If you are importing foods into the United States, you must submit Prior Notice to FDA before the food arrives at its port of arrival.
This article will guide you through the process of creating a web entry and submitting an advanced notice for imported food products.
A Prior Notice can be submitted by any individual with knowledge of the required information, or another individual acting on their behalf.
Creating a Prior Notice
Prior Notice is the notification sent to FDA when food items enter the United States and must meet certain import regulations. It’s required for most shipments of food products, and can be submitted through PNSI as part of the web entry process.
To create a Prior Notice, log on to the PNSI web entry system using your account ID and password. Select “Create” from the Welcome to Prior Notice System Interface page, and follow the instructions provided.
When creating a Prior Notice, you will need to provide information regarding the submitter, country from which it is coming and product details. This data may differ based on entry type.
Once all necessary data has been entered, select “Save Prior Notice.” This converts your Prior Notice from draft status to saved status and does not submit it to FDA until after your web entry is complete.
Once saved, you can edit all data except the Entry Type or system-generated Entry Identifier. When your Web Entry is complete, the Prior Notice will be submitted to FDA and a Prior Notice Confirmation Number issued to the submitter.
Adding a Submitter
Submitters of Prior Notice information to FDA (known as Submitters) can be either companies or individuals. If the Submitter is a company, their Food Facility Registration Number must also be entered; this was issued when they registered with FDA’s Food Facility Registration System.
If the article of food you’re mailing to a foreign country requires the Manufacturer’s Food Facility Registration Number. This number was assigned when the manufacturer registered with FDA’s Food Facility Registration System.
The Product Code is the name or part of a name that accurately describes an article of food. If you don’t know it, click the Search button to build one by finding the relevant product, packaging and processing. Select your article from the list then complete both Product and Related Facilities sections on the Web Entry form. Finally, print your Web Entry Summary Confirmation for confirmation.
Adding a Related Facility
Once the system determines that a food article is not in its natural state, information regarding its Manufacturer, Grower or Consolidator must be provided. Select “Food Article Manufacturer” from the dropdown list in Manufacturer section and click Enter Manufacturer button (Figure 26a).
If you have a Food Facility Registration Number for the Grower or Consolidator, select it from the Type drop-down list and enter it along with their full address including Business Name, Street Address and City as well as Country Subdivision and ZIP/Mail Code, if applicable.
If the manufacturer does not have a Food Facility Registration Number, check the Unknown box and proceed to the next applicable facility on the Prior Notice: Related Facilities page. Once entered, a Confirmation Number will appear in Web Entry (View) page which allows you to return directly to Quantity and Packaging without creating another Prior Notice.
Adding a Product
Adding a product to the FDA prior notice web entry is an efficient way to guarantee it meets FDA safety requirements. Much like applying for a visa, the fda prior notice process requests background data in order to assess import risk and determine whether or not your item is suitable for consumption.
Add a product by entering its FDA Product Code and selecting which country it will be shipped from. Afterward, use either Common Name or Usual Name/Market textboxes to further specify what type of item you are mailing.
You can add a manufacturer to the prior notice by selecting Yes in the Manufacturer section of the Prior Notice: Article (Create) page. Doing so instructs PNSI that this particular manufacturer should serve as the default choice for all new Prior Notices created under this Web Entry.
