The short answer
Bottled water is a food in the U.S., with its own processing rules and quality standards. Names like “mineral water” and “spring water” have legal definitions, so the label must match the water.
What exporters should watch for
🏭 Registration and processing
Bottling plants must register with FDA, name a U.S. Agent and follow the bottled water processing rules in 21 CFR Part 129 — source protection, sanitation, testing and records.
🧪 Quality standards
Bottled water must meet FDA’s quality standards for microbiological, chemical, physical and radiological contaminants (21 CFR 165.110). Test the source and finished product regularly.
🏷️ Names
“Mineral water” must contain at least 250 ppm total dissolved solids from the source; “spring water” must come from an underground formation that flows naturally to the surface. Other names such as artesian and purified water also have definitions.
📦 Labels
Labels need the correct name, net quantity in fluid ounces and metric, and the name and place of business. Added minerals or flavors change the name and labeling.
Common reasons shipments are stopped
- Contaminants above U.S. quality standards
- Wrong name — “mineral” or “spring” that doesn’t meet the definition
- Plant not registered
- Labeling — metric-only volume
- 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
Does bottled water need FDA registration?
Yes. Bottled water is a food, so the bottling plant must register with FDA, name a U.S. Agent and follow 21 CFR Part 129, and each shipment needs Prior Notice. The water must meet U.S. quality standards.
What qualifies as “mineral water” in the U.S.?
Water with at least 250 ppm of total dissolved solids that comes from a protected underground source, with no minerals added. Water below that level, or with added minerals, must use a different name.
Sources
- eCFR — 21 CFR Part 129, Processing and bottling of bottled drinking water
- eCFR — 21 CFR 165.110, Bottled water
- 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.