The short answer
Norway’s FDA-regulated exports to the U.S. are mostly seafood — farmed Atlantic salmon, cod, stockfish and other fish — plus fish oil and omega-3 supplements. Norway is not in the EU, but the U.S. rules are the same as for any other country.
What Norwegian exporters should watch for
🐟 Farmed salmon
Salmon processors must register with FDA, name a U.S. Agent and follow FDA’s seafood HACCP rule. Farmed fish is checked for residues of veterinary drugs not allowed in U.S. seafood, and ready-to-eat smoked salmon for Listeria.
🐠 Cod, stockfish and dried fish
Dried and salted fish must be fully gutted before drying or salting — FDA’s Import Alert 16-74 covers uneviscerated dried, salted and smoked fish because of the botulism risk.
💊 Fish oil and omega-3
Omega-3 products sold as dietary supplements need a Supplement Facts panel and structure/function claims only. The manufacturing facility registers with FDA as a food facility.
🏷️ Labels
Seafood labels need the U.S. common or usual name of the fish, fish declared as a major allergen, Nutrition Facts where required and net weight in ounces and grams.
Common reasons Norwegian shipments are stopped
- Listeria in smoked and ready-to-eat seafood
- Seafood HACCP gaps
- Uneviscerated dried or salted 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
Do Norwegian salmon exporters need FDA registration?
Yes. Processing plants and cold stores that handle salmon for the U.S. must register with FDA, name a U.S. Agent, follow seafood HACCP and file Prior Notice for each shipment. Fish farms are generally exempt from facility registration.
Can Norwegian stockfish be exported to the U.S.?
Yes, if the fish is fully eviscerated (gutted) before drying, as stockfish normally is. Uneviscerated dried or salted fish is covered by FDA Import Alert 16-74 because of the botulism risk. The facility must also register with FDA and follow seafood HACCP.
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.