[Senate Hearing 113-742]
[From the U.S. Government Publishing Office]
S. Hrg. 113-742
AGGRESSIVE E-CIGARETTE MARKETING AND
POTENTIAL CONSEQUENCES FOR YOUTH
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
JUNE 18, 2014
__________
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and Transportation
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SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
JOHN D. ROCKEFELLER IV, West Virginia, Chairman
BARBARA BOXER, California JOHN THUNE, South Dakota, Ranking
BILL NELSON, Florida ROGER F. WICKER, Mississippi
MARIA CANTWELL, Washington ROY BLUNT, Missouri
MARK PRYOR, Arkansas MARCO RUBIO, Florida
CLAIRE McCASKILL, Missouri KELLY AYOTTE, New Hampshire
AMY KLOBUCHAR, Minnesota DEAN HELLER, Nevada
MARK BEGICH, Alaska DAN COATS, Indiana
RICHARD BLUMENTHAL, Connecticut TIM SCOTT, South Carolina
BRIAN SCHATZ, Hawaii TED CRUZ, Texas
EDWARD MARKEY, Massachusetts DEB FISCHER, Nebraska
CORY BOOKER, New Jersey RON JOHNSON, Wisconsin
JOHN E. WALSH, Montana
Ellen L. Doneski, Staff Director
John Williams, General Counsel
David Schwietert, Republican Staff Director
Nick Rossi, Republican Deputy Staff Director
Rebecca Seidel, Republican General Counsel and Chief Investigator
C O N T E N T S
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Page
Hearing held on June 18, 2014.................................... 1
Statement of Senator Rockefeller................................. 1
Statement of Senator Thune....................................... 4
Statement of Senator Boxer....................................... 63
Report entitled ``E-Cigarettes--A Scientific Review'' by
Rachel Grana, PhD, MPH; Neal Benowitz, MD; Stanton A.
Glanton, PhD............................................... 65
Statement of Senator Blumenthal.................................. 83
Statement of Senator Klobuchar................................... 86
Statement of Senator Nelson...................................... 89
Statement of Senator Markey...................................... 95
Witnesses
Susanne E. Tanski, MD, MPH, FAAP, American Academy of
Pediatricians.................................................. 6
Prepared statement........................................... 8
Matthew L. Myers, President, Campaign for Tobacco-Free Kids...... 14
Prepared statement........................................... 16
Jason Healy, Founder and President, blu eCigs, a Subsidiary of
Lorillard...................................................... 45
Prepared statement........................................... 46
Craig Weiss, President and CEO, NJOY............................. 47
Prepared statement........................................... 49
Scott D. Ballin, JD, Health Policy Consultant.................... 51
Prepared statement........................................... 53
Hon. Richard J. Durbin, U.S. Senator from Illinois............... 92
Prepared statement........................................... 92
Appendix
Response to written questions submitted by Hon. Dean Heller to:
Dr. Susanne E. Tanski........................................ 109
Matthew L. Myers............................................. 110
Jason Healy.................................................. 112
Craig Weiss.................................................. 112
Response to written questions submitted to Scott D. Ballin by:
Hon. John Thune.............................................. 114
Hon. Dean Heller............................................. 115
AGGRESSIVE E-CIGARETTE MARKETING AND POTENTIAL CONSEQUENCES FOR YOUTH
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WEDNESDAY, JUNE 18, 2014
U.S. Senate,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Committee met, pursuant to notice, at 2:34 p.m. in room
SR-253, Russell Senate Office Building, Hon. John D.
Rockefeller IV, Chairman of the Committee, presiding.
OPENING STATEMENT OF HON. JOHN D. ROCKEFELLER IV,
U.S. SENATOR FROM WEST VIRGINIA
The Chairman. Well, I'm just going to go ahead.
John Thune is worth waiting for under all circumstances,
but we got a lot of people who may just want to get going.
Okay. Today the Committee is examining the marketing of e-
cigarettes, and I should warn you that, emotionally, I'm on
edge on this whole subject, I'm on edge--a product whose
popularity has recently been soaring including and, especially,
among young people. We will hear today, I assume, from the
tobacco companies, or whatever they call themselves, that
they're just marketing to adults, which I'm going to find an
amazing answer. And we will probe that.
E-cigarettes are battery-operated products that vaporize a
liquid containing something called nicotine. And we all
remember that; don't we? Eight people with their hands raised.
Now we know that a cigarette and an e-cigarette are somewhat
different. But, nicotine is nicotine. Little kids are little
kids. And they're looking for things. And they're looking for
things which they get to see a lot of it in advertising. One of
the nice things is that you can sort of mimic the act of
smoking. It's cool. Kids are cool.
These products are relatively new and their long-term
health effects are unknown at this point, which, to me, raises
the question why in heaven's name are they going ahead and
marketing these things and selling these things and putting
them online with the results of health studies, which are being
done seriously, are still out?
Why would you do that? You want to make money. That's your
answer. You would--that's your answer. You'll tell me you're
just talking to adults, but you're not. You want to make money.
So you plunge in, get what you can, and then the studies come
out. Then, you go ahead and do it until the FDA puts some nice
rules and regulations on you.
These products are relatively new and their long-term
health effects are unknown; however, they do indicate, they do
deliver the nicotine and it's a highly addictive substance.
Nicotine does a variety of things but it can effect brain
development among young kids.
Some people claim that e-cigarettes can help adults quit
smoking combustible cigarettes while others are concerned they
may reduce quitting by encouraging dual use of e-cigarettes
with combustible cigarettes. But we have not done enough
research yet and I admit that, to resolve this question. But
that is not the focus of this hearing. Instead, we're going to
focus on how marketing of erates, excuse me, I like erates a
lot--e-cigarettes reaches America's youth and what consequences
that that fact may have.
Since generations of cigarette users became addicted to
nicotine in their youth, it only makes sense to be concerned
about whether e-cigarettes could get also young people on a
similar path to addiction. Addiction, under any form, I think
is a bad thing. And, I don't know, we figured maybe about 4,000
kids in West Virginia are affected by this badly.
The last thing anyone should want to do is to encourage
young people to start using a new nicotine delivery product.
It's the last thing. Researchers, they're not sure what the
long-term health consequences, not sure about the short-term
health consequences, ah, but there's an opening in the market.
So boom, let's get it in and make as much as we can because
there are no regulations. That's our fault. I apologize for
that.
And welcome the distinguished Senator.
If you put West Virginia and South Dakota together, you
have approximately 72 percent of the United States territory.
[Laughter.]
Senator Thune. It seems that way.
The Chairman. Health experts are sounding several alarms on
these virtually unregulated products. In addition to the issue
of nicotine addiction, e-cigarette that are related cause calls
to poison control centers to be very much on the rise and
particularly involving children, and particularly involving
children under the age of five. Yes, five.
Moreover, some studies indicate that toxins other than
nicotine may be found in e-cigarettes. We don't know that. We
don't know if the answer is yes, partially, or not at all. We
don't know; do we? So we hold off until we know. And then we go
ahead but no, some have chosen a very different course.
Given the health concerns and the lack of data
substantiating health benefits, it's imperative to restrict
youth exposure to e-cigarettes. Simply stated, children and
teens should not be guinea pigs as we await more conclusive
research. I do not understand that. I do not understand the
corporate view on that. Making money is a wonderful thing, but
making money with something like this where you don't know what
the results are, but you do know what the results are with
nicotine in cigarettes, it does not reflect well on corporate
America.
Unfortunately, awareness and use of e-cigarettes by youth
has been surging. So please consider the following: Between
2011 and 2012, I count that to be one year, e-cigarette use
among U.S. teens more than doubled; 1,800,000 kids have tried
these products; and a recent study found that awareness of e-
cigarettes among youth is virtually ubiquitous. Now I guess
that means they have to see stuff somewhere, like advertising,
maybe television, maybe newspapers, maybe magazines, maybe lots
of it. So we'll talk about that. The growth in youth awareness
and use of e-cigarettes has coincided with a flood of recent e-
cigarette marketing activity.
A report published this month in the Journal of Pediatrics
found that youth exposure to e-cigarette advertising on
television increased 256% in two years. That's kind of like all
the results are out on the health surveys. Just go. Go for it.
Go for that dollar. 256% increase. It's extraordinary. A May
American Legacy Foundation report found that last year over 14
million teens saw e-cigarette advertising on TV and 9.5 million
saw printing ads.
So while major e-cigarette companies reiterate that they
only target adults, a large youth audience still appears to be
getting their message pretty loudly and pretty clearly, and
particularly, when they aim the message in TV and magazines
and, you know, social media and events, which just really come
down hard toward kids.
Good morning, Senator Boxer.
Senator Boxer. Good morning. Good afternoon.
The Chairman. You can wish me a happy birthday.
Senator Boxer. And a happy birthday.
The Chairman. Thank you.
[Laughter.]
The Chairman. So to look more closely at this issue, I
joined a group of Senators and Representatives including
Representative Waxman, Senator Durbin--who is going to be here,
when he does, he's going to be able to speak--Senator Harkin
and Committee colleagues like Senator Boxer, Senator
Blumenthal, and Senator Markey, in a recent investigation
asking leading e-cigarette manufacturers about their marketing
practices.
The results of this inquiry, and that's all it was, were
troubling. The joint report we issued this April concluded that
e-cigarette manufacturers are aggressively promoting their
products using techniques in venues that appeal to youth. Now,
I understand that whatever young people go to, you're probably
going to find adults. So if you say, ``We're really targeting
adults,'' I guess, you just have to overlook the fact that a
lot of adults wouldn't go to what you're targeting. But, we'll
see.
Practices of surveyed companies include: Sponsorship of
youth-oriented sporting and cultural events; handing out free
product samples--that's really nice, you know. Free product
samples. I mean, that's neutral. Nothing aggressive about that.
Nothing about enticing the money flow to pick up in that. Using
celebrity spokespeople; God rest their souls. Airing television
ads during programs that reach large youth audiences; using
social media without imposing age restrictions; and marketing
e-cigarettes in flavors that could appeal to children.
Now, I'm an adult so would I be attracted to Cherry Crush,
Chocolate Treat, Peachy Keen, Vanilla Dreams? No, I wouldn't.
Sixty years ago, I probably would have been. So that's the way
it works. The dollars flow in.
This review provided just a snapshot of activities of nine
market leaders in this industry, but there are hundreds of
companies that do this in the marketplace. For example, beyond
the flavors identified in our report, refillable nicotine
liquid is marketed and can be found in flavors include: Bazooka
Joe, no turn on for me; Gummy Bears, no, no, that's not adult
stuff; Chocolate Tootsie, Tootsie, that's not adult stuff.
That's aimed at children.
Products like these sound more like a candy shop display
than a means for delivering nicotine vapor. And it's not hard
to see how they could appeal to kids. Many of the practices
that e-cigarette companies are using to pitch their products
are prohibited for cigarette marketing under measures'
including the comprehensive 2009 Family Smoking Prevention and
Tobacco Control Act, which passed and is the law, but these
restrictions do not currently, I say, apply to e-cigarettes. A
loophole in the law. Chance to rake in cash. Worry about the
kids later. 4,000 kids in West Virginia, well, you know, is
that important or not? To me, it kind of is. To the companies,
they might not be looking at that.
It's worth noting that the Tobacco Control law was enacted
following years and years of litigation that uncovered internal
tobacco company documents showing that, despite claims that
they only promoted to adults, the industry had targeted young
people as a critical market. And of course you have. That's
where the money is. That's where the buying is. That's where
the--got cash in your pocket and you're 12, 8, 14? Out you go.
You want to be cool? Well you can actually hold one of these
things and look like you're Gloria Swanson; was that her name?
In April, the FDA proposed rules to regulate e-cigarettes,
but finalizing these rules could take a long time; making them
complete. Meanwhile the e-cigarette industry is booming, and
tobacco companies with a history of marketing cigarettes to
youth have been jumping into the market. I don't know how many
per day, per week. I just don't know, but a lot. As the e-
cigarette industry continues to rapidly evolve, we need to hold
companies, something called, accountable. Accountable. That's
an American tradition. GM is finding out about that. Toyota
found out about that. Accountable for promotional activities
that encourage kids to start using e-cigarettes before we know
what the health effects really are. Don't wait for what you
might be getting into; what harm you might be doing. But jump
in now and maybe Congress and FDA will be as they always are.
Slow. So you can make a lot of money while we're sorting this
all out. And then again, those 4,000 kids in West Virginia are
not, maybe, at the top of your list.
And because e-cigarettes look so similar to cigarettes, we
must also make sure that e-cigarette marketing doesn't
undermine decades of work to de-glamorize and de-normalize
smoking for American youth and there we are making tremendous
progress; enormous progress after a long period of time.
In any event, I look forward to talking about these issues
with the major e-cigarette companies represented here today and
our panel's accomplished experts.
And now, Senator Thune.
STATEMENT OF HON. JOHN THUNE,
U.S. SENATOR FROM NORTH DAKOTA
Senator Thune. Thank you, Mr. Chairman.
And allow me to add my birthday wishes. Happy birthday to
you. I'm sorry you're stuck spending it with us.
[Laughter.]
The Chairman. No, I'm not. I'm not at all.
Senator Thune. Mr. Chairman, I want to thank you for
holding the hearing and thank today's witnesses for appearing
before the Committee.
According to the World Health Organization, there are more
than one billion smokers in the world. Sadly, in one year
alone, more than 5 million of those people will die prematurely
due to direct tobacco use.
In 1976, Professor Michael Russell, a leading expert on
cigarette addiction, wrote ``People smoke for nicotine, but
they die from the tar.''
The introduction of e-cigarettes which usually contain
nicotine but none of the tar involved in ordinary cigarettes
presents new challenges for policymakers, for regulators, and
for the public health community. It's also a new opportunity
for increased public health to the extent that these new
products may help reduce the number of individuals who smoke
combustible tobacco cigarettes.
Dr. David Abrams at the American Legacy Foundation, a non-
profit organization dedicated to reducing tobacco use, that is
funded by payments from the Master Settlement Agreement between
State Attorneys General and the tobacco industry in 1998, has
called the e-cigarette a potentially ``disruptive technology,
able to render the combustion of tobacco obsolete.''
Similarly, Mitch Zeller, Director of the Food and Drug
Administration's Center for Tobacco Products, recently said
``we have to have an open mind on the potential for these
emerging technologies to benefit public health.''
In addition, a recent study by researchers at the
University College London on the efforts of people to stop
smoking found that e-cigarettes are 60 percent more effective
than nicotine replacement therapy, such as nicotine patches or
gum. Many e-cigarette companies argue that their product is
still an emerging technology and warn that restriction on e-
cigarettes that do not follow the science may inhibit future
innovation to create safer products for existing smokers.
At the same time, we need to be mindful that even if e-
cigarettes are shown to be less harmful than combustible
tobacco cigarettes, nicotine is addictive and the long-term
usage and health effects of these products are currently
unknown. Opponents of the product also believe that e-
cigarettes are a gateway to combustible tobacco cigarettes,
especially among minors.
Recent studies have shown that, with an increase in e-
cigarette marketing, overall awareness of e-cigarettes is
growing and some advertisements, whether they are intended to
or not, are reaching youth audiences. In addition, the Campaign
for Tobacco-Free Kids, represented here today by Mr. Myers, has
identified e-cigarette advertisements that employ similar
campaigns and themes as advertisements from combustible
cigarette companies decades ago. While this is not necessarily
the case for all e-cigarette companies, it raises
understandable concern about the targeting of this advertising.
There has also been a recent rise in the number of calls to
poison centers involving children related to e-cigarettes and
the accompanying solution, which often contains nicotine and
other ingredients. The American Academy of Pediatrics,
represented here today by Dr. Tanski, has raised concerns about
the lack of child resistant packaging on these products.
Earlier this year, the Food and Drug Administration
proposed a deeming rule to regulate e-cigarettes as tobacco
products. A number of questions are being asked about just how
these products should be regulated, especially how they can and
cannot be marketed. Given that these are relatively new
products and given the extent to which they may provide
benefits to public health, I believe sound science should drive
any discussion of Federal regulation.
I also think we should all agree that children should not
be able to purchase these products. My home state of South
Dakota has banned the sale or use of e-cigarettes by those
younger than 18 years of age. And several other states have
done the same.
While I'm opposed to smoking in general, I look forward to
learning more about the apparent potential of e-cigarettes to
reduce harm to current smokers. As with most issues that we
face in Congress, I believe that more scientific investigation
and thoughtful discussion is needed, and Mr. Ballin is here to
discuss some of his work with the University of Virginia to
start a dialogue between various stakeholders on these issues.
I'd like to end with a quote from Dr. Thomas Glynn who is a
director at the American Cancer Society, who sums up the
current debate surrounding e-cigarettes as follows: ``. . . as
with so many highly celebrated or reviled products, their true
nature likely lies somewhere in between, with both pros and
cons to recommend or discourage their use.'' Hopefully we can
shed some light on these pros and cons here today.
So thank you, again, to our witnesses for appearing today
and I look forward to hearing your testimony.
Thank you, Mr. Chairman.
The Chairman. Let's start with Dr. Tanski.
STATEMENT OF SUSANNE E. TANSKI, MD, MPH, FAAP, AMERICAN ACADEMY
OF PEDIATRICS
Dr. Tanski. Good afternoon.
And, may I add my birthday wishes, Mr. Chairman?
The Chairman. No, please don't.
Dr. Tanski. Happy birthday.
Dr. Tanski. I'm Dr. Susanne Tanski, a practicing
Pediatrician and Associate Professor of Pediatrics at the
Geisel School of Medicine at Dartmouth. I'm here today
representing the American Academy of Pediatrics, a professional
membership organization of 62,000 pediatricians. I'm the Chair
of the AAP's Tobacco Consortium and I conduct research on
tobacco and adolescents.
Chairman Rockefeller, Ranking Member Thune, and members of
the Committee, it's my pleasure to be here today to talk about
electronic cigarettes. Pediatricians have numerous and growing
concerns about the known and unknown risks and health impacts
of e-cigarettes. We're seriously concerned that e-cigarettes
may lead adolescents to a lifetime of nicotine addiction and
could serve as a gateway to traditional cigarettes.
The aggressive marketing of electronic cigarettes and its
impact on youth is particularly worrisome. The evidence is
clear that tobacco advertising directly influences youth. Use
of e-cigarettes is rising dramatically as told and we believe
this increase is clearly linked to unfettered advertising.
While there's much we don't yet know about these products, we
do know enough to say this: We must act now to protect children
against these risks from e-cigarettes.
E-cigarettes has mentioned they're devices that heat and
vaporizes solution containing nicotine, flavoring and other
chemicals. Contrary to claims, these products are not without
significant risk. Nicotine itself is not a benign substance.
Nicotine is a psycho-active drug with a high level of toxicity
and rapid addiction. Overdose of nicotine can lead to headache
or dizziness, or seizures and death. It can be absorbed through
the skin and it comes with workplace safety warnings to handle
it with gloves, mask, goggles and protective clothing.
Due to its extreme toxicity, the estimate and lethal dose
of nicotine is somewhere between 1 and 13 milligrams per
kilogram of body weight. Toxic effects would be seen at much
lower levels for those who are nicotine naive like children.
Pediatricians fear it's only a matter of time before a young
child dies from the liquid nicotine used to refill these e-
cigarettes.
Indeed, e-liquid has led to a recent spike in calls to
poison control centers. E-liquid is a likely candidate for
ingestion by young children because it's colorful, it often
smells like candy, and it's often sold without childproof
packaging. At the highest concentration, a small bottle of e-
liquid can contain over 500 milligrams of nicotine. That's
enough to kill several average size curious toddlers.
We find it completely unacceptable that no Federal laws or
regulations currently require the sale of e-liquid in
childproof containers. We call on Congress and the
Administration to help us to act quickly to ensure that this
needless danger to children is eliminated.
The emissions from e-cigarettes are also not harmless water
vapor. The ingredients in e-liquids can cause lung irritation
in the short-term and no research has yet been established to
show their long-term safety. Vapor contains numerous known
toxins and carcinogens albeit at levels markedly lower than
that found in regular cigarettes. The levels of particulates
that are emitted are similar to that in combusted cigarettes.
Flavored e-cigarettes are particularly concerning because
of the well-known appeal of flavored tobacco products to youth.
This is well understood by e-cigarette manufacturers. A parent
education website sponsored by one e-cigarette company notes
that ``Kids may be particularly vulnerable to trying e-
cigarettes due to an abundance of fun flavors such as cherry,
vanilla and pina colada.''
Notably, this same company markets e-cigarettes in cherry,
vanilla and pina colada. Other e-liquid flavors, as mentioned,
include cotton candy, Gummy Bear, Captain Crunch, Atomic
Fireball; clearly enticing children.
Young children being enticed to experiment with nicotine is
concerning because the adolescent brain appears uniquely
susceptible to nicotine addiction with symptoms of dependence
occurring within days to weeks of intermittent nicotine use. If
e-cigarettes cause nicotine addiction to adolescent, there's a
risk that these users will progress to combusted tobacco
products.
Anecdotal reports and limited data suggest that e-
cigarettes may help many smokers or some smokers to reduce or
quit smoking. At this time, further research is necessary to
determine if and how e-cigarettes can play a beneficial role in
reducing tobacco related disease. Research also needs to
identify whether e-cigarettes are used as a bridge to the
smoker's next cigarettes, delaying or inhibiting complete
smoking cessation.
E-cigarettes have yet another cause for concern: the re-
normalization of smoking. We know that children do what they
see. It's therefore very important that we not allow e-
cigarette use to re-normalize the image of a smoker.
Given all these concerns, it's alarming to us that e-
cigarette use among young people is growing dramatically. A
very recent study by Legacy found that 9 percent of 13 to 17
year olds are currently using electronic cigarettes. Marketing
clearly plays a large role on this increase. There's
substantial evidence that tobacco marketing reaches and
influences adolescents.
E-cigarettes are being advertised with many of the same
tools that were historically used by Big Tobacco companies:
celebrity endorsements, glamorous models, and event
sponsorships. They're promoted with messages that are appealing
to youth: freedom, rebellion, independence. These marketing
practices must stop.
America's pediatricians believe that strong regulations of
e-cigarettes are absolutely essential to protect children from
the risk of these products. We support FDA's regulatory
authority to regulate tobacco products for the protection of
the public health. It would be a tragedy if we failed to
regulate e-cigarettes in a way that protects children only
later to find out that we caused serious harm.
The message of America's pediatricians on e-cigarettes is
simple: We have a duty first to protect the children. Thank you
very much for the opportunity to speak here today.
[The prepared statement of Dr. Tanski follows:]
Prepared Statement of Susanne E. Tanski, MD, MPH, FAAP, On behalf of
the American Academy of Pediatrics
Good afternoon. My name is Dr. Susanne Tanski, a practicing
pediatrician and associate professor of pediatrics at the Geisel School
of Medicine at Dartmouth. I am here today representing the American
Academy of Pediatrics, a professional membership organization of more
than 62,000 pediatricians dedicated to advancing the health and well-
being of all children. I am the chair of the AAP's Tobacco Consortium,
which advises the AAP in its scientific, education and policy efforts
to protect children and youth from tobacco. I conduct research on
tobacco and adolescents, with a particular focus on the impact of media
on youth tobacco use.
Chairman Rockefeller, Ranking Member Thune, it is my pleasure to be
here today to discuss e-cigarettes, a critically important issue for
the health of children. Pediatricians have numerous and growing
concerns about the known and unknown health impacts of e-cigarettes. At
present, it is unknown if the availability of these products leads to
smoking initiation among non-smoking youth, and whether experimentation
with these leads to nicotine addiction. Without such data, we worry
that e-cigarettes could lead to a lifetime of nicotine addiction for an
adolescent and could serve as a gateway to use of traditional
cigarettes or other tobacco products. The individual and public health
risks of e-cigarettes are also largely unknown, as the products at
present are highly variable and differ substantially across brands and
types. In spite of the lack of definitive data on the impact of e-
cigarettes, we do know enough to assert that we must protect children
now from risks posed by these products.
The topic of today's hearing, the aggressive marketing of e-
cigarettes and its impact on youth, is of particular concern to
pediatricians. For the first time in over 40 years, tobacco products
are being advertised on television. The historical evidence is robust
that marketing directly influences youth, and a recent study has
identified substantial exposure of youth to televised e-cigarette
ads.\1\ One e-cigarette company has even placed ads during the Super
Bowl, which we know is watched by a substantial number of children. The
nation's pediatricians are concerned that use of electronic cigarettes
among teenagers is rising dramatically as reported in very recent
studies, and that this is linked to its unfettered advertising.
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\1\ Duke JC, Lee YO, Kimm AE, Watson KA, Arnold KY, Nonnemaker JM,
Porter L. Exposure to electronic cigarette television advertisements
among youth and young adults. Pediatrics 2014; 134.
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What are E-Cigarettes and Nicotine-Containing Vapor Devices?
E-cigarettes are a category of products that deliver nicotine and
flavoring on inhalation of a battery-powered device that warms and
vaporizes a nicotine-containing solution. These products are marketed
widely on the Internet and on U.S. television as alternatives to
cigarette use and come in a variety of tobacco, fruit, and food flavor.
Of primary concern for pediatricians is the potential for these devices
to introduce non-tobacco users to nicotine addiction or to perpetuate
smoking among smokers who would otherwise have quit. Use among young
people is growing: in just one year, the ever and current use of e-
cigarettes doubled among U.S. high school students, from 4.7 percent in
2011 to 10.0 percent in 2012 (for ever-use). While the rate of having
tried e-cigarettes is still far lower than that of cigarettes, as of
2012, approximately 1.78 million U.S. students reported using an e-
cigarette. While the overwhelming majority of e-cigarette triers had
also smoked cigarettes, some 7.2 percent of high school ever-users of
e-cigs had never tried a traditional cigarette.\2\ A more recent
Internet-based study in 2013-2014 found markedly higher rates of ever-
use and current-use: 14 percent of 13-17 year olds had ever used an e-
cigarette, and 9 percent currently used them. Among ever-cigarette
users aged 13-17, 32 percent were current e-cigarette users.\3\
Unfortunately, these numbers still may not tell the full story. With
the introduction of ``e-hookahs'' and ``vape-pens'' to the category,
asking only about ``e-cigarettes'' may significantly underestimate the
use of nicotine-containing vapor devices.
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\2\ Centers for Disease Control and Prevention. Notes from the
Field: Electronic Cigarette Use Among Middle and High School Students--
United States, 2011-2012. Morbidity and Mortality Weekly Report.
September 6, 2013, 62(35);729-730.
\3\ American Legacy Foundation. Vaporized: E-Cigarette, Advertising
and Youth. Available at http://legacyforhealth.org/content/download/
4542/63436/version/1/file/LEG-Vaporized-E-cig_Report-May2014.pdf 2014.
Accessed June 16, 2014.
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Nicotine: Health Effects, Addiction, Toxicity and Poisoning Potential
Nicotine itself is not a benign substance. Nicotine is a
psychoactive drug that is well known for its high level of toxicity, as
well as the ease with which dependence occurs. At low doses it acts as
a stimulant, leading to a feeling of pleasure and a reversal of
unpleasant withdrawal symptoms. Very simply, at the level of the brain,
nicotine works within the reward pathways. There are targets for
nicotine (receptors) throughout the body, however, allowing nicotine to
have broad physiological effects. With repeated exposure to nicotine,
tolerance to some of the effects of nicotine develops, and leads to
needing more nicotine. Insufficient nicotine in someone who is
dependent leads to craving and withdrawal symptoms of irritability,
anxiety, restlessness, and anhedonia. The basis of nicotine addiction
is reinforcement of behavior that restores nicotine and makes the user
feel good and avoid withdrawal.\4\ Regular users develop habits
associated with nicotine use that also become connected with the
rewarding feelings of nicotine use, creating cues for use. This is how
smokers become cued to want a cigarette after a meal, or with coffee,
or in certain locations, for example. Cigarettes are carefully
engineered to deliver nicotine quickly and efficiently to the brain to
reinforce addiction. The cigarette is the delivery device, but the
nicotine is the basis of the psychoactive effects.
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\4\ Benowitz NL. Nicotine Addiction. N Engl J Med. 2010, 362:2295-
230.
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Overdose of nicotine can cause nausea, vomiting, abdominal pain,
headache, dizziness, and seizures. In very high doses nicotine can be
lethal. Nicotine, in chemical form, is required to carry a material
safety data sheet (MSDS) warning users to handle it with gloves,
goggles, mask and protective clothing. The MSDS summarizes the acute
potential health effects as follows:
Skin: It can cause skin irritation and rash. It may cause
dermatitis. It is well absorbed by dermal exposure route. May
be fatal if absorbed through skin. Systemic effects similar to
that of ingestion can occur from nicotine poisoning.
Eyes: It can cause eye irritation. Severe pain, lacrimation,
conjunctival reaction, corneal infiltration, partial
opacification of cornea.
Inhalation: It is well absorbed by inhalation exposure route.
Inhalation can produce systemic effects similar to that of
ingestion.
Ingestion: May be fatal if swallowed. It can cause
gastrointestinal tract irritation/disturbances with nausea,
vomiting, diarrhea, stomach pain, burning sensation of the
mouth, throat, esophagus, and stomach, loss of appetite.
Metabolic acidosis and hypokalemia can develop if there is
severe diarrhea. It acts on the central nervous system and
other parts of the nervous system such as the adrenal medulla,
autonomic ganglia, and neuromuscular junctions with initial
stimulation followed by depression. Early signs of toxicity
from small doses include nausea, vomiting, headache, dizziness,
tachycardia, hypertension, tachypnea, hyperpnea, sweating, and
salivation. High exposure can cause dizziness, headache,
tremors, anxiety, restlessness, seizures, hypotonia, decreased
deep tendon reflexes progressing to paralysis, fasciculations,
convulsions, weakness, incoordination, hallucinations,
confusion, coma. Hypertension, tachycardia, and tachypnea
followed by hypotension, bradycardia, and dyspnea, bradypnea
can occur. Tachypnea is one of the principle signs nicotine
poisoning. Respiratory failure may also occur. Other symptoms
can include weak, rapid, and irregular pulse. Vasoconstriction,
atrial fibrillation, and sinoatrial block, and ventricular
fibrillation have also all been reported. Death is usually from
respiratory depression secondary to CNS depression and
peripheral blockade of respiratory muscles.\5\
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\5\ Material Safety Data Sheet L-Nicotine. Available at http://
www.sciencelab.com/msds.php?msdsId=9926222. Accessed June 16, 2014.
Given the tolerance that occurs for nicotine within regular users,
a wide range of doses have been shown to lead to acute toxicity. The
estimated lethal dose of nicotine is 1 to 13 mg per kilogram of body
weight.\6\,\7\ Toxic effects would be seen at much lower
levels among the nicotine naive, such as children, than among
established users.
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\6\ Mayer B. How much nicotine kills a human? Tracing back the
generally accepted lethal dose to dubious self-experiments in the
nineteenth century. Archivef of Toxicology. 2013; 88:5-7.
\7\ Bassett RA, Osterhoudt K, Brabazon T. Nicotine Poisoning in an
Infant. N Engl J Med. 2014; 370:2249-2250.
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The potential for poisoning is a very real concern for
pediatricians, and we fear it is only a matter of time before a child
suffers a lethal poisoning from the refill solutions for e-cigarettes.
Indeed, liquid nicotine sold to refill e-cigarettes, also called ``e-
liquid'' or ``e-juice'' has caused a substantial recent spike in child
poisoning, particularly among young children under the age of five. E-
liquid is a likely candidate for ingestion by young children because it
is colorful, candy flavored and scented, and there is no requirement
for child-proof packaging. Given that nicotine is also dermally
absorbed, e-liquid can be dangerous even if it only comes into contact
with the skin. E-liquids are sold in highly concentrated form, some
containing upwards of 36 mg of nicotine per milliliter of e-liquid. At
this concentration, a small 15 mL dropper bottle of e-liquid would
contain 540 mg of nicotine. Given the estimated lethal dose range of
nicotine, even at the high end of this range this small bottle would
contain enough nicotine to kill four 10 kg children (10 kg is an
average weight for a one-year-old child). Even a single teaspoon of e-
liquid at this concentration could kill a small child, and a smaller
dose would make one quite ill. The CDC reported this year that in the
month of February alone, poison control centers received 215 calls
related to e-cigarette exposures, many of these in young children. As
pediatricians, we are gravely concerned about these risks, and
fervently support requiring child-safe packaging for all nicotine
containing products.
We find it completely unacceptable that no Federal laws or
regulations currently require the sale of e-liquid in child-proof
packaging. We believe that the Food and Drug Administration (FDA) has
the authority to require poisoning prevention measures for tobacco
products, and we are disappointed that the agency failed to propose any
such measures in the proposed rule it published in April to deem e-
cigarettes and other tobacco products subject to FDA regulatory
authority. Further, the Consumer Product Safety Commission (CPSC),
which generally has authority to require child-proof packaging of
hazardous household products, is generally prohibited by law from
regulating any type of tobacco. In effect, there are no regulatory
safeguards in place to protect young children from e-liquid. If nothing
changes, it will not be a matter of if but when we see the first child
death caused by e-liquid. We call on Congress and the Administration to
act quickly to ensure that this danger to children is eliminated.
Health Risks of Recreational Nicotine: Leading to Dependence and
Possible Transitions to Combusted Tobacco
The adolescent brain appears uniquely susceptible to nicotine
addiction, with symptoms of dependence appearing within days to weeks
of intermittent tobacco use and well before daily smoking.\8\ Nearly
all adult smokers initiated smoking before the age of 20, and younger
age of tobacco initiation predicts greater levels of dependence and
difficulty quitting.\9\ Animal studies have demonstrated that nicotine
exposure during the adolescent period has long-standing effects in the
brain including cell damage that leads to both immediate and persistent
behavior changes.\10\ These effects are not found with nicotine
exposure to the adult, supporting the idea that the adolescent is
uniquely susceptible to nicotine addiction. The weight of evidence
suggests that nicotine exposure modifies the developing adolescent
brain and has long-term impacts into adulthood.\11\
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\8\ Difranza JR, et al., Initial symptoms of nicotine dependence in
adolescents. Tobacco Control. 2000, 9:313-319. Difranza JR, et al.,
Symptoms of Tobacco Dependence After Brief Intermittent Use. Arch
Pediatr Adol Med. 2007; 161(7):704-710.
\9\ Chen J. Millar WJ. Age of smoking initiation: implications for
quitting. Health Rep. 1998 Spring; 9(4):39-46.
\10\ Slotkin, TA. Nicotine and the adolescent brain: insights from
an animal model. Neurotoxicology and Teratology. 2002,24: 369-384.
\11\ U.S. Department of Health and Human Services. The Health
Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon
General. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, National Center for Chronic
Disease Prevention and Health Promotion, Office on Smoking and Health,
2014 (Health consequences of nicotine exposure, pages 120-122)
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There is not a specific threshold of nicotine exposure that
predicts addiction, but the source of the nicotine does seem to make a
difference. It has been shown that nicotine replacement therapies have
low potential for dependence due to how they are absorbed.\12\ At
present, it is not known how amounts and rates of nicotine delivery
from e-cigarettes and nicotine-containing vapor devices affects
nicotine addiction, nor is it known how many individuals beginning use
with e-cigarettes persist with e-cigarettes alone or also initiate
combusted tobacco use. Given that these products have only recently
begun to be examined, there have not to date been any trajectory
studies done with youth or young adult populations. The FDA and the
National Institute on Drug Abuse (NIDA) are collaborating on the
Population Assessment of Tobacco and Health (PATH) study that will
assess these trajectories. However they are still recruiting the
baseline sample and have no longitudinal data. The present cross-
sectional data of adolescents and young adults from other studies
suggests that dual use--using both e-cigarettes and combusted products
like cigarettes--is the most common status among e-cigarette users.
There is concern that e-cigarettes may impede individuals from quitting
smoking, by allowing them to maintain their nicotine addiction in
places where combusted tobacco has been prohibited. If these
individuals would otherwise have quit combusted tobacco completely, the
maintenance of use supported by e-cigarettes is of concern.
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\12\ Benowitz NL. Nicotine Safety and Toxicity. New York: Oxford
University Press; 1998.
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Other Public Health Consequences of E-Cigarettes
Anecdotal reports and limited data suggest that e-cigarettes may
help smokers quit or reduce smoking. At this time, further research is
necessary to determine if--and most importantly, under what
conditions--e-cigarettes could play a beneficial role in reducing
tobacco-related disease. E-cigarette companies are alluding to numerous
potential health benefits from e-cigarettes in their marketing
campaigns without appropriate data to support these implications. By
comparison, FDA-approved nicotine replacement therapies such as
nicotine gum have been carefully evaluated for their safety and
efficacy in assisting in tobacco cessation in the context of specific,
evidence-based instructions for use. In the case of e-cigarettes, there
are no instructions on how to use the products to achieve smoking
cessation. Additionally, data show that current e-cigarette users
include distant-former smokers--smokers who quit more than 5 years
ago--suggesting that e-cigarettes could be leading to the re-addiction
of former smokers.\13\ Given the vast differences in the engineering of
e-cigarettes, the doses and chemosensory variations of the e-juice, and
the complete lack of quality standards at present, it is
extraordinarily difficult to quantify the public health consequences.
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\13\ McMillen RC. Trends in electronic cigarette us among U.S.
adults: use is increasing in both smokers and non-smokers. Social
Climate Survey of Tobacco Control, Mississippi State University.
Personal communication.
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Beyond nicotine, e-cigarette vapor is made up of a humectant such
as propylene glycol or vegetable glycerin, and flavoring. The
humectants can cause lung irritation in the short term, but there is no
research into the long-term impact of vaporizing and inhaling these
agents into the lungs. The flavorings themselves are also cause for
concern on multiple levels. There is limited data regarding the safety
of vaporizing the chemical characterizing flavors, and there may be
risks of flavorings to the user directly. There is also the known
appeal of flavored tobacco products to youth. We know from the
traditional cigarette example that flavors increase smoking initiation
among youth, which led to the ban of all characterizing flavors (other
than menthol) in cigarettes. The appeal of flavors for children is well
understood by e-cigarette manufacturers. A parent education website
sponsored by one e-cigarette company notes that ``kids may be
particularly vulnerable to trying e-cigarettes due to an abundance of
fun flavors such as cherry, vanilla, pina-colada and berry.'' \14\
Despite understanding that these products appeal to children, that same
company markets e-cigarettes in cherry, vanilla, pina colada and other
candy flavors. Furthermore, some e-liquids come in flavors like
``cotton candy'' and ``gummy bear'' which seem clearly designed to
entice new youth users.
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\14\ Lorillard Inc. Youth Smoking Prevention Program. What you need
to know about e-cigarettes--Infographic. Available at http://
www.realparentsrealanswers.com/what-you-need-to-know-about-e-
cigarettes-infographic/. Accessed June 16, 2014.
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The emissions from e-cigarettes have been publicized as ``harmless
water vapor,'' but accumulating evidence demonstrates that the vapor
inhaled into the user's lungs does contain numerous known toxins and
carcinogens such as formaldehyde and tobacco-specific nitrosamines,
albeit at levels markedly lower than those found in traditional
cigarettes.\15\ The levels of particulates that are emitted from e-
cigarettes are not very different from combusted cigarettes,
however.\16\ These particulates could have respiratory irritation
potential for those nearby. In fact, preliminary animal model data
shows damage to growing lungs resulting from second-hand exposure to e-
cigarette vapor. The negative health impact of e-cigarettes on children
and non-smokers deserves more research. However, until and unless we
know that these emissions do not cause harms, particularly to
developing lungs, there is an imperative to limit exposure of children
and other non-smokers. We must extend all clean air laws to include the
emissions from e-cigarettes.
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\15\ Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek
J, Prokopowicz A, Jablonska-Czapla M, Rosik-Dulewska C, Havel C. Levels
of selected carcinogens and toxicants in vapour from electronic
cigarettes. Tob Control. 2014; 23:133-139.
\16\ Fuoco FC, Buonanno G, Stabile L, Vigo P. Influential
parameters on particle concentration and size distribution in the
mainstream of e-cigarettes. Environ Pollut 2014; 184:523-529.
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The e-cigarettes have yet another cause for concern: the re-
normalization of smoking. Smoking has become an unpopular behavior
among young people, with smokers having to go outside and in many cases
off campuses to smoke. As such, smoking is not as often seen as it was
20 years ago. The increase of people smoking e-cigarettes in places
where smoking is not currently allowed creates confusion, particularly
among children, who often cannot tell the difference between smoking
and e-cigarette use. Anecdotally, when I've shown children pictures of
people using e-cigarettes, they nearly always report that the person in
the picture is smoking. We know that children do what they see, and
they overestimate the prevalence of behaviors that they see in media,
hence it is important that we not allowing-cigarette use to re-
normalize the image of a smoker.
Marketing to Youth
With tobacco companies now selling e-cigarettes, there is a
significant amount of marketing and attention in the media to e-
cigarettes. Beyond this are the marketing efforts of independent
companies. While there is broad public consensus that e-cigarettes
should not be sold or marketed to youth, there is substantial evidence
that marketing reaches the adolescent demographic and is influencing
them. Age limits on purchase will be ineffective without advertising
restrictions.
The most recent Surgeon General's report clearly stated: ``The
evidence is sufficient to conclude that advertising and promotional
activities by the tobacco companies cause the onset and continuation of
smoking among adolescents and young adults.'' \17\ (emphasis added) In
spite of this, there remain no controls on the marketing of e-
cigarettes, and there is significant penetration of e-cigarette
marketing to youth audiences. Data released earlier this month show
that youth exposure to e-cigarette marketing on television increased
256 percent between 2011 and 2013. The audience of the e-cigarette
companies now includes 24 million youth.\18\ A study from Legacy
released last month found that 17.7 million or 73 percent of 12-17 year
olds were exposed to one e-cigarette company's print and TV ads between
June and November 2013, as just one example.\19\ TV and radio ads for
cigarettes were banned in 1971 to limit exposure to impressionable
children. Our children in 2014 are no less impressionable. We believe
tobacco advertisements have no place on television.
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\17\ U.S. Department of Health and Human Services. The Health
Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon
General. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, National Center for Chronic
Disease Prevention and Health Promotion, Office on Smoking and Health,
2014.
\18\ Duke JC, Lee YO, Kimm AE, Watson KA, Arnold KY, Nonnemaker JM,
Porter L. Exposure to electronic cigarette television advertisements
among youth and young adults. Pediatrics 2014; 134.
\19\ American Legacy Foundation. Vaporized: E-Cigarette,
Advertising and Youth. Available at http://legacyforhealth.org/content/
download/4542/63436/version/1/file/LEG-Vaporized-E-cig
_Report-May2014.pdf 2014. Accessed June 16, 2014.
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E-cigarettes are being advertised with many of the same tools that
were used by big tobacco companies prior to the Master Settlement
Agreement (MSA): celebrity endorsements, glamorous models, event
sponsorships, and the previously mentioned flavors. While event
sponsorships are expressly prohibited in the Tobacco Control Act for
cigarettes and smokeless tobacco, e-cigarettes have no such
restrictions. A recent investigation released by Chairman Rockefeller
and other members of Congress identified that e-cigarette companies
``sponsored dozens of athletic, musical, social and cultural events
that appeal to youth.'' \20\ In addition, e-cigarettes are being
promoted with a variety of messages that are appealing to youth:
freedom, rebellion, and independence. There are also implicit messages
that e-cigarettes are a healthier alternative to smoking, again, a
theme that is attractive to youth.
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\20\ Senators Durbin, Harkin, Rockefeller, Blumenthal, Markey,
Brown, Reed, Boxer, Merkley, Representatives Waxman and Pallone.
Gateway to Addiction. Available at http://www
.durbin.senate.gov/public/index.cfm/files/serve/?File_id=81d14ff7-f2f6-
4856-af9d-c20c0b138
f8f. Accessed June 16, 2014.
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Because of the myriad ways tobacco advertising can negatively
impact children, the AAP endorsed the Protecting Children from
Electronic Cigarette Advertising Act of 2014, which would prohibit e-
cigarette marketing practices that appeal to children, and give the
Federal Trade Commission (FTC) the authority to enforce violations.
E-Cigarette Regulation to Protect Children and the Public Health
America's pediatricians believe that strong regulation of e-
cigarettes is absolutely essential to protecting children from the
risks posed by these products. Some e-cigarette proponents argue that
the products should not be regulated. We disagree. We do not believe it
is inconsistent to both strongly regulate e-cigarettes for protection
of children and allow e-cigarettes to play a role in reducing smoking
if research is able to demonstrate that appropriately regulated e-
cigarettes could benefit the public health as a whole. Until such
evidence is available, however, there is an urgent need to control the
exposure of children and youth to these products, and to immediately
exert all appropriate regulatory authority over them.
In fact, the Tobacco Control Act gives the FDA the authority to
regulate tobacco products based on a protection of the public health
standard. In determining what policies would benefit the public health,
the FDA is required to assess the impact of policy choices on both
users and non-users of tobacco products. We support this regulatory
approach. It would be a tragedy if we fail to regulate e-cigarettes in
a way that protects children and only later find out that a lax
regulatory approach caused more harm than good. We cannot and should
not repeat the mistakes that were made in the public health response to
traditional cigarettes.
As such, the Academy supports strong FDA authority to regulate all
tobacco products, including e-cigarettes. We applaud the agency for
issuing a proposal in April to expand its jurisdiction to include all
types of tobacco products. We are currently in the process of
submitting comments to FDA on its proposal.
The message of America's pediatricians on e-cigarettes is simple:
we have a duty to first protect children. Thank you for the opportunity
to provide this testimony. We look forward to working with this
committee to address the risks e-cigarettes pose to children.
The Chairman. Thank you very much, Dr. Tanski.
And now, Mr. Matthew Myers.
STATEMENT OF MATTHEW L. MYERS, PRESIDENT,
CAMPAIGN FOR TOBACCO-FREE KIDS
Mr. Myers. I'm Matthew Myers, President of the Campaign for
Tobacco-Free Kids. Mr. Chairman, Minority Member Thune, members
of the Committee, I want to thank you for the opportunity. We
worked with many of you for over a decade to help pass the law
giving the Food and Drug Administration authority over
cigarettes, smokeless tobacco and all other tobacco products
precisely to address many of the concerns, Mr. Chairman, that
you raised today.
Over the last several years, we have seen a dramatic growth
in the marketing and sale of e-cigarettes. Despite the rise and
the use of e-cigarettes, as you correctly noted, little is
proven either about their health effects or their population
impact.
Our core position is that responsibly marketed and properly
regulated e-cigarettes could benefit the public health if in
fact they help people switch off of cigarettes to either the
exclusive use of e-cigarettes or to quit the use of nicotine
all together. However, e-cigarettes pose a potential health
risk to the public if they are not used by smokers or other
tobacco users to stop smoking all together; if they cause
children to start or re-glamourize smoking in the eyes of our
Nation's children; or if they discourage smokers from quitting
by providing doses of nicotine to sustain addiction rather than
help people quit.
Today, as you correctly noted, as a result of the failure
of the government to act swiftly and the most irresponsible
action by the manufacturers and marketers of e-cigarette
companies, the marketplace for e-cigarettes has turned into a
true ``Wild West.'' The rapidly growing and, today, completely
unregulated e-cigarette marketplace has not only outpaced the
science, the behavior of the e-cigarette industry itself raises
serious concerns about the ultimate effect of e-cigarettes on
the public health.
How e-cigarettes are made can also impact whether they are
effective at helping people quit smoking cigarettes or whether
they lead to sustained cigarette use or introduce a whole new
generation to smoking. Unfortunately, it appears that a
substantial segment of the industry is neither designing their
products nor marketing with an eye toward reducing the number
of people who smoke cigarettes.
Let me address the issue of marketing because it is the one
that this hearing is about. The marketing practices, themes and
images of e-cigarette manufacturers today, Mr. Chairman,
exactly as you noted, are virtually the same as those used by
cigarette manufacturers to successfully attract kids to smoking
cigarettes for 50 years. It is a battle that we have been
fighting in our slowly but significantly winning.
Yet, for e-cigarettes today, what do we see? We see
celebrity spokespeople with themes like freedom in imagery like
this. We see the use of sex as we saw with the cigarette
companies with themes in images like this. We see placement in
the ``Swimsuit'' issue of Sports Illustrated with placements of
the brand name on the bikini bottom of a scantily clad model in
probably the magazine that is read by more adolescent boys than
any other single magazine in the United States. We've seen a
return of sponsorship of sporting events, rock concerts,
attended by youth all over the country.
Now, when cigarette companies use these exact same images
in these exact same places in the exact same way the impact was
tragic and we're still paying for it. It was a dramatic rise in
flood in youth tobacco use.
Mr. Chairman, as you correctly noted, today we're seeing a
decline in cigarette smoking. But we're also seeing a rapid
rise in youth use and experimentation of e-cigarettes. No one
should be surprised. While it doesn't take a rocket scientist
to look at these ads and figure out who they're targeted to, we
in fact have a whole body of science done by the National
Cancer Institute, the Institute of Medicine, the Surgeon
General, and a plethora of others that have looked at these
techniques in marketing and have determined that they are
directly and causally related to the increase in use of
cigarette smoking among kids. It defies logic, it defies
science, to say the same techniques, the same ads, won't have
the same impact on our nation's youth with regard to e-
cigarettes.
And you're going to hear, I'm sure, that the e-cigarette
manufacturers say ``We don't target kids.'' Well, in fact,
that's exactly what the cigarette companies have been saying
for 50 years. To this day, they have never admitted to running
a single add that targeted kids. The third prong of those eight
CEOs who stood up there after they said that they didn't
believe that smoking caused disease or is addiction was ``We
don't market to children.''
Let me quote from Judge Kessler's decision in the case the
Federal Government brought against the tobacco industry, sadly,
8 years after the tobacco companies promised to stop marketing
to kids. And that was from Lorillard that said, ``Lorillard
tobacco has never marketed or sold its products to youth.''
This is the same company that markets blu e-cigarettes. Judge
Kessler found exactly the opposite; that that was the case.
And as you've correctly said, and I won't repeat, it isn't
a surprise that we've just seen the dramatic rise in youth
because in the last two to 3 years we have seen a fundamental
change in e-cigarette marketing and a sudden fundamental change
in the amount of e-cigarette marketing.
What we're seeing is a start of a potential Tsunami,
because, not that e-cigarettes are good or bad, because of the
behavior of e-cigarette manufacturers and marketers, that's
what is causing the rise here with regards to this. So it's not
a surprise we've seen the dramatic rise and it shouldn't shock
us if we see that rise take off in unprecedented levels. Unless
something is done to stop the kind of marketing that I've shown
you.
Now the same is exactly true with flavorings. And they're
asking us, as well, to turn the world upside down. The exact
same flavors that you quoted, that Dr. Tanski quoted, that
prompted Congress to ban the use of characterizing flavors in
cigarettes are now being found in e-cigarettes and we're
hearing the same thing from them. These aren't about kids, they
say. Here's a bottle of e-liquid, Cinnamon Bun flavored e-
liquid. I would pass it around but your fingers would stink if
you did it. And I would have to caution you not to open because
it says that if it touches your skin, it's toxic. If you inhale
it, it's toxic. And yet, this is being sold over the Internet
with virtually no controls so that it's easily available.
Blue Cherry Crush, with this. Is it a surprise that the
data is already showing an increase in youth use of these very
flavors? Dr. Tanski cited a tobacco company's own website but I
could cite you a string of quotes of internal tobacco industry
documents and quotes that says that these flavors appeal
primarily to young people.
Now whether or not they may or may not help somebody quit
smoking, we don't know. But what we do know is that they appeal
dramatically to young people. And unless somebody gets a handle
on the marketing of these flavors, in a new study out in just
the last week shows that the number of new flavors has
literally exploded. And I can guarantee you nobody is testing
those flavors as they would have to if they were being
regulated by FDA to see whether those flavors entice kids.
In short, Mr. Chairman, this hearing comes at exactly the
right time. It is an urgent need for our government to step in
and protect our kids. This is not a hearing about whether or
not e-cigarettes potentially have a beneficial effect. It is
about the behavior of the e-cigarette companies in how they're
marketing and manufacturing these products. Unless the FDA acts
and acts rapidly, and unfortunately the proposed regulation
doesn't even address the question of e-cigarette marketing or
the flavors in e-cigarettes, so that our kids will continue to
be, as you correctly said, ``human guinea pigs,'' for an
industry that has demonstrated no responsibility in how it is
marketed, where it is marketed, to whom it is targeted, its
products.
We urge you to take strong action to ensure that these
issues are addressed.
Thank you.
[The prepared statement of Mr. Myers follows:]
Prepared Statement of Matthew L. Myers, President,
Campaign for Tobacco-Free Kids
I am Matthew Myers, President of the Campaign for Tobacco-Free
Kids. The Campaign works to reduce tobacco use and its deadly toll in
the United States and around the world. We advocate for public policies
proven to prevent kids from smoking and other tobacco use, help smokers
quit, and protect everyone from secondhand smoke.
Chairman Rockefeller and Ranking Member Thune, I appreciate the
opportunity to testify today on the marketing of electronic cigarettes
and its consequences for youth.
The Debate About E-Cigarettes
Over the last several years, there has been a dramatic growth in
the marketing and sale of e-cigarettes. Despite the rise in use of e-
cigarettes, little is proven about their actual health risk or their
impact on overall tobacco use. Although Congress gave the FDA the
authority in 2009 in the Family Smoking Prevention and Tobacco Control
Act to assert its authority to regulate tobacco products not explicitly
mentioned in the Act, including e-cigarettes, as of today no Federal
agency regulates e-cigarettes. As a result, companies are not required
to control or disclose the level of nicotine or other ingredients in
these products, test them for harmful and potentially harmful
constituents, and there are no restrictions on how they are marketed or
to whom.
Responsibly marketed and properly regulated, e-cigarettes could
benefit public health if they help significantly reduce the number of
people who smoke conventional cigarettes and become sick and die as a
result. However, e-cigarettes pose a potential risk to public health if
they are not used by smokers and other tobacco users to stop smoking
cigarettes altogether; if they cause more people, particularly kids, to
begin using nicotine products; or if they discourage smokers from
quitting cigarettes. It is important to note that the scientific
evidence does not indicate a health benefit if a cigarette smoker uses
both e-cigarettes and regular cigarettes (dual use) or if an e-
cigarette smoker simply reduces the number of cigarettes one smokes but
continues to smoke cigarettes.
Today, as the result of the failure of the government to act
swiftly, the market place for e-cigarettes is truly the Wild West. The
rapidly growing and completely unregulated e-cigarette marketplace has
outpaced the science, and the behavior of the e-cigarette industry
raises serious concerns about the ultimate effect of e-cigarettes on
public health if strong, thoughtful regulation is not adopted quickly
over both the products and how and to whom they are marketed. It is
hard to look at how e-cigarettes are made and marketed today and not be
concerned.
Today's hearing focuses on the marketing of e-cigarettes, and
especially the impact of current e-cigarette marketing on youth, but it
is also important to recognize the significance of the failure of the
FDA to act swiftly to regulate the product itself.
Nicotine is not the substance in cigarettes that causes cancer, but
neither is it benign. The most recent Report of the Surgeon General
issued this January documents extensively the health risks of nicotine.
It found that at high enough levels nicotine can cause ``acute
toxicity'' and is implicated in the increased risk of diseases from
smoking. Nicotine exposure has long lasting consequences. It impacts
fetal development and adolescent brain development.\1\ And, of course,
nicotine is highly addictive, with research indicating that young
people are more susceptible and sensitive to the effects of nicotine
and can often feel dependent earlier than adults.\2\
---------------------------------------------------------------------------
\1\ U.S. Department of Health and Human Services (HHS), The Health
Consequences of Smoking--50 Years of Progress: A Report of the Surgeon
General. Atlanta, GA: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, National Center for Chronic
Disease Prevention and Health Promotion, Office on Smoking and Health,
2014, http://www.surgeongeneral.gov/library/reports/50-years-of-
progress/.
\2\ HHS, Preventing Tobacco Use Among Youth and Young Adults: A
Report of the Surgeon General, Centers for Disease Control and
Prevention, Office on Smoking and Health, 2012 http://
www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-use/
index.html;
---------------------------------------------------------------------------
It is also important to recognize that the term ``e-cigarette'' is
being used to describe literally hundreds of different products that
are changing rapidly.\3\ This means that the few studies that exist do
not cover many of the products now on the market and, in the absence of
FDA getting a handle on the market rapidly, there is no way to know how
helpful or how dangerous the products are that are now on the market.
For example, in the current unregulated environment, e-cigarettes and
refill liquids are sold containing widely varying levels of nicotine
with no controls.
---------------------------------------------------------------------------
\3\ Brown, CJ & Cheng, JM, ``Electronic cigarettes: product
characterisation and design considerations,'' Tobacco Control 23:ii4-
ii10, 2014.
---------------------------------------------------------------------------
How e-cigarettes are made can impact whether they are effective at
helping people quit smoking cigarettes or whether they lead to
sustained cigarette use or introduce a whole new generation to smoking.
Unfortunately, it appears that a substantial segment of the industry is
neither designing their products nor their marketing with an eye
towards reducing the number of people who smoke cigarettes. Instead, it
appears that many if not virtually all of today's products, and much of
the marketing for these products, are designed to expand the e-
cigarette marketplace as broadly as possible, regardless of the age or
smoking status of the consumer.
Concerns About Marketing Practices That Attract Kids
The marketing practices, themes, and images of e-cigarette
manufacturers today are virtually the same as those used by the
cigarette manufacturers to successfully attract kids to smoking--
including many images and strategies that have become unlawful for
cigarettes precisely because of their appeal to youth. Appendix A shows
some illustrative examples that demonstrate:
E-cigarette companies are using celebrity spokespeople to
pitch their products. Actor Stephen Dorff, former Playboy model
Jenny McCarthy and musician Courtney Love are promoting e-
cigarettes just as old Hollywood stars like Gary Cooper,
Marlene Dietrich and Joan Crawford once promoted cigarettes.
E-cigarette companies are using images and themes that
appeal to youth and running ads that depict e-cigarette use as
a way to express masculinity, sexiness, rebelliousness, freedom
and liberation.
E-cigarette companies are reaching millions of teens by
placing their ads in places with huge youth viewership,
including ads on television, online, in newspapers, and in
magazines like Rolling Stone, Sports Illustrated, InStyle and
Us Weekly.
E-cigarette companies are sponsoring youth-oriented sports
and entertainment events, including auto racing and music
festivals, just like cigarette companies used to do.
Blu e-cigarettes even featured a cartoon pitchman named
``Mr. Cool'' on its website, reminiscent of the Joe Camel
cartoon character that so effectively marketed cigarettes to
kids in the 1990s.
Mr. Chairman, the investigative report you released in April with
other Members of the Senate and House provided some of the most
detailed evidence to date about how e-cigarette companies are marketing
their products, including the use of television and radio ads, free
sampling at promotional events, and use of social media.\4\
---------------------------------------------------------------------------
\4\ Durbin, R, et al., ``Gateway to Addiction? A Survey of Popular
Electronic Cigarette Manufacturers and Marketing to Youth,'' April 14,
2014, http://www.durbin.senate.gov/public/index
.cfm/files/serve?File_id=a85bb717-ac5d-4835-a584-206dbdb1f856.
---------------------------------------------------------------------------
When cigarette companies used these marketing practices, they were
extraordinarily successful in increasing the number of kids who smoke.
Congress banned cigarette advertising on television in 1970 precisely
because of the impact of these ads on youth. Congress banned
advertising of smokeless tobacco on TV in 1986 for the same reason. All
50 states sued the tobacco industry in the mid-1990s to bring a halt to
cigarette advertising practices that are virtually identical to what we
now see being used to market e-cigarettes, resulting in the prohibition
of many of these practices in the Master Settlement Agreement between
the major tobacco companies and state Attorneys General in 1998. Just 5
years ago, Congress cited the impact of cigarette marketing on youth as
one of its reasons for enacting the Family Smoking Prevention and
Tobacco Control Act and instructed the FDA to adopt regulations
restricting advertising of cigarettes and smokeless tobacco products.
These marketing restrictions have contributed to a steep decline in
cigarette smoking by youth. Just last week, CDC reported that 15.7
percent of high school students smoked cigarettes in 2013, a decline of
57 percent since the high school smoking rate peaked in 1997.\5\
---------------------------------------------------------------------------
\5\ U.S. Centers for Disease Control & Prevention (CDC), ``Youth
Risk Behavior Surveillance--United States, 2013,'' Morbidity and
Mortality Weekly Report (MMWR) 63(No. 4), June 12, 2014.
---------------------------------------------------------------------------
But while we are seeing a decline in cigarette smoking among youth,
we are seeing a rapid rise in youth use of and experimentation with e-
cigarettes. The percentage of high school students who ever used e-
cigarettes doubled in a single year, from 4.7 percent in 2011 to 10
percent in 2012. An estimated 1.78 million youth (middle and high
school students) had used e-cigarettes as of 2012.\6\ The rise took
place at exactly the same time we witnessed the dramatic growth in both
the amount of advertising for e-cigarettes and the explosion of e-
cigarette advertising using the images and themes that are identical to
those previously used for cigarettes.
---------------------------------------------------------------------------
\6\ CDC, ``Electronic Cigarette Use Among Middle and High School
Students--United States, 2011--2012,'' MMWR 62(35), September 6, 2013.
---------------------------------------------------------------------------
No one should be surprised. The scientific evidence is overwhelming
that cigarette marketing that used these same tactics, themes and
images increased youth tobacco use. A comprehensive report released by
the National Cancer Institute (NCI) in June 2008 and another by the
Institute of Medicine of the National Academy of Sciences found a
causal relationship between tobacco advertising and increased levels of
tobacco initiation by youth, focusing very specifically on the type of
advertising and marketing we are seeing from the e-cigarette industry
today.\7\ The 2012 Report of the Surgeon General also found that the
evidence is sufficient to conclude that there is a causal relationship
between advertising and promotional efforts of the tobacco companies
and the initiation and progression of tobacco use among young
people.\8\
---------------------------------------------------------------------------
\7\ National Cancer Institute, The Role of the Media in Promoting
and Reducing Tobacco Use, Smoking and Tobacco Control Monograph No. 19,
NIH Pub. No. 07-6242, June 2008. Institute of Medicine (IOM), Ending
the tobacco problem: A blueprint for the nation, Washington, D.C.: The
National Academies Press, 2007.
\8\ HHS, Preventing Tobacco Use Among Youth and Young Adults: A
Report of the Surgeon General. Atlanta, GA: HHS, CDC, National Center
for Chronic Disease Prevention and Health Promotion, Office on Smoking
and Health, 2012.
---------------------------------------------------------------------------
The e-cigarette companies claim that they don't market to kids. The
sad reality is that the cigarette companies, including those now
marketing e-cigarettes, have always said the same thing. As shown in
Appendix B, in the case brought by the U.S. Government against the
major U.S. cigarette manufacturers, Judge Kessler quoted Lorillard's
Vice-President for External Affairs as saying, ``Lorillard Tobacco
Company has never marketed or sold its products to youth'' and others
in the industry who made similar statements and then found:
The evidence is clear and convincing--and beyond any reasonable
doubt--that Defendants have marketed to young people twenty-one
and under, while consistently, publicly, and falsely, denying
they do so. \9\
---------------------------------------------------------------------------
\9\ U.S. v. Philip Morris USA, Inc., 449 F.Supp.2d at 691.
Even as Lorillard has, for example, run a provocative ad displaying
the name ``blu'' on the bikini bottom of a scantily clad woman in this
year's swimsuit issue of Sports Illustrated and even more provocative
and sensual YouTube videos online, it has written to FDA claiming that
it does not market e-cigarettes to youth. (See Appendix C for images.
See Appendix D-1 for Lorillard's letter to FDA and Appendix D-2 for the
Campaign's response). This is straight out of the tobacco industry's
old playbook--engage in egregious behavior that impacts youth and then
engage in a campaign of denial.
Concerns about Product Appeal to Youth
It is not just the advertising that raises concerns about the
impact of the current e-cigarette market on youth and other non-
smokers; it is how the product itself is being manufactured. E-
cigarettes are being sold in a way that maximizes their appeal with
little regard to the effect on public health. The use of flavorings is
a prime example. E-cigarettes and e-liquids come in an ever growing
variety of flavors, including fruit-and candy-flavors, that cigarette
companies are prohibited from using. E-cigarette liquids come in
flavors such as vivid vanilla, Cinabon, cherry crush, chocolate, jolly
rancher, gummi bear, bubble gum, and cotton candy and many others (see
Appendix C for examples).
Congress explicitly banned the use of cigarettes with similar
characterizing flavors because of their appeal to youth. Before
cigarettes with fruit-and candy-flavors were prohibited, they were most
attractive to the youngest smokers and were being used primarily by
younger smokers. One study found 22.8 percent of 17 year old smokers
and 21.7 percent of 18 and 19 year old smokers used flavored cigarettes
while only 9 percent of 24-26 year olds did.\10\ Similarly, youth and
young adults prefer cigar brands that come in a variety of flavors, and
that preference declines significantly with age. According to a recent
study, 95 percent of 12-17 year old cigar smokers reported a usual
brand that makes flavored cigars compared with 63 percent of cigar
smokers aged 35 and older.\11\
---------------------------------------------------------------------------
\10\ Klein, S et al., ``Use of flavored cigarettes among older
adolescent and adult smokers: United States, 2004--2005,'' Nicotine and
Tobacco Research, 10(7):1209-14, July 2008.
\11\ Delnevo, C, et al., ``Preference for flavoured cigar brands
among youth, young adults and adults in the USA,'' Tobacco Control,
[Epub ahead of print], April 10, 2014.
---------------------------------------------------------------------------
The addition of fruit and candy flavorings to e-cigarettes creates
the very real possibility of broadening the appeal of this product to
non-smokers who find the flavor of tobacco distasteful, including kids.
Given the rapidity with which new flavors are being introduced and by
whom, it is almost certain that no one is testing these products to
insure that they do not appeal to youth.
Once again the industry claims that flavored e-cigarettes don't
appeal to kids and are about making the product for long term committed
smokers. However, Lorillard's own youth prevention website
acknowledges, ``Kids may be particularly vulnerable to trying e-
cigarettes due to an abundance of fun flavors such as cherry, vanilla,
pina-colada and berry.'' Three of these flavors are also offered by
Lorillard's blu (see Appendix C).
It is not just the flavors that are of concern. Three decades ago,
the smokeless tobacco industry recognized one way to attract youth was
to introduce them to mild, low nicotine products and then ``graduate''
them to stronger products. Internal company documents show that United
States Tobacco developed a strategy for hooking new spit-tobacco users
(meaning kids) some time ago. As one document states:
New users of smokeless tobacco--attracted to the category for a
variety of reasons--are most likely to begin with products that
are milder tasting, more flavored, and/or easier to control in
the mouth. After a period of time, there is a natural
progression of product switching to brands that are more full-
bodied, less flavored, have more concentrated ``tobacco taste''
than the entry brand. \12\
---------------------------------------------------------------------------
\12\ Connolly, GN, ``The Marketing of Nicotine Addiction by One
Oral Snuff Manufacturer,'' Tobacco Control 4(1):73-79, Spring 1995.
We may well be seeing the same tactic with regard to e-cigarettes.
When tested, many e-cigarettes appear to have far less nicotine than is
needed to satisfy the craving of an addicted cigarette smoker but have
a mild enough taste to be easy to use for a non-smoker. This poses two
concerns: Are products being made that make it easy for an adolescent
non-smoker to use? Are they also being made with too little nicotine to
serve as an effective tool to help a cigarette smoker quit, but just
enough to enable a cigarette smoker to use these products when they are
in places where they cannot smoke to serve as a bridge that enables
them to maintain their cigarette addiction?
Recent Studies on Youth Viewership of E-Cigarette Advertisements
E-cigarette companies say they are marketing their products only to
adults. But we should pay attention to what they do, not just what they
say. A look at the numbers tells a different story. Recent studies have
found that advertising by e-cigarette companies is reaching many youth
and young adults.
In a recent report detailing the results of a survey of youth and
young adults, Legacy found that 60 percent of teens 13-17 years old
said they saw e-cigarette advertising at convenience stores and similar
retail outlets always, most of the time, or some of the time; 45
percent said they saw e-cigarette advertising on TV always, most, or
some of the time; and 43 percent saw e-cigarette advertising online
always, most, or some of the time. Viewership of these forms of e-
cigarette advertising was even higher among young adults 18-21 years of
age.\13\
---------------------------------------------------------------------------
\13\ Legacy, Vaporized: E-Cigarettes, Advertising, and Youth, April
2014.
---------------------------------------------------------------------------
A second study in the Legacy report analyzed media expenditure data
to estimate whether e-cigarette advertising was reaching young people.
It estimated that 58 percent of teens ages 12-17 (14.1 million) were
exposed to e-cigarette ads on TV. E-cigarette ads ran on a number of
networks including Comedy Central, USA, ABC Family, Bravo, E!, MTV,
VH1, and Spike. And ads were run on programs featuring mature cartoons
such as South Park and Futurama, reality shows like Bar Rescue and
COPS, and sitcoms like The King of Queens. Legacy's analysis also found
that 39 percent of teens ages 12-17 (9.5 million) were reached through
e-cigarette ads in magazines. Top magazines featuring these ads
included Star, OK!, Entertainment Weekly, Us Weekly, Men's Journal, and
Rolling Stone.\14\
---------------------------------------------------------------------------
\14\ Legacy, Vaporized: E-Cigarettes, Advertising, and Youth, April
2014.
---------------------------------------------------------------------------
Researchers at RTI published a recent study in the journal
Pediatrics that found that youth (12-17 years old) exposure to e-
cigarette television ads increased 256 percent from 2011 to 2013, and
young adult (18-24 years old) exposure increased 321 percent of that
time period. The study also estimated that youth exposure to e-
cigarette television ads was extensive--the equivalent of 50 percent of
12-17 year olds viewing an average of 21 ads from October 2012 to
September 2013. It found that cable network AMC, Country Music
Television, Comedy Central, WGN America, TV Land, and VH1 aired the
most e-cigarette ads in 2013, and e-cigarette ads appeared on programs
that were among the 100 highest-rate youth programs for 2012-2013,
including The Bachelor, Big Brother, and Survivor).\15\
---------------------------------------------------------------------------
\15\ Duke, JC, ``Exposure to Electronic Cigarette Television
Advertisements Among Youth and Young Adults,'' Pediatrics [Epub ahead
of print] pii: peds.2014-0269, June 2, 2014.
---------------------------------------------------------------------------
The Growing Presence of Big Tobacco in the E-Cigarette Marketplace
Both the Legacy and RTI studies noted that blu e-cigarettes, owned
by the cigarette company Lorillard, was by far the largest spender on
advertising. This raises concern about what will happen when the other
cigarette companies fully enter the e-cigarette marketplace. Altria and
Reynolds American have successfully test-marketed their e-cigarettes
and are rolling out nationwide campaigns this year to promote them.\16\
If they follow a marketing strategy similar to the one Lorillard has
used for blu, the amount of e-cigarette advertising is likely to expand
dramatically and result in high numbers of youth exposed to e-cigarette
ads.
---------------------------------------------------------------------------
\16\ Esterl, M, ``Altria To Launch MarkTen E-Cigarette
Nationally,'' The Wall Street Journal, February 19, 2014. Citi, ``Start
Spreading the Vuse: National Launch Slated for 2014,'' November 18,
2013.
---------------------------------------------------------------------------
The growing dominance of Big Tobacco companies in the e-cigarette
market should make us all skeptical of any claims they make about only
marketing to adults.
FDA Must Move More Rapidly to Exercise its Authority to Address
E-Cigarette Marketing
When Congress enacted the Family Smoking Prevention and Tobacco
Control Act in 2009, it recognized the harm to public health that can
arise from the manufacture, marketing and sale of tobacco products not
directly addressed in the legislation, including e-cigarettes, and gave
FDA the authority to assert its authority over all other tobacco
products, including the authority to restrict the advertising and
promotion of these tobacco products if the Secretary of Health and
Human Services determines such regulation is appropriate for the
protection of the public health.\17\
---------------------------------------------------------------------------
\17\ 21 U.S.C. 387a. 21 U.S.C. 387f(d).
---------------------------------------------------------------------------
In April, after three full years of internal deliberation, FDA
issued a proposed rule that would assert its authority over e-
cigarettes and other tobacco products not currently regulated by FDA,
but that proposed rule does not include any marketing, including
flavoring, restrictions for e-cigarettes.\18\ As a result, it could be
years more before FDA even begins to grapple with what restrictions
should be placed on e-cigarette marketing to protect youth and the
public health. It also means that marketing restrictions that FDA
applies today to cigarettes--such as no branded sponsorship of athletic
or musical events, no distribution of non-tobacco merchandise carrying
a tobacco product logo and restrictions on flavorings--will not apply
to e-cigarettes any time in the foreseeable future unless significant
changes are made to the proposed rule before it is finalized.
---------------------------------------------------------------------------
\18\ ``Deeming Tobacco Products To Be Subject to the Federal Food,
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act; Regulations on the Sale and Distribution of
Tobacco Products and Required Warning Statements for Tobacco
Products,'' U.S. Federal Register 79(80):23142-23207, April 25, 2014.
---------------------------------------------------------------------------
FDA has claimed that it cannot address the issue of marketing for
e-cigarettes until after it has issued a final rule asserting
jurisdiction over these products. It is true that FDA cannot actually
impose any restrictions on e-cigarette marketing until it finalizes its
pending rule, but there is nothing that prevents FDA from fully
investigating current e-cigarette marketing practices and proposing
specific restrictions to protect the public that can be finalized
either as part of the pending final rule or immediately thereafter.
Indeed, to do anything else leaves our children vulnerable to the most
unscrupulous e-cigarette marketing.
As a first step, FDA should establish a record to support the
necessary regulation of marketing restrictions on e-cigarettes. Based
on the information that is publicly available, it is our view that the
record will support the application to e-cigarettes the same marketing
restrictions it currently applies to cigarettes, either by
incorporating them during the current rulemaking process or starting a
new rulemaking process that will be finalized shortly after FDA issues
a final rule asserting jurisdiction over e-cigarettes.
Regardless of how one weighs the potential benefits and risks of e-
cigarettes, all should be able to support policies that will reduce the
likelihood of young people using them. Leaving it to the industry to
police itself has led to a situation that puts our Nation's youth at
risk and could reglamorize smoking to youth, undermining the progress
that has been made over the last 30 years.
If e-cigarettes are to provide a benefit to public health, they
must be marketed only to adult cigarette smokers, not youth or adults
who are tobacco-free.
Thank you for the opportunity to testify today.
______
Appendix A--E-Cigarette Companies Are Copying Big Tobacco's Playbook
There has been an explosion in e-cigarette marketing in recent
years, and e-cigarette manufacturers are using the same slick tactics
and imagery long used to market regular cigarettes to kids. These are
just a few examples of how e-cigarette companies are copying Big
Tobacco's marketing playbook.
1. Use of celebrity spokespeople
Like cigarette ads of old, television, online and print ads for e-
cigarettes feature catchy slogans and celebrity endorsers.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
2. Images and themes that appeal to youth
These ads feature today's equivalents of the Marlboro Man and the
Virginia Slims woman, depicting e-cigarette use as masculine, sexy, or
rebellious. E-cigarette ads have appeared on television, online, in
newspapers, and in magazines that reach millions of teens, including
Rolling Stone, Sports Illustrated, InStyle, and Us Weekly.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
3. Sex sells
Like cigarette companies have long done, e-cigarette makers portray
use of their products as sexually attractive.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
4. Use of cartoons
The website for blu cigs has featured a cartoon pitchman named
``Mr. Cool.'' It was reminiscent of the Joe Camel cartoon character
that so effectively marketed cigarettes to kids in the 1990s.
5. Sponsorships
For decades tobacco companies used sponsorships of sports and
entertainment events, especially auto racing and music festivals, to
promote cigarettes to huge audiences, including kids. Cigarette
sponsorships are now banned, but e-cigarette brands have auto racing
sponsorships of their own.
Sponsorship of Music Events
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Sports Sponsorships
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
6. Redeemable Points Program
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
7. Images of Doctors
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
8. ``Switch, Don't Quit'' messages
Tobacco companies have long tried to discourage smokers from
quitting by marketing cigarette changes as reducing health risk. Some
e-cigarette ads carry a similar message.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
______
Appendix B--Excerpts from DOJ Judge Gladys Kessler's Final Opinion in
U.S. v. Philip Morris USA, Inc., et al., No. 99-CV-02496GK (U.S. Dist.
Ct., D.C.), August 17, 2006
2637. Moreover, smokers are remarkably brand-loyal. LeVan PD,
United States v. Philip Morris, 6/25/02, 225:3-228:12, 229:4-230:11
(``premium tobacco brands and smokers are very highly loyal and. .
.they don't switch brands very often.''). Defendants realize that they
need to get people smoking their brands as young as possible in order
to secure them as lifelong loyal smokers. As Bennett LeBow, President
of Vector Holdings Group, stated, ``if the tobacco companies really
stopped marketing to children, the tobacco companies would be out of
business in 25 to 30 years because they will not have enough customers
to stay in business.'' LeBow WD, 63:16-64:1.
2782. On June 2, 1966 Lorillard sent a letter authorizing Grey
Advertising to conduct a ``Penetration/Usage/Image'' study designed to
examine the success of Kent and True marketing. The letter indicated
that the study's results ``will be tabulated out for the age cell of 16
thru 20 years, in order that we may analyze this group separately.''
89834271-4271 (U.S. 20943).
2789. An August 30, 1978 Lorillard memorandum from Ted Achey,
Lorillard's Director of Sales in the Midwest, to company President
Curtis H. Judge regarding ``Product Information,'' demonstrates that
Lorillard recognized the significance of the underage market to the
company:
The success of NEWPORT has been fantastic during the past few
years. Our profile taken locally shows this brand being
purchased by black people (all ages), young adults (usually
college age), but the base of our business is the high school
student. NEWPORT in the 1970s is turning into the Marlboro of
the 60s and 70s. It is the ``In'' brand to smoke if you want to
be one of the group. Our problem is the younger consumer that
does not desire a menthol cigarette. If that person desires a
nonmenthol, but wants to be part of the ``In'' group, he goes
to Marlboro. . . . I think the time is right to develop a
NEWPORT NATURAL (non-menthol) cigarette to attract the young
adult consumer desiring a non-menthol product. . . . A good
test area might be the Camden, New Jersey Division.
03537131-32 (U.S. 22357).
3264. Steven C. Watson, Lorillard Vice President, External Affairs,
was responsible for issuing a press release in 2001, stating
``Lorillard Tobacco Company has never marketed or sold its products to
youth.'' The release was transmitted electronically by e-mail from
North Carolina to P.R. Newswire in New York, and distributed from there
by wire to various news agencies, to be published in newspapers,
magazines or similar publications. Watson PD, United States v. Philip
Morris, 4/2/02, 190:5-191:6.
Conclusions
3296. The evidence is clear and convincing--and beyond any
reasonable doubt--that Defendants have marketed to young people twenty-
one and under while consistently, publicly, and falsely, denying they
do so. Dolan WD, 24:3-16; Krugman WD, 17:2-19:1; Chaloupka WD,
30:832:20; Biglan WD, 100-379.
3302. In the face of this evidence, Defendants have denied, over
and over, with great self-righteousness, that they have marketed to
youth.
______
Appendix C
Image 1. Blu uses provocative images in an advertisement for blu e-
cigarettes placed in the March 2014 Swimsuit issue of Sports
Illustrated and an online video available through blu's YouTube
channel.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Image 2. There are thousands of e-cigarette liquid flavors
available in stores and online, including flavors that can be mixed
according to users' tastes. These are just some of the kid-friendly
options for sale.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Image 3. Lorillard's ``Real Parents Real Answers'' youth prevention
website features an infographic on e-cigarettes, including a statement
that ``kids may be particularly vulnerable to trying e-cigarettes due
to an abundance of fun flavors such as cherry, vanilla, pina-colada and
berry.'' For comparison, Lorillard's blu e-cigarette brand offers
flavor cartridges for sale on its website, including cherry, vanilla,
and pina colada.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Image 4. Billboards by an e-cigarette company and a vape shop.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Billboard off of I-95 South in Miami, FL, December 2013
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Billboard in Janesville, WI, June 2014
Image 5. E-cigarette companies use attractive and scantily-clad
models to promote their products.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
______
Appendix D-1
Lorillard, Inc.
Greensboro, NC, October 23, 2013
Hon. Margaret Hamburg,
Commissioner,
U.S. Food and Drug Administration,
Silver Spring, MD.
Re: FDA Regulation of E-Cigarettes
Dear Commissioner Hamburg,
On behalf of Lorillard Inc., the owner of blu eCigs, the leading
electronic cigarette company in the United States, I am writing to
express our agreement with many of the principles expressed by state
Attorneys General who urged the Food and Drug Administration (FDA) on
September 24, 2013,\1\ to assert its authority to regulate electronic
cigarettes under the Tobacco Control Act.
---------------------------------------------------------------------------
\1\ National Association of Attorneys General. FDA Regulation of E-
Cigarettes. Sept. 24, 2013. Letter to The Honorable Margaret Hamburg.
http://www.naag.org/ags-urge-fda-to-regulate-sale-and-advertising-of-e
cigarettes.php
---------------------------------------------------------------------------
Lorillard agrees that FDA is authorized to regulate e-cigarettes.
Since acquiring blu eCigs in April 2012, Lorillard repeatedly has
stated that it stands ready to work with FDA to develop regulations
fore-cigarettes. Lorillard has reiterated this publicly and in private
meetings with FDA.
E-cigarettes are a product that has the potential to play a
critical role in the national harm reduction discussion. For too many
years, tobacco policy has been mired in an all-or-nothing philosophy.
Under this approach, smokers are presented with just one alternative:
quit. This mindset has prevented the implementation of a comprehensive
public health strategy designed to reduce tobacco-related disease.
E-cigarettes are distinctly different from combustible tobacco
cigarettes in that e-cigarettes have no tobacco smoke, no ash, no odor
and no combustion, resulting in virtually none of the chemicals present
in cigarette smoke. On the other hand, e-cigarettes are similar to
combustion cigarettes, in that they mimic the behavior of traditional
smoking.
Making less harmful products available to smokers as soon as
possible should be a top priority for policy makers. We should arrive
at a place where regulations mirror the continuum of risk Regulation
should promote the development of products that significantly reduce
exposure to harm in the users of tobacco products. These and other
regulatory actions by the FDA should encourage cigarette smokers to
switch to e-cigarettes.
FDA rules should ensure the adoption of quality standards and good
manufacturing practices, accompanied by a regulatory framework that
ensures sales and marketing to youth is prohibited. In the meantime,
absent regulations, blu eCigs has voluntarily implemented many
responsible measures concerninf' the conduct of our business, while
pressing state governments for sales restrictions th,;t prevent youth
access.
To be clear: We agree that electronic cigarettes are not a product
for youth. Any usage of electronic cigarettes by youth is unacceptable;
electronic cigarettes are intended to be used as an alternative to
combustion cigarettes by smokers of legal age, and should not be sold
or used by anyone under age 18.
However, it is disturbing that the Attorneys General and others in
the public health community are relying on their 1990s tobacco playbook
and raising the specter of youth usage of electronic cigarettes as a
reason for FDA to ban or adopt draconian restrictions on the marketing
and sale of these tobacco alternatives. In fact, concerns that youth
are using electronic cigarettes at alarming rates are not supported by
evidence.
In their letter the state Attorneys General cite a recent report by
the Centers for Disease Control and Prevention (CDC) as proof that
youth are taking up the use of e-cigarettes at alarming rates. The CDC
study claimed that electronic cigarette use had more than doubled among
middle and high school students from 2011 to 2012. This report's
``conclusion'' has led many to call for the ban on the sale of
electronic cigarettes, or at the least the imposition of drastic
marketing and sales restrictions that may cause adult smokers to forgo
the opportunity to switch from smoking to vaping. Yet the CDC study did
not offer evidence, nor are we aware of any such evidence, of an
epidemic of youth usage of electronic cigarettes at all.
The CDC survey showed that 2.1 percent of the youth had
experimented with e-cigarettes. It did not report daily or regular use
statistics for e-cigarettes. In other words, the statistic reported by
CDC includes youth who took only so much as one puff from an e-
cigarette and may not have used the product ever again. This means that
the CDC's claim that electronic cigarette use has doubled among
underage youth is likely dramatically overstated. As far as we know
from that survey, none of them are using e-cigarettes daily, in
contrast with the unfortunate fact that many more youth continue to
regularly smoke combustible cigarettes.
Unfortunately, the CDC has claimed that its survey shows that kids
are starting with e cigarettes and then progressing to smoke combustion
cigarettes. This is not supported by the scientific evidence. Dr.
Michael Siegel, professor in the Department of Community Health
Sciences, Boston University School of Public Health, has said the
statement is a ``fabrication'' and that ``the study did not document
any examples of youth starting to smoke as a result of first trying
electronic cigarettes.'' Furthermore, Siegel notes that the ``among
youth who experimented with electronic cigarettes in 2012, the
overwhelming majority--90.6 percent--were smokers.''
Lorillard supports reasonable, science based regulations of e-
cigarettes. However, that regulation must not have the effect of
denying the ham reduction benefits of electronic cigarettes to smokers
looking for an alternative. We think there is an opportunity to enact
sensible regulation to accomplish this.
After its acquisition of blu eCigs, Lorillard made a commitment to
take a leadership role in shaping how manufacturers in this emerging
category can be responsible. We agree that e cigarettes should not be
marketed, sold, or used by anyone younger than 18 years of age, and
have demonstrated our commitment to this in the following ways:
1. Two-Step Age Screening Process on blu eCigs Website
blu eCigs prohibits the sale of e-cigarettes to anyone younger than
18 years of age through strict age-verification and third party
certification procedures on websites or through vendor verification in
stores.
Since its acquisition by Lorillard, blu eCigs has implemented a
two-step age screening process on its website. The website screening
process begins with a self-certification of age. Before being allowed
access to the website, the person is asked to certify that he or she is
18 years of age or over. Only individuals certifying they are 18 years
of age or older are permitted entry. To purchase any product from the
website, a consumer must first provide personal information, including
first and last name, address and date of birth. Then two third-party
age verification systems compare this information to public records to
verify the consumer's identity and that the consumer is 18 years of age
or older. If either system verifies the consumer's identity and that
the consumer is 18 years of age or older, the transaction is completed.
If neither system can verify these facts, the transaction is
terminated. This rigorous screening process established by blu eCigs
prevents persons under 18 years of age from purchasing blu products on
its website.
However, the sale of e-cigarettes to persons under 18 years of age
in a face to face transaction at retail stores is still possible in
several states that do not make it illegal for retailers to sell,
furnish and distribute electronic cigarettes to minors. As a result,
Lorillard has strongly advocated and worked for state legislation to
prevent the sale or distribution of electronic cigarettes to minors. It
is an important step that states can and should take, and we urge the
Attorneys General to support these statutes.
2. Marketing Targeted at Consumers of Legal Age
Responsible e-cigarette manufacturers, including blu eCigs, do not
market to youth. Lorillard understands the sensitivity associated with
advertising and marketing campaigns and their potential influence on
minors. For this reason, blu eCigs is actively and effectively ensuring
that its advertising is directed at adult smokers.
blu has run two advertisements on television. The advertisements
were placed on television shows whose content is directed to viewers
who are 18 years of age or older and shown during time slots when at
least 85 percent of the target audience is 18 years of age or older.
The advertisements were designed primarily to educate smokers regarding
e-cigarettes and included two celebrities. Both celebrities are over 40
years old and have an adult target audience well beyond 18 years of
age.
The Attorneys General also assert that flavored electronic
cigarettes attract youth to these products. However, it is commonplace
for products marketed to adults to be offered in a variety of flavors.
Beer and alcohol are available in numerous types of flavors enjoyed by
adults, as are many types of coffee and tea. Most notably, nicotine
therapy products are also sold in a variety of flavors. For example,
flavors of Nicorette gums and lozenges include White Ice Mint, Fruit
Chill, Cinnamon Surge and Cherry. While Congress did ban cigarettes
with a characterizing flavor other than tobacco or menthol through the
Family Smoking Prevention and Tobacco Control Act, Congress did not ban
characterizing flavors for other tobacco products, and FDA should not
do so with electronic cigarettes. We believe we can and do market and
advertise blu eCigs in a responsible manner to adult consumers so that
all adults who prefer these flavors may continue enjoying them.
Depriving adults the right to use flavored electronic cigarettes may
very likely prevent traditional smokers from switching away from
combustible cigarettes, resulting in many continuing on a lifelong path
of using the most harmful of nicotine products.
We believe strongly that responsible marketing parameters that
prohibit marketing and sales to youth can be achieved without
suppressing adult access to what may be the most significant harm
reduction opportunity ever for traditional smokers.
Lorillard again welcomes the voices of the 40 state Attorneys
General in urging FDA to issue proposed regulations to assert
regulatory oversight of e-cigarettes.
Lorillard encourages the FDA to ensure appropriate and reasonable
regulation of e cigarettes through policies developed by the FDA and
industry in partnership. Like the Attorneys General, Lorillard looks
forward to working collaboratively with the FDA to devise a reasonable,
scientifically based regulatory framework covering e-cigarettes that
does not stifle what may be the most significant harm reduction
opportunity ever for traditional smokers.
Sincerely,
Ronald S. Milstein,
Executive Vice President,
Legal and External Affairs,
General Counsel and Secretary.
cc: James McPherson, Executive Director, National Association of
Attorneys General All States' Attorneys-General
______
Appendix D-2
Campaign for Tobacco-Free Kids
Washington, DC, November 19, 2013
Hon. Margaret Hamburg,
Commissioner,
U.S. Food and Drug Administration,
Silver Spring, MD.
Re: Lorillard Letter on FDA Regulation of E-Cigarettes
Dear Commissioner Hamburg:
On October 23, 2013, Lorillard Inc., which owns blu eCigs,
submitted to you a letter expressing support for Food and Drug
Administration (FDA) regulation of electronic cigarettes (e-
cigarettes). In its letter, Lorillard insists that e-cigarettes are not
a product for youth and claims to have voluntarily implemented
``responsible measures'' to prevent the sale and marketing of e-
cigarettes to youth. At the same time, however, the company questions
new research by the Centers for Disease Control and Prevention (CDC)
that shows a sharp increase in youth use of e-cigarettes.\1\
---------------------------------------------------------------------------
\1\ See October 23, 2013 Lorillard letter to Commissioner Hamburg
regarding FDA regulation of e-cigarettes
---------------------------------------------------------------------------
Lorillard's attack on CDC's research is unwarranted, and its claim
of corporate responsibility with respect to youth access to its
products is utterly misleading.
Youth Use of E-Cigarettes Has Increased
The CDC recently reported that youth use of e-cigarettes among high
school students more than doubled from 2011 to 2012 (from 4.7 percent
to 10 percent). The CDC estimates that nearly 1.8 million U.S. youth
(grades 6-12) had tried e-cigarettes as of 2012, and 160,000 of those
who tried e-cigarettes had never used conventional cigarettes.\2\ This
is a significant and alarming trend and suggests that e-cigarettes may
be encouraging greater youth experimentation with tobacco products.
Rather than recognizing the adverse implications of these findings for
public health, Lorillard dismisses the CDC findings as ``dramatically
overstated'' and lacking evidence. Lorillard's absence of concern for
this documentation of underage use of e-cigarettes is troubling and at
odds with its claims of being a responsible manufacturer.
---------------------------------------------------------------------------
\2\ Centers for Disease Control and Prevention (CDC). ``Electronic
Cigarette Use Among Middle and High School Students--United States,
2011-2012,'' Morbidity and Mortality Weekly Report (MMWR), 62(35):729-
730, September 6, 2013.
---------------------------------------------------------------------------
Like cigarettes, e-cigarettes contain nicotine; and nicotine is
extremely addictive. Kids and adolescents are more susceptible to the
effects of nicotine, because they are still going through critical
periods of growth and their brains are still developing.\3\ Research
shows that youth can experience symptoms of dependence--including
withdrawal and tolerance--after minimal exposure to nicotine.\4\ Thus,
e-cigarettes could serve as a gateway to nicotine addiction and
increase kids' risk of initiating other tobacco products.
---------------------------------------------------------------------------
\3\ U.S. Department of Health and Human Services (USDHSS),
Preventing Tobacco Use Among Youth and Young Adults: A Report of the
Surgeon General, U.S. Department of Health and Human Services, Centers
for Disease Control and Prevention, National Center for Chronic Disease
Prevention and Health Promotion, Office on Smoking and Health, 2012.
See also USDHSS, How Tobacco Smoke Causes Disease: The Biology and
Behavioral Basis for Smoking-Attributable Disease: A Report of the
Surgeon General, U.S. Department of Health and Human Services, Centers
for Disease Control and Prevention, National Center for Chronic Disease
Prevention and Health Promotion, Office on Smoking and Health, 2010.
\4\ USDHSS, How Tobacco Smoke Causes Disease: The Biology and
Behavioral Basis for Smoking-Attributable Disease: A Report of the
Surgeon General, U.S. Department of Health and Human Services, Centers
for Disease Control and Prevention, National Center for Chronic Disease
Prevention and Health Promotion, Office on Smoking and Health, 2010.
---------------------------------------------------------------------------
As a result of nicotine addiction, approximately three out of four
teen smokers end up smoking into adulthood, even if they intend to quit
after just a few years.\5\ Research also shows that the earlier a young
person first tries smoking, the higher his or her chances of ultimately
becoming a regular smoker, and the less likely he or she is to quit.\6\
Lorillard dismisses CDC's data, asserting that it ``includes youth who
took only so much as one puff from an e-cigarette'' but, as FDA's
Tobacco Products Scientific Advisory Committee has stated, ``Regular
cigarette smoking begins with experimentation.'' \7\ The sharp increase
in experimentation with e-cigarettes and its potential to draw youth
into a lifetime of addiction is, therefore, a cause for great concern
and worthy of more serious attention, and responsive action, than shown
by Lorillard.
---------------------------------------------------------------------------
\5\ USDHSS, Preventing Tobacco Use Among Youth and Young Adults: A
Report of the Surgeon General, U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National Center
for Chronic Disease Prevention and Health Promotion, Office on Smoking
and Health, 2012.
\6\ See, e.g., Khuder, SA, et al., ``Age at Smoking Onset and its
Effect on Smoking Cessation,'' Addictive Behavior, 24(5):673-7,
September-October 1999; D'Avanzo, B, et al., ``Age at Starting Smoking
and Number of Cigarettes Smoked,'' Annals of Epidemiology, 4(6):455-59,
November 1994; Chen, J & Millar, WJ, ``Age of Smoking Initiation:
Implications for Quitting,'' Health Reports, 9(4):39-46, Spring 1998;
Everett, SA, et al., ``Initiation of Cigarette Smoking and Subsequent
Smoking Behavior Among U.S. High School Students,'' Preventive
Medicine, 29(5):327-33, November 1999; Breslau, N & Peterson, EL,
``Smoking cessation in young adults: Age at initiation of cigarette
smoking and other suspected influences,'' American Journal of Public
Health, 86(2):214-20, February 1996.
\7\ Tobacco Products Scientific Advisory Committee, ``Menthol
Cigarettes and Public Health: Review of the Scientific Evidence and
Recommendations'' (July 21, 2001), at 215.
---------------------------------------------------------------------------
E-Cigarette Marketing Targets Youth
Lorillard states in its letter that ``Responsible e-cigarette
manufacturers, including blu eCigs, do not market to youth.''
Unfortunately, Lorillard's actions contradict its words. The marketing
strategies Lorillard uses to promote blu are the same as the marketing
strategies that have long been used by tobacco companies to market
cigarettes to kids. They include:
Kid-friendly flavors: Lorillard is the only one of the top
three e-cigarette manufacturers to sell its product in flavors.
In addition to classic tobacco and menthol varieties, blu e-
cigarette cartridges are available in candy and fruit flavors,
like cherry crush, vivid vanilla, pina colada, and peach
schnapps. (See Exhibit A.) Tobacco companies have regularly
used flavored products to appeal to youth, who may otherwise be
turned off by the harsh taste of nicotine. It was for that
reason that Congress approved the prohibition on flavored
cigarette sales when it passed the Family Smoking Prevention
and Tobacco Control Act in 2009. Current research confirms that
flavored tobacco products are particularly popular among youth.
A recently published national study found that 42.4 percent of
youth smokers use flavored little cigars or flavored
cigarettes.\8\ Data from the 2013 Florida Youth Tobacco Survey
show that 18.7 percent of high school students have tried a
flavored tobacco product at least once.\9\ It is reasonable to
expect that flavored e-cigarettes would appeal to youth in the
same way as other flavored tobacco products.
---------------------------------------------------------------------------
\8\ King, B. et al., ``Flavored-Little-Cigar and Flavored-Cigarette
Use Among U.S. Middle and High School Students,'' Journal of Adolescent
Health, August 27, 2013. Flavored cigarettes may include menthol
products.
\9\ 2013 Florida Youth Tobacco Survey.
Magazine advertisements: Lorillard regularly places
advertisements for blu in magazines with high youth readership,
including Rolling Stone, ESPN The Magazine, and Sports
Illustrated. (See Exhibit B). Youth readership (ages 12-17) for
these three magazines alone is more than five million; the
reach for all magazines would be millions more.\10\ With images
of rugged men, glamorous women, and depictions of e-cigarette
use as masculine, sexy, and rebellious, these advertisements
likely appeal to many teenage boys and girls.
---------------------------------------------------------------------------
\10\ GfK Mediamark Research & Intelligence. Youth readership is
2,002,000 for ESPN The Magazine, 1,289,000 for Rolling Stone, and
1,727,000 for Sports Illustrated.
Celebrity endorsements: Lorillard's advertisements for blu
feature TV personality Jenny McCarthy and actor Stephen Dorff.
Lorillard may be right that both celebrities are over 40 years
old, but they are pictured in trendy settings, such as night
clubs, speaking about the ways in which blu enhances their
social and dating lives--scenes and topics that are familiar
and important to many youth. This strategy mirrors tobacco
companies' strategies from the 1940s and 1950s, when they used
celebrities to associate a specific lifestyle and personality
with their cigarettes in an effort to construct positive social
norms around smoking.\11\ And while Lorillard asserts that its
TV advertisements featuring these celebrities were shown during
time slots when at least 85 percent of the viewing audience was
18 years of age or older, it neglects to mention that these
advertisements also are posted on YouTube, a public video-
sharing website that is popular with youth. (See Exhibit C.) As
such, these advertisements--which associate glamour with the
use of blu--can be viewed by individuals of all ages at any
time.
---------------------------------------------------------------------------
\11\ National Cancer Institute. The Role of the Media in Promoting
and Reducing Tobacco Use. Tobacco Control Monograph No. 19. Bethesda,
MD: U.S. Department of Health and Human Services, National Institutes
of Health, National Cancer Institute, June 2008.
Sports, music, and other event sponsorships: Although
Federal law prohibits Lorillard from sponsoring sporting and
music events with its cigarette brands, it continues to take
advantage of these popular, youth-friendly events to market
blu. (See Exhibit D.) Blu currently sponsors cars in the
IndyCar and Nascar circuits. It has sponsored numerous musical
festivals, including The Governors Ball Music Festival in New
York City, June 2013; the Bonnaroo Music and Arts Festival in
Tennessee, June 2013; and Sasquatch! music festival at the
Gorge in Washington state, May 2013. Blu has also sponsored
``vaping areas,'' which show signs displaying the blu logo, in
at least one Six Flags theme park in California. Six Flags is
an amusement park that attracts thousands of visitors each
year--many of which are families and young adults.\12\
---------------------------------------------------------------------------
\12\ Americans for Nonsmokers' Rights. ``Do you think Blu e-
cigarettes should be promoted at Six Flags?'' http://anr.no-smoke.org/
site/MessageViewer?em_id=29281.0.
Cartoons: The website for blu has featured an animated
cartoon pitchman named ``Mr. Cool.'' The cartoon, which
included an animated video, is reminiscent of the notorious Joe
Camel cartoon character that effectively marketed cigarettes to
kids in the 1990s. (See Exhibit E.)
Lorillard's Age Verification for Access to Its E-Cigarette Website is
Superficial
Lorillard prides itself on its two-step age screening process for
the blu website www.blucigs.com. A visit to the website, however,
quickly shows that the age verification is superficial and inadequate
to prevent youth access.
To access the blu website, an individual only needs to click on an
icon that states ``18+ (ENTER).'' No validation of age is required. The
individual is then directed to the full blu website, which includes
information on e-cigarettes, a store, customer reviews, a support
center, and more. This is a stark contrast to the age verification
required to access Lorillard's website for Newport, its leading brand
of cigarettes. Accessing the Newport website is a multi-stage process
that first requires individuals to enter their date of birth.
Individuals are then directed to a second page where they must enter
their full name, address, driver's license number, and the last four
digits of their social security number. Only after this information and
the individual's age are verified are they able to enter the website.
(See Exhibit F.)
Having set up a more rigorous age verification system for its
leading cigarette brand, Lorillard clearly has the knowledge and
experience to set up a more advanced screening process for its e-
cigarette brand. It has not, however; and the company offers no
explanation for why the age verification processes differ. As a result,
youth can be introduced to blu e-cigarettes just as easily as any
adult.
Lorillard states that a second screening process takes place before
an individual is allowed to purchase a product from the blu website. As
before, however, this system lacks the rigor needed to effectively
prevent youth from completing a purchase. Individuals need only enter a
name, birthdate, and credit card information--information that could
easily be taken from an older individual. A driver's license and social
security number are not required for age verification.
Lorillard claims to be a responsible e-cigarette manufacturer and
implies that it is part of the solution for reducing tobacco-related
harms. Its actions, however, show that it still is part of the problem.
The strategies used to market blu e-cigarettes are the same
irresponsible marketing strategies used by tobacco companies to market
cigarettes to kids.
I urge the FDA to move quickly to regulate e-cigarettes and ensure
that tobacco companies, like Lorillard, do not continue to market their
addictive products to another generation of kids.
Sincerely,
Matthew L. Myers,
President,
Campaign for Tobacco-Free Kids.
______
Exhibit A: Screenshot of blu eCigs Website, November 1, 2013
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Exhibit B: Magazine Ads in Magazines with High Youth Readership
Magazine Ad Found In:
Rolling Stone: April 25, 2013; May 23, 2013; June 20, 2013;
July 4-18, 2013
Car and Driver: June 2013; July 2013
Men's Journal: June 2013; July 2013; August 2013
Esquire: June 2013
Field and Stream: June 2013; July 2013
Playboy: June 2013; July/August 2013
Popular Mechanics: June 2013; July/August 2013
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Source: Trinkets & Trash, www.trinketsandtrash.org
Magazine Ad Found In:
Rolling Stone--May 2012
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Source: Trinkets & Trash, www.trinketsandtrash.org
Exhibit C: Screenshots of blu TV Advertisements on YouTube
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Exhibit D: Sports, Music, and Other Events Sponsorships
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Exhibit E: Screenshot of ``Mr. Cool'' Cartoon on blu eCigs Website
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Exhibit F: Screenshots of blu eCigs and Newport Age Verification
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The Chairman. Thank you, sir.
And now, Mr. Jason Healey is President of Lorillard
subsidiary ``blu E-cigs;'' the market leader for sales and
marketing in the e-cigarette industry.
We welcome you, sir.
STATEMENT OF JASON HEALY, FOUNDER AND PRESIDENT, blu eCIGS, A
SUBSIDIARY OF LORILLARD
Mr. Healey. Chairman Rockefeller, Ranking Member Thune, and
members of the Committee, I am Jason Healey, founder and
President of blu eCigs. It is a privilege to come here today to
speak about a new product that has tremendous potential to
reduce tobacco-related harm and disease and hopefully play a
role in eliminating traditional cigarettes.
Back in 2008, I tried my first electronic cigarette. As a
smoker, I saw tremendous opportunity for myself and other
smokers. I immediate saw that this innovative product could
provide an alternative to smokers who enjoy smoking or who
struggle to quit like myself but don't want the negative
effects of traditional cigarettes on their health. I became
convinced that e-cigs are just as much a disruptive force in
tobacco as digital cameras once were to the film industry.
Today, every time I use an e-cig instead of a combustible
cigarette, it is a good decision. I am not alone in seeing the
potential. Public health experts have long considered harm
reduction an effective approach to the reduction of risk caused
by various behaviors. Harm reduction policies applied to
tobacco will make great progress because we desperately need an
alternative policy that complements prevention and cessation.
Different types of nicotine occupy different points along what
FDA calls a continuum of risk. Some activities carry less risk
than others. Lacking combustion, e-cigs fall dramatically lower
on this continuum compared to traditional cigarettes.
That is only logical because traditional cigarettes are
very different. As one example of their significant difference,
a recent study by our researchers found that harmful
constituents present in cigarette smoke were at undetectable
levels in the vapor of blue e-cigs, and similar to that found
in Rumae. Our findings are consistent with other third-party
research. I've included a summary of this analysis in my
submission.
The Chairman. Sir, could you just say that last sentence
once again, please?
Mr. Healey. Our finding--I'm sorry. To the harmful
constituents?
The Chairman. Yes.
Mr. Healey. Our study by our researchers found that harmful
constituents present in cigarette smoke were at undetectable
levels in the vapor of blu e-cigs and similar to that found in
Rumae.
The Chairman. Thank you.
Mr. Healey. We support science-based FDA regulation of e-
cigs. And we are committed to working with the FDA
manufacturing standards to ensure safety; age of purchase to
ensure this is an adult-only product; content and nicotine
labeling to ensure the consumers informed are supported by
responsible manufacturers like blu. We are encouraged that
FDA's preamble to the proposed regulations seems to acknowledge
that regulation should be proportional to harm and a one-size-
fits-all approach is not appropriate.
We agree with Mitch Zeller, FDA's Director of Center for
Tobacco Products when he said ``We have to have an open mind on
the potential for these emerging technologies to benefit public
health.''
blu, however, has not waited for FDA's action to address
youth access. We have actively advocated for and supported
state legislation to prevent minors from purchasing electronic
cigarettes and we require third-party age verification for
online sales.
blu began as a small entrepreneurial company, marketing a
product with an emerging market with a challenge of introducing
a product that did not effectively exist in the U.S. With the
help of our parent company, we adopted strict and responsible
marketing restrictions that reflect a clear and focus on adult
smokers while also substantially reducing youth exposure to blu
ads and promotions.
Our voluntary restrictions such as limiting ad placement to
media and events where the target audience is at least 85
percent adult match or exceed restrictions adopted by
comparable adult consumer product companies. As an industry
leader, we believe these marketing restrictions demonstrate
responsibility.
To reiterate, our marketing focus is to communicate to
adult smokers that e-cigs are a viable alternative to
cigarettes. We previously provided you with an explanation of
the voluntary marketing restrictions that we have adopted. We
have included this explanation in our submission that I
provided to the Committee.
E-cigs have a tremendous untapped potential to positively
change the lives of adult smokers of traditional cigarettes.
Reaching this ambitious goal requires a new way of thinking and
involves compelling marketing to normalize this behavior, and,
as a result, de-normalize smoking. So adult smokers know it is
a viable alternative worth their trial.
Further, we believe that using a variety of flavors is
critical to keeping adult smokers who have switched to e-cigs
from returning to more harmful combustible cigarettes. E-cigs
are likely the most significant tobacco harm reduction product
ever. Making less harmful products available as soon as
possible should be a top priority.
Thank you.
[The prepared statement of Mr. Healy follows:]
Prepared Statement of Jason Healy, Founder and President, blu eCigs
Chairman Rockefeller, Ranking Member Thune and members of the
Senate Commerce Committee, I am Jason Healy, founder and President of
blu eCigs.
It is a privilege to come here today to speak about a new product
that has tremendous potential to reduce tobacco-related harm and
disease, and hopefully play a role in eliminating traditional
cigarettes.
Back in 2008 I tried my first electronic cigarette. As a smoker I
saw tremendous opportunity for myself and other smokers. I immediately
saw that this innovative product could provide an alternative to
smokers who enjoy smoking or who struggle to quit, like myself, but
don't want the negative effects of traditional cigarettes on their
health.
I became convinced that e-cigs are just as much a disruptive force
in tobacco as digital cameras once were to the film industry. Today,
every time I use an e-cig instead of a combustible cigarette, it is a
good decision.
I am not alone in seeing the potential. Public health experts have
long considered harm reduction an effective approach to the reduction
of risks caused by various behaviors. Harm reduction policies applied
to tobacco will make great progress because we desperately need an
alternative policy that complements prevention and cessation.
Different types of nicotine use occupy different points along what
FDA calls a continuum of risk. Some activities carry less risk than
others. Lacking combustion, e-cigs fall dramatically lower on this
continuum compared to traditional cigarettes.
That is only logical because traditional cigarettes are very
different.
As one example of their significant difference, a recent study by
our researchers found that harmful constituents present in cigarette
smoke were at or near non-detectible levels in the vapor of blu e-
cigs--and similar to that found in room air. Our findings are
consistent with other third party research. I have included a summary
of this analysis in my submission.
We support science-based FDA regulation of e-cigs, and we are
committed to working with the FDA. Manufacturing standards to ensure
safety, age-of-purchase to ensure this is an adult-only product,
content and nicotine labeling to ensure the consumer is informed are
supported by responsible manufacturers like blu.
We are encouraged that FDA's preamble to the proposed regulations
seems to acknowledge that regulation should be proportional to harm and
a one size fits all approach is not appropriate. We agree with Mitch
Zeller, FDA's director of the Center for Tobacco Products, when he
said, ``We have to have an open mind on the potential for these
emerging technologies to benefit public health.''
blu, however, has not waited for FDA action to address youth
access. We have actively advocated for and supported state legislation
to prevent minors from purchasing electronic cigarettes and we require
third-party age verification for on-line sales.
blu began as a small entrepreneurial company, marketing a product
in an emerging market with a challenge of introducing a product that
did not effectively exist in the U.S. With the help of our parent
company, we adopted strict and responsible marketing restrictions that
reflect a clear focus on adult smokers while also substantially
reducing youth exposure to blu ads and promotions. Our voluntary
restrictions, such as limiting ad placement to media and events where
the target audience is at least 85 percent adult, match or exceed
restrictions adopted by comparable adult consumer product companies. As
an industry leader we believe these marketing restrictions demonstrate
responsibility.
To reiterate, our marketing focus is to communicate to adult
smokers that e-cigs are a viable alternative to cigarettes. We
previously provided you with an explanation of the voluntary marketing
restrictions that we adopted. We have included this explanation in the
submission I have provided to the Committee.
E-cigs have a tremendous untapped potential to positively change
the lives of adult smokers of traditional cigarettes. Reaching this
ambitious goal requires a new way of thinking and involves compelling
marketing to normalize this behavior, and as a result to denormalize
smoking, so adult smokers know it is a viable alternative worth their
trial. Further, we believe that using a variety of flavors is critical
to keeping adult smokers who have switched to e-cigs from returning to
more harmful combustible cigarettes.
E-cigs are likely the most significant tobacco harm reduction
product ever. Making less harmful products available as soon as
possible should be a top priority.
Thank you.
The Chairman. Thank you very much, Mr. Healey.
And now, Mr. Craig Weiss who is the President and CEO of
NJOY electronic cigarettes; the second largest presence in the
e-cigarette market.
STATEMENT OF CRAIG WEISS, PRESIDENT AND CEO, NJOY
Mr. Weiss. Members of the Committee and Mr. Chairman thank
you very much.
My name is Craig Weiss and I am the President and CEO of
NJOY. NJOY is an independent electronic cigarette company with
no affiliation to the tobacco industry. We are proud to state
that our corporate mission is to obsolete the tobacco cigarette
and the death and disease that it has left in its wake.
I would like to focus on what I believe unites us and our
company with the members of this committee, with the FDA Center
for Tobacco Products and with dedicated women and men in the
tobacco control movement and public health. We look forward to
a day when combustion cigarettes are no longer part of the
American landscape. We are appalled at the toll of the tobacco
epidemic has taken and continues to take each year on this
country including 480,000 adult-Americans dying prematurely
each year from tobacco-related illness.
The evidence clearly indicates that new approaches will be
required to obsolete the combustion cigarette. Electronic
Nicotine Delivery Systems, or ENDS, hold the potential to play
a critical role. ENDS give smokers who either cannot or will
not quit a positive alternative. They provide smokers with the
nicotine that they are addicted to and crave without the
combustion of tobacco. And as stated by the 2014 Surgeon
General's report, ``The burden of death and disease from
tobacco use in the United States is overwhelmingly caused by
cigarettes and other combusted tobacco products. Rapid
elimination of their use will dramatically reduce this
burden.''
We understand the great suspicion caused by the 2012 entry
to the marketplace of the first of three major American
cigarette companies. Well, major tobacco companies have now
entered the category as cigarette sales fall, they did not
create this industry and, most companies in the industry do not
sell combustion products.
NJOY, which was established more than 5 years before the
first major American tobacco company purchased an electronic
cigarette company, is independent of the tobacco industry and
has absolutely no incentive to promote combustion cigarette use
among adults or youth.
ENDS are increasingly displacing cigarettes and their use
is overwhelmingly by adult smokers. Reports from a CDC survey
that experimentation of e-cigarettes among youth has risen
should be taken seriously. However, the early fears that
electronic cigarettes would entice young people to initiate
with these products and then migrate to combustion products
appear to be unsupported by the data at this point.
To be clear, no minor should be using a nicotine containing
product of any kind. The maximum public health benefit will be
achieved by mitigating risks to youth without constraining the
ability for e-cigarettes to effectively compete with combustion
cigarettes among adult smokers. Bans on sales to minors which
we were among the first to support, are essential. We have long
supported FDA regulation of this category and the FDA's
issuance of proposed regulations is a critical milestone.
Cigarette-style advertising restrictions were not part of
the FDA's proposed regulations. Subjecting electronic
cigarettes to combustion cigarette-style advertising
restrictions will only erect unnecessary barriers to effect a
promotion of these products to adult smokers. Smokers are not
going to purchase a smoking alternative that they're not aware
of. It is important to realize that in the event that ENDS face
the same advertising restrictions of combustion cigarettes, the
big winner will be Big Tobacco who get to maintain their
stranglehold on the more than 40 million Americans who smoke.
Still, even responsible television and other advertising
should be delivered in a manner that is consistent with
assertion that it is intended for adult smokers rather than for
kids. NJOY's television campaign ``Friends Don't Let Friends
Smoke'' is a clear illustration of this principle and we need
more rather than less of this kind of advertising.
Analyzing information collected for its May 2014 report on
e-cigarette advertising that Chairman Rockefeller referenced in
his opening remarks, the American Legacy Foundation noted,
``This data suggests that the marketing of NJOY is more focused
on reaching an adult audience.''
According to the Surgeon General, nearly 6 million of
today's children will adopt smoking, grow up, and die
prematurely from cigarette-caused disease if present trends
continue. The best thing we can do for the health of all of our
children is to ensure that they grow up in a world in which
neither their parents nor any of their adult role models are
smoking combustion cigarettes. Providing smokers who cannot or
will not quit with a positive alternative may be the long
sought solution to a massive public health problem that has
cost millions of lives and more and more members of public
health here and abroad are beginning to make their voices heard
in support of this technology.
We need to approach regulation of this category in a manner
that is guided by science rather than emotion or suspicion.
There is too much at stake to do it any other way.
NJOY looks forward to working with the Committee to achieve
the goal of obsoleting combustion cigarettes.
Thank you.
[The prepared statement of Mr. Weiss follows:]
Prepared Statement of Craig Weiss, President and CEO, NJOY
Members of the Committee.
My name is Craig Weiss, and I am the President and CEO of NJOY.
NJOY is an independent electronic cigarette company with no affiliation
with the tobacco industry. We are proud to state that our corporate
mission is to obsolete the tobacco cigarette--and the death and disease
that it has left in its wake. We want to see the combustion cigarette
go the way of the rotary telephone and the horse-drawn carriage and we
believe that technology and innovation are making this possible.
In my testimony today, I would like to focus on what I believe
unites our company with the members of this Committee, the FDA's Center
for Tobacco Products, and with dedicated women and men in the tobacco
control movement and public health throughout the country.
We look forward to a day when combustion cigarettes are no longer
part of the American landscape. We are appalled at the toll that the
tobacco epidemic has taken and continues to take each year on this
country--including 480,000 adult Americans dying prematurely each year
from tobacco-related illness--or almost one adult each minute of every
day. As Acting Surgeon General Lushniak stated during the presentation
of the most recent Surgeon General's Report on smoking--``Enough is
enough.''
While the adult smoking rate has fallen from a high of over 40
percent to just under 20 percent and the teen smoking rate to a record
low of 15.7 percent--the death toll from combustion cigarettes shows no
signs of abating in this country or worldwide. The World Health
Organization predicts one billion premature deaths from smoking in this
century, and almost one American every minute has their life cut short
because of combustion cigarettes.
The evidence clearly indicates that new approaches will be required
to obsolete the combustion cigarette. Electronic nicotine delivery
systems (``ENDS''), developed by entrepreneurs willing to take risks
and break new ground, hold the potential to play a critical role. ENDS
give smokers who either cannot or will not quit a positive alternative
to combustion smoking. They provide smokers with the nicotine that they
are addicted to and crave without the combustion of tobacco. As stated
by the 2014 Surgeon General's Report: ``The burden of death and disease
from tobacco use in the United States is overwhelmingly caused by
cigarettes and other combusted tobacco products; rapid elimination of
their use will dramatically reduce this burden.''
Since at least 1995, influential members of the public health
community have widely discussed a strategy of tobacco harm
minimization, based on the availability of nicotine-containing, non-
combustion products, to play a critical role in ending the tobacco
epidemic. ENDS represent a potentially transformative, disruptive
technology that threatens large and privileged incumbents.
We understand the grave suspicion caused by the 2012 entry to the
marketplace of the first of the three major American cigarette
companies. However, it is wrong to believe that ENDS are part of a
grand plan by Big Tobacco to lure new smokers. While major tobacco
companies have now entered the category as cigarette sales fall, they
did not create this industry and most companies in this industry do not
sell combustion products. Companies such as NJOY--which was established
more than five years before the first major American tobacco company
purchased an electronic cigarette company--are independent of the
tobacco industry and have absolutely no incentive to promote combustion
cigarette use, among adults, or youth.
ENDS are increasingly displacing cigarettes and their use is
overwhelmingly by adult smokers. Reports from a CDC survey that
experimentation of e-cigarettes among youth has risen should be taken
seriously, yet seen in full context. Early fears that electronic
cigarettes would entice young people to initiate with these products
and then migrate to combustion products appear unsupported by the data
to this point, with the rise in electronic cigarette popularity
coinciding with a continued and indeed historic decline in teen
smoking.
To be clear--no minor should be using a nicotine-containing product
of any kind. The maximum public health benefit will be achieved by
mitigating risks to youth without constraining the ability for e-
cigarettes to effectively compete with combustion cigarettes among
adult smokers. Bans on sales to minors, which we were among the first
to support, are essential. As I will discuss in a moment, cigarette-
style restrictions on advertising could inflict an enormous toll by
obstructing the migration of current smokers to ENDS products.
We have long supported FDA regulation of this category, having
first proposed the legal theory under which these products could be
regulated under the Family Smoking Prevention and Tobacco Control Act
of 2009, and we believe that FDA's issuance of proposed regulations is
a critical milestone. Cigarette-style advertising restrictions were not
part of FDA's proposed regulations nor should they have been.
Subjecting electronic cigarettes to combustion cigarette-style
advertising restrictions would only erect unnecessary barriers to
effective promotion of these products to adult smokers. Smokers are not
going to purchase a smoking alternative that they are not aware of, and
advertising is needed to educate adult smokers of this alternative. It
is important to realize that in the event that ENDS face the same
advertising restrictions as combustion cigarettes, the big winner will
be Big Tobacco, who get to maintain their stranglehold on the more than
40 million Americans who smoke.
Still, even responsible television and other advertising should be
delivered in a manner that is consistent with the assertion that it is
intended for adult smokers rather than for kids. NJOY's television
campaign--``Friends Don't Let Friends Smoke''--is a clear illustration
of this principle, and we need more rather than less of this kind of
advertising. Analyzing information collected for its May 2014 report on
e-cigarette advertising, the American Legacy Foundation noted, ``This
data suggests that the marketing strategy of NJOY is more focused on
reaching an adult audience.''
Paradoxically, children could be the biggest losers from an
effort--in their name--to restrict e-cigarette advertising. According
to the Surgeon General, nearly six million of today's children will
adopt smoking, grow up, and die prematurely from cigarette-caused
disease if present trends continue. The best thing we can do for the
health of all of our children--and I am the proud father of two
beautiful young kids below the age of 10--is to ensure that they grow
up in a world in which neither their parents nor any of their other
adult role models are smoking combustion cigarettes.
The balance will not always be a simple one and please be assured
that, as a responsible company, we are committed to doing everything in
our power to try to get it right. Providing smokers who cannot or will
not quit with a positive alternative may be the long-sought solution to
an intractable public health problem that has cost millions of lives--
and more and more members of public health here and abroad are
beginning to make their voices heard in support of this technology. We
need to approach regulation of this category with our eye on the prize
and in a manner that is guided by science rather than emotion or
suspicion. There is too much at stake to do it any other way. NJOY
looks forward to working with the Committee to achieve the goal of
obsoleting combustion cigarettes.
The Chairman. Thank you, Mr. Weiss.
And finally, Mr. Scott Ballin.
Did I get that right?
STATEMENT OF SCOTT D. BALLIN, JD,
HEALTH POLICY CONSULTANT
Mr. Ballin. Ballin.
The Chairman. I apologize.
Mr. Ballin. Close enough.
The Chairman. I was betting on Ballin.
Mr. Ballin. And happy birthday, sir.
The Chairman. Mr. Scott Ballin is a tobacco and health
policy consult.
Mr. Ballin. Yes.
Mr. Chairman and members of the Committee, thank you for
the opportunity to be hear. I've spent much of my professional
career dedicated to working in the public health arena and, in
particular, tobacco and nicotine area. I worked for the Heart
Association for many years, the Coalition on Smoking and
Health. So I've been around a long time. So I also feel the
age.
I come here today to give you my thoughts on issues being
raised in this hearing, as well as on related issues. And some
of those have come up here on what is a very dynamic,
emotionally charged, and rapidly changing environment. This
includes the broad topic of how all tobacco, nicotine and other
products should be regulated, including their advertising and
marketing.
I and many others, including the Director of the FDA Center
for Tobacco Products, believe that we are in a new era; a sort
of evolutionary next stage looking to develop a more
comprehensive rational and workable approach to the regulation
of all tobacco and nicotine products. This next stage could
potentially be as significant as our acquiring of FDA oversight
over tobacco just a few years ago. It entails how best to
regulate a growing spectrum of products including e-cigarettes
that holds significant promise for phasing out or one day
virtually eliminating the deadly combustible cigarettes, but
it's got to be done right.
It entails accepting and using what is commonly referred to
as the continuum of risk today, which would regulate products
based on their risks, their relative risks, and their intended
uses. Gone are the days where we can conveniently say that all
tobacco products are equally harmful. FDA oversight has changed
the equation. Science and technology and innovation have
changed the equation. New entrance into the marketplace, have
changed the equation and consumers have changed the equation.
While there are many issues and sub-issues needing to be
addressed in this new era two general areas of focus come to
mind when it comes to reducing the harms caused by the use of
tobacco. First, we need to be sure that no one, no one, under
the age of 18 should be able to purchase any tobacco or
nicotine product and that we do everything feasible to prevent
the initiation possession and use of any tobacco and nicotine
product by anyone under the age of 18. This includes
advertising and marketing that intentionally or unintentionally
appeals to children and adolescents and it includes a
discussion about what restrictions should be placed on
flavorings. It is generally agreed that if we can prevent youth
initiation we are a long way to advancing our public health
objectives.
Second, we need to ensure that the approximately 40 million
smokers in this country are provided with consumer acceptable
regulated alternatives to the deadly toxic cigarette. That's
what is killing people in this country. And someone noted
earlier, Professor Mike Russell said many years ago, ``People
smoke for the nicotine and they die from the tar;'' which, in
many respects, is what this discussion is all about today.
To do this effectively we do need regulations that
recognize that there are distinct differences in risk and
relative risk between these products. One size does not fit
all. We should also be encouraging better and more focused
research in both the public and private sectors encouraging
innovation, providing incentives to develop science-based
lower-risk products and encouraging competition rather than
stifling it.
In this rapidly changing environment, it's going to be
essential that we approach the discussions of these issues in a
more civil manner. And that is actually happening at this table
today in many respects and I appreciate your leadership, Mr.
Chairman.
There are numerous stakeholders involved who have seemingly
differing views. I believe there's a lot more in common ground
than people think. The Institute for Environmental Negotiation
at the University of Virginia has been in the forefront in
holding a series of safe haven tobacco dialogues where
individuals can discuss issues in a non-adversarial manner. The
first of the dialogues dating back to the 1990s, involved the
public health community and tobacco growers which actually led
to policy changes in this body and in the House that led to the
enactment of the Tobacco Control Act and the tobacco buyout.
That was monumental and many people said it could not be done.
The last three years have been focused on harm reduction
issues and result in the set of core principles that were
developed. Additional safe haven dialogues are being planned
and we are going to try and expand those discussions to include
a broader number of people.
FDA's proposed deeming regulations is also a place to start
where stakeholders and other interested parties can make their
views heard. While some disagree with the specifics of the
proposal, I believe that FDA is also looking for new ideas and
approaches. The door is open and I think that the fact that
they haven't covered issues related marketing and advertising
e-cigarettes allows that discussion to start taking place in
the agency as well.
Mr. Chairman and members of this committee, there is a
balance that needs to be achieved, which in my view can be a
win-win for public health. We can deal with the issue of youth
initiation of all tobacco and nicotine products including the
impact of advertising and marketing, as well as helping
millions of addicted adult smokers.
While we are making some progress, it is not enough.
Clearly, not enough and that has been stated in this hearing as
well. New approaches are needed as Dr. Ken Warner just told
Time magazine a few days ago. And I agree with him. We need to
think outside the box on some of these things.
Within the next 10 years, I would like to see the number of
children and youth initiating and using cigarettes cut by 75
percent. The numbers of adult smokers cut at least in half; a
major shift away from the manufacturing of deadly, toxic
cigarettes to the development, manufacturing, and use of
significantly lower risk, science-based regulated products.
I believe that, given the proper regulatory tools at the
FDA coupled with incentives, innovation, research, marketplace
competition, and cooperation amongst various stakeholders, we
can do it. And we can save a lot of lives in the process.
Thank you.
[The prepared statement of Mr. Ballin follows:]
Prepared Statement of Scott D. Ballin, JD, Health Policy Consultant
``At first people refuse to believe that a strange new thing can be
done, then they begin to hope it can be done, then they see it can be
done--then it is done and all the world wonders why it was not done
centuries ago.''--A Secret Garden Francis Hodgson Burnett
Mr. Chairman and Members of the Committee, I want to thank you for
this opportunity to appear before this Committee. I have spent most of
my professional career dedicated to working in the public health arena
and in particular on tobacco and nicotine issues. FDA regulatory
oversight was something I took on at a time when some said I was on a
``fool's errand''.
In those early years it was pleasure and honor to work with a
number of members of the House and Senate on not just that issue but
others as well. One of the early champions in those efforts was Senator
Durbin who was anticipated to be your leadoff witness. Several members
of this Committee including Senators Markey and Blumenthal have also
been in the forefront on a number of tobacco related issues.
Today we are talking about another potential major monumental
shift, possibly as significant as acquiring FDA oversight of tobacco.
It entails how best to regulate a growing spectrum of tobacco, nicotine
and alternative lower risk products, including e-cigarettes, that hold
promise for significantly reducing, or one day virtually eliminating
the use of the deadly combustible cigarette.
I come here today representing no one but rather to give you my 35
plus years of experience and thoughts on how all stakeholders might
consider ``moving forward''. I include on that list, policy makers,
regulators, public health advocates, researchers, manufacturers,
healthcare practitioners, consumers, and the general public.
The subject of this hearing raises some important questions that
need addressing. I hope that both the majority and minority will
approach the focus of the subject of this hearing as part of a broader
and more comprehensive discussion which encompasses the need for the
regulation of all tobacco, nicotine and alternative products--
regulation which should be set based on the risks, relative risks and
intended uses of those products.
We are in a ``New Era'' of Tobacco, Nicotine and Alternative Products
Regulation
We are in what I and others have called a ``New Era'' and what
FDA's Center for Tobacco Products Director Zeller has called a ``New
Beginning'', an era that demands that we look at more effective and
appropriate ways for regulating a growing spectrum of tobacco and
nicotine products which have very diverse '`risk profiles''. Gone are
the days when we could make the simple statement that all tobacco
products were equally harmful. FDA oversight has changed the equation.
Science has changed the equation. Innovation and technology have
changed the equation. New entrants into the marketplace have changed
the equation and consumers have changed the equation.
The Center for Tobacco Products (CTP) has had and will continue to
have many mountains to climb in not only carrying out the many mandates
that Congress imposed on it but more importantly in dealing with the
challenges for shaping new policy over the next 5-10 years.
In 1976 Professor Michael Russell wrote, ``People smoke for
nicotine and die from the tar''. That statement, made decades ago, is
what this is all about today. This ``New Era'' is therefore about the
development and implementation of a comprehensive and workable tobacco,
nicotine and alternative products policy that will require the active
involvement of all stakeholders. It is about saving lives. The tobacco
nicotine and alternative products environment is at a crossroads.
The swiftness with which e-cigarettes have gained popularity has
caught many off guard including the public health community, tobacco
control advocates, researchers, policy makers, regulators, the public,
and even manufacturers. Today, it is estimated that there are somewhere
between 5,000-10,000 e-cigarette/vaping manufacturers, companies and
stores with a growing array of differing products. While I have long
believed that there would be new categories and new products entering
in the market, I like everyone else have been overwhelmed with what has
happened. This presents both challenges and opportunities. We should
not forget that the cigarette market in the U.S. is around $85 billion.
Most smokers want to quit and if we can provide those smokers with
science-based, consumer acceptable lower risk products we could
fundamentally alter the current marketplace and save hundreds of
thousands of premature deaths.
I see and hear a great deal of emotional, adversarial (some of
which is unproductive) discussions going on in and outside the public
health community about the benefits and harms associated with e-
cigarettes. Research studies are coming to very differing conclusions.
Unfortunately but not unexpectedly, such research is often ``cherry
picked'' for both lobbying and public relations impact.
Regulation of All Tobacco, Nicotine and Alternative Products Should Be
Based on the Risks, Relative Risks and Intended Uses of the
Product
In addition to recognizing the importance of developing a new
comprehensive tobacco and nicotine policy, the FDA's ``deeming''
proposal has also recognized the need to regulate products based on
risks and relative risks--what is referred to as the ``continuum of
risk''. There are significant differences in the risks between products
already in the market place as well as new innovative products being
developed. This includes not only the categories of products such as
the combustible cigarette on one end and nicotine replacement therapies
(NRT) on the other, but other smoke-free tobacco products (snus,
lozenges, inhalers etc.), e-cigarettes and an array of products within
the various categories. As we accept and recognize this reality, we
also will need more focused and in some ways better research being done
that will have to come from both the public and private sectors
including the manufacturers of these products, who will be required to
provide data and information to the FDA to back up their products with
sound scientific evidence.
In terms of better understanding some of the various components at
work with respect these broad-ranging significantly lower risk products
(that includes e-cigarettes) and what will be needed to drive change, I
use the following equation:
REGULATION + Research and Science + Technology + Innovation +
Incentives + Competition + Consumer Acceptability =
A means of advancing public health goals and changing the
behaviors of those manufacturing and marketing tobacco,
nicotine and alternative products.
(Side Comment: While seemingly out of context, I think that we may
one day be having similar conversations about marijuana, an
agriculturally based product; a drug that can be used in both
combustible and non-combustible forms and which is used both
recreationally as well as for medicinal purposes. Will/should it come
under FDA's authority and if so where and how?)
The E-Cigarette Challenges and Opportunities--Critical Elements Needing
to be Addressed
1. First and foremost, e-cigarettes should/must be regulated by the
Food and Drug Administration with regulation being designed to advance
public health goals. This includes how they are manufactured, labeled,
advertised and marketed. When the original statute was drafted the
statute provided no real flexibility for considering other products.
The statute, in spite of its historic importance was already outdated
in many areas the day it was signed into law. FDA has been challenged
with 'defining' nontraditional products often having to try and fit a
square peg into a round hole. They tried initially to regulate e-
cigarettes under the drug and device statutes but gave up on that
approach after legal challenges, and have taken a path to regulating
them as tobacco products as long as no therapeutic claims are made.
Enter the ``deeming'' regulations.
While tardy in being issued, the FDA's ``deeming proposal'' has
opened the door for the involvement of a broader spectrum of
stakeholders and interests to submit their views and comments. Input
and new ideas need to be heard and discussed if we are to move forward.
It is obviously not a process that some believe is fast enough and many
want ``action now`' particularly when it comes to concerns of children
and adolescents. But FDA and all of us who have an interest in the
subject of tobacco and nicotine regulation are on a ``learning curve''
being challenged to think differently and realizing that like it or not
this is not the 1980s or 1990s. The e-cigarette issue is not black and
white, one size does not fit all and we should be very cautious about
over-regulating a product that many believe has the potential for
playing an important role in reducing disease and death caused by the
combustible cigarette-the primary product causing close to 3.5 million
premature deaths globally and 480,000 premature deaths in the U.S.
Just as the disrupting technology advances of 100 hundred years ago
in the form of ``machine-made'' cigarettes that are at the root of
today's smoking epidemic, today we are looking at disrupting
technologies, that if implemented carefully, could help end that 100
years of cigarette-related disease and death. And people are talking
about this possibility in ways that they did not just a couple years
ago.
Here are a couple examples of recent statements, reports that can
now be added to the numerous states that have been issued or made over
the last several years.
A. Letter to WHO Director General Margaret Chan from 53 Tobacco and
Nicotine Specialists
A few weeks ago (May 25) 53 tobacco and nicotine specialists sent a
letter to World Health Organization Director General Margaret Chan
asking that the WHO give serious consideration to incorporating tobacco
harm reduction (which includes e-cigarettes) as part of its efforts to
reduce disease and death caused by the use of tobacco. The opening two
paragraphs of that letter state:
``We are writing in advance of important negotiations on
tobacco policy later in the year at the FCTC Sixth Conference
of Parties. The work of WHO and the FCTC remains vital in
reducing the intolerable toll of cancer, cardiovascular disease
and respiratory illnesses caused by tobacco use. As WHO has
stated, up to one billion preventable tobacco related premature
deaths are possible in the 21st Century. Such a toll of death,
disease and misery demands that we are relentless in our search
for all possible practical, ethical and lawful ways to reduce
this burden.
It is with concern therefore that a critical strategy appears
to have been overlooked or even purposely marginalized in
preparation for FCTC COP-6. We refer to ``tobacco harm
reduction''--the idea that the 1.3 billion people who currently
smoke could do much less harm to their health if they consumed
nicotine in low-risk non-combustible form.''
B. A recent report (June 2014) by Action on Smoking and Health (ASH) in
the UK entitled: Electronic Cigarettes (also known as
vapourisers)
Just released by Action on Smoking and Health in the UK is a report
on electronic cigarettes where those in the UK are having conversations
similar to those going on here in the U.S. While the entire document is
worth reviewing, here is a brief excerpt on the concept of harm
reduction.
Smoking in the largest preventable cause of premature mortality
in the UK. The goal of tobacco harm reduction is to diminish
the harm caused by tobacco products. While the ideal remains
that people stop using tobacco completely and permanently,
consensus currently supports a properly regulated harm
reduction approach for those unable to do so. This is a frame
work by which the harmful effects of smoking are reduced
without requiring the elimination of a behavior that is not
necessarily condoned. Such strategies have proved successful in
the past, for example, within the contexts of needle exchange
programmes, illicit drug use and the promotion of safer sex to
prevent HIV infection.
(The entire report can found at: http://www.ash.org.uk)
C. Position of LEGACY
Last week (June 11, 2014) I attended the Ken Warner Lecture Series
sponsored by Legacy--a one on one discussion between the Legacy's
President and CEO, Robin Kovel and FDA/CTP's Director Mitch Zeller. I
also picked up Legacy's latest position statement on e-cigarettes--E-
CIGARETTE POLICY: THE FDA SHOULD PROMPTLY EXERCISE REGULATORY AUTHORITY
OVER E-CIGARETTES. In reading it I have to say that I concur with much
that was presented and believe they have done a very thoughtful job in
approaching this very challenging and controversial subject. Here are a
couple excerpts, but again I encourage everyone to take a look at this
somewhat cautious but 'forward looking' statement in times of
uncertainty.
``In the U.S., more than 43.8 million people smoked cigarette
in 2011, and about half of lifelong smokers will die premature
from their tobacco use. Legacy recognizes that, on an
individual level, there is a continuum of risk across tobacco
products with combustible products (e.g., cigarettes, cigars,
hookah) posing the most danger and Food and Drug Administration
(FDA) approved nicotine replacement therapies (NRT's) posing
the least harm. Harm reduction is a valuable public health
strategy with the potential to reduce, although not eliminate,
the preventable disease and death caused by tobacco. E-
cigarettes may hold great promise in this regard. While they
are not without risk, initial scientific evidence suggests
that, for the individual smoker, they are likely less harmful
than smoking cigarettes, and they likely have significant lower
levels of known tobacco toxicants than combusted tobacco
products. In addition, e-cigarettes may help some smokers quit.
However, the existing evidence is insufficient to support any
informed inference on net public health benefits versus harm at
this time.
The impact on individuals is only part of the story. We must
also consider e-cigarettes' impact on public health at a
population level . . .
FDA must promptly exercise its statutory authority to regulate
e-cigarettes and begin the process of carefully evaluating and
resolving these literally life and death questions consistent
with that authority. In addition, the Federal Trade Commission
(FTC) should put a stop to the unsupported health claims
currently being made about certain e-cigarette products that
may mislead the public.''
(To view the full statement and other related materials on e-
cigarettes, go to: www.LEGACYFORHEALTH.ORG)
2. Concerns
One of the concerns being raised and which is the subject of
today's hearing is what is happening or may be happening with respect
to increased advertising and marketing that intentionally or
unintentionally might have an impact on children and adolescents. What
is appropriate and what is not, as we wait for FDA to issue its final
deeming regulations? Once we have identified the potential abuses we
then have to ask how those abuses can be curbed without negatively
impacting on how these science-based lower risk products can be used to
help cigarette smokers quit.
There are other concerns as well such the role that flavors might
play in youth imitation, childproof packing of some items, and product
safety issues in general. It will be imperative that as we move forward
in our efforts to address those concerns we look for productive
positive and non-adversarial ways of addressing them. On the issue of
flavorings, any concerns about flavoring and youth initiation should be
balanced with ensuring that significantly lower risk products such as
e-cigarettes are consumer acceptable to the millions of smokers looking
to quit. This obviously involves flavorings and palatability. Nicotine
replacement therapies (NRT) have long been available in a wide variety
of flavors (``fruit chill'', ``cherry'', ``lime'', ``mocha'' etc.) and
are marketed and promoted in variety of ways. Smokeless tobacco
products also have flavoring allowances. Similar types of allowances
could be made for e-cigarettes.
The experience that we encountered with the misleading and
deceptive advertising and marketing practices of Big Tobacco should
never forgotten but this is a very different environment and although
we face similar challenges we can and must approach the issues
differently especially since we now have a regulatory agency (FDA) in
place to address these complex and challenging issues. Big Tobacco
fought us at every turn including oversight and regulation and it is
easy to see why so many of my colleagues remain entrenched in their
views and resistant to new approaches. Today, like it or not tobacco,
nicotine and alternative product manufacturers are considered
stakeholders by the FDA in this new era and they will be obligated to
comply with FDA's rules and regulations or face severe enforcement
penalties.
Juxtaposed to what I laid out above with respect to the need for a
more comprehensive, rational and workable tobacco and nicotine policy
is the need, therefore, to look at some of the children and adolescent
issues being raised.
Without giving Legacy too much attention, I suggest that their e-
cigarette paper gives us some direction on issues related to youth
initiation and raises issues that need to be addressed. The Durbin et
al report, Gateway to Addiction? does the same, as do background papers
from other organizations--some who are appearing at this hearing.
Legacy's position paper on e-cigarettes notes:
``Legacy believes that e-cigarettes should not be sold or
marketed to youth. This includes enacting many of the
marketing/advertising restrictions currently applicable to
cigarettes, including age restrictions on sale, placement of
the product in retail outlets, and restricting advertising that
is directed towards youth. Regulators should carefully research
the issue of whether advertising is re-glamorizing smoking in
general and monitor the impact on youth uptake of e-cigarettes
and combusted products.''
As part of addressing these and other concerns, manufacturers
should be encouraged and be willing to provide non-proprietary
information to the FDA and to the public as the `deeming' regulations
are developed.
Can those interested in the e-cigarette issue who are concerned about
youth but who also recognize the role that harm reduction could
play find common ground to accomplish both?
A. My experience dating back to the 1990s indicates to me that we
can and must. I have had the opportunity to be involved both as a
participant and now as an advisor to ongoing efforts by the Institute
for Environmental Negotiation (IEN) at the University of Virginia to
foster ``safe haven'' professionally mediated dialogues on issues
related to tobacco, nicotine, and alternative products harm reduction.
The IEN had been instrumental in bringing the public health community
and tobacco growers together that resulted in a series of Core
Principles that included FDA regulatory oversight and the tobacco
buyout--something some thought impossible. Today the IEN is carrying on
those discussions and has issued a set of Core Principles that suggest
a number of areas of focus that might successfully help move a tobacco,
nicotine, and alternative products harm reduction strategy forward. In
order to encourage and foster dialogue IEN employs a variation of the
Chatham House Rule. The Core Principles are not intended to be
``owned'' by anyone but can be used ``in toto'' or in part by everyone.
They are a form of guidance. The IEN hopes that more and more people
who support the ``concept'' of tobacco, nicotine and alternative harm
reduction will become more actively engaged.
These Core Principles include topics such as:
1. Definitions and Terminologies: Adapting to a Changing
Environment
2. Regulatory Oversight
3. Research and Science
4. Innovation and Technology
5. Monitoring and Surveillance
6. Consumers and the General Public
7. Tobacco Agriculture
8. Engagement and Dialogue
(For a complete copy of the Core Principles (2013), go to the IEN
website at: www.virginia.edu/ien/tobacco)
B. So where do I think there might be some general consensus on
some general principles by a significant number of stakeholders?
1. That no one under the age of 18 (21) should be able to purchase
any tobacco or nicotine containing product including e-
cigarettes. This should include such things as (as are applied
to some tobacco products already) age verification, face to
face sales, restrictions on vending machines etc.
2. That all tobacco, nicotine, and alternative products are
regulated by the FDA. FDA needs to move forward with the
deeming regulations as expeditiously as possible but it needs
to get it right. Regulations should be designed to advance
public health objectives both for the individual and the
population as a whole.
3. Advertising, marketing and sponsorships should be carefully
scrutinized and restricted where such advertising attracts
children and adolescents.
4. That the degree of regulation of products be determined by using
the ``continuum of risk'' which would regulate products based
on risks, relative risks and intended use.
5. That areas of regulation include but not be limited to sales and
distribution, labeling, ingredient disclosure, product
standards, advertising and marketing, GMP's and the child proof
packaging of all tobacco, nicotine and alternative products
where appropriate.
6. That FDA in conjunction and with the cooperation of
manufacturers, public health authorities, retailers,
distributors and others needs to implement a comprehensive
monitoring and surveillance system that covers all tobacco,
nicotine and alternative products. We need to know what is
happening in the marketplace.
7. That consumers of all tobacco and nicotine products be given
truthful and non-misleading information about the risks and
relative risks of products that includes not only warnings but
other useful information about the growing spectrum of
products;
8. That FDA (and where appropriate the FTC) use its enforcement
authorities to take action against any manufacturer, retailer,
wholesaler etc. who violates the law;
9. That if the use and possession of any ``nicotine'' product by
adolescents is of such great public health concern (as many,
including myself, clearly think it is)--that like alcohol and
other areas where adolescents must bear some responsibly for
their actions, we begin a serious discussion about expanding
minimum age of sale restrictions to include the use and
possession of any tobacco or nicotine product. Given that
initiation is of such great concern, the time may be ripe for
trying to prevent anyone under a certain age (18) from buying,
possessing or using any tobacco or nicotine product.
10. That FDA, while focusing on the abuses of aggressive advertising
targeted at youth, also begin considering how best to convey
truthful, complete and non-misleading information to the public
about the risks, relative risks and intended uses for all
tobacco, nicotine and alternative and consider initiating a
well-balanced public educational campaign. (It is my feeling
that until and unless this happens, confusion will continue to
reign in the marketplace and some companies will continue to
skirt the fine line between what is appropriate advertising and
marketing and what is not).
11. And last not but least that the ``deeming'' regulations should
be considered the primary avenue for setting balanced, fair and
effective standards for regulating all tobacco and nicotine
products and that FDA should continue to encourage the active
participation of all interested parties in submitting their
comments.
While the FDA deeming proposal is where we need to be focusing, are
there things that can be done with respect to curtailing the
advertising and marketing of e-cigarettes to children and
adolescents as we await final regulatory outcomes?
The simple answer is ``yes'' we can and should do more. But in
doing so, we shouldn't be throwing out the baby with the bathwater and
we need to not lose sight of the fact that our public health goals
should be to reduce disease and death caused by tobacco use--the
primary concern of which has been, is and should continue to be with
the deadly toxic cigarette.
Here are some things to consider in keeping attention on this
issue----
1. The public at large and consumers of tobacco and nicotine
products need to be truthfully and honestly educated about the
risks and relative risks of products in the marketplace,
including e-cigarettes. This needs to come from all
stakeholders. This includes information about what our policies
should be with respect to children and adolescents but it goes
much further. The time has come to do this in a serious manner
and to abstain from what often becomes a `media circus' that
does little to nothing to advance the ball forward and that
will only continue to confuse the public.
2. In the area of advertising and marketing FDA and the FTC should
actively work together to monitor advertising, expeditiously
taking action when appropriate and necessary.
3. E-cigarette manufacturers, either through the actions of
individual companies or collectively, need to make it clear
where they stand on a variety of issues not just to regulators
but to policy makers and the public at large. As we wait for
the deeming regulations to be issued, some sort of interim
``code of conduct'' might help in providing some
accountability.
4. This Committee, as well as the Senate Health Education Labor and
Pensions Committee, and your counterparts in the House need to
play a leadership role and less of a reactionary role in
helping to shape the necessary policies to carry us forward.
The time is ripe for our policy makers to come into the 21st
century and recognize that this is indeed a ``New Era''. Design
the policy parameters but let the FDA do its job.
5. FDA needs to consider not just doing ``listening'' sessions but
also be willing to sponsor/convene workshops and forums in
order to keep the discussions on these important issues going
and more visible as we await the final deeming regulations.
Mr. Chairman and members of the Committee I thank you for the
opportunity to be here today to express my views and to suggest some
ideas about how we can move forward in this rapidly changing
environment. There is a balance that needs to be achieved and the only
way we can achieve that balance is to keep the discussions going, our
minds open, our willingness to listen and learn, and to remain focused
on the goal of reducing disease and death from tobacco use.
My views have remained very consistent for many years. In August of
2011, I gave a key note presentation at the Food and Drug
Administration concerning modified risk tobacco and nicotine products
saying:
``The sale and marketing of all tobacco and nicotine products
should (as recommended by the IOM report, Clearing the Smoke,
be carefully monitored and if legitimate and serious issues are
found, corrective actions should be taken by the FDA.
Implementing a workable surveillance system for all products
(not just MRTP's) should be given a high priority. Since
companies (tobacco, pharmaceutical, biotech, etc.) will be the
ones that will be required to collect the data, it needs to be
done in a collaborative way with the FDA in order to achieve
maximum results.''
David Abrams, Professor of Health Behavior and Society at the Johns
Hopkins Bloomberg School of Public Health has referred to this
``balance'' as it relates to e-cigarettes as the Goldilocks test.
Regulation should not be too hot (that we prevent smokers from having
access to consumer acceptable products) and yet it must not be too cold
either (that would allow irresponsible manufacturers the opportunity to
make claims and target children and adolescents). They need to be
``just right''. As we pursue our public goals we must therefore be
careful not to ``throw the baby out with the bath water''.
Thank you.
The Chairman. Thank you, Mr. Ballin.
I almost don't know where to begin.
Mr. Weiss, so I guess what you were saying is that you sort
of had a corporate board meeting and you decided that the
corporate purpose of your company would be to reduce cigarette
smoking among adults and, therefore, you went to e-cigarettes
as a way of so doing?
Mr. Weiss. Yes.
Our corporate mission is to obsolete the combustion
cigarette.
The Chairman. So that would then lead necessarily to the
conclusion that you don't do any advertising in some of these
magazines and TV, which had been discussed. You don't advertise
in areas that would appeal to youth to use e-cigarettes,
because you wouldn't need to do that because you have a
different mission. It's the adults that you're working on.
You're not working on kids.
Mr. Weiss. That's correct.
We're only interested in adult smokers and----
The Chairman. So you don't do any advertising?
Mr. Weiss.--we do advertising that's targeted toward adult
smokers.
The Chairman. And is that advertising that is aimed at
adult smokers the kind that was discussed by Mr. Myers?
Mr. Weiss. He didn't hold up any of NJOY's ads and as I've
mentioned, the American Legacy Foundation----
The Chairman. Well, come on. You understand what I'm
saying. In other words, appealing to young people.
Mr. Weiss. I don't believe that our ads appeal to young
people.
The Chairman. Well life is easy, isn't it, when you can
just answer like that?
All right. You're on the record there.
This is to all the witnesses but not everybody has to
answer. I'm worried, obviously, e-cigarette marketing reaching
youth that appears to be the case. If people have figured out a
way to actually be just trying to affect adults but get 9.5
million people who read advertisements and 14 million people
who see advertisements about e-cigarettes, that's making an
interesting discussion.
But, limiting cigarette marketing to youth has been central
to the multi-decade effort to prevent young people from
becoming addicted to smoking. And, it's well established that
nicotine is the addictive ingredient in cigarettes.
So, Mr. Myers and Dr. Tanski, would you agree that a
sustained and prolonged smoking prevention and tobacco control
effort, there has been an encouraging decline of youth rates of
cigarette smoking in this country?
Dr. Tanski. You're absolutely correct.
There has been a wonderful decline in the rates of smoking.
The data that just came out last week showed a low of 15.9
percent prevalence amongst our high school youth, which is the
lowest rate in 22 years. So there have been great strides in
reducing cigarette smoking among our youth.
The Chairman. OK, I get the drift.
Now, e-cigarette manufacturers say that their target
audience is just adult smokers and that the other, the youth,
don't figure in.
Senator Boxer, what gets me is this gets so to the
integrity of corporate culture and what people will do when
they're given the chance to make money. I'm sorry. That's so
deeply embedded in me that's why I started out by saying I'm on
edge emotionally on this whole hearing.
But by blanketing a wide variety of media with
advertisements, aren't these companies also creating the risk
of introducing a whole new generation of young people starting
zero through five to the highly addictive substance called
nicotine?
Mr. Myers. Yes, sir.
That's exactly our fear. There is a whole generation of
young people who have grown up since the Master Settlement
Agreement and other restrictions who've never seen a TV ad
glamorizing cigarettes, who have never seen the kind of
advertising I showed you and I could have shown you dozens more
of those ads as well. And we are deeply concerned that, while
e-cigarette companies should be free to inform adult consumers,
there are ways to do it that don't require them to put ads on
the bikini bottoms of women in Sports Illustrated, sponsor rock
concerts. I could show you YouTubes of central and provocative
images. There is a way to communicate to adults.
The Chairman. I get your drift. I get your drift.
Now, the argument has been made that nicotine is what
people get addicted to but tar is what kills them. I'm so
stunned by that because of the one and the other are the same.
In other words, you'd have to prove that nicotine is sort of
good for your health for a young person. How would they
possibly saying they're getting addicted on nicotine but there
not being tar present. It's good for them.
Mr. Myers. There are two points. Nicotine is dangerous to
young people, specifically, while their brains are being
formed.
The Chairman. Right.
Mr. Myers. So there is no such thing as the safe delivery
of nicotine particularly in the uncontrolled levels and then
these kinds of things that we've seen for a young person.
Through FDA regulation, we have shown that it is possible
to deliver carefully titrated deliveries of nicotine to adults
for at least periods of time, which going on in the current
marketplace for e-cigarettes, however, is that nicotine is
being delivered in uncontrolled levels with uncontrolled
flavors and no quality control. And to say that that does not
pose a potential risk is a misstatement.
Chapter five of the most recent Surgeon General's report
focused entirely on the toxicity of nicotine. So it is a 100
percent true statement that nicotine isn't what causes cancer
but nicotine is not a benign substance. That's why it has
always been regulated by the FDA and why it needs to be
regulated by the FDA in e-cigarettes to protect the public as
well.
The Chairman. I thank you.
My time is up but I, with the indulgence of my
distinguished Ranking Member, I just want to give Mr. Healey a
chance to respond to what I'm positing.
Mr. Healey. Thank you, Mr. Chairman.
First, for myself, I, being a father besides a businessman,
do not want my product in the hands of children. And it's
something I think we take very, very seriously but, at the same
time, we try not to lose sight of the big picture of the 41
million smokers like myself.
We also look and watch whether it, by our voluntary
advertising restrictions, that we've put in place that we
actually got out of the Tobacco Act. And we put those policies
on ourselves and then we also look at who is buying. And when
we look at who is buying blu, the average age is 51.1 years
old. So we watch both ends of the equation, where we're showing
it, but also what the results of what we're doing now because
we have to be responsible for the results.
The Chairman. As I said, my time is up. And, I apologize to
my Ranking Member.
Senator Thune.
Senator Thune. Thank you, Mr. Chairman.
Mr. Myers, assuming that we all agree that children should
not be able to purchase these products, what's your view on
whether e-cigarettes have the potential to reduce harm if
current adult smokers of combustible tobacco cigarettes
switched to them?
Mr. Myers. As I said, if properly regulated in terms of
quantity of nicotine; how it's delivered; the manner of, and
its delivered; and it's targeted to a current smoker who
couldn't otherwise quit, with the levels of nicotine
sufficiently so that they switched exclusively to e-cigarettes,
I don't there's any doubt that there would be a reduction in
our----
Senator Thune. What's your, sort of, general view with
regard to the science around e-cigarettes? Do you view it as
settled?
Mr. Myers. No.
The science is not settled and the science couldn't be
settled because the product itself is changing. Unfortunately,
we haven't had the kind of rigorous science for this that we'd
require for any other product under the regulation of the FDA.
Our organization, I think all of the other public health
groups, would welcome rigorous science so that if e-cigarettes
have the potential to help millions of smokers quit, we do the
kind of science so that we're sure that the product that we're
selling to them will actually accomplish that goal.
In the absence of regulation, what we've seen is products
with nicotine levels of enormously different levels; high
enough to be of concern and, in some cases, so low that the
fear is it just makes it too easy for kids to start because
nicotine is harsh. And the last thing we want to do is have a
perfect product for a kid to start as well as advertising.
So it is science that should drive the precautionary
principle of protecting our kids in how we go about developing
that science.
Senator Thune. Thank you.
Mr. Ballin, there has been a lot of discussion about the
benefits and harm of e-cigarettes, as you know. In your
testimony, you agree with Mitch Zeller, the Director of FDA
Center for Tobacco Products, who has recently said that
``there's a continuum of risk for nicotine-containing
products.''
You also stated that any regulation of those products
should be based on the relative risk and intended uses. Can you
elaborate on how we can find the appropriate balance for e-
cigarettes and what some of the key players can do to further
the dialogue and scientific research?
Mr. Ballin. Yes.
I think that, you know, what I'm hearing around this table
is actually a common direction of what needs to be done. There
needs to be more research. There's no question about it. It
needs to be done by FDA internally, NIH, and other places
coupled with universities and other academics. Also, industry
has a responsibility.
I think there was a statement made by someone earlier that
there has to be accountability of this industry. And I think
that as the agency begins to regulate these products, and
anybody wants to file an application with the agency, they're
going to have to have the proof to back up whatever they're
asking for the agency to approve a product or also allow a
claim or anything else.
We need to head that in that direction, very quickly. I
agree with a lot of what's been said at this table.
The other thing is I think we need an aggressive monitoring
surveillance system. We talked about that many, many years,
over the years, you know, in the public health community and at
FDA. And I think that in order to find out what's going on in
the marketplace, we need to be able to tap into the industry
documents, if it's a proprietary information, FDA needs to do a
better job of coordinating efforts to see what's happening out
there so we can take the necessary steps to take action.
There are a lot of things that need to be done; there's no
question about it. But I think collectively and responsibly, if
it's done properly, we are going to be able to deal with some
of the issues we've talked about today.
Throwing grenades at each other, I don't think it's going
to be productive. And that's why, over the years, I've come to
the conclusion that when people actually can sit down in a room
without negotiating anything and have a civil conversation off-
the-wall, you know, off-the-record conversation, progress can
be made. It may not be, but until you start talking you're
never going to find out. And I will say that again, for me,
this hearing is beginning that process up here and I appreciate
it.
Senator Thune. Let me ask you, what concerns do you have
about advertising to children and how has the emergence of the
tobacco companies in the e-cigarette field changed the market
or the perception of the advertising?
Mr. Ballin. For me, being from the public health community,
I have the same concerns that many in public health have; about
advertising crossing a line. Now, I don't know where that is,
necessarily, but I will say that some of the things I've seen
bother me as a public health person. But I don't think banning
advertising per se is the route to go because, at the same
time, I think we need to be providing truthful accurate
information to the 40 million smokers out there about what
these products are and how they can be used. That is, I think,
where we need to go.
So I agree that we need monitor this stuff, which is what I
just said earlier; there are things that give me heartburn
about what I see in the marketplace, and I think we need to
deal with them up front and in a very honest manner.
Senator Thune. Just very quickly, Mr. Healey and Mr. Weiss,
what are your companies doing to restrict advertising to
children?
Mr. Healey. As I mentioned briefly, we adopted, with blu, a
policy that we got from the Tobacco Control Act, and that was
that in our print and television and marketing efforts that the
audience be at least 85 percent adult; as I said, which is what
we decided to impose and got that from the Tobacco Control Act.
Mr. Weiss. In NJOY's case, we also self-regulated. So, in
the years that's led up to this regulation, we only advertise
in programming that would have a predominantly adult audience
whether that be on television or in print.
Senator Thune. Mr. Chairman, my time has expired. Thanks.
The Chairman. Senator Heller, you're going to be a very
good person, as you are anyway, and yield to Senator Boxer
because she's the Committee Chair and she's here. And, oh,
Senator Heller is not.
Senator Boxer.
[Laughter.]
STATEMENT OF HON. BARBARA BOXER,
U.S. SENATOR FROM CALIFORNIA
Senator Boxer. Thank you.
Mr. Ballin, you're a very optimistic man. You're talking
about sitting around a table and resolving these things; we
tried it with the tobacco companies. Do you know what it took?
They all sat across there in a different venue, in Congress,
raised their hands, swore to tell the truth and then lied. And
at that point, everyone turned and things began to happen and
we began to make progress at that point.
And I just want to say, we don't ask people to raise their
hands because you just need to know and we all know you have to
tell the truth because of 18 U.S.C. 1001.
So I've heard a couple of things here that are not true.
And I just want to talk about those things.
For example, I think Mr. Healey, you said in your--well,
it's true. It's your opinion. This is the greatest invention
ever to get people off of the other cigarettes. You said that.
Mr. Healey. Yes, Senator.
Senator Boxer. You did. Well, I may ask unanimous consent
to place into the record, an American Heart Association peer-
reviewed scientific journal; have you seen this, sir?
Mr. Healey. I don't believe I have, Senator.
Senator Boxer. OK, we'll get it to you. We'll put it into
the record unless there are objections. OK.
[The information referred to follows and can also be found
at http://circ.ahajournals.org:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Senator Boxer. And here's the deal, it's pretty well peer-
reviewed. They say, ``Health claims and claims of efficacy for
quitting smoking are unsupported by the scientific evidence to
date.''
And these are leading scientists. So, Mr. Myers, you ought
to get a look at this too. Because, I don't think you were
accurate in your response either. I need to go on. I don't have
time. And I have to make some points here.
Now, my two friends from these e-cigarette companies, you
believe, I'm sure, that nicotine is dangerous to adolescents.
Is that correct?
Mr. Weiss. Yes, I do.
Senator Boxer. Do you?
Mr. Healey. Correct.
Senator Boxer. OK.
And you're aware that the U.S. Surgeon General said
``nicotine exposure during adolescence may have lasting adverse
consequences for brain development and adolescents are
particularly vulnerable to this highly addictive drug.''
So I am just asking you, because you said that you are
working to get adults off cigarettes. That's your goal and
that's your mission in your companies. Have you ever had a
conversation in your company, informally, formally, with
another executive, about how this product could be marketed to
non-smokers?
Mr. Healey. I can say I haven't had that conversation.
Senator Boxer. Did anyone in your company ever have that
conversation----
Mr. Healey. Not that I'm aware of, Senator.
Senator Boxer.--marketing to non-smokers? Not that you're
aware.
What about you, Mr. Weiss?
Mr. Weiss. Absolutely not.
Senator Boxer. OK.
What's in your cigarettes? Tell me what's in them?
Mr. Weiss. There's nicotine, propylene glycol, glycerin and
flavorings.
Senator Boxer. OK. How about yours?
Mr. Healey. The same with nicotine and distilled water to
that list.
Senator Boxer. OK.
Are you aware that there were some formaldehyde found in
these cigarettes?
Mr. Weiss. Yes.
We've tested our products and there's no formaldehyde in
the ingredients of our products.
Senator Boxer. How often do you test your products?
Mr. Weiss. We test them pretty frequently.
Senator Boxer. And so, this story that found formaldehyde
had nothing to do with your two companies?
Sir? Mr. Healey?
Mr. Healey. Not for mine, Senator. No.
Senator Boxer. And not for yours? No, they didn't find
any--the New York Times story?
Mr. Weiss. No.
The New York Times was not testing our products; no.
Senator Boxer. Now, it's unequivocal that you do not market
to kids. So here's my question to Mr. Healey. You sell your
products in cherry crush and vanilla flavors. Cherry crush.
Yet, your parent company has a youth smoking prevention
website, your parent company, that says ``Kids may be
vulnerable to try e-cigarettes due to an abundance of fun
flavors such as cherry, vanilla, pina colada, and berry.'' You
sell cigarettes in three of those flavors. How can you sit here
and say you're not marketing to children?
[The information referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Healey. Senator, it's a good question. And flavors----
Senator Boxer. What's the answer?
Mr. Healey. The answer is the average age of a ``cherry''
smoker is in the high 40s but also we found that flavors
increase, or sorry, decrease the ability or possibility of
adult smokers to use e-cigs switching back because they don't
want----
Senator Boxer. Why--whoa, whoa, whoa!
Why did your parent company, in their youth smoking
prevention website, say ``Kids may be particularly vulnerable
to trying e-cigarettes due to an abundance of fun flavors such
as cherry, vanilla, pina colada and berry?'' And you sell them
in three of the flavors. Are you marketing to children?
Mr. Healey. No, I am not.
Senator Boxer. So who is attracted to cherry, berry,
vanilla? Who is attracted to that? Adults?
Mr. Healey. Adult smokers, yes.
Senator Boxer. They are. That's interesting.
And I would like to say to Mr.--even though your parent
company called you out on it?
Mr. Weiss, your company previously committed to not sell e-
cigarettes in flavors. Now, Wall Street investors report you're
going to be offering 10 new flavors and more to come. What are
these flavors? Can you mention them?
Mr. Weiss. Sure.
There are a variety of flavors but pomegranate is one. We
have adult flavors like single-malt scotch, for an example. I
would say that----
Senator Boxer. You have adult flavors as opposed to your
kid's flavors?
Mr. Weiss. Well, for example, we're not offering cotton
candy or Gummy Bears.
Senator Boxer. Oh, wonderful.
What are you offering? What are on the list of your ten? Do
you have them there?
Mr. Weiss. I don't have it listed here. I could probably
remember them off the top of my head.
Senator Boxer. Go ahead.
Mr. Weiss. And so, in addition, there's vanilla bean, there
is also a peach tea, there's also----
Senator Boxer. Sir, since I don't have time because my time
is very limited, would you make that available before the end
of the day?
Mr. Weiss. Yes, no, of course.
Senator Boxer. OK.
And I wanted to show the flavors that we see in e-
cigarettes. I don't know the flavors Mr. Weiss is now coming up
with since he said before he wasn't going to, but I'm just
going to ask our advocacy people here; the two at the end.
You think cotton candy is something that's attractive to
children or adults?
Dr. Tanski. I would argue that cotton candy would be
attractive to children.
Senator Boxer. What about Gummy Bears, Mr. Myers?
Mr. Myers. I would agree and the evidence shows that to be
the case.
Senator Boxer. And then Popsicle. OK.
So for e-cigarettes as an industry, to proclaim that
they're not advertising to kids and they're choosing these
flavors, and we don't know yet Mr. Weiss' flavors, and we now
heard that cherry and berry, even though your parent company
said that they attracted kids, you don't think they attract
kids.
You're wrong. You're wrong.
And let's look at some of the advertisements.
Could somebody help us? Thank you.
These are cartoons. They're not by your companies; other
companies. I want to say to my children's advocacy people, do
those look like they're aimed at children or adults?
Dr. Tanski. Senator Boxer, I would agree that those--that
would be Papa Smurf and that would look like it would be
appealing to children as there are movies that are featuring
the Smurfs.
Senator Boxer. And, as a grandma, I could attest the fact
that the biggest movie now is Frozen, and then the biggest song
is ``Let It Go.'' And one of the e-cigarettes has their logo
``Let It Glow.''
Now, I am saying to my Chairman, whom I adore, whether it's
his birthday or not his birthday, on every day I share his
views on this. And I'm asking Mr. Weiss and Mr. Healey to look
into your heart. You can sit and say whatever you want. You can
con yourself into thinking what you know.
We don't know if this product gets people off cigarettes
yet. It's not proven, number one. So don't think that you're
doing some great mission. And then, don't say that you really
care about kids when you go against your own parent company's
advice and start using these flavors. I have some of these
flavors here. I'm not supposed to touch them because they're
like poison; seriously.
What is this one? Pink Spot. Gummy Bear Pink Spot. Rocket
pop. Cotton candy.
We are seeing a repeat and we, here in this committee, get
it. And I'm just saying, I have a lot of other questions I'll
forward for the record, but I think all of this is very
important. And I know the people in the industry. You can talk
yourselves into everything.
When I was a young woman, doctors said ``Smoke a cigarette,
it will calm you down.''
Thank God my mother said ``Not on your life.''
Don't be a part of this because you'll regret it.
The Chairman. Thank you, Senator Boxer.
Senator Blumenthal.
STATEMENT OF HON. RICHARD BLUMENTHAL,
U.S. SENATOR FROM CONNECTICUT
Senator Blumenthal. Thanks, Mr. Chairman.
And, like the previous colleague, I am tremendously
respectful. I'm not going to go quite so far as saying I'm
adoring, but we love you and happy birthday.
The Chairman. You'd like my daughter too.
Senator Blumenthal. Your daughter is great.
The Chairman. One of your constituents.
Senator Blumenthal. Like all of our children, they are
better generation to generation.
But I also want to thank your staff and our staff for the
excellent work they have done in putting together this really
profoundly important hearing and it does have a very eerie and
haunting feel. The only difference between your testimony today
and the testimony that tobacco executives is that you're not
under oath because I find in this testimony a sense of denial
that I cannot creditable accept. And the reason is that it's
defied by the numbers. The latest report by the Legacy
Foundation shows that 18 million teens were exposed to blu's
print and TV ads within a 6 month period, alone. It shows that
NJOY's ads reached 3 million teens.
There's a legal principle that people are responsible for
the natural and logical effects of what they do because they
know those effects. And you know that you're reaching children
and teenagers. So I think we have seen this movie before, it's
called ``big nicotine comes to children near you.'' And you are
using the same kind of tactics and promotions and ads that were
used by ``Big Tobacco'' and proven so effective.
I want to show you, for example, one, to begin with if we
can show it. You can see our old friend, Joe Camel, and our new
friend who is Mr. Kool.
[]The picture referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Senator Blumenthal. Anybody recognize Mr. Kool?
Mr. Healey. I do, Senator.
Senator Blumenthal. Yes.
Are you here denying that Mr. Kool appeals to teenagers and
children?
Mr. Healey. Mr. Senator, that particular illustration was
not a commercial. It was placed on our website for our
consumers as an education piece. Now, I understand you----
Senator Blumenthal. It was an education piece on your
website.
Mr. Healey. Yes, sir.
Senator Blumenthal. So it was not in any way designed to
represent your company? Is that your testimony? Are you denying
that it represents an official act of your company?
Mr. Healey. No.
What I'm saying is that it wasn't a commercial. It had
education pieces that were specifically aimed at our consumers.
Now, we have taken it down because when I had objections and
people said to me ``I think this is inappropriate.'' Well, I
disagreed that the messaging wasn't aimed at children----
Senator Blumenthal.--inappropriate but the tactics that you
substituted are equally so. You're one step ahead of your
critics.
Let's look at the next visual; if we may.
[The picture referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Senator Blumenthal. Now, anybody recognize him?
Mr. Weiss?
Mr. Weiss. Yes.
Senator Blumenthal. Who is he?
Mr. Weiss. I believe that's Robert Pattinson.
Senator Blumenthal. And what does he have in his mouth?
Mr. Weiss. NJOY electronic cigarette.
Senator Blumenthal. Your product.
Mr. Weiss. Correct.
Senator Blumenthal. He looks a lot like Mr. Kool; doesn't
he?
Mr. Weiss. He's an adult smoker.
Senator Blumenthal. Well, he's an adult smoker but do you
deny in your testimony today that this ad that the use of this
image, it's designed to appeal to children and teenagers?
Mr. Weiss. I do.
Senator Blumenthal. Why?
Mr. Weiss. Because he's a 28-year-old adult smoker.
Senator Blumenthal. So your testimony is that adult role
models have no appeal to children or teenagers? In other words,
if they're older than 18, they have no impact on people under
18? Is that what you're saying?
Mr. Weiss. What I'm saying is that our target is to reach
adult smokers and being able for adult smokers to see other
adult smokers that perhaps that they admire that are using an
alternative to a toxic cigarette; that that's a good thing.
Senator Blumenthal. Well, these ads and these images are
designed to appeal to children. Well, again, they are not only
reminiscent, they're really duplicative in my view of the
tactics adopted by Big Tobacco. You've taken their playbook and
you've modified it to a non-combustible nicotine delivery
mechanism. And this hearing is not so much about the contents
of e-cigarettes or their potential health effects, which I find
somewhat difficult to accept on the evidence we have so far,
it's about the marketing and promotion tactic. The use of
several celebrities like Robert Pattinson and images like Mr.
Kool and others that I hope perhaps we can reach on a second
round of questioning, but in my view the evidence is undeniable
that you are seeking not only to renormalize, but in fact, to
re-glamorize tobacco use. And that these products for many,
many children and teenagers will be a clear path and gateway to
combustible tobacco use, otherwise known as cigarettes.
My time has expired. I apologize, Mr. Chairman. And I hope
that on a second round we can hear more responses.
The Chairman. You've been doing this a long time, Senator
Blumenthal.
Senator Klobuchar.
STATEMENT OF HON. AMY KLOBUCHAR,
U.S. SENATOR FROM MINNESOTA
Senator Klobuchar. Thank you very much, Chairman
Rockefeller.
I'm a former prosecutor and I like to look at the facts
here. And the first fact that Senator Blumenthal mentioned that
really sticks out to me is that a recent study found that
almost 2 million kids have tried these e-cigarettes. That's a
problem right there.
And I look at----
Will you put that picture back up there of the Twilight
guy, Pattinson?
OK. So have you gone to those movies, Mr. Weiss?
Mr. Weiss. Yes. I have.
Senator Klobuchar. OK.
Have you been in those theaters? Because, I have with my
daughter when she was 16. And, I can tell you that the people
in those theaters, for the most part, are kids. And the people
that read those books, for the most part, are girls. And I have
seen this many times because I've had to be up at two in the
morning when they do the premier and all the girls go to see
the movie.
And this is a birthday, happy birthday to Robert Pattinson.
I noticed the, Senator Blumenthal, he is here.
Do you think that really appeals to me or Senator
Blumenthal, to wish him happy birthday?
Mr. Weiss. Again, I'll just repeat what I said earlier,
that he's an adult smoker. We're trying to appeal to adult
smokers.
Senator Klobuchar. OK. He's an adult in movies that appeal
to kids. And that's what matters to me because this is a
marketing technique.
And the third fact that I wanted to move to is the
flavoring issue. And I don't understand why when regular
cigarettes, they can't have flavors; right? Is that correct?
They've been banned from having flavors?
Mr. Weiss. Right.
Senator Klobuchar. I guess I'd ask you, Mr. Myers or Dr.--
why were they banned from having flavors for regular
cigarettes?
Mr. Myers. They were banned because Congress determined,
after substantial evidence, that they mostly appeal to young
people.
Senator Klobuchar. Right, exactly.
And so, I don't understand why you couldn't have your
product without flavors?
Mr. Weiss?
Mr. Weiss. So, for us, we view every decision that we make
through the lens of what is going to help accomplish our
mission to obsolete cigarettes. And so, because we're only
interested in adult smokers, we had not yet sold any products
that contained any flavors. And still, as of today, don't. So
as a responsible company, prior to offering flavors, we
actually conducted research to ensure that, to the greatest
degree possible, we would not appeal to non-smoking youth with
the flavors that we would provide.
And so, we're trying to understand who uses our product
with the goal of appealing to adult smokers without appealing
to minors. And we were satisfied with the results of that
research which we would be happy to submit for the record. The
research was conducted by Saul Shiffman, who is actually
present here today and is willing to answer questions to you or
your staff.
Senator Klobuchar. I got to tell you, just having an 18
year old, just because they have alcohol names on them, they
think those things are cool. I know, I think it was you Mr.
Healey, that had the pina colada brand. I think a lot of youth
think those are cool.
Not to mention the ones that Senator Boxer mentioned, those
flavors. And I just think any flavors of something that kids
like. The other thing, forth fact, I wanted to follow up on is
the Mr. Kool ad that you said was just on a website, was that
right?
Mr. Healey. Correct.
It was in an ad placed in----
Senator Klobuchar. OK.
So let's talk about the website. And I understand that a
lot in the social media and how a lot of this is. And I
understand the study out this month shows that e-cigarettes are
being heavily marketed on Twitter. Over a two-month period
there were 70,000 tweets related to e-cigarettes. Nearly 90
percent of the tweets were from e-cigarette companies, and
almost all of these included a website link.
Now, I also understand that when people sign up for the
Twitter account, they have to say they're over 18. Is that
right or 18 or over; over 18?
Mr. Healey. Yes.
The social media sites have age verification or
certification processes that we install.
Senator Klobuchar. OK, but they're public tweets. So anyone
can get on these Twitter accounts. And anyone can get on
YouTube; right? None of the videos are age restricted; is that
right?
Mr. Healey. Correct.
Senator Klobuchar. So I would just think, I just got to
tell you that my in-laws use, I don't think they use Twitter.
They're in their 70s, but I know that all of my daughter's
friends use Twitter and they all use Facebook and they're very
adept on social media that is putting it in a minor fashion.
And so, I would think that this kind of marketing would be
particularly appealing to kids. And I wondered if you wanted to
comment on that, Dr. Tanski?
Dr. Tanski. I think you're completely correct that using
social media is a particularly adept way of reaching young
people. And to the point of the age restrictions, the websites
for electronic cigarettes, to my knowledge right now, most of
them say ``Are you over 18?'' And you say ``Yes'' and you're in
rather than having the double forms of age verification that
they do, say, on some of the combusted tobacco websites. It's
far easier to just say yes and you can get right in.
So I agree that the protections to youth are relatively
weak to be able to have access to some of this social
marketing. And it's very powerful, as you noted.
Senator Klobuchar. OK.
Mr. Myers?
Mr. Myers. I completely agree.
It isn't 70-year-olds who are looking at Twitter or the
YouTube videos that are out there. And we, too, look at the age
verification on the e-cigarette sites, including Lorillard's,
and it is nowhere near comparable to what is the set of the
requirements for cigarettes. So it's a dual standard; one
allows young people and much, much easier.
Senator Klobuchar. OK.
I just want to conclude in my closing argument, as a former
prosecutor, so what you have here are 2 million kids and
growing; you've got marketing of flavors, which we know from
the past with regular cigarettes, that is the very reason why
we banned flavorings in regular cigarettes and now you have
this happening again like Groundhog Day; and then the third
thing that we know is that we've got a heavy use of social
media, which we also know is targeted to youth. It's a great
way to reach youth; in fact, one of the only ways to reach
youth at times if you got any kid that's on their iPhone
constantly and texting, looking at things.
And then we've got our, sort of, celebrity models, which I
got to tell you about--most people over 50 are not going to
know who Robert Pattinson is as much as you like to think it.
And just that he's 28 years old and has 28 candles; Justin
Bieber is over 18 too. And if so, and put an ad out for him.
You probably wouldn't do that, by the way. But if someone put
him up there, even though he's over 18 years old, I don't think
that anyone is going to think that is marketed adults.
So this is my exhibit. So thank you very much. I just think
that, to me, when you look at all these facts, there is heavy-
duty marketing going on to youth. And the last thing we need,
as to them, get dependent when we've just started to see such
success.
Thank you.
The Chairman. I'm going to sneak a question in before
Senator Nelson.
Mr. Healey, you said that you're a smoker?
Mr. Healey. Yes, Chairman.
The Chairman. How many years have you been a smoker?
Mr. Healey. I started at 23 and I'm 40 and two months. I'm
not good at math, but a fair amount of time.
The Chairman. And you're using e-cigarettes to help you get
rid of your cigarette--I'd like to hear about it's working; how
long have you been doing it; what do you notice?
Mr. Healey. To be honest----
The Chairman. I think what you're, from Mr. Myers over, I
think you're all talking into the clouds in terms of facts.
You're disingenuously trying to say something which you should
not be saying. But to your credit, you're trying to get off of
tobacco, and so how is the e-cigarette helping you do that?
Mr. Healey.--I can only speak to my personal story. I was
smoking a pack and a half of cigarettes a day. Now, at best, I
will smoke five tobacco cigarettes a week; a lot of times,
none. And it makes it very difficult, for me as an e-cig
smoker, that wasn't my intent, necessarily, but being that it
doesn't taste and remind you of tobacco, it's difficult to go
back to tobacco as consistently as you were.
The Chairman. All right.
One other question: Does Lorillard allow distributing of
free samples to kids?
Mr. Healey. blu distributes----
The Chairman. So that means blu.
Mr. Healey. Yes--samples to verified 18 or above smokers.
The Chairman. And, how do you know that they're 18 or
above?
Mr. Healey. We have machines that they have to provide,
first, provide their Driver's License, State Driver's License.
It's swiped to be verified and then the first question they're
asked is: Are they a smoker? If they say no, their experience
with us ends. If they say yes, we talk to them about the
product and then they can acquire a sample.
The Chairman. So you think that's a virtuous civic duty
that you're performing there?
Mr. Healey. I think we should be responsible, particularly
when handing the product to someone.
The Chairman. Senator Nelson.
STATEMENT OF HON. BILL NELSON,
U.S. SENATOR FROM FLORIDA
Senator Nelson. Mr. Chairman, as usual, you have picked a
hearing on an important topic of the day. So thank you very
much.
I want ask Dr. Tanski, you testified that there was a
recent increase of nicotine poisoning cases in young children.
Are these cases mainly coming from children getting into the
refill vials of liquid nicotine or are you seeing the poisoning
cases from the disposable e-cigarettes?
Dr. Tanski. Unfortunately, Senator, we don't actually have
that level of detail. What we know is that the trajectory of
the number of calls has been increasing for electronic
cigarette and nicotine devices very rapidly with 251 calls in
just the month of February. We don't have the kind of detail
that say if they're coming from the refill devices or not. My
personal suspicion is that's the greatest likelihood for the
kids to get into them rather than the whole cigarettes,
themselves; the whole electronic cigarettes themselves.
Senator Nelson. You also note that there are currently now
standards for governing childproof packaging for these liquid
nicotine bottles. And I would like, Mr. Chairman, if this has
not already been entered into a record, it's a photograph of a
number of these liquid flavors: Banana Split, Cotton Candy,
Kool-Aid Grape, Skittles, Sweet Tart, Gummy Bear, Fruity Loops,
Rocket Pop, Hawaiian Punch.
Doctor, would you support giving either the Consumer
Product Safety Commission or the FDA express authority to
enforce childproof packaging for toxic or harmful household
substances on all of those liquid nicotine containers?
Dr. Tanski. Absolutely, Senator.
It is critically important that we protect youth and
children especially from these nicotine containing products.
Everything else in your home that is toxic pretty much has a
child safety cap on it; whether it's a bottle of bleach or the
medications that you take home from the pharmacy. They're all
contained in something that is harder to get into so that it
gives that extra time so a parent can be there so that they
don't have a toxic exposure.
So I ask for your help. We believe that the FDA has
regulatory authority over the packaging, although it's not yet
been commented on, and I would encourage you guys as a
committee to please help us. I think the Consumer Product
Safety Commission should consider, if possible, to include
their oversight to include this as a toxic product. I know that
at present tobacco products are excluded from the packaging
regulations, but perhaps that should be revisited and this
should be considered somehow different from other tobacco
products.
Senator Nelson. Maybe all the more needed, the Gummy Bear
actually has a picture of Gummy Bears on the label.
[The information referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Senator Nelson. Mr. Weiss, you have stated that there
should not be restrictions on responsible advertising of e-
cigarettes or other types of these nicotine vapor products.
Tell us what is responsible. And what is your responsible
advertising in your industry?
Mr. Weiss. Responsible advertising is trying to reach the
more than 40 million adult smokers in this country over almost
500,000 of who die every year prematurely from tobacco-related
illness. Trying to reach those people and get them off of the
toxic products that they're currently using is a responsible
thing to do.
Irresponsible, I think, would be the use of cartoon
characters or images trying to target children with advertising
during television programming that appeals to children; things
of that sort.
Senator Nelson. Well, is it responsible to show an e-
cigarette that looks almost exactly like a combustion cigarette
in a television ad? Is that responsible?
Mr. Weiss. I believe that it is because I think for must
smokers, if you asked what an electronic cigarette is, they
think it's a very complicated device with a lot of wires and it
was important for us to communicate to them that it could be as
close as possible to the product they are currently using and
that would make it as easy as possible for them to transition
from one habit, which is unfortunately a habit that is going to
prematurely end their life, to another habit we felt had the
potential for reduced harm.
Senator Nelson. For an adult who knew all of that, but what
about for a kid that's looking at that TV advertisement?
Doesn't the message send to that kid that doesn't know the
sophistication of what you just said that it's okay to have
either one?
Mr. Weiss. No.
That's why we have in our messaging, for example, ``friends
don't let friends smoke,'' which was our ad campaign that we
did earlier this year. That's the kind of ad campaign that I
think the public health community should support.
Senator Nelson. I think that's where you're going to run
into some problems. In the public sector, we've been through
this with tobacco in children; we have seen how tobacco
companies have tried to hook children through these seductive
advertisements on nicotine because once they get them as a
child it's going to be tough all through their life as an adult
to get off of it. And I think you are going to have some
significant pushback on blending and blurring the two.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Nelson.
Senator Markey, would you forgive me if the power structure
of the--
[Laughter.]
The Chairman. I was actually----
[Laughter.]
The Chairman. No, the power structure is here with coffee.
And black coffee, no sugar. And we were actually going to give
a presentation before all of this started, but because these
are the power structures, he was doing something that required
the use of power.
So would you yield for a moment to Senator----
Senator Markey. I think that----
Senator Blumenthal. You have a right to remain silent.
[Laughter.]
Senator Markey. I spoke on the Durbin Amendment on the
House floor in 1987, I think it was, which was the first
amendment ever brought out on the House or Senate floor to ban
smoking on flights 2 hours or less. And that amendment passed
by a vote. And so, we're here with a historic figure on this
issue with Durbin. So I'll be more than willing to hear, I'm
sure a historic presentation. So----
The Chairman. Yes. You just begin.
STATEMENT OF HON. RICHARD J. DURBIN,
U.S. SENATOR FROM ILLINOIS
Senator Durbin. I want to thank the Chairman for his kind
remarks and also my colleagues. And thank you for your
patience.
And I'm going to submit my statement for the record.
[The prepared statement of Senator Durbin follows:]
Prepared Statement of Hon. Richard J. Durbin, U.S. Senator from
Illinois
I commend Chairman Rockefeller and Senator Thune for their
leadership in convening this hearing, and I thank Chairman Rockefeller
for inviting me to participate.
Although we have cut smoking rates in this country by half, today,
we face a new threat--the rise of e-cigarettes. Thanks to the
exploitation of loopholes and insufficient action by the FDA, e-
cigarettes are being marketed to children today just as cigarettes were
50 years ago.
What's worse, these marketing techniques are just as effective in
reaching today's youth as they were then.
Extent of the Threat
E-cigarette use among our Nation's children is on the rise. The
Centers for Disease Control and Prevention released data last year
showing that, in just one year--from 2011 to 2012--the percentage of
middle and high school students who had used e-cigarettes more than
doubled. This same study found that one in five middle school students
who reported using e-cigarettes had never tried conventional
cigarettes. This suggests that, among young people, e-cigarettes could
be a gateway to nicotine addiction and smoking.
A new study released in JAMA Pediatrics goes even further. This
study found that middle and high-school students who used e-cigarettes
were more likely to smoke traditional cigarettes and less likely to
quit smoking. In fact, according to the 2014 Surgeon General's report,
many kids and young adults who are occasional smokers go on to become
daily smokers--2,100 of them every day.
For tobacco companies, the case for targeting young people is
simple. Nearly 90 percent of adult smokers began smoking before they
graduated from high school. Given how addictive nicotine is, almost all
of those high school kids become a customer for life for tobacco
companies.
But, the human and financial toll is devastating. If current
smoking trends continue, 5.6 million American kids will die prematurely
from a smoking-related illness.
Potentially Harmful Chemicals
E-cigarette manufacturers often claim their products actually
provide some public health benefit. E-cigarette manufacturer Lead by
Sales, which markets for White Cloud brands, states, ``You get the
feeling of smoking real cigarettes without all of their negative side
effects.''
There is little to no evidence to support these claims. Further,
emerging evidence published in JAMA Internal Medicine suggests that e-
cigarettes don't help people quit or reduce overall cigarette
consumption.
The CDC data and JAMA Pediatrics article suggest that e-cigarettes
may actually serve as a gateway to traditional cigarettes, especially
among children.
There's another problem with this claim that there may be a health
benefit. We don't know what is in these products because they are not
currently regulated. Some early studies show that vapors generated by
e-cigarettes contain toxins, including formaldehyde--a known
carcinogen--and acetaldehyde--a potential carcinogen--and metals, such
as cadmium, nickel, and lead.
Nicotine itself also poses serious harms. The number of calls to
poison control centers involving e-cigarette liquids with nicotine has
skyrocketed. In September 2010, there was one call involving e-
cigarette liquid. In February 2014, there were 215.
More than half of these calls involved children under age 5.
Babies, really. Let me tell you about one of these cases. Last summer,
in Illinois, a four year-old child got into a vial of Juicy Vapor e-
liquid, and swallowed a small amount. The child vomited and became
ashen and lethargic. He was rushed to the local Emergency Department,
and luckily, after several hours, he was released from the hospital.
Tobacco Industry Tactics
Unlike regular tobacco, e-cigarette companies are legally allowed
to market their products in ways that reach millions of children. In
April, ten of my Congressional colleagues and I released a report
documenting how leading e-cigarette manufacturers are marketing e-
cigarettes to our young people.
The industry is using longstanding advertising techniques that they
know are effective, because they used the same techniques to hook
previous generations of smokers. We found that many of these companies
hired glamorous celebrities to push their brands through TV and radio
ads. They sponsored events with heavy social media promotion. They even
revived cartoon characters, in a way that calls to mind Joe Camel--the
deadliest cartoon of the 20th century.
Lorillard, as you may recall, was among the seven companies that
testified before a House Committee 30 years ago, arguing that
cigarettes were not addictive. Now Lorillard is back, arguing that they
don't market to kids.
A robust analysis recently published in the journal Pediatrics
suggests otherwise. Between 2011 and 2013, exposure to e-cigarette
marketing by children aged 12 to17 rose 256 percent. 24 million
children saw these ads. Lorillard's Blu e-cigarette accounted for 80
percent of this advertising targeted at 12 to 17 year-olds.
And these tactics seem to be working. A parent was presenting to a
group of 5th grade students in Massachusetts the harmful effects of
smoking. To the parent's dismay, the students--and I mean all 22 of the
students, even the presenter's daughter--were adamant that the ``
`water vapor' cigarettes'' were fine.
And some kids said that they were just like candy cigarettes, with
flavors like bubble gum. When the teacher described how these e-
cigarettes were harmful, the kids were insistent she was wrong.
Perhaps this is why e-cigarette companies have dramatically
increased their spending on marketing--in 2013 alone, the six companies
in our investigation spent $59.3 million to advertise their e-cigarette
products. Lorillard alone increased its advertising budget for Blu from
$2 million in 2011 to more than $40 million in 2013.
But they don't stop there. Not only is the marketing and packaging
intended to appeal to young people, so is the product itself. Let me
read you a list of e-cigarette flavors being marketed by some of the
people here today--vivid vanilla, pina colada, chocolate treat, and
cherry crush. The manufacturer VMR boasts over 42 e-cigarette flavors.
The Family Smoking Prevention and Tobacco Control Act bans flavored
cigarettes largely because of their disproportionate appeal to kids.
Why would we allow the tobacco industry to use this tactic again to
lure in a new generation of tobacco users?
Steps to Effectively Regulate Tobacco
On June 22, we will celebrate the 5th anniversary of the Family
Smoking Prevention and Tobacco Control Act. After years of waiting, the
FDA finally began to issue its regulations on e-cigarettes and other
tobacco products not covered by the Tobacco Control Act. The FDA should
not extend the comment period on these regulations, which would delay
the process even further.
FDA proposes to ban direct sales to minors and to require these
companies to list their ingredients. But the FDA's regulations were
dangerously silent on one of the most pressing questions of all--the
marketing of these addictive products.
Fifty years from now--in 2064, at the 100th anniversary of the
Surgeon General's report--I hope we can look back and not wish that we
had acted more quickly as the threat of e-cigarettes became apparent.
If the FDA takes decisive action now, it can spare the next two
generations from years of suffering and lethal struggle against
nicotine addiction that have brought so much loss and heartbreak since
1964.
Senator Durbin. And first, acknowledge the presence of Matt
Myers. Matt and I have been in this struggle for a long time
trying to save and spare kids from tobacco and what it does to
them.
And we know when addiction starts. They start in your
adolescence. If you can sell an addictive product to an
adolescent, you got them. You may have them for life. And
that's why a lot of marketing is done for children.
Back in the day, it was just bold-faced marketing; Joe
Camel and everything you can imagine. And the kids were wearing
t-shirts and hats and, sadly, becoming addicted to products
that would absolutely be the end of their healthy lives if they
weren't careful.
And now, we have this argument by the e-cigarette industry
that it's just an accident that all your advertising and
marketing is appealing to so many kids. That's a little hard to
understand. I think it's hard to believe. Look at the numbers
here. E-cigarette use among nation's kids is on the rise. CDC
released the end of last year showing in 1 year, from 2011 to
2012, the percentage of middle and high school student who used
e-cigarettes more than doubled. They would have you to believe
that just happens; it's an accident. We know better.
The same study found that one in five middle school
students who reported using e-cigarettes have never even tried
a conventional cigarette. This wasn't about finding a way off
of smoking. This suggests, for many young people, was a gateway
to nicotine addiction and to smoking.
The new study, by GAMMA, goes even further. Middle and high
school students who use these cigarettes are more likely to
smoke traditional cigarettes, less likely to quit smoking. This
didn't come from some liberal think tank; JAMA Pediatrics.
According to the 2014 Surgeon General's report, many kids and
young adults who are occasional smokers go on to become daily
smokers; 2,100 of them every single day.
I'm not going to give the whole statement here, but there
is one part of it that I do want to refer to because it harkens
me back to an era, Senator Markey, that you will remember well.
It was 30 years ago, if you can recall this time, when those
seven tobacco company executives appeared over in the House of
Representatives and took an oath that cigarettes and tobacco
were not addictive.
Now, Lorillard, one of the executives represented
Lorillard, Lorillard is back arguing they don't market to kids.
Look at the analysis recently published in the Journal of
Pediatrics. Between 2011 and 2013, exposure to e-cigarette
marketing by children age 12 to 17 rose 256 percent; 24 million
kids saw these ads. That's no accident in the world of big
business. Lorillard's blu e-cigarette accounted for 80 percent
of this advertising targeted at 12 to 17 years old.
It's the same battle, Mr. Myers. We've been at it before.
They want to addict these kids, this time to an e-cigarette
which has a chemical that's addictive. We know what it leads
to. Sadly, it leads to tobacco addiction, disease, and death.
I don't believe there is a case to be made for e-cigarettes
being sold to children. I hope this committee feels the same
way.
The Chairman. It does.
Thank you, Senator Durbin.
Senator Markey.
STATEMENT OF HON. EDWARD MARKEY,
U.S. SENATOR FROM MASSACHUSETTS
Senator Markey. Thank you, Mr. Chairman.
And, just going back to Dick Durbin, that was a historic
debate on the House floor. And that was the beginning of the
banning of smoking on airplanes in the United States. And we
still are in your debt, Dick, for that day. It changed the
whole course of history.
My father died from lung cancer. He smoked two packs of
Camels a day. He told me at age 12, he said he knew I'd be
starting to smoke very soon. He said to me at age 12. So that's
the year he started to smoke and he knew I would too. And he
was urging me not to, as well as my mother, at age 12 because
my father knew, then, that when he started smoking, maybe in
1930, that the same things was going to be true when I was a
boy and the same thing is true today for boys and girls. That's
when the temptation is greatest and that's when we have to be
most aware of it, because the marketing to them is what makes
it seductive and then, once you got them, you got them for
life.
And so, that's really why we're having this hearing,
because the marketing of this, the allure of this, is so
superficially attractive that we know that all of history tells
us; that it's targeted at young people, at kids. And it has
always been that way. And I miss my father and I wish he had
never smoked two packs of Camels a day, but he couldn't break
the habit once he was into it. Once you're on, you're on.
So we know the technology is a very good thing. We have
transformed rotary phones into iPhones; turned sunlight and
wind into electricity; and plants into lifesaving drugs. There
are certain things, however, that do not need to be reinvented,
repurposed, or modernized; items that served no societal
benefit whatsoever. The cigarette is one of them.
Yet, new cigarettes have exploded into the marketplace
known as everything from e-cigs to advanced nicotine delivery
systems to vaporizers. Like many other new technologies, these
products are designed to appeal to youth, more accessible to
youth, and are explicitly marketed to youth. And because of
this, we are focused on a re-visitation of the history books.
We know what happened in the past, we know what's happening
right now.
After more than four decades of research there are several
incontrovertible facts. Nicotine is addictive. It affects brain
development. And, in combination with tobacco, it is
responsible for claiming millions of lives. These facts are
true and were true two decades ago at the same time as Big
Tobacco willfully, consistently, publicly, and falsely denied
them.
Today, e-cigarette sales in the United States, alone, top
$1 billion. Use of e-cigarettes by high school students doubled
in just 1 year. And more than 20 percent of middle school kids,
typically age 12 to 15, who use these cigarettes, have never
smoked a traditional cigarette.
This data is not at all surprising when one considers the
way these nicotine delivery products market particularly to
youth and now these products are available in a myriad of
flavors from cotton candy to Kool-Aid grape.
In the 1950s, just appealed cigarettes claimed that they
were the best for you and left a clean, fresh taste in the
mouth and today white cloud e-cigarettes promises the gift of
fresh air. In the 1940s, Phillip Morris promised their product
will provide freedom from throat irritation, and Virginia Slims
and other tobacco companies advertised cigarettes as touches of
freedom that equated smoking with women's' rights.
Today, blu cigarettes have a campaign called ``Take Back
Your Freedom'' promoting the use of their products in spaces
where traditional smoking is not allowed. End of the 1970s,
Lorillard advertising executives suggested walking a fine line
in packaging designed to ensure that packaging was geared to
attract the youthful eye, not the watchful eye of the Federal
Government.
Today's electronic cigarettes are no better than the
Marlboros of the 1950s. Cotton Candy-flavored vape liquid can
contain just as much nicotine and sometimes more as a
traditional cigarette. Cherry Crush e-cigs pose the same
addiction risk as Joe Camels of the 1970s. And we know from
years of research that flavors attract young people. And the
younger a person is when they start tobacco use, the more
difficult it is to stop. We know that if a kid hasn't started
to smoke by the age of 19, they're not going to start. We just
know that's a rule.
So you got to get them before 19, because all the social
pressure is no longer effective anymore. OK? Just a rule.
So you have to market younger. That's just the way it
works. Get fine replacement customers for those who have died.
So, Dr. Tanski, if you could give me a yes or a no, is the
nicotine that is present in e-cigarettes and e-liquids any less
addictive than nicotine in traditional cigarettes?
Dr. Tanski. It is no less addictive than anything in a
traditional cigarette.
Senator Markey. Mr. Weiss, Mr. Healey, do you agree with
Dr. Tanski that your products are just as addictive as
traditional cigarettes?
Mr. Healey. I agree that it contains nicotine and we do
acknowledge that nicotine is addictive.
Mr. Weiss. Yes.
Senator Markey. So you agree.
Do you agree with that, Mr. Healey?
Mr. Healey. Yes.
Senator Markey. And so, let's go back over to you, Mr.
Myers. If that is the case and they're addictive, than what
possible argument can they make in order to keep these products
on the market or targeted toward children?
Mr. Myers. It's particularly the reason we're concerned
about the kind of marketing that we've seen in the use of
flavors that we think have traditionally been shown to appeal
to children.
Senator Markey. For many, the thought of Santa Claus brings
back nostalgia of childhood cookies and big white beard. Most
children would think of Santa needing e-cigarettes despite this
social media promotion to the contrary. Other examples,
including images of cartoons like blu's Mr. Cool, bring back
flashbacks of similar strategies used by traditional tobacco
companies.
Mr. Myers, do you think there is a chance that these images
could appeal particularly to young consumers?
Mr. Myers. I think there's no question about that. And our
concern is it's a generation of consumers who have been
protected from this kind of advertising. And so, it's the first
time they'll see them.
Senator Markey. Do you think it's a coincidence that it's
actually called ``cool'' in the same way that Kool cigarettes
with a ``K'' back in the earlier age was meant to be the entry
level for a kid to finally reach Camels, but it would be a
softer entry for the kid to be able to go Kool first and then
move on to the harder cigarette?
Mr. Myers. It requires a level of disbelief to believe that
it could possibly be a coincidence.
Senator Markey. So ``cool'' was a word then and it's a word
now, and each time it's just kind of trying to get the young
kid into the pattern of smoking cigarettes.
Mr. Weiss, Mr. Healey, do you agree with Dr. Myers about
that? That that's really what the intention is to entice a kid
into doing something that's cool, that's ultimately going to
potentially lead to real health consequences for that young
person?
Mr. Healey. Absolutely not.
Our product is intended for adult smokers. I could
understand the opinion if smoking wasn't and we created
smoking. We didn't. We created our product for smokers to get
them away from combusted cigarettes.
Senator Markey. Mr. Weiss, Mr. Healey, in your testimonial
and materials presented to the Committee, you repeatedly state
that your target audience are adults and we continue to hear it
right now. Will your companies commit to not using these types
of materials that could be to particularly appeal to children?
Will you agree not to use that kind of advertising?
It was used when I was a boy, you're using them again
today, we know why young kids used to say, ``I think I'm going
to smoke Kools first.'' So will you agree not to use that kind
of advertising going forward in the future?
Mr. Healey. We've removed at least a year ago, so we commit
to never using that again. Correct.
Senator Markey. Well, will you commit to not using any kind
of cartoons in the future, Mr. Healey?
Mr. Healey. I will agree to that, yes.
Senator Markey. Will you agree to that, Mr. Weiss?
Mr. Weiss. Yes. Yes.
Senator Markey. No cartoons in the future.
Mr. Weiss. Correct.
Senator Markey. Will you commit to going through your
social media sites to erase any past images such as those that
appeal to those who are young kids?
Mr. Weiss. Yes. Absolutely, rigorously go through and we'll
continue to do so.
Senator Markey. Will you agree with that, Mr. Healey?
Mr. Healey. I believe blu already has. Yes, Senator.
Senator Markey. Dr. Tanski, several e-cigarette company
brands use advertising to create the impression that e-
cigarettes are a way to eliminate traditional cigarette use
altogether. This has been acknowledged by the American Legacy
Foundation, who in a recent report stated that some brands
focus their message more responsibly on smokers to quit
combustible use. Let's briefly view a recent television ad by
FIN e-cigarettes, a brand that has recently surged in
popularity.
[Video shown.]
Senator Markey. So, to repeat the closing line, ``There was
a time when no one was offended by it.'' Just smoking amongst
other people indifferent to how it might impact on them. But
``That time has come again'' says the ad. The message seems to
be promoting smoking as a new favorite pastime for young
attractive consumers.
Dr. Tanski, based on your review of e-cigarette marketing
messages, do you have any concerns that these products are
glamorizing smoking in general?
Dr. Tanski. Yes, I do, Senator Markey.
It's clear that many of these images are quite glamorous
and quite attractive and they really are taking a lesson from
the 1950s playbook of the tobacco companies. And that is of
significant concern as we've all heard. And I just want to make
a point that when kids, when young people, see these ads or see
these ads or see people who are using electronic cigarettes or
the vaping devices, it's very indistinguishable for a young
person to make the distinction between what is someone who is
smoking versus someone who is vaping.
My own kids were pretty savvy. They're 13 and 11 years old
and they know what I do. And I've shown them pictures and
videos of people who are vaping and I say, ``What are they
doing?'' And they'll say, ``They're smoking a cigarette.''
So it's very difficult for kids, in particular, to
understand that there's a difference. And so, we really are
seeing, I fear, a renormalization of that kind of image and
behavior. And it's glamorous, it's sexy. They've got very cute
models who are vaping and our kids don't recognize the
difference. So it really is significant cause for concern.
Senator Markey. Do you agree that the blu's tagline
``Nobody likes a quitter'' may be encouraging continued
nicotine and tobacco use by those who would otherwise quit
altogether?
Dr. Tanksi. That, again, is a significant concern; that
we're maintaining dual use rather than getting people quit
their combusted tobacco products.
Senator Markey. And let me, just Mr. Healey, many corporate
companies collect data about their customers to better serve
and deliver products. Do you collect information about the
demographics of you customers?
Mr. Healey. Yes, sir. We do.
Senator Markey. Could you provide the age demographics and
other information about your current users of your products to
the Committee?
Mr. Healey. Yes, I could.
Our average consumer is 51 years old, but we can give you
the total data supplement the record.
Senator Markey. Mr. Weiss, would you do the same for the
Committee?
Mr. Weiss. Yes.
Senator Markey. OK. I thank you so much.
I think that we know what's going on here. You don't have
to be Dick Tracey to figure this out. And we understand the
advertising, we understand who it is being marketed to, we
understand that you got to get someone under 19 to start
smoking or else you've lost the most likely as a customer.
So, Mr. Chairman, I thank you for this hearing. I am
fortunate, I never had a cigarette in my life but that was just
because my father knew he had made a big mistake. And he made
it, along with my mother, very strong admonition to me. But
this was just an avoidable catastrophe. And we just have to
make sure that other young people, who were not protected the
way I was, aren't actually made vulnerable by the marketing of
these companies. Because, otherwise, it's just another gateway
like Kools cigarettes used to be into the worse that can happen
to some of my health perspective.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Markey.
We're going to have a second round because, if Senator
Blumenthal doesn't ask for a second round, I'm not going to
speak to him.
Senator Blumenthal. Thank you, Mr. Chairman.
The Chairman. Senator Nelson.
Senator Blumenthal. I would respectfully request a second
round.
The Chairman. Before you start, I'm going give my
conclusion.
I think this whole thing is nothing more than it's all
about the money. I think it's uncreative. I think it's nasty.
It's like pornography; in my mind. What's to pick between the
one and the other. In fact, maybe what you're doing is much
more dangerous.
I'm ashamed of you. I don't know how you go to sleep at
night. I don't know what gets you to work in the morning except
the color green of dollars. I've never said anything like that
before, but I've never, in my 30 years on this committee, have
I ever heard testimony such as given by you, so too by--so and
by you, sir.
What I want to do is send you to the Middle East because
you say we can just get good people together and we can settle
everything. You should go to the Middle East and settle that.
Then, come back, and you can talk to us more realistically.
But, for you two, you're what is wrong with this country.
And the profit motive is good, but only if it's aimed at
something which is for the general benefit of the public. And
that can be stretched a little bit because the public likes to
be entertained. I can't say professional basketball is
necessary for the existence of democracy in America but people
like it so let's go ahead.
But I think, in your case, you don't have that leeway. It's
simply a matter of the dollars, the money that you rake in; the
256 percent increase in 2 years in advertising. And then you
say it's only for the adults; it's not for the children when
everything else that's come out of this hearing says otherwise.
I think it's dreadful.
I yield to Senator Blumenthal.
Senator Blumenthal. Thank you, Mr. Chairman. And thank you
for giving us a second round and, again, thank you for holding
this hearing.
I want to begin by joining Senator Durbin in thanking Matt
Myers for his long-standing historic and heroic efforts in this
area, which goes back decades. And, in fact, we've worked
together for a couple decades on nicotine addiction and tobacco
use, which are a continuing problem in this country. Let us
never forget, despite the fact that this hearing is on e-
cigarettes, that the evil of tobacco and cigarette use remains
as a primary cause of death and addiction in this country. And
if there is a redeeming fact about your products, it is the
possibility that it offers quick mechanisms, yet unproven, but
at least perhaps a glimmer of hope.
It's the advertising and promotions and the pitches that
bring us here today. So let me begin this second round of
questioning on a, sort of, positive note: in the war against
Big Tobacco, so-called, I was privileged to lead that effort
close to 20 years ago with lawsuits that eventually led to
settlements that produced great advances. Not alone, because it
took an act of Congress in the Tobacco Control Act to take
another step. And we still have more steps to go in the battle
to redeem public health in that area.
But let me ask you, would you be willing to come together,
to sit down, to commit to reaching a settlement and agreement;
a protocol that stops any possible ads and pitches that appeal
to children and teenagers?
Mr. Weiss. I'll answer for NJOY.
We are committed to not--we do not want to attract anyone
who is not an adult smoker to our products and we have
committed to FDA regulation; we've been long supporters of FDA
regulation for the category; for them to make the science-based
data driven decisions.
Senator Blumenthal. I'm asking you to commit to something
more specific, which is to join in talks, specific discussions,
involving others in the industry, the major players, just as
happened in the tobacco area that would produce protocols and
agreements. For example, to avoid use of TV; to avoid of
cartoon characters; to require identification at point of sale;
similar to what was done in the tobacco area.
Mr. Weiss. We would be willing to have the conversations. I
wouldn't be willing to restrict television advertising because
it's an effective means of advertising----
Senator Blumenthal. Well, of course it is, it's an
attractive means to reach children.
I'm asking you to join in conversations that would involve
others in your industry. And I'm asking this question of Mr.
Healey as well. It would at least consider what has been true
of the tobacco industry; it's avoidance of the use of TV ads.
Mr. Healey. I would welcome the ability to sit down and
discuss it. As I said earlier, it's not my intention to sell
this product to children. It's the 41 million smokers. So I am
not averse to sitting down and discussing all possibilities of
how we do that and eliminate tobacco.
Senator Blumenthal. And we're not talking here about
intent, because I am sure that your companies have not done
what the tobacco industry did, which is to do marketing studies
that we've discovered when we brought lawsuits that showed that
despite all their claims under oath, in fact, they had studies
showing that their marketing tactics were aimed at children,
had the effect of reaching children and appealing to children.
I know you're a lot smarter. You don't have those studies in
your files.
But in this hearing is not about you say what your
intentions are, it's about what the effects are of your
marketing strategies, your promotions, your use of celebrities.
And let me just show you just to complete some of the tableau
here. I am sure, Mr. Healey, you recognize this individual.
[The picture referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Healey. That's Jenny McCarthy.
Senator Blumenthal. And you know what product she's using.
Mr. Healey. blu.
Senator Blumenthal. And would you deny that this kind of
promotion appeals to teenagers and children?
Mr. Healey. I would deny that.
Senator Blumenthal. You would?
And even though she's a celebrity, even though she's in an
obviously suggestive pose here, you would deny that it has any
appeal to teenagers and children.
Mr. Healey. Yes. I would deny that.
Senator Blumenthal. Would you say she is smoking in this
promotion?
Mr. Healey. She's vaping.
Senator Blumenthal. Vaping.
So to go to the point that was made earlier, you don't see
any confusion between smoking and vaping in this ad or any of
your other promotions?
Mr. Healey. Of course there is some confusion but, in order
to defeat tobacco and cigarettes, we have to appeal to smokers.
Senator Blumenthal. Let me show you another official
document from your company. It's on your website, is it not, as
part of what you have called the Lorillard Inc. Smoking
Prevention program? Do you recognize it?
Mr. Healey. No, I don't. I'm here to represent blu, not
Lorillard. So I'm not sure where that's from?
Senator Blumenthal. It's your parent company; isn't it?
Mr. Healey. I don't even know what it is you're showing,
sir.
Senator Blumenthal. Well, let me--can I have one of the
staff give it to--and by the way, Mr. Chairman, could I have
all of these documents and the visuals shown by both Senator
Markey and myself and others on the Committee made part of the
official record?
Thank you.
Do you recognize that document?
Mr. Healey. I believe it's from--I forget the technical
name but the site that Lorillard sponsors but they're not
responsible for the messaging or have any editorial control.
But, again, I'm here to speak for blu, this is not----
Senator Blumenthal. Well, if it's a Lorillard document or
if it's on Lorillard's website, you're saying Lorillard's not
responsible for it?
Mr. Healey. This is not on Lorillard's website.
Senator Blumenthal. Is it on yours?
Mr. Healey. No. It's not on mine either.
Senator Blumenthal. So it is not part of ``Real Parents
Real Answers: What you need to know about e-cigarettes
Infographic?''
Mr. Healey. I assume it is, but----
Senator Blumenthal. You assume it is? You've never seen it
before?
Mr. Healey.--I've never looked at the site in-depth.
Senator Blumenthal. You've never looked at the site in-
depth even though you are here representing blu; are you not?
Mr. Healey. Correct.
Senator Blumenthal. Well, let me just ask you then, as
someone who has never seen it before. It says ``For the first
time in 43 years, `smoking' ads are returning to TV with
advertising.'' And you'll have to accept my representation that
this is part of a presentation called ``Real Parents Real
Answers.'' It's sponsored by Lorillard Inc.'s Youth Smoking
Prevention program. And it says that smoking ads are returning
to TV.
Are those your ads?
[The information referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Healey. Well, our ads would be some of them, yes.
Senator Blumenthal. And it says ``Kids may be particularly
vulnerable to trying e-cigarettes due to an abundance of fun
flavors such as cherry, vanilla, pina colada and berry.''
That's a warning about flavors; is it not?
Mr. Healey. That's an opinion of the person that created
the site.
Senator Blumenthal. The person who created it and it might
be Lorillard. But, of course, you haven't seen it before.
Mr. Healey. Lorillard did not create this site and all of
it in the business behind it, they sponsored it. And at the
bottom of the site it even states that the site is the opinion
of the doctor; not Lorillard.
Senator Blumenthal. Well, let me show a couple of charts on
flavors.
Would you say that this kind of promotion or ad appeals to
children?
Mr. Healey. It's completely inappropriate and I would agree
with you.
Senator Blumenthal. And it's a part of what the industry
does. Yes or no?
Mr. Healey. Its one brand in particular, I believe. It's
not what I do or my----
Senator Blumenthal. So wouldn't you agree that as a
``responsible'' marketer, and you're in the business of
promoting and selling these products, that an industry-wide
agreement to ban those kinds of cartoon characters would be a
good thing?
Mr. Healey. Banning cartoon characters in the use of our
advertising, I agree.
Senator Blumenthal. So would you commit to come together
and reach another master settlement agreement that provides for
a ban on this type of inappropriate marketing, the use of
people like Jenny McCarthy, sports and rock concert
sponsorships, all of these kinds of same protocols in agreement
with the result of the tobacco industry coming to the table?
Would you agree to do it?
Mr. Healey. I would agree to sit down to discuss how we
effectively eliminate tobacco, but I would not sit down to
discuss how I relinquish my first amendment rights and losing
focus of the big picture; that we could eliminate tobacco here.
Senator Blumenthal. Well, may I suggest, respectfully, that
I would have more respect for all of the answers that you've
given today knowing that you're the messenger but you don't
make the policy if your companies would commit to help lead and
make yourselves part of the solution, not the problem. And the
problem here, I just want to stress again, I've said it
repeatedly, is not your product. I'm not passing judgment on
your product. There's not enough science to draw conclusions,
as yet. I view it skeptically as a means of quitting or
cessation. But, I'm not passing judgment on the product. I'm
passing judgment on the marketing and promotion which create a
clear and present danger of addicting another generation.
Addicting another generation to nicotine, which is among
the most powerfully addictive drugs known to man, and it is, in
fact, the ingredient in cigarettes that makes them so
pernicious and insidious because it hooks the user to a device
that kills them. Cigarettes kill people. And if your products
are a gateway to cigarette use, they are aiding and abetting at
killing.
So I hope you'll rethink some of your answers. I hope that
we will have another forum where we can revisit some of these
issues and that we can move constructively toward some kind of
solution.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Blumenthal.
Senator Nelson, I think you had a question.
Senator Nelson. Earlier in my comments, I noted to the
toxicity of the concentrated nicotine in an e-cigarette refill
liquid. Let me ask the two gentlemen, Mr. Healey and Mr. Weiss.
In addition to the nicotine, what are the other ingredients in
the liquid nicotine?
Mr. Healey. Speaking to the blu product, the five key
ingredients are propylene glycol, glycerin and vegetable
glycerin, distilled water, nicotine and natural and artificial
flavors.
Mr. Weiss. And in our product it's nicotine, propylene
glycol, glycerin and also flavorings.
Senator Nelson. Are any of those, other than the nicotine,
harmful substances?
Mr. Weiss. We've tested our products and we support the
FDA's HPHC, Harmful and Potentially Harmful Constituent,
testing for these products. And we've submitted our results to
the FDA and are very comfortable with the results that they
are, orders of magnitude, safer than combusted cigarettes.
Senator Nelson. But, as to the substance itself being
harmful or not, I didn't understand your answer.
Mr. Weiss. So the substances are generally regarded as safe
in foods. They haven't been tested in terms of academia logical
studies and inhalation in humans over large periods of time.
Senator Nelson. Do you make a complete listing of all these
substances in the e-cigarette liquid available to the public?
Mr. Weiss. Yes, I do. It's on our website.
Mr. Healey. Yes, sir.
Senator Nelson. I would just note for the record and ask
that it be inserted.
[The information referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Senator Nelson. It has just been brought to my attention.
Here's a billboard at Christmas time in Miami, on I-95, a
picture of what appears to be a Santa Claus-like figure. ``I
don't always vape, but when I do, I choose a Vapor Shark--Kris
Kringle.''
So you are utilizing the seasons of the year.
I would add this to the record, Mr. Chairman.
The Chairman. It will all be included.
[The picture referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Senator Nelson. Models, very attractive models, all
promoting these products.
Thank you, Mr. Chairman.
The Chairman. Thank you all and the hearing is adjourned.
[Whereupon, at 4:49 p.m., the hearing was adjourned.]
A P P E N D I X
Response to Written Questions Submitted by Hon. Dean Heller to
Dr. Susanne E. Tanski
Question 1. Regarding a national standard on age
(a) Should a national standard prohibiting sale of electronic
cigarettes to any person under the age of 18 years old exist?
Answer. The American Academy of Pediatrics (AAP) is dedicated to
eliminating all tobacco use among children and youth, and as such,
strongly supports national standards prohibiting the sale of all
tobacco and nicotine delivery products, including all electronic
cigarettes, to those under 18 at a minimum, or to a higher age standard
designed to protect youth from addiction.
(b) Should the Food and Drug Administration or the Federal Trade
Commission enforce this standard and why?
Answer. The Tobacco Control Act gives the Food and Drug
Administration the resources and authority to help enforce purchase age
restrictions for cigarettes and other tobacco products that the FDA
currently regulates. We believe that the FDA should expand the national
minimum purchase age restriction to electronic cigarettes and is the
appropriate agency to enforce such a restriction.
(c) Should the measure be limited to only an electronic device that
employs a battery to power a heating chamber that converts a liquid
solution containing nicotine or are there other vaporizing devices that
do not fit the description mentioned that should also be prohibited for
sale to minors?
Answer. No vaporizing device--whether designed for vaporizing
liquid nicotine, non-nicotine solution or whole tobacco/herb--has been
proven to be safe in the pediatric population. Even absent nicotine,
there are potential negative health consequences associated with
inhaling the vapor of electronic cigarettes into the still-developing
lungs of a child. In addition, there is a serious risk that if non-
nicotine containing vaporizing devices were allowed to be sold to
children, that they would serve as starter products for youth that may
eventually lead them to try nicotine-containing products or even
traditional cigarettes. Therefore, the AAP would support purchase age
restrictions for all vaporizing products, including those designed for
liquid and whole leaf vaporization.
Question 2. Regarding flavors
(a) How should policy account for the phenomenon of flavor
appearing to be a positive reason for adult smokers to want to switch
from combustion to e-cigarette products that offer novel flavor
alternatives?
Answer. FDA-approved nicotine replacement therapies (NRT) do come
in limited flavors other than tobacco for individuals attempting to
quit smoking who may prefer not to use tobacco-flavored products.
Unlike e-cigarettes, NRT have been approved by the FDA on the basis of
clinical evidence demonstrating safety and efficacy in aiding smoking
cessation and is marketed to existing adult smokers for the purpose of
smoking cessation. Largely because of the limited way in which NRT
products are marketed as well as the way that NRT are absorbed, there
is low abuse/addiction potential of these products and experience has
shown that youth do not use NRT for non-therapeutic use. Unfortunately,
in contrast we have seen dramatic increases in the number of youth
using e-cigarettes. We believe this increase is directly linked to
marketing and candy and other attractive flavorings that appeal to
children and youth. We do not yet have data to understand how the
nicotine from various vaporizing devices is absorbed, so the addiction
potential of these devices with or without flavoring is unknown. In the
absence of this data regarding addiction potential, the AAP believes
that the use of candy and other flavors in e-cigarettes should be
prohibited as it is well known that flavored tobacco products are
attractive to youth.
(b) What is the risk that a ban on flavors would make switching
away from combustion cigarettes relatively less appealing?
Answer. We do not know what this risk is, if any, and we understand
the difficulty with balancing any potential benefit of electronic
cigarettes to the public health in the absence of data. First and
foremost, however, we believe we need to ensure that we do not addict a
new generation of Americans to tobacco. As such, we must regulate e-
cigarettes in a way that limits adolescent use of these products to the
lowest possible level. The use of candy and other flavors in e-
cigarettes is particularly concerning when coupled with advertising and
other marketing practices that are attractive to children. In spite of
claims to the contrary, these advertisements appeal to an audience
broader than current adult smokers. Any e-cigarette or other nicotine
vaporizing product could theoretically seek FDA approval as a smoking
cessation device. It would be conceivable that FDA could determine that
the use of flavors would be appropriate in cessation, so long as there
were appropriate safeguards to prevent adolescent use.
______
Response to Written Questions Submitted by Hon. Dean Heller to
Matthew L. Myers
Question 1. Regarding a national standard on age
(a) Should a national standard prohibiting sale of electronic
cigarettes to any person under the age of 18 years old exist?
Answer. I support the provision in the Family Smoking Prevention
and Tobacco Control Act that established a national minimum age of 18
for sale for cigarettes and smokeless tobacco products and the
accompanying requirement for verification of age, and I support
applying those requirements to e-cigarettes and other tobacco products
not currently regulated by the FDA. Regardless of how one weighs the
potential benefits and risks of e-cigarettes, all should be able to
agree that youth should not be using them. The fact that e-cigarettes
typically deliver nicotine, a highly addictive substance that also
impacts adolescent brain development, is reason enough for the Federal
Government to take steps to reduce youth use of e-cigarettes, including
the establishment of a minimum age of 18 for sale of this product. It
is also important to note that states should remain free to impose a
higher minimum age of sale if they consider it appropriate.
I would also note that it is important that the regulation of
products that deliver nicotine needs to extend beyond a minimum age of
sale and should cover each of the subject matter areas included in the
Family Smoking Prevention and Tobacco Control Act.
(b) Should the Food and Drug Administration or the Federal Trade
Commission enforce this standard and why?
Answer. The FDA should enforce a national minimum age of sale for
e-cigarettes. The FDA already has been given the legal authority
necessary to enforce the minimum age of sale requirement and has
established a mechanism for coordinating with the states, educating
retailers and enforcing the national minimum age of sale for cigarettes
and smokeless tobacco products that could be easily extended to e-
cigarettes. The FDA has tools and an existing legal structure as well
as an ability to enforce a national minimum age of sale that the FTC
does not possess. In addition, the FDA possesses the legal and
technical capacity to regulate e-cigarettes more comprehensively, and
it is essential that there be a comprehensive approach to the
regulation of e-cigarettes.
(c) Should the measure be limited to only an electronic device that
employs a battery to power a heating chamber that converts a liquid
solution containing nicotine or are there other vaporizing devices that
do not fit the description mentioned that should also be prohibited for
sale to minors?
Answer. Given the wide variety of e-cigarettes on the market and
the rapid changes that are occurring in the e-cigarette market, the
broadest possible definition should be applied so that all products
that deliver nicotine should be regulated by the FDA, either as a
tobacco product or as a drug delivery device. Sales of products that
deliver nicotine should not be permitted to people under the age of 18
unless it is an FDA-approved tobacco cessation product prescribed by a
health professional.
Question 2. Regarding flavors
(a) How should policy account for the phenomenon of flavor
appearing to be a positive reason for adult smokers to want to switch
from combustion to e-cigarette products that offer novel flavor
alternatives?
Answer. There is inadequate scientific evidence to conclude that
flavors in general or that specific flavors are either essential or
significantly increase the effectiveness of e-cigarettes in helping
cigarette smokers quit. If any manufacturer believes that the addition
of specific flavors can be shown to increase the effectiveness of e-
cigarettes in helping cigarette smokers quit smoking cigarettes, the
evidence should be presented to the FDA for objective, independent
review and analysis. To date, e-cigarette manufacturers have sought to
avoid the type of meaningful regulation that applies to products
regulated by FDA, putting the public at risk--both in terms of
potential harm to adults and increased risk of youth tobacco use.
There have been no studies presented that meet the normal standards
set by the FDA for evaluating the impact, efficacy or potential harm of
adding ingredients, such as flavors. This is especially important in
this situation for multiple reasons: (a) There are flavoring agents
that are not harmful when consumed in one form that become carcinogenic
when burned or heated and inhaled. There is no evidence that the
flavors being used by the e-cigarette companies across the board have
been evaluated for this purpose; (b) There is substantial reason for
concern that some, if not many flavors, may increase youth use of
nicotine. Given the rapidity of the introduction of different flavors
by many manufacturers, it is clear that no testing is being done to
minimize the risk that the flavors being introduced will increase youth
tobacco use.
Nicotine doesn't cause cancer, but it is not benign. Ingredients
that may expand the appeal of nicotine-based products to non-tobacco
users or former cigarette smokers should be first subjected to the type
of independent scientific review that FDA applies to other products.
Manufacturer claims based on studies that fall far below the standards
traditionally established by FDA are not an adequate substitute. The
reality is that not a single rigorous study has been presented to the
FDA or any other Federal agency that would support a claim or the
conclusion that the addition of the type of flavors that the e-
cigarette industry is using meets any reasonable standard of efficacy
in helping cigarette smokers end their use of cigarettes.
On the other hand, there is reason to be concerned that the
addition of fruit and candy flavorings to e-cigarettes will broaden the
appeal of this product to non-smokers, including kids, who would find
the flavor of tobacco distasteful. Today, e-cigarette liquids come in
an ever growing variety of flavors, including vivid vanilla, cinabon,
cherry crush, chocolate, jolly rancher, gummi bear, bubble gum, and
cotton candy. Congress explicitly banned the sale of cigarettes with
similar characterizing flavors because of their appeal to youth. In
cigars, where use of flavors is still permitted, researchers have found
that youth and young adults prefer cigar brands that come in a variety
of flavors, and that preference declines significantly with age.
The two Internet surveys that have been referenced by the e-
cigarette industry are by no means adequate to conclude either that
flavors are effective in helping cigarette smokers quit or that they
don't appeal to youth.
The evidence is strong enough that flavored tobacco products appeal
to kids and may increase the number of kids who will use them for FDA
to prohibit their use in e-cigarettes, unless and until adequate
scientific evidence is presented based on adequate testing that the use
of specific flavors does increase the ability of cigarette smokers to
switch entirely away from cigarettes and that these flavors can be
added and marketed without appealing unduly to youth or other non-
cigarette smokers.
The proper approach is for FDA to evaluate the science and decide
whether the use of flavors in e-cigarettes is appropriate or should be
prohibited. Congress gave FDA the authority to make determinations like
this so that a science-based process is used to determine what is
appropriate for the protection of public health.
(b) What is the risk that a ban on flavors would make switching
away from combustion cigarettes relatively less appealing?
Answer. The proper way to evaluate both the risk of using flavors
and their benefit is to require e-cigarette manufacturers to submit
their scientific evidence to FDA. For sound reasons, Congress has given
the FDA the authority to evaluate the relative health impact and risk
of tobacco products. It is the best way to protect the American public.
If there is sound scientific evidence that certain flavors will help
cigarette smokers quit, it should be submitted to FDA. FDA was created
so that the American public would not become human guinea pigs for
every manufacturer of a potentially harmful product, and those
protections should be extended to users of e-cigarettes.
The most serious risk to the public will come if the FDA regulatory
process is circumvented. Companies that make NRTs are not allowed to
add flavors without FDA review. No reason exists to allow e-cigarette
manufacturers to do so.
______
Response to Written Questions Submitted by Hon. Dean Heller to
Jason Healy
Question 1. Regarding a national standard on age
(a) Should a national standard prohibiting sale of electronic
cigarettes to any person under the age of 18 years old exist?
Answer. Yes
(b) Should the Food and Drug Administration or the Federal Trade
Commission enforce this standard and why?
Answer. The Federal Drug Administration (FDA) should enforce this
standard because FDA has expressed its intent to regulate electronic
cigarettes as tobacco products and age limits for the purchase and sale
of tobacco products are established in the Family Smoking Prevention
and Tobacco Control Act (TCA). More specifically, pursuant to Section
102 of the TCA, FDA issued final rules on March 19, 2010 that prohibits
the sale of cigarettes and smokeless tobacco to persons under 18 years
of age.
(c) Should the measure be limited to only an electronic device that
employs a battery to power a heating chamber that converts a liquid
solution containing nicotine or are there other vaporizing devices that
do not fit the description mentioned that should also be prohibited for
sale to minors?
Answer. The rule to prohibit the sale to persons under 18 years of
age should apply to all products that contain nicotine, whether the
products are traditional tobacco products, e-cigs, vapor products,
nicotine liquid for vapor products, nicotine replacement therapies
(e.g., nicotine gums and patches), or any other products that contain
nicotine.
Question 2. Regarding flavors
(a) How should policy account for the phenomenon of flavor
appearing to be a positive reason for adult smokers to want to switch
from combustion to e-cigarette products that offer novel flavor
alternatives?
Answer. Policy should permit the responsible marketing of flavors
that appeal to adults. It is commonplace for products marketed to
adults to be offered in a variety of flavors. Beer and alcohol are
available in numerous types of flavors enjoyed by adults, as are many
types of coffee and tea. Most significantly, nicotine therapy products
are also sold in a variety of flavors. For example, flavors of
Nicorette gums and lozenges include White Ice Mint, Fruit Chill,
Cinnamon Surge and Cherry.
While Congress banned cigarettes with a characterizing flavor other
than tobacco or menthol through the TCA, it did not ban characterizing
flavors for other tobacco products such as snuff or chewing tobacco.
Responsible marketing and advertising practices, including the
marketing of flavors that appeal to adults, can ensure that all adults
who prefer flavors may continue enjoying them.
(b) What is the risk that a ban on flavors would make switching
away from combustion cigarettes relatively less appealing?
Answer. If smokers do not like the taste of e-cigs, they are not
likely to try or continue to use e-cigs. blu believes that using a
variety of flavors is critical to keeping adult smokers who have
switched to e-cigs from returning to more harmful combustible
cigarettes. Research supports the importance of flavors in switching
smokers. For example, a study published by Farsolino et al., (2013)
concluded that ``[flavors] play a major role in the overall experience
of dedicated users and support the hypothesis that they are important
contributors in reducing or eliminating smoking consumption.'' The
study also found that tobacco is the preferred flavor when starting to
use e-cigs but users later switch to other flavors, noting that a
significant population of e-cigs users would be dissatisfied and/or
less likely to quit smoking if flavored options were limited. blu's
experience with its consumers also supports that flavors are critical
to switch adult smokers to e-cigs. blu's online cartridge sales show
approximately 50 percent of all sales consist of non-traditional
flavors and that the average purchaser is 45 years of age.
______
Response to Written Questions Submitted by Hon. Dean Heller to
Craig Weiss
Question 1. Regarding a national standard on age
(a) Should a national standard prohibiting sale of electronic
cigarettes to any person under the age of 18 years old exist?
Answer. NJOY strongly supports the provisions in FDA's draft
deeming rule establishing a national prohibition on the sale of
electronic cigarettes (e-cigarettes), also known as electronic nicotine
delivery systems (ENDS), to any person under the age of 18 years old as
well as requiring age verification based on photographic identification
containing the bearer's date of birth (for all persons age 26 and
younger). Additionally, as a company we impose contractual age
verification obligations on retailers to prevent sales to minors. NJOY
was among the earliest companies to support state bans on sales to
minors and the first independent e-cigarette company to join the ``We
Card'' program to prevent underage consumers from accessing our
products. NJOY's position has been and remains that no minor should be
using a nicotine-containing product of any kind. Please note the
following provision related to minors in the warning label on our
products: ``NJOY products are intended for use by adults of legal
smoking age (18 or older in California), and not by children, women who
are pregnant or breastfeeding, or persons with or at risk of heart
disease, high blood pressure, diabetes or taking medicine for
depression or asthma.''
(b) Should the Food and Drug Administration or the Federal Trade
Commission enforce this standard and why?
Answer. NJOY believes that all regulations pertaining to ENDS
should fall under the jurisdiction of FDA's Center for Tobacco Products
(CTP). CTP's science-based approach and extensive body of specialized
knowledge regarding the continuum of nicotine-containing products make
CTP best suited to regulate this new product category and to do so in a
way that properly considers the tremendous potential that these
products are showing to reduce smoking-related harm. NJOY does not
support Federal agencies other than CTP, such as the Federal Trade
Commission (FTC) or Consumer Product Safety Commission (CPSC), neither
of which contains the subject matter expertise or scientific resources
of CTP, exercising new grants of authority regarding ENDS products.
Rather, new areas of regulatory concern should come under the
jurisdiction of CTP, which currently enforces the existing prohibition
on sales of combustion cigarettes and smokeless tobacco to any person
under the age of 18 in accordance with the Family Smoking Prevention
and Tobacco Control Act of 2009.
(c) Should the measure be limited to only an electronic device that
employs a battery to power a heating chamber that converts a liquid
solution containing nicotine or are there other vaporizing devices that
do not fit the description mentioned that should also be prohibited for
sale to minors?
Answer. We strongly support CTP enforcing the aforementioned age
restriction on sales of all known ENDS products (including disposable,
rechargeable, and vaping products) and any other vaporizing devices
capable of being used to deliver nicotine.
Question 2. Regarding flavors
(a) How should policy account for the phenomenon of flavor
appearing to be a positive reason for adult smokers to want to switch
from combustion to e-cigarette products that offer novel flavor
alternatives?
Answer. The issue of flavors in ENDS has attracted a great deal of
attention, with many expressing concern about the potential for certain
flavors to entice youth into trying ENDS.
First, we note that considerable experience in the marketplace
suggests that characterizing flavors are essential to displacing
combustion cigarettes among current adult smokers. Large numbers of
committed ENDS users no longer wish to use products with tobacco or
menthol characterizing flavors once they have stopped smoking
combustion cigarettes, ``reset'' their taste buds, and want fewer
reminders of their prior combustion cigarette experience. Initial and
growing evidence indicates that in such scenarios, ENDS users switch to
products with characterizing flavors, including fruit, coffee, dessert,
and beverage flavors. Moreover, data indicates that the use of flavors
provides greater satisfaction, higher incidence of full conversion away
from combustion, and lower incidence of dual use with combustion.
Therefore, we believe that flavors with appeal to current adult smokers
should be allowed by FDA as a mechanism for accelerating the
displacement of combustion cigarettes--and that CTP should ensure that
any policies on flavor are solidly based on science and do not slow the
progression away from combustion smoking, or drive former smokers back
to smoking.
Second, with respect to the concern over youth appeal, this concern
does not appear to be well-founded. In this regard, NJOY conducted
research to avoid selecting flavor descriptors that might appeal to
non-smoking youth. To make this determination, the company commissioned
a study of flavor appeal among non-smoking teens and adult smokers by
respected tobacco control researcher Dr. Saul Shiffman of Pinney
Associates and the University of Pittsburgh. The study results are
currently being finalized for peer-reviewed publication shortly. In
summary, the results show: the interest of non-smoking teens in e-
cigarettes to be low; flavors do not increase non-smoking teens'
interest; and flavors do increase adult smokers' interest in e-
cigarettes, particularly those with certain characterizing flavors.
(b) What is the risk that a ban on flavors would make switching
away from combustion cigarettes relatively less appealing?
Answer. NJOY's mission is to obsolete combustion cigarettes and the
company offers only ENDS products. As noted above, NJOY's experience
and research show that adult smokers are interested in flavors as part
of switching to ENDS from combustion tobacco products.
An outright ban on flavors would make switching away from
combustion cigarettes relatively less appealing, could drive former
smokers back to smoking and/or perpetuate dual use of ENDS and
combustion cigarettes--and therefore only entrench the smoking epidemic
that costs 480,000 American lives annually.
______
Response to Written Questions Submitted by Hon. John Thune to
Scott D. Ballin
Question 1. Mr. Ballin, as we consider possible regulation of e-
cigarettes, how do we ensure that the smaller players in this market
can compete with the larger, more established tobacco companies, so as
to encourage innovation that might lead to continued improvement and
safety of the products?
Answer. First and foremost, there needs to be regulatory oversight
of this rapidly growing industry. Second, protection of the public
health must be given the highest of priorities but without stifling
innovation and competition within the market place. Smaller companies
that are true innovators, accept the importance of regulation, and have
public health considerations as part of their business plans need to be
given additional incentives and possibly allowed a longer period for
adjusting to the market place regulations. This is something that is
not unique to tobacco and nicotine products and has been applied by the
FDA in areas such as food. The Center for Tobacco Products already
recognizes the distinctions between small and large tobacco product
manufacturers and the Tobacco Products Scientific Advisory Committee
(TPSAC) has non-voting slots for both large and small manufacturers.
While these slots reflect more traditional products and manufacturers
it might be possible to add slots for novel alternative products--both
large and small. That said, merely because a company is a smaller
player should not be a justification for the development or marketing
of an inferior product. It will be critical that as FDA moves forward
with its deeming regulations and sets product standards that all
players have ample opportunity to participate in the process.
Question 2. Mr. Ballin, in your testimony, you mentioned your work
with the Institute for Environmental Negotiation at the University of
Virginia on holding a series of safe haven dialogues to discuss tobacco
and nicotine issues. At the hearing, Senator Blumenthal spoke about his
work on the Big Tobacco lawsuits and settlement and asked Mr. Healy
(blu eCigs) and Mr. Weiss (NJOY) about their willingness to ``come
together to sit down, to commit to reaching a settlement, an agreement,
a protocol that stops any possible ads and pictures that appeal to
children and teenagers.'' While I think it may be a bit early to
produce another master settlement agreement like that which was entered
into between the four tobacco companies and the state attorneys general
in 1998, do you have any further thoughts on how the industry and other
stakeholders can get together to develop voluntary best practices for
the industry?
Answer. My experience over the years, both as an active participant
in dialogues (as part of the American Heart Association, the Coalition
on Smoking OR Health, and the Campaign for Tobacco Free Kids), and now
in working with the University of Virginia, is that ``safe-haven''
engagement with stakeholders and other experts does work. I appreciate
Senator Blumenthal's raising the issue of ``sitting down'' but I don't
think it should be for the purposes of ``negotiating a settlement''.
The e-cigarette industry is not ``Big Tobacco'' and is very diverse and
as I said, the tobacco and nicotine environment is one that is rapidly
changing with many challenges but more importantly many opportunities.
Also critical is that unlike the days of the Master Settlement
Agreement (MSA) we now have a fully funded regulatory agency in place
where the bulk of the work can be done. As one who was actively
involved in the ``wars'' with and against ``Big Tobacco'', I think we
need to realize that, as I and others have said, including FDA/CTP
Director Zeller, we are in a ``New Era''. We have a very unique
opportunity to shape policy that both protects children and youth from
the aggressive advertising and marketing of all tobacco and nicotine
products (as well as access and use) and at the same time allows the 40
million smokers in this country the opportunity to switch to science-
based lower risk products such as e-cigarettes. As to how we can move
forward, there are a number of avenues to take. One is for the Food and
Drug Administration to play a more active leadership role in convening
workshops and generally engaging with a broad spectrum of stakeholders
and interests in a transparent manner. Two is for interested
stakeholders and interested parties to take an active role in the rule
making process. Three is for there to be more private sector
discussions in forums like those at the University of Virginia as well
as in other venues, such as at the Food and Drug Law Institute,
scientific conferences and other tobacco and nicotine conferences. Out
of such meetings, forums etc there could possibly come a set of guiding
principles developed specifically aimed at the e-cigarette industry
that could be used as a tool to govern industry behaviors and practices
as we await FDA regulations. During the hearing Chairman Rockefeller
seemed to take the view that ``sitting down'' and actively engaging in
discussions in a ``safe-haven'' venue was an act of futility. My own
experiences and what I have seen accomplished at the FDA and in other
forums respectfully, suggests otherwise.
______
Response to Written Questions Submitted by Hon. Dean Heller to
Scott D. Ballin
Question 1. Regarding a national standard on age
(a) Should a national standard prohibiting sale of electronic
cigarettes to any person under the age of 18 years old exist?
Answer. Yes. We need a national law that governs all tobacco and
nicotine products, from the combustible toxic cigarette to the nicotine
replacement products such as gums, patches and inhalers. This would
also include all non-combustible products such as smokeless tobacco
products, tobacco lozenges and e-cigarettes.
(b) Should the Food and Drug Administration or the Federal Trade
Commission enforce this standard and why?
Answer. With respect to a national age requirement, the primary
authority should clearly lie with the Food and Drug Administration. A
comprehensive statute (Family Smoking Prevention and Tobacco Control
Act) was enacted with that in mind and the agency has indicated that it
is stepping up its enforcement activities in all of the states. The FTC
authorities should be limited to what the agency already has which
includes working and collaborating with the FDA when necessary and
appropriate.
(c) Should the measure be limited to only an electronic device that
employs a battery to power a heating chamber that converts a liquid
solution containing nicotine or are there other vaporizing devices that
do not fit the description mentioned that should also be prohibited for
sale to minors?
Answer. No. As I indicated in my answer above, I believe that all
tobacco and nicotine products should be regulated and that such
products should not be allowed to be sold to anyone under the age of
18. I would go further to suggest that we need to have a serious
discussion about whether authorities should extend to both possession
and usage (as is done with alcohol and other products) by those under
the age of 18. It seems that there is almost unanimous agreement that
no minor should use tobacco, so it may be time to close this major
loophole. Whether this might be done at the national level, at the
state and local level or a combination of national, state, and local
efforts remains to be determined. Perhaps, the FDA could ask the
Institute of Medicine to look into the issue as they did with respect
to alcohol.
Question 2. Regarding flavors
(a) How should policy account for the phenomenon of flavor
appearing to be a positive reason for adult smokers to want to switch
from combustion to e-cigarette products that offer novel flavor
alternatives?
Answer. In discussing and setting policies for flavorings, we
should be careful not to throw the baby out with the bath water. I
believe that some in the e-cigarette industry have crossed over a line
in promoting products with certain flavorings and affiliations. At the
same time an adult smoker looking for alternatives to using the deadly
combustible cigarette must be given products that are consumer
acceptable, which includes taste. One thing that did not come out in
the hearing was that nicotine replacement products (which contain
nicotine derived from tobacco) have long had flavorings (fruit chill,
lime, mocha etc.) in their products which are widely distributed, sold
and marketed. There has been little to no adverse reaction to the use
of flavorings in these products by either the public health community,
Congress or regulatory agencies. Smokeless products also have certain
flavoring allowances. There are important issues as to how and where
lines get drawn and it will be incumbent on the FDA to set the
appropriate balanced standards taking into consideration the risks,
relative risks and intended uses of the products. The FDA, in
cooperation with manufactures and other stakeholders should also
monitor how products are being used and by whom so that adjustments
might be made if there are unintended consequences. This would include
flavorings.
(b) What is the risk that a ban on flavors would make switching
away from combustion cigarettes relatively less appealing?
Answer. There are approximately 40 million smokers in the United
States. Smoking is an addiction and the cigarette is the most efficient
means of delivering nicotine. It is also the deadliest. Professor
Michael Russell said it best back in 1976 when he said, ``People smoke
for the nicotine but die from the tar.'' If smokers are going to be
given options to quit smoking it is critical that the products that are
available be consumer acceptable. This includes (among other things)
that the product has acceptable tastes. Banning flavors outright would
in my view discourage adult users of cigarettes from using
significantly lower risk regulated products such as e-cigarettes--
thereby undercutting public health objectives.
Question 3.
(a) Mr. Ballin, do you believe e-vapor products are as harmful as
conventional cigarettes?
Answer. In terms of relative risk, no. E-cigarettes and e-vapor
products are generally considered to be significantly lower in risk
than the combustible cigarette. But we must also be very careful in
assuming that all of these diverse products carry the same risk. The
number of products in the marketplace has grown substantially and we
have not gotten a handle on how to evaluate all these products and
their variations. Yet there are good studies that have been conducted
which confirm that many of these products are substantially lower in
risk and could therefore be beneficial to public health--both to the
individual and the general population. Using good science will be the
primary responsibility of the FDA in setting product standards, and it
will require the active involvement and cooperation of all
stakeholders, including manufacturers. Additional and ongoing studies
will also need to be conducted. Some manufacturers are developing
products using scientific methods and manufacturing practices that are
comparable to those used for foods or over-the-counter products while
others are unfortunately producing products with far fewer scientific
and manufacturing protocols.
(b) Would switching to an e-cigarette be a good thing for a
consumer who was trying to quit smoking?
Answer. While the best recommendation is for a consumer to quit
using all forms of tobacco and nicotine, it is increasingly becoming
accepted that for those who cannot quit, there should be other
alternative lower risk products available. While NRT products such as
gums and lozenges have had some impact in helping smokers to quit,
their success rate has been limited. Innovation, technological
advancements and science are now making it possible to give consumers
acceptable science-based lower risk products--including e-cigarette
products. These efforts should be encouraged. That said we do need to
have regulatory policies in place that include labeling, advertising
and marketing allowances and which will provide consumers with the
ability to understand the risks and relative risks of all of the
various products in the market place.
(c) Is a combustible cigarette the same as an e-cigarette? If not,
does it make sense for regulators, be it at the FDA or the states to be
able to treat these products differently so that barriers are not
created that would stop an adult smoker to switch to an e-cigarette?
Answer. As I indicated in my testimony before the Committee there
is a growing recognition by many in public health, including the FDA,
that tobacco and nicotine products should be regulated based on their
risk, relative risk and intended use. This is often referred to as the
continuum of risk. What this means is that products that cause the most
harm and most risk (such as the cigarette) should be the most
stringently regulating, while products further down the continuum of
risk should have regulations tapered to reflect their risk. The FDA's
proposed deeming regulations have recognized the continuum of risk, and
there is now general acceptance that e-cigarettes are not the same as a
cigarette. Many have called e-cigarettes a ``disrupting technology''
that could significantly reduce the use of the toxic cigarette. For
products that meet certain scientific criteria (product standards) I
would suggest that rather than creating barriers to allowing these
products on the market we should actually be providing incentives for
manufacturers to continue to innovate and develop products that have
the potential for moving more and more of the 40 million smokers off
cigarettes. This was the approach suggested by the Institute of
Medicine in its landmark report, Clearing the Smoke.
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