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FDA letter on plastic FCM fluorination

In a letter, US Food and Drug Administration (FDA) reminds manufacturers, distributors, and users “that only certain fluorinated polyethylene containers are authorized for food contact use”; reminder necessary following recent findings by US EPA and civil society organizations that some manufacturers are not following FDA regulations

On August 5, 2021, Dennis M. Keefe, the Director of Food Additive Safety at the US Food and Drug Administration (FDA), released a letter reminding “manufacturers, distributors, and users of fluorinated polyethylene food contact articles” of FDA regulations around the fluorination process. The letter highlights that the FDA does not allow “fluorination of polyethylene containers in the presence of water, oxygen, or gases other than nitrogen.” It further explains that the reminder is necessary because “available information indicates that some manufacturers” are using methods not compliant with the FDA regulations.  

The FDA became concerned after the US Environmental Protection Agency (EPA) released a report in January 2021 that found per- and polyfluoroalkyl substances (PFAS) are likely produced during the plastic fluorination process. The EPA was testing PFAS migration from fluorinated containers used for pesticides, but the FDA is suspicious that “[fluorinated] containers could also be used in contact with food.” In an independent investigation, researchers from Environmental Defense Fund and Green Science Policy Institute found fluorination treatments being used in many “packaged food and consumer products” (FPF reported). 

 

Read More 

Dennis M. Keefe (August 5, 2021). “Letter to Manufacturers, Distributors, and Users of Fluorinated Polyethylene Food Contact Articles.” US FDA (pdf) 

Ariel Wittenberg and E.A. Crunden (August 6, 2021). “FDA raises alarm over PFAS-tainted food containers.” E&E News  

Tom Neltner and Maricel Maffini (August 9, 2021). “FDA acts on fluorinated plastic packaging. What are next steps?EDF

 

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