December 31, 2023: Cosmetics must comply with FDA requirements: adverse event reporting, product listing, and maintaining safety substantiation documents.
December 31, 2024: Cosmetics must comply with fragrance allergy disclosure, labeling updates, and testing.
The Modernization Act
The Modernization of Cosmetics Regulation Act (MoCRA) was signed into law in December of 2022. MoCRA significantly expands FDA oversight of the cosmetics industry. The law introduces regulatory changes that will require action from a “responsible person” such as a cosmetic product manufacturers, packers, or distributors.
Here are a few new regulatory requirements that will need to be addressed by December 2023:
- Adverse Event Recordkeeping and Reporting – Maintain records of all adverse events (AE) associated with any of its cosmetics for six years. Serious AE’s must be reported to the FDA within 15 days of receipt. The FDA will have the authority to request recalls based on AE reports.
- Product Listing – Submit product information for each cosmetic that is marketed in the US and any new products entering the market within 120 days of market-entry. Listings will require full ingredient lists. The FDA has stopped accepting submissions to the voluntary cosmetic registration (VCRP) and listing program and will not be transferring VCRP data to the program it is establishing for the mandatory submission of cosmetic product listing.
- Safety Substantiation Dossiers – Maintain an adequate substantiation dossier that support product safety. This should include tests or studies, research, analyses, or other evidence considered by experts with qualified training to support the product’s safety.
By 2024, the Agency will require fragrance allergens and contact information to be disclosed on all cosmetic labeling, and talc-containing cosmetics to be tested for asbestos. Additional regulatory requirements are also being introduced to cosmetic product manufacturers.
It’s important to be proactive in complying with these new regulations to promote transparency and consumer safety. Lumanity is committed to support you through this process and ensure you are in compliance before the upcoming deadlines.
Contact us to learn how we can help you effectively navigate changes associated with the implementation of MoCRA.