FDA Regulation of Cosmetics

Summary

This practice note addresses the regulatory requirements applicable to products that are classified as cosmetics. Additional requirements for cosmetic products that are also classified drugs or medical devices are not covered by this practice note. This note discusses, among other things, the scope of the Federal Food, Drug, and Cosmetic Act (FDCA); the Modernization of Cosmetics Regulation Act of 2022 (MoCRA); the regulation of cosmetic products by the Food and Drug Administration (FDA); adulterated and mislabeled cosmetics; requirements regarding cosmetic ingredients; requirements regarding registration, listing, and good manufacturing practices; the FDA's authority regarding inspections, adverse event reporting, record keeping, enforcement, and recalls; and federal preemption under MoCRA.