The Food Traceability Rule Is Coming. Here’s What It Means for You

A few weeks ago, a client called me in a panic. She had just read something about the FDA’s Food Traceability Rule and realized she had no idea if it applied to her company or what she was supposed to do about it.

She’s not alone.

Every month, I talk to food business owners and operators who are running great operations, meeting all their current compliance requirements — and yet this rule feels like it came out of nowhere.

It didn’t, of course. It’s been in the works for a long time.

But now it’s real, it’s final, and it has a deadline: January 20, 2026. Although FDA just announced a possible 30 month extension (we will keep you posted).

If you’re in the business of making, processing, packing, shipping, or storing food — especially anything considered high risk — this rule is going to affect you. And waiting until the last minute to get serious about it is a mistake.

So let’s walk through what’s really going on here — not in regulatory jargon, but in plain language — and I’ll share what I’m doing with my own clients to get them ready.

Why This Rule Exists in the First Place

The short version: the FDA is trying to prevent outbreaks and recalls from becoming full-blown disasters.

You’ve seen the headlines. A bag of spinach tests positive for E. coli, and suddenly grocery store shelves are empty, and no one knows exactly which farm it came from. Or salmonella shows up in a batch of peanut butter, and weeks go by before the source is narrowed down.

The Food Traceability Rule is the FDA’s way of speeding up that process. They want to be able to trace a contaminated food item — from the grocery store all the way back to the farm, processor, or distributor — in a matter of hours, not days or weeks.

That means every business that touches a food on their Food Traceability List has to be able to provide detailed, standardized records about where that food came from, where it went, and what happened to it in between.

The List That’s Raising Eyebrows

If you haven’t looked at the list yet — the official “Food Traceability List” or FTL — now is the time.

It includes things like:

• Leafy greens (spinach, romaine, arugula)

• Tomatoes and cucumbers

• Fresh-cut fruit and vegetables

• Shell eggs

• Certain cheeses

• Nut butters

• Finfish and crustaceans

• Ready-to-eat deli salads

  
  

These are foods the FDA has deemed high risk based on factors like how they’re processed, stored, and historically linked to outbreaks.

And here’s the part that catches a lot of businesses off guard: you don’t have to make or sell these products to be responsible for traceability.

If you receive them, use them as ingredients, repack them, store them, or ship them — you’re on the hook. I’ve had clients who assumed they were in the clear, only to find that one sub-ingredient in their product triggered the entire rule.

So, What Does the Rule Actually Require?

Here’s where things get real. The rule introduces two key concepts:

Critical Tracking Events (CTEs) and Key Data Elements (KDEs).

In plain English, the FDA wants to know exactly what happened to a product at key moments in its journey.

When was it packed? Where did it go next?

What lot code was used? Who handled it? When was it received, transformed, or shipped?

And they want that information fast — within 24 hours of the request. Not buried in a stack of paper invoices. Not spread across six spreadsheets and a few “call so-and-so, she might know” conversations.

That’s where many companies are going to struggle. If you’re still relying on manual systems, disconnected platforms, or tribal knowledge in your operations, it’s going to be nearly impossible to respond the way the FDA expects.

What This Means for You (and Why You Need to Start Now)

This is not just about having better records. It’s about rethinking how traceability fits into your operations — and building systems that make it part of your normal workflow.

And it’s not a small lift. For most of my clients, we’re looking at:

• Mapping their current supply chain from end to end

• Identifying every place a critical tracking event occurs

• Updating receiving and shipping processes

• Creating traceability lot codes

• Choosing the right system for storing and retrieving data

• Writing a traceability plan (yes, that’s required too)

• Training staff so they know what to record — and why

  
  

None of that happens overnight. It takes time to get the right systems in place, test them, work out the kinks, and ensure your team can execute consistently.

So when I say you need to start now, I’m not being dramatic. I’m being practical.

The Risk of Waiting

The truth is, that the FDA has been building toward this moment for years. And while they might be generous in the first few months after the deadline, they won’t wait forever.

Noncompliance isn’t just a regulatory risk — it’s a business risk.

If you can’t respond to a traceability request during an outbreak, the consequences can range from warning letters to recalls, fines, or worse — damage to your brand’s reputation and trust.

I’ve seen companies with solid food safety records get caught flat-footed because they didn’t take this seriously until it was too late.

And I’ve seen others — the ones who planned ahead — not just avoid risk, but gain a competitive advantage by being the vendor their customers could trust.

How I Help My Clients Navigate This

This rule is detailed, but it’s not insurmountable — especially if you’re working with someone who understands how to build compliance into your business, not bolt it on like an afterthought.

When I work with clients on traceability readiness, we:

• Figure out if and how the rule applies to your operation

• Identify your current gaps and prioritize fixes

• Design a traceability plan that meets FDA expectations and actually works for your team

• Recommend systems (or optimize what you already use) so you’re not chasing paperwork

• Train your team so this becomes second nature, not another headache

  
  

I don’t believe in one-size-fits-all solutions. Every facility is different. Every supply chain is different. What matters is building a system that’s yours — and that holds up under scrutiny.

If You’re Not Sure Where to Start

You’re not alone. But the worst thing you can do is wait.

If you’re asking yourself:

• “Does this rule apply to us?”

• “Do we have the right records?”

• “Will we be ready if the FDA asks tomorrow?”

Then, it’s time to have a conversation.

Let’s get ahead of this now, while there’s still time to do it right, instead of rushing to patch it together later. Please reach out to info@bustoslawgroup.com to schedule a quick chat with our team.