There is no denying that, at times, the express claims made on dietary supplement labels may seem to convey a broader implied claim to the consumer regarding the supplement’s performance benefits. While that may be true, last month the Ninth Circuit confirmed that plaintiffs cannot successfully allege that a lawful “structure/function” claim misleadingly implies that a dietary supplement will treat, cure, or prevent a disease under state law. In so deciding, the court found that Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) expressly permits dietary supplements to make claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body (i.e., structure/function); and that Section 403A(a)(5) of the FDCA expressly preempts any California law that would differ from the FDCA’s allowance for structure/function claims.
While perhaps not surprising that the court reached this conclusion, a recent Ninth Circuit opinion is worth noting because it is the first time that the court has issued an opinion expressly confirming that lawful structure/function claims will have coverage against California’s strong consumer protection laws. We caution, however, that dietary supplement manufacturers may still face liability under state law if they fail to disclose material information about their products, including its safety profile.
The plaintiff alleged that the defendant’s Vitamin E supplement claims to “support cardiovascular health” and “promote[ ] immune function” were false and misleading in violation of California law because the Vitamin E supplements (1) did not prevent “cardiovascular disease” and (2) might increase the risk of all-cause mortality. The Ninth Circuit disagreed and affirmed the district court’s grant of summary judgment in favor of the defendant.
In evaluating the plaintiff’s claim that the defendant misleadingly advertised its Vitamin E supplement as preventing cardiovascular disease based on the product’s claims to “support cardiovascular health,” “heart health,” and “circulatory health,” the Ninth Circuit went back to basics to discuss the critical distinction in the FDCA between “structure/function claims” and “disease claims.” The former are expressly permitted for dietary supplements under Section 403(r)(6) of the FDCA, while the latter class of disease claims (i.e., claims to diagnose, prevent, treat or cure a specific disease or class of diseases) cannot be lawfully made for dietary supplements—and would render the product an unapproved new drug. The court took note of FDA’s 2001 structure/function rule which identifies the phrase “helps maintain cardiovascular function and a healthy circulatory system” as a permissible structure/function claim.
The court turned next to the issue of federal preemption. Despite the plaintiff’s argument that it did not matter whether the defendant’s claims were structure/function claims or disease claims because such claims were allegedly false and misleading, the court explained “to the contrary, it matters very much.” Specifically, the FDCA expressly (1) allows for structure/function claims and (2) preempts any state law “requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title.” 21 U.S.C. § 343-1(a)(5). Accordingly, if the plaintiff were to successfully challenge a structure/function claim as an implied unlawful disease claim, doing so would undermine the FDCA’s clear distinction between structure/function and disease claims.
Applying the preemption provision to the defendant’s product claims, the court found the plaintiff’s claims concerning the Vitamin E supplement’s effects on cardiovascular health were preempted because he sought to “impose a requirement under California law that structure/function claims—at least those related to cardiovascular, circulatory, and heart health—made on a supplement’s label require proof that the supplement treats or prevents cardiovascular disease.” With regard to the “immune support” claims, however, the court did not preempt such allegations because the plaintiff’s claim turned on whether the defendant failed to disclose any material fact.
Specifically, the plaintiff challenged the Vitamin E supplement’s claim to “promote[ ] immune function” as false and misleading on the grounds that the defendant allegedly failed to disclose that Vitamin E may increase the risk of death. The Ninth Circuit noted that California’s labeling laws mirror the FDCA with respect to the provision that a food label “shall be deemed to be misleading if it fails to reveal facts” that are “[m]aterial with respect to consequences which may result from use of the article.” 21 C.F.R. § 1.21(a)(2). Because California’s law does not differ from federal law, the plaintiff’s state law claim was not preempted.
Reviewing the merits of the plaintiff’s allegation, however, the court found that the plaintiff did not provide sufficient evidence that vitamin E supplements are actually harmful. To that end, because the plaintiff failed to meet his burden to create a genuine issue of material fact as to whether the defendant’s immune-health structure/function claim was misleading, the Ninth Circuit dismissed the claim and affirmed summary judgment in favor of the defendant.
This decision provides important protection to dietary supplement manufacturers making structure/function claims. How much the ruling deters the plaintiffs’ bar remains to be seen.