The Food and Drug Administration (FDA) is set to start enforcing the requirements of the Modernization of Cosmetics Regulation Act (MoCRA) on July 1, 2024. Manufacturers, distributors, or packers of cosmetic products must comply with the requirements to avoid an enforcement action.
MoCRA Background
In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety.
MoCRA was passed in 2022 and aims 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 brings significant changes to the cosmetic industry and regulations under MoCRA impact the entire lifecycle of cosmetics products from manufacturing to marketing.
MoCRA Requirements
New MoCRA requirements include:
- 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.
Take Action Now to Ensure You are in Compliance!
Companies 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.