The short answer
Austria is home to some of the world’s best-known energy drinks and exports pumpkin seed oil, wafers, chocolate, cheese, wine and natural cosmetics to the U.S. Energy drinks raise the most labeling questions.
What Austrian exporters should watch for
⚡ Energy drinks
An energy drink is sold either as a conventional beverage (Nutrition Facts, ingredients must be GRAS or approved) or as a dietary supplement (Supplement Facts). FDA expects the choice to match how the product is marketed. Declare the caffeine source in the ingredient list.
🎃 Pumpkin seed oil
Oil mills and bottlers register with FDA and name a U.S. Agent. Labels need Nutrition Facts and net quantity in fluid ounces and milliliters. Health claims about prostate or heart health need care under FDA claim rules.
🍫 Wafers, chocolate and cheese
Confectionery plants register; check every color against FDA’s approved list and declare hazelnuts as tree nuts. Raw-milk cheeses must be aged at least 60 days.
🍷 Wine and natural cosmetics
Wineries register with FDA and file Prior Notice; labels go through TTB. Natural cosmetics need MoCRA facility registration and product listing, and claims must stay cosmetic.
Common reasons Austrian shipments are stopped
- Energy drink labeled as a beverage but marketed as a supplement
- Unapproved colors or undeclared nuts
- Metric-only net quantity
- Raw-milk cheese aged under 60 days
- No Prior Notice or no FSVP
🏢 No U.S. company to act as FSVP importer? Orionex can be your U.S. FSVP importer (FSVP agent) 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 Austrian energy drinks need FDA approval?
No product approval is needed, but the bottling or canning facility must register with FDA and name a U.S. Agent. Every ingredient must be allowed in U.S. beverages, labels must follow U.S. rules, and each shipment needs Prior Notice.
Does Austrian pumpkin seed oil need FDA registration?
Yes. The oil mill and any bottler or warehouse must register with FDA and name a U.S. Agent, and the U.S. importer needs an FSVP for the oil.
Sources
- FDA — Distinguishing liquid dietary supplements from beverages (guidance)
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- 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.