FDA Compliance Tips: Per- and Polyfluoroalkyl Substances (PFAS) Compliance
Learn What Food Product Manufacturers, Packagers, and Distributors Need to Know About FDA Per- and Polyfluoroalkyl Substances (PFAS) Compliance
PFAS Compliance Team Lead
PFAS Compliance Team Lead
Former DOJ Attorney
PFAS Compliance Team Lead
Former Senior DOJ Trial Attorney
Per- and polyfluoroalkyl substances (PFAS) have recently been making headlines due to human health effects and concerns, and they are also receiving increased attention from the U.S. Food and Drug Administration (FDA) in addition to the Environmental Protection Agency. This presents significant concerns for many food product manufacturers, packagers, distributors, and other companies. As with all areas of FDA compliance, non-compliance with the FDA’s PFAS rules and regulations can have serious consequences, and companies that are subject to the FDA’s oversight need to ensure that they do everything necessary to effectively manage compliance on an ongoing basis.
The FDA began its efforts to regulate PFAS chemicals, including perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), in 2016. Since then, it has undertaken several steps to curtail the use of PFAS in food contact applications, including entering into a phase-out agreement with PFAS manufacturers in 2020. While the phase-out period ended in January 2024, PFAS remain in use (as acknowledged by the FDA), and companies that use PFAS in food contact applications remain subject to the FDA’s oversight. As the FDA explains:
“[W]e will continue to test foods from the general food supply, with the goal of accurately estimating U.S. consumers’ exposure to PFAS from foods. . . . To expedite our testing schedule, we are taking steps to increase our lab capacity. . . .
“If the agency finds that the level of PFAS creates a health concern about a particular food, we take action, which may include working with the manufacturer to resolve the issue and taking steps to prevent the product from entering, or remaining in, the U.S. market.”
As the FDA also explains, it is actively working with other federal agencies and state-level authorities to “identify routes of PFAS exposure, understand associated health risks, and reduce the public’s dietary exposure to PFAS that may pose a health risk.” Thus, while use of PFAS in food applications may be less prevalent than it once was, for companies that use PFAS, compliance remains a significant concern.
The FDA’s View on Per- and Polyfluoroalkyl Substances (PFAS)
While the FDA takes the position that the U.S. food supply “is among the safest in the world,” it also readily acknowledges the health risks associated with the use of PFAS in food contact applications. The FDA recognizes the introduction of PFAS into the U.S. food supply through two primary sources:
- “PFAS in the environment can enter the food supply through plants and animals grown, raised, or processed in contaminated areas;” and,
- “It is . . . possible for very small amounts of PFAS to enter foods through food packaging, processing, and cookware.”
The FDA is continuing to study the health risks associated with the presence of PFAS in foods and food packaging (which it describes as “serious”), and it has announced that grease-proofing agents containing PFAS will no longer be sold in the U.S. as of February 2024. However, other uses of PFAS remain permitted—with prior FDA authorization required in some cases.
FDA PFAS Compliance for Food Product Manufacturers, Packagers, Distributors, and Other Companies
With this in mind, what does it take to effectively manage FDA PFAS compliance in the wake of the FDA’s phase-out? Here are five compliance tips for food product manufacturers, packagers, distributors, and other companies:
1. Ensure Compliance with the FDA’s Current PFAS Rules and Regulations
The first step is to ensure compliance with the FDA’s current PFAS rules and regulations. With the FDA prioritizing PFAS enforcement, all companies that sell food products containing PFAS or packaged with PFAS-containing materials need to ensure that they are doing what is necessary to avoid triggering scrutiny from the agency. Among other things, this involves developing compliance policies and procedures that are custom-tailored to the company’s operations and the products it sells, and effectively implementing these policies and procedures throughout their organizations.
2. Monitor for Updates to the FDA’s PFAS Rules and Regulations
As the FDA is continuing to analyze the health risks associated with PFAS, now that its manufacturing phase-out is complete, food product manufacturers and other companies can expect to see more regulatory action from the FDA in the future. As a result, along with managing compliance with the FDA’s current PFAS rules and regulations, companies must monitor for updates as well.
With the FDA prioritizing PFAS-related compliance, companies that sell PFAS-containing products or use PFAS in food contact applications are at increased risk of facing FDA scrutiny. Given that this is the case, these companies should focus on documenting their PFAS-related compliance on an ongoing basis. As many of the FDA’s PFAS-related investigations are triggered by the agency’s own analyses or data received from third parties, it will be imperative for targeted companies to be prepared with pre-existing affirmative documentation of their compliance efforts.
Currently, certain types of PFAS-containing products are subject to prior authorization by the FDA before they can be sold in the United States. When prior authorization is required, securing authorization is largely a matter of following the requisite pre-market submission procedures and submitting reliable evidence of the subject product’s safety.
Due to multiple instances of fraud involving third-party test labs, the FDA has been paying particular attention to data reliability in recent years. Whether companies conduct their safety testing and measure PFAs in-house or work with third-party test labs, they have an obligation to ensure that all data they submit to the FDA are accurate. Not only can data reliability concerns lead to denial of authorization; but, in some cases, they can lead to additional scrutiny from the FDA as well.
5. Be Prepared to Respond to FDA Scrutiny
The FDA is actively testing food products sold in the United States for PFAS contamination, and it is working with state and local partners that are performing similar testing efforts. Thus, all companies that sell PFAS-containing products need to ensure that they are prepared to respond to FDA scrutiny should it become necessary to do so. Along with ensuring that they have adequate compliance documentation and data substantiation on hand, this involves working with experienced FDA compliance counsel who can intervene in the FDA’s investigation and communicate effectively with FDA personnel on their behalf.
Put our highly experienced team on your side
Dr. Nick Oberheiden
Founder
Attorney-at-Law
Lynette S. Byrd
Former DOJ Trial Attorney
Partner
Brian J. Kuester
Former U.S. Attorney
Hon. Kevin McCarthy
55th Speaker, U.S. House of Representatives (ret.)
Government Consultant
Mike Pompeo
Of Counsel
Former U.S. Secretary of State
John W. Sellers
Former Senior DOJ Trial Attorney
Linda Julin McNamara
Federal Appeals Attorney
Nicholas B. Johnson
Former Prosecutor
Roger Bach
Former Special Agent (DOJ)
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Ray Yuen
Former Supervisory Special Agent (FBI)
FAQs: Managing an Effective FDA PFAS Compliance Program
What Does the FDA’s PFAS Phase-Out Mean for Food Product Manufacturers, Packagers, Distributors, and Other Companies?
While the FDA’s PFAS phase-out means that companies will eventually need to stop selling manufactured PFAS in food products and other food contact applications, environmental PFAS will remain a key area of FDA compliance for many companies. Our FDA lawyers and consultants can help you understand the current regulatory landscape and develop an effective compliance program while also ensuring that your company is prepared to adapt to any changes that may come.
Does the FDA Regulate All Types of Per- and Polyfluoroalkyl Substances (PFAS)?
Yes, the FDA regulates all types of PFAS, including (but not limited to) including perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). While the FDA has primarily focused on PFAS in food-related contexts to date, its regulatory efforts have the potential to impact medical device manufacturers and companies in other industries as well.
Does the FDA Regulate All Food Products that Contain PFAS?
Yes, the FDA regulates all food products that contain PFAS. However, it regulates different types of products differently. For example, while the FDA has effectively banned the use of PFAS in grease-proofing agents (i.e., those used on non-stick cooking surfaces), foods that contain PFAS due to environmental exposure are still generally approved for sale in the U.S.—subject to any specific concerns identified through testing. However, PFAS in water from environmental contamination is generally classified as a contaminant (and thus not authorized by the FDA), and certain PFAS-containing products are subject to the FDA’s pre-market submission and authorization process.
What Does it Take to Effectively Manage FDA PFAS Compliance?
Effectively managing FDA PFAS compliance requires a comprehensive understanding of the relevant laws and regulations and a custom-tailored approach to meeting the FDA’s expectations. At Oberheiden P.C., our lawyers and consultants work closely with our clients to thoroughly identify and address their specific risks and needs.
Selling PFAS-containing food products or using PFAS in food contact applications without FDA authorization can expose companies to substantial penalties. The FDA is actively conducting market surveillance and testing products for PFAS contamination, and it is pursuing investigations and enforcement actions as warranted.
Schedule a Complimentary Initial Consultation at Oberheiden P.C.
Do you have questions or concerns about PFAS-related FDA compliance? If so, we invite you to get in touch. To schedule a complimentary initial consultation with an FDA compliance lawyer or consultant at Oberheiden P.C., please call 888-680-1745 or tell us how we can reach you online today.
