Mojix, a provider of real-time item-level visibility (RTILV) solutions for supply chains, has released a detailed guide to help businesses prepare for and become compliant with the FDAs Food Traceability Rule, also known as FSMA 204. Under this rule, any company or person who “manufactures, processes, packs, or holds'' foods that are considered high-risk as indicated in the Food Traceability List (FTL) is subject to FSMA 204.

“Retailers, restaurants and producers have faced a consistent challenge: ensuring the safety and quality of food. As new regulatory requirements loom on the horizon, we want to empower them with the best ways to begin a compliance strategy that will also increase efficiency and client satisfaction,” says Josh Main, SVP of global sales and partnerships at Mojix. “Today, item-level traceability solutions provide businesses with real-time visibility of every movement throughout their supply chain, empowering them to meet, and exceed, the requirements of FSMA 204.”

The Food Safety Modernization Act (FSMA) has been upholding food safety throughout the U.S. supply chain since 2011. With many improvements since it was passed as law, FSMA enables food producers and retailers to focus on preventing food contamination incidents before they spread instead of merely reacting to incidents when it’s too late. In November of 2022, the FDA released a final rule for section 204 of FSMA - The Food Traceability Rule. This rule mandates businesses to track and trace high-risk foods across the supply chain in order to mitigate public health and safety risks. It requires businesses to maintain precise records of all key data elements (KDEs) and critical tracking events (CTEs). FSMA 204 aims to ensure businesses quickly identify and take action against food contamination instances, decreasing the number of foodborne illnesses throughout the population.

“As part of our on-going commitment to our clients, Mojix is dedicated to providing the tools needed to understand new complex requirements,” says Chris Cassidy, CEO of Mojix. “We look forward to serving a broader audience of companies looking to turn this regulatory requirement into an opportunity for margin improvement.”

The FSMA 204 requirements include: 

  • Any persons involved in the producing, processing, manufacturing, packing, handling or holding of foods on the FDA’s Food Traceability List must keep accurate records of key data elements (KDEs) and critical tracking events (CTEs).
  • Traceability, KDE and CTE data must be collected and stored for at least 24 months.
  • When requested by the FDA, shipping and event data must be provided within 24 hours.
  • Traceability, tracking and shipping event data shall be shared with the operator’s supply chain partners.
In its playbook, "FSMA 204 Compliance Road Map: A Guide for Food Producers and Retailers," Mojix says it provides the information needed to safeguard organizations and achieve traceability compliance with the Food Traceability Rule by 2026. Visit the Mojix site to download the guide: