FDA Update: Increased Cosmetics Oversight Under MoCRA

The U.S. Food and Drug Administration (FDA) recently published a Voices blog, highlighting the progress the agency has made in implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA Background

MoCRA instituted a sweeping overhaul of federal cosmetics regulation that significantly expanded the FDA’s authority over the cosmetics and personal care industry. The FDA views MoCRA as the most substantial expansion of FDA cosmetics oversight since the Federal Food, Drug, and Cosmetic Act was enacted in 1938.

MoCRA was signed into law in December 2022 and introduced a broad range of new regulatory requirements aimed at improving consumer safety, increasing transparency, and strengthening FDA enforcement capabilities. The law applies to a wide array of cosmetic products, including makeup, skincare, fragrances, shampoos, and other personal care items used daily by consumers.

Implementation Update

In its recent update, the FDA highlighted several ways the legislation is already reshaping the cosmetics industry. One of the most significant developments is the agency’s increased visibility into cosmetic manufacturing and ingredient use through mandatory facility registration and product listing requirements. The FDA reported:

• 15,000 unique, active cosmetic product facility registrations
• Over 1 million unique, active cosmetic product listings.
• adverse events reported by industry increased by more than threefold

Before MoCRA, the FDA received just 5,176 cosmetic establishment registrations and 35,102 cosmetic product listings through the Voluntary Cosmetic Registration Program. This nearly three-fold increase in registered cosmetic product facilities and a thirty-fold increase in cosmetic product listings highlight the magnitude of the cosmetic marketplace and the importance of  FDA oversight.

MoCRA implementation has also contributed to the advancement of a top FDA priority: identifying PFAS (per- and polyfluoroalkyl substances). In December 2025, the FDA published a report that included safety reviews of the 25 most commonly used PFAS in cosmetic products marketed in the U.S. The FDA identified these PFAS from the new cosmetic product listings that are now mandatory. 

MoCRA Requirements for Importers

Core requirements for safety substantiation, adverse event reporting, and initial record-keeping became effective on December 29, 2023. The FDA began enforcing facility registration and product listing requirements on July 1, 2024 

MoCRA requirements include:

• FDA registration for cosmetics facilities 
• Product listings for each cosmetic product 
• Adverse event reporting 
• Safety substantiation 
• Compliance with Good Manufacturing Practices (GMPs) 
• Fragrance allergen labeling 

MoCRA also gives the FDA new records access and mandatory recall authority. 

The FDA has issued guidance providing recommendations to assist companies in complying with the law. In addition, the agency developed a new online tool – Cosmetics Direct – dedicated exclusively to product facility registration and cosmetic product listing submissions. 

Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com today to assess the impacts of MoCRA on your cosmetic products.

Learn more:

• MoCRA Update: FDA Provides Summary Data on Facility Registrations and Product Listings
• MoCRA Facility and Product Registration Portal Now Open! 
• A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act 
• FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
• Webinar: Getting MoCRA Compliant
• Webinar: FDA 101

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