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GUIDANCE DOCUMENT

Questions and Answers About Requirements for Additional Traceability Records for Certain Foods Draft Guidance for Industry February 2026

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-2837

Docket Number:
FDA-2025-D-2837
Issued by:
Guidance Issuing Office
Human Foods Program

On November 21, 2022, the Food and Drug Administration (FDA, the Agency, or we) issued a final rule, Requirements for Additional Traceability Records for Certain Foods (87 FR 70910) (Food Traceability Rule), which established additional recordkeeping requirements for persons who manufacture, process, pack or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule promulgated 21 CFR Part 1, Subpart S (21 CFR 1.1300-1.1465), which requires such entities to maintain records containing information on critical tracking events (CTEs) in the supply chain for these designated foods, such as initial packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help the Agency rapidly and effectively identify recipients of these foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death. The regulation was issued in accordance with the FDA Food Safety Modernization Act (FSMA). This guidance answers questions to facilitate industry’s understanding of the final rule.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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