The food industry is facing a critical deadline: by January 20, 2026, all trading partners from manufacturers and processors to suppliers and distributors must comply with the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA) Rule 204. It targets the need for traceability and record-keeping throughout the supply chain so that the FDA can do better, quicker investigations into a foodborne illness or react faster to recalls.
The regulation has many entities within the complex food system turning to digital, tech-enabled systems to achieve end-to-end traceability. This approach not only ensures compliance but also offers significant benefits in efficiency, cost-savings and supply chain transparency.
Lucelena Angarita, Director, Supply Chain Visibility at GS1 US, a not-for-profit global data standards organization, emphasized the importance of FSMA 204’s objective. “Every second that goes by makes an exponential difference, because more people could consume the product at risk. Having shareable data in a common language that clearly, quickly connects the pieces of the puzzle is essential. Currently, companies collect data within their own four walls, often on multiple spreadsheets — there’s no way to connect it.”
The challenge lies in achieving a seamless fusion of data across the industry. “The FDA isn’t prescriptive on what kind of technology or standards to use. They’re saying you can use a sortable spreadsheet, but given the complexity of sharing data across the supply chain, that type of manual solution can make it very difficult.”
To overcome these hurdles, businesses are seeking standardized ways to gather and share information. GS1 provides a common language that enables interoperability regardless of a company’s technological capabilities. “It’s like the Phoenicians coming up with the alphabet because they were trying to transact and couldn’t speak to each other,” Angarita said.
One key path to successful implementation is the use of GS1 Standards, which include unique identifiers such as Global Trade Item Numbers® (GTINs®) for products and Global Location Numbers (GLNs) for locations. These standardized identifiers allow for smooth data exchange across the supply chain, enabling faster and more accurate traceability.
The adoption of these standards has led to significant success stories across the industry. For instance, Golden State Foods and their customer McDonald’s launched a new RFID system to manage retail and warehouse inventory that created a more efficient, digitized supply chain, preparing them for future challenges.
Another example came from IPC/Subway. By implementing GS1 Standards for traceability in anticipation of FSMA 204, they unlocked significant efficiencies. Angarita, who previously worked for IPC, said, “We quantified $1.3 million yearly in cost avoidance, merely looking at some products that had errors on weights. A few years later, we actually quantified about $72 million in cost avoidance with an automated inventory management application based on GS1 Standards.”
Angarita stressed the importance of collaboration. “We all need to work together — we depend on each other to meet this regulation,” she said. “The good news is companies will realize many more benefits than just compliance.”
A common language allowing companies to communicate effectively, regardless of their technological capabilities, is the key. “GS1 Standards provide those tools so everybody can communicate in a common language,” Angarita said.
In the event of a recall, for example, the impact can be dramatic. Angarita noted, “Without a traceability system in place, a business would have to contact every location that could have potentially received the product. With a traceability system based on GS1 Standards, they should be able to know the locations of all impacted cases within minutes.”
While the advantages of better traceability systems are robust, there are challenges. For example, distributors may have to work with customers who have vastly different technical capabilities. Companies should take this as a cautionary tale about the urgency of starting this work now. When they begin implementation, they’re likely to uncover complexities and roadblocks that require time and collaboration to resolve.
As the FSMA 204 compliance deadline approaches, one thing is clear: start now. “Don’t wait until it’s perfect, because it’s a journey, not a destination,” Angarita said. “But if you get started and you can expedite a recall that could have taken days to a couple of hours, and, of course, meet the regulation, which is to provide the traceability records to FDA within 24 hours, you could be saving so many lives.”
GS1 Standards can also enhance sustainability efforts with a common language for traceability data, such as the Electronic Product Code Information Services (EPCIS) Standard. By providing a standardized way to track products throughout their lifecycle, companies can more easily monitor and reduce waste, optimize transportation routes, reduce their carbon footprint, benefit the environment and save money.
This streamlined data-sharing throughout the supply chain lets everyone, including consumers, access it via 2D barcodes, like QR codes, or other digital formats. More transparency about the origin, ingredients, nutritional information and sustainability of products builds consumer trust and loyalty, potentially increasing sales.
While FSMA 204 presents challenges, it offers opportunities for the food industry to innovate, collaborate and ultimately create a safer, more efficient food supply chain. By embracing standards and working together, companies can not only achieve compliance, but also unlock significant benefits, from cost savings and improved inventory management to sustainability and consumer trust.
———
About GS1 US:
GS1 US® enables companies to power their supply chains to deliver safe, consistent, authentic and trusted experiences. Best known as a source for UPC barcodes, GS1 is a not-for-profit global data standards organization that creates a common language for companies to identify, capture and share trusted data that links their physical and digital supply chains. Millions of businesses around the world power commerce with GS1 Standards. Learn more at www.gs1us.org.
