United States · Cosmetics
MoCRA Facility Registration in the United States
A practical guide to MoCRA Facility Registration for cosmetics sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.
Who needs this
- Facilities that manufacture or process cosmetic products for U.S. distribution
- Foreign facilities shipping cosmetics into the United States
Documents you need
- Facility legal name and physical address
- Owner or operator contact details
- U.S. agent name and contact details
Compliance checklist
Tick each item as you collect it. Saved in this browser only.
How to comply
- Check whether the facility is covered or exempt
- Register through the FDA portal
- Update the registration when ownership or address changes
Brief for your lab or agent
Copy this into an email, then edit the product and channel.
Request: MoCRA Facility Registration — United States Product category: Cosmetics Authority: U.S. Food and Drug Administration (FDA) Legal basis: MoCRA, FD&C Act Section 613 Documents we already have: 1. Facility legal name and physical address 2. Owner or operator contact details 3. U.S. agent name and contact details Questions: 1. Does our product fall under MoCRA Facility Registration 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
Register before products reach the market; updates are ongoing.
No published flat fee; confirm portal requirements.
Common rejection reasons
- Registering a product instead of a facility
- Outdated or incomplete contact information
- Duplicate registrations for the same site
Official sources
FAQ
Who must register a facility?
Owners or operators of facilities that manufacture or process cosmetics for U.S. distribution, subject to limited exemptions.
Is a U.S. agent required?
Foreign facilities must designate a U.S. agent as part of registration.
What triggers an update?
Changes to the facility name, address, contact, or ownership should be reflected in the registration.
How long does MoCRA Facility Registration take?
Register before products reach the market; updates are ongoing.
How much does MoCRA Facility Registration cost?
No published flat fee; confirm portal requirements.
What happens if I sell without it?
Product detention and enforcement action for unregistered facilities.
Who regulates MoCRA Facility Registration in the United States?
U.S. Food and Drug Administration (FDA).
Related requirements
Need this checked before launch?
Send the product, target market, and sales channel. You get a document checklist, the gaps, and the official route to fix them.
Request a pre-auditFixed fee $199 · report within 48 hours · free fit check first