United States · Cosmetics
US MoCRA Facility Registration and Product Listing
A practical guide to US MoCRA Facility Registration and Product Listing for cosmetics sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.
Who needs this
- Cosmetic manufacturers, processors, and packagers
- Importers and brands responsible for products marketed in the US
Documents you need
- Facility registration confirmation
- Product listing with ingredient information
- Safety substantiation file
- Adverse event contact details
Compliance checklist
Tick each item as you collect it. Saved in this browser only.
How to comply
- Register each manufacturing or processing facility
- List each marketed cosmetic product
- Prepare and maintain safety substantiation
- Renew registration and listing every two years
Brief for your lab or agent
Copy this into an email, then edit the product and channel.
Request: US MoCRA Facility Registration and Product Listing — United States Product category: Cosmetics Authority: US Food and Drug Administration (FDA) Legal basis: Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Documents we already have: 1. Facility registration confirmation 2. Product listing with ingredient information 3. Safety substantiation file 4. Adverse event contact details Questions: 1. Does our product fall under US MoCRA Facility Registration and Product Listing in the United States? 2. Which test standards or evidence do you accept? 3. What is the current fee and lead time? 4. Is a local representative required, and can you act as one?
Cost and timeline
Registration and listing before marketing; renewal on the biennial cycle.
FDA does not charge a fee for registration or listing.
Common rejection reasons
- Facility not registered before shipment
- Product missing from the listing
- No responsible person or US agent named
Official sources
FAQ
Do small brands still need to list products?
Yes, unless a specific exemption applies; the responsible person must keep the listing current.
Is MoCRA the same as an FDA approval?
No. It is a registration and listing regime, not a pre-market approval.
How long does US MoCRA Facility Registration and Product Listing take?
Registration and listing before marketing; renewal on the biennial cycle.
How much does US MoCRA Facility Registration and Product Listing cost?
FDA does not charge a fee for registration or listing.
What happens if I sell without it?
Refusal of entry and enforcement action for unregistered products.
Who regulates US MoCRA Facility Registration and Product Listing in the United States?
US Food and Drug Administration (FDA).
Related requirements
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