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When Traceability Lot Codes Regulation Will Start Working

When Traceability Lot Codes Regulation Will Start Working

Understand when the FDA's traceability lot code regulation goes into effect, who is affected, and what businesses need to do to prepare for compliance.

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When Traceability Lot Codes Regulation Will Start Working

If you work in the food supply chain, the FDA’s Food Traceability Rule is about to become a major part of your compliance responsibilities. This rule requires certain foods to be tracked using traceability lot codes, improving transparency and speeding up recalls to protect public health.

So, when does this rule take effect—and what do you need to do about it?


Key Date: January 20, 2026

The FDA Traceability Rule, part of FSMA Section 204(d), will go into effect on January 20, 2026.

This means that by this date, all covered entities (from growers and processors to distributors and retailers) must:

  • Assign traceability lot codes at required points
  • Maintain and share Key Data Elements (KDEs) at Critical Tracking Events (CTEs)
  • Be prepared to submit traceability records to the FDA within 24 hours upon request

There is no phased implementation—everyone must be fully compliant by the January 2026 deadline.


Who Is Affected?

The rule applies to businesses that manufacture, process, pack, or hold foods listed on the FDA Food Traceability List (FTL). This includes:

  • Fresh fruits and vegetables
  • Nut butters
  • Finfish and crustaceans
  • Soft cheeses
  • Ready-to-eat deli salads

Entities of all sizes may be affected, although some small farms and restaurants may qualify for exemptions. Read more about exemptions here.


What You Should Be Doing Right Now

Even though the rule doesn’t become enforceable until 2026, the time to start preparing is now. Here’s what you can do today:

✅ 1. Understand Your Responsibility

✅ 2. Map Your Supply Chain

  • Identify your Critical Tracking Events (CTEs) (e.g., receiving, transformation, shipping)
  • Determine where traceability lot codes will need to be assigned or passed along

✅ 3. Invest in Digital Recordkeeping

  • Ensure your system can store and retrieve KDEs
  • Records must be sortable and submitted within 24 hours when requested

✅ 4. Train Staff and Prepare Workflows

  • Train your team on traceability requirements and procedures
  • Run internal audits or mock recalls to identify gaps

What Happens After January 20, 2026?

After this date:

  • The FDA may conduct compliance inspections
  • If your traceability system isn’t in place, you could face enforcement actions, product recalls, or reputational damage
  • You’ll need to respond to FDA traceability requests within 24 hours

Don’t Wait Until the Deadline

The 2026 deadline may seem far off, but implementing traceability systems takes time. Start early to avoid disruption and build a stronger, safer food supply chain.

💬 Need help preparing? Contact our team to assess your traceability readiness and explore FDA-compliant software solutions.


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