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Regulatory & Compliance•5 min read

New FDA Cold Chain Rules: What Every 3PL Needs to Know

The FDA's updated FSMA 204 traceability requirements are tightening, and cold chain 3PLs face the steepest compliance curve. Here's your action plan.

via FreightWaves•February 5, 2026

The Regulatory Landscape

The FDA's Food Safety Modernization Act (FSMA) Rule 204 has entered its next enforcement phase, and the implications for third-party logistics providers handling temperature-sensitive goods are significant. As of January 2026, all entities in the food supply chain must maintain detailed traceability records for foods on the Food Traceability List (FTL).

For 3PLs, this means going beyond basic lot tracking. You now need to capture, store, and transmit Key Data Elements (KDEs) at every Critical Tracking Event (CTE) — receiving, shipping, and transforming.

What's Changed

The biggest shifts for warehouse operators:

  1. Digital-first recordkeeping — paper logs are no longer sufficient for FTL items
  2. 24-hour response window — the FDA can request traceability data with a one-business-day turnaround
  3. Temperature event logging — continuous monitoring data must be tied to specific lot/batch identifiers
  4. Upstream/downstream linking — your records must chain to your suppliers' and customers' records

Building a Compliance Stack

The 3PLs handling this transition smoothly share a few common traits:

  • IoT sensor infrastructure with automated alerts for temperature excursions
  • WMS integration that auto-generates CTE records at each handling step
  • API-based data sharing with trading partners for seamless traceability chains
  • Staff training programs that go beyond "check the box" compliance

The Cost of Non-Compliance

FDA enforcement actions have ramped up. In Q4 2025 alone, three mid-size 3PLs received warning letters for inadequate traceability records. Beyond regulatory risk, there's a market reality: major CPG brands are now requiring FSMA 204 compliance as a prerequisite in RFPs.

Action Steps

If you haven't started, begin here:

  1. Audit your current traceability gaps against the FTL requirements
  2. Evaluate WMS vendors or modules that support KDE/CTE capture
  3. Establish data-sharing protocols with your top 10 trading partners
  4. Run a mock FDA data request to test your 24-hour response capability

The compliance deadline has passed. The question isn't whether to act — it's how fast you can close the gap.

Sources & Further Reading