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How FDA Traceability Lot Codes Support Fast and Accurate Recalls

Learn how FDA Traceability Lot Codes enhance food safety and streamline recalls, ensuring traceability compliance and regulatory protection.

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Why FDA Traceability is Critical in 2025

In 2025, FDA traceability is more important than ever. The Food Traceability Rule (FTR), set to go into effect, mandates additional recordkeeping for foods listed on the Food Traceability List (FTL) [1]. This regulation aims to bolster food safety by enabling quicker identification and removal of contaminated products, thereby reducing foodborne illnesses and fatalities [1]. While the compliance date is currently set for January 20, 2026, the FDA intends to extend it by 30 months [1].

Understanding FDA Traceability Lot Codes

A Traceability Lot Code (TLC) is a unique descriptor, often alphanumeric, used to identify a traceability lot within a company’s records [2]. It’s a crucial component of the FTR, linking to other Key Data Elements (KDEs) [2].

Key Aspects of TLCs:

  • Unique Identification: TLCs provide a way to uniquely identify food products throughout the supply chain.
  • Integration with KDEs: They link directly to other essential data elements, ensuring comprehensive traceability.
  • Mandatory Assignment: Firms must assign a TLC when initially packing a raw agricultural commodity, receiving food from a fishing vessel, or transforming a food [2].
  • Traceability Plan Requirement: While the FDA doesn’t dictate how to define or assign TLCs, companies must document their process in their Traceability Plan [2].

How TLCs Support Fast and Accurate Recalls

The TLC is the most important Key Data Element (KDE) required by the rule because it links a food product to each of the events in its supply chain [2]. The rule requires persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain and provide to their supply chain partners with key data elements (KDEs) for certain critical tracking events (CTEs) in the foods supply chain [2].

Practical Steps for Traceability Compliance

  1. Develop a Traceability Plan: Document your processes for assigning and managing TLCs.
  2. Identify Critical Tracking Events (CTEs): Determine the key points in your supply chain that require tracking.
  3. Implement Lot Tracking Systems: Use technology to efficiently manage and trace lot codes.
  4. Train Your Team: Ensure everyone understands the importance of traceability and their role in compliance.

Benefits of FDA Traceability

  • Enhanced Food Safety: Quickly identify and remove contaminated products.
  • Improved Recall Readiness: Streamline the recall process with accurate lot tracking.
  • Regulatory Protection: Ensure compliance with FDA regulations and avoid penalties.

Explore Traceability Solutions

Ready to enhance your food safety and traceability compliance? Request a consultation today and discover how our solutions can help you meet FDA requirements and protect your customers.

Learn more about FDA Traceability

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