How to Comply with FDA Traceability Lot Code Requirements

In 2025, ensuring food safety and traceability is more critical than ever. The FDA’s regulations are evolving, and compliance is essential for protecting consumers and your business. This guide provides a clear understanding of FDA traceability lot code requirements and practical steps to meet them.

Why FDA Traceability Matters in 2025

The FDA’s focus on traceability is driven by the need to quickly identify and remove contaminated food products from the market. Effective traceability systems:

• Enhance food safety by enabling rapid response to outbreaks.
• Improve recall readiness, minimizing the impact of potential recalls.
• Provide regulatory protection, ensuring compliance with FDA regulations.

Understanding the FDA’s Food Traceability Rule

The Food Safety Modernization Act (FSMA) and the Food Traceability Rule (FTR) establish the foundation for traceability. These regulations require those who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL) to maintain detailed records.

Key aspects of the rule include:

• Key Data Elements (KDEs): Maintaining records containing KDEs associated with specific Critical Tracking Events (CTEs).
• Traceability Plan: Developing and maintaining a plan that includes procedures for record maintenance.
• Food Traceability List (FTL): Identifying foods on the FTL.
• Traceability Lot Codes: Assigning and tracking traceability lot codes.
• Record Availability: Ensuring records are available to the FDA within 24 hours of a request.

Important Update: The compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule is January 20, 2026 [1].

Key Components of a Compliant Traceability System

To comply with FDA regulations, your traceability system should include the following:

1. KDE Records: Meticulously maintain records containing Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs) [1].
2. Traceability Plan: Develop and maintain a comprehensive traceability plan that outlines procedures for record maintenance, identification of FTL foods, and assignment of traceability lot codes [1].
3. Rapid Record Access: Ensure that all required records can be made available to the FDA within 24 hours of a request [1].

Practical Steps for Traceability Compliance

• Assess Your Operations: Determine if your products are on the Food Traceability List (FTL).
• Develop a Traceability Plan: Create a detailed plan outlining your traceability procedures.
• Implement Lot Tracking: Establish a system for assigning and tracking lot codes throughout your supply chain.
• Maintain Accurate Records: Keep thorough and accurate records of all Key Data Elements (KDEs).
• Train Your Staff: Ensure your team understands and follows traceability procedures.

Benefits of Traceability Compliance

Beyond regulatory compliance, a robust traceability system offers significant benefits:

• Enhanced Food Safety
• Improved Recall Efficiency
• Strengthened Brand Reputation
• Reduced Risk of Penalties

Resources

• FDA Food Safety Modernization Act (FSMA) [2]
• FDA’s New Era of Smarter Food Safety [3]
• Internal Link Example

Ready to Enhance Your Traceability?

Ensure your business is prepared for the FDA’s traceability requirements. Explore our traceability solutions or request a consultation today!