On January 4, 2011, President Barack Obama signed the FDA Food Safety Modernization Act (FSMA) into law.15 This amendment of the Federal FD&C Act is the most significant revision of U.S. food law since 1938 when the FD&C Act replaced the Food and Drug Act of 1906. The law is historic both in breadth and depth of its coverage.
With this background history, it is time to review some aspects of the U.S. legal system.
1.3 THE U.S. LEGAL SYSTEM
To understand the legal basis of food regulation in the United States, it is necessary to have an overall understanding of the U.S. legal system and some of the key concepts in American jurisprudence. First, let us look at the basic terminology.
Law: (1) a binding custom of a community; (2) a rule of conduct or action prescribed or enforced by a controlling authority; (3) the whole body of such rules; (4) the control brought about by the enforcement of such law; (5) the legal process; and (6) the whole body of laws relating to one subject.
As you can quickly see, even defining the term “law” is not a simple proposition. To simplify the terminology, this text follows the predominant American meanings for the term “law” and its synonyms:
Law implies imposition by a sovereign authority. Law commonly refers to the entire body of law on the subject, but also is a synonym for “statute.”
Statute means a law enacted by a legislative body.
Regulation implies prescription by administrative agency to carry out their statutory responsibilities. Federal regulations are first published in the Federal Register, which is published daily and organized by date and page number. Later, the regulations are codified in the Code of Federal Regulations (C.F.R.).16
Rule applies to more restricted or more specific laws than statutes. “Rule” often is an abbreviated form of the term “administrative rule,” which is a law promulgated by an administrative agency. Administrative rules are also called regulations. However, administrative rules are only one form of rules. Some administrative orders, resolutions, and formal opinions are also “rules.”
Guideline suggests something advisory rather than binding.
Ordinance applies to an order enforced by a local unit of government, such as a city.
The system of U.S. laws can be divided into four parts:
Constitution
Statutes
Regulations
Common law and case law
These four types of laws are described below in reference to the federal law. However, a similar system of laws occurs within the various states.
1.3.1 The Constitution17
The U.S. Constitution provides the framework for the U.S. legal system. The Constitution both empowers and limits government. The Constitution provides the supreme law of the land, and it is, by design, difficult to alter as a way of protecting long‐standing values.
The U.S. Constitution creates the federal government and divides the power into the three branches: legislative, executive, and judicial. The legislative power is vested in the U.S. Congress (Article I). (However, additional laws can be created by the executive and judicial branches.) The executive power is placed in the President (Article II). The judicial power is vested in the courts (Article III). This “separation of powers” was designed to create checks and balances to protect against tyrannical rule. Each of the three branches is considered separate but equal.
This caution over the concentration of power is a theme that runs throughout U.S. law. The Constitution, in addition to granting powers to government, also limits government’s powers and functions, particularly of the federal government. The first ten amendments of the Constitution are known as the Bill of Rights,18 and they protect individual rights by setting restrictions on the activities of the federal government.
1.3.2 Statutes
Within their power granted by the U.S. and state constitutions, respectively, Congress and state legislatures enact public acts, also called statutes. (Cities and other municipalities generally call their enactments of law “ordinances.”) All statutes must be consistent with the U.S. Constitution. State and local laws must also be consistent with the applicable state constitution.
1.3.3 Regulations
Although Congress and state legislatures have the primary authority to enact laws, they often delegate some of this authority to administrative agencies. This is particularly true for areas requiring technical expertise, such as health and science matters. The laws promulgated by administrative agencies are called regulations or administrative rules.
In theory, the administrative agencies merely execute the laws enacted by the legislature. However—because the legislatures often provide only a broad mandate—the agencies have considerable leeway in interpreting and applying their mandate. Typically, an administrative agency promulgates the detailed regulations that are necessary to translate the legislative mandate into operating standards. The regulations must fall under the scope of authority delegated by the legislature in statute. Regulations must also be consistent with other relevant constitutional and statutory requirements. Generally, regulations have the full force of law found in the enabling statute.
The executive branch agencies have increased in number, size, and importance since the 1930s. However, it is important to remember that the agencies can only carry out that which they are authorized to do by the legislature. In addition, the legislature determines the amount of funding the agencies receive. It is common for legislatures to enact popular statutes with noble sounding mandates but then fail to provide the necessary funds to agencies to carry out the new legislative mandate.
1.3.4 Case Law and Common Law
Both case law and common law are based on judicial decisions. Case law is the law established by the precedents of judicial decisions in cases (as distinguished from laws created by legislatures). Case law is important because of the tradition of following precedents. When a court addresses a legal dispute, it is usually guided by what has been decided previously in similar cases. These precedents become the case law. The general concept is that judges should follow the principles of law set down in prior decisions, unless it would violate justice or fair play to do so. Reliance on precedent serves to promote uniformity, predictability, and foster trust in a rule by law, not by person. Case law precedence is only set by the appellate courts.
Common law is the body of law based on legal tradition, custom, and general principles. Common law is embodied in case law and that serves as precedent or is applied to situations not covered by statute. U.S. common law was originally derived from English legal principles and traditions but now includes the precedents that have developed over time from the decisions of U.S. courts.
Common law generally applies only to areas of law where there is no statutory law. For example, if a firm discharges food‐processing waste on a field, and a foul smell permeates nearby homes, this may violate the common law of nuisance. Private nuisance common law might allow individuals to sue the processing plant. Public nuisance common law might allow a government