Before you export any product to the United States, file a Prior Notice with the U.S. Food and Drug Administration, to avoid the detention of your shipment.
ITB HOLDINGS LLC helps domestic and foreign companies that are manufacturers, exporters, importers, warehouses or distributors, file a Prior Notice, upon request.
■ Trade samples are imported or offered for import to generate sales, which is a commercial, not personal use. Therefore, a Prior Notice is required.
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
private residence
facility is a restaurant, and qualifies for the exemption
facility is a retail food establishment, and qualifies for the exemption
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.
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.