The US FDA Prior Notice is a requirement for all imported food shipments entering the United States. This regulation mandates that all food items be declared to the FDA at least four hours before their arrival at a US port. The prior notice must include details such as the product name, manufacturer, shipper, and recipient information.
This regulation was implemented as a part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Its primary goal is to improve the safety and security of the US food supply by allowing the FDA to identify and intercept potentially harmful food products before they enter the country. The prior notice requirement applies to all food items, including those intended for human and animal consumption.
Non-compliance with the US FDA Prior Notice can result in significant penalties and delays in the clearance of food shipments. Therefore, it is essential for importers and shippers to understand and comply with this regulation to avoid any disruptions in the supply chain.
Understanding Prior Notice
Purpose of Prior Notice
Prior Notice is a requirement of the U.S. Food and Drug Administration (FDA) for all imported food, including animal feed and pet food. The purpose of Prior Notice is to provide the FDA with advance notice of shipments of imported food, so that the agency can take appropriate action to protect public health.
Legal Requirements
Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), importers are required to submit Prior Notice to the FDA for all imported food, including animal feed and pet food. The Bioterrorism Act also requires that the Prior Notice be submitted electronically through the FDA’s Prior Notice System Interface (PNSI) at least four hours before the food arrives at a U.S. port of entry.
Importers who fail to comply with the Prior Notice requirements may be subject to enforcement action by the FDA, including detention, refusal of admission, and civil or criminal penalties.
Compliance Timeline
The compliance timeline for Prior Notice varies depending on the type of food being imported. For most imported food, including animal feed and pet food, Prior Notice must be submitted at least four hours before the food arrives at a U.S. port of entry.
However, for certain high-risk foods, such as produce, dairy products, and infant formula, Prior Notice must be submitted at least eight hours before the food arrives at a U.S. port of entry.
Importers should be aware of the specific compliance timeline for their products and ensure that they submit Prior Notice in a timely and accurate manner to avoid enforcement action by the FDA.
Submission Process
Electronic Submission
The FDA Prior Notice can be submitted electronically through the FDA’s Prior Notice System Interface (PNSI). This system allows for the submission of Prior Notice information for all FDA-regulated products. The PNSI system is available 24 hours a day, 7 days a week, and is accessible from anywhere with an internet connection.
To submit Prior Notice electronically, the submitter must first register with the FDA and obtain a Prior Notice System Interface (PNSI) account. Once registered, the submitter can log in to the PNSI system and enter the required information for the Prior Notice submission.
Required Information
The following information is required for a Prior Notice submission:
- Product information, including the FDA product code, product description, and intended use
- Shipper and receiver information, including name, address, and contact information
- Carrier information, including name, address, and contact information
- Country of origin
- Expected arrival information, including date and time of arrival, port of arrival, and mode of transportation
- Prior Notice confirmation statement
It is important to note that the information provided in the Prior Notice submission must be accurate and complete. Failure to provide complete and accurate information can result in delays or even refusal of entry of the product into the United States.
FDA Confirmation and Intervention
Once the Prior Notice submission is received by the FDA, the agency will review the information provided. If the submission is complete and accurate, the FDA will issue a confirmation number to the submitter.
If the submission is incomplete or inaccurate, the FDA may request additional information or take other actions to ensure the safety and security of the food supply. In some cases, the FDA may refuse entry of the product into the United States.
It is important to note that the Prior Notice submission does not guarantee entry of the product into the United States. The FDA may take additional actions to ensure the safety and security of the food supply, including inspections and sampling of the product.