The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety
regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices,
radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and
the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on
products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.
The FDA is an agency within the United States Department of Health and Human Services. The agency is currently organized into the following
major subdivisions,each focused on a major area of regulatory responsibility:
- The Center for Food Safety and Applied Nutrition (CFSAN)
- The Center for Drug Evaluation and Research (CDER)
- The Center for Biologics Evaluation and Research (CBER)
- The Center for Devices and Radiological Health (CDRH)
- The Center for Veterinary Medicine (CVM)
- The National Center for Toxicological Research (NCTR)
- The Office of Regulatory Affairs (ORA)
- The Office of the Commissioner (OC)
Authorization and regulatory mandate
Most federal laws administered through the FDA are codified into the Food, Drug and Cosmetic Act, also called Title 21, Chapter 9 of
the United States Code (21 USC 9). The programs for FDA safety regulation vary widely by the type of product, its potential risks, and the
regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing,
manufacturing, labeling, advertising, marketing, efficacy and safety. It regulates other products with a set of published standards enforced
with a modest number of facilities inspections.
What FDA Regulates
What FDA Does Not Regulate
Food and dietary supplements regulatory programs
The Center for Food Safety and Applied Nutrition is the branch of the FDA which is responsible for ensuring the safety and accurate labeling of
nearly all food products in the United States. One exception is products derived from traditional domesticated animals, such as cattle and
chickens, which fall under the jurisdiction of the United States Department of Agriculture Food Safety and Inspection Service. Products which
contain minimal amounts of meat are regulated by FDA, and the exact boundaries are listed in a memorandum of understanding between the two
agencies. However, medicines and other products given to all domesticated animals are regulated by FDA through a different branch, the Center
for Veterinary Medicine. Other consumables which are not regulated by the FDA include beverages containing more than 7% alcohol (regulated by
the Bureau of Alcohol, Tobacco, Firearms and Explosives in the Department of Justice), and non-bottled drinking water (regulated by the United
States Environmental Protection Agency (EPA)).
The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs.
Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements. FDA can take action
against dietary supplements only after they are proven to be unsafe. Manufacturers of dietary supplements are permitted to make specific
claims of health benefits, referred to as "structure or function claims" on the labels of these products. They may not claim to treat,
diagnose, cure, or prevent disease and must include a disclaimer on the label.
Bottled water is regulated in America by the FDA. State governments also regulate bottled water. Tap water is regulated by state and local
regulations, as well as the United States EPA. FDA regulations of bottled water generally follow the guidelines established by the EPA, and
new EPA rules automatically apply to bottled water if the FDA does not release an explicit new rule. Water bottlers in the US are subject
to inspection similar to other food firms, but quality controls for the bottled water industry are not nearly as stringent as those for municipal