Food and Drug Administration

The Food and Drug Administration (FDA) is a regulatory agency charged with enforcing laws pertaining to food, drugs, drink, cosmetics, and medical and therapeutic devices sold in the United States. Now within the Department of Health and Human Services, the FDA is responsible for ensuring the safety and efficacy of drugs in the health care system. Throughout its 100 years of existence, the agency has monitored, and responded to, crises that could have been avoided had the agency been given more funding or broader powers. Following almost every instance of catastrophe, usually with attendant deaths, more accountability has been given to the agency.

In its earliest years, the agency now known as the FDA was concerned with drug regulation. Various measures have been taken to keep the citizenry safe, including early laws requiring customs officials to keep adulterated drugs out of the country. The Bureau of Chemistry, founded in 1863, within the U.S. Department of Agriculture, focused more on the dangers inherent in food items than drugs, and even here, the concern about food items ran toward issues of adulteration more than foodborne illness.

The first time attention was paid to a specific drug problem was in 1902, with the passage of the Biologics Control Act. This act, which ensured the safety of serums, vaccines, and other products, was in direct response to tragedies in St. Louis, Missouri, and Camden, New Jersey. In both cities, children died of tetanus after receiving diphtheria antitoxin made from a horse infected with tetanus. The Biologics Control Act, which ultimately led to the Center for Biologics Evaluation and Research, gave the Bureau the authority to regulate biological products and ensure their safety.

The 1906 Pure Food and Drug Act addressed concerns raised by, variously, Upton Sinclair's novel The Jungle and Samuel Hopkins Adams's six-part series on drug adulteration in Collier's magazine. After almost 20 years of agitation, these two documents helped push Congress to create a new agency, the FDA, charged with enforcement of both the Pure Food and Drug Act and the Meat Inspection Act. Drug companies helped conceive of the regulations that bound them, 11 drugs were made illegal, and all product labels were required to be accurate and truthful.

Continued problems with the drug and food supply were highlighted twice in the 1930s. At the 1933 Century of Progress World's Fair in Chicago, the FDA's exhibit space focused on the shortcomings and inadequacies of the 1906 acts. In 1935, 107 people died after using Elixir of Sulfanilamide, a sulfa drug suspended in glycol ether, a deadly combination. Congress responded by passing the 1938 Food, Drug and Cosmetic Act that extended FDA powers to include cosmetics and therapeutic devices, as well as advertising of some of these products.

During World War II, new drug discoveries, as well as supply shortages, kept the agency busy. The 1941 Insulin Amendment required the FDA to test and certify the purity and potency of insulin. Since penicillin's availability had been limited during wartime to government rather than civilian use only, the batches were monitored. In 1945, the Penicillin Amendment did for penicillin what the Insulin Amendment had done for insulin: The FDA tested and certified penicillin, to guarantee its efficacy and safety. This process was discontinued in the 1970s, when the safety of the penicillin supply was unquestionable.

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