The short answer
Czech beer and herbal liqueurs are well known in the U.S., alongside wafers, confectionery, spa cosmetics and a growing medical device sector. Alcohol needs both FDA and TTB.
What Czech exporters should watch for
🍺 Beer and spirits
Breweries and distilleries must register with FDA as food facilities and file Prior Notice. Label approval (COLA), permits and import rules are handled by TTB, and the U.S. importer needs a TTB importer’s permit.
🧇 Wafers and confectionery
Factories register with FDA. Check colors against FDA’s list, declare hazelnuts, milk, soy and wheat, and use U.S. Nutrition Facts and serving sizes.
🧖 Spa cosmetics
Spa salts, mud and natural cosmetics need MoCRA facility registration and product listing. Claims that they treat skin conditions or relieve pain would make them drugs.
🩺 Medical devices
Czech device makers register their establishment, pay the annual FDA fee, list devices and name a U.S. Agent. Most Class II devices also need 510(k) clearance.
Common reasons Czech shipments are stopped
- No TTB permits or label approval for alcohol
- Unapproved colors in confectionery
- Therapeutic claims on spa products
- Device not registered or listed
- No Prior Notice
🏢 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 Czech beer need FDA registration?
Yes. Breweries that make or bottle beer for the U.S. must register with FDA and name a U.S. Agent, and each shipment needs Prior Notice. Labels and permits are handled separately by TTB.
Do Czech spa cosmetics need FDA registration?
Under MoCRA, facilities that make cosmetics for the U.S. must register with FDA and list each product. Products that claim to treat skin or joint conditions are regulated as drugs instead.
Sources
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- FDA — Registration & Listing of Cosmetic Product Facilities and Products
- FDA — Is it a cosmetic, a drug, or both?
- FDA — Device registration and listing
- 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.