MoCRA represents the most significant overhaul of US cosmetic regulation in 80 years. Whether you sell on Amazon, Sephora, or your own Shopify, these requirements apply.

Facility Registration

Every facility that manufactures or processes cosmetics for the US market must register with the FDA and renew biennially. Your contract manufacturer should provide their registration number on request.

Product Listing

Each finished product must be listed with FDA, including its full ingredient declaration. Listings must be updated annually.

Adverse Event Reporting

Brands are now legally required to maintain records of serious adverse events for six years and report them to FDA within 15 business days.

Safety Substantiation

You must hold records that demonstrate adequate substantiation of safety for every product. This typically includes stability data, challenge testing, and toxicological assessment.