Case 2:21-cv-12977-SRC-JSA Document 52 Filed 04/25/22 Page 1 of 20 PageID: 630
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`NOT FOR PUBLICATION
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`Civil Action No. 21-12977 (SRC)
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`OPINION
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`IRIDA KIMCA, DERRICK SAMPSON,
`BRITTANY TOMKO, JANCY ORTIZ,
`DINATRA WYNN, SARAH WARDALE,
`and JUANITA CORNETT,
`individually and on behalf of all others
`similarly situated,
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`Plaintiffs,
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`v.
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`SPROUT FOODS, INC. d/b/a SPROUT
`ORGANIC FOODS and SPROUT
`NUTRITION,
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`Defendant.
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`CHESLER, District Judge
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`This matter comes before the Court upon Defendant Sprout Foods, Inc.’s (“Defendant” or
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`“Sprout”) motion to dismiss the putative class action complaint filed by Plaintiffs Irida Kimca,
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`Derrick Sampson, Brittany Tomko, Jancy Ortiz, Dinatra Wynn, Sarah Wardale, and Juanita
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`Cornett (collectively “Plaintiffs”). Plaintiffs oppose Defendant’s motion. The Court, having
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`considered the papers filed by the parties, proceeds to rule on the motion without oral argument
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`pursuant to Federal Rule of Civil Procedure 78. For the reasons that follow, the Court will grant
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`Defendant’s motion and dismiss Plaintiffs’ First Amended Complaint without prejudice.
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`I.
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`BACKGROUND
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`This case arises out of Defendant’s marketing and advertising of its baby food products.
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`The First Amended Complaint (“FAC”) alleges Sprout’s baby food products contained dangerous
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`1
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`levels of heavy metals. (FAC ¶¶ 6, 7, 81). Nevertheless, Plaintiffs allege Sprout “negligently,
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`recklessly, and/or knowingly” failed to disclose to consumers the presence of these heavy metals,
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`(FAC ¶ 81), and, even further, marketed its products as clean, healthy, and organic, (FAC ¶¶ 87,
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`88). As such, Plaintiffs, and others, purchased Sprout’s products in reliance on these false and
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`misleading representations. (FAC ¶¶ 20, 21, 22, 23, 24, 25, 26, 37).
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`Plaintiffs identify ten Sprout products that allegedly contained unsafe levels of heavy
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`metals: Prunes Organic Baby Food, Carrot Apple Mango Organic Baby Food, Mixed Berry
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`Oatmeal Organic Baby Food, Garden Vegetables Brown Rice with Turkey Organic Baby Food,
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`Organic Veggie Power – Sweet Potato with Mango, Apricot & Carrot, Organic Puffs Baby Cereal
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`Snack, Organic Crispy Chews Red Fruit Beet & Berry with Crispy Brown Rice Toddler Fruit
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`Snack, Organic Wafflez, Organic Curlz, and Organic Crinklez. (FAC ¶ 6). The Court will refer
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`to these products as the “Baby Food Products.” According to the FAC, each of the Baby Food
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`Products have been “tested and confirmed to contain” greater than 10 parts per billions (ppb) of
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`arsenic, greater than 5 ppb of cadmium, greater than 5 ppb of lead, “and/or” greater than 5 ppb of
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`mercury. (FAC ¶ 6 n.1). This testing was done by Plaintiffs’ counsel, the non-profit organization
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`Healthy Babies Bright Futures (“HBBF”), and Consumer Reports. (FAC ¶¶ 54–60).
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`Plaintiffs allege the amount of arsenic, lead, cadmium, and mercury in the Baby Food
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`Products was harmful to their children. In support of this assertion, Plaintiffs rely on certain
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`standards set forth by the Food and Drug Administration (“FDA”), the Environmental Protection
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`Agency (“EPA”), and other organizations. With respect to arsenic, the FAC explains that the FDA
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`and EPA have set a 10 ppb limit on arsenic in bottled and drinking water, respectively. (FAC
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`¶ 70). As to lead, the FAC identifies several possible standards concerning the potential danger
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`arising from the metal’s presence: one report from a non-profit concludes that “no safe level of
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`2
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`exposure has been identified,” several different organizations recommend that lead in baby foods
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`not exceed 1 ppb, and the European Union has set the limit at 20 ppb for infant formula. (FAC ¶¶
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`71, 73). With respect to mercury, the FAC notes that the EPA has set a maximum of 2 ppb in
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`drinking water. (FAC ¶ 77). Finally, regarding cadmium, the FAC states that the EPA and FDA
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`have set a limit of 5 ppb in bottled and drinking water, and the World Health Organization
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`(“WHO”) has set a limit of 3 ppb in drinking water. (FAC ¶ 80).
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`To further bolster their allegations, plaintiffs also describe the deleterious health effects of
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`heavy metals. They explain that lead, arsenic, cadmium, and mercury are all “neurotoxins,” which
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`alter the nervous system. (FAC ¶ 62). The FAC alleges that exposure to these heavy metals can
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`cause cancer, the permanent loss of intellectual capacity, and behavioral disorders. (FAC ¶ 63).
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`Because of these harmful effects, the FDA and WHO have recognized that arsenic, cadmium, lead,
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`and mercury are dangerous to human health. (FAC ¶ 64). The FAC also describes the process of
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`“bioaccumulation,” through which heavy metals accumulate in the body over time, making the
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`consumption of these metals even in small doses harmful, especially for vulnerable infants and
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`babies. (FAC ¶¶ 66–68).
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`Finally, Plaintiffs allege that, despite the presence of these heavy metals in the Baby Food
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`Products, Sprout marketed its food as safe and the “healthiest . . . on the market.” (FAC ¶ 29).
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`They cite Sprout’s marketing materials, which labeled Sprout’s food as “organic,” “nutrient-
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`dense,” “wholesome,” and “clean,” among other descriptors. (FAC ¶¶ 32–35). Moreover, the
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`FAC references the displays Sprout sent to retailers, which Plaintiffs allege “were designed to
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`make consumers believe that Sprout [b]aby [f]ood was healthy and pure,” and, thus did not contain
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`heavy metals. (FAC ¶¶ 36, 37) (internal quotation omitted). As a result of these purportedly
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`3
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`misleading claims, Plaintiffs allege they and other consumers purchased Sprout’s food for their
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`children. (FAC ¶ 37).
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`The FAC contains eleven causes of action based on the above facts.1 (FAC ¶¶ 108–90). It
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`includes claims for breach of express and implied warranties, (FAC ¶¶ 108–28), negligent
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`misrepresentation, (FAC ¶¶ 129–35), fraud, (FAC ¶¶ 136–40), unjust enrichment, (FAC ¶¶ 141–
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`47), and violation of the consumer protection laws of various states, (FAC ¶¶ 148–90). Defendant
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`has brought a motion to dismiss the FAC on a number of grounds. (ECF No. 45). Among other
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`reasons, Defendant argues that the FAC should be dismissed pursuant to Federal Rule of Civil
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`Procedure 12(b)(1) because Plaintiffs do not have standing to pursue the monetary and injunctive
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`relief they seek. (Def. Br. at 13–20, 38–39). As explained more fully below, the Court agrees
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`with Defendant. Thus, the FAC will be dismissed without prejudice.2
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`II.
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`DISCUSSION
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`A. Legal Standards
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`1. Standard of Review
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`Pursuant to Rule 12(b)(1), a court must grant a motion to dismiss if it lacks subject matter
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`jurisdiction. Fed. R. Civ. P. 12(b)(1). “A motion to dismiss for want of standing is . . . properly
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`brought pursuant to Rule 12(b)(1), because standing is a jurisdictional matter.” Ballentine v.
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`United States, 486 F.3d 806, 810 (3d Cir. 2007).
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`1 Plaintiffs seek to certify eight separate classes pursuant to Federal Rule of Civil Procedure 23: one class including
`all consumers who purchased the Baby Food Products in the United States (the “Nationwide Class”), six separate
`classes comprising consumers from Connecticut, Illinois, New Jersey, Texas, New York, and Georgia, respectively
`(the “State Classes”), and a class seeking injunctive relief pursuant to Rule 23(b)(2) (the “Injunctive Relief Class”).
`(FAC ¶¶ 97–113).
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`2 Because the Court dismisses the FAC on the threshold issue of standing, it need not address Sprout’s other proposed
`grounds for dismissal here.
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`The Third Circuit has held that a motion to dismiss for lack of standing is a facial attack,
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`rather than a factual attack, because it contests the sufficiency of the pleadings. In re Schering
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`Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 243 (3d Cir. 2012); S.S. v.
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`Hillsborough Twp. Bd. of Educ., No. 20-cv-13077, 2022 WL 807371, at *4 (D.N.J. Mar. 17, 2022)
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`(“The Court of Appeals for the Third Circuit has held that motions to dismiss for lack of standing
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`are best understood as facial attacks.”). In reviewing a facial attack, a court applies the same
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`standard it would apply under Rule 12(b)(6). Constitution Party of Pa. v. Aichele, 757 F.3d 347,
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`358 (3d Cir. 2014); In re Schering Plough Corp., 678 F.3d at 243. As such, the Court will apply
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`the familiar Rule 12(b)(6) standard to Sprout’s standing arguments.
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`Under this standard, “[w]ith respect to 12(b)(1) motions in particular, ‘[t]he plaintiff must
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`assert facts that affirmatively and plausibly suggest that the pleader has the right he claims (here,
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`the right to jurisdiction), rather than facts that are merely consistent with such a right.’” In re
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`Schering Plough Corp., 678 F.3d at 244 (alteration in original) (quoting Stalley v. Cath. Health
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`Initiatives, 509 F.3d 517, 521 (8th Cir. 2007)). A complaint will meet this plausibility standard
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`when it includes more than mere “labels and conclusions.” Bell Atlantic Corp. v. Twombly, 550
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`U.S. 544, 555 (2007). “[T]he tenet that a court must accept as true all of the allegations contained
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`in a complaint is inapplicable to legal conclusions.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
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`2. Article III Standing and the Injury Requirement
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`Article III of the Constitution limits the federal judicial power to “cases” and
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`“controversies.” U.S. Const., art. III, § 2. Standing—one of several justiciability doctrines that
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`enforces Article III’s case-or-controversy requirement—requires the plaintiff to allege “such a
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`personal stake in the outcome of the controversy as to warrant his invocation of federal-court
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`jurisdiction and to justify the exercise of the court’s remedial powers on his behalf.” Warth v.
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`Seldin, 422 U.S. 490, 498–99 (1975) (internal quotation omitted) (citing Baker v. Carr, 369 U.S.
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`186, 204 (1962)). The plaintiff bears the burden of adequately alleging three elements to establish
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`standing: (1) injury in fact, (2) a “causal connection between the injury and the conduct complained
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`of,” and (3) that it is “‘likely,’ as opposed to merely ‘speculative,’ that the injury will be ‘redressed
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`by a favorable decision.’” Lujan v. Defenders of Wildlife, 504 U.S. 555, 560–61 (1992) (quoting
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`Simon v. Eastern Ky. Welfare Rights Org., 426 U.S. 26, 41–42) (1976)). In the class action
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`context, at least one named plaintiff must satisfy all of these requirements. O’Shea v. Littleton,
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`414 U.S. 488, 494 (1974).
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`Here, Sprout contends that Plaintiffs do not have standing because they have not
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`demonstrated that they suffered an injury in fact. (Def. Br. at 13–20). To satisfy the injury
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`requirement, the alleged injury must be “concrete and particularized,” and “actual or imminent,
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`not conjectural or hypothetical.” Lujan, 504 U.S. at 560 (internal quotation omitted). “[T]he injury
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`in fact test requires more than injury to a cognizable interest. It requires that the party seeking
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`review be himself among the injured.” Id. at 563 (quoting Sierra Club v. Morton, 405 U.S. 727,
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`734–35 (1972)).
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`B. Plaintiffs Lack Standing to Pursue Monetary Relief
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`Sprout argues the FAC fails to establish that Plaintiffs suffered an injury in fact sufficient
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`to establish standing to seek monetary damages for three reasons.3 First, Sprout contends that the
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`FAC does not adequately allege that any of the products purchased by Plaintiffs contained heavy
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`metals. (Def. Br. at 14–17). Second, Sprout maintains that, even if the products purchased by
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`3 Sprout also argues all of Plaintiffs’ claims fail on the merits for these same three reasons because all of their claims
`also require injury as an element. (Def. Br. at 13). Indeed, the parties both discuss injury for standing purposes and
`injury as an element of Plaintiffs’ claims interchangeably. (Def. Br. at 13–20); (Pl. Br. at 8–14). Nevertheless, because
`the standing inquiry is separate from “any assessment of the merits of the plaintiff’s claim,” the Court will limit its
`discussion here to standing without addressing any merits arguments. Cottrell v. Alcon Lab’ys, 874 F.3d 154, 162
`(3d Cir. 2017).
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`Plaintiffs contained heavy metals, the FAC does not adequately allege that the amount of heavy
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`metals in Sprout’s products were unsafe or dangerous. (Def. Br. at 17–18). Finally, Sprout argues
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`that the FAC does not adequately allege economic injury. (Def. Br. at 18–20). The Court finds
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`Sprout’s first argument meritless but agrees with its second and third arguments.
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`1. Plaintiffs sufficiently allege that the Baby Food Products they purchased
`contained heavy metals.
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`First, Sprout highlights the FAC’s failure to allege that Plaintiffs personally purchased any
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`Baby Food Products that contained heavy metals. (Def. Br. at 14). Instead, Plaintiffs rely on
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`testing done by their counsel and other third parties which purportedly demonstrates that the Baby
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`Food Products contained high levels of heavy metals. (Def. Br. at 14–15). Sprout maintains that
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`Plaintiffs’ failure to test the baby food they personally bought dooms their claims—according to
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`Defendant, Plaintiffs cannot rely on testing done on baby food they did not buy or consume to
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`establish injury. (Def. Br. at 15–17).
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`Sprout relies on Wallace v. ConAgra Foods, Inc., 747 F.3d 1025, 1030 (8th Cir. 2014), to
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`support its position. There, the plaintiffs alleged the defendant mislabeled its hot dogs as “100%
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`kosher” when, in fact, some of the defendant’s beef products were not kosher. Id. at 1028. The
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`Eighth Circuit held that the plaintiffs did not have standing to bring the claim because they had
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`only alleged that “some” of the hot dogs were mislabeled. Id. at 1030–31. Therefore, “it [was]
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`pure speculation to say the particular packages sold to the consumers were tainted by non-kosher
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`beef.” Id. at 1031. As relevant here, the court concluded “it is not enough for a plaintiff to allege
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`that a product line contains a defect or that a product is at risk for manifesting this defect; rather,
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`the plaintiffs must allege that their product actually exhibited the alleged defect.” Id. at 1030
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`(quoting In re Zurn Pex Plumbing Prods. Liab. Litig., 644 F.3d 606, 616 (8th Cir. 2011)); see also
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`Pels v. Keurig Dr. Pepper, Inc., No. 19-cv-03052, 2019 WL 5813422, at *4–*5 (N.D. Cal. Nov. 7,
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`2019) (granting a motion to dismiss for lack of standing where the plaintiff did not allege that he
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`purchased water sold by the defendant that contained “violative levels of arsenic” and noting that
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`not all of the defendant’s water came from the same source so it was possible that some contained
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`arsenic and some did not).
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`However, other courts have not required plaintiffs to allege they purchased a defective
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`product, instead allowing them to establish injury for standing purposes using representative
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`testing at the motion to dismiss stage. E.g., John v. Whole Foods Market Grp., Inc., 858 F.3d 732,
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`736–37 (2d Cir. 2017) (finding that a government report indicating that 89 percent of Whole
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`Foods’ pre-packaged products were overweight resulting in overcharges to customers was
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`sufficient to defeat a motion to dismiss based on lack of injury where the plaintiff also alleged he
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`bought pre-packaged products at Whole Foods every month); In re Gen. Mills Glyphosate Litig.,
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`No. 16-cv-02869, 2017 WL 2983877, at *1–*3 (D. Minn. Jul. 12, 2017) (holding that the plaintiffs
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`had adequately alleged injury partly because the complaint referenced independent laboratory
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`testing indicating that the defendant’s products contained the chemical glyphosate); Fishon v. Mars
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`Petcare US, Inc., 501 F. Supp. 3d 555, 565 (M.D. Tenn. 2020) (explaining that the plaintiffs had
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`established standing based on independent testing finding that dog food the defendant advertised
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`as grain-free, in fact, contained grain). Plaintiffs argue the testing results referenced in the FAC
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`are sufficient to establish standing under these cases. (Pl. Br. at 8–9).
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`The Court agrees with Plaintiffs. The case here is analogous to In re General Mills
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`Glyphosate Litigation, No. 16-cv-02869, 2017 WL 2983877 (D. Minn. Jul. 12, 2017). There, the
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`plaintiffs brought suit alleging that General Mills’ Nature Valley products were falsely advertised
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`as containing only whole grain oats when, in fact, the products contained trace amounts of
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`glyphosate—an herbicide and desiccant. Id. at *1. The plaintiffs’ complaint identified twenty-
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`three flavors of Nature Valley Products that contained glyphosate and provided independent
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`laboratory testing to substantiate this claim. Id. at *1. In finding that the plaintiffs had established
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`injury for standing purposes, the court explained that Wallace was inapplicable because the
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`plaintiffs alleged that all of products at issue—that is, every food item sold in each of the twenty-
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`three flavors—contained glyphosate. Id. at *2–*3. By contrast, the Wallace plaintiffs had
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`conceded that at least some of the hot dogs at issue were kosher and, therefore, did not contain the
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`alleged defect.4 Id. at *3. Thus, under In re General Mills, and other cases like it, plaintiffs can
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`establish standing using representative testing where they allege that all of the products sold by
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`the defendant contain the alleged defect. See Fishon, 501 F. Supp. 3d at 565 (“[U]nlike in Wallace
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`there is nothing in the [c]omplaint to suggest that only some [of the products] contained . . .
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`unwanted ingredients.”); Van Slomski v. Hain Celestial Grp., Inc., No. 13-cv-01757, 2014 WL
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`12771116, at *5 (C.D. Cal. June 10, 2014) (distinguishing Wallace based on the fact that the
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`plaintiffs “broadly allege[d] that the teas contain[ed] pesticides, rather than merely alleging that
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`some of the packages contain[ed] pesticides”).
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`Here, Plaintiffs have sufficiently alleged that all of the Baby Food Products contain heavy
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`metals by “focus[ing] their allegations on particular product[s].” Rice-Sherman v. Big Heart Pet
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`Brands, Inc., No. 19-cv-03613, 2020 WL 1245130, at *7 (N.D. Cal. Mar. 16, 2020). Indeed,
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`Plaintiffs identify ten product lines produced by Sprout, and bought by Plaintiffs, that allegedly
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`contain “elevated and unsafe levels of heavy metals.” (FAC ¶ 6). These allegations are supported
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`by testing of individual packages across the ten product lines conducted by three separate entities.
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`4 Other cases have outright rejected Wallace’s reasoning rather than simply distinguishing Wallace on the facts. E.g.,
`McCoy v. Nestle USA, Inc., 173 F. Supp. 3d 954, 964 (N.D. Cal. 2016) (explaining that Wallace creates a “bizarre
`result” wherein “sellers advertising food as halal or kosher, diamonds as conflict-free, or products as union-made
`could knowingly mix compliant and non-compliant products with impunity so long as there was no way for a buyer
`to trace the specific item he or she purchased back to the source”).
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`(FAC ¶¶ 56, 57, 60). And there is nothing in the FAC that indicates some subset of packages
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`within each of these product lines might not contain heavy metals.5 Rice-Sherman, No. 19-cv-
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`03613, 2020 WL 1245130, at *7 (finding that the plaintiffs adequately alleged injury where they
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`did not identify any inconsistencies as to the products that were purportedly falsely advertised).
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`These allegations are sufficient to establish a plausible inference that every package of the Baby
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`Food Products, including those purchased by Plaintiffs, contains the heavy metals.6
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`This conclusion is bolstered by the fact that this case is at the motion to dismiss stage.
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`Courts that have allowed plaintiffs to use representative testing to establish injury have emphasized
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`the leniency of the Rule 12(b)(6) standard. E.g., John, 858 F.3d at 737 (recognizing that the
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`plaintiff “may ultimately be unable to show he was injured under the more demanding standards
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`applicable at summary judgment or trial” but finding that “a facial attack on the pleadings” was
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`not the proper venue for determining the merits of the plaintiff’s testing methodologies and
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`findings). One court explained “[p]laintiffs do not need to prove their case at the pleading stage,”
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`and noted that “courts have permitted consumer claims in nationwide class actions regarding
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`product mislabeling to move forward based on limited testing, including a single test on a single
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`sample of the product at issue.” Fishon, 501 F. Supp. 3d at 566 (quoting In re Herbal Supplements
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`Mktg. & Sales Practice Litig., No. 15-cv-05070, 2017 WL 2215025, at *12 (N.D. Ill. May 19,
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`5 While summarizing the testing done by Plaintiffs’ counsel, the FAC states “[o]ther Sprout baby foods that were
`tested did not contain elevated and unsafe levels of heavy metals.” (FAC ¶ 58). This statement is fairly interpreted
`as referring to products outside of the ten identified in the FAC.
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`6 It appears, however, that Plaintiffs do not allege that they purchased two of the product lines for which the FAC
`contains testing results: Prunes Organic Baby Food and Garden Vegetable Brown Rice with Turkey Organic Baby
`Food. Neither the FAC nor Plaintiffs’ briefing indicates any of them purchased Garden Vegetable Brown Rice with
`Turkey Organic Baby Food. Plaintiffs do argue in their brief that Plaintiff Tomko purchased Prunes Organic Baby
`Food. (Pl. Br. at 11). But this argument is contradicted by the FAC which states that Plaintiff Tomko purchased
`“various Sprout Baby Foods, including but not limited to Carrot Apple Mango Organic Baby Food, Mixed Berry and
`Oatmeal Organic Baby Food, and Organic Puffs . . . .” (FAC ¶ 22). Without any allegation that Plaintiffs purchased
`these products, they do not have standing to bring any claims based on either product line. Lieberson v. Johnson &
`Johnson Consumer Cos., 865 F. Supp. 2d 529, 537 (D.N.J. 2011) (finding that the plaintiff did not have standing to
`bring consumer protection claims based on products she did not purchase or use).
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`2017)). As such, Plaintiffs’ use of representative testing to establish injury here is adequate and,
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`contrary to Sprout’s argument, they need not allege that they personally purchased any products
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`containing heavy metals.
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`2. Plaintiffs fail to allege that the Baby Food Products contained heavy metals in
`amounts sufficient to establish injury.
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`Sprout’s second argument fares better, however. Plaintiffs’ theory of injury is that their
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`children are now at an increased risk of adverse health consequences as a result of their
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`consumption of the Baby Food Products containing heavy metals. While an increased risk of
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`future harm may be sufficient to establish injury for standing purposes, Spokeo, Inc. v. Robins,
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`578 U.S. 330, 341 (2016), the future harm must be “certainly impending,” Lujan, 504 U.S. at 564
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`n.2 (internal quotation omitted). “In increased risk of injury cases involving products liability,
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`courts generally require a plaintiff to allege ‘(i) a substantially increased risk of harm and (ii) a
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`substantial probability of harm with that increase taken into account.’” Backus v. General Mills,
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`Inc., 122 F. Supp. 3d 909, 922 (N.D. Cal. 2015) (quoting Herrington v. Johnson & Johnson
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`Consumer Cos., No. 09-cv-01597, 2010 WL 3448531, at *3 (N.D. Cal. Sep. 1, 2010)).
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`Sprout maintains that Plaintiffs do not meet this standard. According to Sprout, even if
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`Plaintiffs sufficiently alleged that they purchased products with elevated levels of heavy metals,
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`the FAC does not support the conclusion that the consumption of these products caused a
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`substantially increased risk of future harm to their children. (Def. Br. at 17–18). Plaintiffs respond
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`that their allegations are sufficient to raise a plausible inference that the Baby Food Products put
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`their children at a substantial risk of harm. They maintain that the testing referenced in the FAC
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`indicates that each of the ten Baby Food Products “exceed accepted standards” for exposure to the
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`heavy metals. (Pl. Br. at 10–11). For Plaintiffs, it follows that the quantities of heavy metals in
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`the Baby Food Products pose an increased risk of injury sufficient to give rise to standing.7 (Pl.
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`Br. at 10–11).
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`Plaintiffs’ argument fails. Most importantly, it is not clear that the “accepted standards”
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`identified in the FAC are applicable to baby food. The FAC borrows standards promulgated in
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`different contexts. For example, it references the FDA’s 10 ppb limit on arsenic in bottled water,
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`(FAC ¶ 70), the EPA’s 10 ppb limit on arsenic in drinking water, (FAC ¶ 70), the EPA’s 2 ppb
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`limit on mercury in drinking water, (FAC ¶ 77), the EPA’s 5 ppb limit on cadmium in drinking
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`water, (FAC ¶ 80), the FDA’s 5 ppb limit on cadmium in bottled water, (FAC ¶ 80), and the
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`WHO’s 3 ppb limit on cadmium in drinking water, (FAC ¶ 80).8 However, the FAC does not
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`contain any background information or explanation indicating that these are apt comparisons for
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`use in the context of baby food. See Doss v. General Mills, Inc., No. 18-cv-61924, 2019 WL
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`7946028, at *3 (S.D. Fla. June 14, 2019), aff’d 816 F. App’x 312 (11th Cir. 2020) (explaining that
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`the plaintiff’s reference to a “health benchmark” was inconsequential with regard to whether the
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`amount of toxins in the defendant’s food product was dangerous because the plaintiff did not
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`explain how the benchmark level related to the other allegations in the complaint). In fact, the
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`FAC leads to the inference that the opposite is true: it states that the FDA is considering setting
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`the “action level” for arsenic in rice cereal for infants at 100 ppb, more than ten times the FDA’s
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`7 It appears that Plaintiffs do not provide any testing results for one of the Baby Food Products: Organic Crispy Chews
`Red Fruit Beet & Berry with Crispy Brown Rice Toddler Fruit Snack. Without any testing, there is no basis for the
`Court to conclude that the product contained unsafe levels of heavy metals.
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`8 As to lead, the FAC maintains that there is no safe level of exposure. (FAC ¶ 71). However, it also notes that the
`European Union has limited lead in infant formula to 20 ppb. (FAC ¶ 73). Only one of the Baby Food Products
`contains more than 20 ppb of lead: Organic Puffs Baby Cereal Snack. (FAC ¶ 56). Nevertheless, the Court declines
`to conclude that this product plausibly poses a substantial risk of future harm because the European Union’s
`regulations also pertain to a different product—infant formula rather than rice cereal.
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`limit on arsenic in bottled water.9 (FAC ¶ 70). This suggests that the applicable limits for baby
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`food are much higher than those used for bottled and drinking water.
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`Moreover, courts have declined to use similar cross-product comparisons to establish
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`injury at the motion to dismiss stage. For example, in Boysen v. Walgreen Co., No. 11-cv-06262,
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`2012 WL 2953069 (N.D. Cal. Jul. 19, 2012), the court did not apply the FDA’s bottled water
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`standard to juice products. Id. at *5–*6. This decision was based partly on the fact that the level
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`of toxins in the defendant’s juice products were within the FDA’s guidelines advisory ranges for
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`those products. Id. at *5. However, the court also explained that the FDA set higher guidelines
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`levels for juice than for water because juice consumption is lower than drinking water intake. Id.
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`at *5 n.5. Similarly, here, water and baby food are two fundamentally different products which
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`are ingested and processed by the human body differently and consumed in different amounts. As
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`such, the Court cannot plausibly draw the inference from the FAC that the guidelines levels for
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`water are applicable to baby food.
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`Furthermore, in Koronthaly v. L’Oreal USA, Inc., No. 07-cv-05588, 2008 WL 2938045
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`(D.N.J. Jul. 29, 2008), aff’d 374 F. App’x 257 (3d Cir. 2010), the court found that plaintiffs had
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`not adequately alleged injury due to the presence of lead in the defendants’ lipstick. Id. at *4–*5.
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`There, the plaintiff alleged that the lipstick contained dangerous amounts of lead based on the
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`FDA’s regulation of lead levels in candy. Id. at *1. The court dismissed her argument, explaining
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`that the FDA did not regulate the levels of lead in lipstick and, thus, the plaintiff’s only complaint
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`was that “the lipstick’s levels of lead are unsatisfactory to her.” Id. at *5. Here, like the Koronthaly
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`9 The FDA document referenced in the FAC indicates that this action level would only pertain to inorganic arsenic.
`FDA, Inorganic Arsenic in Rice Cereals for Infants: Action Level Guidance for Industry 6 (2020),
`https://www.fda.gov/media/97234/download. According to Plaintiffs’ testing, none of the Baby Food Products
`contain greater than 100 ppb of inorganic arsenic.
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`plaintiff’s reference to the FDA’s regulation of candy, the use of water benchmarks in the baby
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`food context is arbitrary and unexplained. Without any clarification as to why these guidelines
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`might be applicable, Plaintiffs are simply complaining that the quantities of heavy metals in the
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`Baby Food Products were unacceptable to them.
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`Both Boysen and Koronthaly also relied on the fact that the FDA had indicated that the
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`products at issue were safe. In Boysen, the court explained “the FDA has issued reports stating
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`that the levels of lead and arsenic found in juice products such as defendant’s are safe.” No. 11-
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`cv-06262, 2012 WL 2953069, at *6. And in Koronthaly the Third Circuit upheld the district
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`court’s decision by referencing an FDA report “finding that the lead levels in the [d]efendant’s
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`lipsticks were not dangerous.” 374 F. App’x 257, 258 (3d Cir. 2010). Other courts have declined
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`to find injury for standing purposes based partly on similar statements by the FDA. See, e.g.,
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`Herrington, No. 09-cv-01597, 2010 WL 3448531, at *3 n.2 (noting that the FDA concluded that
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`the level of probable carcinogens in the products at issue “d[id] not present a hazard to
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`consumers”). Here, in the wake of Congressional reports regarding heavy metals in baby food,
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`the FDA stated, “at the levels we have found through our testing . . . children are not at an
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`immediate health risk from exposure to toxic elements in foods.” FDA Letter to Industry on
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`Chemical Hazards, Including Toxic Elements, in Food and Update on FDA Efforts to Increase the
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`Safety of Foods for Babies and Young Children (Mar. 5, 2021), https://www.fda.gov/food/cfsan-
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`constituent-updates/fda-letter-industry-chemical-hazards-including-toxic-elements-food-and-
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`update-fda-efforts-increase (cited as Exhibit 3 to Def. Br.).10 At the very least, this statement
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`10 Plaintiffs do not appear to dispute the Court’s power to consider this statement even though it is not contained in
`the FAC. Indeed, the Court may properly take judicial notice of the material on the FDA’s website. On a motion to
`dismiss, a court may consider matters of public record in addition to the allegations in the complaint and exhibits
`attached to the complaint. Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 988 F.2d 1192, 1196 (3d Cir.
`1993);