The short answer
Romania exports acacia honey, sunflower oil, plum brandy, wine, cheese and cosmetics to the U.S. Honey gets the most FDA attention, and spirits also need TTB.
What Romanian exporters should watch for
🍯 Acacia honey
Honey is one of FDA’s most watched imports, for drug residues and for adulteration with cheaper syrups. Packers register with FDA and should keep residue and authenticity test results for every lot.
🌻 Sunflower oil
Crushing plants, refineries and bottlers register and name a U.S. Agent. Labels need Nutrition Facts and net quantity in U.S. units and metric.
🍑 Plum brandy and wine
Distilleries and wineries register with FDA and file Prior Notice. COLA label approval and importer permits go through TTB.
✨ Cosmetics
Romanian cosmetic makers need MoCRA facility registration and product listing. Anti-aging claims must stay cosmetic; claims about treating skin conditions make a product a drug.
Common reasons Romanian shipments are stopped
- Residues or adulteration in honey
- No TTB approval for spirits
- Drug claims on cosmetics
- Metric-only or Romanian-only labels
- No FSVP at the U.S. importer
🏢 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
Does Romanian honey need FDA registration?
Yes. Honey packers and storage facilities must register with FDA and name a U.S. Agent, and each shipment needs Prior Notice. Lot testing for residues and authenticity is strongly recommended.
Can Romanian plum brandy be exported to the U.S.?
Yes. The distillery must register with FDA and the shipment needs Prior Notice. The U.S. importer needs a TTB importer’s permit and approved labels (COLA).
Sources
- FDA Import Alert 36-04 — honey and blended syrup
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- FDA — Registration & Listing of Cosmetic Product Facilities and Products
- 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.