FDA, PFAS and Food Packaging: More to Come?
- The U.S. Food and Drug Administration (FDA) has been active in regulating per- and polyfluoroalkyl substances (PFAS) in food packaging since 2016.
- Now, FDA is considering how PFAS may migrate from high-density polyethylene (HDPE) containers to food and thereby become subject to FDA's jurisdiction over food additives.
- FDA's current activities concerning PFAS and food are motivated, at least in part, by analytical tests that the U.S. Environmental Protection Agency (EPA) conducted on nonfood uses of HDPE containers.
The U.S. Environmental Protection Agency (EPA) is not the only federal agency that regulates per- and polyfluoroalkyl substances (PFAS). And states aren't the only ones scrutinizing PFAS in food packaging products. PFAS, which are wholly synthetic compounds of carbon, fluorine and other elements, are manufactured in chains of various lengths. Long-chain PFAS which are generally compounds with eight or more carbon atoms; short-chain PFAS are generally compounds with seven or fewer carbon atoms. Due to PFAS performance characteristics, including water and grease resistance, they are often found in food packaging, especially products made of paper, paperboard and cardboard. As a result, many states have enacted bans that will phase in over time as described in Holland & Knight's previous alert, "PFAS Food Packaging Regulations Boil Over: Time to Develop a Compliance Plan," June 29, 2023.
FDA and Food Packaging
The U.S. Food and Drug Administration (FDA) has been active in regulating PFAS in food packaging as well. In 2016, FDA banned the use of two previously authorized PFAS substances as indirect food additives to paper and paperboard food packaging. FDA then facilitated the phaseout of the use of long-chain PFAS in food packaging. In 2020, FDA obtained the commitment from certain short-chain PFAS manufacturers to eliminate their use in food contact applications as well. Now, FDA is considering how PFAS may migrate from high-density polyethylene (HDPE) containers to food and thereby become subject to FDA's jurisdiction over food additives.
FDA's current activities concerning PFAS and food are motivated, at least in part, by analytical tests that EPA conducted on nonfood uses of HDPE containers. On March 4, 2021, EPA announced the results of its investigation into the possible source(s) of certain PFAS found in a pesticide product. After rinsing fluorinated and nonfluorinated HDPE containers used to store this pesticide, EPA tested the water used to rinse the containers, also known as rinsate, for certain PFAS. In the rinsate from fluorinated containers, EPA found concentrations of certain PFAS ranging from 20 to 50 parts per billion (ppb). EPA found that the rinsate from the nonfluorinated containers had 1 ppb or less of the same PFAS. EPA concluded that "through the fluorination process of HDPE containers, PFAS compounds may be formed and then partly leach into the products inside the containers." This resulted in EPA's March 2022 warning to manufacturers about the risk of PFAS formation in fluorinated polyolefins, as described in Holland & Knight's previous blog post, "PFAS in Plastic Pesticide Containers: Latest Update," March 18, 2022.
The results of EPA's study also raised concerns at FDA. On Aug. 5, 2021, FDA published a letter reminding manufacturers and users of fluorinated polyethylene food contact articles that FDA's regulations authorize only certain types of fluorinated polyethylene containers for food contact use. Specifically, FDA reminded manufacturers that nitrogen was the only permissible inert diluent allowed during food contact fluorination processes – not oxygen, water or other substances. Food containers "not manufactured in compliance with [this requirement] are adulterated" as defined by the federal Food, Drug and Cosmetic Act (FD&C Act), as amended, 21 U.S.C. § 301 et seq. The FD&C Act prohibits the sale or introduction of adulterated items into interstate commerce and authorizes penalties of $1,000 per violation, up to 364 days of prison or both. FDA concluded its August 2021 letter by encouraging manufacturers and distributors to "consult with FDA regarding the regulatory status of any substances used in contact with food, including processes used during the manufacturing of the final food container."
Almost a year after its Aug. 5, 2021, letter, FDA requested more information on the use and safety of PFAS in food containers. In a notice published in the Federal Register on July 22, 2022, FDA announced that it was "opening a docket to obtain [...] scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and safety of per- and polyfluoroalkyl substances that may migrate from fluorinated polyethylene food containers." FDA has requested this information "to support [its] review of the use of fluorinated polyethylene containers used in food contact applications to help ensure that this use continues to be safe." FDA set Oct. 18, 2022, as the deadline for comments and scientific data to be submitted in response to its request.
No New Regulations from FDA Yet
Since the Oct. 18, 2022, deadline for comments passed, FDA has not proposed any new regulations or interpretations of existing regulations regarding PFAS and food containers. Although in its current regulation of fluorinated containers FDA has approved a particular fluorination process as safe, FDA nevertheless still seeks to assure, as it stated in July 2022, that its regulation of PFAS in food containers "continues to be safe." The possibility of further FDA action in the area of PFAS and polyethylene containers for food cannot be discounted. Given the recent enactment of various state statutes addressing PFAS in food packaging, regulated parties may want to consider not only what the effects of existing FDA regulations are, but also what effect potential FDA interpretations or regulations could have, on state laws. Any analysis undertaken should consider whether FDA's current regulations or interpretations of the FD&C Act have or could have a preemptive effect on state laws regulating food packaging.
State Laws and FD&C Act Preemption
State statutes governing PFAS in food packaging vary. Some ban the use of PFAS completely from any food packaging, while others prohibit PFAS only in paper or compostable food packaging. State laws may also impose labeling requirements. Whatever their requirements, many state statutes define PFAS broadly to encompass any "class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom." (Information on state-specific PFAS laws can be found on the following websites: California, Colorado, Connecticut, Hawaii, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont andWashington.) The breadth of this definition may conflict with FDA's authorization of certain PFAS in paper and paperboard packaging as grease-proofing agents. The possibility that PFAS in food packaging could be considered a food additive subject to FDA jurisdiction suggests another area where future FDA action could preempt current state law regimes. Finally, state labeling requirements involving PFAS and food may conflict with FDA regulations and face preemption.
A general presumption against preemption, however, exists. Acknowledging this presumption and the preciseness of the provisions of the FD&C Act that create preemptive effects, several courts have concluded that no broad implied preemption exists concerning the FD&C Act and its labeling requirements. Specifically, preemption analysis asks whether an FDA requirement exists and, if it does, whether the state's regulations are identical to it. If the state's regulation is not identical to FDA's, the state's regulation may be preempted. An example: Because FDA defines the term "purified water," one court held to be preempted a state law claim that alleged that water compliant with the FDA definition was nevertheless not "pure." In the context of PFAS, California may provide another example of how a state law on package labeling could be preempted. One California PFAS law will require cookware to have an additional label denoting PFAS and other chemical presence by Jan. 1, 2024. The statute defines cookware to include items that store food. To the extent this provision conflicts with FDA's current regulations on HDPE containers or future FDA regulations on PFAS as food additives, the California statute may face the a risk of preemption.
For now, states are taking the lead in establishing PFAS regulatory regimes. Their reach, however, may be restricted by possible preemption and federal action. Moving forward, watch for FDA announcements on uses of fluorinated polyethylene, dietary exposure to PFAS and the migration of PFAS from food containers to the food they contain. When evaluating the effect of these announcements and future regulation on your business and planning for compliance, keep an eye on FDA for updated regulations and consider the possibility of preemption.
Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.