Food and Drug Administration

The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services (DHHS), is charged with regulating food, drugs, biological products, cosmetics, and medical and therapeutic devices sold in the United States. The roots of the FDA lie in the Bureau of Chemistry, founded in 1863 within the Department of Agriculture, and which focused on the adulteration of food products. The modern era of the FDA dates from 1906, the year the Pure Food and Drug Act was passed; this law added regulatory functions to the FDA's mission and broadened the agency's powers. The FDA assumed its current name in 1930; it became part of the Federal Security Agency in 1940, was transferred to the Department of Health, Education, and Welfare (HEW) in 1953, became part of the Public Health Service within HEW in 1968, and part of the DHHS in 1980.

The FDA designated an Obesity Working Group to study the problem of obesity in the United States, which the FDA at its Web site calls an “epidemic.” The final report of this Working Group focused on the concept of caloric balance, that is, that overweight and obesity are a function of the consumption of more calories than are burned in daily activities. The slogan for the FDA's campaign is “Calories Count.” Actions recommended by this committee to combat overweight and obesity include improving food labels to including meaningful serving sizes and to display calorie counts more prominently, initiating a consumer education campaign around the “calories count” concept, encouraging restaurants to provide nutritional information, increasing enforcement actions regarding the accuracy of food labels, revising FDA guidance concerning the development of obesity drugs, and cooperating with other entities, including government agencies, nonprofits, industry, and academia, on obesity research.

The Center for Drug Evaluation and Research (CDER), one of five centers within the FDA, regulates both prescription and over-the-counter drugs. The distinction between prescription and over-the-counter drugs has been made in the United States since the Durham-Humphrey Amendment of 1951. The company marketing the drug performs the actual testing of drugs: CDER reviews the information, including [Page 286]testing data and proposed labeling provided by the company. Two drugs are currently (2007) approved to treat obesity. Orlistat, manufacture by Roche Laboratories Inc. under the trade name Xenical®, was the first approved drug in the lipase inhibitor class; it prevents fat from being broken down and absorbed in the digestive tract, thus reducing caloric intake. Sibutramine, which suppresses the appetite by inhibiting norepinephrine and serotonin reuptake, is produced under the brand name Meridia® by Knoll Pharmaceutical Company. Fenfluramine and phentermine were approved for single-drug, short-term therapy; however, their long-term use in combination (Fen-Phen) has been linked with valvular heart disease and both drugs were withdrawn from the U.S. market.