Key takeaways
- Facility registration and product listing are required for cosmetics sold in the US.
- Foreign manufacturers selling into the US must register their facilities.
- Serious adverse events must be reported and records kept.
The Modernization of Cosmetics Regulation Act changed the US cosmetic market from a largely self-regulated one to a registered one. Facility registration, product listing and adverse event reporting now apply, and they apply to foreign manufacturers selling into the US as well as to domestic ones.
1. Facility registration
A facility that manufactures or processes a cosmetic product for the US market must register with the FDA and renew every two years. The registration covers the facility and its activities rather than individual products. A contract manufacturer registers once and makes products for many brands.
2. Product listing
Each cosmetic product must be listed with the FDA, with the responsible person, the categories and the ingredient list. The listing is per product, and a brand with fifty SKUs has fifty listings. The listing must be updated when the formula or the name changes.
3. Responsible person
MoCRA introduces a US responsible person: the brand or the manufacturer whose name appears on the label. A foreign brand selling into the US without a US entity needs to arrange for one, and the arrangement has to be documented.
4. Adverse events
Serious adverse events must be reported to the FDA within a defined period, and records of all adverse events must be kept. A brand without a complaint intake process cannot meet this obligation, which means the process is a compliance requirement rather than a customer service nicety.
5. Safety substantiation
MoCRA requires that a product be substantiated for safety, and the substantiation must be retained. It does not prescribe a specific method, which means the brand chooses the evidence and must be able to defend it. A CPSR-style file is the practical route.
6. Fragrance and allergens
Fragrance allergen disclosure is part of the MoCRA framework, with a defined list and a threshold. A fragrance-heavy formula will need a longer INCI panel and updated artwork. Plan the label change before the listing.
7. Talc and asbestos
Products containing talc must be tested for asbestos under a defined method. A pressed powder using talc needs a test result per lot, and the record must be retained. This is one of the few MoCRA requirements with a specific analytical method.
8. Deadlines and enforcement
The registration and listing obligations came into force on a schedule, and the FDA has signalled enforcement against unregistered products. A brand that sells into the US without registration is exposed to a market withdrawal rather than a warning letter.
9. Interaction with state rules
US state laws on ingredient bans and on packaging are moving faster than the federal framework. A product compliant under MoCRA can still be non-compliant in a specific state. Compliance planning has to include the states where the product actually sells.
10. Cost
Registration and listing are administrative and low cost per product. The real cost is the record-keeping system, the adverse event process and the label change. For a small brand, the administrative burden is the constraint rather than the fee.
11. Where it fits
US market entry runs across the capsule serum range; the EU equivalent continues in the responsible person entry.
Reference: US FDA cosmetic reform guidance and registration records, 2025
