Overview

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, scholarly research, media opinions, and many others. Additionally, the authors offer significant original content to guide the reader through the myriad complexities of the field. Likewise, the Fifth Edition includes carefully curated notes that illuminate the law in action. The Fifth Edition, like previous editions, is an invaluable resource for practitioners. But the book has been reorganized and edited from top to bottom to make it more accessible than ever for students and professors. The Fifth Edition completely updates the Fourth Edition of 2014 through February 2022. It addresses all statutory developments since 2014, including, for example, the National Bioengineered Food Disclosure Standard Act of 2016, the 21st Century Cures Act of 2016, the FDA Reauthorization Action of 2017, the Right to Try Act of 2018, the Pediatric Drugs and Devices Act of 2017, and the Coronavirus Aid, Relief, and Economic Security Act of 2020. Every major development of the past eight years is addressed, from the flood of new mobile and digital devices to the vital work of the FDA during the COVID-19 pandemic. The authors combine their knowledge of the rich histories in each product area with a deep understanding of the law and the agency to explain the current state of food and drug law and signal where it might be headed.

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