FDA (United States Food and Drug Administration)

FDA (United States Food and Drug Administration)

The Food and Drug Administration (FDA), a Department of Health and Human Services agency, regulates the development, sale, and distribution of food products, prescription and over-the-counter drugs, cosmetics, and medical equipment. The FDA's reach is so extensive that one-fifth of all consumer dollars spent in the U.S. purchase a product regulated by the FDA. The goal of the FDA is to protect consumers by ensuring the safety of food and drug products sold in the U.S.

The FDA traces its history to 1862, when President Abraham Lincoln created a chemistry division under the Department of Agriculture. Congress created the modern FDA in 1906 with the passage of the Food and Drugs Act. The 1906 law gave limited power to the FDA to monitor the safety of food and drug products. In 1938, Congress expanded the power of the FDA by passing the Food, Drug, and Cosmetic Act. This act granted the FDA the power to test drugs and determine their safety and efficacy before allowing companies to sell the new drugs. The act also granted the FDA authority to regulate cosmetics.

While the FDA's primary task is to ensure food and drug safety, in recent years the agency has taken on an increased role in the fight against bioterrorism. The FDA is leading efforts to develop and produce vaccines and treatments plans to prevent or stop the spread of a bioterror attack. In this quest, the FDA must quickly test vaccines, so private companies can produce and stockpile vaccines.

The variety of possible pathogens (disease-causing microorganisms) that might be used in bioterrorism has tested the limits of the FDA. The administration must simultaneously assess the effectiveness of vaccines and treatments for anthrax, smallpox, botulism, plague, hemorrhagic fevers, and other potential bioweapons. Additionally, the FDA, in conjunction with the Centers for Disease Control, must take into account that terrorists might genetically alter existing pathogens to reduce the efficacy of current vaccines and treatments. The FDA plans to thwart potential terrorist attacks by expediting its approval process for new vaccines and drugs that could reduce the severity of a bioterror attack.

█ FURTHER READING:

ELECTRONIC:

Department of Health and Human Services. "United States Food and Drug Administration." <http://www.fda.gov> (May 2003).

SEE ALSO

Bioterrorism, Protective Measures
Food Supply, Counter-Terrorism
Salmonella and Salmonella Food Poisoning
Vaccination