The Food and Drug Administration and Modernization of U.S. Cosmetic Regulations

When Congress passed the Modernization of Cosmetics Regulation Act (MoCRA) in 2022, it was the most significant expansion of the Food and Drug Administration’s (FDA’s) regulatory authority over cosmetics since the Food, Drug, and Cosmetic Act (FD&C Act) in 1938. This new law aims to enhance the safety of cosmetic products that millions of consumers use daily. The FDA’s primary regulatory authority over cosmetics is ensuring that cosmetic products marketed in the U.S. are not adulterated or misbranded. MoCRA amended the FD&C Act, adding provisions that empower FDA to improve product safety, industry accountability, and market surveillance and enforcement by promulgating good manufacturing practice regulations, mandating recalls, and requiring serious adverse event reporting, cosmetic facility registration, cosmetic product listing, and other new authorities. This chapter outlines the U.S. legal framework governing cosmetic regulation with an emphasis on MoCRA’s key provisions, summarizes the historical motivation for and development of these laws, and explains FDA's procedures for administering the law.