A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new law that aims to modernize and strengthen cosmetic regulations in the United States.
MoCRA was signed into law on January 1, 2022, and replaces the previous Cosmetic Act, which had not been updated since 1938. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA will impact the entire lifecycle of cosmetics products from manufacturing to marketing.
New MoCRA requirements include:
- FDA registration for cosmetics facilities
- Product listings for each cosmetic product
- Adverse event reporting
- Safety substantiation
- Compliance with Good Manufacturing Practices (GMPs)
- Fragrance allergen labeling
MoCRA also gives the FDA new records access and mandatory recall authority. In issuing MoCRA regulations, FDA’s aim is to help ensure the overall safety of cosmetic products, and significantly expand the Agency’s ability to trace and track non-compliant products and facilities.
Facility Registration and Product Listing
Cosmetic facilities must register with the FDA (deadline has been extended to July 1, 2024) and renew their registration every two years thereafter . The term “facility” means any establishment that either manufactures or process cosmetic products distributed in the United States. New facilities must be registered within 60 days after they start manufacturing cosmetics.
The FDA may suspend a facility’s registration if the FDA determines […]
The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.