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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 to include some Internet addresses. Inevitably, however, some of these addresses will have changed or the documents will have been removed within days of this book’s printing.

Please realize that learning what types of materials are available is more valuable than finding a specific document. When you find a broken Internet address, take the opportunity to use search engines to find the new location, or to find similar material on the web.

In the types of materials referenced in this text, most of the broken Internet addresses result from reorganization of large document repositories. If search engines cannot find a particular document—and you believe it contains vital information—you may be able to find the document using Internet archives.¹

CITATION FORMAT

Citations in this text generally follow The Bluebook: A Uniform System of Citation (20th Ed.). However, some conventions are modified to save space and repetition.

I hope you find this text offers an appetizing menu for understanding food regulation in the United States.

ACKNOWLEDGMENTS

It is impossible to write a text of this nature without owing many people a debt of gratitude. I cannot begin to list you all, but extend a thank you to everyone who furthered my scholarship on food law. I also wish to acknowledge my wife, Kathy, and daughter, Helen, who supported me through the many months of writing, without which this book would never have been finished.

The following publishers, journals, and authors are thanked for their generosity in granting permission for me to publish excerpts from the following publications:

 Food and Drug Law Institute: Neal Fortin, The Hang‐Up with HACCP: The Resistance to Translating Science into Food Safety Law, 58 FOOD AND DRUG L J 565–594 (2003).

 Food Safety News: Richard Raymond and John Munsel, Is AMI’s Hodges Slinging Mud in the Name of Science? FOOD SAFETY NEWS (Feb. 24, 2012).

 International Food Information Council: FDA/IFIC, Food Additives (1992).

 Journal of Food Law and Policy: Neal D. Fortin, Is a Picture Worth More Than 1,000 Words? 1 J. FOOD L. & POL’Y 239–268 (Fall 2005).

 Thompson‐West: James T. O’Reilly, FOOD AND DRUG ADMINISTRATION, 2d Ed. (2004).

NOTE

1 ¹ For example, the Wayback Machine, which contains 462 billion web pages archived from 1996, http://www.archive.org/web/web.php (last visited Jan. 22, 2016).