U.S. FDA Calls for Traceability

Farmer with tomatoes

Forty-eight million people become sick from foodborne illnesses each year. One in every 10 medicines is failing in low- and middle-income countries because they are substandard or falsified. These recent stats from the Centers for Disease Control and Prevention and World Health Organization (WHO) highlight that preventable foodborne illness and counterfeit medicine are significant public health problems.

Recognizing that ensuring the safety of the food and pharmaceutical supply is a shared responsibility among many different points in the global supply chain, the U.S. Food and Drug Administration (U.S. FDA) has put a call out to both industries for improved traceability.

New U.S. FDA Regulations

The Food Safety Modernization Act (FSMA) and the Drug Supply Chain Security Act (DSCSA), while focusing on different industries, are trying to achieve the same thing—enhanced traceability of products to improve consumer safety. 

Food Safety Modernization Act

Signed into law in 2011, FSMA aims to strengthen the food safety system to protect public health. Since then, the U.S. FDA has finalized several major rules to implement FSMA, including Section 204(d)—also known as FSMA Rule 204 or the U.S. FDA Food Traceability Final Rule. This rule established the framework for end-to-end traceability throughout the food supply chain by requiring companies to keep additional records for designated foods. These records will assist the U.S. FDA in more rapidly and effectively tracking the movement of a food. Finalized in November 2022, the industry will have until January 20, 2026, to comply with FSMA Rule 204 requirements.

Drug Supply Chain Security Act

Signed into law as part of the Drug Quality and Security Act (DQSA), DSCSA aims to address the dangers of counterfeit, contaminated, stolen, or otherwise harmful drugs. Largely created in response to keeping illicit and counterfeit drugs out of the U.S. drug supply chain and protect public health, the act outlines steps for electronically tracking and tracing prescription drugs at the packaging level. It requires manufacturers, wholesalers, healthcare providers, and pharmacies to maintain and share certain prescription drug data in a secure format that can be transmitted between each of their systems. Final deadlines for DSCSA passed in November of 2023, but the U.S. FDA established a one-year stabilization period to accommodate additional time that trading partners may need to meet requirements.

Farmers passing crates
Warehouse operator with tablet

Answering the Call

While the food and pharmaceutical supply chains can operate differently, both can benefit from the standardization of product and location identification to help meet these requirements. GS1 Standards have already been leveraged by many members of the food and pharmaceutical industries to improve traceability. Global Trade Item Numbers (GTINs) can be assigned to products—and the raw materials that compose them—while a Global Location Number (GLN) can be assigned to everything from farms and packhouses to hospitals and pharmacies. 

Leading manufacturers, suppliers, distributors, retailers, and foodservice operators are already answering the call for traceability within the food and pharmaceutical supply chains—learn how you can too!