§2.4 Technology, Market Segmentation, and Food Law: 1938-1958

• Jurisdiction: United States
• Publication year: 2022

§2.4 Technology, Market Segmentation, and Food Law: 1938-1958

The immediate years after passage of the '38 Act saw the courts adjudicating general aspects and definitions under the '38 Act, and the FDA issuing regulations under its new-found, statutory-based power. The passage of time and technological development saw continued segmentation in the industries of food and drugs, foreshadowing the outbreak of dietary supplements as defined articles unto themselves.

The general purposes of the '38 Act were apparently carried forward from the '06 Act, including protection of the consuming public,²²⁴ preventing adulterated food or drugs from entering interstate commerce,²²⁵ preventing misbranded food or drugs from entering interstate commerce,²²⁶ and making violators guilty regardless of intent.²²⁷ There were new foundational principles of food and drug law set forth in the '38 Act, such as authorizing the Secretary to establish definitions and standards of identity to further the general purposes from the '06 Act.²²⁸

The courts continued to liberally construe the provisions of the nations' food and drug laws.²²⁹ Perhaps because of the specificity in the '38 Act, the courts appeared to rely more upon the language of the Act itself when construing, especially when unambiguous.²³⁰ This method fell under the principle of narrow construction.²³¹ In one case, strict construction of the Act led to a holding expanding the scope of adulteration.²³² In a case involving misbranding of a vitamin preparation, the court turned away from utilizing a strict or liberal construction, saying, "The consequence is the distortion of the statute to support a foreordained judicial objective. Legislative language is most faithfully construed when it is held to mean simply what it says, read with common sense."²³³

In United States v. Dotterweich, the Supreme Court held a corporate officer could be found guilty of violating the '38 Act even if the corporation he worked for was not found guilty.²³⁴ The court relied upon the language of the statute as well as the historic understanding of "misdemeanor" in its ruling.

In a dissenting opinion, Justice Murphy pointed out that the statute does not refer to corporate officers as falling within its boundary.²³⁵ In fact, pointing to the legislative history of the '38 Act, it is shown that a provision explicitly bringing corporate officers within its boundary was excluded from the final version of the Act. Speaking against the judgment of the majority, he stated:

"The legislative power to restrain the liberty and to imperil the good reputation of citizens must not rest upon the variable attitudes and opinions of those charged with the duties of interpreting and enforcing the mandates of the law."²³⁶

In another case, a court stated a jury, debating whether a label for an orange drink was misbranded, should apply the standard of the ordinary person in absence of Congress not indicating an extraordinary standard.²³⁷

As in the '06 Act, classifying an article as a "food" or a "drug" was an important step to determine whether an article was adulterated or not. The definition of a "food" was fairly unchanged from the '06 Act, but the definition of a "drug" was broadened under the '38 Act to include articles that intend to "affect the structure or . . . function of the body."²³⁸ In a case in the Minnesota Supreme Court (state court) involving vitamin preparations being sold for non-medicinal purposes, the court debated the classification of vitamins, and set forth a test for classifying vitamins as a food or drug,²³⁹

"We believe . . . the true test is: Can the preparation now under consideration affect the structure or function of the body of man or other animal in a way not ordinarily affected by the consumption of food?"²⁴⁰

In holding the preparations to be a drug, the court addressed whose intent is necessary for vitamin classification: "The question is not so much what the manufacturer or distributor intends to sell the product for as what the consumer intends to use it for . . . it is clear that these preparations may be used for something more than a dietary supplement."²⁴¹

The intended use of the article was a main classifying tool, which could be obtained from labels,²⁴² labeling,²⁴³ or oral statements.²⁴⁴ Laxative products, "Vit-Ra-Tox 19" and "Vit-Ra-Tox 19[a]," were classified as drugs based on the intended use stated on its label and the labeling.²⁴⁵ An herbal tonic formula was deemed a drug based on an oral representation by a sales representative that it was a remedy for treatment.²⁴⁶ The courts relied upon labels and labeling so extensively in determining the intended use that honey, normally a food, was classified a drug based as a treatment for diabetes, high blood pressure, arthritis, and other diseases.²⁴⁷

Often, the courts viewed the labels and labeling in total when classifying articles. In one case involving cigarettes sold for the purpose of reducing weight, the court considered the labels on the containers, the panels on the display cartons, a salesman's catalogue sheet, and a window display streamer in holding the cigarettes to be a drug.²⁴⁸ In most cases, the inherent properties or dictionary definition of the article did not affect its classification.²⁴⁹

In the case United States v. Kaadt, a letter was sent to a potential client detailing a method of treating diabetes with an internal medicine provided by appellant.²⁵⁰ The letter was held to fall within the statutory definition of "labeling" because it ". . . accompan[ied]" the drug even though it was not mailed with the drug.²⁵¹ Based on the statements in the letter, the internal medicine was classified as a drug.²⁵² The phrase "accompanying such article" used in the definition of labeling was apparently not limited by Congress, and therefore even though literature and a product did not travel together, the fact that they had a common origin and a common destination, the literature was deemed "accompanying" the product.²⁵³ The timing of literature and product in interstate commerce also determined whether the literature "accompanied" the product. But, in Alberty v. United States,²⁵⁴ labels bearing statements that a drug would restore color to gray hair and prevent gray hair were shipped more than two months after the drug. Because the charge against appellant was criminal in nature, the statute was strictly construed, and the court held the labels to not be "accompanying" the drug.²⁵⁵ In United States v. 150 Packages, Etc., the court adjudicated several statements to determine whether they intended to diagnose, cure, mitigate, treat, or prevent a disease, thus classifying the tablets as drugs.²⁵⁶

The statements included:

• "Directions: Three to six tablets after meals as required"—this statement classified the article a drug;
• "For use by those who delight in Sulphur Baths"—this statement did not classify the article a drug;
• "As a Dietary Source of Iodine"—this statement classified the article a drug;
• "For those persons wishing to include garlic and parsley-in the regular diet"—this statement did not classify the article a drug;
• "Suggested Use"—this statement classified the article a drug; and
• Suggested Use: One to two tablets daily"—this statement classified the article a drug.

In a separate case, it was held the use of the term "nutritional" did not stop the article from being labeled a drug if it was intended for therapeutic purpose.²⁵⁷

"New drug" was defined under the '38 Act, and an exemption for certain drugs was given in the form of a "grandfather clause."²⁵⁸ A drug may be "new" if it is given under a new or different recommended use, or a new or different duration of administration, even if the drug is not new for another use or duration.²⁵⁹ The "grandfather clause" exempted drugs that were subject to the '06 Act prior to enactment of the '38 Act and its labeling contained the same representations.²⁶⁰ Grandfather clauses were often construed strictly against the one who invoked it.²⁶¹ The FDA set forth regulations for the "newness" of a drug, including combining two or more ingredients, neither of which had previously been a new drug, changing the proportions of the ingredients of a drug, and a new dosage or method of administration or duration.²⁶²

"Adulteration" under the '38 Act was presented similar to "adulteration" under the '06 Act, i.e., "a food shall be deemed adulterated . . .,"²⁶³ "a drug shall be deemed adulterated. . . ."²⁶⁴ In a case involving the providing of samples of candy for analysis, the term "shall" was stated to be ". . . the language of command, a test significant though not controlling."²⁶⁵ However, the court differentiated when "shall" is used in the statute to guide the actions of the officials, i.e., it may be given a "merely directory meaning."²⁶⁶ The term "deemed" was held to "create an irrebuttable presumption, a rule of substantive law . . ."²⁶⁷

The '38 Act expanded adulteration for food to include poisonous articles or deleterious substances that were not added to the food.²⁶⁸ However, a deleterious substance that was not added could be exempted from causing adulteration if the amount did not render the food injurious to health.²⁶⁹ If an article was dangerous or injurious to health, the right of the government to deem an article adulterated superseded the right of an individual to use that article.²⁷⁰

Under the '38 Act, misbranding of foods was expanded to include foods "for special dietary uses."²⁷¹ In 1941, the FDA issued regulations setting forth uses of foods that would classify them as special dietary uses.²⁷²

Of particular note is the third use,

"(3) Uses for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property."²⁷³

In the same Federal Register, findings of fact and regulations relating to label statements for foods to be used for special dietary uses were issued.²⁷⁴ Based on the finding of fact, it was...