MoCRA Compliance
Self-Check
Twelve questions covering the real obligations in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — FDA facility registration, product listing, safety substantiation, adverse-event reporting within 15 business days and the small-business exemption. Built from FDA sources, last verified October 2026. A self-assessment aid, not legal advice.
Who Carries
Which Duty?
Under MoCRA, the responsible person is the manufacturer, packer or distributor whose name appears on the product label (FD&C Act §609(a)). Most duties below — product listing, safety substantiation, adverse-event reporting — sit with that name. Facility registration sits with whoever owns or operates the manufacturing facility. When LuxeFormula Labs manufactures for your brand, our partner facility is FDA-registered (FEI 3031525994) and we supply CoA, SDS and INCI documentation with every order — but the label-side duties stay with the brand named on the label. Answer for your brand.
Registration, listing, safety, adverse events, labels, GMP, records, exemptions.
The deadline to report a serious adverse event to FDA.
Facility registration renewal cycle; changes updated within 60 days.
Average US sales threshold for the small-business exemption (3-year average).
The 12
Questions
Answer every question — unanswered items are flagged in your results. Nothing you answer is uploaded; scoring runs in your browser.
Get the full checklist by email
Sign up for LuxeFormula Labs Updates and we will email you the full MoCRA checklist — all twelve duties with the FDA source for each, in a printable worksheet. Joining is free, every signup is confirmed by a double opt-in email, and you can unsubscribe at any time.
Built on
FDA Sources
Every obligation in this checker traces to the FDA pages below. MoCRA is still being implemented: as of October 2026, FDA has not finalized the fragrance-allergen disclosure rule or the cosmetic GMP rule the statute requires, so those two items are marked “rule pending — prepare now”. Last verified: October 2026.
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — facility registration, product listing, safety substantiation, adverse events, pending rulemakings.
- FDA — Cosmetics & U.S. Law — responsible-person definition; registration renewal every two years; changes updated within 60 days; annual listing updates.
- Cosmetics Direct (direct.fda.gov) — FDA's portal where facility registrations and product listings are actually filed.