- On May 27, 2026, the U.S. Food and Drug Administration (FDA) released a discussion paper to facilitate stakeholder engagement on potential flexibilities regarding the lot-level tracking requirements in the final rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Rule).
- The Food Traceability Rule requires manufacturers that process, pack, or hold foods included on the Food Traceability List (FTL) maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs), which are all used to track critical events in the food’s supply chain.
- The discussion paper contains questions that the FDA would be willing to consider regarding potential flexibilities for satisfying the Food Traceability Rule’s lot-level tracking requirement and is intended to promote deeper and more productive engagements with stakeholders, including the upcoming virtual FDA-led public meeting on June 15.
- FDA is accepting feedback from interested parties on this discussion paper no later than July 15, 2026, Docket No. FDA-2014-N-0053. Keller and Heckman would be happy to assist in submitting feedback.