Professional Documents
Culture Documents
Plaintiff,
Hon.
EONSMOKE, LLC;
ZLAB S.A.; VERIFIED COMPLAINT
ZIIP LAB CO., LTD.; (JURY DEMAND)
SHENZHEN YIBO TECHNOLOGY CO.,
LTD.; and
JOHN DOES 1 – 50,
Defendants.
Case 2:19-cv-08405 Document 1 Filed 03/12/19 Page 2 of 38 PageID: 2
Plaintiff Juul Labs, Inc. (“Juul Labs”), by its attorneys, for its complaint against
Eonsmoke, LLC, with offices in Clifton, New Jersey, ZLab, S.A., with offices in Uruguay, Ziip
Lab Co., Ltd, with offices in China, Shenzhen Yibo Technology Co., Ltd., with offices in China,
INTRODUCTION
1. Juul Labs’ vaporizer products disrupted the traditional cigarette market in the
United States and have given adult smokers a true alternative. This disruption did not occur by
happenstance. Juul Labs has invested millions of dollars to design, produce, and bring to market
the innovative and celebrated Juul-brand products, which consist of the Juul Device and the
replaceable JUULPods that work with it. Together, the products work as an electronic nicotine
delivery system (commonly called a vaporizer or e-cigarette) and, consistent with the company’s
mission, are intended to help adult smokers transition away from traditional combustible
cigarettes. Both are protected by Juul Labs’ design patents, which Juul Labs has never
2. Juul Labs has never intended for underage users to buy or use its products.
Instead, Juul Labs has been in constant contact with the U.S. Food and Drug Administration
(“FDA”) and working with it to fulfill Juul Labs’ mission, including limiting underage use of
nicotine vaporizers. Last fall, when the FDA publicly highlighted new concerns about youth use
of e-cigarette products in the United States, Juul Labs expanded its existing Youth Action Plan to
take additional steps to even more aggressively combat underage use of its products. In line with
that, in November 2018, Juul Labs changed how it was selling its JUULPods so that only
tobacco- and menthol-based (mint and menthol) flavors would be distributed to retail stores.
3. After Juul Labs pulled some of its flavor offerings from retail shelves, Defendants
began purposefully re-filling that same shelf space in retail outlets, such as convenience and
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vape stores, with millions of illegal e-cigarette cartridges that have intentionally kid-friendly
flavor names and packaging like Sour Gummy, Peach Madness, and Silky Strawberry.
Defendants also sell their cartridges online with virtually no age-verification requirements at all
beyond requiring a purchaser to click a button and attest that he or she is over 18 years old,
regardless of whether or not the purchaser is in a jurisdiction that restricts sales of tobacco
products to ages 21 and up. And Defendants have done this while being fully aware of Juul
Labs’ investments and designs, as well as Juul Labs’ efforts to restrict youth access to nicotine
products. Indeed, Defendants initiated email campaigns offering big price cuts just after Juul
Labs announced its voluntary actions, and increased their marketing efforts to highlight how
Defendants’ products are designed as cheaper “Juul compatible” pods that can replace legitimate
JUULPods in the Juul Device. None of Defendants’ products are authorized by Juul Labs. And
none of them are approved by the FDA for sale either; instead, the Defendants are forbidden by
FDA regulations from selling any new products without first obtaining FDA premarket approval.
4. None of this has deterred Defendants at all. Their products have instead
proliferated, incenting other compatibles makers to enter the market and collectively overtake the
number of legitimate JUULPods offered in many retail stores. Defendants have done this as they
skirt regulatory requirements while taking advantage of the opportunity left by Juul Labs’
voluntary decision to pull certain flavors from retail stores in response to FDA concerns.
in New Jersey and elsewhere, particularly youth. And Defendants are doing this by blatantly
stealing Juul Labs’ patented designs, free riding on its goodwill and reputation, and sowing
misperceptions about it in the public. As a result, Juul Labs is being harmed as people
mistakenly attribute Defendants’ unlawful misconduct with Juul Labs. For the reasons described
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below, emergency relief is needed to preliminarily and permanently enjoin Defendants’ ongoing
misconduct.
PARTIES
6. Juul Labs is a corporation organized in the State of Delaware, with its principal
place of business at 560 20th Street, San Francisco, California 94107. Juul Labs was originally
called Ploom and then Pax Labs. In 2017, Juul Labs and Pax Labs, Inc. became separate
companies.
liability company with its principal place of business at 1500 Main Ave., 2nd Floor, Clifton,
its principal place of business at Ave. Golero, 911 Office 27, Punta Del Este, Maldonado,
Uruguay, 20100.
9. On information and belief, Ziip Lab Co., Ltd. (“Ziip Lab”) is a Chinese company
with its principal place of business at E District 4F, 5 Building, Wen Ge Industrial Zone,
Heshuikou, Gongming St., Guangming New District, Shenzhen City, Guangdong Province,
China 518106.
10. On information and belief, Shenzhen Yibo Technology Co., Ltd. (“Yibo”) is a
Chinese company with its principal place of business at E District 4F, 5 Building, Wen Ge
Industrial Zone, Heshuikou, Gongming St., Guangming New District, Shenzhen City,
11. ZLab, Ziip Lab, and Yibo are referred to collectively throughout the Complaint as
“Ziip”.
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12. On information and belief, Defendants John Does 1-50 are the presently unknown
other companies and individuals involved in the knowing and unlawful design, development,
13. This action arises under the patent laws of the United States, 35 U.S.C. § 100 et
seq., and this Court has original subject matter jurisdiction over the subject matter of this action
under 28 U.S.C. §§ 1331 and 1338(a). This Court also has diversity jurisdiction under 28 U.S.C.
§ 1332 and supplemental jurisdiction over the state law claims under 28 U.S.C. § 1367(a).
14. Juul Labs’ claims against Defendants are based on: (i) Defendants’ infringement
of Juul Labs’ design patents; (ii) Defendants’ unfair competition with illegal and unapproved
products; (iii) Defendants’ promotion and sale of such products to consumers in this District; and
(iv) Defendants’ use of instrumentalities in this District to promote and sell the products.
15. Venue is proper under 28 U.S.C. §§ 1391 and 1400(b) because Eonsmoke has a
regular and established place of business in this Judicial District and because ZLab, Ziip Lab,
and Yibo are alien defendants and have committed acts of infringement in this Judicial District.
16. This Court has personal jurisdiction over Defendants because they directly target
business activities toward consumers in the United States, including the State of New Jersey,
through their known distribution and sale of e-cigarette products through at least the Eonsmoke
numerous physical retail stores located in New Jersey. Specifically, upon information and belief,
all of the known Defendants are located in this District, and Defendants’ infringing activities are
targeted to and sales are made to residents of New Jersey. Defendants are committing tortious
acts, engaging in interstate commerce, and have wrongfully caused Juul Labs and the public
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BACKGROUND
17. Juul Labs was founded in 2007. Its mission is to improve the lives of the world’s
one billion adult smokers by eliminating combustible cigarettes. To that end, Juul Labs
revolutionized the e-cigarette space by developing the innovative and award winning Juul
18. The Juul System is a combination of several Juul products: (i) the Juul Device
itself, and (ii) a disposable JUULPod that comes prefilled with an “e-liquid” that is a proprietary
mixture of vaporizer carriers, nicotine salt extracts, and flavoring. When a user inserts a
JUULPod into the Juul Device and inhales through the mouthpiece, the device rapidly heats the
e-liquid in the pod, aerosolizing it to allow the user to inhale a “puff” of the vaporized e-liquid.
6
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19. In 2018, FDA Commissioner Scott Gottlieb said that “[w]hile it’s the addiction to
nicotine that keeps people smoking, it’s primarily the combustion, which releases thousands of
harmful constituents into the body at dangerous levels, that kills people,” and so “new
innovations that don’t use combustion, like the electronic cigarettes, offer an important
opportunity for adults to transition off combustible tobacco.” Exhibit 1. Because the Juul
System allows users to obtain nicotine through a vapor rather than through inhaling smoke from
a traditional combustible cigarette, Juul Labs believes that the Juul System can have a positive
20. Juul Labs has invested millions of dollars to develop, design, and introduce its
innovative and celebrated products. The Juul System has been a resounding success, reaching
76% of the overall pod-based e-cigarette market as reported by third-party analysts in the United
States at the end of 2018. And its broad adoption has led to numerous testimonials from adult
smokers who attest that their lives have improved after switching away from traditional
combustible tobacco products to the Juul System. A recent study showed, for example, that of
9,272 adults who used a Juul Device for three months, 47% (4,367) reported at the end of the
assessment that they had not smoked cigarettes at all in the prior 30 days, and among the
participants still smoking cigarettes three months after initiating with the Juul Device, their
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cigarette consumption had declined 51.7%.1 The Juul Device’s success has also corresponded
with an overall decline in cigarette use among adults. For example, the Centers for Disease
Control and Prevention reported a decrease in cigarette use among adults from 20.9% in 2005 to
14.0% in 2017.2
21. From the time of its release in April 2015, the Juul Device and JUULPods have
been praised for their simple, unique, and sophisticated designs. When the products were first
announced, for example, Wired.com ran an article titled “This Might Just Be the First Great E-
Cig” and praised the company for using its “strong design savvy” to create a “beautiful” device.
Exhibit 2. The article recognized how different the Juul Device was from the current offerings
in the e-cigarette marketplace, noting that earlier products came “in one of two packages,” being
“either small and round, designed to look and feel as much as possible like a cigarette, or they’re
huge, assembled from many parts, and spectacularly complicated. Even the best of them look
like you’re smoking from an oboe.” The Juul Device, however, was “nothing like that.”
22. Industry website Vaping360.com likewise has praised the products, ranking the
Juul System first in its 2017 and 2018 Best E-Cigarettes buyers guides and noting that “[b]y
1
Neil McKeganey Ph.D., Christopher Russell Ph.D., Farhana Haseen Ph.D., Vaping and
the Number of Cigarettes Not Now Smoked: An Additional Means of Assessing the Public Health
Impact of E-cigarettes, JOURNAL OF PULMONARY AND RESPIRATORY MEDICINE (Feb. 18, 2019),
available at https://www.gavinpublishers.com/articles/Research-Article/Pulmonary-and-
Respiratory-Medicine-Open-Access/vaping-and-the-number-of-cigarettes-not-now-smoked-an-
additional-means-of-assessing-the-public-health-impact-of-e-cigarettes.
2
See Current Cigarette Smoking Among Adults in the United States, CENTERS FOR
DISEASE CONTROL AND PREVENTION, available at https://www.cdc.gov/tobacco/data_statistics/
fact_sheets/adult_data/cig_smoking/index.htm.
8
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combining quality technology into a modern design with consistent performance, the JUUL was
23. Juul Labs’ innovative system, unique designs, and proprietary e-liquid
adult customers experience Juul Labs’ excellent customer service. All in all, Juul Labs’ products
24. Juul Labs has protected its innovative designs through design patents, which
cover the unique and novel ornamental appearance of each of Juul Labs’ products. Juul Labs
owns all right, title, and interest in and to each of the asserted design patents.
25. The D825,102 (“D’102”) patent was issued by the United States Patent and
Trademark Office (“PTO”) on August 7, 2018 and is titled “Vaporizer Device with Cartridge.”
The D’102 patent claims “[t]he ornamental design for a vaporizer device with cartridge, as
shown and described,” and includes four embodiments. A true and correct copy of the D’102
patent is attached as Exhibit 7. Figure 1.1 of the patent shows a perspective view of one
3
See Best E-Cigarettes, VAPING360 (July 20, 2018), https://vaping360.com/best-
vapestarter-kits/e-cigarettes/; JUUL Review: See Why It’s the Most Popular Vape, VAPING360
(July 20, 2018), https://vaping360.com/juul/juul-vapor-review/.
9
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26. The D842,536 (“D’536”) patent was issued by the PTO on March 5, 2019 and is
titled “Vaporizer Cartridge.” The D’536 patent claims “[t]he ornamental design for a vaporizer
cartridge as shown and described,” and includes four embodiments. A true and correct copy of
the D’536 is attached as Exhibit 8. Figure 1.2 of the patent shows a perspective view of one
27. The D744,419 (“D’419”) patent was issued by the PTO on December 1, 2015,
and is titled “Charging Device for Electronic Vaporization Device.” The D’419 patent claims
“[t]he ornamental design for a charging device for electronic vaporization device, as shown and
described.” A true and correct copy of the D’419 is attached as Exhibit 9. Figure 1 of the patent
28. These design patents together cover the unique and ornamental appearances of
29. In September 2018, the FDA publicly highlighted its concerns about what it
called an “epidemic of nicotine use among teenagers.” The FDA asked Juul Labs and other e-
cigarette manufacturers to provide action plans detailing steps they would take to address youth
10
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use of their products. Juul Labs, which already had been in communication and working with
the FDA on these and other issues, immediately responded, indicating that it would work
alongside the FDA toward that goal and began taking additional and more aggressive measures
through Juul Labs’ Youth Action Plan, which it had already implemented in April 2018. Exhibit
3.
30. Juul Labs’ products are intended only for adult consumers of legal purchasing
age, and Juul Labs has worked diligently in cooperation with the FDA to prevent sales to, and
use by, minors. See, e.g., Exhibit 4 (FDA Oct. 31, 2018 Press Release commending Juul Labs’
leadership for cooperative dialogue with FDA). In addition, Juul Labs supports 21+ nationwide
31. In November 2018, to further respond to FDA concerns, Juul Labs also
voluntarily stopped distributing certain flavors of JUULPods to retail stores. As such, Juul Labs
would only distribute Virginia Tobacco, Classic Tobacco, Menthol, and Mint flavored
JUULPods to retail stores. Juul Labs’ other flavors, Cucumber, Creme, Fruit, and Mango, can
still be purchased but only by adults 21 and over from the Juul.com website, which utilizes
32. While Juul Labs has been and remains committed to working with the FDA to
address the problem of youth e-cigarette use, Defendants have done the opposite, brazenly
selling millions of illegal e-cigarette cartridges with obviously kid-friendly flavor names like
Sour Gummy and Peach Madness with packaging attractive to underage users. And by design,
Defendants do this with knock-off products that copy Juul Labs’ patented designs.
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33. None of Defendants’ products are authorized by Juul Labs. And none of them are
approved by the FDA for sale; instead, the Defendants are forbidden by FDA regulations from
selling any of their new products without first obtaining FDA approval. See, e.g., Exhibits 5
and 6 (Oct. 12, 2018 letters from FDA to Eonsmoke and ZLab).
34. Defendants do not care. They have instead acted with impunity, selling numerous
infringing and illegal products in retail stores across the country and online:
35. Defendants’ illegal products are rapidly proliferating through physical retail stores
in New Jersey and throughout the United States. Below, for example, are images from an EZ
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Market convenience store on University Avenue in Newark where Eonsmoke’s infringing, fruit-
36. An image from the convenience store at an Exxon in Freehold, New Jersey
additionally shows that Eonsmoke’s illegal, infringing cartridges are marked Juul Compatible
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37. Defendants’ infringing cartridge products include at least Eonsmoke Pods, ZPods,
Airbender Pods, PlusPods, and 4X Pods.4 Many of them are offered at nicotine levels up to 6%
and 7%, where JUULPods are sold at 3% and 5% (with 5% being equivalent to a pack of
traditional cigarettes). There are also no apparent safety or quality guarantees as to the contents
of the e-liquid inside these infringing products, which have an unknown composition and
38. Defendants market their infringing pods using kid-friendly flavor names in
advertisements that often surround the products with images of fruit and dessert:
4
Eonsmoke products are also part of an International Trade Commission investigation
initiated by Juul Labs. In the Matter of Certain Electronic Nicotine Delivery Systems and
Components Thereof, Inv. No. 337-TA-1139, USITC Pub. 3346 (Dec. 10, 2018) (Instituted;
alleging infringement of Juul Labs utility patents by importers of knock-off systems). Eonsmoke
is an unregulated entity.
14
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39. Eonsmoke does the same with the 4X Pod brand that it sells, prominently using
products that infringe Juul Labs’ protected designs to entice customers to buy cartridges such as
the “4X Sour Gummy Juul Compatible 6.5% Salt Nic Pods” and the “4X Green Apple Juul
5
4X Pods are also at issue in this District in Juul Labs, Inc. v. 4X Pods, et al., No. 2:18-
cv-15444-KM-MAH.
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40. Eonsmoke also sells refillable 4X Pods that allow consumers to fill them with
whatever substance they want, for use with the Juul Device. Eonsmoke says “Why buy a
different system, [j]ust fill the pod with your favorite salt nic, cap it and put it into [the Juul
Device].”6
6
See 4X Empty Pod Juul Compatible for Salt Nic, EONSMOKE, available at
https://www.eonsmoke.com/home/506-4x-blue-blackberry-juul-compatible-65-salt-nic-
pods.html.
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actively sowing consumer confusion regarding the affiliation of its pods with Juul Labs products.
biography “Eonsmoke.com is the 2nd largest pod company in the USA and top 5 in Salt Nicotine
Bottled eLiquid. Our pods are Juul compatible so you don’t have to buy another device. 7
comments on Reddit threads such as “What flavors do you guys wanna see next from JUUL?”
with comments such as “We make watermelon. Step over to the dark side!”8
42. Eonsmoke also sells devices that copy the patented design of the Juul Device:
Eonsmoke Devices
7
“Eonjuulcompatiblepod” user profile, REDDIT, available at https://www.reddit.com/
user/Eonjuulcompatiblepod.
8
“What flavors do you guys wanna see next from JUUL?” REDDIT, available at
https://www.reddit.com/r/juul/comments/8kpdun/what_flavors_do_you_guys_wanna_see_
next_from_juul/; see also “Are there any other devices that fit juul pods?” REDDIT, available at
https://www.reddit.com/r/juul/comments/8k5wfa/are_there_any_other_devices_that_fit_
juul_pods/ (same user commenting “Our pods are compatible with the juul device and our
devices are compatible with juul pods and we just lowered the retail to 20$ online after
coupon.”)
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43. Ziip is also associated with Eonsmoke products. For example, on the back of
Eonsmoke Pod packages, it says that the products are “Designed by ZLab S.A. Punta del Este –
Uruguay.”9
44. Ziip also manufactures and sells its own copycat products, including the ZDevice:
9
Ziip products are also part of investigations initiated by Juul Labs in the International
Trade Commission. See In the Matter of Certain Cartridges for Electronic Nicotine Delivery
Systems and Components Thereof, Inv. No. 337-TA-1141, USITC Pub. 3354 (Nov. 20, 2018)
(Instituted; alleging infringement of Juul Labs utility patents by importers of Juul compatible
pods); In the Matter of Certain Electronic Nicotine Delivery Systems and Components Thereof,
Inv. No. 337-TA-1139, USITC Pub. 3346 (Dec. 10, 2018) (Instituted; alleging infringement of
Juul Labs utility patents by importers of knock-off systems). The Ziip Defendants are
unregulated entities.
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45. Ziip also sells fruit-flavored ZPods advertised as being “for [the] Juul Device”:
46. On information and belief, the Ziip Defendants are also affiliated with the
Airbender brand. On social media devoted to Airbender, the Airbender pods are prominently
com/p/BfZ4aDgH0D1.)
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47. In another post on Instagram, the ZDevice is displayed with Airbender pods and
surrounded by fruit, with the following caption: “Paladin pods for the juul and ziip devices.
products with Juul Labs. And such mistaken associations are responsible for the extremely
damaging misconception that youth usage of these unauthorized and infringing products is
49. Defendants are also selling these products through their websites, which have no
meaningful age verification barriers at all. Eonsmoke’s website, for instance, encourages users
to click a green button saying that they are over 18 years old. Even in states such as New Jersey
or California, where the legal age is 21, the message is no different and prompts users to confirm
that they are over 18. Indeed, New Jersey is one of the pioneer states in the 21+ movement, yet
Eonsmoke makes no effort to protect New Jersey’s underage consumers. See STATE System
Tobacco 21 Fact Sheet, CENTERS FOR DISEASE CONTROL AND PREVENTION (Sept. 30, 2018),
10
Airbendereliquid, INSTAGRAM, “Paladin pods for the juul and ziip devices. Who’s
tried them? Let us know how you like them!” available at https://www.instagram.com/p/BiPBF
phjhRV/.
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Jersey as among just 5 states that have a minimum legal age of 21 for buying cigarettes and e-
cigarettes); see also Exhibit 3 (Juul Labs’ Youth Prevention Initiative). In addition to the
deficient notice when the site first appears, there is no age verification when the user actually
50. Similarly, Ziip’s website, while ostensibly asking if the user is over 21 when it
first loads, does not attempt any actual age verification when the user attempts to purchase a
product.
51. Defendants are also selling their infringing and unauthorized products through
partner retail stores throughout the country. In New Jersey alone, Eonsmoke advertises and
identifies the following retail locations on its website where consumers can purchase Eonsmoke
products:
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52. Further, unlike Juul Labs, which has disclosed the ingredients of its JUULPod to
the FDA, Defendants are selling products that have never been approved by the FDA or deemed
appropriate for sale. According to the FDA’s deeming date rule, any new tobacco-related
products (including e-cigarette products) that were not for sale in the United States prior to
August 8, 2016 cannot be sold before the ingredients are submitted to the FDA for approval 90
days before marketing. See 21 U.S.C. § 387j; see also Extension of Certain Tobacco Product
Compliance Deadlines Related to the Final Deeming Rule (Revised), U.S. DEP’T OF HEALTH &
prior to the deeming date, and none have complied with the FDA’s new regulations. See
Exhibits 5 and 6 (Oct. 12, 2018 letters from FDA to Eonsmoke and ZLab).
independent study commissioned by Juul Labs, the Centre for Substance Use Research asked
almost 10,000 teenage respondents to identify the first flavor they ever tried in a Juul Device. Of
the self-reported users, 54.0% reported having initiated use of a Juul Device with a pod flavor
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not manufactured by Juul Labs, whereas 31.2% reported a pod flavor manufactured by Juul
Labs. A quarter of the first-time flavors identified by the adolescents matched products sold by
Ziip. Even more troubling, of the respondents who had used a Juul Device in the past 30 days,
69% identified having used a flavor that the researchers could match back to Ziip.
54. The study also tested the level of interest that youth had in various flavors of
pods, including both legitimate JUULPod flavors and flavors Juul Labs has never made. The top
flavors were Cotton Candy, Strawberry, and Gummy Bear, none of which are JUULPod flavors.
55. In short, Defendants are misusing Juul Labs’ designs and goodwill to put nicotine
products into the hands of youth. And this is all being done in a way that causes the widespread
misconception that Juul Labs is selling or is otherwise affiliated with Defendants’ products. In a
February 11, 2019 interview, the Centers for Disease Control and Prevention (“CDC”) indicated
that they were working with the FDA to update the National Youth Tobacco Survey to include
references to the Juul brand in order to “capture Juul use among kids.” (https://www.cdc.gov/
“Juul compatible” pods, there is a very real risk that researchers and respondents involved in the
CDC’s survey efforts will mistakenly attribute Defendants’ products to Juul Labs, giving the
false impression that Juul Labs is selling products to youth when in fact it is not. It already may
be happening. To the extent the FDA relies on any such inaccurate data to promulgate new
regulations or prohibitions on Juul Labs’ products, the result could be catastrophic to Juul Labs’
56. Defendants’ products also threaten harm to Juul Labs’ brand due to their inferior
quality. Consumers are likely to attribute the poor quality to Juul Labs. Indeed, for many of
Defendants’ products, users have already noted various quality, and even safety, problems:
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4X Pods
“Brand new 4X Pods - mold all over the connections” … “Careful, inhaling
mold spores can be really dangerous especially with direct contact like that.
Might want to get checked out.” See “Brand new 4X Pods - mold all over the
connections,” REDDIT, available at https://www.reddit.com/r/juul/comments/
ai07vt/brand_new_4x_pods_mold_all_over_the_connections/. (emphasis
added here and in following cites).
“Taste like chemicals and leak so bad! The 6.5 got me excited too but they
are horrible.” See “What are all of your thoughts on the brand 4x Pods?”
REDDIT, available at https://www.reddit.com/r/juul/comments/9dxcpy/
what_are_all_of_your_thoughts_on_the_brand_4x_pods/.
“This is second pack of 4X that I have bought, both at different stores, and
they’ve all been leaking like hell.”… “Mine always leak! A lot of times
they’ll burn out halfway through as well.” … “I hate the 4x pods. They all
taste the same and burn up real bad.” … “But bought a pack of 4x Blue
Raspberry and they made it ‘difficult’ to breathe for a minute or so after a
hit.” See “4X pods,” REDDIT, available at https://www.reddit.com/r/juul/
comments/a1igun/4x_pods/.
Airbender Pods
“My local vape shop has AirBender Z-pods. ... The juice itself is great, but the
pods are trash. Every hit you have to pull the pod out and you will notice air
bubbles float out of the coil, if you don’t you’ll get a dry hit. The pods leak
like mad after the first hit and eventually will not fire when you hit your juul.
The only the way to get them to work again is to hit the juul very hard. Which
causes and shit ton of splash back. I have refilled the Z-pods in hopes they
would work better, but no luck. Maybe I happened to get a bad batch, who
knows. So far 3/4 pods are no good. Shoud have just bought juul brand
pods.” See “AirBender Z-Pods,” REDDIT, available at https://www.reddit.com
/r/juul/comments/96tlie/airbender_zpods/.
“I tried every Airbender pod and can honestly say...They’re terrible. Waste
of money. Constantly burn. Trust me, we are all better off with sticking to
regular Juul pods. Don’t waste money like I did.” See “I tried every
Airbender pod and can honestly say...” REDDIT, available at https://www.
reddit.com/r/juul/comments/8bccpk/i_tried_every_airbender_pod_and_
can_honestly_say/.
Eonsmoke Device
“Hey everyone thought I would speak my mind after owning the ‘juul
device’ that eon smoke sells aka the maker of eon pods. First of all let’s start
it off by saying I do not recommend it to anybody. In my own terms I would
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put the ‘juul exchange’ (send your own juul in and they give you one of their
devices) as a blind money grab. Shipping took ages, support is minimal and
there’s more behind the device that you don’t know. The eon device is
cheap, badly manufactured and there’s a large amount of pod problems.”
See “Eon smoke ‘juul device,’” REDDIT, available at https://www.reddit.com/
r/juul/comments/9a16dv/eon_smoke_juul_device/.
Eonsmoke Pods
“From my personal experience. I’ve had a lot of leaking pods from eon . …
Btw idk if it’s just me but they don’t last at all. Like a regular juul pod lasts
me two days and eon last me a day.” See “Eonsmoke pods - are they worth
it?” REDDIT, available at https://www.reddit.com/r/juul/comments/a4b0o0/
eonsmoke_pods_are_they_worth_it/.
“Well i ordered some fresh watermelon and blueberry pods and all 8 are
leaking to all hell. I pulled one out and took 3 rips, and when i pulled it out of
my juul it was half empty. Safe to say eon pods are 100% abject garbage
and they dont deserve your money.” See “HEY EONSMOKE DUDE
YOU'RE PODS ARNET FIXED THEY LEAK TO ALL HELL,” REDDIT,
available at https://www.reddit.com/r/juul/comments/8akrik/hey_eonsmoke_
dude_youre_pods_arnet_fixed_they/.
PlusPods
“[T]they leak a lot and the liquid seems to go buy really fast. you also
sometimes get burnt hits which are nasty af” See “Has anyone tried plus
pods?” REDDIT, available at https://www.reddit.com/r/juul/comments/at4iay/
has_anyone_tried_plus_pods/?ref=readnext.
ZPods
“I’m wondering if I got a bad batch or if they changed the formula. The juice
in the pod is usually clear, but both 4-packs I bought yesterday are sort of a
yellowish color. Plus they do not taste good at all anymore. Fresh out of the
package they just taste....weird. More like menthol than mint, with an
unpleasant aftertaste.” See “Ziip pods question,” REDDIT, available at
https://www.reddit.com/r/juul/comments/90ineq/ziip_pods_question/.
57. Defendants’ infringement of JuulLabs’ design patents and their unfair competition
against Juul Labs is damaging and irreparably injuring Juul Labs, and, unless Defendants are
preliminarily and permanently enjoined, they will further damage and irreparably injure Juul
Labs and the goodwill and reputation it has built through its patented products.
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58. Moreover, Defendants’ misconduct has irreparably injured the public, and, unless
preliminarily and permanently enjoined, it will further irreparably injure the public, which has an
interest in keeping Defendants’ illegal products out of the hands of users — particularly youth —
as well as an interest in being free from deception, confusion, and mistake in the marketplace.
59. Juul Labs repeats and re-alleges paragraphs 1-58 as if fully set forth herein.
60. Defendants have been, and presently are, infringing the D’102 patent within this
judicial district and elsewhere by using, making, selling, offering to sell, and/or importing into
the United States, the Eonsmoke Device and ZDevice in violation of 35 U.S.C. §§ 271 and 289.
61. Juul Labs is informed and believes, and on that basis alleges, that Defendants’
infringement of the D’102 patent has been and continues to be intentional, willful, and without
62. Juul Labs is informed and believes, and on that basis alleges, that Defendants
have gained profits and received investments by virtue of their infringement of the D’102 patent.
63. Juul Labs has sustained damages as a direct and proximate result of Defendants’
64. Juul Labs will suffer and is suffering irreparable harm from Defendants’
infringement of the D’102 patent. Juul Labs has no adequate remedy at law and is entitled to an
injunction against Defendants’ continuing infringement of the D’102 patent. Unless enjoined,
65. Juul Labs repeats and re-alleges paragraphs 1-64 as if fully set forth herein.
66. Defendants have been, and presently are, infringing the D’536 patent within this
judicial district and elsewhere by using, making, selling, offering to sell, and/or importing into
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the United States, products identified in this Complaint in violation of 35 U.S.C. §§ 271 and 289.
Without limitation, this includes pods branded as Eonsmoke, ZLab, Airbender, PlusPods, and 4x.
67. Juul Labs is informed and believes, and on that basis alleges, that Defendants’
infringement of the D’536 patent has been and continues to be intentional, willful, and without
68. Juul Labs is informed and believes, and on that basis alleges, that Defendants
have gained profits and received investments by virtue of their infringement of the D’536 patent.
69. Juul Labs has sustained damages as a direct and proximate result of Defendants’
70. Juul Labs will suffer and is suffering irreparable harm from Defendants’
infringement of the D’536 patent. Juul Labs has no adequate remedy at law and is entitled to an
injunction against Defendants’ continuing infringement of the D’536 patent. Unless enjoined,
71. Juul Labs repeats and re-alleges paragraphs 1-70 as if fully set forth herein.
72. Defendants have been, and presently are, infringing the D’102 patent within this
judicial district and elsewhere by using, making, selling, offering to sell, and/or importing into
the United States, the USB chargers for the Eonsmoke Device and ZDevice in violation of 35
73. Juul Labs is informed and believes, and on that basis alleges, that Defendants’
infringement of the D’102 patent has been and continues to be intentional, willful, and without
74. Juul Labs is informed and believes, and on that basis alleges, that Defendants
have gained profits and received investments by virtue of their infringement of the D’102 patent.
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75. Juul Labs has sustained damages as a direct and proximate result of Defendants’
76. Juul Labs will suffer and is suffering irreparable harm from Defendants’
infringement of the D’102 patent. Juul Labs has no adequate remedy at law and is entitled to an
injunction against Defendants’ continuing infringement of the D’102 patent. Unless enjoined,
77. Juul repeats and re-alleges paragraphs 1-76 as if fully set forth herein.
78. Defendants are selling products in direct competition with Juul Labs that
misappropriate Juul Labs’ patented designs and trade off of Juul Labs’ goodwill without
authorization. Juul Labs is therefore being unfairly forced to compete against its own designs in
the marketplace.
79. Defendants are also selling nicotine products that have not been approved by the
FDA and which are thereby prohibited and illegal for Defendants to sell. Defendants’ products
also appear to lack necessary quality controls, raise safety issues, and create negative public
perception about health and safety that are being wrongly and mistakenly attributed to Juul Labs.
81. Juul Labs is informed and believes, and on that basis alleges, that Defendants
have made profits and gains, and received investments, by virtue of their unfair competition.
Juul Labs has been, and continues to be, harmed. Juul Labs continues to suffer immediate and
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83. Further, Juul has suffered damages, including, but not limited to, loss of sales and
84. Juul Labs has no adequate remedy at law, and if Defendants’ unfair competition is
not enjoined, Juul will continue to suffer irreparable harm to the name, reputation, and goodwill
85. Juul Labs repeats and re-alleges paragraphs 1-84 as if fully set forth herein.
86. Defendants’ actions have disrupted or are intended to disrupt Juul Labs’ business
by, among other things, diverting consumers away from Juul Labs’ products and to Defendants’
infringing products, through using designs identical and/or confusingly similar to Juul Labs’
protected designs.
87. In doing so, Defendants have gained access to Juul Labs’ customers, as to which
Juul Labs had a reasonable expectation of economic benefit. Juul Labs has lost sales because of
88. Defendants knew or should have known about Juul Labs’ expected economic
benefit. Defendants have no legal right, privilege or justification for their conduct. Absent
Defendants’ wrongful and deceptive conduct, Juul Labs would have made sales that Defendants
89. Based on the intentional, willful, and malicious nature of Defendants’ actions,
Juul Labs is entitled to recover monetary damages, exemplary or punitive damages, and
reasonable attorneys’ fees and costs incurred in connection with this action.
90. Juul Labs has no adequate remedy at law, and if Defendants’ intentional
interference with Juul Labs’ prospective economic advantage is not enjoined, Juul Labs will
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continue to suffer monetary damages and irreparable injury to the name, reputation, and goodwill
91. Juul repeats and re-alleges paragraphs 1-90 as if fully set forth herein.
92. As a result of the conduct alleged herein, Defendants have been unjustly enriched
to Juul Labs’ detriment. Juul Labs seeks a worldwide accounting and disgorgement of all ill-
gotten gains and profits, including received investments, resulting from Defendants’ inequitable
activities.
93. Juul repeats and re-alleges paragraphs 1-92 as if fully set forth herein.
94. Defendants, jointly and severally, and without Plaintiff’s consent and
authorization, knowingly, intentionally, and falsely misrepresented to the public that they and
their products were affiliated, sponsored, or otherwise endorsed by Juul Labs, and made further
95. The false and fraudulent misrepresentations of Defendants, all of which were
material, were undertaken with the knowledge and intent that unsuspecting consumers would be
deceived into believing and relying upon said misrepresentations, and that said representations
96. Juul Labs has been injured in its business, property, and reputation and such
injury also is irreparable as a result of Defendants’ unlawful, fraudulent, and infringing actions as
alleged herein, which were intentional, malicious, and willful. Those members of the public who
have been deceived by Defendants’ misconduct may use Juul Labs’ products believing
Defendants’ misrepresentations, and thereby misuse Juul Labs’ products to their potential
detriment. For example, based on Defendants’ misrepresentations, consumers have, and likely
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will continue to, use Defendants’ pods in the Juul Device, or JUULPods in one of Defendants’
devices. Such use is not authorized by Juul Labs and has already led to safety and health risks.
This in turn negatively affects Juul Labs’ reputation and business. Such consequences to the
97. Juul Labs has no adequate remedy at law, and if Defendants’ fraudulent
misrepresentations are not enjoined, Juul Labs will continue to suffer irreparable harm to the
98. Juul Labs repeats and re-alleges paragraphs 1-97 as if fully set forth herein.
99. Defendants, jointly and severally, and without Plaintiff’s consent and
authorization, negligently misrepresented to the public that they and their products were
affiliated, sponsored, or otherwise endorsed by Juul Labs, and made further misrepresentations
100. Defendants have, at minimum, negligently held themselves out as having the right
to make representations about the use and performance of Juul Labs’ products, including in
combination with Defendants’ products. Defendants have negligently misrepresented Juul Labs’
position regarding the use and performance of Juul Labs’ products, which is that there are no
truly “Juul compatible” cartridges other than those manufactured by Juul Labs alone. An
unsuspecting consumer, directly relying on the misrepresentations, could misuse Juul Labs’
products causing injury to members of the public who were deceived into misusing the products.
101. Juul Labs has been injured in its business, property, and reputation as a result of
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102. Juul Labs has no adequate remedy at law, and if Defendants’ negligent
misrepresentation is not enjoined, Juul will continue to suffer irreparable harm to the name,
A. A judgment that Defendants have infringed each of the D’102, D’536, and D’419
patents;
their affiliates, officers, agents, servants, employees, attorneys, dealers, confederates, and all
those persons acting for, with, by, through, under, or in active concert with them from any further
agents, affiliates, employees, and attorneys, and all those persons acting or attempting to act in
concert or participation with them, from designing, making, transferring, importing, exporting,
including devices or pods, without first providing sufficient proof to the Court that such products
have been approved by the FDA for sale in the United States (and this relief to include all online
activities as well);
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L. Any other remedy to which Juul Labs may be entitled, including all remedies
provided for in 35 U.SC. §§ 284, 285, and 289, and under any other law; and
M. Such other relief as the Court may deem just and proper.
JURY DEMAND
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Pursuant to Local Civil Rule 11.2, the undersigned counsel hereby certifies that this
matter in controversy is the subject of the following other matters pending in this Court:
1. Juul Labs, Inc. v. Eonsmoke, LLC, et al., Civil Action No. 18-14608, before the Hon.
2. Juul Labs, Inc. v. King Distribution LLC, et al., Civil Action No. 18-9233, before the
3. Juul Labs, Inc. v. HugeTrunk.com, et al., Civil Action No. 18-10281, before the Hon.
4. Juul Labs, Inc. v. 4X Pods, et al., Civil Action No. 18-15444, before the Hon. Kevin
5. Juul Labs, Inc. v. Juul Monster, et al., Civil Action No. 19-6399, before the Hon. Susan
D. Wigenton, U.S.D.J.
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Under Local Civil Rule 201.1, the undersigned counsel for Plaintiff Juul Labs, Inc.
hereby certifies that it seeks both monetary damages greater than $150,000 and injunctive and
other equitable relief, and therefore this action is not appropriate for compulsory arbitration.
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EXHIBIT 1
3/7/2019 Press
CaseAnnouncements > Statement Document
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1-1 FiledScott Gottlieb,
03/12/19 M.D., onPage
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FDA Statement
Statement
More than a year ago, the FDA unveiled a broad policy to reduce the death and disease caused by smoking.
Smoking remains the number one preventable cause of death in America, killing nearly half a million people a year.
If we aren’t successful in more sharply reducing the rate of addiction to tobacco, then we’ll continue to see this
needless death and disease. FDA’s new legal authorities to regulate tobacco ‒ as part of the Tobacco Control Act ‒
empowered us to alter this trajectory.
We saw an opening to push a generational shift in the deadly course caused by tobacco. And we’ve seized it.
Our comprehensive tobacco plan to combat the ill effects of smoking was founded on a central animating principle.
That what primarily causes death and disease from tobacco use isn’t the nicotine in these products. It’s the act of
lighting tobacco on fire to free that drug for inhalation.
While it’s the addiction to nicotine that keeps people smoking, it’s primarily the combustion, which releases
thousands of harmful constituents into the body at dangerous levels, that kills people.
This fact represents both the biggest challenge to curtailing cigarette addiction ‒ and also holds the seeds of an
opportunity that’s a central construct for our actions.
E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products
and onto nicotine delivery products that may not have the same level of risks associated with them. So, we set out
on a new rulemaking process that seeks to regulate the nicotine levels in combustible cigarettes to render them
minimally or non-addictive. That process is well underway.
And at the same time, we’re developing a path to properly regulate non-combustible forms of nicotine delivery, like
electronic cigarettes, that may be an alternative for adults who still want to get access to satisfying levels of
nicotine, without all the risks associated with lighting tobacco on fire.
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We saw an important opportunity. We saw a chance to leverage the potential benefits of new and non-combustible
technology to allow more adults to get nicotine from sources that could pose a lot less harm than smoking
cigarettes. We continue to believe in this central concept.
But let me be clear that nicotine isn’t a benign substance. This is especially true when it comes to children, and the
effects that nicotine has on a developing brain. That’s why we need a strong regulatory process that puts these new
products through an appropriate series of regulatory gates.
We need a regulatory process that requires product applications to show that the marketing of the product is
appropriate for the protection of the health of the overall population. And we need a regulatory process that keeps
these same electronic cigarette products out of the hands of youth.
This is our current policy framework to fulfill a central premise of our public health mandate.
We need to make sure that we properly evaluate the net public health impact of products like e-cigs before they get
marketing authorization from the FDA and that these products meet their regulatory responsibilities. Such products
may still pose health risks, including possibly releasing some chemicals at higher levels than conventional
cigarettes, and these potential risks require closer scrutiny.
But since electronic nicotine delivery system (ENDS) products had only been recently brought under FDA’s
regulatory jurisdiction, few of the foundational rules and guidance documents for defining and clarifying the
premarket authorization process for such products had been established at the time I joined the FDA 17 months
ago. So, to create this regulatory framework for how we’d properly evaluate the electronic nicotine delivery
products, we’ve committed to the development of guidance and regulations, including product standards, that will
better spell out the rules of the road. And we’re making significant progress toward achieving these procedural
goals.
If we succeed in our overall plan, the public health impact can dwarf anything else we’re able to accomplish in any
reasonable stretch of time. It can dwarf the introduction of any new medical technology. Analysis shows that our
plan has the potential to drop smoking rates from the current 15 percent to as low as 1.4 percent. It can prevent
more than 33 million people ‒ including children ‒ from becoming smokers; avoiding a lot of the death and disease
that’s going to be caused by cigarettes. Yet despite our progress, and these metrics, we find ourselves at a very
challenging crossroads in the execution of this plan.
That’s because we didn’t foresee the extent of what’s now become one of our biggest challenges. We didn’t predict
what I now believe is an epidemic of e-cigarette use among teenagers. Today we can see that this epidemic of
addiction was emerging when we first announced our plan last summer. Hindsight, and the data now available to
us, reveal these trends. And the impact is clearly apparent to the FDA.
Unfortunately, I now have good reason to believe that it’s reached nothing short of an epidemic proportion of
growth.
I use the word epidemic with great care. E-cigs have become an almost ubiquitous ‒ and dangerous ‒ trend among
teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction,
must end. It’s simply not tolerable. I’ll be clear. The FDA won’t tolerate a whole generation of young people
becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.
This fundamental commitment is why FDA launched our Youth Tobacco Prevention Plan earlier this year.
That plan encompassed a series of actions to stop youth use of tobacco products, especially the rising use of e-
cigarettes. Our Youth Tobacco Prevention Plan focuses on three key strategies. First, preventing youth access to
tobacco products. Second, curbing the marketing of tobacco products aimed at youth. And finally, educating teens
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Recognizing that our most immediate tool to address youth use is enforcement, this has been a cornerstone of our
approach. And it’s a tool that we’ll continue to deploy, and with growing vigor, to directly address this challenge.
We’ve taken a series of compliance actions over the past year. In partnership with the Federal Trade Commission,
we targeted misleadingly labeled or advertised e-liquids resembling kid-friendly foods like juice boxes, candy and
cookies. Since then, the manufacturers, distributors, and retailers that were warned by the FDA have stopped
selling products with the offending labeling and advertising. And, today, the FDA issued 12 warning letters to other
companies that continue to advertise and sell the violative products. This includes several companies that are also
cited by the FDA for illegally selling the products to kids.
We’ve also sharply expanded our enforcement against retailers who illegally sell e-cigarettes to kids.
This spring, we focused on sales of JUUL, issuing 56 warning letters and six civil monetary penalties to retailers as
part of this effort. And, today, we’re announcing that we’re taking other, significant enforcement and compliance
actions.
We’re announcing the largest ever coordinated initiative against violative sales in the history of the FDA. This is the
largest single enforcement action in agency history. It’s aimed at retail and online sales of e-cigarettes to minors.
We sent more than 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors. In addition, we
issued another 131 civil money penalties to stores that continued to violate the restrictions on sales to minors.
But we must do more to stem what I see as an epidemic of use of e-cigs among teens, and deeply disturbing trends
that show no sign of abating. So, we’re also going to re-visit the compliance policy that we announced last summer
to extend the application compliance periods for certain deemed products, including and especially the e-cigarettes
that were on the market as of Aug. 8, 2016. Under the current policy, the compliance date for filing applications for
such products was extended to Aug. 8, 2022.
We exercised that discretion for ENDS products because, as part of the tobacco and nicotine regulatory framework
that we developed, which includes pathways to transition smokers off combustible cigarettes, we wanted to allow
time for FDA to establish and more clearly explain the series of appropriate regulatory gates ‒ and for companies to
prepare quality applications for new products like e-cigarettes. That’s where the e-cigarettes and other non-
combustible products come into play. We wanted to make sure ‒ before we began enforcement of the application
requirements ‒ that there was a clear, viable pathway to seek FDA authorization to market alternative products for
adult smokers who still sought access to nicotine.
But in view of the accelerating use among youth, we’re actively considering whether we will enforce the premarket
review provision earlier, when it is apparent that these products are now subject to widespread youth use.
One factor we’re closely evaluating is the availability of characterizing flavors. We know that the flavors play an
important role in driving the youth appeal. And in view of the trends underway, we may take steps to curtail the
marketing and selling of flavored products. We’re now actively evaluating how we’d implement such a policy.
I’ve spent a lot of time considering whether there were different choices we could have made last summer that
would have lessened, or avoided, the epidemic of youth use that I believe is before us. As stewards of public
health, this is an important question that we must ask ourselves as we consider what steps to take at this
challenging crossroads.
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For instance, what if we hadn’t extended the compliance dates for filing applications for e-cigs on the market when
the deeming rule went into effect? In reality, most of those applications wouldn’t have been submitted until last
month. And the e-cigs would have remained on the market for at least an additional year while we reviewed them.
So, products would’ve still been on the market, and we might still have had the disturbing trends gripping us now in
2018.
When we set that comprehensive plan in motion, we also knew we didn’t have all the regulations and guidance that
we wanted in place to more clearly define the application pathway for these non-combustible alternatives. While the
statute places the burden on manufacturers to show with scientific evidence that the public health standards in the
law are met, we also understood that many manufacturers were new to regulation. And many novel products were
already on the market. Given the circumstances, we felt that it was important to provide clear, transparent, and
predictable rules of the road for industry. And so, for these reasons, we wanted to give the e-cig industry time to
come into compliance while we wrote the guidance and regulations to better define and explain how the new
products would meet those application requirements. It was an exercise in good government that was taken to
accommodate the continued availability of innovations that we believe have potential value.
But our public health mandate to prevent youth addiction has forced us to now revisit this element of our overall
plan.
The legal standard for FDA premarket review of a new tobacco product includes consideration of whether the
product would be appropriate for the protection of the public health. We must factor in whether these products get
kids addicted to nicotine. It’s that simple. And we are taking aggressive actions today to address this.
This may create some obstacles for some adults who also enjoy e-cigs. These are the hard tradeoffs that we’re
grappling with. But the youth risk is paramount.
It’s now clear to me, that in closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who
want to migrate off combustible tobacco and onto e-cigs.
I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth
trends. In my view, they treated these issues like a public relations challenge rather than seriously considering their
legal obligations, the public health mandate, and the existential threat to these products. And the risks mounted.
Well, I’m here to tell them that this prior approach is over. The FDA is closely watching the trends in youth use. And
if, as we expect, preliminary data that’s in our possession and will be finalized and released in the coming months
confirm our present observations that the youth use of e-cigs is rising very sharply; we’ll swiftly change course.
In the meantime, the FDA is announcing an escalating series of actions to forcefully address youth use trends.
It starts with the steps that we’re taking today, with the announcement of the largest coordinated tobacco
compliance effort in FDA’s history.
In addition, as I noted, we’re seriously reconsidering our compliance dates for the submission of product
applications when it is apparent that there’s widespread youth use of the product. We’re especially focused on the
flavored e-cigarettes. And we’re seriously considering a policy change that would lead to the immediate removal of
these flavored products from the market.
Today, we sent letters to five e-cigarette manufacturers whose products were sold to kids during the enforcement
blitz and that, collectively, represent more than 97 percent of the current market for e-cigs — JUUL, Vuse, MarkTen,
blu e-cigs, and Logic. These brands will be the initial focus of our attention when it comes to protecting kids.
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They’re now on notice by the FDA of how their products are being used by youth at disturbing rates.
Given the magnitude of the problem, we’re requesting that the manufacturers of these brands and products come
back to the FDA in 60 days with robust plans on how they’ll convincingly address the widespread use of their
products by minors, or we’ll revisit the FDA’s exercise of enforcement discretion for products currently on the
market.
Let me be clear. This may require these brands to revise their sales and marketing practices, including online sales;
to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig
products from the market until they receive premarket authorization and otherwise meet applicable requirements.
In the meantime, we’ll be investigating their marketing and sales practices, including with boots on the ground
inspections. The FDA is going to continue to work to find out why so many kids are using and abusing these
products.
We’re also re-examining the enforcement discretion we currently exercise for other e-cig products currently on the
market without authorization. Today’s letters target the five dominant e-cig manufacturers, including those whose
products were purchased by kids in our enforcement blitz. But the policy reconsiderations apply to the entire
category.
As we do this, we’re considering how the different products are being used by kids. The biggest youth use seems to
be among cartridge-based e-cigarettes, and not the open-tank vaping products. So, we’re exploring policy options
that could let us adjust the policy steps we take to account for different product use patterns between kids and
adults. Our focus is on the products that are being misused by minors.
We’re also going to permanently step up our enforcement actions with a sustained campaign to monitor, penalize
and prevent e-cig sales to minors in convenience stores and other retail sites. It’s clear there’s need for strong
federal enforcement of youth access restrictions.
We’ll continue to hold retailers accountable by vigorously enforcing the law with the help of our state partners. The
e-cig manufacturers ought to follow suit. They should also ensure that their online sales are not part of the problem.
Although today’s action included warning letters for online sales, following up on our retail blitz, we’re taking a hard
look at the manufacturer’s own internet storefronts and distribution practices. We’ll look at whether internet sites are
being used to make straw purchases with the intent for redistribution to minors. If young adults go online and buy
100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify, and FDA
will consider what steps we can take in these circumstances.
Let me be clear: Everything is on the table. This includes the resources of our civil and criminal enforcement tools.
If the companies don’t know, or if they don’t want to know, that straw purchases are occurring, we’ll now be helping
to identify it for them. If violative activities are found, the FDA has both civil and criminal remedies at its disposal.
We are also investigating whether makers of certain e-cig products may be subject to enforcement for marketing
new products that don’t have pre-market authorization and were introduced after the FDA’s compliance date.
And next week, we’re also announcing a national campaign to warn teenagers of the dangers of nicotine and e-
cigarette use. This public campaign will bring these public health messages to online sites that we know teenagers
access, and even to high school bathrooms.
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new steps to address
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8 PageID: of youth e-cigarette …
I challenge e-cig manufacturers to take equally bold action to reform their own practices. There’s some historical
advertising that I’ve seen, especially on social media, that gives me pause as to how earnest some of these
companies were in making sure that kids didn’t use their products.
As I noted earlier, we’ll also be taking steps beyond compliance and enforcement. We plan to update our
recommendations that lay out the Pre-Market Tobacco Product application pathway and the evidence we expect to
see when manufacturers file those applications. We believe there’s no excuse for manufacturers not to file
applications with the FDA because the agency hasn’t told them what they are expected to do. If any manufacturer
wants to get direct, precise guidance on a specific product application, just call us. Request a meeting. Our door is
open. And our policy is to grant pre-submission meetings to help manufacturers understand our expectations.
The staff of our Center for Tobacco Products is also working on an overall policy roadmap to address these trends,
while remaining true to the goals of our comprehensive plan announced last summer, and to the public health
purpose that animates our work every day. They’ll be presenting to me a strengthened approach, building on our
Youth Tobacco Prevention Plan, to address the rising use of e-cigs by minors. I’ll communicate the additional
decisions that we make together as an agency in a timely fashion.
The steps I’m announcing today are the initial elements of these new efforts that we’re committing to right away. I
believe there’s an epidemic of youth use. We have good reason to draw this conclusion based on the trends and
data that we’ve seen, some of which is still preliminary and will be finalized in the coming months and presented
publicly. But our actions today are firmly rooted in what we’ve learned. There’s no mistaking the risks.
At the FDA, we still believe that new innovations that don’t use combustion, like the electronic cigarettes, offer an
important opportunity for adults to transition off combustible tobacco. I still believe in this opportunity. I still believe in
the concept of modified risk products. I still believe that tobacco products exist on a continuum of risk, and that
there are opportunities to move adult smokers down that ladder of harm. The leadership of the FDA’s tobacco
center still firmly believes in this concept.
And we’re all committed to helping reduce the overall burden of risk to our nation.
We’re committed to saving lives. And we’re committed to changing the trajectory of death and disease from
tobacco.
We started to confront these trends right out of the gate with the comprehensive tobacco policy that we announced
last summer. We ramped up these efforts with the announcement of our Youth Tobacco Prevention Plan last spring.
And today, we’re taking a new turn in our efforts as youth trends worsen. We’ll bend that trajectory on this growing
youth addiction. We must succeed. But we’re not the only party to this problem.
Industry must step up to this challenge. The companies selling the brands that resulted in the most illegal sales in
our enforcement blitz have 60 days to respond with forceful plans of their own or face regulatory consequences.
They say they’ve changed from the days of Joe Camel. But look at what’s happening right now, on our watch and
on their watch. They must demonstrate that they’re truly committed to keeping these new products out of the hands
of kids and they must find a way to reverse this trend.
I believe in the power of American ingenuity to solve a lot of problems, including this one. I’m deeply disturbed by
the trends I’ve seen. I’m disturbed by an epidemic of nicotine use among teenagers. So, we’re at a crossroads
today. It’s one where the opportunities from new innovations will be responsibly seized on right now, or perhaps lost
forever.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm 6/7
3/7/2019 Press
CaseAnnouncements > Statement Document
2:19-cv-08405 from FDA Commissioner
1-1 FiledScott Gottlieb,
03/12/19 M.D., onPage
new steps to address
8 of epidemic46
8 PageID: of youth e-cigarette …
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is responsible for the safety and security of our
nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating
tobacco products.
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EXHIBIT 2
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First Great E-Cig | WIRED
Page 2 of 13 PageID: 48
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EVERYONE AT PAX Labs is vaping. Puffs of white clouds rise every few seconds,
from seemingly every desk on the second floor of this unassuming building in
San Francisco's Mission district. As the haze clears, the office comes into focus:
bustling, cramped, and messy. The eight-year-old company is growing quickly,
and the space is too small. It's also one floor below the offices of Burning Man,
which, judging from the loud thumps coming through the ceiling every few
minutes, exists in a perpetual state of Burning Man-ness.
Inside a glass-walled conference room, Pax Labs CEO James Monsees leans back
in his chair and tells the story of the company's newest
Subscribe
product, Juul. It's an e-
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cigarette system, with a pocket-size vaporizer and nicotine juice cartridges you
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It's not a stretch for a company known for cannabis vaporizers, but its arrival in
the e-cig market signals a major shift. Once known as Ploom—the name is still
on its doors and business cards—the company made two beloved vaporizers,
the Pax and Pax 2. Both showed strong design savvy, which lead some to call it
"the Apple of vaping." But it recently sold the Ploom brand name and some of
its intellectual property to Japanese tobacco conglomerate JTI in order to
escape their corporate partnership. Now it's known as Pax Labs.
With a new name comes a new product, Juul. The $50 e-cig is aimed at nothing
less than leveling-up the market with a delicious, beautiful, safe, and just flat-
out better product. It comes at a pivotal moment for the industry, which is
exploding in popularity even as its health concerns and advertising regulations
are hotly debated. Whatever the future, though, Pax is betting on Juul.
So far, even as they've become mainstream, e-cigs have come in one of two
packages. They're either small and round, designed to look and feel as much as
possible like a cigarette, or they're huge, assembled from many parts, and
spectacularly complicated. Even the best of them look like you're smoking from
an oboe.
It's a long, thin, slightly rounded rectangle. It's mostly battery, I'm told, save for
a slot at the top where you pop in a tiny pack of nicotine-infused "juice," which
Pax will sell in color-coded flavors. You don't clean it, and there's no work
involved: just put it in your mouth and inhale. The juice comes in four absurdly-
named flavors—tabaac, fruut, miint, bruulé—and costs $16 for a four-pack of
cartridges (a cartridge is roughly equivalent to a pack of smokes).
Pax is trying to build something different. The team searches for the right
analogy: It's like a Nespresso machine, if a Nespresso machine still made great
coffee. No, it's like a gun. Wait, Monsees cuts in, it's not like a gun. Please don't
make that comparison. What's a thing where you make it easier and better all at
once?
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Not to get all cliché about it, but here's the analogy: Pax is trying to makeSUBSCRIBE
the
iPhone of e-cigs.
It purposely doesn't look or feel like a cigarette. Pax wants the Juul to be an
evolution of the cigarette, not a technologically advanced approximation of it.
Plus, Monsees argues, what makes a cigarette enticing isn't the burning paper
and nasty smell. It's something more ineffable. "It's just objectively cool," says
Ari Atkins, an R&D engineer at Pax. "How do you make somebody look cooler?
Give them a cigarette." That's why Pax paid so much attention to the gray-and-
black design, which looks far sleeker and better than your average gigantic
multi-piece vape. You do look a little like you plugged a USB stick into your
mouth when you use it, but it's undeniably cooler than that insipid mess of
tubes and glowsticks you're probably using now.
Smoking is also all about rituals, which Monsees calls "the fidget factor."
Rolling your own, if you're into that, or banging the pack against your palm if
you're not. The first smoke of the day, the last smoke of the day. Just lighting
the damn thing. The Juul offers a few tics of its own: tap the side of the device
twice, and the LED light on the front blinks an indication of your remaining
battery. It charges in a tiny dock that slips into any USB slot, and there's
something wonderfully satisfying about dropping it into the magnetic charger.
(Magnets!) If you wave the Juul around, it lights up in a rainbow of colors.
PAX LABS
A Different Draw
Monsees isn't puffing on a Juul as he discusses its origins—though several of
the half-dozen people at the table are—but he has a long history with e-
cigarettes. Years ago, he convinced his brother to go to Hong Kong to buy and
ship him the first e-cig on the market. "It was like this giant box you had to buy,
because
3 A r t i c l e syou couldn't buy cartridges for it ever again.
Left So you'd
Subscribe Sign In buy this kit that
cost like 300 bucks, this huge thing." It was terrible. "It didn't produce any
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vapor. The flavor was terrible, it was only one flavor and it was this horrible
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tobacco-type flavor."
Since then, e-cigs have become both popular and plentiful. Forget shipping
from Hong Kong; you can buy one for six bucks at the convenience store. "If you
came in to buy a pack of cigarettes," Monsees says, "which is going to cost you 6
to 12 dollars or something, and there's this thing on the counter that's the same
but costs less, why would you not try that?" Usage and awareness of e-cigs have
been climbing for years, and at least among teens they've even become more
popular than actual cigarettes.
Since there's very little protective intellectual property and very little
regulation, anyone and everyone can get in the e-cig market. "All you have to do
is have a phone call to one of the six manufacturers or so in China that are
producing these e-cigarettes," Monsees says. "And oh, I want it to be an orange
tip on the end and say Orange on the packaging. It's an hour-long conversation,
maybe, and a couple weeks to receive delivery, and you're in the e-cig business."
There's one catch, though: they almost all suck. "One, they don't deliver a lot of
vapor. Two, they're really awkward to use and kind of cheaply made. Three, they
just don't deliver nicotine in the same way the cigarette does." Everyone's
working with essentially the same idea, the same product. As with Big Tobacco
a few decades ago, the war is won and lost in the marketing.
A Salty Solution
Pax hopes it can overcome marketing muscle with quality; the only way to stand
the test of time, and survive whatever regulation is coming, is to simply build
something great. Pax starts with technology: they call themselves a playground
for innovation, and talk often about "modernizing" smoking. This tiny company
believes it can design the product better, build the heating mechanism better,
and make every aspect of the smoking and vaping experience better.
PAX LABS
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Even Pax's nicotine is supposedly better than everyone else's. Atkins tries to
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explain: "In the tobacco plant, there are these organic acids that naturally occur.
And they help stabilize the nicotine in such a way that makes it …" He pauses.
"I've got to choose the words carefully here: Appropriate for inhalation."
Steve Christensen, a design engineer, pipes in. "Smoother," he says. Atkins goes
with that. "Yeah, it's smoother." Most e-cig manufacturers, he explains, are
dissolving raw nicotine into their juices, "and they were not getting the full
picture that they needed." You won't find raw nicotine in nature, he says; it's
mixed in with organic acids and other substances. It's this cocktail that makes
nicotine palatable. "We figured out how to incorporate some of these organic
acids into the juice," Atkins says, "so we were able to get a very cigarette-like
experience."
Long-term, though, the Juul's careful way of vaporizing that nicotine is its real
secret sauce. The temperature of the heating coil is controlled to give you the
largest possible cloud of vapor, but none of the dangerous chemicals or
compounds, like formaldehyde, that come with overheating the coil or the juice.
This is Pax's product, maybe even more than the Juul itself. "The underlying
technology, the vaporization technology, is so valuable and can be really
disruptive in a lot of different markets," Monsees says. He declines to say more,
but the implications are clear: Vaporization is an excellent way to consume
everything from weed to cancer-fighting drugs, and being able to exactly
control delivery could be hugely powerful.
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A Tricky Sell SUBSCRIBE
Let's assume Pax has made the best e-cig on the planet, and that it can convince
people that the Juul is worth paying for. It's still facing huge obstacles that have
nothing to do with the quality of its product. E-cigarettes have until now lived
outside of the tobacco industry's stringent regulation, but that's going to
change quickly, especially as the big tobacco companies continue to take over
and consolidate the market. And until then, those companies are free to spend
millions marketing their products, and Monsees freely admits Pax can't
compete with sexy Blu spreads in the Sports Illustrated swimsuit issue, or
NJOY's yearly Super Bowl ad.
The broader debate, about e-cigs' safety, will have even bigger implications for
Pax and its many competitors. Some celebrate the fast growth of e-cigs, saying
they're leading people to stop smoking more harmful products; there's a fairly
clear correlation in recent data between the uptick in e-cigs among teens and
the downturn in tobacco smoking. Others point to similar correlations between
e-cigs and asthma, lung inflammation, or MSRA. Still others say e-cigs are a
gateway drug into cigarettes, and that they may have long-term effects we don't
yet understand. The only certainty seems to be that no one yet knows for sure.
Monsees neatly avoids taking a stand. He can't take one, really, because making
health claims—even the "it's not the worst thing!" counterfactual—will invoke
the wrath of the FDA. But he also says Pax doesn't need to worry about the
morality of it all. "People are going to do what they want to do." Their job, as in
any market, is to give people a better way to do it. "We want to do the right
thing, but we can't be the mouths of what the right thing is."
Yet he almost can't help but point out a line in a New York Times article that
was broadly negative on the prospects of e-cigs. It quotes David B. Abrams, the
executive director of the Schroeder Institute for Tobacco Research and Policy
Studies. "They're not a gateway in, and they might be accelerating the gateway
out," he tells the Times.
"In the end," Monsees says, "if regulators determine that these are safer
products, how is that not a great thing? And why is that headline not 'Hey,
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finally there's alternatives, there's movement in this industry after 150 years,
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EXHIBIT 3
3/7/2019 JUUL Filed
Case 2:19-cv-08405 Document 1-3 Youth Prevention
03/12/19 | JUULPage 2 of 6 PageID: 61
YOUTH PREVENTION
https://www.juul.com/youth-prevention?&ag=CA 1/5
3/7/2019 JUUL Filed
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03/12/19 | JUULPage 3 of 6 PageID: 62
We have pledged $30 million over the next three years to independent research, youth
and parent education and community engagement. We are working closely with Iowa
Attorney General Tom Miller and the group he assembled consisting of public health
officials and tobacco control experts.
Our e-commerce platform utilizes unique ID match and age verification technology to
make sure minors are not able to access and purchase our products online.
We market our products responsibly, following strict guidelines to have material directed
toward adult smokers and not to youth audiences. (Please read our Marketing & Social
Media Code)
We support effective legislation and regulation to prevent the purchase and use of our
products by minors.
We have reseller terms that include monitoring and penalties for noncompliance with
underage restrictions.
https://www.juul.com/youth-prevention?&ag=CA 2/5
3/7/2019 JUUL Filed
Caseg2:19-cv-08405 Document 1-3 Youth Prevention
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Our packaging includes a prominent nicotine label which reads "WARNING: This
product contains nicotine. Nicotine is an addictive chemical." as well as the
additional statement “The alternative for adult smokers.”
We collaborate with law enforcement on local youth prevention activity and support
local programs that address youth education and prevention.
Because of the regulated nature of our product, we conduct random compliance checks
of independent retail stores using our secret shopping program. We evaluate hundreds
of locations every month.
We actively monitor the internet and process thousands of enforcement actions per
month. Our goal is to ensure only authorized retailers who are subject to our youth
prevention controls are selling JUUL products.
We are restricting the sales of flavored JUUL pods (Mango, Fruit, Cucumber, and Creme)
and stopping their distribution to traditional retail outlets immediately.
These flavored JUUL pods will be sold only through a restricted system that limits sales
to consumers who are at least 21 years old and imposes bulk-purchasing restrictions.
We believe these measures will significantly restrict the ability of youth to access JUUL
products.
We are enhancing our ecommerce platform, JUUL.com, to ensure consumers are at least
21 years old and will continue to restrict bulk purchases. We will implement two-factor
authentication to link purchases to a user’s cell phone for additional identity and age
verification and incorporate facial-recognition technology to prevent the use of
fraudulent identification to override the system.
We are exiting our U.S. social media platforms (Facebook and Instagram), maintaining
our Twitter account only for the use of non-promotional communications.
https://www.juul.com/youth-prevention?&ag=CA 3/5
3/7/2019 JUUL Filed
Case 2:19-cv-08405 Document 1-3 Youth Prevention
03/12/19 | JUULPage 5 of 6 PageID: 64
We are implementing product traceability that will allow us, through confiscated
product, to identify where youth are obtaining JUUL products. We will share this
information with FDA, and take actions immediately to address these access points for
youth.
We will develop a new user-authenticated JUUL device that can prevent those underage
from using the product.
We believe these actions, taken together, will reduce youth use, but will continue to
evaluate how best to ensure no youth ever uses JUUL products.
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EXHIBIT 4
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CaseAnnouncements > Statement Document
2:19-cv-08405 from FDA Commissioner
1-4 FiledScott Gottlieb,
03/12/19 M.D., onPage
meetings
2 with
of 5 industry related 67
PageID: to the agency’s ongoi…
FDA Statement
Statement
Last month, I issued a call to action – to the FDA and to the e-cigarette industry – to stem the alarming increase in
youth use of e-cigarettes. For the FDA, that has included an escalating series of steps that utilize the full range of
our regulatory authorities, including increased enforcement of age- and identification-verification requirements, as
well as re-examining aspects of our comprehensive plan
(/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm) on tobacco and nicotine regulation in order to
strengthen our Youth Tobacco Prevention Plan. We’re committed to announcing a new action plan by mid-
November that will set forth a series of new, forceful steps to firmly confront and reverse the youth addiction trends
that are at epidemic levels.
For the e-cigarette industry, my message was simple: Step up. Even as the FDA builds a framework to mandate
additional restrictions and actions to address these trends, we welcome voluntary steps by companies to address
these concerns. I asked five manufacturers whose products, collectively, represent more than 97 percent of the
current market for closed-system e-cigarettes to meet with me personally to discuss this vital public health
challenge, as well as to submit written plans outlining the steps they intend to take to confront the rising trends in
youth use. Each of these companies market products that recently had been sold illegally to minors, either through
brick-and-mortar stores or online retailers. Everyone involved in this market has a shared responsibility to address
this public health crisis.
Following that call to action, I have met in the past several weeks with the leadership of five companies – Altria
Group Inc., JUUL Labs Inc., Reynolds American Inc., Fontem Ventures, and Japan Tobacco International USA Inc.
These have been constructive meetings. The companies acknowledged the serious public health consequences
associated with youth use of tobacco products. They presented thoughtful proposals, consisting not only of what
steps they would take themselves to restrict youth access to and appeal of these products, but also steps that they
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3 with
of 5 industry related 68
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think the FDA and other policy-makers can take to reverse the trends in youth use of e-cigarettes. Some stated
explicitly that preventing youth use must be a priority, and that any potential benefits of e-cigarettes for adult
smokers cannot justify significant increases in youth use and addiction.
The companies acknowledged the role that flavored e-cigarette products play in appealing to kids, as well as the
role that flavored e-cigarettes can also play in helping adult smokers quit. On this point, their proposals at the
meetings reflected a range of ideas: for instance, that the FDA restrict distribution of certain flavored products to
channels with enhanced age verification processes. Or that the agency require certain products that are more
appealing to kids to come off the market until these products receive premarket authorization from the agency.
The companies also acknowledged the power of social sourcing of tobacco products – in other words, of-age
purchasers sharing or selling products to underage friends – in contributing to youth tobacco use. To address this
issue, some companies said that they would support raising the minimum age to purchase tobacco to 21 years of
age. Companies also described their current actions to promote retailer compliance with age- and identification-
verification requirements, and they committed to providing more information in their written submissions to the
agency.
These have been useful dialogues. We welcome the feedback and proposals to address the youth epidemic, which
will help inform the FDA’s consideration of policy approaches.
At the FDA, we’re considering the data and proposals shared by the companies, in addition to the disturbing data in
youth use trends that has come to light over the past months as we continue to re-examine the FDA’s regulatory
approach. We are committed to taking the necessary steps to fully confront the epidemic of e-cigarette use that has
gripped the nation’s youth and set in motion an accelerating epidemic. I’ve stated clearly, all options are on the
table. In the coming weeks, we’ll continue to communicate about the steps that we are taking to forcefully address
youth use of e-cigarettes. And we will continue to seek public input from a diverse set of stakeholders, including
public health advocates and the manufacturers and retailers affected by these policies.
To inform our approach, we’re looking at a variety of factors, including how different types of electronic nicotine
delivery systems (ENDS) products are used by kids; the popularity of various products, such as cartridge-based e-
cigarettes; the popularity of non-tobacco flavors; and the strength of various distribution methods in ensuring robust
age verification.
As we consider new and updated policies to our initial comprehensive plan for tobacco and nicotine regulation and
address the rising rates of youth e-cigarette use, we’ll also stay true to the public health goals that animated the
approach that we announced in July 2017. We still believe that new innovations that don’t use combustion, such as
many e-cigarettes, may offer an important opportunity for adults to transition off combustible tobacco. We still
believe that non-combustible forms of nicotine delivery may be less harmful alternatives for currently addicted adult
smokers who still seek nicotine, without the risks associated with combustible cigarettes. And we want to keep this
option for adults open.
But, as I’ve said before, the current trends in youth use are not tolerable. We have warned for more than a year that
the availability of e-cigarettes cannot come at the expense of addicting a generation of youth on nicotine through
these products. We gave ample warnings of the worrisome trends we were observing with respect to rising youth
popularity of these products. Now we have hard data to support that public health tragedy that is now underway.
And in order to firmly confront and reverse these trends – and fulfill the central premise of our public health
mandate – we may need to take actions that might narrow the off-ramp from smoking for adults in order to close the
on-ramp to nicotine addiction to kids.
Achieving the right balance requires a strong regulatory process that protects our nation’s youth.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624657.htm 2/4
3/7/2019 Press
CaseAnnouncements > Statement Document
2:19-cv-08405 from FDA Commissioner
1-4 FiledScott Gottlieb,
03/12/19 M.D., onPage
meetings
4 with
of 5 industry related 69
PageID: to the agency’s ongoi…
We welcome the constructive dialogue we had with manufacturers. These manufacturers have an opportunity to
demonstrate – through their actions – that we can work collectively to address this crisis, and that they share our
earnest intent to keep these products out of the hands of kids. We’ll continue to ensure that the companies making
and selling these products are doing their part to reverse this epidemic and we’ll hold accountable those that don’t
take this responsibility seriously.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is responsible for the safety and security of our
nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating
tobacco products.
###
Inquiries
Media
Consumers
888-INFO-FDA
Related Information
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette
use (/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm)
Follow FDA
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624657.htm 3/4
3/7/2019 Press
CaseAnnouncements > Statement Document
2:19-cv-08405 from FDA Commissioner
1-4 FiledScott Gottlieb,
03/12/19 M.D., onPage
meetings
5 with
of 5 industry related 70
PageID: to the agency’s ongoi…
2017 (/NewsEvents/Newsroom/PressAnnouncements/2017/default.htm)
2016 (/NewsEvents/Newsroom/PressAnnouncements/2016/default.htm)
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624657.htm 4/4
Case 2:19-cv-08405 Document 1-5 Filed 03/12/19 Page 1 of 4 PageID: 71
EXHIBIT 5
Case 2:19-cv-08405 Document 1-5 Filed 03/12/19 Page 2 of 4 PageID: 72
It has come to our attention that Eonsmoke, LLC may be manufacturing new finished tobacco
products including, but not limited to, the products referenced below without premarket
authorization, as required by §910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 1 :
The products referenced above appear to meet the definition of a tobacco product as set forth in
§201(rr) of the FD&C Act. Although FDA has extended the compliance deadlines for the
premarketing requirements for deemed products, FDA’s compliance policy applies only to those
deemed products that were on the market as of August 8, 2016. FDA has received complaints
that Eonsmoke, LLC may have first commercially marketed the products referenced above in the
United States after August 8, 2016.
1
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf
U.S. Food & Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Case 2:19-cv-08405 Document 1-5 Filed 03/12/19 Page 3 of 4 PageID: 73
Page 2 - TC0003968
1. For the brand names referenced above, please list all sub-brands under the brand name,
including all applicable sizes, flavors, nicotine strengths, and other variations. For each
sub-brand, confirm whether you are currently marketing the product in the United States,
and the date that the product was first commercially marketed in the United States. FDA
suggests that you use a chart similar to the following example to help us understand your
response:
2. For each of the products listed above, please provide the following information, as
applicable:
a. Evidence that your product was commercially marketed (other than for test
marketing) as of February 15, 2007; 2
b. Evidence that your product is a deemed product that was on the market on August
8, 2016, and has not been modified since that date; 3
c. Evidence that your product was first introduced or delivered for introduction into
interstate commerce for commercial distribution after February 15, 2007, and
prior to March 22, 2011, and for which a 905(j) (or substantial equivalence) report
was submitted no later than March 22, 2011; 4
d. Evidence that FDA has issued an order permitting the marketing of this product;
and/or
e. Evidence, which may include a statement from the firm, that the firm is currently
not marketing the above-listed product(s).
2
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm416495.htm
3
See “Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers and Distributors of Newly
Deemed Products, located here for more information.
https://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm501016.pdf
4
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM436468.pdf
Case 2:19-cv-08405 Document 1-5 Filed 03/12/19 Page 4 of 4 PageID: 74
Page 3 - TC0003968
We request that a written response be submitted within 30 days of receipt of this letter. The
response and any further correspondence regarding this matter should reference the Submission
Tracking Number listed above. We encourage you to send your response electronically via the
CTP Portal 5 using eSubmitter. 6 However, you may also send your response by mail to our
Document Control Center:
If you have any questions concerning this matter, please contact the Center for Tobacco
Product’s Office of Compliance and Enforcement via email at CTP-OCE-
Postmarket@fda.hhs.gov.
Sincerely yours,
5
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Manufacturing/ucm515047.htm
FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal.
6
http://www.fda.gov/ForIndustry/FDAeSubmitter
Case 2:19-cv-08405 Document 1-6 Filed 03/12/19 Page 1 of 4 PageID: 75
EXHIBIT 6
Case 2:19-cv-08405 Document 1-6 Filed 03/12/19 Page 2 of 4 PageID: 76
It has come to our attention that ZLab S.A. may be importing new finished tobacco products
including, but not limited to, Ziip Pods and/or Zpods without premarket authorization, as
required by §910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 1 The products
referenced above appear to meet the definition of a tobacco product as set forth in §201(rr) of the
FD&C Act. Although FDA has extended the compliance deadlines for the premarketing
requirements for deemed products, FDA’s compliance policy applies only to those deemed
products that were on the market as of August 8, 2016. FDA has received complaints that ZLab
S.A. may have first commercially marketed the products referenced above in the Unites States
after August 8, 2016.
1. For the brand names referenced above, please list all sub-brands under the brand name,
including all applicable sizes, flavors, nicotine strengths, and other variations. For each
sub-brand, confirm whether you are currently marketing the product in the United States,
and the date that the product was first commercially marketed in the United States. FDA
suggests that you use a chart similar to the following example to help us understand your
response:
1
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf
U.S. Food & Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Case 2:19-cv-08405 Document 1-6 Filed 03/12/19 Page 3 of 4 PageID: 77
Page 2 - TC0003977
2. For each of the products listed above, please provide the following information, as
applicable:
a. Evidence that your product was commercially marketed (other than for test
marketing) as of February 15, 2007; 2
b. Evidence that your product is a deemed product that was on the market on August
8, 2016, and has not been modified since that date; 3
c. Evidence that your product was first introduced or delivered for introduction into
interstate commerce for commercial distribution after February 15, 2007, and
prior to March 22, 2011, and for which a 905(j) (or substantial equivalence) report
was submitted no later than March 22, 2011; 4
d. Evidence that FDA has issued an order permitting the marketing of this product;
and/or
e. Evidence, which may include a statement from the firm, that the firm is currently
not marketing the above-listed product(s).
We request that a written response be submitted within 30 days of receipt of this letter. The
response and any further correspondence regarding this matter should reference the Submission
Tracking Number listed above. We encourage you to send your response electronically via the
CTP Portal5 using eSubmitter. 6 However, you may also send your response by mail to our
Document Control Center:
2
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm416495.htm
3
See “Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers and Distributors of Newly
Deemed Products, located here for more information.
https://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm501016.pdf
4
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM436468.pdf
5
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Manufacturing/ucm515047.htm
FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal.
6
http://www.fda.gov/ForIndustry/FDAeSubmitter
Case 2:19-cv-08405 Document 1-6 Filed 03/12/19 Page 4 of 4 PageID: 78
Page 3 - TC0003977
If you have any questions concerning this matter, please contact the Center for Tobacco
Product’s Office of Compliance and Enforcement via email at CTP-OCE
Postmarket@fda.hhs.gov.
Sincerely yours,
EXHIBIT 7
Case 2:19-cv-08405 Document 1-7 Filed 03/12/19 Page 2 of 47 PageID: 80
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Page 25
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acute effects of electronic cigarettes : Nicotine delivery profile and Glovsky and Popeo , P.C .; Michael D . Van Loy
cardiovascular and subjective effects,” Cancer Epidemiology
Biomarkers Prevention , 19( 9 ), pp . 1945 - 1953 . Jul. 20 , 2010 . (57 ) CLAIM
Vansickel, et al., “ Electronic cigarettes: effective nicotine delivery The ornamental design for a vaporizer device with cartridge ,
after acute administration ,” Nicotine & Tobacco Research , 15 ( 1) , as shown and described .
pp . 267- 270 . Jan . 2013 .
Vape World ; Original PAX Vaporizers for Portable and Home Use ; DESCRIPTION
retrieved from : https ://www . vapeworld .com / pax -vaporizer -by
ploom ? gclid = CPCi1PKojskCFU06gQodPr; 9 pgs., retrieved Nov . 1. 1 is a top , rear, and right side perspective view of a
13 , 2015 . vaporizer device with cartridge showing a first embodiment
Vaporesso (Shenzhen Smoore Technology Limited ). “ Target Pro of our design ;
Vape Mod .” Vape Batteries & Mods Target Pro Vape Mod 1 . 2 is a top view thereof;
| Vaporesso , Date Accessed Feb . 20 , 2018 . www .vaporesso . com /
vape -batteries -and -mods/target-pro -vape -mod . 1 . 3 is a left view thereof;
Vaporesso (Shenzhen Smoore Technology Limited ). “ TAROT PRO 1 .4 is a rear view thereof;
Vape Mod .” Vape Batteries & Mods | Tarot Pro Vape Mod || 1. 5 is right side view thereof;
Vaporeso , Date Accessed Feb . 20 , 2018 . www .vaporesso .com / vape 1 .6 is a front view thereof; and
batteries-and -mods/tarot-pro -vape -mod . 1 . 7 is a bottom view thereof.
Wells . “ Glycerin as a Constituent of Cosmetics and Toilet Prepa 2 . 1 is a top , rear, and right side perspective view of a
rations." Journal of the Society of Cosmetic Chemists, 1958 ; 9 ( 1 ): vaporizer device with cartridge showing a second embodi
19 - 25. ment of our design ;
Williams,Monique , and Prue Talbot. “ Variability among electronic 2 .2 is a top view thereof;
cigarettes in the pressure drop , airflow rate, and aerosol production .”
Nicotine & Tobacco Research 13 . 12 (2011). 2 . 3 is a left view thereof;
Youtube, “ Pax 2 Unboxing,” retreived from www .youtube .com / 2 .4 is a rear view thereof;
watch ?v = Vjccs8co3YY, posted Apr. 20 , 2015 . 2 .5 is right side view thereof;
YouTube; Firefly Vaporizor Review w / Usage Tips by the Vape 2 .6 is a front view thereof; and
Critic ; retrieved from the internet (http ://www .youtube.com / 2 .7 is a bottom view thereof.
watch ?v = 1J38NOAV7wl); published Dec . 10 , 2013 ; download /print 3. 1 is a top, rear, and right side perspective view of a
date : Feb . 18 , 2015 . vaporizer device with cartridge showing a third embodiment
Youtube; Pax by Ploom Vaporizer Review ; posted Aug . 14 , 2013 , of our design ;
retrieved Sep . 8, 2016 , https://www .youtube.com / 3 .2 is a top view thereof;
watch ? v = Jm06zW3-cxQ . 3 . 3 is a left view thereof;
Zhang, et al., “ In vitro partical size distributions in electronic and
conventional cigarette aerosols suggest comparable deposition pat 3 .4 is a rear view thereof;
terns,” Nicotine Tobacci Research , 15 (2 ), pp . 501 -508 . Feb . 2013 . 3 .5 is right side view thereof;
3 .6 is a front view thereof ; and ,
* cited by examiner 3 . 7 is a bottom view thereof.
Primary Examiner — Michael A . Pratt 1 Claim , 21 Drawing Sheets
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EXHIBIT 8
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EXHIBIT 9
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USOOD744419S
sae«,
JS 44 (Rev. 06/17)
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CIVIL COVER SHEET
The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
(b) County of Residence of First Listed Plaintiff San Francisco, CA County of Residence of First Listed Defendant Passaic, New Jersey
(EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY)
NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.
(c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known)
Arnold B. Calmann (abc@saiber.com); SAIBER LLC
One Gateway Center; 10th Floor, Suite 1000
Newark, New Jersey 07102; Tel.: 973.622.3333
II. BASIS OF JURISDICTION (Place an “X” in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff
(For Diversity Cases Only) and One Box for Defendant)
" 1 U.S. Government " 3 Federal Question PTF DEF PTF DEF
Plaintiff (U.S. Government Not a Party) Citizen of This State " 1 " 1 Incorporated or Principal Place " 4 " 4
of Business In This State
" 2 U.S. Government " 4 Diversity Citizen of Another State " 2 " 2 Incorporated and Principal Place " 5 " 5
Defendant (Indicate Citizenship of Parties in Item III) of Business In Another State
The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as
required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is
required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of
Court for each civil complaint filed. The attorney filing a case should complete the form as follows:
I.(a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use
only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and
then the official, giving both name and title.
(b) County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the
time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land
condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.)
(c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting
in this section "(see attachment)".
II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X"
in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below.
United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here.
United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box.
Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment
to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes
precedence, and box 1 or 2 should be marked.
Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the
citizenship of the different parties must be checked. (See Section III below; NOTE: federal question actions take precedence over diversity
cases.)
III. Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this
section for each principal party.
IV. Nature of Suit. Place an "X" in the appropriate box. If there are multiple nature of suit codes associated with the case, pick the nature of suit code
that is most applicable. Click here for: Nature of Suit Code Descriptions.
VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional
statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service
VII. Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P.
Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction.
Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded.
VIII. Related Cases. This section of the JS 44 is used to reference related pending cases, if any. If there are related pending cases, insert the docket
numbers and the corresponding judge names for such cases.
Date and Attorney Signature. Date and sign the civil cover sheet.
Case 2:19-cv-08405 Document 1-11 Filed 03/12/19 Page 1 of 1 PageID: 188
AO 120 (Rev. 08/10)
In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
filed in the U.S. District Court DISTRICT OF NEW JERSEY - NEWARK COURT on the following
! Trademarks or ! Patents. ( ! the patent action involves 35 U.S.C. § 292.):
In the above—entitled case, the following patent(s)/ trademark(s) have been included:
DATE INCLUDED INCLUDED BY
!
Amendment ! Answer ! Cross Bill ! Other Pleading
PATENT OR DATE OF PATENT
HOLDER OF PATENT OR TRADEMARK
TRADEMARK NO. OR TRADEMARK
1
In the above—entitled case, the following decision has been rendered or judgement issued:
DECISION/JUDGEMENT
Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy