FDA Implements Modernization of Cosmetics Regulation Act of 2022

The act represents the most significant expansion of the FDA's authority over cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938, aiming to ensure the safety of the cosmetic products that consumers use daily. On average, individuals use between six to twelve cosmetic items per day, which include makeup, nail polish, shaving creams, perfumes, and various skincare products.

Defined under the law, an adverse event is any health-related issue associated with a cosmetic product, while a serious adverse event includes more severe outcomes like hospitalization or significant disfigurement. MoCRA grants the FDA new powers such as accessing and copying records pertaining to cosmetic safety under certain conditions and the authority to mandate product recalls if health risks are identified.

Key requirements established by MoCRA for manufacturers include adverse event reporting within 15 business days for any serious incidents, facility registration with the FDA to be renewed biennially, and accurate product listing that includes ingredient information. Responsible persons must maintain safety substantiation records but are not mandated to conduct specific tests unless deemed necessary.

MoCRA also stipulates the establishment of regulations regarding Good Manufacturing Practices (GMP) for cosmetic manufacturers, allergen labeling, and standardized asbestos testing in talc-containing cosmetics.

On December 29, 2025, the FDA published a report assessing the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics, discussing associated risks. While MoCRA includes exemptions for certain small businesses from some requirements, these do not apply to facilities manufacturing products with higher risks, such as those intended for injection or prolonged alteration of appearance.

For further information regarding MoCRA, inquiries can be made to the Food and Cosmetic Information Center (FCIC).