Friday, January 11, 2019

FDCA preempts arguments that structure/function claims in fact mislead about disease prevention

Dachauer v. NBTY, Inc., --- F.3d ----, 2019 WL 150016, No. 17-16242 (9th Cir. Jan. 10, 2019)

Defendants make vitamin E supplements that claim, on their labels, to “support cardiovascular health” and to “promote[ ] immune function,” “immune health,” “heart health,” and “circulatory health.” Dachauer alleged false advertising, because the supplements do not prevent cardiovascular disease and might increase the risk of all-cause mortality. The district court granted summary judgment, and the court of appeals affirmed, mostly on the alternate ground of preemption.

The FDCA distinguishes between “disease claims” and “structure/function claims” for dietary supplements. A structure/function claim “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” or “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function,” but “may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.” A disease claim, conversely, “claims to diagnose, mitigate, treat, cure, or prevent disease,” either explicitly or implicitly. To make a structure/function claim, the manufacturer must have substantiation that the statement is truthful and not misleading; the statement must contain a prominent disclaimer that the FDA hasn’t evaluated the statement and that the product “is not intended to diagnose, treat, cure, or prevent any disease”; and the statement must not itself “claim to diagnose, mitigate, treat, cure, or prevent” disease.

The FDA’s guidance states that structure/function claims may use general terms such as “strengthen,” “improve,” and “protect,” as long as the claims “do not suggest disease prevention or treatment.” It holds that, for example, “supports the immune system” doesn’t imply disease prevention, even though by any ordinary rules of communication it does.  The FDA further allows substantiation of structure/function claims with evidence of an effect on a small aspect of the relevant structure/function, rather than with evidence of an effect on the main disease that consumers associate with that structure or function.  [A concise explanation of the extremely underregulated features of supplement law, as compared to other fields.]

California law doesn’t allow private plaintiffs to demand substantiation for advertising claims. The private plaintiff bears the burden of producing evidence to prove that the challenged statement is false or misleading.  [Though of course it could be false or misleading by explicitly or implicitly claiming to have substantiation that doesn’t exist.]

The FDCA expressly preempts any state law that establishes “any 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 FDCA requirements such as those for structure/function claims. The argument that defendants’ structure/function claims were false because the supplements don’t prevent cardiovascular disease were thus preempted.

There was “ample” evidence that vitamin E supplements, taken in the doses that defendants sell, fail to prevent cardiovascular disease. Plaintiff’s expert argued that “no metric except the absence or presence of cardiovascular disease can measure heart health,” but this was a rejection of the two separate FDCA categories and thus not an acceptable conclusion because it would impose a non-identical requirement on supplements that claim to promote heart health.  [I think this is the right result under the law, which highlights that the current law has nothing to do with truth or truthful communication.  One could have a regime that allowed more specific claims—taking supplements with this ingredient is associated with improved indicator X, which itself may be associated with a lower risk of heart disease—but that’s not the system we have, which allows the manufacturer to skip all the qualifications and inherently imply broad-based efficacy by using the approved structure/function formulation.] The same was true for defendants’ claim that their supplements promote immune health, even if the supplements fail to reduce all-cause mortality.

However, the misleadingness claim based on the argument that the supplements increase the risk of all-cause mortality was not preempted. FDCA regulations say that a 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” under normal conditions of use or the conditions of use that the label prescribes. “In other words, if a supplement’s label recommends taking one capsule per day, and that dose actually causes an increased risk of death—a material fact ‘with respect to consequences which may result from use of the article’—the FDCA would deem it misleading not to reveal that fact on the label.”  That would also violate California law. However, the record lacked evidence that vitamin E supplements were actually harmful, as opposed to simply useless at reducing all-cause mortality (which they do not claim to reduce). At best, the record showed a “small” correlation between high-dose vitamin E supplements and an increased risk of all-cause mortality. The meta-analyses showing this correlation didn’t conclude that vitamin E supplements caused an increased risk of all-cause mortality. That wasn’ enough to create a genuine issue of material fact.

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