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  • On June 22, 2026, FDA posted a Response Letter denying a citizen petition brought by the Tucson Environmental Justice Task Force and two other individuals requesting that FDA set New Temporary Tolerances at the method detection limit (MDL) for various per-fluoroalkyl substances (PFAS). The petition specifically requested limits be established for 30 different PFAS substances that may be inadvertently transferred to foods including lettuce, blueberries, ready-to-eat bread, milk, eggs, salmon, clams, corn silage, and corn snaplage. The requested tolerances were generally based on an MDL of 0.05 micrograms/kg (0.05 ppb) for the relevant PFAS analytes in these food matrices.
  • Under the Federal Food, Drug, and Cosmetic Act (FFDCA), food may be deemed adulterated if it contains a poisonous or deleterious substance that may render it injurious to health. For unavoidable environmental contaminants, FDA may establish action levels, tolerances, or other regulatory limits. FDA has not established broad regulatory limits for PFAS in food as FDA only establishes tolerances when they believe these will not need significant adjustments in the future.
  • As we have previously blogged, the parties filed the petition on November 1, 2023. Following a court order requiring FDA to issue a final response, FDA released the response letter, dated June 17, 2026.
  • In its response letter, FDA explained that the science surrounding PFAS detection, exposure, and potential human health effects continues to evolve rapidly, making it difficult to establish such limits at this time. FDA does intend to continue evaluating PFAS contamination in the food supply and to establish action levels for PFAS in some products, where appropriate. Here, FDA found that the petitioners lacked sufficient evidence to obligate FDA to set temporary tolerances for PFAS.
  • The petitioners attempted to invoke the Delaney Clause which prohibits FDA from approving “food additives” if those additives have “been shown ‘to induce cancer in man or animal.’” Because the PFAS in question are food contaminants, rather than food additives, the Agency rejected this argument.
  • Keller & Heckman will continue to monitor PFAS food law developments.
  • On June 18, 2026, FDA updated its webpage on per- and polyfluoroalkyl substances (PFAS). The webpage outlines the efforts FDA has made to understand and mitigate the risks of PFAS in food while explaining some specific actions FDA plans to take.
  • In the updated webpage, FDA now states that one of its goals is to regulate PFAS levels in bottled water under its authority from the Federal Food, Drug, and Cosmetic Act (FFDCA). Under the FFDCA, FDA may set allowable levels for contaminants in bottled water when EPA sets levels for those same contaminants in drinking water. EPA released a PFAS National Primary Drinking Water Regulation in April 2024, and recently proposed to amend this regulation in May, 2026.
  • This update also notes FDA’s concerns relating to potential PFAS contamination in seafood. FDA is assessing data and determining risk management actions for seafood products after an import alert issued for imported clams contaminated with PFOA. According to FDA, adding firms to an import alert will help reduce PFAS exposure across the food supply. The Agency’s testing under the Total Dietary Study (TDS) found that over 95% of tested fresh and processed foods were PFAS-free while 69% of tested seafood contained PFAS.
  • Additionally, FDA referred to test results for PFAS and other contaminants in infant formula. The Agency will continue researching this category and plans to eventually establish action levels for infant formula contaminants.
  • FDA continues research to identify new types of PFAS in foods through high resolution mass spectrometry (HRMS).
  • Keller & Heckman will continue to monitor FDA updates.
  • FDA recently shared the final results from the testing of domestic and imported bottled water collected at retail locations across the U.S. for per- and polyfluoroalkyl substances (PFAS). Of the 197 samples of purified, artesian, spring, and mineral waters tested, ten samples had detectable levels of PFAS. However, none of those had levels that would have exceeded the EPA’s maximum contaminant levels (MCLs) for PFAS in public drinking water.
  • PFAS are a diverse group of widely used, long lasting chemicals that do not easily break down and can accumulate in the environment and human tissues with negative health consequences. PFAS have been the subject of various testing efforts, lawsuits, and legislation, as we have previously blogged.
  • In the bottled water study, FDA tested for 18 types of PFAS, including the six types with EPA-established MCLs. The ten samples with detectable PFAS levels contained a range of one to four different PFAS in domestic samples and one to two different PFAS in imported samples. Of these, four PFAS were below EPA MCLs for drinking water, and two PFAS detected do not have established MCLs.
  • The Food, Drug, and Cosmetic Act requires FDA to establish a standard of quality regulation for contaminants in bottled water whenever the EPA establishes MCLs for public drinking water as part of a National Primary Drinking Water Regulation. If FDA does not establish a standard for the contaminants or finds that such standards are not necessary to protect public health, then the EPA levels are considered the applicable regulation for bottled water. FDA can then take action against bottled water that presents a safety concern even if there is no standard of quality for a contaminant.
  • Keller and Heckman will continue to monitor activity surrounding PFAS in bottled water and other foods.
  • If passed, Maine’s SB130, titled An Act to Establish the PFAS Response Program and to Modify the Fund To Address PFAS Contamination, would be the first state law to establish PFAS limits in food (PFAS limits have been established for other categories of goods).
  • The bill would formally establish a PFAS response program to “respond to and address PFAS contamination affecting agricultural producers in the State, to assist commercial farms affected by PFAS contamination and to safeguard public health.” We note that the bill would in part codify existing portions of Maine’s PFAS response program, which has already set an action level for PFOS (a type of PFAS) in milk of 210 ppt. 
  • Specifically, under the proposed bill, the PFAS response program would, among other things:
    • Establish maximum levels for PFAS in farm products (defined as “plants and animals useful to humans” and includes, by way of example, products ranging from grains and food crops to Christmas trees).
    • Provide PFAS testing support to help agricultural producers understand the extend of PFAS contamination and provide technical support to assist in mitigation efforts.
    • Provide financial assistance to PFAS-impacted agricultural producers.
    • Establish baseline criteria that agricultural producers would have to adhere to in order to receive technical and financial assistance, including granting property access to conduct PFAS investigations and providing relevant information to program staff.
  • We will continue to monitor and report on PFAS regulation.
  • Last month a lawsuit filed by plaintiffs including the Tucson Environmental Justice Task Force (TEJTF) filed suit against FDA and now former FDA commissioner Robert Califf alleging that FDA had unduly delayed in responding to a petition filed by TEJTF in 2023 which had requested that FDA set tolerances for 30 types of PFAS in lettuce and blueberries and 26 types of PFAS in bread, milk, eggs, salmon, clams, and corn silage.
  • The lawsuit argues that FDA has unduly delayed because it has not acted consistent with its statutory mandate to “promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner” (21 USC § 393) and the delay allegedly is to the detriment of the public health. The lawsuit argues that prior decisions holding that courts should defer to FDA on whether to promulgate tolerances is no longer good law post-Chevron and that the “only discretion FDA may exercise for such chemicals [harmful substances] is the level of tolerance to be set.”
  • We will continue to monitor and report on the regulation of PFAS and other chemicals, including any changes in approach that may be implemented by the new administration.

  • On December 18, 2024, the U.S. Food and Drug Administration (FDA) shared its latest test results for per- and polyfluoroalkyl substances (PFAS) in clams as follow up to its findings in the 2022 PFAS in seafood survey.  The results of FDA’s testing are used to help the agency better understand PFAS in commercially available foods and identify foods or types of foods that would benefit from targeted surveys, to help ensure a safe and nutritious food supply.
  • In the 2022 seafood survey, FDA detected high levels of perfluorooctanoic acid (PFOA) in samples of canned clams from China and determined that the estimated exposure was likely a health concern.  Between October 2022 and September 2024, FDA collected and analyzed 12 samples of processed clams with China as the country of origin.  All 12 samples had detectable levels of at least one type of PFAS, and PFOA was detected in all samples.  Three shipments were refused entry into the US.
  • In 2023, FDA also conducted a survey of domestically acquired clam samples.  All but one of nine samples had PFOA concentrations under the method detection limit and the products remained on the US market.
  • The agency is actively engaging with both imported and domestic clam firms to better understand potential sources of contamination and ways in which PFOA concentrations may be reduced.  FDA also recently issued a request for information to help fill data gaps that remain regarding PFAS in seafood and is conducting two ongoing surveys, focused on molluscan shellfish and other commonly consumed seafood.  FDA will release results of the surveys after completion.
  • On November 19, 2024, FDA issued a request for information on per- and polyfluoroalkyl substances (PFAS) in seafood in an effort to understand the potential for PFAS exposure from seafood and reduce dietary exposure to PFAS that may cause a health concern. According to FDA, seafood presents a unique challenge and opportunity to prevent contamination because many potential hazards can be introduced at the source, such as in growing areas, aquaculture farms, and on fishing vessels.
  • For purposes of this request, FDA defines “seafood” as fresh or saltwater finfish, crustaceans, other forms of aquatic life (e.g., alligator) other than birds or mammals, and all mollusks, which are intended for human consumption. Testing of samples in the general food supply has indicated that seafood may be at higher risk for environmental PFAS compared with other types of food. To expand on the results of these samples, FDA collected additional seafood samples of the most commonly consumed seafood in the United States, including clams, cod, crab, pollock, salmon, shrimp, tilapia, and canned tuna, most of which were imported. Based on perfluorooctanoic acid concentrations in canned clams from China, FDA concluded that their consumption is likely a human health concern, resulting in two voluntary recalls of canned clams from China.  Thus, FDA is requesting information to help enhance the Agency’s knowledge about the types of seafood prone to accumulate PFAS and harvest locations with PFAS contamination, ultimately supporting a comprehensive approach to advance clean air, water, and food.
  • Specifically, FDA is seeking data and information regarding PFAS concentrations in seafood, the environment, and processing water, as well as mitigation strategies for PFAS in seafood. FDA has provided specific questions for each of these categories to help identify where PFAS has been observed. The request for information will be published in the Federal Register on November 20, 2024, with a 90-day comment period ending February 18, 2025.
  • Comments can be submitted electronically on Regluations.gov to docket number FDA02024-N-4604. Keller and Heckman will continue to monitor developments in this area.
  • On March 19, 2024, FDA issued Import Alert 99-49 (“Detention without Physical Examination of Foods Due to Chemical Contamination”), which recommends that FDA field personnel detain without physical examination products offered for import that have previously been found to be contaminated with harmful levels of chemicals, including PFAS.
  • FDA is authorized to refuse admission to food products if the articles appear to violate the Federal Food, Drug, and Cosmetic Act (the “Act”); physical examination is not necessary (21 USC § 381).
  • Companies which have been found to offer violative products for import will have their products added to the import alert’s “Red List,” subjecting future imports of those products to detention without physical examination. Once a product is subject to an import alert, the burden is on the importer to demonstrate to FDA that the product does not violate the Act.
  • It is not clear to what extent FDA will be testing imported food products for chemical contamination, including whether it will focus on particular product types.
  • Keller and Heckman is tracking the regulation of PFAS in various jurisdictions around the world and can assist companies in responding to concerns about PFAS in food and food packaging.
  • About two years have passed since cases were first filed alleging that product marketing deceptively conveyed a lack of PFAS. At this point, many demands have been made, and over 25 cases have been filed. Cases have targeted a variety of products, including fast food packaging, microwave popcorn, juice, waterproof mascara, cosmetic powders and foundation, mouthwash, floss, tampons, waterproof apparel, period underwear, and anti-fog spray for glasses.
  • A handful of cases have targeted claims like “PFAS Free” and “No long-chain PFAS.” Largely, however, plaintiffs argue that claims, such as the following, convey an absence of PFAS: “Safe and comfortable,” “We hold ourselves to the highest quality standards,” “Full of what’s good for you, free of harsh chemicals,” “All the flavors you crave without the ingredients you don’t,” “Ingredients sourced from nature,” “100% Natural,” “Feel good about what’s in this bottle,” “Working toward a sustainable future,” and “Good for you and good for the planet.” Plaintiffs have also targeted claims that products are certified by entities like OEKO-TEX, Forest Stewardship Counsel, and Fair Trade – even where neither the advertising nor the certifiers, themselves, purported to guarantee an absence of PFAS.
  • Most plaintiffs allege that claims are deceptive where testing allegedly showed 100 ppm or more of organic fluorine – which, according to plaintiffs, indicates intentionally added or a “material” amount of PFAS. One case, however, alleged that the threshold was lower, at 20 ppm.
  • So far, over five cases have been dismissed with courts reasoning, for instance, that either the presence of PFAS was disclosed or a company had no duty to disclose PFAS, that migratory chemicals are not “ingredients,” that plaintiffs identified no representations as to PFAS, that plaintiffs failed to test the specific products they purchased, or that organic fluorine does not necessarily indicate the presence of PFAS. Unfortunately, even with such holdings, there is little comfort where courts have not coalesced (and may never coalesce) around how to handle these cases. At least five motions to dismiss remain pending, and at least one motion to dismiss was denied nearly in its entirety. Several cases have settled confidentially, and one settled publicly, with the company agreeing to (1) pay up to $6.5 million in refunds and attorneys’ fees, and (2) take measures to avoid intentionally added PFAS.
  • Keller and Heckman will continue to follow and be available to assist managing risk around PFAS.
  • A class-action lawsuit was filed last week against the manufacturer of a pomegranate juice (and its parent company) for falsely advertising the product (POM) as “all natural” and healthful where it in fact contained non-natural and potentially dangerous PFAS chemicals.  
  • As many of our readers will know, per- and polyfluoroalkyl substances (PFAS) consist of a large group of fluorinated chemicals which bioaccumulate and have been linked to numerous negative health outcomes. Two types of PFAS, perfluorooctanoate (PFOA) and perfluorooctane sulfonate (PFOS) have been the subject of most the research on the health effects of PFAS.
  • Plaintiffs independently tested Defendant’s pomegranate juice and found it to contain 2.5 parts per trillion (ppt) of “6:2FTS” PFAS and 6.5 ppt of “PFPeA” PFAS. Defendants claim this amount is “significant” based on EPA’s interim updated health advisories for PFOA and PFOS of 0.004 ppt and 0.02 ppt, respectively.
  • The complaint does not justify application of EPA’s health advisory limits for PFOA and PFOS to different types of PFAS nor does it explain how the PFAS might have entered the juice or how Defendants could have known about the presence of PFAS.
  • Keller and Heckman will continue to monitor and report on this lawsuit and other claims targeting the food industry.