At a Glance
- FSMA 204 creates strict new traceability requirements starting in 2026, and businesses must be ready to capture and share key data within 24 hours.
- The regulation aims to speed up outbreak response by requiring companies to record “who, what, where, when, and why” for critical tracking events.
- Non-compliance carries serious risks — civil, criminal, and financial — and many businesses still struggle with data capture, system connectivity, and partner collaboration.
- Companies can prepare by running mock traceability drills, mapping current data, aligning with trading partners, and treating traceability as an operational advantage, not a burden.
You’ve built your food business on quality products and reliable operations. Your team knows the drill — pack, ship, and invoice. Rinse and repeat. But there’s a federal requirement coming in January 2026 that could upend your entire operation if you’re not prepared.
FSMA 204 isn’t just another compliance checkbox. It’s a fundamental shift in how the FDA expects food businesses to track and trace products through the supply chain. And if you’re just hearing about it now? You’re not alone — but you are running out of time (don’t panic).
This week, we sat down with Wiggs Civitillo, Founder and CEO of Starfish, a technology company that connects different traceability systems across the food industry. Responsible for developing and leading IBM Food Trust — the world’s largest traceability network — Civitillo has seen firsthand why companies struggle with traceability and what’s at stake when they get it wrong.
In this article, we’ll break down what FSMA 204 actually means for your business, what data you need to capture, the real penalties for non-compliance, and the concrete steps you can take today to get ready.
What Is FSMA 204 and Why Should You Care?
FSMA 204 is part of the Food Safety Modernization Act, a federal law passed in 2011 that’s finally getting teeth. At its core, it’s about one thing: Making food safer through better traceability.
Think about the last major foodborne illness outbreak you heard about. Remember how long it took the FDA to pinpoint the source? That’s because historically, the FDA has been metaphorically working with yarn and pins on a board — literally trying to map out supply chains from scratch every time people get sick.
Traceability changes that equation. When every company captures records of what they did with every product they touch, the FDA can respond in hours instead of weeks. That means fewer people get sick, contaminated products come off shelves faster, and your business isn’t caught in the crossfire of a recall that could have been prevented.
Believe it or not, this regulation can actually protect your business. Think about it: You take pride in making sure your products are just as safe as they are delicious. But what if somewhere in the supply chain, something went wrong, like a warehouse losing power for a few hours? If something were to happen to the food, the source of the problem could be more easily identified. Suddenly, this regulation just got less scary and a lot more impactful and vital — for everyone.
What Data Do You Actually Need to Track?
Here’s where it gets practical. FSMA 204 requires what the FDA calls “Key Data Elements (KDEs)” for “Critical Tracking Events (CTEs)” — moments in your operation that matter for product tracing.
The data requirements boil down to five simple questions: Who, What, Where, When, and Why.
If you’re a grower, packer, or shipper, you need to capture these CTEs:
- Harvesting events: Who harvested? What product? What quantity? Where was it grown? When did it happen?
- Packing events: When did you label and package the product?
- Shipping events: Where did it go and when?
For distributors, it’s simpler: Capture your receiving events and your shipping events. Scan products when they arrive and when they leave.
The goal? If the FDA comes knocking, you can pull a report within 24 hours that shows exactly what happened to any product in your facility.
Are Companies Already Doing This?
Some are. Some aren’t. And that gap tells an important story.
The produce industry learned its lesson the hard way. After devastating romaine lettuce recalls that resulted in fatalities, the industry created the Produce Traceability Initiative (PTI). Companies in that sector have been voluntarily collecting and sharing traceability data ever since.
But not all food categories are keeping up. And FSMA 204 just made it non-negotiable.
What Happens If You’re Not Compliant?
Let’s be blunt: FSMA 204 is federal law. That means civil and criminal penalties are on the table. The head of a company that is not in compliance with FSMA 204 could go to prison. That’s no joke.
Beyond federal enforcement, there’s private litigation. Suppose someone gets sick from a foodborne illness, and your company was involved in the supply chain. In that case, your liability grows exponentially if you were non-compliant with a federal food safety law.
Now, there’s uncertainty about timing. The FDA has stated it’d like to delay enforcement by 30 months, pushing the deadline to July 2028. Some expect the FDA to be lenient in year one, coaching companies rather than prosecuting them.
But here’s the catch: If people are injured (or, worst case, die) and you’re non-compliant, coaching goes out the window.
Where Are Food Businesses Falling Short?
There are three major gaps food companies consistently find themselves facing:
- Data Capture and Digitization: The smaller the company is, the less likely they are to have digitized their operations (typically). Some are still tracking everything on paper or in disconnected spreadsheets. Data capture can be as simple as writing down lot numbers or as sophisticated as IoT sensors (“specialized electronic devices that sense, detect, and measure various parameters in our physical environment,” according to Safety Culture) that auto-scan products. Most companies fall somewhere in between — and some haven’t invested in any system at all.
- System Connectivity: Even companies with good internal data struggle to share it, which is a key requirement of the law. ERPs, warehouse management systems, spreadsheets, PDFs, portals — all these systems may not talk to each other. Sometimes it’s because technology providers compete and won’t share data across platforms. Sometimes it’s just incompatible data formats. Either way, if your systems can’t communicate, you can’t provide the FDA with a complete picture.
- Limited Trading Partner Collaboration: Here’s where it gets complicated. Every company you ship to is a trading partner. By law, you need to send them your shipping data — otherwise, they’re non-compliant, and that’s your fault. The same goes upstream: Your suppliers need to send you their data, or you’re non-compliant.
Previously, there was no clear guidance on what to share or when. FSMA 204 now requires companies — even those using different systems and formats — to align and collaborate.
What Can You Do Right Now?
Don’t panic. Do plan.
Deliberately carve out time to learn about the requirements and assess where you are in comparison to where you need to go.
Here’s your starting point:
Run a mock fire drill. Pretend the FDA just called (not just to say “hi”). You have 24 hours to send them an electronic sortable spreadsheet with all your traceability data for a specific product. Start the clock. How quickly can you pull that data? Where are the gaps?
Assess your role in the supply chain. Are you a grower? Distributor? Processor? Each role has different events to capture. Understand which events you’re responsible for.
Map your current data capture. How much traceability data do you have today? Is it in an ERP? Spreadsheets? Nowhere? Be honest about your starting point.
Identify your trading partners. Who do you buy from? Who do you sell to? These relationships need data-sharing agreements.
If you start taking steps in the right direction, the FDA may be more understanding. The specific law was passed in January 2023 (as part of a broader initiative passed in 2011) with a three-year runway, precisely because the FDA knew it would take time.
Beyond Compliance: The Hidden Benefits
Here’s the part most people miss: FSMA 204 compliance isn’t just an expense. Done right, it’s an investment in operational efficiency.
There are five specific categories of traceability benefits:
- Food safety (obviously)
- Reducing food waste
- Preventing food fraud (no, not a “Hamburglar” situation. Think of advertising Red Snapper and serving a similar-tasting, but cheaper, fish.)
- Supply chain efficiency
- Consumer engagement
Better traceability means you can track products more accurately, reduce spoilage, verify authenticity, optimize operations, and tell better stories about your products. These benefits drive real business value beyond just avoiding penalties.
Are You Ready for FSMA 204?
FSMA 204 is coming whether you’re ready or not. The deadline may shift, but the requirement isn’t going away.
The companies that will thrive are the ones that stop viewing traceability as a compliance burden and start seeing it as an operational advantage. The ones that invest time now to understand what data they need, how to capture it, and how to share it with partners.
You’ve spent years building your food business. Don’t let a federal compliance requirement be what derails it. Carve out time this week to assess where you stand. Run that mock fire drill. Identify your gaps.
Because when the FDA comes knocking, you want to be ready — not just for your sake, but for your customers as well.
Are you interested in finding out more about the fresh food industry and packaging? Visit our Learning Center today and explore a variety of topics.
Do you want to learn more about Starfish? Visit their website today, or contact them at Info@starfish-network.com.
