Food and Drug Law (University Casebook Series)

Roughly 20-25 cents out of every dollar spent by American consumers is for a product regulated by the U.S. Food and Drug Administration. The agency has jurisdiction over food, drugs, cosmetics, medical devices, biological products (including vaccines), animal food and drugs, and tobacco products, as well as electronic products that emit radiation and products that spread communicable disease. FDA regulation thus touches most products that fill the shelves of our supermarkets and drug stores and virtually every product prescribed or used by the medical profession. Indeed, few other agencies regulate products or activities that play so intimate a role in our daily lives. Food and Drug Law is the law governing the actions taken by FDA and its sister agencies to oversee the safety of this vast universe of products, to ensure that the labeling (and in some cases advertising) of products is accurate and reliable, and to shepherd safe and effective new medical products onto the market. The book contains not only the most important court cases in the field, but also materials that show how food and drug law is developed and enforced outside of court, including: Federal Register notices, warning letters, guidance documents, Congressional hearings and investigations, scholarl(more...)