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The Food and Drug Administration (FDA) is the federal agency responsible for ensuring the safety of foods (other than meat and poultry) and of therapeutic biological products such as vaccines, cosmetics, medical devices, radiological products, human drugs, and veterinary drugs. Originally called the Bureau of Chemistry, the agency name was changed to the Food and Drug Administration in 1930. Although currently housed within the Department of Health and Human Services, historically the FDA has been housed in the Department of Agriculture, the Federal Security, the Public Health Service, and the Department of Health, Education, and Welfare, the predecessor to Health and Human Services. In 1862, Charles M. Weatherill was appointed the first chemist of the Department of Agriculture. In 1883, Harvey Wiley became the chief chemist and campaigned for a federal food and drug law. This transformation came with increased regulation, responsibilities, and duties for the agency.

Prior to 1906, the U.S. government was primarily concerned about food and drug safety within particular segments of the general population. A public scandal about contaminated or adulterated medicine given to U.S. troops rushed the passage of the 1848 Drug Importation Act. Signed by President James K. Polk on June 26, 1848, the act established customs laboratories on the borders. The introduction of the law came at the request of pharmacists and physicians who questioned the purity of the medicines they prescribed and compounded.

By the start of the 20th century, many U.S. households had shifted from an agrarian lifestyle and economy to an urban environment, affecting jobs, housing, and consumer goods. Prepared foods and drugs were readily and easily available in the marketplace. Yet the quality of those products was questionable, and state laws were varied and inconsistent in the regulation of the quality of these foods and drugs. In this era of exploding foods, blinding lash dyes, questionable patent medicines, and fermenting catsups, some measures were taken to assure consumers about the drug and food quality. Passed 4 years before the 1906 Food and Drug Act, the 1902 Biologics Control Act called for the regulation of the manufacture and sale of biologics.

The passage of the 1906 Pure Food and Drug Act (also called the Wiley Act) was prompted by internal forces such as Harvey Wiley and by organized social movements that demanded the government regulate the safety and labeling of food and drugs. To understand the effects of preservatives on the human body and to have evidence to build their case for a federal pure food and drug standards act, Wiley and his staff of chemists collected samples of adulterated food and drugs and performed food additive experiments. Also, Wiley built a broad coalition of business leaders, chemists, physicians, women's club members, and journalists who supported food and drug reform. As the Department of Agriculture chemists continued their research and as Wiley cemented support among various groups, journalists and other writers prodded the conscience of the U.S. public by tackling the food industry and upsetting the nation's collective stomach. The most famous muckraker author who wrote about food standards was Upton Sinclair, author of The Jungle, which vividly described the unsanitary conditions of the Chicago meatpacking yards. Other authors included Samuel Hopkins Adams of Colliers and Ray Stannard Baker at McClure's Magazine, who wrote about food safety and drug standards. The publishers of Ladies' Home Journal, Cyrus H. K. Curtis and Edward Bok, refused advertising from patent medicines and medicines laced with high percentages of alcohol.

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