The FDA Prior Notice system was established in 2003 as a way to improve the safety and security of the U.S. food supply. The system requires importers to provide advance notice to the FDA of any food, including animal feed, that will be imported into the United States. The FDA Prior Notice system is designed to help prevent the introduction of contaminated or harmful food into the U.S. food supply.
Under the FDA Prior Notice system, importers are required to provide certain information to the FDA, including the name and address of the importer, the name and address of the manufacturer or grower, the country of origin, and a description of the food being imported. This information must be submitted to the FDA electronically at least four hours before the food arrives at a U.S. port of entry. Failure to provide this information can result in the food being refused entry into the United States.
Understanding Prior Notice
Definition and Purpose
Prior Notice is a notification system implemented by the FDA that requires importers or agents to notify the FDA of food shipments before they enter the United States. The purpose of Prior Notice is to enhance the security of the US food supply chain and to ensure that imported food is safe for consumption.
Legal Framework
Prior Notice is a requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and is enforced by the FDA. The Bioterrorism Act mandates that all food imported into the US must be registered with the FDA and that importers or agents must provide the FDA with prior notice of any food shipments.
Scope and Applicability
Prior Notice applies to all food shipments imported into the US, including food for human and animal consumption, dietary supplements, and food additives. The requirement applies to all importers or agents, regardless of whether they are commercial or non-commercial entities. However, there are some exemptions to the Prior Notice requirement, such as for food imported by individuals for personal consumption or for food that is being transported through the US without being consumed or distributed in the country.
In summary, Prior Notice is a vital component of the US food safety system that helps to ensure that imported food is safe for consumption. Importers or agents must provide the FDA with prior notice of all food shipments entering the US, and failure to comply with this requirement can result in significant penalties.
Compliance and Enforcement
Submission Process
To comply with the FDA Prior Notice requirement, importers must submit information about their shipments electronically through the FDA’s Prior Notice System Interface (PNSI). The PNSI allows importers to submit prior notice up to 15 calendar days before the anticipated arrival of the shipment. Importers must provide detailed information about the shipment, including the name of the product, the quantity, and the country of origin.
Deadlines and Timeframes
Importers must submit prior notice to the FDA before the shipment arrives in the United States. The FDA requires that prior notice be submitted at least 2 hours before the shipment arrives by land, 4 hours before it arrives by air or rail, and 8 hours before it arrives by sea. Importers who fail to meet these deadlines may face consequences.
Consequences of Non-Compliance
Importers who fail to comply with the FDA’s Prior Notice requirement may face penalties, including the detention of their shipments at the port of entry. The FDA may also refuse to allow the shipment to enter the United States. In addition, the FDA may take enforcement action against importers who repeatedly fail to comply with the Prior Notice requirement.
To avoid these consequences, importers should ensure that they submit prior notice in a timely and accurate manner. Importers should also ensure that they provide all required information to the FDA, including information about the product, the quantity, and the country of origin. By complying with the FDA’s Prior Notice requirement, importers can help ensure that their shipments are not delayed or detained at the port of entry.