prior notice regulations

Any Comments on FDA’s New Proposed Rule on Prior Notice Regulations?

By Vicky Wu, Partner

Quick Answer

On November 1, 2023, the FDA issued a proposed rule to amend its prior notice regulations for imported food, including animal feed, under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The proposed rule's key changes include requiring the name of the mail service and a mail tracking number for food articles arriving by international mail. The FDA also proposes specific timeframes for submitting food facility registration and prior notice after receiving certain refusal or hold notices. These updates aim to enhance the FDA's ability to identify and inspect potentially violative food items imported via international mail and to improve efficiency in processing refused or held articles at entry ports.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires the Food and Drug Administration (FDA) to take additional measures for safeguarding the public against potential terrorist attacks on the U.S. food supply and other food-related emergencies.  Among its various provisions, the Act necessitates that the FDA be notified in advance via prior notice about any imported food, including animal feed, that is intended for import into the United States. This prior notification enables the FDA, in collaboration with the U.S. Customs and Border Protection (CBP), to enhance the effectiveness of import inspections and safeguard the nation’s food supply from acts of terrorism and other public health emergencies. 

On November 1, 2023, FDA issued a proposed rule that would make changes to its prior notice regulations, if the rule is finalized. These changes include requiring the name of the mail service and a mail tracking number to be provided in prior notice for food articles arriving by international mail. In addition, the FDA proposes that food facility registration information and prior notice be submitted within a specific timeframe after receiving certain notices of refusal or hold (“post-refusal” and “post-hold” submissions).

The purpose of collecting this information is to help the FDA identify and inspect food items imported through international mail that may violate FDA requirements. By obtaining the name of the mail service and a tracking number, the FDA can collaborate more efficiently with the U.S. Postal Service, U.S. Customs and Border Protection, and other agencies to track and examine articles that could potentially pose a bioterrorism risk. Presently, the FDA doesn’t receive this information, even though many food items are regularly imported by mail and can pose similar risks as other imported foods.  For Instructions on the Prior Notice System Interface (PNSI), see Filing Prior Notice available on FDA’s website,

Furthermore, implementing a timeframe for post-refusal and post-hold submissions can potentially decrease the amount of time food items subject to refusal or hold are held at entry ports, consequently reducing associated costs. It may also prevent the need for the FDA to review multiple and duplicative submissions, allowing for a more optimal use of agency resources.

If you wish to provide feedback, comments on the proposed rule must be submitted by 11:59pm Eastern Time on January 30, 2024.  Electronic comments can be submitted to docket number FDA-2011-N-0179 at https://www.regulations.gov/. Written/paper comments can also be submitted per instructions stated in the proposed rule. 

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Frequently Asked Questions

1 What are the key changes proposed by the FDA's new rule on prior notice regulations?

The proposed rule requires the name of the mail service and a mail tracking number for food articles arriving by international mail. Additionally, it proposes that food facility registration information and prior notice be submitted within a specific timeframe after receiving certain notices of refusal or hold.

2 Which specific food articles and import methods are affected by these proposed FDA prior notice changes?

The proposed changes specifically affect food articles, including animal feed, intended for import into the United States, particularly those arriving by international mail. The rule aims to address risks associated with food items regularly imported by mail.

3 What is the purpose behind the FDA's proposed changes to prior notice regulations?

The purpose is to help the FDA identify and inspect food items imported through international mail that may violate FDA requirements. By obtaining mail service and tracking information, the FDA can collaborate more efficiently with other agencies to track and examine articles that could potentially pose a bioterrorism risk.

4 What are the implications of the proposed 'post-refusal' and 'post-hold' submission requirements?

The FDA proposes that food facility registration information and prior notice be submitted within a specific timeframe after receiving certain notices of refusal or hold. This aims to provide the FDA with more timely and complete information following import issues, enhancing their ability to manage potential risks.