Contents

SUMMARY OF CONTENTS

PREFACE

ACKNOWLEDGMENTS

PART I: INTRODUCTORY CHAPTERS

CHAPTER 1 Introduction to Food Regulation in the United States

1.1 INTRODUCTION

1.2 A SHORT HISTORY OF FOOD REGULATION IN THE UNITED STATES

1.3 THE U.S. LEGAL SYSTEM

1.4 AGENCY PROCEDURAL REGULATION

1.5 AGENCY JURISDICTION

1.6 MAJOR FEDERAL LAWS

1.7 INFORMATIONAL RESOURCES

APPENDIX CONSTITUTIONAL AMENDMENTS I THROUGH X (THE BILL OF RIGHTS)

CHAPTER 2 What Is a Food?

2.1 INTRODUCTION TO THE FOOD, DRUG, AND COSMETIC ACT

DISCUSSION QUESTION

2.2 WHAT MAKES AN ARTICLE A FOOD OR A DRUG?

2.3 THE CENTRAL ROLE OF INTENDED USE

2.4 OTHER CONSIDERATIONS

DISCUSSION QUESTIONS

PART II: REGULATION OF LABELING AND CLAIMS

CHAPTER 3 Food Labeling

3.1 INTRODUCTION

3.2 LEGAL AUTHORITIES

3.3 LABELING TERMINOLOGY

3.4 AFFIRMATIVE LABEL REQUIREMENTS

3.5 MISBRANDED FOOD: PROHIBITED REPRESENTATIONS

3.6 DECEPTIVE PACKAGING

3.7 WARNING STATEMENTS: PRODUCTS REQUIRING WARNING LABELS

3.8 ALLERGENS

3.9 ALCOHOLIC BEVERAGES

3.10 USDA

3.11 OPTIONAL LABEL INFORMATION

CHAPTER 4 Nutritional Labeling, Nutrient Level Claims, and Health Claims

4.1 INTRODUCTION

4.2 THE NUTRITION LABELING AND EDUCATION ACT (NLEA)

4.3 NUTRIENT LEVEL CLAIMS

4.4 NUTRITION PANEL FORMAT

4.5 TRANS FATS

4.6 HEALTH CLAIMS

4.7 NLEA AND RESTAURANTS

4.8 ADVERTISING

CHAPTER 5 Economic and Aesthetic Adulteration

5.1 INTRODUCTION

5.2 DEFINITIONS

5.3 FOOD STANDARDS: REGULATION OF FOOD IDENTITY AND QUALITY

5.4 SANITATION AND AESTHETIC ADULTERATION

PART III: FOOD SAFETY REGULATION

CHAPTER 6 Food Safety Regulation

6.1 INTRODUCTION

6.2 PESTICIDE RESIDUES

6.3 ENVIRONMENTAL CONTAMINANTS

6.4 TAMPERING: THE ANTI-TAMPERING ACT

6.5 CARCINOGENS: THE DELANEY CLAUSE

6.6 HACCP37

CHAPTER 7 Food Additives, Food Colorings, Irradiation

7.1 INTRODUCTION

7.2 BACKGROUND

7.3 FOOD ADDITIVES

7.4 COLOR ADDITIVES

7.5 FOOD IRRADIATION

PART IV: SPECIALIZED FOOD REGULATION

CHAPTER 8 Dietary Supplements

8.1 INTRODUCTION

8.2 BACKGROUND

NOTES AND QUESTIONS

8.3 THE STATUTORY DEFINITION

8.4 APPROVAL AND SAFETY

8.5 ENFORCEMENT

8.6 GOOD MANUFACTURING PRACTICES (GMPs)

8.7 LABELS

8.8 HEALTH CLAIMS

8.9 PROBLEM SUPPLEMENTS

8.10 “STREET DRUG ALTERNATIVES”

8.11 ADVERTISING

CHAPTER 9 Biotechnology and Genetically Engineered Organisms

9.1 INTRODUCTION

9.2 FOOD SAFETY

9.3 FDA POLICY

9.4 USDA’S ROLE

9.5 EPA’S ROLE—THE SAFETY OF PESTICIDES IN BIOENGINEERED PLANTS

9.6 THE RIGHT TO KNOW

CHAPTER 10 Food Terrorism

10.1 THE U.S. FOOD SAFETY SYSTEM

10.2 THE THREAT

10.3 EXAMPLES OF CONTAMINATION

10.4 THE BIOTERRORISM ACT AND FDA’S NEW POWERS

10.5 CONCLUSIONS

CHAPTER 11 Importation and Exportation

11.1 INTRODUCTION

11.2 THE MAJOR FEDERAL AGENCIES

11.3 THE FDA IMPORT PROCESS

11.4 USDA’S IMPORT SYSTEM

11.5 OTHER IMPORT CONTROLS

11.6 COUNTRY-OF-ORIGIN LABELING

11.7 CHALLENGES FACING IMPORT REGULATION

11.8 EXPORT

PART V: INSPECTION AND ENFORCEMENT

CHAPTER 12 Federal Enforcement

12.1 INTRODUCTION

12.2 STATUTORY AUTHORITIES

12.3 ENFORCEMENT JURISDICTION

12.4 ADMINISTRATIVE ENFORCEMENT

12.5 FDA CIVIL COURT ACTIONS

12.6 CRIMINAL ACTIONS

12.7 OTHER REMEDIES AND CONCERNS

CHAPTER 13 Inspections

13.1 INTRODUCTION

13.2 CONSTITUTIONAL LIMITS

13.3 PLANNING FOR THE INSPECTION

13.4 FSIS INSPECTION AUTHORITY

CHAPTER 14 State Laws and Their Relationship to Federal Laws

14.1 INTRODUCTION

14.2 STATE INSPECTION AND ENFORCEMENT POWERS

14.3 STATE WARNING REQUIREMENTS

14.4 FEDERAL PREEMPTION OF STATES

14.5 FEDERAL LAWS DELEGATING AUTHORITY TO THE STATES

CHAPTER 15 Private Actions

15.1 INTRODUCTION

15.2 PRODUCTS LIABILITY

15.3 PREEMPTION OF TORT CLAIMS

15.4 THE FALSE CLAIMS ACT

15.5 NO PRIVATE CAUSE OF ACTION UNDER THE FD&C ACT

PART VI: GENERAL CHAPTERS

CHAPTER 16 International Food Law

16.1 INTRODUCTION

16.2 INTERNATIONAL FOOD STANDARDS

16.3 FOREIGN REGULATORY SYSTEMS

CHAPTER 17 Ethics

17.1 PROFESSIONALISM AND ETHICS

17.2 ETHICAL PRACTICE POINTERS

17.3 ATTORNEY RULES OF ETHICS

17.4 CRIMINAL STATUTES RELATED TO ETHICS

17.5 RESOURCES

TABLE OF ABBREVIATIONS

TABLE OF CASES

INDEX

ABOUT THE AUTHOR

Copyright © 2009 by Neal D. Fortin. All rights reserved.

Published by John Wiley & Sons, Inc., Hoboken, New Jersey

Published simultaneously in Canada

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, (928) 750-8400, fax (978) 750-4470, or on the web at www.copyright.com. Requests to the Publisher for permission should be addressed to the Permission Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at http://www.wiley.com/go/permission.

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Library of Congress Cataloging-in-Publication Data:

Fortin, Neal D.

Food regulation: law, science, policy, and practice/Neal D. Fortin.

p. cm.

Includes index.

ISBN 978-0-470-12709-4 (cloth)

1. Food law and legislation–United States. 2. Food industry and trade–Safety regulations–United States. 3. Food adulteration and inspection–United States.

I. Title.

KF3875.F67 2009

344.7304'232—dc22

2008021433

Dedicated to Katherine Forti and Helen Fortin

SUMMARY OF CONTENTS

Part I: Introductory Chapters

1 Introduction to Food Regulation in the United States A short history of food and drug regulation in the United States. An overview of government agency jurisdictions and authority over food.

2 What Is a Food? Introduction to the Food, Drug, and Cosmetic Act (FD&C Act). What makes an article a food, a drug, a device, or a product outside the scope of the Act?

Part II: Regulation of Labeling and Claims

3 Food Labeling The basic requirements of food labeling, misbranding, legal authorities, labeling terminology, affirmative label requirements, prohibited representations, deceptive packaging, warning statements, and allergens.

4 Nutritional Labeling, Nutrient Level Claims, and Health Claims The requirements for nutritional labeling and health claims on food plus an overview of the regulation of advertising. The Nutritional Labeling and Education Act (NLEA).

5 Aesthetic and Economic Adulteration Key definitions, adulteration, food (unfit for food, packaging materials), esthetic adulteration, defect action levels, GMPs, standards of identity, and economic adulteration.

Part III: Food Safety Regulation

6 Food Safety Regulation Poisonous or deleterious substances, pesticides, the Delaney Clause, the Food Quality Protection Act (FQPA), foodborne illnesses, HACCP, and tampering law. Current issues in foodborne illness, such as mad cow disease.

7 Food Additives, Color Additives, and Irradiation The regulation of food additives, color additives, and irradiation.

Part IV: Specialized Food Regulation

8 Dietary Supplements The regulation of this special class of food that is regulated neither as conventional food nor as food additives. Dietary Supplement Health and Education Act of 1994 (DSHEA), ephedrine; “street drug alternatives,” and dietary supplement ads on the Internet.

9 Biotechnology and Genetically Engineered Organisms The regulation biotechnology, genetically modified foods, and cloning.

10 Food Terrorism A look at food security and the federal government’s new bioterrorism powers.

11 Importation and Exportation The regulation of U.S. food imports and exports, including harmonization of domestic and foreign trade restrictions, and agency enforcement authority.

Part V: Inspection and Enforcement

12 Federal Enforcement An overview of the enforcement tools of the FDA and USDA-FSIS with a focus on seizures, recalls, and penalties.

13 Inspections An overview of the FDA and state inspections, and Fourth Amendment, and practical issues.

14 State Laws and Their Relationship to Federal Laws A discussion of state enforcement, the state food and drug laws, and federal pre-emption.

15 Private Actions Private causes of actions and their regulatory role.

Part VI: General Chapters

16 International Food Law The implications of international trade, international treaties, and the Codex Alimentarius.

17 Ethics Discussion of ethical issues in food law and in government regulation.

PREFACE

Knowledge is the food of the soul.

—Plato

Food regulation is a complex and fascinating field. Study in this area is richly rewarding. From a human-interest perspective, the range of products regulated touches the lives of nearly every American every day. Food regulatory 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 incisive 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 the 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. For this reason the text is appropriate for a wide audience of students and professionals.

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.

The focus is on the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. section 321 et seq., and the Food and Drug Administration (FDA). A good number of the cases and references in this text are to pharmaceuticals, medical devices, and cosmetics. The FD&C Act regulates all these products, and there are commonalities in the regulatory framework for all. In fact, some drug or medical device cases illustrate a point about food law better than any case directly about food.

This casebook presents diverse materials from pertinent sources. Commentary and context are provided as needed, but often the materials can be digested without these aids. The novice may feel challenged at first to understand the materials, but after jumping around the various writing styles and contexts, and the relative value and weight of each source should become discernable. Stay with it, and you will find that the materials become easier.

A ROAD MAP FOR READING THE MATERIALS IN THIS COURSE

In keeping with the way information is encountered in practice, not all readings in this text are equal. Some may be read quickly, while some require close scrutiny. Moreover, materials come in varying levels of formality. Some materials I have condensed to make them easier to read.

Readers new to this teaching style may be disconcerted at first. Do not let this throw you. Persist and trust your instincts, and you will find that your effort quickly pays dividends. In the end, you will learn much more than the mere rules, but develop and hone critical skills that are not only vital in legal analysis but are 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 readers who are new to this teaching method:

1. 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.

2. 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, as the date may indicate that the material is provided for historical perspective, or that part of the information may be pertinent but part may be outdated.

3. The statutes and regulations are the primary source of our food law. That is, food regulatory law is largely bound by statutes and regulations. Therefore these materials should be the beginning of your research to answer a food law question. Often a problem is solved by examination of the statutory definitions (particularly key definitions, e.g., food, drug, misbranding, and adulterated).

4. 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 the footnotes and citations from most of the cases. Remaining footnotes may be renumbered with my own footnotes. Unless otherwise indicated, any footnotes with 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. So 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 [321], such as “food” and “drug,” and the definitions of “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 in the United States Code (U.S.C.). The U.S.C. is organized into subject matter titles with numbering that is unique from the section numbering in the statutes as they were enacted into the public acts. For example, section 1 of the Food, Drug, and Cosmetic Act is codified as 21 U.S.C. § 301. You may also find this section cited with one or the other or both reference numbers, such as “Sec. 1 [301].”

Statutory citations used in this material are to the FD&C Act statutory sections (which is the way practitioners refer to them). The citation within the brackets is the U.S.C. number. Nonetheless, occasionally you will see reference to a United States Code citation.

FD&C ACT REFERENCES

Four free online locations for reference to the FD&C Act follow:

Cornell’s LII: www4.law.cornell.edu/uscode/21/ch9.html

FDA: www.fda.gov/opacom/laws/fdcact/fdctoc.htm

GPO Access: http://www.gpoaccess.gov/uscode/index.html

University of Virginia: www.uvm.edu/nusc/nusc237/ffdcatc.html

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 are designed to encourage thought on the material presented or for class discussion. Often there is not a right or wrong answer but multiple viewpoints on these issues or public policy questions. A great deal of insight can be gained by having candid discussions of these different perspectives.

PROBLEM EXERCISES

The Problem Exercises are designed to encourage critical thinking. They take on a variety of forms, but usually revolve around a public policy question 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 many 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.

However, 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 reference 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 Nonetheless, this text offers a complete and appetizing menu for understanding food regulation in the United States.

CITATION FORMAT

Citations in this text generally follow The Bluebook: A Uniform System of Citation (18th Ed.). However, some conventions are modified to save space and repetition.

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

¹ F or example, the Wayback Machine, which contains 55 billion Web pages archived from 1996, available at: http://www.archive.org/web/web.php (last accessed Sept. 12, 2006).

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:

P. Vincent Hegarty, a great mentor and scholar, who first hired me to teach food law, and unwittingly launched this endeavor.

Peter Barton Hutt and Richard A. Merrill, co-authors of FOOD AND DRUG LAW: CASES AND MATERIALS (1st and 2nd editions), are deans of food and drug law scholarship, and I am indebted to their work.

Caren Wilcox, a guest instructor in my food regulation in the U.S. course, provided me with insight into the problems of bioterrorism.

Elijah Milne, a gifted writer and brilliant student, provided invaluable editorial support and legal research for this book.

My wife, Kathy, and daughter, Helen, 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:

Consumers Union of U.S., Inc.: The Truth about Irradiated Meat, CONSUMER REPORTS 34–37 (Aug. 2003).

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 LAW JOURNAL 565–594 (2003).

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

Journal of Food Law and Policy: Neal Fortin, Is a Picture Worth More Than 1,000 Words? 1 JOURNAL OF FOOD LAW AND POLICY 239-268 (Fall 2005).

Thompson-West: JAMES T. O’REILLY, FOOD AND DRUG ADMINISTRATION (2d ed. 2004).

PART I

INTRODUCTORY CHAPTERS

CHAPTER 1

Introduction to Food Regulation in the United States

1.1 INTRODUCTION

This chapter provides basic information for students with greatly varied backgrounds. While this information may be repetitive or elementary for some readers, the reader is nevertheless encouraged to treat this material as a review and refresher. This introduction also provides a historical background that gives insight into the public policy decisions in food regulation.

This chapter also provides a general explanation of the legal system, regulatory law in general, and the legal basis of food regulation in the United States. To enhance an understanding of the legal structure, and to simplify its otherwise mysteriousness, this chapter begins with an overview of the history of food regulation in the United States. This history accounts for and explains much of the current organization of federal and state regulatory agencies.

This chapter further presents an overview of the major food statutes, regulations, and the jurisdictions of various agencies. This knowledge will allow you to enhance your communication and functioning within this legal framework. In addition, a better understanding of the functions, authority, and interrelationship of various regulatory agencies promotes improved relations with those agencies. This understanding will also improve your ability to function within the regulatory system.

1.2 A SHORT HISTORY OF FOOD REGULATION IN THE UNITED STATES

1.2.1 Why Do We Have Food Laws?

From the beginnings of civilization, people have been concerned about food quality and safety. The focus of governmental protection originated to protect against economic fraud and to prevent against the sale of unsafe food. As early as the fourth century bc, Theophrastus (372–287 bc) in his ten-volume treatise, Enquiry into Plants, reported on the use of food adulterants for economic reasons. Pliny the Elder’s (ad 23–79) Natural History provides evidence of widespread adulteration, such as bread with chalk, pepper with juniper berries, and even adulteration with cattle fodder.¹ Ancient Roman law reflected this concern for adulteration of food with punishment that could result in condemnation to the mines or temporary exile.²

Starting in the thirteenth century, the trade guilds advanced higher food standards. The trade guilds, which included bakers, butchers, cooks, fruiters, among the many tradecrafts, held the power to search for and seize unwholesome products.

Indeed, as the guilds policed the marketplace, they were most interested to ensure continued and strong markets for their goods. Nevertheless, the guilds provide an early demonstration how stringent product quality and safety standards can bring a competitive economic advantage to industries and nations. Trust in food’s safety and wholesomeness is necessary for the market to prosper. A number of commentators have noted the commonality of interest between business self-interest and stringent product safety standards.³

This early Massachusetts Food Act was passed on March 8, 1785.⁴

An Act Against Selling Unwholesome Provisions

Whereas some evilly disposed persons, from motives of avarice and filthy lucre, have been induced to sell diseased, corrupted, contagious, or unwholesome provisions, to the great nuisance of public health and peace:

Be it therefore enacted by the Senate and House of Representatives, in General Court assembled, and by the authority of the same, That if any person shall sell any such diseased, corrupted, contagious or unwholesome provisions, whether for meat or drink, knowing the same without making it known to the buyer, and being thereof convicted before the Justices of the General Sessions of the Peace, in the county where such offence shall be committed, or the Justices of the Supreme Judicial Court, he shall be punished by fine, imprisonment, standing in the pillory, and binding to the good behaviour, or one or more of these punishments, to be inflicted according to the degree and aggravation of the offence.

Nearly all of the regulation of food in the United States in the colonial era was by the state and local governments. Federal activity was limited to imported foods. The first federal food protection law was enacted by Congress in 1883 to prevent the importation of adulterated tea. This was followed in 1896 by the oleo-margarine statute, which was passed because dairy farmers and the dairy industry objected to the sale of adulterated butter and fats colored to look like butter.

Although adulteration and mislabeling of food had been a centuries-old concern, the magnitude of the problems increased in the last half of the nineteenth century. This was an era of rapid development in chemistry, bringing advancements in food science, new food additives and colorings, and new means of adulteration. Fortunately, these scientific advances also provided the tools for detecting adulteration.

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