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FSMA 204 guide

FSMA 204 for food distributors: what to record, and when.

The FDA's Food Traceability Rule asks businesses that hold certain foods to keep lot-level records of what they receive and ship. Here is what it covers, what a distributor's records need to show, and how to get ready before the compliance date.

July 20, 2028The compliance date. Congress directed the FDA not to enforce the rule before then.
24 hoursHow quickly covered records must be produced when the FDA asks.
Lot levelRecords are kept per traceability lot code, not per item.
Food Traceability ListThe rule applies to foods on the FDA's list, not every food you sell.

What the rule is

Section 204 of the FDA Food Safety Modernization Act directed the FDA to set extra recordkeeping requirements for foods it designates as high-risk. The result is the Food Traceability Rule, finalized in November 2022. It applies to anyone who manufactures, processes, packs or holds a food on the Food Traceability List, which includes most food distributors who handle those foods.

The goal is speed: when there is an outbreak or a recall, the FDA wants to follow a contaminated lot through the supply chain in hours rather than weeks. Each business keeps records of the key data elements for the critical tracking events it performs, and passes the traceability lot code along with the food.

The original compliance date was January 20, 2026. In late 2025 Congress directed the FDA not to enforce the rule before July 20, 2028, and the FDA said it would comply with that direction. The FDA also holds public sessions on how lot-level traceability works in practice, including a virtual public meeting scheduled for November 6, 2026.

Which foods are covered

The rule covers foods on the FDA's Food Traceability List, and foods that contain them as ingredients in the same form. The list includes:

  • Leafy greens (fresh and fresh-cut), fresh herbs, cucumbers, melons, peppers, tomatoes, sprouts and tropical tree fruits
  • Fresh-cut fruits and vegetables
  • Shell eggs and nut butters
  • Cheeses other than hard cheeses
  • Finfish, crustaceans and molluscan shellfish
  • Ready-to-eat deli salads

The list has detail and exceptions this summary leaves out, and the rule has exemptions, for example for some small producers and for certain foods that receive a kill step. Check the FDA's list and the rule's exemptions against what you actually stock.

What a distributor records

For most distributors the critical tracking events are receiving and shipping, plus transformation if you repack, cut, mix or otherwise change a covered food. For each event the rule lists key data elements.

When you receive a covered food

  • The traceability lot code
  • The quantity and unit of measure
  • The product description
  • Where it came from (the immediate previous source) and where you received it
  • The date you received it
  • The traceability lot code source, or a reference to it
  • The type and number of the reference document, such as the bill of lading or invoice

When you ship a covered food

  • The traceability lot code, quantity, unit of measure and product description
  • Who you shipped it to (the immediate subsequent recipient) and where you shipped it from
  • The date shipped, the lot code source, and the reference document

When you ship, most of that information has to go to your customer too, so they can keep their own receiving records. If you transform a food, you assign a new traceability lot code and record which input lots went into it.

This is a summary. The exact wording, and the elements for the other events, are in the FDA's Food Traceability Rule.

The traceability plan

Each covered business keeps a written traceability plan. It describes how you maintain the required records and where they live, how you identify foods on the list that you handle, how you assign traceability lot codes if you do, and a point of contact for questions about the plan. When the FDA asks, you must be able to produce your records within 24 hours, and in some situations as an electronic sortable spreadsheet.

Getting ready: a practical order

  1. Find your covered foods. Go through your item list against the Food Traceability List and mark every covered item.
  2. Talk to your suppliers. Ask which of them will send traceability lot codes and their source with each shipment, and how.
  3. Record lots at receiving. Every receipt of a covered food needs its lot code, quantity, source and date, recorded as the truck is unloaded.
  4. Tie shipments to lots. Every line you ship needs to say which lot it came from, so you can name every customer who received a lot.
  5. Write the plan. Keep it short and true to how your warehouse actually works.
  6. Practise. Pick a lot and time how long it takes to produce its records and its customer list.

Want a quick read on where you stand? Take the FSMA 204 readiness check: twelve questions, no sign-up.

How APFoodz helps

The records come from work you are already doing.

In APFoodz every pallet you receive becomes a lot, and what happens to it is recorded as the work happens, from the dock to the customer's door. A trace forward or back is a search, and a recall reaches every customer that received the lot.

Software is one part of being ready. Your traceability plan, and the lot data your suppliers send, are yours.

Traceability in APFoodz
Terms
  • FSMA 204 (Food Traceability Rule)The FDA rule requiring extra traceability records for foods on the Food Traceability List; compliance date July 20, 2028.
  • Critical tracking event (CTE)A point in a food's supply chain, such as receiving or shipping, where the FDA traceability rule requires records to be kept.
  • Key data element (KDE)A piece of information, such as quantity, location or traceability lot code, required for each critical tracking event.
  • Traceability lot code (TLC)The lot identifier, assigned under the FDA traceability rule, that links a food's records as it moves through the supply chain.
  • Lot trackingRecording each batch of product as a lot with its source and dates, so it can be followed from receipt to customer.
  • FEFO (first expired, first out)A stock rotation rule that ships the units with the earliest expiry date first, used for perishable food.
Further reading

FSMA 204 questions distributors ask.

When do we have to comply?

The compliance date is July 20, 2028. Congress directed the FDA not to enforce the rule before that date, and the FDA said it would follow that direction.

Does it apply to every food we sell?

No. It applies to foods on the FDA's Food Traceability List, and to foods that contain them as ingredients in the same form, subject to the rule's exemptions.

We only buy and resell. Do we still keep records?

Yes, if you hold covered foods: receiving and shipping are critical tracking events, and a distributor that holds the food keeps their key data elements.

Do we need special software?

The rule does not require particular software, but it does require you to produce records within 24 hours, and in some situations as an electronic sortable spreadsheet. Lot-level records kept on paper make that hard.

What if a supplier does not send lot codes?

Start the conversation early. Your receiving records depend on what suppliers send, and the rule expects the lot code and its source to travel with the food.

Sources: FDA, Food Traceability Rule; H.R. 5371, 119th Congress. This guide is not legal advice. Last reviewed October 14, 2026.

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