[Federal Register Volume 66, Number 36 (Thursday, February 22, 2001)]
[Notices]
[Page 11172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4374]



[[Page 11172]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0058]


Guidance on Applying the Structure/Function Rule; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting comments 
on the types of information that should be included in a guidance on 
applying the regulations on statements made for dietary supplements 
concerning the effect of the product on the structure or function of 
the body. This action is being taken to assist the agency in preparing 
a guidance that will be optimally useful for industry and other 
interested persons.

DATES: Submit written comments on the topics for the proposed guidance 
by May 23, 2001.

ADDRESSES: Submit written comments on the topics for the proposed 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Copies of this document are available on the Internet at http://
vm.cfsan.fda.gov/~dms/ds-ind.html.

FOR FURTHER INFORMATION CONTACT: Rose E. Cunningham, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5468.

SUPPLEMENTARY INFORMATION:

I. Background

    The Dietary Supplement Health and Education Act (DSHEA) authorizes 
manufacturers of dietary supplements to claim effects on the 
``structure or function'' of the body, but not to make claims to 
mitigate, treat, prevent, cure, or diagnose disease (21 U.S.C. 
343(r)(6)). To explain how this part of DSHEA was to be implemented, 
FDA published the ``structure/function rule'' on January 6, 2000 (65 FR 
1000) (Sec. 101.93(f) and (g) (21 CFR 101.93(f) and (g))). This rule 
distinguishes between disease claims, which create a requirement that 
evidence of safety and efficacy be presented to the agency before 
marketing, and structure/function claims, which do not create such a 
requirement. In the preamble to that final rule, FDA stated that it 
would publish guidance on applying the rule. FDA is seeking public 
comment on the topics that should be included in the guidance.

II. Description of the Guidance

    In the preamble to the structure/function rule, FDA stated that it 
would provide, through guidance, examples of labeling claims that would 
and would not be considered disease claims under the rule, including 
examples of product names. FDA also stated that it would issue 
guidance, if necessary, on the citation of a publication or a reference 
implying the treatment or prevention of a disease 
(Sec. 101.93(g)(2)(iv)(C)). The agency invites comments on whether 
guidance on this topic is necessary. Because issues pertaining to the 
substantiation of structure/function claims are outside the scope of 
the rule (see 65 FR 1000 at 1032), the agency does not plan to address 
such issues in the guidance that is the subject of this notice. 
However, the agency does plan to issue a separate guidance on the 
substantiation of claims.

III. Request for Comments

    FDA invites all interested parties to comment on the topics to be 
included in the guidance, to suggest additional topics for inclusion in 
the guidance, and to address any other issue appropriate for this 
guidance. Interested persons may submit to the Dockets Management 
Branch (address above) written comments by May 23, 2001. Two copies of 
any comments are to be submitted, except that individuals may submit 
one 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: February 15, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-4374 Filed 2-21-01; 8:45 am]
BILLING CODE 4160-01-S