FDA Proposes Enforcement Discretion for Small Retailers and Restaurants Under the Food Traceability Rule
by Hutchinsons Law | Oct 15, 2026 | Law |
- On October 8, 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance addressing the exemption for small retail food establishments (RFEs) and restaurants under Section 1.1305(i) of the Food Traceability Rule. Established under the Food Safety Modernization Act (FSMA), the Food Traceability Rule imposes additional recordkeeping requirements for establishments that manufacture, process, pack, or hold foods on FDA’s Food Traceability List (FTL). Congress has pushed enforcement of the final rule to July 2028 following concerns raised by industry stakeholders about the time needed to implement the rule’s requirements.
- Under the current rule, small RFEs and restaurants with average annual food sales of no more than $250,000 over the prior three years are exempt from the Food Traceability Rule’s additional traceability record requirements. If finalized, the guidance provides FDA with “enforcement discretion for all requirements in the Food Traceability Rule for RFEs and restaurants that have an average annual monetary value of food sold or provided during the previous 3-year period of greater than $250,000 but no more than $1,000,000 (on a rolling basis),” adjusted for inflation (emphasis added). The proposed enforcement discretion was written in response to compliance “challenges” brought to FDA’s attention by small RFEs and restaurants following the issuance of the final rule in 2022.
- FDA also noted in its press release of the draft guidance that it is actively considering additional flexibilities for regulated entities and will hold a public meeting on November 6, 2026, to discuss implementation challenges and potential modifications to lot-level food traceability requirements.
- Keller and Heckman will continue to monitor updates related to FDA’s Food Traceability Rule.
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