FDA Announces End of Sales of PFAS Used in U.S. Food Packaging

The U.S. Food and Drug Administration (“FDA”) recently announced that grease-proofing substances containing per and poly-fluoroalkyl substances (“PFAS”) are no longer being sold by manufacturers for food contact use in the U.S. This development is largely the result of voluntary commitments by industry to stop the sale of grease-proofing substances containing certain types of PFAS that FDA research indicates carry health risks. The voluntary market phase-out of these substances eliminates them from food packaging paper and paperboard, the major source of dietary exposure to PFAS from food packaging.

PFAS are an extensive and diverse group of thousands of chemicals that resist grease, oil, water, and heat. FDA authorized certain PFAS for limited use in cookware, food packaging, and food processing equipment. Manufacturers applied these grease-proofing substances to paper and paperboard packaging such as fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags to prevent leaking of grease and oil and to make the packaging water-resistant.

FDA has worked with industry since the early 2000s to reduce PFAS in food and food packaging. Through voluntary market withdrawals and revocations of FDA authorizations, between 2011 and 2016, manufacturers stopped using grease-proofing agents containing a type of PFAS known as “C8 compounds” or “long-chain” compounds in food contact materials in the U.S. market. Industry used instead substances containing “short-chain” PFAS authorized for this use. In 2020, FDA obtained data that raised potential safety concerns about a specific short-chain PFAS known as 6:2 fluorotelomer alcohol (“6:2 FTOH”). In response to that data, FDA obtained written commitments from each of the manufacturers of PFAS grease-proofing agents that contain this substance to phase out the use of 6:2 FTOH. FDA also is working on a validated analytical method to monitor the market for these food contact substances in food packaging.

While manufacturers of these short-chain PFAS food contact substances have agreed to stop selling food packaging with these short-chain PFAS substances for use in the U.S., their customers are likely to have existing stock for some time. Currently, those businesses may continue to distribute or use the products they already have. The Food Contact Notifications (“FCNs”) for these short-chain PFAS food contact substances remain in effect.

Also, FDA’s announcement does not affect short-chain PFAS food contact substances with effective FCNs for uses other than as grease-proofing agents on paper and paperboard food packaging. For example, FCNs authorize certain PFAS substances in non-stick pots and pans and food processing equipment.

If you have any questions about this development or related issues, please contact AGG Healthcare attorneys Beth Davis, Bob Durkin, or Priya Sinha.