FDA: Discussion Paper on Identifying Additional Flexibilities for Satisfying the Food Traceability Rule’s Lot-Level Tracking Requirement (July 15, 2026)

FMI -The Food Industry Association appreciates the opportunity to provide comments on the U.S. Food and Drug Administration’s (FDA’s) Discussion Paper on Identifying Additional Flexibilities for Satisfying the Food Traceability Rule’s Lot-Level Tracking Requirement (the “discussion paper”).

FMI’s member companies receive and ship thousands of foods on FDA’s Food Traceability List (FTL) each day and are thus uniquely affected by the traceability rule. In keeping with their strong commitment to food safety, our members have dedicated significant time and resources towards understanding the rule’s requirements, enhancing their traceability programs, and coordinating with supply chain partners to ensure compliance. In parallel, FMI has invested substantial resources in supporting industry’s implementation of the rule, including through developing compliance guides, conducting member trainings and webinars, and participating in cross-industry working groups.

Through these efforts, we have identified several components of the rule that continue to present fundamental barriers to effective implementation with minimal benefit to public health, including the de facto case level tracking requirement the rule will place on distributors and the redundant recordkeeping requirements the rule will create for intracompany shipments. Complying with these requirements will place immense burdens on companies, who will be forced to restructure their recordkeeping practices and invest in new technological solutions, while offering little public health benefit relative to current recordkeeping and business practices. The investments required to address these challenges will be cost-prohibitive for many—particularly small- and mid-sized firms—and could ultimately result in increased prices for consumers. This is particularly alarming given that many FTL foods are the types of whole, nutrient-dense foods that consumers are encouraged to prioritize under the recently revised Dietary Guidelines for Americans. These components of the rule also exceed FDA’s statutory authority under the Food Safety Modernization Act (FSMA), which, among other restrictions, prohibits FDA from requiring “product tracking to the case level” or requiring “the creation and maintenance of duplicate records.”

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