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 the U.S. Food and Drug Administration (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 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.
The following can file a Prior Notice:
▪ Domestic and foreign cross-border transporters (rail, truck, ship, air).
▪ Domestic and foreign brokers.
▪ Domestic and foreign manufacturers and growers.
▪ U.S. Agents such as ITB HOLDINGS LLC.
You must file your Prior Notice, then obtain a confirmation from the 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.
Obviously, we do not recommend waiting that late. FedEx, DHL, UPS and your freight forwarder expect you to provide a Prior Notice Confirmation Number, when you drop your package or cargo.
The FDA will reject Prior Notice submissions, unless they include a valid registration number or an appropriate reason.
When no manufacturer registration number is available or provided, you may submit one of the reasons below:
▪ facility is out of business.
▪ private residence.
▪ facility is a restaurant.
▪ facility is a retail food establishment.
▪ manufacturer satisfies the definition of “farm”.
▪ qualifies for the exemption.
Moreover, the FDA could consider the failure to provide adequate prior notice as a factor in determining whether and where to examine an article of food.
If the agency 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.
Finally, keep in mind that trade samples are imported or offered for import to generate sales, which is a commercial, not personal use. Therefore, a Prior Notice is required.
Always available, upon request, from domestic and foreign companies, including in case of an emergency.
- Expedited Service is available upon request.