Unlocking FSMA 204 Compliance With TradeEdge Product Traceability

Consumer demand for greater transparency in the food supply chain, increasing safety challenges, and evolving regulatory standards are significantly transforming the food manufacturing industry. Navigating the FDA’s Food Traceability Rule can be daunting due to the complexity of supply chain networks and the vast amounts of data from various sources and formats. This is where our traceability solution can save the day!

In this blog, we have outlined key information about the FSMA 204 and how our TradeEdge Traceability, our cloud-based, globally scalable solution, can help organizations navigate the complexities of the regulatory landscape and achieve compliance. Read on.

Overview of the FSMA 204 Traceability Rule

The FDA’s FSMA 204 Traceability Rule aims at strengthening food safety through enhanced record-keeping systems, enabling swifter identification and response to foodborne illness outbreaks. It mandates that food manufacturers, processors, packers, distributors, and retailers who handle foods on the Food Traceability List (FTL) comply with FSMA 204. This includes all businesses in the supply chain involved in growing, processing, shipping, or selling these high-risk foods.

With a compliance deadline set for January 20, 2026, all entities involved must be prepared to provide detailed traceability records of Key Data Elements (KDE) associated with Critical Tracking Events (CTE), such as growing, receiving, transforming, and shipping to the FDA within 24 hours of a request.

Four steps to achieve FSMA 204 Compliance with TradeEdge Traceability

Step 1: Understand compliance requirements & prepare a comprehensive traceability plan

The first step requires food manufacturing companies to familiarize themselves with FSMA 204 and develop a holistic plan which includes:

Step 2: Leverage TradeEdge Traceability Solution for data management

Challenges in data — from large data volumes to data complexity due to various sources/formats, make compliance harder to achieve. TradeEdge Traceability solution allows organizations to convert varied data formats and systems into standardized entities, enabling them to track, trace, and hold-and-release inventory in near-real time, making compliance easier.

Step 3: Collaborate & engage with your supply chain partners

Working closely with suppliers and partners to enhance seamless communication and data exchange and ensure everyone adheres to the new traceability protocols.

Step 4: Gain Control and oversight over your supply chain

With the TradeEdge Traceability Portal and Control Tower, organizations can gain real-time access to compliance dashboards and comprehensive reports, enabling informed decision-making. With the hold-and-release feature, they can quickly manage recalls and keep track of compliance rates among partners.

Streamlining FSMA 204 Compliance with TradeEdge Traceability

Consider a global food manufacturing company facing challenges complying with the requirements of FSMA 204. Due to their complex supply chain network, they struggle to manage large volumes of data, ensure seamless communication with partners, and gain end-to-end visibility and compliance tracking. Moreover, the new rule mandates that traceability records be provided to the FDA within 24 hours upon request.

How can companies overcome traceability challenges and comply with the FSMA 204 rule?

Introducing TradeEdge Traceability, a cloud-based, globally scalable solution that helps enterprises maintain near-real-time control over inventory movement and helps organizations achieve FSMA 204 compliance.

As the FSMA 204 compliance deadline approaches, now is the time to act! Prepare now to unlock the benefits of supply chain traceability and improved food safety!

For further information, download our step-by-step guide to achieve FSMA 204 with TradeEdge Traceability!