FDA: The FDA is the Food and Drug Administration, an agency within the U.S. Public Health Service, which is a part of the Department of Health and Human Services.
Background: The FDA regulates over $1 trillion worth of products, which account for 25 cents of every dollar spent annually by American consumers and touches the lives of virtually every American every day. It is FDA's job to see that food is safe and wholesome, cosmetics won't hurt people, the medicines and medical devices are safe and effective, and that radiation-emitting products such as microwave ovens won't do harm. Feed and drugs for pets and farm animals also come under FDA scrutiny. FDA ensures that all of these products are labeled truthfully with the information that people need to use them properly.
Approval of new drugs: The FDA requires that drugs--both prescription and over-the-counter--be proven safe and effective. In deciding whether to approve new drugs, FDA does not itself do research, but rather examines the results of studies done by the manufacturer. The FDA must determine that the new drug produces the benefits it's supposed to without causing side effects that would outweigh those benefits.
Safety of food products: FDA tests food samples to see if any substances, such as pesticide residues, are present in unacceptable amounts. If contaminants are identified, FDA takes corrective action. FDA also sets labeling standards to help consumers know what is in the foods they buy.
Feed and drugs for pets and farm animals: FDA also is responsible that medicated feeds and other drugs given to pets and animals raised for food are not threatening to health.
Safety of the blood supply: FDA investigators examine blood bank operations, from record-keeping to testing for contaminants.
Safety of biologicals: FDA also ensures the purity and effectiveness of biologicals (medical preparations made from living organisms and their products), such as insulin and vaccines.
Safety of medical devices: These are classified and regulated by FDA according to their degree of risk to the public. Devices that are life-supporting, life-sustaining or implanted, such as pacemakers, must receive agency approval before they can be marketed.
Cosmetic, dyes and additive safety: FDA can have unsafe cosmetics removed from the market. The dyes and other additives used in drugs, foods and cosmetics also are subject to FDA scrutiny. The agency must review and approve these chemicals before they can be used.
Inspections and legal sanctions: FDA investigators and inspectors collect domestic and imported product samples for scientific examination and for label checks. If a company is found violating a law that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. When a company can't (or won't) correct a public health problem with one of its products voluntarily, FDA has legal sanctions it can bring to bear. FDA can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties--including prison sentences--are sought against manufacturers and distributors.
Product recalls: About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. In addition, about 30,000 import shipments a year are detained at the port of entry because the goods appear unacceptable.
Scientific expertise: Evidence to back up FDA legal cases is prepared by FDA laboratory scientists. Some analyze samples to see, for example, if products are contaminated with illegal substances. Other scientists review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, coloring agents and medical devices.
This information was condensed from a Statement on Jan. 11, 1999 (Publication No. BG99-1) by the FDA. |
