What Manufacturers Need to Know About PFAS

Manufacturers of all types of products have been using per- and polyfluoroalkyl substances (PFAS) for decades. From a manufacturing perspective, PFAS have several benefits, including resistance to grease, oil, water, heat and stains. However, concerns about health risks associated with PFAS have led to a regulatory crackdown on the use of PFAS in all types of products in recent years.

This trend is continuing in 2024, and major changes appear to be on the horizon. The U.S. Food and Drug Administration (FDA) and several states have begun implementing “phase outs” that either restrict or prohibit the use of PFAS in certain types of products. As this phase-out approach continues, companies in an extremely broad range of industries will need to comply—and, to avoid pulling their products from the market entirely, they will need to work proactively to update or develop products with PFAS alternatives.

How the FDA and State Regulators Are Responding to Concerns Related to PFAS

The FDA began targeting PFAS almost eight years ago. In November 2016, the FDA announced a phase out of long-chain PFAS, including perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) in food contact applications. Then, in 2020, the FDA entered into an agreement with PFAS manufacturers to phase out short-chain PFAS used in food contact applications by January 2024.

Currently, the FDA is in a testing phase to determine what additional measures are warranted. The FDA acknowledges that, “exposure to some types of PFAS have been linked to serious health effects,” and this is the basis for its ongoing investigation into the extent to which PFAS-containing products should be eliminated from the marketplace. In line with ongoing efforts to regulate per- and polyfluoroalkyl substances (PFAS), the FDA recently issued an import alert targeting food products contaminated with PFAS, citing potential health concerns. PFAS, widely used in various industries, face increasing regulatory scrutiny amidst growing awareness of associated health risks. At the same time, however, the FDA notes that the U.S. food supply “is among the safest in the world,” and it is not recommending that people change their consumption habits.

Notably, while much of the FDA’s research to date has focused on the food supply, broad restrictions on the use of PFAS have implications for a wide range of other industries as well. This includes the health industry. Many types of PFAS are commonly used in medical devices, medical equipment and even drugs when applying a broad definition of PFAS, and a broadscale ban on PFAS could have significant and wide-reaching implications within the medical field. In the words of the American Chemistry Council (ACC):

“PFAS are under regulatory and legislative assault at the federal and state levels. In the zeal to eliminate some of these chemistries, however, regulators and lawmakers may undermine the ability to provide life-saving healthcare in the United States.”

Several states have taken steps to ban PFAS as well. These include California, Connecticut, Maine, Minnesota, New York, Vermont and Washington, among others. While these states’ initial efforts have mirrored those of the FDA in terms of focusing on food contact applications, we anticipate that the scope of these efforts will expand as public perception of PFAS shifts toward the negative.

On October 18, 2021, the White House issued a Fact Sheet discussing the health risks associated with PFAS and outlining a series of steps to be taken by the FDA and other federal agencies over the next several years. While the Fact Sheet does not reference the healthcare industry specifically, it broadly condemns the health risks associated with PFAS and espouses the benefits of eliminating PFAS from the environment. If federal and state regulators do not provide exceptions for the medical industry, there could be major impacts. In light of these regulatory risks—as well as potential litigation risks if manufacturers are accused of knowingly selling products that contain dangerous quantities of PFAS—manufacturers in all industries would be well-served to take a proactive approach to reassessing their use of PFAS going forward.

Impact for Medical Device, Medical Equipment and Drug Manufacturers

While efforts to regulate PFAS have not yet expanded to the healthcare industry, companies that manufacture medical devices, medical equipment and drug manufacturers should be paying close attention to PFAS-related regulations and legislation at the federal and state levels. Regulation may be forthcoming—whether in the form of broad prohibitions on the use of PFAS or regulations specifically targeting drugs, implants, personal protective equipment (PPE) or other medical products—and, even with a years-long phase out, it could be difficult for manufacturers to comply short of pulling their products off of the shelves.

Additionally, as public awareness of the risks associated with PFAS grows, the risk of PFAS-related litigation increases as well. PFAS-related class actions have already been filed, and we expect the volume of PFAS-related litigation to increase in the coming years.

Impact for Manufacturers of Foods, Cosmetics and Other Products

As noted, efforts to regulate PFAS already cover food contact applications. Regulation is set to expand to other products. In Minnesota, for example, a law is set to take effect in 2025 that will ban intentionally added PFAS in products including cosmetics and cleaning products, among several others.

The Importance of Seeking Alternatives to PFAS

Due to the health concerns associated with PFAS and the focus on PFAS at the federal and state levels, manufacturers in all industries should consider seeking alternatives going forward. Of course, this is easier said than done. Even 3M, one of the world's largest manufacturers, reportedly expects to lose more than $1 billion when Minnesota’s new law takes effect as a result of being unable to timely replace the PFAS used in many of its products. But, the consequences of non-compliance could be far more severe—and it is these consequences that manufacturers need to consider when deciding how best to approach their use of PFAS in 2024 and beyond.

The Bottom Line

Efforts to eliminate PFAS in consumer products are not likely to end any time soon. This is a reality that manufacturers in all industries must accept going forward. If you have questions about what your company can (and should) be doing to proactively manage its PFAS-related risk, we invite you to schedule a confidential consultation with an FDA regulatory attorney at Gardner Law.