November 7, 2023

The U.S. Food and Drug Administration (FDA) has issued a proposed rule which, if finalized, would amend its prior notice regulations to:

  • Require that prior notice for articles of human and animal food arriving by international mail include the name of the mail service and a mail tracking number.
  • Require that prior notice and food facility registration information be submitted within a certain timeframe after certain notices of refusal or hold have been issued (“post-refusal” and “post-hold” submission).


The FDA uses prior notice information to determine what products should be inspected upon arrival into the United States. To effectively carry out its responsibility to detect food articles offered for import that violate FDA requirements, the FDA must be able to identify and inspect food items that are imported by international mail.
Receiving the name of the mail service and a mail tracking number for articles of food arriving by international mail would enable the FDA to better coordinate with the U.S. Postal Service (USPS), U.S. Customs and Border Protection (CBP), and other agencies to track and inspect articles that have been identified as a possible bioterrorism risk. Currently, the FDA does not receive this information. Many foods are regularly imported by mail, and in the FDA’s experience, these foods can present similar risks to the U.S. food supply as other imported foods.

In addition, requiring a timeframe for post-refusal and post-hold submissions may help to reduce the amount of time articles subject to refusal or holds are held at ports of entry, thus reducing associated monetary charges. This new requirement may also help to limit the need for FDA to review multiple and duplicative submissions, which will allow for more effective use of agency resources.

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