Federal law expressly authorizes manufacturers of dietary supplements to make “structure/function” claims—that is, claims about the effect of particular nutrients on the structure or function of the human body. (Think: “vitamin C supports the immune system” or “calcium supports healthy bones”). Despite this federal authorization, consumers often attempt to bring state-law challenges to manufacturers’ structure/function claims, asserting that they are false or misleading. This type of clash between federal and state law is a classic recipe for preemption. And that is especially true where the relevant federal statute—here, the Food, Drug, and Cosmetic Act (FDCA)—contains an express preemption clause. See 21 U.S.C. § 343-1(a).
On three occasions in the last three years, the Ninth Circuit has addressed whether particular state-law attacks on structure/function claims for dietary supplements were preempted by the FDCA. First, in 2019, the court held that such a challenge was squarely preempted. Dachauer v. NBTY, 913 F.3d 844, 847 (9th Cir. 2019). A year later, however, on somewhat different facts, the Ninth Circuit declined to find preemption, at least at the motion-to-dismiss stage. Kroessler v. CVS, 977 F.3d 803, 813 (9th Cir. 2020).
In a win for supplement manufacturers—and the Supremacy Clause—a new Ninth Circuit decision helps settle the landscape. In Greenberg v. Target, 2021 WL 116537 (9th Cir. Jan. 13, 2021), the court clarified that the FDCA prohibits consumers from challenging truthful, federal-law-compliant claims about a nutrient’s role in the human body on the ground that shoppers will supposedly find such claims misleading. In particular, Greenberg makes clear that, as long as the claim correctly describes the nutrient’s role in bodily structure or function, it does not matter whether consumers would derive an actual health benefit from taking the manufacturer’s supplement. This holding reaffirms important protections for supplement manufacturers against creative plaintiffs’ lawyers and conflicting state-law labeling requirements.
Case background
Todd Greenberg allegedly purchased a bottle of Target’s “Up & Up” dietary supplement, seeking to put an end to his hair loss. As the label states, the “Up & Up” supplement contains biotin, which “helps support healthy hair.” Sadly for Mr. Greenberg, his baldness continued unabated.
Crestfallen, Mr. Greenberg filed a putative class action against Target under California’s consumer protection statutes. He did not dispute that biotin in fact plays a role in maintaining the health of human hair. Instead, he alleged that the supplement’s “healthy hair” claim was misleading because most people already obtain sufficient amounts of biotin from their diet, such that taking a biotin supplement provides no tangible hair-health benefit for ordinary consumers—as opposed to the small subset of the population with a biotin deficiency.
In response, Target argued that “helps support healthy hair” is a federally authorized structure/function claim, and that Target had complied with the FDCA’s prerequisites for making such a claim. Specifically, the FDCA requires that (1) the manufacturer have substantiation that the nutrient in question in fact plays the stated role in normal human bodily structure or function; (2) the product label include a disclaimer stating, inter alia, that the FDA has not evaluated the claim; and (3) the manufacturer not claim or suggest that the product can treat or prevent any disease. 21 U.S.C. § 343(r)(6)(B)–(C). Target argued that because each of these federal-law requirements was readily satisfied, Greenberg’s state-law challenge to its hair-health claim clashed with the FDCA’s authorization of that same claim, and was therefore preempted.
The Legal Backdrop in the Ninth Circuit
In two prior cases, the Ninth Circuit had addressed whether state law challenges to structure/function claims for dietary supplements are preempted. In 2019’s Dachauer decision, the plaintiff took issue with a supplement bearing the claim that vitamin E “support[s] cardiovascular health.” The plaintiff did not dispute that vitamin E plays a role in the normal, healthy function of the human cardiovascular system. But he alleged that the claim was misleading because taking the product would not actually prevent cardiovascular disease or reduce all-cause mortality.
The Ninth Circuit deemed this challenge preempted. Dachauer recognized that, under federal law and regulations, claims of the form “[X] supports [Y] health” mean that nutrient X plays a role in the normal, healthy function of bodily structure or function Y—nothing more and nothing less. In other words, as a matter of federal law, “structure/function claims do not … claim to treat or prevent disease.” See also Kaufman v. CVS, 836 F.3d 88, 96 (1st Cir. 2016) (“Thus, any nutrient or ingredient that, for example, the heart needs might [lawfully] be described as supporting heart health, even if taking the supplement form of the nutrient actually does nothing to improve the health of one’s heart….”). By positing that the manufacturer’s “cardiovascular health” claim required evidence that “the supplement treats or prevents cardiovascular disease” in order not to mislead, the plaintiff impermissibly sought to blur the line between structure/function and disease claims in a way that conflicted with the FDCA.
The next year, in Kroessler, a different Ninth Circuit panel held that the FDCA did not preempt a different state-law challenge to a structure/function claim—at least, not at the motion-to-dismiss stage. There, the plaintiffs took issue with the claim “support[s] joint health” on a bottle of glucosamine tablets. As best we can tell from the complaint, their theory was not that glucosamine plays no role in the normal functioning of human joints. Instead, the plaintiffs alleged that the “joint health” claim was misleading because glucosamine supplementation is supposedly “ineffective at supporting or benefitting joint health, including by positively impacting the signs and symptoms of arthritis.” In support of their theory, they cited a number of scientific studies supposedly concluding that glucosamine supplementation did not effectively prevent or treat osteoarthritis. This theory would seem to run headlong into Dachauer, as the plaintiffs’ fundamental theory was that taking the defendant’s supplement would not actually confer a health benefit (i.e., prevention or alleviation of arthritis or its symptoms). As Dachauer held, properly worded structure/function claims simply do not convey a promise that taking the defendant’s supplement will prevent or treat any disease (or provide any other tangible health benefit). Instead, they merely speak to the role that the relevant nutrient plays in the normal structure or function of the human body. That should have been the end of the line.
But the Kroessler panel didn’t see things that way. While recognizing that CVS “may well succeed” on its preemption defense in the end, it held that the district court should not have found preemption as a matter of law at the pleading stage. It attempted to “distinguish[]” Dachauer as a case that was decided at the summary judgment stage, after discovery had taken place and the plaintiff had been given an opportunity to marshal evidence. But it’s well settled that preemption defenses are appropriate for resolution on the pleadings—and it’s not clear how months or years of expensive discovery would have made the Kroessler plaintiffs’ case any stronger. Again, as a matter of federal law, “glucosamine supports joint health” means only that the nutrient glucosamine plays a role in the structure or function of normal, healthy human joints. It does not mean that taking a glucosamine supplement will improve joint function or joint health in any measurable way. At bottom, the plaintiffs’ attack on CVS’ structure/function claim was premised on studies purporting to show that taking CVS’ glucosamine supplement did not provide tangible joint-health benefits. Even if true, such a theory attempts to ascribe meaning to structure/function claims that, as a matter of federal law, such claims simply do not convey.
The Kroessler panel’s attempt to distinguish Dachauer was expressly driven by its own views of good “public policy.” In particular, the court expressed concern that a broad reading of Dachauer would “bar[] nearly all private rights of action under state law against supplement manufacturers,” thereby “leav[ing] federal regulators as the sole enforcers of the FDCA within the Ninth Circuit.” Such a result, the panel thought, would “contradict[] the FDCA’s stated purpose of promoting public policy by retaining parallel avenues for private and public enforcement actions against false or misleading statements.” This reasoning is problematic: the FDCA does not have a “stated purpose” of “retaining” avenues for private enforcement in this area. To the contrary, Congress made the exact opposite policy judgment when it added a strong express preemption clause to the FDCA with respect to nutrient claims, including structure/function claims.
The Greenberg Decision
Confronted with these precedents, the Ninth Circuit in Greenberg followed Dachauer, holding that Mr. Greenberg’s challenge to “helps support healthy hair” was preempted by the FDCA—even though he alleged that taking Target’s supplement provided no benefit for the vast majority of the population.
Unlike Kroessler, Greenberg started with a correct understanding of what meaning structure/function claims convey as a matter of federal law. Namely, “a structure/function claim does not purport to treat a disease or even refer to the [effect of] the product itself.” 2021 WL 116537, at *3. “Rather, it is a much more narrowly focused statement” that “merely describes the function or role of an ingredient or nutrient on the human body.” Id. Therefore, under the FDCA, “[t]o substantiate such a claim, supplement manufacturers need only show evidence” that the nutrient has “an effect on a small aspect of the [specified bodily] structure/function.” Id. “[T]hey need not provide evidence” that taking the product itself has any particular “impact on a person’s health.” Id.
Moreover, unlike Kroessler, which invoked free-floating notions of “public policy” that supposedly favor private rights of action, the Greenberg court properly emphasized the actual stated policies of Congress and the FDA in this area. Namely, the “stated purpose” of the federal structure/function claims regime is to “increase[] the amount of information available to the consumer without prior FDA review.” Id. at *5 (quoting 65 Fed. Reg. 1000, 1003 (2000)). And Congress’s demonstrated purpose in enacting the FDCA’s express preemption clause was “[t]o avoid a patchwork quilt of conflicting state labeling laws” and court rulings. Id. at *3.
Having properly framed the issues, Greenberg’s conclusion followed in short order. Applying Dachauer, the court explained that “if the defendants’ biotin statement meets the FDCA’s three requirements for a structure/function claim, then any state law claims challenging that claim fall to the wayside.” Id. at *4. Since there was no dispute that Target satisfied the FDCA’s disclaimer requirement and its requirement to avoid making disease references, the dispute turned on whether Target had the required substantiation for its “hair health” claim.
Crucially, Mr. Greenberg did not dispute Target’s evidence that biotin, as a nutrient, plays a role in the structure of normal, healthy human hair. Instead, he argued that it was incumbent on Target to prove that “the product as a whole” provides a demonstrable “health impact” for consumers who take it. Id. As the court correctly observed, accepting this argument would negate the very essence of a structure/function claim under federal law. Again, under the FDCA regime, such a claim “addresses only the general role of an ingredient/nutrient [in] the human body” and “does not purport to convey the product’s health impact on the general population.” Id. at *3-4. As a matter of law, therefore, the panel found that Target’s structure/function claims were sufficiently substantiated.
Takeaways
After the questionable result in Kroessler, Greenberg represents a return by the Ninth Circuit to basic preemption principles in the area of structure/function claims. Rather than working backwards from the assumption that “supplement makers [should be able to] be sued,” as Kroessler did, 977 F.3d at 814, Greenberg started with the strong preemption language that Congress included in the FDCA and followed the plain meaning of that language. This approach is more consistent with the Supreme Court’s modern preemption jurisprudence, which eschews any so-called “presumption against preemption” where an express preemption clause is present. See, e.g., Puerto Rico v. Franklin Cal. Tax-Free Trust, 136 S. Ct. 1938 (2016) (“[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.” (quotation marks omitted)).
Greenberg also appears to back away from Kroessler’s suggestion that preemption determinations usually require discovery and an evidentiary record. Although Greenberg was decided in a summary judgment posture, the court—unlike the Kroessler court—did not ascribe any particular importance to that fact. For example, when affirming the district court’s finding of preemption, it made no reference to the case’s “procedural posture” or to “[t]he quality of the evidence in the record.” Cf. Kroessler, 977 F.3d at 813. Rather, Greenberg’s analysis turned on the legal incompatibility between the plaintiff’s theory of the case, which asserted that taking the supplement did not provide any tangible health benefits, and the federal structure/function claims regime. The same incompatibility would have existed—and required dismissal—at the motion-to-dismiss stage, and the Greenberg court said nothing that suggests otherwise. This approach, too, is more consistent with recent Supreme Court jurisprudence, which emphasizes that preemption is generally “a question of law … for a judge to decide without a jury.” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1679-80 (2019).
Finally, Greenberg reaffirms the critical role that the FDCA (and its preemption clause) plays in ensuring predictability and uniformity in our nationwide economy, to the benefit of both manufacturers and consumers. This is something that the Kroessler court overlooked when it assumed that the FDCA’s one and only “purpose” is to permit untrammeled “private and public enforcement actions against [allegedly] false or misleading statements.” 977 F.3d at 814. Unlike Kroessler, Greenberg recognizes that there are valid policy concerns cutting both in favor and against private enforcement—and that, in enacting the FDCA’s express-preemption clause, Congress has already weighed those competing concerns and struck its preferred balance in favor of preemption. Hopefully, future panels in the Ninth Circuit (and elsewhere) will follow suit.
