Free tool
MoCRA exemption eligibility checker
Six questions, instant verdict, full citations. We'll email you a copy with regulatory references and a short next-steps guide.
Scope: US federal MoCRA only, for products regulated as cosmetics. Sunscreens are OTC drugs and out of scope; contact-lens products are medical devices and out of scope. If you sell both cosmetic and non-cosmetic products, answer based on the cosmetic portfolio only.
Step 1 of 813% complete
What is your average annual gross US sales of cosmetic products over the past 3 years?
FD&C Act §612 uses 'average gross annual sales in the United States of cosmetic products.' Count only US sales of cosmetic products (not non-cosmetic products and not international sales). Use the 3-year average. The threshold is $1,000,000 — note that FDA has not yet published an inflation adjustment, but may do so in the future. If your brand is newer than 3 years, use the average of the years you have been operating; the statute is silent on shorter periods, so this is a reasonable conservative reading.
Disclaimer. This tool provides a preliminary assessment of MoCRA small-business exemption
eligibility based on the criteria set out in FD&C Act §612 (21 U.S.C. §364h).
It is not legal advice and does not create an attorney-client relationship.
This tool addresses U.S. federal requirements under MoCRA only. It does not
address state or local cosmetic regulations.
This tool applies only to products regulated as cosmetics under the FD&C Act.
Products regulated as OTC drugs (including most sunscreens), medical devices
(including contact-lens products), or dietary supplements are outside its
scope.
Statutory interpretation can be nuanced — particularly for borderline revenue
cases, mixed product portfolios, and corporate-affiliation scenarios — and
FDA guidance continues to evolve. Consult qualified regulatory counsel before
relying on any exemption determination.
This tool is provided "as is" without warranty of any kind, express or
implied.