The U.S. Food and Drug Administration (FDA) has released summary data from mandatory registration of cosmetic product facilities and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
MoCRA Background & Requirements
MoCRA was passed in 2022 in an effort to modernize and strengthen cosmetic regulations in the United States. MoCRA replaced the previous Cosmetic Act, which had not been updated since 1938.
Subsequent to the bill's passage, the FDA issued regulations implementing the law. In issuing MoCRA regulations, FDA's aim was to help ensure the overall safety of cosmetic products, and expand the Agency's ability to trace and track non-compliant products and facilities.
MoCRA Requirements:
- FDA registration for cosmetics facilities
- Product listings for each cosmetic product
- Adverse event reporting
- Safety substantiation
- Compliance with Good Manufacturing Practices (GMPs)
- Fragrance allergen labeling
MoCRA also gives the FDA new records access and mandatory recall authority.
The FDA has issued guidance providing recommendations to assist companies in complying with the law. In addition, the agency developed a new online tool – Cosmetics Direct – dedicated exclusively to product facility registration and cosmetic product listing submissions.
New Data
As of January 1, 2025, the number of unique, active facility registrations is 9,528 and the number of unique, active product listings is 589,762.
The top five states for number of domestic registered facilities are:
- California (373)
- Florida (201)
- New Jersey (144)
- Texas (120)
- New York (118)
The top five countries for foreign registered facilities are:
- China (4,260)
- South Korea (617)
- India (309)
- Italy (273)
- France (245)
Are You MoCRA Compliant?
The MoCRA compliance deadline was July 1, 2024.
Companies behind on registration should immediately establish who is responsible for registering products and facilities, and also put in place processes for adverse event reporting, recall inquiries, and record keeping.
Not sure what is required to register a facility or list a cosmetic product? Our online portal will take you through the process step-by-step to ensure you are in compliance.
On our website you can:
- Register a facility
- Assign Diaz Trade Consulting as your U.S. Agent (it is mandatory for foreign facilities to have a U.S. Agent)
- List a cosmetics product
- Pay registration fees
- Complete annual renewal
- Request a UNII code
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
