied the change in trans fat intake by three factors,
representing: (1) the change in serum lipid with change in trans fat
intake, (2) the change in CHD risk with change in serum lipid, and (3)
an adjustment for regression dilution. Table 8 shows that, for Method
1, based on changes in LDL-C, replacement of 0.1 percent of energy from
trans fat with the same percent of energy from cis-monounsaturated fat
would decrease CHD risk by 0.147 percent (-0.1 percent of energy from
trans fat x 1.5 mg LDL-C/dL per percent of energy from trans fat x 0.7
percent change in CHD risk per mg LDL-C/dL x 1.4 adjustment factor for
regression dilution = -0.147 percent change in CHD risk). Based on
changes in HDL-C, replacement of 0.1 percent of energy from trans fat
would decrease
[[Page 41480]]
CHD risk by 0.140 percent (-0.1 percent of energy from trans fat x -0.4
mg HDL-C/dL per percent of energy from trans fat x -2.5 percent change
in CHD risk per mg HDL-C/dL x 1.4 adjustment factor for regression
dilution = -0.140 change in CHD risk based on changes in HDL-C). For
Method 2, based on changes in both LDL-C and HDL-C, the decrease in CHD
risk would be 0.287 percent (-0.147 percent based on LDL-C plus -0.140
percent based on HDL-C = -0.287 percent based on LDL-C + HDL-C). FDA
used these estimation methods to project the decrease in CHD risk in
the November 1999 proposal (64 FR 62746 at 62767).
Table 8.--Sample Calculation for Change in CHD Risk With Substitution of Cis-Monounsaturated Fat for Trans Fat
----------------------------------------------------------------------------------------------------------------
Factor for Factor for
Change in Change in Factor for Adjustment
Estimation Method Trans Intake Type of Serum Serum Lipids Change in CHD of Change in CHD
(% of Energy) Lipid (mg/dL per 1% Risk (% per mg/ Regression Risk (%)
of Energy) dL) Dilution
----------------------------------------------------------------------------------------------------------------
Method 1 LDL -0.1 LDL 1.5 0.7 1.4 -0.147
----------------------------------------------------------------------------------------------------------------
Method 2 LDL + -0.1 LDL 1.5 0.7 1.4 -0.147
HDL
----------------------------------------------------------------------------------------------------------------
.............. HDL -0.4 -2.5 1.4 -0.14
----------------------------------------------------------------------------------------------------------------
.............. LDL+HDL .............. .............. ............ -0.287
----------------------------------------------------------------------------------------------------------------
In the scientific literature, cis-monounsaturated fat is commonly
used as a reference point in describing effects of trans fat intake.
Therefore, FDA first estimated the effect on CHD risk by assuming that
a given amount of trans fat would be replaced by the same amount of
cis-monounsaturated fat in the diet (table 8 in this document and 64 FR
62746 at 62767). However, it is likely that trans fat in the diet would
actually be replaced by a combination of cis-monounsaturated fat, cis-
polyunsaturated fat, and saturated fat. Therefore, FDA also considered
the changes in LDL-C and HDL-C associated with replacement of trans fat
by different types of fatty acids or carbohydrate (64 FR 62746 at 62767
to 62770). Table 9 in this document summarizes the factors for changes
in LDL-C and HDL-C with different macronutrients and combinations of
macronutrients replaced by trans fat. The first four columns of data
show the factors for substitution of trans fat for 100 percent of
individual types of fatty acids or carbohydrate. We project that, due
to trans fat labeling, trans fat will be replaced by combinations of
different types of fatty acids or carbohydrate. By combining the
factors in the first four data columns, we obtained the factors for
substitution of trans fat for combinations of different fatty acids and
carbohydrate, shown in the last three data columns.
We generated the factors in table 9 by combining the results of two
sets of metaanalyses. Table 9 shows the result of linking: (1) The
regression equation coefficients of Katan et al. (Ref. 62) and Zock et
al. (Ref. 69), for substitution of trans fat for cis-monounsaturated
fat and (2) the regression equation coefficients of Mensink and Katan
(Ref. 65), for substitution of saturated and cis-unsaturated fat for
carbohydrate. The regression equations of Mensink and Katan (Ref. 65)
were based on 27 intervention studies that made dietary comparisons for
consumption of carbohydrate, saturated fat, cis-polyunsaturated fat and
cis-monounsaturated fat. The regression equation for LDL-C included 57
dietary comparison data points from 24 studies, and showed that,
holding total energy intake constant, when substituted for one percent
of energy from carbohydrate, each additional percent of energy from
saturated fat was predicted to increase LDL-C by 1.28 mg/dL (0.033
millimol/liter) (p < 0.001), each additional percent of energy from
cis-monounsaturated fat was predicted to lower LDL-C by 0.24 mg/dL
(0.006 millimol/liter) (p = 0.114) and each additional percent of
energy from cis-polyunsaturated fat was predicted to lower LDL-C by
0.55 mg/dL (0.014 millimol/liter) (p = 0.002). The regression equation
for HDL-C included 59 dietary comparison data points from 25 studies,
and showed that holding total energy intake constant, when substituted
for one percent of energy from carbohydrate, each additional percent of
energy from saturated fat was predicted to increase HDL-C by 0.47 mg/dL
(0.012 millimol/liter) (p < 0.001), each additional percent of energy
from cis-monounsaturated fat was predicted to increase HDL-C by 0.34
mg/dL (0.009 millimol/liter) (p < 0.001) and each additional percent of
energy from cis-polyunsaturated fat was predicted to increase HDL-C by
0.28 mg/dL (0.007 millimol/liter) (p = 0.002).
Comparison with the observed data showed that the predicted
regression lines explained 64 percent of the variation in changes in
LDL-C and 88 percent of the variation in changes in HDL-C. The
coefficients of Mensink and Katan (Ref. 65) are expressed as
substitution of each type of macronutrient for carbohydrate, but the
coefficients of Katan et al. (Ref. 62) and Zock et al. (Ref. 69) are
expressed as substitution of trans fat for cis-monounsaturated fat. For
comparability with the coefficients for trans fat, we expressed the
coefficients of Mensink and Katan in terms of substitution of each type
of macronutrient for cis-monounsaturated fat. As stated in the November
1999 proposal (64 FR 62746 at 62769), when substituted for one percent
of energy from cis-monounsaturated fat, saturated fat raised LDL-C by
1.52 mg/dL, cis-polyunsaturated fat lowered LDL-C by 0.31 mg/dL, and
carbohydrate raised LDL-C by 0.24 mg/dL. When substituted for one
percent of energy from cis-monounsaturated fat, saturated fat raised
HDL-C by 0.13 mg/dL, cis-polyunsaturated fat lowered HDL-C by 0.06 mg/
dL, and carbohydrate lowered HDL-C by 0.34 mg/dL. We then combined
these coefficients with the coefficients for trans fat, to obtain the
changes in lipoprotein levels with trans fat substituted for different
macronutrients, as shown in table 9.
Table 9 also gives examples of changes in CHD risk with replacement
of 0.1 percent of energy from trans fat by different macronutrients and
combinations of macronutrients. Table 8 shows the general method and
illustrates the calculation of estimated changes in CHD risk with
replacement
[[Page 41481]]
of trans fat by cis-monounsaturated fat. To account for each type of
macronutrient substitution, we used the corresponding factors from
table 9 for changes in serum lipids. For example, for cis-
polyunsaturated fat, table 9 gives the factor, 1.81 mg LDL-C/dL, for
replacement of 1 percent of energy from cis-polyunsaturated fat by
trans fat. For Method 1, based on changes in LDL-C, the replacement of
0.1 percent of energy from trans fat with the same percent of energy
from cis-polyunsaturated fat would decrease CHD risk by 0.177 percent
(-0.1 percent of energy from trans fat x 1.81 mg LDL-C/dL per percent
of energy from trans fat x 0.7 percent change in CHD risk per mg LDL-C/
dL x 1.4 adjustment factor for regression dilution = -0.177 percent
change in CHD risk). As noted previously, we project that, due to trans
fat labeling, trans fat will be replaced by combinations of different
types of fatty acids or carbohydrate. The changes in CHD risk
associated with specific combinations of fatty acids or carbohydrate
are shown in the last three data columns. The first four data columns
show the change in CHD risk associated with each individual type of
fatty acid and carbohydrate. The column showing trans fat replaced by
100 percent saturated fat is included in table 9 for completeness in
illustrating the data and methods we used to estimate changes in CHD
risk with different macronutrient substitutions. The inclusion of this
column does not indicate that FDA projects that trans fat will be
replaced by 100 percent saturated fat, or that FDA would encourage such
an inappropriate substitution. Rather, the substitutions for trans fat
that FDA considers most likely are shown later, in table 10.
As mentioned earlier, and in the November 1999 proposal (64 FR
62746 at 62769), the economic analysis used changes in both LDL-C and
HDL-C as a second method to quantify the effects of trans fat intake on
CHD risk, with the noted qualification that the primary basis for the
rule was the effect of trans fat on LDL-C. To allow readers to
reproduce all of our estimated changes in CHD risk, table 9 shows
changes in CHD risk based on Method 2, LDL-C and HDL-C, as well as
Method 1, LDL-C. In addition, the cells that show a decrease in CHD due
to a 100 percent replacement of trans fat for saturated fat represent
the relationship between HDL-C and CHD, a relationship that is more
uncertain than the causal relationship between LDL-C and CHD. FDA
accounted for the replacement of trans fat with different combinations
of macronutrients by projecting a range of changes in health states in
terms of life-years gained, number of cases or deaths avoided, and
dollar value of such benefits (64 FR 62746 at 62771-62773).
Table 9.--Summary of Changes in Serum Lipids and CHD Risk With Different Macronutrient Substitutions A. Change in Serum Lipids With Substitution of
Trans Fatty Acids for Different Types of Fatty Acids or Carbohydrate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Macronutrient Cis- Cis- Saturated Carbohydrate Half cis- Half cis- Half cis-
-------------------------------- monounsaturated polyunsaturated Fatty Acid -------------- monounsaturated monounsaturated monounsaturated
Fatty Acid Fatty Acid -------------- and half cis- and half and half
------------------------------------ polyunsaturated saturated carbohydrate
Change in Serum Lipid When mg/dL per 1% mg/dL per 1% --------------------------------------------------------
Replaced by Trans Fat mg/dL per 1% of mg/dL per 1% of of energy of energy mg/dL per 1% of mg/dL per 1% of mg/dL per 1% of
energy energy energy energy energy
--------------------------------------------------------------------------------------------------------------------------------------------------------
LDL 1.5 1.81 -0.02 1.26 1.66 0.74 1.38
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDL -0.4 -0.34 -0.53 -0.06 -0.37 -0.47 -0.23
--------------------------------------------------------------------------------------------------------------------------------------------------------
B. Change in CHD Risk With Replacement of Trans Fatty Acids By Different Types of Fatty Acids or Carbohydrate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Macronutrient Cis- Cis- Saturated Carbohydrate Half cis- Half cis- Half cis-
---------------------------------------- monounsaturated polyunsaturated Fatty Acid -------------- monounsaturated monounsaturated monounsaturated
Fatty Acid Fatty Acid -------------- and half cis- and half and half
---------------------------------- Percent per polyunsaturated saturated carbohydrate
Change in CDH Risk With Replacment of Percent per 0.1% of --------------------------------------------------
Trans Fat Percent per Percent per 0.1% of energy Percent per Percent per Percent per
0.1% of energy 0.1% of energy energy 0.1% of energy 0.1% of energy 0.1% of energy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Method 1, LDL -0.147 -0.177 0.002 -0.123 -0.162 -0.073 -0.135
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDL -0.140 -0.119 -0.186 -0.021 -0.130 -0.163 -0.081
--------------------------------------------------------------------------------------------------------------------------------------------------------
Method 2, LDL + HDL -0.287 -0.296 -0.184 -0.144 -0.292 -0.235 -0.216
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Comment 39) As described previously in this document, FDA received
numerous comments in support of the November 1999 proposal. Several of
these comments noted specifically that labeling of trans fat has the
potential for substantial public health benefits. A number of comments
noted that consumption of trans fat increases the risk of CHD by
increasing total blood cholesterol and LDL-C, and that trans fat
labeling would enable consumers to decrease their trans fat intake and
therefore decrease their risk of CHD. Some comments added that, because
trans fat also increases the risk of CHD by decreasing HDL-C, therefore
the health benefits of trans fat labeling would be greater than the
benefits associated with the effect of trans fat on LDL-C alone. A few
comments
[[Page 41482]]
specifically stated that the prospective studies suggest that there may
be other biological mechanisms by which trans fat contributes to CHD,
in addition to the effects of trans fat on LDL-C and HDL-C. These
comments therefore supported the possibility that the actual benefits
of trans fat labeling may be greater than FDA's estimate using either
Method 1 (LDL-C) or Method 2 (LDL-C and HDL-C).
Other comments, which were opposed to the November 1999 proposal or
some of its provisions, questioned FDA's conclusions regarding the net
health benefits of trans fat labeling. Some comments stated that the
potential harm to the public remedied by trans fat labeling was not
sufficient to outweigh the cost burden to specific industries. These
comments suggested that, although trans fat was shown to increase LDL-C
in some studies, the evidence was inconclusive on how to quantify the
increase in LDL-C and CHD risk due to trans fat intake and on whether
the increase in LDL-C and CHD risk due to trans fat intake were as
large as those due to saturated fat. These comments suggested that
FDA's estimate of health benefits of trans fat labeling was too high.
One comment stated that it is premature to conclude that trans fat
intake lowers HDL-C because many intervention studies showed that trans
fat intake causes only a small decrease or has no effect on HDL-C. The
comment implied that consumption of trans fat may not increase CHD risk
by decreasing HDL-C. A few comments cited an FDA statement from the
November 1999 proposal that no dose-response relationship had been
demonstrated between trans fat intake and CHD (64 FR 62746 at 62752).
The comments argued that, therefore, it is not possible to project
quantitative health benefits due to trans fat labeling. One comment
also stated that the health benefits estimate was inaccurate because it
did not account for either other CHD risk factors, such as obesity, or
other CHD prevention efforts.
A few comments questioned whether health benefits could result from
trans fat labeling because the in the intervention studies the intakes
of trans fat were very high and not representative of U.S. intakes of
about 5.3 g/d (3 percent of calories). Some comments stated that, even
if trans fat has adverse health effects at higher levels of intake,
there is no clinical evidence that lower levels of intake, such as 0.5
g trans fat in a serving of a food product, has any adverse effect.
These comments therefore questioned whether health benefits could
result from labeling of trans fat present in relatively small amounts
in individual foods. Other comments suggested that the emphasis on
trans fat in the proposed labeling regulations was out of proportion to
the emphasis on saturated fat, because the overall amount of saturated
fat in the diet is approximately five times that of trans fat. The
comments stated that, therefore, decreased trans fat intake has much
less potential for lowering CHD risk than does decreased saturated fat
intake, and this should be considered when estimating the health
benefits of trans fat labeling.
Regarding the comments that questioned whether the increase in LDL-
C and CHD risk due to trans fat intake could be quantified and whether
the increase in LDL-C and CHD risk due to trans fat intake were as
large as those due to saturated fat, FDA stated in the review of the
science in the 1999 proposal (64 FR 62746 at 62753) that the available
studies did not provide a definitive answer about whether trans fat has
an effect on LDL-C and CHD risk equivalent to saturated fat on a gram-
for-gram basis. FDA noted that interpretation of the intervention
studies is complicated because, in the individual studies, trans fatty
acids replace other dietary fatty acids that also affect serum
cholesterol levels (64 FR 62746 at 62751). This evaluation was based on
a review and analysis of the individual studies, it was not done for
purposes of an economic analysis. To overcome the difficulties in
interpreting individual intervention studies, in the November 1999
proposal FDA used regression equations based on a meta-analysis of
intervention trials to quantitatively estimate the relationship between
trans fat and LDL (Refs. 62, 65, and 69) in its calculation of the
health benefits of trans fat labeling (64 FR 62746 at 62768-62770). As
noted in section IV of this document, and in the November 1999
proposal, the regression equations do predict a very similar increase
in LDL-C with each one percent of energy increase in either saturated
fat or trans fat. Thus, table 9 in this document shows that the change
in LDL-C is negligible when one percent of energy from trans fat is
substituted for saturated fat. Therefore, FDA disagrees with the
comments that stated that the increases in LDL-C and CHD risk due to
trans fat intake could not be quantified and were not as large as those
due to saturated fat and that FDA's estimate of these health benefits
of trans fat labeling was too high.
Regarding the comment suggesting that it is premature to conclude
that trans fat intake lowers HDL-C, section IV of this document states
that Federal Government advisory groups (Refs. 88 to 90, 140) and an
advisory group of health professionals (Ref. 91) have stated that
substitution of trans fat for saturated fat lowers HDL-C. Specifically,
the Dietary Guidelines 2000 Advisory Report states that trans fatty
acids tend to lower a protective form of serum cholesterol (HDL
cholesterol) (Ref. 88). NCEP 2001 states that randomized clinical
trials show that when trans fatty acids are substituted for saturated
fatty acids, HDL cholesterol levels are lower, with a dose response
effect observed (Ref. 89). The IOM/NAS states that the preponderance of
the data suggest that hydrogenated fat/trans fatty acids, relative to
saturated fatty acids, result in lower HDL cholesterol concentrations
(Ref. 90). AHA 2000 states that it has been established that dietary
trans-unsaturated fatty acids can increase LDL cholesterol and reduce
HDL cholesterol (AHA 2000, p. 2300) (Ref. 91). Therefore, FDA disagrees
with the comment that it is premature to conclude that trans fat intake
may lower HDL-C. As described in Section IV of this document, although
FDA did not place primary reliance upon the relationships among trans
fat intakes and adverse effects on HDL-C and CHD risk in deciding that
nutrition labeling was warranted, FDA also recognizes this possible
relationship, so concerns about possible adverse effects cannot be
ignored. Therefore, we used changes in both HDL-C and LDL-C as a second
method to quantify the effects of trans fat intake on CHD risk, with
the noted qualification that the primary basis for the rule was the
effect of trans fat on LDL-C (64 FR 62746 at 62769).
Regarding the comments discussing FDA's statement in the November
1999 proposal (64 FR 62746 at 62752) that no dose response relationship
had been demonstrated between trans fat intake and CHD, this statement
referred to the effect of trans fat on CHD risk in the observational
studies, not to the effect of trans fat on LDL-C which was used to
estimate the health benefits in Method 1 (LDL-C) and Method 2 (LDL-C
and HDL-C). FDA's statement was a generalization regarding the
observational studies overall, including both case control studies and
prospective observational studies. However, the four large prospective
studies did all show dose-response relationships between trans fat
intake and CHD risk, but in two of the studies the dose-response
relationship was not statistically significant in all analyses. In the
Nurses Health Study, the dose response relationship at both 8 years
[[Page 41483]]
and 14 years of followup was highly statistically significant (Refs. 21
and 38). In a Finnish study, the dose response relationship of trans
fat with risk of CHD death was significant (p = 0.004), but was not
significant for risk of major coronary event (p = 0.158) (Ref. 20). In
a study of U.S. men, the dose response relationship was significant
after statistical adjustment for major CHD risk factors (p = 0.01) but
was not significant after additional adjustment for dietary fiber (p =
0.2) (Ref. 19). Therefore, the prospective studies were consistent with
a dose-response relationship, although the relationship was not
statistically significant in all analyses. Moreover, as discussed
previously in this section, FDA's quantitative estimate of health
benefits was not based on the prospective studies, but was based on the
regression equations summarizing the results of the intervention
feeding studies (tables 8 and 9 in this document and 64 FR 62746 at
62757-62770). The regression equations summarizing the effect of trans
fat on LDL-C and HDL-C in the intervention studies did show a dose
response relationship, as discussed in the November 1999 proposal and
noted in section IV of this document. Additionally, the regression
equations used by FDA in this document and in the November 1999
proposal were for purposes of making a quantitative estimate of the
health benefits as part of an economic analysis and are consistent with
newer regression equations in a study published in 2001 (Ref. 130).
Therefore, FDA does not agree with the comment that it is not possible
to calculate health benefits because there is no dose-response
relationship for the adverse effects of trans fat.
FDA disagrees with the comment that the health benefits estimate
did not account for other CHD risk factors. In the health benefits
estimate, FDA used the factors shown in table 8 to calculate the amount
of CHD risk associated with the expected amount of change in LDL-C and
HDL-C. These factors were derived from large population studies of
serum lipids and CHD risk, in which statistical methods accounted for
other positive and negative risk factors for CHD.
Regarding the comment about the level of trans fat intake in the
intervention studies, Section IV of this document explains that,
because of uncertainty in intake estimates, caution must be exercised
to avoid over-interpretation of the available dietary intake estimates
and their relationship to the trans fat levels used in the intervention
trials. However, in response to the comment, FDA notes some specific
examples of intervention studies with lower trans fat intake. One
example is the study of Judd et al., 1998 (Ref. 34), which found a
significant increase in LDL-C with a difference in trans fat intake of
1.5 percent of calories between the trans fat test diet (3.9 percent of
calories from trans fat) and the comparison diet (2.4 percent of
calories from trans fat). Another example is the study of Lichtenstein
and coworkers (Ref. 82) which studied six test diets and reported a
positive coefficient, i.e., a linear trend, for the association of the
change in LDL-C levels among diets with the change in trans fat intake
(including trans fat changes of 0.4 percent and 2.8 percent of
calories). Such a linear trend does suggest that trans fat intakes
below 3 percent of calories may influence LDL-C levels, and thus, CHD
risk. Therefore, significant increases in LDL were found in specific
intervention studies with trans fat intake at or below the reported
average intake for the U.S. population.
FDA disagrees with the comment that disclosure of 0.5 g trans fat
or greater in a food product has no public health importance and that
health benefits may not result from labeling of trans fat present in
relatively small amount in individual foods. As described earlier in
sections III and V of this document, FDA does not need to demonstrate
adverse health effects of 0.5 g trans fat in a food product in order to
justify requiring disclosure of 0.5 g trans fat on food labels. Rather,
FDA determined that the consistent provision of trans fat information
on foods consumed throughout the day is of public health importance and
can assist consumers in maintaining healthy dietary practices. Further,
FDA has determined that the absence of trans fat information on foods
requiring mandatory labeling would be misleading. However, for the
purposes of economic analysis, the health benefits of decreasing trans
fat intake by 0.5 g can be estimated quantitatively. In a 2,000 calorie
diet, 0.5 g trans fat corresponds to approximately 0.2 percent of
energy. (This correspondence holds because 1 g of fat = 9 kcal, so (0.5
x 9 x 100)/2000 = 0.2 percent of energy). Using the factors in table 8,
replacement of 0.2 percent of energy from trans fat with cis-
monounsaturated fat would decrease CHD risk by 0.29 percent based on
LDL-C and 0.57 percent based on LDL-C and HDL-C. Because CHD is so
common in the U.S. population, a relatively small decrease in risk
corresponds to a large number of cases and deaths avoided and large
dollar value of such benefits, as shown in the example in section IX.A
of this document. Awareness of trans fat contributions from food
products containing 0.5 g and above will assist individual consumers in
maintaining healthy dietary practices, reducing the average 2.6 percent
of energy from trans fat consumed throughout the day.
FDA agrees with the comments that average saturated fat intake in
the United States is about 5 times greater than average trans fat
intake. FDA stated in the November 1999 proposal that it did not want
to distract consumers from years of dietary guidance messages about
saturated fat (64 FR 62746 at 62755). But the potential health benefits
from decreasing trans fat intake compared with decreasing saturated fat
intake do not depend solely upon the average total amount of each in
the diet. The potential health benefits also depend upon the
feasibility of decreasing intake of saturated fat compared with trans
fat. Average U.S. saturated fat intake in 1980 was about 13 percent of
energy and decreased to 11 or 12 percent of energy by the mid-1990s
(Ref. 113). Many additional heart attacks and deaths might be prevented
if saturated fat intake could be decreased to the recommended less than
10 percent of energy. The targeted decrease in saturated fat intake of
one or two percent of energy can be compared with the average trans fat
intake of 2 percent of energy from partially hydrogenated fats and
oils. Labeling of trans fat will create new potential for decreased
trans fat intake by providing an incentive to food manufacturers to
reduce the amount of trans fat in their products and by providing
consumers with information they need to include trans fat content in
their food purchasing decisions.
(Comment 40) Among the comments that supported the potential public
health benefits of trans fat labeling, many noted that benefits would
result from provision of trans fat information on product labels so
that consumers could incorporate this information into their purchasing
decisions. Several comments also specifically noted the likelihood that
trans fat labeling would result in reformulation of products to be
lower in trans fat, and suggested that the public health benefits would
be large because reducing trans fat intake as a result of reformulation
requires little effort by consumers. However, some comments did not
agree that trans fat labeling would be read or understood by consumers,
or that the labeling would affect purchasing decisions. These comments
suggested that the net health benefits of trans fat labeling would be
much smaller than FDA's estimate. Other comments did not agree that
[[Page 41484]]
products could be reformulated in a manner that would result in net
health benefits. Some of these comments stated that trans fat is
beneficial because foods with trans fat replace foods with higher
amounts of saturated fat. Some comments stated that feasible
reformulations that would lower trans fat would also increase saturated
fat, thereby reducing or eliminating health benefits. Other comments
emphasized that manufacturers need competitive incentives in order to
incur the costs of reformulation, and did not agree that the Nutrition
Facts panel and label claims in the November 1999 proposal provided
sufficient incentives for reformulation.
In the November 1999 proposal, FDA based its estimate of health
benefits on scenarios of projected decreases in trans fat intake due to
labeling and reformulation. As summarized in section VI.C of this
document, FDA received specific comments regarding the likely decrease
in trans fat intake due to expected consumer responses to trans fat
labeling and due to the projected amount of product reformulation.
Based on the comments received, on the provisions of this final rule
and on its own reevaluation, FDA has revised its estimate of the
expected decrease in trans fat intake due to labeling (table 2, section
VI.C). Because of uncertainties regarding the magnitude of consumer
response to trans fat labeling we have chosen a very low estimate of
consumer response to the new label, a decrease of 0.1 percent of trans
fat intake (section VI.C.). As described in section IV of this
document, current dietary guidance does not consider trans fat to be
beneficial, but recommends that intake of both trans fat and saturated
fat should be limited. When products containing partially hydrogenated
fats or oils are reformulated to lower the trans fat content,
functionality may require the reformulated products to have more
saturated fat than the original product. However, as shown in a number
of examples included with comments, the total amount of saturated fat
plus trans fat in the reformulated product is commonly lower than in
the original product. Substitution of the reformulated product for the
original product in the diet would have net health benefits using
Method 1, LDL-C, and even higher health benefits using Method 2, LDL-C
and HDL-C. FDA acknowledges that different products have different
functionality requirements for fats and oils, and the constraints on
reformulation alternatives are different for tub and stick margarines
and spreads, household shortenings, frying fats for snacks and chips,
and baking fats for cookies, crackers, cakes and other baked goods. FDA
has summarized specific comments regarding reformulation alternatives
in section IX.C of this document, has taken these into account in
projecting the expected amount of margarine reformulation (table 2),
and is accounting for the replacement of trans fat with different
combinations of macronutrients in its models for calculating changes in
valuation of health states in section IX.E.3 of this document.
Therefore, FDA does not agree with the comments that feasible
reformulations would eliminate health benefits by increasing saturated
fat. In section V of this document, FDA stressed the importance of
providing information on trans fat on the nutrition label to assist
consumers in choosing healthier diets. As described in section IX.E.3
of this document, in response to comments regarding reformulation, FDA
recognizes that different features of this final rule may tend to
either increase or decrease the incentives for reformulation.
Therefore, because of this uncertainty, in this analysis FDA is using a
deliberately low estimate, 10 percent, for the decrease in trans fat
intake due to margarine reformulation. Also, FDA is not using a
quantitative estimate for any decrease in trans fat intake due to
reformulation of baked products or of other products containing
hydrogenated fats and oils. To the extent that the decrease in trans
fat intake due to reformulation is greater than FDA's estimate, this
analysis will underestimate the benefits of trans fat labeling.
(Comment 41) As summarized in section IV.9 of this document, one
comment recommended that comparisons of the health effects of saturated
fat and trans fat should be explicit and consistent throughout the
final rule. The comment noted that in FDA's November 1999 proposal, the
preliminary regulatory impact analysis estimated that the effects of
trans fat and saturated fat on LDL-C were similar for a given percent
of energy, but the review of the science did not make a gram-for-gram
comparison of the effects of saturated and trans fat. The comment
stated that if there is uncertainty about the comparative effects of
saturated fat and trans fat on LDL-C, then this should be reflected in
FDA's estimate of health benefits. The comment also noted that, in the
preliminary regulatory impact analysis, use of Method 2, LDL-C and HDL-
C, would approximately double the expected health benefits of trans fat
labeling, compared with Method 1, LDL-C. The comment suggested that if
the adverse health effects of trans fat are approximately double those
of saturated fat, this should be taken into account in the provisions
for labeling and claims. This comment also suggested that FDA had
misinterpreted the relative risk results of the prospective
observational studies and questioned whether these studies actually
indicated that the risk of CHD due to trans fat intake was much greater
than would be expected due to LDL-C and HDL-C. According to the
comment, relative risk estimates in prospective studies depend on the
base risk used for comparisons. Individuals in some study groups, such
as the Nurses Health Study, may have lower overall CHD risk than
individuals in the general population because the participants are
volunteers whose lifestyles may be healthier than average. A systematic
difference between the study and general populations may result in
inaccuracies when the relative risk from the study population is
related to the absolute risk in the general population.
A few comments to the November 15, 2002, notice to reopen the trans
fat comment period questioned the scientific validity of certain of the
observations and conclusions in the IOM/NAS report. The comments stated
that the IOM/NAS report relied upon a regression equation in an article
by Ascherio et al. (Ref. 83), published in the NEJM, for its
observation that trans fatty acids may have a more adverse effect on
CHD risk than saturated fatty acids and for its conclusion that,
similar to saturated fatty acids, there is a positive linear trend
between trans fatty acid intake and LDL-C and risk of CHD. The comments
stated that the Ascherio et al. article was a commentary that was not
peer-reviewed and should not be accorded the weight given by the IOM
report. Additionally, comments suggested that additional research is
needed to establish whether there is a positive linear trend between
trans fat intake and LDL-C. The comments asserted that there may be an
alternate explanation for the results described by Ascherio et al., and
mentioned unpublished work done at the University of Cincinnati. The
comments did not mention the existence of any other evidence for a
linear trend between trans fat intake and LDL-C, and implied that, in
the absence of the Ascherio article (Ref. 83), there would be no basis
for the existence of such a linear trend.
As stated in section IV.9 of this document, regardless of whether
FDA reviewed the effects of saturated fat and
[[Page 41485]]
trans fat on LDL-C and CHD risk for the science section or the
regulatory impact section, the basic conclusion about those effects is
the same. That is, both trans fatty acids and saturated fatty acids
raise LDL-C levels, a major risk factor for CHD risk. FDA did state in
the review of the science in the 1999 proposal (64 FR 62746 at 62753)
that the available studies did not provide a definitive answer about
whether trans fat has an effect on LDL-C and CHD risk equivalent to
saturated fat on a gram-for-gram basis. However, as stated previously
in both this section and section IV of this document, to overcome the
difficulties in interpreting individual intervention studies, in the
November 1999 proposal FDA used regression equations based on a meta-
analysis of intervention trials to quantitatively estimate the
relationship between trans fat and LDL (Refs. 62, 65, and 69) in its
calculation of the health benefits of trans fat labeling (64 FR 62746
at 62768-62770). The regression equations do predict a very similar
increase in LDL-C with each one percent of energy increase in either
saturated fat or trans fat. The regression equations used by FDA in
this document and in the November 1999 proposal are appropriate for
purposes of making a quantitative estimate of the health benefits as
part of an economic analysis and are consistent with newer regression
equations in a study published in 2001 (Ref. 130).
As previously described in this section and in section IV of this
document, although FDA did not place primary reliance upon the
relationships among trans fat intakes and adverse effects on HDL-C and
CHD risk in deciding that nutrition labeling was warranted, FDA also
recognizes this possible relationship, so concerns about possible
adverse effects cannot be ignored. Therefore, we used changes in both
HDL-C and LDL-C as a second method to quantify the effects of trans fat
intake on CHD risk, with the noted qualification that the primary basis
for the rule was the effect of trans fat on LDL-C (64 FR 62746 at
62769). As discussed in section V of this document, because of chemical
and physiologic distinctions between saturated and trans fats, the
agency has reconsidered the position that the two fatty acids should be
declared as one combined entity. Declaration of the amount of trans fat
on a separate line from saturated fat on the nutrition label is
consistent with the possibility that the health benefits of trans fat
labeling may be due to changes in LDL-C alone (Method 1), or to changes
in both LDL-C and HDL-C (Method 2).
In response to the comment about relative risk in the prospective
studies, FDA acknowledges that relative risk estimates in prospective
studies will depend on the base risk used for comparisons and this
dependence on base risk may result in inaccuracies when the relative
risk is related to the absolute risk in other studies or in the general
population. However, FDA does not agree that this difference would
change the basic conclusion of the prospective studies, that the CHD
risk associated with trans fat in the prospective studies is much
greater than the CHD risk expected due to either Method 1 (LDL-C) or
Method 2 (LDL-C and HDL-C). In the 14-year followup of the Nurses
Health Study (Ref. 38), the increased risk of CHD associated with trans
fat intake compared with carbohydrate intake was more than ten times
the increased risk for the same amount of saturated fat compared with
carbohydrate. This comparison between trans fat and saturated fat was
in contrast to the prediction based on Method 1 (LDL-C) or Method 2
(LDL-C and HDL-C). In Method 1, trans fat would be predicted to be
associated with about the same increased risk as saturated fat, and in
Method 2, trans fat would be predicted to be associated with about
twice as much increased risk as saturated fat, comparing both with
carbohydrate. This comparison was within a single study, so the
difference between the results of this study and what would have been
expected due to Method 1 or 2 cannot be attributed to any differences
in baseline risk between studies. Moreover, although participants in
large prospective studies have different baseline risks of CHD, the
increased risk associated with known risk factors is often reasonably
consistent across many of the studies. For example, the increased CHD
risk associated with saturated fat for female nurses from 1980 to 1994
(Ref. 38) was quite similar to that for male employees of Western
Electric Co. from 1958 to 1976 (Ref. 67) (64 FR 62746 at 62771). The
changes in CHD risk associated with total cholesterol and HDL-C for
male physicians from 1982 to 1987 was comparable to that for men and
women from Framingham, MA in the 1970s (Ref. 131).
A meta-analysis of the relative risk of CHD associated with trans
fat intake was recently published (Ref. 102). The meta-analysis used
the results of prospective observational studies in four cohorts: Women
in the United States, men in the United States, men in Finland, and men
in the Netherlands. The results showed a pooled variance-weighted
relative risk of 1.25 (95 percent confidence interval 1.11 to 1.40) for
CHD associated with 2 percent of energy intake from trans fat. For 0.1
percent of energy intake from trans fat, the meta-analysis results
would predict a relative risk of 1.0112 (confidence interval 1.0052 to
1.0170). That is, for 0.1 percent of energy intake from trans fat, the
increase in CHD risk would be 1.12 percent (confidence interval 0.52 to
1.70 percent). In comparison, the largest change in CHD risk shown in
table 9, associated with 0.1 percent of energy intake from trans fat,
is 0.162 percent using Method 1 and 0.292 percent using Method 2. Thus,
the increase in CHD risk for 0.1 percent of energy intake from trans
fat based on a meta-analysis of prospective studies is larger than the
associated CHD risk estimated using either Method 1, LDL-C or Method 2,
LDL-C and HDL-C. (The calculation of relative risk at different levels
of trans fat intake is based on taking the natural logarithm. For 2
percent of energy intake from trans fat, the estimated relative risk
was 1.25. The coefficient in the logistic regression is the natural
logarithm of 1.25 = 0.223; 0.223/2 = 0.1116, the coefficient for 1
percent of energy from trans fat; 0.1116 x 0.1 = 0.0112, the
coefficient for 0.1 percent of energy from trans fat; the antilogarithm
of 0.0112 = 1.0112, the relative risk associated with 0.1 percent of
energy from trans fat.)
Thus, FDA disagrees with the comment about relative risk in the
prospective studies, and maintains that the prospective studies do
suggest that there may be additional mechanisms, besides changes in
LDL-C and HDL-C, by which trans fat contributes to CHD risk. However,
as discussed previously in this section, and in the November 1999
proposal (64 FR 62746 at 62771), FDA did not use the results of the
prospective studies in its quantitative estimate of the health benefits
of trans fat labeling. The sole use of the prospective studies was to
suggest that there may be additional mechanisms by which trans fat
contributes to CHD. The prospective studies thus indicate the direction
of the uncertainty in the benefits estimate: That the actual benefits
may be higher than the benefits estimated using Methods 1 and 2.
In response to the comments about the Ascherio et al. regression
equation as discussed in the IOM/NAS report (Ref. 140), FDA notes that
according to the NEJM, all submissions to the journal are peer-reviewed
before publication. The comments did not cite any published articles
questioning the 1999 Ascherio et al. paper (Ref. 83), and did
[[Page 41486]]
not submit data from the unpublished work that the comments asserted
could provide an alternate explanation for the Ascherio et al. results.
As noted in section IV of this document, the paper by Ascherio et al.
is not the only information that the IOM/NAS used in concluding that
trans fatty acid consumption should be as low as possible while
consuming a nutritionally adequate diet (see comment 3). Additionally,
the Ascherio paper is not the only information in the IOM/NAS report
that supports a positive linear trend for trans fat intake and LDL-C
and risk of CHD. For example, as mentioned previously in this section
(see comment 39), the study of Lichtenstein et al. (Ref. 82), using six
test diets at different levels of trans fat intake, found a positive
linear trend for trans fat intake and LDL-C level. In discussing trans
fat intake and HDL-C, the IOM/NAS report references work by Zock,
Mensink, and Katan (Refs. 69 and 154). These papers pertain not only to
HDL-C but also to LDL-C. The work of Zock and colleagues (Refs. 62, 69,
and 154) gives one regression equation showing a positive linear trend
between trans fat intake and LDL-C and another regression equation
showing a negative linear trend between trans fat intake and HDL-C.
As noted in section IV and in this section of this document, FDA's
primary rationale for trans fat labeling is the effect of trans fat
intake on LDL-C. Additionally, the economic analysis uses changes in
both HDL-C and LDL-C as a second method to quantify the effects of
trans fat intake on CHD risk, with the noted qualification that the
primary basis for the rule is the effect of trans fat on LDL-C.
Therefore, as stated in the November 1999 proposal (64 FR 62746 at
62770), for purposes of economic analysis we used the equations of Zock
et al. (Refs. 62 and 69) to estimate the effects of trans fat on LDL-C
and HDL-C separately and did not use the equation of Ascherio et al.
(Ref. 83), which estimates the positive linear trend between trans fat
intake and the lipid ratio, LDL/HDL. FDA's Method 2, using the
equations of Zock et al. (Refs. 62 and 69) for changes in both LDL-C
and HDL-C, is different than the method of Ascherio et al. (Ref. 83),
which uses changes in the lipid ratio, LDL/HDL. However, what FDA's
Method 2 and Ascherio's method have in common is that they each provide
a quantitative estimate of the adverse effects of trans fat on CHD risk
using changes in both LDL-C and HDL-C.
As stated previously in this section (see comment 39), the
regression equations of Zock et al. (Ref. 69), showing a positive
linear trend between trans fat intake and LDL-C, are consistent with
newer regression equations in a study published in 2001 by Muller et
al. (Ref. 130). Thus, there is a body of research, including the work
of Ascherio et al. (Ref. 83), Zock et al. (Refs. 62, 69 and 154),
Lichtenstein et al. (Ref. 82) and Muller et al. (Ref. 130), that
supports the existence of a linear trend for trans fat intake and LDL-C
levels, consistent with the conclusions of the IOM/NAS (Ref. 140). As
discussed in the IOM/NAS report, the existence of a linear trend of
saturated fat and LDL-C is very well-established, as shown by three
sets of regression equations described in the IOM/NAS report (Ref. 140,
Figure 8-3, pp. 8-47 to 8-48). Thus, the existence of a positive linear
trend for trans fat intake and LDL-C, as shown by a body of research
(Refs. 62, 69, 82, 83, 130, and 154) and recognized by the IOM/NAS
(Ref. 140) is not unusual, considering that there is also a positive
linear trend between saturated fat intake and LDL-C. Therefore, FDA is
not convinced by the comments questioning the existence of linear
trends between trans fat and lipid levels. FDA finds that, for the
purposes of economic analysis, it is appropriate to quantify the health
benefits of trans fat labeling using regression equations (Refs. 62 and
69) describing a positive linear trend between trans fat intake and
LDL-C and a negative linear trend between trans fat intake and HDL-C.
(Comment 42) One comment stated that FDA's estimate of benefits of
the November 1999 proposal neglected to account for the overall
reductions of mortality and morbidity from heart disease that have been
occurring in the United States for the past few decades. According to
the comment, FDA should have projected the future reduction in heart
disease that would be expected in the absence of labeling. With such a
projection, the baseline for heart disease morbidity and mortality
would be progressively lower over time, and the numbers of heart
attacks and deaths avoided due to trans fat labeling would be
commensurately reduced compared with FDA's estimate. One comment stated
that an overall decline in CHD from 1970 to 1990 coincided with a
decline in intake of fat and saturated fat. The comment stated that
margarine intake (per person) was constant during this period.
Therefore, the comment concluded that substituting margarine for high
saturated fat and cholesterol products had proved beneficial in
decreasing CHD.
FDA agrees that the rate of heart disease mortality and morbidity
in the United States has been decreasing for several decades (Refs. 132
and 133). For example, the age-adjusted death rate from CHD declined
from approximately 290 per 100,000 in 1979 to 190 per 100,000 in 1996
(Ref. 133). However, because the risk of CHD is greater at older ages
and the U.S. population is aging, the decline in the overall (crude)
CHD death rate in this period was more modest, from approximately 225
per 100,000 to 180 per 100,000. Moreover, because of the increase in
the total population, the decline in annual CHD deaths in this period
was even more modest, from approximately 550,000 to 500,000, about a 10
percent decrease over 17 years. The number of deaths was fairly level
during the period, 1992 through 1996. Thus, the baseline number of CHD
deaths, as opposed to age-specific rates, has historically declined at
a modest rate, and has been fairly level in recent years. Therefore,
FDA did not correct for this in its projection of heart attacks and
deaths avoided due to trans fat labeling. In response to the comment
about correcting its estimate for overall reductions in heart disease
over time, FDA acknowledges that, if the actual number of CHD deaths
declines in the future, omitting this correction would result in a
modest overestimate of the health benefits of trans fat labeling.
Regarding the comment about correlations of changes in dietary
intake with declines in CHD from 1970 to 1992, information on trans fat
intake is limited, as noted in section IV of this document. Therefore,
although margarine intake was approximately constant, it is not known
whether overall trans fat intake increased, decreased or remained the
same during this period. Furthermore, the causes of the decrease in CHD
over this time period have not been identified. Decreases in CHD risk
factors, such as serum lipids, and decreases in saturated fat intake
probably played a role, but the relative contributions of decreases in
various risk factors and changes in medical care for heart attack
patients are not adequately explained (Ref. 132). Therefore, FDA
disagrees with the comment's conclusion that time trends in CHD
incidence demonstrate a beneficial effect of margarine intake on
incidence of CHD.
Based on the comments received and its own re-evaluation, FDA is
not making any changes in the sample calculations for changes in CHD
risk (table 8) or in the factors for changes in serum lipids and the
examples of changes in CHD risk and the factors for changes in serum
lipids with substitution of different macronutrients
[[Page 41487]]
(table 9), described earlier in this section. Earlier in this section,
FDA has revised its estimate of projected decreases in trans fat intake
due to labeling (table 2) and discussed the likely substitutions of
different types of fat for trans fat. Using this information, FDA
revised the expected changes in CHD risk due to trans fat labeling.
As shown in table 2, a 0.0378 percent of energy decrease in trans
fat intake is expected to occur by the effective date of the rule.
Approximately 3 years will be needed for predicted changes in trans fat
intake to result in changes in CHD risk (Ref. 137). Table 10 shows the
decreases in CHD risk that would be expected, 3 years after the
effective date, for different examples of macronutrient substitutions
for trans fat. The three specific substitutions shown in table 10 are
those that FDA used to represent the range of likely ingredient
substitutions for trans fat in margarine: (1) 100 percent cis-
monounsaturated fat, (2) a mixture of 50 percent cis-monounsaturated
and 50 percent cis-polyunsaturated fat, or (3) a mixture of 50 percent
cis-monounsaturated and 50 percent saturated fat (Ref. 73). Table 10
shows that, using one of these three substitutions, the predicted
decrease in CHD risk would range from 0.027 percent to 0.061 percent
for Method 1 and from 0.090 percent to 0.110 percent for Method 2.
FDA has identified these likely substitutions, but recognizes that
once reformulation begins, different combinations of ingredients may
emerge. In order to estimate the health effects of reformulation,
however, it is less important to identify the exact formulas to be used
than it is to identify the range of possible changes in CHD risk. To
estimate the potential health benefits from the reformulation of
margarine, FDA used a probabilistic model with a distribution of
effects based on the distribution of possible changes in CHD risk
associated with the three ingredient substitutions. FDA used a
distribution rather than a weighted average because we did not know
which combination was most likely, or what distribution of combinations
would emerge. (The formal distribution we used was a BetaPERT, which
uses three points: A minimum, an intermediate, and a maximum. The model
used the change in CHD risk for a mixture of 50 percent cis-
monounsaturated and 50 percent saturated fat as the minimum, the change
with 100 percent cis-monounsaturated fat as intermediate, and the
change for a mixture of 50 percent cis-monounsaturated and 50 percent
cis-polyunsaturated fat as the maximum. The mean of a BetaPERT
distribution = (minimum + (4 x intermediate) + maximum)/6.)
As shown in table 10, the probabilistic model of substitutions for
trans fat predicted a decrease in CHD risk of 0.052 percent using
Method 1 and 0.106 percent using Method 2.
Table 10.--Predicted Changes in CHD Risk Due to Trans Fat Labeling According to Macronutrient Substitution for Trans Fat
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent Decrease in CHD Risk
Time after Effective Date Decrease in Trans Substitution for --------------------------------------------------------
for Final Rule\1\ Fat Intake (% of Source of Decrease Trans Fat Method 2, LDL and
Energy) Method 1, LDL HDL HDL
--------------------------------------------------------------------------------------------------------------------------------------------------------
3 years 0.0378 Consumer choice and mono -0.056% -0.053% -0.108%
margarine reformulation
--------------------------------------------------------------------------------------------------------------------------------------------------------
................. ........................... mono+ poly -0.061% -0.049% -0.110%
--------------------------------------------------------------------------------------------------------------------------------------------------------
................. ........................... mono+ sat -0.027% -0.062% -0.090%
--------------------------------------------------------------------------------------------------------------------------------------------------------
................. ........................... Substitution from -0.052% -0.054% -0.106%
probabilistic
model.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The time after the effective date for the final rule includes 3 years for decreases in trans fat intake to result in changes in CHD risk.
Approximately 3 years will be needed for predicted changes in trans
fat intake to result in changes in CHD risk (Ref. 137). Table 10 shows
that the 0.0378 percent of energy decrease in trans fat intake expected
to occur by the effective date of the rule will result, 3 years after
the effective date, in a 0.052 percent decrease in CHD risk using
Method 1 and a 0.106 percent decrease in CHD risk using Method 2. FDA
estimated these decreases in risk using a mathematical model that
accounted for the three likely substitutions for trans fat in
reformulation of margarine and direct consumer choice, discussed
previously. Table 10 shows the predicted decrease in CHD risk for each
of the substitutions separately, and the overall estimate from the
mathematical model.
3. Value of Changes in Health
In the previous sections, FDA presented potential changes in food
markets because of this final rule and described calculations of the
decreases in CHD that would result from those market changes.
Uncertainties in these analyses include:
[sbull] The size of consumer substitutions among existing products;
[sbull] The amount of producer reformulation to avoid losing market
shares;
[sbull] The types of ingredient substitutions producers will make
to reduce the amount of trans fat in their products; and,
[sbull] The decrease in CHD that will result from decreased trans
fat in the diet.
FDA used three specific substitutions to represent the range of
likely ingredient substitutions for trans fat in margarine: (1) 100
percent cis-monounsaturated fat, (2) a mixture of 50 percent cis-
monounsaturated and 50 percent cis-polyunsaturated fat, or (3) a
mixture of 50 percent cis-monounsaturated and 50 percent saturated fat
(Ref. 73).
FDA estimated the benefits from the final rule for two methods. The
two methods give low and high estimates of the change in CHD risk
brought about by changing intakes of trans fat. Method 1 assumes that
the reduction in CHD risk associated with reduced trans fat intakes
comes about only through the reduction in LDL-C. Method 2 assumes that
the reduction in CHD risk comes about through a combination of reducing
LDL-C and increasing HDL-C.
[[Page 41488]]
Method 2 results in higher benefit estimates than Method 1.
The reduction in CHD risk is highly uncertain primarily because of
the difficulties in estimating the amount of reformulation, consumer
response, and the reduction in CHD risk due to a decrease in trans
intake. Also, these changes will occur over time and can be affected by
other, unanticipated events. FDA dealt with the uncertainty by
estimating a range of possible reductions in CHD risk associated with
the final rule. The low and high estimated benefits can be interpreted
as a range of potential effects. When we lacked direct evidence on
uncertain values, we dealt with the uncertainty by choosing values that
generated lower-bound estimates of benefits. This practice and the
evidence in the previous section both imply that the actual realized
benefits may exceed the range given by the two methods.
a. CHD morbidity and mortality prevented. FDA calculated the
benefits from the final rule as the reduction (from the baseline) in
CHD multiplied by the value of preventing both fatal and nonfatal cases
of CHD. FDA assumed that the cases of CHD prevented by this rule will
have the same proportions of fatal and nonfatal cases as currently
exist in the population. The AHA estimates that 1.1 million heart
attack cases of CHD occur annually, with 40 percent of them fatal (Ref.
134). The average years of life lost per fatal case is 13, or 8 years
discounted to the present at 7 percent or 11 years discounted to the
present at 3 percent. FDA used these estimates as the baseline for the
estimated benefits. The number of cases varies from year to year, so
FDA treated the annual number of cases as a distribution with a mean
equal to 1.1 million (and a standard deviation of 110,000). FDA applied
the estimated decline in the probability of CHD to the baseline to get
estimates of the number of cases and fatalities prevented by the final
rule. FDA used these estimates in the analysis for the proposed rule,
and comments on this are discussed in the previous section on changes
in health states. FDA estimated the effects using Method 1, which
considers changes only in LDL-C, and using Method 2, which considers
changes in both LDL-C and HDL-C.
The benefits are expected to begin 3 years after the effective
date. The 3-year lag occurs because a dietary change takes several
years to begin to affect the CHD risk (Ref. 137). With Method 1, FDA
estimated that 3 years after the effective date, the final rule would
annually prevent 600 cases of CHD and 240 deaths. Preventing 240 deaths
would annually save about 1,920 discounted life years (240 deaths x 8
years) using a 7 percent discount rate, or 2,640 discounted life years
(240 deaths x 11 years) using a 3 percent discount rate. With Method 2,
FDA estimated that 3 years after the effective date, the final rule
would annually prevent 1,200 cases of CHD and 480 deaths, saving about
3,840 discounted life years (480 deaths x 8 years) using a 7 percent
discount rate, or 5,280 discounted life years (480 deaths x 11 years)
using a 3 percent discount rate. Because the association between trans
fat consumption and CHD through changes in LDL-C is more conclusive,
the benefits estimated using Method 1 should be regarded as more
certain than the benefits estimated using Method 2.
For nonfatal cases, FDA estimated the cost to be the sum of the
medical costs, the cost of functional disability, and the cost of pain
and suffering. The functional disability, and pain and suffering
combine to reduce the quality of life for victims. In a recent study,
Cutler and Richardson (Ref. 77) estimated from National Center for
Health Statistics data that the quality adjusted life year for a CHD
survivor was 0.71, which indicates that the annual loss to the victim
is 0.29 quality adjusted years. This loss represents the combined
effects of functional disability and pain and suffering. FDA assumed
that the loss lasts for 13 years, or 8.4 discounted years. FDA did not
estimate the extent to which nonfatal cases reduce life expectancy or
increase other health costs. Because nonfatal cases probably do have
these effects, FDA may have underestimated the health benefits from
preventing nonfatal cases.
The medical costs for nonfatal CHD are also important. The American
Heart Association estimates that the cost of a new event is about
$22,700 and the total annual costs are $51.1 billion (Ref. 75). If 1.1
million cases lead to $22,700 per case, then all theses cases cost
about $25 billion. The remaining 13.9 million cases average about
$1,900 per year (($51.1 billion - $25 billion) /13.9 million). FDA,
therefore, estimated medical costs per case as $22,700 in the first
year and about $1,900 per year thereafter.
The total cost per nonfatal case is the sum of lost quality-
adjusted life years multiplied by $100,000 per life year plus the
medical costs of $22,700 plus $1,900 per year times the discounted life
years. FDA estimated the morbidity cost per case to be about $282,000
((0.29 x $100,000 x 8.4) + ($1,900 x 8.4) + $22,700).
b. Value of CHD morbidity and mortality prevented. In a May 30,
2003 Memorandum to the President's Management Council, OIRA
Administrator John D. Graham recommended that agencies, when performing
benefit cost-analysis, present results using both VSL and VSLY methods.
Below we present estimates using both methods. The Memorandum also
recommends that agencies present analyses with larger VSLY estimates
for senior citizens. Since many of the beneficiaries of this final rule
are senior citizens, larger VSLY values than the ones we have used will
increase benefits further.
FDA therefore estimates the benefits of this rule using two
approaches that reflect different methods used in the economics
literature. First, it calculates benefits as the extensions to
longevity multiplied by the value of such increases in life-years
gained, plus the number of nonfatal cases prevented multiplied by the
costs of nonfatal cases, plus the savings in medical costs associated
with reductions in nonfatal CHD. Its second calculation is like the
first, except that it values reductions in mortality risk as the number
of statistical deaths prevented multiplied by the willingness to pay to
reduce the risk of death (rather than the extensions to longevity
multiplied by the value of increases in life-years gained), and
calculates the value of reducing the number of nonfatal cases as simply
the savings in medical costs. This section presents these two
approaches in turn, beginning with benefits as the extensions to
longevity multiplied by the value of such increases in life-years
gained, plus the prevented costs of nonfatal cases and medical costs.
Under the first approach, FDA estimated the costs of nonfatal cases
to be the sum of the medical costs, the cost of functional disability,
and the cost of pain and suffering. The functional disability, and pain
and suffering combine to reduce the quality of life for victims. In a
recent study, Cutler and Richardson (Ref. 77) estimated from National
Center for Health Statistics data that the quality adjusted life year
for a CHD survivor was 0.71, which indicates that the annual loss to
the victim is 0.29 quality adjusted years. This loss represents the
combined effects of functional disability and pain and suffering. FDA
assumed that the loss lasts for 13 years, or 8.4 discounted years
(discounted at 7 percent) and 10.6 discounted years (discounted at 3
percent). FDA did not estimate the extent to which nonfatal cases
reduce life expectancy or increase other health costs. Because nonfatal
cases probably do have these effects, FDA may have
[[Page 41489]]
underestimated the health benefits from preventing nonfatal cases.
There are also medical costs for nonfatal cases of CHD. The
American Heart Association estimates that the cost of a new CHD case is
about $22,700 and the total annual costs are $51.1 billion (Ref. 75).
If 1.1 million cases lead to $22,700 per case, then all these cases
cost about $25 billion. The remaining 13.9 million cases average about
$1,900 per year (($51.1 billion - $25 billion) /13.9 million). FDA,
therefore, estimated medical costs per case as $22,700 in the first
year and about $1,900 per year thereafter.
Under the first approach, the total cost per nonfatal case is the
sum of lost quality-adjusted life years multiplied by a value per life
year plus the medical costs of $22,700 plus $1,900 per year times the
discounted life years. FDA estimates the morbidity cost per case to be
about $282,000 ((0.29 x $100,000 x 8.4) + ($1,900 x 8.4) + $22,700),
assuming a value of $100,000 per quality-adjusted life year (VSLY).
In the first approach, FDA uses a range to estimate the value of an
additional year of life to reflect the uncertainty in the literature.
As a lower bound, FDA uses $100,000 per (quality-adjusted) statistical
life year. Cutler and Richardson (Ref. 77) use a similar estimate, and
Garber and Phelps (Ref. 157) conclude that estimates of the value of a
life year are about twice the level of income, though they present a
broad range to reflect uncertainty associated with risk aversion and
discount rates. Updating Garber and Phelps' estimates suggests that
$100,000 per life year is a reasonable estimate, given that median
family income in 2002 was about $51,000 (Ref. 158). Moreover, this
estimate is close to the estimate used in FDA's economic analysis of
the regulations implementing the 1990 amendments. FDA received no
public comments on that estimate. To reflect other underlying
literature, and following suggestions from other Federal agencies, we
begin with an estimate of the value of a statistical life (VSL) of $6.5
million. This estimate is consistent with the survey by Viscusi and
Aldy (Ref. 159) on the premium for risk observed in labor markets.
Annuitizing this value over 35 years at 3 percent and at 7 percent
discount rates, as is consistent with OMB guidance, implies estimates
of a value of an additional year of life of about $300,000 and
$500,000. Therefore, table 11a shows estimated benefits for three
estimates of VSLYs: $100,000, $300,000 and $500,000, for both of the
methods of estimating gains in life years. Total benefits differ from
mortality-related benefits by including the value of reduced morbidity
and health care costs.
Table 11a.--Benefits for Different Values of Statistical Life Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Discounted Life Years Mortality Related Benefits Estimated Total Benefits (in
Gained In Year 3 After the Effective Date millions)
Value of Statistical Life Years Discount --------------------------------------- and Annually Thereafter (in -------------------------
Gained Rate millions)
Method 1 Method 2 -------------------------------------- Method 1 Method 2
Method 1 Method 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
$100,000 7 percent 1,920 3,840 $192 $384 $234 $477
--------------------------------------------------------------------------------------------------------------------------------------------------------
$300,000 3 percent 2,640 5,280 $792 $1,584 $968 $1,973
--------------------------------------------------------------------------------------------------------------------------------------------------------
$500,000 7 percent 1,920 3,840 $960 $1,920 $1,127 $2,295
--------------------------------------------------------------------------------------------------------------------------------------------------------
In applying the second approach to calculating benefits, FDA
assumes values of a statistical life of $5 million and $6.5 million.
These values represent reasonable central tendencies for a larger range
of VSL estimates reported in the literature: $1 million to $10 million
(Ref. 159). The two values FDA uses here are also consistent with one
reasonable interpretation of studies of willingness to pay to reduce
mortality risks (Refs. 159 and 160). FDA uses the lower value to
reflect the fact that many of the estimates of willingness to pay to
reduce mortality risk from papers not surveyed by Viscusi and Aldy are
relatively low. Table 11B shows the annual benefits estimated in this
way for the two different VSLs using both a 3 and 7 percent discount
rate. The totals in the final 2 columns of the table are discounted, so
direct multiplication of the previous columns does not give the totals
in the final columns.
Table 11b.--Benefits for Different Values of Statistical Life and Discount Rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expected Deaths Averted Expected Nonfatal Cases Averted Total Benefits Estimated in
---------------------------------- Average ---------------------------------- Year 3 After the Effective
Medical Costs Date and Annually Thereafter
VSL and Discount Rate per Nonfatal (in millions)
Method 1 Method 2 Case Method 1 Method 2 -------------------------------
Method 1 Method 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
$5,000,000 (3%) ............... ............... $43,000 ............... ............... $1,112 $2,225
------------------------------------- ---------------- -------------------------------
$6,500,000 (3%) 240 480 $43,000 360 720 $1,442 $2,884
------------------------------------- ---------------- -------------------------------
$5,000,000 (7%) ............... ............... $39,000 ............... ............... $991 $1,982
------------------------------------- ---------------- -------------------------------
$6,500,000 (7%) ............... ............... $39,000 ............... ............... $1,285 $2,570
--------------------------------------------------------------------------------------------------------------------------------------------------------
F. Overview of Benefits and Costs
To provide an overview of this analysis, we can compare the
estimated total benefits and costs and summarize the sources of
information used in making these estimates.
1. Summary of Benefits and Costs
Table 12 shows the timing of the discounted benefits and costs
estimated for this rule, as well as the totals. The
[[Page 41490]]
benefits reported in table 12 are based on a VSLY of $300,000 and a
discount rate of 3 percent. The effectiveness of this final rule can
also be seen in the relatively low cost per life year saved. For
example, if we express the one time costs as annualized cost over 20
years (discounted at 3 percent), the medium cost estimate in table 12
comes to about $12 million per year. With Method 1, the cost per life
year saved would be about $4,500 ($12 million/2,600 life years). These
ratios would be even lower if we included the quality-adjusted life
years associated with nonfatal cases. The deaths prevented alone
demonstrate the effectiveness of this final rule.
Table 12.--Summary of Costs and Benefits by Year after Publication, Discounted to Effective Date, in Millions of Dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effective Date
--------------------------------------------------------------------------------------------
Years After Publication Cummulative
2 3 4 5 6 7 Total as of
Year 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low .............................. $139 none none none none none ... $139
Medium .............................. $185 none none none none none ... $185
High .............................. $275 none none none none none ... $275
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Method 1 Annual none none none $968 $940 $913 ... ..............
Cumulative ......... ......... ......... $968 $1,908 $2,821 ... $13,130
----------------------------------------------------------------------------------------------------------------------------
Method 2 Annual none none none $1,973 $1,916 $1,860 ... ..............
Cumulative ......... ......... ......... $1,973 $3,889 $5,784 ... $26,757
--------------------------------------------------------------------------------------------------------------------------------------------------------
2. Summary of Information Sources
Table 12A summarizes the inputs, data sources, and assumptions used
in the Final Regulatory Impact Analysis for this final rule.
Table 12a.--Summary of Inputs, Data Sources, and Assumptions
------------------------------------------------------------------------
Value or Type of Source of Data or
Name of Input Distribution Used Estimate Assumption
------------------------------------------------------------------------
Current trans Total intake, FDA's best USDA trans fat food
fat intake. 2.55% of energy; estimate from composition
intake from available database, (Ref.
hydrogenated data. 40); USDA food
fat, 2.03% of group data from
energy (table 1 CSFII. 1994-96,
of this (Ref. 115).
document).
------------------------------------------------------------------------
Adjustment of 0.063% of energy, FDA's best 15% decrease in
trans fat decrease in estimate from current amount of
intake for current amount available trans fat intake
current level of trans fat data. from margarine
of margarine intake from based on industry
reformulation. margarine (table comments on
2 of this proposed rule.
document).
------------------------------------------------------------------------
Change in trans 0.0359% of energy Low assumption Assume 10% decrease
fat intake due decrease (table based on in remaining trans
to margarine 2 of this uncertainty. fat from margarine.
reformulation. document).
------------------------------------------------------------------------
Change in trans 0.0019% of energy Low assumption Assume 0.1% decrease
fat intake due decrease (table based on in remaining trans
to consumer 2 of this uncertainty. fat intake from
choice. document). hydrogenated fat
after margarine
reformulation.
------------------------------------------------------------------------
Overall change 0.0378% of energy Low assumption Sum of two previous
in trans fat decrease (tables based on values.
intake due to 2 and 10 of this uncertainty.
labeling. document). Excludes
possible
reformulation
of products
other than
margarine.
------------------------------------------------------------------------
Number of 154,000 (table 3 High estimate Main data sources:
products to be of this based on RTI labeling cost
tested. document). uncertainty. model (Ref. 129)
Includes many for number of
products that products likely to
have already be affected and our
been tested. judgement about
what categories of
products are likely
to be affected.
------------------------------------------------------------------------
Per product $261 to $371 Data. RTI labeling cost
cost of (table 4 of this model, Ref. 129.
testing. document).
------------------------------------------------------------------------
[[Page 41491]]
Percent of SKU 84% of branded FDA RTI labeling cost
label changes SKUs, 50% of interpolation model, Ref. 129.
that can be private label of
coordinated SKUs. information
with scheduled on 24 and 36
labeling month
changes. compliance
period
proportions.
------------------------------------------------------------------------
Per product Varies (table 5 Data. RTI labeling cost
category cost of this model, Ref. 129.
of relabeling. document).
------------------------------------------------------------------------
Number of 30 (table 6 of Low assumption Assume 10% of
margarines this document). based on margarine products
reformulated. uncertainty. reformulate.
------------------------------------------------------------------------
Per product $440,000 (table 6 Data. Industry supplied
cost of of this information (64 FR
reformulation. document). 62745 at 62782,
November 17, 1999).
------------------------------------------------------------------------
Overall change 0.147% decrease Low estimate, Multiply change in
in CHD risk in CHD risk per assuming trans fat intake by
per change in 0.1% of energy change in CHD factors below: -
trans fat decrease in risk is 0.1% x 1.5 x 0.7 x
intake. trans fat entirely 1.4 = -0.147%,
intake. Method 1 through decrease in CHD
(table 8 of this effect of risk.
document). trans fat on
LDL-C.
------------------------------------------------------------------------
Overall change 0.287% decrease Intermediate Multiply change in
in CHD risk in CHD risk per estimate, trans fat intake by
per change in 0.1% of energy assuming factors below: -
trans fat decrease in change in CHD 0.1% x -0.4 x -2.5
intake. trans fat risk is x 1.4 = -0.140%,
intake. Method 2 through decrease in CHD
(table 8 of this effect of risk due to change
document). trans fat on in HDL-C. Add to
both LDL-C result from Method
and HDL-C. 1: -0.147% + (-
Excludes 0.140%) = -0.287%,
other decrease in CHD
possible risk, Method 2.
mechanisms
linking trans
fat to CHD
risk.
------------------------------------------------------------------------
Change in LDL-C 1.5 mg/dL per 1% Data. Published meta-
with change in of energy from analyses, Refs. 62
trans fat trans fat and 69.
intake. substituted for
cis-
monounsaturated
fat (table 8 of
this document).
------------------------------------------------------------------------
Change in HDL-C -0.4 mg/dL per 1% Data. Published meta-
with change in of energy from analyses, Refs. 62
trans fat trans fat and 69.
intake. substituted for
cis-
monounsaturated
fat (table 8 of
this document).
------------------------------------------------------------------------
Changes in LDL- Various FDA's best Published meta-
C and HDL-C coefficients estimate from analyses, Ref. 65,
with shown in table 9 available combined with meta-
substitutions of this data. analyses in Refs.
of other document. 62 and 69.
macronutrients
for trans fat.
------------------------------------------------------------------------
Changes in CHD 0.7% increase per Data. Published meta-
risk with 1 mg/dL increase analyses, Refs. 59,
changes in LDL- in LDL-C (table 60, and 61.
C. 8 of this
document).
------------------------------------------------------------------------
Changes in CHD 2.5% increase per Data. Published meta-
risk with 1 mg/dL decrease analyses, Refs. 59,
changes in HDL- in HDL-C (table 60, and 61.
C. 8 of this
document).
------------------------------------------------------------------------
Adjustment for Factor of 1.4 Data. Published data, Ref.
regression increase in 64.
dilution. relationship of
change in CHD
risk with
changes in LDL-C
and HDL-C (table
8 of this
document).
------------------------------------------------------------------------
Overall change -0.052%, Method Factors above BetaPERT
in CHD risk 1;-0.106%, combined with distribution, using
due to Method 2 (table probabilistic the change in CHD
labeling. 10 of this model to risk for a mixture
document). account for of 50% cis-
macronutrient monounsaturated and
substitutions 50% saturated fat
. as the minimum, the
change with 100%
cis-monounsaturated
fat as
intermediate, and
the change for a
mixture of 50% cis-
monounsaturated and
50% cis-
polyunsaturated fat
as the maximum. The
mean of a BetaPERT
distribution =
(minimum + (4 x
intermediate) +
maximum)/6.
------------------------------------------------------------------------
[[Page 41492]]
Time lag 3 years (table Data. 3 years for serum
between 10 of this lipid changes from
effective date document). dietary change.
of labeling Ref. 137.
and first
health
benefits.
------------------------------------------------------------------------
Heart attacks Mean 1.1 million Data for mean. Published data, Ref.
per year. cases, std. dev. Assumption 134.
110,000 cases. for std. dev.
------------------------------------------------------------------------
Percent of 40%. Data. Published data, Ref.
heart attacks 134.
per year that
are fatal.
------------------------------------------------------------------------
Life-years 13, or 8.4 years FDA's best Published data,
saved. discounted to estimate from Refs. 75, 76, and
the present at available 134.
7% (table 10 of data.
this document).
------------------------------------------------------------------------
Life-years 13, or 10.6 years FDA's best Published data,
saved. discounted to estimate from Refs. 75, 76, and
the present at available 134.
3% (table 10 of data.
this document).
------------------------------------------------------------------------
Medical Costs $39,000 at 7% FDA's best Published data, Ref.
saved per non- discount rate; estimate from 134.
fatal case. $43,000 at 3% data and life
discount rate expectancy
(table 11 of calculations.
this document).
------------------------------------------------------------------------
Value of $100,000; Data and FDA's $100,000 from Refs.
Statistical $300,000; best estimate 77 and 68; $300,000
Life Year $500,000 (table from from $6.5 million
(VSLY). 11 of this available for value of
document). data. statistical life
discounting 35
remaining years at
3%; $500,000 from
$6.5 million for
value of
statistical life
discounting 35
remaining years at
7% (Ref. 159).
------------------------------------------------------------------------
Value of $5 million; $6,5 Data. General VSL
Statistical million (table literature (Ref.
Life (VSL). 11 of this 159).
document).
------------------------------------------------------------------------
G. Peer Review
FDA submitted this economic analysis to the Interagency Economic
Peer Review (IEPR) for peer review. The IEPR is a voluntary review
process composed of, but not limited to, Federal economists and
analysts who review Regulatory Impact Analyses and Regulatory
Flexibility Analyses prior to OMB clearance to improve the quality of
economic analysis.
Two Federal economists reviewed this analysis. Their specific
comments and FDA's responses are detailed in Ref. 155. FDA made the
following changes to the analysis in response to the comments of the
reviewers:
[sbull] Added several sections to repeat information contained in
the analysis that accompanied the proposal to provide more background
and context for the reader,
[sbull] Made some style changes for clarity,
[sbull] Added explanations for how some numbers were calculated,
[sbull] Added references for the European market experience with
margarine reformulation,
[sbull] Addressed the comments on costs more explicitly,
[sbull] Explained why the costs of reformulation are included in
the analysis,
[sbull] Added an introduction describing the plan of the benefits
model and the linkages between the various parts of the model,
[sbull] Corrected our description of study subjects in the 1994-
1996 Diet and Health Knowledge Survey (DHKS) in discussing Ref. 119.
X. Final Regulatory Flexibility Analysis
A. Introduction
FDA has examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities. FDA finds that this final rule would have a significant
economic impact on a substantial number of small entities.
B. Economic Effects on Small Entities
1. Number and Type of Small Entities Affected
FDA used data from the 1999 County Business Patterns (Ref. 136) to
estimate the number of small businesses affected by this rule. Table 13
shows the number of small businesses affected by the North American
Industry Classification System (NAICS). The final rule will affect
almost all manufacturers of packaged, labeled food sold in the United
States, with the exception of exempt manufacturers. The criteria for
exemption are: (1) Annual sales of fewer than 100,000 units; (2) no
claims or other nutrition information on product labels, labeling, or
advertising; (3) fewer than 100 full-time employees; and (4) filing of
a notice with the Office of Food Labeling (Sec. 101.9(j)(18) 2002).
FDA has previously estimated that the exemption for all foods would
affect about 1.8 percent of FDA regulated foods by volume (see 58 FR
2927 at 2928, January 6, 1993). FDA estimated the effects of exemptions
only for the total costs to small businesses.
[[Page 41493]]
Table 13.--Number of Small Establishments by NAICS Code
----------------------------------------------------------------------------------------------------------------
Category Description NAICS Code No. of Establishments
----------------------------------------------------------------------------------------------------------------
Rice 311212 60
----------------------------------------------------------------------------------------------------------------
Refined or Blended Fats and Oils 311225 140
----------------------------------------------------------------------------------------------------------------
Breakfast Cereals and Related Products 311230 60
----------------------------------------------------------------------------------------------------------------
Chocolate and Confectionery Products Made from Cacao 311320 150
Beans
----------------------------------------------------------------------------------------------------------------
Nonchocolate Confectionery Products 311340 590
----------------------------------------------------------------------------------------------------------------
Frozen Fruits and Vegetables 311411 230
----------------------------------------------------------------------------------------------------------------
Frozen Specialties, NEC 311412 380
----------------------------------------------------------------------------------------------------------------
Specialty Canned Food 311422 140
----------------------------------------------------------------------------------------------------------------
Dried and Dehydrated Foods 311423 180
----------------------------------------------------------------------------------------------------------------
Fluid Milk 311511 570
----------------------------------------------------------------------------------------------------------------
Creamery Butter 311512 30
----------------------------------------------------------------------------------------------------------------
Cheese 311513 520
----------------------------------------------------------------------------------------------------------------
Dry, Condensed and Evaporated Milk 311514 210
----------------------------------------------------------------------------------------------------------------
Ice Cream and Frozen Desserts 311520 420
----------------------------------------------------------------------------------------------------------------
Fresh and Frozen Seafood 311712 660
----------------------------------------------------------------------------------------------------------------
Commercial Bakery Products 311812 2760
----------------------------------------------------------------------------------------------------------------
Frozen Bakery Products 311813 230
----------------------------------------------------------------------------------------------------------------
Cookies and Crackers 311821 390
----------------------------------------------------------------------------------------------------------------
Flour Mixes and Dough Made from Purchased Powder 311822 230
----------------------------------------------------------------------------------------------------------------
Other Snack Foods 311919 400
----------------------------------------------------------------------------------------------------------------
Mayonnaise, Dressings and Other Prepared Sauces 311941 340
----------------------------------------------------------------------------------------------------------------
Spices and Extracts 311942 280
----------------------------------------------------------------------------------------------------------------
Perishable Prepared Food 311991 480
----------------------------------------------------------------------------------------------------------------
All Other Miscellaneous Food Preparations 311999 850
----------------------------------------------------------------------------------------------------------------
Pharmaceutical Preparations (NAICS classification 325412 880
for dietary supplements
----------------------------------------------------------------------------------------------------------------
Total ............................ 11,180
----------------------------------------------------------------------------------------------------------------
2. Costs to Small Entities
FDA calculated the costs to small businesses with the same basic
model that we used in section IX.D of this document to estimate the
total costs. Although the basic model is the same for large and small
firms, the individual components of costs differ for large and small
firms. On average, small firms produce fewer products, and market fewer
labels. FDA assumes that the estimated margarine reformulation will be
done by large producers.
FDA estimated the total costs of the final rule to small business
by estimating the individual categories of costs and summing them. The
first category is testing costs. Small businesses would need to test
their products to determine the amounts of trans fats. FDA did not have
direct estimates of the number of products produced by the small
businesses affected by the final rule. FDA estimated the number of
products produced by small businesses by using a sample from the
Enhanced Establishment Database (EED) and assuming that the proportion
of all products produced by small businesses was the same as the sample
proportion (85 percent). FDA then multiplied the 60,000 products
estimated to be tested (table 3 of this document) by the proportion of
products produced by small businesses (85 percent) to estimate that
51,000 products will be tested by small businesses. Table 14 shows the
range of testing costs for all small businesses.
[[Page 41494]]
Table 14.--Range of Per Product and Total Testing Costs for Small Businesses
----------------------------------------------------------------------------------------------------------------
Low Medium High
----------------------------------------------------------------------------------------------------------------
Cost per Product $261 $291 $371
----------------------------------------------------------------------------------------------------------------
Total Testing Cost $13,311,000 $14,841,000 $18,921,000
----------------------------------------------------------------------------------------------------------------
Under this final rule many more labels will have to be changed than
under the proposed rule. FDA has used the new Labeling Cost Model to
re-estimate the relabeling costs of this final rule. FDA estimated
reprinting costs for information panels on a per label (SKU) basis. FDA
assumed that the proportion of SKUs from small businesses as a whole
equaled the proportion in the EED (73 percent). Across product
categories the average low relabeling cost per SKU is about $1,100 and
the average high relabeling cost per SKU is $2,600. The reported
estimated costs of changing labels varies within a product category
because different packaging converters and food manufacturers reported
different costs to RTI International. Table 15 shows the total
estimated costs of relabeling per product category and for all small
businesses affected.
Table 15.--Range of Relabeling Costs for Small Businesses by Product Category
----------------------------------------------------------------------------------------------------------------
Product
Categories SKUs Changed Low Medium High
----------------------------------------------------------------------------------------------------------------
Baked Goods 9,100 $7,987,000 $11,870,000 $19,879,000
----------------------------------------------------------------------------------------------------------------
Baking 1,200 $1,179,000 $1,737,000 $2,846,000
Ingredients
----------------------------------------------------------------------------------------------------------------
Baby Foods 100 $120,000 $182,000 $295,000
----------------------------------------------------------------------------------------------------------------
Selected 6,600 $8,666,000 $12,161,000 $18,569,000
Beverages
----------------------------------------------------------------------------------------------------------------
Breakfast 700 $585,000 $903,000 $1,492,000
Foods
----------------------------------------------------------------------------------------------------------------
Selected Candy 3,000 $3,505,000 $5,091,000 $7,819,000
----------------------------------------------------------------------------------------------------------------
Selected 2,700 $2,939,000 $4,358,000 $6,777,000
Condiments,
Dips and
Spreads
----------------------------------------------------------------------------------------------------------------
Dairy Foods 6,400 $7,843,000 $11,698,000 $18,273,000
----------------------------------------------------------------------------------------------------------------
Desserts 2,600 $2,016,000 $3,112,000 $5,141,000
----------------------------------------------------------------------------------------------------------------
Dietary 5,900 $9,818,000 $14,680,000 $24,850,000
Supplements
----------------------------------------------------------------------------------------------------------------
Selected 2,000 $2,123,000 $3,177,000 $4,933,000
Dressings and
Sauces
----------------------------------------------------------------------------------------------------------------
Eggs 1,800 $1,448,000 $2,114,000 $3,713,000
----------------------------------------------------------------------------------------------------------------
Entrees 1,800 $1,469,000 $2,247,000 $3,673,000
----------------------------------------------------------------------------------------------------------------
Fats and Oils 600 $554,000 $847,000 $1,349,000
----------------------------------------------------------------------------------------------------------------
Fruits and 5,500 $5,421,000 $7,968,000 $13,054,000
Vegetables
----------------------------------------------------------------------------------------------------------------
Seafood 1,000 $1,264,000 $1,855,000 $2,764,000
----------------------------------------------------------------------------------------------------------------
Side Dishes 3,000 $2,454,000 $3,741,000 $6,201,000
and Starches
----------------------------------------------------------------------------------------------------------------
Snack Foods 2,600 $2,631,000 $3,860,000 $6,204,000
----------------------------------------------------------------------------------------------------------------
Soups 500 $591,000 $872,000 $1,353,000
----------------------------------------------------------------------------------------------------------------
Weight Control 100 $143,000 $207,000 $357,000
Foods
----------------------------------------------------------------------------------------------------------------
Total 57,200 $62,754,000 $92,590,000 $149,640,000
----------------------------------------------------------------------------------------------------------------
Table 16 of this document shows the total costs to small businesses
of the final rule. The adjusted total costs of the final rule equal the
unadjusted total minus 1.8 percent of the total cost of the rule to all
businesses (see 58 FR 2927 at 2928, January 6, 1993). The average cost
per small business is about $12,000.
[[Page 41495]]
Table 16.--Total Costs for Small Businesses
------------------------------------------------------------------------
Cost Category Low Medium High
------------------------------------------------------------------------
Testing $34,713,000 $38,703,000 $49,343,000
------------------------------------------------------------------------
Relabeling $62,754,000 $92,590,000 $137,891,000
------------------------------------------------------------------------
Total $97,467,000 $131,293,000 $187,234,000
------------------------------------------------------------------------
Adjustment for -$1,754,000 -$ 2,363,000 -$3,370,000
Exemption
------------------------------------------------------------------------
Adjusted Total $96,000,000 $129,000,000 $195,000,000
------------------------------------------------------------------------
FDA has attempted to place the burden that these costs will place
on small businesses in the context of the entire environment in which
small businesses exist. Eastern Research Group under contract with FDA
has developed a model for estimating the impact of regulatory costs on
the survival of small businesses. (Reference: Eastern Research Group,
``Model for Estimating the Impacts of Regulatory Costs on the Survival
of Small Businesses and Its Applications to Four FDA-Regulated
Industries,'' 2002.) This model does not cover the entire range of
products covered by this final rule, so it is not possible to estimate
the burden of this rule. However, table 16a gives a sense of the impact
that this rule may have on three industry categories that have many
small businesses. The model estimates the additional number of small
businesses that will have negative cash flow as a result of the costs
of complying with a regulation. These estimates are likely to be larger
than the actual effects because the model is neither able to take into
account the exemption from nutrition labeling that is available to some
small businesses, nor can it take into account the compliance period of
over 2 years which allows small businesses to budget and plan ahead for
the expense of the label change.
Table 16a.--Illustrations of Impacts on Small Business
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standard Number Additional Small
Average Number of Small Businesses Lost
Product Category NAICS Code Total Number of SKUs Changed Range of Costs Businesses Lost Due to Compliance
Small Businesses Early per Firm per Firm Regardless of Costs of This
Regulation Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonchocolate Confectionery Products 311340 590 6 $8,700-$18,100 30-80 0-30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cheese 311513 520 6 $7,500-$16,300 40-90 0-20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial Bakery Products 311812 2,760 4 $4,200-$9,800 560 10-60
--------------------------------------------------------------------------------------------------------------------------------------------------------
C. Regulatory Options
The Regulatory Flexibility Act requires that FDA consider options
for regulatory relief for small entities.
1. Exemption for Small Businesses
The exemption of small businesses from the provisions of the final
rule would provide regulatory relief. Table 16 of this document shows
that small businesses are expected to bear total costs of about $130
million as a result of the final rule, an average of $12,000 per small
business. As a first approximation, then, exempting small businesses
would reduce the burden by an average of $12,000 per small business.
FDA believes that this option would not be desirable. On the one
hand, because so many of the businesses in the food processing industry
are classified as small by the Small Business Administration, if small
businesses are exempted, most of the potential benefits from the final
rule would not be realized. On the other hand, exempt businesses may be
forced by market pressures to adopt the final label in any case. In
addition, under section 403(q)(5)(E) of the act and implementing
regulations, very small producers (those with fewer than 100 full-time
employees) that: (1) File a notice with the Office of Nutritional
Products, Labeling, and Dietary Supplements; (2) make very low volume
products (fewer than 100,000 units annually); and (3) place no claims
or other nutrition information on product labels, labeling, or
advertising would already be exempt from this final rule.
2. Longer Compliance Period for Small Businesses
Longer compliance periods provide regulatory relief for small
businesses. Some comments requested that the compliance period be
extended several years (e.g., 4 to 7 years) for small businesses. These
comments stated that it was important for small businesses to be able
to phase in the cost associated with the new label requirements so that
they have extra time to absorb the costs of these changes. Some small
manufacturers reported that they have significant inventories of
labels. Also, smaller manufacturers indicated that they would incur
costs, including, loss and disposal of obsolete packaging inventories,
product in obsolete packages, and new printing plates. These small
businesses believe that a longer compliance period would allow them to
more easily manage their inventories and phase in the trans fat
labeling requirements along with other scheduled labeling revisions.
This will help minimize unnecessary labeling costs and costs passed on
to consumers.
To minimize the need for multiple labeling changes and to provide
additional time for compliance by small businesses to allow them to use
current label inventories and phase in label changes, the agency is
setting the effective date at January 1, 2006, the
[[Page 41496]]
next uniform effective date following publication of this rule. This
allows firms more than 2 years to implement this final rule providing
some regulatory relief and economic savings for small businesses. This
should be long enough for most small businesses to coordinate the label
change for this rule with other label changes and reprinting. However,
in this final rule, FDA has decided not to extend the compliance period
for small businesses beyond what is given for all businesses. Because
this final rule does not affect nutrient content or health claims, no
small businesses will have to change the principal display panels or
marketing of their products, which could be very costly.
With small businesses producing 85 percent of the products and 73
percent of the SKUs, extending the compliance period for small
businesses to the uniform effective date after January 1, 2006, would
leave most labels not listing trans fat for almost 5 years after
publication. This could result in significant confusion for consumers
looking for trans fat content on labels and would make the Nutrition
Facts panel inconsistent across product categories. This inconsistency
would be contrary to the intent of the 1990 amendments. It also would
undermine the policy goal of providing consistent nutrition information
to consumers. Also, extending the effective date for products
containing trans fat would delay the benefits of this rule to the
public health.
3. Exemptions for Small Entities
FDA has chosen not to exempt small entities because consumption of
trans fat results in consequences to the consumer. Consumers may
increase or decrease their risk of CHD based on the level of trans fat
in their diets. Thus, the presence or absence of trans fat in a food
product is a material fact under section 201(n) of the act.
Consumers must know the amount of trans fat in food products that
they select as part of their total daily diet to choose products that
would allow them to reduce their intake of trans fat, and thus, reduce
the risk of CHD. Section IV of this document discusses the scientific
evidence for why trans fat consumption places consumers at risk for
CHD. Absent mandatory labeling, consumers would not be able to
understand the relative contribution that foods make to their total
daily intake of trans fat. First, because polyunsaturated and
monounsaturated fats are not subject to mandatory labeling, simply
including trans fat as part of the total fat contribution would not
allow consumers to calculate the trans fat content by finding the
difference between the sum total of all the mandatory fats listed on
the label and the total fat content. Second, even if all component fats
were required to be listed, it would not be realistic to expect
consumers to do such calculations on each product to compare the
relative trans fat contribution of each. Further, the fact that an
individual food product may contain zero gram trans fat, and thus, not
contain a level of trans fat that would contribute to CHD risk, does
not prevent the absence of that fact on the label to no longer be
considered a ``material fact'' for that food. In the context of
mandatory labeling of nutrients in a nutrition facts panel, the
relative contribution of various food products to the total day's
consumption of a heart unhealthy fat is important for consumers ``to
readily observe and comprehend the information and to understand the
relative significance of that information in the context of the total
daily diet'' (section 2(b)(1)(A) of Public Law 101-535).
Further, section 403(q)(2)(A) of the act provides that mandatory
labeling would be appropriate when information about a nutrient would
assist consumers to maintain healthy dietary practices. Information on
the trans fat content of food would assist consumers in this way.
Consumers need the information on trans fat content of all foods that
they consume so that they can reduce their intake of trans fat. The
fact that a food may have no trans fat or a small amount of trans fat
is useful information to the consumer so that food choices can be made
and the consumer can put that product, along with many other products
consumed as part of the daily diet, into the context of the total daily
diet to maintain healthy dietary practices. There is ample discussion
in section IV of this document about the heart unhealthy effects of
consuming trans fat and strong consensus among the scientific community
for reducing trans fat intake.
Survey data show that consumers rely on the Nutrition Facts label
as a guide to choosing foods that meet their dietary objectives. As
consumers learn more about the dietary significance of trans fat and
the dietary advice to limit its consumption, the Nutrition Facts panel
is where label users will expect to find this information. If they
cannot find information on trans fat content there or if it is only
there when claims are made about fatty acids or cholesterol, they will
be hampered in their ability to implement the most recent dietary
guidance, and are likely to be misled about a food's basic
characteristics.
Consumers need the trans fat information on products in order to
determine how each product fits into their individual health goal for
reducing trans fat intake in the context of their total daily diet.
Thus, the agency is requiring trans fat labeling, regardless of whether
claims are made or the levels of other fats are declared, to prevent
products from being misleading under sections 403(a)(1) and 201(n) of
the act. Therefore, as described in section III of this document, in
this rulemaking FDA is relying on its authority under those sections as
well as its authority under section 403(q)(2)(A) of the act to require
that information on trans fat be included in nutrition labeling to
assist consumers in maintaining healthy dietary practices. Not
requiring such information on labels, whether or not voluntary
nutrients are listed or claims are made about fatty acids or
cholesterol, would be inconsistent with statutory directives for
nutrition labeling in section 403(q) of the act.
Furthermore, the benefits of covering products made by small
businesses exceed the costs that would be saved by exempting them. The
medium estimated cost of covering small businesses is a one time cost
of $129 million dollars (table 16). If we assume no benefits from small
businesses reformulating, then the benefits associated only with
changing labels on all food products is $48 million per year using
Method 1 ($99 million using Method 2). If small businesses produce at
least 22 percent of food consumed annually, then benefits of covering
products made by small businesses will exceed the costs that would be
saved by exempting them after 20 years discounted at 3 percent. Using
Method 2 for calculating benefits, small businesses would only need to
account for production of at least 11 percent of food consumed. Since
the Small Business Administration definition of small business includes
the vast majority of food firms, products, and SKUs, even the 22
percent amount is quite plausible.
D. Recordkeeping and Reporting Requirements
The Regulatory Flexibility Act requires FDA to include a
description of the recordkeeping and reporting required for compliance
with this final rule. This final rule does not require the preparation
of a report or a record.
E. Summary
FDA finds that under the Regulatory Flexibility Act (5 U.S.C.
605(b)) this final rule will have a significant economic impact on a
substantial number of small entities. Approximately
[[Page 41497]]
10,300 small businesses could be affected by the rule. The total burden
on small entities is estimated to be between $96 and $184 million, or
about $9,300 to $17,900 per entity.
XI. Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 (Public Law 104-4)
requires cost-benefit and other analyses for rules that would cost more
than $100 million in 1 single year. The final rule qualifies as a
significant rule under the statute. FDA has carried out the cost-
benefit analysis in sections IX.C and IX.D of this document. The other
requirements under the Unfunded Mandates Act of 1995 include assessing
the rule's effects on the following:
1. Future costs;
2. Particular regions, communities, or industrial sectors;
3. National productivity and economic growth;
4. Full employment and job creation; and,
5. Exports.
A. Future Costs
Most of the costs of this rule will be incurred during the
compliance period. Future costs beyond that period would likely be
small, because the food industry would have adjusted to the new
requirements by that time.
B. Particular Regions, Communities, or Industrial Sectors
The final rule applies to the food industry and would, therefore,
affect that industry disproportionately. Any long run increase in the
costs of food production would largely be passed on to the entire
population of consumers.
C. National Productivity and Economic Growth
The final rule is not expected to substantially affect productivity
or economic growth. It is possible that productivity and growth in
certain sectors of the food industry could be slightly lower than
otherwise because of the need to divert research and development
resources to compliance activities. The diversion of resources to
compliance activities would be temporary. Moreover, FDA anticipates
that, because the health benefits are estimated to be significant, both
productivity and economic growth would be higher than in the absence of
the rule. In section IX.C.3 of this document, FDA estimated benefits
from the reduction in functional disability associated with a reduction
in nonfatal CHD. A reduction of functional disability would result in
an increase in productivity. The increased health of the population and
the reduction in direct and indirect health costs could increase both
productivity and economic growth.
D. Full Employment and Job Creation
The human resources devoted to producing certain foods would be
redirected by the final rule. The final rule could lead to some short-
run unemployment as a result of the structural changes within the food
industry, the rise of some product lines and decline of others. The
growth of employment (job creation) could also be temporarily slower.
E. Exports
Because the final rule does not mandate any changes in products,
current export products will not be required to change in any way. Food
processors, however, do not necessarily distinguish between production
for export and production for the domestic market. The effect of the
final rule on U.S. food exports depends on how foreign consumers react
to information about trans fats and to product formulations that
contain lower amounts of partially hydrogenated oils. The new label and
possible new formulations could either increase or decrease exports.
Products in Germany and certain other European countries, for example,
currently use partially hydrogenated oils to a lesser degree than in
the United States, so the final rule could make U.S. exports of
margarine more attractive to consumers in those countries than they
have been. However, it could also make U.S. exports of unreformulated
products that reveal the presence of trans fat less attractive to
consumers in those countries than they have been.
XII. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (64 FR 62746, November 17,
1999). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
XIII. Paperwork Reduction Act
This final rule contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501- 3520). The title, description, and respondent description
of the information collection provisions are shown below with an
estimate of the annual reporting burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
Title: Food Labeling; Trans Fatty Acids in Nutrition Labeling,
Nutrient Content Claims and Health Claims.
Description: Section 403(q)(1)(A) and (q)(1)(B) of the act requires
that the label or labeling of a food bear nutrition information on the
amount of nutrients present in the product. Under these provisions of
the act and section 2(b) of the 1990 amendments, FDA has issued
regulations in Sec. 101.9(c)(2) that require that the Nutrition Facts
panel disclose information on the amounts of fat and certain fatty
acids in the food product. This final rule establishes Sec.
101.9(c)(2)(ii) to require that the Nutrition Facts panel disclose
information on the amount of trans fat in the food product. Similarly,
under the provisions of section 403(q)(5)(F) of the act, FDA has issued
regulations in Sec. 101.36(b)(2) that specify the nutrition
information that must be on the label or labeling of dietary
supplements. This final rule establishes Sec. 101.36(b)(2) (21 CFR
101.36(b)(2)) to specify that when nutrition information is declared on
the label and in labeling, it must include the amount of trans fat.
The regulations set forth in this final rule require that trans fat
be declared in the nutrition label of conventional foods and dietary
supplements on a separate line immediately under the line for the
declaration of saturated fat.
Description of Respondents: Persons and businesses, including small
businesses.
FDA estimates the burden of this collection of information as
follows:
[[Page 41498]]
Table 17.--Estimated Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Operating
21 CFR Section No. of Responses per Total No. of Hours per Total Hours Costs (in
Respondents Respondent Responses Response thousands)
----------------------------------------------------------------------------------------------------------------
101.9(c)(2)(ii) 10,490 27 278,100 2 556,200 $155,200
----------------------------------------------------------------------------------------------------------------
101.36(b)(2) 910 32 29,500 2 59,000 $16,500
----------------------------------------------------------------------------------------------------------------
Totals 615,200 $171,700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs and or maintenance costs associated with this collection of information.
The impact of these requirements concerning trans fatty acids would
be largely a one-time burden created by the need for firms to revise
food and dietary supplement labels. FDA used data from the 1999 County
Business Patterns to estimate the number of respondents. The total
number of responses is equal to the total number of SKUs being changed
(table 3 of this document). Based upon its knowledge of food and
dietary supplement labeling, FDA estimates that firms would require
less than 2 hours per SKU (hours per response) to comply with the
nutrition labeling requirements in this final rule. This 2 hour per SKU
estimate is based on assumptions about the amount of time required per
SKU to test a product for trans fat, to redesign the label as needed,
and to order the change for the label. FDA received no comments
objecting to this estimate.
Multiplying the total number of responses by the hours per response
gives the total hours. FDA has estimated operating costs by combining
the medium testing and relabeling costs from table 7 of this document
($44.9 million + $126.8 million for relabeling) to get the total
operating cost. This total was then apportioned between Sec. Sec.
101.9 and 101.36 according to the proportion of responses for each
section. Based on the labeling cost model, FDA expects that, with a
compliance period of over 2 years, 75 percent of firms will coordinate
labeling revisions required by this final rule with other planned
labeling changes for their products.
The information collection provisions of this final rule have been
submitted to OMB for review. Prior to the effective date of this final
rule, FDA will publish a document in the Federal Register announcing
OMB's decision to approve, modify, or disapprove the information
collection provisions in this final rule. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
XIV. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
has a preemptive effect on State law. Section 4(a) of the Executive
order requires agencies to ``construe * * * a Federal Statute to
preempt State law only where the statute contains an express preemption
provision, or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. That section provides that ``no State or
political subdivision of a State may directly or indirectly establish
under any authority or continue in effect as to any food in interstate
commerce'' certain food labeling requirements, unless an exemption is
provided by the Secretary (and, by delegation, FDA). Relevant to this
final rule, one such requirement that States and political subdivisions
may not adopt is ``any requirement for nutrition labeling of food that
is not identical to the requirement of section 403(q) * * * '' (act
section 403A(a)(4), 21 U.S.C. 343-1(a)(4)). Prior to the effective date
of this rule, this provision operated to preempt States from imposing
nutrition labeling requirements concerning trans fat because no such
requirements had been imposed by FDA under section 403(q) of the act.
Once this rule becomes effective, States will be preempted from
imposing any nutritional labeling requirements for trans fat that are
not identical to those required by this rule.
Section 403A(a)(4) of the act (21 U.S.C. 343-1(a)(4)) displaces
both state legislative requirements and state common-law duties.
Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., concurring in
part and concurring in the judgment); id. at 510 (O'Connor, J., joined
by Rehnquist, C. J., Scalia, J., and Thomas, J., concurring in part and
dissenting in part); Cippollone v. Liggett Group, Inc., 505 U.S. 504,
521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., joined by
Thomas, J., concurring in part in the judgment and dissenting in part).
Although this rule has preemptive effect in that it would preclude
States from adopting statutes, issuing regulations, or adopting or
enforcing any requirements that are not identical to the trans fat
labeling required by this final rule, including State tort-law imposed
requirements, this preemptive effect is consistent with what Congress
set forth in section 403(A) of the act.
Section 4(c) of the Executive order further requires that any
``regulatory preemption of State law shall be restricted to the minimum
level necessary'' to achieve the regulatory objective. The agency is
exercising its discretion under section 403(q)(2)(A) of the act, in a
manner that is consistent with such section, to require that the amount
of trans fat be listed in the label or labeling of food. This action is
the minimum level necessary to achieve the agency regulatory objective.
Further, section 4(e) of the Executive order provides that ``when an
agency proposes to act through adjudication or rulemaking to preempt
State law, the agency shall provide all affected State and local
officials notice and an opportunity for appropriate participation in
the proceedings.'' FDA sought input from all stakeholders through
publication of the proposed rule in the Federal Register. Eight
comments from State and local governmental entities were received; all
supported the proposal. In addition, one supportive comment was
received from a municipal health agency in response to the reopening of
the comment period relating to the proposed footnote.
In conclusion, FDA has determined that the preemptive effects of
the final rule are consistent with Executive Order 13132.
XV. References
The following references have been placed in the Dockets Management
Branch (see ADDRESSES) and may be seen by interested persons between 9
[[Page 41499]]
a.m. and 4 p.m., Monday through Friday.
1. Kris-Etherton, P. M., and R. J. Nicolosi, ``Trans Fatty Acids
and Coronary Heart Disease Risk,'' International Life Sciences
Institute, Washington, DC, 1995.
2. Department of Health and Human Services (DHHS) ``The Surgeon
General's Report on Nutrition and Health,'' p. 96, Washington, DC,
1988.
3. Kris-Etherton, P. M., editor, ``Trans Fatty Acids and
Coronary Heart Disease Risk,'' Report of the Expert Panel on Trans
Fatty Acids and Coronary Heart Disease, American Journal of Clinical
Nutrition, 62:655S-708S, 1995.
4. National Research Council/National Academy of Sciences,
``Diet and Health, Implications for Reducing Chronic Disease Risk,''
pp. 4, 8, 42, 193, 196, 213, and 657, National Academy Press,
Washington, DC, 1989.
5. Second Report of the Expert Panel on Detection, Evaluation
and Treatment of High Blood Cholesterol in Adults, National
Cholesterol Education Program, National Institutes of Health,
Bethesda, MD, September 1993.
6. U.S. Department of Agriculture (USDA)/DHHS, ``Dietary
Guidelines for Americans,'' 4th ed., 1995.
7. Mensink, R. P., and M. B. Katan, ``Effect of Dietary trans
Fatty Acids on High-Density and Low-Density Lipoprotein Cholesterol
Levels in Healthy Subjects,'' New England Journal of Medicine,
323:439-445, 1990.
8. Zock, P. L., and M. B. Katan, ``Hydrogenation Alternatives:
Effects of trans Fatty Acids and Stearic Acid Versus Linoleic Acid
on Serum Lipids and Lipoproteins in Humans,'' Journal of Lipid
Research, 33:399-410, 1992.
9. Almendingen, K., O. Jordal, P. Kierulf, et al., ``Effects of
Partially Hydrogenated Fish Oil, Partially Hydrogenated Soybean Oil,
and Butter on Serum Lipoproteins and Lp(a) in Men,'' Journal of
Lipid Research, 36:1370-1384, 1995.
10. Aro, A., M. Jauhiainen, R. Partanen, et al., ``Stearic Acid,
trans Fatty Acids, and Dairy Fat: Effects on Serum and Lipoprotein
Lipids, Apolipoproteins, Lipoprotein(a), and Lipid Transfer Proteins
in Healthy Subjects,'' American Journal of Clinical Nutrition,
65:1419-1426, 1997.
11. Nestel, P. J., M. Noakes, G. B. Belling, et al., ``Plasma
Lipoprotein Lipid and Lp(a) Changes With Substitution of Elaidic
Acid for Oleic Acid in the Diet,'' Journal of Lipid Research,
33:1029-1036, 1992.
12. Judd, J. T., B. A. Clevidence, R. A. Muesing, et al.,
``Dietary trans Fatty Acids: Effects on Plasma Lipids and
Lipoproteins of Healthy Men and Women,'' American Journal of
Clinical Nutrition, 59:861-868, 1994.
13. Lichtenstein, A. H., L. M. Ausman, W. Carrasco, et al.,
``Hydrogenation Impairs the Hypolipidemic Effect of Corn Oil in
Humans Hydrogenation, trans Fatty Acids, and Plasma Lipids,''
Arteriosclerosis and Thrombosis, 13:154-161, 1993.
14. Wood, R., K. Kubena, B. O'Brien, et al., ``Effect of Butter,
Mono- and Polyunsaturated Fatty Acid-Enriched Butter, trans Fatty
Acid Margarine, and Zero trans Fatty Acid Margarine on Serum Lipids
and Lipoproteins in Healthy Men,'' Journal of Lipid Research, 34:1-
11, 1993.
15. Wood, R., K. Kubena, S. Tseng, et al., ``Effect of Palm Oil,
Margarine, Butter, and Sunflower Oil on the Serum Lipids and
Lipoproteins of Normocholesterolemic Middle-Aged Men,'' Journal of
Nutritional Biochemistry, 4:286-297, 1993.
16. Aro, A., A. F. M. Kardinaal, I. Salminen, et al., ``Adipose
Tissue Isomeric Trans Fatty Acids and Risk of Myocardial Infarction
in Nine Countries: The EURAMIC Study,'' Lancet, 345:273-278, 1995.
17. Roberts, T. L., D. A. Wood, R. A. Riemersma, et al., ``Trans
Isomers of Oleic and Linoleic Acids in Adipose Tissue and Sudden
Cardiac Death,'' Lancet, 345:278-282, 1995.
18. Ascherio, A., C. H. Hennekens, J. E. Burling, et al.,
``Trans-Fatty Acids Intake and Risk of Myocardial Infarction,''
Circulation, 89:94-101, 1994.
19. Ascherio, A., E. B. Rimm, E. L. Giovannucci, et al.,
``Dietary Fat and Risk of Coronary Heart Disease in Men: Cohort
Follow Up Study in the United States,'' British Medical Journal,
313:84-90, 1996.
20. Pietenin, P., A. Ascherio, P. Korhonen, et al., ``Intake of
Fatty Acids and Risk of Coronary Heart Disease in a Cohort of
Finnish Men: The Alpha-Tocopherol, Beta-Carotene Cancer Prevention
Study,'' American Journal of Epidemiology, 145:876-887, 1997.
21. Willett, W. C., M. J. Stampfer, J. E. Manson, et al.,
``Intake of trans Fatty Acids and Risk of Coronary Heart Disease
Among Women,'' Lancet, 341:581-585, 1993.
22. Kromhout, D., A. Menotti, B. Bloemberg, et al., ``Dietary
Saturated and trans Fatty Acids and Cholesterol and 25-Year
Mortality From Coronary Heart Disease: The Seven Countries Study,''
Preventive Medicine, 24:308-315, 1995.
23. Troisi, R., W. C. Willett, and S. T. Weiss, ``Trans Fatty
Acid Intake in Relation to Serum Lipid Concentrations in Adult
Men,'' American Journal of Clinical Nutrition, 56:1019-1024, 1992.
24. Enig, M. G., S. Atal, M. Keeney, and J. Sampugna, ``Isomeric
trans Fatty Acids in the U.S. Diet,'' Journal of the American
College of Nutrition, 9:471-486, 1990.
25. Hunter, J. E., and T. H. Applewhite, ``Reassessment of trans
Fatty Acids Availability in the U.S. Diet,'' American Journal of
Clinical Nutrition, 54:363-369, 1991.
26. Allison, D. B., S. K. Egan, L. M. Barraj, et al.,
``Estimated Intakes of Trans-Fatty Acid and Other Fatty Acids by the
U.S. Population,'' Journal of the American Dietetic Association,
99:166-174, 1999.
27. FASEB Expert Panel (Anderson, S. A., ed.), ``Guidelines for
Use of Dietary Intake Data,'' Federation of American Societies for
Experimental Biology and Medicine, Bethesda, MD, 1986.
28. Beecher, G. R. and R. H. Matthews, ``Nutrient Composition of
Foods,'' pp. 430-439, Present Knowledge in Nutrition, 6th ed.,
edited by M. L. Brown, International Life Sciences Institute, 1990.
29. Ali, L. H., G. Angyal, C. M. Weaver, et al., ``Comparison of
Capillary Column Gas Chromatographic and AOAC Gravimetric Procedures
for Total Fat and Distribution of Fatty Acids in Foods,'' Food
Chemistry, 58:149-160, 1997.
30. Ali, L. H., G. Angyal, C. M. Weaver, et al., ``Determination
of Total trans Fatty Acids in Foods: Comparison of Capillary-Column
Gas Chromatography and Single-Bounce Horizontal Attenuated Total
Reflection Infrared Spectroscopy,'' Journal of the American Oil
Chemists Society, 73:1699-1705, 1996.
31. Report of a Joint Expert Consultation, ``Fats and Oils in
Human Nutrition,'' FAO Food and Nutrition Paper 57, World Health
Organization, pp. 1-7, 73-79, and 103-105, 1993.
32. Report of the Cardiovascular Review Group, Committee on
Medical Aspects of Food Policy, ``Report on Health and Social
Subjects, 46. Nutritional Aspects of Cardiovascular Disease,''
Department of Health, London, HMSO, p. 10, 1994.
33. Government of Canada, ``Consultation Document on Nutrient
Content Claims,'' January 19, 1996.
34. Judd, J. T., D. J. Baer, B. A. Clevidence, et al., ``Effects
of Margarine Compared With Those of Butter on Blood Lipid Profiles
Related to Cardiovascular Disease Risk Factors in Normolipemic
Adults Fed Controlled Diets,'' American Journal of Clinical
Nutrition, 68:768-777, 1998.
35. Derby, B. M., and S. B. Fein, ``Meeting the NLEA Education
Challenge: A Consumer Research Perspective,'' Nutrition Labeling
Handbook, R. Shapiro (ed.), Marcel Dekker, Inc., New York, 1995.
36. Noakes, M., and P. M. Clifton, ``Oil Blends Containing
Partially Hydrogenated or Interesterified Fats: Differential Effects
on Plasma Lipids,'' American Journal of Clinical Nutrition, 68:242-
247, 1998.
37. London, S. J., F. M. Sacks, J. Caesar, et al., ``Fatty Acid
Composition of Subcutaneous Adipose Tissue and Diet in Post
Menopausal U.S. Women,'' American Journal of Clinical Nutrition,
54:340-345, 1991.
38. Hu, F. B., M. J. Stampfer, J. E. Manson, et al., ``Dietary
Fat Intake and the Risk of Coronary Heart Disease in Women,'' New
England Journal of Medicine, 337:1491-1499, 1997.
39. FASEB Expert Panel (Senti, F.R. ed), ``Health Aspects of
Dietary trans Fatty Acids,'' Federation of American Societies for
Experimental Biology and Medicine, Bethesda, MD, 1985.
40. USDA, Agricultural Research Service, USDA Food Composition
Data, Selected Foods Containing trans Fatty Acids, 1995 (Internet
address: http://www.nal.usda.gov/fnic/foodcomp/Data/index.html).
41. Government of Canada, ``Revised Proposals for Nutrient
Content Claims,'' Tunney's Pasture, Ottawa, Ontario, March 18, 1998.
42. Association of Official Analytical Chemists International
(AOAC), AOAC Official Method 965.34 ``Isolated trans Isomers in
Margarines and Shortenings, Infrared Spectrometric Method,'' AOCS-
AOAC Method, Official Methods of Analysis of AOAC International,
16th ed., 3d revision, 1997, 41.1.36. AOAC International,
Gaithersburg, MD.
[[Page 41500]]
43. American Oil Chemists' Society (AOCS), AOCS Official Method
Cd 14-95 (Replaces Cd 14-61, reapproved 1997), ``Isolated trans
Isomers Infrared Spectrometric Method,'' AOAC Official Methods and
Recommended Practices, edited by D. Firestone, Champaign, IL.
44. AOAC, 1998, AOAC Official Method 994.14, ``Isolated trans
Unsaturated Fatty Acid Content in Partially Hydrogenated Fats,''
Official Methods of Analysis of AOAC International, 16th ed.,
41.1.36A, AOAC International, Gaithersburg, MD. 1998, revision March
1998.
45. AOCS, AOCS Recommended Practice Cd 14d-96 (Reapproved 1997),
``Isolated trans Geometric Isomers-Single Bounce-Horizontal
Attenuated Total Reflection Infrared Spectroscopic Procedure,'' AOCS
Official Methods and Recommended Practices, edited by D. Firestone,
Champaign, IL.
46. AOCS, AOCS Official Method Ce 1f-96 (Reapproved 1997)
``Determination of cis- and trans-Fatty Acids in Hydrogentated and
Refined Oils and Fats by Capillary GLC,'' AOCS Official Methods and
Recommended Practices, edited by D. Firestone, Champaign, IL.
47. AOCS, AOCS Official Method Ce 1c-89 (Reapproved 1993,
updated 1995), ``Fatty Acid Composition by GLC-cis, cis and trans
Isomers,'' AOCS Official Methods and Recommended Practices, edited
by D. Firestone, Champaign, IL.
48. AOAC, 1998, AOAC Official Method 985.21 ``Total trans Fatty
Acid Isomers in Margarines, Gas Chromatographic Method,'' Official
Methods of Analysis of AOAC International, 16th ed., 41.1.37, AOAC
International, Gaithersburg, MD, 1998, revision March 1998.
49. AOCS, AOAC Official Method Cd-14b-93, ``Fatty Acid
Composition of Partially Hydrogenated Oils--A Combined GLC-IR
Method,'' (Revised 1995), AOCS Official Methods and Recommended
Practices, edited by D. Firestone, Champaign, IL.
50. AOAC, 1997, AOAC Official Method 994.15, ``Total cis- and
trans Octadecenoic Isomers and General Fatty Acid Composition in
Hydrogenated Vegetable Oils and Animal Fats, Capillary Gas
Chromatographic-Infrared Spectrophotometric Method,'' Official
Methods of Analysis of AOAC International, 16th ed., 3d revision,
1997, 41.1.35A, AOAC International, Gaithersburg, MD.
51. Duchateau, G. S. M. J. E., H. J. vanOosten, and M. A.
Vasconcellos, ``Analysis of cis- and trans-Fatty Acid Isomers in
Hydrogenated and Refined Vegetable Oils by Capillary Gas-Liquid
Chromatography,'' Journal of the American Oil Chemists' Society,
73:275-282, 1996.
52. Adam, M., M. Chew, S. Wasseman, et al., ``Determination of
trans Fatty Acids in Hydrogenated Vegetable Oils by Attenuated Total
Reflection Infrared Spectroscopy: Two Limit Collaborative Studies,''
Journal of the American Oil Chemists' Society, 75:353-358, 1998.
53. Ratnayake, W. M. N., ``AOCS Method Ce 1c-89 Underestimates
the trans Octadecenoate Content in Favor of the cis Isomers in
Partially Hydrogenated Vegetable Oils,'' Journal of the American Oil
Chemists' Society, 69:192, 1992.
54. Select Committee on Nutrition and Human Needs United States
Senate, ``Dietary Goals for the United States,'' U.S. Government
Printing Office, February, 1977.
55. American Heart Association, ``Rationale of the Diet-Heart
Statement of the American Heart Association,'' Circulation, 65:
839A-854A, 1982.
56. American Heart Association, ``Fat, AHA Scientific
Position,'' 1997.
57. Davis, C. E., B. M. Rifkind, H. Brenner, et al., ``A Single
Cholesterol Measurement Underestimates the Risk of Coronary Heart
Disease: an Empirical Example from the Lipid Research Clinics
Mortality Follow-up Study,'' Journal of the American Medical
Association, 264:3044-3046, 1991.
58. Gillman, M. W., L. A. Cupples, D. Gagnon, et al.,
``Margarine Intake and Subsequent Coronary Heart Disease in Men,''
Epidemiology, 8:144-149, 1997.
59. Gordon, D. J., J. L. Probstfield, R. J. Garrison, et al.,
``High-density Lipoprotein Cholesterol and Cardiovascular Disease:
Four Prospective American Studies,'' Circulation, 79:8-15, 1989.
60. Gordon, D. J., and B. M. Rifkind, ``High-density Lipoprotein
- the Clinical Implications of Recent Studies,'' New England Journal
of Medicine, 321:1311-1316, 1989.
61. Gordon, D. J., ``HDL and CHD--An Epidemiological
Perspective,'' Journal of Drug Development, 3(Supplement 1):11-17,
1990.
62. Katan, M. B., P. L. Zock, and R. P. Mensink, ``Trans Fatty
Acids and Their Effects on Lipoproteins in Humans,'' Annual Review
of Nutrition, 15:473-493, 1995.
63. Kris-Etherton, P. and S. Yu, ``Individual Fatty Acid Effects
on Plasman Lipids and Lipoproteins: Human Studies,'' American
Journal of Clinical Nutrition, 65(Supplement):1628S-1644S, 1997.
64. Law, M. R., N. M. Wald, T. Wu, et al., ``Systematic
Underestimation of Association Between Serum Cholesterol
Concentration and Ischaemic Heart Disease in Observational Studies:
Data from the BUPA Study,'' British Journal of Medicine, 308:363-
366, 1994.
65. Mensink, R. P., and M. B. Katan, ``Effect of Dietary Fatty
Acids on Serum Lipids and Lipoproteins: A Meta-analysis of 27
Trials,'' Arteriosclerosis and Thrombosis, 12:911-919, 1992.
66. Rothman, K. J., and S. Greenland, ``Causation and Causal
Inference,'' Chapter 2 in Modern Epidemiology, 2d ed., Philadelphia,
Lippincott-Raven, pp. 7-28, 1998.
67. Shekelle R. B., A. M. Shryock, P. Oglesby, et al., ``Diet,
Serum Cholesterol and Death from Coronary Heart Disease-The Western
Electric Study,'' New England Journal of Medicine, 304:65-70, 1981.
68. Zarkin G. A., N. Dean, J. A. Mauskopf, et al., ``Potential
Health Benefits of Nutrition Label Changes,'' American Journal of
Public Health, 83:717-724, 1993.
69. Zock, P. L., M. B. Katan, and R. P. Mensink, ``Dietary trans
Fatty Acids and Lipoprotein Cholesterol,'' American Journal of
Clinical Nutrition, 61:617, 1995.
70. ASCN/AIN Task Force on Trans Fatty Acids, ``Position Paper
on Trans Fatty Acids,'' American Journal of Clinical Nutrition,
63:663-670, 1996.
71. NIH Consensus Development Panel, ``Triglyceride, High-
density Lipoprotein and Coronary Heart Disease,'' Journal of the
American Medical Association, 269:505-510, 1993.
72. Schucker R. E., A. S. Levy, J. E. Tenney, et al.,
``Nutrition Shelf-labeling and Consumer Purchase Behavior,'' Journal
of Nutrition Education, 24:75-81, 1992.
73. Research Triangle Institute, ``Analysis of Changing Food
Labels to Include Information on Trans Fatty Acids,'' 1998.
74. Research Triangle Institute, ``Estimated Health Benefits of
Nutrition Label Changes,'' 1991.
75. American Heart Association, ``Coronary Heart Disease and
Angina Pectoris,'' (Internet address http://www.amhrt.org/Scientific/HS stats 98/04cornry.html).
76. U. S. Bureau of the Census, ``Statistical Abstract of the
United States: 1997,'' 117th ed., Washington, DC, 1997.
77. Cutler, D. M., and E. Richardson, ``Measuring the Health of
the U.S. Population,'' Brookings Papers on Economic Activity:
Microeconomics, 1997.
78. Letter from Bob Brown, Frito-Lay, Inc., to Richard Williams,
FDA, November 3, 1998.
79. Letter from Amanda Honeycutt, Research Triangle Institute,
to Kathleen Koehler, FDA, November 3, 1998.
80. Memorandum to the file, from David Zorn, FDA, dated November
10, 1998.
81. Guthrie, J. F., B. M. Derby, and A. S. Levy, ``What People
Know and Do Not Know About Nutrition,'' Frazao, E. (Ed.), America's
Eating Habits: Changes and Consequences,'' U.S. Department of
Agriculture, Economic Research Service, Food and Rural Economics
Division, Agriculture Information Bulletin No. 750, pp. 243-280,
April 1999.
82. Lichtenstein, A. H., L. M. Ausman, S. M. Jalbert, and E. J.
Schaefer, ``Effects of Different Forms of Dietary Hydrogenated Fats
on Serum Lipoprotein Cholesterol Levels,'' New England Journal of
Medicine, 340:1933-1940, 1999.
83. Ascherio, A., M. B. Katan, P. L. Zock, et al, ``Trans Fatty
Acids and Coronary Heart Disease,'' New England Journal of Medicine,
340:1994-1998, 1999.
84. Willett, W. C., and A. Ascherio, ``Response to the
International Life Sciences Institute Report on Trans Fatty Acids,''
American Journal of Clinical Nutrition, 62:524-526, 1995.
85. Mensink, R. P., P. L. Zock, M. B. Katan, and G. Hornstra,
``Effect of dietary cis and trans fatty acids on serum
lipoprotein[a] levels in humans,'' Journal of Lipid Research,
33:1493-1501, 1992.
86. Nestel, P. J., M. Noakes, G. B. Belling, et al., ``Plasma
Cholesterol-Lowering Potential of Edible-Oil Blends Suitable for
Commercial Use,'' American Journal of Clinical Nutrition, 55: 45-50,
1992.
87. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, Nutrition and Your Health: Dietary Guidelines
for Americans, 5th ed. Washington DC, Home and Garden Bulletin No.
232, 2000.
88. Dietary Guidelines Advisory Committee, Report of the Dietary
Guidelines Advisory Committee on the Dietary
[[Page 41501]]
Guidelines for Americans, to the Secretary of Health and Human
Services and the Secretary of Agriculture, U.S. Department of
Agriculture, Washington DC, pp. 1-37, 2000.
89. Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults, Third Report of the National
Cholesterol Education Program (NCEP) Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult
Treatment Panel III), Chapter II, ``Rationale for Intervention'' and
Chapter V ``Adopting Healthful Lifestyle Habits to Lower LDL
Cholesterol and Reduce CHD Risk,'' 2001, (Internet address: http://www.NHLBI.nih.gov).
90. IOM/NAS, ``Letter Report on Dietary Reference Intakes for
Trans Fatty Acids,'' Food and Nutrition Board, Institute of
Medicine, July, 2002.
91. Krauss, R.M., R.H. Eckel, B. Howard, et al., ``American
Heart Association Dietary Guidelines, Revision 2000: A Statement for
Healthcare Professionals From the Nutrition Committee of the
American Heart Association,'' Circulation, 102:2296-2311, 2000.
92. FDA, ``Questions and Answers on Trans Fat Proposed Rule,''
November 1999 (Internet address: http://www.cfsan.fda.gov/
[tilde]dms/qatrans.html).
93. van de Vijer, L.P.L., A.F.M. Kardinaal, C. Couet, et al.,
``Association Between trans Fatty Acid Intake and Cardiovascular
Risk Factors in Europe: The transFAIR Study,'' European Journal of
Clinical Nutrition, 54: 126-135, 2000.
94. U.S. FDA/CFSAN, ``Guidance for Industry. Significant
Scientific Agreement in the Review of Health Claims for Conventional
Foods and Dietary Supplements,'' 1999 (Internet address: http://
www.cfsan.fda.gov/[tilde]dms/ssaguide.html).
95. Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults, Executive Summary of the Third Report
of the National Cholesterol Education Program (NCEP) Expert Panel on
Detection, Evaluation, and Treatment of High Blood Cholesterol in
Adults (Adult Treatment Panel III) JAMA, 285: (19) 2486-2497, 2001.
96. Derby, B.M. and A.S. Levy, ``Do Food Labels Work? Gauging
the Effects of Food Labels Pre-and Post-NLEA,'' In P.N. Bloom & G.T.
Gundlach (Eds.), Handbook of Marketing and Society, Sage, Thousand
Oaks, CA, pp. 372-398. 2001.
97. Food Marketing Institute, ``Trends in the United States:
Consumer Attitudes and the Supermarket 1997,'' Washington, DC, pp.
17-18, 66-67, 70-73, and 75, 1997.
98. Judd, J.T., D.J. Baer, B.A. Clevidence, et al., ``Dietary
cis and trans Monounsaturated and Saturated Fatty Acids and Plasma
Lipids and Lipoproteins in Men,'' Lipids, 37:123-131, 2002.
99. de Roos, N.M., M.L. Bots, and M.B. Katan, ``Replacement of
Dietary Saturated Fatty Acids by trans Fatty Acids Lowers Serum HDL
Cholesterol and Impairs Endothelial Function in Healthy Men and
Women,'' Arteriosclerosis, Thrombosis, and Vascular Biology, 21:
1233-7, 2001.
100. deRoos, N.M., E.G. Schouten, and M.B. Katan, ``Consumption
of a Solid Fat Rich in Lauric Acid Results in a More Favorable Serum
Lipid Profile in Healthy Men and Women Than Consumption of a Solid
Fat Rich in Trans-fatty Acids,'' Journal of Nutrition, 131: 242-245,
2001.
101. Denke, M.A., B. Adams-Huet, B.S. Nguyen, ``Individual
Cholesterol Variation in Response to a Margarine- or Butter-Based
Diet--A Study in Families,'' JAMA, 284: 2740-2747, 2000.
102. Oomen, C.M., M.C. Ocke, E.J. Feskens, et al., ``Association
Between trans Fatty Acid Intake and 10-Year Risk of Coronary Heart
Disease in the Zutphen Elderly Study: A Prospective Population-Based
Study,'' Lancet, 357: 746-51, 2001.
103. Canadian Government, ``Regulations Amending the Food and
Drug Regulations (Nutrition Labeling, Nutrition Claims and Health
Claims), Canadian Gazette Part I, 135:39-62, June 16, 2001.
104. List, G., K.R. Steidley, and W.E. Neff, ``Commercial
Spreads Formulation, Structure and Properties,'' Inform, 11:980-986,
September 2000.
105. AOAC, ``AOAC Official Method 996.06, Fat (Total, Saturated,
and Unsaturated) in Foods,'' Official Methods of Analysis of AOAC
International, 17th ed., Revision 1, Chapter 41, pp. 20-24, AOAC
International, Gaithersburg, MD, 2000.
106. Firestone, D., ``General Referee Report: Fats and Oils,''
Journal of the Association of Official Analytical Chemists, 83: 467-
470, 2000.
107. DeVries, J.W., L. Kjos, L. Groff, et al., ``Studies in
Improvement of Official Method 996.06,'' Journal of the Association
of Official Analytical Chemists, 82:1146-54, 1999.
108. Guidance for Industry, FDA Nutrition Labeling Manual--A
Guide for Developing and Using Data Bases,'' 1998 (Internet address:
http://www.cfsan.fda.gov/[tilde]dms/nutrguid.html).
109. Levy, A.S., S. Fein, and R.E. Schucker, ``Performance
Characteristics of Seven Nutrition Label Formats,'' Journal of
Public Policy and Marketing, 15:1-15, 1996.
110. Stouffer Foods Corp. Docket 9250 (September 26, 1994), 118
FTC 746.
111. Center for Food Safety and Applied Nutrition (CFSAN)/FDA,
``Questions and Answers Volume II, A Guide for Restaurants and Other
Retail Establishments,'' 1996, (Internet address: http://
www.cfsan.fda.gov/[tilde]frf/qaintro.html).
112. U.S. Department of Agriculture (USDA)/DHHS, ``Dietary
Guidelines for Americans,'' 1st ed., 1980.
113. National Center for Health Statistics, Healthy People 2000
Final Review, Hyattsville, MD: Public Health Service, pp. 76-92,
2001.
114. USDA, Agricultural Research Service, ``Data Tables: Results
From USDA's 1994-96 Continuing Survey of Food Intakes by Individuals
and 1994-96 Diet and Health Knowledge Survey, Table Set 10,'' USDA,
Agricultural Research Service, 1997.
115. Smiciklas-Wright H., D.C. Mitchell, S.J. Mickle, et al.,
``Foods Commonly Eaten in the United States: Quantities Per Eating
Occasion and in a Day, 1994-1996,'' U.S. Department of Agriculture
NFS Report No 96-5, pre-publication version, 2002 (pp. i-xii, 1-8,
202-204, 216-244, and 252).
116. Koehler, K. M., D. Zorn and C. Nardinelli, ``Estimation of
Trans Fat Intake From Food Groups by U.S. Adults,'' Memo to file,
2002.
117. Krebs-Smith, S. M., P. M. Guenther, A. Cook, et al., U.S.
Department of Agriculture, Agricultural Research Service, ``Foods
Commonly Eaten in the United States: Quantities Consumed Per Eating
Occasion and in a Day, 1989-91,'' U.S. Department of Agriculture NFS
Report No. 91-3, November, 1997 (pp. i-xi, 1-7, 196-198, 210-238,
and 248-249).
118. ``Discovery Health Pulse Top-Line Poll Results,'' Penn,
Schoen & Berland Associates, Inc., Washington, DC, 1999.
119. Kim, S. Y., R. M. Nayga Jr., and O. Capps Jr., ``The Effect
of Label Use on Nutrient Intakes: An Endogenous Switching Regression
Analysis,'' Journal of Agricultural and Resource Economics, 25:215-
231, 2000.
120. Kochhar, S. P., ``Stable and Healthful Frying Oils for the
21st Century,'' Inform, 11:642-647, 2000.
121. Haumann, B. F., ``Fat Modification Tools: Hydrogenation,
Interesterification,'' Inform, 5:668-678, 1994.
122. ``Questions Remain Over Hydrogenated Fats,'' Inform, 5:358-
363, 1994.
123. ``Legal Sea Foods Leads the Way in Healthy Eating With
Innovative All-Natural and Heart-Healthy Frying Oil,'' Legal Sea
Foods, 1998, http://www.lsf.com/fresh/11_3_98.htm.
124. Bayard, C. C. and R. L. Wolff, ``Trans-18:1 Acids in French
Tub Margarines and Shortenings: Recent Trends,'' Journal of the
American Oil Chemists Society, 72:1485-1489, 1995.
125. Becker, W., ``Intake of Trans Fatty Acids in the Nordic
Countries,'' Scandanavian Journal of Nutrition/Nahringsforskning,
40:16-18, 1996.''
126. Haumann, B. F., ``Widening Array of Spreads Awaits
Shoppers,'' Inform, 9:6-13, 1998.
127. Ovesen, L., T. Leth, and K. Hansen, ``Fatty Acid
Composition of Danish Margarines and Shortenings, With Special
Emphasis on Trans Fatty Acids,'' Lipids, 31:971-975, 1996.
128. Ratnayake, W. M. N., G. Pelletier, R. Hollywood, et al.,
``Trans Fatty Acids in Canadian Margarines: Recent Trends,'' Journal
of the American Oil Chemists Society, 75:1587-1594, 1998.
129. RTI International, FDA Labeling Cost Model, April 2002.
130. Muller, H., B. Kirkhus, and J. I. Pedersen, ``Serum
Cholesterol Predictive Equations With Special Emphasis on Trans and
Saturated Fatty Acids: An Analysis From Designed Controlled
Studies,'' Lipids, 36:783-791, 2001.
131. Stampfer, M. J., F. M. Sacks, S. Salvini, et al., ``A
Prospective Study of Cholesterol, Apolipoproteins, and the Risk of
Myocardial Infarction,'' New England Journal of Medicine, 325:373-
381, 1991.
132. ``Decline in Deaths From Heart Disease and Stroke--United
States, 1900-1999,'' Morbidity and Mortality Weekly Report, 48:649-
656, 1999.
133. National Institutes of Health, National Heart Lung and
Blood Institute, ``Morbidity and Mortality: 1998 Chartbook on
Cardiovascular, Lung and Blood Diseases,''
[[Page 41502]]
National Institutes of Health, National Heart Lung and Blood
Institute, Bethesda, MD, October 1998 (p. 31).
134. American Heart Association, 2000 Heart and Stroke
Statistical Update, American Heart Association, Dallas, TX, 1999 (p.
10).
135. National Report 2001-2002: Consumer Attitudes About
Nutrition, Untied Soybean Board, Chesterfield, MO, 2002.
136. U.S. Census Bureau, County Business Patterns, 1999, United
States, Washington, DC, 2001.
137. Stinnett, A. A., M. A. Mittleman, M. C. Weinstein, et al.,
``Appendix C: The Cost-Effectiveness of Dietary and Pharmacologic
Therapy for Cholesterol Reduction in Adults,'' Gold, M. R., J. E.
Siegel, L. B. Russell and M. C. Weinstein (editors), Cost-
Effectiveness in Health and Medicine, Oxford University Press, New
York, 1996, pp. 349-391.
138. Law, M. R., N. J. Wald, and S. G. Thompson, ``By How Much
and How Quickly Does Reduction in Serum Cholesterol Lower Risk of
Ischaemic Heart Disease?'' British Medical Journal 308: 387-373,
1994.
139. USDA, Agricultural Research Service, USDA Nutrient Database
for Standard Reference, Release 15, 2002 (Internet address: http://www.nal.usda.gov/fnic/cgi-bin/nut_search.pl).
140. IOM/NAS, ``Dietary Reference Intakes for Energy,
Carbohydrate, Fiber, Fat, Protein and Amino Acids
(Macronutrients),'' chapters 8 and 11, National Academy Press,
Washington, DC, pp. 335-432, 2002 (Internet address: http://www.nap.edu).
141. Congressional House Record, ``Nutrition Labeling and
Education Act of 1990,'' H 12951-12953, October 26, 1990.
142. USDA, Agricultural Research Service, ``Food and Nutrient
Intakes by Individuals in the United States, 1 Day, 1989-91,'' table
8.1, USDA, Agricultural Research Service, 1995, p. 118.
143. AOAC, Official Methods of Analysis of AOAC International,
17th ed., Revision 1, AOAC International, Gaithersburg, MD, 2002.
144. AOCS, Official Methods and Recommended Practices of the
AOCS, 2002-2003 Methods-Additions and Revisions, AOCS Press,
Champaign, IL.
145. AOCS, AOCS Recommended Practice Cd 14d-96 (reapproved 1997
and revised 1999), ``Isolated trans Geometric Isomers-Single Bounce-
Horizontal Attenuated Total Reflection Infrared Spectroscopic
Procedure,'' AOCS Official Methods and Recommended Practices, 2002-
2003 Methods-Additions and Revisions, AOCS Press, Champaign, IL.
146. AOCS, AOCS Official Method Ce 1f-96 (reapproved 1997 and
revised 2002), ``Determination of cis- and trans-Fatty Acids in
Hydrogenated and Refined Oils and Fats by Capillary GLC,'' AOCS
Official Methods and Recommended Practices, 2002-2003 Methods-
Additions and Revisions, AOCS Press, Champaign, IL.
147. Kaufman, Marc, ``McDonald's to Give Fat a Break, Washington
Post, September 4, 2002, p. A07.
148. Beil, Laura, ``Trans Fat--Linked to Heart Disease--Isn't
Listed on Food Labels,'' Bayarea and Wire Service Sources, September
16, 2002.
149. McDonald's Press Release, ``McDonald's USA Announces
Significant Reduction of Trans Fatty Acids With Improved Cooking
Oil,'' 2002, http://www.Mcdonalds.com.
150. Pepsico Inc., Press Release, ``Frito-Lay Eliminates Trans
Fats From America's Favorite Salty Snacks: Doritos, Tostitos and
Cheetos, 2002.
151. Fischer, K., ``Sorting Fat From Fiction,'' Prepared Foods,
October, 2002, pp. 39-44.
152. Schakel, S. F., L. Harnack, C. Wold, et al.,
``Incorporation of trans-Fatty Acids into a Comprehensive Nutrient
Database,'' Journal of Food Composition and Analysis, 12:323-331,
1999.
153. Bialostosky, K., J. D. Wright, J. Kennedy-Stephenson, et
al., ``Dietary Intake of Macronutrients, Micronutrients, and Other
Dietary Constituents: United States, 1988-94,'' National Center for
Health Statistics: Vital and Health Statistics, series 11, no. 245,
2002, pp. 1-9, 84-85, and 150-158.
154. Zock, P. L. and R. P. Mensink, ``Dietary trans-Fatty Acids
and Serum Lipoproteins in Humans,'' Current Opinions in Lipidology,
7:34-37, 1996.
155. Memo to file from D. Zorn, Comments and responses to
comments from Interagency Economic Peer Review, 2002.
156. Letter to file from J. D. Graham to T. G. Thompson,
September 18, 2001.
157. Garber, A. M. and C. E. Phelps, ``Economic Foundations of
Cost-Effectiveness Analysis,'' Journal of Health Economics, 16:1-31,
1997.
158. U.S. Census Bureau, Statistical Abstract of the United
States, pp. 413-416 and 436, 2002.
159. Viscusi, W. K. and J. E. Aldy, ``The Value of Statistical
Life: A Critical Review of Market Estimates throughout the World,''
AEI-Brookings Joint Center for Regulatory Studies, January 2003.
160. Alberini, A., M. Cropper, A. Krupnik, et al., ``Does the
Value of a Statistical Life Vary with Age and Health Status?
Evidence from the United States and Canada,'' Resources for the
Future, pp. 1-34, April 2002.
List of Subjects in 21 CFR 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
0
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
0
2. Section 101.9 is amended by:
a. Redesignating paragraphs (c)(2)(ii) and (c)(2)(iii) as
(c)(2)(iii) and (c)(2)(iv),
b. Adding new paragraph (c)(2)(ii), and
c. Revising paragraphs (c)(2)(i), (d)(1)(ii)(A), the first sentence
of paragraph (f), the first sentence of paragraph (g)(5), the second
sentence of paragraph (g)(6), and the sample labels in paragraphs
(d)(11)(iii), (d)(12), (d)(13)(ii), (e)(5), (j)(13)(ii)(A)(1), and
(j)(13)(ii)(A)(2).
0
The revisions and additions are to read as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(c) * * *
(2) * * *
(i) ``Saturated fat,'' or ``Saturated'': A statement of the number
of grams of saturated fat in a serving defined as the sum of all fatty
acids containing no double bonds, except that label declaration of
saturated fat content information is not required for products that
contain less than 0.5 gram of total fat in a serving if no claims are
made about fat, fatty acid, or cholesterol content, and if ``calories
from saturated fat'' is not declared. Except as provided for in
paragraph (f) of this section, if a statement of the saturated fat
content is not required and, as a result, not declared, the statement
``Not a significant source of saturated fat'' shall be placed at the
bottom of the table of nutrient values. Saturated fat content shall be
indented and expressed as grams per serving to the nearest 0.5 gram (1/
2) gram increment below 5 grams and to the nearest gram increment above
5 grams. If the serving contains less than 0.5 gram, the content shall
be expressed as zero.
(ii) ``Trans fat'' or ``Trans'': A statement of the number of grams
of trans fat in a serving, defined as the sum of all unsaturated fatty
acids that contain one or more isolated (i.e., nonconjugated) double
bonds in a trans configuration, except that label declaration of trans
fat content information is not required for products that contain less
than 0.5 gram of total fat in a serving if no claims are made about
fat, fatty acid or cholesterol content. The word ``trans'' may be
italicized to indicate its Latin origin. Trans fat content shall be
indented and expressed as grams per serving to the nearest 0.5 (1/2)-
gram increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content, when
declared, shall be expressed as zero. Except as provided for in
paragraph (f) of this section, if a statement of the trans fat content
is not required and, as a result, not declared, the statement ``Not a
significant source
[[Page 41503]]
of trans fat'' shall be placed at the bottom of the table of nutrient
values.
* * * * *
(d)(1) * * *
(ii) * * *
(A) Except as provided for in paragraph (c)(2)(ii) of this section,
a single easy-to-read type style,
* * * * *
(11) * * *
(iii) * * *
[GRAPHIC] [TIFF OMITTED] TR11JY03.000
(12) * * *
[GRAPHIC] [TIFF OMITTED] TR11JY03.001
(13) * * *
(ii) * * *
[[Page 41504]]
[GRAPHIC] [TIFF OMITTED] TR11JY03.002
[[Page 41505]]
* * * * *
(e) * * *
(5) * * *
[GRAPHIC] [TIFF OMITTED] TR11JY03.003
(f) The declaration of nutrition information may be presented in
the simplified format set forth herein when a food product contains
insignificant amounts of eight or more of the following: Calories,
total fat, saturated fat, trans fat, cholesterol, sodium, total
carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C,
calcium, and iron; * * *
* * * * *
(g) * * *
(5) A food with a label declaration of calories, sugars, total fat,
saturated fat, trans fat, cholesterol, or sodium shall be deemed to be
misbranded under section 403(a) of the act if the nutrient content of
the composite is greater than 20 percent in excess of the value for
that nutrient declared on the label. * * *
(6) * * * Reasonable deficiencies of calories, sugars, total fat,
saturated fat, trans fat, cholesterol, or sodium under labeled amounts
are acceptable within current good manufacturing practice.
* * * * *
(j) * * *
(13) * * *
(ii) * * *
(A) * * *
(1) * * *
[GRAPHIC] [TIFF OMITTED] TR11JY03.004
(2) * * *
[GRAPHIC] [TIFF OMITTED] TR11JY03.005
* * * * *
0
3. Section 101.36 is amended by revising paragraph (b)(2)(i) to read as
follows:
Sec. 101.36 Nutrition labeling of dietary supplements.
* * * * *
(b) * * *
(2) * * *
(i) The (b)(2)-dietary ingredients to be declared, that is total
calories, calories from fat, total fat, saturated fat, trans fat,
[[Page 41506]]
cholesterol, sodium, total carbohydrate, dietary fiber, sugars,
protein, vitamin A, vitamin C, calcium and iron, shall be declared when
they are present in a dietary supplement in quantitative amounts by
weight that exceed the amount that can be declared as zero in nutrition
labeling of foods in accordance with Sec. 101.9(c) of this part. * * *
* * * * *
0
4. Appendix B to Part 101 is amended by revising the sample label
following the list of examples to read as follows:
Appendix B to Part 101--Graphic Enhancements Used by the FDA
* * * * *
[GRAPHIC] [TIFF OMITTED] TR11JY03.006
Dated: May 7, 2003.
Mark B. McClellan,
Commissioner of Food and Drugs.
Dated: July 2, 2003.
Tommy G. Thompson,
Secretary of Health and Human Services.
[FR Doc. 03-17525 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S