FDA’s Current Standpoint on PFAS Includes Phaseouts and Regulatory Changes

The FDA approached manufacturers of these short-chain substances in 2020, “and one had already actually stopped selling in the U.S. market, and the other three companies agreed to [phase] out their materials,” Koh-Fallet says.

The phase-out terms included a starting point in January 2021 and completion in December 2023, with “annual reports to give [FDA] updates on the phase-out as well as a mid-year report in the final year,” says Koh-Fallet.

If available, the manufacturers also agreed to provide samples of these substances to help the FDA develop tracking methods for future compliance.

Manufacturers also said they expect existing stocks of these substances to exhaust supply chains within about 18 months after discontinuing sales.

Read this article to learn more about state- and federal-level PFAS regulations and their impacts on packaging companies.

FCN Regulatory Review Changes Possible

These short-chain PFAS may soon be a thing of the past in a practical sense, but their FCN authorizations are still in place.

That’s partly why the FDA in 2022 proposed revisions to 21 CFR 170.105, its guideline to determine an FCN is no longer effective.

The revision would expand the FDA’s ability to revoke FCNs for more than just PFAS, “though that’s probably the most pertinent example currently,” Koh-Fallet says.

Currently, the FDA has separate processes for revoking existing authorization between food additive regulations (under 21 CFR 171.130) and food contact notifications.

For food additives, or “something that’s added to food and is intended to have an effect on the food,” authorization can be revoked based on new safety information, abandonment, or experience with existing regulations, which covers duplicity or inapplicability, Koh-Fallet says. 

The FDA defines food contact substances as intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, without an intent to have a technical effect on the food.

The current administrative process for revoking food contact notifications allows for revocation only based on new safety information.

“This basically means that [FDA] can only remove if we made a safety determination that the use is no longer safe,” Koh-Fallet says. “There is no mechanism for us to remove it based on abandonment; there’s no mechanism for us to remove it if it’s duplicative, and that’s somewhat constraining for the FCN program.”

For the short-chain PFAS currently being phased out, the FDA would have to make a safety determination to remove their authorization, despite them being one foot out the door already.

The FDA’s proposal would allow it to “not only make a determination under safety,” Koh-Fallet explains, “but also allow us to remove an FCN from being effective if it’s abandoned, or if there are duplicative authorizations, such as a food additive regulation that covers the use or a threshold of regulation exemption.”

The proposal is yet to be set in stone, but the administration is currently working on getting the final rule published. 

As the regulatory framework surrounding PFAS and other food contact substances evolves, it is crucial for packaging manufacturers to stay aware of these changes and ensure compliance, not only to avoid regulatory trouble, but also to maintain product safety for consumers.