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Long-awaited study highlights data gaps and stops short of making definitive safety determinations.

By Julia A. Hatcher, Tom Lee, Hunter J. Kendrick, and Meryl E. Bartlett

Key Points:

  • Based on product listings submitted from 2022 through August 2024 identifying all ingredients in each product, FDA identified 51 PFAS intentionally added as ingredients, which were present in 0.41% of the cosmetic products registered during that period.
  • FDA evaluated the safety of the 25 most frequently used PFAS in cosmetics and concluded that, because toxicological data for the majority of the PFAS evaluated were incomplete or unavailable, it could not fully assess the safety risk.
  • FDA pledged to continue working with EPA and the CDC to strengthen recommendations on PFAS across the retail and food supply chain.
  • No federal laws or regulations currently exist that specifically prohibit or restrict PFAS intentionally added as ingredients in cosmetic products, but individual states and foreign jurisdictions have already enacted, or are considering enacting, their own restrictions.

FDA’s PFAS Report

In 2022, Congress passed the Modernization of Cosmetics Regulations Act (MoCRA), a law that the Food and Drug Administration (FDA) itself describes as “the most significant expansion of the [FDA’s] authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act … was passed in 1938.”1 MoCRA required FDA to create a registration program for cosmetics that includes product listings identifying all product ingredients and, among other requirements, also obligated FDA to assess and report to Congress on the use — and potential associated safety risk — of per- and poly-fluoroalkyl substances (PFAS) in cosmetics by the end of 2025. FDA published its report to Congress (the PFAS Report) in December 2025. In preparing the PFAS Report, FDA limited the scope to PFAS intentionally added as ingredients and excluded any PFAS that may be present in a final product as contaminants.  

The Federal Food, Drug, and Cosmetic Act (FDCA) defines “cosmetic” as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”2 In the PFAS Report, FDA noted that PFAS, which “have been widely used in industrial and consumer products, including cosmetic products because they are water- and oil-resistant, and are long-lasting,” have historically been intentionally added as cosmetic ingredients.3 Among other items, FDA noted that some PFAS have been intentionally added to “lipsticks, eyeshadows, moisturizers, nail polish and enamel, blushers and rouges, and cleansers,” because PFAS in those products help to “condition and smoothen skin and hair, making them appear shiny, or to modify product consistency and texture.”4 But FDA also noted that the presence of PFAS in cosmetics has raised growing health and environmental concerns in recent years because of “their persistence and potential toxicity.”5

To prepare the PFAS Report, FDA analyzed cosmetic product listing data submitted to FDA as required under MoCRA between the creation of the framework in 2022 and August 30, 2024.6 Based on the data, FDA concluded that 51 different PFAS were intentionally added as ingredients in 1,744 cosmetic product formulations sold in the United States as of August 2024.7 Those 1,744 products represent 0.41% of the total cosmetic products registered under MoCRA as of August 2024. FDA also identified eye shadows, leave-on face and neck products, eyeliners, face powders, and foundations as the top five product categories for intentionally added PFAS, with those product categories accounting for “approximately 56% of PFAS-containing cosmetic products.”8

FDA focused its safety evaluation on 25 of the 51 PFAS identified because it determined that the 25 selected PFAS accounted for 96% of the total PFAS used in cosmetic products marketed in the US, and therefore were the “most prevalent, and potentially impactful, PFAS ingredients.”9 Notably, polytetrafluoroethylene (PTFE) — a PFAS polymer used in various applications due to its nonstick and quick-drying properties — was the most frequently used, appearing in 28.1% of all product formulations that contained PFAS.10

Ultimately, FDA concluded that “toxicological data for a majority of these PFAS [19 out of the total 25 substances evaluated] are incomplete or unavailable.”11 And, for the toxicological data that were available, FDA’s “evaluations reveal[ed] a significant variability in risk profiles depending on the specific PFAS chemical.”12 For those 19 PFAS with incomplete information, FDA determined that “safety cannot be assessed at present due to lack of critical toxicological data.”13

But for five of the evaluated PFAS, including PTFE, FDA noted that they “appear to have low safety concerns under their intended conditions of use in cosmetic products.”14 FDA suggested that one of the PFAS with sufficient data to be evaluated, perfluorohexylethyl triethoxysilane, could be a potential safety concern, but the regulator noted that “significant uncertainties remain due to limited toxicity data on which the conclusion has been based.”15 FDA pledged to continue monitoring the use of PFAS in cosmetics as more information becomes available.

State and Foreign Government Efforts to Restrict PFAS in Cosmetics

Currently, no US federal laws or regulations specifically address the intentional use of PFAS as ingredients in cosmetic products. Moreover, the FDCA does not require cosmetic products or ingredients to obtain FDA approval before they are distributed in US commerce, except for color additives, which are subject to FDA approval before use. Generally, manufacturers may use “any ingredient in the formulation of a cosmetic product, as long as the ingredient and finished product are safe, the product is appropriately labeled, and the use of the ingredient does not render the cosmetic product adulterated or misbranded.”16 FDA’s current position is that the presence of PFAS alone does not “render [a] cosmetic product adulterated or misbranded,”17 although FDA acknowledged in the PFAS Report that its “position may be subject to change as new scientific evidence emerges.”18

Although the US federal government has yet to pursue restrictions on PFAS in cosmetics, other countries as well as some US states have acted in the meantime. New Zealand and France were two of the first nations to move. In 2024, New Zealand updated its cosmetics regulations to include a ban on the sale of PFAS-containing cosmetic products in New Zealand beginning on January 1, 2028.19 Then, in 2025, the French legislature passed Law No. 2025-188 banning the production, importation, or sale of certain PFAS-containing products — including cosmetics — for which an alternative to PFAS already exists. The French prohibition became effective on January 1 of this year.20

Meanwhile, in 2023, Germany, Denmark, the Netherlands, Norway, and Sweden submitted a dossier to the European Chemicals Agency (ECHA) proposing a broad ban on the manufacture and use of approximately 10,000 PFAS, including their use in cosmetics.21 After the public comment period on the initial proposal closed, ECHA released a revised, somewhat narrower proposal in the summer of 2025. While the basic premise of the revised proposal remains the same as the original (the ultimate prohibition of most PFAS uses), the revised version includes a new regulatory option that would allow for certain uses of PFAS to continue where ECHA determines that associated health risks could be controlled. However, for cosmetics specifically, the revised dossier suggests that a ban on PFAS in cosmetics, without exception — “derogations,” in ECHA’s parlance — may be appropriate because of “[s]ufficiently strong evidence that technically and economically feasible alternatives exist.”22 ECHA may make a final determination on the PFAS proposal as early as this year.

In the US, the lack of comprehensive federal laws governing PFAS in consumer products, including cosmetics, has led to the proliferation of state laws and regulations (see this Latham blog post on Washington State’s regulation of PFAS in consumer products). The same is true in the specific context of PFAS in cosmetics. At least 11 US states have adopted laws or regulations that have, or will soon, restrict or outright ban the intentional use of PFAS in cosmetics. Those states include California, Colorado, Connecticut, Maine, Minnesota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, and Washington, with the relevant regulations taking effect between 2025 and 2028.23 And at least eight other states — Georgia, Hawaii, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, and Tennessee — have proposed but not yet enacted laws to ban or limit the use of PFAS in cosmetics.24

Whether the more developed understanding of the prevalence and types of PFAS used in cosmetic products provided by the PFAS Report will bolster efforts in those eight states — or inspire new efforts elsewhere — to address the potential adverse health or environmental risks associated with PFAS in cosmetics remains to be seen. It is also unclear whether the information in the PFAS Report will lead to an increase in the developing trend of private enforcement of the state prohibitions on PFAS in cosmetics through claims of false advertising, unfair business practices, and consumer legal rights.   

Trends in PFAS Use in US Cosmetics

Perhaps in response to the growing number of states that regulate the use of PFAS in cosmetics, the PFAS Report suggests that the US cosmetics industry is already moving away from the use of PFAS as intentionally added ingredients. The Report indicates that, “based on responses from a limited number of participants, [FDA’s information collection] indicate[d] that cosmetic manufacturers in the US have started reformulating their products to remove PFAS.”25 Of the five responding manufacturers, two reported reformulating their products with “non-PFAS alternative ingredients, such as cellulose-based raw material.”26

Another respondent to FDA’s inquiries specifically noted California’s AB2771, which banned intentionally added PFAS in cosmetics beginning on January 1, 2025, as the impetus for its move away from intentionally added PFAS.27 As the state bans continue to take effect, it will become increasingly onerous — and, likely, cost prohibitive — for any companies that may still use intentionally added PFAS in cosmetic products to direct distribution to jurisdictions that have not adopted PFAS bans. Accordingly, it is likely that the continuing proliferation of US state PFAS laws and regulations will accelerate the apparent market trend away from PFAS in cosmetics.

Moreover, additional federal activity may be on the horizon. As noted above, FDA warned that its policies toward PFAS in cosmetics may change as more scientific evidence emerges. And, in the press release announcing the publication of the PFAS Report, FDA pledged to “continue working with the Centers for Disease Control (CDC) and Environmental Protection Agency (EPA) to update and strengthen recommendations on PFAS across the retail and food supply chain.”28 Regulated companies should prepare for the possibility of more federal regulation, but in the meantime, the growing patchwork of state laws also necessitates a more immediate compliance strategy. The PFAS regulatory landscape is constantly evolving, and regulated industries must evolve with it.   

Latham & Watkins will continue to monitor developments in this area.     

  1. US Food and Drug Administration, “Report on the Use of PFAS in Cosmetic Products and Associated Risks,” at page 8, (Dec. 2025), available at https://www.fda.gov/media/190319/download?attachment (hereinafter, the “PFAS Report”). ↩︎
  2. 21 U.S.C. § 321(i). ↩︎
  3. PFAS Report at 8. ↩︎
  4. Id. ↩︎
  5. Id. ↩︎
  6. Id at 9. ↩︎
  7. Id. ↩︎
  8. Id. ↩︎
  9. Id. ↩︎
  10. Id. ↩︎
  11. Id. at 26–27. ↩︎
  12. Id. at 27. ↩︎
  13. Id. ↩︎
  14. Id. ↩︎
  15. Id. ↩︎
  16. Id at 8. ↩︎
  17. Id. ↩︎
  18. Id. at 8, FN. 2. ↩︎
  19. See New Zealand Environmental Protection Authority, “Updated Rules for Cosmetics,” (January 2024), available at https://www.epa.govt.nz/hazardous-substances/rules-notices-and-how-to-comply/specific-substance-guidance/cosmetics/updated-rules-for-cosmetics/. ↩︎
  20. Le Monde, “French Ban of ‘Forever Chemicals’ in Cosmetics, Clothing to Enter Force,” (Dec. 30, 2025), available at https://www.lemonde.fr/en/france/article/2025/12/30/french-ban-on-forever-chemicals-in-cosmetics-clothing-to-enter-force_6748944_7.html. ↩︎
  21. See European Chemicals Agency, “ECHA and Five European Countries Issue Progress Update on PFAS Restriction,” available at https://echa.europa.eu/-/echa-and-five-european-countries-issue-progress-update-on-pfas-restriction. ↩︎
  22. See, e.g., European Chemicals Agency, “Background Document to the Opinion on the Annex XV Dossier Proposing Restrictions on Per- and Polyfluoroalkyl Substances (PFASs),” (June 24, 2025) at 117 (Cosmetics Annex E.2.6). ↩︎
  23. PFAS Report at 14 (citing state laws targeting use of PFAS in cosmetics). ↩︎
  24. Id. at 14–15. ↩︎
  25. Id. at 23. ↩︎
  26. Id. ↩︎
  27. Id. ↩︎
  28. US Food and Drug Administration, Press Release, “FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products,” (Dec. 29, 2025), available at https://www.fda.gov/news-events/press-announcements/fda-finds-insufficient-data-determine-safety-pfas-cosmetic-products. ↩︎