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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 

Printed for the use of the Committee on Commerce, Science, and Transportation 

( 

(II) 

SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

JOHN D. ROCKEFELLER IV, West Virginia, Chairman 

BARBARA BOXER, California 

BILL NELSON, Florida 

MARIA CANTWELL, Washington 

MARK PRYOR, Arkansas 

CLAIRE MCCASKILL, Missouri 

AMY KLOBUCHAR, Minnesota 

MARK BEGICH, Alaska 

RICHARD BLUMENTHAL, Connecticut 

BRIAN SCHATZ, Hawaii 

EDWARD MARKEY, Massachusetts 

CORY BOOKER, New Jersey 

JOHN E. WALSH, Montana 

JOHN THUNE, South Dakota, Ranking 

ROGER F. WICKER, Mississippi 

ROY BLUNT, Missouri 

MARCO RUBIO, Florida 

KELLY AYOTTE, New Hampshire 

DEAN HELLER, Nevada 

DAN COATS, Indiana 

TIM SCOTT, South Carolina 

TED CRUZ, Texas 

DEB FISCHER, Nebraska 

RON JOHNSON, Wisconsin 

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 

(III) 

C O N T E N T S 

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 

(1) 

AGGRESSIVE E-CIGARETTE MARKETING AND 

POTENTIAL CONSEQUENCES FOR YOUTH 

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 ecigarettes, 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. 

2 

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 

3 

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 youthoriented 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 

4 

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. 

5 

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 nonprofit 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 ecigarettes 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. 

6 

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 

7 

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 naı ̈ve 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 pin ̃ a colada.’’ 

Notably, this same company markets e-cigarettes in cherry, vanilla and pin ̃ a colada. Other e-liquid flavors, as mentioned, include 

cotton candy, Gummy Bear, Captain Crunch, Atomic Fireball; 

clearly enticing children. 

8 

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 ecigarettes 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 renormalize 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 ecigarettes 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 

9 

1Duke 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. 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-EciglReport-May2014.pdf 2014. Accessed June 16, 2014. 4 Benowitz NL. Nicotine Addiction. N Engl J Med. 2010, 362:2295–230. 

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. 

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 nicotinecontaining vapor devices. 

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. 

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 

10 

5Material Safety Data Sheet L-Nicotine. Available at http://www.sciencelab.com/ 

msds.php?msdsId=9926222. Accessed June 16, 2014. 6Mayer 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. 

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

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 naı ̈ve, such as children, than among established users. 

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 

11 

8Difranza 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. 10Slotkin, 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) 12 Benowitz NL. Nicotine Safety and Toxicity. New York: Oxford University Press; 1998. 

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

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. 

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 

12 

13McMillen 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. 14Lorillard Inc. Youth Smoking Prevention Program. What you need to know about e-cigarettes—Infographic. Available at http://www.realparentsrealanswers.com/what-you-need-toknow-about-e-cigarettes-infographic/. Accessed June 16, 2014. 15Goniewicz 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. 16Fuoco 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. 

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. 

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 ecigarette 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, pin ̃ a 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. 

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. 

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 ecigarette 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 

13 

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. 18Duke 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 

lReport-May2014.pdf 2014. Accessed June 16, 2014. 20Senators 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/?Filelid=81d14ff7-f2f6-4856-af9d-c20c0b138 

f8f. Accessed June 16, 2014. 

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. 

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. 

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. 

14 

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 ecigarettes or to quit the use of nicotine all together. However, ecigarettes 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 ecigarette 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 

15 

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 

16 

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 ecigarettes. 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 

17 

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; 3 Brown, CJ & Cheng, JM, ‘‘Electronic cigarettes: product characterisation and design considerations,’’ Tobacco Control 23:ii4–ii10, 2014. 

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

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. 

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 newsVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00021 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
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4Durbin, 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?Filelid=a85bb717-ac5d-4835-a584-206dbdb1f856. 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. 6 CDC, ‘‘Electronic Cigarette Use Among Middle and High School Students—United States, 

2011—2012,’’ MMWR 62(35), September 6, 2013. 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. 

papers, 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

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

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. 

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

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 ComVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00022 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
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9 U.S. v. Philip Morris USA, Inc., 449 F.Supp.2d at 691. 

10Klein, 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. 11Delnevo, 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. 12 Connolly, GN, ‘‘The Marketing of Nicotine Addiction by One Oral Snuff Manufacturer,’’ Tobacco Control 4(1):73–79, Spring 1995. 

pany 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

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

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

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 

20 

13Legacy, Vaporized: E-Cigarettes, Advertising, and Youth, April 2014. 14Legacy, Vaporized: E-Cigarettes, Advertising, and Youth, April 2014. 15Duke, JC, ‘‘Exposure to Electronic Cigarette Television Advertisements Among Youth and 

Young Adults,’’ Pediatrics [Epub ahead of print] pii: peds.2014–0269, June 2, 2014. 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. 

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

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. Ecigarette 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

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

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. 

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 

21 

17 21 U.S.C. 387a. 21 U.S.C. 387f(d). 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. 

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

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. 

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. 

22 

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. 


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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. 


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3. Sex sells 

Like cigarette companies have long done, e-cigarette makers portray use of their 

products as sexually attractive. 


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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 


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Sports Sponsorships 

6. Redeemable Points Program 


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7. Images of Doctors 

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. 


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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. 

29 

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. 


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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. 


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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, pin ̃ a-colada and berry.’’ For comparison, Lorillard’s blu e-cigarette 

brand offers flavor cartridges for sale on its website, including cherry, vanilla, and 

pin ̃ a colada. 


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Image 4. Billboards by an e-cigarette company and a vape shop. 

Billboard off of I–95 South in Miami, FL, December 2013 

Billboard in Janesville, WI, June 2014 


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Image 5. E-cigarette companies use attractive and scantily-clad models to promote 

their products. 


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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-regulatesale-and-advertising-of-e cigarettes.php 

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. 

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 ecigarettes 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, ecigarettes 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 ecigarettes. It did not report daily or regular use statistics for e-cigarettes. In other 

35 

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 selfcertification 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 ConVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00039 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
36 

1See October 23, 2013 Lorillard letter to Commissioner Hamburg regarding FDA regulation 

of e-cigarettes 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. 

trol 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

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 ecigarettes 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 eVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00040 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
37 

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. 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. 6See, 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. 7Tobacco Products Scientific Advisory Committee, ‘‘Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations’’ (July 21, 2001), at 215. 8King, 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. 

cigarettes is troubling and at odds with its claims of being a responsible manufacturer. 

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. 

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. 

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, pin ̃ a 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 stuVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00041 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
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9 2013 Florida Youth Tobacco Survey. 

10GfK 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. 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. 12 Americans for Nonsmokers’ Rights. ‘‘Do you think Blu e-cigarettes should be promoted at 

Six Flags?’’ http://anr.no-smoke.org/site/MessageViewer?emlid=29281.0. 

dents 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. 

• 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. 

• 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. 

• 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

• 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 comVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00042 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
39 

pany 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 


618APPED1.eps
40 

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 

Source: Trinkets & Trash, www.trinketsandtrash.org 


618APPED2.eps
41 

Magazine Ad Found In: 

Rolling Stone—May 2012 

Source: Trinkets & Trash, www.trinketsandtrash.org 


618APPED3.eps
42 

Exhibit C: Screenshots of blu TV Advertisements on YouTube 


618APPED4.eps
43 

Exhibit D: Sports, Music, and Other Events Sponsorships 

Exhibit E: Screenshot of ‘‘Mr. Cool’’ Cartoon on blu eCigs Website 


618APPED5.eps 618APPED6.eps
44 

Exhibit F: Screenshots of blu eCigs and Newport Age Verification 


618APPED7.eps
45 

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 ecigarette 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, ecigs 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 

46 

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 beVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00050 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
47 

haviors. 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, ecigs 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 nondetectible 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 ecigarette 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 

48 

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. 

49 

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 

50 

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, cigarettestyle 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 

51 

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 

52 

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. 

53 

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. 

54 

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 reguVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00058 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
55 

lating 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 

56 

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 ecigarettes’ 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, 

57 

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, 

58 

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 nonmisleading 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 

59 

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 ecigarettes 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—— 

60 

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, 

61 

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 ecigarettes, 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—— 

62 

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. 

63 

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 

64 

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:] 

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Senator BOXER. And here’s the deal, it’s pretty well peerreviewed. 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. 

81 

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, pin ̃a 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:] 

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 ecigarettes due to an abundance of fun flavors such as cherry, vanilla, pin ̃ a colada and berry?’’ And you sell them in three of the flavors. Are you marketing to children? 

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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? 

83 

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. 

84 

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:] 

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—— 


618KOOL1.eps
85 

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:] 

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? 


618PATTI1.eps
86 

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. 

87 

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 pin ̃ a 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? 

88 

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. 

89 

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 reVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00093 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\97626.TXT JACKIE
90 

fill 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:] 


618CHERRY1.eps
91 

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—— 

92 

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 

93 

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, pin ̃ a 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. 

94 

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. 

95 

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 

96 

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 

97 

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 

98 

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? 

99 

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. 

100 

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 toVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00104 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\97626.TXT JACKIE
101 

bacco 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:] 

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 


618JENNY1.eps
102 

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:] 

103 


618REAL1.eps
104 

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, pin ̃ a 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. CigaVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00108 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\97626.TXT JACKIE
105 

rettes 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:] 

106 


618CHART1.eps 618CHART2.eps
107 

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:] 

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.] 


618SANTA1.eps
(109) 

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 stilldeveloping 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 nicotinecontaining 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. 

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(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 ecigarettes. 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 

111 

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. 

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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 

113 

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 ecigarettes, particularly those with certain characterizing flavors. 

114 

(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 specVerDate Nov 24 2008 06:41 Nov 23, 2015 Jkt 075679 PO 00000 Frm 00118 Fmt 6601 Sfmt 6621 S:\GPO\DOCS\97626.TXT JACKIE
115 

trum 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. 

116 

(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-thecounter 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. 

Æ 

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