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).
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 LAW JOURNAL 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 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).
1 INTRODUCTION TO FOOD REGULATION IN THE UNITED STATES
1.1 INTRODUCTION
This chapter provides basic information for students with greatly varied backgrounds. Necessarily, this information may be repetitive or elementary for some readers. Those readers are encouraged to treat this material as a review and refresher. Most of the topics provided in overview in this chapter will be covered later in more depth.
This introduction also provides a historical background that gives insight into the public policy decisions in food regulation. A general explanation of the legal system, regulatory law in general, and the legal basis of food regulation in the United States are included. To enhance an understanding of the legal structures and to simplify its otherwise mysteriousness, this chapter provides 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 BCE, Theophrastus (372–287 BCE) in his ten‐volume treatise, Enquiry into Plants, reported on the use of food adulterants for economic reasons. Pliny the Elder’s (CE 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, and 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. Nonetheless, 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
Regulation of food in the United States dates to the colonial era, but the early
