What Do Food Distributors Need to Know About FSMA 204?

The FDA made a new rule called the Traceability Rule that says certain foods need to have extra tracking records, known as The Food Traceability Rule. Companies who manufacture, process, pack, or distribute foods on the Food Traceability List (FTL) will have to maintain records of Key Data Elements (KDEs) from Critical Tracking Events (CTEs). Some partial and complete exemptions apply.

📅 Compliance goes in effect January 20, 2026.

Key Requirements for Food Distributors

  • Food Traceability List (FTL) – Understand which products you handle are on the FTL. These products require specific traceability information.
  • Recordkeeping – Maintain accurate records of the businesses you receive food from (suppliers) and those you ship food to (customers). This includes information like name, address, and contact details.
  • Recall Capabilities – Be prepared to provide traceability information to the FDA upon request within 24 hours.
  • Lot Tracking – Consider implementing systems to track product movement within your facility, especially if you hold products for extended periods.

CTEs and KDEs for Food Distributors

  • Critical Tracking Events (CTEs) are key stages in a food product’s supply chain, from harvesting to transformation, ensuring traceability and safety.
  • Key Data Elements (KDEs) must be documented at each CTE including:
    • Receiving: The receipt of food products at a facility, after being shipped from another location.
    • Transformation: Significant actions that change the food product. This could include combining ingredients, processing, or repackaging.
    • Shipping: The act of sending food from one place to another, either domestically or internationally.

The areas of focus for most Food DCs are Receiving, Transformation, and Shipping

Tips for Success

What Food Distributors Can Do To Get Compliant

The Food Traceability Rule (FSMA Rule 204) is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. The new rule requires companies to maintain detailed records of Critical Tracking Events (CTEs) and Key Data Elements (KDEs).

Enable Lot Tracking

Have lot tracking turned on for all items on Food Traceability List (FTL) in your ERP.

Look for Barcoded Lot Numbers

Work with suppliers to ensure products are labeled with barcoded lot numbers or GS1 barcodes.

Designate Point of Contact

Designate a Subject Matter Expert for FSMA in your company to help with facilitation of recalls.

Easily track and access the data you need with ProCat's user-friendly traceability solutions.

From the minute items enter the warehouse until they’re in the delivery truck, our technology helps companies feel confident they product visibility.

Comprehensive Data Capture

  • Capture catch weights, lot codes, expiration dates, and temperatures
  • Track Key Data Elements (KDEs) in Critical Tracking Events (CTEs) to support FSMA 204
  • Ensures tracking throughout your operation

Efficient Recall Management

  • Generate reports quickly and easily to accomplish a recall
  • Flag items on the Food Traceability List
  • Record keeping up to 36 months

Improved Warehouse Operations

  • Increase customer order accuracy
  • Boost employee productivity
  • Full training and support for your team

Receiving software

ReceiveRight

The ReceiveRight module enables vendor purchase orders to be confirmed on the receiving dock. The solution allows you to receive multiple PO’s at the same time, print put away and GS1 barcode labels, and scan items on incoming PO’s in any order.

  • Allows inbound freight to be scanned at receiving
  • Captures lot and expiration date information
  • GS1 barcodes can be printed on receiving put away labels that include lots and expiration date

Picking solution

PickRight

PickRight is a leading a hands-free order picking solution that improves order picking accuracy, increases employee productivity, and boosts customer confidence – without having to switch your ERP.

  • Barcode scanning order picking solution
  • Captures product lot numbers and expiration dates at time of pick

Long-term record keeping

TrackRight

TrackRight maintains aggregated data from ReceiveRight, PickRight, and ShipRight up to 3 years to maintain long term data for traceability, reporting, and recalls. TrackRight reporting helps satisfy regulatory requirements from the FSMA (The Food Safety Modernization Act).

  • Supports FSMA regulatory reporting & requirements
  • Maintains a minimum of 36 months of data

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