On November 1, 2023, the US Food and Drug Administration (FDA) published a proposed rule to amend the advance notification requirements for food and animal imports in two key ways:
- Advance notification for human and animal foods arriving by international mail must include the name of the postal service and the tracking number of the mail; and
- The advance notice and food item information must be submitted within a certain period of time after FDA has issued a denial or hold notice.
Additionally, on October 13, 2023, FDA published guidance clarifying how best to comply with the current FDA advance notice rule.
This update summarizes FDA’s advance notice requirements, the agency’s Nov. 1 proposal to amend those requirements, and FDA’s recently published final guidance (its fourth edition) on compliance.
What is advance notice?
Advance notification is a requirement to provide advance information to the FDA about human and animal foods that are imported into the United States. The FDA has required prior notification since 2003. 68 Fed. Reg. 58974 (October 10, 2003). Depending on the method of shipment, the advance notice should include, for example, information about the sender, the shipment, the arrival, and details about the origin, production, and identity of the food. 21 CFR § 1.281. Importers currently submit advance notice either through FDA’s Advance Notification System Interface (PNSI) or through US Customs and Border Protection’s (CBP) ABI/ACE interface.
Consequences. FDA may refuse food arriving at a port of entry if it deems advance notice insufficient (21 CFR § 1.283) or may detain food if it is from an unregistered foreign facility (21 CFR § 1.285). Importers may correct these violations in response to FDA.
The FDA’s proposed November 1 changes would change advance notification requirements by:
- Require advance notice for foods arriving by international mail to include (1) the name of the postal service and (2) a mail tracking number. FDA aims to improve food traceability, identification, inspection, emergency response times, and agency coordination during investigations and surveillance operations.
- Eliminating the requirement that food arriving by international mail be reportable only to FDA’s PNSI. That’s because CBP’s new system, the ABI/ACE interface, can now accept requests for such foods. Food applications arriving by international mail may be reported through the FDA or CBP system.
- Setting deadlines for importers to respond if their foods have been subject to an FDA denial or withholding notice. First, importers will have 10 calendar days to provide FDA with appropriate notice from the date of FDA’s denial of advance notice. Second, importers will have 30 calendar days from the date of receipt of a withholding notice from FDA to obtain food facility registration. The FDA aims to reduce food storage costs at the port of entry by expediting corrective submissions.
Interested parties may submit comments on FDA’s proposed rule until January 30, 2024.
The FDA’s definitive guidance
FDA’s Oct. 13 guidance clarifies that shippers must provide advance notice only to FDA, not both FDA and CBP, and shippers can do so through FDA’s PNSI or CBP’s ABI/ACE interface. (Question D.3.2).
The guide also clarifies:
- Food imported from a country that has a Systems Recognition Agreement (SRA) with FDA or an FDA equivalency determination requires prior notification. (Question C.1.4). An SRA is an agreement between the FDA and a foreign regulatory partner concluding that they operate comparable regulatory programs. Similarly, FDA makes an equivalence determination if it concludes that a country’s safety controls achieve at least the same level of public health protection as that required under the corresponding US requirements.
- FDA requires advance notification for foods that are imported from a country that is a party to a free trade agreement with the United States. (Question B.10.3).
Finally, the Guidance clarifies the procedure for denials or withholdings of FDA notice.
- FDA will send notice of advance notice denials or holds first to CBP and then to the appropriate party (ie, advance notice submitter or transmitter). (Question E.1.6).
- FDA must receive requests for reconsideration of the denial or hold within five calendar days of the day FDA notified the appropriate party (ie, submitter or transmitter of the advance notice). (Question E.1.7).
FDA welcomes stakeholder comments on the final guidance (and no timetable applies).
Taken together, the proposed changes to FDA’s Advance Notice Rule following the publication of the Agency’s Final Guidance on Compliance with Advance Notice Requirements may indicate increased FDA attention to come in the near term on human and animal food imports. It should be noted that on September 29, FDA additionally posted a video on its Human Food Imports page highlighting the applicable FDA requirements that FDA inspects/enforces during the importation of human food into the United States. In light of these developments, affected stakeholders should confirm compliance with FDA import requirements and anticipate a potential increased focus by FDA on human and animal food imports.