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The Food and Drug Administration: Definition, History & Purpose

Instructor: Cirrelia Thaxton

Cirrelia is an educator who has taught K-12 and has a doctorate in education.

Learn about what the Food and Drug Administration does to manage the research and development of food and drug products in the U.S. Study the history and purpose of this consumer protection agency to discover its positive impact on American citizens.

Food and Drug Administration

By definition, a government agency with operations under the jurisdiction of the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) regulates food, drugs, cosmetics, biologics, and blood products. The FDA must oversee its regulatory actions in the U.S. and abroad and consists of the Office of Commissioner and four directorates: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. The FDA is dedicated to protecting public health through effectiveness and efficiency and the assurance of security. Focusing on consumer protection, the FDA seeks to provide Americans with the safest food and drug products on the market.

Highlights of FDA History

Food and Drug Administration logo
fdalogo

The beginning of the FDA can be traced back to the year 1848, when a chemist named Lewis Caleb Beck was hired By the U.S. Patent Office to conduct research on agricultural products. The work of Beck coupled with findings that American soldiers in the Mexican War were dying from weak drugs propelled Congress to pass the Drug Importation Act. This legislation led to tighter controls on unsafe and adulterated drug imports. Yet, by the start of the Civil War, this law was less effective due to the improper tactics of inspectors whose appointments had been made for political gains.

By the early 1900s, much research and development occurred in the area of biological therapeutics, particularly serum therapy, for the control and eradication of infectious diseases. On July 1, 1902, Congress enacted the Biological Control Act, which oversaw the licensing of drug manufacturers, interstate commerce, and the supervision of qualified scientists. Due to the corruption of food and drug production and testing, many states passed laws to underscore rampant fraud. For instance, patent medicine manufacturers had the power to synthesize products made from their chemicals of choice and then advertise in favor of them despite state regulatory laws.

Around this time, Harvey Wiley, the director of the Department of Agriculture's Bureau of Chemistry, fought against the shenanigans of the administration of food and drugs in the U.S. Wiley focused on protection against exploitation by the food and drug industries and the passage of the 1906 Pure Food and Drug Act, a law to halt the misbranding of drugs and to order the labeling of dangerous substances, such as alcohol, morphine, and heroin. The 1906 Pure Food and Drug Act, although initially helpful, would be replaced in three decades later by the 1938 Food, Drug, and Cosmetic Act, which was sponsored by President Franklin D. Roosevelt.

Harvey Wiley (in suit) in the Lab
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It was at this time that the FDA took major shape as the nation's comprehensive consumer protection agency. The agency now required any drug manufacturer to prove the safety and effectiveness of any new drug before it could be put on the market. Moreover, these drugs required clear directions for use and thorough labels with any warnings. Further, any hard drugs that had to be administered by health professionals were labeled accordingly. Thus, the FDA had to control the access and distribution of effective, prescription drugs as well as the restriction of illegal drugs from the 1940s to the 1960s.

In the next decades, the FDA redirected its focus on the treatment of orphan or rare diseases. The organization worked to mobilize pharmaceutical companies that were reluctant in their research and development of drugs for rare disorders. Providing financial aid, planning incentives, and monopolies to market drugs, the FDA enabled these companies to get more involved with saving the lives of people with rare diseases.

More on the FDA's Purpose

Drug Products
pills

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