Federal Register #FDA-2025-D-6952

FDA draft guidance on Food Traceability Rule enforcement for qualifying food retailers and restaurants

The Food and Drug Administration (FDA) is announcing draft guidance on Food Traceability Rule enforcement for certain retail food establishments and restaurants. - Government buyer: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA); no specific sub-agency office is identified. - Notice type: Guidance availability notice, not a procurement opportunity or contract award. - Enforcement policy described: FDA states it does not currently intend to enforce certain Food Traceability Rule requirements for qualifying retail food establishments and restaurants. - The guidance applies to businesses whose average annual value of food sold or provided during the prior three years is greater than $250,000 and no more than $1,000,000, adjusted for inflation. - Guidance status: Draft and nonbinding; it reflects FDA’s current thinking. - Products, services, OEMs, and vendors: None requested or named.

Description

The FDA announces the availability of draft guidance on its enforcement policy for certain retail food establishments and restaurants subject to the Food Traceability Rule. The guidance states that FDA does not intend at this time to enforce the rule’s requirements for retail food establishments and restaurants whose average annual value of food sold or provided over the previous three years is more than $250,000 and no more than $1,000,000, adjusted for inflation. The guidance is nonbinding and describes FDA’s current thinking. Comments on the draft guidance are due by November 23, 2026.

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