U.S. Food and Drug Administration (FDA)

About FDA

The FDA is one of the United States government's regulatory agencies. As the name implies, this agency oversees a broad range of topics that pertain to food and drugs. This includes most food and drink we consume and medications that are available over-the-counter or by prescription. Specific foods included are dietary supplements, bottled water, additives that are included in foods, and infant formulas. An exception to the foods regulated by the FDA includes meat from livestock, poultry and some egg products, which are regulated by the U.S. Department of Agriculture. The FDA regulates biologics which include vaccines, blood (such as donated blood), gene therapy products, tissue, and products that cause common allergies. Medical devices (pacemakers, surgical implants) and radiation emiting products (microwaves, x-ray equipment, etc) are regulated by the FDA as well. Regulation and safety of cosmetic products, food and medicine for animals, and tobacco products are also managed by the FDA.

The FDA is responsible for

• Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
• Protecting the public from electronic product radiation
• Assuring cosmetics and dietary supplements are safe and properly labeled
• Regulating tobacco products
• Advancing the public health by helping to speed product innovations

FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.¹

This responsibility includes enforcing laws that have been passed to ensure public health and protection of those who purchase products covered by the FDA. The 21st Century Cures Act is a recent law that was passed in December of 2016. This law was created to help accelerate the development of medical products and provide new innovations and research advancements to patients who need them in a way that is fast and efficient.

Organization of FDA

The FDA is a large organization with a broad reach to ensure the safety of American's. The Office of the Commisioner is the head office within the organization, and below this are various offices and centers with specific roles and responsibilities. The largest centers and offices include:

• 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 Tobacco Products
• Center for Veterinary Medicine
• Oncology Center of Excellence
• Office of Regulatory Affairs
• Office of Minority Health & Health Equity

Information available on this page was adapted from FDA.gov