[Federal Register: January 9, 2002 (Volume 67, Number 6)]
[Notices]
[Page 1225]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja02-61]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
[Docket No. 98N-0044]
 
 
Small Entity Compliance Guide: ``Structure/Function Claims;''
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 small entity compliance guide (SECG) for a final rule
published in the Federal Register of January 6, 2000 (65 FR 1000),
entitled ``Regulations on Statements Made for Dietary Supplements
Concerning the Effect on the Structure or Function of the Body.'' This
SECG is intended to set forth the requirements of that final rule in
plain language and to help small businesses understand the regulation.
 
DATES: Submit written or electronic comments on the SECG at any time.
 
ADDRESSES: Submit written comments concerning this SECG to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments. Submit written requests for
single copies of the SECG to the Industry Activities Staff (HFS-565),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204. Send one self-
adhesive address label to assist that office in processing your
request. See the Supplementary Information section for electronic
access to the SECG.
 
FOR FURTHER INFORMATION CONTACT: Robert Moore, Center for Food Safety
and Applied Nutrition (HFS-811), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-4605, FAX 202-205-4594.
 
SUPPLEMENTARY INFORMATION: In the Federal Register of January 6, 2000
(65 FR 1000), FDA issued a final rule defining the types of statements
that can be made concerning the effect of a dietary supplement on the
structure or function of the body. The regulation also established
criteria for determining when a statement about a dietary supplement is
a claim to diagnose, cure, mitigate, treat, or prevent disease. The
final rule clarified the types of claims that may be made for dietary
supplements without prior review by FDA and the types of claims that
require prior authorization as health claims or prior approval as drug
claims. This final rule became effective February 7, 2000.
    FDA examined the economic implications of that final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-602). The
agency determined that the final rule would have a significant economic
impact on a substantial number of small entities.
    In compliance with section 212 of the Small Business Regulatory
Enforcement Fairness Act (Public Law 104-121), FDA is making available
this SECG stating in plain language the requirements of this
regulation.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG
represents the agency's current thinking on the subject. 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.
 
I. Comments
 
    Interested persons may, at any time, submit written or electronic
comments on the SECG entitled ``Structure/Function Claims; Small Entity
Compliance Guide'' to the Dockets Management Branch (address above).
Two copies of any comments are to be submitted, except that individuals
may submit one copy. Comments should be identified with the docket
number found in brackets in the heading of this document. A copy of the
SECG and received comments are available for public examination in the
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
 
II. Electronic Access
 
    Copies of the SECG may also be viewed on a personal computer with
access to the Internet. The Center for Food Safety and Applied
Nutrition's home page includes the SECG, which can be found at http://
www.cfsan.fda.gov/dms/guidance.html.
 
    Dated: December 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-451 Filed 1-8-01; 8:45 am]
BILLING CODE 4160-01-S
 

Structure/Function Claims: Small Entity Compliance Guide (also available in PDF)