The Food and Drug Administration touches the lives of virtually every American every day. For it is FDA's job to see that the food we eat is safe and wholesome, the cosmetics we use won't hurt us, the medicines and medical devices we use are safe and effective, and that radiation-emitting products such as microwave ovens won't do us harm. Feed and drugs for pets and farm animals also come under FDA scrutiny. FDA also ensures that all of these products are labeled truthfully with the information that people need to use them properly.
FDA is one of our nation's oldest consumer protection agencies. Its approximately 9,000 employees monitor the manufacture, import, transport, storage and sale of about $1 trillion worth of products each year. It does that at a cost to the taxpayer of about $3 per person.
First and foremost, FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. To carry out this mandate of consumer protection, FDA has some 1,100 investigators and inspectors who cover the country's almost 95,000 FDA-regulated businesses. These employees are located in district and local offices in 157 cities across the country.
These investigators and inspectors visit more than 15,000 facilities a year, seeing that products are made right and labeled truthfully. As part of their inspections, they collect about 80,000 domestic and imported product samples for examination by FDA scientists or for label checks.
If a company is found violating any of the laws that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. A recall is generally the fastest and most effective way to protect the public from an unsafe product.
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. The agency 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.
About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure.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 to be unacceptable.
The scientific evidence needed to back up FDA's legal cases is prepared by the agency's 2,100 scientists, including 900 chemists and 300 microbiologists, who work in 40 laboratories in the Washington, D.C., area and around the country. Some of these scientists 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.
FDA also operates the National Center for Toxicological Research at Jefferson, Arkansas, which investigates the biological effects of widely used chemicals. The agency also runs the Engineering and Analytical Center at Winchester, Massachusetts, which tests medical devices, radiation-emitting products, and radioactive drugs.
Assessing risks -- and, for drugs and medical devices, weighing risks against benefits -- is at the core of FDA's public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they're buying. For example, the agency 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 agency must determine that the new drug produces the benefits it's supposed to without causing side effects that would outweigh those benefits.
Another major FDA mission is to protect the safety and wholesomeness of food. The agency's scientists test 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.
The nation's food supply is protected in yet another way as FDA sees that medicated feeds and other drugs given to animals raised for food are not threatening to the consumer's health.
The safety of the nation's blood supply is another FDA responsibility. The agency's investigators routinely examine blood bank operations, from record-keeping to testing for contaminants. FDA also ensures the purity and effectiveness of biologicals (medical preparations made from living organisms and their products), such as insulin and vaccines.
Medical devices are classified and regulated 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.
FDA's scrutiny does not end when a drug or device is approved for marketing; the agency collects and analyzes tens of thousands of reports each year on drugs and devices after they have been put on the market to monitor for any unexpected adverse reactions.
Cosmetic safety also comes under FDA's jurisdiction. The agency 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.
FDA is an agency within the Public Health Service, which in turn is a part of the Department of Health and Human Services. FDA is headed by Lead Deputy Commissioner Michael A. Friedman, M.D.
July 15, 1997
Rockville, MD 20857