Food traceability is now the law under the FDA’s FSMA 204 food traceability final rule. Grocery retailers, wholesalers, food manufacturers and suppliers are now responsible for more traceability recordkeeping than ever before. Although the FSMA 204 enforcement deadline of January 20, 2026 is fast-approaching, some persistent misconceptions are threatening to slow the adoption of traceability practices throughout the supply chain.
The most common misconceptions among grocery retailers have to do with the viability of labels as a traceability solution, confusion surrounding the legal and regulatory risks from noncompliance, and a general uncertainty about how to start a FSMA 204 compliant traceability program.
In this article, we’ll explain explore three truths that may seem controversial, but will undoubtedly shed some light on the big picture within this small window of time the industry is working with.
TRUTH #1: NO, LABELS CAN’T DO TRACEABILITY.
Why not? While it’s true that some of the information printed on the label needs to be part of the traceability records required by the FDA, not all of that information is capable of being known – let alone printed – at that time.
Think about it this way. When a label is printed and adhered to a package or box, the supplier usually knows and has on-hand:
- The traceability lot code (TLC) for the food
- The product description for the food
- The location description for the TLC source or the TLC source reference
However, at the time a label is printed, there IS NO WAY OF KNOWING or having information about the transactions related to that product that HAVEN’T HAPPENED YET. For example, when a label is printed, there is no way of knowing:
- The location description for where the food was received
- The location description for the immediate previous source (other than the transporter of the food) for the food
- The reference document type and reference document number
- the quantity and unit of measure of the food
- The date the food was received
So, where do these other KDEs come from? The KDEs that can’t be printed on a label are typically found within existing systems or documentation like Advanced Shipping Notices (ASNs), Bills of Lading (BOLs) or within a Warehouse Management System (WMS) or accounting system. These KDEs need to be sent electronically for EVERY shipment…and then they need to be combined with KDEs from the label to form a complete KDE record required by the FDA.
To see what we mean, watch this quick, 90 second video on why labels won’t do traceability, by themselves.
TRUTH #2: THERE ARE REAL LEGAL RISKS FOR NONCOMPLIANCE (AND UNDER-COMPLIANCE) WITH FSMA 204
The FDA is likely to come down first – and heaviest – on the retailer where the food was purchased by the end consumer. That’s where traceability culminates and the data is aggregated; it’s also where investigation begins. If a company can’t demonstrate compliance with FSMA 204, or if its traceability efforts are determined to be insufficient, then the FDA has a powerful set of remedies that it can and will deploy.
Traceability has changed the food supply chain industry forever. It has also brought new pressures in the form of regulatory and tort risk that have never been seen before. The legal threats from traceability were discussed in detail in a recent webinar hosted by ReposiTrak and leading food safety lawyer Shawn Stevens.
Here are some important points from the webinar on the legal threats from FSMA 204:
- Each party in the supply chain has a legal obligation under the law – and a duty to the consumer – to ensure that they’re doing their part to collect and share the required information for traceability.
- If a retailer chooses to do business with a supplier who refuses to do traceability, then the retailer assumes the risk. If a supplier refuses to do traceability, it’s advisable to find another supplier who will.
- FDA will begin every investigation with the retailer; therefore, the retailer must have a robust traceability plan and recordkeeping.
TRUTH #3: THERE IS NO TIME TO WASTE
With the FDA’s enforcement deadline for FSMA 204 still over a year away, some companies think that they have time to wait to start a traceability program. The truth is, that traceability takes time and it takes creating a technical connection with EVERY impacted supplier…regardless of their level of sophistication.
As a retailer or wholesaler considering whether to start a traceability program now, consider this:
In summary, the truth about traceability is that labels alone aren’t enough, there’s a real legal threat to companies that don’t comply, and there’s simply no time to waste. Adopting a true, tech-enabled food traceability program as outlined by the FDA requires time, people and financial resources. Starting now allows you to spread those invaluable resources more evenly over time, minimizing disruptions and ensuring a smoother transition to full compliance.
Keep in mind, too, that traceability data starts with the supplier. That’s where the most vital KDE – the “Traceability Lot Code” or “TLC” – originates. In order to do any traceability at all, the retailers or wholesaler needs to create a physical, technical connection with EVERY impacted supplier, regardless of their level of technical savvy. Through our work onboarding suppliers for compliance and traceability over the past 20 years, we’ve found that more than 70% of suppliers do not have a dedicated IT resource.
With the exchange of this amount of data, errors will occur. Every FSMA 204 food traceability program needs to take into account the method, time and resources required to identify errors, as well as to fix and document resolutions.
At its core, the FDA’s FSMA 204 food traceability final rule is about taking proactive steps to improve food safety throughout the food supply chain. According to the FDA, these traceability requirements “will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.”
FSMA 204 is complex, and the impact will be felt far and wide throughout the retail grocery industry. The critical first step to mee,ting the requirements is to create a connection with each supplier to understand what KDEs they have and how they can share their KDEs with you. You can do this work on your own, or with an established solution like the ReposiTrak Traceability Network the world’s only operating traceability network that already includes hundreds of supplier connections with thousands more in the queue.
To learn more about traceability and the ReposiTrak Traceability Network, contact ReposiTrak today. We’d be happy to help.
