Encyclopedia - Food and Drug Administration

The Food & Drug Administration is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act, along with several related public health laws. One of the nation's oldest consumer protection agencies, the FDA makes sure that food is safe to eat, cosmetics are safe to use, and medicines and medical devices are effective and safe. It does not regulate specific medical procedures. However, it does regulate the medical devices used for medical procedures. For instance, the FDA does not regulate laser eye surgery, but it does evaluate and regulate the lasers that are used for the procedure.

In addition to these responsibilities, the FDA is accountable for the safety of the nation's blood supply and for regulation of medicated feeds and other drugs given to animals that are raised for food. It's also the agency's job to be sure that products are truthfully labeled with the information needed to use them properly.

Even after a product is approved for marketing, the FDA monitors that product for any unexpected adverse reactions. More than 9,000 agency employees monitor the manufacture, import, transport, storage, labeling, and sale of regulated products. Companies found in violation of FDA laws are encouraged to correct the problem voluntarily or to recall the product. The fastest and most effective way to protect the public from an unsafe product is to recall it. The FDA can bring legal sanctions on companies that refuse to correct a public health problem voluntarily. It sometimes even seeks criminal penalties, including prison sentences, against manufacturers and distributors.

The FDA is an agency within the Public Health Service, which is part of the Department of Health and Human Services. If you want more information about the agency, call the FDA Consumer Hotline at 888-INFO-FDA or 888-463-6332, or visit the FDA web site at www.fda.gov/.