Prior Notice Requirements for Imported Food Revised

The Food and Drug Administration has issued a final rule that will make the following changes to its requiring specific information about articles of food imported or offered for import into the U.S. to be submitted in advance of arrival of the food.

Timeframe. FDA regulations generally require an article of food that has been refused entry for no prior notice or inaccurate prior notice, or that has been held because it was imported from an unregistered foreign facility that is required to register, to be treated as general order merchandise if no prior notice is submitted or resubmitted, prior notice is not adequate, or no registration is provided.

The new rule specifies that such submissions must be made within 10 calendar days from the date a notice of refusal or hold, or a response to a request for FDA review, was issued. In addition, submission of a valid food facility registration is required with 30 calendar days of such actions. The FDA states that this change may reduce the amount of time articles subject to refusal or holds are held at ports of entry, thus reducing associated monetary charges.

The FDA notes that if a prior notice is not submitted or resubmitted, or a registration is not provided, within the required timeframes, these changes will require the article to be dealt with as set forth in U.S. Customs and Border Protection regulations relating to GO merchandise. As a result, unless otherwise agreed to by CBP and the FDA, the article may only be sold for export or destroyed.

Means of submission. Prior notice of goods arriving by international mail may be submitted through either the FDA’s Prior Notice Systems Interface or the Automated Broker Interface/Automated Commercial Environment/International Trade Data System.

International mail. Effective Oct. 1, 2026, those submitting prior notice for articles of food arriving by international mail will have to provide the name of the mail service and the mail tracking number. This will enable the FDA to better coordinate with CBP and the U.S. Postal Service to track and inspect articles identified as a possible bioterrorism risk.

For more information on this rule, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.