MoCRA Cosmetics Guide: What FDA Now Requires from Foreign Manufacturers

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, fundamentally changed FDA oversight of the cosmetics industry. For the first time, cosmetics facilities that manufacture or process products for the US market must register with the FDA and submit product listings with ingredient information.

Facility Registration and Product Listing

FDA now requires every cosmetics facility to register and list each product along with its ingredients. This is a separate process from food facility registration and uses its own FDA portal. Both domestic and foreign facilities must comply.

Adverse Event Reporting

Under MoCRA, serious adverse events must be reported to the FDA within 15 business days. Companies must maintain records of complaints and establish a system for reviewing safety data related to their products.

Safety Substantiation and GMP

Every cosmetic product must have adequate safety substantiation, including ingredient review, product testing, and available safety data. All facilities must also operate in compliance with Good Manufacturing Practices (GMP) as defined by FDA.

Small Business Exemption

Companies with annual US sales below one million dollars may be exempt from certain requirements, but facility registration and product listing remain mandatory regardless of revenue.

Enforcement and How FDABridge Can Help

FDA has begun enforcement actions. Cosmetics shipped without proper registration can be detained at the border. FDABridge helps cosmetics manufacturers achieve full MoCRA compliance, from registration through product listing. Contact us at fdabridge.com.