PRODUCT | PFAS and product law: Navigating regulatory and legal risks

PFAS are a large group of man-made chemicals invented in the 1930s and widely used for their unique properties, such as resistance to heat, oil, grease, water, and stains. PFAS are comprised of strongly linked carbon-fluorine bonds that make some of them  relatively persistent. Because PFAS have been used in products for decades PFAS can be found in soil and water.

As a result, even if a company does not intentionally use PFAS in its products, PFAS may nonetheless appear in its products in trace amounts due to their persistence in the environment and supply chain processes.

Scientists are still studying the potential health effects of PFAS exposure, and many questions remain unanswered. The EPA has advised that health effects associated with PFAS are “difficult to specify” because there are “thousands of PFAS with potentially varying effects of toxicity levels, yet most studies focus on a limited number of better known PFAS chemicals.¹ And it is difficult to assess how exposure impacts human health because the “types and uses of PFAS change over time.”²

Despite scientific uncertainty, U.S. regulators and plaintiffs' lawyers claim PFAS are linked to various health issues. However, there is no consensus that all PFAS pose risks to human health. Additionally, there is no agreement on which exposure levels may cause harm in humans, or on the best methods for testing PFAS in products.

Environmental Protection Agency

At the federal level, the United States Environmental Protection Agency (EPA) has intensified its focus on PFAS regulation over the last several years. For example, among others:

• In October 2021, EPA released a multiyear PFAS Strategic Roadmap, outlining its goals to research PFAS exposure and toxicities, restrict PFAS releases, and remediate PFAS contamination.
• In January 2024, the EPA finalized a Toxic Substances Control Act Significant New Use Rule (SNUR) for approximately 300 inactive PFAS. Any new use would require extensive EPA review. The EPA also added nine PFAS to the list of chemicals covered by the Toxics Release Inventory under Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).
• Other rules seeking to regulate PFAS levels in drinking water have been proposed and remain under review. The future of these proposals remains uncertain as the new administration is actively reviewing all pending regulations as well as those finalized but yet to be effective.

Food and Drug Administration

Food

The Food and Drug Administration’s (FDA) PFAS regulation efforts have largely been focused at Human Food Program office. These efforts date back many years and focus on PFAS in food and food contact materials. Although devoid of specific bans, the FDA has taken ad hoc approaches to curtail the use and distribution of products that contain PFAS.

Since 2019, FDA has been developing methods for testing for PFAS in fresh and processed foods under the agency’s Total Diet Study (TDS). To date, FDA reports that no PFAS have been detected in over 97 percent of the fresh and processed foods tested from the TDS. More recently, in January 2025, the FDA announced that 35 food contact notifications (FCNs) related to PFAS are no longer effective. These FCNs were previously authorized for food contact substances used in grease-proof coatings for paper and paperboard packaging. Manufacturers voluntarily stopped production in 2020, and by 2024, these products were no longer sold in the United States.

The FDA has also taken action on a product or company specific basis, such as placing  firms with high levels of PFAS in their products on Import Alert Lists.³

Medical devices

The Center for Devices and Radiological Health (CDRH) has not yet issued specific rules or guidance on PFAS in medical devices. However, PFAS is generally addressed through existing regulations for medical devices, components, and the raw materials used within them. A key consideration in device design is biocompatibility and ensuring devices are evaluated under ISO 10993, Biological Evaluation of Medical Devices. While it is unclear whether CDRH will increase regulatory focus on PFAS, state and international requirements may affect FDA submissions and post-market surveillance.

States have been actively enacting PFAS restrictions including several that are banning PFAS in certain consumer products, including some medical products. State regulations vary widely, with some prohibiting only the intentional addition of PFAS, some setting specific PFAS levels that trigger prohibitions, and others requiring labeling or disclosure of PFAS.

In sum, although regulations seeking to limit or ban the use of PFAS may not be a priority at the federal level, a patchwork of evolving state laws appears to be filling the void, meaning that manufacturers of products that contain PFAS must pay close attention when doing business across the 50 states.

In January 2023, Germany, the Netherlands, Denmark, Sweden, and Norway submitted a proposal to the European Chemicals Agency (ECHA) to restrict the “manufacture, placing on the market, and use of [PFASs] as a chemical class in the EU.” ECHA expanded the scope of PFAS uses into the medical sector in November 2024. It is expected that, if adopted in 2025, some materials would be prohibited as soon as 2026, while any material that received a derogation would have a sunset period of at most 12 years following a transition period.

Actions are also taking place at the country level. In February 2025, France enacted a law that, effective January 1, 2026, prohibits the manufacturing, export, import, sale, or distribution of certain products if they contain PFAS yet to be defined thresholds.

Plaintiffs’ lawyers have been suing over PFAS chemicals for years. PFAS lawsuits initially began years ago when the plaintiffs’ bar primarily targeted large chemical manufacturers with claims related to environmental contamination in the water and soil. In recent years, as regulations and awareness of PFAS have expanded, so too have the companies and industries targeted and the types of PFAS-related claims asserted. Consumer activists and certain plaintiffs’ law firms have initiated aggressive campaigns to test entire categories of consumer products, apparel, cosmetics, beverages, and food packaging materials for the presence of PFAS and expose the results. Lawsuits have quickly followed. Today, if PFAS are found in a company’s finished product – even in trace amounts and/or as an unintentional consequence of environmental contamination – the company is at risk of litigation.

Typically, plaintiffs allege that a product’s label was false or misleading because the product contains PFAS but was marketed as “all natural,” “safe,” “sustainable,” or “free of toxic chemicals,” among other representations. Many PFAS plaintiffs rely on testing co-opted from third-party sources (e.g., Consumer Reports, bloggers, nonprofit organizations), while others conduct independent testing through third-party labs. These testing results may be influenced by contamination during the testing or sampling process or by interference from non-PFAS substances that can mimic a positive PFAS result. The results often suggest that products were subject to inadvertent PFAS contamination during the manufacturing process or afterwards. In fact, many companies faced with this litigation are unaware that their products contain PFAS.

These claims survive motions to dismiss in many cases so far. For example, in a class action alleging that anti-fog spray⁴ was marketed as “safe for use” even though it purportedly contained PFAS, the court held that whether a reasonable consumer would interpret those representations as relating to PFAS was a question of fact that could not be resolved at the motion to dismiss stage. Recently, courts are more likely to grant a motion to dismiss for lack of standing if a plaintiff fails to allege that they tested their own purchases for PFAS, directly.

As to medical devices, cases have been filed against manufacturers of wound dressings and bandages, tampons, condoms, razors, dental floss, and reusable feminine hygiene underwear. In each case, plaintiffs alleged false advertising and claims as well as violation of consumer protection laws.

Although these cases are defensible, costs of defense alone warrant a close look at this issues to mitigate potential litigation risks. Given the various PFAS-disclosure laws and regulations cropping up around the country, we expect to see a flood of omissions-based lawsuits in industries – including MedTech – subject to these regulations unless and until precedent is created to deter the filings of these cases.