Q.01

What does the FDA's new food traceability guidance say?

FDA's newest food traceability guidance is a draft enforcement-discretion policy issued in October 2026. If it is finalized, FDA would not enforce any requirement of the Food Traceability Rule (21 CFR Part 1, Subpart S) against retail food establishments (RFEs) and restaurants whose average food sales over the previous three years are more than $250,000 but not more than $1 million, adjusted for inflation from a 2020 baseline. It is non-binding, and comments are open until November 23, 2026.

Approach: I started with FDA's Human Foods Program guidance catalogue, which lists the traceability guidance documents but not their text. I took the content from FDA's own web pages. The guidance PDFs themselves would not download, so the details below come from FDA's guidance landing pages and announcements.

The October 2026 draft guidance

  • Title and status: "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." It is a draft dated 2026/10 [1]. FDA announced it on October 8, 2026. The docket is FDA-2025-D-6952 and the issuing office is the Human Foods Program.
  • What it covers: smaller RFEs and restaurants that fall outside the rule's existing full exemption for small RFEs and restaurants. For these businesses, FDA says it "does not intend to enforce" the rule's requirements.
  • FDA's reasoning: the policy would "maintain the intended public health benefits of the rule as it would only impact a small percentage of total food sales while also providing relief to numerous smaller RFEs and restaurants."
  • Why now: Congress directed this work in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (P.L. 119-37).
  • Public meeting: a free virtual meeting is set for November 6, 2026, on lot-level traceability challenges. Requests to speak close October 26, 2026, and general registration closes November 5, 2026. This follows a discussion paper (May 27, 2026) and an earlier public meeting (June 15, 2026).

Other traceability guidance and actions

  • Draft Q&A guidance (February 2026): "Questions and Answers About Requirements for Additional Traceability Records for Certain Foods" [2], docket FDA-2025-D-2837. It answers questions about Subpart S, including the records required for critical tracking events (CTEs) such as packing, shipping, receiving and transforming.
  • Small Entity Compliance Guide: final, May 2023 [3].
  • Compliance date: Congress has directed FDA not to enforce the rule before July 20, 2028. The original compliance date was January 20, 2026. A final rule extending the compliance date is on FDA's regulatory agenda, with a target publication date of 2026/7 [4].
  • Cottage cheese: FDA granted an exemption for cottage cheese, published in the Federal Register on February 20, 2026.

I can try the docket documents on regulations.gov next to get the full text of either draft guidance.

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Q.02

When do companies have to comply?

FDA will not enforce the Food Traceability Rule (21 CFR Part 1, Subpart S) before July 20, 2028. That is the practical deadline for companies that manufacture, process, pack or hold foods on the Food Traceability List. The rule's original compliance date was January 20, 2026. Congress has directed FDA not to enforce the rule before July 20, 2028, and FDA says it "intends to comply with this Congressional directive." (FDA Federal Register notice 2026-20720, p. 4)

Approach: I checked FDA's Human Foods Program guidance and regulatory agenda records first. They list the compliance-date extension rule but do not give the date, so I took the date from FDA's rule page and its October 9, 2026 Federal Register notice.

How the date was set

  • Original date: January 20, 2026, for everyone subject to the rule's recordkeeping requirements (FDA rule page).
  • FDA proposal: On August 7, 2025, FDA proposed pushing the date back 30 months, to July 20, 2028 (90 FR 38084, docket FDA-2014-N-0053) (Federal Register).
  • Congress: The Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 (Pub. L. 119-37) told FDA not to enforce the rule before that same date (FR notice 2026-20720).
  • Final extension rule: FDA's regulatory agenda lists a "Compliance Date Extension Final Rule" with a goal publication date of July 2026 [4]. FDA's October 9, 2026 notice still calls the extension "proposed," and I found no published final rule. So the July 20, 2028 date currently rests on Congress's non-enforcement directive, not on an amended compliance date in the rule itself.

Exceptions to the date

  • Smaller retailers and restaurants: Under the October 2026 draft enforcement policy, FDA would not enforce the rule at all against retail food establishments and restaurants with average annual food sales above $250,000 but not above $1 million. This applies only if the policy is finalized. Businesses at or below the lower threshold already fall under the rule's existing exemption.
  • Other exemptions: The rule also has "certain exemptions and partial exemptions," and FDA offers an interactive tool for checking whether they apply (FDA rule page).
  • Possible flexibilities on lot-level tracking: Section 780 of the same Act tells FDA to meet with industry every quarter to find extra flexibilities for the lot-level tracking requirement. Options under discussion include ranges of traceability lot codes (TLCs) or inferred TLCs for distribution-to-retail shipments, relief for eaches and returns, and recognizing GS1 as a data standard. The next public meeting is November 6, 2026, and meeting comments are due December 6, 2026 (FR notice 2026-20720, pp. 4-6).

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Q.03

How long is the comment period?

The comment period on FDA's draft enforcement policy for smaller retailers and restaurants is 45 days. It runs from Federal Register publication on October 9, 2026 to November 23, 2026. The Federal Register notice sets the deadline as 45 days after publication (FR 2026-20721, p. 1), and FDA's guidance page gives the closing date as 11/23/2026 (FDA guidance page).

Approach: FDA's Human Foods Program guidance catalogue lists the draft (dated 2026/10) but not its comment dates [1]. I took the dates from the Federal Register notice of availability and from FDA's guidance page.

How to comment

  • Docket: FDA-2025-D-6952. Every submission must cite it.
  • Online: through regulations.gov. Comments posted there are made public unchanged.
  • On paper: Dockets Management Staff (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. If your comment contains confidential information, use this route and send two copies: one marked "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION" and one redacted (FR 2026-20721, pp. 2-3).
  • After the deadline: FDA says comments on any guidance can be submitted at any time (21 CFR 10.115(g)(5)). However, only comments received by November 23, 2026 are sure to be considered before FDA starts work on the final version (FR 2026-20721, pp. 1, 3).

The separate meeting docket: The November 6, 2026 public meeting on lot-level traceability has different deadlines. Requests to speak close October 26, 2026, and written comments for the meeting are due December 6, 2026 (FR 2026-20720; FDA constituent update).

The February 2026 draft Q&A guidance (docket FDA-2025-D-2837) has its own comment window, and I didn't check it in this answer. I can look it up next if useful.

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Q.04