The crusade against misleading labels: are manufacturers the protectors of consumer interests?

Author:Pezzullo, Andrea M.

"Misbranding was one of the chief evils Congress sought to stop." (1)


    From television commercials and magazine ads to labels and packaging, food and beverage manufacturers spend a significant amount of money advertising their products. (2) Congress passed the Food, Drug, and Cosmetic Act (FDcA) to ensure that food and beverage manufacturers do not mislead or deceive consumers with their advertising. (3) The FDCA's purpose is to protect consumers from adulterated and misbranded food and beverages. (4) The FDCA prohibited misbranding food and beverages using false or misleading labels to further this goal. (5)

    In 1990, Congress amended the FDCA by enacting the Nutrition Labeling and Education Act (NLEA). (6) Before the NLEA, each state passed its own labeling requirements for food and beverage manufacturers, as states saw fit. (7) Recognizing the need for uniformity in the marketplace and the reduction of compliance costs for food and beverage manufacturers, Congress enacted the first national labeling law. (8) To achieve these objectives, Congress included a preemption provision in the NLEA, which prohibited states from enacting label laws that are not identical to the federal requirements. (9) This provision gave the federal government, specifically the Food and Drug Administration (FDA), the exclusive authority to regulate food and beverage labels. (10)

    Congress also created an avenue for manufacturers to seek redress for competitors' false and misleading advertising by way of the Lanham Act. (11) This federal statute allows a competitor to assert a claim against another competitor alleging that the opponent falsely advertised their product, and the false advertising harmed their business. (12) While the Lanham Act does not allow individual consumers to bring claims, it theoretically protects their interests when a manufacturer makes a false advertising claim. (13)

    In POM Wonderful LLC v. Coca-Cola, Co}4 (POM), the Supreme Court determined whether compliance with FDCA label regulations precluded Lanham Act claims premised on allegations of false and misleading labeling. (15) While the FDCA prohibits states from enacting its own labeling requirements, the Court had to determine whether the FDCA barred federal claims alleging misleading labeling. (16) Overturning the Ninth Circuit, the Court held the FDCA does not preclude claims brought under the Lanham Act because the two federal statutes are complementary. (17) The Court reasoned that despite the Lanham Act and the FDCA serving different purposes, the claims brought under the Lanham Act help to better protect the public's interests. (18) In so holding, the Court is entrusting manufacturers to protect consumers' interests indirectly. (19)

    This Note begins with an outline of the history of federal food regulation in the United States. (20) It discusses the FDCA's origin and purpose and its subsequent amendment, the NLEA. (21) This Note will then discuss the NLEA's preemption provision and its interplay with private litigation brought under state consumer protection laws. (22) It will also examine the FDCA's interaction with private litigation brought under the Lanham Act. (23) The discussion then moves to the Supreme Court's decision in POM. (24) This Note will proffer that the Court's conclusion that the Lanham Act is a necessary complement to the FDCA reveals major gaps in the FDA's enforcement of the FDCA. (25) This Note will then examine the reasons for the FDA's sporadic enforcement of the FDCA. (26) Contrary to the Court's reasoning in POM, this Note will argue the Lanham Act is not a suitable complement to resolve the FDCA enforcement issues because manufacturers do not bring these suits to advocate for consumer protection, but rather to self-serve their own commercial interests. (27) Accordingly, this Note will offer an alternate solution aimed at protecting consumer interests, namely, consumer-initiated suits to enforce label regulations, brought under state consumer protection laws. (28)


    Prior to 1906, states were the sole regulators of food and beverage manufacturers. (29) States enacted food and beverage statutes, which focused primarily on trade and protecting consumers from adulterated food. (30) During this time, the federal government did not enact any national food and beverage laws, leaving states to promulgate regulations tailored to its individual needs. (31) As the economy transitioned from an agricultural economy to an industrial economy, however, food production also industrialized to meet the demands of the growing urban population. (32) With expanded interstate commerce, the United States recognized the need for a national food law. (33)

    1. The Pure Food and Drug Act of 1906

      Due to the lack of federal laws regulating industrial food manufacturers, there were unsanitary conditions and uncontrolled uses of toxic coloring and chemical preservatives. (34) Because most states' food laws focused primarily on adulterated food, there were no regulations aimed at preventing food misbranding. (35) Recognizing the need for such regulation, Dr. Harvey Wiley, the head of the Department of Chemistry within the Department of Agriculture, campaigned for a federal pure food bill to prohibit both adulterated and misbranded food, beverages, and drugs. (36) Around the same time as Dr. Wiley's crusade, Upton Sinclair published The Jungle, a novel depicting the unsanitary and revolting conditions in a meat-packing plant. (37) The need for federal regulation of the food and beverage industry received national attention, further pushing Congress to pass a federal food bill. (38) On June 30, 1906, Congress signed the Pure Food and Drug Act (Wiley's Act) into law. (39)

      Wiley's Act prohibited manufacturing and shipping adulterated or misbranded foods in interstate commerce. (40) Congress enacted the legislation to prevent injury to consumers resulting from false and misleading statements on food, beverages, and drugs. (41) While Wiley's Act was a significant step for consumer protection from misbranded foods and beverages, it had flaws. (42) Most notably, Wiley's Act lacked specific guidelines for compliance. (43) Also, it was difficult for the government to prosecute claims of fraud against manufacturers who violated Wiley's Act by misbranding their products. (44)

    2. The Food, Drug, and Cosmetic Act of 1938

      Recognizing the shortcomings of Wiley's Act, Congress amended it several times. (45) Congress soon recognized, however, the necessity of creating an entirely new act. (46) Headed by Rexford Guy Tugwell, the Assistant Secretary of Agriculture in 1933, the FDA drafted a new bill. (47)

      The industry strongly opposed the initial draft (dubbed "Tugwell's Bill") as too harsh, and consumer advocacy organizations scantly praised it. (48) There were numerous successors to this initial draft, and the FDA created many amendments to compete with rival bills from trade associations. (49) Finally, after a five-year legislative battle, Congress passed the FDCA in 1938, replacing Wiley's Act. (50)

      The FDCA's purpose is to protect consumers from adulterated and misbranded food, drugs, and beverages. (51) Congress enacted the FDCA with the intent of protecting the public's livelihood and health because modern industrialization made it difficult for the public to protect themselves. (52) To serve this purpose, the FDCA sets forth regulations to "promote honesty and fair dealing in the interest of consumers" by protecting consumers from false and misleading statements made on food labels. (53)

    3. Misbranding Under the FDCA

      Eradicating false and misleading labels was one of Congress's top priorities. (54) To this end, the FDCA prohibits misbranding food, drugs, devices, tobacco products, and cosmetics. (55) To clarify what constitutes a misleading label, the FDCA defines a label as the written, printed, or graphic materials on a product's container. (56) In determining whether a label is misleading--and thus if food is misbranded--the FDCA considers the representations made or suggested by statements, words, designs, or devices and the degree to which the label fails to disclose material facts. (57) To implement these FDCA provisions, Congress vested the FDA with authority to enforce these requirements. (58) The FDA then promulgated many label regulations under its duty to enforce. (59)

    4. The Nutrition Labeling and Education Act of 1990

      Since the FDCA's enactment in 1938, there were numerous scientific and research advancements relating to the role of diet in health and disease prevention. (60) Food manufacturers began using this progression to their economic advantage by labeling their food and beverages with misleading and false health claims. (61) Recognizing the need to protect consumers from these misleading dietary and health claims, Congress amended the FDCA with the enactment of the NLEA. (62) With the NLEA, Congress sought to strengthen the FDA's authority to require nutrition labeling and set forth requirements for nutrient claims on labels. (63) The NLEA required detailed nutrition labels on all food and beverages, standardized the definitions of nutrient content claims, altered the requirements for packages' ingredient labels, created uniform serving sizes for labels, and limited the types of health claims manufacturers could make. (64)

      In addition to streamlining and reforming the nutritional labeling requirements, the NLEA added an express preemption provision to the FDCA. (65) Prior to the NLEA's enactment, each state had its own different labeling laws, which made compliance costly and difficult for manufacturers. (66) As a result, the food and beverage industry strongly lobbied for a federal food labeling law that would apply nationally and preempt all state labeling laws. (67)

    5. The FDCA and Preemption

      1. Preemption Generally

        Preemption is a doctrine established in the Supremacy Clause of the Constitution, which provides...

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