FDA Proposes Amendments to its Prior Notice Rule

FDA Proposes Amendments to its Prior Notice Rule

November 6, 2023, Covington Alert

On October 31, 2023, the Food and Drug Administration (“FDA”) published a proposal to amend its Prior Notice rule. The Prior Notice rule requires advance notice regarding human and animal food that will be offered for import into the U.S. This proposed rule follows FDA’s October 13, 2023 release of updated, final guidance on prior notice requirements and may signal FDA’s increased focus on tracking and inspecting imported food.

FDA proposed two substantive changes to its Prior Notice rule, in addition to several technical amendments:

• Tracking Numbers. Prior notice for food arriving by international mail would need to include the name of the mail service and the mail tracking number under FDA’s proposal. FDA believes this information will help the agency better coordinate with the U.S. Postal Service and U.S. Customs and Border Protection (“CBP”) to track, inspect, and contain incoming mail shipments that are unlawful or could otherwise threaten the food supply.
• Timeframe for Post-Refusal or Post-Hold Submissions. The proposal would create a new 10-day timeline for submitting or resubmitting prior notice after FDA refuses or holds a shipment due to a failure to submit adequate prior notice. For shipments that are held because the foreign facility is not registered, the proposal would create a 30-day timeline to submit the registration. If these timelines are not met, the food may only be sold for export or destroyed, unless otherwise agreed by CBP and FDA. According to the agency, these timeframes may help reduce the amount of time articles subject to refusal or holds are held at ports of entry.

Comments on the proposed rule are due on January 30, 2024. If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.