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FDA’s Final Rule on FCNs that Are No Longer Effective Expected in April

FDA Building

The U.S. Food and Drug Administration’s (FDA) most recent update of its Unified Agenda of Regulatory and Deregulation Actions was published on January 25, 2024. The latest version of the Unified Agenda gives a target date of April 2024, for publishing a rule to amend the food additive regulations to allow a Food Contact Substance Notification (FCN) to become no longer effective for reasons other than safety. FDA’s most recent list of Foods Program Regulations Under Development can be found here.

Currently, authorization for determining that an FCN is no longer effective is found in 21 Code of Federal Regulations (C.F.R.) § 170.105(a), which states, “[i]f data or other information available to FDA…demonstrate that the intended use of the food contact substance is no longer safe, FDA may determine that the authorizing FCN is no longer effective.” We previously reported on the scope of the proposed amendments to Section 170.105 here

FDA also posted a list of Foods Program Guidance Under Development that are expected to be published as drafts or finals by the end of December 2024 (found here). That list includes: “Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry.”