United States: FDA Publishes Final Rule Revising Bases And Procedures For Revoking FCN Authorizations

The US Food and Drug Administration (FDA) published a Final Rule on March 22, 2024, amending its regulation at 21 C.F.R. § 170.105 to provide additional bases upon which the agency may determine that a Food Contact Notification (FCN) is no longer effective, and the procedures to be followed for doing so. (See 89 Fed. Reg. 20306). This Final Rule also amends FDA's regulation at 21 C.F.R. § 170.102 regarding the confidentiality of information to provide for the disclosure of certain information relating to FDA's determination. The Final Rule will become effective on May 21, 2024 (60 days after the date of its publication in the Federal Register,).

Prior to this amendment, the only basis upon which FDA could determine that an FCN was no longer effective was if the Agency determined that the food contact substance (FCS) was no longer safe for the intended use. This framework resulted in certain cases in which manufacturers have voluntarily agreed to cease introduction into interstate commerce of FCSs covered by effective FCNs, but the FCNs continue to remain effective. (See, e.g., information on the market phase-out of certain short chain per- and polyfluoroalkyl substances (PFAS) and the market phase-out of certain long chain PFAS on FDA's website here). As amended, Section 170.105 provides additional bases upon which the Agency can determine that an FCN is no longer effective, and provides the manufacturer or supplier of the substance with the opportunity to provide input before FDA makes such a determination.

First, FDA may determine that an FCN is no longer effective where data or other information available to FDA demonstrate that the production, supply, or use of the FCS for its intended use by the manufacturer or supplier has ceased or will cease. This is referred to through FDA's Final Rule as "abandonment."

Second, the Final Rule allows FDA to determine that an FCN is no longer effective where the use of an FCS identified in an FCN is either authorized by a food additive regulation or is the subject of an issued Threshold of Regulation (TOR) exemption. FDA included this change to Section 170.105 to reduce confusion created by duplicative authorizations.

The Final Rule also establishes procedures for how FDA will determine that an FCS is no longer safe for its intended use based on new data or information. FDA will inform the affected manufacturer or supplier specified in the FCN, in writing, of FDA's concerns regarding the safety of the intended use of the FCS. The Final Rule provides the manufacturer or supplier who submitted an FCN the opportunity to address the Agency's safety concerns or to otherwise show why an FCN should continue to be effective by a specified date. If the manufacturer or supplier fails to supply the data or other information necessary to address the safety concerns, FDA may determine that the FCN is no longer effective because there is no longer a basis to conclude that the intended use is safe.

In addition, the Final Rule amends the confidentiality of information provisions at 21 C.F.R. § 170.102 to provide for the disclosure of safety and functionality data relating to the Agency's determination that an FCN is no longer effective. (Finally, the Final Rule includes non-substantive changes to both § 170.102 and § 170.105 which mainly clarify the language of the regulations.) FDA states that these changes will create mechanisms to improve the efficiency of the FCN program.

FDA published its Proposed Rule on January 26, 2022. (See 87 Fed. Reg. 3949 (Jan. 26, 2022)). In the Final Rule, FDA noted that it received fewer than 20 comments. In addition to a comment questioning FDA's authority to provide additional reasons for determining that an FCN is no longer effective, comments addressed various topics such as (1) improved efficiency and reduced burden on industry; (2) the circumstances under which FDA would make a determination based on abandonment; (3) providing manufacturers or suppliers the opportunity to respond to FDA's safety questions before determining an FCN is no longer effective; (4) the confidentiality provisions; (5) providing an opportunity for affected parties to comment on the timeframe for food packaging to clear the market; and (6) requesting an additional basis for declaring an FCN no longer effective. In its discussion of the Final Rule, FDA provided a thoughtful response to each of the comments received, carefully explaining the Agency's basis for disagreeing with several of the comments, including the comment challenging FDA's authority to adopt the rule.

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