MoCRA Cosmetics Regulation Grace Period Ends
The grace period for the Modernization of Cosmetics Regulation Act (MoCRA) has ended, meaning brands not yet compliant with new U.S. cosmetic safety and manufacturing regulations now face enforcement actions. The deadline is expected to impact smaller vendors and international brands still adapting to the new rules, potentially leading to divestment of non-compliant inventory.
- This is the most significant expansion of the U.S. Food and Drug Administration's (FDA) authority over cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. Before MoCRA, the FDA's regulatory power was limited, and programs like facility registration and adverse event reporting were voluntary. - Key compliance mandates for brands now include the mandatory registration of all facilities that manufacture or process cosmetics for the U.S. market, the submission of detailed product listings including ingredients, and the substantiation of product safety. Registrations must be renewed with the FDA every two years. - The FDA now has mandatory recall authority for cosmetic products if it determines there is a reasonable probability of serious adverse health consequences. Other new enforcement powers include issuing warning letters, detaining products at ports of entry, and suspending a facility's registration. - A "responsible person" (the manufacturer, packer, or distributor named on the label) must report any "serious adverse events"—such as death, hospitalization, infection, or significant disfigurement—to the FDA within 15 business days of receipt. Records of all adverse events must be maintained for six years. - New product labeling requirements are being phased in, including the mandatory disclosure of fragrance allergens and the inclusion of a domestic address, phone number, or electronic contact information for reporting adverse events. - The FDA is also tasked with establishing standardized testing methods for detecting asbestos in talc-containing cosmetic products and must issue a report assessing the use and safety of per- and polyfluoroalkyl substances (PFAS) in cosmetics. - While MoCRA provides exemptions from certain requirements (like facility registration and Good Manufacturing Practices) for businesses with average gross annual sales under $1 million, these exemptions do not apply to brands that manufacture or process products that come in contact with the eye, are injected, for internal use, or that alter appearance for more than 24 hours.
