Quick Answer
The Modernization of Cosmetics Regulation Act (MoCRA) requires cosmetics companies to register facilities, list products, and report serious adverse events. Several key compliance deadlines fall in 2026, with enforcement ramping up. Companies that have not yet started compliance efforts should act immediately.
What Is MoCRA?
The Modernization of Cosmetics Regulation Act, signed into law in December 2022 as part of the Consolidated Appropriations Act of 2023, represents the most significant update to cosmetics regulation in the United States since 1938. MoCRA grants FDA new authority to regulate cosmetics, including mandatory facility registration, product listing, safety substantiation, and adverse event reporting.
For the first time, cosmetics companies must proactively register with FDA rather than operating on a voluntary basis. This shift affects manufacturers, contract manufacturers, private-label brands, and importers of cosmetic products sold in the United States.
If you are new to MoCRA, our comprehensive MoCRA compliance guide covers the full requirements in detail.
Key MoCRA Deadlines in 2026
While the initial registration deadline passed in 2024, several important deadlines and enforcement milestones are relevant for 2026:
Biennial Registration Renewal
Facility registrations must be renewed biennially (every two years). The first biennial renewal for cosmetics facilities is expected in July 2026. Companies that registered in 2024 must renew during this window or lose their active registration status.
Product Listing Updates
Any new products launched in 2026 must be listed within 120 days of market entry. Existing listings must be updated if formulations, ingredients, or product categories change.
Adverse Event Reporting
Serious adverse events must be reported to FDA within 15 business days of receipt. This is an ongoing obligation with no grace period. Records must be maintained for 6 years.
Safety Substantiation
FDA expects companies to have adequate safety substantiation for all marketed products. While there is no specific filing deadline, enforcement actions are increasing in 2026 as FDA builds out its inspection program.
Facility Registration Requirements
Under MoCRA, every facility that manufactures or processes cosmetic products for US distribution must register with FDA. This includes domestic facilities, foreign facilities exporting to the US, and contract manufacturers. The registration is submitted through the Cosmetics Direct system.
Key registration requirements include:
- Facility name and address: The physical location where cosmetics are manufactured or processed
- Contact person: A designated individual responsible for the registration
- Product categories: The types of cosmetic products manufactured at the facility
- US Agent (for foreign facilities): A person or company located in the US to serve as the communication link with FDA
Foreign facilities need a US Agent for cosmetics registration. Assurentry provides comprehensive US Agent services starting at $249/year for MoCRA compliance.
Enforcement Alert
FDA has begun issuing warning letters to cosmetics facilities that have failed to register. Unregistered facilities risk having their products detained at US ports or subject to recalls. Do not wait for an enforcement action to begin your registration.
Product Listing Obligations
In addition to facility registration, MoCRA requires companies to list each cosmetic product marketed in the United States. Product listings must include:
- Product name and brand
- Product category (using FDA's cosmetic product category system)
- Complete ingredient list in descending order of predominance
- Responsible person information
- Fragrance allergens (proposed rule -- FDA NPRM anticipated ~May 2026; not yet required)
Product listings should be updated whenever there is a significant change to the product's formulation. Companies with large product portfolios may find it helpful to use Assurentry's cosmetics compliance tools to manage listings at scale.
Adverse Event Reporting
MoCRA established mandatory adverse event reporting for cosmetics for the first time. Companies must report serious adverse events to FDA within 15 business days of receiving the report. A "serious adverse event" includes any health-related event that results in death, a life-threatening experience, inpatient hospitalization, a significant or persistent disability, a congenital anomaly, or requires medical or surgical intervention.
Companies must also maintain records of all adverse events (serious and non-serious) for a period of 6 years. Adverse event reporting has been required since March 2025, per FD&C Act Section 607 (as amended by MoCRA).
How to Prepare Now
If your cosmetics business has not yet achieved full MoCRA compliance, here are the steps to take immediately:
- Register your facilities: If you have not registered, do so now through Cosmetics Direct or with the help of a registration service.
- List all products: Compile a complete inventory of products sold in the US and submit listings.
- Set up adverse event procedures: Create internal SOPs for receiving, documenting, and reporting adverse events.
- Review labeling: Ensure all product labels comply with MoCRA requirements. Use our labeling reviewer tool for a free check.
- Prepare safety substantiation: Document the safety data supporting each product's ingredients and formulation.
- Calendar your renewal: Set reminders for the October 1 to December 31 annual renewal window.
For a detailed roadmap, see our MoCRA deadlines 2026 guide or check the deadline calculator to see your specific timelines.
Need help with MoCRA compliance?
Our cosmetics compliance team handles facility registration, product listing, and adverse event setup.
Start My MoCRA RegistrationDo Not Wait for FDA Enforcement
MoCRA compliance is not optional. Let Assurentry handle your facility registration, product listing, and ongoing compliance so you can focus on growing your brand.
Stop reading. Start executing.
Assurentry acts as a technical translation layer. You provide basic business info, and we automatically generate and file the exact electronic submissions required by the FDA.
Automate compliance100% FDA Acceptance Guaranteed