Tag Archives: FSMA 204

Food Fraud Quick Bites

Food Fraud and the Case for Traceability

By Johnna Hepner, Jon Woody
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Food fraud isn’t new, and I don’t know that it’s actually gotten worse over the years. What’s changed is our awareness of it. At its core, food fraud is the intentional substitution, addition, tampering, or misrepresentation of a food or ingredient for economic gain. The drivers haven’t changed much: high-value ingredients, complex global supply chains with more intermediaries than most people realize, price volatility from tariffs or natural disasters, and food safety standards that vary from country to country. Put those together and food fraud is going to keep happening. The question is how well The question is how well companies understand where they’re vulnerable and what they’re doing to reduce that risk.companies understand where they’re vulnerable and what they’re doing to reduce that risk.

I spent 24 years at FDA before retiring in 2025, and this issue followed me through most of that career. I got pulled into response and traceback work on some of the most significant food fraud events involving FDA-regulated products, including the melamine-in-infant-formula crisis, the Peanut Corporation of America case, and, near the end of my time there, the lead contamination of cinnamon that made its way into applesauce pouches sold across the U.S. That last one is worth walking through in detail because it’s a case study in exactly where our current traceability infrastructure falls short, and why that matters.

From Cinnamon Sticks to Lead Chromate

The cinnamon sticks at the center of this case originated in Sri Lanka. From there they were exported to Ecuador, passing through several intermediaries along the way, likely bought and sold more than once, before one of those intermediaries ground the sticks into powder. It was during that grinding step that lead chromate was introduced into the cinnamon.

Why lead chromate specifically? Because the product was being valued primarily based on two things, color and weight, and lead chromate enhances both. It’s the same motive behind decades of similar cases: lead chromate showing up in Hungarian paprika in the 1990s, in turmeric in Bangladesh and India. The objective wasn’t to cause harm. It was to make a cheaper product look and weigh like a more valuable one and get paid accordingly.

That contaminated cinnamon was sold to a processor in Ecuador, Austrofood, that used it to produce applesauce. The finished product was imported into the U.S. by a company called WanaBana and distributed nationally. CDC identified 566 cases of elevated blood lead levels associated with consumption of the pouches, approximately 96% of them in children under six. Nearly 3 million pouches were recalled, and WanaBana filed for Chapter 7 bankruptcy protection within months.

Why This Case Sticks With Me

Of the cases I worked, the Peanut Corporation of America investigation remains the most complex traceback I was ever part of. A single contaminated peanut paste ingredient had worked its way into literally hundreds of products, and untangling that took an enormous amount of manual effort. The cinnamon case was complex in a different way. It wasn’t about how many finished products contained the ingredient. It was about how many countries, companies, and hand-offs the ingredient itself passed through before anyone in the U.S. ever saw it: a grower in Sri Lanka, an exporter, several intermediaries in Ecuador, the grinding operation that FDA had no direct relationship with and no visibility into, a finished-goods processor, an importer, and multiple national distributors. Every additional hand-off adds another place where visibility can be lost and another party a company may know very little about.

FDA didn’t stop at identifying where the contamination happened. The warning letter to Austrofood, the Ecuador-based manufacturer, lays out the part I think is the real lesson here. Austrofood had actually flagged lead as a potential hazard twice before the recall, once in a 2022 hazard analysis covering raw materials generally and again in 2023 when it specifically named the cinnamon ingredient, and both times concluded a preventive control wasn’t necessary. The justification the second time was that the supplier had no history of problems. FDA’s response was direct: given how often lead turns up in spices, and given that this product was intended for infants as young as six months, a knowledgeable person should have reached the opposite conclusion.

There’s another interesting detail buried in the warning letter. Austrofood’s own supply chain program required an annual onsite audit of its Ecuador-based suppliers, including Negasmart, the distributor that supplied the contaminated ground cinnamon. That onsite audit never happened. Austrofood substituted what the letter calls a “desk audit,” a paper review, which FDA noted wasn’t consistent with the company’s own supply-chain program. When FDA tested the cinnamon from that supplier directly, it found lead as high as 5,110 parts per million, along with extremely high chromium levels. Further analysis identified lead chromate in the cinnamon rather than incidental lead contamination. Lead chromate doesn’t turn up in cinnamon by accident.

None of that is really a traceability problem. It’s a prevention problem. Austrofood had information that should have led to stronger supplier controls before the contaminated cinnamon ever reached the applesauce. But once prevention fails, traceability determines how quickly you can figure out where a product came from, where it went, and what else may be affected.

Where FSMA 204 Doesn’t Reach

Here’s the part I think gets missed in a lot of the traceability conversation right now. There’s a lot of attention on FSMA 204, FDA’s food traceability rule, and rightly so, particularly in light of a string of high profile foodborne illness outbreaks this year. But that rule applies specifically to foods on FDA’s Food Traceability List, and a lot of the products that show up again and again in food fraud cases simply aren’t on it. Spices are a good example. Cinnamon isn’t on the list, and neither are a lot of the other high-value, high-fraud-risk commodities that keep showing up in incident after incident. If your compliance program stops at the FTL, you have no visibility into exactly the categories most likely to be defrauded.

So companies that are only building traceability programs to satisfy the letter of FSMA 204 are going to have blind spots in some of the very categories that repeatedly show up in food fraud cases. That’s not a shortcoming of FSMA 204; it wasn’t designed as a food fraud prevention rule or as a universal traceability requirement. But it does mean companies shouldn’t treat FSMA 204 compliance as the endpoint of their traceability programs. This is particularly true for ingredients like spices and honey that show up year after year in global fraud reporting but aren’t covered by the FTL.

Buying Down the Risk

There isn’t one control that’s going to prevent food fraud. What companies are really trying to do is buy down risk. The starting point is recognizing that food fraud is a business risk in the first place, separate from the microbiological and chemical safety risks most food safety programs are already built around.

That risk also changes over time. A commodity that looks relatively low-risk today may look very different after a crop failure, a sudden price increase, new tariffs, or instability in a major sourcing region. Horizon scanning can help companies see those pressures developing and ask where they may be creating new incentives for fraud.

A food fraud vulnerability assessment brings that down to the ingredients and products a company actually buys. Where does an ingredient come from? How many hands does it pass through? Does it have a history of adulteration? Is there an inexpensive way to make it look better, weigh more, or otherwise appear more valuable than it really is? From there, supplier audits and targeted testing can help address the vulnerabilities you’ve identified, although neither eliminates the risk.

Traceability plays a different role. A traceability system wouldn’t have stopped someone in Ecuador from grinding lead chromate into cinnamon to make it heavier and brighter. That’s what the preventive side of the equation is for. But when prevention fails, traceability determines how quickly you can figure out where an ingredient came from, where it went, and what else may be affected. For cinnamon and other high-value ingredients moving through complex global supply chains, that’s worth knowing even when a regulation doesn’t require you to.

The Data Has to Move

The cinnamon case raises a broader question for the food industry: How well do we really understand the journey of an ingredient before it reaches the consumer?

As ingredients move through multiple suppliers, countries, and systems, information can become fragmented. Companies may have the records they need within their own operations, but connecting that information across the supply chain is often a different challenge.

Across the food supply chain, companies already generate enormous amounts of data. The challenge isn’t necessarily a lack of information. It’s that the systems holding that information often weren’t designed to communicate with one another.

A grower may have visibility within its operation. A processor may have the records it needs within its facility. Distributors and retailers may each maintain their own information. Yet gaps can still exist between those systems and trading partners, making it difficult to piece together the complete journey of an ingredient or finished product.

At Starfish, we see this challenge across the food supply chain. Companies often have the information they need within their own operations, but connecting that information across trading partners remains difficult. The next phase of traceability isn’t simply about collecting more data or introducing another technology platform. It’s about making the information companies already generate more accessible and useful across the supply chain.

This is where interoperability becomes important. The ability for different systems to exchange and use information, without requiring everyone to operate on the same platform, can help close gaps in supply chain visibility.

Better connected data won’t prevent someone from intentionally adulterating an ingredient. But it can strengthen supply chain visibility, support investigations, and help companies identify where affected products have moved.

FSMA 204 is helping advance the industry toward more structured, accessible traceability information. But the opportunity extends beyond the foods covered by the rule.

The bigger question isn’t simply whether companies have traceability data. It’s whether they can access and share that information across their supply chains when it matters most.

Learning From the Past

The food industry has decades of experience to learn from. Investigations like the cinnamon case have exposed vulnerabilities in supplier oversight, preventive controls, and visibility across complex supply chains.

Yet many of these same challenges continue to surface. Information remains fragmented, companies struggle to see beyond their immediate suppliers, and investigators often spend valuable time piecing together records from multiple sources.

Technology alone won’t prevent food fraud. But stronger supplier verification, better-connected information, and the ability to share data across trading partners can help companies recognize vulnerabilities and respond more effectively when prevention fails.

The real opportunity is to take what we’ve learned from past incidents and put those lessons into practice. That means looking beyond regulatory requirements and asking whether our systems, processes, and supplier relationships are giving us the visibility needed to identify risks before they become another food safety crisis.

Investigation background draws on the authors’ direct experience with the FDA response, supplemented by Weed et al., “International Investigation of Lead and Chromium Contamination in Imported Apple Puree,” Journal of Environmental Health, Vol. 89, No. 1 (July/August 2026) (DOI link); FDA’s warning letter to Austrofood S.A.S., MARCS-CMS 679052, August 9, 2024; reporting by Will Fitzgibbon for The Examination, in partnership with The New York Times and El Universo; the Food Authenticity Network’s “2024 Global Food Fraud Report”;

Restaurant Food
Beltway Beat

Food Traceability: FDA Issues Draft Enforcement Discretion Policy for Certain Small Retailers and Restaurants

By Food Safety Tech Staff
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Restaurant Food

In response to feedback from stakeholders, and after determining there would be minimal public health impact, the FDA is issuing draft guidance that will, if finalized, provide enforcement discretion from the requirements of the Food Traceability Rule for certain smaller retail food establishments (RFEs) and restaurants that were not previously captured as part of the full exemption for small RFEs and restaurants offered as part of the rule. The FDA states that they believe this additional flexibility will maintain the intended public health benefits of the rule as it would only impact a small percentage of total food sales while also providing relief to numerous smaller RFEs and restaurants.

Under the draft policy, the FDA does not intend to enforce any of the requirements of the Food Traceability Rule for RFEs and restaurants whose average monetary value of food sold or provided during the previous three-year period is greater than $250,000 but not more than $1million, adjusted for inflation using 2020 as the baseline year for calculating the adjustment.

FDA plans to offer additional flexibilities for complying with the Food Traceability Rule, beyond this draft enforcement policy for small RFEs and restaurants. Towards that end, the FDA will hold a public meeting on November 6, 2026. The public meeting is free and open to the public, but registration is necessary to attend.

FSMA 204 Isn’t Just Your Challenge. It’s Your Supplier’s Challenge, Too.

By Kevin Donaghy
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Imagine it’s July 21, 2028. The FDA contacts your site with a traceability request related to a contamination issue. You have 24 hours to provide data on the entire journey of a product through your supply chain, including your suppliers’ entire network.

This means you will need to answer a few questions. Do you know how your suppliers store their records? Do they use the same lot-code formats as you? Can they deliver their critical tracking events (CTEs) and key data elements (KDEs) in a way that is useful to your system?

If you can’t answer this with confidence, you’re not alone. But you are not prepared.

The Mistake Everyone Is Making with FSMA 204

The Food Safety Modernization Act (FSMA) was signed into law by President Obama in 2011 and celebrates its 15th anniversary this year. Section 204, the FDA’s Food Traceability Rule, takes effect on July 20, 2028. It calls for enhanced electronic recordkeeping for specific foods as they travel through the supply chain, including leafy greens, soft cheeses, shell eggs, fresh-cut produce and seafood. If any of these move through your network, you’ll be impacted. So will all of your suppliers.

The rule was originally set to take effect on January 20, 2026, but was extended to “ensure coordination between supply chain partners in order to fully implement the final rule’s requirements,” per the FDA. It cited industry feedback and a concern that trading partners lacked readiness, which points to a very real supplier network problem.

There are two big mistakes manufacturers are making with FSMA 204. The first is assuming that because you’re FSMA-compliant, you’ll be compliant with Section 204. The second is thinking about the rule as an internal issue that can be solved with better recordkeeping.

When the FDA shows up with that traceability request, you’ll be expected to provide an electronic sortable spreadsheet with key details within 24 hours. In order for you to obtain that information quickly – and in the correct format – your suppliers and vendors will also need to be in compliance with the rules.

The 24-Hour Rule: The Creeper Threat

What you, as a quality leader, should be most concerned about isn’t whether you’re capturing the right data (that’s a no-brainer), but whether you can access data from wherever it is in the supply chain, within 24 hours.

So let’s break down what this looks like in the real world: A manufacturer has to contact a co-packer who contacts a raw material supplier who needs to find a lot code in a spreadsheet or legacy ERP system, that may not even be compatible with our system, and you have to do it in 24 hours. That’s an extremely short window.

The financial impact, meanwhile, is massive. The FDA lacks the authority to impose fines directly, but can pursue federal civil or criminal actions if noncompliance is persistent. The greater risk, however, is losing your supplier status with major retail partners – many of which are mandating compliance before enforcement.

The Dirty Little Secret: Data Fragmentation Across Your Network

The uncomfortable truth about supplier networks in food manufacturing is that they weren’t built for this level of complexity. They have evolved, supplier by supplier, system by system. Most operate as a patchwork of disconnected ERPs, spreadsheets, and paper logs. Each node in that network may be capturing traceability data, but almost none of it is shared in a way that easily connects to the next node.

This is really what FSMA 204 is getting at: not whether you’re prepared internally, but how consistently your supply chain as a data-sharing network is performing. Those who will be most challenged won’t be companies that haven’t invested in compliance (many have). It will be those who have invested in their internal operations, but have not extended that effort to their supply networks. The moment the FDA begins tracking, the weakest link in your data chain becomes your biggest liability.

Warehouse worker in protective clothing operating a pallet jack, moving stock within a large, low-temperature cold storage facility

What “Ready” Actually Looks Like

True FSMA 204 readiness requires three interconnected elements, all of which must happen simultaneously, not in sequence.

  • Full chain traceability. All CTEs in your network must be identified and associated with the corresponding KDEs, from farm to fork. Your traceability system must extend beyond your four walls to create a seamless record that connects your supplier data with your own.
  • For manufacturers, a critical factor will be to establish a community of suppliers all speaking the same data language, capable of automatically transmitting data to one another error-free.
  • A rapid recall response is a must. The 24-hour clock isn’t about meeting a deadline for paperwork, it’s a litmus test for operational efficacy. Your quality teams must be able to achieve instant traceback and traceforward without manually combing through supplier emails.

To achieve this, you’ll need a single source of truth where all documentation is readily accessible, lot codes are automatically associated, and automatic notifications are triggered the moment a potential issue arises, all before the FDA ever knocks on the door. That way you can manage proactively and maintain continuity.

The Window Is Narrowing

July 2028 may seem like a long way off, but it’s closer than you think. Interoperability across an entire supply chain takes time, and getting your organization completely aligned on new data standards and traceability is a monumental undertaking that will require significant time and effort.

Companies that don’t take action now, and instead push the problem off until next year, will find themselves in a world of hurt when 2028 rolls around and they still aren’t prepared. Plus, many major retailers are requiring early and expanded compliance, so you’ll want to make sure you’re aligned with the expectations of your customers.

The question now isn’t if you should start preparing. It’s whether you’re preparing for the right things.

Ghost Kitchens and Food Traceability: Understanding Food Safety Responsibilities in a Reinvented Operating Model

By Jeremy Schneider, Johnna Hepner
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The food service industry has undergone significant transformation since the COVID era, and few innovations have evolved as rapidly as the rise of ghost kitchens. Whether operating as delivery-only restaurants, virtual brands, commissary kitchens, multi-branded sites, or shared commercial kitchen spaces, ghost kitchens have allowed for new opportunities for food entrepreneurs while simultaneously introducing unique food safety and traceability challenges.

As regulators, customers, and supply chain partners continue to increase their focus on transparency and traceability, ghost kitchen operators must understand how food safety responsibilities apply to their business and where risks may exist within their operation. While the operating model may be different, the food safety expectations remain the same.

What is a Ghost Kitchen?

A “ghost kitchen” is generally defined as a food preparation facility that produces meals for off-premises consumption, often through third-party delivery platforms, without a traditional dine-in experience.

These operations can take several forms, including:

  • Single-brand delivery-only restaurants.
  • Virtual restaurant brands operating out of existing restaurants.
  • Shared commissary kitchens housing multiple operators.
  • Centralized production kitchens supplying multiple delivery concepts.
  • Hybrid models supporting both retail and delivery operations, which may or may not include virtual or branded concepts.

While these models offer operational flexibility, reduced overhead costs, and open the opportunity to significant new revenue streams, they also create additional complexity when it comes to supplier management, ingredient traceability, allergen control, and recall readiness.

Why Traceability Matters in Ghost Kitchens

Traditional restaurants often have relatively straightforward ingredient flows. Ingredients arrive, are prepared, served, and consumed at a single location.

Ghost kitchens, however, frequently involve multiple brands operating from one facility with shared storage areas and preparation equipment, common ingredients used across several menu concepts, a variety of delivery providers, and central commissaries supplying multiple locations.

This complexity increases the importance of maintaining accurate records that identify:

  • What ingredients were received
  • Which suppliers provided them
  • When products were received
  • How products were used
  • Which menu items contained those ingredients
  • Where finished products were distributed
  • Enhanced requirements outlined within FDA’s FSMA 204 regulations.

Without adequate traceability records, identifying affected products during a food safety incident can become extremely difficult.

Supplier Approval is More Important Than Ever

Many ghost kitchen operators focus heavily on speed and convenience when sourcing ingredients. However, rapid growth can sometimes outpace supplier verification processes.

An effective supplier approval program should include:

  • Approved supplier lists
  • Supplier food safety documentation
  • Third-party audit verification
  • Certificates of Analysis (COA) when appropriate
  • Ingredient specifications
  • Recall and crisis management procedures.

This becomes particularly important when multiple virtual brands rely on common ingredients. A single supplier issue may impact numerous menu offerings simultaneously.

The Recall Challenge for Ghost Kitchens

One of the most significant food safety concerns for ghost kitchens is recall execution.

Imagine a scenario where a contaminated ingredient is used across six virtual restaurant brands operating within the same facility. The affected ingredient may have been incorporated into dozens of menu items sold through multiple delivery platforms over several weeks.

Questions operators must be able to answer include:

  • Which supplier provided the ingredient?
  • What lot codes were received?
  • Which menu items contained the affected ingredient?
  • Which brand(s) utilized the ingredient?
  • During what dates the ingredient was used?
  • How much inventory remains on-site?

The ability to answer these critical questions rapidly can significantly reduce the scope of a recall and help protect consumers.

The Missing Ingredient: Connected Information

One of the biggest misconceptions about traceability is that organizations simply need better software. In reality, most ghost kitchens already have technology. They use procurement systems, inventory platforms, POS systems, kitchen management software, supplier portals, delivery applications, and food safety systems.

The challenge isn’t that the information doesn’t exist. The challenge is that it often lives in disconnected systems owned by different organizations.

A single meal may involve ingredients from multiple suppliers, inventory managed in one application, orders placed through another, delivery fulfilled by a third-party platform, and customer information maintained somewhere else entirely. During a food safety event, operators must quickly connect those pieces together.

The future of traceability in foodservice won’t be defined by replacing existing systems. It will be defined by connecting them, allowing information to move securely between suppliers, operators, delivery partners, and customers while each continues using the technology that best supports its business.

FSMA 204 and Ghost Kitchens

The FDA’s Food Traceability Rule (FSMA Rule 204) has largely focused industry attention on additional traceability requirements for foods appearing on the Food Traceability List (FTL). While many ghost kitchens may not fall directly under all aspects of FSMA 204, operators should pay close attention to how their suppliers and supply chain partners are implementing enhanced traceability systems.

As traceability requirements expand throughout the food industry, businesses that maintain strong receiving records, inventory controls, and ingredient tracking systems will be better positioned to meet customer, regulatory, and supply chain expectations. Many ghost kitchens already utilize digital ordering and inventory management platforms, making them well-positioned to leverage technology for improved traceability. The opportunity isn’t simply to digitize more processes. It’s to ensure the information already being captured can be shared quickly with trading partners, customers, and regulators when needed. Traceability becomes significantly more valuable when it moves beyond compliance and supports day-to-day operations, supplier collaboration, and faster decision-making.

Food Security in Mind

Ghost kitchens frequently receive orders and pickups from multiple delivery services and this can significantly increase food security risks.

Challenges often include:

  • unknown drivers and companies
  • different requirements for handling
  • multiple menu concepts using different handling expectations, or,
  • food packaged in a way that does not protect it from adulteration

Companies should implement processes that protect food during transit from the ghost kitchen to the customer. This often includes tamper evident packaging, external packaging, and other deterrents that limit driver access.

Looking Ahead

Ghost kitchens represent an exciting evolution within the foodservice industry, but they are not exempt from the food safety responsibilities required of their traditional counterparts. In many ways, the complexity of shared facilities, virtual brands, and centralized production models makes robust food safety and traceability programs even more important.

As consumer expectations for transparency continue to increase and regulatory requirements evolve, ghost kitchen operators that invest in supplier management, traceability systems, allergen controls, and recall readiness will be better positioned to protect their customers and their brands.

The question is no longer whether traceability matters in foodservice. The question is whether your operation can quickly identify where ingredients came from, where they were used, and what actions need to be taken when something goes wrong.

 

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FDA Shares Recording of Traceability Public Meeting

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On June 15, 2026 The FDA held a public meeting to give the public an opportunity to share information on continued implementation of the Food Traceability Rule and areas of remaining concern, specifically as they relate to lot-level tracking and flexibilities for compliance. The Agency is now making the video recording of the meeting available for stakeholders. 

The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule) requires persons who manufacture, process, pack, or hold food on FDA’s Food Traceability List to maintain and (in some cases) provide to their supply chain partners key data elements (KDEs) for certain critical tracking events (CTEs) in the food’s supply chain. The requirements in the rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths.

The original compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule was January 20, 2026. The FDA proposed to extend the compliance date for the rule by 30 months to July 20, 2028. Subsequently, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 (the Continuing Appropriations Act) directed FDA not to enforce the Food Traceability Rule prior to that same date of July 20, 2028. The FDA  intends to comply with this Congressional directive.

The Continuing Appropriations Act also required FDA to engage quarterly with regulated entities, including farms, restaurants, retail food establishments, and warehouses distributing to retail food establishments and restaurants, to identify and implement, as appropriate, additional flexibilities for satisfying the Food Traceability Rule’s lot-level tracking requirement. This public meeting is the second of these quarterly engagements.

The recording, and related transcripts, can be found on the public meeting webpage. 

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Beltway Beat

FDA Releases Discussion Paper Ahead of Traceability Public Meeting in June

By Food Safety Tech Staff
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The FDA has released a discussion paper to promote deeper and more productive engagements with stakeholders on potential flexibilities regarding the lot-level tracking requirements in the final rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Rule). The discussion paper includes information and questions to help inform FDA’s engagements with stakeholders, including the upcoming virtual FDA-led public meeting on June 15th.

The FDA encourages those attending and speaking at the public meeting to consider the topics in the discussion paper. The public meeting is free and open to the public, but registration is necessary to attend. If you would like to speak during the public comment period, please register by June 5. All others can register until June 14th. More information about registration and how to request to speak during the public comment period are available on our meeting page.

In addition to the public meeting, the FDA wants to provide all stakeholders with an opportunity to actively engage with the Agency on this topic. Therefore, all interested parties are encouraged to submit feedback on the discussion paper to https://www.regulations.gov, Docket No. FDA-2014-N-0053. Feedback does not need to cover every question that is asked in the document; you are encouraged to focus on whichever aspects of the discussion paper are of the most interest to you. To ensure that we can fully consider your feedback as we continue our stakeholder engagements and work to expeditiously identify flexibilities to help implement the lot-level tracking requirements of the Food Traceability Rule, provide feedback by July 15, 2026.

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Beltway Beat

FDA Takes Several Actions Related to the Food Traceability Rule

By Food Safety Tech Staff
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On February 19, the FDA issued guidance addressing stakeholder questions regarding implementation of the Food Traceability Rule and a notice exempting certain cottage cheese products from the requirements of the Food Traceability Rule. FDA is also announcing a series of engagements with stakeholders to fulfill a directive from Congress in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026.

The Food Traceability Rule establishes additional recordkeeping requirements, beyond those in existing regulations, for those who manufacture, process, pack, or hold foods FDA has designated for inclusion on the Food Traceability List. The final rule requires such entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initial packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help FDA rapidly and effectively identify recipients of these foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.

Questions and Answers Guidance on the Food Traceability Rule

The guidance issued includes questions and answers to assist industry with understanding the scope of the Food Traceability Rule and meeting the requirements of the rule. The guidance addresses several topics, including:

  • Applicability of the rule to entities such as farms, farmers’ market stalls, fishing vessels, first land-based receivers, retail food establishments, and restaurants;
  • Applicability of the rule to activities such as intracompany shipments, commingling, initial packing, and transformation, including answers to questions about breaking pallets and culling produce;
  • Details about the exemption for raw molluscan shellfish;
  • Determining if a product is “fresh-cut” for the purpose of identifying whether it is on the Food Traceability List; and
  • Additional information on the food traceability plan and recordkeeping requirements.

Finalizing Exemption for Certain Cottage Cheese Products from the Requirements of the Food Traceability Rule

In the preamble to the final Food Traceability Rule, FDA announced its intention to consider initiating a process to exempt certain cottage cheese products from the rule. In 2024, FDA published a notice proposing to exempt Grade “A” cottage cheese that appears on the Interstate Milk Shippers (IMS) List (“IMS listed Grade “A” cottage cheese”) from the rule. FDA published a notice announcing that they are finalizing that exemption.

Much of the cottage cheese produced in the U.S. is regulated through the National Conference on Interstate Milk Shipments (NCIMS). FDA and NCIMS have together developed a cooperative, Federal-State program (the IMS Program) to ensure the sanitary quality of milk and milk products shipped interstate. The IMS program relies on the Pasteurized Milk Ordinance (PMO), which represents the most current science-based knowledge and experience concerning the safe production and processing of Grade “A” milk products, including cottage cheese.

After considering the comments on the proposal, FDA has concluded that the exemption is warranted because the processing requirements specified in the PMO for IMS listed Grade “A” cottage cheese address the risk factors that resulted in cottage cheese being included on the Food Traceability List, and because of the enhanced oversight of the manufacturing of IMS listed Grade “A” cottage cheese through the IMS program. In keeping with the statutory and regulatory provisions that allow for this type of exemption, facilities required to register with FDA that manufacture, process, pack, or hold IMS listed Grade “A” cottage cheese will still be required to maintain records identifying the immediate previous source of such food and the immediate subsequent recipient of such food.

Stakeholder Engagement Sessions

The FDA is also announcing a series of engagements with stakeholders, organized by the Partnership for Food Traceability (PFT), to fulfill a directive from Congress in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026. FDA will engage quarterly with regulated entities, including farms, restaurants, retail food establishments, and warehouses distributing to retail food establishments and restaurants, to better understand concerns and explore options for assisting regulated entities with complying with the Food Traceability Rule. The PFT and FDA will hold a series of listening sessions on these topics. The sessions will include opportunities for public input as well as smaller group discussions. The listening sessions will provide an opportunity to engage with FDA on Food Traceability Rule implementation of lot-level tracking, challenges facing regulated entities, and potential solutions. The first session will take place March 6, 2026, for PFT members, with a public session the following quarter. Additional sessions will be announced as they are scheduled.

Additional Information

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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.