If you are importing food into the United States, you may be required to submit a prior notice. This information can help FDA monitor the safety of imported foods and determine if there are any issues with a shipment.
The process for submitting a prior notice includes creating a web entry and then creating prior notices for each article of food in your import shipment. Once all of your Prior Notices are saved, you can submit your web entry.
Submitting a Prior Notice
Prior Notice is a document that FDA uses to evaluate the trustworthiness and risk of a consumable product. It contains detailed information about the product, the manufacturer, and related enterprises.
It is required for any shipments of consumables to the United States. Submitting a Prior Notice is an important step in the process, and must be submitted no more than 15 days before the shipment arrives.
The Prior Notice consists of a web entry that includes all of the necessary information. This information is required to ensure that FDA and CBP can evaluate the food articles that are shipped or mailed to the United States*.
When you create a Prior Notice, it is displayed in static text on the Web Entry (View) page with a system-generated Article Number that counts up from 0001. If you wish to copy it to another Web Entry that contains food articles of the same type, choose Copy.
Creating a Prior Notice
If you’re shipping or mailing consumable products, including food, it’s critical that you create a US FDA prior notice web entry before sending. A properly completed prior notice will allow FDA to verify the contents of your shipment, and will help ensure that you can send your food to US retailers, distributors, and consumers without any problems.
A properly completed prior notice will also help ensure that the FDA will issue a Prior Notice Confirmation Number for your food shipment. This confirmation number must be affixed to your shipment so that FDA can inspect it upon arrival and take action as necessary.
A prior notice can be submitted through CBP’s Automated Commercial Environment (ACE) and the FDA’s Prior Notice System Interface (PNSI). The ACE and PNSI systems have tutorials, interactive feedback, and Help features that can assist you with creating a prior notice.
Editing a Prior Notice
Editing your prior notice web entry is as easy as clicking on a button. You can view the most recent prior notice or add a new one. Choose the Prior Notice: Article (Create) button and enter some or all of the following information.
Depending on the nature of your business, there are numerous ways to display information. For example, you can display the Product Identifier in the enlarged identifier.
In addition to the production identifier, you may want to consider the most efficient way to represent your products. This is especially important if you ship many different articles of food at once. Choosing the most efficient means of representing your products will also help you avoid costly delays at customs. In particular, this is true if you ship food for animals. It can also help you get your shipments approved faster. For more details, see the FDA’s guidance on prior notice submissions. It’s the best place to find answers to your questions and for tips on how to save time and money.
Saving a Prior Notice
The Prior Notice System Interface (PNSI) provides you with an easy way to save the information you provide on your prior notice web entry. It also displays all submitted information and gives you the opportunity to review and make corrections before you submit your prior notice to FDA.
You can create a new Prior Notice by selecting the Create Prior Notice button at the top or bottom of the Web Entry (View) page. The Prior Notice: Article (Create) page changes to display the Identifier, Quantity, and Packaging of your Article.
If your product requires Production Identifiers, enter them by choosing the Add button in the Production Identifiers section header and entering the production lot codes or batch identifiers. Examples of products that require a Production Identifier include low acid canned foods, acidified foods, and low acid infant formula. Then choose the Save button. The Production Identifiers section header displays with the Production Identifiers you entered.