Food Regulation (eBook)
544 Seiten
Wiley (Verlag)
978-1-119-76429-8 (ISBN)
Provides both students and professionals with up-to-date coverage of US food regulatory law
Food Regulation: Law, Science, Policy, and Practice presents an in-depth yet accessible account of all key aspects of United States food regulation. Using a modified casebook format, this comprehensive textbook introduces readers to the case law and statutory scheme of food regulation, defines the inspection authority and enforcement tools of various regulatory agencies, discusses current and emerging public policy issues, and more. Readers explore a wide range of topics in food law, science, policy, and practice; which connect legal theory to practical application.
The third edition is fully updated to reflect significant changes in US food law, such as the regulations implementing the FDA Food Safety Modernization Act (FSMA) and the National Bioengineered Food Disclosure Standard. New case studies and discussion questions highlight important legal trends, policy debates, and application of current law. Offering thorough, highly practical coverage of food regulatory law, this authoritative volume:
- Features new and updated material on US food law, including recent regulations concerning novel food processing
- Covers requirements of food labeling, advertising and health claim guidelines, regulation of US food imports and exports, and international food law
- Discusses important topics such as food defense, regulation of biotechnology, ethical issues, product liability, food safety rules, and substantiation of health claims
- Includes a brief history of food regulation and an overview of US government agency organization and jurisdictions
- Contains problem exercises covering different aspects of food law designed to strengthen critical thinking
Food Regulation: Law, Science, Policy, and Practice, Third Edition, remains the ideal textbook for undergraduate and graduate courses in agriculture, food science, dietetics, law, and regulatory compliance management. It is also a must-have reference for food scientists, attorneys, researchers, quality assurance and regulatory specialists, and other industry professionals responsible for complying with US food regulation.
Neal D. Fortin, JD is an attorney specializing in food and drug law, food safety, food labeling, ingredient evaluation, biotechnology, and advertising. He is a Professor in the Department of Food Science and Human Nutrition and Director of the Institute for Food Laws and Regulations at Michigan State University, where he teaches courses in Food and Drug Law, Food Regulation, Codex Alimentarius, and International Food Law.
FOOD REGULATION Provides both students and professionals with up-to-date coverage of US food regulatory law Food Regulation: Law, Science, Policy, and Practice presents an in-depth yet accessible account of all key aspects of United States food regulation. Using a modified casebook format, this comprehensive textbook introduces readers to the case law and statutory scheme of food regulation, defines the inspection authority and enforcement tools of various regulatory agencies, discusses current and emerging public policy issues, and more. Readers explore a wide range of topics in food law, science, policy, and practice; which connect legal theory to practical application. The third edition is fully updated to reflect significant changes in US food law, such as the regulations implementing the FDA Food Safety Modernization Act (FSMA) and the National Bioengineered Food Disclosure Standard. New case studies and discussion questions highlight important legal trends, policy debates, and application of current law. Offering thorough, highly practical coverage of food regulatory law, this authoritative volume: Features new and updated material on US food law, including recent regulations concerning novel food processing Covers requirements of food labeling, advertising and health claim guidelines, regulation of US food imports and exports, and international food law Discusses important topics such as food defense, regulation of biotechnology, ethical issues, product liability, food safety rules, and substantiation of health claims Includes a brief history of food regulation and an overview of US government agency organization and jurisdictions Contains problem exercises covering different aspects of food law designed to strengthen critical thinking Food Regulation: Law, Science, Policy, and Practice, Third Edition, remains the ideal textbook for undergraduate and graduate courses in agriculture, food science, dietetics, law, and regulatory compliance management. It is also a must-have reference for food scientists, attorneys, researchers, quality assurance and regulatory specialists, and other industry professionals responsible for complying with US food regulation.
Neal D. Fortin, JD is an attorney specializing in food and drug law, food safety, food labeling, ingredient evaluation, biotechnology, and advertising. He is a Professor in the Department of Food Science and Human Nutrition and Director of the Institute for Food Laws and Regulations at Michigan State University, where he teaches courses in Food and Drug Law, Food Regulation, Codex Alimentarius, and International Food Law.
ABOUT THE AUTHOR
FOREWORD
PREFACE
ACKNOWLEDGMENTS
PART I: INTRODUCTORY CHAPTERS
1 Introduction to Food Regulation in the United States
2 What is Food?
PART II: REGULATION OF LABELING, ADVERTISING, AND CLAIMS
3 Labeling
4 Nutritional Labeling and Nutrient Level Claims
5 Health Claims
6 Credence Claims
7 Advertising and Other Regulation of Labeling
PART III: REGULATION OF THE COMPOSITION OF FOOD
8 Economic and Esthetic Adulteration
9 Regulation of the Safety of Unintentional Poisonous or Deleterious Substances in Food
10 Regulation of the Safety of Intentional Components of Food
PART IV: SPECIALIZED FOOD REGULATION
11 Dietary Supplements
12 Biotechnology and Genetically Engineered Organisms
13 Food Defense
14 Importation and Exportation
15 Animal Food
PART V: INSPECTION AND ENFORCEMENT
16 Inspections
17 Federal Enforcement
18 State Laws and Their Relationship to Federal Laws
PART VI: GENERAL CHAPTERS
19 Private Actions
20 Administrative Law and Food Regulation
21 International Food Law
22 Ethics
Glossary of Abbreviations and Specialized Terms
Table of Cases
Index
PREFACE
“Knowledge is the food of the soul.”
Plato
INTRODUCTION
Food regulation is a complex but fascinating field. Study in this area is richly rewarding. From a human‐interest perspective, the food regulation touches the lives of nearly every American every day. Food issues often warrant headline news because this is a subject that commands the public’s attention, whether it be a news flash on a foodborne illness outbreak or information on diet that can help one live a longer and healthier life.
In addition, the regulation of food provides a snapshot of the political, social, and economic currents in our society. Thus, the study of food law provides a fascinating look at important policy decisions on vital aspects of people's everyday lives.
ABOUT THE TEXT
This text is designed to provide an accessible guide to United States food regulation—to be enlightening, without being light. While the text contains in‐depth discussion of the federal statutes, regulations, and the regulatory agencies, the material is not dense, and remains accessible to the average reader. Thus, Food Regulation is appropriate for a wide audience of students and professionals.
The best way to teach food law is to teach so that the subject is equally accessible to those coming from science or the law. Experience gleaned from teaching thirty semesters of food law indicates that nonlawyers, especially scientists, learn food law as well as lawyers and lawyers learn science as well as scientists. Accordingly, this book approaches food law as a single subject for both the lawyer and the food scientist.
A modified casebook method is used. The black letter law is livened with discussion of emerging issues and trends plus case studies that explore important issues. These materials explore not only regulation, but the science, policy, and practice. The reader is challenged to move beyond theory into application of the theory.
Much of the focus is on the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Food and Drug Administration (FDA). Nevertheless, an overview of food regulation by other agencies is covered, particularly at the United States Department of Agriculture (USDA) and the Federal Trade Commission (FTC). Moreover, readers are encouraged to see the thread running between the different laws, such as the similarity of meaning of terms across FDA, USDA, and FTC. For instance, in the study of USDA Food Safety Inspection Service (FSIS) regulation, some of the best court cases to review involve FDA. In addition, do not be surprised to find that some of the cases and references in this text are to pharmaceuticals, medical devices, or cosmetics. The FD&C Act regulates all these products, and there are commonalities in the regulatory framework for all. Sometimes a drug or medical device case illustrates a point about food law better than anything directly about food.
A ROAD MAP FOR READING THE MATERIALS IN THIS BOOK
This text presents diverse materials from pertinent sources. The author provides some commentary and context, but you should digest these materials for yourself. This can be especially challenging to the novice because you not only have to understand the materials, but you also have to jump around the various writing styles, understand the context, and discern the relative value and weight of each source. Stay with it, and you will find it soon becomes easier.
In keeping with the way information is encountered in practice, not all materials in this text are equal. Some may be read quickly. Others will require close scrutiny. Moreover, materials will be presented in varying levels of formality. When possible, the materials are condensed to be easier for you to read.
If you are new to this teaching style, it may be disconcerting at first. Please do not let this throw you. Persist and trust your instincts. You will find that your effort pays dividends quickly. In the end, you will learn much more than the rules but develop and hone critical skills for regulatory analysis. These skills are not only vital in legal analysis but are also extremely useful in winnowing through the mountains of information available on the Internet. In addition, law and regulation are not static subjects, so developing these dynamic skills will be beneficial in the end.
Here are a few tips to those of you who are new to this teaching method:
- Review your road map of each chapter—review the chapter title, the other headings, and the table of contents before reading. These will provide you with an overview of how the chapter material relates to the overall text.
- Put the material in context. Note the source of the material quoted. Who wrote the material will tell you what type of perspective is offered. Often, regulations reconcile conflicting interests; and understanding both sides can be key to a complete picture. Note the date when the material was written, which may indicate that the material is provided for historical perspective, or that part of the information may be pertinent, but part may be outdated.
- In reading the cases, develop the ability to understand how the court reasoned through the conflict to a solution. Identify the particular factors used by the court to decide the case the way it did. Check to see if those factors are present in a problem with which you are dealing. If the factors are not present, then ask yourself if that justifies a different result. If there are any changes in the social or economic conditions that surrounded an earlier decision, ask how that affects the problem now at hand.
- In short, learn to analyze the materials, rather than merely read and memorize rules.
EDITING
I have edited out most of the footnotes and citations from the court cases. Remaining footnotes are renumbered with my own footnotes. Unless otherwise indicated, any footnotes within the cases are those of the court. In addition, materials may be edited for typographic style without notation in the text.
STATUTORY RESEARCH USING THE FEDERAL REGISTER, CFRS, AND STATUTES
Food regulation in the United States is primarily based on statutory law. For this reason, it is generally best to read or review the statutory language before reading the cases and secondary materials, which serve mainly to explain statutory issues. When reading the statutes or regulations, be sure that you also review the definitions of defined terms used—particularly the key definitions in section 201 of the FD&C Act, such as “food,” “drug,” “adulterated,” and “misbranded.” In addition, when reading the statutory language, obtain at least a general idea of what is covered by any statutory cross‐references.
A NOTE ON STATUTE CITATIONS
All federal statutes in force in the United States are codified into the United States Code (U.S.C.). This codification is an organization of many statutes into a single code, which allows the U.S.C. to be organized by subject matter. For example, most food laws are organized into Title 21 of the U.S.C.
In the course of this organization of the statutes, necessarily section numbering of the acts must be renumbered. For example, section 1 of the FD&C Act is codified as 21 U.S.C. § 301. Thus, you may find this section cited with one or the other or both reference numbers, such as “Sec. 1 [301].”
Citations to the Food, Drug, and Cosmetic Act (FD&C Act) in this book material are to the statute. I also follow with a parallel citation within the brackets to the U.S.C. number. For example, section 1 of the FD&C Act is codified as 21 USC § 301 (Title 21 of the United States Code section 301); thus, I would cite this section as “FD&C Act Sec. 1. [301]”. Nonetheless, occasionally, you will see reference to a U.S.C. citation alone in some of the court decisions.
Most (but not all) of the U.S.C. citations are created by dropping the middle digit and putting a 3 in the hundred’s digit. Thus, FD&C Act Section 401 is codified as 21 U.S.C. § 341. Single‐digit FD&C Act sections become 30×; for example, FD&C Act Section 1 becomes 21 U.S.C. § 301.
FD&C ACT REFERENCES
Free online locations for reference to the FD&C Act include the following:
- Cornell’s LII: www.law.cornell.edu/uscode/text/21/chapter‐9
- Office of the Law Revision Counsel: http://uscode.house.gov
- U.S. Government Printing Office (GPO) Access: www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE
Of course, Westlaw and Lexis‐Nexis provide access to the most up‐to‐date text of the FD&C Act.
DISCUSSION QUESTIONS
The discussion questions within the chapters are designed to encourage thought on the material presented or for class discussion. Some of the questions have neither a right nor wrong answer, particularly those questions that have multiple viewpoints on public policy issues.
PROBLEM EXERCISES
The Problem Exercises are designed to encourage critical thinking. They take on a variety of forms but some are designed to provide practice answering essay questions in food law.
INTERNET CITATIONS
The fluid nature of Internet addresses creates difficulty for a textbook of this nature. The food regulation information available on the Internet is far too valuable not...
Erscheint lt. Verlag | 28.3.2022 |
---|---|
Sprache | englisch |
Themenwelt | Naturwissenschaften ► Biologie |
Naturwissenschaften ► Chemie | |
Technik | |
Weitere Fachgebiete ► Land- / Forstwirtschaft / Fischerei | |
Schlagworte | Food Legislation • Food Science & Technology • Law • Law Special Topics • Lebensmittelforschung • Lebensmittelforschung u. -technologie • Lebensmittel-Gesetzgebung • Lebensmittelrecht • Rechtswissenschaft • Spezialthemen Rechtswissenschaft |
ISBN-10 | 1-119-76429-7 / 1119764297 |
ISBN-13 | 978-1-119-76429-8 / 9781119764298 |
Haben Sie eine Frage zum Produkt? |
Größe: 3,2 MB
Kopierschutz: Adobe-DRM
Adobe-DRM ist ein Kopierschutz, der das eBook vor Mißbrauch schützen soll. Dabei wird das eBook bereits beim Download auf Ihre persönliche Adobe-ID autorisiert. Lesen können Sie das eBook dann nur auf den Geräten, welche ebenfalls auf Ihre Adobe-ID registriert sind.
Details zum Adobe-DRM
Dateiformat: EPUB (Electronic Publication)
EPUB ist ein offener Standard für eBooks und eignet sich besonders zur Darstellung von Belletristik und Sachbüchern. Der Fließtext wird dynamisch an die Display- und Schriftgröße angepasst. Auch für mobile Lesegeräte ist EPUB daher gut geeignet.
Systemvoraussetzungen:
PC/Mac: Mit einem PC oder Mac können Sie dieses eBook lesen. Sie benötigen eine
eReader: Dieses eBook kann mit (fast) allen eBook-Readern gelesen werden. Mit dem amazon-Kindle ist es aber nicht kompatibel.
Smartphone/Tablet: Egal ob Apple oder Android, dieses eBook können Sie lesen. Sie benötigen eine
Geräteliste und zusätzliche Hinweise
Buying eBooks from abroad
For tax law reasons we can sell eBooks just within Germany and Switzerland. Regrettably we cannot fulfill eBook-orders from other countries.
aus dem Bereich