IB Business Management – Internal Assessment

2021/2022

To what extent did Juul’s negative publicity affect its position

in the market?

Word count: 1540

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 Table of contents

Introduction…………………………………………...............................................................3

Methodology…………………………………………..............................................................3

SWOT analysis……….………………………………………….............................................3

STEEPLE analysis……….…………………………………………......................................4
Social……………………………………………………………………………………….....5
Environmental…………………………………………………….………………………….5
Economic……………………………………………………………………………………..5
Ethical………………………………………………………………………………………..5

Market Share………………………………………………………………………………...5

Conclusion……………………………………………………………………………….......6

Bibliography………………………………………………………………………………....7

Supporting documents……………………………………………………………………....8

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To what extent did Juul’s negative publicity affect its position in the market?

Introduction

Juul is an American electronic cigarette company, based in San Francisco, USA, that has a
product portfolio of a wide assortment of products now available on the market, ranging from
vapes, electronic cigarettes that appear as pens to relatively bigger items like tank systems.
Rather than burning tobacco, e-cigarettes regularly utilize a coil that is battery-fueled to
transform a fluid into a sort of spray that is breathed in vaped by the user, providing them with
their nicotine intake in a less harmful method compared to burning tobacco.

Vaping has become one of the greatest public health issues, and the largest contributor is Juul’s
products, due to its large market share. Juul’s products became of high demand, since their
introduction to the market in 2015. Even after the FDA (Food and Drug Administration) accused
Juul of promoting underage utilization of tobacco and the organization had to close its social
media accounts, Juul kept proving its popularity as reflected by its rising sales.

However, its contribution to an increase in the spread of several lung diseases & fatality rate of
some of its users, stake holders such as parents of underaged users, have formed pressure groups
set to refute its allowance to sell its product to their children. Therefore, creating negative
publicity to Juul. Leading to the question:
To what extent did Juul’s negative publicity affect its position in the market?

Methodology

This commentary investigates how the negative publicity regarding Juul has influenced its
position in the market. Articles by the FDA, New York Times and Buzz Feed News will be used
to analyze the public health crisis that Juul ignited, in addition to the letters that are sent by the
Commissioner of Food and Drugs addressing the issue. Also, a SWOT analysis, STEEPLE
analysis, and the market share will be used to analyze Juul’s current situation.

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SWOT analysis
SWOT analysis demonstrates the internal characteristics of an organization through the Strengths
and Weaknesses, while Opportunities and Threats present the organization’s external
environment. Such tool assesses the organization’s position, as well as guiding the organization
to build on what they do well, address what they’re lacking, seize opportunities , and minimize
risks.
Strengths:
 A market leader in the e-cigarettes market
 A market share of 75% in the US e-cigarette
market
 It has the highest sales revenue in the e-
cigarettes market
 It has good brand recognition and loyalty
 Its product is relatively inexpensive, easy to
use, and comes in many flavors.
 Its product can be used indoors without
causing any inconveniences to its user.
 It is considered a way to “improve the lives of
the world’s 1 billion adult smokers by
eliminating cigarettes”. (J.Ducharme, 2019)
 Its E-cigarettes contain fewer toxic chemicals
than traditional cigarettes available in the
market
Opportunities:
 The immensity of teen-vaping is incredibly
increasing and kids are becoming an entire
generation of nicotine addicts due to the effect
of media on portraying it as a cool thing to do,
increasing Juul’s market share by allowing it
accessing a younger demographic that its
other competitors cannot due to it being illegal
to smoke before the age of 18
 Juul’s initial marketing expenditures has
declined as the brand received more
promotion on social media through
advertising.
 The e-cigarette market has the potential to
grow by USD 14.39 billion during 2021-2025.
(Capritto, 2019)
https://www.technavio.com/report/e-cigarette-
market-industry-analysis
4
Weaknesses:
 It doesn’t have total control over its interest
due to Altria (the parent company of brands
including Marlboro) buying a 35% stake in
Juul.
 The impacts of its products on consumers
health.
 Being a main contributor to a worldwide
public-health crisis’s affects its brand image
negatively
Threats:
 Juul has no social media presence due to the
FDA restrictions
 Limits set by the government on its online
sales to those 21 and older.
 Constant accusations and warning letters from
the FDA are sent to Juul about being removed
from the market.
 Studies found a link between the use of e-
cigarette and cardiovascular diseases
 The U.S Center for Disease Control and
Prevention and The American Lung
Association advises Americans to not use e-
cigarettes.
 Dentists state that vaping causes more tooth
damage and cavities, as well as dental issues.
 Pressure groups are formed by parents against
e-cigarettes.
 Hundreds of U.S schools hired educational
experts to come up with a program to stop
children using Juul.
 New competitors started to produce cheaper,
disposable e-cigarettes.
 FDA efforts made against Juul continuing to
produce its products, if Juul doesn’t addresss
public health concerns.
STEEPLE analysis
The STEEPLE analysis highlights the external environment’s effect on Juul. Only some aspects
of the STEEPLE analysis will be used due to their significance.

Social:

The product is mostly found in the U.S, and the median age of the U.S is between 37-39, which
is Juul’s target customers. However, studies have shown that the majority of customers that buy
Juul’s products are underage users. Studies show that more than 4 million American teenagers
vape regularly (Edwards, 2020). However, enormous international markets, including India and
China, are restricting the sale of e-cigarettes, preventing Juul from entering these markets.
Pressure groups by parents were set to prevent Juul from selling its products to underage users.
Social trends and different media platforms have increased awareness campaigns against
smoking as it harms the public health and contribute to carbon emissions output that results in
global warming and other environmental issues.

Environmental:

Juul’s e-cigarettes contain fewer toxic chemicals than traditional cigarettes and many people
consider it an opportunity to “improve the lives of the world’s 1 billion adult smokers by
eliminating cigarettes” (Kaplan, 2021). Environmentalist pressure groups efforts against the use
of any smoke limiting substances such as Juul’s products has put a limit on Juul’s product
extension strategies from leaving the development phase of the product lifecycle.

Economic:

Elevated levels of diseases spreading, and the high death caused by Juul’s products has alarmed
governmental entities as it contributes to a higher governmental expenditure on health care, that
has a negative effect on a countries GDP (DUCHARME, 2019).

Ethical:

Juul violates the federal regulations as they’re accused by the FDA of promoting its e-cigarette
as a safer option than traditional cigarettes. Juul also sells its e-cigarettes although it is not yet
approved by health organizations. Therefore, such claims made by Juul have no scientific basis
as no definite research support whether e-cigarettes are in fact a safer alternative to cigarettes.

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Market Share

Results from both the swot analysis and steeple analysis have shown several factors that would
allow for Juul to remain competitive in the market and sustaining its current market position
(Strength & opportunities). However, the threats associated with Juul have made it almost
impossible for Juul to sustain its position in the market.
Articles used provided evidence of a decline in its sales revenue “Sales have plunged by $500
million.” due to a significant decrease in market share, “Juul’s share of the vaping market has
shrunk significantly, to 42 percent last year, according to analysts, from a high of 75 percent in
2018”. It is believed that the significant decrease in market share is due to the negative publicity
that Juul has been facing in the media, from pressure groups and the lawsuits against Juul for
targeting underaged users. That stemmed from its use of social media platforms to market its
products, knowing that it is the main source of entertainment by underaged individuals.

Conclusion

In conclusion, Juul’s negative publicity affected its position in the market negatively, putting
Juul in the risk of being totally removed by the FDA from the market as well as causing Juul’s
sales revenue to decline. Not just parents are trying to combat and eliminate Juul’s product but
also health organizations and the government, which puts Juul in an unfavorable position. Social
trends and the media now frown upon people about smoking as it harms the public health and
contribute to carbon emissions output that results in global warming and other environmental
issues. Juul created the e-cigarettes market and it owns the majority of it, making it the center of
one of the hugest public-health crisis’s worldwide. Even though Juul produces e-cigarettes that
contain fewer toxins than traditional cigarettes, Juul ignited a bigger public health crisis due to its
extreme increase in popularity and teenage utilization as individuals worldwide already suffer
from diseases and high death rates due to the high consumption of traditional cigarettes. The
necessity to protect the environment limits the development of the firm. Juul is extremely
restricted due to the numerous accusations that are sent by the FDA, pressure groups formed by
parents, large organizations like The U.S Center for Disease Control and Prevention, and The
American Lung Association advising people to not use e-cigarettes. The impacts of its products
on health are not clear yet, nevertheless, studies found a link between the use of e-cigarette and
cardiovascular diseases dentists state that vaping causes more tooth damage and cavities, as well
as dental issues. This doesn’t only restrict Juul’s development and expansion but also the firm is
threatened to be removed by the FDA entirely from the market possibly completely eliminating
its market presence, as seen by the drastic drop in their market share from 75 to 42% only.

Word count: 1540

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Bibliography
Capritto, A. (2019). Juul vape: What is it, why are teens addicted, and is it safe?. CNET.
Retrieved 31 October 2021, from https://www.cnet.com/health/personal-care/juul-what-is-it-how-
does-it-work-and-is-it-safe/.

Crisis Review: The Top 20 Crises Of 2019 (Part 2 Of 3). Provokemedia.com. (2020). Retrieved
31 October 2021, from https://www.provokemedia.com/long-reads/article/crisis-review-the-top-
20-crises-of-2019-(part-2-of-3).

DUCHARME, J. (2019). How Juul Hooked Kids and Ignited a Public Health Crisis. Time.
Retrieved 31 October 2021, from https://time.com/5680988/juul-vaping-health-crisis/.

Edwards, J. (2020). Juul Steering the Public Health Crises, Especially Toward Teens •
Mesowatch. Mesowatch. Retrieved 31 October 2021, from https://mesowatch.com/juul-steering-the-
public-health-crises-especially-toward-teens/.

E-cigarette Market by Product and Geography - Forecast and Analysis 2021-2025. Technavio.
(2021). Retrieved 10 March 2022, from https://www.technavio.com/report/e-cigarette-market-
industry-analysis.

How JUUL Hooked Kids & Ignited A Public Health Crisis | TIME. Youtube.com. (2019).
Retrieved 31 October 2021, from https://www.youtube.com/watch?v=_iAg2_PQ9o4.

JUUL and Youth: Rising E-Cigarette Popularity. Tobaccofreekids.org. (2021). Retrieved 31

October 2021, from https://www.tobaccofreekids.org/assets/factsheets/0394.pdf.

Juul Labs competitors. Craft.co. (2021). Retrieved 31 October 2021, from

https://craft.co/juul/competitors.

JUUL Market Share in 2019: Dominating the US E-cigarette Market - Technavio. Technavio.
(2019). Retrieved 10 March 2022, from https://blog.technavio.org/blog/juul-market-share-
dominating-e-cigarettes-market.

Kaplan, S. (2021). Juul Is Fighting to Keep Its E-Cigarettes on the U.S. Market. Nytimes.com.
Retrieved 4 November 2021, from https://www.nytimes.com/2021/07/05/health/juul-vaping-
fda.html.

Patel, N. (2021). Juul and the business of addiction. The Verge. Retrieved 4 November 2021,
from https://www.theverge.com/22554477/juul-lauren-etter-interview-e-cigarettes-addiction.

Street Journal, W. (2021). How Juul’s Valuation Fell by Over $33 Billion in Two Years | WSJ.
Youtube.com. Retrieved 31 October 2021, from https://www.youtube.com/watch?
v=39hU8nkw1Ow.

Vergano, D. (2019). Juul’s Competitors Won’t Quit Selling Flavored Vapes. Buzzfeednews.com.

Retrieved 4 November 2021, from https://www.buzzfeednews.com/article/danvergano/juul-
flavored-vapes-ban

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Supporting documents:

Appendix #1 Campaign for Tobacco-Free Kids, September 1, 2021 / Laura Bach

(Pressure group rep.)

JUUL and Youth: Rising E-Cigarette Popularity

The term “electronic cigarettes” covers a wide variety of products now on the market, from those
that look like cigarettes or pens to somewhat larger products like “personal vaporizers” and “tank
systems.” Instead of burning tobacco, e-cigarettes most often use a battery-powered coil to turn a
liquid solution into an aerosol that is inhaled by the user. One e-cigarette device, called JUUL,
has become increasingly popular since its launch in 2015.
JUUL Labs produces the JUUL device and JUULpods, which are inserted into the JUUL device.
In appearance, the JUUL device looks quite similar to a USB flash drive, and can in fact be
charged in the USB port of a computer. According to JUUL Labs, all JUULpods contain
flavorings and 0.7mL e-liquid with 5% or 3% nicotine by weight; JUUL Labs claims that the 5%
pods contain the equivalent amount of nicotine as a pack of cigarettes. Until November 2019,
JUULpods were available in eight flavors: Mango, Fruit, Cucumber, Creme, Mint, Menthol,
Virginia Tobacco and Classic Tobacco. Until prohibited by a January 2020 Enforcement
Guidance from the FDA, other companies also sold “JUUL-compatible” pods in additional
flavors; for example, the website Eonsmoke sold JUUL-compatible pods in Blueberry, Silky
Strawberry, Mango, Cool Mint, Watermelon, Tobacco, and Caffé Latte flavors. There are also
companies that produce JUUL “wraps” or “skins,” decals that wrap around the JUUL device and
allow JUUL users to customize their device with unique colors and patterns (and may be an
appealing way for younger users to disguise their device).
In mid-2016, the dollar sales share for JUUL products was less than 5%* , the lowest compared
to products sold by the main companies in Nielsen-tracked channels. However, by the end of
2017, JUUL sales had surpassed all other companies’ products, including the e-cigarette brands
manufactured by the major tobacco companies. At its peak popularity in late 2018 and early
2019, JUUL sales comprised over 70% of the market. Today, JUUL sales comprise about 40% of
e-cigarette sales in Nielsen-tracked channels.
In December 2018, Altria, which makes the most popular cigarette among youth (Marlboro),
announced that it was purchasing a 35 percent share in JUUL Labs for $12.8 billion and valued
the company at $38 billion. In 2019, the CEO of JUUL stepped down and was replaced by a top
executive from Altria. As JUUL has surged in popularity, other companies have sought to mimic
JUUL’s sleek design and podbased system, with new devices such as MLV’s PHIX, Mylé
Vapor’s Mylé, Altria’s Markten Elite†, Reynolds’ Vuse Solo, and ITG Brands’ myblu. As of
September 2018, researchers had identified at least 39 JUUL “knock off” devices. JUUL has
filed patent infringement complaints against many of these copycat devices.
JUUL’s Impact on the Youth E-Cigarette Epidemic
JUUL’s rise directly coincided with, and was responsible for, an unprecedented surge in youth e-
cigarette use. According to the National Youth Tobacco Survey (NYTS), high school e-cigarette
use increased by 135% from 2017 to 2019 (from 11.7% to 27.5%). Researchers at the University
of Michigan who conduct another national youth survey, the Monitoring the Future Study, found
that the increase in youth nicotine vaping from 2017 to 2018 was the single largest one year

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increase in youth use of any substance in the survey’s 43-year history. According to the CDC,
“The rise in e-cigarette use during 2017-2018 is likely because of the recent popularity of e-
cigarettes shaped like a USB flash drive, such as JUUL; these products can be used discreetly,
have a high nicotine content, and come in flavors that appeal to youths.” While high school e-
cigarette use declined in 2020 to 19.6%, an alarming 3.6 million kids are still using e-cigarettes –
the same number as when the U.S. Surgeon General first called youth ecigarette use an
“epidemic” in 2018. Among high schoolers, JUUL remained the most popular ecigarette brand in
2020, preferred by 25.4% of users (down from 59.1% in 2019). The Monitoring the Future Study
also found that among 10th and 12th grade e-cigarette users, JUUL remained the most popular e-
cigarette brand in 2020, preferred by 41.1% of users (a decrease from 58.7% in 2019).
News articles, letters from school officials, and anecdotal evidence indicate that JUUL has
gained popularity among youth and young adults across the country, from middle schools to
college campuses. A 2018 study found that nearly one-fifth of youth (ages 12-17) surveyed
reported having seen JUUL used in their school. News stories attribute JUUL’s sleek and
discreet design to its appeal among this population. For example:
“High school and college students are rushing to retailers to buy the product because its discreet
design makes it easy to hide from parents and teachers while also giving the user a big hit of
nicotine. Some students have bragged on social media of using the JUUL in class, even though e-
cigarettes are banned indoors at most schools.” – Pittsburgh Post-Gazette
“An editor for New York University's student newspaper documented JUUL's rising on-campus
popularity, even in dorm rooms. A student newspaper at the University of Illinois called JUUL a
"new epidemic is sweeping across campus." And in suburban D.C., a high school's principal took
doors off its bathroom stalls to keep students from using drugs inside —namely JUUL.” – USA
Today
“One reason JUUL and vape pens are so popular among teens currently might be that they can be
used indoors without attracting unwanted attention or creating a stench…On Twitter, teens post
about their usage in school. The most brazen of them fire up their e-cigarettes while their
teachers' backs are turned.” - NPR
JUUL and Youth Nicotine Addiction
JUUL popularized a new generation of high-tech e-cigarettes that smoothly and effortlessly
deliver a high dose of nicotine in sweet flavors. Nicotine is a highly addictive drug that can have
lasting damaging effects on adolescent brain development. The Surgeon General concluded that,
“The use of products containing nicotine poses dangers to youth, pregnant women, and fetuses.
The use of products containing nicotine in any form among youth, including in e-cigarettes, is
unsafe.”
JUUL pioneered an e-liquid formulation that delivers nicotine more effectively and with less
irritation than earlier e-cigarette models. Researchers estimate that JUUL, which contains the
nicotine equivalent of a pack of 20 cigarettes in each 5% pod, is three or more times as powerful
as most e-cigarettes on the market prior to 2015. According to the company, the nicotine in
JUUL is made from “nicotine salts found in leaf tobacco, rather than free-base nicotine,” in order
to “accommodate cigarette-like strength nicotine levels.”
JUUL’s competitors, seeking to emulate the company’s success, have since flooded the U.S.
market with similar high nicotine e-cigarettes, resulting in what some researchers have referred
to as a “nicotine arms race.” The 5% nicotine pods sold by Juul and its competitors far exceed
nicotine level limits set by many other countries. An analysis of e-cigarette sales in Nielsen-
tracked channels found that products with 5% nicotine or higher increased from 0% of dollar

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sales in 2013 to 31.8% in 2017, and then doubled to 66.4% in 2018. In 2018, fruit-flavored e-
liquids had a higher mean nicotine concentration (4.7%) than any other flavor category.
According to a 2018 Surgeon General advisory on e-cigarette use among youth, the nicotine salt
technology that JUUL uses allow users to inhale high levels of nicotine more easily and with less
irritation than e-cigarettes that use free-base nicotine. As a result, it is easier for young people to
initiate the use of nicotine with these products. News stories from across the country have
documented stories of youth struggling to break their addiction to JUUL, and national survey
data confirms a growing crisis of youth addiction. Kids are no longer just experimenting with e-
cigarettes, but are using them frequently, an indicator of serious addiction. In 2020, 38.9% of
high school users (up from 34.2% in 2019) and 20% of middle school users (up from 18% in
2019) were frequent users of e-cigarettes, reporting use on at least 20 of the preceding 30 days.
Alarmingly, 22.5% of high school users and 9.4% of middle school users reported daily use. This
amounts to 1.3 million middle and high school students who were frequent users of e-cigarettes,
including over 730,000 daily users. Adolescents are more likely to experience nicotine
dependence at lower levels of exposure than adults and can feel dependent after just minimal
exposure and within a relatively short period of time. One study estimated that youth could meet
the threshold for nicotine addiction by consuming just one quarter of a JUULpod per day.
JUUL’s Youth-Friendly Marketing Launch
When JUUL first launched in 2015, the company used colorful, eye-catching designs and youth-
oriented imagery and themes, such as young people dancing and using JUUL. JUUL’s original
marketing campaign included billboards in New York City’s Times Square, YouTube videos,
advertising in Vice Magazine, launch parties and a sampling tour. According to the New York
Times, “Cult Collective, the marketing company that created the 2015 campaign, “Vaporized,”
claimed that the work “created ridiculous enthusiasm” for the campaign hashtag, part of a larger
advertising effort that included music event sponsorships and retail marketing.”
Social media continued to fuel JUUL’s popularity, with lasting effects. JUUL was one of the first
major ecigarette brands to rely heavily on social media to market and promote its products.
JUUL’s initial marketing expenditures in traditional channels were modest compared to
competing brands, and these expenditures decreased as the brand increased content and received
more promotion on social media channels like Instagram and Twitter. A study in JAMA
Pediatrics found that 8 out of 10 of JUUL’s Twitter followers in April 2018 were between the
ages of 13 to 20. Additionally, user-generated posts that tag (e.g., #JUULvapor, #doit4JUUL)
and feature JUUL do not have any restrictions. These kinds of social media posts can increase
exposure to pro-e-cigarette imagery and messaging, by making JUUL use look cool and
rebellious.
JUUL officials claim that its popularity among youth is purely accidental and that the product’s
viral social media presence following its launch was beyond the company’s control. Ashley
Gould, Chief Administrative Officer of JUUL Labs, said that the explosion of youth users “was
not anticipated and completely unexpected to us.” Gould has noted that, “All of the things you
see on social media, we have absolutely nothing to do with.” Contrary to these claims, a New
York Times investigation interviewed a former senior manager at JUUL who “said that he and
others in the company were well aware the campaign launch might appeal to youth. After Juuls
went on sale in June 2015, he said, the company quickly realized that teenagers were, in fact,
using them because they posted images of themselves vaping Juuls on social media.”
Over 700 lawsuits against JUUL Labs (JLI) have been filed across the country, claiming that the
company marketed its products to youth, promoted nicotine use, and failed to warn that its

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nicotine products are more addictive than tobacco cigarettes. In addition, 39 state attorneys
general are leading a multi-state investigation into JUUL’s health claims and marketing tactics
targeting minors and 15 state attorneys general have sued JUUL for targeting youth in their
states. In April 2018, the FDA sent an official request for information to JUUL Labs to obtain
more information about the youth appeal of the product, including the company’s marketing
practices. JUUL subsequently updated its marketing code with the purported goal of limiting
youth exposure to its advertising. In June 2018, JUUL announced a new social media policy that
would no longer use models on those platforms, but instead would feature former smokers who
switched to JUUL. FDA later called on JUUL and other major e-cigarette makers to develop
“robust plans on how they’ll convincingly address the widespread use of their products by
minors.” As part of its response to FDA, in November 2018 JUUL announced the suspension of
its official social media accounts on Instagram and Facebook, and limits on its Twitter posts to
“non-promotional communications only,” as well as age-restricting its Twitter account. In this
same announcement, JUUL noted its coordination with the major social media platforms to
attempt to “police” content and “remove youthoriented social media content from third-parties or
users.” JUUL’s marketing to youth was also the subject of a Congressional hearing in 2019.
Availability and Accessibility of JUUL
JUUL devices and JUULpods are available for sale on JUUL’s website and other online retailers
as well as in convenience stores, vape shops, and tobacco retailers. According to the 2020
Monitoring the Future Survey, 61% of 10th grade students say it would be easy to get a JUUL
device. A 2018 study found that among surveyed youth JUUL users (ages 12-17), half had gotten
JUUL from a social source. Advocates have shared stories of kids pooling together money to
share a device and sell “hits” from the device to recoup the cost.
While most high school e-cigarette user (57.1%) report getting their e-cigarettes from friends,
some underage minors are able to buy their own e-cigarettes. According to the 2020 NYTS,
22.2% of high school e-cigarette users report obtaining e-cigarettes from a gas station or
convenience store in the past month, 17.5% from a vape shop, and 5.4% from the Internet. In
April 2018, the FDA sent warning letters to 40 retailers across the country for illegally selling
JUUL products to minors.

Appendix #2 Article on Juul’s survival strategies

Juul Is Fighting to Keep Its E-Cigarettes on the U.S. Market

The company faces declining sales and thousands of lawsuits claiming it knowingly sold its
trendy vaping products to minors. Soon the F.D.A. will decide whether it can keep selling them
at all.
By Sheila Kaplan
Published July 5, 2021Updated Oct. 12, 2021

Sales have plunged by $500 million. The work force has been cut by three-quarters. Operations
in 14 countries have been abandoned. Many state and local lobbying campaigns have been shut
down.
Juul Labs, the once high-flying e-cigarette company that became a public health villain to many
people over its role in the teenage vaping surge, has been operating as a shadow of its former
11
self, spending the pandemic largely out of the public eye in what it calls “reset” mode. Now its
very survival is at stake as it mounts an all-out campaign to persuade the Food and Drug
Administration to allow it to continue to sell its products in the United States.
The agency is trying to meet a Sept. 9 deadline to decide whether Juul’s devices and nicotine
pods have enough public health benefit as a safer alternative for smokers to stay on the market,
despite their popularity with young people who never smoked but became addicted to nicotine
after using Juul products.
Major health organizations, including the American Heart Association, American Lung
Association, American Academy of Pediatrics and the American Cancer Society’s Cancer Action
Network, have asked the agency to reject Juul’s application.
“The stakes are high,” said Eric Lindblom, a senior scholar at the O’Neill Institute for National
and Global Health Law at Georgetown University, and a former F.D.A. adviser on tobacco. “If
the F.D.A. blows it on this one, they will face public health lawsuits.”
Juul is sparing no expense to push back. Last week, the company agreed to pay $40 million to
settle just one lawsuit (with North Carolina) out of thousands lodged against it, avoiding a
looming jury trial. The company had urgently sought the deal to avoid courtroom testimony from
parents and teenagers while the F.D.A. is reviewing its vaping products.
Juul has not made its 125,000-page application to the agency public. But it paid $51,000 to have
the entire May/June issue of the American Journal of Health Behavior devoted to publishing 11
studies funded by the company offering evidence that Juul products help smokers quit. (A
spokesman for Juul said the editors had rejected one of the company’s submissions.) That fee
included an extra $6,500 to have the subscription journal open access to everyone.
Three editorial board members of the journal resigned over the arrangement.
And Juul’s federal lobbying has remained robust. It spent $3.9 million on federal lobbying in
2020, according to the Center for Responsive Politics, which tracks political spending. Altria, the
big tobacco company that owns a chunk of Juul, spent nearly $11 million.
Juul’s share of the vaping market has shrunk significantly, to 42 percent last year, according to
analysts, from a high of 75 percent in 2018. But some public health experts say they are
concerned that F.D.A. approval will lay the groundwork for the company to rise and expand its
reach again.
Juul has long denied that it knowingly sold its products to teenagers, and it has been pledging
publicly for the last few years to do all it can to keep them away from minors. In its settlement
with North Carolina, the company did not admit intentionally targeting youths.
In an interview, Joe Murillo, Juul’s chief regulatory officer, said, “We have a bigger opportunity
to convert smokers than ever before, but we will get that opportunity if and only if we continue
to combat underage usage and continue to act like the highly regulated company that we are.”
The company is seeking approval for its iconic vaping device, once dubbed the iPhone of e-
cigarettes, with tobacco- and menthol-flavored pods in two nicotine strengths: 5 percent, which
is equivalent to the nicotine in an average pack of cigarettes, and 3 percent.
The decision is one of a number of critical issues the F.D.A. has been wrestling with —
including the agency’s recent approval of a controversial Alzheimer’s drug and decisions on
thousands of vaping products made by companies other than Juul — without a permanent
commissioner in place. President Biden has yet to announce a nominee.
Recently, a House panel questioned the acting commissioner, Dr. Janet Woodcock, about the
agency’s plans for Juul. She said that the agency would base its decision on sound science, and
that she couldn’t prejudge the application, which is still under review.

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The decision will be based in large part on the answer to two questions: Will more smokers use
Juul products as an off-ramp from traditional cigarettes than nonsmokers will use it as an on-
ramp to nicotine? And can Juul really keep the products away from kids?
The bulk of Juul’s published research in the journal edition it bought tracks the 12-month
experience of 55,000 adults who purchased a Juul starter kit. The researchers, all of whom were
paid by Juul, concluded that 58 percent of the 17,000 smokers who stayed in the study had
stopped smoking at 12 months. Twenty-two percent remained dual users of both traditional
and e-cigarettes but cut their smoking by at least half.
Elbert D. Glover, who was editor and publisher of the journal, but retired soon after the issue
came out, said the journal followed its standard protocol for scientists who vet studies before
publication.
The steady decline in Americans who smoke has been a public health success story. The rate has
dropped from 42 percent in 1965 to 14 percent in 2019. Yet smoking remains the leading cause
of preventable death, with some 480,000 people dying from smoking-related diseases each year,
according to the Centers for Disease Control and Prevention.
E-cigarettes, which emerged in the early 2000s, were designed to give smokers the nicotine fix
they craved without the carcinogens that come from burning cigarettes. But until Juul launched
in 2015, no e-cigarette had caught on widely with the public.
Juul’s sleek design and its novel use of nicotine salts in its pods created a high-nicotine, low-
irritant experience in mango, mint and other flavors that quickly became a fad, especially among
high school and middle school students. Public health officials worried that rather than helping
adults quit smoking, Juul was hooking a new generation on nicotine, with potentially harmful
health effects on their developing brains and posing other health risks.
Juul’s rapid growth stayed under the F.D.A.’s radar until 2018, when the agency declared a
youth vaping epidemic.
“The F.D.A. left in place a wide open, Wild West marketplace around these vaping products and
unfortunately Juul and others dove in and exploited it,” said Clifford E. Douglas, director of the
University of Michigan Tobacco Research Network. “What took place then screwed up a
genuine extraordinary public health opportunity for harm reduction. It’s our obligation to come
back to that to serve the public health.”
Mr. Douglas believes that Juul is marketing its vaping products more responsibly now, and that
they could play a role in reducing harm to cigarette smokers.
Mr. Lindblom, the former F.D.A. tobacco adviser, has been highly critical of Juul, but believes
the F.D.A. cannot take past bad behavior into account.
“The F.D.A. has to evaluate this in a forward-looking way and can’t really punish Juul, but it can
certainly take into consideration how popular Juul is among youth,” he said.
Many of Juul’s critics do not believe the company deserves another chance. They are wary of the
company’s “reset,” announced in September 2019 when K.C. Crosthwaite, a top executive of
Altria, maker of Marlboro cigarettes, became Juul’s chief executive.
Mr. Crosthwaite pulled the plug on some of Juul’s controversial state and city lobbying
campaigns. He closed shop in Juul’s foreign markets across the world, except for Britain and
Canada, although Juul is still sold through distributors in Ukraine, Russia, Italy and the
Philippines. Under public pressure, he took mint- flavored pods, which accounted for 70 percent
of sales, off the market. And he suspended all U.S. advertising.
“We must put earning trust at the center of everything we do,” he wrote in an email to company
staff last summer.

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Critics contend that most of these changes were made at gunpoint — undertaken after the F.D.A.
threatened to shut down the business if teenagers continued to have access to Juul.
To these public health advocates, Altria’s purchase of a $12.8 billion stake in Juul in December
2018 makes them even more distrustful.
“The Marlboro man rode into Juul and now wants us to trust them,” said Matthew L. Myers,
president of the Campaign for Tobacco-Free Kids.
The Federal Trade Commission is now trying to unravel the Altria-Juul deal, alleging that the
two companies entered into a series of agreements that eliminated competition in violation of
antitrust laws.
The commission contends that Altria and Juul started as competitors in the e-cigarette markets,
but that as Juul became more popular, Altria dealt with its competitive threat by discontinuing its
Mark Ten e-cigarette in exchange for a share of Juul’s profits. Both companies have denied the
charges.
Even if the F.D.A. approved Juul products, perhaps with restrictions, the company would face
considerable business hurdles.
When Juul was forced to discontinue its fruity flavor pods, new competitors, sometimes
nicknamed Juulalikes, flooded the vacuum with cheap, disposable e-cigarettes in flavors like
Cherry Frost and Dinner Lady Lemon Tart. Altria now estimates Juul’s value at under $5 billion,
a fraction of its $38 billion valuation when Altria bought 35 percent of the business in the 2018
deal.
If Juul survives, the company will most likely spend the next few years trying to settle thousands
of lawsuits.
Fourteen states and the District of Columbia have sued Juul, seeking money to pay for combating
the youth vaping crisis. A criminal investigation of the company by the Justice Department is
still underway.
There is also multi-district litigation in a federal court in California, which has combined nearly
2,000 cases under the purview of one judge, similar to the treatment of opioid cases.
Whether there would be any company left to collect from if plaintiffs prevail is up to the F.D.A.

Appendix #3 News Article by Buzz Feed

Juul Will Stop Selling Most Flavored E-Cigs — But Its Competitors Won’t
“Juul should speak for itself,” said one of the e-cigarette maker’s competitors. A lack of trust in
the vaping industry “is a direct result of its deceptive marketing activities.”
Dan Vergano BuzzFeed News Reporter
Reporting From
Washington, DC
Posted on October 18, 2019, at 3:56 p.m. ET

WASHINGTON — Juul’s competitors are blaming the company for the trouble their industry
faces, and say they won’t stop selling flavored nicotine pods, despite the e-cigarette market
leader stopping such sales.

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On Thursday, Juul’s CEO, K.C. Crosthwaite, announced the suspension of sales of mango,
creme, fruit, and cucumber flavors (but not mint and menthol flavors also threatened by the
Donald Trump administration) in the US. “Given the lack of trust in our industry,” his
announcement said, Juul planned to stop sales until the flavors went through an FDA review
process to assess their risks to public health. Crosthwaite, a former executive at tobacco company
Altria, was recently appointed as CEO of Juul, less than a year after Altria bought a 35% stake in
the company.
Juul, which owned 75% of the market share for e-cigarettes in 2018, has become largely
synonymous with a growing industry for vaporized nicotine products. But its three main
competitors have made no moves to pull their own flavored e-cigarettes, and are attempting to
distance themselves from the company, which is under federal investigation for marketing to
teens. (All of the firms are owned or partly owned by larger tobacco companies.)
“Juul should speak for itself,” Michele Maron of Japan Tobacco International USA Inc., the
tobacco firm that owns the Logic e-cigarette brand, told BuzzFeed News. “The ‘lack of trust in
our industry’ referenced by Juul is a direct result of its deceptive marketing activities. Logic’s
responsible practice of marketing and selling high-quality vapor products to adults remains
unchanged, including flavored products where allowed.”
In September, President Trump said his administration would ban flavored e-
cigarettes nationwide. The announcement came days after the FDA sent Juul a warning
letter over it marketing its e-cigarettes as a medical tool for smokers to quit without agency
approval, and a presentation made by a company representative to a high school that called the
device “totally safe.” Since August, the nationwide outbreak of vaping-related lung illnesses —
now standing at 1,479 cases and 33 deaths — tied to vaping of illicit THC-containing liquids has
led to even tighter scrutiny on the e-cigarette industry.

15
Fontem, a subsidiary of Imperial Tobacco that manufactures the Blu e-cigarette products, told
BuzzFeed News that it planned to keep selling flavored vapes as well.
“Research indicates that access to a variety of flavors is a key factor for those adult smokers who
are looking to choose something other than a combustible tobacco product,” said spokesperson
Kelly Cushman by email. “In order to preserve options for current adult smokers and vapers,
Fontem therefore continues to make responsibly named and marketed flavors available to our
customers over approved sales channels."
Vuse, owned by the tobacco firm R.J. Reynolds Vapor Company, did not reply to a request for
comment on whether it would continue its flavored vape sales. But as of Friday, the company
had made no changes to product availability.
Flavored vapes are widely seen as one of the big draws for teens taking up vaping, which the
CDC and other health agencies are warning has increased precipitously — 38% — in the last two
years. Nicotine is highly addictive and has been the subject of warnings from the US surgeon
general.
Juul suspending the flavor sales in the US is “a good first step,” Kar-Hai Chu of the University
of Pittsburgh’s Center for Research on Media, Technology, and Health told BuzzFeed News.
But, Chu added, given reports of Juul’s marketing practices overseas, he is concerned that the
company is simply writing off the domestic market while using the flavors to hook teens on
nicotine overseas.
Juul's explosive growth has largely been driven by high-nicotine products and highly successful
marketing campaigns that have played out on social media outlets, such as Instagram and
Twitter. The FDA last year sent a warning letter over illegal sales of Juul, Logic, Blu, Vuse, and

16
MarkTen, which together owned 97% of the e-cigarette market, in a crackdown on vaping shops.
MarkTen (which is also owned by tobacco company Altria) stopped sales in January.
Juul’s move to stop flavor sales comes as the firm has become the poster child for widespread
concern over teen vaping, amid a nationwide outbreak of deadly lung illnesses so far attributed to
vaping of illicit THC-containing liquids. But at a congressional hearing on Wednesday, Anne
Schuchat, the CDC principal deputy director, suggested that the popularity of e-cigarettes has
created a culture of vaping "whatever is in the cartridge" that contributed to the illicit vaping
linked to the lung injury outbreak. It was one of two hearings held that day that saw lawmakers
calling for bans and stronger regulation of the vaping industry ahead of Juul’s announcement.
Drug policy expert Leo Beletsky of Northeastern University told BuzzFeed News that Juul is
“fighting for survival."
He was skeptical of any rush to wholesale ban vaping, saying, “Banning a licit market product
will drive people to an illicit market where consumer choice and consumer safety is much more
limited.” He noted that the black market is apparently where the outbreak of lung illnesses
started — the crisis that has thrust vaping nicotine into the national spotlight in the first place.

Appendix #4 Letter from the US Commissioner of Food and Drugs

September 12, 2018

JUUL Labs, Inc.
560 20th Street San Francisco, CA 94107-4344

Dear Mr. Kevin Burns:

Your company is currently marketing JUUL, an electronic nicotine delivery system (ENDS)
product, which is subject to regulation by the Food and Drug Administration (FDA or the
agency) pursuant to Section 901(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),
as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), and
associated regulations. This includes the requirement that a “new tobacco product” undergo
premarket review and receive authorization from FDA permitting the product’s sale and
distribution prior to being offered or delivered for sale into interstate commerce.1 1 2 3 FD&C
Act § 910(a)(2)(A), (c). In May 2016, when FDA issued the regulation deeming ENDS products
subject to FDA’s tobacco authorities, the Agency announced that, as an exercise of enforcement
discretion, it intended to defer enforcement of the premarket review requirement for certain
ENDS, setting a compliance date of August 8, 2018, for submission of premarket tobacco
product applications (PMTAs) for newly deemed finished tobacco products that were on the
market as of August 8, 2016.2 81 Fed. Reg. 28974, 28978 (May 10, 2016). In August 2017, FDA
announced that, as part of its comprehensive plan for tobacco and nicotine regulation, it would
exercise enforcement discretion to extend the premarket review compliance dates for this
category of noncombustible tobacco products until August 8, 2022.3 Guidance for Industry:
Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule
(Revised) (August 2017), available at

17
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/
UCM557716.pdf. This compliance policy does not apply to any new tobacco product that was
not on the market as of August 8, 2016. As described below, FDA is reevaluating its current
compliance policy with respect to JUUL brand products and similar products. We acknowledge
receipt of your company’s letter to FDA of August 7, 2018; however, we request that you
respond to this letter as directed. Failure to respond may result in FDA taking action to enforce
the premarket authorities in the TCA with respect to JUUL products, including the authority to
take action against products that are adulterated within the meaning of section 902(a)(6) of the
FD&C Act in that they are required by section 910(a) to have premarket review and do not have
an order in effect under 910(c)(1)(A)(i).
Background
FDA prohibits the sale and distribution of tobacco products to minors.4 4 5 6 7 21 C.F.R. Part
1140 (2018). In enacting the TCA, Congress expressed concern that an “overwhelming majority
of Americans who use tobacco products begin using such products while they are minors and
become addicted to the nicotine in those products before reaching the age of 18” and that “the
use of tobacco products by the Nation’s children is a pediatric disease of considerable
proportions that results in new generations of tobacco-dependent children and adults.”5 TCA §
2(31), (1), Pub. L. 111-31 (June 22, 2009). In 2016, the final deeming rule extended the agency’s
tobacco authorities to additional tobacco products, including ENDS.6 81 Fed. Reg. at 28974.
During the rulemaking process, and since, FDA carefully considered the public health
implications of a compliance policy regarding the requirement to obtain premarket authorization
for deemed tobacco products that are “new tobacco products.” In the preamble to the final rule,
FDA announced compliance dates intended to balance concerns about the extended availability
of such products without scientific review; concerns regarding flavored tobacco products’ appeal
to youth; and emerging evidence that some adults may potentially use certain flavored tobacco
products to transition away from combusted tobacco use.7
Id. at 28977. Last year, FDA announced a new comprehensive plan for tobacco and nicotine
regulation aimed at better protecting children and significantly reducing tobacco-related disease
and death. A component of that plan involved extending the compliance dates for submission of
premarket applications for certain deemed products. That decision also resulted from a careful
balancing of public health considerations, with the goals of establishing the proper scientific and
regulatory foundation to efficiently and effectively implement the TCA and striking an
appropriate balance between regulation and encouraging development of innovative tobacco
products that may be less dangerous than cigarettes.
This careful balancing is being challenged by new information, from a variety of sources, about
the epidemic rate of increase in youth use of ENDS products, including concerns about flavored
e-cigarettes. Consequently, FDA is evaluating our regulatory tools to address this disturbing and
accelerating trend. During the summer of 2018, FDA conducted an enforcement blitz of retailers
nationwide, which resulted in more than 1,100 Warning Letters and approximately 130 civil
monetary penalties being issued to retailers for underage sale of e-cigarettes. Those cases
included the illegal sale of JUUL products to minors. This is unacceptable, both legally and as a
matter of public health. To fulfill our public health mandate to address youth addiction to
nicotine, FDA is reconsidering its compliance policy for submission of PMTAs for your product
and other similar products that were illegally sold by retailers during this blitz, including whether
earlier enforcement of the premarket review provision might be warranted. The legal standard for
FDA premarket review of a new tobacco product under the PMTA provision includes

18
consideration of whether marketing of the product would be appropriate for the protection of the
public health. As part of our regulatory decision-making, FDA will consider evidence that e-
cigarettes, such as JUUL, contribute to youth use of and addiction to nicotine. Youth are
especially vulnerable to the addictive effects of nicotine because their brains are still developing.
Because most tobacco use is established during adolescence, actions to prevent youth from the
potential lifetime of nicotine addiction are critical.
Moreover, FDA regulations state that manufacturers are responsible for ensuring that their
covered tobacco products comply with all applicable requirements under 21 C.F.R. part 1140.8 8
See 21 C.F.R § 1140.10. Given the disturbing trend of ENDS use by minors, it is crucial that
tobacco product manufacturers take steps to address youth use of their products.
Requested Actions
FDA requests that you take prompt action to address the rate of youth use of JUUL products.
FDA would like to discuss with you the steps you intend to take to address youth use of your
product, in addition to the information outlined in your letter of August 7th. Given the
importance of this issue, we request an acknowledgement of receipt of this letter within 15 days
and a proposed timeline for meeting with FDA.
FDA also requests that, within 60 days of receipt of this letter, you provide a written response to
this letter that includes a detailed plan, including specific timeframes, to address and mitigate
widespread use by minors. For instance, this plan may include:
 Discontinuing sales to retail establishments that have been subject to an FDA civil
monetary penalty for sale of tobacco products to minors within the prior 12 months
 Developing or strengthening any internal program you have to check on retailers, and
reporting to FDA the name and address of retailers that have sold products to minors
 Eliminating online sales, whether through Internet storefronts controlled by your
company or other retailers, or providing evidence to demonstrate that your company’s
online sales practices do not contribute to youth use of JUUL products
 Revising your current marketing practices to help prevent use by minors
 Removing flavored products from the market until those products can be reviewed by
FDA as part of a PMTA.
These are examples of actions that you may take to demonstrate that FDA should continue to
defer enforcement of the premarket review provisions with respect to JUUL products. You are
encouraged to provide additional youth use prevention tools for FDA’s consideration.
The youth tobacco use prevention imperative could affect the marketing of products that may
have potential public health benefit for a different population, namely, cigarette smokers who
may be seeking alternative forms of nicotine delivery. We recognize the challenge here. But
steps must be taken to protect the nation’s young people.
Failure to respond to this letter may result in FDA taking action to enforce the premarket
authorities in the TCA with respect to JUUL products. Products that are required to have
premarket authorization but do not have such authorization are adulterated within the meaning of
section 902(a)(6) of the FD&C Act.
FDA will review the information provided by your firm. If the agency determines that it should
enforce the premarket authorization requirements in the TCA with respect to JUUL products, we
intend to communicate our expectations to you.
The requested information should be submitted to:
Imelda Paredes
Senior Regulatory Counsel

19
Center for Tobacco Products, Office of Compliance and Enforcement
Imelda.Paredes@fda.hhs.gov
General information relating to PMTA requirements can be found on our web site at
https://www.fda.gov/TobaccoProducts.
Sincerely,
/Scott Gottlieb/
Scott Gottlieb, M.D.
Commissioner of Food and Drugs
cc:
Jerry Masoudi
Chief Legal Officer, JUUL Labs Inc.

Appendix #5 News article on behalf of the FDA

FDA requires additional e-cigarette makers to provide critical information so

the agency can better examine youth use and product appeal, amid continued
concerns around youth access to products
For Immediate Release: May 17, 2018
Today, the U.S. Food and Drug Administration continued to take important steps to address
youth use of e-cigarettes by sending official requests for information to four e-cigarette
manufacturers requiring them to submit important documents to better understand the youth
appeal of these products.
With this information, the agency will further examine marketing practices, and the youth use
and appeal of these types of tobacco products. The new letters follow a similar request that the
agency sent to JUUL Labs Inc. last month. These actions are part of the FDA’s Youth Tobacco
Prevention Plan, which aims to protect youth from the dangers of nicotine and tobacco products,
especially e-cigarettes and other electronic nicotine delivery systems (ENDS).
“Too many kids continue to experiment with e-cigarette and vaping products, putting them at
risk for developing a lifelong nicotine addiction. These products should never be marketed to,
sold to, or used by kids and it’s critical that we take aggressive steps to address the youth use of
these products. This includes taking a hard look at whether certain design features and product
marketing practices are fueling the youth use of such products,” said FDA Commissioner Scott
Gottlieb, M.D. “We’ll explore all of our regulatory options, including enforcement actions, based
on what we learn from the information these manufacturers are required to provide. No child
should be using any tobacco product. We’ll continue to take vigorous steps under our Youth
Tobacco Prevention Plan, using the full scope of our authorities, to target youth access to, and
appeal of, these products. Our top priority is to prevent kids from getting hooked on nicotine.”
The companies and the specific products receiving the official requests for information under
section 904(b) of the Family Smoking Prevention and Tobacco Control Act are: J Well, of Paris,
France, for Bo Starter Kit; YGT Investment LLC and 7 Daze LLC, of Baldwin Park, California,
for Zoor Kit; Liquid Filling Solutions LLC, of King of Prussia, Pennsylvania, for Myle Products;
and SVR Inc., of Las Vegas, for SMPO Kit.

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The FDA selected these companies based on product attributes that overlap with those of JUUL,
including:
 The use of e-liquids that contain nicotine salts with corresponding high nicotine
concentration;
 A small size which makes these products easily concealable; and
 Product design features that are intuitive, even for novice users.
The information the FDA is requesting includes, but is not limited to: documents related to
product marketing, documents related to research on product design (as it may relate to the
appeal or addictive potential for youth, youth-related adverse experiences) and consumer
complaints associated with the products. The companies have until July 12, 2018, to respond to
the agency.
Failure to provide the information is a violation of the law and subject to regulatory and
enforcement action by the FDA. The agency also may send letters to additional manufacturers of
products that raise similar concerns about youth use.
In April, as a new part of its comprehensive plan on nicotine and tobacco regulation, the
FDA announced a Youth Tobacco Prevention Plan. The plan began with a nationwide blitz of
brick-and-mortar and online retailers that led to warning letters to businesses that sold JUUL
brand products to minors. The agency also issued numerous warning letters — many in
partnership with the Federal Trade Commission — to manufacturers, distributors and retailers
for selling e-liquids used in e-cigarettes with labeling and/or advertising that cause them to
resemble kid-friendly food products. These e-liquid products resemble juice boxes, candy or
cookies, and some of them included cartoon-like imagery. The agency will take additional
actions under its Youth Tobacco Prevention Plan to continue to address youth use of these
products.
Along with these efforts, the agency is also exploring clear and meaningful measures to make
tobacco products less toxic, appealing and addictive — with an intense focus on deterring youth
use. This could include measures on flavors/designs that appeal to youth, child-resistant
packaging and product labeling to prevent accidental child exposure to liquid nicotine.
Additionally, the agency plans to explore additional restrictions on the sale and promotion of
ENDS to further reduce youth exposure and access to these products. The FDA has
also expanded “The Real Cost” public education campaign with messages focused on preventing
youth use of e-cigarettes and will launch a full-scale campaign this fall.
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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