The announcement follows an FDA post-market scientific analysis of data from rodent studies that found the potential that 6:2 FTOH may also persist in humans following dietary exposure. The agency said further scientific studies are needed to better understand the potential human health risks from dietary exposure resulting from authorized food contact substances for short-chain PFAS that contain 6:2 FTOH.
This phased market removal balances uncertainty about the potential for public health risks with minimizing potential market disruptions during the COVID-19 public health emergency.
Three manufacturers have agreed to a three-year phase-out of their sales of compounds that contain 6:2 FTOH for use as food contact substances in the U.S. marketplace, beginning in 2021. After the three-year period, it is anticipated that it may take up to 18 months to exhaust existing stocks of products containing these food contact substances from the market. The fourth manufacturer informed the FDA in 2019 that it had already stopped sales of their food contact substances that may contain 6:2 FTOH for use in the U.S. market.
Manufacturers of these short-chain grease-proofing agents obtained authorization for the use of these substances in food contact paper packaging applications through the FDA’s Food Contact Notification (FCN) process. This pre-market scientific review ensures food contact materials that contain or are made of food contact substances are safe for their intended use, based on the scientific data that is available at the time of submission.
There are 15 Food Contact Notifications held by the four manufacturers that contain 6:2 FTOH. These compounds are replacements for the long-chain PFAS that are no longer in use in food contact applications through voluntary agreements with manufacturers in 2011 and through FDA regulatory action. At the time the FCNs for short-chain PFAS became effective, the available scientific data showed they were a safe alternative to the long-chain PFAS and did not indicate any potential for biopersistence.