Why Manufacturers Must Lead the Charge on FSMA 204 — And What Happens When They Don’t

‍Why Manufacturers Must Lead the Charge on FSMA 204 — And What Happens When They Don’t

You’ve probably seen the recent Food Manufacturing article making the rounds: FSMA 204: Why the Manufacturing Industry Must Lead the Charge on Food Traceability. It’s a solid overview and hits on an uncomfortable truth many in the supply chain already know but haven’t fully internalized:

If traceability doesn’t start at the manufacturing-node—grower, packer, processor, first land-based receiver—every downstream partner pays for that omission. And pays dearly.

This is not theory. It’s economics, operations, and human psychology rolled into one.

The Hard Truth: The Point of Origin Sets the Pace

If the manufacturer assigns the right identifiers, embeds accurate data, and applies a consistent label at the point of creation or transformation, the rest of the supply chain benefits automatically.

If not?
Well… everyone else becomes an amateur data archaeologist.

This mirrors virtually every lesson learned in the pharmaceutical industry during DSCSA implementation. Pharma manufacturers realized quickly:

It is far cheaper to do identification and labeling upstream than to force distributors, hospitals, and dispensers to enter or interpret data downstream.

Food is no different. In fact, the diversity of formats(fresh, frozen, cut, repacked, bulk, variable measure, etc.) arguably makes the need for manufacturer-driven traceability even more essential.

Case in Point: When the Burden Shifts, Costs Spike

One of my clients—a large airline catering and service provider—recently removed their scanning infrastructure at receiving. Why?

Because performing all the label printing and scanning that should have been done one step upstream proved too costly and too operationally disruptive.

They weren’t fighting FSMA 204. They were fighting physics:

• Extra handling time
• Extra labor
• Extra equipment
• Extra process steps that slow down a high-velocity environment

When upstream partners don’t provide FSMA-ready IDs, dates, and lot codes, companies like this must choose between:

1. Building an expensive micro-manufacturing labeling operation at the receiving dock, or
2. Abandoning the tech altogether because the ROI collapses under its own weight.

This is the consequence of misplaced responsibilities.
And it’s happening everywhere: grocery commissaries, seafood processors, central kitchens, produce distributors, convenience store chains—you name it.

The Misconception: “Downstream Will Handle It”

Many manufacturers (growers, packers, processors) still assume:

“The distributor or retailer will figure out the traceability part.”

They won’t.
They can’t—not efficiently, not accurately, and not at scale.

FSMA 204 is explicitly designed to push data integrity upstream so each node doesn’t have to reinvent what the previous one forgot to do. When manufacturers don’t assign proper identifiers or provide KDEs with consistency, the entire system strains under the weight of manual intervention.

And here’s the kicker:
Downstream partners are increasingly refusing to shoulder that burden.

Retailers are tightening requirements.
Grocery commissaries are strengthening inbound controls.
Airline caterers are refusing to print labels that they shouldn’t be printing.
And software vendors are scrambling to patch gaps they never expected to solve.

A Lesson Borrowed from Pharma: Fix the Front of the Line

Pharma spent a decade learning (sometimes painfully) that:

• The earliest point of standardization is the least costly place to do it.
• Rework at distribution is exponentially more expensive.
• Downstream “interpretation” equals downstream “error.”

The food sector is running the same playbook, only faster and under greater operational variability.

Manufacturers have the most control, the most context, the most stable environments, and the most predictable workflows.
They also benefit the most from modern traceability—cleaner data, better recalls, tighter inventory visibility, and stronger buyer trust.

So What Should Manufacturers Do?

Here is the practical, not-theoretical checklist:

• Adopt global standards (GTIN, GLN, SSCC, AI 10/17/11/21, etc.).
• Label at the earliest logical transformation step.
• Use EDI at minimum provide consistent KDEs electronically.
• Automate printing and encoding—don’t outsource to the receiving dock.
• Work with foodservice, retail, and distributor partners to align expectations.
• Treat traceability as part of operational excellence, not a regulatory bolt-on.

These actions cost far less than forcing your customers (or your customers’ customers) to become de facto label manufacturers.

The Big Picture: FSMA 204 Is a Manufacturer’s Opportunity—Not a Mandate

The Food Manufacturing article gets one thing exactly right:

Manufacturers are the fulcrum. Move the fulcrum, and you move the industry.

FSMA 204 isn’t just compliance.
It’s an upstream economic opportunity to redesign how data flows—starting where it’s cheapest, smartest, and most durable to generate.

When manufacturers lead, everyone else accelerates.
When they don’t, everyone else improvises—and improvisation is expensive.

Conclusion & Call to Action

If you’re a manufacturer, packer, grower, or first receiver, now is the moment to lead—not because FDA is watching, but because your downstream customers are depending on you.

If you’re a retailer, distributor, or foodservice operator, now is the moment to push upstream—and stop absorbing work that was never yours to begin with.

MDB has helped companies like Saputo, McCormick, ShopRite, McCaffrey’s, and major global foodservice providers design practical, scalable, upstream-first traceability programs.

If you want to avoid the downstream cost trap—and build traceability the way FSMA 204 intended—let’s talk.

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