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GUIDANCE DOCUMENT

CPG Sec. 456.100 Non-Rx Drugs Anti-Obesity Preparations March 1995

Final
Docket Number:
None found
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

POLICY:

We are not prepared to take regulatory action against the following class of products particularly those which have been on the market for a significant period of time:

Anti-obesity preparations containing phenylpropanolamine, methylcellulose, benzocaine, and related compounds, with or without vitamins offered only as an aid in reducing.

If the products contain other ingredients which would cause the drug to be dangerous to health when used as directed or if its labeling makes other claims we might wish to consider action. If you encounter such products which you believe warrant action, submit full labeling and formulation to the <> Division of Drug Labeling Compliance, *HFD-310* for advice before collecting samples for regulatory consideration.

*Material between asterisks is new or revised*
<> Indicates material has been deleted

Issued: 10/1/80
Revised: 5/22/87; 3/95

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: None found.

 
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