FSMA Rule 204 Information Hub

FSMA Rule 204 is finalized and will be enforced January 20, 2026. Are you prepared?

iFoodDS has been actively participating in the conversation around FSMA Rule 204. As members of GS1, we’ve been involved in ongoing traceability working groups and have had many discussions with industry leaders on the best path forward after Rule 204 finalization.

This informational hub is designed to be an educational resource for the full supply chain as the food industry navigates FSMA Rule 204. Learn what you need to do to comply and how you can collaborate with your supply chain partners to get the right data.

We’ll be updating this page regularly with new content and updated information if/when the FDA makes further updates to Rule 204.

Standardized Data and the Path to FSMA 204 Compliance

Standardized data is the bedrock of compliance with FDA’s Food Traceability Rule, FSMA 204, facilitating use of the same language throughout the supply chain. This will allow for faster identification and rapid removal of potentially contaminated food from the market when there is an outbreak or recall.
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Timeline to FSMA 204 Compliance, Part 4: REVIEW Your Organization’s Compliance with FSMA 204

If you’ve been following our Timeline to FSMA 204 Compliance series, you’re familiar with the Learn, Plan, Do, Review strategy we’ve referenced in Parts 1-3 of this series. Part 4 will discuss the timeline’s final but ongoing phase, “Review.”
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Timeline to FSMA 204 Compliance, Part 3: DO (Put Your FSMA 204 Compliance Plan Into Action)

By now you should’ve learned how the rule applies to your organization, created your traceability plan, and identified your method for capturing, storing, and sharing KDEs. Now it’s time to act and DO all the work you set out to do.
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Timeline to FSMA 204 Compliance, Part 2: PLAN For FSMA 204

Andy Kennedy of New Era Partners, and co-writer of FSMA Rule 204, designed a timeline outlining the path to compliance. He recommends first LEARNING about FSMA 204 before you act and implement any new processes or systems, then PLANNING your path to compliance.
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Three Areas Where You’ll See the Greatest Return on Your FSMA 204 Investment

Organizations covered by FDA’s Food Traceability Rule often ask two questions: How much will it cost us to comply with the rule? And: Is it worth the risk to not comply?
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Timeline to FSMA 204 Compliance, Part 1: LEARN About FSMA 204

With just over two years until the FDA Food Traceability Rule enforcement date, it’s crucial to start preparing now. Andy Kennedy, Principal Traceability Advisor at New Era Partners and co-writer of FSMA 204, designed a timeline outlining the path to compliance.  Andy recommends learning about the rule before you act and implement any new processes or systems. 
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4 Myths About FSMA 204 Dispelled

There are misconceptions about how to comply with FSMA 204—FDA’s Final Food Traceability Rule—that make the rule appear more complicated than it actually is. We want to ease your concerns about four of the most common myths that have surfaced in recent months and provide facts and resources to consider as you look towards the January 20, 2026 compliance deadline. 
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A Checklist for Choosing the Right FSMA 204 Traceability Partner

Knowing what solution capabilities to look for when evaluating potential solution partners can be daunting. iFoodDS has been working to confidently understand what compliance with FSMA 204 looks like and help the entire supply chain capture, maintain, and share required KDEs across all CTEs. Use our checklist to help ensure your solution partner meets all your requirements
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13 Common Questions Asked About FSMA 204

iFoodDS is committed to helping those who must comply with the FSMA 204 - also known as the Final Food Traceability Rule - understand what's asked of them and what resources are available to help. What follows are some of those questions with links to resources that we hope will help smooth the way forward.
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Two inspectors discuss a quality inspection in a distribution center

Get Personalized Rule 204 Guidance from a Former FDA Traceability Expert

There is no “one size fits all” approach to FSMA Rule 204 compliance. Enterprise food companies need personalized consulting to navigate the rule. That’s why iFoodDS is partnering with Andy Kennedy and Matt Regusci to launch New Era Partners, a technology-neutral advisory service.
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A grocery store employee using a tablet

5 Things Grocery Retailers and Distributors May Not Know about FSMA Rule 204

Learn about nuanced parts of FSMA Rule 204 that impact grocery retailers and independent distributors.
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Retailer, foodservice, distributor KDEs

A Guide to Collecting Key Data Elements as a Grocery Retailer, Foodservice Operator, or Distributor

We've put together a guide on Rule 204 for retailers, foodservice operators, and distributors. Learn how to collect your KDEs without disrupting your operations.
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Creating salad in a processing facility

How Processors Can Collect KDEs Efficiently

Learn about the transformation Critical Tracking Event (CTE) and how processors can collect their KDEs in the complex processing environment. It's critical to get the right information from your suppliers.
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A field of lettuce

How Growers and Packer-Shippers Can Collect KDEs and Comply with FSMA Rule 204

Learn how you can comply with FSMA Rule 204 as a farm or packer-shipper. We've put together a brief guide on collecting the required KDEs.
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A woman packs mangoes for shipment and checks for fruit quality

Are You Prepared for FSMA Rule 204? Here’s What You Need to Know

What are you doing to prepare for Rule 204? Have you thought about leveraging traceability for a competitive advantage? Learn more about Rule 204 and why you should start thinking beyond compliance.
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Produce department in a grocery store

3 Ways End-to-End Traceability Benefits Grocery Retailers

Now that Rule 204 is finalized, how will your grocery brand stand out in the marketplace? Could you leverage your traceability program for a competitive advantage? Here are 3 key benefits of end-to-end traceability.
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A grocery store employee looks up information on his tablet

5 Traceability Challenges Retailers and Foodservice Operators Must Overcome

FSMA Rule 204 has raised many concerns for grocery retailers, independent distributors, and foodservice operators. Here are 5 traceability challenges.
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An employee scans a pallet of fruit in a distribution center

4 Misconceptions About Traceability Technology

Is traceability technology a burdensome cost of compliance, or can it provide a return on investment? We’d like to present the 4 most common misconceptions we hear about traceability technology and show how it can benefit your business.
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Are Your Suppliers Sending You the Information You Need to Comply with FSMA Rule 204?

Our survey found gaps in the information DCs are receiving from suppliers. Here's how to ensure sure you're getting everything you need.
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iFoodDS’ Perspective on the Final Version of FSMA Rule 204

See how the final Rule will impact grocery retail and foodservice businesses and what you can do to start preparing for enforcement.
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Infographics and eBooks

Traceability Plan Infographic

August 10, 2023

The Traceability Plan is a FSMA 204 requirement for all organizations across the supply chain who manufacture, process, pack or hold foods on the Food Traceability List (FTL). Download our Traceability Plan Requirements and Sample Plan infographic to guide your organization in creating your own Traceability Plan.

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Solution Provider Checklist

August 10, 2023

Use our checklist to evaluate whether a solution provider can support compliance with the FDA’s Food Traceability Rule (FSMA Rule 204).

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Capturing FSMA Rule 204 KDEs

October 24, 2022

You’ll need the right information from your suppliers to record your Key Data Elements (KDEs). This infographic shows you ways to get that information so you can comply with Rule 204.

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FSMA Rule 204 Preparedness Checklist

October 3, 2022

The rule will be finalized in November, 2022. Many companies will be subject to the new requirements and will have just 2 years to comply. Are you prepared? Go through our brief checklist to find out.

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Full Supply Chain Traceability Is the Future of Food Safety

September 23, 2022

In this eBook, we explore the connection between traceability and enhanced food safety.

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FSMA Rule 204 Highlights

Under Rule 204, you’ll need to submit traceability information to the FDA in an electronic spreadsheet within 24 hours of a request.

Can you currently do this?

There are 16 fresh food categories on the Food Traceability List. Do you know if you sell any commodities subject to Rule 204?

Which of your products are on the FTL?

Depending on your role in the supply chain, you may be responsible for KDEs (Key Data Elements) associated with more than one CTE (Critical Tracking Event).

Are you currently collecting all required KDEs?

FSMA Rule 204 doesn’t mandate a specific technology for keeping traceability records. Have you thought about the best solution for your company?

Do you have the right technology in place?
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