By ChinRes 
On January 20, 2026, the Food and Drug Administration’s (FDA) new traceability regulations, known as the Food Traceability Final Rule, will be implemented.
The FDA clarified that the regulation “establishes traceability recordkeeping obligations, exceeding those in current regulations, for individuals who manufacture, process, pack, or store foods listed on the Food Traceability List.” The updated regulations would facilitate expedited detection and swift removal of potentially contaminated food from the marketplace, therefore reducing the incidence of foodborne illnesses and fatalities.
Such developments are advantageous for consumers, particularly given that the Centers for Disease Control and Prevention estimates that 1 in 6 Americans (about 48 million individuals) suffer from foodborne illnesses annually, resulting in 128,000 hospitalizations and 3,000 fatalities. Nonetheless, manufacturers and merchants find the implementation of these traceability regulations to be quite perplexing. Essential information for consumers, manufacturers, and sellers.
What is the FDA’s recent traceability regulation?
The FDA delineates that the regulation mandates individuals engaged in the manufacture, processing, packing, or storage of foods on the Food Traceability List (FTL) to maintain records comprising Key Data Elements (KDEs) linked to designated Critical Tracking Events (CTEs) and to furnish information to the FDA within 24 hours or within a mutually agreed-upon timeframe.
What items are included on the Food Traceability List?
The list comprises cheeses (excluding hard varieties such as Parmigiano-Reggiano), “shell eggs” from domesticated chickens, nut butters, cucumbers, leafy greens, herbs, melons, peppers, sprouts, tomatoes, tropical fruits (including mango, papaya, mamey, guava, lychee, jackfruit, and starfruit), fresh-cut fruits and vegetables, finfish (such as tuna, mahi mahi, mackerel, amberjack, jack, swordfish, and yellowtail), crustaceans, mollusks, bivalve-like shellfish, and ready-to-eat deli salads. The whole list is available here.
Which aspects of the regulation are causing the greatest confusion among individuals?
The Reagan-Udall Endowment for the Food and Drug Administration (FDA) produced a report in September outlining three industry roundtables that were held in response to the ruling. The invite-only roundtable participants identified three primary areas of concern: understanding of regulations, labeling, and warehouse management capacity.
The survey indicated that participants exhibited little understanding of the regulation and its precise stipulations throughout the food system, particularly among certain industrial sectors, small and medium-sized suppliers, overseas suppliers, non-chain restaurants, and firms not affiliated with a trade organization.
It stated that these new requirements may represent the inaugural instance in which specific supply chain players — such as small restaurants and cafes — are obligated to furnish information to the Food and Drug Administration, and they “may not consistently uphold or disseminate data at the degree mandated by the rule.”
Moreover, participants said that there are “various interpretations of the final rule, which may cause companies to erroneously assume their existing operations meet compliance requirements.” Roundtable members proposed that more education and clearer instructions for rule implementation might serve as a potential solution to the issue.
Industry groups expressed apprehensions over the new traceability lot code (TLC) requirements stipulated in the final regulation, particularly concerning “the extent of labeling and tracing activities required to produce the essential pieces of knowledge” Some of the participants were of the opinion that labeling and tracking at the case level is essential for the generation of the required information, despite the fact that this is not explicitly mandatory.
They underscored the absence of standards for TLCs and noted that the regulation depends on both labels being intact and the availability of labels for printing and affixing to their merchandise.
Ultimately, the matter of warehouses arises, as roundtable participants said that they may lack the ability to implement the new standards, and warehouse managers may interpret the unclear rules inconsistently. Currently, some stakeholders in the food sector are reading the regulation as necessitating a label on “each case of food,” which is thereafter “scanned to generate the data [the] FDA may require from downstream entities to trace a lot throughout the supply chain.”
Their analysis indicated that it “might necessitate considerable increases in labor, equipment, and space, along with substantial associated expenses.”
What are the subsequent actions?
At the conclusion of the roundtables, FDA leadership expressed anticipation for further discussions on the implementation of the Food Traceability Rule and indicated that they will seek feedback via various channels, including meetings, comments, and other public venues.
The governmental entity expressed its readiness to “engage as suitable in a public-private partnership” should an opportunity arise that may mitigate some of the pressures imposed on producers and sellers by the new regulations. It stated that it “will persist in providing regular updates and resources as the compliance date nears” and that the foundation will “maintain its support of the initiative by aiding in the facilitation of such engagement.”
Consumers should prepare for an increase of labels, however this may not be the sole addition to their preferred items. In September, Food & Wine reported that the FDA is considering mandating the presentation of some nutritional information on the front of packaging, a format often utilized in Europe and other regions.
The FDA has indicated that front-of-package labeling will provide customers with “simplified, at-a-glance nutrition information” to facilitate quicker and more informed decision-making. Nonetheless, in contrast to the traceability regulations, this new directive has not yet been implemented; rather, you may monitor its advancement here.