While cosmetics have been included in the Federal Food, Drug, and Cosmetics (FD&C) Act since its passage in 1938, the Agency saw limited expansion of its authority between 1938 and 2022. However, with the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, that all changed. MoCRA gave new authority to the FDA and established “substantial new requirements for cosmetic companies and individuals who market cosmetics in the United States.”

An article (here) written by Steven Kozlowski, M.D., the FDA’s Chief Scientist, outlines the new authorities and advancements in the regulation of cosmetic products. The new law:

  • Gave the FDA mandatory recall authority
  • Gave the FDA records access authority
  • Requires responsible persons to submit adverse event reports and maintain records demonstrating product safety
  • Requires cosmetic product manufacturers and processors to register facilities
  • Requires responsible persons to list marketed cosmetic products, including product ingredients, with the FDA
  • Directed the FDA to establish regulations for Good Manufacturing Practices (GMPs) for facilities that manufacture or process cosmetic products
  • Provides exemptions for certain small businesses from the facility registration, product listing, and GMP requirements

The results of the legislation and the FDA’s action are already being seen. For instance, “[f]ollowing implementation of MoCRA, the number of adverse events reported by industry to the FDA increased by more than three-fold” and ADEs “are now accessible to the public in the recently announced FDA Adverse Event Monitoring System.” In addition, today “there are over 15,000 unique, active cosmetic product facility registrations and over 1 million unique, active cosmetic product listings. Before MoCRA was enacted, the FDA received 5,176 cosmetic establishment registrations and 35,102 cosmetic product listings through the Voluntary Cosmetic Registration Program.”

The FDA continues its monitoring and oversight of the cosmetic industry to better protect the public. Considerable progress has been made over the three and a half years since the passage of MoCRA as can been seen by the reported results.