Court Opinion

ID: 2767617
Source: CourtListenerOpinion
Date Created: 2015-01-08 20:00:53.789871+00
Date Added: 2024-06-11T11:27:31.604817
License: Public Domain

PUBLISHED

                  UNITED STATES COURT OF APPEALS
                      FOR THE FOURTH CIRCUIT

                             No. 13-2146

MICHELLE NEMPHOS, as Legal Guardian for C.G.N., a Minor
under the age of Eighteen,

                Plaintiff - Appellant,

           v.

NESTLE WATERS NORTH AMERICA, INC.; NESTLE USA,              INC.;
THE DANNON COMPANY, INC.; GERBER PRODUCTS COMPANY,

                Defendants - Appellees.

Appeal from the United States District Court for the District of
Maryland, at Baltimore. George L. Russell, III, District Judge.
(1:12-cv-02718-GLR)

Argued:   October 30, 2014                 Decided:   January 8, 2015

Before WILKINSON, MOTZ, and FLOYD, Circuit Judges.

Affirmed by published opinion.       Judge Wilkinson        wrote   the
opinion, in which Judge Motz and Judge Floyd joined.

ARGUED: Leah Marie Nicholls, PUBLIC JUSTICE, P.C., Washington,
D.C., for Appellant. Catherine Emily Stetson, HOGAN LOVELLS US
LLP, Washington, D.C.; Peter Buscemi, MORGAN LEWIS & BOCKIUS
LLP, Washington, D.C., for Appellees.     ON BRIEF: Leslie A.
Brueckner,   PUBLIC   JUSTICE,   P.C.,   Oakland,   California;
Christopher T. Nidel, NIDEL LAW, PLLC, Washington, D.C.;
Christopher T. Nace, PAULSON & NACE, Washington, D.C., for
Appellant. Victoria J. Miller, Kristin M. Hadgis, MORGAN, LEWIS
& BOCKIUS LLP, Philadelphia, Pennsylvania, for Appellee The
Dannon Company, Inc.    Lauren S. Colton, Baltimore, Maryland,
Michael L. Kidney, HOGAN LOVELLS US LLP, Washington, D.C., for
Appellees Nestle USA, Inc., Nestle Waters North America, Inc.,
and Gerber Products Company.

                              2
WILKINSON, Circuit Judge:

       Appellant       Michelle      Nemphos           filed      suit        against      the

manufacturers of bottled water, infant formula, and baby food

that     her   minor    daughter       had        consumed      before        developing     a

condition known as dental fluorosis. Nemphos brought an array of

tort     and   fraud    claims      under     Maryland         law     against     appellee

manufacturers      Nestlé     Waters    North          America,      Inc.,     Nestlé    USA,

Inc., The Dannon Company, Inc., and Gerber Products Company. The

question in this appeal is whether federal law, which provides

uniform labeling standards for the products at issue, preempts

Nemphos’s state-law claims. We hold that federal law preempts

Nemphos’s bottled water claims and that her complaint as to the

infant    formula      and   baby    food     products         fails     to    satisfy     the

pleading requirements of Federal Rule of Civil Procedure 8(a)(2).

We thus affirm the district court’s dismissal of her action.

                                             I.

       Because the district court dismissed Nemphos’s claims under

Federal Rule of Civil Procedure 12(b)(6) for failure to state a

claim,    we   review    legal      issues        de   novo    and     treat     the    facts

alleged in the complaint as true. Bell Atl. Corp. v. Twombly,

550 U.S. 544, 555-56 (2007); Neitzke v. Williams, 490 U.S. 319,

326-27 (1989).

                                             3
                                            A.

        Nemphos alleges that her minor daughter, C.G.N., consumed

appellees’ products throughout her childhood. From her birth in

1997    until    approximately       her    first       birthday,    C.G.N.       was    fed

Nestlé’s     Carnation       Good    Start       infant       formula,     in    lieu    of

breastfeeding. From approximately four months to one year of

age, C.G.N. ate Gerber baby foods almost exclusively, including

Gerber apple juice that was often mixed into her water. From

approximately      six    months     to    eight    years      of   age,   C.G.N.       also

habitually       drank    Nestlé’s       Poland    Spring       fluoridated       bottled

water and Dannon’s Fluoride To Go bottled water.

       According    to    Nemphos,        C.G.N.    developed       dental      fluorosis

from consuming the appellee manufacturers’ products.                            Although

fluoridated       drinking       water    can    play     a    significant       role    in

preventing tooth decay in children and adults, young children

who consume too much fluoride may develop dental fluorosis -- a

change in the appearance of tooth enamel. Nemphos’s complaint

does not specify the precise extent of C.G.N.’s fluoride-related

injuries, but symptoms may range from specks and discoloration

of teeth in mild cases to mottling and pitting in more severe

ones.

       Dental     fluorosis       results        when     young     children          ingest

excessive fluoride over an extended period of time, while their

adult    teeth    are    still    developing       below      the   surface      of   their

                                            4
gums. To address that risk, federal agencies such as the Food

and    Drug    Administration       (“FDA”)           issue        recommendations      and

regulations for safe water fluoridation levels. The products at

issue in this case are not alleged to have violated federal

fluoride requirements.

                                           B.

       In   September     2012,     Nemphos       filed        a     complaint    on    her

daughter’s behalf against the appellee manufacturers. Although

all of Nemphos’s claims were based on Maryland law, she brought

suit in federal district court because the parties are citizens

of    different   states.    See    28     U.S.C.       § 1332(a).        The    complaint

alleged that      the    manufacturers          had    failed       to   warn   about   the

risks of dental fluorosis for children who consume large amounts

of    fluoride,   and    that     they     had    misleadingly           marketed      their

fluoride-containing         products        as        especially         beneficial      to

children.     Consequently,       the    complaint       maintained,        “C.G.N.     has

suffered, and continues to suffer from, physical and emotional

damages related to her injuries from fluoride, which include,

but are not limited to, dental fluorosis.” J.A. 13. Nemphos’s

complaint     asserted    six     causes    of        action    under     Maryland      law:

strict liability (Count I), negligence (Count II), breach of

implied     warranties    (Count        III),    fraud     (Count        IV),    negligent

infliction of emotional distress (Count V), and violations of

                                           5
the Maryland Consumer Protection Act, which prohibits unfair and

deceptive     trade   practices       (Count   VI).    In    response,    appellees

filed motions to dismiss the complaint under Rule 12(b)(6), for

failure to state a claim upon which relief can be granted.

     The      district    court   granted      the     motions      and   dismissed

Nemphos’s     complaint    with   prejudice.       The     court   concluded    that

federal law preempted Nemphos’s state-law claims. The appellee

manufacturers’ products were already subject either to a federal

“standard of identity” or to other federal labeling regulations.

Granting the relief requested by Nemphos, the court found, would

have required appellees’ products to have fluoride levels below

the FDA’s established limits or to bear warnings not mandated by

the FDA. In other words, Nemphos sought to impose a duty under

Maryland    law   that    was   not    identical      to    the   existing   federal

requirements. 1 Nemphos now challenges the court’s dismissal of

her suit. 2

     1
       Although the underlying merits of Nemphos’s state-law
claims are not directly at issue in this appeal, as a
substantive matter the district court’s opinion left open only
her tort claims invoking strict liability (Count I) and
negligence (Count II). Prior to the court’s decision, Nemphos
had already conceded that Maryland law would not countenance an
independent claim for negligent infliction of emotional distress
(Count V). In its memorandum opinion, the court deemed all of
Nemphos’s claims preempted, but it nevertheless proceeded to
find that her claims regarding breach of implied warranties
(Count III), fraud (Count IV), and Maryland Consumer Protection
Act violations (Count VI) all failed under Maryland law. The
(Continued)
                                         6
                                       II.

     Nemphos first argues that federal law does not preempt her

state-law    claims     about    Nestlé’s        and    Dannon’s    bottled       water

products.    Specifically,       she   alleges         that    Nestlé    and    Dannon

failed to warn about the risks of dental fluorosis and engaged

in misleading marketing. To assess the viability of Nemphos’s

bottled   water    claims,      we   first     need     to    examine    the   federal

statutory and regulatory framework, with particular attention to

the relevant preemption structure. We will then consider her

failure-to-warn and misleading-marketing claims.

                                          A.

     For more than a century, the FDA has been charged with

protecting     Americans        against        foods     and     drugs     that     are

“misbranded”      or   “adulterated.”          See     Federal   Food,    Drug,     and

Cosmetic Act (“FDCA”), ch. 675, 52 Stat. 1040 (1938); Pure Food

Act, ch. 3915, 34 Stat. 768 (1906); see 21 U.S.C. § 331. Today,

a core element of the FDA’s mission is to “protect the public

district court did not address the substance of Nemphos’s strict
liability and negligence claims, nor did it need to do so.
     2
       Nemphos also seeks leave to amend her complaint on remand.
Because we find her claims preempted, we likewise agree with the
district court’s denial of Nemphos’s request on the ground that
any amendment would be futile. See Fed. R. Civ. P. 15(a); Foman
v. Davis, 371 U.S. 178, 182 (1962); Laber v. Harvey, 438 F.3d
404, 426 (4th Cir. 2006) (en banc).

                                          7
health    by     ensuring          that     . . .        foods    are       safe,     wholesome,

sanitary, and properly labeled.” 21 U.S.C. § 393(b)(2)(A). The

states    have       also    played       important          roles      in    food     and    drug

regulation       since      the    time     when      they    were    only     colonies.       See

Wallace F. Janssen, America’s First Food and Drug Laws, 30 Food

Drug Cosm. L.J. 665 (1975). Even as federal laws remain supreme,

U.S. Const. art. VI, cl. 2, the United States has developed a

dual    system       of   food     and    drug       regulation.        A    federal    law    may

preempt state intervention in one aspect of a given food, for

example, while allowing states to act on other aspects of the

same     food.       Lofty    questions          about       federal-state            relations,

however, are not urged upon us in this appeal, and our ruling

does not disturb the balance that has been carefully struck over

the    years.    This       case    turns     on     a    relatively         narrow    issue    of

statutory interpretation.

       The federal Nutrition Labeling and Education Act of 1990

(“NLEA”), Pub. L. No. 101-535, 104 Stat. 2353, secures the FDA’s

authority       to    oversee        food    labeling.           In   passing         the    NLEA,

Congress underscored its intent “to clarify and to strengthen

the Food and Drug Administration’s legal authority to require

nutrition labeling on foods, and to establish the circumstances

under which claims may be made about nutrients in foods.” H.R.

Rep. No. 101-538, at 7 (1990), reprinted in 1990 U.S.C.C.A.N.

3336, 3337. The NLEA builds on the FDCA to develop a nationwide

                                                 8
system of uniform nutrition labeling for covered foods, in part

by   requiring     meaningful       disclosures         about    certain      nutrients

contained in those foods. Id.; see 21 U.S.C. §§ 343, 343-1.

     The   uniform       labeling    system      instituted       by    the   FDCA    and

fortified by the NLEA benefits both manufacturers and consumers

of food products. See 21 U.S.C. § 341; POM Wonderful LLC v.

Coca-Cola Co., 134 S. Ct. 2228, 2234, 2238-40 (2014); 62 Cases

of Jam v. United States, 340 U.S. 593, 596 (1951); Fed. Sec.

Adm’r v. Quaker Oats Co., 318 U.S. 218, 230-31 & n.7 (1943).

Manufacturers      can    produce    and       market    foods    consistently        and

cost-effectively     across       the    United    States.       Consumers      gain   a

reliable     and     comprehensible            means      of     ascertaining         the

nutritional content of the foods they buy, wherever they may

live or travel in this country. Armed with such information,

consumers can make well-informed decisions about the types and

quantities of ingredients in their diets.

                                         B.

     A   system    engineered       to   ensure        national    uniformity        must

exclude some local disuniformities. While the NLEA provides a

nationwide   framework      for     certain      types    of     food   labeling,      it

likewise prohibits states from disrupting that arrangement with

nonidentical requirements. The Act struck a necessary balance

between the two fonts of regulatory authority -- between uniform

                                           9
federal labeling standards and potentially more stringent laws

in    individual     states.       As   the      FDA    has     explained,       “Congress

decided that even though Federal requirements may preempt more

restrictive      State   requirements         in      certain    instances,       the   net

benefits from national uniformity in these aspects of the food

label outweigh the loss in consumer protection that may occur as

a    result.”    State   Petitions         Requesting      Exemption      from     Federal

Preemption, 58 Fed. Reg. 2462, 2462 (Jan. 6, 1993).

       To maintain that balance, the NLEA includes a series of

express     preemption      provisions.          21     U.S.C.       § 343-1(a)(1)-(5).

These     provisions     --        under    the        heading       “National     uniform

nutrition       labeling”     --    forbid       states       from    establishing      any

requirement that is “not identical to” the federal requirements

in five areas of food labeling. Id. One of those areas, and the

one at issue in Nemphos’s bottled water claims, concerns the

“standard of identity.” Id. § 343-1(a)(1).

       This preemption provision, subsection (a)(1), provides as

follows:

       (a) Except as provided in subsection (b) of this
       section, 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 --

            (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

                                            10
            343(g) of this title, except that this paragraph
            does not apply to a standard of identity of a
            State or political subdivision of a State for
            maple syrup that is of the type required by
            sections 341 and 343(g) of this title . . . .

Id.; see also NLEA § 6(c)(1), 104 Stat. at 2364, reprinted in 21

U.S.C. § 343-1, at 87 (specifying that the NLEA preempts state

law only expressly). Several contextual points help to clarify

this language. First, § 341 empowers the FDA to establish “a

reasonable definition and standard of identity” for almost any

food.   Id.     § 341.   Second,       § 343(g)     deems   a   food        product

“misbranded” if it is represented as a particular food yet fails

to conform to the standard of identity. Id. § 343(g). Third,

subsection (a)(1) allows a conspicuous exception to preemption

for but a single product: maple syrup. Id. § 343-1(a)(1). Last,

§ 343-1(b) enables the FDA, “[u]pon petition of a State or a

political     subdivision,”       to   exempt     certain   state      or    local

requirements that would otherwise be barred by subsection (a)(1)

or the four other preemption provisions. Id. § 343-1(b).

     Within     this   context,    the    force   of   subsection   (a)(1)       is

apparent.     First,   the   statute     preempts   “any”   applicable        state

requirement, not just some of them. Id. § 343-1(a)(1). Second,

the statute preempts any nonidentical state requirement for a

“food” that is the subject of a federal standard of identity;

that is, the preempted requirement may be any conflicting state-

law obligation for that food. Id. Third and finally, subsection

                                         11
(a)(1)   uses       the    unequivocal          phrase      “not    identical      to”    the

standard of identity. Id. It does not say any state requirement

merely     “differing           from,”     “conflicting        with,”      “inconsistent

with,” or “dissimilar to” the federal requirement. Nor does the

statute employ here the more limited phrase “in violation of” --

as it does regarding the petition process, later in the same

section.      Id.     § 343-1(b).             The    four     subsequent         preemption

provisions use the same “not identical to” phrasing toward other

categories of labeling requirements. Id. § 343-1(a)(2)-(5). Put

simply, then, we can understand subsection (a)(1) this way: for

a food that is the subject of a federal standard of identity,

this provision preempts any pertinent state requirement that is

not identical to the federal requirement. Id. § 343-1(a)(1).

     The NLEA does afford a specific exception to its preemption

provisions      --        for    state-generated            “safety”      warnings.       The

preemption      provisions          in     § 343-1       do    not       “apply    to     any

requirement respecting a statement in the labeling of food that

provides for a warning concerning the safety of the food or

component     of     the    food.”       NLEA    § 6(c)(2),        104   Stat.    at     2364,

reprinted in 21 U.S.C. § 343-1, at 87. In the context of food

additives, the FDA defines “safety” as entailing “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).          Establishing        “complete        certainty”       of

                                                12
“absolute harmlessness” is not required. Id. Although the NLEA’s

preemption       provisions          sweep    broadly,    state-law         duties       may    be

insulated        from     the    Act’s       preemptive     reach      if    they    involve

warnings about food “safety.”

                                               C.

      A     standard            of       identity        specifies          the      defining

characteristics of a given food. 21 U.S.C. § 341; see also id.

§ 343(g). To “promote honesty and fair dealing in the interest

of    consumers,”         the         FDCA    allows     the     FDA    to        “promulgate

regulations        fixing       and    establishing       for   any    food,       under       its

common     or     usual     name       so    far    as   practicable,        a    reasonable

definition and standard of identity,” as well as standards of

quality and fill. Id. § 341. This power to determine standards

of identity -- in essence, to regulate the ingredients of a food

and   its       representation          in   interstate        commerce      --     is    “far-

reaching.” 62 Cases of Jam, 340 U.S. at 598.

      The standard of identity is important to the FDA’s capacity

to regulate those characteristics of a food label that would

enable a food to be marketed as such, and to ensure that certain

foods     accord    with        consumer     expectations.       Specifically,           to     be

marketed in interstate commerce under a given name -- such as

“bottled     water”       --     a    food    must   conform     to    the       standard       of

identity. See 21 U.S.C. §§ 331, 341, 343(g); 62 Cases of Jam,

                                               13
340 U.S. at 598; see also 21 C.F.R. § 101.3. At the consumer

level, a standard of identity warrants that individuals will

encounter a label reflecting the food’s actual contents -- that

consumers “will get what they may reasonably expect to receive.”

Quaker Oats, 318 U.S. at 232. Significantly, the FDA may also

distinguish “optional ingredients” that manufacturers can add to

a food that is subject to a standard of identity. 21 U.S.C.

§§ 341, 343(g). Any optional ingredients present must be “named

on the label.” Id. § 341; see id. § 343(g).

     Although the details vary from food to food, fundamentally

the standard of identity focuses on the contents of a food and

the way those contents are represented to consumers. Under the

NLEA’s amendments, the FDA now establishes standards of identity

through the agency’s conventional rulemaking process. 21 U.S.C.

§ 371; 21 C.F.R. § 10.40; see James T. O’Reilly, 1 Food and Drug

Administration     § 10:29    &     n.8        (3d    ed.     2014).    Standards     of

identity    have    been     utilized           to     delineate        the     accepted

composition of a food, to indicate permissible formulations or

varieties   of     ingredients,      to        note        optional    or     prohibited

ingredients, to describe appropriate manufacturing processes, to

detail methods of product analysis, to designate a commercial

name, to set ingredient-related labeling requirements. See 21

C.F.R.   pts.    130-169;    see,    e.g.,           id.    § 131.110       (milk);   id.

§ 131.200   (yogurt);       id.     § 137.105           (flour);       id.     § 139.110

                                          14
(macaroni      products);       id.     § 145.110         (canned     applesauce);      id.

§ 150.160      (fruit      preserves     and       jams);    id.    § 155.190       (canned

tomatoes);      id.       § 155.130    (canned       corn);     id.      § 163.130   (milk

chocolate); id. § 169.140 (mayonnaise). In addition to various

descriptive provisions, a “label declaration” regarding a food’s

ingredients often appears in these regulations. See, e.g., id.

§§ 131.110(f),             137.105(b)(1),           139.110(g),           145.110(a)(4),

150.160(e)(2),             155.190(a)(6),            155.130(a)(5),           163.130(d),

169.140(f).

       The FDA regulates bottled water as a food, and the agency

has    developed      a    standard     of     identity      for    bottled    water.   21

C.F.R. § 165.110; see also Beverages: Bottled Water, 60 Fed.

Reg. 57,076, 57,076 (Nov. 13, 1995) (noting that the FDA had

received some 430 responses to the proposed standard during the

comment period). Under the FDA’s standard of identity, “bottled

water”    is     defined      as      “water       that    is   intended      for    human

consumption and that is sealed in bottles or other containers

with no added ingredients except that it may optionally contain

safe   and     suitable      antimicrobial         agents.”     Id.      § 165.110(a)(1).

The standard of identity also classifies fluoride as an optional

ingredient in bottled water. Id. Manufacturers may add fluoride

to bottled water within the limitations established in the FDA’s

“standard       of        quality”      for        bottled      water,      which     sets

microbiological,             physical,          chemical,          and       radiological

                                              15
specifications.          Id.;     see    id.    § 165.110(b)(2)-(5)             (standard         of

quality);      id.        § 165.110(b)(4)(ii)               (fluoride          levels).          The

specific concentration of fluoride permitted depends on what the

retail      location’s         average    maximum          daily      air    temperature         is,

whether the bottled water is packaged domestically or imported,

and      whether              fluoride     has            been        added.         See         id.

§ 165.110(b)(4)(ii)(A)-(D).               If    fluoride         or    any    other       optional

ingredient has been added to the bottled water, the label must

list   each    of       the     ingredients.         Id.    §§ 101.4(a)(1),              130.3(e),

165.110(a)(4).

       Nemphos      attempts       to    ascribe      a     very      restrictive         role    to

standards of identity, claiming flatly that “Federal Standards

of Identity . . . Do Not Address Warnings.” Appellant’s Reply

Br.    at    12;        see     Appellant’s       Br.       at     36.      Aside        from    the

incorrectness of this statement as a general matter, the FDA’s

regulations        do    specifically          indicate      when        manufacturers          must

provide      warnings           about     fluoride          in     bottled       water.          Id.

§ 165.110(c). If the level of fluoride surpasses the specified

maximum       concentration,             the         bottled          water         is      deemed

“substandard.” Id. § 165.110(c); see also id. § 130.14(a). The

label must then state “Contains Excessive Fluoride” or “Contains

Excessive Chemical Substances.” Id. § 165.110(c)(3).

       In establishing the standard of identity for bottled water

in 1995, the FDA actually addressed several issues involved in

                                                16
fluoride      consumption,     including      the      notion       of     a     warning

requirement regarding dental fluorosis. 60 Fed. Reg. at 57,079-

80. The FDA recognized that “an advisory statement . . . may be

appropriate to prevent unwanted aesthetic effects from excessive

doses of fluoride,” and it even “encourage[d] manufacturers to

provide such information to consumers, especially on products

labeled for infant use.” Id. at 57,080. Nevertheless, the FDA

declined to mandate a warning in the standard of identity about

the   risks    of   dental    fluorosis.      In    fact,     the    FDA       had    set

acceptable     fluoride     levels    for    bottled      water     --   which       were

consistent      with   levels        established       by    the     Environmental

Protection Agency and the Surgeon General -- and it had required

substandard bottled water to indicate excessive fluoride content

on the label. Id.; see 21 C.F.R. §§ 165.110(b)(4)(ii), (c). The

agency   accordingly      found   “no    basis”     to    follow     one       comment’s

suggestion “to require an advisory statement concerning infant

fluoride consumption on bottled waters containing 0.3 [parts per

million (‘ppm’)] or more fluoride.” 60 Fed. Reg. at 57,080. Such

water, after all, would not be substandard. The FDA’s fluoride

limits for domestic bottled water range from 0.8 to 1.7 ppm when

fluoride has been added, and from 1.4 to 2.4 ppm when only

naturally       occurring      fluoride       is         present.        21      C.F.R.

§ 165.110(b)(4)(ii)(A), (C). In effect, the proposal rejected by

the FDA would have reduced the threshold for a fluoride-related

                                        17
warning dramatically, from between 0.8 and 2.4 ppm to just 0.3

ppm. 3

                                              D.

         The    preemption          structure      under     the     NLEA       is    highly

“complex,” POM Wonderful, 134 S. Ct. at 2238, but it also forms

the framework for evaluating Nemphos’s claims. Reduced to its

essence, the FDCA and NLEA convey significant powers to the FDA

to regulate food safety. This statutory charge reflects the all-

around       benefits    of     uniform    food     labeling.       One    of   the    FDA’s

crucial        tools    in    its    regulatory      effort    is    the    standard     of

identity.       21     U.S.C.    § 341.    The      express   preemptive         force   of

§ 343-1 allows federal regulations such as a food’s standard of

identity         to     prevail        over        certain     nonidentical           state

requirements. Id. § 343-1(a); NLEA § 6(c)(1), 104 Stat. at 2364.

The FDA regulates bottled water as a food and has promulgated a

standard of identity for it. 21 C.F.R. § 165.110. The parties do

not dispute the FDA’s capacity to regulate bottled water in this

way -- they disagree whether Nemphos’s state-law claims about

fluoridated bottled water are preempted.

         3
       Milligrams per liter, used in the FDA’s bottled water
regulations, is a roughly equivalent measure to parts per
million. See, e.g., 5 Principles and Practices of Water Supply
Operations: Basic Science Concepts and Applications 103 (4th ed.
2010).

                                              18
        To summarize further, fluoride has been the subject of a

great deal of discussion and regulation by the FDA. The agency

has   set    a    range    of     permissible      fluoride      levels    for   bottled

water.      Id.    §§ 165.110(a)(1),         165.110(b)(4)(ii).           Manufacturers

may optionally add fluoride to bottled water so long as the

concentration does not exceed the levels stipulated by the FDA.

Id. § 165.110(a)(1). If those regulatory ceilings are breached,

the   manufacturer         must    place    a     warning   on    the    label    stating

“Contains        Excessive      Fluoride”    or    “Contains      Excessive      Chemical

Substances.”        Id.    § 165.110(c)(3).          But    the    FDA    requires     no

particular warning regarding dental fluorosis. 60 Fed. Reg. at

57,080.

        Finally, Nemphos does not allege that appellees’ bottled

water     products        contained    fluoride       concentrations        above    the

thresholds set by the FDA. She contends instead that federal

statutes and regulations do not preempt her state-law claims.

                                            III.

                                            A.

        As part of her claims about Nestlé’s and Dannon’s bottled

water, Nemphos maintains that the manufacturers failed to warn

consumers about the risks of dental fluorosis. But for a food

such as bottled water that is “the subject of a standard of

identity,” the NLEA preempts any state “requirement” that is

                                             19
“not       identical        to”    the    federal       standard.          21    U.S.C.        § 343-

1(a)(1).

       The term “requirement” in the NLEA’s preemption provisions

must       be     read      broadly.      It     includes          statutes,          regulations,

standards, and other obligations arising from state law. See 21

C.F.R. § 100.1(b)(5). In comparable contexts, the Supreme Court

has    repeatedly         instructed       that       state       “requirements”            encompass

not     only       positive        enactments      from       the     legislature            or     the

executive,          but     also     common-law        rules        and      duties         from    the

judiciary.         See    Riegel     v.    Medtronic,         Inc.,       552    U.S.       312,    324

(2008)       (“Absent        other       indication,          reference          to     a     State’s

‘requirements’ includes its common-law duties.”); Bates v. Dow

Agrosciences LLC, 544 U.S. 431, 443 (2005); Cipollone v. Liggett

Grp., Inc., 505 U.S. 504, 521 (1992). There is no indication

here       that    § 343-1(a)        distinguishes           among     different            types    of

state       obligations.           Nor    does        the     preemption          provision          in

subsection (a)(1) fence off certain foods or certain aspects of

the standard of identity -- with the one exception of maple

syrup.       21    U.S.C.     § 343-1(a)(1).           To     the     extent      that        Nemphos

requests          damages    rather       than    explicitly          demanding         a     warning

requirement,         the     analysis      remains          the    same. 4      However       Nemphos

       4
        Assuming arguendo that the district court correctly
concluded that the only even potentially meritorious state-law
claims were Nemphos’s strict liability and negligence claims,
(Continued)
                                                 20
frames    her    failure-to-warn        claim,      granting     her    relief    would

impose a “requirement” in the form of a warning under Maryland

law.

       Moreover,    Nemphos’s       proposed       “requirement”       would     not   be

“identical” to the FDA’s standard of identity. Id. The statutory

phrase “not identical to,” according to the FDA’s definition,

“means that the State requirement directly or indirectly imposes

obligations or contains provisions concerning the composition or

labeling of food, or concerning a food container,” that either

“[a]re not imposed by or contained in,” or “[d]iffer from,” the

applicable federal regulations. 21 C.F.R. § 100.1(c)(4)(i)-(ii).

Nonidentical       state       requirements,              whatever     their      legal

provenance, are preempted. In each of the areas selected for

preemption,      such   as    the     standard      of     identity    in   subsection

(a)(1),    the     NLEA      sought    to        ensure     a   nationally     uniform

regulatory system, rather than a fifty-state patchwork.

       Federal law already covers the ground that Nemphos aims to

unsettle through her claims. She seeks a required warning that

is additional to and certainly “not identical to” the federal

see supra note 1, the case law is equally clear. The Supreme
Court has specifically found that common-law causes of action
for   strict   liability    and   negligence   constitute  state
“requirements” subject to preemption. See Riegel, 552 U.S. at
323-24. Assigning liability and awarding damages, after all, may
be “a potent method of governing conduct and controlling
policy.” Id. at 324 (internal quotation marks omitted).

                                            21
standard. The FDA’s standard of identity reaches warnings, and

it    does    not    demand       a    warning      about    dental       fluorosis.     The

standard of identity for bottled water stipulates, for example,

that bottled water intended for infants that is not commercially

sterile must bear this conspicuous statement on the label: “Not

sterile. Use as directed by physician or by labeling directions

for use of infant formula.” 21 C.F.R. § 165.110(a)(3)(iii). Yet

when fluoride is present within accepted levels, the standard of

identity demands merely that the label list fluoride among the

ingredients.              Id.         § 165.110(a)(1),             (4);       see        id.

§ 165.110(b)(4)(ii). If the bottled water contains fluoride in

concentrations beyond those permissible levels, only then must

the   label    bear       the    warning    “Contains       Excessive       Fluoride”     or

“Contains Excessive Chemical Substances.” Id. § 165.110(c)(3).

The parties do not dispute, however, that the fluoride levels in

Nestlé’s and Dannon’s bottled water satisfied federal limits.

      The    presence       of    an    express     preemption       clause    “does     not

immediately         end    the    inquiry       because      the     question       of   the

substance and scope of Congress’ displacement of state law still

remains.” Altria Grp., Inc. v. Good, 555 U.S. 70, 76 (2008). But

Nemphos’s     claims       do    not    fall   into    a    gray    area.    The    warning

requirement Nemphos seeks is simply not identical to the FDA’s

                                               22
existing         standard       of    identity.        As   such,      her    failure-to-warn

claim is preempted. 5

                                                  B.

       In    the        other   part    of    her      bottled   water        claims,      Nemphos

asserts          that     Nestlé       and    Dannon        misleadingly           marketed       and

advertised          their       fluoridated            bottled      water          products        as

especially beneficial to children. But this misleading-marketing

claim is essentially the same as her failure-to-warn claim --

albeit       dressed       in   different         clothing.      The     NLEA      preempts       any

state       “requirement”            that    is   “not      identical        to”    the    federal

standard of identity for a food such as bottled water. 21 U.S.C.

§ 343-1(a)(1). The preemption provision encompasses the labels

affixed to a bottle as well as the contents inside. It makes no

exception for marketing or advertising in areas regulated by the

FDA.       The    misleading-marketing             claim     thus   fails          for    the   same

reason       as     the     failure-to-warn             claim.      It       would       impose    a

       5
        As noted, the NLEA also contains an exception to
preemption for “safety” warnings. NLEA § 6(c)(2), 104 Stat. at
2364. This subsection instructs that the statute’s preemption
provisions “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 component of the
food.” Id. While the NLEA thus expressly preserves an important
role for the states when it comes to safety warnings, Nemphos
has failed to press arguments relevant to the “safety exception”
and   appears  to   have   conceded   its  inapplicability.  See
Appellant’s Reply Br. at 27-28; Oral Arg. at 1:49. As such, we
see no need to address the matter here.

                                                  23
requirement      under    state     law       that   diverges       from      the    federal

standard. As such, it would oblige Nestlé and Dannon to issue

warnings about the risks of dental fluorosis for their products

in the state of Maryland, even though the FDA resolved not to

take that same step.

      Nemphos’s       restrictive         conception        of     the     standard         of

identity     simply      fails     to     square      with       the     statutory         and

regulatory structure. A standard of identity does center on the

characteristics of the regulated food. See supra Section II.C.

The   standard    of     identity       for    bottled      water      thus     prescribes

accepted fluoride levels for the bottle’s contents. 21 C.F.R.

§ 165.110(a)(1); see id. § 165.110(b)(4)(ii). But the statutory

reach extends to labeling as well. See supra Section II.C. In

particular,      it    regulates     labeling        that     appears      outside         the

bottle. The standard of identity for bottled water, for example,

governs label statements about mineral content, sourcing from a

community      water        system,            and    sterility.              21      C.F.R.

§ 165.110(a)(3)(i)-(iii).           It     further       requires        the       label    to

announce each of the ingredients contained in the bottled water

if    any   ingredient,     such     as       fluoride,      has    been       added.      Id.

§ 165.110(a)(4); see id. § 101.4(a)(1). The FDA also demands an

array of other label statements for bottled water of substandard

microbiological, physical, chemical, or radiological quality --

                                              24
including      the    “Contains      Excessive         Fluoride”        or    “Contains

Excessive Chemical Substances” warning. Id. § 165.110(c)(1)-(4).

       Beyond the standard of identity in particular, the pattern

in the broader statutory and regulatory structure makes this

point    clear.       The     four   other      NLEA     preemption           provisions

specifically involve food labeling, 21 U.S.C. § 343-1(a)(2)-(5),

and all five are inscribed under the heading “National uniform

nutrition      labeling,”      id.   § 343-1.    The     FDA’s     own       regulations

confirm this assessment: the preemption provisions cover state-

law    requirements     “concerning      the    composition        or    labeling      of

food” that are not identical to applicable federal regulations.

21 C.F.R. § 100.1(c)(4). Food composition and food labeling are

handled in tandem.

       Given   that    the    standard   of     identity     embraces         labeling,

Nemphos would need to identify an exception to subsection (a)(1)

for marketing or advertising. After all, “[e]very labeling is in

a sense an advertisement.” Kordel v. United States, 335 U.S.

345, 351 (1948). But there is no such exception. By statute, the

term “labeling” in this context carries a distinct meaning: it

includes    “all     labels    and   other     written,    printed,          or   graphic

matter,” whether “upon any article or any of its containers or

wrappers” or “accompanying such article.” 21 U.S.C. § 321(m)(1)-

(2).

                                         25
      The labeling requirements in the FDA’s standard of identity

for bottled water already address fluoride content. As noted

earlier, the FDA found “no basis” for a mandatory warning about

dental    fluorosis          and       instead          left        that     option          to     the

manufacturers.        60     Fed.      Reg.        at     57,079-80.          Carving         out     a

preemption     exception          to    subsection         (a)(1)          for     marketing         or

advertising,         when    the       FDA    has        already           made     an       explicit

determination about fluoride-related labeling, would be not only

inconsistent but also potentially confusing. The FDA’s standard

of identity regulates what manufacturers must say about fluoride

content   on    labels       or    other      visual       materials          on,       around,      or

accompanying bottled water. 21 C.F.R. § 165.110(a), (c); see 21

U.S.C. § 321(m). Those are, needless to say, prime areas for

marketing      and     advertising.           To        allow       a     nonidentical            state

requirement to contravene the FDA’s approach in this area would

undermine the NLEA’s preemption framework. Without this system

of   preemption,       a    manufacturer           might       be       whipsawed       by    federal

regulations      delineating           permissible              labeling          and     state-law

claims of impermissibility. In the five areas designated by the

NLEA, preemption shields manufacturers from that predicament. 21

U.S.C. § 343-1(a)(1)-(5). For the foregoing reasons, Nemphos’s

misleading-marketing claim is preempted.

      In reaching this conclusion, we do not suggest that § 343-

1(a)(1)   preempts          all    nonidentical           marketing          and        advertising

                                              26
requirements, even where those requirements are wholly unrelated

to packaging and labeling. For example, a state-law requirement

that    bottled   water        manufacturers        provide    warnings      regarding

dental    fluorosis     in     other    media       of    advertising       presents   a

different question from the one before us today. Because Nemphos

limits her marketing and advertising allegations to claims made

on labeling and packaging, we need not reach the question of

whether state-law requirements for out-of-store advertising and

promotions would be preempted. Those matters are not before us,

and we express no opinion on them.

                                            IV.

       Nemphos also requests relief based on Nestlé’s and Gerber’s

labeling     of   their      respective       infant      formula   and     baby   food

products, which did not provide a warning about the risks of

dental fluorosis. Nemphos has now filed three versions of her

complaint.    Even    her      latest   amended       complaint,      however,     still

falls    short     of     stating       a        plausible    failure-to-warn          or

misleading-marketing claim under federal pleading standards.

       Federal Rule of Civil Procedure 8(a)(2) requires that a

complaint    contain      “a   short    and       plain   statement    of    the   claim

showing that the pleader is entitled to relief.” Fed. R. Civ. P.

8(a)(2). As the Supreme Court has explained in the context of

motions to dismiss, “the pleading standard Rule 8 announces does

                                            27
not require ‘detailed factual allegations,’ but it demands more

than        an         unadorned,          the-defendant-unlawfully-harmed-me

accusation.”         Ashcroft      v.     Iqbal,       556    U.S.     662,    678     (2009)

(quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)).

       Unlike       with   her   bottled     water          claims,    Nemphos    does    not

allege that the appellee manufacturers added fluoride to the

infant formula or baby food products consumed by her daughter.

Nor    does    she     allege    that     Nestlé       or    Gerber    violated      federal

regulations. Food additives generally are presumed unsafe until

approved by the FDA, and the agency regulates the conditions

under which approved additives may be used safely. 21 U.S.C.

§§ 321(s),       348(a).     The    FDA     in    fact       forbids    the    addition    of

fluoride       to    any   foods    other    than       bottled       water,   unless     the

addition results from using fluoridated public water supplies.

21 C.F.R. § 170.45. Although manufacturers may not add fluoride

to infant formula or baby food, some fluoride may nevertheless

be present in the final product because of municipal water used

in the manufacturing process. Nemphos’s concern thus involves

the failure to warn that fluoride -- even at permissible levels,

without       any    addition      by   manufacturers          --     may   contribute     to

causing dental fluorosis over time.

       To     impose    on   manufacturers         a    duty    to     warn    under    these

circumstances, Maryland law would oblige Nemphos to allege a

good deal more than she has put forward in this action. The

                                             28
complaint          is   studded         with    highly       general       and    conclusory

statements that could be adapted to many different products at

many different times. It says little about the contents of the

infant       formula       and   baby    food    products         in    particular,    except

merely that they contain some amount of fluoride. We are left

essentially with a “naked assertion” of liability that lacks the

“further factual enhancement” demanded by Rule 8(a)(2). Twombly,

550    U.S.     at      557.     Even    at     this    stage      of    the     proceedings,

something more is required regarding the precise nature of the

state-law duty the manufacturers are alleged to have breached,

as    well    as     the    grounding      in    state      law    for    whatever    warning

Nemphos proposes to impose. The vagueness of the allegations

simply fails to satisfy the basic “plausibility” requirements of

Rule 8 and Twombly, and it provides an inadequate basis for

overturning the trial court’s dismissal of the infant formula

and baby food claims.

       “Local Rule 103.6 of the District of Maryland requires that

a party requesting leave to amend provide a copy of the proposed

amendment to the court.” Francis v. Giacomelli, 588 F.3d 186,

197 (4th Cir. 2009). Nemphos, like the plaintiffs in Francis,

did not file a separate motion requesting leave to amend her

complaint       or      attach     a     proposed          amended      complaint     to   her

opposition brief. We are therefore compelled to find that the

district       court       did    not    abuse       its    discretion      in    dismissing

                                                29
Nemphos’s third amended complaint with prejudice and denying her

a fourth bite at the apple.

                               V.

     For the foregoing reasons, the judgment is affirmed.

                                                            AFFIRMED

                               30