The short answer
South Africa exports macadamias, citrus, rooibos, wine, fruit and cosmetics to the U.S. Most of these are FDA-regulated foods, and each has a specific point to get right.
What South African exporters should watch for
🥜 Macadamias and nuts
Nut processors must register with FDA and name a U.S. Agent. Nuts are checked for Salmonella and aflatoxins, and tree nuts are a major allergen that must be declared on labels.
🍵 Rooibos and herbal tea
Rooibos processors and packers register with FDA. Labels can describe flavor and origin; claims that rooibos treats or prevents disease would make it a drug in the U.S.
🍷 Wine
Wineries register with FDA as food facilities and file Prior Notice; labels and permits go through TTB.
🍊 Citrus and cosmetics
Fresh citrus needs USDA APHIS approval as well as FDA produce rules. Cosmetics — including marula and rooibos skincare — need MoCRA facility registration and product listing.
Common reasons South African shipments are stopped
- Salmonella or aflatoxins in nuts
- Health claims on rooibos and herbal products
- Undeclared allergens such as tree nuts
- Cosmetics not registered or listed under MoCRA
- Labeling — no Nutrition Facts, metric-only net quantity
🏢 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 rooibos need FDA registration?
Yes. Facilities that process or pack rooibos for the U.S. must register with FDA and name a U.S. Agent, each shipment needs Prior Notice, and the label must meet U.S. rules. Disease claims on the label would make it an unapproved drug.
Do South African macadamia exporters need FDA registration?
Yes. Cracking, processing and packing facilities must register with FDA and name a U.S. Agent. U.S. buyers will also ask for Salmonella and aflatoxin controls, since nuts are tested at the border.
Sources
- FDA Import Alert 99-19 — Salmonella (notes separate alerts for black pepper from India and Brazil)
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- FDA — Registration & Listing of Cosmetic Product Facilities and Products
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.