MoCRA – Modernization of Cosmetics Regulation Act of 2022
In the USA, in Dec 2022 a new law called the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by Congress. FDA enforces laws enacted by Congress and issues regulations as authorized by Congress. MoCRA is the most recent law enacted since 1938 to strengthen FDA regulation of cosmetics for the safety of cosmetics. This is an important law on that affects marketing, making, and selling cosmetics. To implement this new authority the FDA will be conducting rule making and issuing guidance documents. The FDA will inform the cosmetic industry throughout this process.
Some key points:
-Voluntary Cosmetic Registration Program (VCRP) has been discontinued. The FDA is creating a new registration system. The new system has not been announced yet and the online forms are not available yet for cosmetic companies to register.
-It is mandatory to report to the FDA within 15 days of any adverse reactions (any health related events) reported to the compnay by a customer using their cosmetic.
-Records inspections: FDA is allowed access to records if they have reason to believe a cosmetic is adulterated and/or adverse reactions and during a facility inspection.
-Cosmetic manufacturers and processors must register their facilities with the FDA and renew their registration every 2 years.
-Prohibited to sell or distribute cosmetics with a suspended registration.
-Must list ingredients in marketed products with FDA and provide updates annually.
-FDA can mandatory recall cosmetics if adulterated if company doesn’t do voluntarily.
Enforceable by Dec. 29, 2024:
-Contact Information: must included to be contacted by customer if they experience an adverse reaction using the product, domestic address, phone number or electronic contact information like a website.
-Labeling of Fragrance Allergen Rule: display list of allergens on label
-FDA to establish GMPs consistent with national and international standards to ensure cosmetics are not adulterated.
Testing for Asbestos in Talc
-FDA to develop regulations to identify standard testing methods for detecting methods for asbestos in talc in cosmetic products.
By Dec. 29, 2025:
FDA Report on safety of PFAS in Cosmetics
-Report due on the safety of in cosmetics per- and polyfluoroalkyl substances, PFAS. PFAS are chemicals that resist oil, grease, water, and heat. These are potentially toxic materials that break down very slowly in the environment. Used in cosmetics the product is easier to apply, smooth, add shine to hair, and water resistant. (polytetrafluoroethylene – PTFE, perfluorooctyl triethoxysilane, perfluorononyl dimethicone, perfluorodecalin, and perfluorohexane).
Watch the FDA webinar of an overview of MoCRA: