Food and Drug Administration

The Food and Drug Administration (FDA), one of the oldest consumer protectionagencies in the United States (formed in 1927), ensures that foods are safeand wholesome, that medicines and medical devices are safe and effective, that cosmetics and products which emit radiation are harmless, and that productsare honestly labeled and packaged. FDA is also responsible for feed and drugs for pets and farm animals.

Each year, the agency monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods. It regulates almost 95,000 businessesin the United States. Headquartered in Rockville, Maryland, it is part of theUnited States Department of Health and Human Services, Public Health Servicedivision. FDA has more than 9,000 employees working in district and local offices in 157 cities nationwide. Agency staff include 2,100 scientists workingin 40 laboratories nationwide, and 1,100 investigators and inspectors who visit 15,000 facilities each year.

FDA enforces the Federal Food, Drug, and Cosmetic Act and related public health laws. If the agency finds a company in violation of any of the laws whichit enforces, FDA can encourage the firm to voluntarily correct the problem orto recall the faulty product. If the company cannot or will not correct theproblem voluntarily, FDA can go to court to force the company to stop sellingthe product and have products seized and destroyed, and seek criminal penalties against manufacturers and distributors. Each year, FDA finds about 3,000products unfit for consumers and withdrawals them from the market, and 30,000import products are detained from entering the United States.

Agency scientists prepare evidence for legal cases, and review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, coloring agents, and medical devices. In reviewing new drug approvals,the agency determines whether the new drug's benefits outweigh risks.

To protect food, agency scientists test food samples to make sure that substances such as pesticide residues are not present in unacceptable amounts. If they are, FDA takes corrective action.

The agency sets labeling standards so people know what the food they buy contains and ensures that medicated feeds and drugs given to animals raised for food do not threaten public health. The agency also protects the nation's blood supply by examining blood bank operations and ensures that biologicals (medical preparations made from living organisms and their products), such as insulin and vaccines, are pure and effective. Medical devices that are life supporting, life sustaining, or implanted in the body must be approved by the agency before they can be marketed. FDA continues to monitor drugs and devices after they have been approved for marketing. Each year, the agency collects and analyzes tens of thousands of reports to monitor unexpected adverse reactions.

The agency can also have unsafe cosmetics taken off of the market. Dyes and others additives used in drugs, food, and cosmetics must be reviewed and approved before they can be sold.

The FDA Modernization Act of 1997 focused on reforming the way food, medicalproducts, and cosmetics are regulated. The act's most important provisions: re-authorized the prescription drug user fees for five more years, modernizedthe regulation of biological products, increased patient access to experimental drugs and medical devices and accelerated agency review of important new medications, allowed drug manufacturers to distribute certain information on off-label use and drug economics, created an exemption to allow pharmacists toprepare individualized therapies not commercially available, focused resources on the riskiest medical devices, eliminated the requirement for food packaging and other substances that come in contact with food to be approved before being marketed, and simplified regulatory obligations while maintaining high standards for medical products.

FDA is comprised of: Office of the Commissioner, Office of Operations, Officeof Policy, Office of External Affairs, and Office of Management and Systems.Within the Office of Operations, the Center for Biologics Evaluation and Review reviews the safety and efficacy of vaccines, blood and blood products, certain diagnostic products, and other biological and biotechnically-derived human products. The Center for Devices and Radiological Health ensures the safety and effectiveness of medical devices and eliminates unnecessary human exposure to man-made radiation. The Center for Drug Evaluation and Research ensures that marketed drugs are safe and effective. The Center for Food Safety andApplied Nutrition ensures that the nation's food supply is safe, sanitary, wholesome, and honestly labeled; and that cosmetic products are safe and properly labeled. The Center for Veterinary Medicine ensures animal health and thesafety of food derived from animals. The National Center for Toxicological Research conducts research to define what makes some products regulated by FDApoisonous. The Office of Orphan Products Development promotes the development of products to treat rare diseases or conditions.

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