[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Notices]
[Page 19597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9702]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0090]
Dietary Supplements: Notice of Withdrawal of Regulatory Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
has withdrawn a number of import alerts, import bulletins, and
compliance policy guides involving dietary supplements. FDA has taken
these actions to conform its regulatory guidance to the changes made to
the Federal Food, Drug, and Cosmetic Act (the act) by the Dietary
Supplement Health and Education Act (DSHEA).
FOR FURTHER INFORMATION CONTACT: Loretta A. Branch Carey, Center for
Food Safety and Applied Nutrition (HFS-456), Food and Drug
Administration, 200 C Street SW., Washington, DC 20204, 202-205-5372.
SUPPLEMENTARY INFORMATION: On October 25, 1994, the President signed
into law the DSHEA (Pub. L. 103-417). Among the most significant
changes in the act made by the DSHEA is the addition of section
201(s)(6) (21 U.S.C. 321(s)(6)), which excepts dietary ingredients of
dietary supplements from coverage under the food additive provisions of
the act (section 3(b) of the DSHEA). As a result of this change, such
ingredients are no longer subject to a premarket safety review.
In response to this change, FDA has reviewed the regulatory
guidance that it issues to its field offices to conform that guidance
to the change. As a result of this review, FDA has found that it is
appropriate to withdraw the following import alerts, import bulletins,
and compliance policy guides because they are no longer consistent with
the act.
A. Compliance Policy Guides
1. CPG 7117.04, entitled ``Botanical Products for use as Food''
2. CPG 7118.01, entitled ``Dietary Supplements-Misbranding
Nutritionally Insignificant Ingredients''
B. Import Alerts
1. 24-14 Products containing Bracken
2. 26-02 Flaxseed/Linseed Oil
3. 54-03 Carnitine
4. 54-05 Ultra Bios 2000 Food Supplement
5. 66-02 Ginseng
6. 66-04 Oil of Evening Primrose
C. Import Bulletins
1. 31-B01 Selfheal Flower, Prunella Vulgaris
2. 54-B06 Tricosanthis
3. 66-B62 Ephedra
The Agency continues to review and revise the remaining related
import alerts, bulletins, and compliance policy guides, in order to
comply with DSHEA.
FDA notes that it does not usually give notice in the Federal
Register of its issuance or withdrawal of import alerts or bulletins.
It is doing so in this instance, however, because of the on-going
congressional interest in FDA's implementation of the DSHEA. FDA
advises that issuing this notice does not mark any type of change in
the agency's usual procedures for issuing or withdrawing these alerts
or bulletins.
In response to the DSHEA, FDA has also reassessed its general
enforcement priorities with respect to dietary supplements. FDA advises
that in enforcing the act with respect to these products, its primary
focus is likely to be, as it always has been, on safety concerns. The
agency advises, however, that its regulatory priorities are subject to
adjustment in response to changing circumstances. For example, the
labeling of dietary supplements will likely be given a higher priority
by the agency after December 31, 1996, when compliance with FDA's
nutrition labeling and nutrient content claim regulations for dietary
supplements is to begin.
Dated: April 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-9702 Filed 4-18-95; 8:45 am]
BILLING CODE 4160-01-F
