MoCRA 2025: Cosmetics Facility Registration & Product Listing
Introduction
The cosmetics industry is facing a significant regulatory shift with the introduction of the Modernization of Cosmetics Regulation Act (MoCRA). For the first time in over 80 years, the FDA has new authority to oversee cosmetic products in the United States. If you’re a cosmetics manufacturer, distributor, or brand owner, understanding the new registration and product listing requirements is crucial for your continued access to the U.S. market.
Understanding MoCRA 2025
Definition and Purpose
MoCRA represents the most substantial update to cosmetics regulations since the Federal Food, Drug, and Cosmetic Act of 1938. Signed into law as part of the Consolidated Appropriations Act of 2023, MoCRA aims to enhance safety standards and bring much-needed transparency to the cosmetics industry.
Before MoCRA, the FDA had limited oversight of cosmetic products. Companies weren’t required to register their facilities, list their products, or even report adverse events. This created potential safety gaps that the new legislation addresses head-on.
Key Provisions of MoCRA
Facility Registration
One of the cornerstones of MoCRA is mandatory facility registration. All facilities that manufacture or process cosmetic products for U.S. distribution must register with the FDA. This includes:
- ✔️ Domestic manufacturers and processors
- ✔️ Foreign facilities that export to the U.S.
- ✔️ Contract manufacturers
- ✔️ Private label manufacturers
Registration must include basic information about the facility, such as its name, address, and the types of activities performed there. For many companies, this represents a completely new FSVP compliance requirement.
The registration process opens on January 1, 2024, with an initial deadline of July 1, 2024. After that, facilities will need to renew their registrations every two years.
Product Listing
Alongside facility registration, MoCRA requires cosmetic product listing with the FDA. This means companies must submit information about each product they manufacture or distribute in the U.S., including:
- ✔️ Product name and category
- ✔️ Complete list of ingredients
- ✔️ Copy of the product label
- ✔️ Contact information for adverse event reporting
Product listings must be submitted by July 1, 2024, and updated annually. This creates a comprehensive database that helps the FDA track products and respond quickly to safety concerns.
Safety Regulations
MoCRA introduces new safety requirements for cosmetic products. Companies must:
- ✔️ Maintain records of product safety substantiation
- ✔️ Report serious adverse events to the FDA within 15 business days
- ✔️ Include contact information on product labels for adverse event reporting
These safety measures aim to prevent harmful products from reaching consumers and enable quick action when safety issues arise.
FDA Authority
The FDA now has enhanced powers under MoCRA, including:
- ✔️ Authority to suspend facility registrations if products present serious health risks
- ✔️ Ability to order mandatory recalls for unsafe products
- ✔️ Right to access records related to serious adverse events
- ✔️ Authority to inspect registered facilities
These new powers give the FDA real teeth to enforce compliance and protect public health.
Implementation Timeline
MoCRA’s provisions are being phased in gradually:
- ✔️ December 29, 2022: MoCRA enacted
- ✔️ December 29, 2023: Good Manufacturing Practices (GMP) regulations to be proposed
- ✔️ January 1, 2024: Facility registration and product listing systems open
- ✔️ July 1, 2024: Deadline for initial facility registrations and product listings
- ✔️ December 29, 2024: Final GMP regulations to be issued
This timeline gives companies time to understand the requirements and implement necessary changes to their operations.
Impact on the Industry
Increased Accountability
MoCRA creates a framework of accountability that hasn’t previously existed in the cosmetics industry. By requiring facility registration, product listing, and adverse event reporting, the law ensures that companies take responsibility for the safety of their products.
For consumers, this means greater confidence that the products they use daily meet basic safety standards. For businesses, it means new compliance obligations but also an opportunity to demonstrate commitment to product safety.
Industry Adjustments
Companies will need to adapt to MoCRA’s requirements by:
- ✔️ Establishing systems for tracking and reporting adverse events
- ✔️ Developing comprehensive product safety files
- ✔️ Implementing or enhancing Good Manufacturing Practices
- ✔️ Creating processes for facility registration and product listing
These changes may require significant resources, particularly for smaller companies that may not have dedicated regulatory staff.
How to Register Your Cosmetics Facility Under MoCRA 2025
The registration process for cosmetics facilities under MoCRA involves several key steps:
- ✔️ Determine if your facility requires registration (manufacturers, processors, packers)
- ✔️ Gather necessary information about your facility and responsible individuals
- ✔️ Create an account in the FDA’s registration portal (launching January 2024)
- ✔️ Complete the registration form with accurate facility information
- ✔️ Submit the registration and retain confirmation for your records
Remember that registrations must be renewed every two years, and any significant changes to facility information must be reported to the FDA within 60 days.
Guidelines for Cosmetics Product Listing MoCRA 2025
When preparing your product listings, follow these guidelines:
- ✔️ Compile a comprehensive inventory of all products distributed in the U.S.
- ✔️ Ensure you have complete and accurate ingredient lists for each product
- ✔️ Prepare digital copies of product labels
- ✔️ Organize contact information for adverse event reporting
- ✔️ Set up systems to track product formulation changes for annual updates
Product listings must include all cosmetic products your company manufactures or distributes for retail sale in the United States.
Compliance with MoCRA 2025 for Cosmetics
Achieving compliance with MoCRA goes beyond just registration and listing. Companies should:
- ✔️ Review and update safety substantiation for all products
- ✔️ Implement systems for adverse event tracking and reporting
- ✔️ Ensure labels meet all new requirements
- ✔️ Stay informed about evolving Good Manufacturing Practices
- ✔️ Train staff on new regulatory requirements and procedures
Being proactive about compliance can help prevent costly regulatory issues down the road.
Cost of Cosmetics Facility Registration MoCRA 2025
The FDA has announced that facility registration under MoCRA will involve fees, though the exact fee structure hasn’t been finalized. Companies should budget for:
- ✔️ Initial registration fees (expected to be tiered based on company size)
- ✔️ Biennial renewal fees
- ✔️ Costs associated with systems for maintaining compliance
- ✔️ Potential consultant fees for regulatory assistance
For many businesses, especially smaller ones, these costs represent a new line item in their operational budgets.
Conclusion
MoCRA 2025 marks a watershed moment for cosmetics regulation in the United States. The new requirements for facility registration and product listing create greater transparency and accountability throughout the industry. While compliance will require effort and resources, the end result should be safer products and greater consumer confidence.
Companies that start preparing now will be better positioned to meet the July 2024 deadlines without disruption to their business. Taking a proactive approach to MoCRA compliance is not just about avoiding regulatory issues—it’s about demonstrating a commitment to product safety and quality.
Need help navigating the new MoCRA requirements? Global Import Agent can guide your cosmetics business through the facility registration and product listing process with confidence. Our FDA compliance specialists have extensive experience helping companies meet regulatory requirements for U.S. market access. We’ll handle the complex paperwork and ensure you meet all deadlines, allowing you to focus on your products. Contact us today for a personalized consultation and learn how we can streamline your MoCRA 2025 compliance journey.
