In the recent case of Gallagher v. Bayer AG, Case No. 14-cv-04601-WHO (N.D. Cal. March 10, 2015), the plaintiffs asserted that the defendants Bayer AG and related entities (collectively, “Bayer”) engaged in false advertising under California, New York, and Florida law. The products in question were 20 varieties of One-A-Day vitamins that each included advertising on their labels stating that they supported “heart health,” “immunity” and “physical energy.” On behalf of a putative class of purchasers, the plaintiffs alleged that the statements were false, misleading, and constituted illegal advertising under state law based on the regulations of the Food & Drug Administration (the “FDA”). Bayer moved to dismiss the complaint on multiple grounds, including the argument that the claims satisfied federal law, thereby preempting the plaintiffs’ state law claims.
To understand Bayer’s preemption argument, some context is necessary. The FDA, through the Federal Food, Drug, and Cosmetic Act (“FDCA”), is empowered to regulate the labeling of foods and drugs. The FDCA expressly preempts state laws that purport to impose “more or inconsistent burdens on manufacturers than the burdens imposed by the FDCA.” Bayer, p. 6. Thus, a manufacturer that complies with the FDCA’s labeling requirements need not also comply with different labeling requirements established by 50 different states.
The other relevant statute to this case, the Dietary Supplement Health and Education Act (“DSHEA”), defines the rules regarding advertising and labeling for dietary supplements. DSHEA, generally, defines two types of advertising claims: “disease” claims and “structure/function” claims. “Disease” claims are “express or implied claims ‘to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.’” Bayer, p. 6. “Structure/function” claims, on the other hand, may “…describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, [and/or] characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.” Bayer, pp. 5-6. Importantly, while a supplement manufacturer must receive pre-approval from the FDA before making any “disease” claims in its advertising, a “structure/function” claim only requires that the manufacturer make appropriate disclosures and submit the claim to the FDA within 30 days of its first appearance. Bayer, p. 6 n. 2.
In this case, the plaintiffs argued that Bayer’s advertising of “heart health” and support for “immunity” were unapproved “disease” claims (the plaintiffs conceded that the statement “supports physical energy” was a structure/function claim). Thus, if these claims were, in fact, “disease” claims that had not been preapproved by the FDA, then Bayer could be liable for unlawful advertising practices.
In addressing Bayer’s motion to dismiss, the Court first found that the express preemption language of the FDCA applied equally to the supplement advertising rules set forth under DSHEA. Bayer, pp. 7-8. The Court reasoned that, because DSHEA gives the FDA authority to regulate the labeling of supplements, the language of the FDCA must apply to the regulations of DSHEA such that no state may impose burdens that “exceed or contradict the labeling requirements” of the DSHEA. Bayer, pp. 8-9. Thus, if Bayer’s advertising claims were permissible under DSHEA, then they could not be illegal under state law.
The Court then evaluated whether the alleged advertisements were “disease” or “structure/function” claims. With respect to the “supports heart health” claim, the Court relied on guidance and regulations from the FDA that found that similar advertisements (like “helps maintain cardiovascular function”) were structure/function claims. Bayer, pp. 9-10. For the “supports immunity” claim, again, the Court relied on FDA guidance to note that similar claims (like “supports the immune system”) had been determined to be structure/function claims. Bayer, p. 11. Thus, because Bayer’s advertising consisted of structure/function claims, the express preemption of the FDCA prevented the plaintiffs from using state law to impose liability against Bayer for making illegal “disease” claims. The plaintiffs were given leave to amend, however, to allege “by virtue of specifically identified packaging or marketing” that Bayer was actually linking these advertisements to the prevention or treatment of disease. Bayer, p. 11.
Simply proving that the FDCA and DSHEA preempted the plaintiffs’ attempts to impose liability under state law was only half the battle. Indeed, under both state law and DSHEA, advertisements may not be false or deceptive, so state laws requiring truthful advertising of supplements are not preempted. Bayer, p. 9. Thus, as an alternative theory, the plaintiffs argued that the statements “supports heart health,” “supports immunity,” and “supports physical energy” were false and misleading even if they were not illegal “disease” claims. Bayer, pp. 12-13.
The Court found that the plaintiffs’ complaint failed to adequately allege the falsity of the “heart health” and “immunity” claims. The Court noted that the complaint cited numerous studies attempting to show that the ingredients in Bayer’s products did not treat or prevent heart disease or provide immunity from disease. Bayer, p. 13. Those studies, however, would only disprove the advertising if the advertising consisted of “disease” claims. Bayer, p. 13. Since, under preemption, the “heart health” and “immunity” claims were permissible structure/function claims, the plaintiffs “are limited to alleging that Bayer’s statements that its Supplements ‘support’ or help heart health and immunity are false.” Bayer, p. 13. As the complaint’s allegations did not disprove the structure/function claims, the claims based on the “heart health” and “immunity” statements were dismissed with leave to amend. Bayer, p. 14.
The Court reached a different result with respect to the “supports physical energy” advertisement. The complaint alleged that scientific evidence “confirms that the vitamins Bayer asserts help support immunity do ‘not affect the energy levels of typical Americans.’” Bayer, p. 14. Although Bayer attempted to argue that the studies were only inconclusive, the Court found that, on a motion to dismiss, the record was too undeveloped to dismiss the claims as a matter of law and, therefore, claims based on the advertisement of supporting “physical energy” were allowed to proceed. Bayer, p. 14.
The Bayer decision shows the interplay between federal regulations governing supplement advertisements and state laws addressing false advertising. In finding that the FDCA’s preemption provisions apply to DSHEA, the Court suggests that, if the advertising adheres to federal law, then a defendant can limit its liability for “illegal” advertising under state law. That being said, no amount of preemption will allow supplement manufacturers to use false statements to advertise their products: regardless of whether it is a “structure/function” claim or a “disease” claim, the advertising must not be misleading. However, as demonstrated by the Bayer decision, the distinction between these kinds of claims is still relevant because it defines what evidence would be required to prove their falsity, greatly magnifying the importance of finding FDA guidance and regulations regarding advertisements that are similar to the claims at issue.