Regulatory compliance Rule 204 feature image

Get a Jump on Regulatory Compliance in Light of New FSMA Rule 204

| Quality Management | Product Lifecycle Management | Regulatory
Posted By: Jovan Hadžić

2026 is Just Around the Corner for the Food Industry

Food companies across the supply chain have until January 20, 2026, to ensure full compliance with the new FDA rule on “Requirements for Additional Traceability Records for Certain Foods” (commonly known as Rule 204). 

That’s not a lot of time.

As Melanie Neuman, Executive VP and General Counsel at Matrix Sciences International puts it, “Three years might seem like a lot of time, but it’s not. Not to figure out what parts of the rule apply to you. Not if you want to pressure test your system to see if you can actually track, trace, and manage all of the relevant data. And particularly to convert your practices to be able to do things like honoring a previously applied traceability lot code. So, my advice is, don’t wait. Put a project plan together so that you are in a position to be compliant. And be able to pressure test your system. Ideally six months before the rule takes effect.”

The Far-Reaching Impacts of FSMA Rule 204

Rule 204 of the FSMA (the most recent extension of the landmark 2011 Food Safety Modernization Act) affects many ingrained and embedded food industry practices that must be changed or updated within the next three years. 

For example, under Rule 204 a specific “lot code” must stay with a given product throughout its lifecycle, with few exceptions.  

“One of the fundamental changes brought on by the new rule has to do with mindset,” explains Melanie Neuman. “As manufacturers, we’re used to being able to apply our own new lot code, however we define that. But now, by regulation, there are several circumstances in which we cannot do that and must honor the traceability code that’s been applied by someone else.”

Food industry attorney Shawn Stevens adds, “A lot of what we’re going to be trying to do between now and 2026 is predict how the FDA would apply the rule in circumstances we might find ourselves in. Probably the first question is, ‘am I exempt?’ If not, ‘what do I need to do to comply?’ My advice? Make sure your internal deadlines come long before the FDA’s deadline, so that any gaps are filled so that you’re off to the races when the rule goes into effect.”

Keeping up with the FDA

Leading food manufacturing companies are shifting to highly advanced tools and sophisticated traceability mechanisms to keep up with changing regulations, to prepare for implementation of FSMA Rule 204, and to survive and thrive going forward.

“I see the traceability rule as an extension of the FDA’s war on pathogens,” says Stevens. “What is the purpose of FSMA? In large part it’s Congress saying to the FDA, ‘make food-borne illnesses stop.’ So, this is yet another tool, and another rule, that FDA has in its arsenal, as it continues to open up many different fronts in its war on pathogens.”

Trace One Devex PLM Makes Adaptation and Implementation Easier

Trace One Devex PLM is the ideal tool to help food industry professionals meet new regulatory requirements such as Rule 204 and maintain food safety. As more and more companies are discovering, Trace One Devex PLM gathers and centralizes data to harmonize information across an enterprise, make tracking and tracing easier, and prevent problems from emerging in the first place. 

An example of this data usage is Trace One Devex PLM’s embedded regulatory compliance module that makes traceability easier. Such a control helps eliminate oversights based on human error or manual input and ensures that users are compliant according to regional mandates—all within one system.

To get ahead of upcoming regulatory developments you can turn to Trace One Devex PLM for Food & Beverage, a category-leading PLM solution designed from the ground up to help food manufacturers remain compliant as they grow and thrive.

Interested in finding out how Trace One Devex PLM can help your company stay up to speed on evolving regulations? Schedule a demo today.