Court Opinion

ID: 4031443
Source: CourtListenerOpinion
Date Created: 2016-09-06 17:00:35.781616+00
Date Added: 2024-06-11T14:35:36.522125
License: Public Domain

United States Court of Appeals
                       For the First Circuit

No. 16-1199

                          RONDA KAUFMAN,
     on behalf of herself and all others similarly situated,

                       Plaintiff, Appellant,

                                 v.

          CVS CAREMARK CORPORATION; CVS PHARMACY, INC.,

                       Defendants, Appellees.

          APPEAL FROM THE UNITED STATES DISTRICT COURT
                FOR THE DISTRICT OF RHODE ISLAND

              [Hon. Mary M. Lisi, U.S. District Judge]

                               Before

                  Torruella, Kayatta, and Barron,
                          Circuit Judges.

     Brian D. Penny, with whom Goldman Scarlato & Penny, P.C., was
on brief, for appellant.
     Robert M. Andalman, with whom A&G Law LLC was on brief, for
appellees.

                         September 6, 2016
             KAYATTA, Circuit Judge.            CVS Pharmacy, Inc. ("CVS")

sells a Vitamin E dietary supplement with a label that touts the

product as supporting "heart health."                 Having purchased CVS's

Vitamin E product, Ronda Kaufman alleges that CVS's label deceives

consumers because no scientifically valid studies show that the

label's   "heart     health"   statements       are   both   truthful   and   not

misleading.     Finding that federal law does not preempt Kaufman's

effort to maintain this action under New York's consumer protection

law, we reverse the district court's order dismissing Kaufman's

complaint.

                               I.     Background

             Because the district court dismissed this lawsuit on a

motion to dismiss for failure to state a claim, Fed. R. Civ.

P. 12(b)(6), our review is de novo and we assume that the facts

alleged in the complaint, plus reasonable inferences drawn from

those facts, are true.          In re Celexa & Lexapro Mktg. & Sales

Practices Litig., 779 F.3d 34, 39 (1st Cir. 2015).

             Ronda   Kaufman        purchased    CVS-brand    Vitamin    E    400

International Units ("IU") Softgels (100 count) at a CVS located

in Plainview, New York.             The bottle containing the Vitamin E

product bore the following label:

                                       - 2 -
Kaufman alleges that in deciding to purchase the product, she

relied on the label.

              Kaufman now claims that there are no scientifically

valid studies supporting CVS's "heart health" statements.        Rather,

she alleges that various studies1 evaluating Vitamin E "demonstrate

that       vitamin   E   and   vitamin   E   supplementation   offer   no

       1
       Stephen P. Fortmann et al., Vitamin and Mineral Supplements
in the Primary Prevention of Cardiovascular Disease and Cancer:
An Updated Systematic Evidence Review for the U.S. Preventive
Services Task Force, 159 Annals of Internal Med. 824 (2013); I-Min
Lee et al., Vitamin E in the Primary Prevention of Cardiovascular
Disease and Cancer--The Women's Health Study:         A Randomized
Controlled Trial, 294 J. Am. Med. Ass'n 56 (2005); Eva Lonn et
al.,   Effects   of  Long-Term   Vitamin   E   Supplementation  on
Cardiovascular Events and Cancer: A Randomized Controlled Trial,
293 J. Am. Med. Ass'n 1338 (2005); Edgar R. Miller III et al.,
Meta-Analysis: High-Dosage Vitamin E Supplementation May Increase
All-Cause Mortality, 142 Annals of Internal Med. 37 (2005); Howard
D. Sesso et al., Vitamins E and C in the Prevention of
Cardiovascular Disease in Men--The Physicians' Health Study II
Randomized Controlled Trial, 300 J. Am. Med. Ass'n 2123 (2008);
Paul G. Shekelle et al., Effect of Supplemental Vitamin E for the
Prevention and Treatment of Cardiovascular Disease, 19 J. Gen.
Internal Med. 380 (2004); Salim Yusuf et al., Vitamin E
Supplementation and Cardiovascular Events in High-Risk Patients,
342 New Eng. J. Med. 154 (2000).

                                    - 3 -
cardiovascular benefit" and "do[] not reduce the risk of suffering

a cardiovascular event, such as a heart attack, nor [do they]

reduce the risk of dying from cardiovascular disease."                She adds

that one study reflects "that those taking vitamin E had higher

rates of heart failure and were more likely to be hospitalized for

heart failure," while another study found "an increase in mortality

that progressively increased as daily dosage exceeds 150 iu."                The

complaint further states that "[a]ll variations of [CVS's] pill-

type vitamin E products exceed the 150 iu level shown to increase

mortality    in    this   study."     As   a   result,    she   alleges,   CVS's

representation       that    its    product    supports    heart    health    is

misleading.

            Kaufman marshalled these allegations in service of a

putative class action complaint that advances two counts at issue

on appeal:        violation of the New York Consumer Protection Act,

N.Y. Gen. Bus. Law § 349 ("NYCPA section 349"), which makes

unlawful "[d]eceptive acts or practices in the conduct of any

business, trade or commerce or in the furnishing of any service"

in New York, id. § 349(a), and a piggy-back common law claim of

unjust enrichment.          The district court found that federal law

preempts both of these statements because CVS's label on its

Vitamin E product complied with labeling requirements for dietary

supplements under the Federal Food Drug and Cosmetic Act ("FDCA"),

21 U.S.C. §§ 301 et seq.; see also id. § 343-1(a)(5).               Kaufman v.

                                      - 4 -
CVS Caremark Corp., No. 14-216-ML, 2016 WL 347324, at *8 (D.R.I.

Jan. 28, 2016).

                              II.    Discussion

              The parties initially debate whether the district court

erred    in    requiring   Kaufman    to   state    with    particularity   the

circumstances constituting the alleged deception at issue in this

case under Federal Rule of Civil Procedure 9(b).                 We agree with

CVS that Kaufman waived any objection to that requirement, having

failed twice to argue in the district court that Rule 9(b) did not

apply.    See United States v. Argentine, 814 F.2d 783, 791 (1st

Cir. 1987).      At the same time, we also find that the applicability

of Rule 9(b) has no bearing on any possible disposition of this

appeal.       The circumstances to be stated with particularity under

Rule 9(b) generally consist of "the who, what, where, and when of

the allegedly [misleading] representation."                Alt. Sys. Concepts,

Inc. v. Synopsys, Inc., 374 F.3d 23, 29 (1st Cir. 2004) (quoting

Powers v. Bos. Cooper Corp., 926 F.2d 109, 111 (1st Cir. 1991)).

CVS makes no argument that the complaint fails to provide this

particularity.         And,     indeed,    it     does     contain   sufficient

particularity:      CVS is the "who"; the heart health statements are

the "what"; the label is the "where"; and the occasion on which

Kaufman purchased the product is the "when."                 Therefore, as CVS

acknowledges, "[t]he District Court's decision did not turn on

                                      - 5 -
whether the applicable pleading standard was pursuant to Fed. R.

Civ. P. 8(a) or 9(b)."        Neither does our decision.

            Rather, the pivotal question on this appeal is whether

Kaufman's complaint plausibly describes conduct by CVS that fell

outside the preemptive safe harbor provided by federal law.

A.     FDCA Preemption

            The FDCA circumscribes Kaufman's ability to bring this

claim against CVS.      Section 343-1(a)(5) of the FDCA provides that

no state may "establish . . . any requirement respecting any claim

of the type described in section 343(r)(1) of [the FDCA], 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).      Section

343(r)(1), in turn, governs statements, among others, that concern

a    nutrient's   relationship    "to    a   disease   or    a   health-related

condition."2      Id. § 343(r)(1)(B).          The parties agree (and we

therefore   assume)    that    section    343(r)(6),     which    provides   the

requirements for statements made on labels of dietary supplements,

relates    back   to   section   343(r)(1)(B),     and      section   343(r)(6)

       2
       The regulations promulgated by the FDA define a "[d]isease
or health-related condition" as "damage to an organ, part,
structure, or system of the body such that it does not function
properly (e.g., cardiovascular disease), or a state of health
leading to such dysfunctioning (e.g., hypertension)." 21 C.F.R.
§ 101.14(a)(5). A health claim, in turn, is defined as "any claim
made on the label or in labeling of a food, including a dietary
supplement, that expressly or by implication . . . characterizes
the relationship of any substance to a disease or health-related
condition." Id. § 101.14(a)(1).

                                    - 6 -
statements      are    therefore       governed     by     section    343-1(a)(5)

preemption.     Effectively adding belt to suspenders, the New York

law under which Kaufman seeks to proceed independently welcomes

the   preemptive      force   of   the    federal      statute,   providing     that

compliance with applicable federal rules and regulations provides

a "complete defense" to a claim under NYCPA section 349(a).                     N.Y.

Gen. Bus. Law § 349(d).         On all of this, the parties agree.

             The net effect of the foregoing is that CVS must prevail

if its label satisfies the requirements of FDCA section 343(r),

but neither federal nor state law poses any bar to recovery under

NYCPA section 349 to the extent that recovery is predicated on a

failure   by    CVS     to    comply      with   the     requirements     of    FDCA

section 343(r).       Accordingly, we turn our attention to determining

whether   the   complaint      plausibly     alleges      conduct    by   CVS   that

violates the requirements of FDCA section 343(r).

B.    Compliance with FDCA Labeling Requirements

             Section 343(r)(6) of the FDCA provides that

             a statement for a dietary supplement may be
             made if--

             (A) the statement . . . describes the role of
             a nutrient or dietary ingredient intended to
             affect   the   structure   or   function   in
             humans . . . ,

             (B) the manufacturer of the dietary supplement
             has substantiation that such statement is
             truthful and not misleading, and

                                         - 7 -
             (C) the statement contains, prominently
             displayed and in boldface type, the following:
             "This statement has not been evaluated by the
             Food and Drug Administration. This product is
             not intended to diagnose, treat, cure, or
             prevent any disease.".

             A statement under this subparagraph may not
             claim to diagnose, mitigate, treat, cure, or
             prevent a specific disease or class of
             diseases.   If the manufacturer of a dietary
             supplement proposes to make a statement
             described in the first sentence of this
             subparagraph in the labeling of the dietary
             supplement, the manufacturer shall notify the
             Secretary no later than 30 days after the first
             marketing of the dietary supplement with such
             statement that such a statement is being made.

21 U.S.C. § 343(r)(6).

             CVS's label for its 400 IU Vitamin E supplement makes

four statements that are subject to the requirements of section

343(r)(6):     that Vitamin E "supports antioxidant health"; that

Vitamin E helps "maintain healthy blood vessels"; that Vitamin E

"supports heart health"; and that Vitamin E "supports the immune

system."      The parties agree--and we therefore presume without

deciding--that these statements are all what the Food and Drug

Administration ("FDA") calls "structure/function claims" under

FDCA section 343(r)(6)(A).       See 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, 1002 (Jan. 6,

2000)      (codified   at   21     C.F.R.   pt.   101).        So-called

structure/function claims are statements that "describe[] the role

                                   - 8 -
of   a   nutrient    or    dietary   ingredient   intended     to     affect   the

structure or function in humans."           21 U.S.C. § 343(r)(6)(A).          The

manufacturer of a dietary supplement may make such statements if

the manufacturer both "has substantiation that such statement is

truthful and not misleading," id. § 343(r)(6)(B), and includes on

the label a prominent disclaimer stating that the FDA has not

evaluated the label's statement and that the "product is not

intended to diagnose, treat, cure, or prevent any disease," id.

§ 343(r)(6)(C).      The parties agree, and we therefore again assume

without deciding, that the label in this case contains just such

a disclaimer.        We therefore limit our inquiry to determining

whether     the     complaint     plausibly     alleges     that      CVS   lacks

"substantiation"          that    the      "support"      and/or      "maintain"

structure/function statements are "truthful and not misleading."

            In    urging    an   affirmative    answer    to   this    question,

Kaufman offers no developed argument that CVS lacks substantiation

that Vitamin E functions as an antioxidant.            Kaufman also does not

develop any argument that challenges the sufficiency of CVS's

substantiation of the statements that Vitamin E supports the immune

system or that it helps maintain healthy blood vessels.                 Instead,

training her critique on the label's several statements that

Vitamin E "supports heart health," Kaufman asserts that there

exists no substantiation that such a description of the nutrient's

function is truthful and not misleading.

                                        - 9 -
               The FDCA does not define the term "substantiation."

FDA guidance, however, advances a common sense interpretation of

"substantiation," also adopted by the Federal Trade Commission, as

meaning "competent and reliable scientific evidence."                    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 (last accessed

Aug. 22, 2016) (hereinafter "Guidance for Industry").                        Kaufman's

express       allegation    that    there    are      no   "scientifically       valid

studies"       substantiating      CVS's    heart     health      statements    fairly

implies that CVS has no competent and reliable evidence to support

its heart health statements.3               This allegation would normally

        3   Paragraph 1 of the complaint reads:

               CVS markets, sells, and distributes six
               versions of vitamin E supplements.      On all
               vitamin E packages, Defendants represent the
               product is intended for "heart health."
               However,   numerous   double-blind,   placebo-
               controlled studies demonstrate that vitamin E
               and vitamin E supplementation offer no
               cardiovascular benefit.    Vitamin E does not
               reduce the risk of suffering a cardiovascular
               event, such as a heart attack, nor does it
               reduce the risk of dying from cardiovascular
               disease.        There   are   no   comparable,
               scientifically   valid    studies   supporting
               Defendants' representation.

We read "representation" in the last sentence as referring to what

                                       - 10 -
suffice   to   save   from    preemption    Kaufman's   attempt   to   impose

liability on CVS for misleading customers because the imposition

of such a liability would not establish any requirement that

differs from the requirement of section 343(r)(6)(B)--that CVS

must have substantiation for its heart health statements.              See 21

U.S.C. § 343-1(a)(5); Dachauer v. NBTY, Inc., No. 16-cv-00216-VC,

2016 WL 3176612, at *1 (N.D. Cal. June 3, 2016).4

             CVS, however, contends that Kaufman effectively shot

herself in the foot by describing in the complaint seven studies

of Vitamin E that, CVS argues, provide the required substantiation.

See Trujillo v. Walgreen Co., No. 13 CV 1852, 2013 WL 4047717, at

*3 (N.D. Ill. Aug. 9, 2013) (plaintiff "effectively pled herself

out of Court" by not disputing that Vitamin E is an antioxidant

and   that     antioxidants     have   been    shown    to   contribute    to

cardiovascular health).       In CVS's words, the studies show Vitamin

E's "salutary functions in the body" are "scientific fact."

             We agree with CVS that the district court's, and now

our, consideration of the studies cited in the complaint is

CVS is said to "represent" in the first sentence (the heart health
statement that the parties agree is a function/structure claim).

      4 A 2012 report by the Inspector General revealed that many
dietary supplements failed to meet federal requirements for making
structure/function claims. Daniel R. Levinson, Inspector General,
Dietary Supplements: Structure/Function Claims Fail to Meet
Federal            Requirements            (Oct.            2012),
https://oig.hhs.gov/oei/reports/oei-01-11-00210.pdf.

                                   - 11 -
appropriate even under Rule 12(b)(6) where the complaint itself

directly references and purports to summarize the studies.               See

Giragosian v. Bettencourt, 614 F.3d 25, 27–28 (1st Cir. 2010).

That consideration though, provides no license to engage at this

stage of litigation in rejecting plausible readings of those

studies.    See Abdallah v. Bain Capital LLC, 752 F.3d 114, 119 (1st

Cir.    2014)   ("no   fact   finding"   in   assessing   complaint    under

Rule 12(b)(6)).        Rather, we look at the studies for a limited

purpose: do the studies on their face render implausible Kaufman's

claim    that    there    exist    no    scientifically      valid   studies

establishing that CVS's heart health statements are truthful and

not misleading?        For at least two independent reasons, they do

not.

            First, read in chronological order and with attention to

what they presume and what they find, the studies do not support

a judicial declaration under Rule 12(b)(6), unaided by expert

testimony, that they substantiate the heart health statements.            As

CVS itself concedes, none of the studies were designed to test the

statement   that   Vitamin    E   functions   to   support   heart   health.

Rather, most of the studies presumed that to be so, and instead

tested the hypothesis that Vitamin E prevents certain diseases.

See, e.g., I-Min Lee et al., Vitamin E in the Primary Prevention

of Cardiovascular Disease and Cancer--The Women's Health Study:           A

Randomized Controlled Trial, 294 J. Am. Med. Ass'n 56, 56 (2005)

                                   - 12 -
("Vitamin E has antioxidant properties . . . leading to the

hypothesis     that   it      can   prevent      [cardiovascular       disease]."

(emphasis supplied)); Eva Lonn et al., Effects of Long-Term Vitamin

E   Supplementation      on    Cardiovascular        Events   and    Cancer:     A

Randomized Controlled Trial, 293 J. Am. Med. Ass'n 1338, 1338

(2005) ("Epidemiological data indicate an inverse association

between cardiovascular risk and vitamin E intake from dietary

sources and/or supplements." (emphasis supplied)); Edgar R. Miller

III et al., Meta-Analysis:          High-Dosage Vitamin E Supplementation

May Increase All-Cause Mortality, 142 Annals of Internal Med. 37,

37 (2005) ("On the basis of the premise that vitamin E reduces

oxidative stress, many clinical trials have tested vitamin E

supplementation as a therapy to prevent various chronic diseases."

(emphasis supplied)); Howard D. Sesso et al., Vitamins E and C in

the Prevention of Cardiovascular Disease in Men--The Physicians'

Health Study II Randomized Controlled Trial, 300 J. Am. Med. Ass'n

2123,   2123    (2008)        ("Basic     research     studies      suggest    that

vitamin E . . . and other antioxidants reduce cardiovascular

disease by trapping organic free radicals, by deactivating excited

oxygen molecules, or both, to prevent tissue damage." (emphasis

supplied)); Paul G. Shekelle et al., Effect of Supplemental Vitamin

E for the Prevention and Treatment of Cardiovascular Disease, 19

J. Gen. Internal Med. 380, 380 (2004) (referencing literature

"suggest[ing] a beneficial effect of antioxidant-rich foods, as

                                        - 13 -
well       as   specific   antioxidants,"   such   as    Vitamin   E   (emphasis

supplied));         Salim Yusuf et al., Vitamin E Supplementation and

Cardiovascular Events in High-Risk Patients, 342 New Eng. J. Med.

154, 154 (2000) ("Observational and experimental studies suggest

that the amount of vitamin E ingested in food and in supplements

is associated with a lower risk of coronary heart disease and

atherosclerosis" (emphasis supplied)).

                Second, the studies Kaufman cites, including the results

of a randomized controlled trial,5 are also plausibly construed,

in the aggregate, as indicating that Vitamin E, in dosages such as

that packaged by CVS, can even damage the heart.               One study, for

example, found that in some populations, increasing Vitamin E

intake by supplementation may increase the risk for heart failure.

See Lonn et al., supra page 12, at 1346.                And another found that

"high-dosage" Vitamin E supplements of 400 IU or more--the very

dosage that Kaufman purchased--may increase all-cause mortality.

Miller III et al., supra page 13, at 37, 40.                 This indication,

which the studies at least render plausible, would seem to mean

that Vitamin E can play a role in harming heart health.

       5
       See Lonn et al., supra note 1. The FDA has indicated that
such trials are the "gold standard," whereas animal studies and in
vitro studies such as those relied on by CVS and the district court
cannot, by themselves, provide adequate substantiation.         See
Guidance for Industry, supra page 10.

                                     - 14 -
             The statute grants CVS a preemptive license to describe

in its label "the role of a nutrient or dietary ingredient."           21

U.S.C. § 343(r)(6)(A) (emphasis supplied).       In so doing, Congress

did not similarly license a description of "a role" of the nutrient

that may mislead the consumer by omitting mention of a directly

related, conflicting role.      If Vitamin E's actual role is both to

support and to harm heart health, depending on the dosage actually

supplied, then a label on a product presented in the harmful dosage

yet revealing only the former aspects of the vitamin's role

relative to health is incomplete in a way that could be material

to the consumer's exercise of choice in deciding whether to buy

the product.

             This conclusion finds textual support in section 321(n)

of the FDCA, which provides that when evaluating whether an article

(i.e.,   a    product)   is   misbranded   because   the   labeling6   is

misleading, we "shall" take into account, among other things,

             not only representations made or suggested by
             [the] statement . . . but also the extent to
             which the labeling . . . fails to reveal facts
             material in the light of such representations
             or material with respect to consequences which
             may result from the use of the article to which
             the labeling . . . relates under the
             conditions   of    use   prescribed    in   the
             labeling . . . or under such conditions of use
             as are customary or usual.

     6  "Labeling," includes the product's "label," 21 U.S.C.
§ 321(m), which includes "written, printed, or graphic matter upon
the immediate container of any article," id. § 321(k).

                                 - 15 -
Id. § 321(n).

               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

health statement is both "truthful and not misleading."                         Id.

§ 343(r)(6)(B). More broadly, it aligns well with the FDA's stated

mission to "promote," id. § 393(b)(1), and "protect the public

health     by    ensuring    that    .     .   .   [dietary   supplements]      are

safe . . . and properly labeled," id. § 393(b)(2)(A).                          If a

particular dietary supplement functions to harm health in the

supplied or recommended dosage, a label claiming that the product

supports health is plausibly viewed as misleading within the

meaning of section 343(r)(6)(B).               To rule otherwise would be to

treat    the     FDCA   as   granting     license    to   entice    consumers    to

unwittingly incur risk and harm.

               In so reasoning, we do not accept Kaufman's argument

that evidence showing a supplement does not reduce heart disease

necessarily implies that the nutrient itself has no function in

maintaining heart health.           On the contrary, Congress has expressly

specified that sellers of dietary supplements can "describe[] the

role of a nutrient . . . intended to affect the structure or

function in humans," id. § 343(r)(6)(A), even while simultaneously

disavowing any claim that the product is intended "to . . . prevent

any disease," id. § 343(r)(6)(C).                   And the FDA has in turn

                                         - 16 -
promulgated   a     regulation     blessing   terms     like      "promote,"

"maintain," and "support," so long as the seller has substantiation

for the description.      See Regulations on Statements Made for

Dietary Supplements Concerning the Effect of the Product on the

Structure or Function of the Body, 65 Fed. Reg. at 1014.               Thus,

any nutrient or ingredient that, for example, the heart needs might

be described as supporting heart health, even if taking the

supplement form of the nutrient actually does nothing to improve

the health of one's heart, as long as the claimed beneficial

function is substantiated and the description of the nutrient's

role is not misleadingly incomplete.        And while Kaufman plausibly

suggests that the drawing of such a distinction between the

ingredient's function and its lack of any impact on morbidity

likely tricks many consumers who unwittingly think that such a

product will reduce the likelihood of poor heart health, this is

a form of finesse that the statute and the regulations allow. See,

id.   (suggesting   increased    consumer   "choice"   as   a    reason    for

allowing such marketing).       On the other hand, a section 343(r)(6)

disclaimer,    while     legally      sufficient       to       immunize     a

structure/function claim that is truthful and not misleading, does

not immunize a structure/function claim for which the manufacture

lacks the required substantiation or that misleadingly fails to

disclose the harmful aspects of the nutrient's structure/function.

                                  - 17 -
           As we have already noted, we read the studies referenced

in the complaint only to see if, on their face, they render

implausible Kaufman's allegation that substantiation for CVS's

heart health statements does not exist.              CVS might have other

studies that paint a different and more credible overall picture.

Expert testimony might also shed a different light than that cast

by the complaint or by a bare reading of the studies unaided by

additional context.       The point, simply, is that the cited studies

do not on their face render implausible the allegation that CVS

lacks substantiation that the "heart health" and "supports heart

health" statements are truthful and not misleading descriptions of

the function of Vitamin E supplements in humans.             For purposes of

Rule   12(b)(6),    it    therefore   follows     both     that   Kaufman   has

adequately pled that CVS's labeling of its Vitamin E supplement is

not in keeping with the requirements of FDCA section 343(r), and

that federal law does not, therefore, preempt application of New

York state law for the purpose of holding CVS accountable for

misleading consumers by failing to satisfy those requirements.

With CVS advancing no argument that unsubstantiated and deceptive

health   claims    made   in   marketing    a   consumer    product   are   not

actionable under New York law, we therefore reverse the dismissal

of Kaufman's claim under NYCPA section 349.

                                   - 18 -
C.      Unjust Enrichment

             Kaufman's claim of unjust enrichment under New York law

rests     necessarily    on   her    allegation   that   CVS's   label   was

"deceptive."     CVS correctly observes that if the label does not

violate the FDCA's requirements, the unjust enrichment claim also

necessarily fails.       See Cleary v. Philip Morris, Inc., 656 F.3d
511, 517 (7th Cir. 2011) ("[I]f an unjust enrichment claim rests

on the same improper conduct alleged in another claim, then the

unjust enrichment claim will be tied to this related claim--and,

of course, unjust enrichment will stand or fall with the related

claim.").     The district court agreed, and dismissed the unjust

enrichment claim.       Kaufman, 2016 WL 347324, at *8.

             Given our finding that the complaint adequately alleges

that the label's statements were misleading in a manner that

violated the requirements of section 343(r), it follows that the

unjust enrichment count is also not preempted to the extent that

its reference to deceptive conduct is solely to the conduct that

would render the label misleading under section 343(r). CVS offers

no other grounds for dismissing the unjust enrichment count.             We

therefore reverse the dismissal of that count for all the reasons

set forth concerning the NYCPA section 349 count.

                              III.   Conclusion

             The district court's dismissal of Kaufman's complaint is

reversed.

                                     - 19 -