A Paradigm Shift in U.S. FDA Cosmetic Regulations: Modernization of Cosmetics Regulation Act (MoCRA)

Abstract

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) signifies the most significant reform in U.S. cosmetic regulation since 1938. Previously governed under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetic oversight in the U.S. largely relied on voluntary measures. MoCRA establishes a mandatory, structured, and enforceable regulatory framework. This article reviews the key features of MoCRA and compares them to the former voluntary registration system, highlighting implications for domestic and international cosmetic manufacturers.