The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, represents the most significant update to US cosmetics regulation in over 80 years. For cosmetics brands — especially those based in China and Asia — understanding and complying with MoCRA is now essential for continued access to the US market.
| Requirement | Who | Deadline / Status |
|---|---|---|
| Facility Registration | All cosmetic manufacturers, processors, packers | Required since July 1, 2024 |
| Product Listing | Responsible persons (brand owners) | Required since July 1, 2024 |
| Safety Substantiation | Responsible persons | Required (ongoing) |
| Labeling Updates | All cosmetic products | Phased implementation |
| Serious Adverse Event Reporting | Responsible persons | Required since December 2023 |
Under MoCRA, every facility that manufactures or processes cosmetic products for distribution in the US must register with the FDA. Registration must be renewed every two years. For foreign facilities, the registration must include the name and contact information of a US Agent.
Registration is done through the FDA's Cosmetics Direct system. Each facility receives a unique Facility Registration Number (FRN) upon registration.
In addition to facility registration, the "responsible person" (typically the brand owner or US importer) must submit a product listing for each cosmetic product marketed in the US. The product listing must include:
The FDA has authority under MoCRA to take enforcement action against non-compliant facilities and products, including:
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