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

Abstract

Should products containing alpha-hydroxy acids or similar substances be considered cosmetics or drugs under the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)? Under most interpretations of the FDCA with regard to cosmetics, the answer to this question would be rooted not in the chemical composition or physiological effect of AHAs but rather in how the manufacturer has positioned the product and the promises made as to its effects. The cosmetic/drug distinction has considerable implications for the cosmetics industry because of the difference in regulation between cosmetics and drugs, most notably the lack of any requirement of premarket review for cosmetic products. A decision that AHAs are to be regulated as drugs could force manufacturers to pull available products from the market and submit extensive tests as to the products' safety and effectiveness for FDA approval, clearly an undesirable result for the industry. But a decision that the products are to be treated as cosmetics means that any regulation of their safety comes completely ex post in the form of product liability suits or FDA seizure proceedings, which involve considerable government resources.

Keywords: FDA, cosmetics, cosmeceuticals, alpha-hydroxy, AHA