FDA Draft Guidance Q&A on Food Traceability Records

FDA Guidance Documents

Published May 21st, 2026

Detected February 27th, 2026

Summary

The FDA has issued draft guidance in a Q&A format to help industry understand the requirements for additional traceability records for certain foods, as established by a final rule in 2022. Comments on this draft guidance are due by May 21, 2026.

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The FDA has released draft guidance in a Q&A format to clarify the requirements of the Food Traceability Rule, which mandates additional recordkeeping for certain foods. This guidance aims to assist entities that manufacture, process, pack, or hold foods designated for the Food Traceability List (FTL) in understanding their obligations regarding critical tracking events (CTEs) in the supply chain. The final rule, issued in November 2022, established these requirements to enhance the ability to rapidly identify food recipients and mitigate foodborne illness outbreaks.

This draft guidance is intended to help regulated entities comply with the existing rule. While FDA guidances are generally non-binding recommendations, this document provides clarity on specific aspects of the Food Traceability Rule. Stakeholders, including food manufacturers, processors, packers, and holders of designated foods, should review this guidance to ensure their recordkeeping practices align with the FDA's expectations. Comments on the draft guidance are due by May 21, 2026, and can be submitted online via regulations.gov under docket number FDA-2025-D-2837.

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05/21/2026

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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