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MoCRA eligibility — frequently asked questions
Do I need a MoCRA US agent?
If your facility is outside the United States and manufactures or processes cosmetics sold in the US, yes — a foreign facility cannot complete FDA registration without a designated US agent on file. Take the 2-minute eligibility checker above for a read on your situation.
What is the MoCRA small business exemption?
Businesses averaging under $1 million in gross US cosmetics sales over the previous three years are generally exempt from facility registration and product listing. The exemption does not cover adverse-event reporting or labeling duties — and it disappears if you make higher-risk products (eye-area, injected, internal-use, or >24-hour wear products).
I use a contract manufacturer. Who registers with the FDA?
Only one registration is needed per facility — filed either by the manufacturer or by you as the responsible person. If that facility is outside the US, it needs a US agent on file. Ask your manufacturer which country the facility is in and whether it is already registered.
Can I switch from my current US agent?
Yes. The incoming agent files an amended registration with the FDA — it is a straightforward process. See our step-by-step transfer guide.
Is this checker legal advice?
No. It is general information based on the FDA’s published MoCRA rules, and rules can change. For service and pricing questions, see our FAQ or contact us.