Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 1 of 31
`
`
`Jonas B. Jacobson (Cal. Bar No. 269912)
`jonas@dovel.com
`Simon Franzini (Cal. Bar No. 287631)
`simon@dovel.com
`
`DOVEL & LUNER, LLP
`201 Santa Monica Blvd., Suite 600
`Santa Monica, California 90401
`Telephone: (310) 656-7066
`
`
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`
`Krystal Lopez, individually and on behalf of
`all others similarly situated,
`
` Plaintiff,
`
`vs.
`
`Zarbee’s, Inc.,
`
` Defendant.
`
`Case No. 3:22-cv-04465-CRB
`
`FIRST AMENDED CLASS ACTION
`COMPLAINT
`DEMAND FOR JURY TRIAL
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`Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 2 of 31
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`I. 
`II. 
`III. 
`IV. 
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`B. 
`C. 
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`Table of Contents
`Introduction. ............................................................................................................................... 1 
`Parties. ........................................................................................................................................ 2 
`Jurisdiction, venue, and divisional assignment. ......................................................................... 2 
`Facts. .......................................................................................................................................... 2 
`It is important to consumers that over-the-counter melatonin is accurately
`A. 
`dosed and labelled. ......................................................................................................... 2 
`The FDA does not allow melatonin to be unreasonably overdosed............................... 5 
`Scientific research reveals serious problems with the accuracy of melatonin
`dosing and labelling in Canada. Scientists warn that the same is likely true of
`some U.S. brands. .......................................................................................................... 6 
`Zarbee’s markets melatonin for children and sells melatonin supplements to
`millions of U.S. consumers. ........................................................................................... 7 
`Scientific testing reveals that, unlike other manufacturers, Zarbee’s Melatonin
`has an unreasonable excess of melatonin. ...................................................................... 9 
`Zarbee’s labelling is false and misleading to reasonable consumers. .......................... 11 
`F. 
`Zarbee’s overcharges millions of consumers. .............................................................. 12 
`G. 
`Ms. Lopez was misled and harmed by Zarbee’s misleading labelling. ....................... 13 
`H. 
`Plaintiff has no adequate remedy at law. ..................................................................... 14 
`I. 
`Class action allegations. ........................................................................................................... 15 
`V. 
`VI.   Claims. ..................................................................................................................................... 17 
`Count 1: Violations of State Consumer Protection Acts .......................................................... 17 
`Count 2: Violation of California Unfair Competition Law (UCL) .......................................... 18 
`Count 3: Violation of California’s False Advertising Law (FAL) ........................................... 19 
`Count 4: Violation of the California Consumers Legal Remedies Act (CLRA) ..................... 20 
`Count 5: Breach of Express Warranty ..................................................................................... 21 
`Count 6: Unjust Enrichment/Quasi-Contract ........................................................................... 22 
`VII. Jury Demand. ............................................................................................................................ 22 
`VIII. Prayer for Relief. ...................................................................................................................... 22 
`
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`D. 
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`E. 
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`First Amended Complaint
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`Case No. 3:22-cv-04465-CRB
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`Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 3 of 31
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`I.
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`Introduction.
`1.
`Melatonin is a neurohormone that regulates the brain’s sleep cycle. Millions of
`consumers take over-the-counter melatonin supplements to help them sleep. Because melatonin
`alters brain chemistry, it is important that these supplements are accurately dosed and labelled.
`2.
`A few years ago, scientists tested Canadian melatonin supplements and found that, for
`a number of brands, the true amount of melatonin varied wildly from the label. Scientists, the
`National Institutes of Health, and consumer advocates have warned that the same is true in the U.S.
`3.
`Zarbee’s is a major U.S. brand of melatonin supplements, sold nationwide at retailers
`like Walmart, Kroger, and Target. Many Zarbee’s melatonin products are specifically marketed for
`young children. Each bottle claims to have a specific dose of melatonin per serving. For example:
`
`4.
`Like millions of other consumers, Ms. Lopez bought Zarbee’s melatonin for her
`children and trusted the accuracy of Zarbee’s dosing and labelling. To determine how much
`melatonin is really in Zarbee’s, a university mass-spectrometry laboratory tested multiple bottles,
`including her bottle. The results were alarming. The true amount of melatonin in her bottle was
`216% of the claimed amount. The tested bottles had far more melatonin than the amount on the label
`(and far more melatonin than the “reasonable excess” permitted by the FDA).
`5.
`Zarbee’s systematically misrepresents how much melatonin is in the supplements it
`sells. Consumers are being misled and overcharged, and children are being put at risk.
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`First Amended Complaint
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`Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 4 of 31
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`II.
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`Parties.
`6.
`Plaintiff Krystal Lopez is domiciled in Salinas, California. She purchased a bottle of
`Zarbee’s Children’s Sleep Melatonin in California.
`7.
`The proposed class includes citizens of every state.
`8.
`Defendant Zarbee’s Inc. is a Delaware corporation with its principal place of business
`at 11650 State St. #101, Draper, Utah 84020.
`III.
`Jurisdiction, venue, and divisional assignment.
`9.
`This Court has subject matter jurisdiction under 28 U.S.C. § 1332(d)(2). The amount
`in controversy exceeds $5,000,000, exclusive of interest and costs, and the matter is a class action in
`which one or more members of the proposed class are citizens of a state different from Defendant.
`10.
`The Court has personal jurisdiction over Defendant because Defendant sold Zarbee’s
`melatonin products to consumers in California, including to Plaintiff.
`11.
`Venue is proper under 28 U.S.C. § 1391(b)(1) and 28 U.S.C. § 1391(d) because
`Defendant would be subject to personal jurisdiction in this District if this District were a separate
`state, given that Defendant sold Zarbee’s melatonin products to consumers in this District,
`including Plaintiff. Venue is also proper under 28 U.S.C. § 1391(b)(2) because a substantial part
`of Defendant’s conduct giving rise to the claims occurred in this District, including Defendant’s
`sale to Plaintiff.
`12.
`Divisional Assignment. This action arose in Monterey County (San Jose Division).
`Ms. Lopez purchased Zarbee’s melatonin while living in Salinas (in Monterey County). Thus, a
`substantial part of the events giving rise to the claim occurred in Monterey County.
` IV. Facts.
`A.
`It is important to consumers that over-the-counter melatonin is accurately dosed
`and labelled.
`13. Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone produced by the pineal
`gland in the brain. It regulates the brain’s circadian rhythm and sleep cycle.
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`First Amended Complaint
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`Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 5 of 31
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`The chemical structure of melatonin
`14. Millions of U.S. consumers take melatonin supplements to treat sleep problems,
`anxiety, and other issues. Melatonin is one of the most popular over-the-counter supplements in the
`U.S., and its use has “significantly increased” in the last 20 years. 1 Its use to help children sleep is
`becoming increasingly popular too, which concerns health experts. 2
`15.
`As scientists explained in the Journal of Clinical Sleep Medicine, because melatonin is
`“self-prescribed” (i.e., purchased directly by consumers who are not experts), it is particularly
`“important that labels are informative and representative of the product,” i.e., that the “label claim
`values for the active ingredient are accurate.” 3
`16.
`In particular, it is important to consumers that melatonin is not excessively dosed,
`compared to what is represented on the label. The likelihood of side effects from melatonin increases
`with the dosage. Side effects of melatonin include headaches, dizziness, nausea, or excessive or
`unwanted sleepiness. 4 As the Texas Health hospital network explains, a “lower dose” will reduce
`the risk of “side effects” and thus “using the lowest effective dose will give you the best outcomes
`while keeping any undesirable side effects at bay.” 5 And as another major manufacturer of melatonin
`
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`1 JAMA Research Letter, Trends in Use of Melatonin Supplements Among US Adults, 1999-
`2018, 327(5) JAMA 483 (2022).
`2 The New York Times, Parents Are Relying on Melatonin to Help Their Kids Sleep. Should
`They?, https://www.nytimes.com/2020/05/18/parenting/melatonin-sleep-kids.html
`3 Erland, L. & Saxena, P., Melatonin Natural Health Products and supplements: Presence of
`serotonin and significant variability of melatonin content, 13 Journal of Clinical Sleep Medicine
`275–281 (2017).
`4 NIH National Library of Medicine Medline Plus, Melatonin,
`https://medlineplus.gov/druginfo/natural/940.html
`5 https://www.texashealth.org/areyouawellbeing/Health-and-Well-Being/Is-It-Safe-to-Take-
`Melatonin-Every-Night
`First Amended Complaint
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`Case No. 3:22-cv-04465-CRB
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`Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 6 of 31
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`supplements states: “The likelihood of these side effects [headaches, upset stomach, grogginess,
`sleeplessness, irritability and dizziness] increases with the dosage.” 6 This is why “[m]any experts
`recommend starting with the smallest available dosage — 0.5 milligrams to 1 milligram.” 7
`17.
`These concerns are especially serious for children. When melatonin is given to
`children, the American Academy of Pediatricians (AAP) warns that “quality may not be the same for
`all melatonin products” and recommends its use only “cautiously and carefully.” The AAP
`recommends: “Start with the lowest dosage. Many children will respond to a low dose (0.5 mg or 1
`mg).” 8
`18. When melatonin is falsely labeled, consumers unwittingly take “higher doses” that
`increase the risk of “unpleasant/unexpected side effects.” 9 And regardless of side effects, consumers
`don’t want to take excessive amounts of a neurohormone that alters brain chemistry. Consumers
`certainly don’t want to give such excessive dosages to their children.
`19.
`In addition, it is important to consumers that melatonin is accurately (not excessively)
`dosed because the long-term safety of melatonin is not established, and higher doses carry greater
`long-term safety concerns. As the National Institutes of Health explains, the long-term safety of
`melatonin remains unknown:
`For melatonin supplements, particularly at doses higher than what the body normally
`produces, there’s not enough information yet about possible side effects to have a clear
`picture of overall safety. Short-term use of melatonin supplements appears to be safe for most
`people, but information on the long-term safety of supplementing with melatonin is lacking.10
`20.
`Long-term safety is especially uncertain for children:
`
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`6 https://www.zzzquil.com/en-us/faq/zzzquil-pure-zzzs-melatonin-faq (made by Proctor &
`Gamble)
`7 The New York Times, Melatonin Isn’t a Sleeping Pill. Here’s How to Use It,
`https://www.nytimes.com/2022/01/11/well/mind/melatonin-sleep-insomnia.html
`8 Melatonin for Kids: What Parents Should Know About This Sleep Aid, healthychildren.org
`(from the American Academy of Pediatricians), https://www.healthychildren.org/English/healthy-
`living/sleep/Pages/melatonin-and-childrens-sleep.aspx
`9 Grigg-Damberger, M. & Ianakieva, D., Poor quality control of over-the-counter melatonin:
`What they say is often not what you get, 13 Journal of Clinical Sleep Medicine 163–165 (2017).
`10 https://www.nccih.nih.gov/health/melatonin-what-you-need-to-know
`First Amended Complaint
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`Case No. 3:22-cv-04465-CRB
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`Melatonin supplements at normal doses appear to be safe for most children for short-term use,
`but there aren’t many studies on children and melatonin. Also, there’s little information on the
`long-term effects of melatonin use in children. Because melatonin is a hormone, it’s possible
`that melatonin supplements could affect hormonal development, including puberty, menstrual
`cycles, and overproduction of the hormone prolactin, but we don’t know for sure.11
`21. Melatonin for adults is available on the market in a range of doses, e.g., 1 mg, 3 mg, 5
`mg or 10 mg. This is because consumers want to make their own, informed decision about the
`dosage that is right for them. When marketed for children, melatonin is generally only available at
`lower doses (e.g., 1 mg or 0.5 mg per serving), because higher doses are not generally recommended.
`No consumer wants an informed choice to be robbed from them by inaccurate labelling and dosing.
`For example, if a consumer purchases a 1 mg dose (and not a higher dose), this is because they want
`1 mg and no more. This choice is objectively reflected by their decision to purchase 1 mg, instead of
`a higher dose. Each consumer has the right to make their own, informed choice about what dosage to
`purchase and ingest (or provide to their children). No reasonable consumer wants to be tricked into
`taking a higher dose when they wanted.
`B.
`The FDA does not allow melatonin to be unreasonably overdosed.
`22.
`The FDA recognizes that consumers have a right to make an informed decision about
`how much of supplements, like melatonin, they are really taking. The FDA also recognizes that some
`supplements, such as melatonin, degrade over time, such that a product that contains a certain amount
`of a supplement when it is put on the shelves might have less of that supplement at expiration.
`23.
`The FDA balanced these competing considerations by providing that, for dietary
`supplements “reasonable excesses over labeled amounts are acceptable within current good
`manufacturing practice,” 21 C.F.R §101.36(f)(1), i.e., within amounts reasonably necessary to ensure
`that the product “meets the amount specified on the label throughout the product's shelf life.” Current
`Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for
`Dietary Supplements, 72 Fed. Reg. 34752, 34884 (June 25, 2007). But, as the FDA provides,
`manufacturers are prohibited from adding “unspecified amounts [of an ingredient] that would be in
`
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`11 https://www.nccih.nih.gov/health/melatonin-what-you-need-to-know
`First Amended Complaint
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`Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 8 of 31
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`excess of the amount actually needed to meet the label declaration.” 68 Fed. Reg. 12158, 12158 (Mar.
`13, 2003). So, an excess is not a “reasonable excess” (and violates FDA regulations) if the excess is
`materially in excess of the amount actually needed to meet the amount declared on the label
`throughout the product’s shelf life.
`24.
`The FDA does not review and approve any particular overages for dietary
`supplements—the duty falls on manufacturers to assure compliance with the “reasonable excess”
`limit.
`
`25.
`Certain U.S. manufacturers comply with the FDA’s limits. For context, Plaintiffs’
`testing has shown that melatonin by other U.S. manufacturers who do not unreasonably overdose
`their products is put on shelves with an excess amounting to approximately 10-15% more than the
`amount declared on the label. This excess is reasonable because, by the time the shelf life ends, the
`product has approximately the amount of melatonin that is declared on the label. In this situation, the
`excess is not materially in excess of the amount actually needed to meet the label declaration, and so
`it complies with the FDA’s mandates.
`26.
`By contrast, if a manufacturer includes materially more melatonin than is actually
`needed to ensure that by the time the shelf life ends, the product has approximately the amount of
`melatonin that is declared on the label, this violates FDA’s mandates. Because such an excess is
`more than the amount actually needed to meet the label declaration, it is not a “reasonable” excess. It
`is therefore not permitted under the FDA regulations (and is instead prohibited).
`C.
`Scientific research reveals serious problems with the accuracy of melatonin
`dosing and labelling in Canada. Scientists warn that the same is likely true of
`some U.S. brands.
`27.
`In 2017, a study of Canadian melatonin brands found “high variability, ranging from
`−83% to +478%, of the labelled concentration of melatonin content in melatonin supplements.” 12
`For over 70% of the tested brands, the true amount of melatonin varied more than 10% from the
`listed amount. The amount of melatonin also varied highly between different lots (manufacturing
`
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`12 Lauren, Melatonin Natural Health Products and supplements, 13 Journal of Clinical Sleep
`Medicine at 276.
`First Amended Complaint
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`Case No. 3:22-cv-04465-CRB
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`batches) of the same product. The researchers concluded that “manufacturers require increased
`controls to ensure melatonin supplements” are accurately labelled.
`28.
`U.S. scientists warned that this Canadian study “herald[s] what may also be true in
`OTC melatonin supplements marketed in the United States.” 13 Likewise, the National Institutes of
`Health has warned that “some melatonin supplements may not contain what’s listed on the product
`label.” 14 And Consumer Reports warned: “The findings … offer the latest proof of something
`supplement industry critics have long warned about: When it comes to this poorly regulated corner of
`modern medicine, consumers often don’t know what they’re buying.” 15
`D.
`Zarbee’s markets melatonin for children and sells melatonin supplements to
`millions of U.S. consumers.
`29.
`Zarbee’s is a major U.S. brand of melatonin supplements. Its melatonin products are
`available nationwide at retailers like Walmart, Kroger, and Target. Zarbee’s makes and sells
`melatonin marketed specifically for children (“Zarbee’s Melatonin”). Millions of U.S. consumers
`buy Zarbee’s Melatonin and rely on the accuracy of its labelling. Exhibit 1 identifies the accused
`children’s melatonin products.
`30.
`For each product, the label claims a specific amount of melatonin per unit (1 mg), on
`the back label. For example:
`
`
`13 Madeleine, Poor quality control of over-the-counter melatonin, 13 Journal of Clinical Sleep
`Medicine at 163.
`14 NIH National Center for Complementary and Integrative Health, Melatonin:What You Need
`To Know, https://www.nccih.nih.gov/health/melatonin-what-you-need-to-know
`15 Consumer Reports, New Study Questions Ingredient Levels in Some Melatonin
`Supplements, https://www.consumerreports.org/melatonin/study-questions-ingredient-levels-some-
`melatonin-supplements/
`First Amended Complaint
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`Case No. 3:22-cv-04465-CRB
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`31.
`These claims on the back of the product are substantially similar for all accused
`Zarbee’s Melatonin products. They all advertise melatonin as a key active ingredient and claim to
`have the same, specific amount of melatonin (1 mg) per unit. See Exhibit 1.
`32.
`Each Plaintiff and each class member was presented with the materially-identical
`representation on the back of all products.
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`First Amended Complaint
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`33.
`By selling a melatonin supplement for sleep (i.e., a supplement that alters brain
`chemistry), Zarbee’s is representing to consumers that its products are accurately dosed and labelled.
`When a consumer picks up a bottle of Zarbee’s Melatonin, they reasonably expect that it actually has
`the dosage for which Zarbee’s designed the recommended serving. No reasonable consumer expects
`that a melatonin supplement has an unreasonable overdose of melatonin, compared to what it is
`supposed to have. And specifically, when a bottle of Zarbee’s says it has a particular amount of
`melatonin per unit (1 mg), consumers expect this to be accurate (and not unreasonably excessive).
`This is especially true for melatonin marketed for children.
`E.
`Scientific testing reveals that, unlike other manufacturers, Zarbee’s Melatonin
`has an unreasonable excess of melatonin.
`34.
`Liquid Chromatography-Mass Spectrometry analysis (LC-MS) can accurately measure
`the true amount of melatonin in an over-the-counter supplement. LC-MS is a reliable and appropriate
`analytical procedure for measuring melatonin content.
`35.
`For Zarbee’s Melatonin, a university mass-spectrometry laboratory used LC-MS to
`test Zarbee’s Melatonin, among other brands. The lab tested both non-expired bottles and expired
`bottles, from different manufacturing lots (batches).
`36.
`If Zarbee’s Melatonin were reasonably dosed, the amount of melatonin at the end of
`the shelf life (when the bottle expires) would be materially the same as the claim on the label, i.e.,
`close to 100% of the claimed amount. In contrast, if Zarbee’s is unreasonably overdosed, even after a
`bottle expires (i.e., its shelf life is over) there will be materially more melatonin than the amount
`specified on the label. The test results, summarized below, confirm that Zarbee’s has an
`unreasonable excess of melatonin:
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`First Amended Complaint
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`Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 12 of 31
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`Zarbee’s type 16
`
`Claimed
`melatonin dose
`(mg / gummy)
`
`True
`melatonin dose
`(mg / gummy)17
`
`True melatonin
`dose
`(%)18
`
`1.00
`
`2.23
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`+222%
`
`Zarbee’s Children’s
`Sleep with Melatonin
`Gummies (Expired)
`Lot: FA200901222685
`Exp: 9/2022
`Tested: 8/2022
`Zarbee’s Children’s
`Sleep with Melatonin
`Gummies
`Lot: 2124301250
`Exp: 8/2023
`Tested: 4/2022
`Zarbee’s Children’s
`Sleep with Melatonin
`Gummies
`Lot: FD2108070924519
`Exp: 8/2023
`Tested: 7/2022
`37.
`These results show that the melatonin content of non-expired Zarbee’s is far higher
`than the claimed dosages. For example, Ms. Lopez’s bottle had more than twice the amount of
`melatonin listed on the label.
`38.
`Unsurprisingly, once Zarbee’s Melatonin expires, there is still far too much melatonin,
`compared to the amount claimed on the label. The laboratory tested an expired bottle of Zarbee’s
`Melatonin (Lot# FA20090122268). This bottle expired in September 2022. Yet when it was recently
`tested (just before it expired), it still had 222% of the claimed melatonin content. In other words,
`after expiration, the bottle is still substantially overdosed. Because the excess is materially more than
`reasonably necessary to ensure that the melatonin meets the amount specified on the product label
`throughout the product’s shelf life, Zarbee’s Melatonin is unreasonably overdosed.
`39.
`Zarbee’s own data will confirm that its melatonin products are unreasonably
`overdosed. Dietary supplement manufacturers are required to test the dietary supplements they sell
`
`16 “Lot” is the lot number printed on bottle. “Exp” is the expiration date printed on bottle.
`“Tested” is the month the lab conducted the test.
`17 The lab tested three gummies per bottle and averaged the results. There was little variance
`in the melatonin content between gummies in the same bottle.
`18 The percentage ratio of the true dose to the claimed dose.
`19 Ms. Lopez’s bottle.
`First Amended Complaint
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`1.00
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`1.00
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`1.29
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`2.16
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`+128%
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`+216%
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`Case No. 3:22-cv-04465-CRB
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`for compliance with the FDA’s regulations. That testing must be performed using a random 12-
`sample composite method. 21 C.F.R. § 101.9(g)(2) (describing this method). Manufacturers like
`Zarbee’s must retain the data from these tests. As shown above, in Plaintiff’s testing, all of the
`Zarbee’s samples were substantially overdosed. Accordingly, it is reasonable to infer that Zarbee’s
`own testing (using FDA protocols) will confirm that the products are substantially (and unreasonably)
`overdosed.20
`Zarbee’s labelling is false and misleading to reasonable consumers.
`F.
`40.
`As detailed above, each Zarbee’s Melatonin label claims to have a specific amount of
`melatonin per unit (1mg). But in truth, the dosing is unreasonably excessive. In this way, Zarbee’s
`affirmative representations are misleading to reasonable consumers. For all accused Zarbee’s
`Melatonin, the label is false in the same way.
`41.
`As also detailed above, the inaccurate dosing and labelling of Zarbee’s Melatonin is
`material to reasonable consumers. Consumers need melatonin supplements to be accurately dosed
`and labelled, so that consumers can make an informed choice about what dosage to buy and ingest.
`No reasonable consumer wants to unwittingly buy and ingest a supplement containing an
`unreasonably excessive amount of melatonin, compared to what they thought they were purchasing
`and ingesting. This is especially true for melatonin products marketed to children.
`42.
`Zarbee’s recognizes that its consumers demand accuracy in dosing and labelling.
`Zarbee’s website claims that “Each gummy contains 1 mg melatonin, which is safe” and can “help
`your little one.”21 The point is not that all consumes read the website—the point is that Zarbee’s
`itself admits that accurate dosing and labelling is material to reasonable consumers. Zarbee’s makes
`this claim because it recognizes that consumers want this to be true, i.e., consumers demand products
`that are accurately labelled and dosed. But for Zarbee’s Melatonin, this is not true.
`43.
`Zarbee’s admits that it is undesirable and even dangerous for consumers to ingest
`more melatonin than the recommended dosage on the bottles. Zarbee’s states on its bottles: “Take
`only as directed. Do not exceed recommended dosage.” 22 But due to Zarbee’s inaccurate labelling
`
`20 At this stage, Zarbee’s own testing is uniquely within its own possession.
`21 https://www.zarbees.com/product/childrens-sleep-with-melatonin-gummies/
`
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`First Amended Complaint
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`Case 3:22-cv-04465-CRB Document 24 Filed 10/12/22 Page 14 of 31
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`and unreasonably excessive dosing, Zarbee’s customers are unknowingly doing exactly what
`Zarbee’s recommends against (exceeding the recommended dosages).
`44.
`As described above, Zarbee’s claims that it determines the melatonin content of “each
`gummy” to ensure “safety.” And it is a standard practice in the industry for manufacturers to test the
`potency of supplements before they are distributed. Therefore, Zarbee’s reasonably should have
`known that the dosing of Zarbee’s Melatonin is unreasonably excessive, compared to the labels. 23
`45.
`To be clear, while Zarbee’s unreasonably excessive dosing violates the FDC Act,
`Plaintiff is not seeking to enforce the FDC Act itself (i.e., Plaintiff is not suing merely because the
`conduct violates the Act). Zarbee’s false and misleading labeling (and unreasonably excessive
`dosing) is independently illegal under state consumer protection and warranty laws. It is these state
`laws that Plaintiff asserts.
`46.
`Nor is Plaintiff seeking to impose disclosure requirements not required by the FDA.
`Plaintiff wants Zarbee’s to fix its dosing so that it is reasonable (instead of unreasonably excessive)
`and so that its labels are not misleading. This is identical to what the FDC Act and FDA require.
`G.
`Zarbee’s overcharges millions of consumers.
`47.
`Zarbee’s false and misleading labelling drives the demand for Zarbee’s Melatonin. As
`explained above, consumers demand melatonin that is accurately dosed and labelled. This is
`recognized by scientists, Consumer Reports, and Zarbee’s itself. If consumers knew the truth—that
`its dosing and labelling was seriously inaccurate—the price of its products would crater. For
`example, on the Target website, a bottle of Zarbee’s Children’s Sleep with Melatonin Gummies costs
`$16.89. If consumers knew the truth—that this bottle likely has an unreasonably excessive amount of
`melatonin per serving—Zarbee’s could not sell it for anything close to $16.89 (or sell it at all). For
`example, a reasonable consumer who wanted to buy a product with 1 mg of melatonin (for children)
`would not buy an unreasonably overdosed and inaccurately labelled product, and would instead buy a
`reasonably dosed and accurately labeled product. Plaintiff and each class member paid a substantial
`price premium driven by Zarbee’s false and misleading labelling.
`
`
`23 At this stage, Plaintiff is not alleging intentional deception or fraud, but reserve the right to
`amend if discovery reveals evidence of Zarbee’s fraudulent intent.
`First Amended Complaint
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`Case No. 3:22-cv-04465-CRB
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`48.
`In fact, without accurate dosing and labelling, Zarbee’s Melatonin is worthless. What
`reasonable consumer wants to buy a supplement that alters brain chemistry, if the product is
`inaccurately labelled and unreasonably overdosed? Every reasonable consumer would instead buy an
`accurately dosed and labelled product, so that they could trust what they are getting. Plaintiff and
`each class member paid for Zarbee’s Melatonin products that are, in truth, worthless. Thus, the full
`economic injury here is the entire price of the Zarbee’s Melatonin that Plaintiff and class members
`purchased.
`H. Ms. Lopez was misled and harmed by Zarbee’s misleading labelling.
`49.
`Like millions of other consumers, Ms. Lopez bought Zarbee’s Melatonin and relied on
`the accuracy of Zarbee’s dosing and labelling.
`50.
`In or around early June 2022, Ms. Lopez bought a bottle of Zarbee’s Children’s Sleep
`with Melatonin Gummies (Lot # FD21080709245) from a Walmart in Salinas, to give to her child
`(age 8