Food and Drug Law - 5th Edition - Hutt

Food and Drug Law 5th Edition ISBN 9781636596952 explores one of the most far-reaching and consequential areas of regulatory law in the United States. With the U.S. Food and Drug Administration overseeing approximately 20 to 25 cents of every consumer dollar spent, FDA regulation touches nearly every corner of American life. From the groceries in our shopping carts to the medications we take, from vaccines and medical devices to cosmetics, tobacco products, and even radiation-emitting electronics—the FDA plays a critical role in safeguarding public health.

This casebook examines the legal framework that empowers the FDA and its sister agencies to regulate this vast array of products. It delves into how the agency ensures product safety, enforces accurate labeling and advertising, and facilitates the approval of innovative medical treatments. The scope of the book reflects the intimate relationship between FDA regulation and our daily lives—making it one of the most relevant subjects in modern administrative and health law.

The Fifth Edition presents not only foundational court cases but also the full breadth of materials that shape food and drug law outside the courtroom. Students and practitioners will encounter Federal Register notices, warning letters, agency guidance, Congressional hearings, investigative reports, academic scholarship, and media commentary. These materials, coupled with extensive editorial notes and original insights from the authors, provide a comprehensive and practical understanding of how food and drug law operates in the real world.

Food and Drug Law 5th Edition ISBN 9781636596952

Thoroughly reorganized and updated from cover to cover, the Fifth Edition is more accessible than ever for both students and instructors. It incorporates all major statutory developments since 2014, including:

• The National Bioengineered Food Disclosure Standard Act of 2016

• The 21st Century Cures Act of 2016

• The FDA Reauthorization Act of 2017

• The Right to Try Act of 2018

• The Pediatric Drugs and Devices Act of 2017

• The CARES Act of 2020 (in response to COVID-19)

The text also addresses regulatory and technological shifts of the past decade, including the FDA’s evolving oversight of digital health technologies, mobile medical apps, and the agency’s unprecedented response to the COVID-19 pandemic.

Written by leading experts, this casebook blends historical depth with forward-looking analysis. It offers a clear path through the complex web of statutes, regulations, and policies that govern food and drug law today—and provides thoughtful perspectives on where the field is headed.

ISBN 978-1636596952