Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 1 of 23
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`
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`Gary T. Lafayette (SBN 88666)
`glafayette@lkclaw.com
`Brian H. Chun (SBN 215417)
`bchun@lkclaw.com
`LAFAYETTE & KUMAGAI LLP
`1300 Clay Street, Suite 810
`Oakland, CA 94612
`Telephone: (415) 357-4600
`Facsimile: (415) 357-4605
`
`Steven A. Zalesin (Pro Hac Vice)
`sazalesin@pbwt.com
`Joshua Kipnees (Pro Hac Vice)
`jkipnees@pbwt.com
`PATTERSON BELKNAP WEBB & TYLER LLP
`1133 Avenue of the Americas
`New York, New York 10036
`Telephone: (212) 336-2110
`Facsimile: (212) 336-2111
`
`Attorneys for Defendant Zarbee’s, Inc.
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`SAN FRANCISCO DIVISION
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`
`KRYSTAL LOPEZ, individually and on
`behalf of all others similarly situated,
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`Plaintiff,
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`v.
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`ZARBEE’S, INC.
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`Defendant.
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`13857028
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`Case No. 22-cv-4465
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`DEFENDANT ZARBEE’S, INC.’S NOTICE
`OF MOTION TO DISMISS AND MOTION
`TO DISMISS; MEMORANDUM OF POINTS
`AND AUTHORITIES IN SUPPORT
`THEREOF
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`Hearing Date: November 4, 2022
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`Time: 10:00 a.m.
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`Place: Courtroom 6 – 17th Floor
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`Judge: Hon. Charles R. Breyer
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 2 of 23
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`
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`NOTICE OF MOTION AND MOTION
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`TO THE PLAINTIFF AND HER ATTORNEY OF RECORD IN THE ABOVE-
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`CAPTIONED MATTER:
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`PLEASE TAKE NOTICE that on November 4, 2022 at 10:00 a.m., or as soon thereafter as
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`the matter may be heard, in Courtroom 6 before Honorable Charles Breyer of the Northern District of
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`California, Defendant Zarbee’s, Inc. (“Zarbee’s”) will and hereby does move the Court to dismiss
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`Plaintiff Krystal Lopez’s Complaint against Zarbee’s, ECF No. 1, in which Plaintiff alleges violations
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`of the California Consumer Legal Remedies Act (“CLRA”), Cal. Civ. Code § 1750, the California
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`Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq., the California False
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`Advertising Law (“FAL”), id. § 17500 et seq., and the consumer protection laws of Connecticut,
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`Illinois, Maryland, Missouri, and New York, as well as claims asserting breach of express warranty,
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`negligent and intentional misrepresentation, and unjust enrichment.
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`This motion is made pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6) on the
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`grounds set forth in the accompanying memorandum of points and authorities.
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`Respectfully submitted,
`
`/s/ Gary T. Lafayette___________
`Gary T. Lafayette (SBN 88666)
`glafayette@lkclaw.com
`Brian H. Chun (SBN 215417)
`bchun@lkclaw.com
`LAFAYETTE & KUMAGAI LLP
`1300 Clay Street, Suite 810
`Oakland, CA 94612
`Telephone: (415) 357-4600
`Facsimile: (415) 357-4605
`
`Steven A. Zalesin (Pro Hac Vice)
`sazalesin@pbwt.com
`Joshua Kipnees (Pro Hac Vice)
`jkipnees@pbwt.com
`PATTERSON BELKNAP WEBB & TYLER LLP
`1133 Avenue of the Americas
`New York, New York 10036
`Telephone: (212) 336-2110
`
`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Dated: September 21, 2022
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`13857028
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 3 of 23
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`Facsimile: (212) 336-2111
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`Attorneys for Defendant Zarbee’s, Inc.
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 4 of 23
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`TABLE OF CONTENTS
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`Page
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`TABLE OF AUTHORITIES ....................................................................................................... ii
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`STATEMENT OF ISSUES ...........................................................................................................1
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`SUMMARY OF THE ARGUMENT ...........................................................................................2
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`STATEMENT OF FACTS ............................................................................................................4
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`A.
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`B.
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`C.
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`The Parties ...................................................................................................4
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`FDA Regulations for Dietary Supplements .................................................4
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`Plaintiff’s Allegations and Claims ...............................................................5
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`ARGUMENT ..................................................................................................................................7
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`I.
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`Plaintiff’s Claims Are Expressly Preempted ...........................................................7
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`A.
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`B.
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`Plaintiff’s Claims Concerning FDA-Permitted Overages Are
`Preempted ....................................................................................................7
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`Preemption Also Bars Plaintiff’s Claims Based on Tests that
`Deviate from FDA’s Mandatory 12-Sample Protocol .................................9
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`II.
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`Plaintiff Lacks Standing to Pursue Claims Regarding Products She Did
`Not Purchase and Website Statements She Did Not See .......................................11
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`A.
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`B.
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`Claims Based on Unpurchased Products ...................................................11
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`Claims Based on Statements on the Zarbee’s Website ..............................12
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`III.
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`Plaintiff’s Claims for Equitable Relief Fail Because Adequate Remedies
`Exist At Law ..........................................................................................................12
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`IV.
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`Plaintiff Lacks Standing to Pursue Claims Based on Other States’ Laws .............14
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`V.
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`Plaintiff’s Negligent Misrepresentation Claim Also Fails .....................................14
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`CONCLUSION ............................................................................................................................15
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`13857028
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 5 of 23
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`TABLE OF AUTHORITIES
`
`
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`Page(s)
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`Cases
`
`Amavizca v. Nutra Manuf., LLC,
`No. 8:20-cv-1324, 2020 WL 8837145 (C.D. Cal. Oct. 20, 2020) ...........................................11
`
`Brazil v. Dole Food Co., Inc.,
`No. 12-cv-1831, 2013 WL 5312418 (N.D. Cal. Sept. 23, 2013) .............................................12
`
`In re Carrier IQ, Inc.,
`78 F. Supp. 3d 1051 (N.D. Cal. 2015) .....................................................................................14
`
`Carter v. Novartis Consumer Health, Inc.,
`582 F. Supp. 2d 1271 (C.D. Cal. 2008) .....................................................................................9
`
`Diamos v. Walmart Inc.,
`No. 2:19-cv-5526, 2020 WL 1942322 (C.D. Cal. Jan. 9, 2020) ..............................................11
`
`Dysthe v. Basic Research LLC,
`No. CV 09-8013, 2011 WL 5868307 (C.D. Cal. June 13, 2011) ............................................11
`
`In re Ford Tailgate Litig.,
`No. 11-cv-2953, 2014 WL 1007066 (N.D. Cal. Mar. 12, 2014) .........................................3, 13
`
`Granfield v. NVIDIA Corp.,
`No. C 11-5403, 2012 WL 2847575 (N.D. Cal. July 11, 2012) ................................................11
`
`Greenberg v. Target Corp.,
`985 F.3d 650 (9th Cir. 2021) .....................................................................................................9
`
`Holt v. Foodstate, Inc.,
`No. 15cv78, 2015 WL 9592534 (S.D. Cal. Dec. 31, 2015) .....................................................11
`
`Ivie v. Kraft Foods Glob., Inc.,
`961 F. Supp. 2d 1033 (N.D. Cal. 2013) ...............................................................................3, 12
`
`Jones v. Micron Tech. Inc.,
`400 F. Supp. 3d 897 (N.D. Cal. 2019) .................................................................................4, 14
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`Knievel v. ESPN,
`393 F.3d 1068 (9th Cir. 2005) ...................................................................................................4
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`Ladore v. Sony Computer Entm’t Am., LLC,
`75 F. Supp. 3d 1065 (N.D. Cal. 2014) .................................................................................4, 15
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`13857028
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 6 of 23
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`
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`Larsen v. Trader Joe’s Co.,
`No. C 11-5188, 2012 WL 5458396 (N.D. Cal. June 14, 2012) ...........................................3, 11
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`Lozano v. Bowmar Nutrition LLC,
`No. 2:21-cv-4296, 2021 WL 4459660 (C.D. Cal. Aug. 19, 2021) ....................................10, 14
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`In re MacBook Keyboard Litig.,
`No. 18-cv-2813, 2020 WL 6047253 (N.D. Cal. Oct. 13, 2020) ..............................................13
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`McKinney v. Corsair Gaming, Inc.,
`No. 22-cv-312, 2022 WL 2820097 (N.D. Cal. July 19, 2022) ..................................3, 4, 13, 15
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`Mee v. I A Nutrition, Inc.,
`No. C-14-5006, 2015 WL 2251303 (N.D. Cal. May 13, 2015) ...........................................3, 10
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`Ochoa v. Church & Dwight Co.,
`No. 5:17-cv-2019, 2018 WL 4998293 (C.D. Cal. Jan. 30, 2018) ................................3, 8, 9, 10
`
`Robie v. Trader Joe’s Co.,
`No. 20-cv-7355, 2021 WL 2548960 (N.D. Cal. June 14, 2021) ..............................................14
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`Robinson Helicopter Co. v. Dana Corp.,
`34 Cal.4th 979 (2004) ..............................................................................................................14
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`Robinson v. J.M. Smucker Co.,
`No. 18-cv-4654, 2019 WL 2029069 (N.D. Cal. May 8, 2019) ................................................15
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`Rubio v. Orgain, Inc.,
`No. 18-2237, 2019 WL 1578379 (C.D. Cal. Mar. 5, 2019) .................................................3, 10
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`Rugg v. Johnson & Johnson,
`No. 17-cv-5010, 2018 WL 3023493 (N.D. Cal. June 18, 2018) ..............................................12
`
`Salazar v. Honest Tea, Inc.,
`74 F. Supp. 3d 1304 (E.D. Cal. 2014)..................................................................................3, 10
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`Smith v. Allmax Nutrition, Inc.,
`No. 1:15-cv-744, 2016 WL 9434768 (E.D. Cal. Dec. 24, 2015) .............................................10
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`Sonner v. Premier Nutrition Corp.,
`971 F.3d 834 (9th Cir. 2020) .......................................................................................12, 13, 14
`
`Teresa Adams v. Cole Haan, LLC,
`No. 20-913, 2020 WL 5648605 (C.D. Cal. Sept. 3, 2020) ......................................................13
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`Welk v. Nutraceutical Corp.,
`No. 17-cv-2266, 2018 WL 3818033 (S.D. Cal. Aug. 10, 2018) ..........................................3, 10
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`13857028
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 7 of 23
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`Zaback v. Kellogg Sales Co.,
`No. 3:20-cv-268, 2020 WL 6381987 (S.D. Cal. Oct. 29, 2020) ..............................................14
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`
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`Statutes
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`21 U.S.C. § 321 ................................................................................................................................7
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`21 U.S.C. § 332 ............................................................................................................................5, 9
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`21 U.S.C. § 333 ................................................................................................................................5
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`21 U.S.C. § 343 ........................................................................................................................5, 7, 9
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`Cal. Civ. Code § 1780(a) ...............................................................................................................13
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`Other Authorities
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`21 C.F.R. § 100.1 .............................................................................................................................7
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`21 C.F.R. § 101.9 ................................................................................................................... passim
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`21 C.F.R. § 101.36 ................................................................................................................. passim
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`58 Fed. Reg. 2079 (Jan. 6, 1993) ...................................................................................................10
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`60 Fed. Reg. 67194 (Dec. 28, 1995) ................................................................................................5
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`62 Fed. Reg. 49826 (Sept. 23, 1997) ...................................................................................2, 5, 7, 8
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`68 Fed. Reg. 12158 (Mar. 13, 2003) ................................................................................................5
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`72 Fed. Reg. 34752-01 (June 25, 2007) ...................................................................................2, 5, 8
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`13857028
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 8 of 23
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`STATEMENT OF ISSUES
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`1.
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`Are Plaintiff’s claims preempted by the federal Food, Drug, and Cosmetics Act
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`(“FDCA”) because they seek to hold Zarbee’s liable for including ingredient overages that the Food
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`and Drug Administration (“FDA”) expressly permits, and because the claims rely on tests whose
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`methodology does not conform to an FDA-mandated protocol?
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`2.
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`Does Plaintiff lack standing to bring claims related to (a) Zarbee’s products that she
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`did not purchase and (b) statements on Zarbee’s website on which she did not rely?
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`3.
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`Should Plaintiff’s claims for equitable relief be dismissed where the Complaint fails to
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`allege that she lacks adequate remedies at law, and in fact demonstrates the opposite?
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`4.
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`Does Plaintiff lack statutory standing to bring claims under the consumer protection
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`laws of states where she does not reside and where she did not purchase any Zarbee’s products?
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`5.
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`Should Plaintiff’s negligent misrepresentation claim be dismissed under the economic
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`loss rule given that Plaintiff has not suffered any non-economic harm?
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
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`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 9 of 23
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`SUMMARY OF THE ARGUMENT
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`In this putative class action, Plaintiff impermissibly seeks to hold Zarbee’s liable for
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`manufacturing and labeling its melatonin supplements in the precise manner FDA permits. Plaintiff
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`alleges that Zarbee’s misled her by including in its Children’s Sleep with Melatonin product more
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`melatonin than is stated on the label. FDA, however, expressly authorizes supplement manufacturers
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`to formulate their products with ingredient “overages” to ensure that the product contains at least the
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`full amount declared on the product label throughout the product’s shelf life. Plaintiff’s attempt to
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`subject Zarbee’s to labeling, manufacturing and testing requirements that differ from those authorized
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`by FDA is expressly preempted. For this and other reasons, all of Plaintiff’s claims fail as a matter of
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`law, and her Complaint should be dismissed with prejudice.
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`Plaintiff’s claims are preempted for two reasons. First, as noted above, FDA expressly permits
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`manufacturers to formulate supplements with “overages” of ingredients, such as melatonin, that
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`degrade over time, and does not require that the overage be noted on the product label. See 21 C.F.R.
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`§ 101.36(f)(1) (“Reasonable excesses over labeled amounts are acceptable within current good
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`manufacturing practice.”); 62 Fed. Reg. 49826, 49831 (Sept. 23, 1997) (declared amounts of dietary
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`ingredients should not “include any overages that a manufacturer includes in anticipation of
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`degradation”). These overages are essential to meeting federal labeling requirements because, under
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`FDA regulations, ingredients like melatonin must be present in amounts “at least equal to the value
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`. . . declared on the label” for the product’s entire shelf life. 21 C.F.R. § 101.9(g)(4)(i) (emphasis
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`added); 72 Fed. Reg. 34752-01, 34884 (June 25, 2007) (permitting manufacturers to “us[e] an
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`additional amount of certain ingredients to ensure the product meets its specifications for the amount
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`of the ingredient during” its shelf life). Indeed, if the amount of such an ingredient dips below the
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`declared amount at any point prior to the expiration date, the product becomes “misbranded” under
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`federal law, exposing the manufacturer to liability. 62 Fed. Reg. at 49839. Requiring Zarbee’s to
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`refrain from including melatonin overages in its products, or to disclose those overages on the label,
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`would impermissibly impose requirements that differ from the federal regulatory regime for
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
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`CASE NO. 22-4465-CRB
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`supplements. See Ochoa v. Church & Dwight Co., No. 5:17-cv-2019, 2018 WL 4998293, at *4-5
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`(C.D. Cal. Jan. 30, 2018).
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`Second, Plaintiff’s claims are preempted because they are based on laboratory tests for
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`melatonin content that depart from the test methods mandated by FDA. FDA regulations require
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`manufacturers to determine the labeled quantity of certain ingredients, including melatonin, with tests
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`that employ a rigorous 12-sample methodology. See 21 C.F.R. § 101.9(g). Here, Plaintiff admits she
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`did not follow FDA’s prescribed test method, and instead tested only two bottles. As courts in this
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`Circuit have recognized, such challenges to declared ingredient amounts that are not based on FDA’s
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`specified test method are preempted by the FDCA. See Rubio v. Orgain, Inc., No. 18-2237, 2019 WL
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`1578379, at *3-4 (C.D. Cal. Mar. 5, 2019); Ochoa, 2018 WL 4998293, at *5; Welk v. Nutraceutical
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`Corp., No. 17-cv-2266, 2018 WL 3818033, at *4-5 (S.D. Cal. Aug. 10, 2018); Mee v. I A Nutrition,
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`Inc., No. C-14-5006, 2015 WL 2251303, at *4 (N.D. Cal. May 13, 2015); Salazar v. Honest Tea, Inc.,
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`74 F. Supp. 3d 1304, 1313 (E.D. Cal. 2014).
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`While all of Plaintiff’s claims should be dismissed on preemption grounds, many also fail for
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`additional reasons. Plaintiff lacks Article III standing to bring claims with respect to Zarbee’s products
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`she neither purchased nor tested, because she does not—and cannot—plausibly allege they caused her
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`injury-in-fact. See Larsen v. Trader Joe’s Co., No. C 11-5188, 2012 WL 5458396, at *4-5 (N.D. Cal.
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`June 14, 2012). Plaintiff’s claims regarding the Zarbee’s website should be dismissed because she
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`does not allege that she relied on those representations when purchasing any Zarbee’s product. See
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`Ivie v. Kraft Foods Glob., Inc., 961 F. Supp. 2d 1033, 1047 (N.D. Cal. 2013). Plaintiff’s claims for
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`equitable relief, including those for an injunction and for unjust enrichment, should be dismissed
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`because she has adequate remedies at law. Plaintiff’s claim for unjust enrichment is also duplicative
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`of her claim for damages and does not offer “a true alternative theory of relief.” In re Ford Tailgate
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`Litig., No. 11-cv-2953, 2014 WL 1007066, at *5 (N.D. Cal. Mar. 12, 2014) (quotation marks omitted);
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`accord McKinney v. Corsair Gaming, Inc., No. 22-cv-312, 2022 WL 2820097, at *10 & n.6 (N.D.
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`Cal. July 19, 2022) (Breyer, J.). Plaintiff, a California resident who purchased her Zarbee’s product
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`in California, does not have standing to bring claims under the consumer-protection laws of other
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 11 of 23
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`states, even in a putative class action. See Jones v. Micron Tech. Inc., 400 F. Supp. 3d 897, 908 (N.D.
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`Cal. 2019) (collecting cases). And Plaintiff’s negligent misrepresentation claim is barred by the
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`economic loss rule because she has not alleged any non-economic harm flowing from her purchase of
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`Zarbee’s products. See McKinney, 2022 WL 2820097, at *11; Ladore v. Sony Computer Entm’t Am.,
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`
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`LLC, 75 F. Supp. 3d 1065, 1075 (N.D. Cal. 2014).
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`STATEMENT OF FACTS1
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`A.
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`The Parties
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`Defendant Zarbee’s, Inc. is a Delaware corporation that produces and markets a variety of
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`over-the-counter supplement products for children and adults. Zarbee’s products are sold by retailers
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`nationwide. Some Zarbee’s products are formulated with melatonin, a dietary supplement that helps
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`regulate the brain’s sleep cycle. Compl. ¶¶ 1, 3, 18-19, ECF No. 1.
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`B.
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`FDA Regulations for Dietary Supplements
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`Federal law imposes a comprehensive regulatory scheme for dietary supplements. See
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`generally FDCA, 21 U.S.C. § 301 et seq.;2 21 C.F.R. Part 100 et seq. Under applicable FDA
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`regulations, melatonin—an ingredient for which FDA has not established a Reference Daily Intake or
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`Daily Reference Value—qualifies as an “other dietary ingredient.” See 21 C.F.R. § 101.36(b)(3)(i).
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`This means that the quantity of melatonin in a supplement product must be listed or declared on the
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`product label. Id. The declared quantity, moreover, must be established by a specific, FDA-mandated
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`test “consist[ing] of 12 subsamples (consumer units), taken 1 from each of 12 different randomly
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`1 All facts are taken from Plaintiff’s Complaint and the materials incorporated by reference or cited
`therein, which are assumed to be true solely for purposes of this motion. See Knievel v. ESPN, 393
`F.3d 1068, 1076 (9th Cir. 2005) (courts may consider “documents whose contents are alleged in a
`complaint and whose authenticity no party questions, but which are not physically attached to the
`[plaintiff’s] pleading” (internal quotation mark omitted)).
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`2 As relevant to this action, Congress has twice enacted significant amendments to the FDCA to
`establish
`requirements
`for
`the
`safety, manufacturing,
`and
`labeling
`of
`dietary
`supplements. See Nutrition Labeling and Education Act (“NLEA”), Pub. L. 101-535 (1990); Dietary
`Supplement Health & Education Act (“DSHEA”), Pub. L. 103-417 (1994).
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`chosen shipping cases, to be representative of a lot.” 21 C.F.R. § 101.9(g)(2); 21 C.F.R. § 101.36(f)(1)
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`(applying this methodology to “other dietary ingredients”).
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`FDA regulations further require the quantity of dietary ingredients, such as melatonin, to “be
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`at least equal to the value . . . declared on the label” for the product’s full shelf life. 21 C.F.R.
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`§ 101.9(g)(4)(i). If the ingredient level falls below the labeled amount at any point prior to the
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`product’s expiration date, the product is deemed “misbranded” under federal law. See 62 Fed. Reg. at
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`49839. Manufacturers that distribute “misbranded” products face potential FDA enforcement actions,
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`civil penalties, and fines. See 21 U.S.C. §§ 332, 333, 343.
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`Because some dietary ingredients, including melatonin, degrade over time, FDA allows
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`manufacturers to formulate their supplements with “overages”—i.e., more than the labeled amount of
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`those ingredients. This ensures “the finished product can meet the label declaration for that dietary
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`ingredient throughout the product’s shelf life.” 68 Fed. Reg. 12158, 12203 (Mar. 13, 2003). This
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`industry-standard practice is codified in the federal regulations, which provide that, for “other dietary
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`ingredients” like melatonin, “[r]easonable excesses over labeled amounts are acceptable within current
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`good manufacturing practice.” 21 C.F.R. § 101.36(f)(1).
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`At the same time that it has permitted these overages, FDA has explicitly instructed
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`manufacturers that declared amounts of dietary ingredients should not “include any overages that a
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`manufacturer includes in anticipation of degradation.” 62 Fed. Reg. at 49831; see also 72 Fed. Reg.
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`at 34884 (“[I]t is not necessary to include the reason for adding the intentional excess amount.”). FDA
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`has also expressly declined to adopt any specific upper-bound on these overages. See 60 Fed. Reg.
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`67194, 67207 (Dec. 28, 1995) (declining proposal to cap overages at “20 percent in excess of the
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`amount declared”).
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`C.
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`Plaintiff’s Allegations and Claims
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`Plaintiff, a resident of Salinas, California, alleges that she purchased one bottle of Zarbee’s
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`Children’s Sleep with Melatonin Gummies (“Gummies”) from a Walmart store in Salinas in June
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`2022. Compl. ¶¶ 6, 33. The product label for the Gummies declares that each gummy contains 1 mg
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 13 of 23
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`
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`of melatonin. Compl. ¶ 21. Plaintiff alleges that she reviewed the declared melatonin content on the
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`label’s Supplement Facts panel when deciding to purchase the Gummies. Compl. ¶¶ 30-33.
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`According to the Complaint, Plaintiff thereafter commissioned a liquid chromatograph-mass
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`spectrometry analysis on three gummies from each of two bottles of Gummies, including the bottle
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`she purchased. That analysis allegedly showed that the three tested gummies in her bottle contained,
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`on average, 2.13 mg of melatonin, and the three tested gummies in the other bottle contained, on
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`average, 1.29 mg of melatonin. Id.
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`Plaintiff alleges that, because her tests of two bottles allegedly showed more melatonin than
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`the amount stated on the label, the Gummies were “not accurately dosed or labeled,” and therefore
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`“worthless” to her. Compl. ¶ 33. Plaintiff does not, however, allege that the Gummies were ineffective
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`in helping to facilitate sleep, or that they adversely affected her or any member of her family.
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`Moreover, despite testing only two bottles of one Zarbee’s product, Plaintiff alleges that all of Zarbee’s
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`“melatonin products” are deceptively labeled, based on her speculation that they all contain more
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`melatonin per serving than their respective labels indicate. See Compl. ¶¶ 20, 23-29.
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`On this basis, Plaintiff purports to bring claims on behalf of purchasers of all of Zarbee’s
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`melatonin-containing products nationwide, as well as several sub-classes of purchasers from
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`individual states. See Compl. ¶¶ 35-43. The Complaint asserts seven causes of action: (1) violations
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`of the California CLRA, as well as the consumer protection laws of Connecticut, Illinois, Maryland,
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`Missouri, and New York, on behalf of the California sub-class and state sub-classes for each of those
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`states, Compl. ¶¶ 44-48; (2) violations of the UCL on behalf of the California sub-class, Compl. ¶¶ 49-
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`61; (3) violations of the FAL on behalf of the California sub-class, Compl. ¶¶ 62-68; (4) breach of
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`express warranty on behalf of the nationwide class, Compl. ¶¶ 69-75; (5) negligent misrepresentation
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`on behalf of the nationwide class, Compl. ¶¶ 76-84; (6) intentional misrepresentation on behalf of the
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`nationwide class, Compl. ¶¶ 85-93; and (7) unjust enrichment on behalf of the nationwide class,
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`Compl. ¶¶ 94-97. Plaintiff seeks damages as well as equitable relief, including an injunction
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`“forbidding Zarbee’s from selling its melatonin unless it has fixed the dosing and labelling problem.”
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`Compl. ¶¶ 34, 99.
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 14 of 23
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`I.
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`Plaintiff’s Claims Are Expressly Preempted
`
`ARGUMENT
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`The FDCA expressly preempts state-law claims that seek to impose manufacturing and
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`labeling requirements for dietary supplements that are “not identical to” federal requirements of the
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`same type. See 21 U.S.C. § 343-1(a)(1); see also 21 C.F.R. § 100.1(c)(4) (“not identical to” means
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`“that the State requirement directly or indirectly imposes obligations . . . concerning the composition
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`or labeling of food” that are “not imposed by or contained in the applicable [federal statute or
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`regulation]” or “[d]iffer from those specifically imposed by or contained in the applicable [federal
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`statute or regulation]”); 21 U.S.C. § 321(ff) (explaining that dietary supplements are “a food” within
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`the meaning of the FDCA).3
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`Here, Plaintiff’s Complaint should be dismissed in its entirety because it seeks to hold Zarbee’s
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`liable for following FDA-permitted manufacturing, testing, and labeling practices for dietary
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`ingredients like melatonin.
`
`A.
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`Plaintiff’s Claims Concerning FDA-Permitted Overages Are Preempted
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`FDA regulations expressly permit manufacturers to formulate their supplement products with
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`more melatonin than the amount declared on the label, and instruct manufacturers not to include the
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`excess in the declared amount.
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`FDA regulations require that the amount of a dietary supplement in a product be “at least equal
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`to the value for that nutrient declared on the label.” 21 C.F.R. § 101.9(g)(4)(i) (emphasis added); see
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`id. § 101.36(f)(1) (explaining that the labeling of dietary supplements is also governed by Section
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`101.9(g)’s requirements). This must remain true for the duration of the product’s expected shelf life:
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`at no point may the quantity of the ingredient present in the product slip below 100% of the declared
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`amount. 62 Fed. Reg. at 49839 (“[M]anufacturers are appropriately charged with ensuring that the
`
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`3 Plaintiff’s proposed requirements fall within the FDCA’s preemption provisions because they are
`(4); see 21
`“of
`the
`type
`required by section
`.
`.
`. 343(q).” 21 U.S.C. § 343-1(a)(3),
`U.S.C. § 343(q)(5)(F) (requiring dietary supplement product labels to include “the quantity of”
`dietary ingredients “per serving”).
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`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT
`OF DEFENDANT ZARBEE’S MOTION TO DISMISS
`CASE NO. 22-4465-CRB
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`Case 3:22-cv-04465-CRB Document 21 Filed 09/21/22 Page 15 of 23
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`amounts present are at least 100 percent of the amounts declared throughout the shelf life of their
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`products.”). If the product fails to meet this requirement, it is “misbranded” under federal law. Id.
`
`A