Welcome to Womble Perspectives, where we explore a wide range of topics, from the latest legal updates to industry trends to the business of law. Our team of lawyers, professionals and occasional outside guests will take you through the most pressing issues facing businesses today and provide practical and actionable advice to help you navigate the ever changing legal landscape.
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Host 1:
Traceability has become a central part of how the FDA approaches food safety, and it’s something manufacturers are increasingly feeling across their operations. From farm to fork, food passes through many hands, and when something goes wrong, knowing exactly where a product has been can make all the difference. That reality is what’s driving FDA’s Food Traceability Rule. It’s designed to improve how certain higher-risk foods are tracked as they move through the supply chain.
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In many past food safety investigations, especially involving fresh produce, records existed, but linking them together took far too long. Romaine lettuce outbreaks are a good example. Products moved from fields to packing houses to distributors, and it often took weeks to narrow down the source. During that time, companies with no connection to the issue were still affected.
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Those situations really highlighted where traceability breaks down. Food is often packed, repacked, processed, shipped, and redistributed multiple times before it reaches consumers. When records don’t connect easily across those steps, traceback becomes slow and imprecise. That’s why Congress, through the Food Safety Modernization Act, directed the FDA to strengthen traceability for certain higher-risk foods.
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The Food Traceability Rule reflects that direction. Instead of focusing on business type, the Rule applies based on what food is being handled and what activity is happening at that point in the supply chain. Even within a single company, some products or processes may be covered while others are not. It really comes down to whether a food is on FDA’s Food Traceability List and how it moves.
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The Food Traceability List includes foods FDA has associated with higher traceability risk. That includes fresh and fresh-cut fruits and vegetables like leafy greens, tomatoes, herbs, and melon. It also includes shell eggs, certain cheeses, some seafood, and ready-to-eat deli products. Once a food falls under the Rule, FDA’s traceability framework defines what information has to be captured.
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That framework centers on a few key concepts. There are Critical Tracking Events, like receiving, processing, and shipping, where information must be recorded. At those points, companies capture Key Data Elements such as lot codes, quantities, and locations. And when FDA requests that data, companies need to be able to provide it within 24 hours.
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In practice, that’s easier said than done. FDA recognized those challenges and moved the compliance date from January 2026 to July 2028. Traceability depends not just on one company’s systems, but on how information flows across multiple partners, tools, and workflows. Bringing those records together in a usable way takes time.
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With that added time, many companies are taking a closer look at how traceability works day to day. They’re identifying gaps in lot-level tracking, testing whether they can meet the 24-hour response requirement, and improving data consistency. Even small differences in lot formats or naming conventions can make records hard to connect.
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Teams are also mapping required tracking events to real operations, coordinating more closely with supply chain partners, and evaluating whether current systems can link and export data effectively. Mock tracebacks are another common step, because they often reveal issues that aren’t obvious during routine operations.
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At its core, the Food Traceability Rule is about keeping the entire journey in view. FDA’s goal is faster, more precise traceback for higher-risk foods when safety concerns arise. The extended timeline gives companies space to test, adjust, and strengthen how information moves across their supply chains.
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Companies that use this time to understand their data flows, work with partners, and stress-test their processes will be better positioned when the Rule takes effect.
Thank you for listening to Womble Perspectives. If you want to learn more about the topics discussed in this episode, please visit The Show Notes, where you can find links to related resources mentioned today. The Show Notes also have more information about our attorneys who provided today's insights, including ways to reach out to them.
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