FDA Draft Guidance Q&A on Food Traceability Records

The FDA has released draft guidance in a Q&A format to clarify the requirements of the Food Traceability Rule, which mandates additional recordkeeping for certain foods.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This draft guidance is intended to help regulated entities comply with the existing rule.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 Comments on the draft guidance are due by May 21, 2026, and can be submitted online via regulations.gov under docket number FDA-2025-D-2837.