[Federal Register Volume 68, Number 34 (Thursday, February 20, 2003)]
[Proposed Rules]
[Pages 8163-8179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4100]
[[Page 8163]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 91N-384H and 96P-0500]
RIN 0910-AC49
Food Labeling; Nutrient Content Claims, Definition of Sodium
Levels for the Term ``Healthy''
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the regulation for sodium levels for foods that use the nutrient
content claim ``healthy.'' The agency is proposing that a previously
established, but not yet implemented, more restrictive, second-tier
sodium level would be permitted to take effect as a criterion that
individual foods must meet to qualify to bear the term ``healthy.'' The
agency is proposing to retain the current first-tier sodium level for
meal and main dish products because implementing the second-tier sodium
level could result in the substantial elimination of meal and main dish
products bearing the claim ``healthy'' from the marketplace. After
evaluating data from various sources, the agency believes that the
proposed sodium levels will help consumers achieve a total diet that is
consistent with current dietary recommendations, as the proposed levels
will give consumers a reasonable number of ``healthy'' products from
which to choose. The agency has also revised the regulatory text for
the definition of ``healthy'' to clarify the scope of the regulation
and conform to the Presidential Memorandum instructing Federal agencies
to use plain language.
DATES: Submit written or electronic comments by May 6, 2003.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Ellen M. Anderson, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1798.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 10, 1994 (59 FR 24232), FDA
published a final rule amending Sec. 101.65 (21 CFR 101.65) to define
the term ``healthy'' as an implied nutrient content claim under section
403(r) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
343(r)). The final rule defined criteria for use of the implied
nutrient content claim ``healthy,'' or a related term (e.g.,
``health,'' ``healthful'') on individual foods, including raw, single-
ingredient seafood, and game meat, and on meal and main dish products.
It also established two separate timeframes in which different criteria
for sodium content would be effective for foods bearing a ``healthy''
claim (i.e., before January 1, 1998, and after January 1, 1998).
Before January 1, 1998, under Sec. 101.65(d)(2)(ii)(A) and
(d)(2)(ii)(B), for an individual food to qualify to bear the term
``healthy'' or a related term, the food could contain no more than 480
milligrams (mg) of sodium (first-tier sodium level): (1) Per reference
amount customarily consumed per eating occasion (reference amount); (2)
per serving size listed on the product label (serving size); and (3)
per 50 grams (g) for products with small reference amounts (i.e., less
than or equal to 30 g or less than or equal to 2 tablespoons). After
January 1, 1998 (Sec. 101.65(d)(2)(ii)(C)), an individual food bearing
the term ``healthy,'' or a related term, could contain no more than 360
mg of sodium (second-tier sodium level) per reference amount, per
serving size, and per 50 g for products with small reference amounts.
The agency derived this 360 mg sodium level by applying a 25 percent
reduction to the original sodium disclosure level of 480 mg for
individual foods (59 FR 24232 at 24240).\1\
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\1\ Under Sec. 101.13(h)(1) (21 CFR 101.13(h)(1)), individual
foods containing more than 480 mg sodium per reference amount, per
labeled serving size, or per 50 g (if the reference amount is 30 g
or less or 2 tablespoons or less) must bear a label statement
referring consumers to information about the amount of sodium in the
food. Such nutrient disclosures are required when a food contains
more than certain amounts of total fat, saturated fat, sodium, and
cholesterol and that food bears a nutrient content claim. id., see
section 403(r)(2)(B) of the act. The agency developed disclosure
levels based on dietary guidelines and taking into account the
significance of the food in the total daily diet, based on daily
reference values for total fat, saturated fat, cholesterol, and
sodium (58 FR 2302 at 2307, January 6, 1993).
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To qualify to bear ``healthy'' or a related term, meal and main
dish products could contain no more than 600 mg of sodium (first-tier
sodium level) per serving size before January 1, 1998 (Sec.
101.65(d)(4)(ii)(A)), and no more than 480 mg of sodium (second-tier
sodium level) per serving size after January 1, 1998 (Sec.
101.65(d)(4)(ii)(B)). The agency selected the 480 mg level because it
was low enough to assist consumers in meeting dietary goals, while
simultaneously giving consumers who eat such foods the flexibility to
consume other foods whose sodium content is not restricted; because
there were many individual foods and meal-type products on the market
that contained less than 600 mg sodium; and because comments suggesting
other levels did not provide supporting data (59 FR 24232 at 24240).
Higher levels of sodium were rejected in the earlier rulemaking (59 FR
24232 at 24239) because the agency determined higher levels would not
be useful to consumers wanting to use foods labeled ``healthy'' to
limit their sodium intake to achieve current dietary recommendations.
On December 13, 1996, FDA received a petition from ConAgra, Inc.
(the petitioner) requesting that the agency amend Sec. 101.65(d) to
``eliminate the sliding scale sodium requirement for foods labeled
`healthy' by eliminating the entire second-tier levels of 360 mg sodium
for individual foods and 480 mg sodium for meals and main dishes'' (FDA
Docket No. 96P-0500/CP1, p. 3). As an alternative, the petitioner
requested that the January 1, 1998, effective date for the second-tier
sodium levels be delayed until such time as food technology ``catches
up'' with FDA's goal of reducing the sodium content of foods and there
is a better understanding of the relationship between sodium and
hypertension.
FDA responded to ConAgra's petition in the Federal Register of
April 1, 1997 (62 FR 15390), by announcing a partial stay of the
second-tier sodium levels in Sec. 101.65(d)(2)(ii)(C) and
(d)(4)(ii)(B) until January 1, 2000. This stay was intended to allow
time for FDA to: (1) Reevaluate the second-tier sodium levels based on
the data contained in the petition and any additional data that the
agency might receive; (2) conduct any necessary rulemaking; and (3)
give industry an opportunity to respond to the rule or to any change in
the rule that might result from the agency's reevaluation.
On December 30, 1997 (62 FR 67771), FDA published an advance notice
of proposed rulemaking (ANPRM) announcing that it was considering
whether to initiate rulemaking to reevaluate and possibly amend the
implied nutrient content regulations pertaining to use of the term
``healthy.'' FDA requested comments on whether it should propose to
amend the sodium levels for the term ``healthy.'' Comments
[[Page 8164]]
suggesting that the agency should amend the ``healthy'' definition were
asked to address what the amended regulation should require to ensure
that the term ``healthy'' could appear on a significant number of
foods, without being ``so broadly defined as to lose its value in
highlighting foods that are useful in constructing a diet that is
consistent with dietary guidelines'' (62 FR 67771 at 67772). FDA asked
those who believed the second-tier sodium requirements were appropriate
and should not be changed to provide data demonstrating that the
second-tier ``healthy'' definition was not so restrictive as to
effectively preclude the use of the term.
In the ANPRM, FDA requested data or evidence on what would happen
to the use of the term ``healthy'' in the marketplace if the second-
tier sodium levels were to take effect. In addition, the agency asked
how many ``healthy'' products would be eliminated if the second-tier
sodium levels were to take effect and whether there would be other
impacts on the number of consumer choices. The agency also asked for
data regarding the technological feasibility of reducing the sodium
content of individual foods, including raw, single-ingredient seafood
and game meats, to 360 mg per reference amount and of reducing the
sodium content of meals and main dishes to 480 mg sodium per serving
size.
FDA also requested information and views on consumer acceptance of
foods at the second-tier sodium levels. The agency further requested
information about the availability or lack of availability of
acceptable sodium substitutes, the difficulties in manufacturing
different lines of food products with lowered sodium levels, and the
impact of these lower sodium levels on the shelf-life stability and
safety of the food. FDA also requested comments on other approaches to
reducing the amount of sodium in foods that bear the term ``healthy''
(62 FR 67771 at 67773 and 67774).
If comments responding to the ANPRM revealed agreement that there
were technological hurdles that could not be overcome for all foods or
certain types of food, the agency stated that it would be interested in
exploring different options for maximizing the public health gains
expected from reducing dietary sodium levels. The agency identified
four options. First, the agency could make no changes in the stayed
rule, and the second-tier sodium levels in Sec. 101.65(d)(2)(ii) and
(d)(4)(ii) would become effective at the end of the stay period. This
was identified as the default option if industry failed to provide
evidence, data, or arguments that supported amending the rule. Second,
as requested by the petitioner, FDA could propose to amend the
definition of ``healthy'' to make the first-tier sodium levels the
qualifying levels for all food products, and to delete in their
entirety the second-tier sodium levels. Third, the agency could
continue the stay based on data and information submitted in response
to the ANPRM suggesting technological advancements could be made but
would require more time. Fourth, the agency could reconsider the
second-tier sodium levels and create new levels based on other factors
such as percentile reductions based on market basket norms (62 FR 67771
at 67774).
In response to requests for an extension to coincide with the end
of the comment period for the U.S. Department of Agriculture's (USDA's)
interim final rule on the use of ``healthy'' on the label or labeling
of meat and poultry products (63 FR 7279, February 13, 1998), FDA
extended the closing date of the comment period for the ANPRM, from
March 16, 1998, to May 19, 1998 (63 FR 13154, March 18, 1998).
In the Federal Register of March 16, 1999 (64 FR 12886), FDA
published a final rule extending the partial stay of the second-tier
sodium requirements in Sec. 101.65 until January 1, 2003. The agency
noted that it took this action to provide time for: (1) FDA to
reevaluate the supporting and opposing information received in response
to the ConAgra petition, (2) the agency to conduct any necessary
rulemaking on the sodium limits for the term ``healthy,'' and (3)
companies to respond to any changes that may result from agency
rulemaking. On May 8, 2002 (67 FR 30795), FDA issued another final rule
to extend the partial stay of the second-tier sodium requirements in
Sec. 101.65 until January 1, 2006.
While the partial stay was pending, USDA and the Department of
Health and Human Services jointly published the ``Dietary Guidelines
for Americans 2000'' (dietary guidelines) (Ref. 1). This report
provides recommendations for nutrition and dietary guidelines for the
general public and suggests a diet with a moderate sodium intake, not
exceeding 2,400 mg per day. The health concerns relating to high salt
intake are high blood pressure and loss of calcium from bones, which
may lead to risk of osteoporosis and bone fractures (Ref. 1).
II. Summary of Comments From the ANPRM
FDA received 22 responses, each containing one or more comments, to
the December 30, 1997, ANPRM.
Most of the comments stated that the requirements for the use of
the term ``healthy'' should be amended and presented evidence to
persuade the agency to change the sodium levels. The comments provided
information that a large number of meal and main dish products
currently labeled as ``healthy'' would not be able to meet the
``healthy'' definition should the second-tier sodium levels take
effect. The comments also stated that technological advances have not
yet yielded an acceptable salt substitute.
Several comments discussed the possibility of the agency engaging
in rulemaking to set new sodium levels. For instance, a few comments
suggested using a sodium level based on a percentile reduction from the
market-basket norm (e.g., 25 percent less sodium than otherwise
comparable products that are currently on the market). The levels could
be established for each food category or for those particular food
items having difficulty meeting the second-tier sodium levels. One
comment objected to ``relaxing'' the standards and suggested even
tighter regulation in the interest of public health (200 mg for
individual foods and 400 mg for meal products).
A few comments stated that the second-tier sodium levels were
reasonable and should no longer be delayed. Evidence presented in these
comments consisted of: (1) Information suggesting that manufacturers
could conform to the second-tier sodium levels without presenting food
safety concerns, and (2) summary lists of products that would remain in
the marketplace if the second-tier sodium levels took effect.
The remaining comments did not directly address the issue of
whether FDA should amend the sodium levels, but, rather, provided
general information or opinions regarding sodium levels. For example,
one such comment stated that there are health risks associated with a
low-sodium diet.
FDA used information provided in the comments, along with
information the agency gathered through an independent data analysis,
to determine its proposed action.
III. Proposed Action
A. Introduction
The agency established a definition for the term ``healthy'' as an
implied nutrient content claim (59 FR 24232).
[[Page 8165]]
The fundamental purpose of a ``healthy'' claim is to highlight those
foods that, based on their nutrient levels, are particularly useful in
constructing a diet that conforms to current dietary guidelines, which
suggest that daily sodium intake not exceed 2,400 mg (Ref. 1). To
assist consumers in constructing such a diet, a reasonable number of
``healthy'' foods should be available in the marketplace.
FDA stated in the ANPRM that its goal was to establish sodium
levels for the definition of ``healthy'' that are not so restrictive as
to preclude the use of the term ``healthy,'' and not so broadly defined
as to cause the term to lose its value in identifying useful products
for constructing a healthy diet (62 FR 67771 at 67772).
To assess the number of ``healthy'' products in the marketplace,
FDA conducted a marketplace data analysis (Ref. 2) using information
from the Information Resources, Inc. (IRI) InfoScan database. The IRI
InfoScan database contains dollar and sales information for food and
dietary supplement products. InfoScan includes information collected
weekly from a selected group of grocery, drug, and mass merchandiser
stores across the continental United States with annual sales of $2
million and above (sample store data)--more than 32,000 retail
establishments. The retail stores are statistically selected, and the
database contains sales data for all products in these retail stores
that are scanned (i.e., sold) at check out. IRI applies projection
factors to the sample store data to estimate total sales in the
continental United States from stores that have annual sales of $2
million and above. Using the IRI InfoScan database, FDA estimated the
number of ``healthy'' brands and ``healthy'' products in the
marketplace during 1993 to 1999.
In the following discussion of the marketplace data analysis, the
term ``brands'' refers to brand names (not manufacturers) in the IRI
InfoScan database (e.g., Healthy Choice, Health Valley, Healthline),
while the term ``products'' refers to the different items (i.e.,
separate Universal Product Codes) sold under that brand name (e.g.,
raisin bran versus corn flakes; 12-ounces (oz) package versus 16-oz
package) (Ref. 2).
B. Individual Foods
1. Conventional Foods
In the marketplace data analysis of ``healthy'' individual foods,
the agency estimated the total number of ``healthy'' products and
brands available in 1993, in 1999, and any time in the timeframe from
1993 to 1999. The agency also estimated the number of ``healthy''
individual foods for specific food categories. FDA does not have any
data to determine either the number of ``healthy'' products or the pace
of increase in the availability of ``healthy'' products prior to 1993.
When compiling the marketplace data analysis, the agency considered all
conventional foods that did not meet the meal or main dish definition
in Sec. 101.13(l) and (m) (including soups, salads (e.g., precut in a
bag, prepared refrigerated salads), and single-ingredient seafood and
game meats) to be individual foods. FDA considered dietary supplements
separately using a different database. Dietary supplements are
discussed in section III. B.2 of this document.
FDA estimated that in 1999 the marketplace had 872 ``healthy''
individual food products available to the consumer, compared to 842
such products available in 1993 (Ref. 2). There was also an increase in
the number of ``healthy'' brands for individual foods in the
marketplace from 1993 to 1999. In 1993, only 50 brands carried a
``healthy'' product, while 69 brands were available in 1999.
Considering that the 1993 figures are representative of the
marketplace prior to the 1994 final rule defining ``healthy,'' the
increase in ``healthy'' products shows that, in addition to
manufacturers being able to comply with the definition established in
1994, they have also been able to develop additional ``healthy''
products. Manufacturers have increased the number of available
``healthy'' brands as well as the number of available ``healthy''
products at or below the first-tier sodium level.
There has been an increase in the number of ``healthy'' individual
food products in many of the specific food categories defined by IRI
(Ref. 2). For example, in the IRI category of ``Salty Snacks'' (e.g.,
pretzels, potato chips), there were 18 available ``healthy'' products
in 1993 and 46 in 1999, with 3 ``healthy'' brands available in 1993 and
5 in 1999. For popcorn products identified in the IRI category of
``Popcorn/Popcorn Oil,'' no ``healthy'' products existed in 1993, but
in 1999 there were 10 ``healthy'' products and 2 ``healthy'' brands in
the marketplace. Similarly, in the IRI category ``Fresh Breads &
Rolls,'' 21 ``healthy'' products and 5 ``healthy'' brands were on the
market in 1993, while in 1999, 64 ``healthy'' products and 9 brands
were available. Increases can also be seen in the IRI category of ``FZ
[Frozen] Seafood''; 14 ``healthy'' products were available in 1993,
while 22 were available to consumers in 1999, with 3 ``healthy'' brands
in both 1993 and 1999. These are only a few examples of increases in
the number of ``healthy'' individual food products available to the
consumer.
Not all food categories, however, had an increase in the number of
``healthy'' products from 1993 to 1999. For instance, foods in the IRI
categories ``Cold Cereal,'' ``Cookies,'' Dried Fruit,'' ``Salad
Dressings--SS'' (where SS stands for shelf stable), ``Sauce,'' and
``Carbonated Beverages'' saw a drop in the number of ``healthy''
products available from 1993 to 1999 (Ref. 2). For food categories such
as cold cereal, salad dressing, and sauces, sodium may have been a
factor in the decrease in the number of products available from 1993 to
1999 because the sodium levels in these products cover a very wide
range, and some exceed the first-tier requirement for products labeled
as ``healthy'' (Ref. 3). However, based on typical sodium levels for
other food categories, such as cookies, dried fruit, and carbonated
beverages, it is unlikely that sodium was responsible for the decrease
in the number of these ``healthy'' products in the marketplace because
typical sodium levels are below both the first- and second-tier sodium
levels (Ref. 3).
In addition, certain food categories generally contain little
sodium. Foods such as fish, fruit juices, hot cereals, rice,
vegetables, pastas, and yogurt typically have considerably less than
360 mg sodium per reference amount and per serving size (Ref. 3). For
most of these foods, there was an increase or no change in the number
of brands and products available in 1999 compared to 1993 (Ref. 2).
There was a decrease in the number of vegetable and pasta products
labeled ``healthy;'' however, there is no reason to believe that this
decrease was due to the sodium content. Because these categories of
food generally contain little sodium, the proposed second-tier sodium
level is unlikely to have an impact on the number of ``healthy''
products in the marketplace.
The agency also evaluated data from the 1997 Food Label and Package
Survey (FLAPS) (Ref. 4), which represents data collected in 1997 from a
limited number of product brands in specific food categories. The
agency reviewed this database because it includes data that were not
available in the marketplace data analysis, including information on
claims and other information included on product labels. For example,
FDA found a number of ``healthy'' claims on individual foods (Ref. 4),
such as ``Healthy real egg product'' and ``Apple sauce is a
[[Page 8166]]
delicious and healthy fruit product, which contains no fat, very low
sodium, and no cholesterol.'' Such statements are implied nutrient
content claims for ``healthy'' that the marketplace data analysis did
not identify because the term ``healthy'' was not part of the brand
name of the product. This leads FDA to believe that there are
individual foods in the market place bearing ``healthy'' claims in
addition to those identified in the marketplace data analysis. As some
``healthy'' claims are not part of the brand name of the product and,
therefore, were not captured in the marketplace data analysis, it is
likely that the number of ``healthy'' individual foods included in that
analysis underestimates the number of individual food products bearing
``healthy'' claims.
The agency notes that individual foods with reference amounts on
the lower end of the scale are also less likely to be affected by
adoption of the second-tier sodium level because they are able to claim
the same 360 mg sodium level for a ``healthy'' product as other
individual foods with larger reference amounts. For example, bread or
rolls have a reference amount of 50 g (Sec. 101.12(b) (21 CFR
101.12(b)), table 2, ``Bakery products: Breads (excluding sweet quick
type), rolls''). A 50 g serving of bread or rolls typically contains
less than 360 mg sodium (Ref. 3) and would meet the second-tier
criterion. Contrast that with individual foods such as pasta or potato
salad, which have a reference amount of 140 g (Sec. 101.12(b), table 2
``Salads: Pasta or potato salad''). Assuming other aspects of the
``healthy'' definition are met, 140 g of pasta or potato salad must
contain no more than 360 mg sodium to be considered ``healthy,''
although the reference amount for pasta or potato salad (140 g) is
almost three times that of bread or rolls (50 g). Many other individual
foods are similar to the bread and rolls, having a reference amount on
the lower end of the scale, which allows those products more
flexibility in their sodium level.
Additionally, the agency believes that some individual foods may be
close to meeting the second-tier sodium level. If the second-tier
sodium level goes into effect, manufacturers may choose to reformulate
such products in order to retain a ``healthy'' claim.
The ConAgra petition and other comments identified a few specific
categories of individual foods for which the ability to make
``healthy'' claims could be negatively affected by permitting the
second-tier sodium levels to take effect (e.g., soups, cheeses,
frankfurters, and luncheon meats). FDA examined the marketplace data
analysis for these specific food categories (Ref. 2).
The total number of ``healthy'' wet and dry soup products available
in the marketplace increased during 1993 through 1999. In 1993, 104
``healthy'' soup products were on the market. In 1999, over 20 more
products were available, for a total of 126 ``healthy'' soup products
in 1999. The number of ``healthy'' brands remained steady at six in
both 1993 and 1999.
The petitioner indicated that its ``healthy'' soup products would
not be able to meet the second-tier sodium level. The petitioner stated
that it had expended numerous resources (e.g., consulting with experts
in the field of food technology and conducting research and development
programs with flavor companies) and was not able to find a satisfactory
salt replacement for its ``healthy'' line of soups.
On the other hand, a comment by a major manufacturer of soups
claimed that it has been able to reduce the sodium levels in its
``healthy'' soups and is currently able to meet the second-tier sodium
level for ``healthy'' individual foods. The comment from this major
soup manufacturer indicated that it was able to reformulate its
``healthy'' soup product line by modifying the flavor system with
ingredient changes on a product by product basis. The comment also
noted that reducing sodium in a product is technically difficult but
not unsolvable and that the flavor profile of a product can be
manipulated so that it maintains consumer appeal.
Because one major soup manufacturer has been able to develop a
``healthy'' soup line that meets the second-tier sodium level for
``healthy'' individual foods, FDA tentatively concludes that it is
technologically feasible to produce a ``healthy'' soup product that
meets the second-tier sodium level and is palatable to consumers. The
petitioner also stated that cheese might not be able to meet the
second-tier ``healthy'' sodium requirement because salt is required in
the manufacturing process and cannot be reduced without jeopardizing
taste and texture. The petitioner also contended that if FDA permits
the second-tier sodium level to take effect for individual foods, there
will be no ``healthy'' version of cheese in the marketplace.
Another comment stated that if it is not possible to manufacture a
``healthy'' cheese, then no exception should be made, and cheese
products should be removed from the ``healthy'' marketplace until
manufacturers are capable of producing a cheese that meets the
``healthy'' definition.
The petitioner's comments regarding cheese are reinforced by the
trend seen by FDA in its marketplace data analysis (Ref. 2). For
example, there has been a general decline in the number of ``healthy''
cheeses in the marketplace. In 1993, before the final rule defining
``healthy'' was issued, there were a total of 60 ``healthy'' cheese
products with 3 different brands on the market; however, in 1999, the
numbers dropped to 32 products with only 1 brand in the marketplace.
Furthermore, in Spring 2001, FDA staff made an informal telephone
inquiry to the customer service center of the only manufacturer of
``healthy'' cheese identified in the marketplace data analysis for 1999
(Ref. 5). The manufacturer indicated that its ``healthy'' line of
cheese had been discontinued. To the best of the agency's knowledge, no
new manufacturer has entered the ``healthy'' cheese market.
FDA agrees that cheese generally requires salt in the manufacturing
process. Cheese is made from the coagulation of milk into curds and
whey. The whey is drained off and salt (sodium chloride) is typically
added to the curd to control microbial growth and enzyme activity,
assist in curd synthesis (whey expression), and directly cause changes
in cheese proteins that will influence cheese texture (Ref. 6). The
agency requests comments on whether salt is the limiting element in
achieving a ``healthy'' cheese and whether salt can be removed from the
cheese-making process.
FDA notes that ``healthy'' cheeses may have been removed from the
marketplace for reasons other than the sodium requirement. Some
``healthy'' cheeses (e.g., light mozzarella cheeses) were able to meet
the proposed second-tier sodium level for ``healthy'' individual foods;
nonetheless, those products were removed from the marketplace (Ref. 5).
In addition to sodium, cheese also typically contains fat and saturated
fat, which have been identified as nutrients to limit when constructing
a ``healthy'' diet (Ref. 1). Because the ``healthy'' claim sets limits
on all three nutrients, the multiple requirements may be the reason why
``healthy'' cheeses are no longer in the marketplace. FDA requests
comments that would help clarify whether it is the sodium limit, the
fat or saturated fat limits, the combination of limits, or some other
factor or factors that have resulted in manufacturers discontinuing the
manufacture and marketing of ``healthy'' cheeses.
Further, the agency is not persuaded that it is necessary to
provide for
[[Page 8167]]
``healthy'' cheese since the lack of a ``healthy'' cheese product is
not likely to prevent consumers from constructing a diet consistent
with dietary guidelines. Although cheese contributes calcium to the
diet (Ref. 1), consumers can obtain their reference daily intake (RDI)
of calcium from many other sources such as low-fat milk, yogurt, and
dark-green leafy vegetables, to name a few.
For consumers who choose to eat cheese, there are alternative
cheese products such as ``reduced fat'' or ``reduced sodium'' cheeses.
These claims accurately describe the specific attributes of the product
without claiming that it conforms to the requirements for ``healthy.''
FDA also is concerned that treating cheese differently from other
foods could be misleading to consumers trying to construct a healthy
diet. Cheese has a small reference amount (30 g) (Sec. 101.12(b),
table 2, ``Dairy Products and Substitutes: Cheese, all others except
those listed as separate categories--includes cream cheese and cheese
spread''), and therefore, more than one serving can be consumed easily.
In general, approximately 32 g to 46 g of cheese is consumed per eating
occasion (Ref. 7). Because the actual amount consumed is typically
larger than the reference amount (30 g), it appears that consumers will
be better served if the second-tier sodium level applies to all foods,
including cheese. Applying the second-tier sodium level to cheese will
help maintain a reasonable sodium intake even for those people who
consume larger amounts of cheese.
However, FDA invites comments on whether having no ``healthy''
cheeses may have a negative impact on consumers, and if so, whether the
agency could establish a reasonable alternative sodium requirement for
``healthy'' cheese. Alternative methods might include: (1) Leaving
cheese at the current first-tier sodium level for ``healthy''
individual foods (480 mg) or (2) establishing ``healthy'' sodium levels
based on a percent reduction of market-basket norms.
The first alternative of leaving cheese at the current first-tier
sodium level for ``healthy'' individual foods may encourage cheese
manufacturers to reenter the marketplace, since they would no longer
have to face uncertainty as to whether the sodium level would be
reduced to the second-tier level. The marketplace data analysis showed
that there were 32 ``healthy'' cheese products in 1999, demonstrating
that manufacturers were capable of producing a ``healthy'' cheese at
the current first-tier sodium level.
The second alternative of establishing a ``healthy'' sodium level
based on a market-basket norm may not be practical for all individual
foods but may be appropriate for cheese because of its special
manufacturing process. To consider both alternatives, it would be
helpful to have additional information, such as: (1) The sodium levels
for various cheeses currently in the marketplace that do not bear the
term ``healthy'' (i.e., the current market-basket norm) and what might
be an achievable percent reduction for sodium from that market-basket
norm; (2) the impact that exempting cheese, not exempting cheese, or
establishing an alternative sodium level would have on diets; (3) the
minimum levels of sodium that can be achieved in the production of an
acceptable cheese product; (4) the technology available to reduce
sodium levels in cheese products; and (5) the extent to which salt
(sodium chloride) is required in the cheese-making process.
Comments received in response to the ANPRM also indicated that
frankfurters and luncheon meat may have difficulty meeting the second-
tier sodium level of the ``healthy'' definition. However, those
products fall outside FDA's jurisdiction, as they are regulated by
USDA; therefore, they are not addressed in this proposal.
Another issue raised by the petitioner was the role of salt as a
preservative in refrigerated foods, particularly meat and poultry
products, because the petitioner contended that refrigeration alone
cannot be relied upon to ensure food safety. However, a comment stated
that the difference between the first-tier (480 mg) and the second-tier
(360 mg) sodium levels is insignificant with respect to food safety.
The comment noted that sodium does not protect against microbiological
contamination in processed meats and that no one factor is responsible
for product safety.
Again, since meat and poultry fall outside FDA's jurisdiction, they
will not be addressed in this rulemaking. The agency requests comments
on whether sodium levels of 360 to 480 mg are protective and play a
role in food safety for foods that FDA regulates; whether changing from
the first- to the second-tier sodium level would negatively impact food
safety; and what other preservation methods could be used to ensure
food safety in conjunction with lower sodium levels.
Based on the data summarized, it appears that: (1) A reasonable
number of ``healthy'' individual food products were available in the
marketplace from 1993 through 1999; (2) in many food categories there
has been an increase in the number of ``healthy'' products and brands;
and (3) many ``healthy'' individual foods, such as those with reference
amounts at the lower end of the scale or those that typically contain
limited amounts of sodium, would remain unaffected by the proposed
change to the second-tier sodium level for individual foods. Therefore,
with the possible exception of cheeses, the overall impact of
permitting the second-tier sodium level to take effect for individual
foods appears to be limited to minor reductions in the number of
``healthy'' products in some food categories.
Accordingly, the agency tentatively concludes that the second-tier
sodium level is the appropriate sodium requirement for the ``healthy''
definition for individual foods. The agency believes the second-tier
sodium level provides a meaningful definition of ``healthy'' that will
enable consumers to construct a diet that is consistent with current
dietary guidelines but is not so narrowly defined as to disqualify many
foods that are recommended to be in the diet (59 FR 24232 at 24240).
Therefore, the agency is proposing not to amend the second-tier
``healthy'' sodium level of 360 mg for individual foods in current
Sec. 101.65(d)(2)(ii)(C)(1) and (d)(2)(ii)(C)(2), and (d)(3)(ii)(C)(1)
and (d)(3)(ii)(C)(2). These paragraphs are being revised in format,
however, as discussed in section III. F of this document. The second-
tier sodium level for individual foods is to take effect at the end of
the stay period, January 1, 2006 (67 FR 30795).
The agency is requesting comments and information on the potential
impact of the second-tier sodium level on specific individual food
categories. In particular, FDA is seeking information on the range of
sodium content in food categories and the proportion of products that
contain sodium at or below the first- and second-tier levels of current
Sec. 101.65.
2. Dietary Supplements
Dietary supplements, like other individual foods, must meet all of
the requirements in Sec. 101.65(d)(2) to make ``healthy'' claims. FDA
has evaluated data for dietary supplements and tentatively concludes
that permitting the second-tier sodium level to go into effect is
unlikely to reduce the availability of ``healthy'' dietary supplements.
The agency assessed the prevalence of dietary supplement products that
contain salt or sodium and are labeled as ``healthy.'' The agency used
a database developed by Research Triangle Institute (RTI) (Ref. 8),
which includes detailed information on approximately 3,000 dietary
supplement
[[Page 8168]]
products collected between November 1999 and February 2000, including
information from labels of products purchased from retail
establishments and information taken from mail-order catalogs and
Internet sites. In selecting dietary supplement products, RTI used the
definition of ``dietary supplement'' from the Dietary Supplement Health
and Education Act of 1994 (Public Law 103-417), which includes, among
other things, vitamins, minerals, herbs and other botanicals, and amino
acids (section 201(ff) of the act (21 U.S.C. 321(ff))). RTI included
only information available to consumers at the point-of-sale.
The RTI sampling procedure was designed to include the maximum
number of different products and different ingredients, which led to a
relatively greater variety of products than would be representative of
consumer purchase patterns. In order to get as many products as
possible with different characteristics, RTI over-sampled health food
stores. This led to an over-sample of herbals and botanicals, which,
according to the database, are more likely to contain sodium. Thus, the
design of the survey (e.g., how the products were sampled) would be
likely to lead to an overestimate of the percentage of dietary
supplements that contain sodium.
FDA recognizes that the RTI database cannot be used to make
precise, quantitative estimates of dietary supplement characteristics;
nevertheless, in the absence of other available data, FDA used these
data to estimate the proportion of dietary supplement products that
might be affected by permitting the second-tier sodium requirements to
take effect for the term ``healthy.'' FDA found these data useful as
they allow for a conservative estimate of the impact of the proposed
rule on dietary supplement products, because it is likely that a
smaller proportion of products will be impacted than the proportion
calculated under this assessment. FDA requests comments on this
assessment of dietary supplement products that may contain sodium and
welcomes any additional available data concerning dietary supplements.
To estimate the proportion of dietary supplement products in this
dataset that contain sodium, FDA reviewed the ingredient information in
the RTI database, which includes information on the first 30
ingredients contained in the product. The agency searched for
ingredients containing either the term ``salt'' (sodium chloride), the
most common source of sodium in foods, or the term ``sodium'' (e.g.,
sodium benzoate). This process would not have identified ingredients
containing other sources of sodium (i.e., ingredients that include
sodium-containing components that do not include sodium in their name).
FDA identified 133 dietary supplement products in this dataset (4
percent) containing the terms ``sodium'' or ``salt'' in one or more of
the first 30 ingredients.
To estimate the proportion of dietary supplement products in this
dataset that may contain sodium and also bear a claim for ``healthy,''
FDA reviewed the database for brand names, product names, and claims on
the 133 dietary supplement products. The agency found 1 product with
the term ``health'' in the brand name, 1 product with the term
``health'' in the product name and also in the product claim, and 32
products with claims containing the terms ``health'' or ``healthy.''
Most of the claims on the products were structure/function claims under
21 CFR 101.93(f) (e.g., ``Helps promote bone health'') or health claims
under 21 CFR 101.14 (e.g., ``Enough calcium helps maintain good bone
health and reduce the risk of osteoporosis''); such claims would not be
considered ``healthy'' claims under Sec. 101.65(d). FDA did, however,
identify 11 products in this dataset (0.4 percent) bearing ``healthy''
claims under Sec. 101.65(d) either as part of the brand or product
name or as a separate claim on the product (Ref. 8). Since this dataset
over-sampled products that are more likely to contain sodium, it is
likely that less than one percent of dietary supplement products would
potentially be affected by requiring individual foods bearing the claim
``healthy'' to meet the proposed, second-tier sodium requirement.
In addition to the relatively small proportion of dietary
supplement products overall that contain sodium and bear ``healthy''
claims, judging from our sample of 11 products in this dataset, the
amount of sodium contained in these dietary supplement products is
probably quite limited for a variety of reasons. Since ingredients are
listed on product labels in descending order of predominance by weight
(21 CFR 101.4), the amount of sodium in dietary supplement products is
likely to be small because the sodium-containing ingredients tend to be
minor ingredients (Ref. 8). Furthermore, dietary supplement products
tend to have small serving sizes (e.g., pills, capsules, packets,
teaspoons).
In addition, only a small proportion of most sodium-containing
dietary supplement ingredients is actually sodium. For example, salt
(sodium chloride) is the ingredient with the highest proportion of
sodium, about 40 percent. The agency calculated the percentage of
sodium for the other sodium-containing ingredients about which the
agency had sufficient information, and these other ingredients contain
a significantly smaller proportion of sodium, varying from around 12 to
27 percent (Ref. 8). Thus, dietary supplements are likely to contain
limited amounts of sodium because the sodium-containing ingredients
themselves contain limited amounts of sodium.
An example may help to illustrate how the two factors discussed
work in tandem to limit the amount of sodium in dietary supplement
products. Only one of the 11 products bearing a healthy claim listed
salt as an ingredient. This product lists salt as the 14th ingredient
in order of predominance. Thus, the amount of sodium in that particular
dietary supplement product is likely to be small since it is only 40
percent of a very minor ingredient.
Also, unlike conventional food products that use salt to improve
taste, dietary supplement products are taken to supplement the diet and
are not generally consumed for their taste. Most dietary supplement
products are in pill, tablet, or capsule form (Ref. 8) and are
swallowed without chewing. Therefore, since taste is not a factor for
most of these products, manufacturers selecting ingredients for their
dietary supplement products can easily avoid sodium-containing
ingredients if they are trying to limit the sodium content in order to
make ``healthy'' claims.
Thus, given the foregoing information and observations based on the
RTI data sample, FDA does not anticipate that the sodium content of
dietary supplement products will have an impact on their ability to
qualify for ``healthy'' claims. Furthermore, the agency received no
comments to the ANPRM from dietary supplement manufacturers indicating
that dietary supplement products currently making ``healthy'' claims
would be affected. Thus, FDA does not believe that changing the sodium
content requirement for individual foods bearing ``healthy'' claims
will adversely affect dietary supplement manufacturers wishing to make
such claims. The agency requests comments on whether its assessment
regarding dietary supplement products is accurate and whether or not
the availability of dietary supplement products bearing a ``healthy''
claim would be adversely affected by this rulemaking. FDA requests
specific information on such products, including the numbers and types
of products affected, the current
[[Page 8169]]
level of sodium in the products, and the types of ``healthy'' claims
that are being made.
C. Meal and Main Dish Products
For purposes of this section, meal and main dish products, which
are defined separately in Sec. 101.13(l) and (m), will be considered
together. This is consistent with earlier treatment in the proposed
rule, the final rule, the partial stays, and the ANPRM.
To assess the status of meal and main dish products, the agency
separated the data on meal and main dish products from the data on
other products in the marketplace data analysis. When determining the
number of products and brands that fall within the meal and main dish
category, the agency included chili with meal or main dish products. In
performing this assessment, the agency considered three categories: (1)
Frozen meals and main dishes, (2) refrigerated and shelf-stable meals
and main dishes, and (3) chili. FDA identified 148 meal and main dish
products labeled ``healthy'' among 10 brands in the IRI analysis (Ref.
2). The 1997 FLAPS did not identify any meals or main dishes that used
a ``healthy'' claim but were not from a ``healthy'' brand (Ref. 4).
The petitioner stated that a number of ``healthy'' meal and main
dish products would ``disappear'' if the second-tier sodium levels were
to take effect for meal and main dish products. The petitioner further
indicated that it would not be able to produce many meal or main dish
products that meet the second-tier sodium level and that are palatable.
The petitioner also commented that some weight-control meal and main
dish products are substantially higher in sodium than the second-tier
level established for ``healthy'' meal and main dish products.
The petitioner provided the agency with data regarding how the
current first-tier sodium levels for the ``healthy'' definition aid the
consumer in achieving a diet that is consistent with dietary
guidelines. The data included a sample menu of an average adult's daily
consumption of ``healthy'' individual foods and meal and main dish
products at the current first-tier sodium levels (Ref. 9). The sample
menu demonstrated that an adult using ``healthy'' as a guidepost could
obtain a diet with a sodium level close to the recommended daily sodium
intake (Ref. 1).
In contrast, another comment supported permitting the second-tier
sodium level for ``healthy'' meal and main dish products to take effect
and claimed that the lower sodium level is attainable. However, that
comment did not come from a firm that produces ``healthy'' meal or main
dish products. In addition, the comment did not provide any basis for
concluding that a reasonable number of ``healthy'' meal and main dish
products would remain in the marketplace if the second-tier sodium
levels were to take effect for meal and main dish products.
Based on the marketplace data analysis, the agency found that there
were a limited number of ``healthy'' meal and main dish products that
met the current first-tier sodium level. The agency further found a
general decline in the number of meal and main dish products available
in 1999 compared to 1993 (Ref. 2).
The number of ``healthy'' frozen meals and main dishes decreased
from 177 products in 1993 to 119 products in 1999. During 1993 through
1999, 272 ``healthy'' frozen meal and main dish products were placed on
the market, with less than half surviving until 1999. Similarly, the
number of ``healthy'' frozen meal or main dish product brands has also
decreased. In 1993, there were nine ``healthy'' brands available, and
only six brands remained in 1999.
The number of ``healthy'' shelf-stable or refrigerated meal and
main dish products also has decreased, with 23 products available in
1993 and only 11 products in 1999 (Ref. 2). During 1993 through 1999,
33 ``healthy'' shelf-stable and refrigerated meals and main dish
products were introduced into the market, with only 30 percent of those
products surviving in 1999. The number of brands marketing a
``healthy'' shelf-stable or refrigerated meal or main dish product has
dropped slightly, with five brands available in 1993, and four brands
in 1999. Only ``healthy'' chili products have increased in number from
10 in 1993 to 18 in 1999, and from 1 to 2 brands in that same
timeframe.
Overall, the number of available meal and main dish products
(including frozen, shelf-stable, refrigerated, and chili products)
decreased by 30 percent, from 210 products in 1993 to 148 products in
1999 (Ref. 2). This appears to indicate that providing consumers with a
palatable ``healthy'' product at the current, first-tier sodium level
is difficult.
The limited number of ``healthy'' meal and main dish products
affects FDA's goal to provide a definition for ``healthy'' that permits
consumers access to a reasonable number of products that bear the
``healthy'' claim. If FDA were to allow the second-tier sodium level
for ``healthy'' meal and main dish products to take effect, there would
likely be an even greater reduction in the number of available
``healthy'' meal and main dish products in the marketplace.
Furthermore, some manufacturers of ``healthy'' meal and main dish
products might choose to limit only fat or calorie levels and change to
``lean,'' ``low calorie,'' or ``low fat'' claims. Although those claims
do provide some assistance to consumers who are trying to construct a
diet consistent with dietary guidelines, there are additional
nutritional benefits in products bearing a ``healthy'' claim.
``Healthy'' meal and main dish products, in addition to meeting the
sodium limit, also meet the definition of ``low'' for fat and saturated
fat; contain no more than 90 mg of cholesterol per serving size, and
contain at least 10 percent of the RDI or daily reference value per
serving size of two (for main dish products) or three (for meal
products) of the following nutrients: Vitamin A, vitamin C, calcium,
iron, protein, and fiber (Sec. 101.65(d)).
Moreover, FDA finds the petitioner's comment that a number of meal
and main dish products would ``disappear'' to be persuasive because the
petitioner is one of only a few manufacturers currently producing
``healthy'' meal and main dish products. The marketplace data analysis
for ``healthy'' meal and main dish products and brands showed that
there were a limited number of ``healthy'' meal and main dish
manufacturers, with one manufacturer producing most of the ``healthy''
meal and main dish products. In 1999, most of the meal and main dish
products available were frozen dinners and entr[eacute]es. There were
only 6 ``healthy'' brands of frozen meal and main dish products, and 5
of the brands comprised only 16 percent of the products available (Ref.
2). The remaining 84 percent of ``healthy'' meal and main dish products
were manufactured by the petitioner. Between 1993 and 1999, there were
10 brands marketed by firms other than the petitioner. Five brands that
were available for sale in 1993 had completely disappeared from the
market by 1999; two brands had significantly fewer products for sale;
two brands that were not available in 1993 offered only a few products
in 1999; and one brand had more products for sale in 1999 than in 1993.
The petitioner also had more ``healthy'' products for sale in 1999 than
in 1993. Considering the petitioner's expertise in the ``healthy''
frozen meal and main dish market, and the trends seen in the
marketplace, FDA believes that the petitioner raised valid concerns
about the second-tier sodium level for meal and main dish products.
Furthermore, the sodium content of the sample menu provided by the
[[Page 8170]]
petitioner in support of retaining the first-tier sodium levels is
close to the recommended daily sodium intake set forth in the dietary
guidelines (Ref. 9). FDA believes that minor adjustments, such as the
lower sodium level the agency is proposing for ``healthy'' individual
foods, would be sufficient to bring such a menu within dietary
guidelines.
The 1997 FLAPS data (Ref. 4) did not contain any additional
``healthy'' claims for meal and main dish products that were not
already identified in the marketplace data analysis. This further
supports the contention that there are a limited number of ``healthy''
meal and main dish products in the marketplace.
Meal and main dish products make a major contribution to the total
daily diet, and FDA believes that sodium requirements for these
products should reflect this contribution, while remaining consistent
with current dietary guidelines. For example, under Sec. 101.13(l), a
meal is defined as weighing at least 10 oz per labeled serving and
containing not less than three-40 g portions of food, or combinations
of foods, from two or more of the four food groups: (1) Bread, cereal,
rice, and pasta; (2) fruits and vegetables; (3) milk, yogurt, and
cheese; and (4) meat, poultry, fish, dry beans, eggs, and nuts. Under
the first-tier sodium requirement, a ``healthy'' meal must fall within
the 600 mg sodium level per serving size of not less than 10 oz (282
g), or approximately 2.1 mg sodium per g of food. A ``healthy'' main
dish, under Sec. 101.13(m), must contain not less than 40 g of food,
or combinations of foods, from each of at least two of the four food
groups, and must contain 600 mg or less sodium per serving size of 6 oz
(170 g), or approximately 3.5 mg sodium per g of food.
By contrast, the first-tier sodium level for ``healthy'' meal and
main dish products is more stringent than the sodium level of a meal
consisting of ``healthy'' individual foods at the second-tier sodium
level. For example, both fresh or frozen vegetables and cooked fish/
shellfish have reference amounts of 85 g (Sec. 101.12(b), table 2,
``Vegetables: All other vegetables without sauce: fresh, canned, or
frozen'' and ``Fish, Shellfish, Game Meats, and Meat or Poultry
Substitutes: Entrees without sauce, e.g., plain or fried fish and
shellfish, fish and shellfish cake''). Prepared fried potatoes have a
reference amount of 70 g (Sec. 101.12(b), table 2, ``Potatoes and
Sweet Potatoes/Yams: French fries, hash browns, skins, or pancakes'').
Under the second-tier sodium definition of ``healthy,'' individual
foods are limited to 360 mg sodium per reference amount and per serving
size. The sodium levels under these requirements would be approximately
4.2 mg sodium per g of fish or vegetables and approximately 5.1 mg
sodium per g of potato. These levels are more than 200 percent higher
than the sodium level that ``healthy'' meals are required to meet at
the first-tier sodium level (2.1 mg sodium per g of food) and 120
percent higher than the first-tier sodium level for ``healthy'' main
dish products (3.5 mg sodium per g of food). These examples demonstrate
that the first-tier sodium level for ``healthy'' meal and main dish
products is already more stringent than the second-tier sodium level
proposed for ``healthy'' individual foods typically included in such
meals and main dishes.
Furthermore, the first-tier sodium level proposed for ``healthy''
meal and main dish products is proportionate to and adequately reflects
their contribution to the total daily diet while remaining consistent
with current dietary guidelines. If each meal or main dish product has
a maximum of 600 mg sodium and if one meal or main dish product is
consumed at each of three meals during a typical day, then this
accounts for a total of 1,800 mg sodium from meal and main dish
products. This is consistent with previous agency assumptions that
daily food consumption patterns include three meals and a snack with
about 25 percent of the daily intake contributed by each (final rule on
nutrient content claims (58 FR 2302 at 2380, January 6, 1993)). The
1,800 mg sodium level is well below the suggested 2,400 mg
recommendation (Ref. 1) and allows for flexibility in the rest of the
daily diet (i.e., the snack).
A number of comments to the ANPRM addressed whether there is an
acceptable salt substitute that could be used to replace salt in meal
and main dish products. Most of those comments indicated that currently
it is not technologically feasible to manufacture a ``healthy'' meal or
main dish product that uses a salt substitute to help meet the second-
tier sodium level. Many flavor manufacturers stated that although they
have been working towards a flavor profile to replicate salt, an
acceptable salt substitute is not yet available. The comments stated
that some of the salt substitutes currently available are ammonium salt
and potassium chloride. The comments further stated that these are not
effective salt substitutes because they leave an off or bitter
aftertaste and require a masking of that aftertaste that is not always
successful. One flavor manufacturer asserted that it is not necessary
to change the sodium requirements for the definition of ``healthy''
because this manufacturer had created a salt substitute that is
acceptable for use in most processed foods. However, the petitioner
described working with that manufacturer and using that salt substitute
to try to reduce sodium in their products (e.g., frozen entr[eacute]es)
without success.
It appears that technological advances have not yet yielded an
acceptable salt substitute that would allow meal and main dish products
to meet the second-tier sodium level for the definition of ``healthy.''
Furthermore, the second-tier sodium levels have been stayed several
times to give manufacturers more time to develop alternatives. Because
of the apparent difficulty of producing an acceptable salt substitute,
FDA is no longer convinced that providing additional time will lead to
the development in the near future of a salt substitute that is
acceptable to manufacturers and palatable to consumers.
FDA tentatively concludes that the first-tier sodium level for meal
and main dish products allows a ``healthy'' definition that is neither
too strictly nor too broadly defined. The first-tier sodium level will
allow consumers to meet current dietary guidelines for sodium intake
while still maintaining flexibility in the diet. Additionally, the
agency believes that by retaining the first-tier sodium level, a
reasonable number of ``healthy'' meal and main dish products will
remain available to consumers. Therefore, the agency has tentatively
concluded that the current first-tier level of 600 mg sodium per
serving size should be retained as the sodium criterion for ``healthy''
meal and main dish products. Accordingly, the agency is proposing to
eliminate the second-tier sodium level of 480 mg for meal and main dish
products and to make the first-tier sodium level permanent for those
products.
D. Conclusion
FDA is proposing to permit the previously-established, second-tier
sodium level to take effect for ``healthy'' individual foods and to
retain the first-tier sodium level for ``healthy'' meal and main dish
products. FDA believes that this combination of actions is necessary to
provide for a reasonable number of ``healthy'' products in the
marketplace. The marketplace data analysis indicated that the number of
``healthy'' individual foods has been increasing while the number of
``healthy'' meal and main dish products has been decreasing.
[[Page 8171]]
Further, the first-tier sodium level for ``healthy'' meal and main
dish products provides a lower sodium intake than the amount that would
be consumed if a meal or main dish product consisted of ``healthy''
individual foods at the second-tier sodium level. The agency believes
that the proposed sodium requirements represent levels that are
achievable by manufacturers but sufficiently restrictive to provide
consumers with a meaningful definition of the term ``healthy'' that
will assist them in constructing a diet consistent with dietary
guidelines. Thus, FDA tentatively concludes that the second-tier sodium
level is appropriate for individual foods, and the first-tier sodium
level is appropriate for ``healthy'' meal and main dish products.
E. Clarification
To clarify the scope of implied nutrient content claims under Sec.
101.65(d), FDA is modifying Sec. 101.65(d)(1) to specify that a claim
that suggests that a food, because of its nutrient content, may be
useful in maintaining healthy dietary practices, is an implied nutrient
content claim if it is made in connection with either an explicit or
implied claim or statement about a nutrient. This change makes the
regulatory text consistent with the preamble discussions in both the
proposed and final rules (58 FR 2944 at 2945, January 6, 1993; 59 FR
24232 at 24235, May 10, 1994), where FDA made clear that claims made in
association with an implied claim or statement about a nutrient would
be covered by the regulation. Thus, the regulation now states that a
claim that suggests that a food, because of its nutrient content, may
help consumers maintain healthy dietary practices, is an implied
nutrient content claim if it is made in connection with an explicit or
implicit claim or statement about a nutrient.
F. Plain Language
By January 1, 1999, Federal agencies were to use plain language in
all proposed and final rulemaking documents published in the Federal
Register (Ref. 10). FDA is therefore proposing to revise the format in
Sec. 101.65(d) for all nutrient requirements for the term ``healthy.''
The codified language is currently in a text-based format. FDA is
proposing a summary table format. This new format should aid the reader
in comprehending and following these regulations.
Finally, FDA is proposing several minor changes in the wording of
Sec. 101.65(d) to make the regulation more concise and easier to
understand. These changes are not intended to affect the meaning of the
regulation.
IV. Environmental Impact
The agency tentatively concludes under 21 CFR 25.30(k) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
V. Analysis of Economic Impacts
A. Preliminary Regulatory Impact Analysis
FDA has examined the economic impacts of the proposed rule under
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, public 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 or adversely affecting in
a material way a sector of the economy, competition, or jobs. A
regulation is also considered a significant regulatory action if it
raises novel legal or policy issues. The Office of Management and
Budget has determined that this proposed rule is a significant
regulatory action under Executive Order 12866, although it is not
economically significant.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) requires that agencies prepare a written statement of
anticipated costs and benefits before proposing any rule that may
result in an expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100 million in any one
year (adjusted annually for inflation). This proposed rule is not
expected to result in any 1-year expenditure that would exceed $100
million, adjusted for inflation. The current inflation-adjusted
statutory threshold is $115 million.
1. The Need for Regulation
To bear the term ``healthy,'' products must not exceed established
levels for fat, saturated fat, cholesterol, and sodium. The existing
regulation states that meals and main dishes, as defined in Sec.
101.13(l) and (m) respectively, must have sodium levels no higher than
600 mg per serving size (usually the entire meal) in the first-tier
compliance period, and sodium levels no higher than 480 mg per serving
size in the second-tier compliance period, which was originally
scheduled to begin on January 1, 1998. The regulation also states that
``healthy'' foods other than meals and main dishes must have sodium
levels no higher than 480 mg per reference amount in the first-tier
compliance period, and sodium levels no higher than the second-tier 360
mg per serving size thereafter. The agency initially stayed the second-
tier sodium levels until January 1, 2000 (62 FR 15390, April 1, 1997).
FDA has since extended the stay twice: First until January 1, 2003 (64
FR 12886), and more recently until January 1, 2006 (67 FR 30795, May 8,
2002).
In December 1996, ConAgra petitioned FDA to eliminate the second-
tier, lower sodium levels. The petitioner claimed that these levels
were too difficult to meet, and therefore would force the removal from
the market of many products that were still healthy and contained less
sodium than their direct competitors.
This proposal modifies the definition of the term ``healthy'' in
only one respect: It makes the first-tier sodium level of 600 mg
permanent for meals and main dishes. ``Healthy'' individual foods still
would have to comply with the second-tier limit of 360 mg per serving
once that limit goes into effect.
2. Regulatory Options
FDA identified several options in the ANPRM: (1) Make no change to
the current rule, i.e. allow the second-tier sodium levels to go into
effect; (2) amend the definition of ``healthy'' as requested in the
petition, i.e. eliminate the second-tier sodium levels; (3) continue
the stay to give producers time to develop technological alternatives
to sodium; or (4) consider different second-tier sodium limits.
Analyzing probable technological change (option 3) is beyond the scope
of this analysis; innovation is very difficult to predict. FDA views
any technological change as mitigating the eventual cost of this rule,
but requests comments as to how to quantify this effect.
Also, analyzing alternative second-tier sodium limits in terms of
net benefits (option 4) is not feasible in this analysis. The optimum
sodium level for individual foods, meals, and main dishes balances the
health benefits of limiting sodium intake with the cost to industry and
of making food product preparation more complicated and the cost to
consumers of limiting product choice. In the analysis that follows, we
[[Page 8172]]
argue that the first-tier sodium level strikes that balance better than
the second-tier level for meals and main dishes, but that the second-
tier level strikes the balance better for individual foods. Other
sodium levels may perform well in this type of analysis, but FDA has no
way of differentiating health effects or manufacturing costs due to
marginal differences in the allowable sodium content of ``healthy''
food products.
Therefore, the options we consider for this analysis are option 1
(allow second-tier levels to take effect) and option 2 (eliminate
second-tier levels), split into separate categories for individual
foods (2a) and meals and main dishes (2b). The proposed rule would
adopt 2b, but not 2a.
1. Implement the current rule without modification, which would
make the second-tier sodium levels effective on January 1, 2006.
2a. Amend the current rule, adopting as permanent the first-tier
sodium level for all or specific ``healthy'' individual foods.
2b. Amend the current rule, adopting as permanent the first-tier
sodium level for ``healthy'' meals and main dishes.
2c. Amend the current rule, adopting as permanent the first-tier
sodium levels for ``healthy'' meals and main dishes and for all or
specific ``healthy'' individual foods.
The ``baseline'' in this case is the current rule or option 1, so
the benefits of the other options are the reformulation, rebranding,
and relabeling costs avoided by retaining the first-tier sodium content
requirements for individual foods or meals and main dishes. The cost of
the other options is the negative health impact due to a net increase
in sodium intake under options 2a, 2b, and 2c.
Option 2a: Retain the First-Tier Sodium Level for Individual
``Healthy'' Foods. FDA considers the current rule's second-tier sodium
level for ``healthy'' appropriate for individual foods. Although this
analysis does not quantify in detail the net benefit associated with
lower sodium levels in food, the costs associated with option 2a in all
likelihood outweigh the benefits. The agency does not have the
information necessary to calculate the effects on the market of the 870
foods that use a ``healthy'' claim, but FDA invites comments regarding
how to quantify the qualitative effects summarized here.
Benefits of Option 2a. The benefits are the reformulation,
rebranding, and relabeling costs avoided by manufacturers if they do
not have to modify their products to meet the second-tier sodium level
for individual foods. In the market analysis, FDA identified 870
individual food products among 69 brands that make a ``healthy'' claim
(Ref. 2). The FLAPS survey also identified several additional
individual foods that make a ``healthy'' claim but are not from a
``healthy'' brand (Ref. 4). However, according to the comments on the
ANPRM and subsequent analysis by FDA, only 3 of the over 80 food
product categories would have material trouble meeting the second-tier
``healthy'' sodium level: Soups, cheeses, and meats (primarily
frankfurters and ham). Of the three food product categories that FDA
tentatively concludes are impacted by this option, sodium levels for
``healthy'' meats are regulated by USDA and therefore are not part of
this analysis. Discussions on cheese and soup categories follow.
Other individual foods in other categories may have costs
associated with meeting the second-tier sodium level, but FDA has no
information concerning costs for those other individual foods. FDA
invites comments on the costs that may be incurred by other ``healthy''
individual foods, including dietary supplements, in meeting the second-
tier sodium level.
Cheese. Reformulating cheeses to meet the second-tier sodium level
would be difficult. However, FDA believes that, as of May 2001, every
``healthy'' cheese product had already been taken off the market. FDA
identified 32 ``healthy'' cheeses, under one brand, on the market in
1999 according to the marketplace data analysis (Ref. 2). In an
informal telephone inquiry, FDA confirmed that by May 2001, there were
no longer ``healthy'' cheeses produced under this brand (Ref. 5).
Having no products to analyze prevents FDA from performing a
detailed analysis of the potential impact of the second-tier sodium
level on cheese. ``Healthy'' cheeses could have been taken off the
market for several reasons. First, an aspect of the product unrelated
to sodium content (e.g. lower fat requirements) could have been
responsible for low product demand. If so, option 2a would not lead to
any societal benefits through influencing the market for cheese.
Second, firms may not be able to create an acceptable ``healthy''
cheese product even under the first-tier sodium level for individual
foods. This means that there would be no cost or benefit difference
between the first and second tiers of sodium content. Third, if
``healthy'' cheeses were taken off the market in anticipation of being
unable to comply with the second-tier sodium level, adopting option 2a
would probably encourage producers to re-introduce ``healthy'' cheese
products.
In this case, FDA believes it likely that sodium content was not
the primary factor in the decision to take ``healthy'' cheeses off the
market. Many light mozzarella cheeses currently have a sodium content
lower than second-tier sodium levels--between 167 and 357 mg per 50 g
serving in our examples from Washington, DC, area grocery stores (Ref.
5)--and the ``healthy'' version of this cheese was among the most
popular sellers among all ``healthy'' cheeses but was still pulled from
the market (Ref. 2).
Soups. Costs associated with the current rule, and therefore
benefits of avoiding these costs under option 2a, would be small for
soups. ``Healthy'' soups had about a 7 percent market share by sales in
1999, but a major producer of ``healthy'' soups supports the second-
tier sodium level; this is persuasive evidence that the private
benefits to producers of preserving ``healthy'' as a high-quality
health signal can be as valuable as the private cost of reformulation.
This producer states in its comments to the ANPRM that, for most major
varieties of its brand of ``healthy'' soup, it was able to achieve
taste parity under the second-tier sodium level. However, another major
soup producer does not support the second-tier level.
Costs of Option 2a. The principal costs of this option are all
associated with the deterioration of ``healthy'' as a signal of a truly
healthy individual food.
Based on the comments to the ANPRM, over 90 percent of ``healthy''
individual foods could meet the second-tier sodium limit without
material adverse changes in taste or texture. Cheeses and soups
represent a small percentage of all ``healthy'' individual foods.
Retaining the first-tier sodium level for all individual foods would
diminish the effectiveness of the ``healthy'' low sodium signal
substantially, compared to the current rule. Alternatively, if FDA
retained the first-tier ``healthy'' sodium level only for soups and
cheeses, FDA believes this inconsistency would also diminish the
usefulness of the term ``healthy'' as a low sodium signal.
In addition, the current and proposed rule's second-tier level for
individual foods is more consistent with the ``healthy'' definition for
meals and main dishes. As explained in detail in section III of this
document, the first-tier sodium level for combinations of ``healthy''
individual foods allows significantly more sodium than when those same
foods are combined into meals and main dishes. ``Healthy'' meal
[[Page 8173]]
and main dish products must contain at least two noncondiment food
groups, and still can only contain 600 mg sodium per meal or main dish
under the first-tier sodium level. In contrast, two ``healthy''
individual foods combined in exactly the same way could contain 720 mg
sodium under the stayed second-tier level, and up to 960 mg sodium
under option 2a, or 40 percent of the RDI. The current and proposed
rule's second-tier level for individual foods is fairly consistent with
the meal and main dish first-tier sodium level, but the first-tier
difference of up to 360 mg sodium between a meal and two individual
foods is substantial and could have a health effect if consumers are
using ``healthy'' specifically as a low sodium signal. FDA believes
this inconsistency in the labeling claim ``healthy'' could lead to
higher sodium intake, if the first-tier sodium level were to remain in
effect for individual foods.
FDA believes that the major cost of option 2a is the increased
health risk caused by higher sodium intake due to retaining the higher
first-tier sodium level for individual foods. FDA further believes that
the costs of this option outweigh the benefits of adopting as permanent
the first-tier sodium limit for all or particular individual foods.
Option 2b: Retain the First-Tier Sodium Level for Meals and Main
Dishes (the Proposed Rule).
Costs of Option 2b. The cost of this option, as in option 2a for
individual foods, is the increased health risk due to higher sodium
intake. However, FDA finds that adopting option 2b will not
significantly affect the average amount of sodium consumed in an
overall diet. The net increase in sodium intake under the proposed rule
is insubstantial even under the most favorable assumptions of the
effects of the current rule. Under some plausible scenarios, the
average amount of sodium consumed could remain the same or actually
increase if the current rule were implemented without amendment.
In the original analysis of the regulation defining the ``healthy''
claim, FDA referred to the many benefits of improved nutrition
labeling, including decreased rates of cancer, coronary heart disease,
obesity, hypertension, and allergic reactions to food. FDA also
considered ``healthy'' claims an important contributor to the $4.4
billion to $26.5 billion benefit of improved food labels over the 20
years following the rule (59 FR 24232 at 24247 and 24248). Several
comments on the 1997 ANPRM expressed concern that ``healthy'' claims at
the first-tier sodium level may undermine consumer attempts to improve
their diets and health, as these meals are not truly healthy. An
inaccurate ``healthy'' claim is not a useful signal that a product is
indeed healthy.
In order to get a rough estimate of the difference in sodium intake
between the current and proposed rule, we took a sample of 106 frozen
meals and main dishes from a Washington, DC area grocery store (Ref.
5). The agency believes this sample is reasonably representative of the
U.S. prepared dinner market, although it may not encompass all meal and
main dish choices available nationwide. We also tested these results
with a second Web-based sample (Ref. 5).
According to the Washington, DC grocery store sample, the current
market for meals and main dishes can be characterized as having three
segments. The first is the bargain segment, with two or three producers
that offer basic meals, usually priced from $1 to $1.50 lower than the
average product on the market. The second segment, or ``normal''
market, also has two or three major producers, with prices ranging from
slightly lower to the same as the health-positioned goods in the third
segment. Products in the second segment appear to compete mainly on
taste or price rather than health attributes, although such products
sometimes make health-related or dietary claims (e.g., ``low-fat'').
The third segment is the ``claims'' segment, which includes the
``healthy'' branded products, low-fat products, and more expensive
specialty dishes such as organic goods. Many of these products
prominently display fat and calorie information on the front of the
package; these brands clearly use nutritional content as a marketing
tool.
According to our analysis (Ref. 5), the ``healthy'' branded goods
have the lowest average sodium content among the ``claims'' brands and
the lowest average sodium content on the market. On average, they have
42 mg less sodium per meal than their next lowest competitor. Both the
``healthy'' branded goods and their main competitor that does not make
``healthy'' claims have average sodium levels under the first-tier
limit of 600 mg for meals and main dishes.
We explore several possible consumer and producer responses to
option 2b--retaining the first-tier sodium level for meals and main
dishes--as compared to option 1--allowing the second-tier sodium level
to go into effect--in the following scenarios. If FDA adopted option 1,
firms would respond to the imposition of the second-tier sodium level
for meals and main dishes in a strategic way. Among the ``healthy''
brands, producers would have the option of either reformulating their
products to meet the second-tier level, or relabeling their products
without the ``healthy'' claim or the ``healthy'' brand name. The
concern here is the consumer response to these actions. Reformulated
products may be less palatable or more expensive, leading to a loss of
market share. Rebranded (or relabeled) products would no longer carry
the ``healthy'' claim and therefore would not be subject to a sodium
limit. Indeed, several independent comments to the ANPRM expressed
concern that lowering the sodium requirement to the second-tier level
could encourage a consumer to switch to higher sodium alternatives.
The scenarios are summarized in table 1 of this document. The first
number in each cell is the average amount of sodium in mg and the
second number in parentheses is the market share for each brand. The
average sodium content amounts of 551 mg, 593 mg, 722 mg, and 856 mg
per meal are the result of analysis explained in a technical memo (Ref.
5). The ``healthy'' brand has slightly over 9 percent of the total
frozen dinner meal market when measured by sales volume, and the non-
``healthy'' brand 1 in the ``claims'' segment of the market has 10.5
percent. Nonfrozen meals and main dishes, including chili, are also
important in the overall market, but 99 percent of the sales of the
``healthy'' brand and 100 percent of the sales of ``claims'' brand 2
are in the frozen meal category. The ``other'' brands in table 1 of
this document represent the normal and bargain market segments
previously described. We assume that the three ``claims'' brands in
this analysis are a reasonable approximation to the ``claims'' market
segment as previously described in this document. Each of their shares
in the total market is divided by the sum of the shares of the three
brands in the total market, which makes their market shares in the
``claims'' segment of the market (.45 + .52 +.03) equal to 1.
[[Page 8174]]
Table 1.--Sodium Consumption Scenario Analysis for Sample 1 Meals and Main Dishes
----------------------------------------------------------------------------------------------------------------
Healthy Brand Claims Brand Claims Brand
Sodium mg 1 Sodium mg 2 Sodium mg Other Sodium
Scenario (Market (Market (Market mg (Market Average Sodium mg
Share) Share) Share) Share)
----------------------------------------------------------------------------------------------------------------
(1) Present market 551 (.45) 593 (.52) 722 (.03) 856 (0) 579
----------------------------------------------------------------------------------------------------------------
(2) Perfect 476 (.45) 593 (.52) 722 (.03) 856 (0) 544
reformulation
(option 1)
----------------------------------------------------------------------------------------------------------------
(3) Switch point, 476 (.45 - 593 (.52 + 722 (.03 + 856 (.047) 579
random share loss .142) .047) .047)
(option 1)
----------------------------------------------------------------------------------------------------------------
(4) Switch point, 476 (.45 - 593 (.52 + 722 (.03 + 856 (0) 579
equal share loss .193) .097) .097)
to claims
competitors
(option 1)
----------------------------------------------------------------------------------------------------------------
(5) Reformulation 600 (.45) 593 (.52) 722 (.03) 856 (0) 600
up (option 2b)
----------------------------------------------------------------------------------------------------------------
(6a) Combined 480 (.45 - 593 (.52 + 722 (.03 + 856 (0) 566
total response to .113) .056) .056)
option 1.
----------------------------------------------------------------------------------------------------------------
(6b) Combined 580 (.45 + 593 (.52 - 722 (.03 - 856 (0) 588
total response to .04) .02) .02)
option 2b.
----------------------------------------------------------------------------------------------------------------
(6) Total effect ---------- ---------- ---------- ---------- 22
(6b-6a)
----------------------------------------------------------------------------------------------------------------
Since option 1, or not amending the current rule, is the baseline
for exploring the effect of option 2b, the first five scenarios are
designed to demonstrate how different responses to the current rule
(option 1) and the proposed rule (option 2b) affect the average amount
of sodium consumed. Scenarios 6a and 6b combine the responses in the
previous scenarios in an attempt to capture the total effect of the
proposed rule. The last row, in the last column, is the total change in
sodium when comparing the proposed rule (6b) to the option 1 (6a)
(scenario 6--``total effect'').
Scenario 1: The Present Market. The first-tier sodium level applies
until 2006, but firms may be trying to prepare for the second-tier
sodium level, causing the average amount of sodium in the ``healthy''
brand to be lower than it would be under the proposed rule. The average
``claims'' segment meal, as reported in the last column of table 1 of
this document, contains 579 mg sodium, the average ``healthy'' brand
meal contains 551 mg sodium, and several ``healthy'' brand meals in
this sample are under the second-tier sodium level of 480 mg sodium.
Scenario 2: Perfect Reformulation. Under the very optimistic
perfect reformulation assumption, where the ``healthy'' manufacturer
could replicate every aspect of its product except the sodium level,
the sodium level of the average ``claims'' segment meal would decrease
to 544 mg (476*.45 + 593*.52 + 722*.03) under option 1. The difference
between this and the current market is 1.5 percent of the RDI of 2400
mg/day.
Scenario 3: Random Loss of Market Share. Some ``healthy'' brand
consumers may switch to other products if manufacturers of ``healthy''
products cannot perfectly reformulate their products. In this scenario,
the ``healthy'' brand loses market share to each of its competitors and
to the rest of the market (``other'' brands) in equal amounts. If the
loss of market share is small, sodium levels will still decline under
option 1. However, the average sodium level per meal and per main dish
would not change if the ``healthy'' product lost 32 percent of its
market (14 percent of the ``claims'' market) under these assumptions.
Scenario 4: Loss of Market Share to Claims Competitors. Consumers
are likely to switch from ``healthy'' products to other ``claims''
products. Since these alternatives have less sodium than the rest of
the frozen foods market, the amount of ``healthy'' business lost that
would still leave average sodium levels lower or unchanged would be
higher than in scenario 3 under option 1. If the ``healthy'' product
lost 43 percent of its market share (which is smaller than the 45
percent of their products one major producer of ``healthy'' products
stated the current rule would adversely affect) equally to both
``claims'' competitors, the average ``claims'' segment meal's sodium
content would be unchanged at 579 mg.
Scenario 5: Reformulation Up to First-Tier Limit. Here, we assume
that only the current belief that the second-tier restrictions will
become effective discourages the ``healthy'' product from increasing
the amount of sodium up to the first-tier limit. Therefore, under the
proposed rule, every ``healthy'' meal and main dish would contain 600
mg of sodium per meal. These meals and main dishes would no longer be
the low sodium products in the market, but they would still be the
second lowest sodium products among major producers, with ``claims''
brand 1 slightly lower. The average meal and main dish in the
``claims'' market would increase to 600 mg as well, which is 21 mg per
meal more than the current amount and 56 mg more than the total under
scenario 2, the most optimistic, perfect reformulation total.
Scenario 6: Total Effect. Scenario 6, which is scenario 6a
(combined total response to option 1) subtracted from scenario 6b
(combined total response to option 2b), represents the agency's
estimate of the total effects of option 2b, which would adopt as
permanent the first-tier sodium level for ``healthy'' meals and main
dishes. In scenarios 6a and 6b, we make behavioral assumptions for both
option 1 and option 2b.
Scenario 6a: Combined Total Response to Option 1. Of the
``healthy'' meals and main dishes in this sample, 75 percent are above
and 25 percent are below the second-tier sodium level of 480 mg. If the
second-tier sodium level were to take effect, we assume that the meals
and main dishes already below 480 mg (25 percent of the total) would
[[Page 8175]]
be reformulated up to 480 mg. Based on comments to the ANPRM, we assume
that 37.5 percent of all ``healthy'' meals and main dishes (one-half of
the 75 percent of ``healthy'' meals and main dishes currently above 480
mg) would be reformulated down to 480 mg of sodium without a loss of
taste. An additional 19 percent of all healthy meals and main dishes
(one-fourth of the 75 percent of ``healthy'' meals and main dishes
currently above 480 mg) would be reformulated even though the
reformulation would lead to some loss of taste. The remaining 19
percent of all healthy meals and main dishes (one-fourth of the 75
percent of ``healthy'' meals and main dishes currently above 480 mg)
would either have ``healthy'' removed from the label or cease being
produced.
The total response of producers to the second-tier level of 480 mg
would therefore be:
[sbull] Producers increase the sodium level to 480 mg for the 25
percent of ``healthy'' meals and main dishes that are currently below
480 mg of sodium.
[sbull] Producers reduce the sodium level to 480 mg for 56 percent
of ``healthy'' meals and main dishes (37.5 percent with no loss of
taste, 19 percent with some loss of taste).
[sbull] Producers either drop ``healthy'' from the label or cease
producing 19 percent of all ``healthy'' meals and main dishes.
In this scenario, consumers respond to the loss of taste and
disappearance of products by switching choices within the ``claims''
segment of the market, which includes ``healthy'' and similar meals and
main dishes. They switch with equal probability to any one of the three
brands in the ``claims'' segment, which means that one-third will
switch to another ``healthy'' product and two-thirds will switch to
non-``healthy'' products. The market share loss of the ``healthy''
brand is therefore 25 percent of its market, or two-thirds of the 37.5
percent of the market that experiences loss of taste, or disappearance
of products. This is 11.3 percent of the total ``claims'' market. The
average sodium intake implied by the market activity in this scenario
under option 1 is 566 mg per meal.
Scenario 6b: Combined Total Response to Option 2b. We assume that
producers will reformulate most, but not all, of the ``healthy''
products to the first-tier limit. We believe producers of ``healthy''
products will choose to position themselves as a slightly lower sodium
alternative in this market, as they are currently positioned, but
reformulate to increase sodium for taste reasons. Because of improved
taste, these producers increase their market share by 10 percent under
this scenario, so the average sodium intake under the proposed
amendment would be 588 mg per meal.
The difference between scenarios 6a and 6b is the best estimate of
the ``sodium cost'' of the proposed rule, which is only 22 mg per meal.
FDA's technical memo (Ref. 5) repeats the basic parts of this
analysis for a second sample of products pulled from the Web sites of a
producer of ``healthy'' products and a ``claims'' segment producer,
which we performed as a stress test of the first sample conclusions.
The result from this somewhat different sample of meal products is
quite close to the 22 mg ``sodium cost'' calculated in scenario 6 of
table 1 of this document.
According to our analysis, the sodium increase under option 2b, the
proposed rule, would be insubstantial. Almost all studies linking
sodium's influence on hypertension, coronary heart disease, and stroke
consider the effect of a change in sodium consumption two orders of
magnitude larger than these changes. A 100 mmol (2,300 mg) difference
per day is typical in both clinical and epidemiological studies; these
studies do not address the relative dose-response relationship of the
small sodium intake differences found in the scenarios. Even if the
effect were linear (i.e., even if the health risk associated with the
mg change per day in sodium due to this proposed rule were a simple
percentage of the 2,300 mg risk), the total statistical lives saved by
implementing the second-tier sodium level for meals and main dishes
would be less than 1 under the total effects calculation in table 1 of
this document and in the results of the second sample (Ref. 5).
However, FDA does not make this linear assumption. FDA believes that
the health effects from this low level of sodium increase are
negligible.
Benefits of Option 2b. The benefits of avoiding reformulation and
relabeling costs under this option are substantial. As discussed in
section III. C of this document, FDA identified 148 meal and main dish
products labeled ``healthy'' among 10 brands.
Producers would have to expend resources to reformulate their meals
to meet the second-tier sodium level. Lost market share due to product
reformulation would not be a net loss, but rather a transfer from one
company to another. Reformulation costs themselves are the lower limit
of the cost to society of the current rule. If producers could
reformulate perfectly, without altering any property other than sodium
content, then reformulation would be the total cost of the rule. But if
they could not replicate the desirable characteristics of their
product, consumers would also suffer the utility loss of a market with
fewer meal choices. This is a concern, since some dieticians recommend
``healthy'' claim products for their lower sodium content.
In the product samples used for the scenario analyses regarding the
cost of the second-tier sodium level on meals and main dishes, a
significant percentage (around 75 percent in the store-based sample and
50 percent in the Web site sample) of the major ``healthy'' producer's
products are above the second-tier sodium levels. If this is
representative of the market as a whole, then approximately 74 to 111
products would need to reduce their sodium to meet the second-tier
level. In estimating the total effects of the second-tier sodium level
on meals and main dishes, we assumed 56 percent reformulation, or 83 of
the 148 products on the market (see scenario 6a, in table 1 of this
document).
Preliminary testing costs incurred in the first stage of
reformulation--according to comments on the ANPRM received from a
frozen meal ``healthy'' brand producer that has begun investigating
possible reformulation--are well over $1 million, but we do not have
detailed reformulation cost estimates for meals and main dishes. The
following reformulation cost estimations are based on a detailed
example of tortilla chip reformulation, but the steps are typical of
food reformulation in general. FDA requests information on any
reformulation processes for the meal and main dish industry that are
different from those described here.
The reformulation process typically starts in a laboratory, where
researchers develop a new lower sodium formula for their meals. Then
the company investigates availability and price of new ingredients
(herbs, for example) and new equipment. If the reformulated meal passes
these obstacles, it moves to the test kitchen, where researchers
produce the product in small batches. If approved at this level, the
meal graduates to a pilot plant. Cooking the product in large runs at
the pilot plant may prove unsuccessful and require a manufacturer to
restart the reformulation process, incurring additional expense.
However, if pilot plant tests go well, full scale plant trials
commence.
For reformulation of a meal, FDA assumes 5,000 hours of
professional time at $30 per hour, $190,000 for development and pilot
plant operating expenses, and $100,000 for market
[[Page 8176]]
testing per product, based on this industry example. Since this
reformulation would be undertaken to keep an existing product, we
assume no relabeling or marketing costs. The total reformulation costs
are therefore $440,000 per product, or $36,520,000 for the 83 meals
assumed to be reformulated if adopting the second-tier sodium levels
for meals and main dishes under scenario 6a. This cost would be
incurred in the first year or two after the introduction of the rule.
Assuming 50 percent of the cost is incurred per year for 2 years, and
ignoring the time discount, the cost is $18,260,000 per year.
Regardless of the relative costs of reformulation, FDA believes
that a substantial number of market participants will choose to rebrand
or relabel their products out of the ``healthy'' category if it becomes
too restrictive. This has already happened under the current first-tier
level: The number of ``healthy'' meals and main dish products dropped
from 210 to 148 from 1993 through 1999, and the number of ``healthy''
brands dropped from 13 to 10. This time period spans the adoption of
the current definition of ``healthy'' in 1994.
In this case, the direct costs of relabeling the product and
conducting a marketing campaign would be social costs, since they
represent extra investment that will not increase or improve the choice
of products for consumers. Although FDA has no information about the
costs of this type of rebranding activity to the manufacturer, they are
most likely substantial.
However, the market may put a premium on ``healthy'' brands. This
premium is a good measure of what consumers are willing to pay for the
``healthy'' signal. Since consumers would presumably be paying less for
a less valuable product, the total effect of rebranding on consumer
utility is negative but limited. However, firms have made an investment
in the ``healthy'' brand based on an expected return closely related to
this ``willingness to pay'' premium, and this investment would now be
worthless if the product is unable to use the ``healthy'' claim. If the
new definition of ``healthy'' with the second-tier sodium level is no
more useful a health signal than the old definition, as we argue, this
lost investment is a cost to society. In the original analysis of the
regulation defining ``healthy'' (59 FR 24232 at 24247), which was
issued in 1994, FDA estimated that the average premium (measured as the
selling price difference) that the market placed on ``healthy'' brand
goods was $0.57 per 16 oz equivalent. FDA used the Washington, DC store
sample of 106 meals and main dishes referred to earlier to reestimate
this premium for 2000, with similar results.
According to the analysis in FDA's technical memorandum (Ref. 5),
the ``healthy'' brand competitor has a significant $0.32 premium over
the other major health positioned producer in this market, and at least
as high a premium over the other major claims producer. Excluding the
specialty organic products, the ``healthy'' brand is the highest priced
product on the market in our sample. FDA believes $0.32 to be a
reasonable estimate of the market premium for the ``healthy'' brand. At
average serving sizes of 10 oz, this translates into a $0.51 premium
per 16 oz, which is very close to the $0.57 premium estimated in 1994.
In the 1994 analysis, the total value of each brand was based on
this premium and average sales volumes. Sales of the brands still in
the market were approximately 1.3 million units per product in 1999
(Ref. 2). Under the assumption of 19 percent rebranding in order for
meals and main dishes to comply with the second-tier sodium level
(scenario 6a), 28 products would be changed, with a total lost premium
of $11,648,000 per year (28 products x $0.32 premium lost x average
sales of 1.3 million units per year).
Adding this to the reformulation costs of the 83 products yields a
total cost estimate of $29,908,000 for years one and two, and a
residual of the lost premium of $11,648,000 for what would have been
the rest of the normal life cycle of the lost ``healthy'' brand.
Clearly, these costs are very large for a rule which would lead to
little or no health benefit for the population, and avoiding these
costs represents a large benefit of option 2b, the proposed rule.
Option 2c: Retain the First-Tier Sodium Levels for ``Healthy''
Meals and Main Dishes and Individual ``healthy'' Foods. The benefits
and costs of option 2c are very close to the sum of the benefits and
costs associated with options 2a and 2b. However, as stated in the
discussion of option 2a previously in this document, retaining the
first tier sodium levels for ``healthy'' individual foods would
significantly decrease the consistency between sodium levels in
``healthy'' meals and main dishes and the sodium levels in meals put
together by combining ``healthy'' individual foods. The less consistent
the sodium levels in ``healthy'' meals and individual foods, the less
consistent, and therefore less useful, is the low sodium signal
conveyed by the ``healthy'' label.
Costs of Option 2c. The cost of this proposed amendment, as with
option 2a for individual foods, and option 2b for meals and main
dishes, is the increased risk due to higher sodium intake and the
diminishing effectiveness of the ``healthy'' low sodium signal. Since
option 2c is essentially combining options 2a and 2b, the costs
associated with a higher sodium intake are roughly the sum of the costs
associated with options 2a and 2b.
As discussed previously in detail in this document, the average
increased sodium intake occurring under option 2b is insubstantial
(roughly 22 mg per meal) and the health effects from this low level of
sodium increase are negligible. As stated previously, even under the
conservative assumption of a linear dose response, the statistical
lives saved by decreasing allowable sodium in ``healthy'' meals and
main dishes to tier-2 levels would be less than 1. Furthermore, the
effectiveness of the ``healthy'' low sodium signal would not be
diminished since tier-1 levels of sodium for meals and main dishes
allow for even less sodium than would appear in a meal composed of
tier-2 individual ``healthy'' ingredients.
However, the potential increase in sodium intake, as discussed in
detail under option 2a, due to relaxing the current level of sodium
allowable in individual ``healthy'' foods, as well as the costs
associated with the deterioration of the ``healthy'' signal, is
significant.
Therefore, FDA believes the costs of option 2c, due to the reduced
effectiveness of the ``healthy'' low sodium signal and the health risks
due to increased sodium intake are significant, but only negligibly
higher than those costs described for option 2a.
Benefits of Option 2c. The benefits of avoiding reformulation,
rebranding, and relabeling costs under this option are roughly the sum
of the benefits associated with options 2a and 2b.
FDA estimates, as discussed in the benefits section of option 2a,
that the benefits of avoiding reformulation and relabeling costs
associated by retaining the first-tier sodium levels for individual
``healthy'' foods are small.
As discussed in the benefits section of option 2b, the benefits of
avoiding reformulation, rebranding, and relabeling costs by retaining
first-tier sodium levels for ``healthy'' meals and main dishes are
substantial. FDA estimates the total cost of reformulation and
relabeling avoided in option 2b is $29,908,000 for years one and two,
and $11,648,000 per year thereafter.
[[Page 8177]]
Therefore, FDA believes the benefits of option 2c, due to the
avoided reformulation and relabeling costs associated with implementing
the tier-2 sodium levels for both ``healthy'' meal and main dishes and
``healthy'' individual foods, are substantial but only slightly higher
than those benefits described for option 2b.
Net Benefits of Option 2c. The net benefits of option 2c, retaining
the first-tier level of sodium for both ``healthy'' meals and main
dishes and individual ``healthy'' foods, are roughly the sum of the net
benefits of options 2a and 2b.
The net benefits of option 2a, retaining the first-tier level of
sodium for individual ``healthy'' foods are negative. The costs due to
the health risk associated with increased sodium intake and the lost
consistency and meaning of the ``healthy'' low sodium signal outweigh
the benefits due to avoided reformulation, rebranding, and relabeling
costs.
The net benefits of option 2b, retaining the first-tier level of
sodium for ``healthy'' meals and main dishes are positive. The benefits
in avoided reformulation, rebranding and relabeling costs substantially
outweigh the negligible costs due to a very small potential increase in
average daily sodium intake.
Since the net benefits of retaining the first-tier sodium level for
``healthy'' meals and main dishes are so substantial, FDA believes the
net benefits of 2c, roughly the sum of the net benefits associated with
2a and 2b, are positive, but lower than the net benefits of the
proposed rule, which would adopt as permanent the first-tier sodium
limits for meals and main dishes only.
3. Net Benefits of the Proposed Rule
This analysis attempts to take limited data to illustrate in some
detail what would actually take place in the market under the proposed
rule. First, the costs to the ``healthy'' signal's meaning and
consistency outweigh the benefits of retaining the first-tier sodium
level for individual foods. However, the meal and main dish analysis
shows that while the benefits of retaining the first-tier sodium level
(the costs foregone) are substantial for companies that would need to
reformulate to comply with the second-tier sodium level or rebrand and
relabel themselves out of the ``healthy'' market, the health costs
associated with retaining the first-tier sodium level are both
unquantifiable and most likely quite insubstantial or nonexistent.
Therefore, the net benefits of the proposed rule, which would allow the
second-tier sodium level to go into effect for individual foods but
would adopt as permanent the first-tier sodium level for meals and main
dishes, are positive.
B. Small Entity Analysis
FDA has examined the economic implications of this proposed 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 minimize the economic effect of the rule
on small entities. FDA finds that this proposed rule would not have a
significant economic impact on a substantial number of small entities.
This proposed rule would make permanent the less restrictive fist-
tier sodium level that meals and main dishes must meet to make a
``healthy'' claim. Without this proposed rule, the more restrictive
second-tier sodium level would raise the costs of making a ``healthy''
claim on such products. If a small business were to market a
``healthy'' meal or main dish, it would be able to do so at lower cost
under the proposed rule than if FDA left the current rule unmodified.
This proposed rule does not modify the current rule for the sodium
content of ``healthy'' individual foods, under which the second-tier
sodium level for those foods will take effect in 2006. Although the
proposed rule does not impose a cost on small businesses over and above
the rule that would otherwise be in place, FDA could lower the cost to
small businesses of making a ``healthy'' claim by adopting as permanent
the first-tier sodium level for individual foods.
As stated in the preliminary regulatory impact analysis discussed
earlier, manufacturers of ``healthy'' foods in three categories--
cheeses, soups, and some meats--are likely to be affected by the
implementation of the second-tier sodium level. These foods are
discussed in this document. As FDA has no information concerning costs
for other individual foods and has received no comments indicating that
manufacturers of these other foods would have difficulty meeting the
second-tier sodium level, the agency tentatively concludes that the
impact on small entities producing other types of ``healthy''
individual foods is not significant. FDA invites comments regarding
small entities producing other ``healthy'' individual foods that may be
adversely impacted by this proposed rule.
Of the affected individual food categories, meat is regulated by
the USDA and is not part of this analysis. The Small Business
Administration (SBA) considers a cheese manufacturer small if it
employs 500 or fewer workers, but no small or large business currently
produces ``healthy'' cheese. The SBA considers a miscellaneous food
manufacturer (neither SBA nor the Census Bureau specifically tracks
soup producers) small if it employs 500 or fewer employees. According
to the 1999 survey of foods used for this analysis, six companies
produce ``healthy'' soups (Ref. 2), but none of these companies
qualifies as a small business according to the standard SBA criteria.
According to the 1999 Statistics for Businesses from the United States
Census Bureau, over 90 percent of food manufacturers are small by the
standard SBA criteria, so new entries into this industry in the future
are likely to be small businesses. FDA tentatively concludes that this
proposed rule will not have a significant impact on small entities.
VI. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
VII. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has tentatively
determined that the rule does not contain policies that have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Accordingly, the agency has tentatively concluded that the rule does
not contain policies that have federalism implications as defined in
the Executive order and, consequently, a federalism summary impact
statement is not required.
VIII. Comments
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES), written or electronic comments regarding this document.
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two hard copies of any written comments, except
that individuals may submit one hard copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 8178]]
IX. References
The following references have been placed on display in the Dockets
Management Branch (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. U.S. Department of Agriculture and Department of Health and
Human Services, ``Dietary Guidelines for Americans,'' 5th ed., U.S.
Government Printing Office, Washington, DC, 2000.
2. Anderson, Ellen M., memorandum to file, September 3, 2002.
3. Kim, Heili, memorandum to file, July 16, 2001.
4. Anderson, Ellen M. and Heili Kim, memorandum to file, August
30, 2001.
5. Mancini, Dominic, memorandum to file, May 23, 2002.
6. Cheese: Chemistry, Physics and Microbiology, edited by P.F.
Fox Chapman & Hall, 2d ed.
7. Kim, Heili, memorandum to file, May 15, 2001.
8. Anderson, Ellen M., memorandum to file, August 19, 2002.
9. Kim, Heili, memorandum to file, May 15, 2001.
10. National Partnership for Reinventing Government, Plain
Language Action Network, Presidential Memorandum on Plain Language
(www.plainlanguage.gov/cites/memo.htm).
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
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; 42 U.S.C. 243, 264, 271.
2. Section 101.65 is amended by revising paragraph (d) to read as
follows:
Sec. 101.65 Implied nutrient content claims and related label
statements.
* * * * *
(d) General nutritional claims. (1) This paragraph covers labeling
claims that are implied nutrient content claims because they:
(i) Suggest that a food because of its nutrient content may help
consumers maintain healthy dietary practices; and
(ii) Are made in connection with an explicit or implicit claim or
statement about a nutrient (e.g., ``healthy, contains 3 grams of
fat'').
(2) You may use the term ``healthy'' or related terms (e.g.,
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as
an implied nutrient content claim on the label or in labeling of a food
that is useful in creating a diet that is consistent with dietary
recommendations if:
(i) The food meets the following conditions for fat, saturated fat,
cholesterol, and other nutrients:
------------------------------------------------------------------------
The The
If the food The fat saturated fat cholesterol The food
is... level must level must level must must
be... be... be... contain...
------------------------------------------------------------------------
(A) A raw Low fat as Low saturated The N/A
fruit or defined in fat as disclosure
vegetable Sec. defined in level for
101.62(b)(2) Sec. cholesterol
101.62(c)(2) specified in
Sec.
101.13(h) or
less
------------------------------------------------------------------------
(B) A single- Low fat as Low saturated The N/A
ingredient defined in fat as disclosure
or a mixture Sec. defined in level for
of frozen or 101.62(b)(2) Sec. cholesterol
canned 101.62(c)(2) specified in
fruits and Sec.
vegetables 101.13(h) or
less
------------------------------------------------------------------------
(C) An Low fat as Low saturated The N/A
enriched defined in fat as disclosure
cereal-grain Sec. defined in level for
product 101.62(b)(2) Sec. cholesterol
101.62(c)(2) specified in
Sec.
101.13(h) or
less
------------------------------------------------------------------------
(D) A raw, Less than 5 Less than 2 g Less than 95 At least 10
single- grams (g) saturated milligrams percent of
ingredient fat per fat per RA (mg) the RDI\2\
seafood or RA\1\ and and per 100 cholesterol or the
game meat per 100 g g per RA and DRV\3\ per
per 100 g RA of one
or more of
vitamin A,
vitamin C,
calcium,
iron,
protein, or
fiber
------------------------------------------------------------------------
(E) A meal Low fat as Low saturated 90 mg or less At least 10
product as defined in fat as cholesterol percent of
defined in Sec. defined in per SS\4\ the RDI or
Sec. 101.62(b)(3) Sec. the DRV per
101.13(l) or 101.62(c) SS of two
a main dish nutrients
product as (for a main
defined in dish) or of
Sec. three
101.13(m) nutrients
(for a
meal) of
the
following
six
nutrients--
vitamin A,
vitamin C,
calcium,
iron,
protein, or
fiber
------------------------------------------------------------------------
(F) A food Low fat as Low saturated The At least 10
not defined in fat as disclosure percent of
specifically Sec. defined in level for the RDI or
listed in 101.62(b)(2) Sec. cholesterol the DRV per
this 101.62(c) specified in RA of one
document Sec. or more of
101.13(h) or vitamin A,
less vitamin C,
calcium,
iron,
protein, or
fiber
------------------------------------------------------------------------
\1\ RA means Reference Amount Customarily Consumed per Eating Occasion
(Sec. 101.12(b)).
\2\ RDI means Reference Daily Intake (Sec. 101.9(c)(8)(iv)).
\3\ DRV means Daily Reference Value (Sec. 101.9(c)(9)).
\4\ SS means Serving Size Listed on the Label (Sec. 101.9(b)), also
referred to as Labeled Serving Size.
[[Page 8179]]
(ii) The food meets the following conditions for sodium:
------------------------------------------------------------------------
If the food is... The sodium level must be..
------------------------------------------------------------------------
(A) A food with a RA\1\ that is 360 mg or less sodium per RA and
greater than 30 g or 2 tablespoons per SS\2\
(tbsp)
------------------------------------------------------------------------
(B) A food with a RA that is equal 360 mg or less sodium per 50 g\3\
to or less than 30 g or 2 tbsp
------------------------------------------------------------------------
(C) A meal product as defined in 600 mg or less sodium per SS
Sec. 101.13(l) or a main dish
product as defined in Sec.
101.13(m)
------------------------------------------------------------------------
\1\ RA means Reference Amount Customarily Consumed per Eating Occasion
(Sec. 101.12(b)).
\2\ SS means Serving Size Listed on the Label (Sec. 101.9(b)), also
referred to as Labeled Serving Size.
\3\ For dehydrated food that is typically reconstituted with water or a
liquid that contains insignificant amounts per RA of all nutrients (as
defined in Sec. 101.9(f)(1)), the 50 g refers to the ``prepared''
form of the product.
(iii) The food complies with the definition and declaration
requirements in part 101 of this chapter for any specific nutrient
content claim used in labeling the food;
(iv) For foods in paragraph (d)(2)(i)(B) of this section, you may
add ingredients that do not change the nutrient profile;
(v) Enriched cereal-grain products in paragraph (d)(2)(i)(C) of
this section must conform to a standard of identity in part 136, 137,
or 139 of this chapter; and
(vi) If you add a nutrient to the foods in paragraph (d)(2)(i)(D),
(d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 10 percent
requirement, that addition must be consistent with the fortification
policy for foods in Sec. 104.20 of this chapter.
Dated: February 13, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4100 Filed 2-19-03; 8:45 am]
BILLING CODE 4160-01-S