MoCRA
Companies that have distributed or marketed cosmetic or personal care products in the U.S. before December 29, 2022, must meet two crucial FDA deadlines this year.
1. Product Listings
Every facility distributing cosmetic or personal care products in the U.S. must now submit a comprehensive cosmetic product listing, including ingredients, fragrance or flavor, responsible person, and manufacturing facility details. We offer assistance in handling these product listings with the FDA, allowing you to focus on your operations.
2. Facility Registration
All cosmetic companies must register with the FDA and ensure compliance with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). If your facility is outside the U.S., you'll need a mandatory U.S. Agent for FDA communications, and we can act as your international facility's responsible person.
MoCRA will bring significant changes to the cosmetic industry, including:
- Mandatory FDA Registration for cosmetic facilities
- Mandatory Product Listings for all cosmetics marketed in the USA
- Adverse Event Reporting
- Adherence to FDA-issued Good Manufacturing Practices (GMPs)
- Record Keeping, including adverse event and safety substantiation records
- Mandatory Recalls
- Declaration of Fragrance Allergens
