For all foreign and domestic food facility operators and U.S. food importers, now is the time to renew food facility registrations with the U.S. Food and Drug Administration (“FDA”) if your food (including dietary supplements) is distributed for consumption in the United States. On October 22, 2012, FDA began accepting biennial registration renewals from food facilities, and will continue to accept the renewals through December 31, 2012. Renewal of the registration during this period is mandatory, even for facilities that are already registered with FDA.
Food Facility Registration Requirements -
Section 305 of the Bioterrorism Act, enacted in 2002, amended the Federal Food, Drug and Cosmetic Act (the “FD&C Act” or “the Act”) to impose a mandate requiring “any facility engaged in manufacturing, processing, packing, or holding ‘food’ for consumption in the United States” to register with FDA. The requirement applies to all such facilities, whether in the U.S. or abroad, but excludes foreign facilities whose food products are significantly further manufactured or processed by a subsequent facility prior to export to the United States. Facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture’s Food Safety and Inspection Service (“FSIS”) (i.e., facilities that exclusively process “poultry products,” “meat food products,” or “egg products” and facilities that slaughter poultry, cattle, sheep, swine, equines, or goats) are also exempt. Pursuant to the Act, the registrations may be submitted by the “owner, operator, or agent in charge of the facility” for domestic or foreign facilities. However, registrations for foreign facilities must also name a U.S. agent for that facility. The failure to timely register a facility constitutes a violation of the Act, and for foreign facilities, as explained below, the Act provides that food from such a facility that is imported, or offered for import into the U.S., is subject to refusal under Section 801 of the FD&C Act.
The FDA Food Safety and Modernization Act (“FSMA”), signed into law by President Obama in January 2011, expanded the registration mandate implemented under the Bioterrorism Act, and introduced three additional significant changes that: (1) required all facilities subject to the registration requirements to submit registration renewals during the period from October through December of each even numbered year; (2) compelled all domestic and foreign facilities’ registration to include a statement of their agreement to allow FDA to inspect their facilities; and (3) subjected registered facilities to suspension provisions that authorize FDA to suspend a facility’s registration, thereby prohibiting imports or exports of food from the facility into the U.S. and prohibiting the introduction of food from the facility into interstate or intrastate commerce in the U.S., upon a determination that the facility created or had reason to know that food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
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