Food and Drug Administration
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine 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.
Some of the key events about Food and Drug Administration
- 1906Established the Pure Food and Drug Act, marking the beginning of federal food and drug regulation in the United States
- 1937Failed to prevent the sulfanilamide disaster, resulting in over 100 deaths
- 1938Enacted the Federal Food, Drug, and Cosmetic Act, expanding the FDA's authority to regulate food, drugs, and cosmetics
- 1962Implemented the Kefauver-Harris Amendment, requiring drug manufacturers to provide proof of a drug's effectiveness before approval
- 1962Delayed approval of thalidomide, but not before thousands of birth defects occurred worldwide
- 1976Gained authority to regulate medical devices through the Medical Device Amendments
- 1976Rushed approval of swine flu vaccine, leading to increased cases of Guillain-Barré syndrome
- 1988Implemented the Prescription Drug Marketing Act to combat counterfeit, adulterated, and expired drugs
- 1989Approved Prozac despite concerns about increased suicidal thoughts in some patients
- 1990Introduced the Nutrition Labeling and Education Act, requiring standardized nutrition labels on packaged foods
- 1992Established the Prescription Drug User Fee Act, accelerating the drug approval process
- 1997Modernized food safety regulations with the Food Safety Initiative
- 1999Approved troglitazone (Rezulin) for diabetes, later withdrawn due to liver toxicity
- 2004Failed to act promptly on evidence linking antidepressants to increased suicide risk in young people
- 2004Withdrew rofecoxib (Vioxx) from market after increased heart attack and stroke risks were revealed
- 2009Gained authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act
- 2009Delayed recall of contaminated peanut products, leading to a salmonella outbreak
- 2011Implemented the Food Safety Modernization Act, the most sweeping reform of food safety laws in over 70 years
- 2012Failed to adequately oversee compounding pharmacies, resulting in a meningitis outbreak
- 2019Approved controversial Alzheimer's drug aducanumab despite limited evidence of efficacy
Disclaimer: This material is written based on information taken from open sources, including Wikipedia, news media, podcasts, and other public sources.
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