Court Opinion

ID: 9400892
Source: CourtListenerOpinion
Date Created: 2023-06-09 18:00:49.648787+00
Date Added: 2024-06-11T17:19:48.749122
License: Public Domain

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.), 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

                                         - 3 -
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),

                                     - 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 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,

      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., 251 F.3d 227, 232 (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, 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

       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, 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

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, 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").

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., 985 F.3d

650 (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."           Id. at 654.   A disease claim, in

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

or treat a disease."      Id.      But Greenberg did not say that merely

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

acceptable structure/function claim.               See id.       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, 836 F.3d at 93.          But the FDA's guidance defines

it as "competent and reliable scientific evidence."                 Id. (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 id., 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 21 U.S.C. § 321(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., 718 F.3d 28, 35 (1st Cir. 2013) ("We will not ordinarily

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

(quoting Dean v. United States, 556 U.S. 568, 572 (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."               21 U.S.C. § 355(d); see

also   Mut.    Pharm.   Co.    v.   Bartlett,   570    U.S.   472,   476   (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   21    C.F.R.

§ 101.93(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., 718 F.3d at 35

("[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, 508 U.S. 200,

208 (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), 1994 WL

562259,     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, 2022 WL 974048, 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, 17 Stan. L. & Pol'y Rev. 165,
166 (2006); Peter J. Cohen, Science, Politics, and the Regulation
of Dietary Supplements: It's Time to Repeal DSHEA, 31 Am. J.L. &
Med. 175, 179–180 (2005); Stephen H. McNamara, Dietary Supplements
of Botanicals and Other Substances: A New Era of Regulation, 50
Food & Drug L.J. 341, 341 (1995).

                                   - 18 -
recommendation         "unless     specific        regulatory     or      statutory

requirements are cited."           Id. Part I.A.; see also Greenberg, 985

F.3d at 656 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, 552 F.3d 75, 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, 590 F.3d 7,

16 (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.      21

U.S.C.    § 343.      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.

Id. § 321(n); see also Kaufman, 836 F.3d at 95 ("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, 985 F.3d at 656.         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.

Id.    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 id. ("[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., 977

F.3d   803,    812    (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 -