How to Comply with the FDA’s Food Traceability Final Rule (FSMA 204)

The U.S. FDA’s Food Traceability Final Rule, known as FSMA 204, is a critical step toward improving food safety by enhancing traceability throughout the supply chain. If you handle foods listed on the Food Traceability List (FTL), you’ll need to comply with specific requirements for maintaining records, assigning traceability lot codes (TLCs), and integrating marking and coding practices.

Steps to compliance

Step 1: Understand the key requirements

FSMA 204 “requires persons who manufacture, process, pack, or hold foods on the FTL to maintain and provide to their supply chain partners with key data elements for certain critical tracking events in the food’s supply chain.” 

  • Critical tracking events (CTEs): Key points in the supply chain, such as growing, receiving, transforming, shipping, harvesting, cooling, and initial packing.
  • Key data elements (KDEs): Specific details tied to each CTE, such as product descriptions, lot numbers, dates, locations, and quantities.

These records are tied to TLCs to allow the food’s movement to be traced through the supply chain in the event of a recall or outbreak. TLCs are unique alphanumeric identifiers assigned to FTL foods during specific CTEs to connect all traceability records.

  • TLCs may include the lot/batch codes that are already being printed on food products
  • TLCs are central to FSMA 204 compliance. The assigned code ensures traceability throughout the supply chain.
  • If the food is repackaged or transformed, the new packaging must reflect the original or updated TLC.

Learn more about CTEs, KDEs, and TLCs in this document from the FDA.

Step 2: Assign and manage TLCs

These codes are used to uniquely identify food lot numbers and link them to critical tracking records, enabling faster traceback during a recall or outbreak.

  • When to assign TLCs:
    • During initial packing of raw agricultural commodities (RACs) other than those from fishing vessels
    • When a food obtained from a fishing vessel is received at a land-based facility for the first time
    • When food is transformed (e.g., commingling, repackaging, or relabeling)
  • Best practices for assigning TLCs:
    • Use a unique alphanumeric code for each lot to avoid duplication.
    • Ensure the code is linked to all KDEs for each CTE in your records.
    • If you receive an FTL food from an exempt entity, assign a TLC if none exists (unless it’s received by a retail food establishment or restaurant).
    • Consider including an identifier of the product’s manufacturing location. The FDA refers to this as the traceability lot code source.
  • Where to use TLCs:
    The TLC can be shared with the next recipient of the food using various methods that ensure the required traceability information is accessible. While labeling the food with the code is not required, the TLC must be delivered in a format that allows the recipient to maintain the records required under the rule. Methods for sharing TLCs include:
    • Bill of Lading: Including the TLC on shipping documents
    • Advance Shipment Notice (ASN): Providing the TLC electronically before the food is delivered
    • Email: Sending the TLC as part of a separate communication
    • Packaging: 2D machine-readable codes, such as QR or DataMatrix codes printed on primary or secondary packaging or related documents
    • Packaging: GS1-128 1D codes printed on primary and/or secondary packaging

This flexibility allows businesses to choose the most efficient method for their operations.

  • Transformation events:
    Repacking food on the Food Traceability List (FTL) is considered a transformation event under the FDA’s Food Traceability Rule. Transformation includes any activity that changes the food or its packaging, such as commingling, repacking, or relabeling, as long as the result remains an FTL food. Here’s what you need to know:
    • What qualifies as a transformation event?
      • Manufacturing or processing the food
      • Changing the food through commingling, repacking, or relabeling
      • Altering the food’s packaging or packing
    • When a new TLC is required
      • A new TLC is typically required for repacked products.
      • However, if the repacking involves combining items from the same traceability lot (“like into like”), the original TLC may be retained.

        If the original TLC is kept, additional steps are required to maintain compliance:
    • Maintain transformation records
      • Document that the lot codes before and after repacking are identical.
      • Update the traceability lot code source to reflect the location where the repacking occurred.

Step 3: Develop a traceability plan

A traceability plan is required under FSMA 204 to help ensure that you have a clear strategy for managing traceability records, codes, and labels. It should include:

  • How you will capture, store, and maintain KDEs and TLCs for all CTEs.
  • The format (paper, electronic) and location of these records.
  • Detailed steps for assigning TLCs to FTL foods.
  • A list of FTL foods you handle and how you will ensure they are properly tracked, labeled with TLCs, and included in your traceability records.
  • For farms, include detailed maps showing growing areas or aquaculture containers, with geographic coordinates and identifiers for each location.
  • Designate a point of contact who is responsible for managing the traceability plan and answering questions about records, TLCs, and compliance.

Step 4: Implement a traceability system

To comply with FSMA Rule 204, you’ll need a robust traceability system that integrates records, codes, and labeling. This system should ensure accuracy and accessibility while enabling seamless sharing of traceability information with supply chain partners.

  • Adopt digital tools:
    • Use enterprise resource planning (ERP) systems, blockchain technology, or other electronic record-keeping solutions to track KDEs, CTEs, and TLCs.
    • Ensure your system can generate labels with TLCs and update them during transformation or repackaging.
  • Train employees:
    • Provide training on how to assign TLCs, update labels, and enter traceability data accurately.
    • Teach employees how to respond promptly to FDA requests for records or traceability information.
  • Conduct regular audits:
    • Periodically review your traceability system to ensure KDEs, TLCs, and labels are correctly maintained.
    • Test your processes for retrieving and sharing data within the required 24-hour FDA timeframe.

Step 5: Collaborate with supply chain partners

End-to-end traceability depends on strong collaboration with your supply chain partners. This includes aligning systems, sharing traceability data, and ensuring TLCs follow products through the supply chain.

  • Align recordkeeping practices:
    • Work with your suppliers, distributors, and other partners to ensure they capture and share KDEs and TLCs.
    • Confirm that all labels include the correct TLCs, even after food is repackaged or transformed.
  • Share traceability information:
    • Exchange KDEs, TLCs, and other required data at each CTE.
    • Ensure your partners understand their role in maintaining traceability under FSMA Rule 204.

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Revised compliance timeline

On March 20, 2025, the FDA announced its intention to extend the compliance deadline for the Food Traceability Rule by 30 months. Originally set for January 20, 2026, the new extended compliance deadline has not yet been finalized but is expected to provide additional time for businesses to fully implement the rule’s requirements.

With this additional time, you could:

  • Start preparing now: Evaluate your current traceability systems, identify gaps, and begin upgrading processes to meet the requirements.
  • Leverage FDA resources: Take advantage of FDA-provided guidance, tools, and opportunities for dialogue with regulators during the transition period.
  • Collaborate with partners: Use the extended timeline to align recordkeeping systems, TLCs, and labeling practices with your supply chain partners.

By proactively addressing the rule’s requirements during this extended period, you’ll position your business for full compliance while contributing to a safer, more transparent food supply chain.

How Videojet can help

Videojet, a global leader in coding, marking, and printing solutions, provides the tools that food manufacturers need to help comply with the traceability and labeling requirements of FSMA 204. This rule requires the application of clear and durable TLCs on food packaging, and advanced Videojet solutions are designed to simplify this process

Videojet offers a range of technologies, including continuous inkjet (CIJ), thermal inkjet (TIJ), thermal transfer overprinting (TTO), laser marking, large character printers, and labelers, to meet the diverse needs of food manufacturers. These solutions deliver:

  • Flexible options for printing 2D traceability codes containing essential information such as lot , date, and batch codes, or other production identifiers.
  • High-quality, machine-readable codes on a variety of packaging materials, including plastic, glass, cardboard, and flexible film.
  • Fast, reliable performance to support high-speed production environments.
  • Seamless integration with existing production lines to minimize downtime and help ensure efficiency.

In addition to robust hardware, Videojet provides software and support to help manufacturers address FSMA 204’s traceability requirements. These solutions include:

  • VideojetConnect™ software for linking TLCs to key data elements (KDEs) and integrating with enterprise planning systems such as ERP, MRP, and MES.
  • Data management, enabled with Videojet CLARiSUITE®, logs data that was entered by the operator or sent to the printer to a log file, which may then be exported to CSV. With the support of Videojet partners, real-time data management can simplify the sharing of traceability records with supply chain partners or the FDA.

Videojet coding, marking, traceability solutions, and support, together with our network of partners, can help you confidently meet FSMA 204 requirements while enhancing operational efficiency and food safety.