The Smart Leader's Guide to the New FSMA 204 Compliance Date

Our Vice President of Supply Chain Strategy and Insights, Julie McGill, recently sat down with Lucy Angarita, Director of Supply Chain Visibility at GS1 US, Christian Hahn, Director of Technical Business Development at FEIG Electronics, and  Amber Engebretson, Solution Consultant at PLM TrustLink, for a deep dive into the future of food safety on a two-part AIM North America podcast episode tackling the final traceability rule in section 204 of the Food Safety and Modernization Act (FSMA).

While the government has moved the official FSMA 204 compliance date to July 20, 2028, Julie and her fellow panelists believe this extra time is a valuable opportunity. Together, they broke down what leaders need to know about the rule, the extension, and how your industry peers are handling this latest change to the FSMA calendar.

Ready for the new FSMA 204 Compliance Date? Download our Comprehensive Guide to FSMA 204

The core insight from the session is this: leading companies see the extended deadline as a valuable opportunity and smart leaders aren't slowing down in the interim. Instead, they're treating 2026 as something of a soft launch for traceability programs that are compliance-ready well before the 2028 deadline arrives.

The FSMA 204 Compliance Date Extension: A Regulatory Reality Check

The Food Safety Modernization Act (Section 204) is all about making sure we can track food quickly if someone gets sick, Christian Hahn explained, noting that its overall goal is better protecting public health by strengthening the US food safety system.

"Specifically," he said, " FSMA 204 requires that companies must keep records for designated foods to protect the overall public health by studying past outbreaks, identifying foods with the highest risks, and evaluating traceability for potential gaps."

Read More: Food Labeling Recalls: The Surprising Impact & How to Prevent Them

Under the new law, food records must be produced within 24 hours of being requested by the FDA and these records need to be maintained for at least two years.

With windows that tight,  pen-and-paper record-keeping, spreadsheet spaghetti, disparate systems, and data siloes simply cannot get the job done. Getting everything digitized, organized, and centralized so it can be reviewed in case of a withdrawal event is a very big job, however. One that the FDA determined, after working with the Reagan-Udall Foundation to formally gather feedback from the industry, required more time to do properly. 

"Ahead of the extension a lot of these programs were already underway," McGill explained, "but there continues to be a big gap in education and awareness. As we got closer to that 2026 deadline, the FDA was getting feedback from stakeholders and companies were sharing their concerns over the compliance date. They were finding that their suppliers just weren't ready." 

The consensus among the experts on the podcast panel was that for the companies leading the industry, the extension is perceived as less of a grace period and more of a gas pedal.

"Leading retailers and operators are continuing their efforts to establish communication and traceability across the supply chain," Lucy Angarita observed, pointing to the adoption of the Produce Traceability Initiative (PTI) back in 2009. "In the FSMA 204 work group, where all industry members and solution providers could talk, we've seen alignment like we've never seen in the past. No matter where you are in the supply chain, you can't do this in a silo. It's created this direction and this path that we're seeing now in so-called 'Dear Supplier' letters, pointing to GS1 standards and best practices." 

The 'Dear Valued Supplier' Letter: What to Do When It Hits Your Inbox

If you're a supplier, the first sign of these changes usually is not a knock from the government. Instead, it is a "Dear Valued Supplier" letter from your biggest customer. These letters are the primary way industry stakeholders like retailers and restaurants communicate their expectations regarding the usage of data standards, data accuracy, and product identification to their suppliers before the FSMA 204 compliance date.

If you find one of these letters in your inbox, here's what you should do next:

1. Route the Letter to Your Traceability Team Immediately
   
   McGill has seen that these letters often sit in a someone's inbox for too long. This letter is a technical requirement, not only outlining steps for regulatory compliance, but also your customer's traceability program requirements for your company. Your FSMA and compliance teams need to see it immediately to start planning.

2. Audit Your Barcode Scannability
   
   Many companies have put scanning programs in place and are beginning to grade barcodes to check for scannability, according to McGill's observations, and sending back reports to their suppliers with information about how they expect to collect data and what needs to be fixed to facilitate that ahead of the compliance deadline. Noncompliance could result in future fines, she warns, adding that "That's at the trading partner level, not the FDA level."

3. Review Your Data Accuracy

   These letters usually ask for specific Global Trade Item Numbers (GTINs) or EDI updates. Use this as a chance to remove obsolete items from your system. If your data is out of sync with your buyer, your shipments could be delayed.

4. Confirm Trading Partners’ Timelines and Formats
   
   Many companies have their own milestones that happen well before the final FSMA 204 compliance date.
   Check the letter for specific dates to understand when they expect you to begin sending digital shipping notices or updated labels.

The expert warning from the group is clear: the requirements have not changed, and this extension of the FSMA 204 compliance date is not an invitation to stop building strong traceability programs to meet them. 

Food Tech Talk Podcast: Traceability, Consumer Trust & Kroger's Approach to FSMA 204

The Business Case for Immediate Action (The ROI)

Strengthening traceability with data that's clean, accessible, and on-time is necessary to achieving FSMA 204 compliance. But when you crunch the numbers, it's plain to see that it's also good business sense. That certainly turned out to be the case for a regional distributor McGill recalled working with several years ago who was able to reap the benefits of implementing GS1-128 scanning to provide traceability information to an operator:

"He realized he could use the scan data not only to meet his customer's requirement, but also for his own internal operations," McGill explained, noting that the required lot-level visibility which is also required by FSMA 204 enabled one operational shift with many beneficial outcomes.

"He changed their receiving and put away processes from FIFO (First-In, First-Out) to FEFO (First-Expired, First-Out). Using that data, he saw better turns, better product visibility in the warehouse, and fresher product was being delivered to the customer."

Lucy Angarita agreed that the cost of reacting too slowly is high, while taking a proactive approach can reap rewards quickly, recalling a partnership with a restaurant that implemented inbound scanning upon delivery, calling the results "significant" and "eye-opening".

"We could pinpoint the issues. If there were issues with the product, we could know exactly where the issue was and be able to fix it quickly instead of trying to figure out anywhere in the supply chain where it could have happened."

- Lucy Angarita
Director of Supply Chain Visibility, GS1-US

Precision data allows for "recall surgery" where you only pull the specific items that are a risk. The romaine lettuce recall in 2019 exemplified the risk of being reactive for Angarita. "That cost the industry between $276 and $340 million, and then we all stopped eating lettuce for a while," she recalled. "The cost to not be able to quickly react and go to those locations that actually are impacted is massive." 

Having a solid plan in place before the FSMA 204 compliance date helps you protect your brand and your bottom line. Strengthening traceability can also lead to gains in everyday operational efficiency. Take these real-world examples of how this data creates a return on investment, according to the panel:

• Recall 'Surgery': Hahn pointed to recent research that showed a 50-95% reduction in the scope of recalls with traceability technology.
  
• Food Waste Reduction: There are benefits outside of the ability to pinpoint contaminated food, as well. Companies can reduce the delivery of expired products to nearly zero. This ensures that only the freshest food reaches the customer.

• Cost Avoidance: Angarita recalled a traceability case study developed for IPC Subway where cleaning up the company's master data resulted in $1.3 million in savings after correcting errors around truck optimization and materials handling. 

• Automated Inventory Savings: In the same case study, the company was able to realize $72 million in cost avoidance by automating their inventory and ordering and moving from a manual to digital system.

• Labor Efficiency: Good data prevents staff from spending hours rearranging shelves or looking for missing products. This allows them to focus on serving customers.

Then there are the returns that are more qualitative than quantitative, according to Hahn, particularly where audits are concerned: 

"Nobody wants to do [audits]. They're usually done manually, maybe once or twice a year, and it takes forever. Once traceability systems are in place, it's going to reduce the stress around these audits; they are going to be less scary and intimidating. The data is going to be readily available, easy to obtain, and these audits become a lot more rudimentary."

- Christian Hahn
Director of Technical Business Development, FEIG Electronics 

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Accurate, up-to-date data that lives in an accessible, centralized location is data that can be used to do much more than meet FSMA compliance requirements, McGill agreed, acknowledging the gap between collecting data and using it to inform strategy. "If you don't have good, accurate data as the foundation, you can't do all the cool stuff. You need a good foundation of product information that is in sync with the latest version of that product," she advised.

"I cannot stress enough that, with FSMA 204, companies have an opportunity to make data cleanup a part of the project. It will only make their traceability data better, and help find those hidden opportunities that add up to big dollars in savings."

- Julie McGill
VP of Supply Chain Strategy and Insights, Trustwell

Traceability Tools & Technology that Simplify Complying with FSMA 204 Regulations

As the final FSMA 204 compliance date approaches, the experts agreed that laying a strong data foundation with the right technology today will determine how much value you get out of your investment down the road. The group discussed how new tools are making it easier to capture data without slowing down operations and. Each panelist identified a specific trend or technology that will help companies meet the FSMA 204 compliance date while adding real value to their business.

The Power of RFID for Traceability

Hahn highlighted Radio Frequency Identification (RFID) as a proven technology for track-and-trace use cases. Unlike standard barcodes, RFID tags can be read automatically and without a direct line of sight. Christian explained that these tags can record product movement, and associated data like lot numbers, dates, and locations, making them useful for meeting the requirements in the traceability rule around critical tracking events (CTEs) and key data elements (KDEs).  

"This removes human error from the process and ensures that the information is ready for an FDA reporting," Hahn said, adding that: "RFID infrastructure helps create a digital record of the food's journey, ensuring data is readily available for FDA audits and compliance."

2D Barcodes Can Streamline FSMA 204 Compliance

Angarita pointed out that there is a lot of focus and interest now in 2D barcodes, specifically the GS1 DataMatrix, which has begun to supplant the widely adopted GS1-128 barcode. These small, square barcodes are much more robust than the old versions. Lucy explained that if a standard barcode gets scratched or smudged, you cannot read it, but the 2D version has "error correction" that allows it to still be scanned. These barcodes also hold a lot more information: over 2,300 characters to the GS1-128's 14 character limit.  

"For FSMA 204, this is a big plus because we can put a traceability lot code source reference (GLN) in that barcode and point to master data for information about where the product was packed and where the lot code was assigned," Angarita explained.

The Interoperability 'Handshake'

McGill identified a renewed focus on interoperability —  the idea that different software systems should be able to talk to each other without any issues, explaining that early pilots established the necessity of data standards for enabling interoperability. 

"As companies are implementing traceability measures, the interoperability discussion is back. Companies are looking at how to share this data across systems, whether B2B or via third-party solutions. As companies digitize their traceability programs, that component has become essential." 

- Julie McGill
VP of Supply Chain Strategy and Insights, Trustwell

An Expert Roadmap to Achieving Compliance with FSMA 204

The path forward is about progress rather than being perfect. To help you navigate the years leading up to the final FSMA 204 compliance date, our guest speakers shared their final pieces of advice for the industry:

Lucy Angarita (GS1 US): "Don't wait. Do not wait to see what happens. If you haven't started yet, start now. This is just not going to go away. Don't do this alone; don't reinvent the wheel. Leverage what others have done. We have the GS1 US work groups, AIM, PTI, NFI—so many associations are helping their members. Map out your physical and digital processes and understand where the gaps are. There's nothing like a drawing to put it together."

Angarita also advises companies to prioritize along the 80/20 rule:

"Don't focus on every single supplier or product. Look at the highest volume; and start there. That's where you get the biggest bang for your buck and the low-hanging fruit. Don't let yourself get bogged down by exceptions or scenarios that aren't the regular part of your process. Look at the biggest volume and work with the suppliers that are ahead of the curve in terms of technology, but then also plan for the smaller ones." 

Christian Hahn (FEIG Electronics): Hahn believes that companies should be moving past the research phase and into action.

"Businesses shouldn't be looking at pilots or proof of concepts. Even though the date was extended, deployments or phased approaches should be in place. There should be a framework on how to deploy systems that provide the data to comply. To meet these compliance dates, a phase one needs to be developed by Q2 of this year. 24 months or two years is a lot closer than everybody thinks."

Julie McGill (Trustwell): McGill urges companies to focus on "progress, not perfection", putting the emphasis on communication.

"Talk to your trading partners and your internal teams. Make sure you're communicating with your trading partners to understand their timelines and what formats they will accept. Are they enhancing their existing 856? Do they use a third-party software system? If you're managing data on behalf of another partner, you have to have a legal agreement in place as part of your traceability plan that you can show to the FDA. There are a lot of nuances." 

As a group, each expert agreed that it's important to leverage the expertise of peers in the industry and collaborative opportunities like the AIM North America Food Supply Chain Work Group, where professionals can stress-test ideas and share knowledge either informally or by participating in workshops. 

Resource Roundup: The FSMA 204 Compliance Date is Sooner Than You Think

The bottom line here is that FSMA 204 can and should be a catalyst for building a smarter, more resilient supply chain. The companies that treat this extension as an opportunity to strengthen data foundations, align with trading partners, and invest in interoperable technology will be the ones best positioned to protect their brands and unlock operational gains long before the July 2028 FSMA 204 compliance date.

If you're not sure where to start, there are resources that can help you build momentum (including the two-part podcast!):

• Food Safety Modernization Act (FSMA) Guidance & Regulation (FDA)
• FSMA Rule 204 Implementation Toolkit (GS1 US)
• FSMA 204 Resource Center (AIM North America)
• Guide to FSMA 204 Compliance (Trustwell)

If you’re ready to move from planning to progress, Trustwell can help. Our purpose-built traceability and product information solutions are designed to simplify FSMA 204 compliance while driving measurable business value. Learn more about how Trustwell supports end-to-end traceability and take the next step toward compliance by getting in touch today.