Tomorrow is Another One-A-Day: FDA Guidelines Preempt Vitamin Claims, but Consumer Class Still Has Opportunity to Supplement
Although consumer class actions in California are dime-a-dozen, a recent Northern District of California case involving One A Day vitamins stands out because it demonstrates how federal regulations can preempt certain state law claims regarding the health benefits of dietary supplements.
The putative class alleged that three statements made by Bayer on their One A Day multivitamin labels—that the vitamins promote or support “heart health,” “immunity” and “physical energy”—falsely and deceptively misrepresent the health benefits of the supplements in violation of state laws. Bayer moved to dismiss, arguing that the three statements are “structure/function” claims that are explicitly approved by regulations promulgated under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Dietary Supplement Health and Education Act (DSHEA) and, consequently, plaintiffs’ allegations are preempted by federal law.
FDA guidance defines a “structure/function” claim as one that “claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.”
The FDA distinguishes structure/function claims from “disease” claims, which are express or implied statements that claim “to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.”
FDA guidance has explicitly characterized particular statements – like “helps maintain cardiovascular function and a healthy circulatory system” – as permissible structure/function statements for supplements, rather than disease claims. So unless plaintiffs alleged that Bayer somehow used those particular statements outside of the permissible structure/function context to make a claim about treating a specific disease, plaintiffs’ claims regarding those statements would be preempted.
The court held that two of Bayer’s statements—“supports heart health” and “supports immunity”—were indeed structure/function claims under explicit FDA guidance. While FDA recognizes that a structure/function claim can become a disease claim if the statement location or use links it to treatment or prevention of a disease, plaintiffs failed to point to specific language on the product packaging, websites or advertising that would convert the structure/function claim to a disease claim. The court therefore granted Bayer’s motion to dismiss those claims, with leave to amend to allow plaintiffs a chance to plead facts that would move the structure/function claim to a disease claim.
Like a never-ending bottle of vitamins, that was not the end of the decision. While the third statement—“supports physical energy”—is also a structure/function claim, plaintiffs alleged it was false and misleading. Bayer countered that plaintiffs’ claim is based on a lack of substantiation theory, which has been rejected under the state consumer protection laws at issue in this case. Plaintiffs maintained that their claim was not a lack of substantiation claim because they provided a weight of scientific evidence going against the truth of the “supports physical energy” statement. Unable to weigh the evidence on a motion to dismiss, the allegation survived dismissal. The court also gave plaintiffs leave to further amend their claims regarding the “heart health” and “immunity” statements, giving them an opportunity to find a weight of scientific evidence going against the truth of these statements as well.
While plaintiffs have a second bite at the apple, so far in this case, federal regulations have served as a shield for supplement companies to use against state law liability, rather than a sword to be used against them.