Ferrari v. Vitamin Shoppe Indus. LLC

70 F.4th 64

Richard FERRARI, individually and on behalf of all others similarly situated;William Bohr, individually and on behalf of all others similarly situated, Plaintiffs, Appellants, v. VITAMIN SHOPPE INDUSTRIES LLC f/k/a Vitamin Shoppe Inc., Defendant, Appellee.

No. 22-1332

United States Court of Appeals, First Circuit

June 9, 2023

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS [Hon. George A. O'Toole, Jr., U.S. District Judge]

Mark R. Sigmon, with whom Nick Suciu, III, Milberg Coleman Bryson Phillips Grossman PLLC, Charles J. LaDuca, Brendan S. Thompson, Cuneo Gilbert & LaDuca, LLP, Joseph J. Siprut, Erica C. Mirabella, Charles E. Schaffer, and Levin Sedran & Berman LLP were on brief, for appellants.

Michael R. McDonald, with whom Caroline E. Oks and Gibbons, P.C. were on brief, for appellee.

Before Montecalvo and Thompson, Circuit Judges, and Carreño-Coll,^* District Judge.

CARREÑO-COLL, District Judge.

Richard Ferrari and William Bohr purchased three dietary supplements with glutamine in the hope that the glutamine would -- as the labels said -- help their muscles grow and recover after intense exercise. When they did not see any results, they sued the products' manufacturer, Vitamin Shoppe, for several state torts. The district court granted summary judgment to Vitamin Shoppe, ruling that the plaintiffs' state law claims are preempted because the labels comply with federal law. We affirm.

I.

The Food, Drug, and Cosmetic Act ("FDCA") is designed to protect consumers from harmful products. Perham v. GlaxoSmithKline LLC (In re Zofran (Ondansetron) Prods. Liab. Litig.), 57 F.4th 327, 330 (1st Cir. 2023). Congress amended the FDCA through the Dietary Supplement Health and Education Act of 1994 ("DSHEA") to establish a uniform framework to regulate dietary supplements. Pub. L. No. 103-417, 108 Stat. 4325, 4325-26 (1994). Under the FDCA and DSHEA, manufacturers may make so-called "structure/function claims" about dietary supplements. Kaufman v. CVS Caremark Corp., 836 F.3d 88, 92 (1st Cir. 2016). 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." 21 U.S.C. § 343(r)(6)(A). That a nutrient, for example, "helps promote digestion" or "supports the immune system" is a structure/function claim. 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, 1006, 1028-29 (Jan. 6, 2000) (codified at 21 C.F.R. pt. 101). To make such a claim, the manufacturer must have "substantiation that [the claim] is truthful and not misleading." § 343(r)(6)(B). And the dietary supplement's label must bear a disclaimer stating that the claim has not been evaluated by the Food and Drug Administration ("FDA") and that the "product is not intended to diagnose, treat, cure, or prevent any disease." § 343(r)(6)(C). Finally, the claim itself may not purport "to diagnose, mitigate, treat, cure, or prevent" disease. § 343(r)(6).

If the manufacturer's label satisfies § 343(r)(6)'s requirements, consumers may not attack the structure/function claim under state law. See Kaufman, 836 F.3d at 91-92. To keep labeling requirements uniform, the FDCA expressly preempts "any requirement" under state law "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 requirement of section 343(r)." 21 U.S.C. § 343-1(a)(5). Structure/function claims under § 343(r)(6) fall within § 343(r)(1)'s ambit. See § 343(r)(6) (stating that, "[f]or purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if" the statement complies with certain requirements). So they are "claim[s] of the type described in section 343(r)(1)." And they are claims made in the labeling of food because dietary supplements are "deemed" food under the FDCA, except in limited circumstances that do not apply here. See 21 U.S.C. § 321(ff). Thus, the FDCA expressly preempts any state law that establishes labeling requirements for structure/function claims that are not identical to the requirements in § 343(r)(6). See Dachauer v. NBTY, Inc., 913 F.3d 844, 847-48 (9th Cir. 2019). The "net effect" of this is that the manufacturer "prevail[s] if its label satisfies the requirements of [§ 343(r)(6)]." Kaufman, 836 F.3d at 92.

With our statutory scaffolding in place, we turn to what happened below. The plaintiffs purchased three dietary supplements: Glutamine, Creatine & Glutamine with Beta-Alanine, and BCAA & Glutamine.¹ Glutamine is a main ingredient in all three of them. The Glutamine supplement states that glutamine "is involved in regulating protein synthesis and has been shown to possess [a]nti-[c]atabolic properties² to help preserve muscle" and that "[i]ntense exercise can deplete glutamine stores, however, supplemental glutamine is thought to replenish these stores allowing for enhanced recovery." The Creatine & Glutamine with Beta-Alanine supplement says that "[g]lutamine helps support muscle growth and recovery as well as immune health."³ And the BCAA & Glutamine supplement states that glutamine has "anti-catabolic properties." The plaintiffs claimed that these statements are false and misleading under state law.

Vitamin Shoppe moved for summary judgment on the ground that the FDCA preempts the plaintiffs' state law claims because its products' labels comply with § 343(r)(6). The plaintiffs responded that the labels' statements about glutamine are claims about supplemental glutamine -- not naturally occurring glutamine (glutamine that the body produces) -- and so to comply with § 343(r)(6), Vitamin Shoppe needed to substantiate those claims with evidence about supplemental glutamine. Because Vitamin Shoppe, they asserted, substantiated its claims about supplemental glutamine with evidence about naturally occurring glutamine, the claims are not substantiated within the meaning of § 343(r)(6) and thus the FDCA does not preempt their state law claims.

The district court granted summary judgment to Vitamin Shoppe, ruling that the FDCA preempts the plaintiffs' state law claims. In doing so, it held that the contested statements about glutamine are structure/function claims, that there is no "meaningful distinction" in the record between supplemental glutamine and naturally occurring glutamine, and that the parties' experts largely agreed that glutamine does what Vitamin Shoppe's labels claim. This appeal followed.

II.

We review de novo the district court's order granting summary judgment. Perham, 57 F.4th at 335. Through that lens, we view the facts in the record in the light most favorable to the plaintiffs, as the nonmovants, and draw all reasonable inferences in their favor.⁴ Id. The district court's preemption ruling is reviewed de novo, too, because it "presents a pure question of law." Medicaid & Medicare Advantage Prods. Ass'n of P.R., Inc. v. Hernández, 58 F.4th 5, 11 (1st Cir. 2023).

III.

The plaintiffs argue that the district court erred by holding that the FDCA preempts their state law claims because the statements about glutamine on Vitamin Shoppe's labels are not structure/function claims and, even if they were, Vitamin Shoppe lacks substantiation that the statements are truthful and not misleading.⁵ We take each argument in turn.

A.

We begin with whether the statements about glutamine on Vitamin Shoppe's labels are structure/function claims. Recall that a structure/function claim describes a nutrient's effect on the human body's structure or function or explains how the nutrient maintains that structure or function. § 343(r)(6)(A). Vitamin Shoppe's statements about glutamine fit the bill.

First, the statement "[i]ntense exercise can deplete glutamine stores, however, supplemental glutamine is thought to replenish these stores allowing for enhanced recovery"⁶ explains how supplemental glutamine helps maintain glutamine stores, which help our muscles recover after intense exercise. So it fits comfortably within the definition of a structure/function claim. Indeed, the FDA has approved of a substantially similar claim: "[The] FDA believes that a claim that a product is useful because it counterbalances the effects of a drug in depleting a nutrient . . . would be acceptable as a structure/function [claim]." 65 Fed. Reg. at 1029. The plaintiffs assert that this statement "go[es] too far" because by referring to a "specific situation and usage," Vitamin Shoppe is claiming that the product itself has this beneficial effect. But their reading finds no support in the text of the statement. The statement claims that supplemental glutamine is thought to replenish glutamine stores after intense exercise -- not that taking the product will replenish glutamine stores after intense exercise. Although this distinction may be lost on consumers, it is a "form of finesse" that § 343(r)(6)(A) allows. Cf. Kaufman, 836 F.3d at 96 (stating that drawing a "distinction between the ingredient's function" and its effect on health "likely tricks many consumers," but the FDCA allows this "form of finesse").

Next, the statements that glutamine "helps support muscle growth and recovery as well as immune health" and has "anti-catabolic properties" are structure/function claims, too. For each describes how glutamine affects a structure or function in the human body. And these claims are substantially similar to others that the FDA has blessed, such as "supports the immune system" and "boosts stamina, helps increase muscle size, and helps enhance muscle tone." See 65 Fed. Reg. at 1028-30.

The plaintiffs nonetheless contend that these statements are not structure/function claims because they refer to the products -- not just to the nutrient glutamine. For example, the Glutamine...