PAUL DACHAUER, On Behalf of Himself and All Others Similarly Situated, Plaintiff-Appellant, v. NBTY, INC., a Delaware corporation; NATURE‘S BOUNTY, INC., a Delaware corporation, Defendants-Appellees.
No. 17-16242
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
January 10, 2019
Opinion by Judge Graber
D.C. No. 3:16-cv-00216-VC. Appeal from the United States District Court for the Northern District of California. Vince Chhabria, District Judge, Presiding. Argued and Submitted November 13, 2018 San Francisco, California. Before: Sidney R. Thomas, Chief Judge, Susan P. Graber, Circuit Judge, and Leslie E. Kobayashi, District Judge.
FOR PUBLICATION
Opinion by Judge Graber
*SUMMARY**
California Law / Federal Preemption
The panel affirmed the district court‘s summary judgment in favor of makers of vitamin E supplements in a plaintiff/consumer‘s action alleging that the labels on the supplements violated California laws against false advertising.
For dietary supplements, the Federal Food, Drug, and Cosmetic Act (“FDCA“) distinguishes between “disease claims” and “structure/function claims” that manufacturers make about their products. A structure/function claim describes the role of a dietary ingredient, but may not claim to mitigate a specific disease.
The panel held that
The panel held that the record lacked evidence that vitamin E supplements are actually harmful, as opposed to simply useless at reducing all-cause mortality (which they do not claim to reduce). The panel concluded that, on this record, plaintiff failed to meet his burden to create a genuine issue of material fact as to whether defendants’ immune-health
COUNSEL
Robert Andalman (argued) and Rachael Blackburn, A&G Law, LLC, Chicago, Illinois; William A. Delgado, Willenken Wilson Loh & Delgado LLP, Los Angeles, California; for Defendants-Appellees.
OPINION
GRABER, Circuit Judge:
Defendants NBTY, Inc., and Nature‘s Bounty, Inc., 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.”1 Plaintiff Paul Dachauer purchased one bottle of the supplements for health reasons. He claims that the labels’ statements violate two California laws against false advertising, because the supplements do not prevent cardiovascular disease and might increase the risk of all-cause mortality. The district court disagreed and granted Defendants’ motion for summary judgment. Reviewing de novo, and viewing the evidence in the light most favorable to Plaintiff, Albino v. Baca, 747 F.3d 1162, 1168 (9th Cir. 2014) (en banc), we affirm.
A. Relevant Statutes and Regulations
Plaintiff sued under California‘s Unfair Competition Law,
For dietary supplements, the FDCA distinguishes between “disease claims” and “structure/function claims” that manufacturers make about their products. 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.”
The FDA has published guidance in the Federal Register discussing, among other things, acceptable structure/function claims. 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). The guidance recognizes 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.” Id. at 1028. For example, the guidance identifies the phrase “helps maintain cardiovascular function and a healthy circulatory system” as a permissible structure/function claim. Id. at 1012; see also id. at 1029 (The “FDA does not agree that . . . ‘supports the immune system’ implies disease prevention.). The guidance further explains that manufacturers of supplements can substantiate structure/function claims with evidence of an effect on a small aspect of the related structure/function, rather than with evidence of an effect on the main disease that consumers might associate with a given bodily structure or function. See id. at 1012 (“For example, to substantiate the claim ‘supports mood,’ it is not necessary to study the effects of a substance on clinical depression. Instead, it is quite possible to assess the effects of a substance on mood changes that do not constitute clinical depression.“).
Although the FDCA requires manufacturers to have substantiation for their structure/function claims, California law does not allow private plaintiffs to demand substantiation for advertising claims. Nat‘l Council Against Health Fraud, Inc. v. King Bio Pharm., Inc., 133 Cal. Rptr. 2d 207, 213-14 (Ct. App. 2003). Instead, a private plaintiff bears the burden of producing evidence to prove that the challenged statement is false or misleading. Id.
B. Preemption
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 the requirement of section 343(r) of this title.”
The preemption provision governs claims “of the type described in section 343(r)(1).”
As applied here,
Plaintiff‘s expert witness, Edgar Miller, Ph.D., M.D., offered ample evidence that vitamin E supplements, taken in the doses that Defendants sell, fail to prevent cardiovascular disease. In Dr. Miller‘s view, no metric except the absence or presence of cardiovascular disease can measure heart health (and, accordingly, no other metric can demonstrate whether a supplement promotes or supports heart health). In essence, Dr. Miller rejects the discrete categories of claims that the FDCA establishes; by definition, structure/function claims do not and may not claim to treat or prevent disease.
On appeal, Plaintiff argues that it does not matter whether he categorizes Defendants’ claims as structure/function claims or as disease claims, because he addressed the falsity of the labels’ text. To the contrary, it matters very much. Plaintiff‘s argument would vitiate the FDCA‘s distinction between disease claims and structure/function claims. 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. 65 Fed. Reg. at 1012. Manufacturers need not also have evidence that those structural or functional effects reduce the risk of developing a certain disease. See Kaufman v. CVS Caremark Corp., 836 F.3d 88, 95 (1st Cir. 2016) (rejecting the plaintiff‘s argument that “evidence showing a supplement does not reduce heart disease necessarily implies that the nutrient itself has no function in maintaining heart health“). Plaintiff disagrees with the federal statutory scheme for dietary supplements, but we cannot accept his invitation to upend it. We hold that
As for Defendants’ structure/function claim that their supplements promote immune health, Plaintiff argues that the claim is false and misleading, either because
But the FDCA does not preempt Plaintiff‘s claim that Defendants’ structure/function claim about immune health is misleading because their supplements increase the risk of all-cause mortality. FDCA regulations state 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” under normal conditions of use or the conditions of use that the label prescribes.
Likewise, a label that omitted that fact would be misleading under California law. The associated structure/function claim would have “a capacity, likelihood or tendency to deceive or confuse the public,” because a reasonable consumer would not expect to suffer an increased risk of death from taking the product. Williams, 552 F.3d at 938 (quoting Kasky, 45 P.3d at 250). Because the FDCA and California law have the same labeling requirement with respect to failing to disclose an increased risk of death,
C. Defendants’ Immune-Health Claim
Conceivably, evidence that a supplement endangered users by increasing their risk of death could prove that a structure/function claim that omitted the risk was misleading. But the record lacks evidence that vitamin E supplements are actually harmful, as opposed to simply useless at reducing all-cause mortality (which they do not claim to reduce).
At best, the record reveals, in Dr. Miller‘s words, a “small” correlation between high-dose vitamin E supplements (which Defendants sell) and an increased risk of all-cause mortality. Miller cited four meta-analyses3 for this point, but none of them concluded that vitamin E supplements caused an increased risk of all-cause mortality. See, e.g., Goran Bjelakovic et al., Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention, 297 J. Am. Med. Ass‘n 842, 842, 854 (2007)4 (concluding
we hold that, on this record, Plaintiff failed to meet his burden to create a genuine issue of material fact as to whether Defendants’ immune-health structure/function claim is misleading.
AFFIRMED.