Clarkston Consulting
Skip to content

Preparing for the Food Traceability Final Rule: How Companies Can Ensure Compliance

In light of recent recalls and safety alerts in the food industry, there’s a growing emphasis on food traceability and regulatory compliance. The FDA has set a deadline of January 2026 for food companies to fully comply with the regulations of the Food Traceability Final Rule. In this piece, we outline key recommendations for companies preparing for the food traceability final rule and how they can ensure compliance. 

What is the FDA Food Traceability Final Rule? 

The FDA’s final rule on Requirements for Additional Traceability Records for Certain Foods, also known as the Food Traceability Final Rule, requires detailed and standardized recordkeeping to keep supply chain steps electronically traceable. The main goal of the Final Rule is to improve food safety and protect public health by being more prepared to handle food-borne illnesses and other contamination problems. 

The FDA has mandated that the industry and its regulators be aligned with compliance rules by January 20, 2026. The Food Traceability List (FTL) outlines all the foods for which additional recordkeeping is required, so companies must adhere to the full list of regulations. Foods such as fruits, vegetables, and cheeses are listed as high-risk and require stricter tracing. 

Meeting Compliance Requirements 

By January 2026, all food companies must comply with the Final Rule, which can be a lengthy process. The central requirement for compliance is for suppliers or producers of foods on the FTL to maintain greater traceability of their products and report details to the FDA. The expectation is that records will contain Key Data Elements (KDEs) that pair with Critical Tracking Events (CTEs) to outline all product movements. A CTE may be, for example, the harvesting of a product, and one of many associated KDEs will be the quantity and unit measure of the food. This ensures full transparency of the product’s movements and maximizes food safety. 

Companies can benefit from strict compliance because the ability to eliminate unsafe food quickly can reduce the risk of company liability. The compliance process can be extensive, so companies must start making strides toward traceability to ensure compliance by the FDA’s deadline. Working with supply chain partners can be an effective way to share traceability information and understand recordkeeping systems. 

Reducing the Number of Food Product Recalls  

The Food Traceability Final Rule is coming into effect in the aftermath of ongoing food safety recalls. Product recalls due to contamination events or inaccurately labeled products can generate significant brand reputation damage and loss of consumer trust. As seen most recently in December 2023 and January 2024, The Quaker Oats Company recalled various cereals, bars, and snacks that may have been contaminated with Salmonella, resulting in a serious food safety issue. In February, the recall was again expanded to include an additional granola bar.  

Consumers are much less likely to put trust in a brand when safety issues are common. The Food Traceability Final Rule seeks to address food safety concerns, like the Quaker contamination, much earlier and effectively. Greater traceability of ingredients and safety risks will allow for faster identification of unsafe products and fewer business recalls. 

How to Prepare for the Food Traceability Final Rule   

In an increasingly global and complex supply chain, achieving and maintaining true end-to-end traceability poses a challenge for many companies. Organizations will need to invest the time, money, and resources into the right tools, systems, and processes – particularly when it comes to collecting and recording comprehensive and accurate data (e.g., supplier info, product/ingredient data, manufacturing production data, quality data, batch/lot numbers, etc.) – to help them achieve their traceability goals. 

To prepare for the upcoming January 2026 compliance deadline, we recommend that organizations consider these four steps:  

  1. Educate your team on upcoming compliance guidelines and what will be expected. Knowing what’s to come and what changes or adjustments you’ll need to make to your processes, operations, or systems ahead of time is critical to ensuring you’re set for the January 2026 deadline.  
  2. Audit current processes to determine gaps or areas of vulnerability. A product recall can make or break your brand. Identify areas of vulnerability across your supply chain so that if contamination occurs, your team can quickly and efficiently trace an item’s origin and journey from end to end and then respond appropriately.  
  3. Implement end-to-end traceability and analytics solutions to enable visibility and strengthen decision-making. Whether you’re leveraging existing technologies or investing in new ones, traceability solutions can provide real-time tracking and required reporting capabilities – in addition to greater end-to-end supply chain visibility – that help you meet regulatory compliance. Comprehensive and robust data governance is paramount to an organization’s traceability capabilities – data such as product/ingredient data, supplier information, production and quality data, and batch/lot information.  
  4. Partner with a food traceability expert. Preparing your organization for the January 2026 deadline might seem overwhelming, given the complexity of the global supply chain, the stringent tracking and reporting requirements, and the challenges that come with any large-scale organizational change. Effective coordinated execution across multiple sites and geographies requires keen program-level monitoring and project management discipline. Considering these factors, it’s advisable to partner with a trusted advisor who can provide guidance on traceability best practices and ensure that any assessment – or remediation – activities are conducted holistically and with rigor. 

For further guidance on traceability best practices or how to prepare your organization for the FDA’s Food Traceability Final Rule, connect with our team today 

Subscribe to Clarkston's Insights

  • I'm interested in...
  • Clarkston Consulting requests your information to share our research and content with you.

    You may unsubscribe from these communications at any time.

  • This field is for validation purposes and should be left unchanged.

Contributions from Samantha Weitzel

Tags: Traceability