FDA Proposes Revising Regulations for Determining When an FCN is No Longer Effective

Proposed Rule Would Permit FDA to Revoke the Effective Status of an FCN for Reasons Other than Safety

The U.S. Food and Drug Administration (FDA) proposed amending its regulation on determining that a premarket notification for a food-contact substance (FCS) is no longer effective, 21 C.F.R. §170.105, and its regulation on confidential information to explicitly cover such determinations, §170.102(e). The proposed rule would, among other things:

• Provide manufacturers or suppliers the opportunity to provide input before FDA determines that a food-contact notification (FCN) is no longer effective, and
• Allow additional reasons as the basis for FDA to determine that an FCN is no longer effective other than safety. 

Additional reasons that FDA could use to determine that an FCN is no longer effective are: 

• The production, supply, or use of the FCS for its intended has ceased or will cease, or 
• The FCS identified in an FCN is authorized by a food additive regulation or covered by a threshold of regulations (TOR) exemption. 

Comments on the proposed rule are due 75 days following publication in today’s Federal Register. That is by April 11, 2022.

Under the current regulatory scheme, FDA may only determine that an FCN is no longer effective due to safety concerns. Withdrawal of an FCN by a notifier is not permitted nor may FDA determine an FCN to be no longer effective based solely on removal of an FCS from the marketplace. The proposed modification to the regulation removes this limitation on FDA’s authority by allowing the Agency to determine that an FCN is no longer effective based on a finding that the FCS is not or will soon not be produced or marketed in the United States. After FDA determines that an FCN is no longer effective on this basis, a manufacturer or supplier may subsequently submit a new FCN for the same FCS, including for the same intended use, unless already authorized by a food additive regulation or covered by a TOR exemption.

Concerning the proposal to remove an effective FCN because the intended use of the FCS is authorized by a food additive regulation or a TOR, FDA wrote in the Federal Register notice, “Issuing a food additive regulation can be more efficient than reviewing multiple FCNs for the same food contact substance and for the same use.” The Agency added that it could reduce confusion created by duplicative authorizations by removing effective FCNs for intended uses that are also authorized by food additive regulations or covered by a TOR.

FDA also is proposing to amend 21 C.F.R. §170.102 concerning confidentiality of information for an FCN to include information related to an Agency’s determination that an FCN is no longer effective. The proposed rule amends the regulation to cover all safety and functionality data and information submitted with or incorporated by reference in an FCN or submitted in reference to an effective FCN. This specifically allows data and information related to FDA’s determination that an FCN is no longer effective to be made available for public disclosure. The amended regulation would also explicitly delineate that all correspondence and written summaries of oral discussions relating to FDA’s determination that the FCN is no longer effective are also available for disclosure.