The short answer
Energy drinks are sold in the U.S. either as conventional beverages or as liquid dietary supplements. FDA’s guidance explains how to tell them apart, and the choice changes the label and the ingredient rules.
What exporters should watch for
🥤 Beverage or supplement
Drinks sold in large cans, marketed for refreshment or as a soft-drink alternative are usually conventional beverages with Nutrition Facts. Small “shots” marketed for a specific use can be supplements. FDA’s 2014 guidance sets out the factors.
☕ Caffeine
FDA cites 400 mg a day as an amount not generally linked to negative effects in healthy adults. Brands commonly state caffeine content per can and add advisory statements for children and pregnant women.
🧪 Ingredients
In a conventional beverage, ingredients such as taurine, herbal extracts and vitamins must be GRAS or approved for that use. Some botanicals allowed in supplements are not allowed in beverages.
🏭 Registration and labels
Bottlers and canners register with FDA and name a U.S. Agent. Labels need U.S. units (fl oz), allergens and either Nutrition Facts or Supplement Facts.
Common reasons shipments are stopped
- Supplement label on a product marketed as a soft drink
- Ingredients not allowed in beverages
- Missing caffeine or advisory information expected by buyers
- Metric-only volumes
- 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 an energy drink a food or a supplement in the U.S.?
Either is possible. FDA looks at the product’s name, packaging, serving size, marketing and how people consume it. Drinks marketed like soft drinks are conventional beverages.
Is there a U.S. caffeine limit for energy drinks?
FDA has not set a specific limit for energy drinks, but cites 400 mg a day as generally safe for healthy adults. Caffeine must be listed as an ingredient, and stating the amount per serving is standard practice.
Does an energy drink bottler need FDA registration?
Yes. Facilities that make, bottle or store drinks for the U.S. must register with FDA, name a U.S. Agent and file Prior Notice for each shipment.
Sources
- FDA — Guidance: Distinguishing Liquid Dietary Supplements from 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.