Any establishment that conducts business in the food or drug industry in the United States must register with the Food and Drug Administration. This includes any owner, operator or agent of domestic or foreign facilities that manufacture, pack or hold food for consumption.
Foreign facilities that are required to register but fail to do so are refused admission to the United States, and their products are held at the port of entry, sometimes resulting in civil or criminal prosecution. Cosmetics, medical devices and tobacco must all be registered with the FDA. New prescription and some over-the-counter drugs must be evaluated for safety before they can be marketed in the U.S.