On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule which, if finalized, would amend its prior notice regulations for imported human and animal foods imported by mail.

The FDA uses prior notice information to determine what products should be inspected upon arrival into the U.S. To carry out its responsibility to detect food articles offered for import that violate FDA requirements, FDA must be able to identify and inspect food items that are imported by international mail.

The proposed amendments include:

  • Requiring 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)

Receiving the name of the mail service and a mail tracking number for articles of food arriving by international mail, which the agency does not currently receive, would enable 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. Many foods are regularly imported by mail, and in FDA’s experience, such 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 reduce the amount of time articles subject to refusal or holds are held at ports of entry, thus reducing associated monetary charges. The new requirement may also help limit the need for FDA to review multiple and duplicative submissions, which will allow for more effective use of agency resources.