The cargo was already on the plane when the customs broker called: “Where is the FDA Prior Notice confirmation number?” A Hsinchu tea-bag producer ran into this on its very first export to the US. The exporter assumed the forwarder would file, the forwarder assumed the broker would, and in the end nobody did. The cargo reached Los Angeles airport and could only be held — waiting for the filing, waiting for FDA review — five extra days in all. Prior Notice is a hard FDA requirement for all imported food; without it, the cargo is not even eligible to queue for inspection.
What Prior Notice is and why it is mandatory
In 2002 the US passed the Bioterrorism Act, requiring anyone importing or offering for import human or animal food to notify FDA before arrival so that FDA has time to decide whether to inspect. That is the Prior Notice (PN). A successful filing returns a PNC (Prior Notice Confirmation) number, which goes on the customs entry and, ideally, on the package as well.
Food without a PNC can be refused outright; the cargo is held at the port or airport at the importer’s expense and eventually re-exported or destroyed.
Who files
The rules allow any of the following to submit: the exporter, the importer, the customs broker, the forwarder, or an agent they appoint. In practice there are three common arrangements:
- Courier (FedEx / UPS / DHL): usually the courier or the shipper files in FDA’s system at shipping time, and the PNC travels with the shipment documents
- Air or ocean freight, FCL or LCL: mostly filed by the US-side customs broker together with the ACE entry
- Self-filing: register an account in FDA’s PNSI (Prior Notice System Interface), file it yourself, and pass the PNC to the broker
Whichever you choose, the exporter must settle “who files” up front. The Hsinchu tea-bag plant’s problem was that all three parties assumed someone else would.
What to enter
Most of the data a Prior Notice needs comes from the exporter:
- Submitter and transmitter details
- The FDA Product Code, common name, brand, quantity and packaging of the food
- Manufacturer name and FDA facility registration number (without registration this field cannot be filled — which is why registration is the first gate)
- Grower (for fresh produce) or shipper
- Country of origin, port of arrival, anticipated arrival date and time
- Importer, consignee, carrier and mode of transport, bill of lading or air waybill number
The Product Code is the field most often filled in wrong. FDA uses its own classification (industry code, class, subclass, process, container) that has nothing to do with the HS code. Frozen scallion pancakes, ambient tea bags and chilled sauces all carry different codes, and a wrong code is rejected by the system immediately.
Deadlines depend on the mode of transport
FDA accepts a Prior Notice as early as 15 days before arrival; the latest deadline depends on the mode:
| Mode of transport | Latest submission |
|---|---|
| Air | 4 hours before arrival |
| Ocean | 8 hours before arrival |
| Road | 2 hours before arrival |
| Rail | 4 hours before arrival |
| International mail | Before the package is sent |
Courier parcels follow the air rule of 4 hours. In practice we recommend filing on the day of shipment rather than at the deadline: if the shipment details change after the PNC is issued (quantity, flight), the notice must be updated before arrival, and a last-minute filing leaves no time to fix it.
The three most common rejections
- Facility registration number expired or wrong: registration must be renewed every two years; if it is not renewed between October and December of an even-numbered year the number lapses and the Prior Notice cannot be submitted
- Product code does not match the actual goods: a frozen product coded as ambient, a meat-containing product coded as vegetarian; when FDA samples and it does not match, the cargo is held
- PNC and bill of lading disagree: a flight delay or a split shipment after filing without updating the PNC, and customs bounces it on comparison
How SKYCARGO handles it
SKYCARGO INC holds FDA and USDA agent status and can act as Importer of Record and consignee. For cargo where we are the importer, our US team files the Prior Notice at shipping time, the product codes are matched to your items in advance, the PNC is sent back to the Taiwan side to attach to the documents, and the same team receives the cargo at our Oregon or Los Angeles warehouse for inspection and release — no gap where three parties wait on each other.
If you are exporting food to the US for the first time, tell us the product category, packaging and shipping method; we confirm the facility registration and product code first, then arrange the shipment.
This article summarizes FDA 21 CFR Part 1 Subpart I (Prior Notice) for reference only. Deadlines and fields are subject to the latest FDA announcements.
