Definition of Food and Drug Administration
Food and Drug Administration definition - medical term The FDA, 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.
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