Scientific Publications by FDA Staff

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.