The Modernization of Cosmetics Regulation Act (MoCRA), passed in 2022, gave FDA much stronger oversight of cosmetics. Foreign manufacturers selling into the US must comply.
Key MoCRA requirements
| Requirement | Who |
|---|---|
| Facility registration with FDA | Facilities manufacturing or processing cosmetics for the US, including foreign facilities |
| Product listing | The "responsible person" (manufacturer, packer or distributor named on the label) |
| Safety substantiation | Responsible person must hold evidence the product is safe |
| Adverse event reporting | Serious adverse events reported to FDA |
| Labelling | Domestic contact information for adverse event reports, ingredient list, net quantity |
Logistics points
- Liquids, aerosols and perfumes may be dangerous goods for air freight — see DG services.
- Temperature-sensitive products may need climate control in summer.
- Products that are also drugs in the US (e.g. sunscreens) follow drug rules.
Related: partner government agencies.