[Federal Register: February 17, 2006 (Volume 71, Number 33)]
[Notices]
[Page 8597]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe06-76]
[[Page 8597]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0066]
Draft Guidance for Industry and FDA Staff: Whole Grains Label
Statements; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry and FDA
Staff: Whole Grain Label Statements.'' The draft guidance is intended
to provide guidance to industry about what the agency considers to be
``whole grain'' and to assist manufacturers in labeling their products.
DATES: Submit written or electronic comments concerning the draft
guidance by April 18, 2006, to ensure their adequate consideration in
preparation of the final guidance. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Office of Nutritional Products, Labeling, and
Dietary Supplements (HFS-800), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740. Include a self-addressed adhesive label to
assist that office in processing your request. Submit written comments
on the draft guidance, to the Division of Dockets Management (HFA-305),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.
To ensure more timely processing of comments, FDA is no
longer accepting comments submitted to the agency by e-mail. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Shellee Anderson, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1491, e-mail:
shellee.anderson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Through the years, the Federal Government has worked to provide
consistent and scientifically sound recommendations to consumers about
healthy eating patterns and wise food choices. Such advice originated
with the ``Basic Four'' and has progressed through today's ``Dietary
Guidelines for Americans'' (developed jointly by the U.S. Department of
Health and Human Services and the U.S. Department of Agriculture).
``Dietary Guidelines for Americans, 2005'' (2005 DG) recommends that
Americans, among other things, ``consume 3 or more ounce-equivalents of
whole grain products per day, with the rest of the recommended grains
coming from enriched or whole-grain products'' and that ``in general at
least half the grains should come from whole grains'' (Ref. 1).
Manufacturers may make factual statements about whole grains on the
label of their products, such as ``100% whole grain'' (as percentage
labeling under 21 CFR 102.5(b)) or ``10 grams of whole grains'' (21 CFR
101.13(i) (3)) provided that the statements are not false or misleading
under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 343(a)) and do not imply a particular level of the
ingredient, i.e., ``high'' or ``excellent source.'' In addition,
manufacturers may use health claims relating whole grains to a reduced
risk of coronary heart disease and certain cancers on their product
labels for qualifying foods based on notifications FDA received under
section 403(r) (3) (C) of the act (21 U.S.C. 343(r)(3)(C)) (health
claims based on an authoritative statement of a scientific body) (see
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/~dms/labfdama.html). To assist manufacturers
in labeling their products, the agency has reviewed various industry
and scientific definitions of ``whole grains'' and developed guidance
to industry about what the agency considers to be ``whole grain.''
The agency has adopted good guidance practices (GGPs) that set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (21 CFR 10.115). This draft
guidance is being issued as a Level 1 guidance document consistent with
the GGPs. The draft guidance represents the agency's current thinking
on the topic. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. You may use an
alternative approach if such approach satisfies the requirements of
applicable statutes and regulations. If you want to discuss an
alternative approach, contact the FDA staff responsible for
implementing this guidance (see FOR FURTHER INFORMATION CONTACT).
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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. If you base your comments on
scientific evidence or data, please submit copies of the specific
information along with your comments. 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 draft guidance
at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/guidance.html.
IV. References
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. U.S. Department of Health and Human Services and U.S.
Department of Agriculture, ``Dietary Guidelines for Americans,
2005,'' http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.healthierus.gov/dietaryguidelines, 2005.
Dated: February 14, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-1509 Filed 2-15-06; 8:45 am]
BILLING CODE 4160-01-S