US Market Entry: Registration & Filing
MoCRA puts two obligations on the way to the US market: the facility that makes the product must be registered with the FDA, and each marketed product must be listed. The responsible person holds the listing duty and the safety file.
At a glance
- Regulator
- US FDA
- Facility obligation
- Facility registration, renewed every two years
- Product obligation
- A separate listing for each marketed product
- Foreign manufacturers
- Must designate a US Agent as the FDA point of contact
What the market requires
Facility registration
Cosmetics manufacturing or processing facilities for the US market register with the FDA and keep that registration current. A brand does not register itself; it relies on the facility making its product being registered.
Product listing
Each marketed cosmetic must be listed, identifying the product and the responsible person. Listings are per product rather than per formula, so a twelve-shade range is twelve listings rather than one.
Responsible person and the safety file
MoCRA places the safety substantiation duty and the adverse event obligations on the responsible person, which in an import arrangement is normally the brand or its importer rather than the factory.
What this means for your brief
Because the facility side is already registered, the practical work for a launch sits on your side: supplying product data for listing and holding the safety file. Ask for the facility's registration details at quotation stage, because a listing cannot be completed without them.
What we provide
- An FDA-registered facility under MoCRA, so the facility half of your filing is already in place
- Facility registration details and the documentation your product listing references
- The formula documentation and testing records your safety file is built from
Capabilities above are limited to what is verifiable: GMPC and ISO 22716 certification audited by third parties, cosmetics production licence 粤妆20250206, and FDA MoCRA facility registration. See certifications.
Market questions
Do I need to register with the FDA as a brand?
No. Under MoCRA the facility registers and the product is listed. A brand that imports generally acts as the responsible person, which carries the safety substantiation and adverse event duties.
Does facility registration cover every product?
No. Registration covers the facility, while each marketed product is listed separately. Both are filed through the same FDA portal, but they are distinct obligations.
More on United States market entry
Regulatory requirements change. Confirm the current position for your product with your local adviser or appointed representative before you place artwork or place an order. See also certifications and compliance and the sourcing glossary.
Sourcing for United States?
Send your product brief with the destination market — quotation and formula recommendations within 24 hours.
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