The short answer
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became law on December 29, 2022. Almost four years later, the parts that apply directly to companies are in force — facility registration, product listing, serious adverse event reporting, safety substantiation and the U.S. contact on labels. The parts that need FDA rules are still waiting: there is no cosmetic GMP rule and no fragrance allergen labeling rule yet, and FDA withdrew its talc testing proposal in November 2025.
What is in force now
| Requirement | Status | What you must do |
|---|---|---|
| Facility registration | In force; FDA has enforced since July 1, 2024 | Register each facility that manufactures or processes cosmetics for the U.S. Renew every 2 years; update within 60 days of changes. |
| Product listing | In force | The responsible person lists each product with its ingredients and updates listings every year. |
| Serious adverse events | In force | Report serious adverse events to FDA within 15 business days. Keep adverse event records for 6 years (3 years for qualifying small businesses). |
| Safety substantiation | In force | Keep records showing each product is safe. The law does not set specific tests. |
| U.S. contact on labels | In force | Labels must show a U.S. address, U.S. phone number or electronic contact (such as a website) for adverse event reports. |
| Mandatory recall | FDA authority in force; draft Q&A guidance December 2025 | Have a recall procedure ready. |
What is still pending
- Good Manufacturing Practice (GMP) rule. MoCRA requires FDA to issue cosmetic GMP regulations. As of November 2026, no proposed rule has been published. FDA’s warning letters already show it expects sanitary manufacturing, especially at sites that make both drugs and cosmetics.
- Fragrance allergen labeling. MoCRA requires FDA to identify fragrance allergens that must be named on labels. FDA’s regulatory agenda targeted a proposed rule for November 2026, but these dates often slip. Until a final rule exists, “fragrance” on the label is still allowed.
- Talc testing. FDA proposed asbestos testing methods for talc-containing cosmetics on December 27, 2024, then withdrew the proposal on November 28, 2025, saying it will issue a revised one.
- PFAS. FDA published its required report on PFAS in cosmetics on December 29, 2025. It found insufficient data to reach safety conclusions.
Key facts about registration and listing
- FDA does not issue certificates. In September 2026 FDA repeated that it does not provide certificates for cosmetic registration, and that registration and listing are not approval. See Does FDA issue registration certificates?
- Foreign facilities need a U.S. Agent for registration.
- The facility number is the FEI. FDA uses the FEI number as the facility registration number in Cosmetics Direct, so foreign facilities need an FEI first.
- Small businesses may be exempt from registration and listing, but not for every product type. See the MoCRA small business exemption.
Example: a skincare brand in South Korea
A brand that makes serums in South Korea and sells through a U.S. distributor needs: the factory registered with FDA (with a U.S. Agent), each product listed by the responsible person, a U.S. contact on every label, a process to report serious adverse events within 15 business days, and safety records for each formula. It should also plan for fragrance allergen labeling — EU allergen lists are a sensible starting point.
What to do now
- 1Check your registration is currentRenew every 2 years and update within 60 days of changes such as a new address or new product categories.
- 2Update listings every yearNew products, discontinued products and formula changes.
- 3Fix labelsU.S. contact for adverse events, English ingredient list in descending order, and no drug claims.
- 4Build your safety fileIngredient data, stability and microbiology results, and the reasoning that the product is safe as used.
- 5Prepare for GMP and allergensISO 22716 is a practical base for GMP; know which fragrance allergens your products contain.
Cosmetic facility registration with U.S. Agent from $300 (1 year) or $450 (2 years). Product listing $150 per product. Cosmetic label review $250.
Frequently asked questions
When did MoCRA take effect?
MoCRA became law on December 29, 2022. Facility registration and product listing were due from December 29, 2023, and FDA began enforcing them on July 1, 2024.
Has FDA issued the cosmetic GMP rule?
Not yet. As of November 2026, FDA had not published a proposed GMP rule for cosmetics.
Do I have to list fragrance allergens on US labels now?
Not yet. MoCRA requires FDA to make a rule first, and that rule has not been finalized. FDA’s agenda targeted a proposal for November 2026.
How fast must serious adverse events be reported?
Within 15 business days after the responsible person receives the report.
Sources
- FDA — FDA clarifies it does not provide certificates for cosmetic registration (September 9, 2026)
- Foley & Lardner — How MoCRA is reshaping FDA oversight of cosmetics in 2026 (March 2026; talc withdrawal 90 FR 54603, PFAS report, dashboard)
- Crowell & Moring — FDA delays enforcement of MoCRA registration and listing to July 1, 2024
- dicentra — MoCRA in 2026: what has changed (October 2026)
- Certified Cosmetics — FDA agenda targets November 2026 for fragrance allergen proposal (July 2026)
Dates checked on November 11, 2026. Rule dates on FDA’s agenda can change; check FDA’s MoCRA page for updates. This article is general information, not legal advice.