Emerging Issues in FDA Regulation: Warning Letters, Internet Promotion, and Tobacco

The mission of the United States Food and Drug Administration (FDA) is to protect and promote the public health. The agency is charged with assuring the safety of America’s foods; the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and the safety and security of cosmetics and products that emit radiation. Americans spend close to $1.5 trillion a year on these products—about twenty percent of the entire consumer economy. The FDA’s Office of Chief Counsel (OCC) manages the legal work of the agency. This Article will discuss the organization of OCC, along with several important issues now facing the agency: warning letters, Internet promotion, and tobacco.