FDA food traceability rule guidance for retailers and restaurants

FDA food traceability rule guidance for smaller retailers and restaurants

The FDA food traceability rule guidance issued October 8, 2026 proposes enforcement relief, if finalized, for retailers and restaurants with average annual food sales above $250,000 and no more than $1 million. Comments are due November 23, 2026 (FDA guidance page).

It is an enforcement policy under the FSMA 204 Food Traceability Rule, not a records guide. Key data elements and lot codes are in a separate draft Q&A guidance from February 2026.

What the draft guidance says

The full title is "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants" (docket FDA-2025-D-6952, Human Foods Program) (FDA guidance page). The Federal Register notice of availability is October 9, 2026, 91 FR 64629 (Federal Register).

The rule (21 CFR Part 1, Subpart S) already fully exempts retailers and restaurants whose average annual food sales over the previous 3 years are no more than $250,000 (21 CFR 1.1305(i)). The draft adds a second tier. For businesses above $250,000 but no more than $1,000,000, FDA "intends to exercise enforcement discretion for all requirements in the Food Traceability Rule" (FR notice PDF). Both thresholds use the same test: a rolling 3-year average of the value of food sold or provided, adjusted for inflation using 2020 as the baseline year.

The rule's only relief for this sales band is format. These businesses may already give FDA requested information in a form other than an electronic sortable spreadsheet (21 CFR 1.1455(c)(3)(iii)(B)). If finalized, FDA would not enforce any Food Traceability Rule requirement against this group, and the draft sets no conditions (guidance PDF).

FDA acted on stakeholder feedback "after determining there would be minimal public health impact" (FDA constituent update). Many of these businesses "struggle to stay in business and can only employ a very small staff" and often lack resources for training, technology or staffing. FDA says firms with annual sales under $1 million account for about 6% of food sales in these sectors and 50% of establishments. FDA expects the policy to apply at the compliance date and to continue while it works to understand those challenges (guidance PDF).

Who it does not cover

This proposed relief covers only retail food establishments and restaurants with average annual food sales above $250,000 and no more than $1 million (guidance PDF). It does not cover manufacturers, processors, packers, distributors or farms. Small farms have their own exemptions under 21 CFR 1.1305(a).

The document is still a draft, marked "Not for implementation" (FDA guidance page). The Federal Register notice says it "does not establish any rights for any person" and is not binding on FDA or the public. It applies only if finalized (FR notice PDF).

How to comment by November 23, 2026

Submit by November 23, 2026 if you want FDA to consider the comment before it begins work on the final version. You can still comment on any guidance at any time under 21 CFR 10.115(g)(5) (FR notice PDF).

Submit online through regulations.gov, where comments are posted publicly as received. Or send paper to Dockets Management Staff (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Put docket FDA-2025-D-6952 on every submission. Confidential information goes by paper only, in two copies: one marked "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION" and one redacted (submission instructions).

Food traceability rule compliance date and enforcement

The final rule was published November 21, 2022 (87 FR 70910) and implements FSMA section 204(d) (Federal Register). Its original compliance date was January 20, 2026. In August 2025, FDA proposed moving it 30 months, to July 20, 2028 (90 FR 38084) (Federal Register).

Section 780 of Division B of Pub. L. 119-37, approved November 12, 2025, says no funds in that Act may be used to administer or enforce the rule "prior to July 20, 2028" (Pub. L. 119-37). FDA says it "intends to comply with this Congressional directive" (FDA rule page).

FDA's October 9, 2026 notice still calls the extension proposed, so July 20, 2028 is a no-enforcement date set by Congress, not an amended rule date (Federal Register notice).

What the rule requires if you are still covered

Subject to exemptions, domestic and foreign firms that manufacture, process, pack or hold Food Traceability List foods for US consumption must keep key data elements (KDEs) for critical tracking events (CTEs) (FDA rule page).

CTEs are harvesting, cooling before initial packing, initial packing of a raw agricultural commodity other than food from a fishing vessel, first land-based receiving of food from a fishing vessel, shipping, receiving and transformation. A traceability lot code is a descriptor, often alphanumeric, that uniquely identifies a lot and must pass unchanged unless the food is transformed (FDA rule page). The list includes soft and fresh soft cheeses, shell eggs, nut butters, fresh cucumbers, fresh herbs and fresh leafy greens, plus foods that contain a listed food in the same form, such as fresh (Food Traceability List).

A written traceability plan must describe recordkeeping procedures, how list foods are identified, how lot codes are assigned and a point of contact (21 CFR 1.1315). Records are kept for 2 years and must reach FDA within 24 hours of a request, in an electronic sortable spreadsheet during an outbreak or recall unless an exception applies (21 CFR 1.1455).

Record details are in the February 20, 2026 draft Q&A guidance, docket FDA-2025-D-2837 (FDA guidance page). The period for considering comments on that draft closed May 21, 2026. Certain cottage cheese products regulated under the NCIMS Grade "A" Pasteurized Milk Ordinance have been exempt since February 20, 2026 (Federal Register).

FDA lot-level tracking meetings and comments

Section 780 also tells FDA to engage quarterly with farms, restaurants, retailers and supplying warehouses on lot-level tracking (Pub. L. 119-37). After a May 2026 discussion paper and a June 15 meeting, FDA summarized 26 comments. Comment themes included ranges or inferred lot codes on distribution-to-retail shipments, with guardrails and concern this could broaden recalls, plus flexibility for individual units, returns, reclamations and food waste recovery, intracompany shipments, and GS1 as a data standard (FR notice PDF).

The next meeting is virtual and free on November 6, 2026, from 12:00 pm to 3:30 pm ET. Requests to speak close October 26, general registration closes November 5, and there is no same-day registration. Meeting comments go to docket FDA-2014-N-0053 by December 6, 2026 (Federal Register).

Guidance comments go to FDA-2025-D-6952 by November 23, 2026; lot-level meeting comments go to FDA-2014-N-0053 by December 6, 2026. FDA says it plans more flexibilities beyond this draft policy (FDA constituent update).

RegAffairs AI answers this question from the FDA and Federal Register sources.