Key Highlights of MoCRA and Its Impact on the Cosmetics Industry
UPDATE: The FDA announced it will delay implementation of MoCRA until July 1, 2024, to provide additional time to comply with these requirements.
Original Article: In 1938, the Food, Drug, and Cosmetic Act (FDCA) was enacted. Since then, no major amendments have taken place that are cosmetics related. This past year, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S. Food and Drug Administration’s (FDA) regulation of cosmetic products in the United States. MoCRA amends the Federal Food, Drug, and Cosmetic Act (FDCA) and imposes extensive new requirements related to cosmetic products.
Key highlights of MoCRA and its impact on the cosmetics industry:
- Facility Registration
- Mandatory Product Listings
- Good Manufacturing Practices
- Adverse Events
- Safety Substantiation
- Mandatory Recalls
- Responsible Person
We understand this change can be overwhelming and we are here to make the transition as painless as possible. Our lab is already GMP compliant and registered with the FDA as a drug manufacturer requiring minimal action on our end. We are here to provide guidance to our clients in the roles that they will be responsible for such as product and ingredient listings as we learn.
We’d like to share a couple of links for additional resources and information that explains MoCRA in better detail.
MoCRA Increases FDA Oversight of the Cosmetics Industry | Loeb & Loeb LLP (loeb.com)
Modernization of Cosmetics Regulation Act of 2022 | ArentFox Schiff (afslaw.com)
The Regulatory Impact of the Modernization of Cosmetics Regulatory Act | (nsf.org)
Modernization of Cosmetics Regulation Act of 2022 | (fda.gov)
Consolidated Appropriations Act of 2023 | MoCRA starts at page 1,389
We will continue to share updates on our News Page as they become available.
