Lopez v. Zarbee's, Inc.

CourtDistrict Court, N.D. California
DecidedJanuary 17, 2023
Docket3:22-cv-04465
StatusUnknown

This text of Lopez v. Zarbee's, Inc. (Lopez v. Zarbee's, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Lopez v. Zarbee's, Inc., (N.D. Cal. 2023).

Opinion

1 2 3 4 5 IN THE UNITED STATES DISTRICT COURT 6 FOR THE NORTHERN DISTRICT OF CALIFORNIA 7 8 KRYSTAL LOPEZ, Case No. 22-cv-04465-CRB

9 Plaintiff,

ORDER GRANTING IN PART AND 10 v. DENYING IN PART MOTION TO DISMISS 11 ZARBEE’S, INC., 12 Defendant.

13 Plaintiff Krystal Lopez brings this putative class action against Defendant Zarbee’s, 14 Inc. in connection with Zarbee’s melatonin supplements.1 Lopez alleges that Zarbee’s 15 products include significantly more melatonin than the label asserts, and therefore violate 16 state consumer protection laws. Zarbee’s moves to dismiss, arguing that all of the claims 17 are completely preempted, and that Lopez lacks standing as to some claims. See MTD 18 (dkt. 26). The Court found this matter suitable for resolution without oral argument, and 19 therefore vacated the motion hearing. See Civil Local R. 7-1(b). Because Zarbee’s 20 arguments largely fail at this stage, the Court grants in part and denies in part the motion. 21 I. BACKGROUND2 22 A. The Parties 23 Zarbee’s, a Delaware corporation, sells melatonin supplements nationwide at 24 retailers like Walmart and Target. FAC (dkt. 24) ¶¶ 3, 8. Lopez lives in California, and 25 purchased a Zarbee’s melatonin product in California. Id. ¶ 6. 26 27 1 This is one of several melatonin suits brought by this law firm. Murphy v. Olly Public Benefit Corp., 22-cv-3760-CRB, is also before this Court. B. FDA Regulations for Dietary Supplements 1 Melatonin is a neurohormone that regulates sleep. Id. ¶ 1. Millions of consumers 2 take over-the-counter melatonin supplements to help them sleep. Id. ¶ 14. Federal law 3 imposes a comprehensive regulatory scheme for dietary supplements, including melatonin 4 supplements. See generally FDCA, 21 U.S.C. § 301 et seq.; 21 C.F.R. Part 100 et seq. 5 Under applicable FDA regulations, melatonin qualifies as an “other dietary ingredient,” 6 meaning that the quantity of melatonin in a supplement must be listed on the product label. 7 21 C.F.R. § 101.36(b)(3)(i). The declared quantity of melatonin must be established by a 8 specific FDA-mandated test “consisting of 12 subsamples (consumer units), taken 1 from 9 each of 12 different randomly chosen shipping cases, to be representative of a lot.” See 21 10 C.F.R. § 101.9(g)(2); 21 C.F.R. § 101.36(f)(1) (applying this testing method to “other 11 dietary ingredients”). 12 The FDA forbids supplement labels that overstate quantities. FDA regulations 13 require that the quantity of melatonin “be at least equal to the value . . . declared on the 14 label” for the product’s full shelf life. See 21 C.F.R. § 101.9(g)(4)(i). A product that has 15 less melatonin than is listed on the label is “misbranded.” See 62 Fed. Reg. 49826-01 at 16 49839 (Sept. 23, 1997). 17 The FDA treats supplement labels that understate quantities differently. The FDA 18 recognizes that some supplements, like melatonin, degrade over time, “such that a product 19 that contains a certain amount of a supplement when it gets put on the shelves might have 20 less of that supplement at expiration.” FAC ¶ 22. The FDA further recognizes that some 21 manufacturers formulate their supplements with overages to ensure “that the finished 22 product can meet the label declaration for that dietary ingredient throughout the product’s 23 shelf life.” 68 Fed. Reg. 12158, 12203 (Mar. 13, 2003). Accordingly, there is a safe 24 harbor: “[r]easonable excesses over labeled amounts are acceptable within current good 25 manufacturing practice.” 21 C.F.R. § 101.36(f)(1). Current good manufacturing practice 26 requires manufacturers to keep track of “any intentional overage amount of a dietary 27 1 ingredient.” 21 C.F.R. § 111.210(e).3 2 Although the FDA allows for overages, it does not intend “to allow a manufacturer 3 to add excess dietary ingredients in unspecified amounts that would be in excess of the 4 amount actually needed to meet the label declaration.” 68 Fed. Reg. 12158, 12203; see 5 also 72 Fed. Reg. at 34884 (“the amount of overage should be limited to the amount 6 needed to meet the amounts listed in accordance with final § 111.210(d).”). The FDA has 7 declined to adopt a specific cap on overages. See, e.g., 60 Fed. Reg. 67194-01 at 67207 8 (Dec. 28, 1995) (declining proposed 20% overage cap). 9 C. This Litigation 10 In June of 2022, Lopez purchased a bottle of Zarbee’s Children’s Sleep with 11 Melatonin Gummies from a Walmart store in Salinas, California. FAC ¶ 50. The 12 gummies were for her 8-year-old child. Id. Lopez “relied on the fact that Zarbee’s 13 dosages were well-controlled” and “read and relied on the accuracy of the melatonin 14 content on the label.” Id. She chose the 1mg dose per gummy “because she did not want 15 to give her child more melatonin, due to increased concerns about side effects and safety.” 16 Id. She gave him the gummies and noticed that they sometimes “would have a very strong 17 tranquilizing effect that concerned her, and then the next day he would be unusually 18 subdued.” Id. 19 Lopez did a liquid chromatograph-mass spectrometry analysis on three gummies 20 from each of two bottles of gummies, including the bottle she purchased. Id. ¶ 36. The 21 gummy from Lopez’s bottle had more than twice the amount of melatonin than what 22 Zarbee’s stated on the label (2.16mg instead of 1mg). Id. A gummy from a bottle that was 23 one month away from expiring still had 222% of the claimed melatonin content (2.23mg 24 instead of 1mg). Id. 25 Lopez initially brought suit in August of 2022, arguing that the product “was not 26 accurately dosed or labeled.” See Compl. (dkt. 1) ¶ 33. Zarbee’s moved to dismiss the 27 1 original complaint, arguing that the FDA allows for overages and that Lopez’s testing 2 methodology was inadequate. See First MTD (dkt. 21) at 7–11. Lopez amended. FAC. 3 The FAC now alleges that “[b]ecause the excess is materially more than reasonably 4 necessary to ensure that the melatonin meets the amount specified on the product label 5 throughout the product’s shelf life, Zarbee’s Melatonin is unreasonably overdosed.” Id. ¶ 6 38. It includes claims for violation of: (1) California, Connecticut, Illinois, Maryland, 7 Missouri, and New York consumer protection acts; (2) California’s Unfair Competition 8 Law (UCL); (3) California’s False Advertising Law (FAL); (4) California’s Consumers 9 Legal Remedies Act (CLRA); as well as: (5) breach of express warranty; and (6) unjust 10 enrichment/quasi-contract. Id. ¶¶ 67–110. Zarbee’s again moves to dismiss. See MTD. 11 II. LEGAL STANDARD 12 Under Rule 12(b)(6) of the Federal Rules of Civil Procedure, the Court may dismiss 13 a complaint for failure to state a claim upon which relief may be granted. The Court may 14 base dismissal on either “the lack of a cognizable legal theory or the absence of sufficient 15 facts alleged under a cognizable legal theory.” Godecke v. Kinetic Concepts, Inc., 937 16 F.3d 1201, 1208 (9th Cir. 2019) (cleaned up). 17 A complaint must plead “sufficient factual matter, accepted as true, to state a claim 18 to relief that is plausible on its face.” Ashcroft v.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Bell Atlantic Corp. v. Twombly
550 U.S. 544 (Supreme Court, 2007)
Ashcroft v. Iqbal
556 U.S. 662 (Supreme Court, 2009)
Dairyland Power Cooperative v. United States
16 F.3d 1197 (Federal Circuit, 1994)
Leadsinger, Inc. v. BMG Music Publishing
512 F.3d 522 (Ninth Circuit, 2008)
Carter v. Novartis Consumer Health, Inc.
582 F. Supp. 2d 1271 (C.D. California, 2008)
Tucker Durnford v. Musclepharm Corp.
907 F.3d 595 (Ninth Circuit, 2018)
Robert Cohen v. Conagra Brands, Inc.
16 F.4th 1283 (Ninth Circuit, 2021)

Cite This Page — Counsel Stack

Bluebook (online)
Lopez v. Zarbee's, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/lopez-v-zarbees-inc-cand-2023.