On May 30, 2013, the Food and Drug Administration issued a final rule implementing a new prior notice requirement for food imported into the United States.

The new requirement, which is authorized by the Food Safety and Modernization Act (FSMA), requires importers of a food product to notify the FDA if any other country has refused entry of that food product for food safety reasons. The purpose of the new rule is to provide FDA with additional information to better identify imported food that may pose a safety or security risk to American consumers.

Even before the May 30, 2013 rule, importers of food into the U.S. needed to notify the FDA prior to a food shipment. In other words, the new requirement simply adds to the list of information importers must provide to the FDA. The Prior Notice of Imported Food regulations, available at 21 CFR 1.276 -1.285, require importers to electronically submit notification to the FDA before any imported food arrives in the U.S. The type of information that must be in a Notice includes the country of production, the name of the shipper, the identity of the grower or manufacturer, and the common market name of the food product.

The time by which importers must submit Notice varies depending on how the food enters the country. For example, the FDA must receive notice of food arriving by roadway no less than 2 hours before the food arrives in the country, but no less than 8 hours before food arrives by water. Depending on what electronic system the importer uses to submit the Notice, the Notice can be submitted either thirty or fifteen calendar days before the anticipated date of arrival.

The new rule is effective immediately, so food importers must be mindful to begin identifying any entry refusals in their Notices.