United States Court of Appeals For the First Circuit

No. 22-1332

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.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. George A. O'Toole, Jr., U.S. District Judge]

Before

Montecalvo and Thompson, Circuit Judges, and Carreño-Coll, 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.

 Of the District of Puerto Rico, sitting by designation. June 9, 2023 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.),

(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.

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.,

(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

- 3 - function."

(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,

, 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)."

(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),

- 4 - 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

(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.,

, 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,

.

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,

1Ferrari purchased Creatine & Glutamine with Beta-Alanine, and Bohr purchased Glutamine and BCAA & Glutamine. We group the products together for analytical ease. 2An anti-catabolic substance reduces the breakdown of muscle proteins.

- 5 - 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

3 There is some sparring in the briefing about whether two additional claims on this product -- "[c]reatine helps to improve strength and performance during high intensity exercise and training" and "[b]eta-alanine helps support muscle strength, endurance and overall athletic performance" -- are at issue. Vitamin Shoppe contends that this appeal is limited to claims about glutamine. The plaintiffs insist that they have "always challenged" these two additional claims. But in their complaint, the plaintiffs bolded only the product's statement about glutamine, and their opposition to Vitamin Shoppe's motion for summary judgment did not contest the other claims. Thus, any appellate argument based on those claims is waived. See Davis v. Lucent Techs., Inc.,

(1st Cir. 2001) ("[W]here a plaintiff fails to present arguments to the district court in opposition to a defendant's motion for summary judgment, we have refused to consider those arguments for the first time on appeal.").

- 6 - 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,

. 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

The district court's preemption ruling is

The parties disagree about whether we should defer to the 4

district court's resolution of factual disputes subsumed within the preemption question: Vitamin Shoppe argues that we should review the court's findings for clear error, whereas the plaintiffs imply that we should disregard its findings and view the record in the light most favorable to them as the nonmovants. Because we would affirm the district court under either standard, we view the facts in the more appellant-friendly way -- in the light most - 7 - reviewed de novo, too, because it "presents a pure question of

law." Medicaid & Medicare Advantage Prods. Ass'n of P.R., Inc.

v. Hernández,

(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

favorable to the plaintiffs. 5 The plaintiffs do not challenge the district court's conclusion that Vitamin Shoppe satisfied § 343(r)(6)'s other requirements. So we need not dwell on them. 6 The plaintiffs concede that the other claim on the Glutamine - 8 - 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,

(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").

supplement, which says that glutamine "is involved in regulating protein synthesis and has been shown to possess [a]nti-[c]atabolic properties to help preserve muscle," is a structure/function claim.

- 9 - 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 supplement talks about supplemental glutamine (i.e., the

form of the nutrient in the product), one of the statements about

glutamine is prefaced by the phrase "[a]lso added [to the

product]," and one of the labels says that the product "combines"

three nutrients before listing each with a description of the

nutrient's physiological role. The plaintiffs' contention is

rooted in some language from Greenberg v. Target Corp.,

(9th Cir. 2021). Greenberg, in emphasizing the differences

between structure/function claims and another type of claim called

disease claims, said that a structure/function claim does not

"refer to the product itself."

. A disease claim, in

contrast, "refers to a statement that the product itself can cure

or treat a disease."

But Greenberg did not say that merely

- 10 - noting that the nutrient is in the product negates an otherwise

acceptable structure/function claim. See

Nor do we see any

reason why it would. After all, a structure/function claim is

about a nutrient or dietary ingredient in the product. See

§ 343(r)(6) (listing claims that can be made "for a dietary

supplement"); 65 Fed. Reg. at 1002 (stating that the FDA's "final

rule establishes criteria for determining whether a statement made

about a dietary supplement is acceptable as a structure/function

claim under section 403(r)(6)").

The plaintiffs' last line of attack is that a reasonable

jury could construe the contested statements about glutamine as

claims about the products' benefits instead of claims about

glutamine's effect on the human body. Assuming that the jury has

a role to play in deciding whether a statement is a

structure/function claim, no reasonable jury would construe the

contested language as discussing the products' benefits instead of

glutamine's physiological role. The statements plainly make

claims about what glutamine does -- not about what the products

do. That a consumer might hope or infer that the product will do

what the nutrient does is a far cry from a reasonable jury finding

that the words "nutrient X does Y" is best construed as meaning

"product Z does Y because it contains nutrient X."7

In the end, the plaintiffs all but abandon their argument 7

that the contested statements are not structure/function claims. - 11 - In sum, because the contested statements about glutamine

on Vitamin Shoppe's labels describe glutamine's effect on the human

body's structure or function or explain how glutamine maintains

that structure or function, they are structure/function claims

under § 343(r)(6)(A).

B. The plaintiffs argue next that the FDCA does not preempt

their state law claims because Vitamin Shoppe failed to

substantiate its products' statements about glutamine. They

assert that the evidence substantiating each structure/function

claim must be about the supplemental form of the nutrient. Because

the district court, they say, looked at evidence about naturally

occurring glutamine rather than supplemental glutamine, it did not

realize that Vitamin Shoppe's statements about glutamine are

bereft of evidentiary support.

To make a structure/function claim, the manufacturer

must "ha[ve] substantiation that [the claim] is truthful and not

misleading." § 343(r)(6)(B). The term "substantiation" is not

defined. Kaufman,

. But the FDA's guidance defines

it as "competent and reliable scientific evidence."

(quoting

They say in their reply brief that "the best and most consistent position may be . . . that the claims here are proper-in-form structure/function claims." And at oral argument, they conceded that the statements are structure/function claims at "some level."

- 12 - Food & Drug Admin., Guidance for Industry: Substantiation for

Dietary Supplement Claims Made Under Section 403(r)(6) of the

Federal Food, Drug, and Cosmetic Act Part I.B. (Dec. 2008),

http://www.fda.gov/food/guidanceregulation/guidancedocumentsregu

latoryinformation/dietarysupplements/ucm073200.htm [hereinafter

Guidance for Industry]). Because we have used that definition

before, see

and both parties use it, we will also do so here.

Thus, to comply with § 343(r)(6)(B), Vitamin Shoppe must have

competent and reliable scientific evidence that its

structure/function claims about glutamine are truthful and not

misleading. Before we decide whether it has that evidence, we

resolve first a dispute about which form of glutamine the evidence

must be about.

The plaintiffs argue that the evidence substantiating

Vitamin Shoppe's structure/function claims about glutamine must be

about the supplemental form, not the naturally occurring form.

They are right for the simple reason that Vitamin Shoppe's claims

are about supplemental glutamine and so its substantiation must

be, too. One of the labels openly talks about what "supplemental

glutamine" does. On another label, the statement about glutamine

is prefaced by the phrase "[a]lso added," which means that the

claim is about supplemental glutamine -- the glutamine added to

the product -- not naturally occurring glutamine. The statement

about glutamine on the third label appears in a list of three

- 13 - nutrients "combine[d]" in the product. So this statement also

refers to the form of glutamine in the product. Because the

structure/function claims here are about supplemental glutamine,

"substantiation that [the claims are] truthful and not misleading"

must be about supplemental glutamine, too.8 See § 343(r)(6)(B).

But in the end, the distinction between naturally

occurring glutamine and supplemental glutamine is, as the district

court said, meaningless. At oral argument, we asked the

plaintiffs if supplemental glutamine and naturally occurring

glutamine play the same role in the human body. The plaintiffs

conceded that, on this record, they do. Our review of the record

reveals only one difference between them: The parties' experts

agreed that our bodies may struggle absorbing supplemental

glutamine and that therefore much of it may be lost during

digestion. But some of it survives. Indeed, the plaintiffs'

8 The plaintiffs' "first reason" why evidence about supplemental glutamine is required (i.e., that the claims are about supplemental glutamine) suffices here. They nonetheless ask us to go further: They ask us to hold that every structure/function claim must be substantiated by evidence about the supplemental form of the nutrient. We see no reason to set down a hardline rule in a case that does not call for one, especially given the wide array of substances in dietary supplements and the wide array of forms they take. See

(ff) (defining "dietary supplement" as a product that, among other things, contains "a vitamin," "a mineral," "an herb or other botanical," "an amino acid," "a dietary substance for use by man to supplement the diet by increasing the total dietary intake," or "a concentrate, metabolite, constituent, extract, or combination of any ingredient described").

- 14 - expert acknowledged that some people -- such as those who exercise

intensely or have suffered physical trauma, severe illness,

surgery, or burns -– benefit from taking supplemental glutamine.

So where does that leave the disagreement between the parties?

The plaintiffs contended at oral argument that Vitamin Shoppe loses

on substantiation "if you take a pill and it does not actually

affect the body's structure or function as the label claims."

Section 343(r)(6)(B), they said, requires "efficacy that the

product supports the body's structure or function as claimed."

Vitamin Shoppe argues that the plaintiffs are seeking to impose a

substantiation requirement above and beyond what the plain text of

§ 343(r)(6)(B) requires.

With the facts and arguments ironed out, this case now

looks a lot like Greenberg. The issue there was whether Target

had substantiation that its claim that biotin "helps support

healthy hair and skin" was truthful and not misleading when the

evidence showed that most people get the biotin they need through

their diet and thus taking biotin is useless for all but a select

few who have a biotin deficiency. Greenberg, 985 F.3d at 652–53.

The appellant argued that Target's "structure/function claim must

be true not only as to the nutrient itself but [also as to] the

product as a whole." Id. at 655. Greenberg rejected that

argument based on the plain text of the FDCA. A structure/function

claim, it said, "addresses only the general role of an

- 15 - ingredient/nutrient on the human body," not "the product's health

impact on the general population." Id. at 655–56. Thus, the

manufacturer need only have substantiation that its claim about

"the ingredient's function on the human body" is truthful and not

misleading. Id. at 656.

We agree with Greenberg that the plain text of

§ 343(r)(6)(B) requires a manufacturer to have substantiation that

a nutrient's claimed effect on the human body's structure or

function is truthful and not misleading, not that the product has

the claimed effect. Section 343(r)(6)(B) requires "the

manufacturer of the dietary supplement [to] ha[ve] substantiation

that such statement" -- i.e., the statement that describes the

nutrient's effect on the human body's structure or function -- "is

truthful and not misleading." Nowhere in the text of

§ 343(r)(6)(B) is the manufacturer required to show that taking

the dietary supplement affects the structure or function as

claimed. See United States ex rel. Heineman-Guta v. Guidant

Corp.,

(1st Cir. 2013) ("We will not ordinarily

read requirements into a statute that 'do not appear on its face.'"

(quoting Dean v. United States,

(2009))).

Had Congress wanted to add an efficacy requirement to

§ 343(r)(6)(B), it could have. Products that are regulated as

drugs have an efficacy requirement. The FDA will deny an

application to sell a new drug if, among other things, "there is

- 16 - a lack of substantial evidence that the drug will have the effect

it purports or is represented to have under the conditions of use

prescribed, recommended, or suggested."

(d); see

also Mut. Pharm. Co. v. Bartlett,

(2013)

(describing the new-drug application and approval process). And

there is a reason why structure/function claims may not purport to

treat disease and why a product bearing such claims must expressly

repudiate any intention of treating disease: A dietary supplement

that makes a disease claim is regulated as a drug and must meet

the efficacy requirement discussed above. See

(f); § 355(d). So Congress knows how to add an efficacy

requirement when it wants to and intentionally excluded one from

structure/function claims. See Guidant Corp.,

("[W]hen Congress includes language in one section of a statute

but omits it in another, 'it is generally presumed that Congress

acts intentionally and purposely in the disparate inclusion or

exclusion.'" (quoting Keene Corp. v. United States,

(1993))).

There is more. Congress found in the DSHEA that "safety

problems with [dietary] supplements are relatively rare" and that

"legislative action that protects the right of access of consumers

to safe dietary supplements is necessary in order to promote

wellness." § 2(14), (15)(A), 108 Stat. at 4326. It enacted the

DSHEA to "ensur[e] that the Federal Government erects no barriers

- 17 - that impede the ability of consumers to improve their nutrition

through the free choice of safe dietary supplements" and "to

clarify that dietary supplements are not drugs . . . [and] should

not be regulated as drugs." S. Rep. No. 103-410 (1994),

, at *2. Needless to say, Congress intended dietary

supplements to escape the regulatory gauntlet that drugs must go

through.9

The plaintiffs have a back-up argument. Putting aside

§ 343(r)(6)(B)'s text, they contend that we must defer to the FDA's

guidance about substantiation, which, they say, "requires

substantiation of actual efficacy of the supplement." It is true

that the FDA's guidance opines that manufacturers should have

evidence that their dietary supplements affect the human body's

structure or function as claimed and under the conditions of use

recommended on the products' labels. Guidance for Industry,

supra, Part II.B–D. But the guidance calls itself a nonbinding

9 Our conclusion is bolstered by several law review articles that the district court cited. See Ferrari v. Vitamin Shoppe, Inc., No. 17-10475-GAO,

, at *3 (D. Mass. Mar. 31, 2022). The DSHEA appears to be the result of intense lobbying by dietary supplement manufacturers and consumers in response to proposals to heavily regulate dietary supplements. See Lars Noah & Barbara A. Noah, A Drug by Any Other Name . . . ?: Paradoxes in Dietary Supplement Risk Regulation,

, 166 (2006); Peter J. Cohen, Science, Politics, and the Regulation of Dietary Supplements: It's Time to Repeal DSHEA,

, 179–180 (2005); Stephen H. McNamara, Dietary Supplements of Botanicals and Other Substances: A New Era of Regulation,

, 341 (1995).

- 18 - recommendation "unless specific regulatory or statutory

requirements are cited."

Part I.A.; see also Greenberg,

n.3 (stating that this guidance is "not on-point and

in any event [is] not binding"). And we see no statutory or

regulatory authority backing its opinion that, for a

structure/function claim to be substantiated within the meaning of

§ 343(r)(6)(B), the manufacturer must have evidence that the

nutrient plays the physiological role claimed under the conditions

of use recommended on the label. Assuming (without deciding) that

the guidance is the type of agency interpretation warranting

Chevron deference, see Doe v. Leavitt,

, 79–80 (1st

Cir. 2009), our analysis above about why the plain text of

§ 343(r)(6)(B) only requires substantiation that the

structure/function claim is truthful and not misleading dooms the

plaintiffs' Chevron argument. See Saysana v. Gillen,

(1st Cir. 2009) ("We have concluded that the text of the statute

is clear. Consequently, . . . there is nothing for the agency to

interpret -- no gap for it to fill -- and there is no justification

for resorting to agency interpretation to address an ambiguity.").

We turn now to whether Vitamin Shoppe has substantiation

that its structure/function claims are truthful and not

misleading. Recall that substantiation requires competent and

reliable scientific evidence. The plaintiffs claim that Vitamin

Shoppe put forward evidence only about how naturally occurring

- 19 - glutamine –- not supplemental glutamine -- affects the human body's

structure or function. But the record tells a different story.

Vitamin Shoppe's expert, Dr. Hoffman, presented a myriad of studies

showing that glutamine supplementation supports immune health and

muscle growth and recovery; is involved in regulating protein

synthesis; has anti-catabolic effects, which help preserve muscle;

and may help replenish glutamine stores after intense exercise.

The plaintiffs' expert, Dr. Candow, attacked these studies on

several grounds, including that they used higher doses of glutamine

than Vitamin Shoppe's labels recommend, involved different forms

of administration (e.g., intravenous), incorporated other

additives, used animal subjects, and used disease-state human

subjects. In crafting his report, Dr. Candow evaluated Vitamin

Shoppe's structure/function claims with respect to healthy humans

at the doses recommended on the labels. And after evaluating each

claim through this lens, he concluded that glutamine

supplementation at the doses recommended is useless. He did,

however, agree that glutamine supplementation at some dose and for

some people affects the human body's structure or function as

Vitamin Shoppe's labels claim. Because the plaintiffs assert that

he was talking about naturally occurring glutamine when he said

that, we will address each claim to show that there is no genuine

dispute between the experts that supplemental glutamine plays the

physiological role that Vitamin Shoppe's labels claim.

- 20 - We start with the claim that glutamine supplementation

supports muscle growth and recovery and immune health. The

following exchanges took place at Dr. Candow's deposition:

Q. Now, going to the glutamine statement which says, "Glutamine helps support muscle growth and recovery as well as immune health." A. Okay. Q. Is it your opinion that this statement is false? A. Yes. Specifically to the dose that is recommended. . . . . [Q.] At what dosage does glutamine help support immune health? A. I believe in all the articles the minimum dose was 10 grams a day. . . . . Q. Has glutamine supplementation been shown to decrease the incidence of infections? A. I believe so. I believe so, yes. Q. Has glutamine been shown to improve the response of cells in the immune system? A. Yes. . . . . Q. And do you disagree that glutamine supplementation can cause an increase in recovery? A. It can only at a specific dosage. Q. But in general, glutamine supplementation can increase recovery in the body? A. Again, at a specific dosage. So 1 gram, no. 2 grams or the dosage here is a specific dosage. Q. What is the dosage at which glutamine . . . supports recovery? A. I believe the minimal amount was 6 grams. . . . . Q. Glutamine supplementation can increase muscle protein synthesis 10 and prevent

10 Dr. Candow states in his report, "Muscle growth reflects the net balance between muscle protein synthesis and protein breakdown . . . . Muscle growth may be the result of a decrease in protein breakdown, an increase in protein synthesis, or both." - 21 - metabolism in certain situations. Correct? A. That's correct. Thus, Dr. Candow's dispute with this structure/function claim

comes down to the dose recommended on the product. The same is

true for the other claims. As for the claim that taking

supplemental glutamine after intense exercise is thought to

replenish depleted glutamine stores, leading to enhanced recovery,

Dr. Candow agreed that, as a general matter, intense exercise can

deplete glutamine stores and that glutamine supplementation can

help maintain these stores and enhance recovery. He also agreed

that supplemental glutamine is involved in regulating protein

synthesis. And he agreed that supplemental glutamine, in some

circumstances such as in disease-state humans,11 has anti-catabolic

properties, which help preserve muscle tissue by preventing

protein breakdown. Thus, there is no genuine dispute that Vitamin

Shoppe has substantiation that its claims about supplemental

glutamine's physiological role are truthful.

The plaintiffs have one more arrow in their quiver.

They argue that Vitamin Shoppe's labels are nonetheless misleading

By agreeing that glutamine supplementation increases muscle protein synthesis, he agreed that glutamine supplementation supports muscle growth. Dr. Candow explained that humans might need more glutamine 11

than we naturally produce during times of extreme physical stress, such as trauma, cancer, HIV/AIDS, surgery, burns, sepsis, radiation, chemotherapy, and intense exercise.

- 22 - because they fail to reveal material facts about taking the

supplements as recommended (i.e., that taking the supplements as

recommended does nothing). Section 343 governs when food

products, including dietary supplements, are misbranded.

. Section 321(n) provides that when evaluating

whether a product is misbranded because the labeling is misleading,

we must consider, among other things:

[T]he extent to which the labeling . . . fails to reveal facts material in . . . light of [the] representations [on the label] or material with respect to consequences which may result from the use of the [product] to which the labeling . . . relates under the conditions of use prescribed in the labeling . . . thereof or under such conditions of use as are customary or usual.

§ 321(n); see also Kaufman,

("This statutory

command that we consider the omission of material facts fits hand-

in-glove with the mandate of section 343(r)(6)(B) that the seller's

substantiation show that a [claim] is both 'truthful and not

misleading.'" (quoting § 343(r)(6)(B))). The question here is

whether omitting the fact that glutamine supplementation is

useless at the doses prescribed on the labels renders Vitamin

Shoppe's claims about glutamine's physiological role misleading.

In Greenberg, the Ninth Circuit answered no. It reasoned that if

a true claim such as "vitamin C boosts immunity" is misleading

because most people do not need nor benefit from taking vitamin C,

then "virtually any structure/function claim for dietary

- 23 - supplements would potentially be misleading to the great majority

of people" because most people are not walking around with vitamin

deficiencies. Greenberg,

. Such an outcome, it

said, would conflict with the FDCA's text and Congress's purpose

in enacting a regulatory carve-out for structure/function claims.

We agree. Section 343(r)(6)(B) requires the manufacturer to

have substantiation that its claim about a nutrient's

physiological role is not misleading. That taking the product as

directed does not reap the benefits the label attributes to the

nutrient has nothing to do with whether the nutrient's claimed

physiological role is misleading. See

("[M]anufacturers may

make structure/function claims about a nutrient's general role on

the human body without disclosing whether the product will provide

a health benefit to each consumer.").

To be sure, a structure/function claim is misleading if

it omits a nutrient's conflicting or harmful role in affecting the

human body's structure or function. See Kaufman, 836 F.3d at 95–

96 (failing to disclose the nutrient's harmful effect on the human

body's structure or function plausibly renders a

structure/function claim misleadingly incomplete). And a

structure/function claim is untruthful if the nutrient does not

have the claimed effect. See Kroessler v. CVS Health Corp.,

(9th Cir. 2020) (reversing dismissal of the

plaintiff's complaint on preemption grounds where the plaintiff

- 24 - alleged that glucosamine does not have the claimed effect on the

human body's structure or function). But this is not such a case.

Because the experts here agree that Vitamin Shoppe's claims about

glutamine's physiological role are truthful and there is no

contention that these claims are misleading as to that role,

Vitamin Shoppe has complied with § 343(r)(6)(B).

IV. The statements about glutamine on Vitamin Shoppe's

labels are structure/function claims under § 343(r)(6). And

Vitamin Shoppe has complied with the FDCA's requirements to make

such claims. The plaintiffs' state law claims attacking those

statements are therefore expressly preempted by the FDCA. The

district court's judgment is affirmed.

- 25 -