Nemphos Ex Rel. C.G.N. v. Nestle Waters North America, Inc. , 775 F.3d 616 ( 2015 )

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
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