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Peter Barton Hutt,Richard A. Merrill,Lewis A. Grossman,Nathan Cortez,Erika Fisher Lietzan,Patricia J. Zettler

Food and Drug Law

Food and Drug Law

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The U.S. Food and Drug Administration is responsible for regulating approximately 20-25 cents of every dollar spent by American consumers. The agency has jurisdiction over a wide range of products, including food, drugs, cosmetics, medical devices, biological products, animal food and drugs, and tobacco products. The Fifth Edition of Food and Drug Law is an invaluable resource for practitioners and students, providing comprehensive coverage of the field. It updates the Fourth Edition through February 2022 and addresses all statutory developments since 2014, including the COVID-19 pandemic.

Format: Hardback
Length: 2073 pages
Publication date: 30 October 2022
Publisher: West Academic Publishing


The U.S. Food and Drug Administration (FDA) plays a crucial role in regulating a significant portion of the products consumed by American consumers. Approximately 20-25 cents out of every dollar spent goes towards products that fall under the FDA's jurisdiction. This extensive authority encompasses a wide range of items, including food, drugs, cosmetics, medical devices, biological products (including vaccines), animal food and drugs, and tobacco products. Furthermore, the FDA's reach extends to electronic products that emit radiation and products that can spread communicable diseases. As a result, FDA regulation impacts virtually every product found on supermarket shelves and in drug stores, as well as the medications prescribed and used by the medical profession. In comparison, few other agencies have such a profound impact on our daily lives.

Food and Drug Law is the legal framework that governs the actions taken by the FDA and its sister agencies to ensure the safety of the vast array of products available to consumers. It encompasses a range of activities, including the regulation of product labeling, advertising, and the approval of new medical products. The book aims to provide a comprehensive resource for practitioners, scholars, and students alike.

In addition to presenting the most significant court cases in the field, the book also offers valuable insights into the development and enforcement of food and drug law outside of the courtroom. This includes Federal Register notices, warning letters, guidance documents, congressional hearings and investigations, scholarly research, media opinions, and various other materials. The authors have also contributed original content to guide readers through the complexities of the field.

The Fifth Edition of this book has undergone significant reorganization and editing to enhance its accessibility for students and professors. It has been updated to reflect the latest developments in the field and includes carefully curated notes that provide practical examples and explanations of the law in action.

As with previous editions, the Fifth Edition of Food and Drug Law remains an invaluable resource for practitioners. However, it has been designed to be more user-friendly and approachable for those studying the field, making it an essential tool for anyone interested in understanding the regulatory landscape of food, drugs, and medical products.

Weight: 2346g
Dimension: 194 x 263 x 71 (mm)
ISBN-13: 9781636596952
Edition number: 5 Revised edition

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