[Federal Register Volume 67, Number 221 (Friday, November 15, 2002)]
[Proposed Rules]
[Pages 69171-69172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29096]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 94P-0036]
RIN 0910-AB66
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient
Content Claims, and Health Claims; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening to
December 16, 2002, the comment period for a proposed rule published in
the Federal Register of November 17, 1999 (64 FR 62746), in which FDA
proposed to amend its regulations on nutrition labeling to include the
amount of trans fatty acids present in a food in the amount and percent
Daily Value declared for saturated fatty acids. Since publication of
the proposed rule, the National Academy of Sciences issued a report
entitled ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber,
Fat, Fatty Acids, Cholesterol, Protein and Amino Acids'' that did not
provide a dietary reference intake value for trans fat. In response to
this report, FDA intends to take a more incremental approach and
provide for mandatory declaration of trans fat content on a separate
line within the Nutrition Facts panel. FDA is reopening the comment
period to receive comment on a footnote statement that it is proposing
be required on the label when trans fat is listed. Lastly, FDA is
outlining conditions for when it would consider exercising enforcement
discretion for manufacturers who wish to begin labeling the trans fat
content of food products prior to publication of a final rule.
DATES: Submit written or electronic comments on the proposed footnote
by December 16, 2002.
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: Joyce Saltsman, Center for Food Safety
and Applied Nutrition (HFS-306), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1641.
SUPPLEMENTARY INFORMATION:
I. Reopening of Comment Period
In the Federal Register of November 17, 1999 (64 FR 62746) (the
November 1999 proposal), FDA (we) proposed to amend our regulations on
nutrition labeling to require that the amount of trans fatty acids
(trans fats) present in a food, including dietary supplements, be
included in the amount and percent of Daily Value (% DV) declared for
saturated fatty acids. We also proposed that, wherever saturated fat
limits are placed on nutrient content claims, health claims, or
disclosure or disqualifying levels, the amount of trans fatty acids be
limited as well. Finally, we proposed to define the nutrient content
claim ``trans fat free.'' In that document, we requested comments on
the proposal by February 15, 2000. In the Federal Register of February
16, 2000 (65 FR 7806), we reopened the comment period to April 17,
2000, in response to requests for more time to submit comments. In the
Federal Register of December 5, 2000 (65 FR 75887), we again reopened
the comment period to January 19, 2001, in response to comments
regarding nutrient content claims.
Subsequent to FDA's November 1999 proposal, the Institute of
Medicine of the National Academy of Sciences (IOM/NAS) issued a report
entitled ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber,
Fat, Fatty Acids, Cholesterol, Protein and Amino Acids'' (the IOM/NAS
macronutrient report) and found ``a positive linear trend'' between
trans fatty acid intake and total and low density lipoprotein-
cholesterol (LDL-C) concentration, and therefore increased risk of
coronary heart disease (Ref. 1).
The report summarized that the scientific evidence would suggest a
tolerable upper intake level (UL) of zero, but because trans fats are
unavoidable in ordinary diets and achieving such a UL would require
extraordinary changes in dietary intake patterns that might introduce
other undesirable effects and unknown health risks, a UL was not
proposed. Instead, the report recommended ``that trans fat consumption
be as low as possible while consuming a nutritionally adequate diet.''
Likewise, the conclusions in the Dietary Guidelines for Americans, 2000
(Ref. 2) and recent guidelines from the National Cholesterol Education
Program (NCEP) (Ref. 3) are similar with recommendations to limit trans
fat intake in the diet.
The IOM/NAS report (Ref. 1) underscores the relationship between
the intake of trans fat and the increased risk for heart disease and
emphasizes that consumers need to limit trans fat in their diets. FDA
recognizes that, to accomplish this, information on the trans fat
content of foods needs to be available on food labels. But the IOM/NAS
report did not provide a dietary reference intake (DRI) value for trans
fat or information that the agency believes is sufficient to support
its establishing a daily reference value (DRV) to assist the agency in
providing other information on the label, such as a % DV for trans fat.
Comments to the November 1999 proposal stressed the importance of
helping consumers understand the relevance of the quantitative amount
of trans fat in relation to recommended dietary intake patterns. In
addition, Section 2(b) of the Nutrition Labeling and Education Act of
1990 (the 1990 amendments) (Public Law 101-535) states that the
Secretary of Health and Human Services, and by delegation FDA, shall
require the declaration of nutrients ``be conveyed to the public in a
manner which enables the public to readily observe and comprehend such
information and to understand its relative significance in the context
of a total daily diet.'' The % DV has been added to nutrition labeling
for most nutrients to achieve this purpose. However, we do not have a
basis on which to establish a DV for trans fat at this time. Therefore,
in light of the public health recommendations to reduce trans fat
intake in the American diet, FDA is proposing to require an asterisk
(or other symbol) in the % DV column for trans fat when it is listed,
that is tied to a similar symbol at the bottom of the Nutrition Facts
box and
[[Page 69172]]
that is followed by the statement ``Intake of trans fat should be as
low as possible.'' In the absence of a % DV for trans fat, the footnote
statement will provide guidance to consumers when using the
quantitative information to help maintain healthy dietary practices.
This statement is taken from the IOM/NAS macronutrient report and is
consistent with the dietary guidance in the other recent scientific
reports referenced in this document.
For interested parties who would like to submit comments on the
proposed use of the footnote statement ``Intake of trans fat should be
as low as possible,'' we are reopening the comment period of the
November 1999 proposal for a period of 30 days. Comments submitted
during this period are to be limited to those that directly address the
proposed use of the footnote. We are not requesting comments on any
other issue, and we do not intend to consider such comments if
submitted.
Following receipt of comments on this document, FDA intends to
publish in early 2003 a final rule requiring mandatory declaration of
trans fat content within the Nutrition Facts panel under the
declaration for saturated fat, similar to the declarations of mono- and
polyunsaturated fats. In response to interest expressed by
manufacturers and trade associations to begin labeling the trans fat
content of food products prior to publication of the final rule, we
will consider the exercise of our enforcement discretion for such
labeling as long as the footnote statement is also included in the
Nutrition Facts panel. The agency cautions manufacturers that a final
rule on this issue may differ from this proposal and that manufacturers
would then be required to change their labels to conform to the final
rule.
II. How to Submit Comments
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments. Two copies of any mailed
comments are to be submitted, except that individuals may submit one
copy. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Identify all comments with the docket number found in
brackets in the heading of this document. You may review received
comments in the Dockets Management Branch office between 9 a.m. and 4
p.m., Monday through Friday.
III. 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. FDA has verified the
following three Web site addresses, but is not responsible for
subsequent changes to the Web sites after this document publishes in
the Federal Register.
1. IOM/NAS, ``Dietary Reference Intakes for Energy,
Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and
Amino Acids,'' chapter 8, National Academy Press, Washington, DC,
pp. 335-432, 2002 (Internet address: http://www.nap.edu/books/0309085373/html/).
2. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, Nutrition and Your Health: Dietary Guidelines
for Americans, 5th ed. Washington, DC; Home and Garden Bulletin No.
232, pp. 27-31, 2000 (Internet address: http://www.usda.gov/cnpp/Pubs/DG2000/Index.htm).
3. Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults, Third Report of the National
Cholesterol Education Program (NCEP) Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult
Treatment Panel III), Chapter II. ``Rationale for Intervention'' and
Chapter V ``Adopting Healthful Lifestyle Habits to Lower LDL
Cholesterol and Reduce CHD Risk,'' 2001 (Internet address: http://www.nhlbi.nih.gov/guidelines/cholesterol/index.htm).
Dated: November 8, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-29096 Filed 11-12-02; 3:33 pm]
BILLING CODE 4160-01-S