The short answer
Nuts are valuable exports — and FDA watches them closely for aflatoxin, Salmonella and allergen labeling.
| Requirement | What it means | Who |
|---|---|---|
| FDA food facility registration | Every facility that makes, packs or holds the food for the US registers with FDA and renews every two years (Oct–Dec of even years) | Your facility |
| U.S. Agent | Foreign facilities name a U.S. Agent on the registration | Your facility |
| FDA-compliant label | English label, ingredients, Nutrition Facts, allergens, net quantity, responsible business | Your facility / brand |
| Aflatoxin control | FDA acts above 20 ppb; test each lot | Your facility |
| Prior Notice | Filed with FDA before every shipment arrives | Exporter, importer, broker or Orionex |
| FSVP | The US importer verifies your food safety | FSVP importer (your buyer or Orionex) |
Aflatoxin: the main border risk
Aflatoxins are toxins made by moulds that grow on nuts and seeds in warm, humid conditions. Under FDA's Compliance Policy Guide 555.400, FDA recommends legal action when aflatoxins in human food are above 20 ppb. Brazil nuts, pistachios and peanuts are covered by their own separate guides.
- Test each lot with a validated method, from a properly drawn sample.
- Control drying, moisture and storage — most aflatoxin forms after harvest.
- Keep certificates of analysis ready for your importer.
Allergen labeling
Peanuts and tree nuts are major food allergens. The label must name the specific nut — “cashew”, “almond”, “walnut” — not just “nuts”. Sesame is also a major allergen. For mixes and products made on shared lines, make sure every nut present is declared.
Salmonella and processing
Nuts are usually eaten without cooking, so Salmonella control (roasting, pasteurization or another validated step) is a key part of your food safety plan. Your US importer will ask how you control it as part of its FSVP.
Nut butters: traceability from 2028
Tree nut and peanut butters are on FDA's Food Traceability List in all forms. Companies that make, pack or ship them for the US must keep key traceability records by July 20, 2028. Whole nuts are not on the list.
Example
A cashew processor in Vietnam or India registers with FDA, names a U.S. Agent, labels its packs “Cashews. Contains: cashew”, tests every lot for aflatoxin and keeps the results with each shipment's documents. Its US importer reviews the food safety plan and test records for FSVP.
Step by step: getting your nuts and seeds into the US
- 1Register your facility with FDAEvery facility that makes, packs or holds the product for the US registers, and renews between October 1 and December 31 of each even-numbered year. Foreign facilities name a U.S. Agent.
- 2Make the label US-readyEnglish text, the right name, ingredients, the correct facts panel, allergens, net quantity and the responsible business — plus the product-specific points above.
- 3Agree the import roles with your buyerWho is the importer of record, who is the FSVP importer, and which customs broker files the entry. See who does what.
- 4Send your food safety documentsYour FSVP importer needs evidence that hazards are controlled — food safety plan, certificates, test results.
- 5File Prior Notice for every shipmentFDA must receive it before arrival — at least 8 hours by sea, 4 hours by air or rail, and 2 hours by road.
Checklist
- FDA registration and U.S. Agent in place
- Aflatoxin tested per lot; results on file
- Validated Salmonella control step
- Specific nut names declared; sesame declared
- Nut butters: traceability records ready by July 20, 2028
- Prior Notice for every shipment; FSVP documents for your importer
Tell us your product — we send your US requirements in writing, free.
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
What aflatoxin level does FDA use for nuts?
For human foods covered by Compliance Policy Guide 555.400, FDA recommends legal action when aflatoxins are above 20 ppb (20 micrograms per kilogram). Brazil nuts, pistachios and peanuts have their own separate guides.
How must tree nuts be declared on the label?
Tree nuts are a major food allergen. The label must name the specific nut — for example almond, cashew or walnut — either in the ingredient list or in a “Contains” statement.
Are nut butters covered by the Food Traceability Rule?
Yes. Tree nut and peanut butters are on FDA’s Food Traceability List in all forms, including shelf-stable. The rule’s compliance date is July 20, 2028.
Are seeds treated like nuts?
Registration, Prior Notice and FSVP rules are the same. Sesame is a major food allergen and must be declared; other seeds are not major allergens, and seed butters are not on the Food Traceability List.
Who files Prior Notice for my shipments?
Anyone with the required information can file it — the exporter, the US importer, the customs broker or a consultant such as Orionex. It must reach FDA before the shipment arrives: at least 8 hours by sea, 4 hours by air or rail and 2 hours by road.
Sources
- FDA — Registration of Food Facilities and Other Submissions
- FDA — Prior Notice of Imported Foods
- FDA — FSVP Final Rule At-A-Glance
- FDA — Import Alerts (search by product, country and firm)
- FDA — CPG Sec. 555.400 Foods: Adulteration with Aflatoxin
- FDA — Food Allergen Labeling Guidance: Frequently Asked Questions
- FDA — Food Traceability List
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.