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FSMA 204 for importers: what you keep when your supplier is overseas

, 5 minute read

It depends on whether you hold the food. FDA’s traceability rule FAQs (item TIM.1) say importers that physically hold food on the Food Traceability List are subject to the rule for the events that apply to them, most likely receiving and shipping. Importers that “do not physically possess” listed food are not subject to it.

This guide covers who is covered, how the rule differs from the import safety program (FSVP), which records an importer keeps, and what to ask your overseas suppliers for.

Does FSMA 204 apply to imported food?

Yes. FDA’s FAQ (TIM.2) says the recordkeeping requirements “apply to imported Food Traceability List (FTL) foods.” Foreign farms, packers, manufacturers and distributors are covered too, unless an exemption applies (TIM.4). They are responsible for the parts of the rule that apply to their own events, and FDA may inspect them (TI.7).

Check first that your food is on the list. Our guide to the Food Traceability List walks through each category.

Is this the same as FSVP?

No. They are different rules with different purposes. FDA’s FSVP page says an FSVP importer is “the U.S. owner or consignee of a food offered for import into the United States.” FSVP asks that person to verify, based on risk, that a foreign supplier’s food is safe. It is about hazards and supplier performance.

The traceability rule is about records that let a lot be followed through the supply chain. FDA’s FAQ (TIM.5) says FDA does not routinely expect to request traceability records from FSVP importers, but it may. So an importer should plan for both sets of duties, and treat the traceability records as their own task.

Which records does an importer keep?

It follows the events you perform. An importer that takes the food into a warehouse usually has two.

Receiving. 21 CFR 1.1345 asks for, linked to each lot:

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

Shipping. 21 CFR 1.1340 asks for the lot code, quantity, product description, the location you shipped from and the next recipient (not a transporter), the ship date, the lot code source, and a reference document. You must also give the first seven of those items to the next recipient.

If you only pass the food along and never transform it, those are the two events that matter. If you repack or cut it, add the records in our transformation guide.

Do I have to record the customs entry number?

No. FDA’s FAQ (TIM.3) says there is “no requirement for any covered entity to record or send the entry number assigned to an imported FTL food.” You may still keep it. The rule asks you to record a reference document type and number, such as a commercial invoice or bill of lading you already receive. It does not name one particular document.

Do I have to collect all the upstream data?

Not by default. The same FAQ ties an importer’s duties to what it does with the food and the tracking events it performs. In other words, a covered entity only has to meet the parts of the rule that apply to the events it carries out. FDA also “encourages U.S. importers to work with their foreign suppliers” so they understand the requirements (TG.2).

In practice, your receiving record needs a lot code and a lot code source from someone. If your supplier does not send one, a gap appears the first time FDA or a buyer asks you to trace a lot. Our guide on traceability lot codes explains who assigns them.

What should I ask my overseas suppliers for?

This is a practical checklist, not a legal requirement. Ask each supplier for:

  • The traceability lot code on every case or pallet label, and on the invoice or packing list
  • The location of the lot code source, such as the packing house or factory
  • A clear product description that matches what you will record
  • Shipping dates and the location description of where it left
  • A contact who can answer a trace-back question quickly
  • Whether they believe an exemption applies, and on what basis

Put the answers in writing. If a supplier says it is exempt, remember that exemptions have conditions and sit in 21 CFR 1.1305. See our exemptions guide and check with FDA or a food safety professional.

How long do I keep records, and when does this start?

Under 21 CFR 1.1455, records are kept for 2 years and must be available to FDA within 24 hours of a request. Our record retention guide covers the detail.

On timing, FDA’s rule page says the compliance date “was Tuesday, January 20, 2026.” FDA proposed to extend it by 30 months to July 20, 2028, and Congress directed FDA not to enforce the rule before that date. Buyers may ask sooner, as our retailer guide explains.

Where Lotcrumb fits

Lotcrumb is being built to read the commercial invoices, packing lists and bills of lading you already receive, pull out lot codes and key data elements, and produce a sortable spreadsheet on request. Join the waitlist for early access.

This guide is general information, not legal or regulatory advice. Import rules depend on your products and supply chain, so confirm your duties with FDA or a qualified professional.