Food and Drug Administration

AuthorJeffrey Lehman, Shirelle Phelps

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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.

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.

History

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

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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.

HOW THE FDA APPROVES NEW DRUGS

The process by which the Food and Drug Administration (FDA) approves drugs as safe and effective is generally long and complicated, though it may vary according to the type of drug and the nature of the illness for which it is being developed. The FDA refers to drugs under development as investigational new drugs, or INDs.

The evaluation of new drugs requires the skills of many different FDA scientists and professionals performing a wide variety of tasks. Biochemists and molecular biologists evaluate the basic chemistry and biology of new chemical compounds and molecular structures. Toxicologists assess the potential harm of proposed drugs, and pharmacologists study how these drugs affect the body and are broken down and absorbed by it. Computer scientists create electronic models that aid in the understanding of new chemicals...

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