The FDA's food traceability rule, part of the Food Safety Modernization Act, requires additional recordkeeping for foods on its Food Traceability List. The FDA has extended the compliance date to July 20, 2028. This is an overview for planning, not legal advice. Read the FDA's rule page and ask your compliance lead which of your products are covered.
What the rule is built around
- Critical tracking events (CTEs): points where a food is handled in a way that matters for tracing, such as receiving, transformation and shipping.
- Key data elements (KDEs): the information you must record at each event, tied to a traceability lot code.
- The ability to give the FDA the records in a usable form when requested.
What your system needs to capture
- A traceability lot code on every received case or pallet, with the date, quantity and unit.
- The supplier and the location where the food was received.
- For products you transform or repack, the input lots linked to the new output lot.
- For shipments, the lot codes, quantities, and the destination.
- The reference document for each event, such as the PO or the bill of lading.
Where lot data usually breaks
- Lot codes written on paper receiving sheets and typed in later, or not at all.
- Mixed pallets where two lots share a location and the picker cannot tell them apart.
- Repacking that loses the link between input and output lots.
- Returns put back into stock without their lot.
A minimum viable system
- Capture lot, best-by date and supplier at receiving with a scan, and label the pallet.
- Store stock by location and lot, and pick against lot with FEFO.
- Record shipments with the lot on each line.
- Provide forward and backward trace by lot and export it as a sortable spreadsheet.
- Test it: pick a lot and time how long it takes to find every customer who received it.