FDA Requests Information on Food Contact Uses of Fluorinated Polyethylene

In response to an alert about unintended per- and polyfluoroalkyl substances (PFAS) in packaging, the U.S. Food and Drug Administration (FDA) issued a request on July 20, 2022, for information[1] on food contact use of fluorinated polyethylene containers.

Context: The fluorinated plastics issue first surfaced in September 2020 with the discovery of unintended PFAS in pesticide products. In the 6 months that followed the initial report, the U.S. Environmental Protection Agency (EPA) and the organization that alerted the agency confirmed fluorinated containers to be PFAS sources. Subpoenas and recommendations to discontinue use of affected products ensued.

When these findings emerged, Integral toxicologists cautioned[2] that pesticides were only the tip of the iceberg. This came with the understanding that almost 40 years prior, FDA had amended food additive regulations[3] to enable the use of fluorine-treated polyethylene for food-contact surfaces.

Midway through 2021, FDA followed up with a letter[4] to manufacturers, distributors, and users of fluorinated polyethylene food contact articles. In that letter, the administration specified approved manufacturing conditions and acknowledged its awareness of the formation of PFAS during high-density polyethylene fluorination. It also linked the generation of PFAS to the presence of water, oxygen, and non-nitrogen gases—conditions non-compliant with those authorized in federal regulations for food-contact use.

Call to Action: FDA’s recent request opened a docket to gather scientific data and information on current food contact uses of fluorinated polyethylene. This includes potential consumer dietary exposure resulting from those uses and the safety of certain PFAS that may migrate from fluorinated polyethylene food containers. Using data on manufacturing processes and process controls, analytical information, and the safety of fluorinated polyethylene, FDA hopes to refine its food contact use exposure estimates and update safety assessments.

Submissions for this request are invited through October 18, 2022.

References

1] https://www.federalregister.gov/documents/2022/07/20/2022-15455/fluorinated-polyethylene-containers-for-food-contact-use-request-for-information

[2] Kristian Fried, “Stewardship for Product Packaging,” invited speaker at Household and Commercial Products Association’s IMPACT2021 Mid-Year Meeting, May 27, 2021

[3] 48 FR 39057, Aug. 29, 1983

[4] https://www.fda.gov/media/151326