White v. Colgate-Palmolive Co. et al

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
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DOUGLAS WHITE, individually and on behalf of all
others similarly situated
Plaintiffs,
MEMORANDUM AND ORDER
-against- 	25-CV-00662 (OEM) (LKE)
TOM’S OF MAINE, INC.,
Defendant.
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ORELIA E. MERCHANT, United States District Judge:
Plaintiff Douglas White (“Plaintiff”) brings this putative class action against defendant
Tom’s of Maine, Inc. (“Defendant”) alleging that Defendant deceptively and misleadingly
manufactured, marketed, and sold Kid’s Natural Fluoride-Free Toothpaste Silly Strawberry and
Toddler Natural Fluoride-Free Toothpaste Mild Fruit products (“Products”) without disclosing to
consumers that they are contaminated with unsafe levels of lead or arsenic. 	See generally First
Amended Class Action Complaint, Dkt. 13 (“Amended Complaint” or “Am. Compl.”). Defendant
moves to dismiss the Amended Complaint in its entirety under Federal Rule of Civil Procedure
12(b)(1) (“Rule 12(b)(1)”) for lack of standing and Federal Rule of Civil Procedure 12(b)(6)
(“Rule 12(b)(6)”) for failure to state a claim.1
For the following reasons Defendant’s Motion is granted in part and denied in part.
1 Memorandum of Law in Support of Defendant Tom’s of Maine, Inc.’s Motion to Dismiss Plaintiff’s First Amended
Class Action Complaint, Dkt. 17 (“Motion” or “Mot.”); Plaintiff’s Memorandum of Law in Opposition to Defendant’s
Motion to Dismiss, Dkt. 19 (“Opposition” or “Opp’n”); Reply Memorandum of Law in Further Support of Defendant
Tom’s of Maine, Inc.’s Motion to Dismiss Plaintiff’s First Amended Class Action Complaint, Dkt. 18 (“Reply”).
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BACKGROUND2
A. The Parties
Defendant is a corporation with its principal place of business in Maine. Am. Compl. ¶ 62.
Defendant markets, advertises, and distributes the Products throughout the United States. Id. ¶ 63.
Plaintiff is a citizen and resident of Staten Island, New York. Id. ¶ 60. He brings this action
against Defendant on behalf of himself and those similarly situated “who purchased the Products
during the appliable statute of limitations period.” Id. ¶¶ 9, 25, 64. Plaintiff purchased the Products
“on multiple occasions from brick-and-mortar stores located in Staten Island and gave his child
Defendant’s products” including in January 2025. Id. ¶ 60.
B. Allegations of Lead and Arsenic
Plaintiff alleges that Defendant’s marketing represents that “the Products are each healthy
toothpastes for kids.” 	Id. ¶ 31. 	Plaintiff contends that independent testing of a Kid’s Natural
Fluoride-Free Toothpaste Silly Strawberry product that he purchased detected lead at 0.455 mg/Kg
or 455 parts per billion and arsenic at 0.068 mg/Kg or 68 parts per billion. 	Id. ¶ 30. 	Further,
Plaintiff cites two webpages allegedly reporting additional independent testing that has indicated
lead and arsenic in the Kid’s Natural Fluoride-Free Toothpaste Silly Strawberry Product and lead
in the Toddler Natural Fluoride-Free Toothpaste Mild Fruit Product at “dangerous levels.” Id. ¶ 29
(first citing Tamara Rubin, Tom’s of Maine Kid’s Natural Fluoride-Free Toothpaste in Silly
Strawberry Flavor Tests Positive for Lead and Arsenic: 2025 Lab Report Here, LEAD S AFE M AMA
(June 	14, 	2025), 	https://tamararubin.com/2025/02/toms-of-maine-kids-natural-fluoride-free-
toothpaste-silly-strawberry; then citing Tamara Rubin, Testing Tom’s of Maine Fluoride-Free
Toddler Toothpaste in Mild Fruit Flavor for Lead, Mercury, Cadmium, & Arsenic Using
2 The following facts taken from Plaintiff’s Amended Complaint are accepted as true for the purposes of Defendant’s
Motion. The Court recites only those facts relevant to resolving the pending Motion.
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Independent (Community-Funded), Third-Party Laboratory Testing, LEAD S AFE M AMA (June 5,
2025), https://tamararubin.com/2025/04/toms-of-maine-fluoride-free-toddler-toothpaste-in-mild-
fruit-flavor/). The Products’ packages do not identify lead or arsenic as ingredients, nor do they
include a warning that lead or arsenic is or may be included in the Products. Id. ¶ 32.
C. Alleged Injuries
Plaintiff alleges that Defendant made false, misleading, and deceptive omissions regarding
the Products’ lead or arsenic levels, id. ¶ 47, and that the Products were healthy for kids, id. ¶ 31,
that Defendant knew and intended that consumers would pay a premium for Products, id. ¶ 54, and
thereby injured Plaintiff and similarly situated persons, id. ¶ 55. Specifically, Plaintiff alleges he
was harmed in six ways as a result of Defendant’s “false, misleading, and deceptive representation
and omission” by: (1) paying a sum of money for Products that were not what Defendant
represented; (2) paying a premium price for Products that were not what Defendant represented;
(3) being deprived of the benefit of the bargain because the Products he purchased were different
from what Defendant warranted; (4) being deprived of the benefit of the bargain because the
Products he purchased had less value than what Defendants represented; (5) ingesting substances
that were of a different quality than what Defendant promised; and (6) being denied the benefit of
the properties of the Products Defendant promised. Id.
LEGAL STANDARD
A. Rule 12(b)(1) Motion to Dismiss
A motion to dismiss for lack of standing under Rule 12(b)(1) challenges the district court’s
subject-matter jurisdiction. See SM Kids, LLC v. Google LLC, 963 F.3d 206, 210 (2d Cir. 2020).
At the pleading stage, “[t]he task of the district court is to determine whether the [p]leading
‘allege[s] facts that affirmatively and plausibly suggest that [the plaintiff] has standing to sue.’”
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Carter v. HealthPort Techs., LLC, 822 F.3d 47, 56 (2d Cir. 2016) (third and fourth alterations in
original) (quoting Amidax Trading Grp. v. S.W.I.F.T. SCRL, 671 F.3d 140, 145 (2d Cir. 2011) (per
curiam)). While the Court must take all facts alleged in the plaintiff’s complaint as true and draw
all reasonable inferences from the complaint, it is nonetheless the plaintiff’s burden to establish
standing under Article III of the Constitution. Id. at 56-57 (distinguishing between facial and fact-
based standing challenges). To establish standing, a plaintiff must allege that he has “[(1)] suffered
an injury-in-fact . . . [(2) that is] fairly traceable to the challenged conduct of the defendant, and
[(3) that is] likely . . . to be redressed by a favorable judicial decision.” See id. at 55 (quoting Lujan
v. Defs. of Wildlife, 504 U.S. 555, 560-61 (1992)).
B. Rule 12(b)(6) Motion to Dismiss
To survive a Rule 12(b)(6) motion to dismiss, “a complaint must contain sufficient factual
matter, accepted as true, to ‘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)). A claim
may be deemed facially plausible if the alleged facts allow the court to reasonably infer “that the
defendant is liable for the misconduct alleged.” 	Id. (citing Twombly, 550 U.S. at 556). 	The
principle that a court must accept the allegations in a complaint as true does not apply to
“[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory
statements.” Id. (citing Twombly, 550 U.S. at 555).
DISCUSSION
Invoking this Court’s diversity jurisdiction, Plaintiff brings four causes of action against
Defendant: (1) violation of New York General Business Law § 349 (“GBL § 349”); (2) violation
of New York General Business Law § 350 (“GBL § 350”); (3) negligence per se; and (4) unjust
enrichment. Am. Compl. ¶¶ 76-114. Defendant moves to dismiss the complaint on the grounds
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that: Plaintiff lacks standing “because he does not plausibly allege that the level of lead and/or
arsenic purportedly found in the [Products] poses any material health risk, and therefore has failed
to allege any concrete injury-in-fact”; Plaintiff’s claims are expressly preempted by the Food,
Drug, and Cosmetic Act 21 U.S.C. §§ 301 et seq. (“FDCA”); and Plaintiff has failed to sufficiently
plead any cause of action as to all four of his claims. See Mot. at 2-3. The Court addresses each
argument in turn.
A. Standing
Defendant argues that Plaintiff has failed to allege a concrete injury-in-fact because he fails
to state that the lead and arsenic levels “pose any material safety risk or rendered the [Products]
unsafe, unusable, or worthless.” Mot. at 4-5. Plaintiff asserts that he has successfully alleged an
injury-in-fact by explaining that he paid a “price premium,” that is, he “paid more for [the
Products] than he would have had Defendant disclosed the presence of lead and arsenic.” Opp’n
at 6-8.
Injury-in-fact is a “low threshold” that “helps to ensure that the plaintiff has a personal
stake in the outcome of the controversy.” John v. Whole Foods Mkt. Grp., Inc., 858 F.3d 732, 736
(2d Cir. 2017) (first quoting WC Capital Mgmt., LLC v. UBS Secs., LLC, 711 F.3d 322, 329 (2d
Cir. 2013); then quoting Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014)). “[O]ne
method of demonstrating actual injury in the consumable goods context is by showing that the
plaintiff paid a ‘price premium’ – that is, as a result of the defendant’s deception, the plaintiff paid
more for a product than he otherwise would have.” 	In re Lindt & Sprüngli (USA), Inc., Dark
Chocolate Litig., 23-CV-1186 (AMD) (JAM), 2024 WL 4107244, at *3 (E.D.N.Y. Sep. 6, 2024)
(first quoting Eidelman v. Sun Prods. Corp., 21-1046-cv, 2022 WL 1929250, at *1 (2d Cir. June
6, 2022); then citing Axon v. Florida’s Nat. Growers, Inc., 813 F. App’x 701, 703-04 (2d Cir.
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2020) (finding that allegation that the product was inflated as a result of the defendant’s deception
meets the injury requirement)).
Plaintiff has met this threshold. 	In his Amended Complaint, Plaintiff alleges that if he
knew the truth about the content of lead and arsenic in the Products, he would have paid less for
them or not paid for them at all. See Am. Compl. ¶¶ 48, 55, 56-59 (misnumbered ¶¶ 53-56), 64
(misnumbered ¶ 61), 93 (misnumbered ¶ 90).3 Plaintiff also alleges that the Products are marketed
as “healthy toothpastes for kids” and do not include any indication of lead or arsenic on the label.
Id. ¶¶ 31-32. As a result, Plaintiff has alleged that he paid more for the Products than he otherwise
would have as a result of the alleged deceptive marketing that the Products were healthy for kids.
Defendant’s arguments to the contrary are unconvincing. 	When asserting that Plaintiff
must allege that the amount of heavy metals in the Products is harmful, Defendant relies on In re
Beech-Nut Nutrition Co. Baby Food Litigation. Mot. at 6-7 (citing In re Beech-Nut Nutrition Co.
Baby Food Litig., 771 F. Supp. 3d 96, 105 (N.D.N.Y. 2025) (holding that the plaintiffs lacked
standing because they did not allege that the existence of heavy metals in baby food rendered the
food unsafe, unusable, and therefore, worthless), vacated and remanded sub nom., Cantor v.
Beech-Nut Nutrition Co., 25-821-cv, 2026 WL 304246 (2d Cir. Feb. 5, 2026)). However, there,
the Second Circuit vacated the U.S. District Court for the Northern District of New York’s holding.
See generally Cantor v. Beech-Nut Nutrition Co., 25-821-cv, 2026 WL 304246 (2d Cir. Feb. 5,
2026). Specifically, the Second Circuit determined that the plaintiffs plausibly alleged an injury
by stating that they would not have purchased the products or paid as much for them had they
known the company failed to adequately test for heavy metals. 	Id. at *2. 	It also held that the
plaintiffs’ citation to a report and third-party testing that described the company’s “systemic failure
3 The Amended Complaint misnumbers its paragraphs starting after Paragraph 55. 	The Court accounts for the
typographical error by citing to the correct paragraph number followed by the misnumbered paragraph number.
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to deliver on its bargained-for assurances regarding its testing and safety standards” rendered their
claims plausible. 	Id. 	Plaintiff has done just so here. 	See Am. Compl. ¶¶ 29, 48, 55, 56-59
(misnumbered ¶¶ 53-56), 64 (misnumbered ¶ 61), 93 (misnumbered ¶ 90).
Furthermore, overpayment is a sufficient economic injury for Article III standing. 	See
Cantor, 2026 WL 304246, at *3. Plaintiff has plausibly alleged that he overpaid for the Products
based on a misrepresentation that the products were safe and healthy for kids. See Am. Compl.
¶¶ 48, 55, 56-59 (misnumbered ¶¶ 53-56), 64 (misnumbered ¶ 61), 93 (misnumbered ¶ 90).
Accordingly, Defendant’s motion to dismiss for lack of standing is denied.
B. Express Preemption
Plaintiff alleges that (1) Defendant misrepresented the Products and (2) omitted lead or
arsenic on their ingredient lists: “Defendant’s labeling and advertisements contain untrue and
materially 	misleading 	statements 	and 	omissions 	concerning 	its 	Products 	inasmuch 	as 	it
misrepresents that the Products are safe for use and doesn’t list that the Products contain lead
and/or arsenic.” 	Am. Compl. ¶ 92 (misnumbered ¶ 89); see also id. ¶ 84 (misnumbered ¶ 81).
Defendant argues that Plaintiff’s misrepresentation and omission theories, upon which his GBL
claims are based, are preempted by the FDCA because they seek to impose requirements on
Defendant that are different from the FDCA. Mot. at 7-8. In response, Plaintiff argues that his
misrepresentation allegations comport with the FDCA requirements which deem a cosmetic
misbranded if its labeling is false or misleading. 	Opp’n at 9-11. 	As for his omission theory,
Plaintiff contends that the FDCA requires disclosure of the lead and arsenic quantities in the
Products and, therefore, does not seek to hold Defendant to any standards that are different or
additional to the FDCA’s labeling requirements. Id. at 9-10.
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Thus, the question is whether Plaintiff’s state-law claims seek to impose requirements that
are different from or not identical to the applicable FDCA requirements. 	Express preemption
arises when Congress “define[s] explicitly the extent to which its enactments pre-empt state law.”
English v. Gen. Elec. Co., 496 U.S. 72, 78-79 (1990).
The parties do not dispute that the Products are cosmetics. 	See Am. Compl. ¶ 103
(misnumbered ¶ 100). U.S. Code title 21, section 379s(a), which applies to cosmetics, provides:
[N]o State or political subdivision of a State may establish or continue in effect any
requirement for labeling or packaging of a cosmetic that is different from or in
addition to, or that is otherwise not identical with, a requirement specifically
applicable to a particular cosmetic or class of cosmetics under [the FDCA].
In other words, the FDCA preempts “any state law that provides for labeling requirements that are
not exactly the same as those set forth in the FDCA and its regulations.” Critcher v. L’Oreal USA,
Inc., 959 F.3d 31, 35-36 (2d Cir. 2020).
Plaintiff’s misrepresentation allegation is not expressly preempted. The FDCA prohibits
the labeling or packaging of cosmetics in a false or misleading way. 	See 21 U.S.C. §§ 331(a),
352(a)(1), 362(a). 	Plaintiff alleges that Defendant “misrepresents that the Products are safe for
use,” Am. Compl. ¶ 92 (misnumbered ¶ 89), and “healthy toothpastes for kids,” id. ¶ 31, and that
those representations are false and misleading because the Products contain lead or arsenic, which
are not “safe for use” or “healthy” for kids, see id. ¶¶ 34-41 (summarizing the adverse effects of
lead and arsenic exposure in children). Therefore, Plaintiff’s claim parallels the FDCA and seeks
to impose a requirement that Defendant not label the Products in a false or misleading way. See
Canale v. Colgate-Palmolive Co., 258 F. Supp. 3d 312, 320 (S.D.N.Y. 2017) (concluding that the
plaintiff’s 	claims 	were 	not 	expressly 	preempted 	because 	she 	alleged 	the 	defendant’s
representations regarding deep whitening were false and misleading which sought to impose
requirements identical to the FDCA).
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Now turning to the FDCA’s labeling requirements relevant to Plaintiff’s omission theory.
The FDCA labeling requirements for cosmetics require a manufacturer to disclose “a declaration
of the name of each ingredient in descending order of predominance[.]” 21 C.F.R. § 701.3. An
“ingredient” is defined as “any single chemical entity or mixture used as a component in the
manufacture of a cosmetic product.” 	Id. § 700.3(e). 	Further, the FDCA provides that “[t]he
provisions of this section do not require the declaration of incidental ingredients that are present
in a cosmetic at insignificant levels and that have no technical or functional effect in the cosmetic.”
Id. § 701.3(l). 	“Incidental ingredients” are defined as “[s]ubstances that have no technical or
functional effect in the cosmetic but are present by reason of having been incorporated into the
cosmetic as an ingredient of another cosmetic ingredient” or “[p]rocessing aids[.]” 	Id.
§§ 701.3(l)(1)-(2).
While the Second Circuit has yet to address whether an omission theory is expressly
preempted by the FDCA, the Court is persuaded by the reasoning of other district courts that have
determined that such theories are expressly preempted. See Navarro v. Walgreens Boots All., Inc.,
1:24-cv-00290-JLT-SAB, 2025 WL 1411406, at *11 (E.D. Cal. May 15, 2025) (reasoning that
federal labeling regulations do not require that the labels disclose that the product might contain
benzene, “so [p]laintiffs’ claims, insofar as they [are] grounded on [a theory of omission] are
expressly preempted”), report & recommendation adopted, 1:24-cv-00290-JLT-SAB, 2025 WL
3485004 (E.D. Cal. Dec. 4, 2025); Bojko v. Pierre Fabre USA Inc., 22 C 6728, 2023 WL 4204663,
at *4-5 (N.D. Ill. June 27, 2023) (distinguishing cases where it is alleged that a defendant has
misrepresented the effectiveness of a product from where a defendant has omitted an item from
the ingredients list, concluding that because the plaintiff did not allege benzene was an “ingredient”
but rather that it was a “contaminant,” the plaintiff’s claims sought to impose a requirement in
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addition to what federal law requires). 	Here, Plaintiff has not alleged that lead or arsenic are a
“component in the manufacture of” the Products; rather he asserts that the Products are
“contamina[nts].” See Am. Compl. ¶ 45. Plaintiff also has not alleged that lead or arsenic have
any “technical or functional effect” in the Product and confirms that he does not concede that the
lead or arsenic are “incidental ingredients.” Opp’n at 12. Consequently, Plaintiff fails to allege
that lead and arsenic are “ingredients” and, thus, Plaintiff has not plausibly alleged that Defendant
is required, under the FDCA, to include lead or arsenic in the Products’ labels. Thus, Plaintiff’s
claim, if successful, would impermissibly impose an additional requirement on what the FDCA
already requires.
Accordingly, to the extent Plaintiff alleges the labels are misleading because they
misrepresent the Products as safe and healthy, Defendant’s motion to dismiss based on preemption
is denied. However, to the extent Plaintiff’s claims rely on the omission of lead and arsenic from
the Products’ ingredients list, Defendant’s motion to dismiss based on preemption is granted and
they are dismissed.
C. GBL § 349 and GBL § 350 Misrepresentation and Deceptive Practice Claims
Plaintiff claims that Defendant violated GBL § 349 by “misleadingly, inaccurately, and
deceptively” 	advertising 	and 	marketing 	the 	Products 	to 	consumers, 	Am. 	Compl. 	¶ 83
(misnumbered ¶ 80), and by failing to disclose that the Products contain lead or arsenic, which is
materially misleading, and that Defendant made those statements and omissions “willfully,
wantonly, and with reckless disregard for the truth,” id. ¶ 84 (misnumbered ¶ 81). Plaintiff alleges
that Defendant violated GBL § 350 for the same reasons. 	Id. ¶¶ 92 (misnumbered ¶ 89), 95
(misnumbered ¶ 92). In opposition, Defendant asserts that Plaintiff’s New York GBL claims fail
for three reasons: (1) that Plaintiff does not identify any false statement or material omission, Mot.
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at 11-12; (2) that Plaintiff’s omission-based GBL claims fail because he does not plausibly allege
Defendant had actual or constructive knowledge of the presence of any lead or arsenic in the
Products, id. at 12-13; and (3) that Plaintiff does not adequately plead any alleged economic injury
under a price-premium theory because Plaintiff does not allege that the Products were “marketed
as ‘lead-free,’ ‘arsenic-free,’ or otherwise free from elemental impurities,” id. at 13-15.
GBL § 349 prohibits “[d]eceptive . . . acts or practices in the conduct of any business, trade
or commerce or in the furnishing of any service[,]” N.Y. GEN. B US . LAW § 349(a), and GBL § 350
prohibits “[f]alse advertising in the conduct of any business, trade or commerce or in the furnishing
of any service[s]” that is “misleading in a material respect,” id. §§ 350, 350-a(1). “To successfully
assert a claim under either section, ‘a plaintiff must [establish] that a defendant has engaged in (1)
consumer-oriented conduct that is (2) materially misleading and that (3) plaintiff suffered injury
as a result of the [] deceptive act or practice.’” Orlander v. Staples, Inc., 802 F.3d 289, 300 (2d
Cir. 2015) (quoting Koch v. Acker, Merrall & Condit Co., 967 N.E.2d 675 (N.Y. 2012)). “The New
York Court of Appeals has adopted an objective definition of ‘misleading,’ under which the alleged
act must be ‘likely to mislead a reasonable consumer acting reasonably under the circumstances.’”
Id. (quoting Cohen v. JP Morgan Chase & Co., 498 F.3d 111, 126 (2d Cir. 2007)).
As discussed above, Plaintiff’s omission-based claims are expressly preempted. Thus, to
the extent that Plaintiff’s GBL § 349 and GBL § 350 claims are based on an omission theory, such
claims are dismissed, and the Court need not consider Defendant’s argument that they be dismissed
for 	failure 	to 	adequately 	allege 	knowledge. 	See 	Mot. 	at 	12-13. 	However, 	Plaintiff’s
misrepresentation-based GBL § 349 and GBL § 350 claims are not expressly preempted.
Consequently, the Court considers Defendant’s arguments that Plaintiff fails to allege any false
statement or material omission and has not adequately pleaded injury. See id. at 11-14.
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As to Defendant’s argument that Plaintiff has failed to allege a false statement or material
omission, Mot. at 11-12, Plaintiff responds that he plausibly alleges that the branding conveys that
the products are “safe, natural, and appropriate for pediatric use,” yet fails to convey the presence
of lead or arsenic, Opp’n at 14-15. To determine whether an act or advertising is misleading, the
standard is whether a reasonable consumer could be misled by the alleged act, such as labeling and
marketing. 	See Sitt v. Nature’s Bounty, Inc., 15-CV-4199 (MKB), 2016 WL 5372794, at *12
(E.D.N.Y. Sep. 26, 2016) (citing Ackerman v. Coca-Cola Co., CV–09–0395 (JG)(RML), 2010 WL
2925955, at *16 (E.D.N.Y. July 21, 2010)); See Segedie v. Hain Celestial Grp., Inc., 14–cv–5029
(NSR), 2015 WL 2168374, at *11-12 (S.D.N.Y. May 7, 2015) (concluding that the allegation of
synthetic ingredients in foods labeled as “natural” brought “the claim of deception into the realm
of plausibility”); Colangelo v. Champion Petfoods USA, Inc., 6:18-CV-1228 (LEK/ML), 2020 WL
777462, at *10-11 (N.D.N.Y. Feb. 18, 2020) (explaining that there was not an unreasonable link
between “biologically appropriate” label on dog food and the idea that it would contain no arsenic).
The Court is conscious that “[w]hether the labels would mislead a reasonable consumer is
a question of fact for the jury.” 	Segedie, 2015 WL 2168374, at *12. 	Therefore, at this stage,
Plaintiff’s allegations “bring[] the claim of deception within the realm of plausibility.” Id. Plaintiff
alleges that the Products are marketed to appeal to children by claiming the Products “are each
healthy 	toothpastes 	for 	kids.” 	Am. 	Compl. ¶ 31. 	Plaintiff 	also 	claims 	that 	Defendant
“misrepresents that the Products are safe for use.” 	Id. ¶ 92 (misnumbered ¶ 	89). 	There is a
plausible link between the belief that the Products are “healthy,” or safe for children and the
allegation that the Products contain potentially unsafe levels of lead or arsenic. 	Additionally,
Defendant argues that Plaintiff fails to allege that the Products “pose any material safety risk” or
cause harm to consumers and thus fails to plausibly allege that the advertising materials are false
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or misleading. Mot. at 11-12. Any inquiry into whether the toothpastes pose “any material safety
risk” is a question reserved for summary judgment. See Levy v. Hu Prods. LLC, 23 Civ. 1381 (AT),
2024 WL 897495, at *4 (S.D.N.Y. Mar. 1, 2024) (explaining that any inquiry into “safe” levels of
lead is an issue of fact reserved for summary judgment).
As to Defendant’s argument that Plaintiff does not plead any economic injury because he
fails to allege that the Products were marketed as “lead-free” or “arsenic-free,” Plaintiff responds
that Plaintiff adequately pleads a price-premium theory of damages. Opp’n at 17-18. To plead an
injury pursuant to either GBL § 349 or GBL § 350, “a plaintiff must allege that, on account of a
materially misleading practice, she purchased a product and did not receive the full value of her
purchase.” 	Orlander, 802 F.3d at 302. 	A plaintiff “must plead something more than the
defendant’s deception; for example, that ‘the price of the product was inflated as a result of
defendant’s deception or that use of the product adversely affected plaintiff’s health.’” Preira v.
Bancorp Bank, 885 F. Supp. 3d 562, 677 (S.D.N.Y. 2012) (quoting Baron v. Pfizer, Inc., 42 A.D.3d
627, 840 N.Y.S.2d 445, 448 (App. Div. 2007)); see also Colpitts v. Blue Diamond Growers, 527 F.
Supp. 3d 562, 567 (S.D.N.Y. 2021) (“A price premium theory requires a plaintiff to ‘allege[] that
a company marketed a product as having a unique quality that the marketing allowed the company
to charge a price premium for the product, and that the plaintiff paid the premium and later learned
that the product did not, in fact, have the marketed quality”) (quoting Duran v. Henkel of Am., Inc.,
450 F. Supp. 3d 337, 350-51 (S.D.N.Y. 2020)); Segedie, 2015 WL 2168374, at *12 (finding that
the plaintiffs adequately alleged that they paid a price premium by claiming that they would not
have paid if the products were not labeled “natural” or “all natural”).
Plaintiff alleges that he paid a premium on the Products that were misrepresented as safe
for use, see Am. Compl. ¶ 92 (misnumbered ¶ 89), and later learned that the Products contained
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lead or arsenic, see id. ¶¶ 11-12. Thus, Plaintiff alleges the Products were not safe for use and did
not have the marketed quality he purchased them for and that he purchased more of or paid more
for the Products that he otherwise would have had they not been marketed as safe or healthy for
kids. 	Id. ¶ 64 (misnumbered ¶ 61). 	Plaintiff has therefore adequately alleges a price-premium
theory. To the extent that Defendant argues Plaintiff fails to allege the existence of comparable
products, see Mot. at 14, courts have denied motions to dismiss GBL § 349 claims despite the
plaintiffs not identifying competitors or prices in their complaints, see Goldemberg v. Johnson &
Johnson Consumer Cos., 8 F. Supp. 3d 467, 481 (S.D.N.Y. 2014) (collecting cases), and the same
outcome is warranted here.
Accordingly, Defendant’s Motion with respect to Plaintiff’s misrepresentation-based GBL
§ 349 and GBL § 350 claims is denied.
D. Negligence Per Se Claim
Plaintiff alleges that Defendant is liable for negligence per se due to its violation of the
FDCA, namely §§ 331, 361, and 362.4 	Am. Compl. ¶¶ 102-06 (misnumbered ¶¶ 99-103). 	In
opposition, Defendant argues that the Amended Complaint fails to allege any facts showing that it
violated state or federal law, Mot. at 15-16, because Plaintiff has not alleged (1) facts showing that
the level of lead or arsenic is harmful, which is a requirement for adulteration, or (2) that anything
on the labeling was false or misleading, which is a requirement for misbranding, Reply at 9.
Plaintiff counters that he has adequately plead facts showing that the lead and arsenic caused the
Products to be adulterated and that Defendant failed to warn consumers about lead and arsenic,
which caused the Products to be misbranded. Opp’n at 19.
4 The Court notes that in the Amended Complaint Paragraph 106, misnumbered Paragraph 103, Plaintiff cites to 21
U.S.C. § 361 but quotes from 21 U.S.C. § 362.
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As an initial matter, Plaintiff has a private cause of action for his negligence per se claim
for Defendant’s alleged FDCA violations. 	Sita v. Danek Med., Inc., 43 F. Supp. 2d 245, 262
(E.D.N.Y. 1999) (“a private cause of action for per se negligence arises under New York State law
upon violation of the FDCA” (citing Ezagui v. Dow Chem. Corp., 598 F.2d 727, 733 (2d Cir.
1979))).
Plaintiff has plausibly alleged adulteration. 	The FDCA prohibits “[t]he adulteration or
misbranding of any . . . cosmetic in interstate commerce.” 21 U.S.C. § 331(b). U.S. Code title 21,
section 361(a) defines the adulteration of cosmetics as that which “bears or contains any poisonous
or deleterious substance which may render it injurious to users under the conditions of use
prescribed in the labeling thereof.” Plaintiff claims that the Products are “‘adulterated’ because
they each contain lead and/or arsenic which are injurious to health.” 	Am. Compl. ¶ 107
(misnumbered ¶ 104). Plaintiff alleges that lead is a “powerful neurotoxin . . . shown to reduce
intelligence, and to increase the risk of mental illness, dementia, hypertension, arrhythmia, and
breast cancer,” id. ¶ 34, and is particularly harmful to children, see id. ¶¶ 36-41. Plaintiff alleges
that arsenic has similar impacts on children. See id. ¶¶ 36-41. Therefore, Plaintiff has adequately
pleaded that the presence of lead or arsenic in the Products “may render” them injurious to health.
See Hernandez v. Wonderful Co., 23-cv-1242 (ER), 2024 WL 4882180, at *8-9 (S.D.N.Y. Nov.
25, 2024) (concluding that the plaintiff adequately pleaded that the product was adulterated by
pleading that the presence of PFAS may render it injurious to health).
Plaintiff has also plausibly alleged misbranding. 	The FDCA defines a cosmetic
“misbranded” “[i]f its labeling is false or misleading in any particular.” 	21 U.S.C. § 362(a).
Plaintiff claims the Products are “‘misbranded’ because their labeling is false and misleading in
that they omit any mention or warning of the fact that they contain or risk containing dangerous
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lead and/or arsenic.” Am. Compl. ¶ 108 (misnumbered ¶ 105). This case differs from Henson v.
Write Med. Tech., Inc., upon which Defendant relies. Mot. at 15-16 (citing Henson v. Write Med.
Tech., Inc., 5:12-CV-805 (FJS/TWD), 2013 WL 1296388 (N.D.N.Y. Mar. 28, 2013) (granting
motion to dismiss concluding that the plaintiff did not plausibly allege violations of 21 U.S.C. §§
331(a) and 333(a)(2)). Part of the Henson court’s reasoning was that the plaintiff failed to allege
that the defendants provided inaccurate warnings for the product’s intended use. 	Id. 	Here,
however, Plaintiff does not allege that the product did not have accurate warnings. 	Instead,
Plaintiff has concretely alleged that Defendant marketed the Products as healthy for kids,
constituting at least a plausible claim that Plaintiff was misled by the Products’ ingredients and
“kid-safe” character. Moreover, there are material facts yet to be determined as to the potentially
misleading nature of the Products’ misbranding. Hernandez, 2024 WL 4882180, at *10 (reasoning
that there were material facts concerning whether the product was misbranded that could not be
decided on a motion to dismiss).
Accordingly, Defendant’s motion to dismiss Plaintiff’s negligence per se claim is denied.
E. Unjust Enrichment Claim
Defendant argues that Plaintiff’s unjust enrichment claim should be dismissed because: (1)
it is duplicative of Plaintiff’s GBL claims; (2) Plaintiff fails to allege anything false or misleading
that would cause any gains to be unjust; and (3) Plaintiff does not allege any unusual situation that
creates an equitable obligation on Defendant. 	Mot. at 16-17. 	Plaintiff responds to Defendant’s
duplicity argument, stating that the elements for his GBL claims are distinct from the elements of
an unjust enrichment claim. Opp’n at 19-20.
Plaintiff’s unjust enrichment claim fails. To prevail on an unjust enrichment claim in New
York, “a plaintiff must establish (1) that the defendant benefitted; (2) at the plaintiff’s expense; and
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(3) that equity and good conscience require restitution.” 	Beth Israel Med. Ctr. v. Horizon Blue
Cross & Blue Shield of N.J., Inc., 448 F.3d 573, 586 (2d Cir. 2006) (quoting Kaye v. Grossman,
202 F.3d 611, 616 (2d Cir. 2000)). While the elements of a claim under GBL § 349 and GBL § 350
are distinct from an unjust enrichment claim, see Warner v. StarKist Co., 1:18-cv-406 (GLS/ATB),
2019 WL 1332573, at *3 (N.D.N.Y. Mar. 25, 2019),5 where unjust enrichment claims rely on the
same “theory of liability” and injury as a GBL claim, courts have dismissed them as duplicative,
see, e.g., Hernandez, 2024 WL 4882180, at *10 (collecting cases); Cooper v. Anheuser-Busch,
LLC, 553 F. Supp. 3d 83, 115-16 (S.D.N.Y. 2021); Goldemberg, 8 F. Supp.3d at 483-84. 	Here,
Plaintiff’s unjust enrichment claims rest upon the same theory as the price premium theory that
underlies his GBL claims: that Defendant was unjustly enriched in realizing revenues from the
Products to Plaintiff’s detriment even though the Products were misrepresented. 	Compare Am.
Compl. ¶ 114 (misnumbered ¶ 111) (“Defendant’s unlawful conduct . . . allowed Defendant to
knowingly realize substantial revenues from selling its Products at the expense of, and to the
detriment or impoverishment of, Plaintiff and Class Members and to Defendant’s benefit and
enrichment,”), and id. ¶ 115 (misnumbered ¶ 112) (Plaintiff “conferred significant financial
benefits and paid substantial compensation to Defendant for the Products, which were not as
Defendant represented them to be”), with id. ¶ 85 (misnumbered ¶ 82) (Plaintiff has “been injured
inasmuch as [he] purchased Products that were mislabeled, unhealthy, and entirely worthless [and]
received less than what [he] bargained and paid for”), and id. ¶ 93 (misnumbered ¶ 90) (Plaintiff
has “been injured inasmuch as [he] relied upon the labeling, packaging, and advertising and
5 In Warner, the court, out of an abundance of caution, denied the motion to dismiss the unjust enrichment claim as
duplicative because the defendant did not argue that the plaintiff failed to plausibly allege facts that could support the
elements of an unjust enrichment claim. 2019 WL 1332573, at *3. Here, Defendant asserts that Plaintiff fails to
plausibly allege that there was anything false or misleading, or any unusual situation that created unjust circumstances.
See Mot. at 17.
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purchased Products that were mislabeled, unhealthy, and entirely worthless [and] received less
than what [he] bargained and paid for”).
Accordingly, Defendant’s motion to dismiss Plaintiff’s unjust enrichment claim is granted
and this claim is dismissed.
CONCLUSION
For the foregoing reasons, Defendant’s Motion is granted in part and denied in part.
Defendant’s Motion is denied with respect to standing, Plaintiff’s misrepresentation-based GBL
§ 349 and GBL § 350 claims, and negligence per se claims. Defendant’s Motion is granted with
respect to express preemption of Plaintiff’s omission-based GBL § 349 and GBL § 350 claims and
unjust enrichment claim. 	Accordingly, Plaintiff’s omission-based GBL § 349 and GBL § 350
claims and unjust enrichment claim are dismissed.
SO ORDERED.
/s/
ORELIA E. MERCHANT
United States District Judge
March 11, 2026
Brooklyn, New York
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