[Federal Register Volume 69, Number 75 (Monday, April 19, 2004)]
[Proposed Rules]
[Pages 20838-20839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8778]


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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; Extension of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advanced notice of proposed rulemaking; extension of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA) is extending for 60 
days the comment period for an advanced notice of proposed rulemaking 
(ANPRM) published in the Federal Register of July 11, 2003 (68 FR 
41507). FDA reopened the comment period in the Federal Register of 
March 1, 2004. Since reopening the comment period, FDA has scheduled a 
Food Advisory Committee (FAC) Nutrition Subcommittee meeting for April 
27 and 28, 2004. The outcome of this meeting may help determine the 
course of action for trans fat labeling. FDA is extending the comment 
period to receive comments that consider the information resulting from 
this upcoming FAC Nutrition Subcommittee meeting 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 
labeling.

DATES: Submit written or electronic comments by June 18, 2004.

ADDRESSES: You may submit comments, identified by Docket No. 2003N-
0076, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the 
agency Web site.
     E-mail: [email protected]. Include Docket 
No. 2003N-0076 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or 
CD-ROM submissions]: Division of Dockets Management, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No. or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.fda.gov/dockets/ecomments, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the ``How to 
Submit Comments'' heading of the SUPPLEMENTARY INFORMATION section of 
this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/dockets/ecomments and/or 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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 
published 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 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

[[Page 20839]]

and how to use the information to make healthy food choices. The 
comment period was open until October 9, 2003.
    In December 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'' 
(the 2003 report) in which the overarching goal was to have updated 
nutrition labeling that consumers can use to make informed dietary 
choices. The IOM/NAS's Dietary Reference Intake (DRI) 2002 report on 
macronutrients 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 suggested 
an approach 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 recommended that 
saturated fat and trans fat amounts be listed on separate lines, but 
that one numerical value for the percent DV (%DV) be included in the 
nutrition facts panel for these two nutrients together. In response to 
requests received in this docket, FDA reopened the comment period on 
March 1, 2004 (69 FR 9559), 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.
    Recently, FDA has scheduled a FAC Nutrition Subcommittee meeting 
for April 27 and 28, 2004 (see the notice of meeting in the Federal 
Register of March 29, 2004 (69 FR 16275), or http://www.fda.gov/OHRMS/DOCKETS/), to discuss, in part, the current scientific evidence for 
determining a maximal daily intake value of trans fat and how trans fat 
compares to saturated fat with respect to reducing coronary heart 
disease risk. The outcome of this meeting may help determine the course 
of action for trans fat labeling. We believe it is necessary to extend 
the comment period to allow stakeholders time to consider the new 
information when commenting in this docket. Using this new information 
will provide a stronger science base for a subsequent proposal. 
Therefore, we are requesting comment on whether the available 
scientific evidence, as will be discussed in the FAC Nutrition 
Subcommittee meeting, supports listing the %DV for saturated fat and 
trans fat together or separately on the nutrition facts panel and what 
the maximal daily intake of trans fat may be. A transcript of the 
subcommittee meeting is expected to be placed in Docket 2003N-0076 by 
May 14, 2004.
    We are continuing to request comments 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 
coronary heart disease. 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: (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 %DV for saturated and trans fat on 
the nutrition label to assist consumers in maintaining healthy dietary 
practices.

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 electronic 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 at http://www.gpoaccess.gov/fr/index.html by browsing the ``Table of Contents 
from Back Issues'' and selecting the publication date of Friday, July 
11, 2003.

    Dated: April 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8778 Filed 4-14-04; 2:05 pm]
BILLING CODE 4160-01-S