FSMA 204 Is the Story: How Retailers and OU Direct Are Raising the Traceability Bar 

FSMA 204 (food traceability rule) is accelerating traceability requirements for high-risk foods. While the FDA has proposed extending compliance to July 2028, major retailers like Walmart, Kroger, and Target—together representing over 10,000 OU kosher-certified products—are already demanding strict compliance with electronic record keeping. These retailers are leading the charge in raising traceability standards ahead of FSMA 204 deadlines. OU Direct, OU’s kosher program management portal, can help manufacturers meet these new standards by streamlining the gathering and reporting of key traceability data. 

Why Traceability Matters Now 

When a food-safety incident occurs, the impacts are immediate: 

  • Retailers pull products, post notices, and respond to customer concerns. 
  • Manufacturers must rapidly isolate affected lots, notify partners, and trace product movement. 

Fast, accurate traceability protects consumers and brands by enabling swift identification and removal of potentially contaminated foods. 

FSMA 204: The Rule Is Here 

FSMA 204 applies to companies that make, process, pack, or hold foods on the Food Traceability List (FTL). These businesses must capture Key Data Elements (KDEs) at Critical Tracking Events (CTEs) such as receiving, shipping, and transformation. Records must be provided to the FDA in an electronic, sortable format upon request. The regulation’s goal is to accelerate identification and removal of contaminated food from the supply chain. 

Regulatory Update:
In 2025, the FDA proposed extending the compliance deadline from January 2026 to July 2028. This extension gives partners additional time to coordinate; however, the requirements themselves remain unchanged. Retailers are advancing their expectations regardless of FDA timelines. 

Retailers Are Setting Faster Timelines 

Major retailers have set traceability deadlines ahead of the FDA’s schedule: 

  • Walmart and Sam’s Club require suppliers to confirm FSMA eligibility, meet packaging specifications, and provide advance ship notices (ASNs). 
  • Kroger mandates an EDI 856 ASN for every shipment, strict pallet label alignment, and applies the traceability program to all foods, not only those on the FTL—making portfolio-wide traceability the default. 
  • Target has implemented comprehensive supply chain mapping and traceability programs to support transparency and food safety across their business partners. 

OU Kosher’s Role—and How OU Direct Helps 

OU certification fosters strong traceability discipline within kosher programs by managing: 

  • Approved ingredients and suppliers (master data). 
  • Bills of Materials (BOMs) tied to production runs, linking ingredient lots to finished goods. 
  • Equipment status and changeover documentation for lot integrity. 
  • Transport sanitation records to meet hygiene expectations. 

While OU Direct does not generate a turnkey FSMA 204 report, the kosher records it maintains map directly to many FDA-required KDEs at Receiving, Transformation, and Shipping. Manufacturers export OU Direct data and combine it with shipping/ASN records to create the electronic, sortable spreadsheet regulators and retailers request. Rabbinic Coordinators can help you  identify the best OU Direct reports and standardizing export processes into ERP or traceability systems. 

Plain-English Note:
A Bill of Materials (BOM) is the “recipe” for a SKU. For traceability, it’s essential to connect ingredient lot codes used in production to the finished-goods lot code that leaves the facility. 

Timeline: What to Expect Through 2028 

Period What to Expect
Now–2026 Retailer mandates push suppliers beyond FDA’s minimum, encouraging portfolio-wide traceability.
2026–2028 Audits, ASN discipline, and label/lot alignment increase pressure; companies consolidate data.
Beyond 2028 Traceability and retailer scorecards will likely expand to all products, not just FTL items.

Bottom Line 

FSMA 204 establishes a non-negotiable baseline for traceability. Meanwhile, retailers are moving up requirements. Using OU Direct can shorten the path to FDA-ready electronic records, showing control to buyers. OU-certified manufacturers adopting best traceability practices protect brand trust on the shelf and in regulatory scrutiny. 

Phyllis Koegel
As the Marketing Director for OU Kosher, the world’s leading Kosher certifying agency, Phyllis is responsible for the marketing and new business development by assisting food producers worldwide obtain OU Kosher certification for their products. Phyllis developed an early passion for consumer behavior and marketing. She joined the Orthodox Union in 2006 after serving as Marketing Manager for Sabra Hummus. At Sabra Hummus, she helped launch the hummus category to the American market. Hummus became a staple in American households and grew to a billion-dollar food category. Sabra Hummus was purchased by Pepsico in 2008 and has grown to over $1 billion in annual sales. Prior to joining Sabra, Phyllis was involved in the development and success of the International Kosherfest Trade show. As Show Director from 1989 – 2002, she worked with thousands of Kosher food manufacturers and oversaw the strategic planning and execution of the show. Phyllis was born and raised in Brooklyn, N.Y. She obtained an MBA in Marketing from Pace University in 1988. She now lives in Woodmere, N.Y. and has three children and sixteen grandchildren.