[Federal Register Volume 67, Number 6 (Wednesday, January 9, 2002)]
[Notices]
[Page 1225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-451]


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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