From Cosmetic to Drug: Crossing the Line

Abstract

In comparison to drugs, cosmetics are minimally regulated in the United States. However, the statutory definitions of cosmetic and drug are conveniences rather than scientific interpretations and Food and Drug Administration (FDA) classification appears to depend on claims made, the “intended use” doctrine. The cosmetic manufacturer may face legal challenge and the daunting responsibility of compliance to drug regulations when claims make cosmetics “new drugs.” This article explores the history of the drug-cosmetic debate, describes the legal precedents for improper drug claims for cosmetics, and examines recent regulatory interpretations. Also discussed are the intensified drug-cosmetic debate as evidenced by a steady stream of FDA warning letters to cosmetic manufacturers who have “crossed the line” and the growing interest in litigated Lanham Act cosmetic cases.