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 food laws were nearly all state and local regulation. 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. * * * * * An Early Massachusetts Food Law 4 Passed March 8, 1785
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.
* * * * * 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. We face a new situation in history. Ingenuity, striking hands with cunning trickery, compounds a substance to counterfeit an article of food. It is made to look like something it is not; to taste and smell like something it is not; to sell like something it is not, and so deceive the purchaser. Congressional Record, 49 Congress I Session 1886. In this era, food production began shifting from the home to the factory, from consumers buying basic ingredients from neighbors in their community, to food processors and manufacturers more often at a distance. With this trend, consumers found it harder to determine the safety and quality of their food. Inevitably, the responsibility for ensuring the safety of foods only shifted from local to state government, and the demand for federal oversight increased. As national markets grew, legitimate manufacturers became concerned that their markets were being harmed by the dishonest and unsafe goods. 1.2.2 The 1906 Pure Food and Drug Act In 1883, Dr. Harvey Wiley became the chief chemist of the U.S. Bureau of Chemistry (at that time, part of the Department of Agriculture). Dr. Wiley expanded research and testing of food and documented widespread adulteration.5 He helped spur public indignation by his publications and by campaigning for a national food and drug law. Wiley dramatically focused concern about chemical preservatives as adulterants through his highly publicized “Poison Squad.”6 The Poison Squad consisted of live volunteers who consumed questionable food additives, such as boric acid and formaldehyde, to determine the impact on health. Observation and documentation of the ill effects and symptoms of the volunteers provided an appalling crude gauge of food additive safety.7 However, crude by today’s standards, Wiley’s leadership with the galvanize public awareness and advanced food safety. Public support for passage of a federal food and drug law grew as muckraking journalists exposed in shocking detail the frauds and dangers of the food and drug trades, such as the use of poisonous preservatives and dyes in food and deadly opiate‐laced syrups for children.8 A final catalyst for change was the 1905 publication of Upton Sinclair’ The Jungle. Sinclair portrayed nauseating practices and unsanitary conditions in the meatpacking industry, such as food handlers sick with tuberculosis and carcasses covered in rat droppings being made into
