It’s About Time: FDA’s Proposed Rule to Amend Prior Notice Regulations

November 10, 2023By Sophia R. Gaulkin & Riëtte van Laack

On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines.  More specifically, the proposed rule, if finalized, would:

  • Amend 21 C.F.R. § 1.281(b)(10) to require that prior notice for articles of human and animal food arriving by international mail include the name of the mail service and tracking number; and
  • Amend 21 C.F.R. §§ 1.283 and 285 to require that, once a notice of refusal or hold is issued, prior notice be submitted within 10 calendar days and food facility registration information be submitted within 30 calendar days.

“Prior notice” informs FDA about the products it can expect to be offered for import into the country. The requirement for prior notice originates in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act).  This law directs FDA to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. Among other things, the Act requires that FDA receive prior notification of food that is imported or offered for import into the United States. This advance notice of import shipments is intended to help FDA, with the support of the U.S. Customs and Border Protection (CBP), target import inspections more effectively and help protect the nation’s food supply against terrorist acts and other public health emergencies.  The FDA Food Safety Modernization Act (FSMA) enacted in 2011, aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.  Pursuant to FSMA, FDA amended the requirements for prior notice of imported food, to include a requirement to report the name of any country to which the article has been refused entry.  As a result FDA can make better informed decisions in managing potential risks of imported food into the United States.  Over time, FDA amended the prior notice regulations to require tracking numbers and other information to more easily identify foods that pose a higher health risk.

However, currently, prior notice of food articles arriving by international mail requires the notifier to provide to FDA only with the anticipated date of mailing.  This information is insufficient to allow FDA to predict when a shipment will arrive.  As a result, FDA cannot monitor, locate, inspect, and if needed, contain any shipment that has been identified as a possible public health or bioterrorism risk.  More detailed information about the mailing such as the tracking number and the mailing service would help FDA to better coordinate with other federal agencies and refuse or hold specific food shipments that pose risks.

The proposed rule also establishes a timeframe by which food articles subject to refusals or holds must become compliant.  In some cases, foods imported without a prior notice, with inadequate prior notice, or from an unregistered foreign food facility that is required to register have been held at ports for weeks or months, accumulating substantial demurrage costs for the importers.  Under the proposed rule, if held articles are not brought into compliance within 10 days (if held because prior notice was missing) or within 30 days (if held because food facility registration was missing), they may only be sold for export or destroyed, unless otherwise agreed to by FDA and CBP.

Like The Marvelettes, FDA is tired of wondering when its mail will arrive and “waitin’ so patiently” for importers to achieve compliance.  But unlike this Motown girl group, FDA doesn’t need to plead with the postman; it can propose a rule.

Comments on the proposed rule can be submitted here until January 30, 2024.