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FDA Issues Final Rule: Information Required in Prior Notice of Imported Food

CFSAN Constituent Update

May 29, 2013

The U.S. Food and Drug Administration issued today a final rule that adopts, without change, the interim final rule, Information Required in Prior Notice of Imported Food (issued May 5, 2011). This final rule adds an additional element of information to prior notice requirements already established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Specifically, a person submitting prior notice of imported food, including food for animals, must report the name of any country that has refused entry of that product.

Section 304 of the Food Safety Modernization Act required this amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act). The law in part gives FDA important new tools to better ensure that imported foods are produced under the same safety standards as those in the United States. On May 5, 2011, FDA issued an interim final rule that implemented Section 304 and requested public comments. The interim final rule became effective July 3, 2011. The final rule today adopts the regulatory requirements outlined in the interim final rule.

The Prior Notice provision was part of the Public Health Security and Bioterrorism Preparedness and Response Act (known as the Bioterrorism Act), signed into law in June, 2002. This Act amended the FD&C Act by adding a provision that FDA must receive a notice including certain information about imported foods before they arrive in the United States. It also provided that an article of food imported or offered for import is subject to refusal of admission into the U.S. if adequate prior notice has not been provided to FDA.

This final rule is effective May 30, 2013. 

For more information see:

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