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FDA Issued a Proposed Rule to Amend Prior Notice Regulation
Wednesday, November 1, 2023
  • On November 1, the FDA published a proposed rule which would amend the prior notice regulations to:
    • Require that prior notice for articles of food and feed arriving by international mail include the name of the mail service and a mail tracking number; and
    • Require prior notice and food facility information be submitted within a certain timeframe after certain notices of refusal or holds have been issued.
  • “Prior notice” refers to the information that must be provided to the FDA in advance of the arrival of food at the U.S. border. The FDA uses prior notice information to determine what products should be inspected upon arrival. As stated in their press release, to effectively carry out the Agency’s responsibilities to detect food articles offered for import that violated FDA requirements, the FDA must be able to identify and inspect food items imported via international mail. Knowing the name of the mail service and tracking number 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.
  • Additionally, requiring a timeframe for post-refusal and post-hold submissions may reduce the amount of time food articles subject to refusal or holds are held at ports which would also reduce associated monetary charges. It may also help limit the need for the FDA to review multiple and duplicative submissions.
  • Stakeholders may submit comments on this proposed rule until January 30, 2024. 
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