The short answer
Bolivia is the world’s largest exporter of Brazil nuts and a major source of quinoa and chia. Aflatoxins in nuts and filth or pesticides in grains are the main FDA risks.
What Bolivian exporters should watch for
🥜 Brazil nuts
Brazil nuts are prone to aflatoxins, so processors control drying and storage and test each lot. Processing plants register with FDA, and nuts must be declared as tree nuts.
🌾 Quinoa
Cleaning, washing and packing plants register with FDA. Quinoa is checked for pesticide residues and filth; organic claims must meet USDA organic rules.
🌱 Chia and grains
Chia and other seeds are tested for Salmonella and filth; labels need Nutrition Facts and net weight in ounces and grams.
☕ Coffee and cocoa
Coffee and cocoa processors and warehouses register with FDA; farms that only grow and dry their own crops are generally exempt.
Common reasons Bolivian shipments are stopped
- Aflatoxins in Brazil nuts
- Pesticide residues in quinoa
- Salmonella and filth in seeds
- Undeclared tree nuts
- Labeling — Spanish-only labels
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP agent service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Why are Bolivian Brazil nuts tested by FDA?
Brazil nuts can develop aflatoxins — toxins from mold — if they are not dried and stored properly. FDA tests imported nuts, and lots above U.S. limits are refused. Good drying, sorting and lot testing are the best protection.
Does Bolivian quinoa need FDA registration?
Yes. Facilities that clean, wash, sort or pack quinoa for the U.S. must register with FDA and name a U.S. Agent, and each shipment needs Prior Notice.
Sources
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- eCFR — 21 CFR Part 1 Subpart I, Prior Notice of Imported Food
- FDA Import Alert 99-19 — Salmonella (notes separate alerts for black pepper from India and Brazil)
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.