§2.1 Defining "Food" and "Drug" Mid-to-Late 19th Century

• Jurisdiction: United States
• Publication year: 2022

§2.1 Defining "Food" and "Drug" Mid-to-Late 19th Century

A discussion of current United States (U.S.) dietary supplement regulations should begin with a review of food and drug legal history. The legislative history, judicial reasoning, and regulatory pronouncements may give understanding to the present-day laws.

U.S. food and drug laws were birthed from English common laws. The adulteration of food in 19th-century England was commonly used to improve the economic condition of the seller. However, the term "adulteration" wasn't used in early cases. In one of the earliest reported decisions, a baker was charged with supplying to the Royal Military Asylum in Chelsea bread that he knew to be mixed with allum. The court convicted the baker, holding that because he knew the bread to contain allum and the allum was in a very dangerous [high] amount, he was guilty.¹

In another early case, the North Carolina Supreme Court disregarded the reasons as to why a defendant provided unwholesome and poisonous beef, and convicted him under common law reasoning of protecting the public health.² Early statutes showed concern for fraudulent food being sold to the public.³ Further cases avoided determining reasons for unwholesome or poisonous food, focused on the mere fact that it was done.⁴

As many of the early cases were criminal in nature, the intent of adulterator was at issue, i.e., did he perform "knowingly" or "unknowingly?" Knowingly selling unwholesome provisions was a misdemeanor at common law.⁵

Nationwide protection of the public from "adulterated" foods and drugs first appeared to guard against foreign importers. The "Act to prevent the Importation of adulterated and spurious Drugs and Medicines" required the examination of ". . . all drugs, medicines, medicinal preparations, including medicinal essential oils. And chemical preparations . . . imported into the U.S. from abroad."⁶ The drugs or medicines were deemed to be adulterated if they were deteriorated such to render them ". . . inferior in strength and purity to the standard. . . ."⁷ The standard was set by United States, Edinburgh, London, French, and German pharmacopoeias.⁸ The Tea Act of 1883 made it unlawful to import into the U.S. tea adulterated with spurious or exhausted leaves, or mixed with chemicals or other substances as ". . . to make it unfit for use."⁹

A statute addressing domestic adulteration was enacted in 1888.¹⁰ It was enforceable within the District of Columbia only. The statute made it a misdemeanor to "mix, color, stain or powder any article of food or drugs with any ingredient so as to render the article injurious to health."¹¹ Additionally, under the statute, a person was not liable of selling the adulterated product without possessing knowledge of adulteration.¹² Further, a person was not liable if the ingredient did not injure health, the food or drug was in a state that could be consumed, and the adulteration was not an economic adulteration. Liability was also waived where the drug or food was a proprietary medicine.¹³ "Food" was defined in the act as ". . . every article used for food or drink by man other than drugs"; "drugs" was defined as ". . . all medicines for internal or external use."¹⁴ A later statute, also enforceable within the District of Columbia only, expounded on the definition of "food" as ". . . including confectionary [and] condiments" and the definition of drugs as ". . . include[ing] antiseptics, disinfectants, and cosmetics."¹⁵ This act did not set forth that adulterating a food or drug was a misdemeanor, but rather set forth that an ". . . article shall be deemed adulterated . . ." if a drug, sold under a name recognized by the U.S., German, French, or English pharmacopoeias, differs from the standard of strength, quality, or purity set forth in the pharmacopoeias.¹⁶ An article was further adulterated if it did not contain all the ingredients listed on the label.¹⁷

Early court cases relating to food and drug adulteration involved determining the intent of Congress. In Buttfield v. Bidwell, the Second Circuit Court of Appeals, relying upon reports made by the Congress when debating the act at issue, held that the Secretary of the Treasury was authorized to create standards for teas.¹⁸ Throughout the history of U.S. food and drug laws, and continuing to present day, courts would turn to congressional report, and comparing and contrasting congressional bills to determine congressional intent.

The constitutionality of U.S. food and drug laws was also at issue in early court cases. In Powell v. Pennsylvania, the U.S. Supreme Court adjudicated the validity of a Pennsylvania statute relating to the adulteration of dairy products.¹⁹ The appellant manufactured an article made from pure animal fats that contained the same elements as dairy butter, save that the article contained a smaller proportion of the fatty substance known as "butterine." Because the appellant's article was not made from pure milk or cream, the defendant was indicted under that statute as selling an article being an imitation butter. Evidence was accepted that the article was a new invention as opposed to an adulteration of a previous article, it was a wholesome and nutritious article, and large investments were made by the appellant in the purchase of real estate, buildings, machinery, and ingredients. The defendant contended that the statute violated his constitutional rights of liberty and property without due process, and denied him equal protection guaranteed by the Fourteenth Amendment. In holding the statute to be tenable to the Fourteenth Amendment by providing equality to all those engaged in the same business as appellant, the Court supported the power of the legislature to promote the general welfare of the public health.²⁰

An issue that would continue to sound throughout U.S. food and drug laws was presented in American School of Magnetic Healing v. McAnnulty.²¹ In American School, the Supreme Court adjudicated whether the Postmaster General was justified in enforcing a statute based on his judgment that Defendant's homeopathic services were "false" or "fraudulent."²² In holding the homeopathic services to not be a violation of the laws of Congress, the court emphasized the differences of opinion that exist among practitioners and experts in the field:

". . . it cannot be said that it is a fraud for one person to content that the mind has an effect upon the body and its physical condition greater than even a vast majority of intelligent people might be willing to admit or believe. Even intelligent people may and indeed do differ among themselves as to the extent of this mental effect. Because the complainants might or did claim to be able to effect cures by reason of working upon and affecting the mental powers of the individual, . . . who can say that it is a fraud or a false pretense or a promise within the meaning of these statutes? . . . The claim of the ability to cure may be vastly great[er], . . . and yet those who might deny the existence or virtue of the remedy would only differ in opinion from those who assert it."²³

The differences of opinions among experts would remain an issue throughout U.S. food and drug law regulation.

In Buttfield v. Stranahan, the Secretary of the Treasury's power to set standards for imported teas was challenged.²⁴ In discussing the constitutional right of Congress to delegate such authority, the Court took note of the plenary power of Congress to regulate foreign commerce. Referring to the congressional power to regulate commerce with the Indian Tribes, the court said: "We entertain no doubt that it was competent for Congress, by statute, under the power to regulate foreign commerce, to establish standards and provide that no right should exist to import teas from foreign countries into the United States, unless such teas should be equal...