Ensuring Safe Imports: Understanding The Fda Prior Notice Requirement

Under the Food and Drug Administration and Border Protection Act (FDCA), FDA must be informed before any food that enters the US is imported, enabling Customs and Border Protection (CBP) to conduct more effective inspections, and prevent potentially hazardous foods entering our food chain.

On the Prior Notice: Article (Create) page, select the country from which your item was shipped and enter its FDA Product Code. Next, navigate to the Manufacturer section where you can add Food Facility Registration Number, business name and city information about its manufacturer.

It is a requirement for all food imported into the U.S.

The Food and Drug Administration’s prior notice requirement applies to food imported into the US from abroad, making timely submission of accurate prior notices essential. Doing so allows FDA inspectors to verify authenticity prior to arrival. Failing this step could result in refusal of shipment at port of entry as well as additional government requirements being placed upon it.

Prior notice is intended to facilitate trade; however, some commenters expressed concerns that regulations may prevent importers from taking advantage of final equivalence determinations to bypass prior notice requirements.

The FDA requires that any food imported via international mail comes accompanied with a Prior Notice Confirmation Number to indicate it has been reviewed and received by them for consideration. When arriving, CBP requires this PN Confirmation Number be given as part of its inspection procedure.

It allows the FDA to inspect food shipments at their first port of arrival

Importers who import food into the United States must notify the FDA. This information allows the agency to identify and prevent food safety risks before they reach American markets, while also permitting an inspection at its first port of arrival.

To file a prior notice, you must submit a PNC number and information about the food being shipped. The FDA may determine additional inspection or information is necessary, so failure to provide this could delay or refuse entry of your shipment by U.S. Customs and Border Protection.

An initial submission should include details such as the article name, country of origin, manufacturer/grower information and intended recipient in the United States. You should also include information regarding related facilities and shipping carriers depending on entry type; required fields will vary based on entry type. Once complete, click “Save” button to save submission.

It helps to protect public health

The Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) mandates that FDA take all steps necessary to safeguard Americans against terrorist attacks on U.S. food supplies. As part of their response, FDA issued the Start Printed Page 66298 IFR final rule to fulfill this mandate; its enforcement policy establishes graduated enforcement, while offering submitters time to become acquainted with requirements as they adjust business practices and processes accordingly.

IFR requires prior notice for products imported to be used as food additives or materials with food contact applications, although complications can arise when products that fall into both categories are also imported with non-food applications.

Importers can take steps to exempt their product from the prior notice requirement, including marking the invoice “Intended Only for Food Contact Substances or Packaging-Not Intended to Add Directly to Food.” This can prevent improper holding at ports of entry.

It is free

The FDA Prior Notice System Interface (PNSI) is a web-based system that enables PN Submitters to submit and edit Prior Notices online at any time, 24 hours per day, 7 days per week. When CBP’s ABI/ACE or ACS systems fail, this alternative option becomes useful.

To create a PN, start by clicking “Create New Prior Notice” from the Welcome to PNSI page. Choose your PN type and provide all pertinent details – your draft notice will then display.

As soon as a PN is in draft status, click the Save button to save it and keep it from becoming outdated. When saving, your PN will remain draft status until completed or cancelled; during drafting process you can use Copy feature to avoid duplicative data entry; this option only available within Web Entry itself and appears next Article number after its original.