A Profile of the FDA – what it is and what it regulates

 

The Agency

 The Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services (DHHS).  It is responsible for protecting the U.S. public by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the food supply (except for meat, poultry, and some egg products), cosmetics, and products that emit radiation.  The agency also ensures that these products are accurately and informatively represented to the public. 

The enforcement activities of the FDA are often closely related to those of other federal agencies, such as the Environmental Protections Agency (EPA), The Drug Enforcement Administration (DEA), The Federal Trade Commission (FTC), and the U.S. Department of Agriculture (USDA).

 The Agency’s Legal Authority 

Various federal legislations spell out the FDA authority.  The following are three significant landmarks. 

• The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 was passed after a legally marketed toxic elixir killed 107 people, including many children.  The FD&C Act overhauled the public health system.  Among its provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.

 

• The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) is divided into five titles.  FDA is responsible for carrying out certain provisions of the Bioterrorism Act, particularly Title III, Subtitle A–Protection of Food Supply and Subtitle B–Protection of Drug Supply. 

 

• The Food and Drug Administration Amendments Act (FDAAA) of 2007 expanded the FDA authority.  Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded.  These programs ensure that FDA staff have the additional resources needed to conduct the extensive reviews necessary of new drugs and devices.

 The FDA’s Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities as well as providing FDA leadership on imports, inspections, and enforcement policy.  ORA supports the five FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the U.S.  In addition, ORA develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans. 

The Products Regulated by the Agency 

Products regulated by the FDA include: 

Biologics: 

• product and manufacturing establishment licensing
• safety of the nation’s blood supply
• research to establish product standards and develop improved testing methods. 

Drugs: 

• product approvals
• Over-the-Counter (OTC) and prescription drug labeling
• drug manufacturing standards. 

Foods: 

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

Veterinary Products: 

• livestock feeds
• pet foods
• veterinary drugs and devices. 

Cosmetics: 

• safety
• labeling 

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
• accrediting and inspecting mammography facilities. 

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