The short answer
Alcoholic beverages are split between two agencies. FDA covers facility registration, Prior Notice and food safety; TTB covers labels, formulas and importer permits. Many exporters only know about TTB and miss the FDA steps.
What exporters should watch for
🏭 FDA facility registration
Wineries, breweries and distilleries that make or bottle drinks for the U.S. must register with FDA as food facilities and name a U.S. Agent, renewing every even-numbered year. Each shipment needs Prior Notice.
🏷️ TTB labels and permits
Most wine (7% alcohol and above), beer (malt beverages) and spirits need a Certificate of Label Approval (COLA) from TTB, and the U.S. importer needs a TTB federal basic permit. Some products also need formula approval.
📋 FSVP exemption
Alcoholic beverages are exempt from FDA’s FSVP rule when the foreign facility follows the alcoholic beverage rules, so the U.S. importer usually does not need an FSVP for them. Non-alcoholic ingredients bought separately may still need one.
🍹 Low-alcohol and flavored drinks
Wine under 7% alcohol, and malt drinks not made with hops and malted barley, are labeled under FDA food rules instead of TTB, including Nutrition Facts. Flavors and colors must be allowed in U.S. food.
Common reasons shipments are stopped
- No FDA registration or Prior Notice
- No COLA or importer permit
- Unapproved colors or additives
- Low-alcohol products labeled under the wrong agency
- Missing allergen statements on FDA-labeled drinks
🏢 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
Do wineries and distilleries need FDA registration?
Yes. Facilities that make, bottle or store alcoholic beverages for the U.S. must register with FDA as food facilities, name a U.S. Agent and file Prior Notice for each shipment, in addition to meeting TTB’s label and permit rules.
Does a U.S. importer need an FSVP for wine or spirits?
Usually not. FDA’s FSVP rule exempts alcoholic beverages when the foreign facility follows the alcoholic beverage rules. The importer still needs TTB permits and approved labels.
Which low-alcohol drinks follow FDA labeling instead of TTB?
Wines under 7% alcohol by volume and some malt-based drinks that are not “malt beverages” under TTB rules are labeled under FDA food rules, with an ingredient list, allergens and Nutrition Facts.
Sources
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- eCFR — 21 CFR 1.501, FSVP exemptions (including alcoholic beverages)
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- FDA — Import Alerts by Publish Date
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.