The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.
Key Functions and Responsibilities of the FDA
- Regulating Food Safety: The FDA ensures that foods, except for most meat and poultry products which are regulated by the USDA, are safe, wholesome, and correctly labeled. This includes ensuring the safety of food additives and overseeing guidelines for dietary supplements.
- Drug Approval and Regulation: The FDA reviews and approves pharmaceutical drugs, both prescription and over-the-counter, ensuring they are safe and effective for their intended uses. The agency also monitors drug manufacturing processes, packaging, and labeling.
- Medical Device Regulation: The FDA regulates medical devices, from simple items like tongue depressors to complex technologies like heart pacemakers. The agency ensures these devices are safe and effective and monitors their manufacturing and labeling.
- Ensuring Cosmetic Safety: While cosmetic products and ingredients do not require FDA approval (except for color additives), the FDA monitors cosmetics on the market to ensure they are safe and properly labeled.
- Regulation of Tobacco Products: The FDA regulates the manufacture, marketing, and distribution of tobacco products to protect public health, particularly among minors.
- Biologics and Vaccine Regulation: The FDA ensures the safety, purity, potency, and effectiveness of biological products, including vaccines, blood products, and cellular and gene therapies.
- Regulation of Radiation-Emitting Products: The FDA regulates products that emit radiation, including X-ray equipment, microwave ovens, and laser products, to ensure they are safe for public use.
- Monitoring Adverse Events and Product Recalls: The FDA monitors adverse events related to the use of its regulated products and can issue recalls or safety alerts if a product is found to be unsafe.
- Public Health Promotion and Education: The FDA provides information and guidance to consumers, healthcare professionals, and industry stakeholders on health and safety topics related to its regulatory scope.
In summary, the FDA's role is critical in ensuring the safety and efficacy of a wide range of products affecting public health in the United States, from food and drugs to medical devices and cosmetics. The agency's work is grounded in science and research, and it plays a key role in national efforts to protect and advance public health.