The short answer
Paraguay is a major source of yerba mate, stevia, sesame and chia for the U.S. Stevia is the product most often misunderstood: only highly purified extracts are allowed in food.
What Paraguayan exporters should watch for
🧉 Yerba mate
Yerba mate is a food (an herbal tea). Processing and packing plants register with FDA and name a U.S. Agent. Buyers expect testing for pesticide residues and polycyclic aromatic hydrocarbons from smoke drying.
🌿 Stevia
Only highly purified steviol glycosides with GRAS status may be used as sweeteners in U.S. food. Stevia leaves and crude extracts used in food fall under Import Alert 45-06, although leaf may be sold as a dietary supplement ingredient.
🌱 Sesame and chia
Sesame is a major allergen and has been linked to Salmonella; seed cleaners and packers register and should test lots. Chia seeds need the same Salmonella controls.
🥩 Beef is USDA
Beef and other meat are regulated by USDA FSIS, not FDA. Plants must be approved for export to the U.S. through USDA, so FDA registration does not apply.
Common reasons Paraguayan shipments are stopped
- Stevia leaf or crude extract used as a food sweetener
- Salmonella in sesame or chia
- Pesticides or PAHs in yerba mate
- Undeclared sesame allergen
- No Prior Notice or FSVP
🏢 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.
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
Can Paraguayan stevia be exported to the U.S.?
Highly purified steviol glycoside extracts with GRAS notices can be used as sweeteners. Whole stevia leaves and crude extracts cannot be added to conventional foods and are on Import Alert 45-06, but may be sold as dietary supplement ingredients.
Does yerba mate need FDA registration?
Yes. Facilities that process, pack or store yerba mate for the U.S. must register with FDA and name a U.S. Agent, and each shipment needs Prior Notice. The U.S. importer also needs an FSVP.
Sources
- FDA Import Alert 45-06 — stevia leaves, crude extracts and foods containing them
- FDA — Import Alerts by Publish Date
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.