Food and Drug Administration

FDA’s Mission Statement

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

What FDA Regulates

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency's specific responsibilities include:

• Biologics- product and manufacturing establishment licensing, safety of the nation's blood supply, research to establish product standards and develop improved testing methods

• Cosmetics-safety and labeling

• Drugs- product approvals for both over-the-counter (OTC) and prescription drugs, labeling, drug manufacturing standards

• Foods- labeling and safety of all food products (except meat and poultry) and bottled water

• Medical Devices- premarket approval of new devices, manufacturing and performance standards, tracking reports of device malfunctioning and serious adverse reactions

• Radiation-Emitting Electronic Products- radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps as well as accrediting and inspecting mammography facilities

• Veterinary Products- livestock feeds, pet foods, veterinary drugs and devices

What FDA does not regulate

• Advertising- The Federal Trade Commission is the federal agency which regulates all advertising, excluding prescription drugs and medical devices. FTC ensures that advertisements are truthful and not misleading for consumers. Telephone (202) 326-2222.

• Most Alcohol- The labeling and quality of distilled spirits, wines, and malt beverages are regulated by the Treasury Department's Bureau of Alcohol, Tobacco, and Firearms. ATF's telephone (202) 927-7777. Some beers are not "malt beverages" because they are not made with malted barley or are made without hops.^[1]

• Consumer Products- While FDA regulates a large portion of the products that consumers purchase, the agency has no jurisdiction over many household goods. The Consumer Product Safety Commission (CPSC) is responsible for ensuring the safety of consumer goods such as household appliances (excluding those that emit radiation), paint, child-resistant packages, and baby toys. CPSC operates a toll-free hot line at (800) 638-2772 or TTY (800) 638-8270 for consumers to report unsafe products or to obtain information regarding products and recalls.

• Drugs of Abuse- Illegal drugs with no approved medical use--such as heroin and marijuana--are under the jurisdiction of the Drug Enforcement Administration. FDA assists DEA in deciding how stringent DEA controls should be on drugs that are medically accepted but that have a strong potential for abuse. DEA establishes limits on the amount of these prescription drugs that are permitted to be manufactured each year. Telephone (202) 307-1000.

• Health Insurance- The FDA does not regulate health insurance, the cost of health care products or procedures, or reimbursement for health and medical expenses. Questions about Medicare should be directed to the Centers for Medicare and Medicaid Services.

• Meat and Poultry- The U.S. Department of Agriculture's Food Safety and Inspection Service is responsible for the safety and labeling of traditional meats and poultry. (FDA regulates game meats, such as venison, ostrich and snake.) Telephone (800) 535-4555.

• Pesticides- FDA, USDA, and the Environmental Protection Agency share the responsibility for regulating pesticides. EPA determines the safety and effectiveness of the chemicals and establishes tolerance levels for residues on feed crops, as well as for raw and processed foods. These tolerance levels (the amount of pesticide allowed to be present in a food product) are normally set 100 times below the level that might cause harm to people or the environment. FDA and USDA are responsible for monitoring the food supply to ensure that pesticide residues do not exceed the allowable levels in the products under their jurisdiction. Telephone (202) 260-2080.

• Restaurants and Grocery Stores- Inspections and licensing of restaurants and grocery stores are typically handled by local county health departments.

• Water- The regulation of water is divided between the Environmental Protection Agency and FDA. EPA has the responsibility for developing national standards for drinking water from municipal water supplies. FDA regulates the labeling and safety of bottled water.

History of the FDA

From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848.

FDA History Page

Milestones in U.S. Food and Drug Law History

The FDA History Office

Organizational Structure of the FDA

FDA is an agency within the Department of Health and Human Services and consists of nine centers/offices, which are listed below.

• Center for Biologics Evaluation and Research (CBER)

• Center for Devices and Radiological Health (CDRH)

• Center for Drug Evaluation and Research (CDER)

• Center for Food Safety and Applied Nutrition (CFSAN)

• Center for Veterinary Medicine (CVM)

• National Center for Toxicological Research (NCTR)

• Office of Chief Counsel

• Office of the Commissioner (OC)

• Office of Regulatory Affairs (ORA)

Click here for an overall Organizational Chart of the FDA

Click here for the Organizational Chart of the Office of the FDA Commissioner

Leadership/Directors

OFFICE OF THE COMMISSIONER

1. COMMISSIONER OF FOOD AND DRUGS: Andrew C. von Eschenbach, M.D.
2. PRINCIPAL DEPUTY COMMISSIONER & CHIEF SCIENTIST: Frank M. Torti, M.D., MPH

Publications

FDA Publications

External Links

The Food and Drug Administrations’ Home Page