The short answer
Ice cream has a legal definition in the U.S., and frozen desserts have been linked to Listeria outbreaks. Product names, sanitation and dairy import rules all matter.
What exporters should watch for
📏 What counts as “ice cream”
Under 21 CFR 135.110, ice cream must contain at least 10% milkfat and 20% total milk solids and weigh at least 4.5 lb per gallon. Products below that are sold under other names, such as “frozen dairy dessert”.
🦠 Listeria control
Frozen desserts have been linked to Listeria outbreaks. Plants need strong sanitation, environmental monitoring and pasteurization controls under FDA preventive controls rules.
🧾 Dairy import quota
Some dairy products, including ice cream, fall under U.S. tariff-rate quotas. Imports above the quota pay a much higher duty, so check this with your importer early.
🏷️ Labels
Mochi, gelato and sorbet need U.S. Nutrition Facts, allergens (milk, eggs, wheat, nuts) and approved colors. Plants register with FDA and name a U.S. Agent.
Common reasons shipments are stopped
- Called “ice cream” without meeting the standard
- Listeria found in testing
- Unapproved colors
- Missing allergens such as milk or nuts
- Quota and duty surprises at entry
🏢 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
What is the U.S. definition of ice cream?
Ice cream must contain at least 10% milkfat and 20% total milk solids and weigh at least 4.5 pounds per gallon (21 CFR 135.110). Products below that are named differently, for example “frozen dairy dessert”.
Do ice cream factories need FDA registration?
Yes. Facilities making frozen desserts for the U.S. must register with FDA, name a U.S. Agent, follow preventive controls and file Prior Notice for each shipment.
Is gelato regulated differently from ice cream?
“Gelato” has no U.S. standard of identity. If a gelato meets the ice cream standard it may be called ice cream; otherwise it is sold as gelato with an accurate description.
Sources
- eCFR — 21 CFR Part 135, Frozen desserts
- 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.