The short answer
Sweden exports oat drinks, crispbread, candy, seafood and cosmetics to the U.S., and is one of Europe’s strongest medical device exporters. Each product type has its own FDA route.
What Swedish exporters should watch for
🥛 Oat and plant-based drinks
Plant-based drinks are FDA-regulated foods. FDA’s draft guidance suggests clear names such as “oat beverage” or “oat milk” and, where relevant, a statement comparing nutrients with cow’s milk. Plants register and name a U.S. Agent.
🍬 Crispbread, candy and licorice
Bakeries and candy makers register. Colors must be on FDA’s approved list, and licorice should stay within the glycyrrhizin levels allowed under FDA’s GRAS rule for licorice (21 CFR 184.1408).
🩺 Medical devices
Swedish device makers must register their establishment with FDA, pay the annual FDA fee, list each device and name a U.S. Agent. Most Class II devices also need 510(k) clearance.
✨ Cosmetics
Cosmetic manufacturers need MoCRA facility registration and product listing, with a U.S. contact on the label for adverse event reports. Claims must stay cosmetic.
Common reasons Swedish shipments are stopped
- Unapproved colors in candy
- Plant-based drinks with misleading dairy names
- Devices without registration, listing or 510(k)
- Cosmetics with drug claims
- No Prior Notice for food shipments
🏢 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 Swedish medical device companies need FDA registration?
Yes. Foreign device establishments must register with FDA, pay the annual establishment fee, list their devices and name a U.S. Agent before exporting. Many devices also need 510(k) clearance or another premarket route.
Can a Swedish oat drink be called “oat milk” in the U.S.?
FDA’s draft guidance on plant-based milk alternatives accepts names like “oat milk” as long as the plant source is clear, and recommends a voluntary statement on how its nutrients compare with dairy milk.
Sources
- FDA — Plant-based milk alternatives labeling (draft guidance)
- FDA — Device registration and listing
- FDA — Registration & Listing of Cosmetic Product Facilities and 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.