The short answer
Cheese and dairy have some of FDA’s most specific rules: how long raw-milk cheese must be aged, what a named cheese must contain, and extra rules for “Grade A” products such as fluid milk.
What exporters should watch for
⏳ Raw-milk 60-day rule
Cheese made from unpasteurized milk must be aged at least 60 days at no less than 35°F (1.7°C) before sale in the U.S. Fresh and young raw-milk cheeses cannot be imported.
📏 Standards of identity
Many named cheeses — cheddar, mozzarella, parmesan, swiss and others — have FDA standards (21 CFR 133) covering moisture, fat and process. Products that don’t meet them need a different name.
🦠 Listeria
Soft and semi-soft cheeses are checked for Listeria monocytogenes; firms with positive results can be placed on import alerts and detained. Environmental monitoring and testing records matter.
🥛 Grade A products
Fluid milk and some other “Grade A” products have extra U.S. rules under the Pasteurized Milk Ordinance. Most imported dairy is cheese, butter and powders, which follow the general food rules.
Common reasons shipments are stopped
- Raw-milk cheese aged less than 60 days
- Listeria in soft cheeses
- Cheese names that don’t meet the standard
- Labeling — milk allergen, Nutrition Facts, net weight
- Facility not registered or no Prior Notice
🏢 No U.S. company to act as FSVP importer? Orionex can be your U.S. FSVP importer (FSVP agent) 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
Can raw-milk cheese be exported to the U.S.?
Yes, if it is aged at least 60 days at no less than 35°F (1.7°C). Raw-milk cheeses aged less than that, such as many fresh and soft cheeses, cannot be sold in the U.S. The plant must be registered with FDA.
Does imported butter or milk powder need special approval?
No special approval, but the plant must register with FDA and name a U.S. Agent, each shipment needs Prior Notice, and labels must meet U.S. rules. Some dairy products also have standards of identity, and Grade A fluid products have extra rules.
Sources
- eCFR — 21 CFR Part 133, Cheeses and related cheese products
- FDA — Import Alerts by Publish Date
- 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.