What is FDA Prior Notice?

fda prior notice

A Prior Notice FDA is an essential tool that the FDA utilizes to track and investigate the safety of imported food, as well as determine if there is a significant risk to public health.

Under section 801(m) of the FD&C Act and 21 CFR 1.279, prior notice must be given before an article of food is offered for import or imported into the United States.

What is a Prior Notice?

A prior notice is a notification sent by an import shipment of food to the FDA before it arrives in America. It includes details about the product, quantity and packaging as well as who is importing it, who will be responsible for shipping, and who will receive it once arrived in America.

Food safety certificates are required for all shipments of human and animal food products, including dietary supplements and drinks. They can be issued by manufacturers, exporters, brokers, U.S. agents, or anyone else with the necessary information.

The FDA requires prior notice of imported foods to guarantee there are no unsafe items or tainted products in the United States. It also helps Customs and Border Protection (CBP) target import inspections more effectively and safeguard the nation’s food supply against terrorist acts or other public health emergencies.

Why do I need a Prior Notice?

The FDA Prior Notice rule was created to guarantee that food destined for the United States isn’t imported or offered for import with inaccurate, incomplete or false information. Furthermore, it helps guarantee shipments of food don’t arrive in America with foreign ingredients, contaminants or other potential hazards that would compromise consumer safety.

Under the Prior Notice rule, all shipments of foods must be submitted to the FDA prior to arrival in America. This submission can be done electronically through U.S. Customs and Border Protection’s Automated Broker Interface of the Automated Commercial System or through an FDA Prior Notice System Interface.

Prior Notice is required for all shipments that have not been approved under the personal use exemption of 21 CFR 1.277(b)(1). This exemption only applies to foods carried or accompanied by an individual entering America and are not intended for sale or other distribution.

How do I get a Prior Notice?

When importing food or feed into the United States, you must give FDA Prior Notice before your shipment arrives. Doing this helps enhance risk assessment and inspection processes.

Your information will enable FDA and Customs and Border Protection (CBP) to quickly intercept shipments of potentially contaminated products. As mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, both agencies are responsible for controlling food imports while preventing terrorism or other potential threats against America’s food supply.

Submitting a Prior Notice requires either the Prior Notice System Interface of the FDA or Automated Commercial Environment/Automated Broker Interface (ACE or ABI) of CBP. If these systems are down, you can check System Status on CBP’s web page to determine if a prior notice submission is necessary.

Once you have entered all necessary information for a Web Entry, it must be successfully submitted. Otherwise, any associated saved Prior Notices will be cancelled.

What are the requirements for a Prior Notice?

Prior notice is necessary for all imported food shipments that will be transshipped or transported through the United States, including food that will be consumed here, such as tea, and food intended for future export.

Submitting a Prior Notice requires providing specific details about the shipment, such as article quantity and packaging. Furthermore, you must identify who is responsible for sending in the Prior Notice along with their business address and contact info.

For instance, if the shipper is a registered facility, their registration number and city may be provided instead of their full address.

FDA regulations require you to identify any countries to which an article was refused entry if you choose to submit information as part of a prior notice. This information can assist in informing FDA’s decisionmaking regarding admissibility, particularly if there was a safety risk involved.