How FDA is Implementing Landmark Cosmetics Legislation to Positively Impact Public Health
By: Steven Kozlowski, M.D., Chief Scientist
Over the course of a single day, most Americans use multiple cosmetic products including face and body cleansers, shaving cream, and haircare products.
While cosmetic products were included in the landmark 1938 Federal Food, Drug, and Cosmetic (FD&C) Act that overhauled the U.S. Food and Drug Administration’s oversight of food and drugs and gave the agency authority over cosmetics, the FDA's cosmetics authority saw limited expansion between 1938 and 2022, with the Fair Packaging and Labeling Act of 1967 being a notable exception.
This meant that the FDA had fewer tools to protect public health and help ensure safe cosmetic products than it did for other FDA-regulated products. For example, although cosmetic companies and individuals who market cosmetics are responsible for ensuring the safety of their products, there were no requirements to register cosmetic facilities with the FDA, to list cosmetic products, or to report serious adverse events as many other FDA-regulated companies did.
Expansion of FDA’s Authority over Cosmetics with MoCRA
This changed on December 29, 2022. After more than a decade-long bipartisan effort, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), significantly expanding the FDA’s authority over cosmetics and establishing substantial new requirements for cosmetic companies and individuals who market cosmetics in the United States.
MoCRA provided new authorities to the FDA including mandatory recall and records access authority. Responsible persons are also now required to report serious adverse events to FDA and maintain records supporting that there is adequate substantiation of the safety of their cosmetic products. The FDA was directed to establish regulations for fragrance allergen labeling requirements, and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
MoCRA also established requirements for cosmetic product manufacturers and processors to register facilities and for responsible persons to list marketed cosmetic products, including product ingredients, with the FDA. In addition, the FDA was directed to establish regulations for good manufacturing practices (GMPs) for facilities that manufacture or process cosmetic products; MoCRA provides exemptions for certain small businesses from the facility registration, product listing and GMP requirements.
Wide Array of Achievements Implementing Provisions of MoCRA over Three Years
Over the last three years, the FDA has worked tirelessly, mostly using existing resources, to implement the provisions added or required by MoCRA. Achievements implementing MoCRA include:
- Issuing multiple guidance documents on cosmetic product facility registration and product listing and developing tools to assist industry in this process. By March 2025, the FDA began providing summary data of numbers of cosmetic product facility registrations and cosmetic product listings that is updated regularly at Registration & Listing of Cosmetic Product Facilities and Products | FDA.
- Launching Cosmetics Direct, an electronic submissions portal for the registration and listing of cosmetic product facilities and products, in addition to the Electronic Submissions Gateway Next Generation (ESG NextGen) and paper submission options.
- Updating tools and applications to assist industry in submitting mandatory serious adverse event reports for cosmetic products.
- Issuing draft guidance documents to provide clarity on the FDA’s mandatory recall and records access authority for cosmetics.
- Holding a virtual listening session to consult cosmetics manufacturers, including smaller businesses and contract manufacturers, and consumer organizations to help inform the FDA’s development of cosmetic GMP regulations.
Important New Information Positively Impacts Public Health
Already, the new FDA authorities over cosmetics added by MoCRA have yielded important information that can be used to positively impact public health.
For example, prior to MoCRA, only a fraction of adverse events associated with cosmetic products were reported by industry because such reporting was voluntary. Following implementation of MoCRA, the number of adverse events reported by industry to the FDA increased by more than three-fold. Further, adverse event data are now accessible to the public in the recently announced FDA Adverse Event Monitoring System, which is a single, streamlined, user-friendly dashboard for all adverse events reported to the FDA. The FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public.
In addition, we now know that to date there are over 15,000 unique, active cosmetic product facility registrations and over 1 million unique, active cosmetic product listings. Before MoCRA was enacted, the FDA received 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 thirty-fold increase in cosmetic product listings highlights the magnitude of the cosmetic marketplace, underscoring the critical importance of mandatory registration and listing for effective FDA oversight. Facility registration gives us insight into who is manufacturing or processing cosmetic products and where, while product listing provides detailed information about what cosmetic products are being marketed and their ingredients. Together, they are valuable resources for the FDA to effectively monitor the cosmetic product marketplace.
MoCRA also required the FDA to assess the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products and the scientific evidence regarding the safety of such use, including any associated risks. 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 United States. The FDA identified these PFAS from the new cosmetic product listings that are now mandatory for industry to submit to the agency. These PFAS-containing cosmetic products represent 0.41% of the total products listed as of August 2024 as reported in the Report on the Use of PFAS in Cosmetic Products and Associated Risks.
Advancements under the FD&C Act and Fair Packaging and Labeling Act
MoCRA implementation hasn’t been our only focus. The FDA continues its regulatory and compliance activities for cosmetics under the previously existing authorities of the FD&C Act and the Fair Packaging and Labeling Act. For example, the FDA has issued final guidance for industry to help tattoo ink manufacturers and distributors recognize situations in which a tattoo ink may become contaminated with microorganisms. In 2025, the FDA also issued a consumer alert after finding several gel nail polish removers marketed as cosmetic products that contain methylene chloride, a prohibited ingredient at any level in cosmetics.
Amidst all this work, the FDA’s Office of Cosmetics and Colors has also been settling into a new home. In 2024, the office was transferred from the Center for Food Safety and Applied Nutrition to the Office of the Chief Scientist for better alignment with its core mission.
The FDA will continue to provide information and updates on the safety of cosmetic products and ingredients through our webpages and social media, including cosmetics recalls and results of FDA testing of certain cosmetic products. We also remain committed to providing continued regular updates to the public about our activities, including implementing MoCRA.
To learn more, visit the Modernization of Cosmetics Regulation Act of 2022 | FDA and Cosmetics News & Events | FDA webpages regularly, Sign-Up for Email Updates for cosmetics, and Follow Us on X.