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. The rule emphasizes the need for traceability and recordkeeping throughout the supply chain, allowing FDA to conduct faster and more effective investigations into foodborne illnesses or respond more quickly to recalls.
This regulation has forced many organizations within the complex food system to move to digital technology-enabled systems to achieve end-to-end traceability. This approach not only ensures compliance, but also offers significant benefits in terms of efficiency, cost savings, and supply chain transparency.
Lucellena Angarita, supply chain visibility lead at GS1 US, a nonprofit global data standards organization, emphasized the importance of the FSMA 204 goals: “Every second that passes makes an exponential difference, putting more people at risk of consuming a product. Having shareable data with a common language that connects the pieces of the puzzle clearly and quickly is essential. Today, companies often collect their data locally in multiple spreadsheets. There is no way to connect them.”
The challenge is achieving seamless data convergence across the industry. “The FDA is not prescriptive about what kind of technology or standards should be used. They say you can use a sortable spreadsheet, but given the complexity of sharing data across the supply chain, that type of manual solution can be very difficult.”
To overcome these obstacles, companies are looking for a standardized way to collect and share information. GS1 provides a common language that enables interoperability regardless of a company’s technical capabilities. “It’s like when the Phoenicians tried to trade and couldn’t talk to each other, they came up with the alphabet,” Angarita said.
One of the key paths to successful implementation is the use of GS1 standards, which include unique identifiers such as Global Trade Item Numbers.® (GTIN)®) Global Location Number (GLN) for products and Global Location Number (GLN) for locations. These standardized identifiers enable seamless data exchange throughout the supply chain, enabling faster and more accurate tracking.
Adopting these standards has led to significant success stories across the industry. For example, Golden State Foods and its customer McDonald's have rolled out a new RFID system to manage retail and warehouse inventory, creating a more efficient, digitalized supply chain and preparing for future challenges.
Another example comes from IPC/Subway, which realized significant efficiencies by implementing the GS1 standard for traceability in anticipation of FSMA 204. “We quantified $1.3 million in annual cost savings by looking at just a few products that had weight errors,” says Angarita, formerly of IPC. “A few years later, we actually quantified about $72 million in cost savings with an automated inventory management application based on the GS1 standard.”
Angarita stressed the importance of collaboration. “We all have to work together. We depend on each other to comply with these regulations,” she said. “The good news is that companies will realize many benefits beyond compliance.”
Regardless of technical capabilities, a common language that allows companies to communicate effectively is key. “GS1 standards provide the tools to enable everyone to communicate in a common language,” Angarita said.
When a recall occurs, for example, the impact can be huge. “Without a tracking system, companies would have to contact every location that could potentially have received the product,” Angarita said. “With a tracking system based on GS1 standards, you should be able to know the location of every affected case within minutes.”
The benefits of a better tracking system are solid, but there are also challenges. For example, distributors may have to work with customers who have vastly different technical capabilities. Companies should take this as a cautionary tale to start working on this now. Once you start implementing it, you will likely find complexities and obstacles that require time and cooperation.
As the FSMA 204 compliance deadline approaches, it’s clear to start now. “Don’t wait until it’s perfect. It’s a journey, not a destination,” Angarita said. “But if you start and expedite the recall process, which can take days or hours, and of course meet the requirements of providing FDA with a track record within 24 hours, you’ll save lives.”
GS1 standards can also strengthen sustainability efforts by providing 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 life cycle, companies can more easily monitor and reduce waste, optimize transportation routes, reduce carbon footprints, benefit the environment, and save money.
This streamlined data sharing across the supply chain makes data accessible to everyone, including consumers, through 2D barcodes such as QR codes or other digital formats. Increased transparency about a product’s origin, ingredients, nutritional information, and sustainability increases consumer trust and loyalty, and potentially increases sales.
FSMA 204 presents challenges, but it also provides an opportunity for the food industry to innovate, collaborate, and ultimately create a safer and more efficient food supply chain. By embracing the standards and collaborating, companies can not only comply with regulations, but also achieve significant benefits ranging from cost savings, improved inventory management, sustainability, and consumer trust.
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About GS1 US:
GS1 USA® Helping businesses deliver secure, consistent, authentic and trustworthy experiences across their supply chains. Best known as the source of the UPC barcode, GS1 is a non-profit global data standards organization that creates a common language for businesses to identify, capture and share trusted data that connects physical and digital supply chains. Millions of businesses around the world power commerce with GS1 standards. Learn more at www.gs1us.org.
