US FDA Prior Notice

Submitting a US FDA prior notice is a vital part of the process of importing and exporting food to the United States. Failure to do so can result in penalties, injunctions, and even criminal prosecution.

Luckily, there are affordable and easy-to-use solutions that can simplify the process of submitting a US FDA prior notice. By learning the fundamentals, you can avoid this costly mistake.

What is a Prior Notice?

Before food and beverages can be allowed into the United States, importers must submit a Prior Notice to the FDA. This process helps the FDA to determine whether a shipment is trustworthy and if there are any risks associated with it.

The Prior Notice also includes important details about the product, like the quantity, quality, and packaging, along with information about the importer, manufacturer, owner, shipper, and consignee. All of this information is necessary for the FDA to assess trustworthiness and risk, and it helps CBP intercept contaminated goods before they reach the U.S.

The Prior Notice rule is a critical part of FSMA’s efforts to safeguard the American people against terrorism-related health threats. Importers who don’t comply with the requirements can face hefty fines and penalties. These can include criminal prosecution and bans on future importation. The government doesn’t take smuggling lightly, so you should consider submitting a Prior Notice as soon as possible.

How do I create a Prior Notice?

To create a Prior Notice, select the Create Prior Notice button at the top or bottom of the Web Entry (View) page. The Prior Notice: Article (Create) page displays with the Entry Identifier of your Web Entry and a system-generated Article Number.

The Prior Notice: Related Facilities (View) page displays information about up to five related facilities, including the Manufacturer or Grower/Consolidator if the food article is in its natural state, Shipper, Owner, Ultimate Consignee and Holding Facility. The hyperlinks on each facility type lead to related topics that provide further information.

For the Shipper section of the Prior Notice: Related Facilities (View) page, enter the Shipper’s Food Facility Registration Number and business name if you have it. If not, choose from the dropdown list and enter all required data denoted by asterisks.

What are the requirements for a Prior Notice?

Before an import shipment of food for human or animal consumption is allowed to enter the United States, FDA must receive a Prior Notice. This requirement is mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

Anyone who has knowledge of the required information can submit a Prior Notice. This person is referred to as the “submitter” and may also use another person to transmit this information on their behalf, called the “transmitter.”

When an article of food arrives in the United States by water, it must be submitted to FDA no less than 8 hours before arriving at the port of arrival.

Anyone with knowledge of the required information can submit a prior notice through the FDA Prior Notice System Interface (PNSI). Brokers and filers who currently submit Entries for admissibility processing through the Automated Broker Interface (ABI) to the Bureau of Customs and Border Protection (CBP) Automated Commercial Environment (ACE) can also submit a prior notice using their Entry Identifiers.

What is the process for submitting a Prior Notice?

US FDA prior notice is used to inform the agency of imported shipments of articles of food before they enter the U.S. They include information about the article, quantity and packaging, along with the product’s manufacturer, shipper, owner and ultimate consignee.

Any person who has the required information for a Prior Notice can submit it, including importers/exporters, brokers and U.S. agents.

Depending on entry type, the FDA requires a valid Manufacturer’s Food Facility Registration Number (unless otherwise specified). This number was issued when the manufacturer registered with the FDA using its Food Facility Registration System.

Submitting a Prior Notice through the FDA’s PNSI or CBP’s ABI/ACS is simple and easy, with interactive feedback and Help to minimize errors. Once you have submitted all of the required information, you will receive confirmation of your submission from FDA directly or through CBP’s ABI/ACS. You can then print the Prior Notice confirmation for your records. It also includes all of the Prior Notice information you submitted.

Leave a Reply

Your email address will not be published.