On December 29, 2022, President Biden signed into effect the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), amending Chapter IV of the Federal Food, Drug and Cosmetic Act.
The Act increases oversight of cosmetics and personal care products and their ingredients by the Food and Drug Administration (FDA).
MOCRA provides the FDA with significant new powers and places several new requirements on the cosmetics industry, including the development of Good Manufacturing Practices (GMPs) (Final Rule to be published no later than December 29, 2025), facility registrations and inspections, adverse event reporting, records review and mandated product recalls.
MOCRA also introduces new obligations for the Responsible Person, defined as the manufacturer, importer, packer or distributor of a cosmetic product, and whose name appears on the product labeling.
Changes are summarized below:
Registration of manufacturing and processing facilities (biennial renewal)
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