The Cosmetic/Drug Dilemma: FDA Regulation of Alpha-Hydroxy Acids

November 1997

Issue: 52 Food and Drug Law Journal 357-375 (1997)

The legislators who enacted the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) almost certainly did not anticipate the development of what are now commonly known as "cosmeceuticals," cosmetic products with drug-like effects. Perhaps the most popular of these products on the market are skin-care preparations containing alpha-hydroxy acids (AHAs), an ingredient that exfoliates the top layer of the skin to reveal "newer" skin cells underneath. The popularity of AHAs has focused attention on the potential dangers of the product, including increased susceptibility to sun damage. Under current interpretations of the FDCA, however, products containing AHAs are regulated as cosmetics as long as their label claims remain relatively benign. Because cosmetics are not as stringently regulated as drugs, cosmetics manufacturers often escape premarket regulatory review simply by their choice of label language. The effectiveness of AHAs calls into question the ability of the Food and Drug Administration (FDA) to ensure consumer safety, given the agency’s current statutory authority in this matter. This article argues that FDA’s authority is too narrowly drawn, and proposes the creation of a cosmeceutical product category to enable FDA to regulate AHA-containing products more aggressively.


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