What is the FDA?

The Food and Drug Administration is the federal government agency that oversees the safety of drugs, medical devices and most food.
Image: FDA Building
The Food and Drug Administration campus in Silver Spring, Maryland on Oct. 14, 2015.Andrew Harnik / AP file

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By Maggie Fox

The Food and Drug Administration is the agency that approves new drugs, vaccines and other treatments and also keeps an eye on the safety of 80 percent of the country’s food supply.

When you hear about the approval of a new drug, it’s almost certainly been through the FDA approval process, which general requires drugmakers to demonstrate that their product is safe, that it works as designed and, often, that is works as well as or better than products already on the market.

The FDA also regulates biologics, which are treatments made using tissue or blood. They include insulin, stem cell therapies and immune therapies. The agency regulates some medical devices, also. It has more limited authority over cosmetics, supplements and vitamins and is barred by Congress from pre-approving them.

FDA inspectors make sure drugs are made using Good Manufacturing Processes, and this authority extends to products made overseas for use on the U.S. market. The FDA helps recall products that are faulty, contaminated or otherwise unsafe.

Since 2009, the FDA also has some authority to regulate tobacco products, although Congress continues to prevent FDA from banning tobacco outright.

The FDA is the agency that watches for the safety of most food, with the exception of meat, poultry and some egg products, which come under the U.S. Department of Agriculture. FDA inspectors check food processing facilities and farms as part of its work making sure food is safe. With the Centers for Disease Control and Prevention, the FDA monitors and investigates outbreaks of foodborne illness.

The FDA falls under the authority of the Department of Health and Human Services. About 17,500 people work at the FDA, which has an annual budget of $5.4 billion. Just under half of this is paid for by user fees from the industry. The FDA is headquartered in Silver Spring, Maryland, just outside Washington, D.C.