[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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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://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://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://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://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