FDA’s MoCRA report finds insufficient data to determine the safety of PFAS, often called forever chemicals, in cosmetics, highlighting major research gaps.
Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration released a congressionally mandated report on December 29, 2025, under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), evaluating the use and safety of per- and polyfluoroalkyl substances (PFAS) in cosmetic products. The agency’s findings underscore major data gaps and uncertainty rather than confirm safety or risk thresholds for PFAS in cosmetics, reflecting broader concerns over chemical exposure laid out in recent federal strategy documents.
Background on MoCRA and PFAS Requirements
MoCRA represents the most significant service of U.S. cosmetics law since 1938, requiring the FDA to assess PFAS use in cosmetic products and publish a detailed report by December 29, 2025. The law aims to modernize oversight of cosmetic ingredients and ensure better safety data are available for products sold in the United States.
PFAS are a broad class of synthetic chemicals valued for properties such as water resistance, durability, and texture modification. They have been widely used in consumer products, including cosmetics, but also raise environmental and health concerns due to their persistence in the body and environment.
Scope and Key Findings of the FDA Report
The report titled Report on the Use of PFAS in Cosmetic Products and Associated Risks summarizes data gathered from mandatory cosmetic product listings submitted to the FDA under MoCRA. It shows that 51 distinct PFAS are intentionally added as ingredients in 1,744 cosmetic formulations marketed in the U.S.
To assess potential safety effects, the agency prioritized toxicological evaluation of the 25 most frequently used PFAS, representing about 96% of PFAS intentionally added to cosmetics. However, the FDA found that toxicological data were incomplete or unavailable for the majority of these substances, limiting the ability to draw firm safety conclusions.
Among the PFAS assessed:
- Five PFAS were considered to pose low safety concerns under their intended use conditions.
- One PFAS (perfluorohexyl ethyl triethoxysilane) was identified as having a potential safety concern when used at the highest reported concentration in body lotion.
- Data were insufficient to determine safety for the remaining 19 PFAS studied.
The report deliberately focuses on PFAS intentionally added to products, not contaminants present from raw materials or environmental sources.
Regulatory Context and Enforcement
Currently, there are no federal laws that specifically prohibit the intentional use of PFAS in cosmetics. FDA’s announcement reiterates that while no new ingredient bans are in place, the agency will continue enforcement under existing authorities if safety concerns arise.
The lack of definitive safety conclusions reflects broader regulatory gaps. Unlike food and drugs, cosmetic products and ingredients generally do not require pre-market approval by the FDA, though MoCRA has strengthened post-market requirements for facility registration, product listing, and adverse event reporting.
Alignment With the MAHA Strategy
The FDA’s interpretation of the findings echoes themes from the Make America Healthy Again (MAHA) Strategy, a federal initiative released in 2025 that sets broad public health goals, including reducing cumulative chemical exposures. The MAHA Strategy emphasizes research, monitoring, and coordination across federal agencies such as HHS, CDC, EPA, NIH, and FDA to address chemical exposures and their potential health impacts.
In its press release, the FDA explicitly aligned its next steps with the MAHA Strategy, noting plans to work with the Centers for Disease Control and Prevention and the Environmental Protection Agency to strengthen PFAS recommendations across consumer product and food supply chains.
What This Means for Industry and Consumers
For manufacturers, the report highlights the need for improved toxicological data on PFAS used in cosmetics and underscores potential regulatory scrutiny at both federal and state levels. Some states already have PFAS bans or reporting requirements in cosmetics, painting a complex compliance landscape alongside federal effort.
For consumers, the FDA’s findings do not point to immediate, definitive safety risks for PFAS in cosmetics. However, the uncertainty and data gaps signal that ongoing research and monitoring are needed, and regulators may pursue more robust safety frameworks or specific ingredient restrictions in the future.
Next Steps and Future Research
The FDA has indicated it will continue monitoring scientific developments, collect additional data, and support expanded testing and surveillance of PFAS exposures across consumer products. Aligning with broader federal strategy goals, future work will likely emphasize cross-agency collaboration, data transparency, and filling critical gaps in toxicological understanding.
In summary, The FDA’s congressionally mandated MoCRA report on PFAS in cosmetics emphasizes significant uncertainty due to data limitations rather than offering clear safety determinations. The findings reflect a cautious regulatory stance that prioritizes further research and aligns with the federal MAHA Strategy’s focus on reducing chemical exposures and strengthening public health protections. Continued scientific investigation, improved toxicology data, and regulatory coordination will be essential in shaping future PFAS oversight in the cosmetics industry.
References
FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products, 29 Dec 2025, US FDA, https://www.fda.gov/news-events/press-announcements/fda-finds-insufficient-data-determine-safety-pfas-cosmetic-products
Per and Polyfluoroalkyl Substances (PFAS) in Cosmetics, 29 Dec 2025, US FDA, https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics
Modernization of Cosmetics Regulation Act of 2022 (MoCRA), 29 Dec 2025, US FDA, https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
Report on the Use of PFAS in Cosmetic Products and Associated Risks, December 2025, US FDA, https://www.fda.gov/media/190319/download?attachment=
New US FDA MoCRA budget targets PFAS in cosmetics, 04 December 2025, https://www.alsglobal.com/en/news-and-publications/2024/04/new-us-fda-mocra-budget-targets-pfas-in-cosmetics