Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 1 of 18
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`BURSOR & FISHER, P.A.
`L. Timothy Fisher (State Bar No. 191626)
`Joel D. Smith (State Bar No. 244902)
`Sean L. Litteral (State Bar No. 331985)
`1990 North California Boulevard, Suite 940
`Walnut Creek, CA 94596
`Telephone: (925) 300-4455
`Facsimile: (925) 407-2700
`E-Mail: ltfisher@bursor.com
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` jsmith@bursor.com
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` slitteral@bursor.com
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`Attorneys for Plaintiff
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`UNITED STATES DISTRICT COURT
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`NORTHERN DISTRICT OF CALIFORNIA
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`ERIC BARNES and KATTY LOPEZ
`individually and on behalf of all others similarly
`situated,
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`IOVATE HEALTH SCIENCES U.S.A., INC.,
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` Defendant.
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`Plaintiff,
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`v.
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` Case No.
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`CLASS ACTION COMPLAINT
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`JURY TRIAL DEMANDED
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`CLASS ACTION COMPLAINT – JURY TRIAL DEMANDED
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 2 of 18
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`Plaintiffs Eric Barnes and Katty Lopez (hereafter “Plaintiffs”), individually and on behalf
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`of all other similarly situated purchasers (hereafter the “Class”), bring this consumer class action
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`against Iovate Health Sciences U.S.A., Inc. (hereafter “Defendant”) for the distribution,
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`advertisement, and sale of certain products, including (1) HydroxyCut Hardcore, (2) HydroxyCut
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`Hardcore Elite, (3) HydroxyCut Ultra Lean, and (4) HydroxyCut Pro Clinical (collectively the
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`“Products”) in violation of Dietary Supplement Health and Education Act of 1994, Pub. L. No.
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`103-417, 108 Stat. 4325.
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`JURISDICTION AND VENUE
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`1.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1332(d)(2)(A)
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`because this case is a class action where the aggregate claims of all members of the proposed
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`class are in excess of $5,000,000.00, exclusive of interest and costs, and Plaintiff, as well as most
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`members of the proposed class, are citizens of states different from Defendant. This Court also
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`has supplemental jurisdiction over state law claims pursuant to 28 U.S.C. § 1367.
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`2.
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`Pursuant to 28 U.S.C. § 1391, this Court is the proper venue for this action
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`because Plaintiffs are citizens of California and reside in this District, and because Plaintiffs
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`purchased the Products in this District. Moreover, Defendant purposefully availed itself of this
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`District through its distribution, advertisement, and sale of the Products, which are the subject of
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`the present complaint, in this District.
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`THE PARTIES
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`3.
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`Plaintiff Eric Barnes is an individual domiciled in Saratoga, California. Plaintiff
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`Barnes purchased (1) HydroxyCut Hardcore and (2) HydroxyCut Hardcore Elite at numerous
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`points during the last four years from a Walmart store in Santa Clara County for personal use in
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`California. In doing so, Plaintiff Barnes relied upon Defendant’s advertising, packaging, labeling
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`and other promotional materials, which were jointly prepared and approved by Defendant and its
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`agents and disseminated through advertising media containing the unlawful claims alleged herein.
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`Plaintiff Barnes would not have purchased the Products if he had known that they were unlawful to
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`sell under California law.
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`///
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`CLASS ACTION COMPLAINT – JURY TRIAL DEMANDED
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 3 of 18
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`4.
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`Plaintiff Katty Lopez is an individual domiciled in Antioch, California. Plaintiff
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`Lopez purchased (1) HydroxyCut Ultra Lean and (2) HydroxyCut Pro Clinical at numerous points
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`during the last four years from a Walmart store in Antioch for personal use in California. In doing
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`so, Plaintiff Lopez relied upon Defendant’s advertising, packaging, labeling and other promotional
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`materials, which were jointly prepared and approved by Defendant and its agents and disseminated
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`through advertising media containing the unlawful claims alleged herein. Plaintiff Lopez would
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`not have purchased the Products if she had known that they were unlawful to sell under California
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`law.
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`5.
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`Defendant Iovate Health Sciences is a Delaware corporation with its principal place
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`of business in Wilmington, Delaware. At times relevant to this Complaint, Defendant has
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`advertised, marketed, and sold a variety of cosmetic products, including the Products at issue, to
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`consumers throughout the United States and the State of California. Defendant has sold the
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`Products directly to consumers via the Internet and through third-party retail stores throughout the
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`United States, including in this District.
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`The Labelling Requirements for Dietary Supplements
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`FACTUAL ALLEGATIONS
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`6.
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`In 2020, the dietary supplements market in the U.S. was estimated at $46 Billion,
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`and the global market for dietary supplements is expected to grow to $298.5 Billion by 2027.1
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`7.
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`For decades, consumers have been prioritizing their health and wellness through the
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`use of dietary supplements. That interest took on even greater resonance when the COVID-19
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`pandemic struck last year, with millions of American consumers seeking out ways to stay healthy
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`and boost their immunity.
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`8.
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`According to leading market research firm IRI, spurred by the pandemic, the
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`vitamin and supplement category has skyrocketed. IRI calculates that vitamin, mineral and
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`supplement sales have risen 21% since the pandemic began, with market shares of certain types of
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`1
`https://www.businesswire.com/news/home/20210219005385/en/Global-Dietary-
`Supplements-Market-Report-2020-Market-to-Reach-298.5-Billion-by-2027---U.S.-Market-is-
`Estimated-at-46-Billion-While-China-is-Forecast-to-Grow-at-12.7-CAGR---
`ResearchAndMarkets.com.
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 4 of 18
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`vitamins and supplements increasing exponentially. Crowe, Emily, Behind the growth in the
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`dietary
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`supplement, vitamin market. Smart Brief
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`(March 3, 2021)
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`(accessible at:
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`https://www.smartbrief.com/original/2021/03/behind-growth-dietary-supplement-vitamin-market).
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`9.
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`Larry Levin, executive vice president of consumer and shopper marketing at IRI
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`states that: “Prior to COVID-19, 80% of consumers were using vitamins, minerals and supplements
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`as part of their ritual anyway, but I think the pandemic just strengthened their commitment to the
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`product category.” Id.
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`10.
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`IRI data shows that buying vitamins and supplements has been at the forefront of
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`consumers’ minds since the early days of the pandemic, with 35% of households buying vitamins
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`in the four weeks ending April 5, 2020. Id. The momentum has continued, with 40.6 million
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`households purchasing vitamins in January 2021, compared to 35.5 million the prior year.
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`According to Mr. Levin, “When you think about the impact that category has on our lifestyle, it’s
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`really profound.” Id.
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`11.
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`The COVID-19 pandemic has demonstrated more than ever that consumers will
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`seek to support their health through dietary supplements and, in making those critical purchasing
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`decisions, must be able to trust that labels and claims for dietary supplements are truthful,
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`substantiated, and meet all legal requirements to be lawfully sold over the counter.
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`12.
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`The Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. § 301 et seq. (the
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`“FFDCA” or the “Act”), as amended by the Dietary Supplement Health and Education Act of
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`1994, Pub. L. No. 103–417, 108 Stat. 4325 (“DSHEA”), as well as the regulations implementing
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`the FFDCA and DSHEA set forth the legal requirements for labelling and selling dietary
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`supplements. These requirements are fully incorporated into California’s Sherman Food, Drug, and
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`Cosmetic Law, Cal. Health & Safety Code § 109875 et seq. (“Sherman Law”).
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`13.
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`Under the FFDCA, a “drug” is defined, in part, as an “article[] intended for use in
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`the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” or an
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`“article[] (other than food) intended to affect the structure or any function of the body of man or
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`other animals.”
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`14.
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`Under 21 U.S.C. §§ 331(d) and 355(a), the FDA must approve new drugs before
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 5 of 18
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`they can be sold on the market. The FFDCA creates an exemption from this pre-approval process
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`for dietary supplements “intended to affect the structure or function of the body” if the dietary
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`supplements carry a prominent FDA disclaimer on the product labels and advertising.
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`15.
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`Under these regulations, supplement companies like Defendant are prohibited from
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`labeling, marketing, or selling dietary supplements bearing claims that “describe[] the role of a
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`nutrient or dietary ingredient intended to affect the structure or function in humans, [or that]
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`characterize[] the documented mechanism by which a nutrient or dietary ingredient acts to
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`maintain such structure or function” (known as “structure/function claims”), unless the label carries
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`a prominent disclaimer (the “DSHEA Disclaimer”) on each panel bearing such claims. See 21
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`U.S.C. §§ 321(g)(1), 331(d), 343(r)(1)(B), 343(r)(6), 355(a); 21 C.F.R. § 101.93(d) (“On product
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`labels and in labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on each panel or page
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`where there [is a structure/function claim].”).
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`16.
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`The DSHEA Disclaimer must be prominent and bolded, and it must read:
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`These statements have not been evaluated by the Food and Drug
`Administration. This product is not intended to diagnose, treat,
`cure, or prevent any disease.
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`21 U.S.C. § 343(r)(6)(C); see also 21 C.F.R. § 101.93(b)-(e).
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`17.
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`As one Court recently explained, the DSHEA Disclaimer requirement is important
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`for consumer safety:
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`The disclaimer requirement aligns with the FDA’s recognition that
`few dietary supplements have been the subjects of adequately
`designed clinical trials. Without the disclaimer, structure/function
`claims convey therapeutic drug claims, thereby encouraging self-
`treatment without the benefit of a medical diagnosis or treatment.
`The point of the disclaimers are to make sure that consumers
`understand that structure/function claims are not reviewed by [the]
`FDA prior to marketing, and to caution consumers that dietary
`supplements bearing such claims are not for therapeutic uses.
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`Arora v. GNC Holdings, Inc., No. 19-cv-02414-LB, 2019 WL 6050750, at *3 (N.D. Cal. Nov. 15,
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`2019) (internal quotation marks and citations omitted) (emphasis in original).
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`18.
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`Dietary supplements that do not bear the required DSHEA Disclaimer on all panels
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`with structure/function claims, and/or the disclaimer lacks the prominence required, are
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`misbranded and unlawful. 21 U.S.C. § 343(r)(1)(B), (r)(6); 21 C.F.R. § 101.93(d).
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 6 of 18
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`19. Moreover, such products qualify as “drugs” under the FFDCA because they are
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`marketed with structure/function claims but do not include the DSHEA Disclaimer. See 21 U.S.C.
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`§§321(g)(1), 343(r)(6). To avoid being regulated as drugs under the FFDCA, dietary supplements
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`bearing structure/function claims must comply with the DSHEA Disclaimer requirements. Id.
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`20. Misbranded dietary supplements and/or unapproved drugs are unlawful and cannot
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`be sold legally under federal and identical California law. 21 U.S.C. §§ 331, 333.
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`Defendant Iovate Health Sciences’ Unlawful Advertising, Sale and Labeling of the Products
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`21.
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`Unfortunately for consumers, Defendant Iovate continues to advertise, sell, and
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`label its products in violation of the statutes referred to herein.
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`22.
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`At numerous points during the Class Period, Plaintiff Barnes purchased Defendant
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`Iovate’s HydroxyCut Hardcore and Hardcore Elite. As the photographs below demonstrate,
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`Iovate’s products do not comply with the laws and regulations set out herein.
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`23.
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`Photographs of the relevant panel and structure / functions claims made as a part of
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`the packaging for HydroxyCut Hardcore is set out below. HydroxyCut Hardcore’s left-facing
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`panel contains numerous structure or function claims. Iovate claims that “[w]hen you’re looking
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`for hardcore results, reach for the power of HydroxyCut Hardcore. Formulated with a
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`scientifically researched key weight loss complex (green coffee extract). HydroxyCut Hardcore
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`has been designed to deliver the significant weight loss results you’ve been looking for.” (emphasis
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`added). Iovate also claims that green coffee extract is a “Key Weight Loss Ingredient Tested in 2
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`Scientific Studies.” (emphasis added). In support of this statement, Iovate states that “[i]n one
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`study, subjects taking the primary ingredient (green coffee extract) . . . for 60 days lost, on
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`average, 10.98 lbs versus the placebo group.” (emphasis added). Iovate then notes that “[i]n a
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`separate 8-week study, subjects using the same key ingredient lost an average of 3.7 lbs versus
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`the subjects using a placebo.” (emphasis added). But Iovate does not stop there. Instead, Iovate
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`goes onto claim that “HydroxyCut Hardcore contains another powerful ingredient (caffeine
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`anhydrous) that’s been shown to deliver a serious boost of energy. After your very first dose
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`you’ll experience extreme energy for maximum intensity.” (emphasis added).
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`24.
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`Each of these statements explicitly describe the role of the green coffee extract and
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 7 of 18
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`caffeine anhydrous ingredients and their role, namely weight loss and energy development,
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`experienced by humans consuming these ingredients. Accordingly, these statements represent
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`structure/function claims. However, as the photographs set out below demonstrate, these
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`statements are not accompanied by the requisite DSHEA Disclaimer.
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`25.
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`Likewise, the left-facing panel of Iovate’s HydroxyCut Hardcore Elite contains
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`multiple controverted statements that violate the Dietary Supplement Health and Education Act of
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`1994. Iovate encourages consumers to “[f]uel your most intense workouts and tackle your jam-
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`packed days with a scientifically researched dose of caffeine anhydrous that boosts energy and
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`mental focus.” (emphasis added). Iovate doubles down by noting that “ [i]n one study,
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`researchers monitored subjects who took C. canephora robusta – the key weight loss ingredient
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 8 of 18
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`in HydroxyCut Hardcore Elite – for 60 days. On average, they lost 10.95 lbs, while the placebo
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`group lost an average of 5.4 lbs.” (emphasis added). Iovate then advertises that “[i]n a separate 8-
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`week study, researchers monitored two groups following a calorie-reduced diet and performing
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`moderate exercise. Subjects using C. canephora robusta lost an average of 3.7lbs, while those
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`using a placebo lost an average of 1.25 lbs.”
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`26.
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`Again, these statements specifically describe the role of “key” ingredients, caffeine
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`anhydrous and C. candephora robusta, to their role, namely weight loss and energy development,
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`experienced by humans consuming these ingredients. Accordingly, these statements represent
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`structure/function claims. However, as the photograph set out below demonstrates, these
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`statements are not accompanied by the requisite DSHEA Disclaimer.
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 9 of 18
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`27.
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`Iovate’s failure to comply with the regulations set out above also affected Plaintiff
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`Lopez’s purchase of HydroxyCut Ultra Lean and HydroxyCut Pro Clinical. On one panel of
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`HydroxyCut Ultra Lean, Defendant Iovate claims that “[t]he HydroxyCut research and
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`development team have developed this unique synergistic ingredient combination for weight
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`loss.” (emphasis added). Iovate claims that “CurcumaSlim™ is a combination of two
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`ingredients: pure turmeric / curcumin that provides 95% curcuminoids and alpha lipoic avid
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`(ALA), a compound found naturally in the body that helps turn glucose into energy.” (emphasis
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`added). Iovate goes on to claim that “[t]wo scientific studies support the weight loss results from
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`CurcumaSlim™.” (emphasis added). Specifically, Iovate writes that “[i]n two 16-week studies,
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`subjects using the key ingredient combination (alpha lipoic acid and curcumin) lost an average
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`of 12.56lbs v. 6.12 lbs for placebo and 4.84 lbs v. 0.87 lbs for placebo, respectively.” (emphasis
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`added). A photograph of the panel bearing these statements are set out here:
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 10 of 18
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`28.
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`Each of these statements connect the role of ingredients puretumeric and curcumin
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`on a structure or function in the human body. Accordingly, these constitute structure/function
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`claims. However, these statements are not accompanied by the requisite DSHEA Disclaimer. For
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`these reasons, the statements on this panel violate the principles set out here.
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`29.
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`Similarly, Iovate’s HydroxyCut Pro Clinical contains multiple violative statements.
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`On one panel, Defendant claims that “HydroxyCut is formulated with a scientifically researched
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`key weight loss ingredient to produce significant weight loss results.” (emphasis added). Iovate
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`supports this statement by noting that “[s]ubjects taking the key ingredient in HydroxyCut (C.
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`canephora robusta) for 60 days lost an average of 10.95 lbs versus the placebo group, which lost
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`an average of 5.40 lbs.” (emphasis added). Iovate then claims that “[i]n a separate 8-week study,
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`subjects taking C. canephora robusta lost an average of 3.7 lbs versus the placebo group, which
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`lost 1.25 lbs.” (emphasis added).
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`30.
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`Iovate next claims that HydroxyCut’s key ingredient “[p]romotes increased energy
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`expenditure to help you burn more calories.” (emphasis added). Iovate supports this statement
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`by noting that “[i]n short term studies, research shows that caffeine can help temporarily
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`promote increased energy expenditure (calorie burning).” (emphasis added).
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`31.
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`Iovate then advertises that “[n]aturally sourced coffee extract has been included to
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`give you a clean energy boost.” (emphasis added). Iovate notes that the product “[c]ontains
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`naturally sourced caffeine to help increase energy.” (emphasis added).
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`32.
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`Finally, Iovate claims that “Vitamin D has been added to help support general
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`good health and B vitamins to help metabolize carbs, fats and proteins” and that the product
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`“[c]ontains B vitamins, which help with the conversion of carbs, protein and fat.” (emphasis
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`added).
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`33.
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`A photograph of this panel is included on the following page:
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`CLASS ACTION COMPLAINT – JURY TRIAL DEMANDED
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`34.
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`Each of these statements describe the role of an ingredient on the structure or
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`function in the human body. Accordingly, these statements represent structure/function claims.
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`But, significantly, these statements are not supported by the required DSHEA Disclaimer directly
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`on this panel. Therefore, in light of the principles described herein, the statements contained on
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`this panel violate the Dietary Supplement Health and Education Act of 1994.
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`CLASS ACTION COMPLAINT – JURY TRIAL DEMANDED
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 12 of 18
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`Plaintiff’s Purchase of the Product
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`35.
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`Plaintiffs purchased several of the offending Iovate Products during the Class
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`Period. Prior to purchasing the Products, Plaintiffs saw, heard and relied upon packaging, labeling,
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`advertisements,
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`representations and statements made by Defendant
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`Iovate,
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`including
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`advertisements and labels set forth above.
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`36.
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`As a result of Defendant’s representations, sale, and offer for sale, of the Products,
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`Plaintiffs believed that the Products were lawful, correctly branded, subject to a governmental
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`review and approval process, and had therapeutic value, including that they were intended to
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`prevent or treat disease.
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`37.
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`Plaintiffs have suffered injury in fact and lost money as a result of Defendant’s
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`conduct described herein. Plaintiffs would not have purchased the Products had they known that
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`the Products were unlawful to sell. Plaintiffs otherwise paid more for the Products than had they
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`known the truth about these Products and that they were unlawful to sell.
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`38.
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`If Plaintiffs were confident that the marketing and sale of the Products was lawful,
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`truthful, and non-misleading, Plaintiffs may purchase the Products in the future. At present,
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`however, Plaintiffs cannot purchase the Products because Plaintiffs cannot be confident that the
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`Products are lawful and that their labeling is truthful and non-misleading.
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`39.
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`On May 19, 2021, Plaintiffs issued a pre-suit demand for corrective action to
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`Defendant, notifying it of its violations of California law. Defendant refused to repair or correct its
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`violations, thus requiring Plaintiff to file this action.
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`CLASS ACTION ALLEGATIONS
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`40.
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`Class Definition: Plaintiffs brings this class action on behalf of themselves, and as a
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`class action on behalf of the following putative classes (the “Class”):
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`Nationwide Class
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`All individual residents of the United States who purchased the Products through the date of
`class certification. Excluded from the Class are: (1) Defendant and all directors, officers,
`employees, partners, principals, shareholders and agents of Defendant; (2) Any currently
`sitting United States District Court Judge or Justice, and the current spouse and all other
`persons within the third-degree of consanguinity to such judge/justice; and (3) Class
`Counsel.
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`CLASS ACTION COMPLAINT – JURY TRIAL DEMANDED
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 13 of 18
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`California Sub-Class
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`All individual residents of the State of California who purchased the Products through the
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`date of class certification. Excluded from the Class are: (1) Defendant and all directors,
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`officers, employees, partners, principals, shareholders and agents of Defendant; (2) Any
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`currently sitting United States District Court Judge or Justice, and the current spouse and all
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`other persons within the third-degree of consanguinity to such judge/justice; and (3) Class
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`Counsel.
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`41.
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`Plaintiffs reserves the right to amend the Class definitions if further investigation
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`and discovery indicates that the Class definitions should be narrowed, expanded, or otherwise
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`modified, including through the use of multi-state subclasses to account for material differences in
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`state law, if any.
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`42.
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`Numerosity and Ascertainability: Plaintiffs do not know the exact number of
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`members of the putative classes. Due to Plaintiffs’ initial investigation, however, Plaintiffs are
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`informed and believe that the total number of Class members is at least in the tens of thousands,
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`and that members of the Class are numerous and geographically dispersed throughout the United
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`States and California. While the exact number and identities of the Class members are unknown at
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`this time, such information can be ascertained through appropriate investigation and discovery,
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`including Defendant’s records, either manually or through computerized searches.
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`43.
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`Typicality and Adequacy: Plaintiffs’ claims are typical of those of the proposed
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`Class, and Plaintiffs will fairly and adequately represent and protect the interests of the proposed
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`Class. Plaintiffs do not have any interests that are antagonistic to those of the proposed Class.
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`Plaintiffs have retained counsel competent and experienced in the prosecution of this type of
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`litigation.
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`44.
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`Commonality: The questions of law and fact common to the Class members, some
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`of which are set out below, predominate over any questions affecting only individual Class
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`members:
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`a. whether Defendant committed the conduct alleged herein;
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`b. whether Defendant’s conduct constitutes the violations of laws alleged herein;
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`CLASS ACTION COMPLAINT – JURY TRIAL DEMANDED
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 14 of 18
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`c. whether Defendant’s labeling, sale and advertising set herein are unlawful, untrue,
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`or are misleading, or reasonably likely to deceive;
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`d. whether Defendant’s conduct violates public policy;
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`e. whether Defendant engaged in unfair or unlawful business practices in marketing
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`and distributing the Products;
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`f. whether the Products are adulterated and/or misbranded under the California Health
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`& Safety Code and identical federal law;
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`g. whether Defendant knowingly concealed or misrepresented material facts for the
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`purpose of inducing consumers into spending money on the Products;
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`h. whether Defendant’s representations, concealments and non-disclosures concerning
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`the Products are likely to deceive the consumer;
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`i. whether Defendant’s representations, concealments and non-disclosures concerning
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`the Products violate the UCL and/or the common law;
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`j. whether Defendant should be permanently enjoined from making the claims at issue;
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`and
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`k. whether Plaintiff and the Class are entitled to restitution and damages.
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`45.
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`Predominance and Superiority: Common questions, some of which are set out
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`above, predominate over any questions affecting only individual Class members. A class action is
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`the superior method for the fair and just adjudication of this controversy. The expense and burden
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`of individual suits makes it impossible and impracticable for members of the proposed Class to
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`prosecute their claims individually and multiplies the burden on the judicial system presented by
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`the complex legal and factual issues of this case. Individualized litigation also presents a potential
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`for inconsistent or contradictory judgments. In contrast, the class action device presents far fewer
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`management difficulties and provides the benefits of single adjudication, economy of scale, and
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`comprehensive supervision by a single court on the issue of Defendant’s liability. Class treatment
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`of the liability issues will ensure that all claims and claimants are before this Court for consistent
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`adjudication of the liability issues.
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`CLASS ACTION COMPLAINT – JURY TRIAL DEMANDED
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`46. Manageability: The trial and litigation of Plaintiffs’ and the proposed Class’ claims
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`are manageable. Defendant has acted and refused to act on grounds generally applicable to the
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`Class, making appropriate final injunctive relief and declaratory relief with respect to the Class as a
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`whole.
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`47.
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`Notice: If necessary, notice of this action may be affected to the proposed Class
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`through publication in a manner authorized in the California Rules of Court, Civil Code, and/or the
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`Federal Rules of Civil Procedure. Also, Class members may be notified of the pendency of this
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`action by mail and/or email, through the distribution records of Defendant, third party retailers, and
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`vendors.
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`FIRST CAUSE OF ACTION
`VIOLATION OF UNFAIR COMPETITION LAW
`(CAL. BUS. & PROF. CODE § 17200, et seq.)
`(Unlawful and Unfair Prongs of the Act)
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`48.
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`Plaintiffs incorporate by this reference the allegations contained in the preceding
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`paragraphs as if fully set forth herein.
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`49.
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`Plaintiffs bring this claim individually and on behalf of the proposed California Sub-
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`Class against Defendant.
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`50.
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`California Business and Professions Code § 17200 prohibits any “any unlawful,
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`unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading
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`advertising.” For the reasons discussed above, Defendant has engaged in unlawful and unfair acts
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`in violation of California Business & Professions Code §17200.
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`51.
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`As alleged herein, Plaintiffs have standing to pursue this claim as Plaintiffs have
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`suffered injury in fact and have lost money or property as a result of Defendants’ actions.
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`Specifically, Plaintiffs purchased the Products for their own personal use. In so doing, Plaintiffs
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`relied upon the representations referenced above. Plaintiffs would not have purchased the Products
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`had they known that the Products were unlawful to sell in California and the United States.
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`52.
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`Unlawful Business Practices: Defendant’s actions, as alleged herein, constitute
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`illegal and unlawful practices committed in violation of the Business & Professions Code §17200.
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`53.
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`As alleged herein, Defendant has violated provisions of the FDCA, as amended by
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`DSHEA, and implementing regulations, and in turn, the California Health & Safety Code,
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`CLASS ACTION COMPLAINT – JURY TRIAL DEMANDED
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`14
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`Case 5:21-cv-04978 Document 1 Filed 06/28/21 Page 16 of 18
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`including, at least, the following sections: 21 C.F.R. § 101.93(b); 21 U.S.C. § 403(r)(6)(C); 21
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`U.S.C. § 343(r)(6); and 21 U.S.C. §§ 331, 333.
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`54.
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`As alleged herein, Defendant’s conduct, including the above violations, violates the
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`provisions of the California Sherman Food, Drug, and Cosmetic Law, Cal. Health & Safety Code §
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`109875 et seq. (the “Sherman Law”), including, but not limited to, the following sections: §
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`110100; § 110395; § 110398; § 110400.
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`55.
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`Plaintiffs and the California Sub-Class reserve the right to allege other violations of
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`law which constitute other unlawful business acts or practices. Such conduct is ongoing and
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`continues to this date.
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`56.
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`Unfair Business Practices: California Business & Professions Code § 17200 also
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`prohibits any “unfair ... business act or practice.”
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`57.
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`Defendant’s conduct alleged herein also constitute “unfair” business acts and
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`practices within the meaning of Business & Professions Code § 17200 et seq. in that its conduct is
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`substantially injurious to consumers, offends public policy, and is