Biotin Supplement Suit Dismissed on Preemption Grounds
A California federal judge tossed a proposed class action against allegedly “worthless” biotin dietary supplements on preemption grounds earlier this week, citing the Ninth Circuit’s recent decision in Dachauer v. NBTY, Inc., 913 F.2d 844 (9th Cir. 2019).
In Greenberg v. Target Corp., et al., the plaintiff filed a putative class action alleging that labeling for Target’s Up & Up brand of biotin dietary supplements was misleading under California’s Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA).
The at-issue supplement’s only active ingredient was biotin, a “nutrient that plays a cellular and biochemical role in the support of healthy hair, skin, nails, and energy.” The plaintiff purchased the supplement “with the hope that it would help with his [unspecified] disease” that caused hair loss “by fostering hair growth” and would receive “the benefits that were advertised on the label.” The supplement’s label stated it would “help[ed] support healthy hair and skin,” with asterisks directing readers to a disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Weeks later, a friend told the plaintiff the supplement did not provide any benefits.
The plaintiff filed suit in the United States District Court for the Northern District of California and moved for class certification. The defendants moved for summary judgment on the theory that the Food, Drug, and Cosmetics Act (FDCA) preempted the plaintiff’s claims. The court granted the defendants’ summary judgment motion, holding that the plaintiff’s claims were preempted by the FDCA in light of the Ninth Circuit’s recent decision in Dachauer, which held that section 343(r)(1) of the FDCA preempts state law requirements for claims about dietary supplements that differ from the federal requirements.
Structure/Function Claims versus Disease Claims
A quick lesson on the FDCA is necessary to understand the court’s holding. The FDCA distinguishes between “disease claims” and “structure/function claims” in dietary supplement labels. “Disease claims” are claims that the supplement may be used “to diagnose, mitigate, treat, cure, or prevent disease.” “Structure/function claims” are those in a label that “[describe] the role of a nutrient or dietary ingredient to affect the structure or function in humans” or “characterizes the documented mechanisms by which a nutrient or dietary ingredient acts to maintain such structure or function.”
“Structure/function claims” – like those made by the biotin dietary supplement’s label – must meet three requirements under the FDCA: (1) the manufacturer must substantiate the statement’s truthfulness; (2) the statement must contain a prominent disclaimer that FDA has not evaluated the statement in the label; and (3) the statement must not “claim to diagnose, mitigate, treat, cure, or prevent” disease.
Application of Dachauer Results in Preemption
In Dachauer, the plaintiff alleged that a vitamin E supplement’s label was misleading under California’s UCL and CLRA. The Ninth Circuit held these claims were preempted because the plaintiff sought to support his allegation that the manufacturer’s “structure/function claims” were false with evidence regarding the supplement’s inability to treat or prevent disease – i.e., the standard applied for “disease claims.” This “mismatch” was the death knell for the plaintiff’s claims.
Considering the Dachauer holding, the Northern District of California noted that a finite amount of biotin is required for normal bodily functions, usually achieved through the average person’s daily diet. Any remainder of biotin above that amount becomes functionally superfluous and conveys no additional health benefits. The plaintiff alleged that the biotin dietary supplement’s “structure/function claims” were misleading “based on evidence that any form of supplemental biotin is superfluous for the general public.” Acknowledging that “Dachauer’s fact pattern [was] not identical” because “[there was] no . . . mismatch here,” the court nevertheless held that the plaintiff’s claims were preempted under “Dachauer’s ultimate holding that a plaintiff’s claims are preempted where he seeks to support his allegations that a manufacturer’s structure/function claims are false with evidence that is not required for substantiation of a structure/function claim under” the FDCA. Here, because the evidence the plaintiff relied on – the “superfluous effect that supplemental biotin has on the general population” – is not required to state a valid “structure/function claim” under the federal regulations, his claims were preempted.In dismissing the plaintiff’s case without prejudice, the court acknowledged that the plaintiff did “plausibly suggest that the drawing of . . . a distinction between biotin function and its supplement’s superfluous impact on the general population likely tricks many consumers” into thinking that the product “will reduce the likelihood of poor hair and skin.” Nevertheless, “this is a form of puffery the statute and regulations allow.”