The Regulatory Responsibilities of the U.S. Food and Drug Administration (FDA)

專利工程師暨法務專員  林春宏
美國柏克萊加州大學  分子生物學士
美國柏克萊加州大學  資訊管理 碩士
加拿大英屬哥倫比亞大學  法律博士
2012-12-10

The U.S. Food and Drug Administration (FDA) is a federal agency of the U.S. Department of Health and Human Services.  The FDA is responsible for regulating food safety, dietary supplements, drugs, vaccines, blood products, biologics, medical devices, electronic products, cosmetics, veterinary products, and tobacco products. 

The FDA Food Safety Modernization Act was passed by the Congress and signed into law by President Obama in 2011.  The new law aims to ensure that the food supply in the United States is safe by shifting the focus from responding to food contamination to preventing it.  The law has mandated increased inspection frequency based on risk, including domestic food production and foreign food imports.  Dietary supplements are regulated as foods according to the Dietary Supplement Health and Education Act.

The FDA also regulates the drug approval process, over-the-counter (OTC) pharmaceutical drugs and prescription drug labeling, as well as the drug manufacturing standards.  In addition, the FDA regulates the approval and manufacturing of vaccines, ensures the safety of blood supply, and establishes biological product standards.

Furthermore, the FDA regulates medical devices and certain electronic products such as those that emit electromagnetic radiation or ultrasound.  The FDA also ensures the safety of cosmetics and veterinary products.  The Family Smoking Prevention and Tobacco Control Act (2009) gave FDA the authority to set requirements for marketing and labeling of tobacco products. 

References:

U.S. Food and Drug Administration (FDA)

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm

http://www.fda.gov/Food/FoodSafety/default.htm