December 30, 2025
Dear International Colleague,
The U.S. Food and Drug Administration has released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. While the report reviews available scientific evidence on potential safety concerns, the FDA’s evaluation did not reach definitive safety determinations and underscores significant uncertainty due to gaps in existing data on PFAS exposure through cosmetics.
“In accordance with our congressional mandate, the FDA released its assessment of PFAS in cosmetic products,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety. This lack of reliable data demands further research. Consistent with the MAHA Strategy Report, the FDA will continue working with the CDC and EPA to update and strengthen recommendations on PFAS across the retail and food supply chain.”
Based on mandatory cosmetic product listing data submitted to the FDA, 51 PFAS are used in 1,744 cosmetic formulations. To assess safety, the FDA evaluated the 25 most frequently used PFAS, which represent approximately 96% of PFAS intentionally added to cosmetic products. The agency found that “toxicological data for a majority of these PFAS are incomplete or unavailable,” limiting its ability to fully assess risk. The FDA’s ability to effectively collect toxicology data was limited by the fact that most of the data is not publicly available. While five PFAS appeared to present low safety concerns under their intended conditions of use, the safety of most PFAS could not be definitively established, and one PFAS was identified as having a potential safety concern with significant remaining uncertainty.
The report focuses on PFAS intentionally added to cosmetic products as ingredients, rather than PFAS that may be present as contaminants. PFAS are synthetic chemicals used for properties such as water resistance, durability, and texture modification, but their persistence and potential toxicity have raised health and environmental concerns and prompted increasing regulatory scrutiny at the state, federal, and global levels.
There are currently no federal regulations that specifically prohibit PFAS intentionally added to cosmetic products. However, consistent with FDA enforcement policies, the agency will take appropriate action if safety concerns emerge related to such cosmetic products.
The FDA will continue to monitor emerging scientific data and devote additional resources to address data gaps, supporting the Department of Health and Human Services’ Make America Healthy Again efforts to reduce PFAS across the food and consumer product supply chain through expanded testing, monitoring, and surveillance.
For more information on PFAS in cosmetic products, visit the FDA’s website: https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics.
An unofficial translation of this announcement is provided below.
翻译参考：
FDA发现目前尚无足够数据来确定化妆品中全氟和多氟烷基物质（PFAS）的安全性
2025年12月30日，美国食品药品管理局（FDA）根据 2022 年《化妆品监管现代化法》(MoCRA) 发布了一份国会授权的报告，评估全氟和多氟烷基物质（PFAS）在化妆品中的使用情况。虽然该报告审查了有关潜在安全问题的现有科学证据，但 FDA 的评估并未得出明确的安全结论，并强调由于现有关于通过化妆品接触 PFAS 的数据存在不足，因此存在显著的不确定性。
“根据国会授权，FDA 发布了其对化妆品中PFAS的评估报告，”FDA局长Marty Makary博士表示。“我们的科学家发现，大多数 PFAS 的毒理学数据不完整或缺失，这使得消费者安全问题存在显著不确定性。这种缺乏可靠数据的情况亟需进一步研究。根据MAHA战略报告，FDA将继续与美国疾病预防控制中心（CDC）和美国环境保护署（EPA）合作，更新并强化零售和食品供应链中PFAS的相关建议。”
根据企业向 FDA 提交的强制性化妆品产品登记数据，共有51种PFAS被用于1,744种化妆品配方中。为评估其安全性，FDA重点分析了使用频率最高的25种PFAS，这些物质约占有意添加至化妆品中的PFAS总量的96%。FDA发现，“大多数PFAS的毒理学数据不完整或无法获得”，从而限制了其对风险进行全面评估的能力。由于大多数数据并未向公众公开，FDA有效收集毒理学数据的能力受到限制。尽管有五种PFAS在其预期使用条件下似乎不存在明显安全隐患，但大多数PFAS的安全性仍无法确定，且其中一种PFAS被确定可能存在安全性问题，且仍存在显著的不确定性。
该报告重点关注作为成分有意添加至化妆品中的PFAS，而非可能作为污染物存在的PFAS。PFAS是一种人工合成化学物质，因其防水性、耐久性和改善质地等特性而被广泛使用，但其环境持久性和潜在毒性已引发健康和环境方面的担忧，并在州级、联邦以及全球层面受到日益严格的监管审查。
目前，尚无联邦法规专门禁止在化妆品中有意添加PFAS。然而，依据FDA的执法政策，一旦这类化妆品出现安全问题，FDA将采取适当的监管措施。
FDA将继续监测最新的科学数据，并投入更多资源以弥补数据缺口，通过扩大检测、监测和监督，减少食品和消费品供应链中的 PFAS支持美国卫生与公众服务部（HHS）“让美国再次健康”（Make America Healthy Again）倡议的相关工作。
如需了解有关化妆品中PFAS的更多信息，请访问FDA网站：https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics
|
