radiation . . ., all animal drugs and feed; and even all cosmetics" (FDA, FDA's Growing Responsibilities for the Year 2001 and Beyond, p. 1).
Historical Expansion of FDA's Powers and Responsibilities
The history of FDA largely consists of a steady but episodic accretion of its regulatory powers in response to external developments.
Pre-World War II Regulation of Food and Drugs. Federal regulation of food and drugs which was assigned until 1938 to the Bureau of Chemistry of the Department of Agriculture (DOA) derived its mandate from federal laws the enactment of which stemmed from two scandals. The Biologics Act of 1902 (dealing with humans) arose out of deaths caused by contaminated diphtheria antitoxin in St. Louis. A corollary statute covered animal vaccines, the Virus, Serum, and Toxin Act of 1913. The 1906 Pure Food and Drug Act was prompted by Upton Sinclair's novel, The Jungle, which exposed unsanitary conditions in the meatpacking industry. These were penal statutes which were concerned primarily with adulteration of vaccines, food and drugs and the sale of patent medicines and under which the government lacked the power to approve or deny approval of products before they were marketed. However, in the 1937 Elixir Sulfanilamide scandal, a number of people were poisoned to death by a hastily marketed drug containing an untested solvent (diethylene glycol). In 1927 the food and drug functions of the Bureau of Chemistry were transferred to a new agency which in 1931 was named FDA. Under the 1938 Food, Drug, and Cosmetics Act (FD&C) FDA was empowered to object to the marketing of any new drug on safety grounds; however, "Congress stopped short of requiring that new drugs obtain an affirmative premarket approval" (Miller, 2000, p. 13). Drug companies were required to submit to FDA an application for an investigative drug exemption (IND) before it began testing a drug on humans. With the IND, the drug's sponsor has to pro...