[Federal Register Volume 71, Number 33 (Friday, February 17, 2006)]
[Notices]
[Page 8597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1509]



[[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Draft Guidance for Industry and FDA Staff: Whole Grains Label 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 The draft guidance is intended 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DATES: Submit written or electronic comments concerning the draft 
guidance by April 18, 2006, to ensure their adequate consideration in 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance document to the Office of Nutritional Products, Labeling, and 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on the draft guidance, to the Division of Dockets Management (HFA-305), 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://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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.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: 
[email protected].

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://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://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://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