§2.2 Adulteration and Misbranding Under 1906 Act
| Jurisdiction | United States |
| Publication year | 2022 |
§2.2 Adulteration and Misbranding Under 1906 Act
Following enactment of the '06 Act, judicial decisions set the metes and bounds of the '06 Act, and in response legislators revisited the Act to either extend or compress the boundaries.
Courts reviewed the purpose of the '06 Act to determine how to construe it. As on purpose was the promotion of public health, the rule of strict construction was held not to apply.55 Other stated purposes included securing the purity of food and drugs, informing purchasers of what they were buying,56 and preventing injury to the consumer.57 In view of the purposes of the '06 Act, liberal construction was applied by the courts; for example, to extend the list of ingredients that could adulterate confectionery.58
The Supreme Court took a view of the purposes of the '06 Act in discussing its constitutionality. In Hipolite Egg Company v. United States, the Supreme Court addressed the question of whether the jurisdiction of the '06 Act extended to eggs, which were already within the physical jurisdiction of a state.59 The court understood Congress had the power to stop the interstate transportation of adulterated food and drugs under the commerce clause of the Constitution.60 However, in order to achieve the purposes of the '06 Act, Congress' power needed to be extended beyond merely stopping the physical interstate movement of adulterated articles. Achieving these purposes involved preventing a trade in adulterated articles between the States.61 To completely achieve the purpose, the court held the seizure of adulterated articles within a state to be within Congress' power to regulate interstate commerce under the Constitution,62 so long as the articles were in unbroken packages. But the extension of Congress' power did not invalidate States' food and drug laws.63
The intent of Congress in the '06 Act was continually adjudicated post-enactment. However, courts varied on what the intent may have been; compare an Eighth Circuit Court ruling,
"The act of Congress was not enacted to catch and punish merchants who are conducting their business by customary . . . methods with no intent to deceive purchasers . . ."64
with a district court ruling,
"[The] Food and Drugs Act . . . does not make the knowledge or intent of shipper an essential element of the offense."65
Under the '06 Act, to "deem" an article adulterated first required classifying the article as either a "drug" or a "food."66
To be a "drug" under the act, the use or intended use of an article must have been known. Mineral water was held to be a drug based on its labeling that possessed the statement "Recommend in the treatment of Bright's disease . . ." the word "recommend" showing its intended use.67 Labels touting the benefits of an article with regard to improving health could be evidence of its intent for use as a drug.68 A vaporous substance was also held to be a drug for its indicated use for head colds.69
Regarding "food," wine was held to be a food.70 Articles could also be classified as foods and medicines simultaneously.71 Classification of an article led to the circumstances when an article was deemed adulterated. In a case involving an article labeled "flavor of vanilla." "Adulteration" was defined as ". . . means to corrupt, debase, or make impure by an admixture of a foreign or a baser substance."72 The court differentiated between the terms "extract" and "flavor[ing]"73 in holding that the flavoring of an ingredient is not an adulteration of the extract of the ingredient.74 Under the '06 Act, adulteration occurred when the article was made less than what it normally should have been, i.e., economic adulteration. Adding a substance to improve the article was not considered an adulteration.75 In the case of food, even if an ingredient was not added, the food may be adulterated.76 But adulteration may not have occurred if an added ingredient was not deleterious to health (regarding confectioneries).77
The Supreme Court adjudicated the affect an ingredient can have on an article to render it adulterated. In United States v. Lexington Mill and Elevator Company,78 flour had been treated with a chemical process called the "Alsop Process" and, as a result, contained added ingredients such as nitrites, nitrogen peroxide, nitrous acid, and nitric acid. The charge of libel for adulteration and misbranding was upheld at the lower court, and had been overturned at the Court of Appeals. The Supreme Court, giving significance to the wording of the statute, pointed out that adulteration occurs "if it contain[s] any added poisonous or other added deleterious ingredient which may render such article injurious to health."79 The court noted the previous decision did not give attention to the statement ". . . which may render such article injurious to health." In holding the flour adulterated, the court found the ingredient might render the flour injurious to health. "The word 'may' is here used in its ordinary and usual signification, there being nothing to show the intention of Congress to affix to it any other meaning."80
Thus, as the flour may be consumed by all walks of society ". . . the strong and the weak, the old and the young, the well and the sick," because there is a possibility that any one of these consumers could be injured by consuming the flour containing the ingredients that is not appropriate for him, it is banned by the statute as adulterated.81
As technology in the field of foods developed, companies created new articles based on entirely new formulas. The Supreme Court addressed the issue of adulteration for an article developed from a new formula in United States v. Coca Cola Company of Atlanta.82 The formula was for a syrup used as a base for soft drinks. The syrup contained sugar, water, caffeine, glycerine, lime juice, and other flavorings.83 The addition of caffeine brought a charge of adulteration by the Government as the caffeine was alleged to be ". . . an added poisonous or deleterious ingredient . . .," which ". . . might render the product injurious to health . . .".84 The Coca Cola company contended that as the formula did not have a standard, the formula itself was the standard and therefore the caffeine was not an added ingredient but rather a usual and normal constituent of the formula.85 Therefore, the formula was outside the definition of an adulterated food.
The court, in holding that caffeine adulterated the formula, construed the statutory meaning of "article" and decided the formula was the "article" under statute.86 The various constituents were combined together to make the formula, i.e., they were "added" together to make the formula. As an "added" poison or deleterious substance can adulterate a food under the '06 Act, an adulteration occurred in this case because the formula included the ingredient caffeine, which might render the article injurious to health.87
In another case, a new strawberry-based product was held not adulterated as being "inferior" or "damaged" simply because it was different from the original product.88 The determination of a product being "inferior" was an issue of fact to be decided by a jury or a judge when no jury is present.89 As new ingredients, such as preservatives, were developed, issues regarding the effects were questions of fact for a jury because the health effects of the new ingredients were not immediately known.90 Regardless of the health effects, a legislature could condemn articles containing a new ingredient as adulterated.91
The '06 Act listed several ingredients that, if present in any amount, constituted adulteration. "Talc" included in confectionery was on such ingredient;92 the phrase ". . . or other mineral substance . . ." for adulteration of confectioneries was deemed to include substances similar to the substances listed before the phrase.93 Some manufacturers attempted to make arguments against adulteration based on the business customs of their field, to no avail.94
As the possibility of injury to health was one requirement for the adulteration of food, a product with an extensive sales history could create the assumption of the product not being deleterious or injurious.95
The 1929 Report of the Food, Drug, and Insecticide Administration contained an assessment of Drug and Drugs Products in the United States. Among accusations were manufacturers "flooding" the market with products for the influenza outbreak of 1928, seizure of articles the Administration deemed misbranded, malaria remedies possessing insufficient quantity of active ingredient, and the public's growing interest in vitamins and manufacturers' attempts to "exploit" that interest, for example, by selling "cod-liver-oil extract."96
The McNary-Mapes Act of 1930 amended the '06 Act by authorizing the Secretary of Agriculture to set regulations for canned food.97 Regulations were not meant to operate in a vacuum, but rather in view of the '06 Act. Regulations that were unreasonable and inconsistent with the law were deemed illegal and unenforceable.98 The '06 Act also addressed the act of misbranding of food and drugs.99 In United States v. Johnson, a shipper was indicted for shipping a medicine bearing labels with the title "Dr. Johnson's Mild Combination Treatment for Cancer," and possessing other statements as to its efficacy.100 The Supreme Court faced the question of whether the statements were misleading, as required in Section 8 of the '06 Act, to qualify as misbranded. In construing the language of the Act, the Court relied upon an idiomatic standard "...
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