FDA: Traceability: Guidance for Industry (May 21, 2026)

FMI appreciates the opportunity to comment on the U.S. Food and Drug Administration’s (“FDA” or “the agency”) Draft Guidance titled "Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Guidance for Industry” (“Draft Guidance”). As the Food Industry Association, FMI works with and on behalf of the entire industry to advance a safer, healthier, and more efficient consumer food supply chain. FMI members are committed to protecting public health by facilitating quick traceback activities to enable swift identification of contaminated products, help prevent future public health outbreaks, and avoid sweeping public advisories. We appreciate FDA’s continued engagement, including the Draft Guidance and other resources, to help covered entities design and implement compliant traceability programs.

In these comments, we provide specific areas where additional guidance from the agency is needed and provide direct feedback on certain FDA responses in the Draft Guidance. Specifically, the Draft Guidance does not adequately address many key implementation challenges that have been outlined in FMI’s previously submitted comment letters and other engagement with the agency, including: (1) the de facto requirement for case-level tracking; (2) the use of Traceability Lot Code Source References; and (3) flexibility for intracompany shipments.