According to the USDA Foreign Agricultural Service, Taiwan’s agri-food exports to the United States keep growing — and so does the number of Taiwanese food shipments detained by FDA. The most common reason is not food safety; it is paperwork: the facility was never registered, no Prior Notice was filed, the ingredient list was in the wrong order. In other words, many shipments are not bad products — they simply never finished the process.
The first question most producers ask is “How do I apply for FDA certification?” The answer may surprise you: FDA has no certification scheme for ordinary food. FDA will not issue you a certificate. It wants three things: your plant is registered, each shipment is announced before it leaves, and someone on the import side is responsible for your food safety. Internally we call these the “three gates.” Walk through them in order and you will not get stuck.
Gate one: Food Facility Registration
If your plant manufactures, processes, packs or holds food for sale in the US, it must register with FDA (FFR). Registration is free, but three conditions are often overlooked:
- You must name a U.S. Agent with a physical US address and phone number — not a PO box or an answering service
- Registration must be renewed every two years, between 1 October and 31 December of even-numbered years; miss it and the registration lapses and cargo is refused at the port
- You receive a registration number that customs entries and Prior Notices will use
Most “FDA registration services” only do this step. It matters, but it is only the ticket in.
Gate two: Prior Notice
This is the step most Taiwanese producers have never heard of. Before any food shipment arrives in the US, a Prior Notice must be filed through FDA’s system stating what the goods are, which plant they come from, who imports them and which port they use. The deadline depends on the mode of transport:
- Air: at least 4 hours before arrival
- Sea: at least 8 hours before arrival
- Road: at least 2 hours before arrival
- International mail: before the package is sent
The notice is usually filed by the broker or importer, but the data comes from the exporter: registration number, product code, lot number, quantity. We once handled a shipment of tea bags from Hsinchu where the exporter assumed the forwarder would file, the forwarder assumed the broker would, and nobody did. The cargo sat in Los Angeles for five extra days, and the cold-storage and demurrage charges exceeded the freight.
Gate three: FSVP supplier verification
Once the cargo is in the US, FDA has one more check. Under FSMA, the US importer must run a Foreign Supplier Verification Program (FSVP) proving it has evaluated you as a supplier: hazard analysis done, preventive controls reasonable, no history of detentions. The FSVP Importer’s name and DUNS number go on the entry, and FDA audits that company directly and asks to see the documents.
The key to this gate is having a US party willing to be the FSVP Importer. US buyers often refuse, because it means taking responsibility for your food safety. Without an FSVP Importer, the first two gates mean nothing.
Who opens the gates: the exporter, the buyer or the logistics company?
| Gate | What the exporter prepares | US-side role needed |
|---|---|---|
| Facility registration | Plant details, product categories | U.S. Agent |
| Prior Notice | Registration number, product code, lot number | Importer or broker files |
| FSVP | HACCP / hazard analysis, test reports, labels | FSVP Importer (with DUNS) |
Each gate needs a US-side role, and when the three roles sit in three different companies, the usual outcome when something goes wrong is finger-pointing. SKYCARGO INC holds FDA and USDA agent status and can act as U.S. Agent, Importer of Record and consignee at the same time, and deal directly with USDA/APHIS quarantine inspection. Cargo arrives at our Oregon or Los Angeles warehouse, and the same team handles customs, inspection and cold-chain delivery. Taijiang milkfish went from SGS testing and label review through FDA and USDA inspection and release on exactly this one line.
Pre-shipment checklist
- Is the facility registration number still valid, and who is the agent?
- Who files the Prior Notice for this shipment, and when?
- Who is declared as FSVP Importer at entry, and can they obtain my hazard analysis?
- Have ingredient order, allergens and nutrition facts on the label been adjusted to the US format?
- Cold chain or ambient? Who receives and who delivers on the US side?
Only when all five have answers is the shipment really ready. If you want all three gates opened by one company with US warehouses and customs capability, send us the product category and target channel and we will reply within one working day.
This article summarizes FDA food facility registration, Prior Notice and FSVP requirements for reference only. Always check the latest FDA announcements.
