The short answer
New Zealand was the first country whose food safety system FDA recognized as comparable, in 2012. That makes life easier for U.S. importers — but New Zealand facilities still need FDA registration, a U.S. Agent, Prior Notice and U.S.-compliant labels.
What New Zealand exporters should watch for
🤝 Systems recognition
Under the 2012 arrangement, U.S. importers can use modified FSVP requirements for food from New Zealand suppliers in good standing with MPI, when the food is not for further processing. Facility registration and labeling rules are unchanged.
🍯 Manuka honey
Honey packers must register with FDA. Grading terms such as UMF or MGO are fine, but health claims like “heals wounds” or “treats infections” make honey an unapproved drug in the U.S. Medical-grade wound honey is a medical device.
🍷 Wine and dairy
Wineries register with FDA as food facilities, with labels approved by TTB. Dairy processors register too; many dairy products have extra U.S. requirements, so check the product before shipping.
💊 Supplements
Products sold as dietary supplements need a Supplement Facts panel and structure/function claims only. FDA lists New Zealand firms on alerts for unapproved new drugs (66-41), often for products making disease claims.
Common reasons New Zealand shipments are stopped
- Health claims on manuka honey and supplements
- Labeling — NZ nutrition panel, metric-only net quantity
- Economic adulteration concerns (Import Alert 99-47)
- Undeclared sulfites or colors
- No Prior Notice or facility not registered
🏢 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 products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Can manuka honey be sold in the U.S. with health claims?
No. In the U.S., a claim that honey treats, heals or prevents a disease makes it a drug. Manuka honey sold as food can use grading terms such as UMF or MGO and describe taste and origin, but not disease claims. Wound-care honey products are regulated as medical devices.
Does systems recognition mean New Zealand exporters skip FDA registration?
No. Systems recognition helps U.S. importers meet FSVP with less paperwork, but every New Zealand food facility exporting to the U.S. must still register with FDA, name a U.S. Agent, file Prior Notice and use U.S. labels.
Sources
- FDA — Systems Recognition (Food)
- FDA — Import alerts for New Zealand
- FDA — Is it a cosmetic, a drug, or both?
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.