Probata
Free tool

Does MoCRA require your cosmetic brand to register with FDA?

The Modernization of Cosmetics Regulation Act of 2022 brought the biggest change to US cosmetics regulation in decades — but small brands may qualify for an exemption from facility registration and product listing. Find out where your brand stands in three minutes.

Check my exemption eligibility

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Scope. This tool addresses U.S. federal MoCRA requirements for products regulated as cosmetics. Sunscreens are regulated as OTC drugs (not cosmetics) and are outside its scope. Contact-lens products are regulated as medical devices. If your only products are sunscreens or other non-cosmetics, this tool does not apply to you. For brands that sell both, the verdict assesses only the cosmetic side of your portfolio.
3 minutes
Six questions, plain language, instant verdict with the relevant FD&C Act citations.
Built on the statute
Verdict logic implements FD&C Act §612 (21 U.S.C. §364h) as added by MoCRA. We cite our work.
Not legal advice
For borderline cases — affiliated entities, mixed product portfolios — we'll tell you to consult counsel.

The MoCRA basics

MoCRA — the Modernization of Cosmetics Regulation Act of 2022 — is the first major US cosmetics regulation in over 80 years. It was signed into law on December 29, 2022 as part of the Consolidated Appropriations Act.

Most provisions became effective December 29, 2023. The big ones for brand owners are:

  • Facility registration with FDA, every two years (FD&C Act §607)
  • Product listing for every cosmetic SKU, updated annually (§607)
  • Adverse event reporting, including a 15-business-day deadline for serious adverse events (§605(c))
  • Safety substantiation records for every product (§608)
  • Labeling updates including fragrance allergen disclosure (rule pending)

The FDA cGMP rule for cosmetics is still pending, with a final rule expected 2026–2027.

Under FD&C Act §612, certain small businesses are exempt from facility registration and product listing — but not from any other MoCRA requirement. The exemption has two conditions: revenue under a threshold AND not making certain higher-risk product categories. The free tool walks you through both.