FDA draft guidance would pause food traceability rule enforcement for mid-sized retailers and restaurants

On October 9, 2026, FDA published a Federal Register notice announcing a draft guidance on its Food Traceability Rule (21 CFR Part 1, Subpart S), which implements FSMA Section 204. The draft states that FDA does not intend to enforce any of the rule's requirements for retail food establishments and restaurants whose average annual monetary value of food sold or provided over the previous 3 years is more than $250,000 but no more than $1,000,000, adjusted for inflation from a 2020 baseline. Businesses at or below $250,000 already have a full exemption under the rule. FDA says retail and restaurant businesses raised compliance challenges for smaller firms that did not qualify for that exemption. Comments on the draft (Docket No. FDA-2025-D-6952) are due November 23, 2026. The draft guidance is not binding.

The same day, FDA announced a virtual public meeting, Challenges and Solutions in Lot-Level Food Traceability, for November 6, 2026, from 12:00 to 3:30 p.m. Eastern Time, with comments due December 6, 2026 (Docket No. FDA-2014-N-0053). The notice explains that the Continuing Appropriations Act of 2026 directed FDA not to enforce the rule before July 20, 2028, and to engage with regulated entities on more flexibility for the lot-level tracking requirement. It also summarizes earlier comments on ideas such as allowing a reasonable range of traceability lot codes when foods move from distribution to retail.

This is guidance, which isn't legally binding. It describes the agency's current thinking.