The short answer
Ukraine is one of the world’s largest sunflower oil exporters and a major source of honey, frozen berries, walnuts and confectionery for the U.S. Honey gets the most FDA attention.
What Ukrainian exporters should watch for
🌻 Sunflower oil
Crushing plants, refineries and bottlers must register with FDA and name a U.S. Agent; each shipment needs Prior Notice. Labels need Nutrition Facts and net quantity in U.S. units and metric.
🍯 Honey
Honey is checked for unsafe drug residues (Import Alert 36-04) and for economic adulteration with cheaper syrups (99-47). Test each lot for residues and authenticity and keep the results.
🫐 Frozen berries
Frozen berries have been linked to viral outbreaks in other markets, so U.S. buyers expect strong hygiene controls, water testing and lot traceability. Freezing and packing plants register with FDA.
🥜 Walnuts and confectionery
Nut processors register; walnuts are checked for Salmonella and aflatoxins and must be declared as tree nuts. Confectionery must use FDA-approved colors only.
Common reasons Ukrainian shipments are stopped
- Residues or adulteration in honey
- Salmonella or aflatoxins in nuts
- Unapproved colors in confectionery
- Labeling — Cyrillic-only text, metric-only weights
- 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 Ukrainian honey need FDA registration?
Yes. Honey packers and storage facilities that handle honey for the U.S. must register with FDA and name a U.S. Agent, and each shipment needs Prior Notice. Honey is tested for drug residues and adulteration, so lot testing matters.
Do Ukrainian sunflower oil exporters need FDA registration?
Yes. Plants that crush, refine, bottle or store sunflower oil for the U.S. must register with FDA and name a U.S. Agent. The U.S. importer also needs an FSVP for the oil.
Sources
- FDA Import Alert 36-04 — honey and blended syrup
- 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.