FDA's Food Traceability Public Meeting: Recap and Signals for Industry

The U.S. Food and Drug Administration's (FDA) June 15, 2026 public meeting provided an updated look at how the agency is thinking about implementing the Food Traceability Rule before the July 2028 compliance deadline. Although stakeholders broadly supported the rule's food-safety objectives, the discussion focused on whether FDA should provide additional flexibility for real-world supply chain challenges such as mixed lots, broken shipping cases, and complex distribution networks. The meeting also offered insight into the issues FDA is most likely to address as it develops future implementation guidance.

What We Learned

Supply Chain and Distribution Challenges

A substantial portion of the discussion focused on the practical challenges of complying with lot-level traceability requirements. One of the most common concerns involved the handling of products after they leave the manufacturer. Several stakeholders argued that traceability systems work most effectively when complete and accurate information is established at the beginning of the supply chain and preserved throughout distribution.

Participants questioned whether distributors, retailers, and restaurants should bear responsibility for reconstructing traceability information that is not readily available on products or packaging when they are received. For example, representatives from retail-related associations described difficulties implementing the current version of the rule to mixed pallets, commingled inventory, and store transfers. Many stakeholders with this perspective advocated for stronger traceability measures at the manufacturing and processing stage, where lot codes are originally assigned. Conversely, a representative from a national manufacturing association agreed that there are issues with case-level tracking and mixed pallets, but advocated that manufacturers be given greater flexibility over performing these tracking requirements.  

The "eaches" issue

The issue of eaches emerged as a major topic of discussion. Stakeholders explained that products are routinely removed from master shipping cases and distributed as individual units or smaller inner packs. Once a case is broken apart, key traceability information may no longer accompany the individual product. Several participants from distribution companies argued that this creates a significant compliance challenge for downstream entities in the supply chain and proposed greater use of product-level labeling, including printing traceability lot codes and related information directly on individual packages and inner packs. According to these commenters, this approach would better align with existing recall practices and reduce the need for additional recordkeeping systems.

Further compliance flexibility: greater accuracy or unsafe allowances?

Another significant theme was whether the FDA should adopt additional compliance flexibilities for entities struggling to maintain exact lot-level visibility. Some participants supported approaches discussed in the FDA's traceability position paper, including the use of inferred lot codes, reasonable ranges of potential lot codes, or other methods that rely on operational and historical data to estimate product movement. Supporters argued that these approaches more accurately reflect how products move through real-world supply chains and could substantially reduce implementation costs while still providing valuable information during recalls and traceback investigations.

Not all participants agreed with that approach. Several commenters cautioned that flexibility measures relying on assumptions or probabilistic models could weaken the public-health benefits underlying the rule. These stakeholders emphasized that the purpose of the Food Traceability Rule is to increase the speed and precision of foodborne illness investigations. In their view, systems dependent on estimated or inferred data could introduce uncertainty, broaden recalls, or delay the identification of contaminated products. Some speakers encouraged the FDA to treat any flexibility measures as transitional tools rather than permanent alternatives to lot-level traceability.

Technology solutions and automation

Technology solutions featured prominently throughout the meeting. Numerous participants highlighted software platforms, automation tools, scanning technologies, standardized data frameworks, and other systems designed to facilitate compliance.

For instance, a number of software providers and technology companies used the meeting to demonstrate technologies they believe can facilitate compliance. Representatives from blockchain-based platforms, food safety software companies, and digital traceability vendors described systems capable of capturing critical tracking events, linking key data elements, and automatically generating FDA-compliant records. Several speakers argued that existing software can dramatically reduce compliance burdens by integrating traceability into existing operational workflows rather than creating separate recordkeeping systems. However, several other commenters contended that technology adoption remains uneven across the food industry, particularly among smaller operators with limited resources and technical expertise.

Commenters also emphasized the importance of capturing traceability information at the point where food is received, prepared, labeled, or otherwise handled. These speakers argued that successful implementation requires designing systems around existing operational practices rather than expecting employees to perform additional manual data-entry tasks.

Data standardization and interoperability

Relatedly, many speakers emphasized the importance of interoperability and common data standards. Participants repeatedly noted that traceability information must move efficiently between trading partners if the rule is to achieve its intended purpose. Several commenters urged the FDA to encourage broader adoption of existing data standards and information-sharing frameworks that could reduce fragmentation and facilitate communication throughout the supply chain. Concerns were also raised about the growing number of proprietary traceability platforms being required by individual customers, which some stakeholders argued increases costs and complexity without necessarily improving food safety outcomes.

Small business concerns

Smaller businesses emerged as another key area of concern. Independent grocers, restaurants, convenience stores, distributors, and smaller producers described the operational and financial challenges associated with implementing new traceability systems. Stakeholders cited concerns regarding technology investments, labor requirements, supply-chain coordination, training needs, and ongoing compliance costs. Several participants requested additional guidance, implementation assistance, or flexibility measures to ensure small businesses are able to comply without disrupting operations or increasing food costs for consumers.

International supply chains

The discussion also highlighted the international dimension of food traceability. Participants noted that many covered products originate outside the United States and emphasized the need for coordination among foreign suppliers, importers, regulators, and trading partners. Speakers raised questions regarding cross-border compatibility, standardized data exchange, and methods for improving awareness of rule requirements throughout global supply chains.

Although participants often differed on specific solutions, a broad consensus emerged that successful implementation of the Food Traceability Rule will require continued collaboration between the FDA and industry. Stakeholders generally supported the FDA's ongoing engagement efforts and encouraged the agency to continue refining its approach as it evaluates potential compliance flexibilities ahead of the July 2028 compliance date.

Key takeaways for industry

• FDA appears to be narrowing in on a handful of recurring operational challenges. Many of the same issues identified in FDA's earlier discussion paper—including mixed pallets, broken shipping cases ("eaches"), commingled inventory, and warehouse operations—dominated the meeting. These recurring themes may offer the clearest indication of where future guidance or compliance flexibilities are most likely to emerge.
• The greatest implementation challenges often arise at supply-chain handoffs. Much of the discussion centered on what happens after products leave the manufacturer, highlighting that traceability depends on coordination across distributors, retailers, food service operators, and other trading partners. Companies may benefit from evaluating not only their own traceability systems, but also whether critical traceability information is preserved as products move through the supply chain.
• FDA continues to seek practical solutions without compromising traceback capabilities. While many stakeholders advocated for concepts such as inferred lot codes or reasonable lot-code ranges, others cautioned that those approaches could reduce the precision needed during foodborne illness investigations and recalls. The discussion suggests that FDA will continue to scrutinize whether proposed flexibilities preserve the rule's underlying public health objectives before adopting them.

Stakeholder engagement is likely to remain important. Because FDA is still evaluating potential implementation flexibilities, companies affected by the rule may wish to monitor future public meetings and guidance closely. Businesses facing operational challenges that were not discussed during this meeting should also consider whether future engagement opportunities present an opportunity to raise those concerns.

+++

*Tara Taggart is a summer associate at Davis Wright Tremaine LLP.

Kristi Wolff is a partner in DWT's Washington, D.C. office, and Laura Warf is a partner in the firm's Portland office. For any questions or more insights, please contact the authors or another member of our food and beverage team and sign up for our alerts.