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FDA Proposed Rule

November 7, 2023

The US Food and Drug Administration (FDA) today issued a proposed rule which, if finalized, would amend its prior notice regulations to require:

  • Prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number.
  • 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 US Postal Service (USPS), US 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 US 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.

To Submit Comments

Comments on the proposed rule should be submitted within 90 days after publication in the Federal Register. You may submit electronic comments to to docket number FDA-2011-N-0179.

All written comments should be identified with the docket number FDA-2011-N-0179 and with the title “Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-refusal and Post-hold Submissions.”

Additional Information

Questions or comments about the Proposed Rule and Prior Notice of Imported Foods regulation may be sent to