Prior Notice is a term that is well-known among importers. In this article, UCC aims to provide a deeper understanding of Prior Notice meaning and its related information.
1. The meaning of Prior Notice
To implement the regulations of the Bioterrorism Act, the U.S. Food and Drug Administration (FDA) has issued a rule requiring prior notice for all imported food shipments into the United States. Since May 6, 2009, the FDA has required U.S. food importers to submit a Prior Notice for imported food and animal products, unless specific items are exempt from these regulations.
It can be understood as the process of registering advance information about imported food, beverages, and dietary supplements. This provides the FDA with important information about food shipments arriving in the U.S., helping the agency ensure food safety for both humans and animals.
2. Essential Information Required
Certain information must be submitted to the FDA prior to the importation of shipments into the United States.
- Product Description: An accurate description of the imported goods, including ingredients, contents, and their intended purpose.
- Manufacturer/Shipper Information: The importer must provide information about the manufacturer and shipper, along with their personal contact details.
- Country of Origin: The importer must provide information about the country where the product was produced or manufactured.
- Importer Information: According to the documentation, the importer must include their name, address, and contact information.
- Shipping Method
- Carrier Information: The importer must provide information about the carrier responsible for transporting the goods, such as the vessel name, flight number, or vehicle registration.
- Arrival Information: Expected date and time of arrival, port of entry, and shipping method.
- FDA Product Code: The importer must provide all required information as per FDA regulations.
3. When Do You Need a Prior Notice?
4. How to submit an FDA Prior Notice?
There are four steps to create a Prior Notice with the FDA as follows:
Step 1: Access PNSI
To begin, visit the official FDA Industry Systems Access website at www.access.fda.gov. On the homepage, locate the “Login” button in the upper right corner. Clicking this button will direct you to the login interface, where you can input your account information. This step is similar to using a key to unlock access to the FDA’s control system.
Step 2: Create a new Web entry
This is the first and most important step in the process of submitting a Prior Notice. On the main interface of the PNSI system, you will see the “Create Web Entry” button. Clicking this button will take you to the page where you can enter the basic information about the shipment.
On this page, you will find a dropdown menu to select the type of entry. There are two main options: “Mail (Commercial Purpose)” and “Mail (Non-commercial Sender).” You need to choose the type that matches your shipment and then click the “Next” button to continue. Selecting the correct type of entry will help the FDA easily classify and process the information.
Accordingly, you will sequentially fill in the relevant information, such as entry details, port of arrival, sender, importer, and more.
Step 3: Create and save the Prior Notice
Select the “Create Prior Notice” button at the bottom of the Web Entry page.