MoCRA Small Business Exemption Worksheet

Do you qualify for the small business exemption?

Answer 5 quick questions for an instant read. MoCRA exempts small businesses from FDA facility registration, product listings, and GMP — but only if your U.S. sales stay under the threshold and none of your products fall into four higher-risk categories.

1 What were your average gross annual U.S. sales of cosmetic products over the previous 3 years?
2 Do you make any products that regularly contact the mucus membrane of the eye under normal conditions of use?

Examples: mascara, eyeliner, eye shadow, eye creams or serums.

3 Do you make any products that are injected?

Example: dermal fillers.

4 Do you make any products intended for internal use?

Examples: mouthwash, breath sprays. (Lip products like lipstick and lip balm are applied to the lips rather than taken internally; if you are not sure whether a product counts, choose “Not sure” below or run the full eligibility checker.)

5 Do you make any products intended to alter appearance for more than 24 hours, where removal is not part of normal use?

Examples: permanent hair dyes, tattoo inks, permanent makeup.

Next step: run the full eligibility check

This worksheet covers the small business exemption only. Our free 5-question eligibility checker looks at the whole picture — facility location, U.S. sales, and agent status — and tells you exactly what to do next.

Run the eligibility checker

Need a U.S. agent?
We handle the FDA facility registration, FEI, and act as your designated U.S. agent — $450 one-time + $34.99/mo.

Start intake See pricing

Or reach us directly: usmocra@outlook.com · +1 (909) 997-0000

This worksheet is general information, not legal advice. We are not affiliated with, endorsed by, or acting on behalf of the FDA.

Powered by
Scroll to Top