The short answer
Iceland’s FDA-regulated exports are mostly seafood — cod, haddock, salmon, stockfish — plus cod liver oil and skyr. Iceland is not in the EU, but U.S. rules apply the same as everywhere.
What Icelandic exporters should watch for
🐟 Cod and haddock
Fish processors register with FDA, name a U.S. Agent and follow seafood HACCP; each shipment needs Prior Notice. Labels must use the U.S. common name of the species.
🐠 Stockfish and dried fish
Dried fish must be fully gutted before drying — Import Alert 16-74 covers uneviscerated dried or salted fish because of the botulism risk. Dried fish heads and similar products need care.
💊 Cod liver oil
Cod liver oil sold as a dietary supplement needs a Supplement Facts panel and structure/function claims only; the facility registers as a food facility.
🥛 Skyr and dairy
Dairy plants register with FDA; labels need U.S. Nutrition Facts, milk declared as an allergen and net weight in ounces and grams.
Common reasons Icelandic shipments are stopped
- Uneviscerated dried or salted fish
- Seafood HACCP gaps
- Listeria in smoked or ready-to-eat fish
- Supplement claims that sound like disease claims
- Labeling — wrong species name, metric-only weights
🏢 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 Icelandic dried fish heads and stockfish be exported to the U.S.?
Yes, if the fish is fully eviscerated before drying, salting or smoking. Uneviscerated fish is covered by FDA Import Alert 16-74 because of the botulism risk. The facility must register with FDA and follow seafood HACCP.
Does cod liver oil need FDA registration?
The facility that makes or packs cod liver oil for the U.S. must register with FDA and name a U.S. Agent. Sold as a dietary supplement, it needs a Supplement Facts panel and only structure/function claims.
Sources
- FDA Import Alert 16-74 — uneviscerated fish
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- eCFR — 21 CFR Part 1 Subpart I, Prior Notice of Imported Food
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.