Monthly newsletter Material Concerns: Legal Updates on Substances of Emerging Concern keeps clients informed on the latest legal, regulatory and scientific developments related to substances of emerging concern. Each issue delivers concise, actionable insights to help companies navigate the evolving landscape of environmental law.

FDA to Limit PFAS in Bottled Water

By Kate Klaus

The U.S. Food & Drug Administration (FDA) has announced plans to regulate per- and polyfluoroalkyl substances (PFAS) in bottled water. 

The decision stems from a requirement under the Federal Food, Drug, and Cosmetic Act. When EPA sets limits for a chemical in public drinking water, FDA must establish corresponding limits for bottled drinking water, unless the agency determines the chemical is not present in bottled water.

Prompted by EPA’s enforceable maximum levels for certain PFAS in public drinking water finalized in 2024, FDA conducted a study to analyze the presence of PFAS in bottled water. Of the 197 samples tested, 10 were found to have detectable concentrations of PFAS, although all were below EPA’s limits for public water. 

Against this backdrop, FDA has stated it “is working on a regulation to establish levels for certain PFAS in bottled water.” The agency currently has until late 2028 to set these standards, which must be “no less stringent” than those set by EPA for drinking water. If FDA does not meet this deadline, EPA’s limits will automatically apply to bottled water.

At present, EPA has set drinking water thresholds for six PFAS compounds, ranging from four to 10 parts per trillion. FDA has indicated it “is reviewing EPA’s regulations to determine what allowable levels for PFAS are appropriate in our standard of quality regulation for bottled water.” 

However, the regulatory landscape remains in flux. In its announcement, FDA also acknowledged EPA’s recent proposal to rescind its drinking water limits for four of the six regulated PFAS, leaving in place only the standards for PFOA and PFOS. FDA did not offer any detail on how this change may affect its approach. 

Beyond bottled water, FDA’s announcement suggests a broader focus on PFAS and the food supply. The agency highlighted seafood and infant formula as “potential priority targets” for future PFAS-related efforts, including additional testing and potential action levels.

FDA Denies Citizen Petition for PFAS Food Tolerances

By Jennifer E. Hackman

A citizen petition submitted on November 1, 2023, (and supplemented on May 15, 2025) requested that the U.S. Food and Drug Administration (FDA) establish regulatory limits for per- and polyfluoroalkyl substances (PFAS) in foods. The petition asked FDA to establish “tolerances” (legally binding maximum levels) for residues of either 26 or 30 PFAS at the method detection limit (MDL)—the lowest level that can be reliably measured—and to apply those limits to foods including produce, dairy, seafood and animal feed commodities. Alternatively, the petition requested FDA establish a combination of tolerances and “action levels” (nonbinding enforcement thresholds used as guidance) for certain PFAS and foods. 

The petition relied on authorities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. §§ 342, 346), which governs adulterated food and allows FDA to set contaminant limits, as well as FDA’s regulations at 21 C.F.R. Part 109 addressing unavoidable contaminants. 

In a letter dated June 17, 2026, FDA denied the petition in full. FDA concluded that the petition did not provide sufficient scientific evidence to support establishing tolerances or action levels for the specific PFAS, foods and levels requested. FDA noted that the petition did not provide the type of data FDA typically relies on, including toxicological reference values for some of the PFAS cited, exposure data, and feasibility (achievability) analyses needed to set limits. FDA also emphasized that it retains discretion under the FD&C Act to determine whether and when to establish tolerances or action levels, and that it is not required to do so in response to a citizen petition. 

FDA also rejected arguments that it must set limits at zero or at detection limits in accordance with  food additive provisions such as the “Delaney Clause” (a provision often understood to impose a zero-tolerance standard for carcinogens). Rather, FDA explained that contaminants like PFAS are regulated under adulteration provisions, not food additive rules, and thus are not subject to a zero-tolerance mandate. 

Importantly, FDA reiterated that it can take enforcement action even without established limits if a contaminant renders food “injurious to health” under section 402(a)(1) of the FD&C Act. 
Although it denied the petition, FDA emphasized that addressing PFAS in food remains a priority and outlined several ongoing and planned agency actions:

• Data development and monitoring
  • Testing thousands of food samples and expanding analytical methods to detect more PFAS at lower levels.
  • Increasing laboratory capacity and continuing nationwide surveillance programs such as the Total Diet Study, FDA’s long-standing program that measures chemical contaminants in commonly consumed foods. 
• Targeted risk management and enforcement
  • Conducting safety assessments and taking action where PFAS poses a health concern (e.g., recalls, import refusals).
  • Using tools such as import alerts to block contaminated products.
• Regulatory development
  • Actively considering whether to establish action levels for PFAS in certain foods as more data becomes available. 
  • Reviewing EPA’s drinking water standards to determine whether to regulate PFAS in bottled water.
• Research and policy evolution
  • Developing approaches to assess cumulative exposure to multiple PFAS. 
  • Continuing to gather data through requests for information and scientific studies.

FDA emphasized that the science on PFAS is rapidly evolving and that regulatory limits generally require a stable and mature evidentiary record before being set. 

As to potential implications for stakeholders, FDA’s denial means there are currently no binding federal tolerances or action levels for most PFAS in food, though FDA retains authority to take action against products deemed unsafe, even without formal thresholds. As a result, companies face ongoing compliance uncertainty.
 
At the same time, FDA’s expanded monitoring efforts suggest greater oversight of supply chains, particularly for higher risk categories such as seafood and products sourced from regions with known contamination. FDA’s statements suggest that action levels or other guidance may be forthcoming, particularly as more toxicological and exposure data are developed. The focus on PFAS—alongside EPA and state actions—signals a continued trajectory toward tighter controls, even if formal limits are not yet established.

California Packaging and Plastics Extended Producer Responsibility Law Challenged in Multiple Lawsuits; Oregon EPR Case Set for Trial in July

By Joseph Zaleski 

On June 22, a coalition of 17 state attorneys general and the National Association of Wholesaler-Distributors brought suit in California federal district court to block implementation of California’s packaging and plastics Extended Producer Responsibility (EPR) law. The state plaintiffs include Nebraska, Alabama, Florida, Georgia, Idaho, Indiana, Iowa, Louisiana, Missouri, Montana, North Dakota, Oklahoma, South Carolina, South Dakota, Texas, Utah, and West Virginia.

California’s EPR law—formally called the Plastic Pollution Prevention and Packaging Producer Responsibility Act and codified at Cal. Pub. Res. Code §§ 42040-42084—was enacted in June 2022. EPR laws generally shift the cost and responsibility for managing post-consumer waste from governments to producers. Like similar EPR laws recently enacted in Oregon, Colorado, Minnesota, Maryland, Maine, and Washington, California’s statute generally requires producers of regulated packaging and plastic products to report the amounts and weights of those materials entering the state and to pay annual program administration fees to defray the administrative costs to manage the waste and recycling. 

The California law also establishes a series of ambitious performance targets. Among other requirements, it mandates a 25% reduction in all single-use packaging and food service ware entering the state by 2032, requires a 65% recycling rate for covered materials, and provides that 100% of such items must be either recyclable or compostable. While the California Department of Resources Recycling and Recovery (CalRecycle) is the state agency tasked with enforcing the law, California has also designated the Circular Action Alliance as the official third-party “producer responsibility organization” responsible for administering the program, including coordinating data collection, reporting and fee payments from obligated producers.

The state and trade association lawsuit challenges the California law on a number U.S. and California constitutional grounds. These include alleged violations of the Commerce Clause (by improperly burdening interstate commerce), Due Process Clause, and the First Amendment (including compelled speech), as well as claims that the law unlawfully delegates regulatory authority to a private entity. The plaintiffs also assert related claims under California’s constitution, including nondelegation principles.

This federal suit follows closely on the heels of another legal challenge to the California EPR program that three environmental advocacy organizations—the Natural Resources Defense Council, Californians Against Waste Foundation, and Oceana, Inc.—filed on June 2 in San Francisco Superior Court. Unlike the state and trade association challenge in federal court, the state case alleges that CalRecycle’s implementing regulations, finalized in May 2026, do not go far enough and fail to fully implement the statute’s requirements.

California is not the only state to have its EPR law challenged on constitutional grounds in recent months. In 2025, the National Association of Wholesaler-Distributors also brought suit against Oregon’s state EPR law in federal district court. In February 2026, the court issued a limited injunction against implementation of the state EPR program only as to the association and its members while allowing the program to proceed more broadly. The court also scheduled a date for trial on the merits to begin on July 13.

The California and Oregon federal lawsuits are primed to have significant impacts well beyond those states. EPR programs in Colorado, Minnesota, Maryland, Washington, and Maine are structured similarly—particularly in their reliance on a third-party “producer responsibility organization” like the Circular Action Alliance. Accordingly, the legal theories and constitutional challenges being tested in the California and Oregon lawsuits may apply with equal force to other state EPR programs that have not yet been challenged. 

Also, if the federal district court in California chooses to issue a preliminary injunction to stop enforcement of the EPR program while considering the merits of the challenge, that injunction may be extended to producers in all 17 states that have joined the suit as well as to the National Association of Wholesaler-Distributors and its members—a much broader and more significant stay than the limited injunction granted as to the Oregon EPR program.