Neal D. Fortin

Food Regulation


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additives, but that is an exception and most advisory committees are established at FDA’s discretion.

      1.4.6 Freedom of Information Act (FOIA)

      A popular Government without popular information or the means of acquiring it, is but a Prologue to a Farce or a Tragedy or perhaps both. Knowledge will forever govern ignorance, and a people who mean to be their own Governors, must arm themselves with the power knowledge gives.

      James Madison

      Federal executive branch agencies are required under the FOIA to disclose most records requested in writing by any person. Agencies may withhold information under nine exemptions and three exclusions in the statute.

      FOIA litigation is a complex area of law with thousands of court decisions interpreting the act. However, this should not intimidate you from understanding the fundamentals of the law or from making a request yourself. More information on FOIA is found in Chapter 20 infra.

      1.4.7 Constitutional Limitations on Agency Power

      Police power, specifically the power of state governments to regulate for the health and welfare of the people, has been upheld to be quite broad in reach and impact. Generally, these laws will be upheld if they are at all rational attempts to protect and promote the public’s health, safety, or general welfare. The courts will not review whether the laws are the best option or even whether they are “good” laws, but merely whether they avoid being arbitrary or capricious.

      Although the courts have interpreted the state police power broadly, governmental authorities do have limits placed on their powers. Limitations on state and federal powers are mainly found in these documents:

       The U.S. Constitution.

       The constitutions of individual states.

       Federal and state laws.

      Food laws are sometimes challenged as infringing upon constitutionally protected individual rights. The first ten amendments to the Constitution, the Bill of Rights, define those things that government cannot do to the individual. If Congress or a state legislature enacts a law inconsistent with any of these constitutional provisions, the courts may be asked to invalidate the law as being “repugnant to the Constitution.”

      In the area of food safety, however, the courts historically have been hesitant to invalidate these laws, even for the sake of protecting individual rights. Nonetheless, food laws have been challenged on this basis, and some important aspects highlighted below foreshadow issues that will rise in subsequent chapters. The cases illustrate how an individual’s rights are balanced against society’s need for protection from preventable harms.

      The Bill of Rights is generally applicable to the states through the Fourteenth Amendment. Right by right, the Supreme Court has applied most, but not all, of the Bill of Rights’ restrictions to the state governments through the Fourteenth Amendment. For example, the states may not pass laws that abridge the freedom of speech, press, or assembly. Technically, the state law would be in violation of the Fourteenth Amendment, but for ease of reference, this chapter will refer to the underlying Bill of Rights amendment (in this example, the First Amendment’s protections of the freedom of speech, press, and assembly).

       Free Speech

      Laws may be invalidated because they conflict with the part of the First Amendment that protects the free communication of ideas: “Congress shall make no law … abridging the freedom of speech or of the press … .” As with all the Bill of Rights, the First Amendment rights are not absolute and may be abridged under certain circumstances. Justice Holmes famously noted that the First Amendment does not afford a right to cry “fire” in a crowded theater.

      In Cox v. New Hampshire, 312 U.S. 569 (1941), the U.S. Supreme Court upheld an ordinance that required parade permits, although a group who challenged the law argued that it abridged their First Amendment rights of assembly and communication. The Court concluded:

      The authority of a municipality to impose regulations in order to assure the safety and convenience of the people in the use of public highways has never been regarded as inconsistent with civil liberties, but rather as one of the means of safe‐guarding the good order upon which they ultimately depend … . The question in a particular case is whether that control is exerted so as not to deny or unwarrantedly abridge the right of assembly and the opportunities for the communication of thought and the discussion of public questions immemorially associated with resort to public places.

      Source: Cox v. New Hampshire, 312 U.S. 569 (1941), U.S. Supreme Court. Public domain.

      First Amendment issues will be discussed in later chapters regarding the right of free expression of commercial speech in conjunction with food advertising and claims.

       Searches

      The Fourth Amendment to the U.S. Constitution provides that:

      The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue but upon probable cause supported by Oath or affirmation and particularly describing the place to be searched and the persons or things to be seized.

      This is particularly relevant to how agencies conduct inspections. The courts have generally upheld the validity of laws granting government agencies the right to inspect food establishments; however, the scope of inspections is more controversial. The right to take photographs and the right to access records, such as complaint files, formulation files, and personnel files, will be discussed in later chapters.

      The Fifth Amendment contains three provisions that are particularly pertinent to food regulation:

       Self‐Incrimination: No person shall be compelled to be a witness against himself in any criminal case.

       Due Process: No person shall be deprived of life, liberty, or property without due process of law.

       Just Compensation: No private property shall be taken for public use without just compensation.

       Self‐Incrimination

      Under the Fifth Amendment’s protection that no person shall be compelled to be a witness against himself in a criminal case, a person may refuse to answer official questions if the answers could