The short answer
Nepal’s FDA-regulated exports to the U.S. are mostly orthodox tea, large cardamom, ginger, spices and herbal products. Small volumes mean every shipment counts — and the most common problems are easy to prevent.
What Nepali exporters should watch for
🍵 Orthodox tea
Tea factories and packers must register with FDA and name a U.S. Agent; each shipment needs Prior Notice. Pesticide residues must have a U.S. tolerance for tea.
🌿 Large cardamom and spices
Spices are tested for Salmonella (Import Alert 99-19), filth and mycotoxins. Smoke-dried large cardamom should be tested and stored dry.
🫚 Ginger
Fresh ginger needs USDA APHIS entry conditions; dried and processed ginger is an FDA food — the processing facility registers and lots are tested for Salmonella and pesticides.
🌱 Herbal products
Herbal products sold as dietary supplements need a Supplement Facts panel and structure/function claims only. Claims to treat disease make them unapproved drugs; test for heavy metals.
Common reasons Nepali shipments are stopped
- Salmonella and filth in spices
- Pesticide residues on tea
- Disease claims on herbal products
- Labeling — no Nutrition Facts, non-English text
- Facility not registered or 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 products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Does Nepali tea need FDA registration?
Yes. The tea factory and any packer or warehouse handling tea for the U.S. must register with FDA and name a U.S. Agent. Each shipment needs Prior Notice, and pesticide residues must be allowed on tea under U.S. rules.
Can Nepali herbal products be sold as supplements in the U.S.?
Yes, if they follow dietary supplement rules: a registered facility, a Supplement Facts panel, structure/function claims only and, for ingredients new to the U.S., an NDI notification. Disease claims make them unapproved drugs.
Sources
- FDA Import Alert 99-19 — Salmonella (notes separate alerts for black pepper from India and Brazil)
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- 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.