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.

Public Health Law in a Nutshell, 4th Edition provides a compelling and informative assessment of the critical role of law in American society to protect the community's health, a theme punctuated by the COVID-19 pandemic. Understanding the field of public health law encompasses its constitutional sources and limits as well as historic and modern attempts to regulate in the interests of public health and safety. This new edition of the Nutshell explains and addresses these issues within a modern framework supporting the role of law toward improved health outcomes in routine and emergency applications. Updated to reflect key developments through the COVID-19 pandemic in mid-2021, the Nutshell's 12 chapters and 150+ graphics, illustrations, and figures lay out definitive legal issues underlying core public health powers to prevent and control communicable and chronic conditions as well as injuries and related deaths. It also explores legal routes to counter other public health threats, including tobacco and alcohol use, guns, vehicles, and defective products. Additional chapters center on difficult trade-offs related to public health information surveillance and privacy, commercial speech regulation, zoning and the built environment, and emergency legal preparedness generally. The all-new Chapter 12 centers on the dynamic legal and policy issues implicated during the COVID-19 pandemic, the most impactful public health crisis in U.S. history. This edition of the Nutshell is a "must read" and "go to" resource text for thousands of legal or public health practitioners in the field, law- and policy-makers, and collegiate or graduate students in schools of law, public health, or medicine assessing these issues as part of their coursework or research interests.

"Pure food" became the rallying cry among a divergent group of campaigners who lobbied Congress for a law regulating foods and drugs. James Harvey Young reveals the complex and pluralistic nature not only of that crusade but also of the broader Progressive movement of which it was a significant strand. In the vivid style familiar to readers of his earlier works, The Toadstool Millionaires and The Medical Messiahs, Young sets the pure food movement in the context of changing technology and medical theory and describes pioneering laws to control imported drugs and domestic oleomargarine. He explains controversy within the pure food coalition, showing how farming and business groups sought competitive commercial advantage, while consumer advocates wished to promote commercial integrity and advance public health. The author focuses on how the public became increasingly fearful of hazards in adulterated foods and narcotic nostrums and how Congress finally achieved the compromises necessary to pass the Food and Drugs Act and the meat inspection law of 1906.

Originally published in 1989.

The Princeton Legacy Library uses the latest print-on-demand technology to again make available previously out-of-print books from the distinguished backlist of Princeton University Press. These paperback editions preserve the original texts of these important books while presenting them in durable paperback editions. The goal of the Princeton Legacy Library is to vastly increase access to the rich scholarly heritage found in the thousands of books published by Princeton University Press since its founding in 1905.

Marijuana Law in a Nutshell (2d ed. 2022) is a compact and thorough overview of marijuana law. It is organized by the basic divisions of marijuana law: by the dichotomy between federal and state law; and second, by the bifurcation between illegal and legal status of marijuana. As to federal law, the Nutshell details the Controlled Substances Act of 1970 (CSA), and the ramifications of marijuana's placement on Schedule I-for law enforcement, hemp and CBD, scientific research, and international law. Also explored are constitutional challenges to the CSA, including whether state laws are preempted by the CSA. As to states, the Nutshell explains the various marijuana laws of the 50 states-whether traditional criminalization, decriminalizing, medical marijuana states, or recreational marijuana states. Where marijuana use is illegal, the Nutshell explains the criminal law of marijuana in such topics as sentencing, asset forfeitures, search and seizure, and pretextual stops. Where legal, the Nutshell has chapters covering marijuana activity and banking, employment, impaired driving, professional responsibility for lawyers, taxation, bankruptcy, and parental custody issues. In its comprehensive treatment of marijuana law, the Nutshell includes a history of marijuana law, and presents medical and public policy arguments for and against legalization. It also investigates marijuana's place in American culture and social life, in world law, and how marijuana compares to other potentially harmful substances, both legal and illegal. Looking forward, the Nutshell assesses marijuana reform bills. Finally, the Appendix charts medical, recreational, and CBD legality by federal and state jurisdiction. All in all, a thorough summation of the key statutes, cases, policies, and law of marijuana.

Practicing Bioethics Law provides basic readings in the field of bioethics law, including court cases, statutes, administrative regulations, briefs, and law review and other academic articles. The text presents theoretical debates about the latest bioethical subjects as well as practice-based materials that expose students to a wide range of possible bioethics-related careers. The book's companion website provides practice documents, videos, pictures, scientific materials and other information that is too complex to include in a traditional casebook. The authors combined the book and the website so readers could learn more about the practice of bioethics law at the same time they are beginning to understand the theory and content of bioethics law. The second edition includes updated materials on the meaning of informed consent, death and dying, reproductive rights, the ways in which advances in genetics (including CRISPR) affect patent and other rights, genetic editing, and neuroethics, as well as discussions of the ways in which bioethics has been affected by the COVID-19 pandemic.

"Injury" offers the first sustained anthropological analysis and critique of American injury law. The book approaches injury law as a symptom of a larger American injury culture, rather than as a tool of social justice or as a form of regulation. In doing so, it offers a new understanding of the problematic role that law plays in constructing Americans' relations with the objects they consume.

Through lively historical analyses of consumer products and workplace objects ranging from cigarettes to cheeseburgers and computer keyboards to airbags, Jain lucidly illustrates the real limits of the product safety laws that seek to redress consumer and worker injury. The book draws from a wide range of materials to demonstrate that American law sets out injury as an exceptional state, one that can be redressed through imperfect systems of monetary compensation. "Injury" demonstrates how laws are unable to accommodate the ways in which physical differences among citizens are imposed by the physical objects of culture that distribute risk differently among populations. The book moves between detailed accounts of individual legal cases; historical analyses of advertising, product design, regulation, and legal history; and a wide reading of cultural theory.

Drawing on an extensive knowledge of law and social theory, this innovative book will be essential reading for anyone with an interest in design, consumption, and the politics of injury.

Title 42 presents regulations that apply to: medical personnel; medical care and examinations; health related grants; fellowships, internships, and training; quarantine, inspection, and licensing; occupational safety and health research; health assessments; vaccines; Medicare and medical assistance programs; and standards and certification of facilities and services. Additions and revisions to this section of the code are posted annually by October. Publication follows within six months.

Title 42 presents regulations that apply to: medical personnel; medical care and examinations; health related grants; fellowships, internships, and training; quarantine, inspection, and licensing; occupational safety and health research; health assessments; vaccines; Medicare and medical assistance programs; and standards and certification of facilities and services. Additions and revisions to this section of the code are posted annually by October. Publication follows within six months.

Title 42 presents regulations that apply to: medical personnel; medical care and examinations; health related grants; fellowships, internships, and training; quarantine, inspection, and licensing; occupational safety and health research; health assessments; vaccines; Medicare and medical assistance programs; and standards and certification of facilities and services. Additions and revisions to this section of the code are posted annually by October. Publication follows within six months.

Title 42 presents regulations that apply to: medical personnel; medical care and examinations; health related grants; fellowships, internships, and training; quarantine, inspection, and licensing; occupational safety and health research; health assessments; vaccines; Medicare and medical assistance programs; and standards and certification of facilities and services. Additions and revisions to this section of the code are posted annually by October. Publication follows within six months.

Title 44 presents regulations and provisions governing insurance and hazard mitigation. Information relating to fire prevention and control, disaster assistance, and preparedness is included. Additions and revisions to this section of the code are posted annually by October. Publication follows within six months.

Title 42 presents regulations that apply to: medical personnel; medical care and examinations; health related grants; fellowships, internships, and training; quarantine, inspection, and licensing; occupational safety and health research; health assessments; vaccines; Medicare and medical assistance programs; and standards and certification of facilities and services. Additions and revisions to this section of the code are posted annually by October. Publication follows within six months.