What is MoCRA?
The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant update to U.S. cosmetic regulation in over 80 years. Signed into law in December 2022, it gives the FDA new authority over cosmetic products.
Key MoCRA Requirements
1. Facility Registration
All facilities that manufacture or process cosmetics for the U.S. market must register with FDA through the Cosmetics Direct portal.
2. Cosmetic Product Listing
Every cosmetic product distributed in the U.S. must be listed with FDA, including ingredient lists and labeling information.
3. Safety Substantiation
Companies must have adequate substantiation of safety for their cosmetic products and ingredients.
4. Adverse Event Reporting
Serious adverse events must be reported to FDA within 15 business days of receipt.
5. Labeling Updates
Products must include a U.S. contact for adverse event reporting on the label.
6. Good Manufacturing Practices
FDA is developing mandatory GMP regulations for cosmetic manufacturing.
Your MoCRA Compliance Checklist
- Register your manufacturing facility on Cosmetics Direct
- List all products with complete ingredient declarations
- Compile safety substantiation documentation
- Establish adverse event reporting procedures
- Update product labels with domestic contact information
- Review ingredient lists against FDA prohibited/restricted lists
- Prepare for GMP compliance requirements
Need Help with MoCRA Compliance?
United Regulatory has helped hundreds of cosmetics companies navigate MoCRA requirements. Contact us for a compliance assessment.