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:
FAQs
What is the purpose of the FDA’s Cosmetic Facility and Product Registration Summary?
The FDA’s Cosmetic Facility and Product Registration Summary provides an overview of registration and product listing data collected under the Modernization of Cosmetics Regulation Act (MoCRA). It highlights the number of registered facilities, listed cosmetic products, and key ingredient categories. The report helps manufacturers understand industry trends, improve transparency, and ensure compliance with FDA regulations.
Who needs to register their cosmetic facility with the FDA under MoCRA?
Any business that manufactures or processes cosmetic products for U.S. distribution must register its facility with the FDA. This includes domestic and foreign manufacturers. However, certain small businesses, distributors, and those producing cosmetics regulated as drugs (like sunscreens or medicated creams) may be exempt. Each product must also be listed with details such as ingredients and responsible person information.
What information must be submitted during cosmetic facility registration and product listing?
Companies must provide the facility name, address, contact details, registration number, and list of cosmetic products manufactured. Product listings must include the product name, category, ingredients, and responsible person’s details. Any updates, such as formulation or label changes, must be reported to the FDA annually to maintain compliance.
How often must cosmetic facilities renew or update their registration with the FDA?
Cosmetic facilities are required to renew their registration every two years. Product listings must be updated annually or whenever significant changes occur — such as discontinuation, ingredient modification, or rebranding. Regular updates ensure that the FDA maintains accurate data for market surveillance and consumer safety oversight.
What are the potential penalties for non-compliance with FDA cosmetic registration requirements?
Failure to register a cosmetic facility or submit product listings can result in regulatory enforcement actions, including warning letters, import detentions, or product recalls. Non-compliant companies may also face distribution restrictions and reputational damage. Staying compliant not only helps avoid penalties but also builds trust with retailers and consumers.
