Food and Drug Administration

Founded in 1927, the Food and Drug Administration (FDA) is an agency of the Untied States Public Health Service . One of the nation's oldest consumer protection agencies, the FDA is charged with enforcing the Federal Food, Drug, and Cosmetics Act, and other related public health laws. The agency assesses risks to the public posed by foods, drugs, and cosmetics, as well as medical devices, blood, and medications such as insulin which are made from living organisms. It also tests food samples for contaminants, sets labeling standards, and monitors the public health effects of drugs given to animals raised for food.

To carry out its mandate of consumer protection, the FDA employs over 9,000 investigators, inspectors, and scientists who collect domestic and imported product samples for examination by FDA scientists. The FDA has the power to remove from the market those foods, drugs, chemicals , or medical devices it finds unsafe. The FDA often seeks voluntary recall of the product by manufacturers, but the agency can also stop sales and destroy products through court action. About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace based on FDA action. Also, about 30,000 import shipments each year are detained at the port of entry on FDA orders.

FDA scientists analyze samples of products to detect contamination, or review test results submitted by companies seeking agency approval for drugs, vaccines, food additives , dyes, and medical devices. The FDA also operates the National Center for Toxicological Research at Jefferson, Arkansas, which conducts research to investigate the biological effects of widely used chemicals. The Agency's Engineering and Analytical Center at Winchester, Massachusetts, tests medical devices, radiation-emitting products, and radioactive drugs. The Bureau of Radiological Health was formed in 1971 to protect against unnecessary human exposure to radiation from electronic products such as microwave ovens.

The FDA is one of several federal organizations that oversees the safety of biotechnology , such as the industrial use of microorganisms to processes waste and water products.

In 1996, when the FDA declared that cigarettes and smokeless tobacco are nicotine-delivery devices, it took responsibility for regulating those products under the authority of the Federal Food, Drug, and Cosmetics Act. With regard to these products, the FDA has issued federal mandates concerning sales to minors, sales from vending machines, and advertising campaigns.

[Linda Rehkopf ]

RESOURCES

PERIODICALS

Gibbons, A. "Can David Kessler Revive the FDA?" Science 252 (April 12, 1991): 200–3.

Iglehart, J. K. "The Food and Drug Administration and Its Problems." New England Journal of Medicine 325 (July 18, 1991): 217–20.

ORGANIZATIONS

U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville, MD USA 20857-0001 Toll Free: (888) INFO-FDA, <http://www.fda.gov>