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U.S. Department of Health and Human Services

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Drug Info J 1987 Oct;21(4):409-16

Legal Perspective-OTC Drugs and Cosmetics

Wion AH


Under the Federal Food, Drug, and Cosmetic Act products may be regulated both as “drugs” and as “cosmetics” because the statutory definitions are not mutually exclusive. Although there are some similar statutory provisions governing drugs and cosmetics, more restrictions and requirements are attached to products classified as drugs than to products classified solely as cosmetics. The limits of the drug definition have been tested in court more frequently than the limits of the cosmetic definition. This article discusses the statutory definitions of “drug” and “cosmetic,” the associated legal requirements, and judicial and administrative interpretations of these definitions. The article then presents an approach to making drug/cosmetic determinations.

Category: Journal Article
DOI: 10.1177/009286158702100406
Includes FDA Authors from Scientific Area(s): Women's Health
Entry Created: 2012-11-01 Entry Last Modified: 2015-01-15