The Food and Drug Administration (FDA) has published an updated guidance document, Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3). This draft guidance is being distributed for comment purposes only. Although comments on FDA guidance documents may be submitted at any time (see 21 C.F.R. § 10.115(g)(5)), to ensure that the agency considers any comment on this draft guidance before it begins work on the final version, electronic or written comments must be submitted by May 30, 2014. 79 Fed. Reg. 17,947 (Mar. 31, 2014).
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires that FDA receive prior notification of food, including animal feed, intended for import into the United States. Advance notice of import shipments allows FDA, with the support of U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect that nation’s food supply against terrorist acts and other public health emergencies. Pursuant to the Food Safety Modernization Act (FSMA), FDA on May 5, 2011, published an interim final rule requiring that a person submitting a prior notice report the name of any country to which the food has been refused entry.
The draft guidance includes information related to this new requirement that a prior notice include the name of any country that has refused entry of the food. It also addresses questions received by FDA since publication of the second edition of the guidance in May 2004.