score

MoCRA Compliance Readiness Score

redflags

We sell cosmetics in the US and MoCRA applies to us — we've confirmed it

We're a small business — under about $1M in average annual US cosmetic sales over the last 3 years

Honestly, we've never checked whether MoCRA applies to us

Does MoCRA actually apply to your operation?

Yes — our facility (or our contract manufacturer's facility) is registered, and we've verified it

Our manufacturer says they handle it — we've never verified it ourselves

We assumed our small-business exemption covered registration

Is the facility that manufactures your products registered with FDA?

Does your label carry a domestic address, phone number, or electronic contact (a website alone counts) where adverse event reports can be received?

Our distributor / manufacturer handles listings — we've never seen them

No — we didn't know products had to be listed

Has each of your cosmetic products been listed with FDA by the Responsible Person — the company whose name is on the label?

Yes — the full dossier is on file and current

Partial — we have some testing (e.g., stability) but not the full package

Our manufacturer holds the data — we've never reviewed it

If FDA asked tomorrow, could you produce a safety substantiation dossier — tests, studies, and evidence supporting a reasonable certainty that your products are safe?

Not sure — we've never checked our label against the requirements

Only on social media / our Amazon listing — not on the label

Our marketing team / agency writes the copy — I'm not sure what it says

Yes — we've used 'heals,' 'treats,' or 'repairs' in marketing

Do your label, website, or social media use words like 'treats eczema,' 'stimulates collagen,' or 'repairs the skin barrier'?

We have a written procedure: triage serious vs. non-serious, report serious events to FDA within 15 business days, and retain all adverse-event records

We'd take care of the customer, but we have no formal reporting procedure

Our distributor / retailer handles complaints — we never see them

We didn't know cosmetic brands had to report anything to FDA