FSMA 204 Information Hub

Navigate FSMA 204 with Confidence

FSMA 204 is FDA’s Food Traceability Rule, requiring enhanced traceability records for foods on the Food Traceability List (FTL). With the July 20, 2028 compliance deadline approaching, food companies should be evaluating their processes, data, and supply chain readiness now. 

Whether you’re just getting started or advancing your traceability program, this hub provides practical guidance on FSMA 204 requirements, implementation strategies, compliance milestones, and supply chain collaboration best practices. 

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

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FSMA 204 Compliance Deadline

Why FSMA 204 Matters

The FSMA 204 Food Traceability Rule is intended to help the food industry trace certain foods more quickly and accurately when questions arise. For foods on the FDA’s Food Traceability List, the rule introduces additional recordkeeping requirements designed to make it easier to identify affected products, support faster recalls, and better protect consumers. 

Preparing for FSMA 204 can feel more manageable when companies give themselves time to understand what applies to their business, review current processes, and coordinate with supply chain partners. Starting now can help reduce last-minute pressure, uncover data or process gaps early, and build a more practical path toward compliance before the July 20, 2028 deadline. 

Trusted FSMA 204 Expertise

Understanding FSMA 204 requires more than reading the regulation—it requires understanding how traceability works in real-world food supply chains. The iFoodDS team includes experienced food safety, traceability, and supply chain professionals who actively participate in industry initiatives and standards organizations, including GS1 and the Produce Traceability Initiative (PTI), helping shape practical approaches to traceability and data exchange. 

For organizations seeking personalized guidance, iFoodDS offers FSMA 204 consulting services through New Era Partners, our consulting division led by former FDA traceability expert and iFoodDS Chief Traceability Officer Andy Kennedy. Drawing on deep regulatory and operational experience, the team helps companies understand the real-world impact of FSMA 204, assess readiness, and develop practical compliance strategies that align with their unique operations. Learn more about iFoodDS and our traceability expertise.

FSMA 204 Compliance Checklist

Are you on track for FSMA 204 compliance? Use the checklist below to assess your organization’s readiness and identify potential gaps before the July 20, 2028 compliance deadline.
  • Have you determined whether your products are covered by the Food Traceability List (FTL)?
  • Have you identified the Critical Tracking Events (CTEs) and Key Data Elements (KDEs) that apply to your business?
  • Have you established a traceability plan?
  • Can you provide traceability records quickly?
  • Have you assessed your technology and data management capabilities?
  • Are your trading partners aligned?
  • Have you tested your traceability processes?

Read Expert Articles

FSMA 204 Readiness Milestones: Building the Foundation

Explore the foundational milestones suppliers should complete to prepare for FSMA 204, build scalable traceability processes, meet evolving customer requirements, and confidently move toward 2028 enforcement.
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Key Milestones for FSMA 204 Readiness (Infographic)

A practical roadmap that helps suppliers prioritize FSMA 204 readiness, identify what should be completed now, and build scalable traceability capabilities through phased milestones before 2028 enforcement.
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Get Ready for FSMA 204 with iFoodDS’ TraceApproved™ – a New Online Learning Program Crafted by Traceability Experts

Adopting new software can be daunting, especially when compliance is on the line, but it doesn’t have to be. TraceApproved gives you access to traceability experts, compliance assurance, step-by-step support, TraceApproved badge to demonstrate your traceability readiness, and best-in-class training.
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5 Common Misconceptions About FSMA 204—and What They Mean in Practice

Think you're ready for FSMA 204? Explore five common misconceptions that can delay compliance and learn practical steps to strengthen your traceability program before the compliance deadline arrives.
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From Compliance to Capability—Making FSMA 204 Operational

FSMA 204 readiness goes beyond compliance. This article explores how connected data, repeatable processes, and partner alignment turn traceability into an operational capability across the supply chain.
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Traceability in Action: How Data Drives Outbreak Investigations

Learn how traceability supports foodborne illness outbreak investigations, where traceback challenges emerge across the supply chain, and how FSMA 204 is designed to improve data access, speed, and precision during food safety response and corrective action efforts.
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Why Data Readiness Determines Traceability Success

End-to-end traceability depends on accurate, consistent data flowing between companies, systems, and supply chain partners. When that data is incomplete, fragmented, or difficult to access, traceability processes slow down — or fail entirely. Here are three of the most common data challenges that can derail traceability initiatives.
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Partners iFoodDS and TraceGains Support Supplier Readiness for FSMA 204

This expanded partnership between TraceGains and iFoodDS will give suppliers a clear path forward to meeting federal food traceability requirements sooner rather than later.
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ASNs Sent Using EDI Advance Traceability, Support FSMA 204 Compliance

Sharing shipment data is required to comply with FDA’s FSMA 204. Exchanging this data in an ASN using EDI is increasingly required of suppliers by retailers and distributors.
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FSMA 204: Who’s Covered and Who’s Not

FSMA 204 is complex, and many businesses throughout the fresh food supply chain may have questions about how FSMA 204 applies to their unique situations.
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What to Tackle in 2026: Build the Infrastructure

Key FSMA 204 compliance milestones suppliers should tackle in 2026 to be ready by 2028: strengthen systems and streamline data sharing to move closer to operational readiness.
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2025: Lay the Foundation for FSMA 204 – Start Now to Hit July 2028

Key milestones suppliers should tackle now to build capability, align with customers, and stay on track for the July 2028 compliance date.
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Keeping Track: How to Maintain Traceability Records for FSMA 204

Learn the essentials of FSMA 204 recordkeeping. Explore answers to frequently asked questions about FDA requirements for companies across the food supply chain.
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9 Common Questions Enterprise Retailers, Foodservice Operators, and Distributors Ask About FSMA 204

To help you get started, we’ve updated this list of the most common FSMA 204 questions we hear from retailers, foodservice operators, and distributors—along with practical guidance for what to do next.
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FSMA 204 Compliance: Answers to the Top Questions from Fresh Food Suppliers

If you supply fresh foods, FSMA 204 likely applies to you. In this post, we answer top questions from suppliers about the FDA’s Food Traceability Rule, what the delayed enforcement means, and why your customers still expect compliance now.
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The Road to FSMA 204 Compliance: Challenges Ahead, but Solutions in Reach

The fresh food industry will have more time to meet the requirements of FDA’s Food Traceability Rule, (FSMA 204), but food producers and suppliers still see significant challenges ahead. Even with the extra time, there is a lot of work to be done and questions about how to comply.
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A Checklist for Choosing the Right FSMA 204 Traceability Partner For Suppliers

Knowing what solution capabilities to look for when evaluating potential partners can be daunting. iFoodDS has built a clear understanding of FSMA 204 compliance and helps the supply chain capture, maintain, and share required KDEs across all CTEs. Use our checklist to ensure your solution partner meets your requirements.
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Now Is the Time: Why Forward-Thinking Food Suppliers Are Moving Ahead with Digital Traceability

While FDA is signaling an intent to extend the FSMA 204 compliance date, there is no reason to pause traceability efforts. Foodborne illnesses, costly recalls, and supply chain disruptions are not slowing down—and the risks to your brand, customers, and bottom line are very real. 
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FSMA 204 Countdown to Compliance – Are You Ready?

FDA’s Food Traceability Rule (FSMA 204) takes effect on January 20, 2026 – just one year from today. Are you prepared to meet compliance requirements?
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Navigating FSMA 204: Progress, Challenges, and the Road Ahead

2024 was a busy and often challenging year for the food supply chain. Looking back on 2024 and the FSMA 204 compliance date just over a year away, we wanted to hit on some of the most talked-about areas of traceability, food safety, and FSMA 204.
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FDA Provides an Example of the Electronic Sortable Spreadsheet

Recently, FDA published an electronic sortable spreadsheet example template organizations can use as a guide when pulling their own traceability records into an electronic sortable spreadsheet format. FDA clearly notes that this specific template is not required to comply with the rule.
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Going Beyond Compliance – Using Systems and Data You’re Already Using for FSMA 204 Compliance to Improve Food Quality

As you research traceability solution providers and the best systems to put in place for compliance with FDA’s Food Traceability Rule, there’s an important factor to consider that may impact your choices: How you can use these systems and data to enhance food quality.
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5 Key Reasons the Traceability Lot Code Is So Important

5 key reasons why the Traceability Lot Code, the most important piece of data in FDA’s Food Traceability Rule (FSMA 204), is so important.
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A Look at the Changing Landscape of FSMA 204 Data Carriers

The food industry is in the midst of a data‑sharing revolution. Companies are deploying established and emerging data‑sharing technologies to comply with FDA’s Food Traceability Rule and increase supply chain transparency.
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Going Beyond FSMA 204 Compliance by Harnessing the Power of Data and Technology

Many FSMA 204–covered companies are focused on the July 20, 2028 deadline. But stepping back, it’s important to recognize that the work underway today delivers long‑term operational benefits well beyond compliance.
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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 FDA Food Traceability Rule enforcement, now is the time to prepare. Andy Kennedy, Principal Traceability Advisor at New Era Partners and co‑writer of FSMA 204, outlines a timeline to compliance—starting with understanding the rule first.
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4 Myths About FSMA 204 Dispelled

There are misconceptions about FSMA 204—the FDA’s Final Food Traceability Rule—that make it seem more complex than it is. We address four common myths and share facts and resources to consider as you prepare for the January 20, 2026 compliance deadline.
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A Checklist for Choosing the Right FSMA 204 Traceability Partner

Evaluating FSMA 204 solution partners can be daunting. iFoodDS has built deep expertise in what real compliance looks like—helping the supply chain capture, maintain, and share required KDEs across all CTEs. Use our checklist to ensure your solution partner meets your requirements.
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13 Common Questions Asked About FSMA 204

iFoodDS is committed to helping FSMA 204–covered organizations understand what’s required and what resources can help. Review these common questions, with links to guidance designed to help smooth the path forward.
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Get Personalized Rule 204 Guidance from a Former FDA Traceability Expert

FSMA 204 compliance isn’t one‑size‑fits‑all. Enterprise food companies need tailored guidance, which is why iFoodDS partnered with Andy Kennedy and Matt Regusci to launch New Era Partners, a technology‑neutral advisory service.
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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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Highlights from IFPA’s Virtual Town Hall on FSMA Rule 204

We provide highlights from IFPA's Virtual Town Hall on FSMA Rule 204. Here's what the panelists, including our own VP of Product Management, had to say.
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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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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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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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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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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.
Read more

View Guides & Tools

The True Cost of Customer-by-Customer Compliance

August 10, 2026

Managing traceability customer by customer creates increasing complexity and cost as your customer base expands. Suppliers can simplify operations with a single, scalable approach.

View Infographic

Key Milestones for FSMA 204 Readiness

August 6, 2026

A practical roadmap that helps suppliers prioritize FSMA 204 readiness, identify what should be completed now, and build scalable traceability capabilities through phased milestones before 2028 enforcement.

View Infographic

One Platform. Every Customer. Less Complexity

August 3, 2026

With less than two years until the FSMA 204 compliance deadline, organizations are focused on strengthening traceability capabilities. But beyond collecting and maintaining data, another challenge is emerging: sharing it efficiently across a growing customer base.

View Infographic

Cyclospora and the Search for Answers: How Outbreak Investigations Work

July 24, 2026

Join Andy Kennedy, Chief Traceability Officer, and Claire Zoellner, Ph.D., Director of Data Science at iFoodDS, for an in-depth discussion of the three legs of an outbreak investigation that public health officials rely on to solve foodborne outbreaks.

View Webinar Recording

Solving Final Mile Traceability with Collaboration and Data Science eBook

March 30, 2026

FSMA 204 introduces new traceability requirements that challenge distribution workflows. Discover how approaches like Calculated Lot Code enable lot-level traceability—without scanning every case.

View eBook

Key Milestones to Achieving FSMA 204 Compliance for Enterprise Retailers, Foodservice Operators, and Distributors

June 27, 2025

A milestone-based roadmap to help your organization move forward with confidence and meet FSMA 204 requirements by the enforcement date. 

View Infographic

A Checklist for Choosing the Right FSMA 204 Traceability Partner for suppliers looking for a cost-effective, flexible compliance solution

May 29, 2025

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

View Checklist

Step-by-Step Timeline for FSMA 204 Compliance

November 27, 2024

Check out our Timeline to FSMA 204 Compliance that walks you through the 4 critical steps to achieving end-to-end traceability: Learn, Plan, Do, Review.

View Infographic

FSMA 204 Resources and Templates

May 2, 2024

Review our collection of FSMA 204 resources, guides, and templates developed by:

  • FDA (FSMA 204 developed by FDA)
  • iFoodDS (traceability solution provider)
  • New Era Partners (FSMA 204 consulting firm)
  • Industry Associations (GS1, PTI, FMI)
Read the Guide

Food Traceability List in Pictures eBook

March 21, 2024

Gain a better understanding of what items are covered by reviewing our FTL in Pictures eBook, and check out the appendix for a more comprehensive list.

Read the eBook

eBook de la Lista de Trazabilidad de Alimentos en Imágenes

March 21, 2024

Obtén una mejor comprensión de los artículos que están cubiertos revisando nuestro eBook Lista de Trazabilidad de Alimentos en Imágenes, y consulta el apéndice para una lista más completa.

Read the eBook

What the Past Tells Us About the Future of FSMA 204

December 13, 2023

In this white paper, by Dr. Bob Whitaker, a produce safety expert and veteran, you will learn about the outbreak investigations and outcomes, and how the timelines and outcomes may have been different had FSMA 204 been in place.

Read the White Paper

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.

View infographic

FSMA 204 Traceability Solution Partner Requirements for Food Retailers, Restaurants, and Distributors with Large Supplier Networks

July 31, 2023

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

View Checklist

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.

View infographic

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.

View Checklist

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.

Read the eBook

Your FSMA 204 Readiness Questions, Answered

Expert guidance for suppliers, retailers, distributors, and foodservice organizations preparing for digital traceability.

Click each question to expand.

FSMA 204 compliance means meeting the regulatory requirements of the FDA Food Traceability Rule. Traceability readiness means having the people, processes, technology, and trading partner connections needed to consistently put those requirements into practice. An organization can be working toward compliance while still lacking the operational capabilities needed to reliably capture, manage, test, and electronically share traceability data. 

A traceability-ready organization can: 

  • Capture and maintain accurate traceability data across products, locations, and applicable Critical Tracking Events (CTEs).  
  • Electronically exchange traceability data with suppliers, customers, and other trading partners.
  • Test and validate its processes through mock trace exercises and data-sharing activities.
  • Respond quickly to FDA traceability requests without relying on disconnected records or manual work.
  • Scale its traceability processes as suppliers, customers, and business requirements evolve.  

Key takeaway: FSMA 204 compliance defines what records are required. Traceability readiness demonstrates your organization’s ability to consistently use, share, and retrieve those records in day-to-day operations. 

A company isn’t truly FSMA 204-ready simply because it can collect traceability data. Readiness means being able to consistently capture, maintain, retrieve, and electronically share accurate traceability records across your operations and trading partners. Just as importantly, those processes have been tested—not simply documented. 

Ask yourself these questions: 

  • Can we capture the required Key Data Elements (KDEs) for every applicable Critical Tracking Event (CTE)?
  • Is our master product, location, supplier, and customer data complete and accurate?
  • Can we electronically share FSMA 204 traceability data with customers using their preferred method?
  • Have we tested our ability to retrieve and provide traceability records within the required timeframe?
  • Have we validated our processes with suppliers and other trading partners?  

Some of the most common traceability gaps include inconsistent master data, incomplete or inaccurate traceability records, disconnected systems, limited testing, and relying on manual processes to exchange information across the supply chain. Identifying and resolving these gaps before they’re exposed during customer onboarding, traceability testing, or an FDA request gives organizations more time to refine their processes and build a repeatable, scalable traceability program. 

Key takeaway: Traceability readiness isn’t measured by whether a plan exists—it’s measured by whether your people, processes, and technology can consistently support traceability in day-to-day operations. 

Many retailers, distributors, wholesalers, and foodservice organizations are already asking suppliers to begin participating in their FSMA 204 traceability programs—well before the enforcement deadline. Rather than waiting until compliance is required, they’re onboarding suppliers, testing electronic traceability data sharing, and validating readiness across their supply chains to identify and resolve gaps early. 

Common reasons customers are starting early include: 

  • Building traceability across a supply chain takes time. Organizations need to onboard suppliers, validate master data, integrate systems, and test traceability processes before they become part of everyday operations.  
  • Customer requirements often extend beyond FDA requirements. Many organizations have their own expectations for supplier onboarding, electronic data sharing, labeling, or data formats.  
  • Early testing reduces implementation risk. Validating supplier data and processes before the enforcement deadline gives both suppliers and customers time to resolve issues without disrupting business.  
  • Digital traceability supports broader business goals. Many organizations are strengthening recall readiness, improving supply chain visibility, and standardizing data sharing—not simply preparing for regulatory compliance.  

Key takeaway: Early supplier onboarding reflects the reality that FSMA 204 readiness takes time. Companies that begin participating now have more time to validate data, test processes, resolve gaps, and meet both customer expectations and regulatory requirements. 

For many organizations, FSMA 204 readiness takes 12–24 months because it involves much more than implementing new technology. Building a successful traceability program requires aligning people, processes, data, systems, suppliers, and customers—and validating that everything works together before the enforcement deadline. 

While every organization’s journey is different, a practical readiness roadmap typically includes these key milestones: 

  • Build the foundation. Identify Food Traceability List (FTL) products, applicable Critical Tracking Events (CTEs), and required Key Data Elements (KDEs). Validate master data, establish traceability processes, and select the technology needed to support your program.  
  • Connect and test. Integrate business systems, begin electronically sharing traceability data with customers, conduct mock trace exercises, and identify process gaps while there’s still time to address them.  
  • Scale across the business. Expand proven processes across facilities, suppliers, products, and trading partners so traceability becomes a consistent operational capability rather than a series of one-off projects.  

Many retailers and distributors are already evaluating supplier readiness through onboarding programs and traceability testing. Programs such as TraceApproved™ can help suppliers build practical capabilities, demonstrate progress, and prepare for customer requirements while there’s still time to improve. 

Key takeaway: Organizations that make steady progress through each phase of readiness are better positioned than those that wait until the enforcement deadline to begin. 

👉 For a more detailed breakdown of what to prioritize at each stage, explore our FSMA 204 Readiness Roadmap, which outlines the key milestones organizations should complete before the enforcement deadline. 

The best way to prepare for an FDA traceability records request is to test your traceability process before you need it. Organizations that regularly conduct mock trace exercises are more likely to identify gaps in their data, systems, and workflows while there’s still time to improve. 

An effective readiness exercise should confirm that your organization can: 

  • Retrieve complete traceability records quickly, including the required Key Data Elements (KDEs) for applicable Critical Tracking Events (CTEs).  
  • Trace products backward and forward across suppliers, facilities, and customers. 
  • Provide records in the required format, including an electronic sortable spreadsheet when requested by the FDA.  
  • Coordinate across teams and trading partners so everyone understands their role during a traceability event.  

If testing reveals that your team is searching through spreadsheets, emails, paper records, or disconnected systems to assemble traceability information, it’s a sign that your processes may need refinement before an actual request occurs. 

Key takeaway: Don’t let an FDA request—or a customer traceback exercise—be the first time you test your traceability program. Regular testing helps ensure your data, people, and processes are ready when they’re needed most. 

FSMA 204 does not require a specific label format or labeling standard. Instead, it requires organizations to maintain and share the traceability records associated with a product. A well-designed traceability label helps connect the physical product to those records while supporting efficient data sharing across the supply chain. 

For many fresh food suppliers, industry best practices include: 

  • Using GS1 standards and the Produce Traceability Initiative (PTI) Harmonized Case Label where appropriate.  
  • Including a Global Trade Item Number (GTIN) and batch or lot number to identify the product and support Traceability Lot Code (TLC) management.  
  • Providing both human-readable information and a machine-readable barcode to improve accuracy and scanning efficiency.  
  • Aligning labels with both customer requirements and widely adopted industry standards.  

A traceability label is only one part of FSMA 204 readiness. Companies must also capture the required Key Data Elements (KDEs), maintain traceability records for applicable Critical Tracking Events (CTEs), and electronically share traceability data when required. 

Key takeaway: A standardized traceability label helps connect products to their traceability records, but true FSMA 204 readiness depends on the quality of the underlying data and the processes used to manage and share it. 

Not necessarily. FSMA 204 does not require companies to use a specific traceability platform or software. In many cases, suppliers can continue using their existing ERP, WMS, traceability software, or other business systems—as long as they can capture the required traceability data and exchange it with customers in an accepted format. 

Before adopting a new platform, ask: 

  • Can our existing systems capture the required Key Data Elements (KDEs)?  
  • Can we exchange traceability data using our customer’s preferred method, such as APIs, EDI, flat files, or other electronic formats?  
  • Will this approach support multiple customers without creating additional manual work?  
  • Can our technology integrate with other traceability platforms as customer requirements evolve?  

Many retailers, distributors, and foodservice organizations have preferred onboarding processes or data-sharing methods, but that doesn’t necessarily mean suppliers must replace their existing systems. A scalable, interoperable approach allows organizations to exchange traceability data across different platforms while continuing to use the technology that best supports their business. 

Key takeaway: The goal isn’t for every company to use the same software—it’s to ensure different systems can reliably exchange standardized traceability data across the food supply chain. 

A future-ready traceability solution should do more than help you meet today’s compliance requirements. It should support a repeatable, scalable traceability program that can adapt as your business grows, customer expectations evolve, and new trading partners come online. 

When evaluating a traceability solution, look for the ability to: 

  • Capture and maintain the required Key Data Elements (KDEs) for applicable Critical Tracking Events (CTEs).  
  • Integrate with existing ERP, WMS, labeling, and other business systems.  
  • Exchange traceability data with retailers, distributors, suppliers, and other trading partners using multiple methods, including EDI, flat files, and other electronic formats.  
  • Standardize traceability data across multiple customers instead of creating customer-specific workflows.  
  • Quickly retrieve records for FDA requests, recalls, and customer traceability exercises.  
  • Scale without requiring significant manual work or new IT projects every time a customer or supplier is added.  

A future-ready traceability solution should help simplify operations—not create additional complexity. The goal is to establish one standardized process for capturing and sharing traceability data that can support both today’s requirements and tomorrow’s opportunities. 

Key takeaway: Choose a traceability solution that grows with your business. The right platform should reduce manual work, support interoperability, and make it easier to serve multiple customers through one scalable approach. 

 

Yes. The FDA does not require companies to use a specific traceability software platform, and spreadsheets may be sufficient for organizations with relatively simple operations or a limited number of trading partners. The more important question is whether your current approach will continue to support your business as your traceability program grows. 

As operations become more complex, organizations often encounter challenges such as: 

  • Traceability data spread across spreadsheets, emails, PDFs, ERP systems, and other disconnected records.  
  • Manual data entry that increases the risk of errors, duplicate work, and inconsistent information.  
  • Difficulty assembling complete traceability records quickly during a recall, customer request, or FDA inspection.  
  • Processes that become harder to manage as additional suppliers, customers, facilities, and products are added.  

Spreadsheets can still be valuable for reporting and analysis, but many organizations find they become increasingly difficult to use as the primary system for collecting, managing, and sharing FSMA 204 traceability data. 

Key takeaway: The goal isn’t to eliminate spreadsheets—it’s to ensure your traceability process remains accurate, efficient, and scalable as your business and customer requirements grow. 

Many suppliers can capture FSMA 204 traceability data, but sharing that data with multiple retailers, distributors, and foodservice customers is often the greater challenge. While the FDA establishes the minimum traceability requirements, individual customers may have different onboarding processes, data formats, integration methods, or additional business requirements. 

A scalable approach should: 

  • Capture traceability data once using a standardized internal process.  
  • Exchange the same data with different customers through their preferred methods, such as APIs, EDI, flat files, portals, or other electronic formats.  
  • Reduce duplicate data entry and customer-specific manual work.  
  • Make it easier to onboard new trading partners as customer requirements evolve.  

Rather than creating separate workflows for every customer, suppliers should focus on standardizing how traceability data is captured and managed internally. Technology should adapt to customer requirements—not require your business to reinvent its processes for every new trading partner. 

Key takeaway: The most scalable approach is to build one repeatable traceability process that can support many customers, rather than a different process for every customer. 

For many retailers, distributors, wholesalers, and foodservice organizations, supplier onboarding is one of the most time-consuming parts of FSMA 204 readiness. The most successful organizations avoid treating each supplier as a separate project. Instead, they establish a standardized onboarding process that can be repeated across their supplier network. 

A scalable supplier onboarding program should: 

  • Clearly communicate FSMA 204 requirements, timelines, and expectations.  
  • Provide consistent guidance on required Key Data Elements (KDEs), labeling, and data-sharing methods.  
  • Validate each supplier’s ability to electronically share traceability data before relying on production data.  
  • Track supplier progress from onboarding through testing and ongoing participation.  

How do you know if suppliers are actually ready? 

Supplier readiness should be demonstrated—not assumed. A supplier should be able to consistently capture, manage, and electronically share accurate traceability data, successfully complete testing, and repeat those processes as part of normal operations. Tracking these milestones provides a more meaningful measure of readiness than simply asking whether a supplier intends to comply. 

What happens if a supplier can’t share FSMA 204 traceability data? 

The impact depends on each customer’s requirements. Some organizations may work with suppliers to close readiness gaps, while others may require successful onboarding, test data sharing, or demonstrated traceability capabilities before moving forward with certain business requirements. That’s why many companies are beginning supplier onboarding well before the enforcement deadline. 

Programs such as TraceApproved™ can help suppliers build and demonstrate traceability readiness through guided education, practical implementation activities, and a recognized readiness badge. This gives customers greater visibility into supplier progress while helping suppliers build capabilities they can use across multiple customer relationships. 

Key takeaway: Standardizing supplier onboarding and validating readiness early helps organizations scale their traceability programs while reducing manual work and improving supplier participation. 

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