The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. As 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 FDA is responsible for protecting public health by regulating most food (excluding meat and poultry), tobacco products, dietary supplements, prescription and over-the-counter (nonprescription) drugs, clinical drug trials, vaccines, biologics, cosmetics, blood products, medical devices, devices that emit electromagnetic radiation, and veterinary products, including pet food. The FDA does not regulate meat and poultry. These products are regulated by the U.S. Department of Agriculture (USDA). It does not regulate alcohol, water quality, or pesticide use, nor does it inspect grocery stores or restaurants.
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. In addition, the Office of Regulatory Affairs conducts inspections of drug and food manufacturing facilities (except meat and poultry foods), inspects imported foods and drugs, and enforces FDA regulations.
As of 2012, the FDA had 6 centers, each addressing one main area of regulation.
Although the Food and Drug Administration did not acquire its current name until 1930, as early as 1848, the United States Congress passed laws requiring that imported drugs be inspected to prevent adulterated or low-quality drugs from entering the country. The first sweeping piece of legislation to regulate food and drug quality was the 1906 Pure Food and Drugs Act. This law addressed both the quality and labeling of food and drugs by prohibiting interstate commerce in adulterated and misbranded food and drugs. It also regulated veterinary drugs and animal feed.
Another important aspect of the 1938 law was that it made the distinction between drugs that required a prescription and those that could be purchased without a prescription or over the counter. However, the debate over what should be considered a prescription drug and what constituted an over-the-counter drug was not clarified until 1951.
In the 1960s the Kefauver-Harris Amendments to the 1938 law instituted new provision such as requiring informed consent by patients participating in clinical trials. It also transferred regulation of prescription drug advertising from the Federal Trade Commission (FTC) to the FDA and established a set of good manufacturing practices (GMPs) for food and drug producers. The Kefauver-Harris Amendments also strengthened the FDA's ability to enforce food and drug laws relating to food, drug, and cosmetic safety, truth-in-labeling, dietary supplements, and additives.
In the 1970s, responsibility for food on airplanes and other interstate travel carriers, radiation-emitting consumer and professional electronic products, and pre-market licensing authority for therapeutic agents of biological origin was transferred from the Public Health Service to the FDA. In the 1980s, scientists learned how to insert genes from one species into a different species to create a genetically modified organism (GMO) and the scope and duties of the FDA continued to expand.
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. In 2000, however, in FDA v. Brown & Williamson Tobacco Corp., the Supreme Court of the United States ruled that the FDA did not have the authority to regulate tobacco. The Court noted that Congress had not explicitly granted the FDA that authority under the Food, Drug, and Cosmetics Act. Furthermore, subsequent tobacco legislation enacted by Congress indicated that members of Congress did not intend for the FDA to have the power to regulate tobacco. In 2009, however, Congress passed the Family Smoking Prevention and Tobacco Control Act, which explicitly granted the FDA the power to regulate the tobacco industry.
In 2004 the FDA allowed the production and marketing of the first living organism for use as a prescription medical device. The FDA approved medical maggots for “debriding non-healing necrotic skin and soft tissue wounds.” Also in 2004 the FDA approved the use of a species of leaches to drain pooled blood around regrafted amputated appendages.
The FDA, along with the Environmental Protection Agency (EPA) and the USDA, is responsible for overseeing regulation of genetically modified foods. The role of the FDA is to assure nutrient content and observance of GMPs during the production genetically modified foods.
Over time, the role of the FDA has expanded to provide increased protection to consumers. The food and drug supply in the United States is one of the safest in the world due to FDA inspections and regulation. The FDA investigates suspected violations and has the power deny a manufacturer the right to market a new drug or medical device and to force manufacturers to recall defective, harmful, unsafe, adulterated, or mislabeled products. 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.
See also Bioterrorism ; Food additives ; Public Health Service ; Radiation ; Smoking ; Water quality .
Ekins, Sean, and Jinghai J. Xu. Drug Efficacy, Safety, and Biologics Discovery: Emerging Technologies and Tools. Hoboken, NJ: John Wiley & Sons, 2009.
Pampel, Fred C. Threats to Food Safety. Library in a book. New York: Facts On File, 2006.
Simon, Michele. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006.
Food and Drug Administration. “FDA's Origins & Functions.” http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/default.htm (accessed October 18, 2012).
United States Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20993, (888) INFO-FDA (463-6332), http://www.fda.gov .
Tish Davidson, AM