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The U.S. Food and Drug Administration (FDA) is a federal agency charged to protect public health. The agency, created by the 1906 Food and Drugs Act, defines its mission as
- To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;
- With respect to such products, protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled;
- Participate through appropriate processes with the representatives of other countries to reduce the burden of regulation, harmonize requirements, and achieve appropriate reciprocal arrangements.
Change refers to the rapid industrialization in the United States during the late 1800s, including discoveries in chemistry leading to synthetic medicines and changes in markets as consumers moved away from the village merchants they knew and trusted for pure food. Complexity refers to the problem of how the federal government should address the problems of deceptions and hazards in food and drugs. Some products were regulated under individual laws, but how could the government address the many products that existed and the continuing flow of new products coming into the market?
Competition refers to the reality at the time that adulterated food could be produced and sold more cheaply than healthier and safer foods. With lower prices, questionable and unsafe foods were competing with reputable food makers, and an uninformed public had little basis for judging the difference in quality. Throughout the 1890s, business groups pressured Congress for protection. Many state laws were enacted, but they were often contradictory, creating inefficiency for national producers.
The fourth C, crusading, evolved when animal-rights groups, the National Consumer League, and the General Federation of Women’s Clubs began pushing for tougher food-and-drug safety laws and the U.S. Department of Agriculture (USDA) began to oversee food-adulteration practices. Initially food adulteration was perceived as a harmless fraud, but with USDA research, the threat to consumers’ health was explored and articulated. Harvey Wiley, a chemist and physician who became the chief chemist for the USDA, joined forces with other agricultural groups, medical professionals, and sympathetic journalists, creating the fifth C, a coalescence of forces for reform. Compromise recognized the many different groups and interests among government, business, and consumer interests. Wiley organized three National Pure Food and Drug Congresses between 1898 and 1900 to work out agreements.
As James Harvey Young states, “In the end it took the seventh ‘C,’ catastrophe, to fuel the final compromise and get the law enacted.” Investigations showing that “embalmed beef” had been shipped to troops in the Spanish-American war and the publication of Upton Sinclair’s The Jungle, describing filthy conditions in meat-packing plants, pressured politicians into passing the Food and Drug Act.
Since the act’s passage, numerous responsibilities have been assigned to the Food and Drug Administration, including medical labeling, narcotic-substance control, cosmetic and therapeutic device supervision, advertising of FDA-regulated products, hazardous-substance labeling, sanitation programs, and many others. In 1997 Congress pressured the Food and Drug Administration to speed up its drug-review process. Consumers and pharmaceutical industry representatives pointed to European drug-review processes, which often took one or two years less than the Food and Drug Administration’s system, allowing new therapies to be available sooner.
Recent “hot topics” confronting the FDA include buying medicines over the Internet, mad-cow disease, LASIK surgery, and radiation of foods.
