Kaufman v. CVS Caremark Corporation et al

Filing 25

ORDER AND MEMORANDUM granting 9 Motion to Dismiss. Defendants' Motion to Dismiss Complaint is granted and the Complaint is dismissed with prejudice. So Ordered by Senior Judge Mary M. Lisi on 1/27/2016. (Feeley, Susan)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND

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

C.A. No. 14-216-ML

CVS CAREMARK CORPORATION and
CVS PHARMACY, INC.,
Defendants.
ORDER AND MEMORANDUM
The plaintiff in this action, Ronda Kaufman (“Kaufman”) has
brought

claims1

holding

company,

against
CVS

CVS

Pharmacy,

Caremark

Inc.

Corporation

(“CVS”)
(“CVS

and

its

Caremark”,

together with CVS, the “Defendants”), related to the allegedly
fraudulent

labeling

of

CVS-brand

vitamin

E

supplements.

The

matter before the Court is the Defendants’ motion to dismiss the
complaint. For the reasons that follow, the Defendants’ motion is
GRANTED.
I.

Factual Background
Kaufman asserts that, on an unspecified date, she purchased

1

Kaufman’s complaint (the “Complaint”) is styled as a Class
Action Complaint and, as part of her requested remedies, she seeks
an order “that this action may be maintained as a Class Action
under Rule 23 of the Federal Rules of Civil Procedure, that
Plaintiff be appointed to represent for the [national] Class and
[Rhode Island and New York] subclass, and that Plaintiff’s counsel
be appointed as counsel for the Class and subclass.” Complaint at
14.
1

CVS vitamin E 400 IU Softgels (100 count) at a CVS located in
Plainview, New York. According to Kaufman, “[p]rior to making her
purchases, [she] read and reviewed the representation regarding
heart health made on the product packing and, in reliance upon
those statements,” she bought the supplement. Complaint at 3.
Kaufman further alleges that she believed the supplement would
“provide the promised heart health benefits” and that, “[a]s a
result of her purchases,” she “suffered injury in fact and lost
money.”

Id. Finally, Kaufman asserts that she would not have

purchased

the

supplement,

“had

she

known

the

truth

about

Defendant’s misrepresentations and omissions.” Id. It is unstated
whether

Kaufman

actually

consumed

any

of

the

supplements

or

whether she has any concerns regarding her risk of heart health.
In essence, Kaufman’s claim is based on the assertion that CVS’s
deceptive marketing caused her to lose money.
According

to

the

Complaint,

in

addition

to

the

product

purchased by Kaufman, six other CVS vitamin E supplements (one
vitamin E oil preparation and five different softgel capsules)
feature a “Heart Health” label on the front, see depiction on
page

4

of

the

Complaint.

In

addition,

the

soft

gel

bottles

contain the statement “Vitamin E helps maintain healthy blood
vessels and promotes heart health.” Complaint at 5. As evident
from the complete label provided by CVS in its memorandum in
2

support of its motion to dismiss (Dkt. No. 10), that statement is
followed by another statement that “Vitamin E also supports the
immune system,” both of which are marked with asterisks, as are
the term “Heart Health” and the phrase “Supports Antioxidant
Health.” In a separate text box, the asterisks are explained as
follows: “These statements have not been evaluated by the Food
and

Drug

Administration.

This

product

is

not

intended

to

diagnose, treat, cure or prevent any disease.” CVS Mem. at 4. The
same label also indicates that the product is subject to a “CVS
Quality Money Back Guarantee.” Id.
Based on the information provided on the label, Kaufman
asserts that she was “misled by Defendants’ statements to believe
its vitamin E products would reduce her risk of heart disease
when they

do

not.”

Complaint

at

7.

Kaufman’s

assertion

that

Defendants misrepresented the benefit of their products is based
on (1) a selection of seven medical journal articles referenced
in her Complaint and subsequently submitted to this Court; and
(2)

the

unsupported

contention

that

other,

unnamed

studies

“finding any benefit to consuming vitamin E are generally either
epidemiological,

flawed,

or

are

findings

that

occurred

by

chance.” Complaint at 7. Kaufman claims that “[a]s a result of
Defendants’

deceptive

marketing,

[she]

and

other

consumers

suffered injury in fact and lost money or property.” Complaint at
3

7.
II. Procedural History
On

May

2,

2014,

Kaufman

filed

a

three-count

Complaint,

alleging (Count I) violation of the Rhode Island Deceptive Trade
Practices

Act, R.I. Gen. Laws § 6-13.1 et seq.2; (Count II)

violation of the New York Consumer Protection Act (“NYCPA”),
codified at New York General Business Law § 349; and (Count III)
Unjust Enrichment/Restitution. Kaufman brings the action on her
own behalf and on behalf of (1) a proposed class of United States
residents who purchased CVS vitamin E products featuring a “heart
health” label or stating that “Vitamin E helps maintain healthy
blood vessels and promotes heart health;” and (2) two subclasses
of (a) Rhode Island3 and (b) New York State residents, who made
such purchases. In addition to class certification, Kaufman seeks
a permanent injunction against the Defendants; disgorgement of
profits;

actual,

statutory,

and

punitive

damages;

attorneys’

fees, costs, and prejudgment interest. Complaint at 14.
On August 7, 2014, the Defendants filed a motion to dismiss

2

Kaufman subsequently withdrew her claim under the Rhode Island
Deceptive Trade Practices Act. Pltf.’s Obj. (Dkt. No. 11) at Page
8 of 27 n.1. It remains undisputed that the single transaction on
which Kaufman’s claims are based took place in the State of New
York.
3

See n. 2 herein.
4

(Dkt. No. 9) the Complaint pursuant to Fed. R. Civ. P. 12(b)(1)
and 12(b)(6) on the grounds that (1) Kaufman’s claims are moot;
(2) Kaufman fails to plead a false or fraudulent act; and (3)
Kaufman’s claims are preempted by Federal Law and/or exempted by
the New York Consumer Protection Act. Defs.’ Mem.

(Dkt. No. 10).

On August 25, 2014, Kaufman filed a response (Dkt. No. 11)
in opposition to the Defendants’ motion, to which the Defendants
filed a reply on September 4, 2014 (Dkt. No. 12).
Following a telephone conference with the parties on October
23,

2014,

the

Court

advised

the

parties

that

it

would

hold

Defendants’ motion to dismiss the Complaint in abeyance, pending
a decision by the First Circuit Court of Appeals in the case of
Bais Yaakov of Spring Valley v. Act, Inc., 798 F.3d 46 (1st Cir.
2015).
On August 21, 2015, the First Circuit issued a decision in
Bais Yaakov, holding that “a rejected and withdrawn offer of
settlement

of

the

named

plaintiff's

individual

claims

in

a

putative class action made before the named plaintiff moved to
certify

a

class

jurisdiction

by

did

not

mooting

divest
the

the

named

court

of

plaintiff's

subject

matter

claims.”

Bais

Yaakov, 798 F.3d at 46. The First Circuit’s decision was based on
the determination that the defendant’s offer did not moot the
litigation

because

the

plaintiff
5

had

not

“received

complete

relief.” Id. at 55.
Days
Defendants

after

the

Bais

submitted

an

Yaakov

additional

opinion

was

briefing

to

issued,
this

the

Court,

seeking to distinguish the instant case from the facts in Bais
Yaakov

(Dkt.

No.

13).

Kaufman

promptly

filed

a

response

in

opposition (Dkt. No. 15), to which the Defendants filed a reply
(Dkt. No. 16). On October 14, 2015, Kaufman filed a motion for
leave to file a supplemental brief (Dkt. No. 17) in opposition to
the Defendants’ motion to dismiss the Complaint. After her motion
was granted, Kaufman filed the supplemental brief on October 26,
2015 (Dkt. No. 19).

The following day, the Defendants filed a

motion for leave to file a response (Dkt. No. 20) to Kaufman’s
supplemental memorandum. That motion having been granted as well,
the Defendants filed a Reply Memorandum on November 17, 2015
(Dkt. No. 22). Finally, on December 10, 2015, Kaufman filed a
motion for a hearing (Dkt. No. 23) on the Defendants’ motion to
dismiss her Complaint. However, given the extensive and thorough
briefing the Defendants’ motion has generated, the Court is of
the opinion that no such hearing is necessary and proceeds to
render a decision without oral argument.
III. Standard of Review
A motion to dismiss for lack of subject matter jurisdiction
is governed by Fed. R. Civ. P. 12(b)(1). A motion to dismiss for
6

failure to state a claim upon which relief may be granted is
governed by Fed. R. Civ. P. 12(b)(6). If a motion is brought
under both 12(b)(1) and 12(b)(6), “a district court, absent good
reason to do otherwise, should ordinarily decide the 12(b)(1)
motion first.” De La Cruz v. Irizarry, 946 F.Supp.2d 244, 249
(1st

Cir.

2013)(quoting

Northeast

Erectors

Ass'n

of

BTEA

v.

Secretary of Labor, Occupational Safety & Health Admin., 62 F.3d
37, 39 (1st Cir.1995) (citing 5A Charles Wright & Arthur Miller,
Federal Practice and Procedure § 1350, at 210 (1990)).
The standard of review accorded a dismissal under either
Rule 12(b)(1) or 12(b)(6) is “similar.” Murphy v. United States,
45 F.3d 520, 522 (1st Cir. 1995). Accordingly, in considering a
motion

to

dismiss

a

complaint

the

Court

must

construe

the

complaint in the light most favorable to the plaintiff, taking
all well-pleaded facts as true, and giving the plaintiff the
benefit of all reasonable inferences. Arruda v. Sears, Roebuck &
Co., 310 F.3d 13 (1st Cir. 2002). In order to withstand a motion
to dismiss, a claim “must contain sufficient factual matter ...
to state a claim to relief that is plausible on its face.” Katz
v. Pershing, LLC, 672 F.3d 64, 72-73 (1st Cir. 2012)(citations
omitted). The complaining party must include “factual content
that allows the court to draw a reasonable inference” in the
pleader’s favor. Id. “If, under any theory, the allegations are
7

sufficient to state a cause of action in accordance with the
law,” the motion to dismiss must be denied. Vartanian v. Monsanto
Co., 14 F.3d 697, 700 (1st Cir.1994). The Court ignores, however,
“statements in the complaint that simply offer legal labels and
conclusions or merely rehash cause-of-action-elements.” Schatz v.
Republican State Leadership Comm., 669 F.3d 50, 55 (1st Cir.
2012). In addition, “the party invoking the jurisdiction of a
federal

court

carries

the

burden

of

proving

its

existence.”

Johansen v. United States, 506 F.3d 65, 68 (1st Cir.2007).
In a case alleging fraud or mistake, Federal Rule 9 requires
that a party “must state with particularity the circumstances
constituting fraud or mistake.” Fed. R. Civ. P. 9(b). The First
Circuit has explained that “‘Rule 9 requires specification of the
time, place, and content of an alleged false representation, but
not the circumstances or evidence from which fraudulent intent
could be inferred.’” Doyle v. Hasbro, Inc., 103 F.3d 186, 194
(1st Cir. 1996)(quoting McGinty v. Beranger Volkswagen, Inc., 633
F.2d 226, 228 (1st Cir.1980), and noting that the heightened
pleading requirement
notice

to

defendants

imposed
of

the

by

Rule

9

is intended

plaintiffs'

claim,

to

to “give
protect

defendants whose reputation may be harmed by meritless claims of
fraud, to discourage ‘strike suits,’ and to prevent the filing of
suits that simply hope to uncover relevant information during
8

discovery”). In other words, a plaintiff alleging fraud must “set
forth what is false or misleading about a statement, and why it
is false.” In re GlenFed, Inc. Sec. Litig., 42 F.3d 1541, 1548
(9th Cir.1994) (en banc), superseded by statute on other grounds
as stated in Ronconi v. Larkin, 253 F.3d 423, 429 n. 6 (9th
Cir.2001).
Although

the

Court

generally

may

not

consider

documents

outside of the complaint unless it converts the motion to dismiss
pursuant to Rule 12(b)(6) into one for summary judgment, it may
make an exception “for documents the authenticity of which are
not disputed by the parties; for official public records; for
documents central to the plaintiffs’ claim; or for documents
sufficiently referred to in the complaint.”4 Watterson v. Page,
987 F.2d 1, 3 (1st Cir. 1993). The Court may also consider
materials

outside

the

pleadings

on

a

Rule

12(b)(1)

motion.

Gonzalez v. United States, 284 F.3d 281, 288 (1st Cir. 2002).
IV.

The Parties’ Contentions
A.

The Defendants’ Position

The Defendants assert that Kaufman’s claims are moot, on the
4

The Court notes that, six weeks after filing her fifteen-page
Complaint (Dkt. No. 1), Kaufman submitted ninety pages of exhibits
in support of the Complaint (Dkt. No. 4)(Dkt. No. 5 is
duplicative). The exhibits, which are also referenced in the
Complaint, include the 2012 CVS Caremark annual report and seven
medical journal articles related to the effects of taking vitamin
E supplements.
9

grounds that (1) the vitamin E supplement was subject to a moneyback guarantee; and (2) CVS made a Rule 68 Offer of Judgment to
Kaufman on July 11, 2014, offering to settle her personal claims
in full by paying her $7305, plus costs and reasonable attorneys’
fees (Dkt. No. 10-1 at 4-5).(Kaufman rejected the offer on July
24, 2014)(Dkt. No. 10-1 at 7). Following the First Circuit’s
decision in Bais Yaakov, the Defendants sought to distinguish
that case from the instant claim by pointing out that the moneyback guarantee on the vitamin E label at issue offered complete
relief to Kaufman or any member of the putative class. Defs.’
Notice of Decision (Dkt. No. 13) at 2.
Second, the Defendants assert that Kaufman’s claims that she
was

fraudulently

induced

to

purchase

vitamin

E

supplements

because of misrepresentations and deceptive advertising on the
product label is based entirely on studies which do not support
her allegations. Specifically, the Defendants point out that the
product label merely states that vitamin E supports heart health
and that, at the same time, the label disclaims that the vitamin
E supplement cures or prevents disease.
Further, the Defendants suggest that Kaufman’s claims are
5

The Defendants’ offer was calculated on (1) the assumption
that Kaufman would have taken two vitamin E supplements a day for
ten years, and (2) the current sales price of $8 for the product
purchased by Kaufman, plus $2 in taxes. Defs.’ Mem. at 9 (Dkt. No.
10).
10

preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”),
21 U.S.C. §301 et seq., which precludes states from imposing
requirements on nutrition labeling that are not identical to the
federal requirements.
The Defendants also assert that Kaufman’s claim pursuant to
the

NYCPA

is

exempted

thereunder.

Finally,

with

respect

to

Kaufman’s claim for unjust enrichment, the Defendants assert that
the claim is duplicative and depends entirely on the success of
Kaufman’s other claims.
B.

Kaufman’s Position

Kaufman maintains that she has adequately supported her New
York state law claim by “demonstrating the absence of any hearthealth benefit from vitamin E.” She also suggests that it would
be premature to resolve disputed facts regarding the meaning
and/or consumer understanding of “heart health.” Pltf.’s Obj.
(Dkt. No. 11) at Page 6 of 27.
With respect to the Defendants’ contention that Kaufman’s
claims are preempted by the FDCA, Kaufman asserts that (1) her
claims under New York Business Law § 349 do not seek to impose
requirements inconsistent with the FDCA; and (2) the vitamin E
label at issue does not satisfy the requirements necessary to
support

either

“structure/function

claims”

or

“health-related

claims” because the Defendants’ claims are unsubstantiated, false
11

and misleading. Id. at Page 6 of 27.

Kaufman also asserts that

she reasonably believed taking vitamin E would help her heart to
be well or free from disease but that prevailing science does not
support the Defendants’ representations on which her belief was
based.

Id.

contention,

at

Page

Kaufman

10

of

27.

points

to

With

respect

the

medical

to

that

journal

latter

articles

attached to her Complaint, which, according to Kaufman, reveal
that vitamin E does not decrease or prevent heart disease. Id. at
12 - 14 of 27. In essence, Kaufman suggests that her claims
pursuant

to

New

York

Business

Law

§

349

are

not

expressly

preempted by the FDCA because the Defendants’ “‘heart health’”
claims are false and misleading,” and because the Defendants
“misrepresent

that

vitamin

E

reduces

the

risk

of

heart

disease.”Id. at Page 17 of 27.
Kaufman further asserts that she has not yet had sufficient
opportunity to develop a record in support of class certification
and that the Defendants’s Rule 68 Offer of judgment constitutes
an attempt to “pick off” the claims of a representative plaintiff
in order to moot the putative class action. Id. at Page 22 of 27.
In response to the Defendants’ suggestion—following the decision
in Bais-Yaakov—that the money-back guarantee on the vitamin E
label offers complete relief to Kaufman and the putative class,
Kaufman

suggest

that

the

guarantee
12

fails

to

provide

for

injunctive relief, attorney’s fees, and statutory and punitive
damages. Pltf.’s Response (Dkt. No. 15) at 2. Finally, Kaufman
maintains that she has pleaded sufficient facts to establish a
claim for unjust enrichment. Id. at Page 25 of 27.
It is noted that both parties took the opportunity within
their supplemental briefing to apprise the Court of additional
case

law

development

after

the

parties

filed

their

primary

memoranda in 2014. Pltf.’s Supplemental Brief (Dkt. No. 19) and
Defs.’ Response (Dkt. No. 22). Even as late as last week, Kaufman
filed a notice of supplementary authority (Dkt. No. 24).
V.

Discussion
(A)

Existing Case and Controversy

In light of the First Circuit Court’s determination in Bais
Yaakov, this Court’s jurisdiction over Kaufman’s claims after her
rejection

of

the

Defendants’

Rule

68

offer

is

no

longer

in

question. Although the Defendants maintain that, given the moneyback guarantee on the product label at issue, there is no actual
case or controversy to be resolved in this case, relevant case
law indicates otherwise. See, e.g. F.T.C. v. Pantron I Corp., 33
F.3d 1088, 1103 (9th Cir. 1994)(holding that “the existence of a
money-back guarantee is insufficient reason as a matter of law to
preclude a monetary remedy.”); Montgomery Ward & Co. v. F.T.C.,
379

F.2d

666

(7th

Cir.1967)(holding
13

that

allowing

a

general

company money-back guarantee policy as a defense “would make the
false advertising prohibitions of the Act a nullity. Anything
might then be advertised as long as unsatisfied customers were
returned their money.”)
Kaufman’s ability to withstand the Defendants’ motion to
dismiss the Complaint, both on the basis of preemption under the
FDCA and for failure to assert a claim upon which relief may be
granted, depends on whether she has raised sufficient allegations
that the statements on the Defendants’ vitamin E product labels
constitute misrepresentations. The Court now proceeds to consider
Kaufman’s claims.
(B)

The Nutrition Labeling and Education Act

In 1990, prompted by “concerns from consumer groups about
unsubstantiated health claims on food and beverages,” Congress
passed the Nutrition Labeling and Education Act (“NLEA”), Pub.L.
No. 101–535, 104 Stat. 2353 (1990) (codified at 21 U.S.C. § 343
et seq.) Holk v. Snapple Beverage Corp., 575 F.3d 329, 331 (3d
Cir.2009). The NLEA’s purpose is to “ ‘clarify and to strengthen
[FDA's] authority to require nutrition labeling on foods, and to
establish the circumstances under which claims may be made about
the nutrients in foods.’” Nat'l Council for Improved Health v.
Shalala, 122 F.3d 878, 880 (11th Cir.1997) (quoting H.R.Rep. No.
101–538, at 7 (1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337).
14

In other words, “[t]he NLEA places limits on health claims that
may be made on food and dietary supplement labels.” Id.
(C)

No Private Right of Action

The NLEA enforces the FDCA and its regulations; it does not
provide for a private right of action. 21 C.F.R. §7.40; Bronson
v. Johnson & Johnson, Inc., 2013 WL 1629191 (N.D.Cal. April 16,
2013). See also, Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S.
341, 349 n. 4, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (noting, in
the context of the medical device provisions of the FDCA that,
due to 21 U.S.C. § 337(a), “[t]he FDCA leaves no doubt that it is
the Federal Government rather than private litigants who are
authorized to file suit for noncompliance with the [FDCA]”).
(D)

FDCA Requirements

Pursuant to 21 U.S.C. § 343(r)(6), a statement for a dietary
supplement may be made if-(A) the statement claims a benefit related to a
classical nutrient deficiency disease and discloses the
prevalence of such disease in the United States,
describes the role of a nutrient or dietary ingredient
intended to affect the structure or function in humans,
characterizes the documented mechanism by which a
nutrient or dietary ingredient acts to maintain such
structure or function, or describes general well-being
from consumption of a nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has
substantiation that such statement is truthful and not
misleading, and
(C) the statement contains, prominently displayed and
in boldface type, the following: “This statement has
15

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. § 343(r)(6).

(E) Preemption of State Laws
The

NLEA contains an express preemption provision, which

states, in relevant part:
Except as provided in subsection (b),[6] no State or
political subdivision of a State may directly or
indirectly establish under any authority or continue in
effect as to any food in interstate commerce —
. . .
(5) any requirement respecting any claim of the type
described in section 343(r)(1) of this title [i.e.,
nutrition levels and health-related claims], made in
the label or labeling of food that is not identical to
the requirement of section 343(r) of this title. 21
U.S.C. § 343–1(a)(5).
If

a

statement

requirements,

any

for

a

consumer

dietary
fraud

supplement

claims

under

satisfies
state

law

FDCA
are

precluded. Trujillo v. Walgreen Co., 2013 WL 4047717 at *1 (N.D.
Ill. Aug. 9, 2013)(citing Turek v. General Mills, Inc., 754 F.
Supp. 2d 956, 961 (N.D. Ill. 2010)).
16

(F)

This Case

Kaufman’s claims result from her single purchase of the
Defendants’ vitamin E supplement, which features a product label
containing the term “Heart Health*” and the statements “Supports
Antioxidant Health*” and
vessels

and

supports

“Vitamin E helps maintain healthy blood

heart

health.*”

As

noted,

supra,

the

asterisks refer to a disclaimer that the FDA has not evaluated
the

statements

and

that

the

supplement

is

diagnose, treat, cure or prevent any disease.”

“not

intended

to

(Dkt. No. 10-1 at

Page 2 of 48).
Kaufman

alleges

that

she

and

other

consumers

have

been

fraudulently induced to purchase vitamin E supplements that do
not perform as advertised. Specifically, Kaufman alleges that she
was “misled by Defendants’ statements to believe its vitamin E
Products would reduce her risk of heart disease when they do
not.”

Complaint

representations

at
on

¶

21.

the

Kaufman’s

product

label

assertions

at

issue

are

that

the

false

and

misleading are based solely on a selection of studies attached to
the

Complaint,

supplement

some

of

containing

which

vitamin

have
E

does

concluded
not

that

reduce

taking

a

risk

of

the

suffering a cardiovascular event or of dying from cardiovascular
disease.

According

to

Kaufman,

“the

entire

premise”

of

her

Complaint is that “CVS’s ‘heart health’ claims are false and
17

misleading,” Pltf’s. Obj. (Dkt. No. 11) at 12, and she suggests
that the “Defendants would not violate any FDA regulation if they
removed these representations.” Complaint ¶ 29.
As Kaufman clarifies in her pleadings, she is asserting a
“false structure/function” claim. Pltf.’s Supp. Brief (Dkt. No.
19) at 4. The core of Kaufman’s claim is the allegation that the
struction/function claims on Defendants’ vitamin E product label
are

“false

and

misleading”

and,

therefore,

do

not

meet

the

requirement under the FDCA that those claims must be “truthful
and not misleading.” 21 U.S.C. § 343(r)(6)(B). As noted, the sole
support for Kaufman’s allegation depends on the submitted case
studies.
A review of the product label at issue reveals that the
statements on the vitamin E label are in compliance with FDCA
regulations. The label is limited to asserting that Vitamin E
supports antioxidant health, maintains healthy blood vessels, and
supports heart health.6 12 U.S.C. § 343(r)(6)(A). As such, the
role of vitamin E as an antioxidant is substantiated by several
of the studies cited by Kaufman:
(1)

“The

rationale

for

using

[dietary]

supplements

is

supported by many in vitro and animal studies showing that they

6

The label further states that Vitamin E supports the immune
system, which is an assertion not at issue in this case.
18

protect

against

Stephen

P.,

Primary

Prevention

of

Updated

Systematic

Evidence

et

[]

damaging

al.,

cellular

Vitamin

and

mechanisms.”

Mineral

Cardiovascular
Review

Supplements

Disease
for

Fortmann,

the

and
U.S.

in

the

Cancer:

An

Preventive

Services Task Force, 159(12) Annals of Internal Medicine 824
(December 17, 2013). Pltf.’s Ex. B.
(2)

“Basic

research

studies

suggest

that

vitamin

E,

vitamin C, and other antioxidants reduce cardiovascular disease
by trapping organic fee radicals, by deactivating excited oxygen
molecules, or both, to prevent tissue damage...Some, but not all
prospective

cohort

studies

support

a

role

for

vitamin

E

in

cardiovascular disease prevention.” Sesso, H.D., et al. Vitamins
E and C in the Prevention of Cardiovascular Disease in Men. The
Physicians' Health Study II Randomized Controlled Trial, 300(18)
JAMA 2123 (November 12, 2008), Pltf.’s Ex. C;
(3)

“Vitamin

E

has

antioxidant

properties,

including

inhibition of oxidation of low-density lipoprotein cholesterol in
plasma, leading

to

the

hypothesis

that

it can

prevent these

chronic diseases. In some, but not all, basic research reports,
vitamin E supplementation retarded atherogenesis [formation of
abnormal fatty

deposits

in

an

artery].”

Lee,

I–Min,

et

al.,

Vitamin E in the Primary Prevention of Cardiovascular Disease and
Cancer. The Women's Health Study: A Randomized Controlled Trial,
19

294(1) JAMA 56 (July 6, 2005), Pltf.’s Ex. D;
(4)

“In humans, [Vitamin E] can improve endothelial [the

inner lining of blood vessels] function. Epidemiological data
indicate an inverse association between cardiovascular risk and
vitamin E intake from dietary sources and/or supplements.” Lonn,
E., et al., Effect of Long-term Vitamin E Supplementation on
Cardiovascular Events and Cancer: A randomized Controlled Trial,
293(11) JAMA 1338 (March 16, 2005), Pltf.’s Ex. E.
It is noted that, with the exception of the Lee study—which
itself acknowledged that its finding of a “26% reduction in major
cardiovascular events observed among women aged at least 65 years
assigned to vitamin E” could have been “due to chance, arising
from multiple comparisons”—each of the studies cited by Kaufman
ultimately concluded that the taking of vitamin E supplements
provided

no

benefit

cardiovascular

disease

cardiovascular

events,

for
or

the
the

including

prevention
reduction
heart

of

failure

of
risk
and

cancer
of

or

major

death.

In

addition, at least one study concluded that high-dosage (400
IU/d) vitamin E supplements may increase all-cause mortality and
should be avoided. Miller, Edgar R. III, et. al, Meta-Analysis:
High-Dosage Vitamin E Supplementation May Increase All-Mortality,
142(1) Annals of Internal Medicine 37 (January 4, 2005).
The statements on the Defendants’ product label, however,
20

make

no

assertions

that

conflict

specific

disclaimer

that

the

intended

to

complies

with

diagnose,
FDCA

with

these

Defendants’

treat,

cure

requirements.

or

The

findings.

supplement

prevent
results

any
of

The

“is

not

disease,”

these

cited

studies cannot support a finding of misrepresentation by the
Defendants for the limited content of their function/structure
claims, which is, moreover, supported by the same studies.
Although Kaufman concedes that the FDCA expressly preempts
state laws that seek to impose requirements not identical to
those set forth in the NLEA, she suggests that the prohibition
against deceptive acts or practices under Section 349 of New York
General

Business

Law,

structure/function
Pltf.’s

Obj.

at

“mirrors”

claims
12.

In

federal

requirements

be

“truthful

and

not

other

words,

Kaufman

that

misleading.”

suggests

that,

because the Defendants’ labeling is insufficient under the FDCA,
it provides grounds for a claim under New York state law that is
not preempted by federal law.
Neither Kaufman’s allegations nor the studies on which she
relies support such a conclusion. The label on the Defendants’
Vitamin
Kaufman’s

E

products

is

allegations

in
that

compliance
“Defendants

with

FDCA

misled

regulation.

consumers

to

believe these products protect consumers’ hearts and/or reduce
consumer’s risk of heart disease;” and that she “was misled by
21

Defendants’ statements to believe its [sic] vitamin E products
would reduce her risk of heart disease” are inconsistent with the
statements that are actually written on the label, and they are
in direct contravention of the explicit disclaimer on the product
label.
In sum, Kaufman fails to connect her claims regarding the
alleged misrepresentations on the Defendants’ vitamin E label
with the findings in the clinical studies on which she relies.
The label on the vitamin E supplement Kaufman purchased states
that vitamin E helps maintain healthy blood vessels and supports
heart health. However, the submitted selection of studies, on
which

Kaufman

relies

for

her

misrepresentation

claims,

investigated the benefits of taking vitamin supplements in the
primary prevention of cardiovascular disease and/or cancer. As
such, the results of the studies fail to refute the statements on
the vitamin E label. Moreover, the Defendants’ vitamin E label
explicitly states that the product itself is not intended to
diagnose, treat, cure or prevent any disease, making the ultimate
conclusions of the cited studies irrelevant. In addition, several
of the studies cited by Kaufman support, rather than refute, the
representations on the Defendants’ product label. Under those
circumstances, the Court concludes that Kaufman has failed to
allege that the representations on the product label are false
22

and misleading. Accordingly, Kaufman’s claims are both preempted
by the FDCA and insufficient to state a claim for fraud. In the
absence of a viable fraud claim, Kaufman’s unjust enrichment
claim must fail as well.
Conclusion
For the reasons stated herein, the Defendants’ motion to
dismiss the Complaint is GRANTED and the Complaint is DISMISSED
with prejudice7.
SO ORDERED.
/s/ Mary M. Lisi
Mary M. Lisi
Senior United States District Judge
January 27, 2016

7

The Court has considered Kaufman’s argument in favor of
amending her Complaint for further clarification that Defendants’
heart health structure/function claims are simply false. In light
of the foregoing, the Court finds that an amendment would be
futile.
23