Curated Content United States: Any Comments On FDA's New Proposed Rule On Prior Notice Regulations?

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.

Check out our new Digital Magazine Get the inside scoop on the Braumiller Law Group & Braumiller Consulting Group "peeps." Expertise in International Trade Compliance.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.