Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 1 of 48
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
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`THE CITY OF NEW YORK,
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` Plaintiff,
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`-against-
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` Civil Action No. __
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` COMPLAINT
`MAGELLAN TECHNOLOGY, INC., ECTO WORLD,
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`LLC, d/b/a Demand Vape, MATTHEW J. GLAUSER,
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`DONALD HASHAGEN, RUSSELL ROGERS, MAHANT
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`KRUPA 56 LLC d/b/a Empire Vape Distributors, NIKUNJ
`PATEL, DEVANG KOYA, STAR VAPE CORP., and
`NABIL HASSEN,
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`Defendants.
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`Plaintiff the City of New York by its counsel, Hon. Sylvia O. Hinds-Radix,
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`Corporation Counsel of the City of New York, respectfully alleges with knowledge of its own
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`actions and on information and belief as to the actions of others, as follows:
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`Nature of the Action
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`1.
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`New York City (the “City”) seeks injunctive and other equitable relief, damages
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`and penalties for the defendants’ distribution and sale of flavored electronic nicotine delivery
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`devices, also known as “e-cigarettes.”1 The defendants violate nearly every federal, New York
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`1 The term “electronic nicotine delivery system,” often abbreviated as “ENDS,” refers to a variety of devices – “vapes,”
`“vaporizers,” “vape pens,” “hookah pens,” “electronic cigarettes” “e-cigars,” and “e-pipes” among others, that contain
`solutions containing nicotine (“e-liquids”) for delivery of nicotine-containing aerosols to the user or “vaper.”
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`Electronic nicotine delivery devices can be manufactured to resemble conventional cigarettes, cigars, or pipes, pens
`or even USB flash drives, but many devices bear little or no resemblance to traditional cigarettes. The devices may
`be re-fillable when the e-liquid is depleted or may be disposable, discarded after the e-liquid is consumed. The devices
`vary in the volume of the e-liquid they contain and are advertised and priced according to the approximate number of
`“puffs” the device provides.
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 2 of 48
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`State and New York City law applicable to the marketing, distribution, and sale of flavored e-
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`cigarettes, the sales of which are prohibited under laws enacted by all three jurisdictions.
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`2.
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`Flavored disposable vaping devices (“FDVs”) are one type of “electronic nicotine
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`delivery device,” or “e-cigarette” that use a battery to heat a nicotine-containing solution (an “e-
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`liquid”) to create an aerosol inhaled by the user as a substitute for the combustion-generated
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`tobacco smoke of a conventional cigarette. E-liquids in their simplest formulation are mixtures of
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`natural or most often synthetic nicotine dissolved in propylene glycol and vegetable glycerin. E-
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`liquids can be formulated to produce a vapor tasting like tobacco but the vast majority, and those
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`at issue here, are artificially flavored to impart to the inhaled aerosol exotic or evocative tastes of
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`fruits, candy or desserts.
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`3.
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`Although this action speaks principally about FDVs, the favorite type of electronic
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`nicotine delivery system among youth and the most intentionally directed to that market, the City
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`seeks relief for defendants’ violation of laws applicable to e-cigarettes regardless of the type of
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`device with which the violation is committed. Any non-FDA approved e-cigarette containing a
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`flavored e-liquid is governed by the laws under which the City’s claims are brought and the City
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`seeks relief with respect to all such devices.
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`4.
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`Nicotine known to be a highly addictive substance with the ability comparable to
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`heroin or cocaine to addict users.2 Nicotine is the principal driver of addiction to conventional
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`cigarettes. Most e-liquids provide nicotine levels far exceeding that of conventional cigarettes
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`with more than 90% of disposable e-cigarettes sold between 2017-2022 in the United States
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`2 See e.g., U.S. Dep’t of Health and Human Servs., The Health Consequences of Nicotine Addiction: A Report of the
`Surgeon General, DHHS Publication Number (CDC) 88-8406 (1988)( https://profiles.nlm.nih.gov/101584932X423).
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 3 of 48
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`containing nicotine concentrations of 5% or higher, at least 2.5 times the maximum allowed in
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`Canada, the United Kingdom and the European Union.3
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`5.
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`Youth, i.e., those up to approximately 25 years of age, are particularly vulnerable
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`to nicotine addiction, which can harm the developing adolescent brain. The United States Surgeon
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`General has branded “[t]obacco use [a]s a pediatric epidemic.” Nine out of ten smokers begin by
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`age 18, and eighty per cent who begin as teens will smoke into adulthood,4 compelling the Surgeon
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`General to warn that the “epidemic of youth e-cigarette use” may condemn a generation to “a
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`lifetime of nicotine addiction and associated health risks.”5
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`6.
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`By distributing devices that provide larger than normal doses of nicotine in a mild
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`aerosol formulated to reduce or eliminate the harshness of burning tobacco and tasting pleasantly
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`of fruit, candy or desserts, FDV manufacturers and distributors have triggered the largest increases
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`in youth nicotine use ever seen.6
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`7.
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`The major manufacturers of FDVs and the e-liquids with which they are filled are
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`principally located in China: Shenzhen Weiboli Technology Co. Ltd, manufacturer of the best-
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`selling “Elf Bar,” 6099 Baoan Avenue, Baoan District, Shenzhen 518000 Guangdong, China;
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`Shenzhen Daosen Vaping Technology Co., Ltd., manufacturer of the “Puff Bar,” located at 10th
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`Floor Junfeng Business Bldg., B5-1 Bldg., Fuyong Chongqing Rd., Shenzhen, China; and
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`Shenzhen IVPS Technology Co., Ltd., manufacturer of the best-selling “Hyde” brand of FDVs
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`3 Ali, et al, Trends in US E-cigarette Sales and Prices by Nicotine Strength, Overall and by Product and Flavor Type,
`2017–2022, Nicotine & Tobacco Research, Volume 25, Issue 5, May 2023, Pages 1052–
`1056, https://doi.org/10.1093/ntr/ntac284
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`4Preventing Tobacco Use Among Youth and Adults, A Report of the Surgeon General at 1 (2012), https://www
`hhs.gov/surgeongeneral/reports-and-publications/tobacco/index.html.
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`Among
`Use
`E-cigarette
`on
`Advisory
`General’s
`5Surgeon
`https://www.cdc.gov/tobacco/basic_information/e-cigarettes/surgeon-general-advisory
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`Youth,
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`available
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`at
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`6 Id.
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 4 of 48
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`distributed by all of the present defendants, 101 Building B8, No. 2, Cengyao, Industrial Area,
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`Yulv Community, Yutang Subdistrict, Guangming District, Shenzhen, China.
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`8.
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`The China-based manufacturers sell and ship their products directly or through
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`middlemen to “master distributors” or sub-distributors in the United States. The defendants on
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`information and belief import FDVs manufactured in China (and elsewhere) and distribute them
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`to retail stores that in turn sell FDVs to the public. Some distributors, for example defendant
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`Magellan Technology, Inc., sell directly to the public from brick-and-mortar locations and/or
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`Internet websites.
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`PACT Act Violations
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`9.
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`FDVs are “cigarettes” within the meaning of the federal Prevent All Cigarette
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`Trafficking (“PACT”) Act, 15 U.S.C. § 375 et seq. FDVs, like all e-cigarettes, are regulated
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`identically to conventional cigarettes, subject to the PACT Act’s detailed conditions imposed on
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`remote sales known as “delivery sales.” A delivery sale is any sale or delivery of an FDV to a
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`“consumer” in which buyer and seller are not in one another’s physical presence either upon
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`ordering or receiving the product. A “consumer” includes any person, corporation, company,
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`association, firm or partnership purchasing cigarettes that is not lawfully operating a tobacco
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`business.
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`10.
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`All or nearly all of the defendants’ sales and deliveries are delivery sales to
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`consumers as defined in the PACT Act: No person to whom the defendants sell and deliver FDVs
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`is “lawfully operating a tobacco business” because, inter alia, defendants distribute vape product
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`to retailers that violate all or virtually all federal, New York State and New York City laws
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`regulating e-cigarette sales.
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 5 of 48
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`Racketeering Violations
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`11.
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`Defendants conceal and conspire to conceal from federal, New York State and City
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`authorities their FDV sales by failing, as required by the PACT Act; i) to register as delivery sellers
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`with federal, state and City authorities as required by the PACT Act; ii) to report to federal, New
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`York State and City authorities the details of each delivery sale they make into the State and City,;
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`and iii) to identify their packages of FDVs as containing “cigarettes,” or as “vapor products” as
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`required under New York State law.
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`12.
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`Defendants thereby use or conspire to use the mails or wires to obtain money or
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`property through false or fraudulent pretenses, in violation of the mail and wire fraud statutes, 18
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`U.S.C. §§ 1341 and 1343. That conduct constitutes “racketeering activity” when undertaken with
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`sufficient frequency by members of an “enterprise.” That racketeering activity injures the City in
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`its business or property, inter alia, in the form of damages incurred by the required disposal of
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`defendants’ products as hazardous waste, thereby constituting a violation of 18 U.S.C §§ 1961,
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`1962(c), 1962(d), the Racketeering Influenced Corrupt Organizations (“RICO”) Act.
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`New York State and City Law
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`13.
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`“Flavored” vape products are products that have a taste or aroma other than that
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`of tobacco and intended or reasonably expected to be used with or for consuming nicotine. See
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`New York Public Health Law § 1399-mm-(1) (“PHL §1399-mm-(1)”).
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`14.
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`PHL §1399-mm-(1) prohibits dealers in vapor products from selling or offering
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`for sale at retail in New York any flavored vapor product to be used in connection with the
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`consumption of nicotine. New York City Administrative Code § 17-715 (b) (“Ad. Code § 17-715
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 6 of 48
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`(b)”) prohibits any person in the City from selling, offering for sale, or possessing with intent to
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`sell or offer for sale, any flavored electronic cigarette or flavored e-liquid.7
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`15.
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`New York Public Health Law § 1399-ll (“PHL §1399-ll”), with exceptions not
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`relevant here, prohibits shipments of electronic vapor products except to licensed tobacco dealers
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`holding a certificate of registration as a vapor products dealer under article twenty-eight-C of the
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`tax law (a “Vape Certificate”).
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`16.
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`The defendants offer for sale and sell, possess with intent to offer for sale or with
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`intent to sell FDVs that they ship to persons in New York City who are not permitted to receive
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`vapor product shipments.
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`Public Nuisance
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`17.
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`The defendants sell or offer at retail flavored vapor products in New York City, and
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`that conduct violates the PACT Act, the RICO statute, PHL § 1399-mm-(1), PHL § 1399-ll, and
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`Ad. Code § 17-715 (b).
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`18.
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`The sale of flavored vapor products by the defendants endangers the health and
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`safety of a large number of persons in New York City and thereby constitutes a public nuisance.
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`Relief
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`19.
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`The violations of the law described above entitle the City to an order (i) enjoining
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`the defendants from making delivery sales of FDVs into or in New York City in violation of the
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`PACT Act, PHL 1399-ll, PHL 1399-mm-(1) and the NYC Ad. Code § 17-715(b); (ii) awarding
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`the City treble damages under the RICO statute in an amount to be determined at trial, and
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`attorneys’ fees; (iii) awarding the City the civil penalties provided under the PACT Act and PHL
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`7 Both statutes permit the sale of tobacco flavored e-liquids.
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 7 of 48
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`§ 1399-ll, and (iv) requiring the defendants to establish a fund to abate the public nuisance caused
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`by their conduct.
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`Jurisdiction and Venue
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`20.
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` The Court has jurisdiction over the subject matter of this action pursuant to 15
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`U.S.C. § 378, 18 U.S.C. § 1961 et seq., 28 U.S.C. § 1331, and 28 U.S.C. § 1367(a).
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`21.
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`Venue is proper in this district under 28 U.S.C. § 1391(b), because a substantial
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`part of the events and omissions giving rise to the claims occurred in this district.
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`22.
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`The City is a municipal corporation organized under the laws of the State of New
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`Parties
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`York.
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`23. Magellan Technology Inc. (“Magellan”) is a corporation formed under the laws of
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`the State of Virginia with a principal place of business at 2225 Kenmore Avenue, Buffalo, NY
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`14207. Magellan sells electronic nicotine delivery devices, including Hyde-branded FDVs and
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`flavored e-liquids, to the public at retail and at wholesale in New York State and elsewhere and/or
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`owns or controls other businesses that do so. Magellan sells FDVs to the public, inter alia, from
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`the Internet website https://www. hydevapeofficial.com.
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`24.
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`Ecto World, LLC d/b/a/ Demand Vape (“Demand Vape”) is a corporation formed
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`under the laws of the State of Virginia with a principal place of business at 2225 Kenmore Avenue,
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`Buffalo, NY 14207. Demand Vape sells electronic nicotine delivery devices, including FDVs and
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`flavored e-liquids, to the public at retail and at wholesale in New York State and elsewhere and/or
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`owns or controls other businesses that do so. Demand Vape sells FDVs to the public, inter alia,
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`from the Internet website https://www.demandvape.com.
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 8 of 48
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`25. Mathew J. Glauser is the president of Magellan Technology Inc. and the president,
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`founder and chief strategy officer of Demand Vape. Glauser is a citizen of the State of New York
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`with a business address at 2225 Kenmore Avenue, Buffalo, NY 14207.
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`26.
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`Donald Hashagen, is a vice president of Magellan Technology Inc. and is a citizen
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`of the State of Virginia with a business address of 5604 Charles City Circle, Henrico, VA 23231.
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`27.
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`Russell Rogers is a vice president of Magellan Technology Inc. and is a citizen of
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`the State of Virginia with a business address of 4551 Macon Farms Dr., Powhatan, VA 23139.
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`28. Mahant Krupa 56 LLC is a limited liability company formed under the laws of the
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`State of New York doing business as Empire Vape Distributors (“Empire Vape”) with a principal
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`place of business located at 56-01 Maspeth Avenue, Maspeth, Queens 11378. Empire Vape sells
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`electronic nicotine delivery devices, including FDVs and flavored e-liquids at retail and at
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`wholesale to the public at retail and at wholesale in New York State and elsewhere and/or owns or
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`controls other businesses that do so. Empire Vape sells FDVs to the public, inter alia, from the
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`Internet website https://empiresmokedist.com.
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`29.
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`Nikunj Patel is a principal of Mahant Krupa 56 and a citizen of the State of New
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`York with a business address of 56-01 Maspeth Avenue, Maspeth, Queens 11378.
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`30.
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`Devang Koya is a principal of Mahant Krupa 56 and a citizen of the State of New
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`York with a business address of 56-01 Maspeth Avenue, Maspeth, Queens 11378.
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`31.
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` Star Vape Corp. (“Star Vape”) is a corporation formed under the laws of the State
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`of New York with principal places of business at 416 4th Avenue, Brooklyn, New York, and 283
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`67th Street Brooklyn, New York, 11220. Star Vape sells electronic nicotine delivery devices,
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`including FDVs and flavored e-liquids at retail and at wholesale to the public throughout New
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 9 of 48
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`York and elsewhere and/or owns or controls other businesses that do so. Star Vape sells FDVs to
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`the public, inter alia, from the Internet website https://www.starvapecorp.com.
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`32.
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`Nabil Hassen is the Chief Executive Officer of Star Vape and a citizen of the State
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`of New York with a business address of 416 4th Avenue, Brooklyn, New York.
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`Background
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`FDVs and the Tobacco Control Act
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`33.
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`The most popular electronic nicotine delivery system among young people8 is the
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`FDV device, a battery-powered metal heating coil immersed in a plastic tank filled with a liquid
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`usually containing nicotine – among the most addictive substance used by humans. As with
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`electronic nicotine delivery systems generally, suction on the device switches on the battery, which
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`heats the liquid to produce a nicotine-laced aerosol inhaled by the user.
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`34.
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`Pursuant to the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C.
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`§§ 387, et seq. (“Tobacco Control Act”), the FDA in 2016 adopted the “Deeming Rule,” 21 C.F.R.
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`§ 1143.1, which subjects electronic cigarettes to the Tobacco Control Act and to the FDA’s
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`authority. Electronic cigarettes are accordingly regulated by the FDA as “tobacco products” under
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`the Tobacco Control Act because they “contain[] nicotine from any source” and are “intended for
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`human consumption.” 21 U.S.C. § 321(rr)(1).
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`35.
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`The Tobacco Control Act requires manufacturers of tobacco products to obtain
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`authorization from the FDA before any “new” tobacco product – a tobacco product not on the
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`market as of February 15, 2007 – can be sold in the United States. No FDV product is known to
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`have been commercially marketed in the United States as of February 15, 2007, and FDVs are
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`8 Cooper M, Park-Lee E, Ren C, Cornelius M, Jamal A, Cullen KA. Notes from the Field: E-cigarette Use Among
`Middle and High School Students — United States, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1283–1285.
`DOI: http://dx.doi.org/10.15585/mmwr.mm7140a3.
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`accordingly all “new” tobacco products that must have “premarket review” by the FDA to obtain
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`the “premarket authorization” that allows the device to be sold in the United States. See 21 U.S.C.
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`§ 387j(a)(1)-(2). A new tobacco product without premarket authorization is an “adulterated
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`product,” 21 U.S.C. § 387(b) prohibited by the Tobacco Control Act from “introduction or
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`delivery for introduction into interstate commerce. . .” 21 U.S.C. 331(a). The marketing and sale
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`of any FDV without premarket authorization is a per se violation of 21 U.S.C. § 331(a). An FDV
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`without premarket approval is also “contraband per se,” i.e., an item having no legal use and
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`subject to seizure by law enforcement.
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`36.
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`The Tobacco Control Act requires premarket authorization of a new tobacco
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`product to be denied unless the FDA finds that marketing the product is “appropriate for the
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`protection of the public health.” 21 U.S.C. § 387j(c)(2), (4). Consistent with congressional
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`findings that tobacco use by youth “is a pediatric disease of considerable proportions,” Tobacco
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`Control Act § 2(1), 123 Stat. at 1777, an applicant for premarket authorization of an FDV must
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`show a net benefit to the public health by comparing the risk of youth initiation against the
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`product’s ability to reduce or end adult use of combustible tobacco.
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`37.
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`The FDA has to date authorized only tobacco-flavored and unflavored electronic
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`nicotine delivery devices under the “net benefit” standard.9 E-cigarettes, especially those with
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`flavored e-liquids, present so substantial a risk of youth initiation that the FDA requires strong
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`proof of a marked reduction in adult combustible tobacco use to meet the net benefit standard.
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`38.
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`To date, no FDV has met the standard and the FDA has not authorized the
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`marketing of any FDV (other than tobacco-flavored) and has denied dozens of applications for
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`9 See https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-
`marketing-granted-orders (“To date, the FDA has authorized marketing of 45 products, including 23 tobacco-flavored
`e-cigarette products and devices.”) (last visited June 30, 2023)
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`failure to prove the device meets the “net benefit” standard. All FDVs are thus now marketed
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`unlawfully.
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`FDV Use By Young Persons
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`39.
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` The primary driving force of the vaping epidemic among young people is “youth
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`appeal and youth access to flavored tobacco products.”10 The long-standing yearly decline in youth
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`smoking underwent a dramatic reversal when in 2018, it was found that more than one in four U.S.
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`high school students reported use of a tobacco product in the past thirty days.
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`40.
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`In December 28, 2018, the National Adolescent Drug Trends Report issued by the
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`University of Michigan reported that increases in adolescent e-cigarette use from 2017 to 2018
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`were the “largest ever recorded in the past 43 years for any adolescent substance use outcome in
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`the U.S.”11 The percentage of 12th grade students reporting nicotine use nearly doubled between
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`2017 and 2018, a 78% surge in the number of youth using electronic nicotine delivery devices that
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`was “twice as large as the previous record for the largest-ever increase among 12th graders.”12 E-
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`cigarette use by middle school students surged by 48%.
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`41.
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`By 2018, approximately 3.6 million middle and high school students used e-
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`cigarettes regularly, with approximately 20% of 12th graders reporting e-cigarette use in the 30-
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`10 Id.; “[FDVs] have rapidly become popular—especially among young people, who have overwhelmingly adopted
`flavored [FDVs] products as their tobacco products of choice.” Magellan Tech., Inc. v. United States FDA, No. 21-
`2426, 2023 U.S. App. LEXIS 15016, at *3 (2d Cir. June 16, 2023).
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`11 National Adolescent Drug Trends in 2018, Univ. of Mich. Inst. for Social Research (Dec. 17, 2018),
`http://monitoringthefuture.org/pressreleases/18drugpr.pdf.
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`12 News Release, Teens Using Vaping Devices in Record Numbers, Nat’l Insts. of Health (Dec. 17, 2018)
`https://www nih.gov/news-events/news-releases/teens-using-vaping-devices-record-numbers.
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`day sample period.13, 14 By late 2019, 5 million students reported active use of electronic nicotine
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`delivery devices, with 27.5% of high school students and 10.5% of middle school students having
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`used the devices within the thirty-day sample period.15
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`42.
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`By 2020, the FDA determined that two of the largest 2019 surveys of youth tobacco
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`use found e-cigarette use to have reached the highest levels ever recorded,16 and that youth
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`consumption of e-cigarettes had doubled among middle and high school students.17 In 2019, the
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`total number of middle and high school students reporting current use of e-cigarettes surpassed
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`five million for the first time in history.18
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`43.
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`Consistent with the national trend, youth e-cigarette consumption rates in New
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`York City school remain higher than rates of combustible tobacco use. In 2021, 11% of NYC
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`public high school students reported using an e-cigarette in the past month, while only 3% reported
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`smoking cigarettes. In 2018, 6.7% of public middle school students surveyed reported they were
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`current users of electronic vapor products, while only 0.9% reported currently smoking
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`cigarettes.19
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`13 See Jan Hoffman, Addicted to Vaped Nicotine, Teenagers Have No Clear Path to Quitting, N.Y. Times (Dec. 18,
`2018), https://www.nytimes.com/2018/12/18/health/vaping-nicotine-teenagers.html.
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`14 Id.
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`15 National Youth Tobacco Survey, U.S. FDA (2019), https://www.fda.gov/tobacco-products/youth-andtobacco/
`youth-tobacco-use-results-national-youth-tobacco-survey; Karen Cullen et al., e-Cigarette Use Among
`Youth in the United States, 2019, 322 JAMA 2095 (2019).
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`16 Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the
`Market Without Premarket Authorization, U.S. FDA (Jan. 2020), https://www.fda.gov/media/133880/download.
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`17 Karen A. Cullen et al., E-cigarette Use Among Youth in the United States, 2019, 322 JAMA 2095 (2019).
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`18 Id.
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`19 2021 Youth Risk Behavior Survey, Centers for Disease Control and Prevention (2021), available at
`https://www.cdc.gov/healthyyouth/data/yrbs/results.-htm.
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 13 of 48
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`44.
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`The substantial increase in youth smoking in the space of only one year20 was
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`considered remarkable as occurring in the absence of an increase in the consumption of
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`conventional tobacco products such as cigarettes or cigars. The increase in youth smoking was
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`instead reflected solely as an increase in e-cigarette use.21 Use of all other tobacco products
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`continued its decades-long decline while e-cigarette use increased 78% in just one year,22 such that
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`the Centers for Disease Control and Prevention (“CDC”) described youth e-cigarette use to be an
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`“epidemic.”23
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`45.
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`The Surgeon General has explained that nicotine in e-cigarettes affects the
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`developing brain and produces addiction in youth more easily than in adults as a result of the
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`enhanced learning abilities of the developing brain.24 The effects of nicotine exposure on the brain
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`of youth and young adults include addiction, priming for use of other addictive substances, and
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`impaired impulse control, attention and cognition deficits and mood disorders.25 As a highly
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`addictive, psychoactive substance targeting brain areas involved in emotional and cognitive
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`processing, nicotine poses a particularly potent threat to the adolescent brain, as it can “derange
`
`(Feb. 11, 2019),
`
`the Main Reason, CDC
`
`(Feb. 2019),
`
`
`Increased During 2017-2018, CDC
`20Progress Erased: Youth Tobacco Use
`https://www.cdc.gov/media/releases/2019/p0211-youth-tobacco-use-increased.html.
`
`Is Rising: E-Cigarettes are
`21Tobacco Use By Youth
`https://www.cdc.gov/vitalsigns/youth-tobacco-use/index.html.
`
`22 Scott Gottlieb, Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth
`by preventing access to flavored tobacco products and banning menthol in cigarettes, FDA (Nov. 15, 2018),
`https://www
`fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-
`proposednew-steps-protect-youth-preventing-access.
`
`23Jerome Adams, Surgeon General’s Advisory on E-cigarette Use Among Youth, CDC (Dec. 2018), https://ecigarettes.
`surgeongeneral.gov/documents/surgeon-generals-advisory-on-e-cigarette-use-among-youth-2018.pdf.
`
`24 U.S. Surgeon General and U.S. Centers for Disease Control & Prevention, Office on Smoking and Health, Know
`the Risks: E-Cigarettes and Young People (2019), https://ecigarettes.
`surgeongeneral.gov/.
`
`25 Menglu Yuan et al., Nicotine and the Adolescent Brain, 593 J. Physiology 3397 (2015), www.ncbi nlm
`nih.gov/pmc/articles/PMC4560573/.
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 14 of 48
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`the normal course of brain maturation and have lasting consequences for cognitive ability, mental
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`health, and even personality.”26
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`46.
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`In the summer of 2019, hundreds of otherwise healthy young adults began to appear
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`in emergency rooms nationwide with dangerous respiratory damage, in which 1,080 lung injury
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`cases associated with cannabis and nicotine e-cigarette products had been reported to the CDC as
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`of October 1, 2019. Eighteen deaths from 15 states were confirmed. By December 2019, more than
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`2,500 reported cases of e-cigarette-related hospitalizations for lung injury were reported, including
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`more than fifty confirmed deaths.27 New York City alone experienced fifty cases of e-cigarette
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`lung injury and four confirmed deaths. Cases continue nationwide and in New York City.
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`47.
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`E-cigarettes present hazards even to presumed non-vapers. According to the CDC,
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`between April 1, 2022 and March 31, 2023, 7,043 e-cigarette exposure cases were reported to the
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`National Poison Data System, a compilation of all cases reported to U.S. poison centers. The data
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`showed a 32% increase in reported poisoning from e-liquid ingestion during this period, with
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`nearly 90% of the cases in children less than five years old. The most reported brand involved was
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`Elf Bar, a disposable e-cigarette available in a variety of flavors and sold by all or most of the
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`present defendants.28
`
`48.
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`The explosive increase in the use of electronic nicotine delivery devices among
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`youth is believed attributable to the devices’ high nicotine content, youth-friendly candy, fruit and
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`dessert flavors, and amenability for surreptitious use, i.e., the ability to use the devices “discreetly.”
`
`
`26 Natalia A. Goriounova & Huibert D. Mansvelder, Short- and Long-Term Consequences of Nicotine Exposure
`During Adolescence for Prefrontal Cortex Neuronal Network Function, 2 COLD SPRING HARBOR PERSP.MED.
`12 (2012), https://www ncbi.nlm.nih.gov/pmc/articles/PMC3543069/.
`
`27 Karen A. Cullen et al., E-cigarette Use Among Youth in the United States, 2019, 322 JAMA 2095 (2019).
`
`28Tashakkori NA, Rostron BL, Christensen CH, Cullen KA. Notes from the Field: E-Cigarette–Associated Cases
`Reported to Poison Centers — United States, April 1, 2022–March 31, 2023. MMWR Morb Mortal Wkly Rep
`2023;72:694–695. DOI: http://dx.doi.org/10.15585/mmwr.mm7225a5
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 15 of 48
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`Nearly 85% of current e-cigarette users used flavored e-cigarettes, with fruit flavors being the most
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`popular, followed by candy, desserts, or other sweets.
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`49.
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`FDVs are adopted at a higher rate by youth when the devices contain flavored e-
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`liquids. Adolescents whose first tobacco product was flavored are more likely to continue using
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`tobacco products than those whose first product was not flavored. Flavored e-liquids were used by
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`81% of first-time users aged twelve to seventeen who had ever used electronic nicotine delivery
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`devices; 85.3% of current youth users had used a flavored e-liquid in the past month; 81.5% of
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`current youth users said they used electronic nicotine delivery devices “because they come in
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`flavors I like.” 29, 30 Another peer-reviewed study concluded that young adults who use electronic
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`cigarettes are more than four times as likely to begin using regular cigarettes when compared with
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`peers who have not used e-cigarettes.31
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`50.
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`Flavored e-liquids multiply the risk of nicotine addiction risk by making it easier
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`and more pleasant to ingest nicotine, with e-liquids expressly formulated to make them more
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`palatable to novice smokers.32 Adolescents whose first tobacco product was flavored are more
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`likely to continue using tobacco products than those whose first product was not flavored.
`
`
`
`
`
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`29 See Bridget K. Ambrose et al., Flavored Tobacco Product Use Among US Youth Aged 12-17 Years, 2013-2014,
`314 JAMA1871 (2015).
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`30 Karma McKelvey et al., Adolescents and Young Adults Use in Perceptions of Pod-based Electronic Cigarettes. 1
`JAMA NETWORK OPEN e183535 (2018), https:// doi:10.1001/jamanetworkopen.2018.3535.
`31 See Brian A. Primack, et al. Initiation of Traditional Cigarette Smoking after Electronic Cigarette Use Among
`Tobacco-Naïve US Young Adults, 131 AM. J.MED. 443.e1 (2018).
`
`32 See U.S. Dep’t of Health & Human Servs., How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis
`for Smoking-Attributable Disease: A Report of the Surgeon General, Chapter 4 (Centers for Disease Control and
`Prevention ed. 2010), https://www ncbi.nlm.nih. gov/books/NBK53018/ #ch4.s92.
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`Case 1:23-cv-05880-LLS Document 1 Filed 07/10/23 Page 16 of 48
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`Flavor Bans
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`51.
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`In 2009, the FDA banned flavored cigarettes (other than menthol) pursuant to its
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`authority under the Tobacco Control Act. “Flavored cigarettes attract and allure kids into
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`addiction,” Health and Human Services Assistant Secretary Howard Koh, MD, MPH, said at a
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`news conference held to announce the ban.33 In January 2020, in response to “epidemic levels of
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`youth use of e-cigarettes” the FDA banned flavored e-cigarette “pods”34 (other than “tobacco” and
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`“menthol” flavors), announcing a policy to prioritize enforcement against unauthorized flavored
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`vape products, because these products are “so appealing” to children.”35
`