The short answer
Georgia — the country in the Caucasus — exports wine, hazelnuts, mineral water, sauces and traditional sweets such as churchkhela to the U.S.
What Georgian exporters should watch for
🍷 Wine
Wineries, including traditional qvevri producers, must register with FDA as food facilities and file Prior Notice; label approval and permits go through TTB.
🌰 Hazelnuts
Hazelnut processors register with FDA; nuts are checked for aflatoxins and Salmonella and must be declared as tree nuts on labels.
💧 Mineral water
Mineral and bottled water are FDA-regulated foods: the bottling plant registers, follows 21 CFR Part 129 and must meet U.S. quality standards, with labels that match the water type.
🫙 Sauces and sweets
Tkemali and other sauces in sealed bottles may be acidified foods needing FCE/SID filings. Churchkhela and sweets need English labels with nuts declared.
Common reasons Georgian shipments are stopped
- Aflatoxins in hazelnuts
- Mineral water outside U.S. quality standards
- Acidified sauces without FCE/SID
- Undeclared tree nuts
- Labeling — Georgian-only text
🏢 No U.S. company to act as FSVP importer? Orionex can be your U.S. FSVP importer (FSVP agent) 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 Georgian mineral water need FDA registration?
Yes. Bottled and mineral water are foods in the U.S., so the bottling plant must register with FDA, name a U.S. Agent, follow 21 CFR Part 129 and meet U.S. bottled water quality standards. Each shipment needs Prior Notice.
Does a Georgian qvevri winery need FDA registration?
Yes. Every winery exporting to the U.S. must register with FDA as a food facility and file Prior Notice for each shipment. TTB separately handles label approval and import permits.
Sources
- eCFR — 21 CFR Part 129, Processing and bottling of bottled drinking water
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- FDA — Acidified & Low-Acid Canned Foods (LACF) registration
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.