The three statutory elements of an FDCA violation involve the definitions of food, drug, cosmetic, and device; the meaning of adulterated or misbranded; and the introduction of the item into interstate commerce. The two categories of defenses are constitutional challenges related to administrative searches, due process, and self-incrimination and the impossibility defense, in which the corporate officer proves that the officer was powerless to prevent the violation. The FDCA authorizes inspectors of the Food and Drug Administration to enter and inspect certain premises, provided that the statutory prerequisites are met. The law provides for both criminal and civil penalties. The numbers of arrests and convictions pursuant to the FDCA has increased in recent years. In addition, the Food and Drug Administration has begun efforts to prevent health risks to the public by pursuing new regulation of drugs and tobacco products, despite concerns regarding funding. Footnotes