Tracing and Technology at the Food and Drug Administration

The American public has become increasingly concerned about food safety. Recent concern arose, in part, from a multistate outbreak of Cyclospora, a parasite that can cause intestinal illness in humans. The outbreak was linked to contaminated iceberg lettuce. Although the U.S. Food and Drug Administration (FDA) has issued a national recall of affected products and provided regular updates about the outbreak, critics contend that the agency should have identified the source of the contaminated lettuce more quickly.

Many scholars and policy experts blame the FDA for the continued spread of Cyclospora. Some critics argue that the agency’s inability to contain the outbreak stems from inadequate food traceability rules. A robust traceability regime would require firms to maintain meticulous records about their food products, including batch numbers, shipment dates, and destinations. Under such a regime, government officials could use these records to determine the origin of the contaminated food and act to protect the public. Many European nations impose strict traceability rules on companies that produce, process, pack, or sell food.

The U.S. Congress has recognized the value of traceability rules. In 2010, Congress created the Food Safety Modernization Act (FSMA). Section 204 of the FSMA mandated that the FDA issue a final traceability rule by 2013. After the FDA missed this deadline, the Center for Food Safety sued the agency. The lawsuit resulted in a new deadline of November 2022, which the FDA met. The agency initially set January 2026 as the compliance and enforcement date, but in March 2025, delayed compliance until July 2028.

These repeated delays have frustrated many scholars and food safety advocates. Before the rule takes effect, scholars have proposed new ways to improve food safety, traceability, and transparency. Some scholars argue that stricter tracing rules could improve responses to foodborne illness outbreaks. Technology experts suggest that blockchain, a shared electronic data ledger, can enable faster tracing in complex food supply chains. Other analysts attribute outbreaks to broader problems beyond tracing, including the FDA’s food product standards and enforcement policies.

In this week’s Saturday Seminar, scholars discuss how best to improve food safety.

• In a note in the University of Miami Business Law Review, Carolina Gomez of the University of Miami School of Law argues that the FDA’s traceability requirements contain significant regulatory gaps. She explains that the FDA’s rule does not apply to small-scale food distribution operations, including farmers markets, small businesses, and roadside stands. To address this shortcoming and others, Gomez recommends that the FDA model its traceability system more closely on the European Union’s system, which requires all food producers to maintain tracing records. Although implementing a similar policy in the United States may entail compliance costs for firms, Gomez predicts that the fewer recalls expected could reduce the food industry’s overall costs.
• In an article in Food Safety and Health, Ahmed Hamad of Egypt’s Benha University, and Tanima Bhattacharya of Malaysia’s Lincoln University College posit that blockchain technology could improve traceability in complex supply chains, such as those in the United States. Hamad and Bhattacharya explain that a food producer could enter its information into a blockchain record and add it to the information entered by companies that previously processed the product. They anticipate that blockchain storage would improve traceability and inhibit tampering. Hamad and Bhattacharya find that blockchain can also increase transparency by allowing consumers to access food production information. They urge the global public to stay informed about food tracing developments and advocate for enhanced transparency.
• In an editorial in the Journal of Consumer Protection and Food Safety, Marion Gottschald of the German Federal Institute for Risk Assessment (BfR) argues that interoperable software tools and harmonized data elements form the backbone of a transparent and safe food supply chain. She explains that although food tracing is essential for identifying contaminated products, many small businesses and local authorities still rely on non-standardized paper records, which complicate tracing for government agencies. Gottschald cites the FDA’s New Era of Smarter Food Safety and the EFSA–BfR Universal Traceability data eXchange project as models that pair regulation with technical standardization. She concludes that governments must invest in interoperable tools and cross-border partnerships to create an effective traceability system.
• In an article in the European Journal on Criminal Policy and Research, Alice Rizzuti of the United Kingdom’s University of Hull and Jon Davies of the United Kingdom’s University of Manchester present the first exploration of blockchain technology as a tool to combat falsified food records. Rizzuti and Davies acknowledge blockchain’s benefits, including improved transparency, tamper-proof records, and alignment with situational crime prevention. They note, however, that blockchain’s reliability depends on human data entry and that firms largely rely on voluntary self-regulation in an unregulated space. Rizzuti and Davies ultimately argue that blockchain often functions as a “gimmick” that fails to address the deeper issues driving food fraud and call instead for a more human-driven approach.
• In an article in the American Journal of Law & Medicine, Katya S. Cronin of the George Washington University Law School argues that the FDA should hold food to the same safety standards as drugs. She explains that under the current system, food companies can determine that an ingredient is safe through a process called “Generally Recognized as Safe,” leaving an underfunded agency and everyday consumers to bear the consequences. Cronin proposes regulations that would close this loophole, require companies to pay fees when submitting ingredients for review, and order firms to report safety problems after their products reach store shelves.
• In an article in the Missouri Law Review, Timothy Lytton of the Georgia State University College of Law examines how lawsuits improve food safety rules, using contaminated leafy greens as an example. Lytton explains that foodborne illness lawsuits can attract media attention, mobilize consumer advocacy groups, and pressure Congress and the FDA to tighten regulations. He argues that the FDA’s 2015 Produce Safety Rule, created under the FSMA, included strict industry standards that emerged from this cycle of litigation, news coverage, and public outrage. Lytton notes that current tracing problems make it difficult to identify companies responsible for outbreaks, which can discourage litigation.