U.S. Customs and Border Protection (CBP) modified the Automated Broker Interface of the Automated Commercial Environment (ABI/ACE) to allow prior notice to be submitted to FDA through the existing interface between CBP and FDA.
The Prior Notice System Interface (PNSI) is available to individuals or companies who cannot, or choose not to, file through CBP.
PRIOR NOTICE CONFIRMATION NUMBER
U.S. CUSTOMS CLEARANCE
You must always file a PRIOR NOTICE with the FDA to avoid the detention of your shipment.
ITB HOLDINGS LLC assists domestic and foreign companies that are manufacturers, exporters, importers, warehouses or distributors, file a Prior Notice, upon request.
Domestic and foreign cross-border transporters (rail, truck, ship, air)
Domestic and foreign importers
Domestic and foreign exporters
Domestic and foreign filers and brokers
Domestic and foreign manufacturers and growers
Prior Notice of imported food shipments allows the FDA to:
review and evaluate information before a food product arrives in the U.S.
better deploy resources to conduct inspections
intercept contaminated products.
■ Trade samples are imported or offered for import to generate sales, which is a commercial, not personal use. Therefore, a Prior Notice is required.
Prior Notice must be submitted and the submission must be confirmed by FDA no less than:
2 hours before arrival, if the food is arriving by land by road
4 hours before arrival, if the food is arriving by land by rail
4 hours before arrival, if the food is arriving by air
8 hours before arrival, if the food is arriving by water.
We do not recommend waiting that late. FedEx, DHL, UPS or your freight forwarder expect you to provide a Prior Notice Confirmation Number, when you drop your package or cargo.
FDA will reject prior notice submissions, unless they include a valid registration number or an appropriate reason.
One of the following reasons may be submitted when no manufacturer registration number is provided:
facility is out of business
facility is a restaurant
facility is a retail food establishment
manufacturer satisfies the definition of “farm”
and qualifies for the exemption.
■ FDA may consider the failure to provide adequate prior notice as a factor in determining whether and where to examine an article of food.
■ If FDA decides not to refuse an article of food, this decision does not affect FDA’s ability to initiate other types of actions such as assessment of civil penalties, seizures, injunctions, or prosecutions.
Any individual with knowledge of the required information can submit Prior Notice. This includes individuals, manufacturers, exporters, brokers, importers, and U.S. Agents.
However, contact ITB HOLDINGS LLC, because subsequent system review and review by FDA staff may result in inspection of the imported food shipment upon arrival, or other action.