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U.S. Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency of the U.S. government, responsible for ensuring the safety of foods (except meat and poultry), human and veterinary drugs, biological products, medical devices, cosmetics, and radiation-emitting electronic products. The FDA covers all food products including bottled water, with the exception of meat and poultry, which are regulated by the United States Department of Agriculture. The FDA is responsible for ensuring that the products under their jurisdiction are honestly, accurately, and informatively represented to the public. The FDA also helps speed up innovations that make medicines and foods more effective, safer, and more affordable and helps the public get the information they need regarding the use of medicines and foods. The FDA works with numerous federal, state, and local governments and agencies to carry out its duties, including the consumer product safety commission to enforce the Poison Prevention Packaging Act, the FBI to enforce the Federal AntiTampering Act, the Department of Transportation to enforce the Sanitary Food Transportation Act, and the U.S. Postal Service to enforce laws against mail fraud.

The FDA employs more than 9,000 people who work in locations around the country. The FDA staff who work in the Washington, D.C, area focus on product review and regulatory policy. The employees who work in the network of field offices are generally the first point of contact for the public and manufacturers. These employees focus on inspection and surveillance, laboratory work, and public and industry education.

FDA-regulated products play a large role in the lives of Americans, accounting for about 25 cents of every consumer dollar spent. The FDA monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of products annually, at a cost to taxpayers of about $3 per person. The agency has existed in its present form since 1931, after some reorganization and shifting of duties from other federal agencies.

Overview of the FDA's Product Responsibilities

The FDA is responsible for ensuring that ingredients used in foods are safe and that food is free from contaminants. The FDA approves new food additives and regulates and monitors food labeling to ensure accurate information to consumers. The FDA monitors cosmetic products to ensure they are safe and properly labeled but does not require safety testing of cosmetics.

The FDA requires manufacturers to undergo extensive testing and get preapproval for medicines and medical devices to ensure product safety for both human and animal drugs and devices. The FDA sets drug manufacturing standards, inspects manufacturing facilities, and regulates over-the-counter (OTC) and prescription drug labeling. Medical devices ranging from thermometers to heart pacemakers must receive premarket approval. The FDA sets manufacturing and performance standards and tracks reports of device malfunctioning and serious adverse reactions. The FDA is responsible for the safety of the nation's blood supply and for regulating biologics, which include vaccines, blood products, biotechnology products, and gene therapy.

The FDA sets 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. The FDA accredits and inspects mammography facilities.

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