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Food and Drug Administration

From lawbrain.com

One of the oldest U.S. Consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply. Recently, the FDA announced a recall of Watson Pharmaceuticals Triad Alcohol Prep Products and as a result the Company is cooperating fully with the FDA, and notifying its customers of the recall.

To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways.

The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the scientific evidence to back up its regulatory and inspection duties. These scientists analyze samples of products for purity and review test results of new products. The FDA itself does not do research for a new medical product. Instead, it evaluates the results of studies undertaken by the manufacturer.



Food production in the United States has been regulated since the late eighteenth century. Colonies and, later, states passed laws banning impurities from selected foods. In 1848, the United States began regulating imported drugs, under the Drug Importation Act (Ch. LXX, 9 Stat. 237). The enforcement of food and drug laws was first assigned to the Chemical Division of the new u.s. department of agriculture (USDA) in 1862 (12 Stat. 387).

The need for laws to regulate food and drug purity became increasingly urgent in the late nineteenth century, when substances such as opium, cocaine, and heroin were commonly added to medicinal elixirs and tonics. The need for government regulation was also made evident in Upton Sinclair's book, The Jungle, which exposed the unsanitary conditions of Chicago's meatpacking industry and shocked the nation. On June 30, 1906, Congress, with the support of President Theodore Roosevelt, passed two landmark pieces of Progressive Era legislation that strengthened the government's ability to protect consumers: the Food and Drug Act (34 Stat. 768 [21 U.S.C.A. § 1–15]) and the Meat Inspection Act (21 U.S.C.A. § 601 et seq.). The former prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs, and the latter addressed the unsanitary conditions and use of poisonous preservatives and dyes in the meatpacking industry.

In 1927, Congress authorized the creation of the Food, Drug, and Insecticide Administration within the U.S. Department of Agriculture. In 1930, the agency's name was changed to the current one, Food and Drug Administration (Agriculture Appropriation Act, 46 Stat. 976).

In 1937, 107 people died after taking the elixir sulfanilamide, a supposedly healing tonic. This tragedy prompted the passage of the next major reform of food and drug law, the Federal Food, Drug, and Cosmetic Act of 1938 (21U.S.C.A. § 301 et seq.). The FDA was then entrusted with the regulation of cosmetics and therapeutic devices and was authorized to do factory inspections. Even more importantly, the act required new drugs to be tested on animals and humans for safety before being marketed. In 1957, the Food Additives Amendment (Pub. L. 85-250, Aug. 31, 1957, Stat. 567) required the evaluation of food additives to establish safety, and in the following year, the Delaney Clause (Pub. L. 85-929, Sept. 6, 1958, 72 Stat. 1784) forbade the use in food of substances found to cause cancer in laboratory animals.

In 1962, the Kefauver-Harris Drug Amendments (Pub. L. 87-781, Oct. 10, 1962, 76 Stat.780) were passed. These laws required drug manufacturers not only to show that their drugs were safe but also to prove that their drugs achieved the effects claimed. That same year, FDA regulations were shown to be effective after the drug thalidomide, for which the FDA had delayed approval, caused thousands of birth defects in western Europe.

In 1979, the FDA was made part of the Department of Health and Human Services (96 Stat. 668, 695). Other laws with major implications for the FDA's activities include the 1990 Nutrition Labeling and Education Act (Pub. L. 101-535, Nov. 8, 1990, 104 Stat. 2353), which requires all packaged foods to carry labels with nutrition information, and the Prescription Drug User Fee Act of 1992 (Pub. L. 102-571, Title 1, Oct. 29, 1992, 106 Stat. 4491 to 4500), which requires drug and biologics manufacturers to pay fees that support FDA assessment of their products.

Effective October 2002, the FDA implemented its National Organic Program (NOP) under the Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501 et. seq. The NOP sets the first national standards for the use of the label term organic on food items and products. Products that qualify as "100 percent organic" under NOP rules may use the "USDA Organic" seal on their principal display panel. The rules specifically prohibit the use of genetic engineering methods, ionizing radiation (irradiation), and sewage sludge for fertilization. In addition, all agricultural products that are labeled organic must originate from farms or handling operations that have been certified by a state or private agency accredited by the USDA.


The FDA carries out its activities through a number of subdivisions. The Center for Drug Evaluation and Research regulates the safety, effectiveness, and labeling of all prescription and over-the-counter drugs intended for human use. It also monitors drug advertising for accuracy, ensures the safety and rights of patients in drug studies, and distributes information on drug products to the medical community and the public.

The Center for Biologics Evaluation and Research regulates biological products, which include blood, vaccines, human tissues, and drugs derived from living organisms. It coordinates an AIDS program, which works to develop an AIDS vaccine and AIDS diagnostic tests. It also conducts research on the safety of blood and blood products and inspects manufacturing plants to ensure compliance with FDA standards.

The Center for Food Safety and Applied Nutrition develops regulations related to food, food additives and colorings, and cosmetics. The Center for Devices and Radiological Health seeks to ensure the safe use of potentially hazardous radiation such as that produced by X rays. It conducts research into the effects of exposure to radiation-producing medical devices and develops manufacturing standards for such devices.

The Center for Veterinary Medicine evaluates the safety of drugs and devices used on animals. The National Center for Toxicological Research assesses the biological effects of toxic chemical substances.

Other offices of the FDA include the Office of Policy, the Office of External Affairs, the Office of Management and Systems, the Office of AIDS Coordination, the Office of Orphan Products Development, and the Office of Biotechnology. The administration operates six field offices, 21 district offices, and 135 resident inspection posts throughout the United States and Puerto Rico.

Further Readings

Branding, Frederick H. 2003. "Preparing for and Surviving FDA Inspections." Corporate Counsel's Quarterly 19 (January): 28–35.

Burkholz, Herbert. 1994. The FDA Follies. New York: Basic Books.

"Center for Drug Evaluation and Research." 1995. U.S. Food and Drug Administration (March 14). Available online at <http://www.fda.gov> (accessed March 13, 2003).

Clinton, Bill, and Al Gore. 1995. Reinventing Drug and Medical Device Regulations. National Performance Review series (April). Washington, D.C.: U.S. Government Printing Office.

——. 1995. Reinventing the Regulation of Drugs Made from Biotechnology. National Performance Review series (November). Washington, D.C.: U.S. Government Printing Office.

"FDA Mission Statement: Protect Public Health." 1995. U.S. Food and Drug Administration (March 30). Available online at <http://www.fda.gov> (accessed March 13, 2003).

Harmon, Daniel E. 2002. The Food and Drug Administration. Philadelphia: Chelsea House Publishers.

"Milestones in U.S. Food and Drug Law History." 1995. U.S. Food and Drug Administration (August). Available online at <http://www.fda.gov> (accessed March 13, 2003).

Parver, Deborah G. 1999. "Expediting the Drug Approval Process: An Analysis of the FDA Modernization Act of 1997." Administrative Law Review 51 (fall): 1249–66.

U.S. Food and Drug Administration. 1995. FDA Consumer: From Test Tube to Patient: New Drug Development in the United States. 2d ed. Washington, D.C.: U.S. Food and Drug Administration.

U.S. Food and Drug Administration Website. Available online at <http://www.fda.gov>.

U.S. Government Manual Website. Available online at <http://www.gpoaccess.gov> (accessed November 10, 2003).



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