ABSTRACT
At the turn of the twentieth century, the unsanitary conditions in the United States (US) food and drug industries were appalling. Upton Sinclair’s novel, The Jungle, described the filth of the meat packing industry and made Americans leery of eating meat. The Food and Drug Act of 1906 (also known as the Wiley Act) was enacted to give the government a role in protecting the public against unsafe or adulterated foods and drugs moving in interstate commerce. Although the Food and Drug Act of 1906 defined adulterated and misbranded drugs, it was the responsibility of the government to prove that the seller intended to defraud the buyer. Medical devices were not addressed at all in the 1906 act.
