The Food and Drug Administration proposes to stop enforcing its additional food-traceability requirements for a band of small restaurants and retail food establishments that exceeds the rule's existing exemption. The policy is draft guidance released for comment, not a new legal exemption.
Which businesses it covers
FDA's draft describes an existing full exemption for establishments with no more than $250,000 in average annual food sold or provided during the previous three years. That is a rolling average, adjusted for inflation using 2020 as the baseline.
The proposed enforcement policy covers establishments above that threshold but at or below $1 million, measured the same way. FDA would exercise enforcement discretion for all requirements of the Food Traceability Rule in that band.
Those businesses already have narrower relief, according to the draft: they can provide required information in an alternate format instead of an electronic sortable spreadsheet. The proposed policy reaches beyond the format of the records.
What remains unsettled
FDA says these businesses can face staffing, training and technology constraints even when they are too large for the existing exemption. The draft says the agency anticipates continuing the policy while considering solutions that minimize effects on tracing contaminated food.
It does not amend the regulation or establish enforceable rights. FDA's guidance page marks it as not for implementation. Separately, FDA says Congress directed it not to enforce the traceability rule before July 20, 2028. The draft anticipates its proposed policy being in effect when the compliance date is reached and continuing afterward.
Two comment opportunities
For FDA to consider feedback before beginning work on final guidance, submit draft-policy comments by November 23, 2026, under docket FDA-2025-D-6952. FDA permits comments on guidance at any time; November 23 is the stated window for that consideration.
A separate virtual meeting on lot-level tracking begins November 6 at noon Eastern. Speaker registration closes October 26; general registration closes November 5, with no same-day registration. Written meeting comments are due December 6, with online submissions accepted until 11:59 p.m. Eastern, under the different docket FDA-2014-N-0053.
The meeting will consider implementation challenges and potential flexibility. It does not itself adopt changes to the rule. FDA warns that ordinary electronic comments become public and gives separate instructions for confidential submissions.