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ORAL ANTISEPTICS MAKING ONLY NON-THERAPEUTIC CLAIMS ARE COSMETICS

This article was originally published in The Rose Sheet

Executive Summary

ORAL ANTISEPTICS MAKING ONLY NON-THERAPEUTIC CLAIMS ARE COSMETICS, FDA said in the OTC oral antiseptics tentative final monograph, published in the Feb. 9 Federal Register. The agency stated that "oral products that contain antiseptic ingredients are considered 'cosmetics' and not 'drugs' if only deodorant (or other cosmetic) claims are made for the product." FDA's position on this matter differs from the recommendation of the OTC Oral Cavity Drug Product Review Panel, which concluded that mouth odor suppression claims in the labeling of an oral product containing an antiseptic ingredient were sufficient to make that product a drug.
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