FSMA 204 for restaurants and retailers: what they keep and ask suppliers for

Restaurants and retail food establishments are covered by the FDA Food Traceability Rule unless they are small enough to be exempt. The main thing a covered restaurant or store must do is keep receiving records for Food Traceability List foods. If you sell to them, those records are built from the lot codes and shipping details you send. FDA has also drafted a plan, not yet final, to hold off enforcing the rule on restaurants and stores with average annual food sales between $250,000 and $1 million. This guide explains who is in, who is out, what they keep, and what it means for a supplier.

Are restaurants and stores covered by FSMA 204?

Yes, unless an exemption applies. FDA’s October 2026 draft guidance describes the rule as covering persons who manufacture, process, pack or hold foods on the Food Traceability List. It also describes the small retail and restaurant exemption in the rule itself.

21 CFR 1.1305(i) says the rule does not apply to a retail food establishment or restaurant with an average annual monetary value of food sold or provided of no more than $250,000 over the previous 3 years, on a rolling basis, adjusted for inflation using 2020 as the baseline year.

Above that line, a restaurant or store is covered. Our guide to FSMA 204 exemptions covers the other exemptions.

What changes between $250,000 and $1 million in sales?

Two things, one in the rule and one proposed.

• In the rule: FDA’s draft guidance says retail food establishments and restaurants averaging more than $250,000 but no more than $1,000,000 over 3 years (rolling, inflation-adjusted) are exempt from the electronic sortable spreadsheet requirement, so the rule’s threshold for that exemption is $1 million. They can give FDA the required information in another format. The citation is 21 CFR 1.1455(c)(3)(iii)(B).
• Proposed: In the same draft guidance, FDA says it intends to use enforcement discretion for all requirements of the rule for restaurants and stores in that same $250,000 to $1,000,000 band. The document is dated October 2026, is marked as a draft for comment and says it contains nonbinding recommendations. Until FDA finalizes it, treat it as a signal, not a rule.

Check your customers’ status before you assume anything. A customer’s sales size is their business, and you may not know it.

What must a covered restaurant or store record?

The core event is receiving. 21 CFR 1.1345(a) lists the key data elements to keep when you receive a Food Traceability List food:

1. The traceability lot code
2. The quantity and unit of measure
3. The product description
4. The location description for the immediate previous source (other than a transporter)
5. The location description for where the food was received
6. The date received
7. The location description for the traceability lot code source, or the lot code source reference
8. The reference document type and number

Restaurants and stores may also have shipping or transformation records, depending on what they do with the food. A restaurant that cooks or combines listed foods, for example, should read the transformation section of the rule. Our key data elements guide walks through each event.

Covered businesses must also keep a traceability plan, keep records for 2 years and provide records to FDA within 24 hours of a request (or a reasonable time FDA has agreed to). The draft guidance summarizes these points in its background section. See our record retention guide.

What if the supplier is exempt or the food comes straight from a farm?

The rule has special handling here. Under 21 CFR 1.1345(b), when food arrives from a person the subpart does not apply to, the receiver keeps similar receiving details, but the lot-code item in paragraph (b)(1) does not apply to a retail food establishment or restaurant.

21 CFR 1.1305(j) is a partial exemption for a restaurant or store that buys directly from a farm. Where it applies, the rest of the subpart does not, and the buyer must keep a record of the farm’s name and address for 180 days, according to the Cornell Legal Information Institute’s text of the section. Read the paragraph for the conditions on the farm’s sale and shipment.

What does this mean if you supply restaurants and stores?

A covered customer cannot fill in its receiving record if your paperwork leaves out the pieces. The practical risk is a gap between what you ship and what they need to write down. Here is a short, illustrative checklist for suppliers:

• Put the traceability lot code on the case label, the packing slip and the invoice, so the same code shows up everywhere.
• Print the product description, quantity and unit of measure the same way every time.
• Show your location description and the ship-to location, plus the ship date, on the document that travels with the load.
• Give each shipment a reference document number the customer can quote back to you.
• Keep your own copy. If you are covered and a customer is traced back to you, FDA’s 24-hour request lands on you too.

Whether a given customer needs all this depends on their exemption status. Some may ask anyway, since buyers can set their own supplier rules, as our post on retailer traceability demands explains.

When do these rules start to be enforced?

FDA’s rule page says the original compliance date was January 20, 2026. FDA proposed to extend the compliance date by 30 months to July 20, 2028, and Congress directed FDA not to enforce the rule before that same date. FDA says it intends to comply with this directive.

Where Lotcrumb fits

Lotcrumb is being built to read the invoices, bills of lading and case labels you already send and pull the lot codes and key data elements into one place, so a customer or FDA request becomes an export. Join the waitlist for early access.

This guide is general information, not legal or regulatory advice. Exemptions depend on your customers’ facts and on rules FDA may change, so confirm them with FDA guidance or a food safety professional.