[Federal Register: February 22, 2001 (Volume 66, Number 36)]
[Notices]
[Page 11172]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22fe01-70]
 
 
[[Page 11172]]
 
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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.
 
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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
 

Final Rule: Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body (Federal Register, January 6, 2000)