Amazon's FSMA 204 Compliance Requirements: What Food Sellers Must Know About Traceability Data Sharing
Amazon requires food suppliers to meet FSMA 204 traceability data-sharing standards including ASNs with Key Data Elements, SSCC pallet labels, and GS1-128 case barcodes for all Food Traceability List items.
Overview
Amazon has published detailed data-sharing requirements for food suppliers in response to the FDA's Food Safety Modernization Act Section 204 (FSMA 204), which takes effect on January 20, 2026. This regulation mandates enhanced traceability for foods on the FDA's Food Traceability List (FTL), requiring supply chain participants to capture and share specific Key Data Elements (KDEs) so records can be quickly provided to the FDA during potential foodborne illness investigations. Amazon sellers who supply food products covered by the FTL need to understand and implement these requirements to continue selling through the platform.
Key Points / What Sellers Need to Know
- Effective Date — FSMA 204 takes effect on January 20, 2026, but Amazon asked suppliers to comply with its own data-sharing requirements by January 1, 2025, giving the company a head start on traceability infrastructure.
- Who Is Affected — Sellers who manufacture, process, pack, or hold foods listed on the FDA's Food Traceability List (FTL) must meet these requirements. Not all food items are covered — only those specifically identified on the FTL.
- GS1 Standards Are Required — Amazon has endorsed GS1 standards for global traceability as the preferred method for achieving data-sharing interoperability across the supply chain, calling them the most simple and cost-effective approach.
- Three Core Requirements — Compliance centers on three main areas: Advanced Shipping Notices (ASNs) with complete KDEs, License Plate (LP) labels on pallets, and GS1-128 barcodes on cases.
- Lot Segregation Is Mandatory — Each case must contain only one lot or batch number, and each pallet must contain only one lot or batch number per UPC. Mixed lots require separate pallets or shipments.
ASN Requirements for FTL Items
All confirmed purchase orders for items on the Food Traceability List must include an Advanced Shipping Notice (ASN). These ASNs must contain a defined set of minimum Key Data Elements (KDEs) required for compliance under FSMA 204. At minimum, each ASN must include the purchase order number, ship-from and ship-to addresses, the Global Trade Item Number (GTIN), and lot or batch number information. Amazon also requires quantity, expiration date, and other shipment identifiers. These data points allow the FDA to trace products through the supply chain in the event of a food safety incident, making accurate and complete ASNs a foundational part of compliance.
Analysis & Recommendations
Why This Matters
Food sellers who fail to comply with FSMA 204 data-sharing requirements risk shipment rejections and supply chain disruptions. Amazon's compliance deadline has already passed, making immediate action essential for affected suppliers.
Key Takeaways
- FSMA 204 takes effect January 20, 2026, but Amazon required supplier compliance by January 1, 2025
- All FTL item shipments need ASNs with complete KDEs, SSCC pallet labels, and GS1-128 case barcodes
- Cases and pallets must be segregated by lot/batch number — no mixing allowed
- Amazon recommends adopting these standards for all food items, not just FTL-regulated products
Recommended Actions
- →Review the FDA's Food Traceability List to determine if your products are regulated under FSMA 204
- →Ensure your ASNs include all required KDEs: PO number, ship-from/to addresses, GTIN, lot number, and dates
- →Update case labeling to include GS1-128 barcodes with GTIN, date, and lot number encoded via proper Application Identifiers
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