We have taken a daily multivitamin ever since our doctor told us that we were chronically deficient in a particular vitamin, the one you can get from being out in the sun. Given our chosen line of work, we should not be surprised that we don’t get enough sunlight. We should also not be surprised that dietary supplements—such as our daily chewable multivites—generate substantial litigation, usually based on the premise that the supplements don’t do what their sellers say they are supposed to do.
Plaintiffs often file these kinds of lawsuits in California because of California’s liberal consumer protection laws, but many of them find out that the FDA regulates dietary supplements as food. Regular readers of the blog can see where this is headed.
That’s right. Federal preemption.
Take for example the Ninth Circuit’s recent opinion in Dachauer v. NBTY, Inc., No. 17-16242, 2019 WL 150016 (9th Cir. Jan. 10, 2019). In that case, the plaintiff purchased vitamin E supplements that claimed on their labels to “support cardiovascular health” and to “promote[ ] immune function.” Id. at *1. The court noted that the plaintiff “purchased one bottle of the supplements for health reasons.” Id. We think it is more likely that the plaintiff’s attorneys had an expert who questioned the value of vitamin E supplements and sent the plaintiff to buy his “one bottle” for litigation reasons, rather than “health reasons.” But we don’t really know and are probably just being cynical.
Regardless, the plaintiff sued under California’s consumer statutes alleging that the supplements do not present cardiovascular disease and might increase the risk of all-cause mortality, rather than promote “immune function.” Id.
Here is where the FDA’s regulation of dietary supplements comes into play, and there are only two things you really need to know. First, the FDCA has an express preemption provision for certain food labeling claims, under which federal law preempts any state law that establishes “any requirement respecting any claim . . . made in the label or labeling of food that is not identical to [federal requirements].” Id. at *3 (citing 21 U.S.C. § 343-1(a)(5)). This is a strong preemption provision, and the “identical to” language is arguably even stronger than the “different from or in addition to” language that we are used to in the medical device context.”
Second, when it comes to dietary supplement labeling, the FDCA distinguishes between “disease claims” and “structure/function claims.” A “structure/function claim” describes the role of a nutrient or ingredient intended to maintain the structure or function of the body. By comparison, a “disease claim” claims to diagnose, mitigate, treat, cure, or prevent disease.” Id. at *2. An FDA guidance provides that structure/function claims can use general terms, such as “strengthen,” “improve,” and “protect,” so long as the claims “do not suggest disease prevention or treatment.” Id. (quoting Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 65 Fed. Reg. 1000-01 (Jan. 6, 2000)). Apropos to this case, the guidance identifies “helps maintain cardiovascular function” as an example of a permissible structure/function claim. Id.
Having made labeling claims that are quite clearly permissible structure/function claims, the defendant moved for summary judgment on the basis that the plaintiff’s claims were preempted. In other words, the plaintiff was asserting that state law required labeling different from the federally approved labeling. The district court granted summary judgment, and the Ninth Circuit affirmed. With regard to the labeling claim that the supplement “support[ed] cardiovascular health,” the plaintiff had an expert who disagreed, but the federal requirement was what it was, and the plaintiff’s expert could not just erase it:
The FDA allows manufacturers of supplements to make general claims—such as “promotes heart health”—and to substantiate them with evidence that a supplement has some structural or functional effect on a given part of the human body. Manufacturers need not also have evidence that those structural or functional effects reduce the risk of developing a certain disease. Plaintiff disagrees with the federal statutory scheme for dietary supplements, but we cannot accept his invitation to upend it.
Id. at *3 (emphasis added, citations omitted). The Ninth Circuit came to a similar conclusion with regard to the plaintiff’s arguments targeting the “promoted immune function” claims. The FDCA does not require that manufacturers substantiate structure/function claims about immune health with proof that their supplements reduce the risk of all-cause mortality. Thus, “[b]ecause any such requirement under California law would differ from the FDCA’s labeling requirements, the FDCA preempts Plaintiff’s claim to the extent that he argues that Defendants make a false structure/function claim because their supplements fail to reduce the risk of all-cause mortality.” Id. at *4.
The only claim that survived was the plaintiff’s claim that the defendant’s structure/function claim about immune health was misleading because the supplements actually increase the risk of all-cause mortality. Because that claim would be misleading under either federal or state law, it was not expressly preempted. Id. The plaintiff, however, did not submit evidence sufficient to raise a triable issue of fact. His expert cited four meta-analyses, but none concluded that vitamin E supplements caused an increased risk. Id. With no substantial evidence that the defendant’s “promoted immune function” claim was misleading, the plaintiff was not entitled to proceed. Summary judgment affirmed.
The Dachauer opinion comes to the right result for the right reasons. For our part, we will continue to take our daily multivitamin with modest expectations, and maybe we will try to get out into the sun more often.