Tag Archives: FSMA 204

Connected Factory, manufacturing

Predictive, Preventive, Powerful: The Future of Data-Driven Food Safety

By Wiggs Civitillo
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Connected Factory, manufacturing

Food safety is at an inflection point. Regulations are shifting, deadlines are moving, and technology is advancing faster than most organizations can keep up. The FDA’s FSMA 204 Traceability Rule is a clear signal: data is now central to compliance, consumer trust, and competitive resilience. But here’s the hard truth — extending compliance dates doesn’t extend the shelf life of risk. Outbreaks won’t wait until 2028. Consumer expectations won’t wait either.

The challenge before us is simple but daunting: can the food industry shift from a reactive mindset — responding after the fact — to a predictive and preventive one, powered by data?

From Reactive to Predictive

For decades, food safety has been a compliance exercise. Check the box, pass the audit, and move on. That model doesn’t work anymore. The industry has too much complexity, too many blind spots, and too much at stake.

The next era of food safety will be defined by predictive tools — artificial intelligence, machine learning, anomaly detection, and real-time visibility platforms that allow us to see risk before it becomes crisis. Imagine spotting a deviation in cold chain patterns before it leads to spoilage, or detecting unusual movement in supply chains that hints at fraud. These tools exist today, but they can only succeed if the data feeding them is complete, consistent, and trusted.

What’s Holding Us Back

So why aren’t we there yet? The barrier isn’t the lack of technology. The tools exist. The real problem is data fragmentation and trust.

  • Fragmentation: Every player in the food chain speaks a slightly different “data language.” A grower might record harvest time in one format, while a processor logs it differently, and a retailer doesn’t capture it at all. Even when companies are technically compliant, the data sets don’t align. What should be a continuous record ends up a patchwork that’s hard to stitch together in real time.
  • Manual Workarounds: In too many cases, people are still rekeying data from one system into another, or relying on email, PDFs, or even phone calls to close gaps. These workarounds introduce errors and slow response times. In a recall, hours matter — and a manual process can be the difference between containment and escalation.
  • Trust & Control: Many companies hesitate to share data because they fear it will be used against them — to negotiate harder, cut margins, or reveal competitive strategies. This lack of trust creates bottlenecks. Without a neutral space, every data exchange feels like a negotiation rather than a collaboration.
  • Short-Term Compliance Thinking: Too often, data-sharing investments are framed only in terms of passing an audit or meeting FSMA 204 requirements. That keeps the focus narrow: “What’s the minimum we need to do?” rather than, “How do we build a system that gives us real-time visibility, predictive insight, and long-term resilience?”

The result is that AI and machine learning don’t have clean, connected data to work with. Instead of unlocking predictive power, they reinforce the fragmentation — analyzing partial views that miss the bigger picture. In other words, bad or siloed data doesn’t just limit progress; it actively undermines the promise of next-gen tools.

What Needs to Change

If we want predictive, preventive, and truly powerful food safety systems, we need to rethink how we share data. That means moving from a “winner take all” mentality to an ecosystem mindset — where data isn’t a competitive advantage but a shared asset.

The key isn’t ripping and replacing existing systems. The food industry has invested heavily in ERP, WMS, quality, and compliance platforms — and those systems aren’t going anywhere. What we need is a neutral connectivity layer: a translator that lets each system keep doing what it does best, while still moving data securely and consistently across trading partners.

Neutrality matters. If one player owns the data exchange, others will always hesitate. But when no one company controls the pipes, collaboration becomes possible. That’s when we can unleash the full potential of AI, machine learning, and real-time analytics — because the data finally flows freely.

With connected, high-quality data, predictive models can detect anomalies earlier. Preventive actions become possible before outbreaks spread. And companies can move beyond compliance to true resilience — strengthening trust with consumers and trading partners alike.

The Call to Leadership

This isn’t about compliance dates or government mandates. It’s about leadership. The companies that lean into collaboration, prioritize interoperability, and invest in data quality will define the future of food safety. They will turn regulation into trust, compliance into resilience, and risk into competitive advantage.

The future of food safety is predictive. It’s preventive. It’s powerful. But only if we decide, as an industry, to break down silos and build systems that can truly talk to each other.

We don’t have 30 months to wait. The opportunity — and the responsibility — is right in front of us.

Traceability Unwrapped: How Packaging Protects Every Bite

By Emily Newton
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Food traceability captures key data by following a product’s journey through every production stage, processing and distribution. It safeguards public health by enabling rapid identification and removal of contaminated goods, upholds quality through continuous monitoring, and ensures compliance with stringent industry regulations.

At the center of this system is packaging, which is the physical container and the digital gateway for traceability information. From printed barcodes to embedded smart labels, it carries the data that links each item to its origin, safety record and handling history. For food manufacturers, this makes packaging essential for transparency and safety.

The Intersection of Packaging and Traceability

Packaging is the food supply chain’s first and most persistent touch point, accompanying a product from when it leaves the production line until it reaches the consumer’s hands. A well-designed label protects and presents the product and is pivotal in this process. It reduces the information gap between producer and consumer by making key data accessible and easily understood.

When packaging design is aligned with tracking systems — whether through barcodes or digital watermarks — vital information flows seamlessly across every stage of the supply chain. Formats such as tamper-evident seals, smart labels with embedded chips and multi-layer labels for multilingual compliance enable better tracking and transparency.

Technologies Driving Food Traceability

Barcodes and quick-response (QR) codes remain the most accessible tools for traceability. They offer quick scanning for internal inventory control and consumer-facing transparency. Radio frequency identification (RFID) and near-field communication (NFC) tags enable real-time tracking and seamless data transfer across the supply chain. In fact, 93% of U.S. retailers have already adopted RFID technology to improve inventory management.

Blockchain integration adds another layer of security by creating immutable records that verify product safety, authenticity and compliance. Meanwhile, digital watermarks provide invisible yet scannable identifiers embedded directly into packaging, which offers discreet but powerful traceability without altering the visual design.

Ensuring Food Safety Through Packaging

Food traceability is a frontline defense in safety that enables manufacturers to identify and remove affected products before they reach consumers. Accurate tracking reduces the risk of foodborne illnesses and large-scale recalls, while building trust by showing customers that safety is a top priority. Traceable packaging can also stop unsafe products — like batches with allergen contamination or temperature breaches — from ever hitting store shelves.

This rapid response protects public health and minimizes financial losses and reputational damage. Beyond immediate safety benefits, robust systems help brands comply with global food safety regulations and demonstrate compliance, reinforcing credibility and market access.

Protecting Brand Reputation and Consumer Confidence

Transparent packaging information gives buyers and regulators a clear window into a product’s journey, from sourcing and production to quality checks and delivery. By openly sharing details, brands position themselves as honest and accountable, which can be a decisive factor in earning long-term loyalty.

Research shows that packaging has an average of seven seconds to make a favorable impression before a customer moves on to the next option. Clear and credible cues — like QR codes linking to origin stories or sustainability data — can turn that fleeting moment into a lasting connection.

Brands highlighting these details in marketing campaigns can transform food traceability from a compliance necessity into a positive public relations tool. It reinforces their commitment to safety, ethics and quality. Educating consumers on reading and using this information further strengthens this edge, making packaging a competitive differentiator in crowded marketplaces.

Operational Benefits for Food Manufacturers

Traceable packaging allows food manufacturers to see exactly where products are, how they move and when they need replenishment. It creates a more streamlined approach to inventory and production control. This visibility allows operations to match output with demand, which reduces waste and avoids costly overproduction. It also enables more accurate demand forecasting, helping teams plan smarter and respond faster to market shifts.

Beyond internal efficiency, food traceability holds suppliers to higher standards by making every step of the supply chain transparent, from raw material sourcing to final delivery. With cleaner, more accurate data, manufacturers can meet compliance requirements and maintain consistency while building stronger trust with customers and partners.

Future Trends in Food Traceability

AI-powered defect detection allows manufacturers to spot issues quickly before products leave the facility. These systems can automatically identify packaged products during industrial inspections, flagging defects such as misprints, seal breaks or labeling errors using deep learning techniques. Predictive recall capabilities take it further, analyzing patterns to anticipate potential safety risks before they escalate.

Alongside these advancements, eco-friendly materials with built-in tracking technologies make traceability more sustainable. This innovation reduces environmental impact without sacrificing performance. Consumers also now enjoy greater access to product journey data through mobile apps, empowering them to scan packaging and instantly see sourcing details, safety records and sustainability credentials. These factors turn transparency into a tangible part of the customer experience.

Making Traceability a Strategic Asset

Food traceability safeguards product safety and streamlines operations across the supply chain. Proactively adopting traceable packaging is a long-term investment that strengthens compliance and builds lasting consumer trust. Manufacturers should audit their current systems and make strategic upgrades to stay ahead of regulations and market expectations.

EAS Consulting Group Announces New Webinar: A Guide to FSMA 204

By Food Safety Tech Staff
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EAS Consulting Group, a trusted leader in regulatory affairs and food safety consulting, has announced its upcoming webinar: “A Guide to FSMA 204: Sorting Through the Confusion of the FDA’s New Traceability Rule for Added Food Safety.”

This exclusive online event will take place on Wednesday, September 24, 2025, and will offer invaluable insights into the Food Safety Modernization Act (FSMA) Rule 204, focusing on the FDA’s new traceability requirements that are shaping the future of food safety.

FSMA 204, or the Food Traceability Rule, will require enhanced recordkeeping for facilities handling foods that have a high risk of foodborne illness. To comply with the law, manufacturers who are subject to the rule must maintain enhanced traceability records, develop traceability plans, and provide records to the FDA in 24 hours.

Why Attend? Compliance with the requirements was originally set for January 2026. However, the FDA has now delayed implementation by 30 months to allow more time for small grocers to comply without undue financial and logistical strain. Compliance is likely to become mandatory in mid-2028.

While the compliance date has shifted, it’s never too early to determine whether your facility is subject to the rule, and if so, to better understand the requirements.

Webinar Details:

  • Date: Wednesday, September 24, 2025
  • Time: 1:00 PM ET
  • Duration: 1 hour
  • Cost: Free (registration required)

The webinar will be led by two of EAS Consulting Group’s seasoned regulatory experts – Senior Director for Food Services Tim Lombardo and Independent Consultant Thomas Bell.

Participants will have the opportunity to ask questions prior to and following the webinar in order to gain personalized advice based on their unique challenges.

How to Register:To register for the webinar, visit https://easconsultinggroup.com/a-guide-to-fsma-204/ and secure your spot today. Contact trainings@easconsultinggroup.com with any questions or concerns.

Track and Trace, traceability, supply chain

Traceability Is a Competitive Advantage, Not Just a Regulation

By Ellie Gabel
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Track and Trace, traceability, supply chain

Traceability adoption in the food and beverage industry is normalizing. It is expanding across jurisdictions, highlighting a desire for greater food safety. Legislators and technological innovations are in a perfect place to enable the most advanced solutions in history.

They will enhance operational productivity while promoting a trustworthy brand. Compliant companies are global health stewards, and customers demand food chain traceability to reduce risk. It is time to be an early adopter.

Regulatory Drivers in Food Chain Traceability

The Food Safety Modernization Act (FSMA) in the U.S. asserts that the global supply chain is responsible for maintaining public health. Traceability is a central tenet, emphasizing more robust recordkeeping and faster removal of potentially contaminated products.

The European Union also requires traceability as part of the General Food Law Regulation. If the source presents a safety concern, manufacturers are required to recall it and notify the authorities to determine whether it demands greater attention. Traceability highlights how food safety is a national affair.

Food quality control guidelines vary worldwide, and many prioritize safety. The Hazard Analysis Critical Control Points framework forces companies to identify potential biological, physical and chemical contamination sources. Analyses must cover the food’s origin, working environment and transportation medium. Other valuable guidelines include the Good Manufacturing Practices and nationally specific legislation. These have laid the foundation for new regulations.

Noncompliance will cost companies more than auditor fines. Quality oversights will begin without tracking traceability, driving customers to more adherent and reputable businesses. Additionally, organizations must deal with adverse health care implications if they neglect adherence.

Digital Tools Powering Modern Food Chain Traceability 

Data management, food manufacturing
Managing the data required for FSMA compliance is an ideal example of the importance of pursuing digital transformation in food manufacturing facilities. (Image courtesy of One Neck IT Solutions, LLC

Manual documentation is sufficient for tracking food. However, modern tech expedites the process and eliminates tedium, increasing the likelihood of continuous compliance. It allows companies of all sizes to commit more to enhancing traceability and maximizing the value of those efforts to achieve competitive advantages. These are some of the most notable:

  • Blockchain: Rapidly validates and uploads immutable digital certifications and logs transactions
  • The Internet of Things (IoT): Automatically senses and scans smart tags to enable real-time food monitoring
  • Cloud infrastructure: Seamlessly eliminates siloes and encourages collaboration through immediate information sharing
  • RFID tags: Quickly capture metadata about food sources
  • Enterprise resource planning systems: Immediately connects stakeholders throughout the food’s value chain in a single dashboard

Markets like the IoT will have an estimated potential worth of $12.6 trillion by 2030 because of the value it could bring to manufacturers worldwide.

Market Forces and Transparency as a Brand Differentiator

The Centers for Disease Control and Prevention estimates 9.9 million people experience foodborne illness every year. As a result, customer expectations for transparency and safety are rising. Norovirus was the most common, leading to the most hospitalizations, with salmonella causing the most deaths.

Brands as large as Walmart are using traceability to obtain a market advantage. It leveraged blockchain in its food supply ecosystem to track mango sales in U.S. stores and pork in Chinese locations. The system used digital certificates to validate authenticity and shortened provenance identification from seven days to 2.2 seconds.

The research was an important food chain traceability win for Walmart because customers had all but lost faith in romaine lettuce after a massive recall. The trial was so successful that Walmart will require leafy green suppliers to use the system.

Food sellers also differentiate themselves with traceability because it supports farmers’ livelihoods. Improving detectability and tracking locates the illness source faster, narrowing it down to one or a few origins. Governments can communicate these concerns with a recall, potentially pulling products before they hit shelves.

The swiftness preserves farmers’ reputations, who may struggle with the changing growing seasons. Food manufacturers that protect stakeholders will also see their public image shift in their favor. The initiative promotes them as thought leaders and essential collaborators in the volatile industry.

Operational Benefits of Integrating Traceability

Integrating traceability offers organizations benefits beyond compliance adherence. Every advantage reinforces positive brand perception, creating additional competitive advantages.

Traceability streamlines supply chains and recall processes. The technology and data visibility speed up the triage phase, identifying contaminated products faster. Employees spend less time investigating and more time communicating with authorities and stakeholders about what matters most.

Additionally, data-driven decision-making will create cost savings. Companies no longer carelessly throw away products because they have a more precise idea of what is contaminated due to improved inventory management and live stock updates.

Turning Compliance Into Competitive Advantage 

Food chain traceability is an organizational growth tool. Many view it as a regulatory hurdle, but it promotes accountability and transparency. Customers and clients will appreciate the commitment to public safety and quality, deepening their brand loyalty to the most dedicated. Corporations adopting traceability guidelines early will reap these benefits and more, scaling into new heights of profitability and efficiency.

Food Safety Supply Chain Management Virtual Conference

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Although the FSMA 204 compliance date has been extended, there remains global momentum for traceability, with many downstream suppliers still requiring full traceability plans, consumers pushing for transparency, and businesses discovering unexpected benefits – providing cause of businesses to continue their drive to compliance without pause. The extension has provided time to develop and fine tune a robust, industry interoperable program. Join us in the virtual conference where you will learn the best practices of companies well into FSMA 204 compliance, potential pitfalls that you might encounter, how to navigate the complexities of FSMA compliance and finally, how to achieve end-to-end traceability across your supply chain.

Beltway Beat

FDA Intends to Extend Compliance Date for Food Traceability Rule

By Food Safety Tech Staff
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The U.S. Food and Drug Administration (FDA) announced on its website that it intends to extend the compliance date for the Food Traceability Rule (the “final rule”) by 30 months. The FDA intends to extend the compliance date using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register.

The FDA remains committed to successful implementation of the full requirements of the final rule, as they will allow for faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Accordingly, the compliance date extension does not amend the requirements of the final rule. Instead, the compliance date extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.

The final rule establishes additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods on the Food Traceability List. The final rule requires a higher degree of coordination between members of the food industry than has been required in the past. Therefore, to achieve the full public health benefits of the final rule, all covered entities must be in compliance. Even those few entities who are well positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated. Therefore, FDA intends to allow industry additional time, across all regulated sectors, to fully implement the final rule’s requirements.

The FDA intends to use the extended time period to continue the agency’s work with stakeholders, including by participating in cross-sector dialogue to identify solutions to implementation challenges and by continuing to provide technical assistance, tools, and other resources to assist industry with implementation.

The final rule applies to domestic and foreign entities producing food for U.S. consumption and was issued in 2022 in accordance with the FDA Food Safety Modernization Act.

Navigating Challenges of FSMA 204 Compliance

By Subhash Chaudhary
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The Food Safety Modernization Act (FSMA) Section 204—known as the Food Traceability Final Rule—aims to ensure food safety through enhanced traceability of high-risk foods. By mandating structured tracking and tracing of food products from farm to fork, the rule not only minimizes the risk of contamination but also provides a rapid recall mechanism if needed. With FSMA 204, food manufacturing companies must take a significant step toward enhancing food safety and protecting public health.

This article delves into what the new traceability rule means for food manufacturing companies, the operational challenges involved in complying with FDA’s requirements, and how advanced product traceability solutions can help organizations turn compliance into a competitive advantage.

FSMA 204 Compliance: 3 Key Components.

FSMA 204 requires food companies to implement robust traceability systems focusing on three key components:

  1. Food Traceability List (FTL):
    The FDA’s FTL identifies high-risk foods (e.g., nut butters, leafy greens, fresh-cut produce) that require enhanced recordkeeping. For instance, nut butters must be tracked carefully through the supply chain due to their inclusion in the FTL.
  2. Key Data Elements (KDEs):
    For every step, the FDA mandates the collection of detailed data:

    • Source Details: Information about where the product originated (e.g., the distributor’s business name, address, and facility details).
    • Destination Details: Where the product is being sent (e.g., the chocolate manufacturer’s facility).
    • Product Details: Specifics such as product description, lot numbers, quantities, units of measure, and packaging information.
    • TLC Source Details: In cases where a product is repackaged (e.g. when a distributor repackages nut butter and assigns a new Traceability Lot Code), the original source must be captured.
  3. Critical Tracking Events (CTEs):
    These are specific points in the supply chain where traceability records must be maintained. Examples include:

    • Shipping: For example, when a distributor ships nut butter from its warehouse to a chocolate manufacturer, the shipment date, origin, destination, and unique traceability lot code are recorded.
    • Receiving: Upon arrival, the chocolate manufacturer confirms the product’s integrity, quantity, and the corresponding lot code.
    • Transformation: When the chocolate manufacturer or its co-manufacturing partner transforms the nut butter by incorporating it into chocolate bars, details of the process—such as production dates, ingredients used, and the new lot code—are documented.

This detailed approach ensures that every touchpoint is recorded, enabling rapid identification of the product’s journey if a recall or investigation becomes necessary.

Operational Challenges in FSMA 204 Compliance

Implementing these enhanced traceability systems is not without its challenges.

  • Fragmented Data Sources: Data complexity due to various sources/formats and variable data attributes makes data management, accuracy, and accessibility across different stakeholders a challenge. For example, while a distributor might capture shipment data in one system, the manufacturer could use an entirely separate ERP to receive and transform details. This is where an ERP-agnostic product traceability solution can help enterprises with seamless ingestion and harmonization of data.
  • Data Completeness and Standardization: Without standardized data capture methods, many companies risk having incomplete records. Consider a scenario where different suppliers use varying formats for lot numbers or unit measurements, complicating the integration process.
  • Real-Time Data Visibility: The regulation demands immediate access to traceability data—which is critical during a recall or contamination event. Legacy systems, which rely on manual data entry or batch uploads, may fall short of meeting these time-sensitive requirements.
  • Interoperability Between Systems: Many companies use diverse ERP, WMS, and legacy systems that do not naturally communicate with each other. Integrating these into a single, cohesive traceability framework is a significant hurdle.
  • Supplier and Partner Readiness and alignment: Smaller suppliers or those in less digitized environments (e.g., field operations still using pen-and-paper logs) can slow down the entire compliance process, requiring additional training and technical support.  Formats and protocols to share and receive the KDE data also need to be aligned with partners.
  • Compliance Reporting and Monitoring: Businesses must generate accurate compliance reports and monitor traceability requirements continuously, which can be difficult without an integrated digital solution.

Business Impact and Analysis

Achieving FSMA 204 compliance offers more than just meeting a regulatory requirement—it creates real business value:

  • Enhanced Brand Trust:
    Transparent traceability systems boost consumer confidence. When a company can quickly and accurately trace a product’s journey—from the distributor’s repackaging of nut butter to its final transformation into a chocolate bar—it reassures consumers about the safety and quality of the product.
  • Operational Efficiency:
    Streamlined, digital systems reduce manual entry errors, cut down on time delays, and optimize the recall process, ultimately lowering costs and increasing supply chain efficiency.
  • Risk Mitigation:
    A well-integrated traceability system reduces the risk of prolonged contamination exposure, minimizes financial losses, and helps maintain a company’s reputation by enabling swift action during food safety incidents.

FSMA 204 Compliance Checklist for Your Organization

A brief checklist your organization can use to ensure continued FSMA 204 compliance:

  • Review & Update Your Traceability Plan:
    Confirm that your traceability plan clearly details procedures for recording Critical Tracking Events (CTEs) and Key Data Elements (KDEs) across all stages—from receiving nut butter to its transformation into a finished product. Include updated traceability lot code assignments and designate a clear point of contact for FSMA inquiries.
  • Verify Data Accuracy and Accessibility:
    Ensure that all records (whether electronic or paper) are complete, legible, and easily retrievable within 24 hours upon FDA request. Test your systems through internal audits and mock recalls to confirm data integrity.
  • Align with Supply Chain Partners:
    Engage with co-manufacturers, co-packers, and distributors to confirm that all parties share consistent traceability records. Establish written agreements that outline data sharing and process responsibilities for each Critical Tracking Event (CTE).
  • Invest in Technology & Traceability Solutions:
    Evaluate your current systems to determine which Key Data Elements (KDEs) are already being captured and where they reside. Identify any gaps or modifications needed to meet FSMA 204 requirements. This assessment will help you decide if your existing ERP, inventory, or traceability software needs upgrades or integration with new digital tools. Investing in dedicated traceability solutions ensures that your organization can reliably capture, manage, and share the required data across all Critical Tracking Events, ultimately strengthening your compliance and food safety efforts.
  • Staff Training and Continuous Improvement:
    Regularly train your staff on FSMA 204 requirements and recordkeeping practices. Update standard operating procedures as needed and keep documentation of training sessions to demonstrate compliance readiness.

By following these steps, your organization will be well-positioned to not only meet FSMA 204 requirements but also enhance overall operational efficiency and food safety throughout your supply chain.

Conclusion

FSMA 204 compliance requires a detailed, standardized, and real-time approach to traceability and rigorous record-keeping requirements.

This is where a cloud-based, globally scalable product traceability solution can ensure regulatory compliance in a dynamic landscape, enhance operational efficiency, food safety, and transparency, as well as collaboration among supply chain partners. Moreover, food manufacturing companies can overcome traceability challenges that impede long-term compliance by embracing digital solutions that integrate specific examples and granular data capture—from shipping details to transformation records.

Comprehensive traceability systems are thus essential as they enable food manufacturing companies to reduce the time to track product movement across disconnected supply chains, enhancing visibility and empowering both organizations and consumers to make informed decisions.

Resources:

https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list

SGS, food safety

SGS Launches FSMA 204 Food Traceability Solutions

By Food Safety Tech Staff
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SGS, food safety

SGS, a testing, inspection and certification company, has launched comprehensive, integrated FSMA 204 Food Traceability Solutions to help food manufacturers and producers meet the US Food and Drug Administration’s (FDA) latest Food Safety Modernization Act (FSMA) Section 204 requirements.

FSMA 204 aims to enhance food safety by improving supply chain traceability. It targets high-risk foods on the Food Traceability List and mandates detailed recordkeeping, traceability plans and rapid data sharing.

While the compliance deadline is January 20, 2026, many retailers are already seeking early adoption by suppliers.

Naghmeh Raiyat, Global Head of Food Assurance at SGS, said: “As the compliance deadline for FSMA 204 approaches, businesses face mounting pressure to enhance their traceability systems. Thanks to our extensive knowledge of FSMA requirements, we have developed a solution that will empower businesses with the tools and confidence to not only achieve compliance but also build more resilient and transparent supply chains. Ultimately, this marks another welcome step forward in strengthening consumer trust in food safety.”

Designed to address the increasingly complex compliance needs of stakeholders in the food industry, FSMA 204 Food Traceability Solutions combine FSMA 204 audits, training and the TRAKKEY digital traceability platform:

  • FSMA 204 audits: ensures that organizations meet the FDA’s rigorous traceability requirements. These audits focus on verifying the accuracy, completeness and timeliness of Key Data Elements (KDEs) and Critical Tracking Events (CTEs). By assessing the readiness of traceability systems, the audits support the swift identification and removal of contaminated food products to safeguard public health
  • FSMA 204 training: provides food businesses with the knowledge and skills to implement robust traceability plans. Available online and in person, these courses cover critical aspects of FSMA 204, including traceability rules, KDEs and CTEs, enabling organizations to navigate FDA inspections and meet regulatory demands confidently
  • TRAKKEY digital traceability platform: ensures real-time supply chain-wide visibility. Validated by billions of annual transactions, TRAKKEY integrates effortlessly into existing IT systems and workflows, offering a scalable and powerful tool to:
    • Enhance outbreak investigations: quickly identify contamination sources to enable faster responses
    • Reduce recalls: pinpoint contaminated products to minimize financial losses
    • Improve product information: insights into the origin, processing and distribution of food items
    • Streamline data sharing: efficient communication between trading partners

For more information about the FSMA 204 Food Traceability Solutions, please visit: https://www.sgs.com/en/services/fsma-204-food-traceability-solutions

Why now is the time to prepare for FSMA 204

By Geoff Olsen
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In recent years, food recalls have become a concern for the food and beverage (F&B) industry, with regulatory bodies tightening oversight as the number of recall-related incidents continues to rise. The F&B industry is no stranger to recalls, but recent trends indicate a steady increase in frequency, with the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) issuing 313 recalls in 2023, an 8% increase from the previous year. This uptick can be attributed to various factors, including the detection of undeclared allergens, which made up almost half of food recalls last year, and contamination by harmful bacteria such as Listeria, Salmonella, and E. coli.

Consumers are taking notice of these continuous food recalls as a new Gallup poll revealed that Americans’ perspective of the grocery industry has turned negative due to inflation and food safety concerns. It also showed that, for the first time, Americans have more negative views (47%) than positive (33%) of the grocery industry. The growing number of recalls, plus consumer concerns, has intensified calls for stricter compliance and enhanced traceability within the food supply chain.

Major Changes Are Coming

These recalls have become a persistent public health problem, with over 1,100 Americans falling ill from foodborne illnesses linked to recalled products. However, significant steps are being taken to address these concerns in the next few years. To reduce the number of foodborne illnesses, the FDA introduced the Food Safety Modernization Act (FSMA) 204, a regulation requiring F&B businesses to provide detailed traceability information within 24 hours of a recall. Starting in January 2026, this rule will focus on tracking food inputs from suppliers, enabling companies to pinpoint the source of contamination more efficiently.

FSMA 204 will bring major changes to the F&B industry by enhancing traceability requirements for high-risk foods. The rule mandates that companies must improve tracking across the supply chain to ensure key data points are recorded at critical stages of food production, processing, and distribution. This means F&B businesses must implement more stringent record-keeping processes, invest in technology for real-time tracking, and increase collaboration with suppliers to ensure compliance.

However, many organizations aren’t prepared to undergo the data process transformations needed to align with this new traceability rule. Below are a few actionable steps companies can take to prepare their supply chains for FSMA 204:

Investing in Solutions to Streamline Reporting

Despite the wide scale impact FSMA 204 will have across the F&B industry, a main challenge for companies will be updating and investing in new systems and processes to comply with the rule. FSMA 204 mandates that F&B companies provide detailed, accurate traceability data within a 24-hour window during a recall, which requires modern technology capable of handling real-time information. Many existing systems are outdated or not equipped to meet this new level of compliance. As a result, suppliers will need to adopt new software, train staff, and overhaul data management processes. These changes are certain to be time-consuming and raise operational costs. The complexity of this process, especially in a global and multifaceted supply chain, can be overwhelming without the right tools in place.

In addition, suppliers face the challenge of integrating these new systems with their broader supply chain networks. Ensuring seamless communication between suppliers, manufacturers, and retailers is essential for meeting the strict reporting timelines under FSMA 204. The coordination required to share and track data effectively across multiple partners adds an additional layer of complexity. Suppliers must also ensure their traceability solutions are scalable to accommodate future growth and evolving regulations, all while maintaining business continuity and protecting their bottom line.

Investing in scalable technology not only ensures compliance but also enhances business resilience. It provides better visibility into the supply chain, helping businesses respond quickly to disruptions, recall situations, or emerging food safety threats. Furthermore, these solutions enable businesses to streamline their data-sharing processes with trading partners, improving collaboration and reducing the time and resources spent manually documenting transactions.

While this can be costly, investing in robust technology systems and implementing effective food safety quality programs for employees provides the benefit of demonstrating a commitment to food safety and helps ensure smoother operations.

A few solutions suppliers can consider include advanced technologies like supply chain control towers and blockchain. These solutions provide real-time insights into inventory, orders, and potential disruptions, allowing companies to trace food origins and pinpoint contamination sources quickly. Supply chain control towers centralize data collection, management, and analysis, streamlining reporting processes, while blockchain offers a secure, tamper-proof record that ensures data consistency and transparency across all participants in the supply chain. By leveraging these technologies, suppliers can enhance traceability, reduce contamination risks, and build greater consumer trust.

Enhancing Data Consistency

Data consistency works in tandem with the integration of new technologies. The success of any traceability system under FSMA 204 relies on the consistency and accuracy of data collected throughout the supply chain. However, one of the most significant challenges businesses face is ensuring that data is recorded uniformly across different suppliers and systems. Inconsistent or incomplete data can lead to gaps in traceability, making it difficult to track products effectively or respond quickly to a recall. With the new regulation requiring detailed traceability information within 24 hours of a recall, any discrepancies or gaps in data could lead to delays in identifying contamination sources.

To ensure data consistency, suppliers can implement standardized data collection practices and utilize integrated technologies, such as supply chain control towers and blockchain. By implementing uniform data entry protocols across the entire supply chain, suppliers can avoid errors, discrepancies, and miscommunication that often result from inconsistent or fragmented data. Standardization helps streamline reporting and ensures that all parties—from suppliers to distributors—are working from the same set of accurate, reliable information.

Bringing Employees Along on the Journey

Investing in technology and ensuring data consistency are vital steps in preparing for FSMA 204, but they are only part of the equation. For these initiatives to succeed, businesses must also invest in their employees through training and education. Compliance with FSMA 204 requires everyone involved in the food supply chain to understand their role in the traceability process and the importance of accurate data reporting.

Training programs can be implemented at all levels of the organization to educate employees on the new traceability requirements and how they affect day-to-day operations. This includes not only teaching staff how to use new software solutions but also fostering a culture of accountability and food safety awareness, including setting up conversations with employees at every stage of the supply chain. Employees must understand that even minor data collection or reporting lapses can have significant consequences, from costly recalls to legal penalties and damage to brand reputation.

Continuous education is also key to keeping up with the evolving regulatory landscape. As food safety regulations change and new technologies emerge, businesses must keep their teams informed and updated. This can be achieved through regular workshops, webinars, or online courses that keep employees engaged and equipped with the latest knowledge.

The Cost of Non-Compliance

Failure to comply with FSMA 204 can lead to serious consequences for both suppliers and retailers. The FDA has the authority to enforce various penalties, including civil or criminal actions in federal court. It’s important to remember that this rule is considered mandatory, and parties will be under real pressure from the government if they don’t take the necessary steps to ensure the traceability requirements under this act. Non-compliance can lead to legal repercussions for both companies and suppliers in the form of lawsuits and litigation. In addition, the FDA has the authority to impose significant fines, sanctions, and criminal penalties for non-compliance.

Suppliers that are unable to meet FSMA 204 requirements may also face financial loss and damage to the company’s reputation as retailers and manufacturers may decide to switch to more reliable partners. Compliance penalties can also result in lost sales and brand damage that can impact consumers’ decisions.

Operationally, non-compliance with FSMA 204 can disrupt supply chain processes, leading to delays in identifying and resolving contamination issues. The inability to quickly trace food inputs can result in prolonged and costly recalls. Furthermore, non-compliance can strain relationships with trading partners who rely on accurate traceability data for product safety.

Preparing for FSMA 204 requires a multifaceted approach that combines technology, data standardization, and employee engagement. By investing in solutions that streamline reporting, enhance data consistency, and bring employees along through training and education, F&B companies can position themselves for success. These actions will help ensure compliance with FSMA 204 and lead to more efficient, transparent, and resilient supply chains, ultimately improving food safety for consumers.

It’s Five O’Clock Somewhere! Episode 3 Recording: Partnership for Food Traceability

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Watch this recorded webinar where host Rick Biros as he welcomes Dr. Ben Miller from The Acheson Group and Eric Marshall from Leavitt Partners on the “It’s Five o’clock Somewhere” webinar. They’ll unpack the FDA’s FSMA 204 Traceability Rule and explore how the groundbreaking Partnership for Food Traceability (PFT) is leading the way in helping companies and regulators prepare for the new rule.