IFMA’s SVP of Member Value, Mike Schwartz, analyzes FSMA 204, which mandates that companies in the food supply chain keep extensive records on food traceability by January 2026. This aims to enhance food safety and streamline responses to outbreaks of foodborne illnesses.
By January 2026, companies connected to the food supply chain must retain detailed records on food traceability to enhance food safety and quicken responses to foodborne illness outbreaks as dictated by the FDA’s final rule on Requirements for Additional Traceability Records for Certain Foods. Referred to as FSMA 204, this regulation requires tracking “Key Data Elements” and “Critical Tracking Events” for foods listed on the Food Traceability List, encompassing the entire journey from farm fields to consumer transactions.
Companies require ample time, varying from six to 14 months, and significant financial commitments to update systems and technology for FSMA 204 compliance, underscoring the urgency of initiating preparations immediately.
Some may regard Jan. 20, 2026, as distant. However, when facing a significant overhaul in the way your business archives data, January 2026 is rapidly approaching.
The FSMA Rule 204 and its deadline for implementation.
FSMA 204 is a new FDA mandate for entities involved in the manufacture, processing, packaging, or storage of foods listed on the Food Traceability List (FTL). Starting in January 2026, these entities must maintain records containing specific food-related information and deliver this information promptly to the FDA. The rule is applicable to both domestic and foreign firms producing food for consumption in the U.S across the entire supply chain. These requirements will enable the FDA to quickly and effectively track food movement, thereby preventing outbreaks of foodborne illnesses and minimizing product recalls.
All of this sounds promising, right? As consumers and business proprietors, we welcome enhancements in food safety and the introduction of new procedures to expeditiously handle food-related issues. However, complying with FSMA 204 poses a considerable challenge to our sector.
The FTL includes categories such as multiple fresh produce varieties, diverse cheeses, nut spreads, specific seafood categories, and ready-to-eat deli salads. You can consult the complete list on the FDA’s website. Each entity along the supply chain must monitor a defined set of Key Data Elements (KDEs) and all stages where the food is transported, delivered, processed, or bought, also referred to as Critical Tracking Events (CTEs).
Given the extensive involvement of companies within the food supply chain, transmitting and consistently updating KDE and CTE data at each stage (from farm fields/harvesting to processing/manufacturing to distribution to operator/restaurant to consumer) represents the most critical aspect for FSMA204 compliance. These two data sets encompass the actual operational phases of food products.
It is undeniable, as recognized by FSMA 204 experts and the government, that all food entities will need to heavily invest in system enhancements and technology to capture the numerous steps involved in producing KDE and CTE information. The lead time required to accurately furnish all the necessary data extends beyond a 6-8 month timeframe if your organization already utilizes a fundamental reporting system. If your organization is just commencing this process, the lead time expands beyond 12-14 months. The financial commitment will also be substantial due to the array of providers that could be deployed based on the technological platforms relied upon by each trading partner.
If your organization has yet to commence preparations for adapting to FSMA 204, the time to mobilize is now, especially considering the deadlines and financial implications ahead. An additional essential factor in this process is the requisite transparency and data exchange among trading partners, which must be mutually agreed upon before executing any compliance strategy. Time and resources once again serve as the principal motivations to meet the compliance deadline and evade severe penalties or potential operational halts that the government could enforce.
In the future, when all parties comply with these obligations, we will achieve genuine traceability of these foods from origin to consumption. FSMA 204 introduces a standardized approach to recordkeeping throughout the food supply chain, paving a path for our sector to adopt more effective traceability systems across the entire ecosystem. This will facilitate rapid identification of product sources in the event of contamination, thereby minimizing recall scopes and waste, and reducing health or safety risks.
Naturally, standardizing recordkeeping across a vast industry like ours presents challenges. At IFMA, we have engaged experts from GS-1 US to address FSMA 204 complexities at various events.
GS1 is a non-profit global organization standardizing data, notably as the sole provider of EAN/UPC barcodes. Presently, suppliers, distributors, trade associations, and others are collaborating with GS1 US to enhance confidence in food traceability before FSMA 204 enforcement.
We recommend acquainting yourself with GS1’s endeavors concerning these new traceability prerequisites if you are not already aware of them. Explore their food safety insights on their website. They can provide clarity on compliance requisites and aid in integrating new procedures into your data management.
IFMA’s annual virtual Marketing and Sales Conference, scheduled for August 6-8, will feature a session on FSMA 204 (both live and available on-demand for several weeks post-event). This conference is open to all industry stakeholders. Learn more and register here. We will also discuss the implications of FDA’s food traceability requirements at our Presidents Conference in November, more information here.
Despite advancements making traceability technology more cost-effective, no “free” solutions exist. Additionally, remember that 18 months is a relatively brief period. If your company has yet to address preparations for meeting FSMA 204 guidelines, the time to start is now! For those not handling any foods on the current FTL, anticipate expansion of that list in the upcoming years. Stay informed and leverage IFMA and industry resources to remain proactive.