Ninth Circuit Affirms Federal Preemption Over Dietary Supplement Claims

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...

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