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`SUPERIOR COURT OF THE STATE OF CALIFORNIA
`FOR THE COUNTY OF ALAMEDA
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`
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`Wyatt A. Lison (SBN – 316775)
`wlison@fdpklaw.com
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`FEINSTEIN DOYLE PAYNE
` & KRAVEC, LLC
`
`429 Fourth Avenue, Suite 1300
`
`Pittsburgh, PA 15219
`Tel.: (412) 281-8400
`Fax: (412) 281-1007
`
`Antonio Vozzolo (pro hac vice to be filed)
`avozzolo@vozzolo.com
`Andrea Clisura (pro hac vice to be filed)
`aclisura@vozzolo.com
`VOZZOLO LLC
`345 Route 17 South
`Upper Saddle River, NJ 07458
`Tel.: (201) 630-8820
`Fax: (201) 604-8400
`
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`ATTORNEYS FOR PLAINTIFFS
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`CASE NO.:
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`COMPLAINT:
`
`Plaintiffs,
`Violation of California’s Unfair
`Competition Law, Cal. Bus. & Prof.
`Code §§ 17200, et seq.
`
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`JOYCE BENTON, MELISSA GRECO,
`ANTHONY SWETALA, AND RALPH
`MILAN,
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` v.
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`CVS HEALTH CORPORATION AND CVS
`PHARMACY, INC.,
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`
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`Defendants.
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`
`
`COMPLAINT
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`Case 3:22-cv-01640-JSC Document 1-1 Filed 03/15/22 Page 3 of 48
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`Plaintiffs Joyce Benton, Melissa Greco, Anthony Swetala, and Ralph Milan (“Plaintiffs’), by
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`and through their attorneys, bring this action against Defendants CVS Health Corporation and CVS
`Pharmacy, Inc. (collectively “CVS”) and allege as follows based upon their personal experience as to
`their own acts and status, and based upon the investigation of their counsel, and information and belief
`as to all other matters:
`
`I. NATURE OF THE CASE
`This is an action to enjoin CVS from selling homeopathic products labeled as drugs to
`1.
`diagnose, cure, mitigate, treat, or prevent any disease or to affect the structure or any function of the
`body1 (hereinafter “Homeopathic Products”) in California that are labeled in violation of the Federal
`Food, Drug and Cosmetic Act (“FDCA”) and California’s Sherman Food, Drug, And Cosmetic Law
`(“Sherman Law”). It is illegal in California to sell any drug without the required prior approval of the
`U.S. Food and Drug Administration (“FDA”) or California’s Department of Health Services (“DHS”),
`and no Homeopathic Product has been approved by FDA or DHS to be sold as a drug. This action is
`not an attempt to stop the sale of products purporting to be homeopathic treatments generally; rather,
`it is to enjoin CVS’s sale of Homeopathic Products in California stores that are labeled as drugs
`without the required prior approval.
`Plaintiffs are bringing this action to enjoin CVS from selling Homeopathic Products
`2.
`because they are a Health Fraud,2 designed to entice consumers to purchase what are labeled as natural,
`side-effect free treatments usually associated with self-limiting conditions like the cold and flu, when
`in fact there is no modern scientific tests showing that they are effective to treat any condition. The
`
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`1 Homeopathic Products are not food, which are allowed to be labeled as having an effect on the
`structure or function of the body if the claim is truthful, and substantiated.
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`2 See FDA Compliance Policy Guide 120.500 (“The deceptive promotion, advertisement, distribution
`or sale of articles, intended for human or animal use, that are represented as being effective to diagnose,
`prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health,
`but which have not been scientifically proven safe and effective for such purposes. Such practices may
`be deliberate, or done without adequate knowledge or understanding of the article”).
`
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`COMPLAINT
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`harm in selling what are essentially placebos3 is obvious. By purchasing and using Homeopathic
`Products rather than effective treatments, people put their health at risk by delaying proven effective
`treatments. People also unwittingly put the health of those around them at risk by failing to treat
`conditions such as coughing and sneezing that readily spread infection, which is particularly
`troublesome given the current COVID-19 pandemic. Egregiously, Homeopathic Products are being
`sold under the auspice of CVS’s licensed pharmacists, one of the most trusted professions in the
`country, giving the products the appearance of scientific legitimacy. And why would CVS and its
`licensed pharmacists sell Homeopathic Products or sugar pills under the guise of effective medicines?
`Because CVS generates twice the profit from the sale of Homeopathic Products than it does on
`approved, regulated over-the-counter (“OTC”) drugs.
`II. JURISDICTION AND VENUE
`This Court has jurisdiction and venue pursuant to Cal. Civ. Proc. Code §§ 395.5 and
`3.
`410.10 over the claims raised in this Complaint for the following reasons: (i) CVS regularly sells,
`advertises, markets and/or distributes Homeopathic Products in Alameda County and throughout the
`State of California; (ii) a substantial portion of the underlying transactions and events complained of
`herein occurred in Alameda County; and (iii) Plaintiff Benton purchased Homeopathic Products from
`CVS in Alameda County.
`Jurisdiction in, and removal to, federal court would be improper. First, there is no
`4.
`Article III jurisdiction in federal court for Plaintiffs’ claim for injunctive relief to enjoin CVS from
`selling Homeopathic Products as Plaintiffs do not allege that they would purchase Homeopathic
`Products at CVS in the future. (See Davidson v. Kimberly-Clark Corp. (9th Cir. 2017). 873 F.3d
`1103, 1116.) Second, there is no federal equity jurisdiction over Plaintiffs’ claims which seek
`equitable relief under California’s Unfair Competition Law as Plaintiffs do not allege they lack
`otherwise adequate remedies at law for a refund of the Homeopathic Products they purchased. (See
`
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`3 A placebo is as a substance that has no therapeutic effect used as a control in testing new drugs. A
`placebo is sometimes given for a psychological benefit (i.e., to calm someone), but has no true
`physiological effect.
`
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`COMPLAINT
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`Sonner v. Premier Nutrition Corp. (9th Cir. 2020) 971 F.3d 834, 844; Guthrie v. Transamerica Life
`Ins. Co. (N.D. Cal. Sep. 23, 2021) --- F.Supp.3d. ---, 2021 WL 4314909.)
`III. THE PARTIES
`Plaintiff Joyce Benton is a citizen of the State of California and a resident of Alameda
`5.
`County, California. In or around January 2021, Ms. Benton purchased Boiron branded
`Oscillococcinum from a CVS pharmacy located within a Target store in Alameda County near her
`home based on it being marketed as a drug effective to treat influenza or flu symptoms, including body
`aches, headache, fever, chills and fatigue. When she purchased the Boiron Oscillococcinum, Ms.
`Benton did not know or understand the principals behind homeopathy. Had the product not been
`labeled as being effective to treat flu symptoms, she would not have purchased the product. Ms.
`Benton does not intend to purchase homeopathic products from CVS in the future.
`Plaintiff Melissa Greco is a citizen of the State of California and a resident of Tulare
`6.
`County, California. In or around December 2019, Ms. Greco, along with her husband Anthony
`Swetala, purchased CVS Health brand Homeopathic Skin Tag Remover from a CVS pharmacy near
`her home based on it being marketed as a drug effective to treat skin tags. When she purchased the
`CVS Health brand Homeopathic Skin Tag Remover, Ms. Greco did not know or understand the
`principals behind homeopathy. Had the skin tag remover not been labeled as being effective to treat
`skin tags, she would not have purchased the product. Ms. Greco does not intend to purchase
`homeopathic products from CVS in the future.
`Plaintiff Anthony Swetala is a citizen of the State of California and a resident of Tulare
`7.
`County, California. In or around December 2019, Mr. Swetala, along with his wife Melissa Greco,
`purchased CVS Health brand Homeopathic Skin Tag Remover from a CVS pharmacy near his home
`based on it being marketed as a drug effective to treat skin tags. When he purchased the CVS Health
`brand Homeopathic Skin Tag Remover, Mr. Swetala did not know or understand the principals behind
`homeopathy. Had the skin tag remover not been labeled as being effective to treat skin tags, he would
`not have purchased the product. Mr. Swetala does not intend to purchase homeopathic products from
`CVS in the future.
`
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`COMPLAINT
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`Plaintiff Ralph Milan is a citizen of the State of California and a resident of Orange
`8.
`County, California. In or around February 2020, Mr. Milan purchased CVS Health brand
`Homeopathic EarAche Ear Drops from a CVS pharmacy near his home based on it being marketed as
`a drug effective to treat earaches. When he purchased the CVS Health brand Homeopathic EarAche
`Ear Drops, Mr. Milan did not know or understand the principals behind homeopathy. Had the EarAche
`Ear Drops not been labeled as being effective to treat earaches, he would not have purchased the
`product. Mr. Milan does not intend to purchase homeopathic products from CVS in the future.
`Defendant CVS Health Corporation is a Delaware corporation with its principal
`9.
`executive offices at One CVS Drive, Woonsocket, Rhode Island. CVS touts itself as being a
`diversified health services company with the purpose of “helping people on their path to better health.”
`CVS Health Corporation is the parent company of CVS Pharmacy, Inc., a retail pharmacy chain that
`sells prescription and OTC drugs, and a variety of general merchandise. CVS has more than 9,900
`retail locations, and California is the state with the greatest number of CVS Pharmacy retail locations
`with over 1,100 in the state. As the parent corporation of CVS Pharmacy, Inc., CVS Health
`Corporation has the ability to stop the sale of Homeopathic Products in its retail stores in California.
`Defendant CVS Pharmacy, Inc. (“CVS Pharmacy”) is a Rhode Island corporation with
`10.
`its principal executive offices at One CVS Drive, Woonsocket, Rhode Island. CVS Pharmacy is a
`subsidiary of CVS Health Corporation and responsible for the CVS retail pharmacies throughout
`California and the United States and registered in California as C2543240. CVS Pharmacy operates
`CVS’s retail pharmacy locations in California, including in Alameda County and in Target stores, and
`throughout the United States. CVS Pharmacy typically sells, among other items, prescription drugs
`and OTC drugs, including the Homeopathic Products at issue in this action directly to consumers.
`
`IV. FACTUAL ALLEGATIONS
`Homeopathy and Homeopathic Principals
`A.
`Homeopathy is an alternative medical practice that has a historical basis in theory first
`11.
`established in the late 1700s. Homeopathy is based on two main principles: (1) that a substance that
`causes symptoms in a healthy person can be used in diluted form to treat symptoms and illness (known
`as “like-cures-like” or the “law of similars”); and (2) the more diluted the substance, the more potent
`4
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`COMPLAINT
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`it is (known as “ultra-dilution” or the “law of infinitesimals”). Proponents of homeopathy claim that
`a significantly diluted aqueous solution, consisting mainly of water molecules, retains therapeutic
`properties due to a “memory” of the substance diluted in it. However, there is no scientific explanation
`or basis for how such “memory” might lead to therapeutic value, when the vast majority of the water
`never touched any of the purported active ingredient. Rather, medical science considers the notion
`that ultra-dilutions can maintain an imprint of substances previously dissolved in them to be
`scientifically implausible. See House of Commons, Science and Technology Committee, Evidence
`Check 2: Homeopathy, Fourth Report, 2009-10, HC 45, ¶ 61 (U.K.).
`Historically, homeopathic drugs have been identified through “provings,” in which
`12.
`substances are administered to healthy volunteers in concentrations that provoke overt symptoms.
`Symptoms experienced by volunteers are recorded to indicate possible therapeutic uses for the
`substances. In other words, if a substance elicits a particular symptom, individuals experiencing that
`symptom would be treated with a more diluted solution made from that substance. However, these
`“provings” are not valid clinical trials which could show that the diluted substance treats any condition
`or symptoms of the condition that the less-diluted substance caused.
`Understanding the principals of homeopathic dilutions is the key to understanding why
`13.
`homeopathic products do not and cannot have a drug-like physiological effect. In producing these
`remedies, homeopaths use a process called “ultra-dilution” whereby a substance is diluted with alcohol
`or, more commonly, distilled water. Homeopaths believe that the most potent remedies are those that
`have been potentized to the point where no ‘active’ molecule is left. Defendants use the decimal scale
`to describe the dilution ratio of its “active ingredients.” The standard homeopathic preparation is
`labeled by the “centesimal,” or “C.” For every 1C, the substance is diluted by a factor of 100. For a
`2C preparation, the substance would, for example, first be diluted in 100 liters of water, and 1 liter of
`that sample would be placed in another 99 liters of water to make the second dilution. In other words,
`a 2C preparation is a 1/10,000 dilution of the purportedly “active” substance.4
`
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`4 Additionally, under homeopathic theory, following each dilution, homeopathic remedies are then
`vigorously shaken by ten hard strikes against an elastic body, in a process which homeopaths term
`“succession” or “succussion.” Each dilution followed by succession is assumed to increase the
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`COMPLAINT
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`However, any claim that decreasing the concentration of a drug increases its
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`therapeutic activity is diametrically in opposition to the scientifically proven dose-response principle
`of pharmacology. Because of the logarithmic nature of the dilution of homeopathic “active”
`ingredients, homeopathic products act, at best, as a placebo because none of the original “active”
`ingredient is detectable in the final drug preparation.
`
`New Drug Laws and Historic Regulation of Homeopathic Drugs
`B.
`There is no uniform licensing or professional standards for the practice of homeopathy
`15.
`in the United States. Homeopathic Products,5 however, are regulated by the FDCA, 21 U.S..C §§ 301,
`et seq. and in California by the Sherman Law, Cal. Health & Safety Code § 109875, et seq.6
`16. When the FDCA was passed in 1938, homeopathic products were specifically included
`within the definition of “drugs” subject to regulation thereunder. Specifically, the Act defined a “drug”
`as including “(1) articles recognized in the official United States Pharmacopeia, official Homeopathic
`Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them;
`and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
`in man or other animals; and (3) articles (other than food) intended to affect the structure or any
`function of the body of man or other animals; and (4) articles intended for uses as a component of any
`article specified in clause (1), (2), or (3).”7
`The term “intended use” for determining if a product is a drug can be shown by a
`17.
`person’s expressions, the design or composition of a product, by the circumstances surrounding the
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`effectiveness of the remedy. Homeopaths call this process of ultra-dilution and succussion
`“potentization.”
`
`5 As used throughout this Complaint, Homeopathic Products are those products labeled as being
`homeopathic, and also labeled as drugs to diagnose, cure, mitigate, treat or prevent any disease or to
`affect the structure or any function of the body. Any homeopathic preparation not also labeled as a
`drug to diagnose, cure, mitigate, treat or prevent any disease or to affect the structure or any function
`of the body is not intended to be included in this Complaint, and Plaintiffs do not seek to enjoin CVS
`from selling any such product.
`
`6 The Sherman Law incorporates FDA regulations for new drugs and nonprescription drugs as the
`regulations of California. Sherman Law § 110110.
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`7 Sherman Law § 109925 (same); Cal. Bus. & Prof. Code § 4025 (same).
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`COMPLAINT
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`distribution of the product, and any other relevant source. This includes label claims, advertising
`materials, oral or written statements by persons or their representatives about the product.8
`18. When the Act was passed in 1938, its primary focus was on drug safety and not on drug
`efficacy.9 By recognizing homeopathic products as drugs in 1938, Congress recognized their apparent
`safety (due to their extreme dilutions) and that they met certain quality standards for the time, but not
`that homeopathic preparations were in any way effective since at that time the FDCA did not regulate
`efficacy.10
`In 1962, after recognizing the catastrophic consequences of thalidomide use on unborn
`19.
`children, Congress passed the Kefauver-Harris Drug Amendments to the FDCA requiring drug
`manufacturers to prove not only that their products were safe, but also provide substantial evidence of
`effectiveness for the product’s intended use prior to marketing.11
`The FDCA now defines a “new drug” as (1) “[a]ny drug …the composition of which
`20.
`is such that such drug is not generally recognized, among experts qualified by scientific training and
`experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the
`condition prescribed, recommended, or suggested in the labeling thereof,” or (2) “[a]ny drug … the
`composition of which is such that such drug, as a result of investigations to determine its safety and
`effectiveness for use under such conditions, has become so recognized, but which has not, otherwise
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`8 21 C.F.R. § 201.128.
`
`
`
`9
`https://www.fda.gov/about-fda/histories-product-regulation/promoting-safe-effective-drugs-100-
`years.
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`10 The reason that homeopathic products are identified as drugs in the original FDCA is because one
`of the Senators drafting the bill, Royal Copeland, was at the time a homeopathic practitioner and
`wanted to protect the products’ legitimacy as true pharmacology was on the rise. See Amy Gaither,
`“Over the Counter, Under the Radar: How the Zicam Incident Came About Under FDA’s Historic
`Homeopathic Exception,” American Bar Association, Administrative Law Review; 62:2 (2010), pp.
`487-522.
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`11 https://www.fda.gov/about-fda/histories-product-regulation/promoting-safe-effective-drugs-100-
`years.
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`COMPLAINT
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`than in such investigations, been used to a material extent or for a material time under such conditions.”
`21 U.S.C. § 321(p).12
`The FDCA prohibits the introduction or delivery of any new drug in interstate
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`commerce and allows drug manufacturers to submit proof of safety and efficacy of any new drug to
`the FDA for review and, if appropriate, approval to be sold in the United States. 21 U.S.C. § 355.13
`A nonprescription (i.e., OTC) drug is misbranded if it has not been approved by FDA
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`as being safe and effective, or if it does not comply with any of the previously approved monographs
`for OTC drugs. 21 U.S.C. § 352(ee).14 An OTC monograph is a rule book for each therapeutic
`category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and
`testing, under which an OTC drug is generally recognized as safe and effective (“GRAS/E”) and can
`be marketed without a new drug application (“NDA”) and FDA pre-market approval.
`Scientific proof of safety and efficacy must be submitted to, accepted by, and approved
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`by the FDA before a product can be marketed as a drug. 21 U.S.C. § 355.15
`The FDCA prohibits receiving and selling misbranded drugs. 21 U.S.C. § 331(c).16
`24.
`25.
`In addition to incorporating the FDCA’s prohibition from possessing or selling any
`misbranded drug, California’s Sherman Law prohibits advertising any drug represented to have any
`effect in certain conditions, disorders or diseases unless approved by FDA through an NDA, an
`abbreviated new drug application (“ANDA”) or by virtue of following an established OTC
`
`12 Sherman Law § 109980 (same).
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`13 Sherman Law § 110110 (requiring approval of any new drug); § 111550 (prohibiting the sale,
`delivery or gifting any new drug in California unless approved by FDA or California’s Department of
`Health Services).
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`14 Sherman Law § 110111 (adopting all nonprescription drug regulations enacted pursuant to the
`FDCA as the regulations of California); Cal Bus & Prof. Code § 4025.1 (requiring nonprescription
`drugs to be labeled in accordance with the requirements of the laws and rules of California and the
`federal government).
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`15 Sherman Law § 110550(b) (requiring scientific proof of safety and efficacy for approval by the
`DHS).
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`16 Sherman Law §§ 111440 (same for selling and offering to sell misbranded drugs) and 111450 (same
`for receiving misbranded drugs).
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`COMPLAINT
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`monograph.17 This prohibition is not limited to just serious diseases such as cancer, diabetes and
`AIDS, it also includes common conditions affecting the ears, eyes and skin. Moreover, the prohibition
`is broad, encompassing a product’s packaging in addition to written and radio advertisements about a
`product.18
`Even though articles recognized in the official Homeopathic Pharmacopeia of the
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`United States are included within the definition of drugs in the FDCA, they are still subject to the same
`regulatory requirements as allopathic (i.e., non-homeopathic or science-based) drugs.19 In other
`words, any homeopathic product that is intended for use in the diagnosis, cure, mitigation, treatment,
`or prevention of disease or to affect the structure or any function of the body in man or other animals
`must comply with FDCA’s requirement to be proven safe and effective prior to being sold to
`consumers.20 Nothing in the FDCA or California’s Sherman Law exempts Homeopathic Products
`from any of the requirements related to approval, adulteration, or misbranding, including labeling
`requirements when they are labeled as drugs.
`Despite the requirement that Homeopathic Products go through the pre-approval
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`process to be labeled as drugs, no homeopathic product has been approved by FDA or California’s
`DHS as being safe and effective to diagnosis, cure, mitigate, treat, or prevent any disease or to affect
`the structure or any function of the body in man or animal. In fact, no Homeopathic Product
`manufacturer has even sought approval through the NDA or ANDA process; no Homeopathic Product
`sold today complies with any OTC drug monograph; and no Homeopathic Drug manufacturer has
`sought GRAS/E status of any Homeopathic Product.
`
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`17 Sherman Law §§ 110403; 110405(b).
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`18 Sherman Law § 10988.
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`19 https://www.fda.gov/drugs/information-drug-class/homeopathic-products (“Under the [FDCA],
`homeopathic products are subject to the same requirements related to approval, adulteration and
`misbranding as other drug products. There are currently no homeopathic products approved by FDA.”)
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`20 Sherman Law § 111550(b) (requiring scientific proof of safety and efficacy for approval by the
`DHS).
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`COMPLAINT
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`Accordingly, any homeopathic product labeled as a drug to diagnose, cure, mitigate,
`28.
`treat, or prevent any disease or to affect the structure or any function of the body – including the use
`of “Drug Facts” that identify a purpose or use of a homeopathic ingredient to treat disease or affect
`the structure or any function of the body – is a new drug which may not be possessed or sold until
`approved by the FDA or, alternatively in California, by California’s DHS.
`Unlike Homeopathic Products intended to diagnosis, cure, mitigate, treat, or prevent
`29.
`any disease or to affect the structure or any function of the body in man or animal which are unlawful
`new drugs, homeopathic preparations that are not labeled or advertised as drugs to diagnosis, cure,
`mitigate, treat, or prevent any disease or to affect the structure or any function of the body in man or
`animal would not be a new drug, and could be labeled and sold as what they are (e.g., diluted
`oscillococcinum) without violating the FDCA or the Sherman Law.
`The FDCA provides an exception for certain historically marketed products from the
`30.
`definition of a new drug, which may continue to be marketed as drugs without FDA approval.21 To
`meet this exception, all the product’s active and inactive ingredients, as well as its labeling, must have
`remained unchanged since June 25, 1938.
`31. When Congress amended the FDCA to require that drug manufacturers prove that
`drugs are also effective on October 10, 1962, an exemption was given for drug products that 1) were
`commercially used or sold in the United States preceding October 9, 1962; 2) was not a new drug as
`defined in the 1938 Act; 3) was not covered by an approved NDA under the 1938 Act; and 4) “when
`intended solely for use, under conditions prescribed, recommended, or suggested in the labeling with
`respect to such drug.”22
`According to FDA, few, if any, currently marketed drugs fit within either of these
`32.
`exemptions.23 Also according to FDA, “[t]he two grandfather clauses in the [FDCA] have been
`
`21 21 U.S.C. § 321(p)(1).
`
`
`
`22 Pub. L. 87-781, sec. 107(c)(4), 76 Stat. 788, note following 21 U.S.C. 321.
`
`23 FDA Compliance Policy Guide 440-100, Marketed new drugs Without Approved NDAs and
`ANDAs.
`
`
`COMPLAINT
`
`10
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`

`

`Case 3:22-cv-01640-JSC Document 1-1 Filed 03/15/22 Page 13 of 48
`
`
`
`construed very narrowly by the courts. FDA believes that there are very few drugs on the market that
`are actually entitled to grandfather status because the drugs currently on the market likely differ from
`the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of
`administration, indications, or intended patient population.”24
`No Homeopathic Product currently sold by CVS in California (or elsewhere) meets the
`33.
`1938 exemption because no Homeopathic Product manufactured and sold today has maintained the
`same active and inactive ingredients and labeling since June 25, 1938. Similarly, no Homeopathic
`Product sold by CVS meets the 1962 exemption because no Homeopathic Product sold today was sold
`in the United States with the same active and inactive ingredients and labeling since October 9, 1962.
`In 1972, FDA initiated rulemaking procedures for OTC drugs to determine which drugs
`34.
`being sold at the time were GRAS/E and not misbranded. At that time, homeopathy held an extremely
`small segment of the OTC market and given the unique nature of the products FDA did not include
`them in its review. To date, FDA has not reviewed any homeopathic product to determine if it is
`GRAS/E for the labeled use.
`There are no FDA-approved OTC monographs for drugs labeled as homeopathic.
`35.
`36.
`FDA previously exercised its enforcement discretion concerning OTC homeopathic
`products labeled as drugs intended solely for self-limiting, non-chronic conditions amenable to self-
`diagnosis and treatment, but that enforcement discretion was withdrawn by the FDA in October 2019,
`so it is no longer applicable. See former Compliance Guide 400.400 (hereinafter the “Withdrawn
`Enforcement Discretion”). The Withdrawn Enforcement Discretion limited FDA enforcement actions
`to homeopathic products that were harmful, improperly labeled or manufactured in violation of good
`manufacturing practices.
`As it was just a notice of enforcement discretion, the Withdrawn Enforcement
`37.
`Discretion had no force of law and could not make Homeopathic Products “legal” to possess or sell
`under the FDCA, which requires prior FDA approval based on a showing of safety and efficacy before
`then can be lawfully sold in the United States. In fact, FDA and multiple courts have recognized that
`
`
`
`24 Id., p. 9.
`
`
`COMPLAINT
`
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`Case 3:22-cv-01640-JSC Document 1-1 Filed 03/15/22 Page 14 of 48
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`FDA does not have the authority to exempt a product or class of products that are new drugs under the
`FDCA from the new drug approval requirements. While not legal under the FDCA, FDA intended
`the Withdrawn Enforcement Discretion to provide the conditions under which Homeopathic Products
`could be marketed without FDA initiating any enforcement action regarding the product, but again
`that all ended in October 2019.
`At the time FDA announced its Withdrawn Enforcement Discretion in 1988, the
`38.
`homeopathic industry was still an extremely small segment of the OTC drug marketplace. However,
`after FDA issued its Withdrawn Enforcement Discretion, the homeopathic industry ballooned. The
`National Health Interview Survey, conducted by the Centers for Disease Control and Prevention’s
`National Center for Health Statistics, estimated that in 2007 adults spent about $2.9 billion on
`Homeopathic Products. This was due, in part, to their newly-used sales channels in national retail
`pharmacies such as CVS, Walgreens and Rite Aid, in big-box stores such as WalMart and Target, and
`in regional supermarkets such as Safeway. As recently as 2016, over 85% of sales of Homeopathic
`Products were in conventional stores including WalMart, CVS and Rite Aid.25 A 2019 survey
`estimated that the global market for homeopathic products would grow to $4.5 billion by 2024, and
`credited the sale of purported natural self-help OTC products to making “Homeopathic products at
`retail [] one of the biggest success stories of a niche category going mainstream.”26
`
`FDA Withdrew its Enforcement Discretion over Homeopathic Products
`C.
`In March of 2015, Australia’s National Health and Medical Research Counsel, the
`39.
`country’s top body for health and medical research, published results of a meta-analysis of over 1,800
`studies of the efficacy of various homeopathic products. ANHMR’s study concluded that there are no
`health conditions for which there is reliable evidence that homeopathy is effective.27
`
`
`25 https://drugstorenews.com/otc/consumer-use-natural-otcs-increases.
`
`26 https://drugstorenews.com/dsn-am/homeopath-to-success-homeopathic-products-go-mainstream.
`
`27
`htt

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