Step-by-Step Guide to Implementing FDA-Compliant Traceability Lot Codes

Why FDA Traceability is Critical in 2025

In 2025, FDA traceability remains a critical aspect of food safety and regulatory compliance. While the FDA intends to extend the compliance date for the Food Traceability Rule to July 2028 [1], proactive implementation offers numerous benefits. This guide provides a step-by-step approach to implementing FDA-compliant Traceability Lot Codes (TLCs).

What are FDA Traceability Lot Codes?

A Traceability Lot Code (TLC) is a descriptor, often alphanumeric, used to uniquely identify a traceability lot within a firm’s records [2]. It’s a crucial element for tracking food products through the supply chain. Firms must assign a TLC when:

• Initially packing a raw agricultural commodity (RAC)
• Performing the first land-based receiving of food from a fishing vessel
• Transforming a food [2]

The TLC must be linked to Key Data Elements (KDEs) at each Critical Tracking Event (CTE) [2]. The FDA does not prescribe a specific way to define or assign a TLC; however, the firm must describe the process used to assign TLCs in their Traceability Plan [2].

Step-by-Step Guide to Implementing FDA-Compliant Traceability Lot Codes

1. Develop a Traceability Plan: Document your firm’s procedures for assigning, tracking, and managing TLCs. This plan should outline how TLCs are generated, linked to KDEs, and maintained throughout the supply chain [2].
2. Define TLC Generation Process: Establish a clear and consistent method for creating TLCs. This could involve using alphanumeric codes, dates, or other unique identifiers. Ensure the method is well-documented in your traceability plan [2].
3. Link TLCs to Key Data Elements (KDEs): At each Critical Tracking Event (CTE), link the TLC to relevant KDEs such as product name, quantity, date, and location. This ensures comprehensive traceability throughout the supply chain [2].
4. Maintain Accurate Records: Keep detailed records of all TLCs and their associated KDEs. These records should be readily accessible and easily searchable for efficient tracking and tracing [2].
5. Regularly Review and Update: Traceability plans and procedures should be regularly reviewed and updated to reflect changes in FDA regulations, supply chain operations, or product handling practices [2].

Benefits of FDA Traceability

Implementing FDA-compliant traceability systems offers numerous benefits beyond regulatory compliance, including:

• Improved supply chain visibility and risk management [3]
• Enhanced quality control and product safety [3]
• Increased operational efficiency and reduced waste [3]
• Positive impact on ESG (Environmental, Social, and Governance) initiatives [3]
• Strengthened customer trust and brand protection [3]
• Cost avoidance by preventing seizure of goods and mitigating fines from recalls [3]
• Cost reduction by reducing food waste and improving data management [3]

Ready to Enhance Your Traceability?

Explore our traceability solutions or request a consultation today to ensure your compliance and optimize your supply chain. Learn more about FDA traceability in our FDA Traceability Overview Guide and on the FDA website.