On March 13, 2025, the U.S. Food and Drug Administration (FDA) released its first public summary data on the mandatory registration of cosmetic product facilities and the listing of cosmetic products, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
If you’re a manufacturer, processor, or brand owner distributing cosmetics in the U.S., this release marks a key moment. It signals the FDA’s increased oversight and commitment to transparency. Keep reading to learn how these updates may impact your regulatory obligations and what you need to do to stay compliant.
Overview of MoCRA Requirements
Under MoCRA, all facilities that manufacture or process cosmetic products for distribution in the United States must register with the FDA and renew this registration every two years. Additionally, a “responsible person” must list each marketed cosmetic product with the FDA, including product ingredients, and provide annual updates.
Exemptions apply to certain small businesses and to specific products and facilities already regulated as drugs or medical devices.
Key Highlights from the FDA’s Summary Data
The FDA’s new public data provides a snapshot of:
- The number of cosmetic facilities that have registered to date
- Volume and categories of product listings
- Common ingredients reported in listings
The FDA’s Registration and Listing of Cosmetic Product Facilities and Products page provides access to this data. This release helps both regulators and industry stakeholders better understand the current landscape and prepare for future compliance initiatives.
What This Means for Cosmetic Companies
If you manufacture, process, or market cosmetic products in the U.S., it is your responsibility to ensure your facility is registered and your products are properly listed. The release of summary data signals increased monitoring and expectations for compliance.
To stay compliant, ensure you:
- Register your facility with the FDA and renew every two years
- List each marketed cosmetic product and its ingredients
- Submit updates annually or when changes occur
Companies unsure of their obligations or seeking regulatory support are encouraged to consult with regulatory specialists. Quality Smart Solutions offers full-service assistance with FDA cosmetic registration and listing.
Accessing FDA Guidance and Support
If you’re unsure how these requirements apply to your business or want help completing your FDA cosmetic registration, Quality Smart Solutions can guide you through every step. Fill out the form below for a free consultation or contact us directly to speak with a regulatory expert.
For more detailed information, consult the following FDA resources:
