The short answer
Switzerland exports medicines, chocolate, cheese, coffee products, luxury skincare and medical devices to the U.S. Swiss approvals and the Swiss quality reputation help with buyers, but FDA registration and U.S. rules apply in full.
What Swiss exporters should watch for
💊 Medicines
Swissmedic authorization does not apply in the U.S. Drug plants need FDA drug establishment registration, NDC and drug listing, and the product must be approved or legally marketed in the U.S. FDA can inspect Swiss plants.
🍫 Chocolate and confectionery
Chocolate makers register with FDA. Colors must be FDA-approved for food, labels need U.S. Nutrition Facts, and milk, soy, tree nuts and wheat must be declared as allergens.
🧀 Cheese
Raw-milk cheeses such as many Alpine cheeses must be aged at least 60 days at no less than 35°F (1.7°C) before sale in the U.S. — hard cheeses usually meet this easily.
✨ Skincare and devices
Luxury skincare needs MoCRA facility registration and product listing; anti-aging claims that promise to change the skin’s structure can make a product a drug. Devices need FDA registration, listing and often a 510(k).
Common reasons Swiss shipments are stopped
- Medicines without U.S. approval or FDA listing
- Drug-like claims on skincare
- Cosmetics not registered or listed under MoCRA
- Labeling — EU/Swiss format nutrition panel, metric-only weights
- Undeclared allergens in chocolate
🏢 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 Swissmedic approval count for the U.S. FDA?
No. Swissmedic approvals apply in Switzerland only. A medicine sold in the U.S. needs FDA approval or must meet an FDA monograph, and the manufacturing site needs FDA drug establishment registration, NDC and drug listing.
Can Swiss raw-milk cheese be exported to the U.S.?
Yes, if it is aged at least 60 days at no less than 35°F (1.7°C), the facility is registered with FDA and the label meets U.S. rules. Most Swiss hard cheeses are aged far longer than 60 days.
Sources
- eCFR — 21 CFR Part 133, Cheeses and related cheese products
- FDA — Is it a cosmetic, a drug, or both?
- FDA — Registration & Listing of Cosmetic Product Facilities and Products
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.