The short answer
Denmark is home to some of the world’s largest makers of insulin and diabetes medicines and food enzymes, and also exports cheese, butter cookies, fish oil and seafood to the U.S.
What Danish exporters should watch for
💊 Medicines
Danish drug plants need FDA drug establishment registration, NDC and drug listing every year. Under the EU–US MRA, FDA can rely on EU GMP inspections, which can reduce FDA inspections but not registration.
🧀 Dairy and cheese
Dairy plants register with FDA. Raw-milk cheeses must be aged at least 60 days at no less than 35°F (1.7°C); labels need U.S. Nutrition Facts and milk declared as an allergen.
🍪 Butter cookies
Bakeries register with FDA; labels need English ingredients, Nutrition Facts and the U.S. major allergens (wheat, milk, egg).
🐟 Fish oil and enzymes
Fish oil sold as a dietary supplement needs a Supplement Facts panel and structure/function claims only. Food enzymes and ingredients must be GRAS or approved for their use in the U.S.
Common reasons Danish shipments are stopped
- Drug listings not renewed or out of date
- Raw-milk cheese aged less than 60 days
- Labeling — EU nutrition panel, metric-only weights
- Food ingredients without U.S. GRAS or approval status
- Supplement claims that sound like disease claims
🏢 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 Danish pharmaceutical plants need FDA registration under the MRA?
Yes. The EU–US Mutual Recognition Agreement lets FDA rely on EU GMP inspections, but every plant making drugs for the U.S. must still register with FDA every year, have an NDC labeler code and list its drugs.
Can a food enzyme approved in the EU be used in U.S. foods?
Only if it is GRAS or approved as a food additive for that use in the U.S. EU approval does not carry over, so check the enzyme’s U.S. status before selling to U.S. food manufacturers.
Sources
- EMA — EU–US mutual recognition agreement for inspections
- eCFR — 21 CFR Part 133, Cheeses and related cheese 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.