What Is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant overhaul of U.S. cosmetics regulation in over 80 years. Signed into law on December 29, 2022, as part of the Consolidated Appropriations Act of 2023, MoCRA fundamentally changes the FDA's authority over cosmetics and imposes new mandatory requirements on both domestic and foreign cosmetics companies.
Before MoCRA, the FDA had very limited authority over cosmetics. Companies were not required to register facilities or list products. MoCRA changed all of that.
Key Changes Under MoCRA
1. Mandatory Facility Registration
Every facility that manufactures or processes cosmetic products for distribution in the United States must register with the FDA. This includes foreign facilities. Registration must be renewed every two years.
Initial registration deadline: Domestic facilities had until December 29, 2023. Foreign facilities had until December 29, 2023 (same date).
2. Mandatory Product Listing
All cosmetic products marketed in the United States must be listed with the FDA. Product listing must include:
- The cosmetic product name
- List of ingredients (in INCI format where established)
- The facility registration number of the facility where the product is manufactured
- Name and contact information of the responsible person
3. Responsible Person Designation
MoCRA requires each cosmetic product to have a designated "Responsible Person" — the manufacturer, packer, or distributor whose name appears on the product label. The responsible person bears legal responsibility for compliance.
4. Adverse Event Reporting
Responsible persons must report to the FDA any serious adverse events associated with cosmetics within 15 business days of receiving information about the event. Records of all adverse events (serious or not) must be maintained for 6 years.
5. Safety Substantiation
Responsible persons must ensure each cosmetic product and its ingredients are safe under intended conditions of use and labeled appropriately. While MoCRA does not require pre-market safety approval, it makes safety substantiation a formal legal obligation.
6. Mandatory Recall Authority
For the first time, the FDA now has the authority to order a mandatory recall of cosmetics that it believes pose a serious risk to consumers. Previously, all cosmetics recalls were voluntary.
Timeline for Compliance
MoCRA Compliance Deadlines
- December 29, 2023: Facility registration and product listing required for most companies
- December 29, 2024: Small businesses (under $1M annual receipts) facility registration and product listing deadline
- July 1, 2025: Fragrance allergen labeling requirements (when FDA finalizes rule)
- Ongoing: Adverse event reporting (already in effect)
What Counts as a Cosmetic Under MoCRA?
MoCRA uses the same definition of cosmetic as the existing FD&C Act: articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.
Products that are both cosmetics and drugs (such as SPF sunscreens, anti-dandruff shampoos, fluoride toothpastes) are subject to both cosmetic and drug regulations.
How Regovant Can Help
Regovant handles complete MoCRA facility registration and product listing for foreign cosmetic manufacturers. We designate as your U.S. Agent, handle all FDA communications, and ensure your registrations are current with every renewal cycle.