The Federal Food, Drug, and Cosmetic Act (FD&C Act) establishes substantially different regulatory requirements in the United States for cosmetics and drugs. This chapter traces the history of U.S. regulatory policy for these two categories of products, discusses the application of U.S. law to products that fall within both categories at the same time (i.e., cosmetic drugs3), and considers potential strategies for resolving the long-standing concern that the drug provisions of the Act impose overly stringent requirements on cosmetic drugs.