[Federal Register Volume 74, Number 2 (Monday, January 5, 2009)]
[Notices]
[Pages 304-305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0303] (formerly Docket No. 2004D-0466)


``Guidance for Industry: Substantiation for Dietary Supplement 
Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and 
Cosmetic Act;'' 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 guidance entitled ``Guidance for Industry: 
Substantiation for Dietary Supplement Claims Made Under Section 
403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' The guidance 
describes the amount, type, and quality of evidence that FDA recommends 
a manufacturer have to substantiate a claim under this section of the 
Federal Food, Drug, and Cosmetic Act (the act).

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  Submit written comments on the guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
on the guidance to http://www.regulations.gov. Submit written requests 
for single copies of the guidance to the Office of Nutrition, 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. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Robert Moore, Center for Food Safety 
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1441.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 9, 2004 (69 FR 64962), FDA made 
available a draft guidance entitled ``Guidance for Industry: 
Substantiation for Dietary Supplement Claims Made Under Section 
403(r)(6) of the Federal Food, Drug, and Cosmetic Act'' and gave 
interested parties an opportunity to submit comments by January 10, 
2005. FDA considered received comments as it finalized this guidance.
    This guidance describes the amount, type, and quality of evidence 
FDA recommends a manufacturer have to substantiate a claim under 
section 403(r)(6) of the act (21 U.S.C. 343(r)(6)). This final guidance 
document is limited to issues pertaining to substantiation under 
section 403(r) of the act; it does not extend to substantiation issues 
that may exist in other sections of the act.
    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). This guidance represents FDA's current thinking on the 
substantiation for dietary supplement claims made under section 
403(r)(6) of the act. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in the guidance was approved under OMB 
Control No. 0910-0626.

III. 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket

[[Page 305]]

management system. Electronic comments or submissions will be accepted 
by FDA only through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://www.cfsan.fda.gov/guidance.html.

    Dated: December 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-31249 Filed 1-2-09; 8:45 am]
BILLING CODE 4160-01-S