The U.S. Food and Drug Administration (FDA or the Agency) recently announced that substances containing certain Per- and Polyfluoroalkyl Substances (PFAS) for use as grease-proofing agents on paper food packaging are no longer being sold in the U.S. by their manufacturers. This new development is primarily the result of the fulfillment of voluntary market phase-out commitments made by the manufacturers of specific short-chain
6:2 fluorotelomer alcohol (6:2 FTOH) PFAS substances for use as grease-proofing agents on paper food packaging. And although FDA had not raised concerns with other types of FDA-authorized short-chain PFAS substances, FDA also recently received confirmation that the manufacturers of the remaining FDA-authorized grease-proofing short-chain PFAS substances had also voluntarily ceased to sell such substances for food contact use in the U.S. Of note, food contact substances containing long-chain
PFAS have not been sold in the U.S. since around 2016, as a result of similar voluntary market phase-out commitments by manufacturers, as well as FDA's revocation of certain regulations that had authorized long-chain PFAS in food packaging.
Importantly, although the manufacturers of these short-chain PFAS food contact substances have voluntarily agreed with FDA to stop selling them for these uses in the U.S., distributors and other businesses may still have existing stocks on hand of food contact material (e.g., food wrapping) containing these short-chain PFAS food contact substances. For now, such distributors and businesses generally may continue to distribute and use such products, as the Food Contact Notifications (FCNs) for these short-chain PFAS food contact substances remain effective and have not been withdrawn. FDA acknowledges in its announcement that it may take until June 2025 to exhaust existing market inventory.
As manufacturers wound down their production of these short-chain PFAS food contact substances under their voluntary market phase-out commitments, efforts have been made to try to ensure that comparable, alternative food contact materials will be available on the market. For example, in a recent letter from a manufacture to FDA regarding the manufacturer's voluntary market phase-out commitments, the manufacturer noted that the company had secured an FCN for an alternative grease-proofing agent and that the company would continue to work on further replacement chemistries to allow industry to successfully transition to alternative grease-proofing products.
It is also important to note that short-chain PFAS food contact substances with effective FCNs for uses other than as grease-proofing agents on paper food packaging are beyond the scope of FDA's announcement. For example, FCNs authorizing certain PFAS substances as manufacturing aids in the production of other food contact polymers are unaffected. Other unaffected FCN-authorized uses of PFAS include uses in non-stick applications on pots and pans and in the manufacture of rubber o-rings and gaskets used in food processing equipment. In an email to media, FDA noted that "Current research demonstrates that the potential exposure to PFAS through the remaining limited authorized uses is exceedingly low."
Nevertheless, FDA will continue to monitor the food supply for PFAS content, including any PFAS content present as an unintended impurity or contaminant. For example, since 2019 FDA has included testing for PFAS as part of the Agency's periodic "Total Diet Study" (in which FDA samples and tests different foods on the market for nutrient elements, toxic elements, pesticide residues, and other chemicals). FDA also recently announced that the Agency is working towards a validated analytical method that would allow FDA to monitor the market for PFAS specifically in food packaging.
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