Introduction to Statutory Framework and Case Law

There is a long history of ineffective state regulation in the U.S. prior to 1906. The common law made it a crime to sell diseased meat , for example, as early as 1860. The trouble with the common law approach was two-fold. First, it relied on individuals to bring a suit in law or equity against a seller. There was no State enforcement mechanism to assist in the litigation, thus leaving the full cost and burden of enforcement, including investigations, on private individuals. This proved impractical for the average consumer. Second, the States were powerless when the poison of tainted food poured across State lines. The U.S. was a collection of sovereign States. The private litigant struggled to take their cause of action across State lines. Furthermore, the States relied on the Federal government under its authority to regulate interstate commerce . Absent a Federal statute or Federal agency the interstate sell of food went unregulated.

The end of the Civil War and the start of the Industrial Revolution are for many the roots of Federal food safety legislation . Following the Civil War the family farm was largely replaced by the impersonal corporation. Accountability faded and corruption flourished. In the period between 1879 and 1905 over 100 food and drug bills were debated in Congress (FDA Milestones).⁹ Yet none of them passed. As it so often is, crisis drives change in politics. In this case it was not until the “embalmed beef scandal ” of the Spanish-American War was Congress spurred to action. The scandal is so named because the commander of the Army, General Nelson A. Miles, in testimony to Congress described the beef as having an “odor like an embalmed dead body.” The incident gained widespread media attention with many claiming the tainted meat killed more soldiers than Spanish bullets (See Fig. 1.2).

In 1906, not long after the embalmed beef scandal , Congress passed the Pure Food and Drug Act . The initial act addressed two issues. It set out to proscribe dangerous foods and drugs and to curtail deceptive marketing and labeling practices. The initial Act was fraught with issues. Chief among the issues was the failure to enact any pre-market testing or review procedures for regulated products.

The 1906 Act persisted for 22 years before another scandal brought change. In 1937 a new cure-all was relased on the market called, “Elixir of Sulfanilamide .” Dissatisfied with the taste, smell, and apperance of the elixir the manufacturer added a combination of chemicals used in paint, varnish, and anti-freeze (FDA Consumer Magazine).¹⁰ The toxic effects were never considered and with no FDA pre-market approval process the product simply entered the market. By the time the FDA could take action to remove the product from the market nearly 100 people died. The victims were predominately children. Congress clamoured to act and in 1938 passed the Food Drug and Cosmetic Act . This is still the statute in effect today. The statute which served as the basis for amendments and now the Food Safety Modernization Act (FSMA ) builds on.

There are three lessons from the passage of the 1938 Act which serve as the tripritie lense through which we must view all Agency actions. These lessons are necessary to also effectively interpret the Act and understand how courts will do the same. These lessons are: (1) the drafter’s indicated court’s should broadly contrue the new Act to protect the public, (2) Congress rejected the 1906 Act’s assumption that consumers were capable of protecting themselves and (3) the objective of the 1938 Act continued to carry the mantale of protecting the public health but also added emphasis to defending consumers by preventing fraud (See Fig. 1.3). We will see the broad construction and deference courts give the Agency and the Act as we discuss nearly every topic. The ignorant consumer standard will be particularly noticeable as we disucuss labeling and restrictions on speech.

For readers outside the U.S. it is necessary to take a brief moment to introduce several key concepts of U.S. law and the structure of government . The United States as its name suggests is a union of several sovereign States. Sovereign that is to the extent allowed by the U.S. Constitution . The Constitution is the foundational document both for the creation of a Federal government but also for stipulating how in certain circumstances States govern their citizens. The U.S. Constitution plays three pivotal roles. Absent the Constitution there would be neither Federal agencies nor any Federal laws, like the Food Drug and Cosmetic Act or the FDA . Also without the Constitution there would be no legal grounds for any entity other than a state to regulate food production or safety within its borders. And if never ratified many individual rights and freedoms, like the protection from unreasonable search and seizure, would be missing. The Constitution, therefore, provides a framework for Federal regulation that plays a role in interstate commerce and individual and corporate freedoms and liberties.

The U.S. Constitution establishes a Federal government . Meaning it provides specific powers to the Federal government and the remaining powers to the States. Like a corporate merger the States forfeited rights and reserved others to a new superior organization. This concept is often referred to as Federalism , but can simply be thought of as a vertical division between the Federal government and the States (See Fig. 1.4).

Federalism places limits on what laws States can enact. Generally speaking the States reserved “police powers,” those powers necessary to protect its citizens’ health and welfare. Still Federal law can enter this zone of State authority using a secondary basis, such as the power to regulate commerce. This is a one way street. Only the Federal government can enact laws where States normally exercise authority. Within certain narrow exceptions States cannot enact laws where Federal law already exists. This is a concept known as preemption . States can enact limited legislation where Federal law exists so long as it does not “unduly burden” interstate commerce . Preemption provides a narrow space for States to regulate. In some instances States, like California, may pass more stringent laws for activities, but the laws will only impact intrastate food production. The more stringent law may be a model for future Federal legislation, but cannot otherwise exercise any effect outsides its borders.

The U.S. Constitution does more than play a role in the relationship between the Federal government and the States. It also provides the primary framework for the laws and structure of the Federal government. From this document the U.S. derives its three branches of government —the legislative , the executive , and the judicial . A term often used around this structure is the “separation of powers ” or “checks and balances .” The essential purpose of the design was to disperse power among several institutions and leaders.

In order to understand the concepts in the chapters to follow it is important to have a basic idea of the role of each branch of government. The legislative branch consists of the bicameral Congress . Congress is comprised of a House of Representatives and a Senate . The U.S. Congress is solely responsible for passing new legislation , such as it did in 1906 with the Pure Food and Drug Act . The executive branch is comprised of the President, Vice President and their administration. In terms of domestic policy, the role of the President is to ensure a duly passed law is implemented and executed. The President organizes the executive branch through a series of Federal agencies that will be responsible for an area of regulation. The two primary food agencies we have today are the U.S. Food and Drug Administration and the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS ). Once a law is passed typically the Agency implementing the law will promulgate a series of rules to provide structure and clarity to vague or broad statutory provisions. The Pure Food and Drug Act , for example, when passed was a mere five pages long! The Federal court system makes up the judicial branch. Federal courts are organized into three layers—district, circuit, and Supreme Court . Nearly every case begins at the district court level and in a series of appeals may be heard by the Supreme Court. Some districts operate with a magistrate judges providing an initial review or decision before the district court. It is the role of the judiciary, the Federal judges across the U.S., to hear challenges to both the statutory provisions and the administrative rules .

The U.S. Constitution not only plays a role in the structure of the Federal government but also constrains the limits of Federal laws. The Constitution enumerates both the limits of Federal power with the States and with individuals. The first ten amendments to the Constitution list the familiar individual freedoms, commonly known as the Bill of Rights . The Bill of Rights includes the freedom of speech , freedom from unreasonable searches , and the protection against self-incrimination among others. If a law infringes on any Constitutional provision it can be challenged, and if successful, the law invalidated. Although Constitutional rights are typically thought of as pertaining solely to individuals, they also apply to corporations. In later chapters we will see First Amendment challenges to advertising and labeling , Fourth Amendment challenges to facility inspections, and Fifth Amendment Due Process challenges when Agencies take enforcement actions.

There are numerous sources of laws. To make the regulatory landscape more manageable this text will narrow the scope of laws covered. As mentioned above the GAO estimates 30 laws directly involve food topics. From this selection only around five statutes will be discussed. This set of core statutes will cover the most common areas of enforcement and agency approval. A strong understanding of the core statutes serves many valuable purposes. Chief amongst those is understanding the classification of a product. Classification informs many other decisions, such as the controlling agency and the regulatory burden of the product.

Statutes are not the only source of law to consider. The Code of Federal Regulations (CFR ) contains the administrative rules issued by various Federal agencies. The rules are organized by Titles, which groups rules by agency or statute. In most cases the CFR title corresponds to the enabling statute. For example, Title 21 covers the rule promulgated to implement and interpret Title 21 of the United States Code , the FD&C Act. Other Titles related to food are Title 7 (agriculture) and Title 9 (animal and animal products). Title 9 contains the bulk of FSIS regulations , whereas Title 7 relates to other USDA activities. When an action is taken by an agency or division of an agency it is important to identify the appropriate statute and regulations associated with that action. Each agency is only responsive to the particular statutes outlining its authority and the regulations providing meaning to that authority.

In the array of agencies involved in food safety two stand as the megaliths in the center. The FDA and FSIS , the inspection arm of the USDA compose the bulk of Federal funding and staffing of the Federal government ’s food regulatory system. This makes the FDA and FSIS the primary agencies regulating food safety . As will be discussed in detail below, the size of these two agencies matches the massive mandate for each entity.

The definition of food is not what a lay person would think it to be. Asked on the street, “What is food?” One could point to a number of examples—fruit, a bag of chips, or maybe even a sports drink . The definition in the Act, however, is more nuanced. It is a term of art. There are in fact three definitions of food in the Act. Those are provided in the table below.