This post is general information, not legal advice. The rule is long and has exemptions this page doesn’t cover. FDA’s own pages are listed at the end; for how it applies to your business, ask a food-safety adviser or a lawyer.
The rule in one paragraph
The rule comes from section 204 of the FDA Food Safety Modernization Act, which is why people call it FSMA 204. It applies to anyone who manufactures, processes, packs or holds a food on FDA’s Food Traceability List. A distributor holds food, so it is in. For each listed food you keep Key Data Elements — set pieces of information — at Critical Tracking Events. For a distributor that buys and resells without repacking, two events matter: receiving and shipping. The thread through both is the traceability lot code: the lot code given to the food where it was first packed, first landed from a fishing boat, or transformed. You also keep a written traceability plan.
July 20, 2028, and what is still moving
The original compliance date was January 20, 2026. FDA proposed moving it 30 months, to July 20, 2028, and Congress, in a continuing appropriations act, directed FDA not to enforce the rule before that same date. FDA says it intends to comply with that directive.
The details are still being discussed in public:
- A draft policy for small restaurants and stores. On October 8, 2026, FDA issued a draft saying it does not intend to enforce the rule for retail food establishments and restaurants with average annual food sales above $250,000 and up to $1 million (over three years, adjusted for inflation). Those at or under $250,000 are already exempt. It is a draft, and it is about your customers: it does not mention distributors.
- A public meeting on November 6, 2026. FDA holds a free virtual meeting on lot-level traceability and “potential flexibilities for compliance.” General registration is open until November 5; the deadline to register as a speaker was October 26.
Flexibilities may come out of those meetings. Until they do, plan for the rule as it is written.
Is your product on the list?
Start with the Food Traceability List. A food that isn’t on it isn’t covered. For a produce, seafood or cheese distributor, some products almost certainly are. FDA lists them like this:
- Produce: cucumbers (fresh), herbs (fresh), leafy greens (fresh), leafy greens (fresh-cut), melons (fresh), peppers (fresh), sprouts (fresh), tomatoes (fresh), tropical tree fruits (fresh), fruits (fresh-cut), and vegetables other than leafy greens (fresh-cut).
- Seafood: finfish (fresh, frozen, and previously frozen); smoked finfish (refrigerated, frozen, and previously frozen); crustaceans (fresh, frozen, and previously frozen); molluscan shellfish, bivalves (fresh, frozen, and previously frozen).
- Dairy and eggs: cheeses, other than hard cheeses; shell eggs.
- Also: nut butters, and ready-to-eat deli salads (refrigerated).
Read the footnotes, because they move products in and out. Whole head cabbage isn’t on the list. Avocados and citrus aren’t tropical tree fruits. Hard cheeses such as cheddar and parmesan are out. Some produce FDA treats as rarely eaten raw, such as collards and dill, is exempt.
What a distributor records
When you receive a lot of a listed food, you keep, linked to that lot:
- the traceability lot code;
- the quantity and unit of measure — “6 cases”, “200 pounds”;
- the product description;
- where it came from: the business you got it from, not the trucking company;
- where you received it;
- the date you received it;
- the traceability lot code source — the place the lot code was assigned — or a reference to it, such as its FDA food facility registration number or a web address;
- the reference document type and number: the bill of lading, invoice or purchase order.
A “location” in the rule means business name, phone number, street address, city, state and ZIP code.
When you ship, you keep the same list in the other direction: lot code, quantity and unit, product, the customer you shipped to, where you shipped from, the ship date, the lot code source and the reference document. And you send the first seven of those to your customer — on paper, electronically or in another written form.
You pass the lot code on; you don’t make a new one. FDA says firms must not create a new traceability lot code for activities like shipping. If you repack or relabel — a case of tomatoes into smaller bags under your own label — the rule calls that transformation: you assign a new code and keep transformation records. Breaking down pallets counts as holding, not transformation. For anything in between, check FDA’s FAQ.
The plan and the retention. The written traceability plan says how and where you keep these records, how you identify the listed foods you handle, how you assign lot codes if you ever do, and who to contact about it. Records are kept for two years.
The 24-hour request
When FDA needs records to deal with an outbreak, a recall or another threat to public health, you have 24 hours — or a longer time FDA agrees to — to produce them for the foods and dates or lot codes it names. Receiving and shipping records go to FDA as an electronic sortable spreadsheet.
There is one size threshold. A business other than a farm, store or restaurant with average annual food sales of $1 million or less over the previous three years (adjusted for inflation from 2020) may provide them in another form. It still has 24 hours.
Records can be on paper or electronic, and someone else can keep them for you — but you remain responsible for getting them to FDA in time. Twenty-four hours is the real reason to start early. A binder of bills of lading is a record. Turning three weeks of them into one sortable spreadsheet by tomorrow morning is a different job.
What to start now
- Mark your listed products. Go through your product list against the Food Traceability List, footnotes included, and tag every product that is in.
- Ask your suppliers how lot codes will reach you. On the case label, the bill of lading, an advance ship notice? Ask for the lot code source too. If a supplier is exempt from the rule, the regulation says you assign the lot code when you receive from them — so find out which suppliers those are.
- Write the lot code down when you receive. One line per lot, with the receiving items above. A spreadsheet is enough to start.
- Write it down again when you pack. When a packer pulls romaine for a restaurant, note which lot went into that order. This is the hard habit: a warehouse that picks from whichever case is nearest has to learn to record it.
- Keep the lot with the order. The customer, the delivery date and the order number on one side; the lot codes on the other. That link is your shipping record.
- Put it on the paperwork. The delivery slip or invoice that travels with the food is the natural place for the lot code, the lot code source and your ship-from address.
- Practise the 24 hours. Pick one product and one week, and time how long it takes to produce every receipt and shipment of it as one sortable spreadsheet. Do it again in three months.
Where Supligo fits — and where it doesn’t
To be plain: Supligo does not record lot codes or traceability records today. It records orders, weights and deliveries — who ordered what, what was packed and at what weight, and what was handed over at the door — not lots. Your lot records need to live somewhere else for now, and a well-kept spreadsheet is a fine place to start. If you use Supligo, write the order number next to each lot you ship; it ties the spreadsheet to the order, the packed weights and the delivery. More on what Supligo does for produce distributors.
Sources
- FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods — US Food and Drug Administration
- Food Traceability List — US Food and Drug Administration
- Frequently Asked Questions: FSMA Food Traceability Rule — US Food and Drug Administration
- Traceability Lot Code — US Food and Drug Administration
- Food Traceability: FDA Issues Draft Enforcement Discretion Policy for Certain Small Retailers and Restaurants and Announces Public Meeting — US Food and Drug Administration
- FDA Public Meeting - Challenges and Solutions in Lot-Level Food Traceability — US Food and Drug Administration
- 21 CFR § 1.1310 - What definitions apply to this subpart? — Legal Information Institute, Cornell Law School
- 21 CFR § 1.1315 - What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold? — Legal Information Institute, Cornell Law School
- 21 CFR § 1.1340 - What records must I keep and provide when I ship a food on the Food Traceability List? — Legal Information Institute, Cornell Law School
- 21 CFR § 1.1345 - What records must I keep when I receive a food on the Food Traceability List? — Legal Information Institute, Cornell Law School
- 21 CFR § 1.1455 - How must records required by this subpart be maintained and made available? — Legal Information Institute, Cornell Law School