On June 15, 2026, the U.S. Food and Drug Administration (FDA) hosted a 3-hour public meeting entitled “Challenges and Solutions in Lot-Level Food Traceability.” The Public Meeting provided the public with an opportunity to share information regarding the implementation of the Food Traceability Rule (Food Safety Modernization Act (FSMA) § 204) and provide feedback on areas of remaining concern, including lot-level tracking and compliance flexibilities.
With the compliance deadline currently set for July 20, 2028, FDA is actively gathering feedback on how to implement the rule and is working to balance concerns around public health and food supply chain operations.
What Does the Food Traceability Rule Require?
At its core, the rule is about being able to track food quickly and accurately through the supply chain.
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- Critical Tracking Events (CTEs): Key points like growing, packing, shipping, receiving, or transforming food where data must be captured.
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- Key Data Elements (KDEs): The specific information recorded at each step (e.g., lot code, product details, dates).
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- Traceability Lot Code (TLC): A lot identifier assigned early (usually at packaging) that stays with the product unless it is transformed.
The goal of the rule is that if there is a food safety issue, FDA should be able to trace the product back quickly and remove only the affected items (rather than the entire categories of food).
Key Takeaways from the Public Meeting
Overall, stakeholders support traceability in principle, and many see lot-level traceability as already feasible. However, successful implementation will depend on balancing accuracy, flexibility, cost, and global coordination.
i. Practical Challenges Exist
Supply chains do not operate in neat, one-to-one lot systems. Products are often mixed or commingled in warehouses, and breaking bulk (splitting cases into individual units) can cause traceability data to disappear. Smaller businesses and last-mile operators face added strain, as they often lack the systems and staff to manage complex recordkeeping. Across the board, cost is a major concern as new technology, labor, and process changes will add expense, likely passed on to consumers.
ii. Flexibility is essential, but others see it as risky
Industry supports FDA’s efforts to build flexibility into the rule. Common ideas include allowing multiple lot codes for mixed shipments, reassigning lot codes at distribution points, and simplifying records within closed systems. But stakeholders cautioned that too much flexibility, especially if based on estimates, could erode accuracy and weaken food safety
iii. Standardization is a major gap
Today, traceability data comes in many formats (paper, spreadsheets, and incompatible systems), which creates inefficiencies and compliance risks. Many pointed to GS1 standards as a common “language,” especially critical for global supply chains. Without shared standards prior to traceability implementation, even strong traceability systems struggle to work together
iv. Technology helps, but is not a cure-all
Tools such as barcodes, RFID, blockchain, and AI can enhance traceability; however, adoption is uneven, and cost remains a significant barrier. There are also concerns about data reliability, particularly with automated or inferred data. A practical approach, combining physical product labeling with digital records, was widely seen as the most workable solution.
v. Global challenges
Because the food supply is international, alignment across countries is essential. Differences in regulations, data formats, and language all add complexity. Without consistency, traceability requirements risk disrupting trade rather than strengthening safety.
What This Means for Industry
The direction from FDA is becoming clearer, even as details are still evolving. Therefore, regulated industry should expect that:
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- Traceability must be built on accurate, consistent lot identification.
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- Data must be captured at key points and shared quickly when needed.
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- Systems should be auditable and able to support real-world recalls.
The biggest risk may not only be failing to have a system, but having a system that is inconsistent, incomplete, or cannot stand up to scrutiny during an investigation.
Looking Ahead
FDA is actively seeking input on flexibility options through July 15, 2026, and has said they are committed to ongoing engagement with industry. Additional guidance is expected, including policies for smaller businesses and enforcement approaches.
As traceability comes into sharper focus, companies that invest early in standardized, upstream, and verifiable systems will be better positioned for compliance and for managing risk when issues arise.
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We hope this proves useful. Please contact Kyla Kaplan ([email protected]) or Jamie Woodside ([email protected]) if you have any questions or would like assistance.
