Filing for Prior Notice with the FDA
All exporters of food and dietary supplements to the United States are required to provide the U.S. Food and Drug Administration (FDA) with advance notice of all arriving shipments. This advance notice allows the FDA to more effectively protect the U.S. food supply against foreign threats. Your shipment will be refused at U.S. ports if you fail to file Prior Notice on time. This can have devastating effects that reverberate all the way down your supply chain and interfere with your business.
What is Prior Notice?
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Act”) directed the FDA to take measures to protect the public from threatened or actual terrorist attacks on imported food. Under rules promulgated by the Act, the FDA requires importers to alert them of incoming shipments by filing Prior Notice. In 2011, the FDA published a final rule that a person submitting Prior Notice disclose the name of any country in which their product was refused entry. This further helps the FDA manage potential risks.
When do you need to file Prior Notice?
The amount of Prior Notice depends on the method of shipment (express carrier, air, sea, land, rail, mail or baggage), so it is important to file within the allotted time frame. The FDA allows importers to file Prior Notice in two ways:
- through the U.S. Customs and Border Protection (CBP) Automated Broker Interface of the Automated Commercial Environment; or
- through the Prior Notice System Interface (PNSI).
How US Imports can help
Determining the correct amount of Prior Notice and filling out the paperwork correctly is a complex process. Don’t let this get in the way of expanding your business. US Imports' compliance specialists can assist in drafting and filing Prior Notices on time to comply with FDA regulations.
