Federal Preemption of 'Structure/Function' Claims on Dietary Supplements


New Jersey Law Journal

December 14, 2020

By: Michael R. McDonaldMary K. Bessemer

Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) with the Nutrition Labeling and Education Act (NLEA) in 1990 and, in 1994, with the Dietary Supplement Health and Education Act (DSHEA), which provided the Food and Drug Administration (FDA) with regulatory authority over dietary supplements and specifically established “standards with respect to dietary supplements.” Together, the NLEA and DSHEA established “a new category of food products—specifically, dietary supplements—that have unique safety, labeling, manufacturing, and other related standards.” Kroessler v. CVS Health Corp., 977 F.3d 803, 808 (9th Cir. 2020). With Congress finding consumers “should be empowered to make choices” about potential benefits of dietary supplements, DSHEA implemented major shifts in dietary supplement regulation, including exempting “dietary supplements” from FDA drug approval and FDA food additive approval, 21 U.S.C. §321(g)(1), and expressly permitting dietary supplement labels to make “structure/function claims.” 21 U.S.C. §343(r)(6)(A).

By definition, 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.” Id. at §343(r)(6). Federal law allows such label claims, provided: (1) the manufacturer “has substantiation that such statement is truthful and not misleading”; (2) the label contains a prominent disclaimer that the statement was not evaluated by FDA and the product is not intended to treat or prevent any disease; and (3) the statement does not claim that the supplement is intended to “diagnose, mitigate, treat, cure, or prevent” disease. Id. at §343(r)(6)(B)(C).

The regulatory framework distinguishes between “disease claims” and “structure/function claims,” applying different regulatory standards to each. Unlike structure/function claims, “disease claims” are, in fact, claims “‘to diagnose, mitigate, treat, cure, or prevent disease,’ either explicitly or implicitly (such as by claiming that a product treats a disease’s ‘characteristic signs or symptoms’).” 21 C.F.R. §101.93(g)(2).

On Jan. 6, 2000, the FDA published a final rule in the Federal Register defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body and establishing criteria for determining when a statement about a dietary supplement is a disease claim. See Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body (“Regulations”), 21 C.F.R. §101. The Regulations allow structure/function claims to use general terms such as “promote,” “maintain,” “support,” “strengthen,” “improve,” and “protect,” as long as the claims do not suggest disease prevention or treatment and there is substantiation for the description.

Substantiation of Structure/Function Claims

In January 2009, FDA published a guidance document “intended to describe the amount, type, and quality of evidence FDA recommends a manufacturer have to substantiate a claim under section 403(r)(6).” Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the FDCA (Jan. 2009) (“FDA Guidance”). Federal courts have recognized that FDA “advances a common sense interpretation of ‘substantiation,’ also adopted by the Federal Trade Commission, as meaning ‘competent and reliable scientific evidence.’” Kaufman v. CVS Caremark Corp., 836 F.3d 88, 93 (1st Cir. 2016), citing FDA Guidance.

The Regulations explain 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.” Dachauer v. NBTY, Inc., 913 F.3d 844, 847-48 (9th Cir. 2019). “Manufacturers need not also have evidence that those structural or functional effects reduce the risk of developing a certain disease.” Id. Indeed, Congress expressly authorized statements that describe a nutrient’s structure or function in humans, “even while simultaneously disavowing any claim that the product is intended ‘to … prevent any disease,’ … as long as the claimed beneficial function is substantiated and the description of the nutrient’s role is not misleadingly incomplete.Kaufman, 836 F.3d at 95-96.

FDCA Preemption

The FDCA expressly preempts any state law that establishes “any requirement respecting any claim of the type described in section 343(r)(1) … made in the label or labeling of food that is not identical to the requirements of section 343(r) of this title.” 21 U.S.C. § 343-1(a)(5). Structure/function claims fall under the FDCA’s preemption umbrella. Dachauer, 913 F.3d at 847. Therefore, lawsuits claiming that structure/function claims are false are expressly preempted to the extent they seek to impose requirements that are “not identical” to the FDCA’s requirements, i.e., requirements that “‘directly or indirectly impose[ ] obligations or contain[ ] provisions concerning the composition or labeling of food [that] … [a]re not imposed by or contained in … or [d]iffer from those specifically imposed by or contained in the applicable [federal regulation].’” Kroessler, 977 F.3d at 808.

Where lawsuits challenge structure/function claims, the preemption inquiry focuses on whether a plaintiff seeks to support falsity allegations with evidence not required for substantiation under section 343(r). In Dachauer, for example, plaintiff challenged a claim that a vitamin E supplement promoted heart health by citing studies that the supplement did not prevent heart disease. But, plaintiff “mismatched his evidence, presenting studies alleging that vitamin E did not prevent cardiovascular disease when, based on his claims, he should have presented studies alleging that vitamin E did not support cardiovascular health—the supplement’s actual claim.” Kroessler, 977 F.3d at 810, citing Dachauer, 913 F.3d at 848. Evidence of the dietary supplement’s inability to treat or prevent disease did not address the label’s claim that the supplement affects human structure or function. Thus, these claims were preempted because the state law claim would have required evidence of the supplement’s effect on a disease to substantiate a structure/function claim, which was “‘not identical to the requirement of section 343(r).’” Dachauer, 913 F.3d at 848. For the same reason, challenges to the “support immune health” claim were preempted to the extent plaintiff argued the label was false because the supplements could not reduce all-cause mortality.

However, the FDCA does not preempt state law causes of action where a plaintiff “attempts to hold a defendant to the same substantiation standard required by the FDCA.” Kroessler, 977 F.3d at 812. For example, in Dachauer, the “support immune health” claim was not preempted to the extent plaintiff argued it was misleading for failing to disclose that the supplements actually “increase the risk of all-cause mortality.” 913 F.3d at 849. Dachauer explained that FDCA regulations deem a label 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.” Id., quoting 21 C.F.R. §1.21(a)(2). Thus, because FDCA and state law had the “same labeling requirement with respect to failing to disclose an increased risk of death,” that claim escaped preemption (but was nonetheless dismissed because there was no evidence that the supplement was “actually harmful, as opposed to simply useless”). Dachauer, 913 F.3d at 848-49.

Since Dachauer, most federal courts have sought to evaluate preemption of structure/function claims employing the Dachauer framework. In Greenberg v. Target Corp., plaintiff claimed a biotin supplement’s structure/function claim—“helps support healthy hair and skin”—was false because “the general population would derive no health benefits from biotin supplements in any form.” 402 F.Supp.3d 836, 838 (N.D. Cal. 2019). Though plaintiff’s expert conceded that the nutrient biotin played a “cellular and biochemical role in the support of healthy hair, skin,” the average person already ingests more than enough biotin, and any surplus of the nutrient is unable to “convey any additional health benefits.” Id. at 837-38. Based on Dachauer’s ultimate holding, Greenberg held that plaintiff’s claims were preempted because the evidence “regarding the superfluous effect that supplemental biotin has on the general population is not required to state a valid structure/function claim.” Id. at 840.

Korolshteyn v. Costco Wholesale Corp. demonstrates the preemption principle described by the First Circuit in Kaufman, that the defendant “must prevail if its label satisfies the requirements of FDCA section 343(r).” Kaufman, 836 F.3d at 92. In Korolshteyn, plaintiff argued that defendant’s ginkgo biloba supplement’s structure/function claims were false based on studies showing that ginkgo was useless. However, since defendant proffered “competent and reliable scientific evidence” to support the claims, the court decided, as a matter of law, that the label claims were substantiated and thus, preempted. Korolshteyn v. Costco Wholesale Corp., 393 F. Supp. 3d 1019, 1024-25 (S.D. Cal. 2019).

At the heart of the Korolshteyn appeal, pending in the Ninth Circuit, is the application of the FDCA’s substantiation standard, specifically, whether the scientific evidence proffered was sufficient to substantiate the structure/function claims when weighed against plaintiff’s contradicting evidence. Since the Supreme Court has recently held that “a judge, not the jury, must decide the preemption question,” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1676 (2019), presumably, the court properly decided whether the evidence satisfied the applicable substantiation standard. Notably, while FDA guidance posits a substantiation standard requiring only “competent and reliable scientific evidence,” the plaintiff in Korolshteyn advocates for employing a “totality of the evidence” standard, which the defendant argues is itself different from and “not identical” to section 343(r)’s requirements for structure/function claims. The Ninth Circuit would be the first Circuit to weigh in on the substantiation standard when faced with conflicting scientific evidence directly addressing the structure/function claims.

Reprinted with permission from the December 14, 2020 issue of the New Jersey Law Journal. © 2020 ALM Media Properties, LLC. Further duplication without permission is prohibited. All rights reserved. For information, contact 877-257-3382 or reprints@alm.com or visit www.almreprints.com.