Top 5 Mistakes to Avoid with FDA Traceability Lot Codes

In 2025, FDA traceability is more critical than ever. The Food Safety Modernization Act (FSMA) is transforming how the food industry approaches safety and compliance. Accurate and reliable traceability, especially concerning FDA Traceability Lot Codes, is essential for food safety, efficient recalls, and maintaining consumer trust. This post highlights the top 5 mistakes to avoid to ensure your compliance and protect your business.

Why FDA Traceability Matters in 2025

With increasing consumer awareness and stricter FDA regulations, robust traceability systems are no longer optional. They are a necessity for:

• Food Safety: Quickly identify and isolate contaminated products to prevent outbreaks.
• Recall Readiness: Execute targeted and efficient recalls, minimizing financial and reputational damage.
• Regulatory Protection: Demonstrate compliance with FSMA and avoid costly penalties.

Common Mistakes with FDA Traceability Lot Codes

Here are some common misconceptions and potential mistakes related to FDA traceability lot codes:

1. Assuming Existing Programs Suffice:

   • Mistake: Thinking your current traceability efforts are enough.
   • Reality: The Traceability Rule has specific requirements, such as Traceability Lot Code (TLC) and TLC Source, that may not be covered in existing programs.

2. Believing Computerized Systems are Mandatory:

   • Mistake: Thinking you must implement a fully computerized system.
   • Reality: While helpful, the rule doesn’t mandate computerized systems. However, efficient systems are highly recommended.

3. Ignoring Other FDA Requirements:

   • Mistake: Believing the Traceability Rule replaces all other FDA traceability requirements.
   • Reality: It adds to existing requirements like the one-up, one-back rule.

4. Misunderstanding the Food Traceability List (FTL):

   • Mistake: Thinking that if you don’t handle products on the FTL, you are exempt from all traceability requirements.
   • Reality: If you are subject to the one-up, one-back traceability requirements, you must continue to meet those requirements.

5. Improper Lot Code Handling:

   • Mistake: Importers assuming their internal lotting practice aligns with the TLC requirement. Not assigning a TLC when required or changing the TLC when not performing a Critical Tracking Event (CTE).
   • Reality: A TLC must be assigned when initially packing a raw agricultural commodity, performing the first land-based receiving of a food obtained from a fishing vessel, or transforming a food. Persons may not change the TLC if they are not performing those Critical Tracking Events (CTEs).

Additional Mistakes to Avoid:

• Cold storage facilities/warehouses assuming the rule doesn’t apply to them because they don’t own the products. The rule applies if they handle foods on the FTL.
• Assuming the FDA will only audit data when an outbreak occurs. GFSI food safety certifications may also check for compliance.
• Thinking MSC/ASC Chain of Custody is enough. These may not include the specific FSMA requirement for traceability lot codes.
• Not sharing the TLC with the next step in the supply chain, along with the relevant Key Data Elements (KDEs).
• Not maintaining records. The violation of any recordkeeping requirement under section 204 of FSMA is a prohibited act.

FDA Enforcement

While routine inspections for compliance with the Food Traceability Rule will not begin until 2027, the FDA may conduct inspections for-cause basis, such as during an outbreak investigation, once the compliance date of January 20, 2026, is reached. The violation of any recordkeeping requirement under section 204 of FSMA is a prohibited act. The FDA may issue advisory action letters, bring a civil action, or bring a criminal action for violations. An article of food is subject to refusal of admission if it appears that the recordkeeping requirements have not been complied with.

Best Practices for FDA Traceability Compliance

To ensure you’re on the right track, follow these best practices:

• Understand KDEs and CTEs: Know your Key Data Elements and Critical Tracking Events.
• Develop a Traceability Plan: Create a comprehensive plan tailored to your operations.
• Maintain Accurate Records: Ensure records are legible, secure, and available to the FDA within 24 hours upon request.
• Communicate with Partners: Work with supply chain partners for seamless information flow.
• Stay Updated: Keep abreast of FDA guidance and regulations.

Ready to Enhance Your Traceability?

Navigating FDA traceability can be complex, but you don’t have to do it alone. Explore our traceability solutions or request a consultation to ensure your business is ready for the future of food safety.