Overview: MoCRA 2025 Enforcement
The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant expansion of FDA authority over cosmetics since 1938. As of 2025, full enforcement is underway.
Updated for 2025 Enforcement
Key Deadlines for 2025
| Deadline | Requirement | Status |
|---|---|---|
| July 1, 2024 | Original Facility Registration & Product Listing deadline | Passed (enforcement discretion applied) |
| January 1, 2025 | Full enforcement of Registration & Listing. FDA inspections begin. | Active |
| December 29, 2025 | GMP (Good Manufacturing Practices) rule finalization deadline | Upcoming |
Source: FDA
1. Facility Registration
Every facility that manufactures or processes cosmetic products for distribution in the US must register with the FDA. This applies to both domestic and foreign facilities.
Key Change from Old Rules
Facility Registration Requirements
- Register through FDA's Cosmetics Direct portal
- Provide facility name, address, and DUNS number
- List product categories manufactured
- Designate a US Agent (for foreign facilities)
- Renew registration biennially
2. Product Listing
Brands must list each cosmetic product with the FDA, including its ingredients and the facility where it was made.
Product listing must include:
- Product name and product category
- Complete ingredient list (in descending order)
- Facility registration number where manufactured
- Responsible person contact information
Annual Updates
3. Safety Substantiation (Critical)
This is the most technically demanding part of MoCRA. Brands must maintain records supporting that their products are safe.
What Counts as "Adequate Substantiation"?
The FDA does not prescribe specific tests, but industry standard (and expected) data includes:
Safety Substantiation Documentation
- Microbiological Testing (USP 61/62)
- Preservative Efficacy Testing (USP 51)
- Stability Testing (Shelf Life)
- Toxicological Risk Assessment (TRA)
- Raw material safety data
- Clinical testing data (if applicable)
Important Change
4. Adverse Event Reporting
Under MoCRA, serious adverse events must be reported to the FDA.
Reporting Requirements:
- Report serious adverse events within 15 business days
- Keep records of all adverse events (even non-serious) for 6 years
- Small businesses: 3-year record retention
- Maintain contact information for adverse event reporting on labels
MoCRA (Modernization of Cosmetics Regulation Act) is US legislation that significantly expanded FDA authority over cosmetics. It was signed into law on December 29, 2022, with various requirements phasing in through 2025.
Yes. If you manufacture, process, or pack cosmetics for distribution in the US — regardless of sales channel — you must register your facility with the FDA, unless you qualify for the small business exemption.
Facilities that fail to register may face FDA enforcement action including warning letters, import alerts (for foreign facilities), or other regulatory consequences. Late registration is still strongly recommended.
No. MoCRA applies to all cosmetics regardless of how they are marketed. Natural, organic, clean, and conventional cosmetics are all subject to the same requirements.
No. Unlike drugs, cosmetics do not require pre-market FDA approval. However, you must register your facility, list your products, and comply with all MoCRA requirements.
Facility registration identifies WHERE cosmetics are made. Product listing identifies WHAT products are sold. Both are required under MoCRA, and both are done through FDA's Cosmetics Direct portal.