The short answer
Uruguay exports honey, Tannat and other wines, rice, dairy and citrus to the U.S. (beef goes through USDA). Honey is the product FDA checks most closely.
What Uruguayan exporters should watch for
🍯 Honey
Honey is checked for unsafe drug residues (Import Alert 36-04) and economic adulteration (99-47). Packers register with FDA and should test each lot for residues and authenticity.
🍷 Wine
Wineries register with FDA as food facilities and file Prior Notice; labels and permits go through TTB.
🍚 Rice
Mills and packers register; rice is checked for pesticide residues and filth, and labels need Nutrition Facts.
🧀 Dairy and citrus
Dairy plants register; raw-milk cheese must be aged at least 60 days at no less than 35°F (1.7°C). Fresh citrus needs USDA APHIS approval as well as FDA produce rules.
Common reasons Uruguayan shipments are stopped
- Residues or adulteration in honey
- Pesticide residues in rice
- Raw-milk cheese aged less than 60 days
- Labeling — Spanish-only labels
- No FSVP at the U.S. importer
🏢 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
Does Uruguayan honey need FDA registration?
Yes. Honey packers, blenders and storage facilities must register with FDA and name a U.S. Agent, and each shipment needs Prior Notice. Lot testing for drug residues and authenticity protects against detention.
Does Uruguayan beef need FDA registration?
No. Beef is regulated by USDA FSIS, and only plants approved under the USDA system can export it to the U.S. FDA registration applies to other foods such as honey, rice and dairy.
Sources
- FDA — Import Alerts by Publish Date
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- eCFR — 21 CFR Part 133, Cheeses and related cheese products
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.