The FDA is seeking scientific data and input from industry on current food contact uses of fluorinated polyethylene, as well as consumer dietary exposure that may result from those uses. On July 19, the agency issued a request for information due to concerns that fluorination of polyethylene may result in the formation of per- and polyfluoroalkyl substances (PFAS).
The FDA authorized fluorinated polyethylene for general use in contact with food in 1983 (21 CFR 177.1615). However, the regulation requires specific manufacturing conditions that must be in place during the fluorination process. In 2021, testing by the Environmental Protection Agency (EPA) noted the migration of perfluorooctanoic acid (PFOA), a type of PFAS, from fluorinated polyethylene containers used to hold pesticides. In response, the FDA issued a letter to food manufacturers, reminding industry that only certain fluorinated polyethylene containers are authorized for food contact use.
The July 19 call for input and data is part of the FDA’s efforts to monitor new scientific information on food contact surfaces (FCS) as it becomes available. “This includes reviewing scientific literature and studies from other regulatory and health agencies in the U. S. and in other countries. Considering recent developments, the FDA is seeking additional information on current practices to ensure the safe use of fluorinated polyethylene in contact with food,” said the FDA in its letter to industry.
Those interested in providing information can submit comments electronically on Regulations.gov to docket number FDA-2022-N-1526.
Submit written/paper submissions with Docket No. FDA-2022-N-1526 for “Fluorinated Polyethylene Containers for Food Contact Use; Request for Information” to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852