kicked by horses; still more deal with the licensing and racing of horses, or with the care veterinarians give to horses, or with prizes at horse shows. Any effort to collect these strands into a course on ‘The Law of the Horse’ is doomed to be shallow and to miss unifying principles.”1
An especially important concern of Judge Easterbrook was that “The Law of the Horse” resulted in “courses suited to dilettantes.” He noted, “We are at risk of multidisciplinary dilettantism, or, as one of my mentors called it, the cross‐sterilization of ideas… . the worst of both worlds.”2
Accomplishment at legal scholarship perhaps more than other disciplines can imbue hubris regarding competence in other fields. Lawyers are not epidemiologists. Lawyers are not evolutionary biologists. Lawyers are not sociologists. And they should not live action role play them.
With the purpose of giving you the best of a single world, this book offers you a deep understanding of food law in the traditional sense. The traditional topic is a rich one and a rewarding one. I have endeavored to make this text interesting enough that you will not be tempted by the sirens’ call of the “law of food” dilettantism.
Neal D. Fortin
Spring 2022
Notes
1 1 Frank H. Easterbrook, Cyberspace and the Law of the Horse, U.Chi. Legal F. 207 (1996).
2 2 Id.
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