[Federal Register: April 19, 2004 (Volume 69, Number 75)]
[Proposed Rules]
[Page 20838-20839]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap04-25]
 
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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: fdadockets@oc.fda.gov. 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

Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer Research to Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements; Advance notice of proposed rulemaking Federal Register July 11, 2003