The U.S. Food and Drug Administration ("FDA") has issued two related regulations under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act"). The first requires all domestic and foreign "facilities" that "manufacture, process, pack, or hold food" for consumption in the United States to register with the FDA (68 Fed. Reg. 58893). The second requires prior notice before food is imported or offered for import into the United States (68 Fed. Reg. 58974).

Both rules apply to all food products regulated by the FDA, including fish and seafood, dairy products, shell eggs, bakery goods, snack food, candy, fruits, vegetables, raw agricultural commodities for use as food or components of food, chewing gum, dietary supplements, infant formula, beverages (including alcoholic beverages and bottled water), canned goods, food additives, live food animals, and animal feed (including pet food).