On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023.  Among the new legal requirements created under MoCRA, cosmetic product manufacturers must be aware of and consider how the following may impact their operations:

1. Facility Registration and Product Listing. Cosmetic manufacturing facilities will be required to register their facilities with the FDA, as well as report to the FDA each cosmetic product they produce;
    
2. Mandatory Recall Authority.  The FDA will have new authority to require recalls of cosmetic products that are likely to cause serious adverse health events;
    
3. Allergen Labeling. The FDA will prepare a list of allergens which, if included in a cosmetic product, must be disclosed on its labeling;
    
4. Adverse Event Reporting.  Cosmetic product manufacturers will be required to report to the FDA instances of consumer harm caused by their products;
    
5. Safety Substantiation.  Manufacturers will be required to develop records that adequately substantiate that their cosmetic products are safe, including asbestos testing for talc-containing products; and 
    
6. Good Manufacturing Practices (GMPs). Cosmetic product manufacturers will be required to adhere to new “good manufacturing practice requirements” outlined by the FDA. These GMPs, as well as other portions of MoCRA, will also require the FDA to consider local, state, and international requirements such as the European Union’s much stricter cosmetic product regulations in formulating the new rules governing cosmetic products.

Companies that manufacture, distribute, sell, or otherwise handle cosmetic products should monitor any guidance from the FDA regarding MoCRA and consider implementing policies and procedures to ensure compliance with MoCRA’s new requirements. For additional guidance on these new changes, please contact your Dinsmore healthcare attorney.