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Not So Fast, PFAS: FDA Can’t Determine Safety in Cosmetics

Published January 18, 2026
Published January 18, 2026
Philip Oroni via Unsplash

Key Takeaways:

  • An FDA report says it cannot determine the safety of most intentionally added PFAS in cosmetics.
  • Significant data gaps prevented the agency from reaching definitive safety conclusions for most of the PFAS it evaluated. 
  • Experts warn that this report shifts the onus to brands and manufacturers, forcing them to defend testing methods.

The use of per- and polyfluoroalkyl substances (PFAS), otherwise known as “forever chemicals,” is stuck in limbo following the release of a new report from the U.S. Food and Drug Administration (FDA).

The FDA’s Report on the Use of PFAS in Cosmetic Products and Associated Risks, released on December 29, 2025, examined PFAS that have been intentionally added to cosmetic products as ingredients. (The report explicitly excluded PFAS that may be present as contaminants.) The report ultimately concluded that the safety of most of the PFAS reviewed could not be definitively established due to “insufficient toxicological data.”

In a corresponding press release, the FDA reaffirmed its commitment to continuously monitor new information regarding the use and safety of PFAS in cosmetics.

“Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety,” said FDA Commissioner Marty Makary, MD, MPH, in a press release. “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.”

As consumers continue to express concern about PFAS in products like cosmetics, some brands are responding by adding PFAS-free claims to labels. Experts caution against making this claim, particularly in light of the recent FDA report, which seemingly shifts responsibility for PFAS safety from federal regulators to cosmetics brands and manufacturers themselves.

The PFAS Problem

The FDA’s investigation into PFAS was congressionally mandated as part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which stopped short of banning this class of chemicals. Instead, the agency ordered further investigation into PFAS safety, setting a deadline of December 29, 2025.

PFAS have been used in industrial and consumer products since the 1950s and encompass nearly 15,000 synthetic chemicals, according to CompTox, a chemicals database maintained by the U.S. Environmental Protection Agency (EPA). The hallmark of PFAS is their strong, stable carbon-fluorine (C-F) bond, which makes them resistant to heat, water, oil, chemicals, and natural degradation processes like hydrolysis, photolysis, and microbial breakdown.

Because of this strong bond, PFAS degrade very slowly or not at all in natural environments, persisting for decades to centuries and building up over time in water, soil, and within the bodies of living organisms—including humans. Current scientific research suggests that exposure to certain PFAS may be linked to various health issues; however, research is still ongoing to determine how different levels of exposure to different PFAS impact human health.

According to the FDA’s report on the use of PFAS in cosmetics, certain PFAS are intentionally added as ingredients to cosmetic products, including lipsticks, eyeshadows, moisturizers, nail polish and enamel, blushers and rouges, and cleansers. These PFAS are purportedly used to “condition and smoothen skin and hair, making them appear shiny, or to modify product consistency and texture.”

In recent years, the persistence and potential toxicity of PFAS have raised health and environmental concerns and prompted increasing regulatory scrutiny at the state, federal, and international levels. California's PFAS-Free Cosmetics Act, passed in 2022, banned the manufacture, sale, and distribution of cosmetic products containing intentionally added PFAS starting January 1, 2025. Colorado, Maryland, Minnesota, and Washington implemented bans last year, with other states set to follow this year and in 2027.

Earlier this month, France became the first EU country to ban PFAS in cosmetics, wax, and textile products. Dr. Theresa Callaghan, a cosmetic claims and scientific affairs expert and the owner of Callaghan Consulting International, told BeautyMatter that she anticipates the move will accelerate and, potentially, inform EU policymaking, now that restrictions have been shown to be "achievable and potentially manageable, both economically and technically.”

Conclusions from the FDA's Report Regarding PFAS Use in Cosmetic Products

MoCRA imposed several new requirements for cosmetic manufacturers and brands, including mandatory cosmetic product registration. The FDA used this cosmetic product listing data to determine that 51 distinct PFAS are used across 1,744 cosmetic formulations. The FDA's safety assessment focused on the 25 most frequently used PFAS in cosmetic products, which account for about 96% of PFAS found to be intentionally added to cosmetics.

The agency found that “toxicological data for a majority of these PFAS are incomplete or unavailable,” which limited the FDA’s ability to fully assess risk.

The FDA’s report regarding PFAS in cosmetics concluded the following: 

  • 76% of the reviewed PFAS could not be definitively determined due to the lack of critical toxicological data. 
  • Five PFAS (PTFE, perfluorodecalin, HC Yellow No. 13, perfluorohexane, and tetrafluoropropene) were deemed to have low safety concerns under intended use conditions. 
  • Only one PFAS, perfluorohexylethyl triethoxysilane, was identified as having a potential safety concern when used in body lotion at the highest use level

The FDA's assessment highlighted that its evaluation of PFAS is subject to “significant uncertainties, including limited data on use level, lack of dermal and oral absorption data, and mechanistic information, as well as the absence of dermal toxicity data.”

“Consumers should know that PFAS are intentionally added to only a very small fraction of cosmetics in the United States, and while the FDA’s review found that some PFAS intentionally added to cosmetic products appear to present low safety concerns, more research is needed to address gaps in existing data on PFAS exposure through cosmetics,” a representative for the FDA told BeautyMatter.

The representative said that the agency 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” (MAHA) efforts to reduce PFAS across the food and consumer product supply chain through expanded testing, monitoring, and surveillance.

There are currently no federal regulations that specifically prohibit PFAS from being intentionally added to cosmetic products.

Naveen Kumar, PhD, DABT, Senior Regulatory Toxicologist and consultant at Precision Toxicological Consultancy, wasn’t surprised by the FDA’s conclusions.

“[The FDA] conducted a systematic review and confirmed, based on the available data, what many in the industry already suspected: more research is needed,” he told BeautyMatter. “There are significant data gaps, and these chemicals are difficult to study, so it’s still unclear whether the use of PFAS in cosmetics is safe or not.”

Kumar also does not expect to see a federal ban on PFAS as a class of chemicals anytime soon, given their functional roles in cosmetics.

“If you ban it, you are running into the risk of regrettable substitution,” he said. “What is it being replaced with, and is that alternative safer than PFAS, and how can you prove that? It’s an endless cycle.”

According to the FDA report, many cosmetics companies have already begun reformulating their products to remove PFAS. The FDA reached out to a total of nine firms, but only five responded. Two companies said they had eliminated PFAS from their products and replaced them with non-PFAS alternatives, such as cellulose-based ingredients. Another company reported phasing out PFAS to comply with California’s ban, and the other two said they are in the process of discontinuing and reformulating PFAS-containing products.

“The question of PFAS safety is not going away anytime soon.”
By Naveen Kumar, PhD, DABT, Senior Regulatory Toxicologist + consultant, Precision Toxicological Consultancy

Who Is Responsible for PFAS Safety? 

Testing and evaluating PFAS for safety is “easier said than done,” according to Joanne Starkey,  Quality and Regulatory Affairs Consultant at Trail Stone Consulting.

“It’s a very complicated process,” Starkey told BeautyMatter. “This is another example of the industry moving faster than the regulation.”

While methods to identify and test for specific PFAS do exist, they are not yet standardized for complex chemistry of cosmetic formulations, according to Kumar. The current gold standard, known as targeted analysis, covers only about 50 of the thousands of chemicals classified as PFAS. He also pointed to the emergence of non-targeted analysis, an approach that can, with some degree of confidence, detect unknown PFAS compounds, but cannot yet reliably quantify them.

“Developing one would be a critical next step, because it would resolve many open questions and make things easier for both industry and FDA scientists by providing a clear reference method and defined quality-control criteria for the data,” he said. “It would be a win-win for both sides.”

The lack of critical toxicological data put the FDA in a difficult position: the agency doesn’t have enough information to enact new regulations. Instead, the FDA can only enforce current regulations, which require cosmetics brands and manufacturers to have documented safety substantiation for products (including scientific evidence and ingredient data) and must report serious adverse events to the FDA within 15 business days of receiving them.

In short, Starkey argued, the FDA passed the baton of proving PFAS safety back to the brands.

"The FDA is basically saying, 'We don't know what we don't know,’ and that is legalese for saying just because there isn't information out there doesn't mean we can’t act."

If the FDA believes there is reason to take action against a brand because it hasn’t proven the safety of its products, it can and will initiate enforcement action against the brand.

“[Cosmetic brands and manufacturers] need validations for [their] testing methods, and you have to be able to prove the safety and efficacy of your product,” she said. “The challenge is that there's a gap between the regulatory language and what the industry is capable of doing.”

The Myth of PFAS-Free Products

Beauty and wellness brands are under pressure from concerned consumers to bring products to market that are labeled “PFAS-free.” The “significant uncertainties” outlined in the FDA’s report may complicate this for brands. If a brand is going to make a claim that a product is PFAS-free, it needs evidence to support that assertion.

In theory, a company could support such a claim with validated test methods, tightly controlled facilities, and rigorous documentation, which can be costly and time-consuming for brands to maintain. But even then, the result would only apply to the specific PFAS compounds tested, per Starkey.

“It is not a true statement to say that it is all PFAS-free, because unless you’re testing for every single one of those compounds, you cannot say that,” she noted, adding that an FDA inspector could reasonably challenge the claim. “It's a difficult thing to comply with right now because [PFAS are] absolutely everywhere.”

“It’s opening up a can of worms,” added Kumar. “Don't use the PFAS-free label loosely. You need strong scientific evidence that it is truly PFAS-free.”

With PFAS safety stuck in regulatory limbo, brands must be prepared to defend not just their testing, but the assumptions underlying any “PFAS-free” promise.

“Stick to the [regulatory] language as it stands now,” advised Starkey. “Make sure you're not making any extraordinary claims on your labels.”

What’s Next for PFAS?

While the future of PFAS regulation remains murky, the FDA has made it clear that it will continue to monitor emerging data on PFAS to ensure the continued safety of cosmetic products. Both Starkey and Kumar couldn’t estimate a timeline for the release of additional safety data or new regulations, but they did affirm that this issue is top of mind for federal regulators.

“The question of PFAS safety is not going away anytime soon,” said Kumar. “They are forever chemicals, and their persistence in nature raises a lot of questions that science has yet to answer.”

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