August 5, 2021
Today the U.S. Food and Drug Administration issued a letter reminding industry that only certain fluorinated polyethylene containers are authorized for food contact use. The agency took this step to ensure that manufacturers that produce, distribute, or use these types of containers are aware of FDA’s regulation pertaining to the requirements for fluorinating polyethylene containers used with food (21 CFR 177.1615).
Fluorination allows for improved chemical barrier properties in containers. Recently, based on testing performed by the Environmental Protection Agency (EPA), the FDA has become aware that certain per- and polyfluoroalkyl substances (PFAS) can form and migrate from some fluorinated high-density polyethylene (HDPE – a type of polyethylene) containers. EPA’s testing was conducted on containers that are not regulated by the FDA (containers intended to hold mosquito-controlling pesticides not approved for direct use on food crops). The type of PFAS detected are called perfluoroalkyl carboxylic acids (PFCAs), several of which are associated with adverse health effects. Analytical studies indicate that PFCAs can result from fluorination processes that are not compliant with FDA’s regulations.
While the FDA has no evidence that these alternative fluorination processes are used to manufacture food containers, the agency is encouraging manufacturers and distributors to consult with the FDA regarding the regulatory status of any manufacturing processes used for fluorinated polyethylene containers intended for use with food.
The FDA is committed to ensuring that food containers are safe for consumers. We will work with manufacturers and distributors of fluorinated polyethene containers used with food to ensure that their products comply with FDA regulations.