The short answer
Hong Kong is a major re-export hub for goods made in mainland China and Southeast Asia, and it also has its own food, cosmetics and supplement makers. For FDA, the facility that makes or handles the product matters — not the trading company.
What Hong Kong exporters should watch for
📦 Re-exports
A Hong Kong trading company that never handles the goods does not register with FDA, but the manufacturer must — wherever it is. A Hong Kong warehouse or repacker that holds or relabels food for the U.S. must register, and Prior Notice must name the real manufacturer.
🦐 Seafood
Import Alert 16-131 lets FDA detain aquacultured shrimp, dace and eel from China and Hong Kong — including product farmed elsewhere but processed there — because of drug residues, unless the firm is on the Green List.
🥢 Sauces and snacks
Food plants register with FDA; acidified or low-acid canned foods need FCE/SID filings, and labels need English, Nutrition Facts and the U.S. major allergens.
✨ Cosmetics and supplements
Cosmetics need MoCRA facility registration and product listing; supplements need a Supplement Facts panel and structure/function claims only. Products with disease claims are unapproved drugs.
Common reasons Hong Kong shipments are stopped
- Drug residues in farmed shrimp, dace and eel
- Wrong facility registered for re-exports
- Labeling — Chinese-only text, undeclared allergens
- Disease claims on supplements and herbal products
- Cosmetics not registered or listed under MoCRA
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP agent 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 a Hong Kong trading company need FDA registration?
Not if it only buys and sells without handling the goods. The factory that makes the product must register with FDA, and so must any Hong Kong warehouse or repacker that holds or relabels food for the U.S. Prior Notice must identify the actual manufacturer.
Why is seafood from Hong Kong detained by FDA?
Import Alert 16-131 covers aquacultured shrimp, dace and eel from China and Hong Kong, including product processed in Hong Kong, because of residues such as malachite green and nitrofurans. Shipments are detained unless the firm is on the alert’s Green List.
Sources
- FDA Import Alert 16-131 — aquacultured shrimp, dace and eel from China and Hong Kong
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food 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.