[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45221-45222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0209] (formerly Docket No. 2007D-0491)


Guidance for Industry: Questions and Answers Regarding the 
Labeling of Dietary Supplements as Required by the Dietary Supplement 
and Nonprescription Drug Consumer Protection 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 document entitled ``Questions and Answers 
Regarding the Labeling of Dietary Supplements as Required by the 
Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' 
The document provides guidance to the dietary supplement industry for 
complying with the labeling requirements prescribed for dietary 
supplement manufacturers, packers, and distributors by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA). 
Separate guidance on labeling requirements for nonprescription (over-
the-counter) human drugs marketed without an approved application, 
issued by FDA's Center for Drug Evaluation and Research, is announced 
elsewhere in this issue of the Federal Register.

DATES: Submit written or electronic comments on the guidance 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 20750. 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.

FOR FURTHER INFORMATION CONTACT: Vasilios Frankos, Center for Food 
Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2375.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 22, 2006, the President signed into law DSNDCPA (Public 
Law 109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, 
and Cosmetic Act (the act) with respect to serious adverse event 
reporting for dietary supplements and nonprescription drugs marketed 
without an approved application. The law also amended the act to add 
section 403(y) (21 U.S.C. 343(y)), which requires the label of a 
dietary supplement marketed in the United States to include a domestic 
address or domestic telephone number through which the product's 
manufacturer, packer, or distributor may receive a report of a serious 
adverse event associated with the dietary supplement.
    In the Federal Register of January 2, 2008 (73 FR 197), FDA 
announced the availability of a draft guidance entitled ``Questions and 
Answers Regarding the Labeling of Dietary Supplements as Required by 
the Dietary Supplement and Nonprescription Drug Consumer Protection 
Act.'' In addition to providing guidance for industry on how to comply 
with the labeling requirements in section 403(y) of the act, the draft 
guidance stated that FDA intended to begin enforcing the requirements 
of section 403(y) for dietary supplements labeled on or after January 
1, 2009. Although interested parties can comment on any guidance at any 
time, to ensure that the agency would have the opportunity to consider 
comments on the draft guidance before it began work on the final 
version, FDA requested that interested parties submit comments by March 
3, 2008. On December 11, 2008 (73 FR 75438), FDA announced the 
availability of a revised version of the draft guidance document to 
notify the dietary supplement industry and other members of the public 
that it intended to exercise enforcement discretion with regard to the 
labeling requirements of section 403(y) of the act for an additional 1-
year period (i.e., for dietary supplements labeled before January 1, 
2010) because the agency was still in the process of reviewing the 
comments and finalizing the guidance. The agency has now completed its 
review and evaluation of the comments received and has modified the 
guidance where appropriate.
    The guidance contains questions and answers relating to the 
labeling requirements in section 403(y) of the act and provides 
guidance to industry on the following topics: (1) The meaning of 
``domestic address'' for purposes of the

[[Page 45222]]

labeling requirements of section 403(y) of the act; (2) FDA's 
recommendation for the use of an introductory statement before the 
domestic address or domestic telephone number that is required to 
appear on the product label under section 403(y) of the act; and (3) 
that FDA intends to begin enforcing the labeling requirements of 
section 403(y) of the act for products labeled on or after September 
30, 2010.
    FDA is issuing this guidance consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the labeling of dietary supplements as 
required by the DSNDCPA. 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 
collections of information in this guidance were approved under OMB 
control no. 0910-0642.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the guidance. 
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.

IV. Electronic Access

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

    Dated: August 26, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21094 Filed 8-31-09; 8:45 am]
BILLING CODE 4160-01-S