[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