The short answer
Kombucha and other fermented drinks are FDA foods — as long as they stay below 0.5% alcohol by volume. Because they keep fermenting in the bottle, alcohol control is the most important compliance point.
What exporters should watch for
🍺 The 0.5% alcohol line
Drinks with less than 0.5% alcohol by volume are regulated by FDA as food. At 0.5% or more, kombucha is an alcoholic beverage under TTB rules, with permits, taxes and different labels.
🫧 Alcohol in the bottle
Live kombucha can keep fermenting after bottling, especially if it warms up during shipping. Test alcohol at bottling and at the end of shelf life, and control temperature.
🏭 Registration and safety
Breweries register with FDA as food facilities and name a U.S. Agent; most need a food safety plan with controls for pH, fermentation and sanitation. Each shipment needs Prior Notice.
🏷️ Labels
Labels need Nutrition Facts, ingredients (including any added sugar and caffeine sources) and net quantity in fluid ounces and metric. Health claims about “detox” or curing disease make it a drug.
Common reasons shipments are stopped
- Alcohol at or above 0.5% in an FDA-labeled drink
- Unstable products that keep fermenting
- Health claims such as detox or disease treatment
- Labeling — missing Nutrition Facts or added sugars
- Facility not registered or 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 product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Is kombucha regulated by FDA or TTB?
By FDA if it contains less than 0.5% alcohol by volume — throughout its shelf life. At 0.5% or more it is an alcoholic beverage regulated by TTB. Because kombucha can keep fermenting, test alcohol at bottling and at the end of shelf life.
Does a kombucha brewery need FDA registration?
Yes. A brewery making non-alcoholic kombucha for the U.S. must register with FDA as a food facility, name a U.S. Agent and file Prior Notice for each shipment, and most need a written food safety plan.
Sources
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- eCFR — 21 CFR Part 1 Subpart I, Prior Notice of Imported Food
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.