[Federal Register Volume 59, Number 233 (Tuesday, December 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29988]


[[Page Unknown]]

[Federal Register: December 6, 1994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Ch. 1

[Docket No. 93N-0178]
RIN 0905-AD90

 

Regulation of Dietary Supplements; Withdrawal of Advance Notice 
of Proposed Rulemaking

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is withdrawing an advance notice of proposed rulemaking (ANPRM) on the 
regulation of dietary supplements that it published in the Federal 
Register of June 18, 1993 (58 FR 33690) (hereinafter referred to as the 
June 18, 1993, ANPRM). This action is necessary because of recently 
enacted legislation and terminates the rulemaking initiated by the 
ANPRM.

FOR FURTHER INFORMATION CONTACT: Judith S. Kraus, Center for Food 
Safety and Applied Nutrition (HFS-456), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5372.

SUPPLEMENTARY INFORMATION: In the June 18, 1993, ANPRM, FDA requested 
public comment on approaches, consistent with the requirements of the 
Federal Food, Drug, and Cosmetic Act, for assuring the safety of 
products offered for sale as dietary supplements. In particular, the 
ANPRM requested information on the safety and use of amino acids, or 
combinations of amino acids, as ingredients in dietary supplements. 
Additionally, FDA announced the availability of a report entitled 
``Task Force on Dietary Supplements Final Report'' and requested 
comments on the recommendations made in the report. FDA received over 
6,000 comments to the ANPRM. While some of these comments expressed 
concern about the safety of dietary supplement products, most strongly 
objected to many of the possible courses of action that the agency 
outlined in the ANPRM.
    On October 25, 1994, President Clinton signed into law the Dietary 
Supplement Health and Education Act of 1994 (Pub. L. 103-417). Section 
11 of this act declares the June 18, 1993, ANPRM to be null and void 
and of no force and effect. It also directs the Secretary (and by 
delegation, FDA) to publish notice to this effect in the Federal 
Register.
    After consideration of the comments received, and in light of 
section 11 of the new law, FDA has decided to withdraw the June 18, 
1993, ANPRM. Therefore, under the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq), the agency hereby withdraws the ANPRM that it 
published in the Federal Register of June 18,1993 (58 FR 33690), on the 
regulation of dietary supplements.

    Dated: November 30, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-29988 Filed 12-5-94; 8:45 am]
BILLING CODE 4160-01-F