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
Revised: 5/22/87; 3/95
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.