Nemphos v. Nestle Waters North America, Inc. et al

Filing 26

MEMORANDUM OPINION. Signed by Judge George Levi Russell, III on 8/21/2013. (aos, Deputy Clerk)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MARYLAND
MICHELLE NEMPHOS ex rel.
C.G.N.,

:
:

Plaintiff,
:
v.

Civil Case No. GLR-12-2718
:

NESTLÉ USA, INC., et al.,
:
Defendants.
:
MEMORANDUM OPINION
THIS MATTER is before the Court on Defendants Nestlé USA,
Inc.,

Nestlé

Gerber

Waters

Products

Company,

Inc.’s

North

Company,

America,
Inc.

(“Dannon”)

Motions to Dismiss.1

Inc.

(“Gerber”),

(collectively,

(ECF Nos. 16, 17).

Plaintiff Michelle Nemphos’s

(jointly,

allegations

and
the

“Nestlé”),
The

Dannon

“Defendants”)

This case concerns
that the Defendants’

products exposed her daughter to excessive amounts of fluoride
and caused aesthetic damage to her teeth, without warning of the
risk of such harm, in violation of Maryland statutory and common
law.

Specifically, Nemphos alleges (1) strict liability, (2)

negligence, (3) breach of implied warranties, (4) fraud, (5)
negligent infliction of emotional distress,2 and (6) a violation

1

Nestlé and Gerber originally filed a Motion to Dismiss
(ECF No. 16), in which Dannon joined (ECF No. 17).
2
Nemphos has since conceded that Maryland law does not
recognize an independent claim for negligent infliction of
emotional distress.

of the Maryland Consumer Protection Act (“MCPA”), Md. Code Ann.,
Com. Law §§ 13-301 et seq. (West 2013).
The

issues

necessary.

have

been

fully

briefed

and

See Local Rule 105.6 (D.Md. 2011).

no

hearing

is

For the reasons

outlined below, the Motions will be granted.
I.
Nemphos
C.G.N.,

for

Defendants’

seeks

relief

damages
products

BACKGROUND3
on

behalf

of

from

the

resulting

containing

her

minor

consumption

fluoride.

The

daughter,
of

the

prolonged

ingestion of excessive fluoride during tooth development causes
dental fluorosis, which is characterized by mottled enamel and
pitting of the teeth.
fluoride

overexposure,

Children are particularly at risk of
and

developing

dental

fluorosis,

from

birth to age eight when the permanent teeth develop beneath the
gums.
Nestlé and Dannon manufacture, market, and sell fluoridated
bottled water.

They produce the Deer Park Brand Natural Spring

Water with Added Fluoride, Poland Spring Brand Natural Spring
Water with Added Fluoride, and Fluoride to Go bottled water, all
of which contain up to 0.8 ppm of fluoride.

Nestlé and Dannon

market all three bottled water brands with the slogan “the one
designed with kids in mind.”

(Compl. ¶¶ 11–13, ECF No. 1).

3

Unless otherwise noted, the following facts are stated as
alleged in the Complaint (ECF No. 1).
2

Nestlé also manufactures, markets, and sells Carnation Good
Start

Infant

Formula,

which

contains

fluoride.

Gerber

manufactures, markets, and sells baby food and powdered infant
formula

containing

fluoride.

The

Defendants

marketed

their

products to children without providing any warning regarding the
risks

of

excessive

fluoride

exposure

for

children

aged

zero

through eight.
C.G.N. was born on December 4, 1997.
one,

C.G.N.

formula.

consumed

Nestlé’s

Carnation

She was not breastfed.

From birth to age
Good

Start

infant

From the time C.G.N. was four

months old until she turned one, she also consumed Gerber baby
food products almost exclusively.

At six months old, C.G.N.

began consuming a mixture of Gerber apple juice, which Nemphos
does not allege to have contained fluoride, with
Dannon’s

fluoridated

bottled

water.

Nestlé

C.G.N.’s

and

parents

specifically purchased Nestlé and Dannon’s bottled water because
they believed it was beneficial to their daughter’s developing
teeth.

Until 2005, approximately ninety percent of the water

C.G.N.

consumed

was

Nestlé

and

Dannon’s

fluoridated

bottled

water.

The remaining amount C.G.N. consumed was tap water from

Baltimore, Maryland.
In

or

around

2005,

C.G.N.

stopped

consuming

Nestlé

and

Dannon’s bottled water and began drinking bottled water with no
added fluoride.

Ninety percent of the water C.G.N. continued to
3

drink was bottled water with no added fluoride.

Nemphos alleges

that

damages

C.G.N.

suffered

[including]

dental

Defendants’

bottled

(Compl. ¶ 32).

“physical

fluorosis”
water,

and
as

emotional

a

baby

result

food,

of

and

.

.

ingesting

infant

.

the

formula.

She also alleges that the Defendants promoted

the consumption of their products containing fluoride as safe
and without risk despite the “significant risk” young children
would suffer long-term effects from fluoride consumption.

(Id.

¶¶ 21–22).
On September 11, 2012, Nemphos filed a Complaint against
the Defendants in this Court on her daughter’s behalf.
1).

(ECF No.

On January 3, 2013, Nestlé and Gerber jointly filed a

Motion

to

Dismiss

for

Failure

to

State

a

Federal Rule of Civil Procedure 12(b)(6).

Claim

pursuant

(ECF No. 16).

to

Also

on January 3, 2013, Dannon filed a Motion to Dismiss for Failure
to State a Claim and Notice of Joinder in Nestle and Gerber’s
Motion. (ECF No. 17).
II.
A.

DISCUSSION

Standard of Review
To

survive

a

Federal

Rule

of

Civil

Procedure

12(b)(6)

motion, the complaint must allege facts that, when accepted as
true, “state a claim to relief that is plausible on its face.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 570 (2007)) (internal quotation
4

marks omitted).

A claim is plausible on its face when “the

plaintiff pleads factual content that allows the court to draw
the reasonable inference that the defendant is liable for the
misconduct alleged.”

Id. (citing Twombly, 550 U.S. at 556).

Legal conclusions or conclusory statements do not suffice and
are

not

entitled

to

the

assumption

Twombly, 550 U.S. at 555).

of

truth.

Id.

(citing

Thus, the Court “must determine

whether it is plausible that the factual allegations in the
complaint

are

enough

speculative level.”

to

raise

a

right

to

relief

above

the

Monroe v. City of Charlottesville, 579 F.3d

380, 386 (4th Cir. 2009) (quoting Andrew v. Clark, 561 F.3d 261,
266 (4th Cir. 2009)) (internal quotation marks omitted).
In determining whether to dismiss, the Court must examine
the complaint as a whole, consider the factual allegations in
the complaint as true, and construe the factual allegations in
the light most favorable to the plaintiff.

Albright v. Oliver,

510 U.S. 266, 268 (1994); Lambeth v. Bd. of Comm’rs of Davidson
Cnty., 407 F.3d 266, 268 (4th Cir. 2005).
Moreover,
diversity

this

matter

jurisdiction.

is

before

the

Court

This

Court

is

thus

through

its

obligated

to

interpret the law in accordance with the Court of Appeals of
Maryland.

Ellis v. Grant Thortnon LLP, 530 F.3d 280, 287 (4th

Cir. 2008) (citing Wells v. Liddy, 186 F.3d 505, 527–28 (4th
Cir. 1999)).

Where the law is unclear, this Court must rule how
5

it appears the Court of Appeals of Maryland would rule, and it
may consider restatements, treatises, and recent decisions of
the Court of Appeals.
B.

Wells, 186 F.3d at 527–28.

Analysis
1.

Preemption
a.

The

Non-Identical State Law Requirements

Defendants

argue

Nemphos’s

claims

are

preempted

by

federal law because they are based on common law duties that
would require the Defendants’ products to contain less fluoride
than the Food and Drug Administration (“FDA”) allows or bear a
warning that the FDA does not require.

Nemphos contends that

her claims are not preempted because she only seeks damages for
her

daughter’s

injuries

and

does

not

seek

to

impose

requirements not identical with the FDA’s regulations.

state

For the

same reasons stated in Mills v. Giant of Maryland, LLC, 441
F.Supp.2d 104 (D.D.C. 2006), aff’d 508 F.3d 11 (D.C. Cir. 2007),
the Court agrees with the Defendants and concludes:
Defendants’
identity

or

products
labeling

are

subject

regulations

either
under

to

the

a

(1)

the

standard

of

Food,

Drug,

and

Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq. (2012), and (2)
the

relief

Nemphos

seeks

would

impose

a

state

identical to the FDCA’s labeling requirements.

6

law

duty

not

The preemption doctrine is based on the Supremacy Clause of
the United States Constitution.4

Duvall v. Bristol–Myers–Squibb

Co., 103 F.3d 324, 328 (4th Cir. 1996).

Preemption is the

standard

invalid

to

the

extent

Id.

It

can

be

by

conflicts

which

with

a

federal

express or implied.
U.S.

363,

373

state

law

is

legislation.

it

either

Crosby v. Nat’l Foreign Trade Council, 530

(2000).

Express

preemption

is

“present

when

Congress’s intent to preempt state law is ‘explicitly stated in
the statute’s language.’”

Mills, 441 F.Supp.2d at 106 (quoting

Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977)).

Implied

preemption is “applicable ‘where compliance with both federal
and

state

state

law

regulations
stands

as

is
an

a

physical

obstacle

to

impossibility,
the

or

where

accomplishment

and

execution of the full purposes and objectives of Congress.’”
Id. (quoting Gade v. Nat’l Solid Wastes Mgmt. Ass’n, 505 U.S.
88, 98 (1992)).
The FDCA expressly preempts state food and bottled water
labeling

requirements

requirements.

that

Congress

are

enacted

non-identical
the

Nutrition

to

its

own

Labeling

and

Education Act of 1990 (“NLEA”), Pub.L.No. 101-535, 104 Stat.
2353 (1990) (codified as amended at 21 U.S.C. §§ 301, 321, 337,
4

The Supremacy Clause states: “This Constitution, and the
Laws of the United States which shall be made in Pursuance
thereof . . . shall be the supreme Law of the Land . . . any
Thing in the Constitution or Laws of any State to the Contrary
notwithstanding.” U.S. Const. art. VI, cl. 2.
7

343,

343–1,

authorized

345,
the

371

FDA

labeling standards.

(2012)),

to

which

establish

amended

uniform

the

FDCA

national

and

nutrition

Mills, 441 F.Supp.2d at 106.

The FDCA provides in pertinent part:
(a) [N]o 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—
(1) any requirement for a food which is the subject of
a standard of identity established under section 341
of this title that is not identical to such standard
of identity or that is not identical to the
requirement of section 343(g) of this title . . . .
21 U.S.C. § 343-1(a)(1).
Section 343-1 “prevent[s] State and local governments from
adopting inconsistent requirements with respect to the labeling
of nutrients.”

H. Rep. No. 101–538 (1990), reprinted in 1990

U.S.C.C.A.N. 3336, 3337.
state

requirements.

It does not, however, preclude all

State

laws

are

not

preempted

if

the

labeling requirements they impose are identical to the FDCA’s
requirements.

See § 343–1(a)(5) (prohibiting requirements that

are not identical); Beverages: Bottled Water, 60 Fed.Reg. 57076,
57120 (Nov. 13, 1995) (codified at 21 C.F.R. pts. 103, 129, 165
& 184) (“[I]f the State requirement is identical to the Federal
law, there is no issue of preemption.”); Vt. Pure Holdings, Ltd.
v. Nestlé Waters N. Am., Inc., No. Civ.A.03–11465 DPW, 2006 WL
839486,

at

*5

(D.Mass.

Mar.

28,

8

2006)

(same);

Reyes

v.

McDonald’s Corp., Nos. 06 C 1604, 06 C 2813, 2006 WL 3253579, at
*6 (N.D.Ill. Nov. 8, 2006) (same); Ackerman v. Coca–Cola Co.,
No. CV–09–0395 (JG)(RML), 2010 WL 2925955, at *6 (E.D.N.Y. July
21, 2010) (same).
When the state statute or cause of action would impose a
requirement that is not the same as the federal requirement, it
is

preempted.

See,

e.g.,

Mills,

441

F.Supp.2d

at

108–09

(finding that requiring a warning on milk products regarding
lactose intolerance exceeds the requirements of the NLEA and is
preempted); In re PepsiCo, Inc., Bottled Water Mktg. & Sales
Practices

Litig.,

588

F.Supp.2d

527,

536–37

(S.D.N.Y.

2008)

(holding that requiring a disclosure that purified water was
from

tap

water

rather

than

other

sources

went

beyond

the

requirements of disclosure set forth by the NLEA).
Mills is perhaps the most instructive case.

The plaintiffs

in Mills brought a putative class action suit against nine milk
sellers, requesting they adopt a warning label on their milk
products alerting customers about the possible risks of lactose
intolerance.
alleged

Mills,

they

had

441

F.Supp.2d

exhibited

at

symptoms

105.

consistent

intolerance after ingesting the milk products.
alleged

that,

despite

the

prevalence

The

of

with

Id.

lactose

plaintiffs
lactose

They also
intolerance

among American adults, the milk sellers “propagated the myth
that

milk

is

a

necessary

part
9

of

a

healthy

diet

while

simultaneously

stifling

lactose intolerance.”
1(a)(1)

preempted

information

Id.

the

about

the

incidence

of

Examining whether 21 U.S.C. § 343-

plaintiffs’

claims,

the

United

States

District Court for the District of Columbia hinged its analysis
on two questions: (1) whether the food upon which the plaintiffs
sought

to

impose

a

duty

was

one

subject

to

a

standard

of

identity under the FDCA, and (2) whether the duty sought was
identical

to

the

FDCA

labeling

requirements.

Id.

at

107

that

was

undisputedly

subject to a standard of identity under the FDCA.

Id. at 108.

(citation omitted).
First,

the

court

concluded

milk

The plaintiffs thus sought to impose a requirement upon a food
subject to a standard of identity.

Id.

that

nature

“a

warning

label

of

the

Second, the court found
requested

by

[the]

plaintiffs would far exceed the labeling requirements mandated
by the standard of identity established by” the FDA regulations.
Id.

The

court

noted

that

the

FDA’s

standard

of

identity

delineated a detailed list of information required to appear on
a product’s label, of which a warning label was not included.
Id.

Because the plaintiffs attempted to impose a non-identical

requirement without following the procedures provided under the
FDCA, see 21 U.S.C. § 343-1(b) (allowing deviations from the
requirements

pending

approval

through

10

a

formal

application

process

to

the

FDA),

the

court

expressly preempted by the FDCA.
Similarly,

Nemphos’s

held

that

their

claim

was

the

FDCA

Id. at 109.

claims

are

preempted

by

because the Defendants’ bottled water, baby food, and infant
formula are subject to FDA regulations, and Nemphos seeks to
impose non-identical labeling requirements upon them.
The

FDA

promulgated

concerning bottled water.5
Fed.Reg.

at

57076

standard-of-identity
See

(establishing

regulations

Beverages: Bottled Water,
a

standard

of

identity

60
for

bottled water); 21 C.F.R. § 165.110 (2013) (providing a standard
of identity for bottled water).
established

a

series

of

Namely, the FDA has already

requirements

specifically regarding fluoride.

for

bottled

water

“Fluoride may be optionally

added” to bottled water packaged within the United States, 21
C.F.R. § 165.110(a)(1), so long as the bottled water does “not
contain fluoride in excess of [0.8 to 1.7 milligrams per liter]
.

.

.

based

on

the

annual

average

of

maximum

daily

air

temperatures at the location where the bottled water is sold at
retail.”

Id. § 165.110(b)(4)(ii)(C).

“Imported bottled water

to which fluoride is added shall not contain fluoride in excess
of 0.8 milligram per liter.”

Id. § 165.110(b)(4)(ii)(D).

5

Where

A “standard of identity” is a regulation in which the FDA
fixes the ingredients of, and consequently the definition of, a
food. 62 Cases, More or Less, Each Containing Six Jars of Jam
v. United States, 340 U.S. 593, 598 (1951).
11

bottled water exceeds these limits, its label must warn that it
“Contains Excessive Fluoride”
Substances.”

See

id.

statement).

Beyond

§

or “Contains Excessive Chemical

165.110(c)(3)

these

(requiring

requirements,

no

FDA

a

warning

regulation

requires a warning regarding dental fluorosis.
Infant formula and baby food marketed in the United States
are also subject to FDA regulations.

The FDA prohibits the

addition of fluoride to food products other than bottled water,
unless

the

ingredient.

product

contains

Id. § 170.45.

fluoridated

public

water

as

an

Infant formula and baby food are

under the purview of FDA regulations, see 21 U.S.C. §§ 342, 350a
(regulating foods generally and infant formula), and are thus
subject to these restrictions.

Nemphos does not allege that

Nestlé and Gerber violated these regulations or added fluoride
to their infant formula and baby food products.
Moreover, federal law does not require products containing
no

added

fluorosis.

fluoride

to

bear

information

concerning

dental

See Turek v. Gen. Mills, Inc., 662 F.3d 423, 427

(7th Cir. 2011) (barring labeling requirements concerning inulin
in

fiber

where

no

federal

law

imposes

such

requirement).

Indeed, the specific labeling requirements for infant formula
include no such disclosure.

See 21 C.F.R. § 107.10 (delineating

the labeling requirements for infant formulas).

12

The

Defendants’

products

adhere

to

these

labeling

requirements, where the FDCA does not demand the Defendants warn
of dental fluorosis.
an

obligation

upon

Granting Nemphos relief would thus impose
them

to

warn

customers

of

the

risks

of

fluoride consumption, lest they remain susceptible to common law
liability.

The obligation to warn would be non-identical to the

FDCA’s labeling requirements.
That

Nemphos

requirement
liability

is
would

seeks

of

damages

no

and

consequence.

nevertheless

552

U.S.

312,

324

(2008)

an

express

warning

Assigning

common

a

create

precisely prohibited by the FDCA.
Inc.,

not

requirement

See

state

law

Riegel v. Medtronic,

(“[R]eference

to

a

State’s

‘requirements’ includes its common-law duties. . . . [C]ommonlaw liability is ‘premised on the existence of a legal duty,’
and a tort judgment therefore establishes that the defendant has
violated a state-law obligation.” (quoting Cipollone v. Liggett
Grp., Inc., 505 U.S. 504, 522 (1992)); Bates v. Dow Agrosciences
LLC,

544

U.S.

431,

446

negligent-failure-to-warn
rules

that

packaging.’”).

qualify

as

(2005)
claims

(“[P]etitioners’
are

premised

‘requirements

An obligation

and/or duty

for

on

fraud

and

common-law

labeling

of this nature is

preempted by the FDCA, and Nemphos’s claims will be dismissed.

13

or

b.

Preemption of Health Claims on Food

The Defendants next argue Nemphos is preempted from using
state tort law to require a health claim linking fluoride in
bottled water, infant formula, or baby food to dental fluorosis.
Nemphos maintains that the FDCA only preempts affirmative claims
that advertise the specific health benefits of food products,
and that dental fluorosis is the undesired aesthetic consequence
of

fluoride

overconsumption,

not

a

disease

condition subject to the regulations.

or

health-related

The Court partly agrees

with Nemphos.
As previously discussed, although Nemphos does not seek a
requirement that the labels on the Defendants’ products link
fluoride

to

dental

requests

would

fluorosis,

nonetheless

referenced under the FDCA.

the

common

constitute

a

law

liability

state

she

requirement

Riegel, 552 U.S. at 324.

As a

consequence, the Court must determine whether the relief Nemphos
seeks would impose a duty upon the Defendants to make a health
claim on their products.
The FDCA regulates health claims on food, providing that:
(a) [N]o 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, made in
the label or labeling of food that is not identical to

14

the
requirement
title . . . .

of

section

343(r)

of

this

21 U.S.C. § 343-1(a)(5).
A food is mislabeled under § 343(r) where it expressly or
impliedly bears a health claim not authorized by the FDA.
343(r)(1)(B).

Id. §

The FDA defines “health claim” 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.”

21 C.F.R. § 101.14(a)(1);

see also

Whitaker v.

Thompson, 248 F.Supp.2d 1, 3 n.4 (D.D.C. 2002) (“‘Health claims’
are statements that describe a relationship between a nutrient,
such as calcium, and a disease or health-related condition, such
as osteoporosis.”).
or

component

of

“Substance” is defined as “a specific food

food,

regardless

of

whether

the

food

is

in

conventional food form or a dietary supplement that includes
vitamins,

minerals,

substances.”

herbs,

or

other

21 C.F.R. § 101.14(a)(2).

similar

nutritional

Neither party disputes

that fluoride is a substance.
The

question

is

whether

dental

disease or health-related condition.

fluorosis

constitutes

a

The FDA defines “disease”

and “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

15

leading to such dysfunctioning (e.g., hypertension).”
101.14(a)(5).

Id. §

Although the FDA has not spoken directly as to

whether dental fluorosis is a health-related condition, it has
consistently characterized dental fluorosis as a “significant
adverse aesthetic effect[],” rather than a condition affecting
the functionality of teeth.

See Beverages: Bottled Water, 58

Fed.Reg. 393, 401 (Jan. 5, 1993) (codified at 21 C.F.R. pts.
103,

129,

165

&

184)

(noting

further

that

the

fluoride

guidelines in bottled water are intended to “protect consumers
from any adverse effects on the body, even those that may be
characterized as aesthetic”).
Its position is consistent with a ruling of the United
States Court of Appeals for the District of Columbia Circuit
affirming

an

opinion

of

the

Environmental

Protection

Agency

(“EPA”) that dental fluorosis constitutes a cosmetic effect but
not a health effect.

See Natural Res. Def. Council, Inc. v.

EPA, 812 F.2d 721, 724–25 (D.C. Cir. 1987) (finding reasonable
the EPA’s opinion that dental fluorosis was a cosmetic effect,
not

an

maximum

adverse
fluoride

health
levels

effect,

for

the

under

the

Safe

purposes
Drinking

of

setting

Water

Act

because it did not appear to cause mortal injury or the loss of
function).6

6

from

The EPA has since recognized, in a report it commissioned
the National Research Council, the distinction between
16

Because
aesthetic

the

effect,

FDA
it

considers
would

not

dental
be

a

fluorosis
health

to

claim

be
to

an
link

fluoride to dental fluorosis, and any obligation to do so falls
outside the health claim preemption of the FDCA.

This does not

excuse the fact, however, that Nemphos’s claims are preempted as
state requirements not identical to the FDA’s regulations.

As a

result, Nemphos’s claims still fail.
c.

Safety Concern

Nemphos further argues her claims are permissible through
the

NLEA’s

disagrees

safety
because

concern
the

use

preemption
of

exception.

fluoride

in

the

The

Court

Defendants’

products does not implicate a safety concern.
Congress enacted a limited exception in the NLEA, declaring
its express preemption “shall not be construed to apply to any
requirement respecting a statement in the labeling of food that
provides for a warning concerning the safety of the food or

dental
fluorosis
and
severe
dental
fluorosis,
which
is
characterized by the loss of enamel, noting that severe dental
fluorosis may constitute an adverse health effect.
Sulfuryl
Fluoride; Proposed Order Granting Objections to Tolerances and
Denying Request for a Stay, 76 Fed.Reg. 3422, 3430 (Jan. 19,
2011) (codified at 40 C.F.R. pt. 180).
The FDA has also
distinguished between dental fluorosis and severe dental
fluorosis. See Drug Products for the Relief of Oral Discomfort
for Over-the-Counter Human Use; Establishment of a Monograph, 47
Fed.Reg. 22,712, 22,751 (May 25, 1982) (codified at 21 C.F.R.
pt. 354) (noting the level of fluoride consumption required for
both conditions).
This further suggests that, while severe
dental fluorosis might be a health-related condition, dental
fluorosis is not.
17

component of the food.”

Pub.L.No. 101-535, 104 Stat 2353 §

6(c)(2); Holk v. Snapple Beverage Corp., 575 F.3d 329, 338 (3d
Cir. 2009).

On the one hand, the FDA defines “safe” or “safety”

as “a reasonable certainty in the minds of competent scientists
that the substance is not harmful under the intended conditions
of use.”

21 C.F.R. § 170.3(i).

“Harm,” on the other hand,

means “the capacity to injure or otherwise damage the health of
individuals consuming the additive.”

Food Additives Permitted

for Direct Addition to Food for Human Consumption; Olestra, 61
Fed.Reg. 3118, 3119 (Jan. 30, 1996) (codified at 21 CFR pt.
172).

The FDA has already determined that fluoride is safe to

include in bottled water, and in products containing fluoridated
public water as an ingredient, if manufacturers abide by its
regulations.

See

fluoride

food

in

21

C.F.R.

§

170.45

products);

(limiting

In

re

the

use

Bisphenol-A

of

(BPA)

Polycarbonate Plastic Prods. Liab. Litig., No. 1967, 2009 WL
3762965,

*6

(W.D.Mo.

determination

whether

Nov.
[an

9,

2009)

(concluding

additive]

is

‘safe’

is

show

Defendants

that

“the

solely

the

province of the FDA”).
Nemphos’s
those

allegations

regulations.

consequences
fluorosis

of

Moreover,

consuming

injurious

to

the
the

FDA,

fluoride,

one’s

health

18

when

did
but

not

complied

with

considering

the

consider

rather

an

dental
adverse

aesthetic effect.

See supra Part II.B.1.b.

Accordingly, the

safety concern exception is inapplicable to Nemphos’s case.
2.

Substantive State Law Arguments

The

Defendants

offer

additional

arguments

Nemphos’s claims fail under Maryland law.

as

to

why

Understanding that

federal law preempts each of Nemphos’s claims, the Court will
address two of those arguments in turn.
a.
Nemphos
violation

of

Fraud and the Maryland Consumer Protection Act
alleges
the

unfair

MCPA

and

or

deceptive

fraud

on

trade

two

practices

grounds:

(1)

in
the

Defendants materially failed to disclose the risk of fluorosis
in consuming their products and (2) Nestlé and Dannon advertised
their fluoridated water as “the one designed with kids in mind.”
(Pl.’s Resp. & Opp’n to Defs.’ Mot. to Dismiss [“Pl.’s Resp.”]
at 42, ECF No. 23).
because

Nemphos

specificity.
Federal

The Defendants argue these claims fail

does

not

plead

them

with

the

required

The Court agrees.
Rule

of

Civil

Procedure

9(b)

imposes

a

higher

pleading standard upon claims sounding in fraud, requiring the
plaintiff

to

“state

constituting fraud.”

with

particularity

Fed.R.Civ.P. 9(b).

the

circumstances

This standard requires

the plaintiff to “at a minimum, describe the time, place, and
contents of the false representations, as well as the identity
of the person making the misrepresentation and what he obtained
19

thereby.”
525

F.3d

U.S. ex rel. Wilson v. Kellogg Brown & Root, Inc.,
370,

379

(4th

Cir.

quotation marks omitted).

2008)

(citations

and

internal

“These facts are often ‘referred to

as the ‘who, what, when, where, and how’ of the alleged fraud.’”
Id. (citations omitted).
Here,

Nemphos

generally

alleges

that

Nestlé

and

Dannon

marketed their fluoridated bottled water as “the one designed
with kids in mind,” (Compl. ¶¶ 11–13), with no mention as to the
time, place, or particular marketing materials of the alleged
fraud.

She has not, therefore, pled her fraud and MCPA claims

with the particularity required under Rule 9(b).
Nemphos

contends

that

her

allegations

satisfy

Rule

9(b)

because pleading omission with that degree of particularity “is
tantamount to asking [her] to prove a negative.”
at

43).

The

Court

disagrees.

Rule

(Pl.’s Resp.

9(b)’s

specificity

requirement cannot be ignored.
Regarding claims of omission, while Rule 9(b)’s standard
undergoes

a

more

relaxed

analysis,

Hill

v.

Brush

Engineered

Materials, Inc., 383 F.Supp.2d 814, 822 (D.Md. 2005) (citation
omitted), Nemphos fails to satisfy even this relaxed standard.
In

cases

involving

partial

disclosures,

the

plaintiff

must

“specify (1) the partial and fragmentary statements of fact that
created a duty . . . to speak, (2) who made the statements, (3)
when the statements were made, and (4) how she came to rely on
20

them.”
these

Id. at 823.
allegations

“To withstand dismissal, she needs to make

with

particularity

and

be

especially

clear

about how and when she came to know of the partial disclosures
noted in the Complaint and how she relied upon them.”

Id.

Nemphos predicates her fraud and MCPA claims on Nestlé and
Dannon’s partial disclosure that their fluoridated bottled water
is “the one designed with kids in mind,” (Compl. ¶¶ 11–13), but
she does not allege when the disclosure was made, how it was
communicated, how it became known, or how it had been relied
upon.

Nemphos only offers that the Defendants knew or should

have known she would rely on the disclosure, and that she relied
on it to her detriment.
assertions

are

not

(Id. ¶¶ 66, 70–71, 80).

enough

to

satisfy

Rule

Her conclusory
9(b)’s

relaxed

analysis.7
b.

Breach of Implied Warranties

In the Complaint, Nemphos alleges breach of the implied
warranty of merchantability and the implied warranty of fitness
for a particular purpose under a single claim.

The Defendants

challenge both, arguing first that Nemphos’s claim fails because
7

Nemphos’s fraud and MCPA claims may present an additional
issue in that she appears to advance them on her own behalf,
even though she brings this action as her daughter’s next
friend.
See Brown v. Daniel Realty Co., 976 A.2d 300, 314–18
(Md. 2009) (discussing whether, and to what extent, a next
friend is a “party” when representing a minor litigant).
Regardless, even if this ambiguity were reconciled, Nemphos
still fails to plead either claim with the specificity required
by Rule 9(b).
21

she did not provide notice before filing suit.

Nemphos contends

that her daughter was not the buyer and had no duty to provide
notice.

This Court agrees.

Once a buyer accepts goods, the Maryland Commercial Code
requires

him

to

notify

the

seller

of

a

breach

“within

a

reasonable time after he discovers or should have discovered any
breach.”

Md. Code Ann., Com. Law § 2-607(3)(a) (West 2013).

This requires the buyer to give notice to his immediate seller
to

preserve

warranty.

any

right

of

action

for

breach

of

an

implied

Lloyd v. Gen. Motors Corp., 575 F.Supp.2d 714, 722–23

(D.Md. 2008) (citing Firestone Tire & Rubber Co. v. Cannon, 452
A.2d 192, 196 (Md.Ct.Spec.App. 1982)).

The Court of Appeals of

Maryland

this

has

consistently

held

that

requirement

only

applies to the actual buyer and does not extend to third-party
beneficiaries.

See, e.g., Mattos, Inc. v. Hash, 368 A.2d 993,

996–97 (Md. 1977) (concluding that third-party beneficiaries are
under no duty to notify the seller of a breach before recovering
for breach of an implied warranty); Phipps v. Gen. Motors Corp.,
363 A.2d 955, 962 (Md. 1976) (same); Frericks v. Gen. Motors.
Corp., 363 A.2d 460, 465 (Md. 1976) (same).
C.G.N. did not purchase the Defendants’ products and, as a
third-party beneficiary, was not required to give notice of a
breach before an implied warranty claim could be maintained on

22

her behalf.

The Maryland Commercial Code does not bar her claim

in this regard.
The Defendants argue, however, two additional reasons why
Nemphos’s claim should fail.
by

the

Maryland

First, Nemphos’s claim is barred

Commercial

Code’s

four-year

statute

limitations for breach of implied warranty claims.

of

See Md. Code

Ann., Com. Law § 2-725(1) (“An action for breach of any contract
for sale must be commenced within four years after the cause of
action has accrued.”).

The statute of limitations begins to run

“on the date the breach occurs, regardless of the aggrieved
party’s lack of knowledge of the alleged breach.”
F.Supp.2d

at

721.

Nemphos

alleges

she

last

Lloyd, 575

purchased

the

Defendants’ products in 2005, seven years prior to the start of
this action.

(Compl. ¶ 32).

The latest a cause of action could

have accrued was well beyond the statutory period.

The statute

of limitations thus bars her breach of implied warranty claim.
The Defendants next argue Nemphos’s claim for breach of the
implied

warranty

of

fitness

for

a

particular

purpose

specifically fails because she does not allege purchasing the
Defendants’ products for a purpose other than their ordinary
use.
Consumers can recover for breach of the implied warranty of
fitness for a particular purpose under Maryland law, Md. Code
Ann., Com. Law § 2-315(1), but only if:
23

(1) The seller [has]
particular purpose.

reason

to

know

the

buyer’s

(2) The seller [has] reason to know that the buyer is
relying on the seller’s skill or judgment to furnish
appropriate goods.
(3) The buyer . . . rel[ies] upon the seller’s skill
or judgment.
Ford Motor Co. v. Gen. Accident Ins. Co., 779 A.2d 362, 374–75
(Md. 2001) (citation omitted).
The implied warranty of fitness for a particular purpose
only applies if the product is used for a specific, non-ordinary
purpose.
Cir.

Lowe v. Sporicidin Int’l, 47 F.3d 124, 132–33 (4th

1995).

Defendants’
breach

of

Because
products

the

Nemphos

were

implied

used

warranty

does
for
of

not

a

allege

non-ordinary

fitness

for

a

that

the

use,

her

particular

purpose also fails and must be dismissed.
3.

Leave to Amend

Nemphos requests leave to amend any deficiencies in her
Complaint, which the Court will deny.

Leave to amend should be

freely given “when justice so requires.”

Fed.R.Civ.P. 15(a)(2).

Accordingly, “leave to amend a pleading should be denied only
when the amendment would be prejudicial to the opposing party,
there has been bad faith on the part of the moving party, or the
amendment would have been futile.”
404, 426 (4th Cir. 2006).

Laber v. Harvey, 438 F.3d

Because the FDCA preempts Nemphos’s

24

claims, amendment of her Complaint would be futile.

Nemphos’s

request for leave to amend will be denied.
III. CONCLUSION
For

the

foregoing

reasons,

the

Court

will,

by

separate

Order, GRANT the Defendants’ Motions to Dismiss (ECF Nos. 16,
17) Nemphos’s Complaint (ECF No. 1).
Entered this 21st day of August, 2013
/s/
_____________________________
George L. Russell, III
United States District Judge

25