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 -