[Federal Register: March 1, 2004 (Volume 69, Number 40)]
[Proposed Rules]               
[Page 9559-9560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01mr04-16]                         

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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[[Page 9559]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2003N-0076]

 
Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer 
Research to Consider Nutrient Content and Health Claims and Possible 
Footnote or Disclosure Statements; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advanced notice of proposed rulemaking, reopening of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 45 
days the comment period for an advanced notice of proposed rule making 
(ANPRM) published in the Federal Register of July 11, 2003 (68 FR 
41507), in which FDA is requesting information and data that 
potentially could be used to establish new nutrient content claims 
about trans fatty acids (trans fat); to establish qualifying criteria 
for trans fat in current nutrient content claims for saturated fatty 
acids and cholesterol, lean and extra lean claims, and health claims 
that contain a message about cholesterol-raising lipids; and, in 
addition, to establish disclosure and disqualifying criteria to help 
consumers make heart-healthy food choices. Since publication of the 
ANPRM on July 11, 2003, the Institute of Medicine of the National 
Academy of Science (IOM/NAS) issued a report entitled ``Dietary 
Reference Intakes: Guiding Principles for Nutrition Labeling and 
Fortification.'' FDA is reopening the comment period to receive 
comments that consider the information in the IOM/NAS report specific 
to this ANPRM and trans fat labeling. Information and data obtained 
from comments to this ANPRM may be used to help draft a proposed rule 
on trans fat.

DATES: Submit written or electronic comments by April 15, 2004.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.


FOR FURTHER INFORMATION CONTACT: Julie Schrimpf, Center for Food Safety 
and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450, FAX: 
301-436-2636.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 11, 2003 (68 FR 41507), FDA issued 
an ANPRM to solicit information and data that potentially could be used 
to establish new nutrient content claims about trans fatty acids (trans 
fat); to establish qualifying criteria for trans fat in current 
nutrient content claims for saturated fatty acids (saturated fat) and 
cholesterol, lean and extra lean claims, and health claims that contain 
a message about cholesterol-raising lipids; and, in addition, to 
establish disclosure and disqualifying criteria to help consumers make 
heart-healthy food choices. We (FDA) also requested comments on whether 
we should consider statements about trans fat, either alone or in 
combination with saturated fat and cholesterol, as a footnote in the 
nutrition facts panel or as a disclosure statement in conjunction with 
claims to enhance consumers understanding about such cholesterol-
raising lipids and how to use the information to make healthy food 
choices. The comment period was open until October 9, 2003.
    Since the end of the previous comment period, the IOM/NAS issued a 
report entitled ``Dietary Reference Intakes: Guiding Principles for 
Nutrition Labeling and Fortification'' (the 2003 report) in which the 
overarching goal is to have updated nutrition labeling that consumers 
can use to make informed dietary choices (Ref. 1). In response to 
requests received in this docket, we are reopening the comment period 
to allow interested persons the opportunity to consider the 2003 report 
and its discussion specific to trans fat labeling in comments submitted 
on the ANPRM. The IOM/NAS's dietary reference intake (DRI) 2002 report 
on macronutrients (Ref. 2) did not establish an estimated average 
requirement (EAR), an adequate intake (AI), or an acceptable 
macronutrient distribution range (AMDR) for trans fat because the 
presence in the diet meets no known nutritional need, hence there are 
no DRI values that can be readily used as the basis for a trans fat 
daily value (DV). Therefore, to establish a DV for trans fat, the 2003 
report suggests the use of food composition data, menu modeling, and 
data from dietary surveys to estimate minimum intakes consistent with 
nutritionally adequate and health-promoting diets for diverse 
populations. It specifically suggests estimating minimal trans fat 
intake levels via menu modeling and then further evaluating them 
against achievable health-promoting diets (identified in dietary survey 
data) in order to arrive at appropriate recommendations for the intake 
of trans fat. We are requesting comment on the approach recommended in 
the 2003 report to estimate minimum trans fat intakes within a 
nutritionally adequate North American diet and use this value to 
establish a DV for trans fat.
    The 2003 report also recommends that saturated fat and trans fat 
amounts be listed on separate lines, but that one numerical value for 
the percent DV be included in the nutrition facts panel for these two 
nutrients together. The 2003 report recognizes that trans fat and 
saturated fat are chemically distinct and acknowledges that research 
demonstrates different physiological effects among the fatty acids; 
however, both trans fat and saturated fat raise total and low density 
lipoprotein (LDL) cholesterol levels, which are potential contributors 
to coronary heart disease risk. We are requesting comment about the 
development of a joint DV for saturated and trans fats. If a joint DV 
for saturated and trans fats is pursued, we are requesting comment 
about the use of the same approach that the 2003 report recommended for 
establishing a DV for trans fat (noted previously) to establish a new 
DV for saturated fat that would then be added to the DV for trans fat 
to establish a new combined DV, or, alternatively, to directly 
establish a joint DV for saturated and trans fats. Additionally, we are 
requesting

[[Page 9560]]

comment about how either a DV for trans fat or a joint DV for saturated 
and trans fats may affect the qualifying criteria for trans fat in 
trans fat nutrient content claims and qualifying criteria for saturated 
and trans fats in current nutrient content claims for saturated fat and 
cholesterol, lean and extra lean claims, and health claims that contain 
a message about cholesterol-raising lipids as well as disclosure and 
disqualifying criteria for saturated and trans fats to help consumers 
make healthy food choices.
    We are also requesting comment on whether a DV for trans fat or 
joint DV for saturated and trans fats would eliminate the necessity for 
considering a disclosure statement, in conjunction with nutrient 
content or health claims, concerning levels of saturated fat, trans 
fat, or cholesterol in a food or in the diet or a message about the 
role of such cholesterol-raising lipids in increasing the risk of CHD. 
Further, we are requesting comment on whether a DV for trans fat or a 
joint DV for saturated and trans fats would eliminate the need for a 
footnote about trans fat, either alone or in combination with saturated 
fat and cholesterol.
    Information and data obtained from comments and from consumer 
studies may be used to help draft a proposed rule on trans fat to do 
the following: (1) Establish criteria for certain nutrient content or 
health claims; (2) require the use of a footnote, or other labeling 
approach, about one or more cholesterol-raising lipids in the nutrition 
facts panel; and (3) develop a DV for trans fat either alone or in 
combination with saturated fat for use with a joint percent DV for 
saturated and trans fat in the nutrition facts panel to assist 
consumers in maintaining healthy dietary practices. At a later date, we 
will solicit comment on the remaining parts of the 2003 report.

II. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this ANPRM. 
Submit a single copy of electonic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the ANPRM text or 
PDF at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.gpoaccess.gov/fr/index.html by browsing the ``Table 

of Contents from Back Issues'' and select the publication date of 
Friday, July 11, 2003.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen between 
9 a.m. and 4 p.m., Monday through Friday. FDA has verified the 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 2003, ``Dietary Reference Intakes: Guiding Principles 
for Nutrition Labeling and Fortification,'' National Academy Press, 
Washington DC (Internet address: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.iom.edu/report.asp?id=17117
).

    2. IOM/NAS 2002, ``Dietary Reference Intakes for Energy, 
Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino 
Acids,'' National Academy Press, Washington, DC (Internet address: 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.iom.edu/report.asp?id=4340).


    Dated: February 20, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4504 Filed 2-27-04; 8:45 am]

BILLING CODE 4160-01-S