Skip to main content

Michigan State University Helps You Understand Vaping

Largest E-Cigarette Face Questions About Safety, Marketing And Teen Vaping


states as well as the associated public

health implications the chair now

recognizes herself for the purposes of

an opening statement today we're here

again to continue our examination of a

growing public health crisis

the soaring use of e-cigarettes by young

people simply put our nation faces a

youth vaping epidemic in September this

panel heard from federal and state

health officials about the skyrocketing

use of e-cigarettes throughout the

United States last year more than 5

million young people reported using

e-cigarettes up from 3.6 million who

reported using them the year before just

the other day I met with a group of high

school students in Denver at my alma

mater South High School and while the

most recent national survey found that

one in four high school students are

currently vaping when I told this to the

students they all shook their heads and

said they believe the actual rate is

much much higher in fact one sophomore I

talked to thinks that more than 60% of

his peers are using e-cigarettes now as

I've said before many times

this team vaping epidemic is personal to

me because in my state of Colorado we

have the highest percentage of teens

vaping than anywhere according to the

Centers for Disease Control and

Prevention ecig arete spose risk to all

users but most particularly to young

people the vast majority of e-cigarettes

contain nicotine which according to the

National Institutes of Health can be as

addictive as heroin or cocaine a fact

which anecdotally was cemented by the

high school students I actually talked

to the other day nicotine can harm brain

development affect respiratory health

and can lead to heart disease

further research shows that youth who

use e-cigarettes are more likely to be

using combustible cigarettes effect also

confirmed to me by the high school

students each cigarette manufacturers

have been negligent at best or

intentional at worse in attracting young

people to their products flavor options

because

liberal designs highly addictive

nicotine levels and slick marketing

campaigns have all been used to lure

millions of young people into using

e-cigarettes parents and public

officials have been left scrambling to

address this epidemic and no one not

parents not public health officials and

not the students who've able fully

understands the health impacts of

e-cigarettes

what's worse as many of the young people

actually believe that these products are

safe or harmless also confirm me to me

by the South High rebels I was talking

to and you know what this simply is not

true the CDC has stated that all tobacco

products including e-cigarettes carry

health risks

the only reason e-cigarettes are

available on the market today is because

the Food and Drug Administration gave

them a temporary pass by exercising or

refusing to exercise its enforcement

discretion no e cigarette currently

being sold in the United States has been

reviewed by the FDA for its impact on

public health instead the e-cigarette

industry has essentially been allowed to

conduct a public health experiment in

real time without knowing what the

consequences of these products may be

and our young people are paying the

price

so this is why the Congress decided to

act in December Chairman Paulo myself as

well as some of my other colleagues

today took an important first step to

raise the nationwide minimum age to buy

any tobacco product including

e-cigarettes 2:21 clearly more needs to

be done such as advancing legislation

that Chairman pallone I and others have

introduced to tackle this public health

priority these efforts are all the more

important given that the recent the

administration recently came to industry

influence despite the FDA's announcement

last September that it intended to ban

all non tobacco flavored each cigarette

products to address the rising youth

rate use rate the final policy issued in

January includes exemptions and

loopholes not only are menthol flavored

a cigarette still allowed under the

FDA's new guidelines

over the fruity and sweet flavored

illiquid and disposable e-cigarette

products these loopholes may lead to

young people shifting to using menthol

flavored products or disposable

e-cigarette

that remain on the market in fact there

are reports that the shift is already

happening the kids a South told me that

it's harder for them to get these

cigarettes at the gas station good news

bad news is people are just going to

these vape shops to get these products

so while companies claim that the

e-cigarettes have the potential to help

adults who smoke combustible cigarettes

it's important to note that CDC cautions

such as a health benefit would only

apply if the smoker were able to quit

and completely we know that a majority

of adult cigarette users however our

dual users meaning they both smoked an

vape which could be more dangerous than

using either product alone so now the

question is for every adult smoker who

may quit smoking because they're using

an e-cigarette how many young people

will start using those cigarettes and

develop a lifelong nicotine addiction we

must ensure that we're not only

attempting to solve one public health

problem and by creating another at the

expense of young people's health the

responsibility to protect young people

from these dangerous products cannot

fall solely on parents teachers and

health officials and I'm glad you

gentlemen are here because the industry

caused this mess and the industry needs

to be responsible for cleaning it up

today we're going to hear from the

companies responsible for these products

I really do appreciate you coming

because I really do want you to be part

of the solution and so we're gonna have

a lot of questions we're looking forward

to this hearing I know I went a little

over time mr. Guthrie which I don't

usually do so I'm happy to give you

another minute for your opening

statement and with that I'm pleased to

recognize the ranking member of the folk

of the subcommittee mr. Guthrie for 5

minutes 6 minutes 6 minutes well thank

you a chair to get I appreciate the

opportunity to be hearing preciate all

of our witnesses here this morning I

thank you for holding this important

here

and I share your concern about youth

aping trends that have emerged in the

United States in recent years the US

Surgeon General has called a cigarette

usage by youth and epidemic and warned

that it threatens decades of progress

towards ensuring that fewer young people

use tobacco the most recent data from

the National Youth tobacco survey show

that 27 and a half percent of use and of

course you said did you think it's

higher than that from your sample there

we reported using these cigarettes

compared with 20.8% in 2018 we do know

it's more and the market as it has

increased the marketing of e-cigarette

products to children must stop and youth

access to e-cigarette products must be

prevented this will require an

all-hands-on-deck approach from all

parties including the federal government

manufacturers and retail stores we've

already made strides to curb youth

access and tobacco since we last held a

hearing in September in December as

mentioned by the chair Congress passed

and and President Trump signed into law

a legislation to raise the legal age to

purchase tobacco products including

e-cigarettes from 18 to 21 On January

the second 2020 FDA issued guidance

finalizing in its enforcement policy

regarding unauthorized flavored

cartridge based cigarettes that appeal

to children including fruit and MIT

under this policy as of February the six

2020 tomorrow companies must cease

manufacturing distribution and sale of

unauthorized flavored cartridge-based

cigarettes other than tobacco or menthol

or risk ft enforcement action this

guidance also gives the FDA the ability

to pivot its its enforcement priorities

as needed I hope to hear from our

witnesses today whether this enforcement

guidance will effectively target youth

access or if there are other or more

effective steps the FDA should take

either alone or in conjunction with the

industry further according to FDA's new

guidelines manufacturers like the ones

before us today must submit pre market

tobacco product applications to FDA by

May 12 2024 deem tobacco products

including e-cigarettes they're on the

market as of August the 8th 2016 through

their applications manufacturers or

importers must demonstrate to the FDA

among other things

Marketing of new tobacco products would

be appropriate for the protection of

public health as part of this

determination FDA must consider the risk

and benefits of the product to the

population as a whole

including users and non-users of tobacco

products if manufacturers do not submit

their pre market applications by May

12th any products for which an

application is not submitted must be

pulled from the market these legal and

regulatory developments will drastically

change Issa grant landscape in the

coming months and year while these

actions are aimed at reducing the

attraction of e-cigarettes to youth and

protecting broader public health wide

bands and airing of what is legally

available in the legitimate marketplace

will almost certainly ship product use

for existing users to other products

that are still available we must be

vigilant and respond to this potential

shift in utilization which may result in

an increase of black-market or

counterfeit demand for each cigarette

products we must ensure there are

efforts to protect our youth and the

broader public health do not

inadvertently create a bigger and more

complicated problem though not directly

related today's hearing I'll continue to

be concerned about the lung injury

outbreak associated with vaping and

e-cigarette use these illnesses must be

have been closely associated with

black-market products in THC or

marijuana derivative while the number of

cases appear to have peaked when this

subcommittee held its first EC red

hearing in September we have since

learned that according to the Center for

Disease Control an illness outbreak was

strongly linked to vitamin E acetate

addictive and additive to THC or

marijuana cigarettes we need to more

clearly understand the cause of these

illnesses it is my understanding that

e-cigarette manufacturers have taken

have taken and are continuing to take

their own actions to prevent youth

prevent youth access to their products

this hearing can serve as a constructive

discussion first to us to learn more

about what these manufacturers are doing

to prevent youth utilization of

e-cigarettes before I conclude I would

like to make a quick comment and

recognize the subsidiary Reynolds that

is located in my district it's Kentucky

bio processing Kentucky bar processing

was found

Owensboro Kentucky with a group of

visionary local entrepreneurs who wanted

to find ways to use the tobacco plant

that is constructive to public health

and in doing so they found that was a

host for growing vaccines to the Ebola a

population that was used in emergency

situations and the previous of all

outbreak and is now working to address

potential of vaccines with the

coronavirus I am glad that kbp is

working on alternative uses for tobacco

in order to better America's public

health

I think our witnesses for being here

today and being part of this important

discussion and I thank the gentleman

chair now recognizes the chair of the

full committee mr. Pulham for five

minutes thank you madam chair I'm

pleased we're holding this hearing so we

can shed more light on the youth tobacco

epidemic and how we got here the

significant progress that was made to

curb tobacco use has simply vanished

last year 6.2 million middle school and

high school students reported using

tobacco products including one in three

high school students and one in eight

middle school students and these are

shocking and concerning numbers and

today we're here to not only ask how

this happened but what is going to be

done to reverse these dangerous new

trends in tobacco use well federal Legg

regulators share in this blame a large

portion of culpability rests with the

manufacturers of e-cigarette products

these manufacturers saw an opportunity

to hook a new generation on their

products and used every trick in the

book to make their products appeal to

kids through sweet flavors glossy

marketing campaigns and slick product

designs it's long past time that the

Food and Drug Administration move

forward with reviewing the health and

safety risk of the e-cigarette products

that are currently on the market and

then the FDA must act swiftly to remove

any products that are not in compliance

but it's also time for the manufacturers

including those before us today to

acknowledge the responsibility they have

to ensure young people are protected

from a lifetime of nicotine addiction we

do not know all the long-term health

implications of e-cigarette use but we

do

know that nicotine harms the developing

brain and that young people who use

e-cigarettes are more likely to try

combustible cigarettes as well and

that's why I'm so disappointed the

president Trump chose to side with

industry over the nation's public health

by permitting flavored products to

remain on the market like menthol

disposable e-cigarette and open tank

systems mixed in vape shops the

president's announcement last month

falls far short of the promises he made

last year to address the youth tobacco

epidemic and we shouldn't be fooled a

so-called flavor ban that exempts

menthol and vape shops is not a flavor

band at all and that's also why it's

critical that we continue to move

forward legislatively with a solution

since the Trump administration will not

and I look forward to bringing my bill

the reversing the youth tobacco epidemic

Act to the floor soon my legislation not

only includes a full flavor bin it also

bans certain non face-to-face sales and

protects kids from predatory marketing

it's a comprehensive approach to end

this epidemic and I hope that it

Garner's the bipartisan support that it

deserves when it comes to the floor in

the meantime I want to hear more from

the manufacturers and what role they

believe their companies have played in

the creation of this epidemic and what

they're doing to correct it it's

chilling to sit and watch as we are

seeing history repeat itself we've been

here before as the tobacco industry

admitted to misleading millions of users

on the safety of tobacco products and we

can't sit idly by as this happens again

for that reason I hope that witnesses

today are forthcoming and acknowledge

the role they must play in reversing

these dangerous and disturbing trends

and I just wanted to say a few years ago

I started going around to some of my

middle schools and talking to the

students and I was amazed at how they

didn't think that there was any harmful

aspect of e-cigarettes that they didn't

contain any nicotine that didn't cause

any addiction that they actually were

you know just you know bubble gum or

cotton candy and that was it

it's the misleading marketing in my

opinion that has caused this epidemic

and made young people

you know feel that there was absolutely

no problem with vaping and that's why

all the gains that we made from trying

to discourage tobacco use cigarettes

putting the warnings all that's

evaporated now because we have this

young generation that until recently

just thought that was not a problem and

I'm pleased to see that we have some

younger people here in the audience

today speaking out against this not here

necessarily but you know outside and and

getting the public and the media more

aware thank you madam chair thank you

gentlemen

sure now yields five minutes to the

ranking member of the full committee mr.

Walden thank you very much madam chair

and I - mr. chairman I'm glad these

young people here when I was a student

body president in high school I know I

was a long time ago I led the effort

before the school board to get smoking

out of the bathrooms was illegal there

but we actually created a smoking area

outside which was revolutionary had that

parental permission and all this other

stuff but we got it out of the bathrooms

because I hated smoke I was the only one

of my family didn't smoke and my we've

come a long way so stay involved in all

of this and she's got three I'd be

curious to I'm gonna go over to the

coronavirus briefing for the house and a

few minutes so I hope we can find out

more about the work that's being done

with the tobacco plant because vaccines

and getting to him quicker is something

that we've all been working toward for a

long time so chair to get thank you for

holding this hearing like trying

cigarettes or e-cigarettes the lung

illnesses associated with vaping the

youth vaping epidemic these are major

health concerns for the United States

and particularly and sadly in my home

state of Oregon which unfortunately is

one of the 27 states where there was a

confirmed death from an e-cigarette or

vaping product use associated lung

injury a valley since the subcommittee's

hearing in September with federal and

state health officials we have learned

more about what causes these tragic lung

illnesses according to the Centers for

Disease Control and Prevention

laboratory data show that vitamin E

acetate and additive in some THC

containing containing vaping products is

strongly linked to the E valley outbreak

while there is still

or to learn about the e Valley and what

causes it we must remain vigilant about

a separate but equally alarming issue

the troubling statistics regarding East

cigarette use among youth as Republican

leader Guthrie noted the most recent

data from the National Youth tobacco

survey is alarming we all share this

concern twenty-seven and a half percent

of youth reported using e-cigarettes in

2019 that compares to 20.8% 2018 it's a

big jump from eleven point three percent

just three years ago given these trends

Trump administration the state's

manufacturers all of you before us today

in this committee or right to look for

solutions to curb stopped youth access

the e-cigarettes I applaud the Trump

administration's pursuit of a solution

to the to address our country's youth

vaping epidemic for example in December

President Trump signed legislation to

raise the legal age to purchase tobacco

products from 18 to 21

additionally the US Food and Drug

Administration FDA issued guidance in

January finalizing its enforcement

policy regarding unauthorized flavored

cartridge-based

ease cigarettes that appeal to children

including fruit and mint in addition to

these two changes the May deadline for

manufacturers to submit the pre-market

tobacco product applications pmta to FDA

is quickly approaching which will shift

the industry's landscape even further

now all these are all promising steps we

remain concerned about the counterfeit

and black market products that current

ecig arete users including our youth may

increasingly turn to when products they

are currently using will no longer be

available in the in legal and legitimate

marketplace I'm also concerned about the

potential shifts to youth usage to other

non cartridge-based

cigarettes and I'm interested in hearing

from the companies today their thoughts

on how we can prevent this from

occurring I'd also like to note the

irony of the health subcommittee of this

full committee holding a hearing just

two weeks ago that included bills 2d

scheduled and decriminalize marijuana

much of which is smoked followed by this

hearing where my colleagues are now

denouncing smoking tobacco in all forms

while I have concerns about the epidemic

of youth tobacco usage I believe that

concern should extend to expanded youth

access to marijuana and mayor

related products especially considering

the death in Oregon was likely related

to a THC vape pod purchased at a

dispensary denouncing smoking tobacco in

all forms while embracing the D

scheduling or legalization of marijuana

is at best inconsistent when considering

long-term health outcomes the lack of

research and data in addition the

committee's ongoing work chair to get I

hope you'll invite the FDA to testify

again once the PMT a deadline passes in

May I think we could really benefit

excellent well we heard from the FDA in

September it's critical for all of us to

continue to hear from the FDA as the

issue evolves and the FDA begins to

evaluate manufacturers pmta s

we also need a full investigation into

counterfeit and black market products

that are likely to fill the void of the

products that are expected to exit the

market whether from the administration's

January guidance or from manufacturers

who do not file PM tas and accordingly

remove their products from the market we

want to make sure the FDA stands ready

to address these issues as they arise to

protect current e-cigarette users but

most importantly our youth so I want to

thank the companies before us or

voluntarily coming here it's important

that we hear from you and madam chair I

appreciate you holding this hearing

and I'll have to go over that

coronavirus hearing for the members but

we'll be back and forth and I yield back

notes over there yeah and I just want to

say I don't think there's anybody on

this committee that thinks marijuana

should be legalized for people under 21

and in addition in addition I think

everybody on this committee will agree

that we need to continue to do the

research on that too there's been

woefully inadequate research and if we

agree we're planning to have a hearing

on that thank you madam chair chair will

now ask unanimous consent that the

members written in a written opening

statements be made part of the record

without objection so ordered chair would

also like to recommend of shillelagh for

joining us at the hearing today

representative shillelagh is not on this

committee and so under Rule 11 of the

house of representatives members

delegates and residents can participate

in committee hearings but but they're

not able to

question witnesses but I think we could

all stipulate that she probably has more

institutional knowledge about health

care policy than anybody in this

Congress so we're really happy to have

you join us I'd now like to introduce

our witnesses for today's hearing mr.

casey crosthwaite CEO of jewell welcome

mr. Ricardo Oberlander who's the

president and CEO of Reynolds America

Inc welcome glad to have you mr. Ryan

Niva cough CEO of enjoy LLC mr. Antoine

blonde who is president of funtom us

welcome Mary mr. Jerry Lofton who's the

president of Logic Technology

Development LLC and welcome to you too

mr. Lofton thank you thanks to all of

our witnesses for appearing today before

the subcommittee you're aware that the

committee is holding an investigative

hearing and when doing so has the

practice of taking testimony under oath

does anyone have any objection to

testifying under oath today let the

record reflect that the witnesses have

responded no the chair then advises you

that under the rules of the house and

the rules of the committee you're

entitled to be accompanied by counsel

does anyone desire to be accompanied by

counsel today let the record reflect

again that the witnesses have responded

now if you would then please rise and

raise your right hand so that you may be

sworn in do you swear the testimony that

you're about to give is the truth the

whole truth and nothing but the truth

you may be seated

let the record reflect the witnesses

have responded affirmatively and all of

you are now under oath and subject to

the penalty set forth in Title 18

section 100 1 of the US Code the chair

will now recognize our witnesses for a

five minute summary of their written

statements in front of each of you

there's a microphone a timer and a

series of lights the timer will count

down your time and the red light will

turn on when your your five minutes have

come to an end

and so now mr. Crosswhite I'm delighted

to recognize you for five minutes please

mr. Oberlander see if your microphone

works hello

okay can you pass that over to mr.

Crosswhite

thank you so much

cheer to get chairman pallone ranking

members Guthrie and Walden other

distinguished subcommittee members my

name is Casey crosthwaite and I am CEO

of jewel labs a position I assumed when

I joined the company about four months

ago at UWE Labs are thousands of US

employees are committed to helping adult

smokers transition away from combustible

cigarettes while combating the serious

problem of underage use as we look at

the vapor category it is helpful to

begin by noting the significant changes

that have taken place in a relatively

short period of time at the start of

2019 most Americans lived in states

where the legal age or purchase was just

18 vapor products were available in a

wide array of flavors there was low

awareness of black-market vapor products

and the deadline for pmta submissions to

the FDA was uncertain in contrast today

21 plus is the law of the land thanks to

many of you on this committee under FDA

guidance pat based products are now

available in only tobacco and menthol

Congress the FDA and the president have

raised the alarm on black-market

products and the pmta deadline of May

2020 is rapidly approaching actual labs

we recognize the importance of these

steps over the past few years trust in

our company and category has eroded we

know some of our past actions have

contributed to that erosion and we are

committed to taking concrete action to

relearn that trust we halted our

broadcast print and digital product

advertising we voluntarily restricted

the sale of flavors other than tobacco

and menthol and we restructured our

company to focus on developing

technologies to combat underage use and

to conduct research in support of our

pmta

submission clearly we still have a long

way to go

underage use rates remain unacceptably

high but we believe that this challenge

can and must be met it threatens the

entire harm reduction opportunity

represented by vapor products and that

opportunity is too important to lose

combustible cigarettes remain the

leading cause of preventable death in

our country and worldwide more than 34

million Americans still smoke each year

nearly half a million Americans die from

smoking related diseases to be clear

anyone who doesn't use nicotine

shouldn't start anyone who smokes should

quit for those who can not or will not

quit less harmful alternatives like

vapor products should be available

public health authorities agree that

it's not the nicotine but the burning of

tobacco and smoke that causes disease

and death as the FDA note in 2017 in

quote nicotine while highly addictive is

delivered through products that

represent a continuum of risk and is

most harmful when delivered through

smoke particles in combustible

cigarettes and a quote at the same time

the FDA stated its intent to encourage

innovation that could provide adult

smokers a less harmful way to consume

nicotine jool products are one example

of this type of innovation our products

are not risk-free but research indicates

that vapor products are substantially

lower risk than cigarettes research also

indicates that many if not most adult

smokers who try jewelle products are

able to successfully transition

completely off of cigarettes we will

provide all this research to the FDA

through the PMT a process that process

which we support is a science and

evidence-based review that will evaluate

the harm reduction potential of our

products along with the ability to

prevent you

usage if I authorized by the FDA our

products will be marketed under strict

oversight subject to the comprehensive

regulatory powers invested in the agency

by Congress chair to get ranking member

Guthrie my company is working hard to

listen to our stakeholders so together

we can make progress towards the twin

goals of helping more adult switch away

from cigarettes while combating underage

use my hope is today's panel can be

another step along that path I thank you

for the opportunity I look forward to

answering your questions thank you so

much chair now recognizes mr. Oberlander

for five minutes for an opening

statement and and actually yeah what

hold off for one minute we're going to

replace mr. cross weights microphone so

you don't have to keep shifting back and

forth all day

thank you so much mister Oberlander

you're now recognized for five minutes

Oh Thank You chair to get ring came ago

three members of the subcommittee

chairman pallone ranking member Walden

and distinguished members my name is

ricardo Burlando and the presidency

uranus american inc i appreciate this

opportunity to share information about

our company it should continue this

important conversation today over a

decade ago Reynaud set a goal to

transform the tobacco markets through

innovative products that could make

tobacco harm reduction a reality for

adult smokers doing so requires us to

provide consumer acceptable products

that may present less risk including

products in the 15 category in pursuing

this goal we have focused on both

innovation and responsibility

because the two must not be separated

the way we bring innovative products to

market and how we market those products

as important as a products themselves

our marketing is important it is how we

communicate with adult smokers about

alternatives to combustible cigarettes

as details now submissions to the

committee

we have rigorous standards in place to

ensure our marketing is accurate and is

responsibly directed to adult smokers 21

and older we impose numerous

restrictions on the content of our

marketing and limit with whom we

communicate our vapor brand is views our

consumer demographics confirm our focus

on adults 95% of views consumers are

over 25 and 70% are over 35 with respect

to use vaping when views was a market

leader through 2017 youth vaping rates

actually declined in the most recent

National Youth tobacco survey results

show that views is not popular among

youth thus we have demonstrated in

continued to demonstrate that it is

possible to responsibly market

alternative products and manufacture

them and the rigorous product

stewardship standard

the increase in youth vaping over the

past two years and serious health issues

from illicit products are now at the

heart of a national discussion these

issues are being discussed within

families by educators and in state and

local governments they are being

discussed in law enforcement communities

the white house here today in the United

States Congress

we support action by the administration

and Congress to address both issues it

is important to public health into adult

consumers looking forward FDA's

pre-market tobacco application process

provides a pathway for vapor products

aligned with public health priorities we

believe vapor products can be

manufactured and marketed responsibly

within this framework in fact we have

already made extensive pmc submissions

for our views products there are

additional actions be encouraged you to

consider first transparency in the BMJ

process is critical we suggest FDA

disclose which products have been

submitted for PMT approval this will

help retailers and the public know which

vapor products undergoing PMT a review

and are eligible to remain on the

markets and will help FDA and state

officials enforce the law

second FDA needs to adopt regulations

that expedite important innovations for

example we are exploring technologies

that could provide additional measures

for reducing potential youth usage

however the current pmj process although

Thoreau and welcome would significantly

delay delay bringing this type of

responsible innovation to market third

FDA should consider adopting additional

and rotating warnings for vapor products

these warnings could reinforce the

vaping products are not safe and not for

youth we already include many such

statements on our packaging and brand

website and finally FDA has a track

record of success with its youth

prevention program we applaud the

agency's success and encourage it to be

and expanded in conclusion we believe a

level setting of the vapor market

through the pmj process will help

address the serious issues facing us

today at the same time it will force a

continuous from issue the tobacco

category and significantly benefit

public health I thank the committee for

the opportunity to share rayna's views

about these important issues and

reiterates our full commitment to

cooperate this committee and fda thank

you so much mr. nevikov now you are

recognized for five minutes please good

morning chair to get chairman pallone

ranking member Guthrie ranking member

Walden and distinguished members of the

subcommittee my name is Ryan Novikov and

I'm the CEO of enjoyment thank you for

the opportunity to testify today to

discuss with you

the important public health dynamics

associated with electronic cigarettes I

am humbled to be here today to provide

enjoys insights into this complex and

vitally important conversation by way of

background I joined I enjoy for deeply

personal reasons as I'm sure is the case

with many of the people in this room my

family has been victimized by one of the

most deadly articles of commerce ever

created the combustible cigarette as a

boy I watched as my grandmother perished

while before her time and as my once a

virile grandfather a veteran of the Army

and Marine Corps and a police officer

for over 38 years spent the last six

years of his life attached feebly to an

oxygen tank unable to even sit up

without losing his breath it is with

these horrifying memories in mind that I

joined njoy and wrote our mission

statement to make smoking history by

helping adults find an alternative to

combustible cigarettes from day one it

was clear to me that neither we had

enjoined nor other pioneers and harm

reduction would be able to advance that

mission if the public health benefits of

electronic cigarettes were overshadowed

by a surge of youth use to that end and

joy has pursued its mission with the

goal of ensuring that our products do

not fall into the hands of America's

youth though hollow as it may sound this

industry has the greatest incentive both

moral and economic to ensure that youth

use is eliminated if that goal is not

accomplished this

life-changing technology may rightfully

and ironically be relegated to the

ashtray of history we see today's

hearing is an opportunity for productive

dialogue to move forward together

collectively to protect the public

health

there are approximately thirty four

million Americans who still smoke

combustible cigarettes and over a

billion people worldwide those smokers

face a greater than 50% chance of

premature death death if they continue

to smoke and each year nearly 500,000

Americans die prematurely from smoking

related disease switching adult smokers

from combustible cigarettes to

electronic cigarettes has the potential

to save millions of lives and trillions

of dollars in preventable health care

expenses these assertions are not mere

industry taglines designed to obfuscate

otherwise nefarious or profit driven

motives former FDA Commissioner Scott

Gottlieb has stated if you can fully

switch every currently addicted adult

smoker who is using combustible tobacco

products onto e-cigarettes you will have

a profound impact on public health with

this in mind and joy has recognized from

inception that contrary to popular

opinion addicting a new generation of

nicotine users would not further our

moral or financial bottom lines but

rather be our undoing we've built our

business in accordance with that ethos

and the data prove that it is working

according to the National Youth tobacco

survey in 2019 only 1.2 percent of high

school students who used electronic

cigarettes within the prior 30 days

reported using Android products indeed

in the most recent National Youth

tobacco survey enjoys youth rate for

high schoolers despite being one of the

top three national brands is over nine

times lower than the combined use of two

brands that were not even part of the

survey but were written in by students

who used those brands further the FDA's

yearly retail inspection violated

violation data consistently shows that

enjoys products are involved in the

fewest violations of the top four e

cigarette brands for example in the

fiscal year beginning October 2017 FDA

recorded more than 3300 violations

including electronic cigarettes of which

only twenty involved njoy products which

is less than 1% the following fiscal

year FDA recorded over 5,000 250

violations only 28 of which involved

Android products

1/2 of 1% and in the present fiscal year

enjoy products were involved in only 8

violations of the 839 recorded by FDA

thus far again less than 1% well enjoy

will strive to continue to reduce this

number even farther and joy is proud of

its track record of success thus far to

be clear however my goal is not to a

grand eyes and Joy's track record nor to

draw comparisons against my competition

rather I provide this data merely to

demonstrate that with proper regulation

and vigilant self policing there is a

path forward for this life-changing

technology a path that can provide an

off-ramp for adults without creating an

on-ramp for youth and I'm confident that

everyone on this panel shares that very

same dedication to eliminating underage

vaping I welcome the opportunity to

share with the subcommittee more detail

about the policies and procedures by

which njoy has been able to serve its

its mission to adult smokers while

minimizing access to youth I look

forward to answering your questions and

thank you again for the opportunity to

be here thank you so much I now

recognize mr. blonde for five minutes

for an opening statement

Shelly get chairman Palin ranking member

go three members of the subcommittee

thank you for the opportunity to appear

today before the House Committee of

Energy and Commerce Oversight and

investigation subcommittee to discuss

the important issues regarding

electronic nicotine delivery system in

the escamole referred as east cigarettes

my name is Antoine blondie and I am

president I'm from time us incorporated

from time us market and sell the blue

brand which we acquired from another

company in June 2015 as you are aware

phantom has cooperated extensively with

the committee's investigation since it

began last August and provided several

hundred of pages of material in response

to the committee's request for

information we believe the facts make

clear that phantom is a responsible

actor in the e-cigarette marketplace and

we are committed to ensuring to our

business that our business practices are

consistent with our objective of

providing other consumers only with the

highest quality products and an

enjoyable product

variance I would like to briefly address

four points first Fontan believes

without equivocation that youth should

not use any cigarette product we share

the subcommittee's view that preventing

youth access to e-cigarette is an issue

of critical importance in these regards

for them does not and has never directed

its marketing efforts for e-cigarettes

youth second front mtext extensive steps

to ensure that its each cigarettes tell

channel reflects from times commitment

to use access prevention for them

cigarettes are sold through three main

distribution channel the traditional

brick and mortar which are the

convenience stores the gas station

ecommerce and web shops in each

distribution channel from temp take

steps to ensure that youth do not have

access to blue product third phantom has

invested extensively in its project

stewardship program phantom is also

committed to responsibly product

stewardship practices and ensuring

protic wada t is thoughtfully integrated

from prada conception to consumer use

fourth phantoms product have not been

found by the us center of Disease

Control to be involved in any of the

incidence of respiratory illness

it has investigated we were deeply

concerned by reports last year leaking

respiratory illnesses to the use of

vaping product and we join calls for the

CDC to investigate resistances as soon

as possible vitamin E acetate is not and

has never been an ingredient in blue

product and we are not aware of any

front end product being referenced by

the CDC as involved in incidences it has

investigated further we fully agree with

the CDC's advice that consumers should

not buy any vaping product especially

the one containing THD from unknown

sources or in black market of course

we will continue to monitor these

developments very closely these

initiatives are some examples of fun

times extensive efforts in the areas of

youth access prevention and product

quality all of us at fountain are

dedicated to ensuring that our products

are of the highest quality and that they

are marketed and sold only to other

consumers I thank you for your time and

attention to these important issues on

behalf of funtom you as we look forward

to working with the Congress in FDA and

continue doing so and I'm happy to

answer any question you will have Thank

You mr. Monday and I apologize for

mispronouncing your name earlier mr.

Lofton you are now recognized for five

minutes for an opening statement

chairman to get ranking member Guthrie

and members of the subcommittee thank

you for inviting me to testify at this

hearing I'm Jay Lofton president of

logic and I appreciate the opportunity

to contribute to this very important

inquiry to my knowledge only one company

has all of its ends pre-market tobacco

applications accepted for substantive

review by the FDA that's logic logic has

consistently acted responsibly since we

started logic has had numerous measures

to deter earth youth access to ends we

share your concerns regarding unlawful

products and those that intentionally

target minors or our marketed as low

risk or cessation products without

approval so as much as I am grateful for

the opportunity to participate today and

discuss the numerous challenges we face

I do not wish to be painted with the

same brush as others because we operate

differently we've made every effort to

responsibly market our products with

controls in place aimed at preventing

youth appeal and access we did this not

because it was mandated by law at the

time or because we were facing lawsuits

or because we generated bad publicity

with our products or marketing we did

this because it's the right thing to do

we don't suggest that our products or

cessation devices we have not and do not

use influencers to convince children or

adults to try our products

we're not evangelist claiming to offer a

cure for smoking other companies have

caused tremendous damage to the

reputation of this category while

putting America's youth in harm's way

logic has always and will always

responsibly market and sell its products

to adults only period from our first day

logics product packaging and website

have carried a warning clearly stating

that our products contain nicotine which

is addictive our products are for adults

only an underage sale is prohibited

purchases through our website have

always been restricted aged verified

adults and even before the deeming

regulations took effect we further

restricted sales to those aged 21 and

above perhaps others now have some of

these practices in place but introducing

these when you must rather than because

it's the right thing to do is different

altogether logic isn't a brand that

resonates with youth our online data

shows that logics typical consumer looks

much more like me than my adult children

this is not by chance it's the result of

the responsible steps that logic is

taken such as only using people who are

over the age of 30 and our consumer

marketing materials was it difficult to

stand by and watch others take a less

responsible approach and see our

competitors business soar yes it was

their growth came at great cost it is

tarnished the entire category caused a

serious youth uptake problem and created

doubt and fear in this country rather

than treated counterfeits products as an

excuse for the problems at hand logic

has committed substantial resources

towards eliminating them for nearly four

years we've worked with the FDA homeland

security CBP and law enforcement to stop

thousands of little illegitimate sales

of our products online and at retail we

vocally and consistently called for the

FDA to close the window that it opened

when it pushed the pmta deadlines back

and for the 58 to immediately and

robustly impose and enforce pre mark

regulatory requirements the FDA has the

authority to rid the market of products

that are not appropriate for their

protection of Public Health and to

determine based on science and evidence

including a likely impact on the

population as a whole whether a product

should remain on the market irrespective

of design irrespective of flavor

yes logic has flavored products that's

because many adults prefer them to the

taste of menthol the simple existence of

flavors doesn't cause a youth problem

what does is irresponsible marketing

combined with products that are designed

and marketed to appeal to youth that's

why we don't agree with wholesale bans

on flavors that's why we believe in

allowing the FDA to decide which

products should be on the market the PMT

process having never manufactured or

marketed our products to appeal to young

people having acted with responsibility

and integrity I and everyone at logic

will do what we can to support the

committee with this ongoing work thank

you for your time thank you so much mr.

Lofton it's now time for the committee

to ask crushes and the chair will

recognize herself for five minutes

people are confused when it comes to the

health and safety of e-cigarettes and I

heard this the other day over South High

School the US Surgeon General has noted

that young people try e-cigarettes

assuming that either they're less

harmful than other tobacco products or

even that they're not harmful at all so

I want to clear a couple of things up

with this panel these questions should

be able to be answered with a simple yes

or no answer so my first question is

isn't it true that nicotine is addictive

mr. Kraus weaith yes nicotine is

addictive

mr. Oberlander tea is addictive mr. Niva

cough yes mr. blunt a yes mr. Loftin yes

and isn't it true then that using the

products each of your companies makes

which contain contain nicotine could

lead to nicotine addiction mr. cosway's

yes nicotine is addictive and your

products could lead to nicotine

addiction correct yes

mr. Oberlander any product containing

nicotine is addictive and your products

that that people use containing nicotine

could cause people to become addicted

yes yes mr. Niva cough yes ma'am mr.

Pandey yes mr. Loftin yes and nicotine

can do you agree with the medical

studies that show that negative that

nicotine can have neck negative

consequences for respiratory health and

can cause an increase in blood pressure

heart rate and lead to heart disease and

also could harm brain development in

young people mr. Crosswhite is part of

our pmta we will have all of our studies

submitted to be reviewed so so have you

seen the studies that show that there

are these issues that I just mentioned

I'm not familiar that one you don't know

so do you do do you maintain that

nicotine causes no health consequences

in people then no nicotine is addictive

and does it have health consequences you

can cause harm yes but mr. Oberlander

did you hear my question about the

studies what's your view all scientific

team actually monitors all the

literature so so so would you agree that

nicotine could cause respiratory health

issues blood pressure heart rate and

brain development issues as I said

before nicotine is addictive and tobacco

products can cause harm could they cause

the harms I just talked about you don't

know mr. Niva cough what about you I'm

not in a position to corroborate and you

don't know you don't know if it could

cause those harms nicotine can cause

health issues on issues do you just not

in a position to what health issues do

you think they could cause nicotine can

raise your blood pressure okay it can it

can cause headaches mm-hmm okay but you

don't really know about any other things

I'm not aware of the studies I know

you're the CEO of the company okay

mr. Pandey nicotine is addictive and as

such can cause arm okay

the harm okay I find it fascinating no

one really wants to talk about what that

harm

the medical studies show that it can

cause respiratory health problems blood

pressure heart rate problems and brain

development problems in young people do

you think it caused any of those harms

I've noise them to doubt those studies

but I'm not aware thank you very much

mr. Lofton nicotine is addictive and we

put all the warning labels on where I

probably understand that do you think it

could cause the harms that I'm talking

about we're going to leave that up to

the FDA decide to the pmta process the

specific so you're not going to commit

to that either see when you say nicotine

is addictive I don't think that a lot of

young people understand what that means

in terms of health consequences

mr. Niva cough I was really moved by

what you said about your I think your

grandmother and your grandfather my

mother died of lung cancer at age 54

from smoking which she started doing

when she was under 21 and I sure she

knew it was addictive but I don't think

she had any idea and I think people

think that e-cigarettes sure they're

addictive but they're not going to cost

the same harm as cigarettes in fact we

don't really know now I want to ask you

another yes-or-no question maybe you'll

answer it do you agree with the CDC that

there's no completely safe tobacco

product including e-cigarettes mr. cross

with yes our products are not mr.

Oberlander including your cigarettes

mr. Niva cough yes ma'am I agree mr.

blunt a I agree and mr. Loftin all

tobacco products carry risk okay one

last question do you all agree that

there's a youth vaping epidemic in this

country and that people under 21 should

not be using e-cigarettes including your

products mr. Crossway I completely agree

mr. Oberlander other goods mr. Novik huh

yes ma'am I agree mr. Blunt absolutely

mr. Loftin I agree what did you want to

say one youth vaping is too many thank

you thank you very much I appreciate all

of you and now I've recognized mr.

Guthrie for five minutes good to see you

all here thank you for being here and I

want to begin by asking actually I want

to begin by

understanding the FDA's authorities so

concerns have been raised about

disposable products still being on the

market and therefore potentially

available to youth included newer

flavored products such as puffs bars or

posh and this is directed to mr. blunt a

mister never calm I want to make sure we

all understand FDA's authorities is it

correct that under the F the deeming

rule FDA can currently remove products

that enter the market after August the

8th 2016 yes sir that's correct that's

correct it's correct in fact the FDA has

usually Authority removing nearly a

hundred flavor products by Eon smoke

from the market in October of 2019 so to

mr. Pandey and mr. Novik office under

the January enforcement guidance what

actions can FDA take against

manufacturers of non cartridge based

products such as disposable products if

the AFT if the FDA finds the

manufacturers fail to keep them away

from minors who would you like to go

first sir you can go first yeah I think

what's what's sometimes lost in in the

FDA guidance is that there were three

prongs of the FDA's guidance document

that allowed FDA to take action against

products products that included flavors

and products that are targeted towards

minors or our manufacturer of a market

in a way that make them attractive to

youth so the products that you refer to

well I can't comment on their Genesis I

can say that to the extent that they

create an increased level of youth use

FDA has the sweeping authority to remove

them from the market summarily so you

answer that and all Isis mr. blonde day

to answer this second you first in a

second so what is your company because

they have disposable products for the

other so what what have you done to

prevent disposable products from being

available to youth well historically our

disposable products have not contributed

to really any statistically meaningful

level of youth use our historical

practices to avoid youth use across the

spectrum of our products have been

avoiding in Lynn in in in our case

eliminating all advertising activity

that that occurs outside of the confines

of the physical premises of a licensed

tobacco retailer how we've eliminated a

social media presence and then

specifically with respect to I think the

inference regarding flavored disposables

a week ago we made the decision to

voluntarily remove our flavored products

or flavoured disposable products from

stores albeit not because those products

have created increased access to youth

use we did so because we felt it was

consistent with the spirit of the FDA

guidance that the large businesses use

the PMT a process to adjudicate whether

or not flavors are appropriate for the

protection of Public Health okay mr.

blonde and I have another question to

get to so I want to you just what your

your companies to keep disposable

products out of the hands of youth what

is your company doing as for all of our

products we give all of our products

outside of the hand of use we're a very

robust use as access prevention program

and and this is through our marketing

practices all over it

the use of all the means that we put in

in marketing are only dedicated to other

consumers and we are being very careful

about that we are using as very strict

labelling rules as well to make sure

that our products are informative and

appropriate for consumption for adult

smokers only and we engage very activity

we are with our retailers partners to

make sure that not any product is being

sold to to youth I think and so the

other three cents our answer I would I

just want to get to what actions is your

company recent actions as your company's

taken to curb youth access to the

products and do you monitor access and

and how do you make sure youth aren't

using them and then I think mr. Loftin

use the term there they have controls in

place so if you want to talk about what

controls in place each of you the other

to kind of answer that question to keep

youth from having access to your product

thank you when I joined the organization

it was obvious to me that youth use

levels were unacceptable and we took

immediate action when I joined and we

pull back and stopped all of our product

our digital and broadcasts print

advertising when I saw the access that

youth were getting to certain flavors

including bars we stopped shipping mint

in November of last year we are also

focused at preventing access in the

retail channel and working on technology

solutions with retailers to ensure that

identification czar scanned and bulk

limit purchases are in place so that

transactions are only happening with

adults in retail stores it's it's an

effort that we are focused on and we

know we must combat the underage access

to

can I jump to mr. Oberlander and then

we'll get to mr. Loftin hopefully first

of all communication has been directed

to adult consumers 21 plus since the

very beginning second most of our

engagements is one-to-one

permission-based

third we are early supporters or tobacco

children one plus fourth we have

educated protocols in process for all

our online interactions fourth we have

state-of-the-art staged gauging for

online purchases if we have you ain't so

contracts with policies and penalties

but I took indulgence of the chairman

aloft and you said you have controls in

place or gonna give me a few seconds yes

sir we always have a health warning

online we have strict age verification

we have no marketing flavors that we

specifically go after minors consumer

marketing all our models are above 30

years old and we use no social

influencers thank you very much back

chair now recognizes the chairman of the

full committee for five minutes mr.

pallone thank you madam chair I just

wanted to say a little disclaimer here I

heard all of you over and over again say

you were responsible men men of

integrity that is not true

people who are have integrity and

responsibility I'll project which after

listening to mr. gets questions you

admit make people sick probably kill

people if you want to be men of

integrity and responsible men you would

not be selling this product you'd do

something else

so I just want you to understand I I'm

very upset by hearing this constant

reference to your integrity and

responsibility it's just false but I

wanted to get to the bottom of this I

don't believe for one minute that any of

you did not purposely target young

people but you're not going to MIT that

so let me get to my questions I continue

to be alarmed by the rapid increase in

the number of young people who are using

your product youth interest in curiosity

and e-cigarettes type stems not only

from availability and kid-friendly

flavors but also from the persuasive and

targeted marketing tactics and these

tactics are not dissimilar to those used

by big tobacco decades ago

instead of Joe Camel cigarette companies

have used social media to convince

consumers these products will make you

cool

a stanford study found that in the years

following the launch of its product

jewels advertising was and I quote

widely distributed on social media

channels frequented by youth was

amplified by hash tag extensions and

catalyzed by compensated influencers and

affiliates so my questions are all of

you mr. causseaux if I could ask the

others but I don't have enough time mr.

Krause wait at the time that you'll use

these tactics where any controls in

place to prevent their advertising and

marketing activities from reaching young

people briefly if you could answer were

there any controls or any effort to

prevent the advertising and marketing

from reaching young people so just to be

clear we do not do any of the social

media programs today they're not in

place now I'm talking about when you

started doing it for my recollection

looking back in time this company never

had any intention to market to youth I

know you're gonna say you had no

intention I don't think anybody who's

gonna admit their intent was to market

to youth but what I'm asking you at the

time that you were doing this were any

controls in place to prevent the

advertising and marketing activities

from reaching young people if the answer

is no you could say no it was before my

time at the counter it was before your

time so she module has acknowledged that

it was not able to prevent young people

from engaging with its product on social

media so I'm not going to issue that but

in the November 2018 release announcing

your action plan to address underage use

of e-cigarettes drill stated and I

quoted user-generated social media posts

involving troll products or our brand

are proliferating across platforms and

must be swiftly addressed unpro so mr.

Crosswhite what was the tipping point

that led jewel to decide that its

marketing practice were a problem that

needed to be addressed I know you're

going to say you didn't target young

people but your action plans state that

at some point you realize that the

social media was causing that so what

was the tipping point that led field to

decide that this marketing practices

were a problem that you should address

at what point well the company in the

past has

taking actions when youth data became

available and I believe it was in my

best recollection 2018 the company

stopped now you have disabled Facebook

and Instagram accounts but hashtags

involving your products continue to be

shared across these social platforms

despite your efforts to end your social

media presence is clear that your

influence continues to be active through

user-generated content as you indicated

and again in this action plan and I

quote there is no question that this

user-generated social media content is

linked to the appeal of vaping to

underage users so mr. Crosswhite after

years of marketing practices to attract

young people is it reasonable to say

that Jools actions were too little too

late I mean hasn't the train already

left the station because now you know

the under that the social media is being

used by the people themselves not by

yours so don't you so don't you think

that taking this off the market or all

social media was a little little too

late

yes or no when I joined the organization

I knew more needed to be done and that's

why I took the steps that I took to

combat this issue that we're facing ok

last question cuz only got a few minutes

do you agree that kids who cannot

legally purchase tobacco products should

never be the target of tobacco product

advertising including e-cigarettes izing

and marketing yes or no no the products

should never be intended to be marketed

to youth and that is not the company's

intention alright thank you thank you

madam chair recognizes mr. McKinley for

5 minutes thank you madam chair

I'm going to go back to the numbers of

studies that were done by the National

Academy of Science medicine and

engineering and as a result of all those

studies they made they've come to a

conclusion

they said that included in the vaping

products or heavy metals ultrafine

particles and talk seeking carcinogen

materials ingredients I'm gonna

any of you deny that there are ultrafine

particle let's just focus on the

ultrafine particles particles in the

fluids did any of you deny that these

particles are there despite the reports

across wait sorry I'm not familiar with

the specific report you're referring to

but I will tell you for our let's just

it's just a conclusion

do you really specifically to your

product

do you have ultrafine particles in your

product I'm not familiar with the

ultrafine particles that ultrafine

particles are defined as 1 micron 1

micron of materials it was in a hearing

earlier they indicated that one micron

exists in almost all if not all and

maybe even larger but their concern for

young people and well maybe for anyone

is 1 micron getting in someone's lungs

can have some long-term very deleterious

effect and if we're allowing one micron

to be in these fluids it's going to be

introduced to people's lungs and young

people won't be anyone this used this

product is going to have a health risk

health problem with it and they're

saying that so you don't know any the

rest of you acknowledge that yeah maybe

it's in there can I use your mic please

can you hear me no okay sorry I

understand your concern sir but we do

believe it actually through the PMT

applications we can actually provide

their TA with all the evidence

understand what's the level of exposure

of chemicals that you have mentioned in

other in other substances in order to

for the FDA to make a decision about the

impact on public health okay I'm not a

parent Lee I'm not gonna get quite the

answer I'm looking for or just an answer

just for people to understand one micron

the size of a micron most people

wouldn't understand

then but it 50 microns 50 microns or

visible to the naked eye we're talking

about one fiftieth of a micron it's

gonna be in your lungs we're gonna be

introducing it it's it's a millionth of

a meter we're talking about something

extremely small and if one micron

getting into your lungs you're gonna

have some long-term problem we have it

when we've been debating the Clean Air

Act and and issues on that we allow up

to two and a half that's that's a limit

we think that we can tolerate two and a

half but we're allowing this product to

be down to one micron significantly

causing long-term health care risks and

so Mike Mike I guess my concern is we're

not only are we allowing these small

microns to get into our lungs but we're

also allowing people to introduce other

cancerous materials the with this in THC

the acetate is that something that we

should be paying more attention to how

to prevent people from aftermarket

introducing a product into their device

and how do we make it so that it's it's

not tamper resistant but tamper proof so

that people can't play with this and

cause even more healthcare concerns CDC

has come out with quite a study about

all this the THC additive that we were

talking about the vitamin E acetate how

that's being put into aftermarket

utilization are any of you doing

anything to prevent the aftermarket

introduction of THC and this vitamin C

acetate any of you made a lot Bluffton

please yes congressman we have proceed

pre filled sealed cartridges that they

can't get in at this point okay so we

got one of you it's got a preventive

medicine preventive

I've run out of time I yield back thank

you thank the gentleman

chair now recognizes mr. Kowski for five

minutes so last September or the last

September president Trump promised to

take action to take all of the non

tobacco flavored products from the the

marketplace in response to the youth

beeping epidemic but he didn't that's

not true

incredibly the Trump administration

caved to special interests and created

exemptions for for disposable

e-cigarette in every imaginable flavor

and menthol flavored e-cigarettes

so mr. blondie this carve-out will allow

as my understanding that phantom vivid

vivid vanilla and cherry blast - these

are disposable products clearly not

aimed at adults to remain on the market

we'll get back to that later we already

have reports of use of young people

shifting to these fruit and dessert

flavored disposable products there's a

headline in The New York Times last week

that says teens find a big loophole in

the new flavored vaping ban so you so

you all say your products were created

to help adults to stop smoking tobacco

but thanks to your products this is an

entire generation of young people that

are now addicted to nicotine and we've

heard discussion about what that problem

can be and the microns and I think mr.

McKinley for that mr. Crosswhite jewel

cannot deny the the role of its legacy

in the epidemic jewel is lit as literal

a common room now Zhu Ling is now what

people are talking about and each of you

must accept responsibility for the role

that you have played in reviving the

youth tobacco epidemic

so mr. louvet peeing epidemic mr. Lufkin

yes or no do you believe the

administration's example for any

exemption rather for any disposable

product will leave many mint fruity and

other sweetie cigarette products easily

accessible to young people we were

disappointed in the guidance we thought

I should have gone further and all

companies and all products should have

been a part of the pmta process mr. aney

vakif enjoy recently decided to

voluntarily stop selling all flavored

disposable products and that they're not

available to youth do you believe there

is a risk that they will simply turn to

using disposable prop the disposable

flavored products as the data is

demonstrated and joy' hasn't contributed

statistically to youth use historically

so the notion that youth would switch

from our flavored disposable product to

another flavored disposable product is

is factually inaccurate because they

haven't been using it to begin with

so disposable e-cigarette are attractive

to youth because they cost less can be

easily hidden and have an enticing range

of flavors

mr. blondie given what you've heard here

today will you join enjoy and commit to

voluntarily suspending the sales of your

disposable vivid vanilla and cherry and

cherry crush products

our disposable products have been in the

market for about 10 years and as for all

the other disposable product is a widely

adopted by very older consumers we are

not aware of any issue current issue

caused by our disposable flavored and

the fact that the FDA excluded the

disposables from the guidance that we

will comply on completely but on

disposables we do have nine million

vapors in the US more or less adult

smokers that are currently using our

products which look like a cigarette it

has been designed like that and didn't

change of design in the last ten years

and we're not concerned that those are

also used by kids that they may be

attracted by those names we don't have

any any issue we've now had an issue

right now on on historical and we are

monitoring that very carefully I have a

concern though I've seen the New York

Times article recently about new

disposables coming into the market that

probably don't have a youth access

prevention program that would be robust

enough and as well apparently represent

some form factors that would be very

appealing my time has expired I fear a

lot of you relying on the Food and Drug

Administration and it seems to me with

that as much as we want to have the data

that you ought to know I was just

shocked that you did not know that about

the reports about the content of your

vaping products and I will I will yield

back thank you general chair now

recognizes mr. Duncan for five minutes

thank you madam chair and thank you all

for being here today you know e

cigarette products have been in use at

least since the early 2000s I believe

and I know we can all agree that the

youth vaping epidemic is a serious

problem but if you look at this has been

a recent development so you have to stop

and ask yourself if the products have

been out there for that long you have to

ask yourself why is this a recent

occurrence

I say recent within the last few years

if cigarettes were developed as an art

turn to tobacco products tobacco

products what you can contain tar and

other things that are damaging to the

body but you also have to ask yourself

if a products are used these cigarette

products are used in Europe and other

places in the world why are they aren't

seeing the uptick in health related

problems that we're seeing in the deaths

that we're seeing here in the United

States these are rhetorical questions

that we have to ask ourselves and I want

a reference madam chair a political

article dated October of 2019 and submit

it for the record that objection in that

article it also references that the

Trump administration is urging people to

avoid buying unregulated bait products

and I think we can point to the

unregulated bait products the black

market products and the tampered with

products as the leading cause for the

the health problems but they're not

seeing that in Europe in fact constantin

var Davos a European respiratory society

scientific regulations director within

the EU says this we have not seen

anything like what we're seeing in the

US recently in Europe to my knowledge as

a scientist and I'm pretty aware of the

field clive bates former chief of the UK

charity Action on Smoking and health

said this you're terrifying people who

are benefiting from vaping by not

smoking I think that was the ultimate

reason the e-cigarette products were

created in the first place so the

question I have is are youth being

pushed a black market where they're

finding THC pods and other counterfeit

products the lung illnesses that have

been reported over the last several

months are almost directly linked to the

black market products not the

commercially produced products by the

companies represented here today so I

think it's extremely important that we

have an ongoing conversation about how

your companies are working to minimize

the number of black market products and

what we in Congress can do instead of

attacking you for developing an

alternative cigarette use we ought to

talk about how we can work together to

help this industry because it is an

alternative smoking I personally believe

that much more could be done to assist

the Customs and Border Protection with

identifying

and Immigration and Customs Enforcement

which seems to get the ire of the left

but their customs enforcement officers

that are actually enforcing our customs

laws okay we need to help identify help

them to identify an intercept

black-market eat cigarettes so my first

question for all the witnesses is can

you speak to the relationships your

companies have with CBP agents and how

you're working alongside them to combat

the influx of black-market e-cigarettes

and I'll start mister constant thank you

and first are our hearts go out to

anyone who was hurt and impacted by the

unfortunate evilly situation and we were

fully supportive when that investigation

was going on and we do not sell any THC

products or products that contain

vitamin E but you're right to call out

the amount of illicit products that

exist in the United States market is it

difficult for the CBP officers to detect

a counterfeit product versus a

legitimate product if it's manufactured

overseas so we have a brand protection

organization within our company who

works with law enforcement Border Patrol

other regulatory agencies on education

awareness in helping combat this issue

mr. Wilander

when the valley crisis broke out we were

very concerned about I resolved for the

pain actually the families the victims

actually we're going through and we

immediately contacted the FDA and the

CDC offered our help we have knowledge

no confirm cases associated with obvious

products I mean associated with the

victims of the valley crisis can you

move the microphone back up I chemistry

it's okay

I'm not used and in this at the time I'm

running out here and indefinitely we

have worked with enforcement agencies in

order to curb illicit trade which is a

serious problem for this schedule amount

of time guys let me just reiterate we

need to work with customs order Patrol

immigration customs enforcement agencies

and this committee needs to work with

them as well even though we don't have

necessarily jurisdiction to figure out

how we can stop the counterfeit products

from coming in this country and address

the real problem and that is tampering

with the legitimate products and the

counterfeit products that people are

using in this country because apparently

it's not a problem Europe without I

yield back

gentleman yields back chair now

recognizes mr. Kennedy for five minutes

thank you madam chair for holding this

hearing thank you for our witnesses for

being here we've heard consistent

testimony from from all of you this

morning saying he's Martin these

products were designed to help people

transition off of cigarettes that they

were not designed to market to children

or youth in that if you're not a smoker

you should not start and echo some with

the skepticism for my colleagues some of

these products are marketed for $0.99

seems pretty easy to get started

I had a youth counsel from high school

students from my district with of course

the past ten four years there's probably

bout four years ago where a high school

student asked me if Congress was gonna

step in and regulate e-cigarettes

because everyone in their school was

smoking it's a bit difficult for us I

think that here you're concerning

critias it or your concern for youth

when their worth was systemic and

systematic and strategic social media

campaigns to get products in front of

kids it's very difficult for me to

understand I am certain that all of you

are safe followed this information I

can't imagine that your companies don't

I can't imagine you'd be CEO if you

didn't but when Johns Hopkins says from

2016 to 2018 and the adults and

non-smokers that are now using

e-cigarettes has doubled that there's no

six million people that you claimed were

not the target market audience for your

products that there's six million more

customers that have come in that weren't

the folks that supposedly at least

outwardly people were marketing to then

I had a 20-19 to Youth tobacco survey a

quarter of high school students had

vaped in the last 30 days and yet we're

saying we're not marketing to them

I think it's pretty hard to say that the

consequence of the products that you

have injected as the the ways in which

you have gone about your businesses

haven't

marketed to kids and we've seen mr.

cross wait I understand that you're

nearly at the position I understand that

the previous executives might not have

done things the way that you would

wanted your company would wanted

certainly I would have wanted so we've

seen a change there but respectfully

what are you gonna do fix it it's up

advertising now you can stop putting up

some of these bars and I appreciate that

but we've now created it an epidemic

that is gonna be touching that today

eighth quarter of all high school

students that the bars that you put up I

disagree a bit with miss Duncan's

formulation of this but he's not wrong

we now just have been deregulate you

created incentives for a black market

kids are gonna go someplace else your

company now is old news and they're off

to the next one because of an industry

that you helped create and there's

quotes in the New York Times from people

in your company that have said that that

was in fact never really the objective

and now you're before us saying yeah

we're open to regulation what are we

gonna do to stop this what do I do

and if the concern is a black market and

an evolution of new products that will

come out that don't have the robust

protections that you all are are now

putting in place would you pledge at

this moment not to purchase one of those

companies or acquire one of those

companies are engaged in those product

sales that's Crosswhite we're we do not

sell any you not sell well you not will

you pledge not to acquire a company that

is engaged in as you have put up bars

but there's new products out there from

new companies that don't face that

regulation would you pledge not to

acquire such a company with that engages

in the practices we're focused on is

submitting our pmta I haven't we have no

no plans at this time to zone no plan

mr. blender do a question please will

you will you pledge not to acquire a

company that does not currently abide by

the practices that you say you'll abide

by as they increase their own market

share will not focus on targeting and so

on that second non-answer mr. Nikolov I

would fully pledge fully pledged mr. Bob

on it we don't have any intent to

purchase a new company

you'll often we have no intent but we

will honor that we will always mark it

responsibly and so given that we have

now created this industry that has a

younger generation that is now addicted

what do you want us to do about it mr.

Carson I fully recognize that the

opportunity for the millions of adult

smokers who still use combustible

cigarettes to have an alternative is at

risk if we don't address this issue and

we are focused on combating underage

access because I know it puts it all at

risk if we don't make progress here sir

how do I trust what you say my actions

so far since I've joined support our

recognition that more needed to be done

so we've taken action and we recognize

more needs to be done to turn this issue

around we have been successful

converting millions of adults away from

the most harmful form of tobacco use and

it also recognized that's at risk if we

don't continue to make progress

you'll back sir now recognizes mr.

Griffith for five minutes thank you very

much madam chair I appreciate it

oh we heard testimony earlier from dr.

Nora Volkow this was at a previous

hearing that in December the number of

youth who were using the vaping products

were there was more there were more

youth using THC vaping products than

nicotine vaping products the youth

vaping epidemic is a separate health

concern from the e-cigarette vaping

Association lung injury a valley

outbreak the use of vitamin E acetate

THC has been strongly linked linked to

those lung illnesses is vitamin E

acetate used in any of your brand's

cartridges we'll start with you mr.

Crosswhite oh sweet no congressman oh no

sir no sir no sir

and do any of your your so none of your

companies sell anything that contains

THC or is specifically designed to be

used with THC products that can I assume

that to be correct correct we do not

know sir no sir no sir

now Ken your products be adulterated so

they can be used with THC products

modified or changed you know our

products are not designed to be changed

or modified they are a tamper resistant

all products also designed to be

temperate resistance same answer sir

same answer sir

our products are pre sealed cartridges

they can't get in them and what steps do

you have or plan to take to prevent

somebody using your device with with

some kind of a knockoff product that

could be used with one of your devices

so we take steps when we see in the

market illegal products that come on to

work to get them removed from the market

there are pods out there that are not

intended to be used with our device when

we see it we try to get them off the

market my knowledge this point in time

we don't

of any cultivate illicit products

actually for all views products anybody

actually monitored markets thank you

does anybody have a different answer

okay you know it's interesting because I

had some folks who own vape shops coming

to see me recently and what they said

was look we we want people to come in

and inspect us we want them to see that

we're using the right products that were

not selling anything that's contraband

or has been smuggled into the country or

that has THC when it's not you know not

supposed to be there and we don't sell

those products and would you all agree

that it's it's important that we have

regulations but that we also make it

possible for there to be outlets for

adults to go to vape shops instead of

being bought on a street corner from

some renegade company alright so we

completely support the FDA process and

believe it is the most appropriate body

to provide oversight for this industry

and in fact to preserve the chance for

adults to have access to alternate

system possible cigarettes and does

anybody else have a different answer or

something they'd like to add to that

Mister logic we don't believe it's going

far enough we think all products and all

companies should go through the same

process alright I appreciate that and I

also understand that some of some of you

make a zero nicotine product can you

explain why and for what purpose a

nicotine free EVP might service that

would be a vaping product for those who

are watching at home no nicotine we do

not make that product don't make that

product do you all make things anybody

else make that product at this point in

time we don't have it situated no sir

okay yeah we do tell me about it in some

cases some smokers have evolved their

way of taking nicotine and at blue we

want to offer a full range of nicotine

and they still want to have the the feel

of having something in in their mouth or

something that they're breathing in is

that wood yeah as in my opening

statement I mean some of some of our

other consumers decide to keep their

pressure professional experience with

our products but without nicotine right

mr. Loftin do you all have a product

like that no sir okay well very good

I was just about up and I appreciate you

the gentleman you'll be oh you do

37 seconds mr. blonde a what what

percentage of your sales are the known

nicotine each cigarettes I don't have a

precise number everybody it's it's quite

it's quite low quite low could you

supplement your answers with the exact

number I would be happy thank you so

much thank you

okay are you back sure now recognizes

miss castor for five minutes

well thank you madam chair for calling

this important hearing today it's really

highlighted how easy grits and vape

manufacturers have enticed young people

to their products now I'm particularly

concerned about companies marketing

through social media to target it's an

insidious use of social media to target

young people and its continued to happen

even after the harm has become clear to

to young people the addictive nature the

impact on the developing brain among

other health impacts mr. Cosway

prior to reforming your social media

marketing efforts in November 2018 a

large number of the jules social media

followers were young people in fact

according to the Journal of American

Medical Association Pediatrics almost

half of your Twitter followers were aged

13 to 17 you testified here today that

you should never Jule should never be

marketed to youth but they were

extensively marketing to youth in the

past I assumed that Jule addressed its

social media presence because it was

concerned about how its social media

activities did impact youth is that

correct it was before I joined the

organization when the company stopped in

social media activity and what we're

actually focused on today with social

media is getting post off so we look for

posts that we think are inappropriate we

ask them to be taken down so that the

the access to this type of information

is not available so mr. Bandhu you just

heard mister

swaye state that they have a strategy

the social media strategy but he

acknowledges social media doesn't impact

youth use of the vapes as a mayor major

player in the industry

phantom continues to use social media as

a marketing tool on one hand you've said

here today boy you're you have a an

access program you're trying to do

everything you can to discourage but on

the other hand you continue to actively

market to to you through social media

why do you do that we do not market to

youth in in any shape or form

well one aspect of phantom social media

activity I'm concerned about is the use

of the social media influencers underage

youth who may be blocked from your

social media accounts still can go to

youtube and see your posts that promote

your product the influencers promotion

of these products is especially harmful

because the popularity of the

influencers the individuals can sway

young people into believing that the

products are attractive and they're

trendy will you commit here today to end

your use of influencers to market the

vapes to young people we have currently

stopped producing any content from those

influences what have you done to the to

actively then and the influencers use

the the use on YouTube of all of those

videos we have a very strict measures as

as far as pretend to social media we

believe social media is an accepted

platform of communication for others

it's a I mean what social media is and

the use of the influencers now it makes

it very difficult to control the

dissemination of those market of the

marketing information mr. Crosswhite do

you think that e-cigarette the

e-cigarette industry as a whole should

end its use of social media as a

marketing tool given the difficulty in

preventing youth from

being exposed to this material

influencers included what I've been

focused on is CEO since I've joined is

taking every step I believe I can to

minimize that yes access to we're not on

social media I have stopped actually all

of our through the market leader now

what would you say to these other CEOs

who are not taking not going down the

same path I can just share what I have

been focused on which is addressing

youth getting any really access to to

information that they should not and

that's why I've taken the steps I have a

CEO mr. Loftin do you use influencers we

do not use influencers mr. McCaul no

ma'am we do not use influencers mr.

Oberlander it does not use social

influences so mr. Bandhu you're the odd

man out here again I mean the the use of

influences as far as well

the choice of influencers is making sure

that all people that we are interacting

to are above 25 and Lucca above 25 well

it's not good enough in today's age of

social media you've got to be proactive

and you've got to control if you're not

if you say on the one hand I'm not gonna

market to youth and on the other hand

you're allowing the dissemination of

videos and influencers on those

platforms you're you're really being

hypocritical and needs to be brought

under control we understand how harmful

these products are you have a

responsibility especially with the

growing harm the growing evidence of the

health impacts to young people not to

market to them I yield back my time

gentleman from New Hampshire mr.

Custer's recognized for five minutes

thank you cheering woman to get and

thank you for holding this very very

important hearing let me just start by

saying as a mother of two sons I spent

the last 30 years trying to keep them

from smoking cigarettes and instead

you've come into our life with nicotine

that is highly addictive so I wanted to

say based on the data that we are in the

precipice of minimizing tobacco's hold

on our Nathan

use but confronting alarming rates of

youth nicotine use as a result these

cigarettes are now the most commonly

used tobacco product among youth

surpassing the rate of youth use of

conventional cigarettes five years ago

in fact e cigarette use among youth

doubled again from 2017 to 2019

demonstrating that this problem is only

getting worse and in my home state of

New Hampshire the Department of Health

and Human Services estimates that at

least a quarter of high schoolers are

using vaping products and those numbers

are on the rise now doctor suit and ski

who was before this committee recently a

pediatrician from Dartmouth Hitchcock

has helped us to understand this very

issue based upon her testimony sworn

under oath

we know that biologically the brain is

more susceptible to nicotine addiction

during adolescence late adolescence

begins around 18 and for most lasts well

into the 20s a brain that is not exposed

to psychotropic drugs such as nicotine

during adolescence is less likely to

develop addiction my state is in the

throes of the worst opioid epidemic in

our lifetime that began with misleading

marketing and lack of regulatory

oversight and my fear is that we are

repeating those same mistakes and making

way for a new generation grappling with

addiction that we all fought to avoid so

I just want to say 26 years ago we had

tobacco companies CEOs sitting in this

room testifying before this committee

that they did not believe that nicotine

in their cigarette products was

addictive four years later the CEOs were

forced to admit to the risk of nicotine

and another hearing before this

committee today schools around the

country warn students about the harms of

nicotine particularly on developing

brains

mr. crow 3 jul 5 percent nicotine

content pod which the company claims

releases an amount of nicotine similar

to a pack

twenty cigarettes some young users

report going through a single jewel pod

in three hours to try to reduce their

nicotine and cake these young people are

now turning to combustible cigarettes to

reduce their nicotine and cake are you

aware of reports of e-cigarette users so

highly addicted to your products that

they feel the need to switch back to

regular cigarettes and if so do these

reports concern you come soon I share

your concern about the amount of youth

getting access to eBay / it's

unacceptable

I mean what's work to competitors that

you're doing about it today so since

I've joined the company about four

months ago we took action to address the

this issue so we stopped shipping when I

became a CEO in November our mint

product which at the time we got the

data that youth were getting access to

men and that was 70% of our company at

that time frame 70% going to youth for

nicotine addiction know 70% of your

profits were from this product that

youth were using is that the number

you're trying to explain to us no just

to clarify when we stopped shipping mint

in November at that time of all of our

sales that product was 70% of our

business that's what I'm trying to say I

mean for the American people 70% of your

product was going to youth in our

country and four months ago you stop

that practice so in November when I saw

that youth were getting access to mint

flavors and found it appealing I took it

off the market for our company what

about the other flavors that are

currently on the market so today we sell

tobacco and menthol in the company

menthol you cigarette yes in the US

market and do you think that's getting

access to youth well we paid very close

attention to the data is there any

reason not to take that off the market

well today there are over 10 million

Americans who use menthol combustibles

how many youth we saw the data menthol

was not one of the leading flavors that

you through getting access how many it

was quite small I believe in my

recollection as I believe the number was

a few percentage points but I'll have to

refer back to the report specifically my

time is up

I just want you to know mothers and

fathers across this country are watching

this hearing very carefully Thank You

chair now recognizes the ranking member

of the full committee mr. Walden for

five minutes

thank you get a madam chair for having

this hearing and as I mentioned my

opening statement I'm concerned about

the counterfeit products among other

things and the safety issues they

present in the e-cigarette space there

are plenty of news articles about

seizures of counterfeit jewel products

in particular I understand the FDA's

office Criminal Investigations has

several ongoing criminal investigations

related to counterfeit jewel products

that are unrelated to the lung injury

investigation so for each of you and

pretty quickly what concerns do you each

have about counterfeiting of your

product I don't think your mics on

excuse me

counterfeit products are an issue it's

something we've been very focused on the

United States market getting them off of

the marketplace all right at this point

in time we haven't seen any counterfeits

all right we've not seen any reports of

counterfeit supplies we don't see any

report of counterfeit product we're very

concerned about counterfeit and in fact

I'd love the show's share some of our

results by working with FDA Homeland

Security CBP and local law enforcement

all right yeah if you want real quick

through the help of everyone in that I

just mentioned and all the outside

agencies Factory we close the factory in

China shipping in we also at eight

seizures last year just in the US and

2019 1.5 million dollars worth of

product confiscated in Nassau County in

New York 681 cease-and-desist 1859

unauthorized online sellers if I could

get that from you I've got a couple

other questions I want to get to but I

appreciate you've answered the question

well but I'd like to get the full

from you across the way I want to go

back to you to make sure I understood

your answer to mr. Custer did you say

70% of jewels profits are come from

youth mint use I don't think that's what

you were saying right no no crime so

what I was saying is when we saw the

youth data write him out and that youth

were getting access to mint

we stopped shipping that in the United

States and when we stopped shipping mint

United States at that time it was 70% of

what the company sold in the United

States to all users not just youth

correct okay all right I want a few

months ago the entire industry in just a

few months I mean the entire industry is

going to undergo yet another shift when

the PMT a filing deadline passes after

May 12th only products for which a PMT

has been submitted can remain on the

market so question I have is how will a

consumer a retail store owner know which

products are allowed on the market after

this date and which one should be

removed

what kind of transparency should we be

thinking of do we need to do something

here once once that process is is

completed across wait anybody want to

take that yeah go ahead Sarah we look

forward to submitting our pmta in May

and to be in that process which we think

is a very important step for the

industry to go through for the FDA to

review these products and of course that

whatever way we need to be communicating

about our status in that process we'll

do so but to the retailers and consumers

right how will they know things are left

behind

yes a congressman as I mention my oral

statement it's paramount that actually

the FTA gives full transparency of all

products that have submitted MJ's so

that retailers enforcement agencies in

FDA actually have full visibility but

which products are eligible to be in the

market or not okay sir I can't speak to

my competitors however our products are

almost exclusively sold and highly

compliant Tier one channels with

corporate counterparties that have

fairly robust compliance groups within

their stores and as a result with

respect to our products I don't think

there will be any confusion we strongly

encourage the people the pmta process we

intend to submit or

here to the FDA by May and and I agree

that we strongly support the fact of

full transparency to make sure only

reliable actors retain the market mr.

Loftin we strongly agree with the pmta

process in fact we're in sustaining

review and working with him right now

all right perfect now this this issue

with cannabis THC whatever vitamin E

what's the best thing we can do here to

put a stop to that because that's

somewhere the lung injuries occurring

State like Oregon that's legalized

everything we're seeing this and if you

want to weigh in on what were the best

best course of action for Congress to do

to deal with that issue I think you add

all products and all companies involved

in that under the pmta process as well

like get at it I believe the FDA has a

discretionary power and the enforcement

power actually to understand the root

causes of the situation actually go

after they from the culprits in this

crisis all right and the benefit of a

pmta process is you have preclinical

clinical behavior research for us for

example we'll have 100 scientific

studies submitted so the FDA can fully

evaluate a product and determine if it's

appropriate for the protection of public

health all right my time is expired

thank you madam chair thank you to all

of you for your testimony thank the

gentleman chair now recognizes mr. Ruiz

for five minutes

thank you very much thank you all for

being here everyone here agrees that

youth should not be using vaping

products but it is still happening at

disturbing rates that's why this

committee accepted my bill the no vape

Act when we marked up the reversing the

youth tobacco epidemic act the no vape

Act would increase penalties on

retailers who sell vape products to

underage teens I'm also working on

legislation to require manufacturers to

label the vaping products not just the

packaging to make it clear that nicotine

in vaping is addictive and harmful to

health I'm a doctor I know that

and to make it clear for parents and

teachers to identify vaping products it

would also prohibit the sells of

products that are clearly being used to

attract teens with the ability to easily

conceal their use like this sweatshirt

the thread in the hood is the vaping

product or these vaping products

disguised as juice boxes juice boxes who

else are products like these marketed

toward but underage youth these are

egregious tactics that companies have

employed to attract an a dick youth to

their products and we must stop it mr.

Loftin in your testimony you linked the

dramatic increase in youth usage of

e-cigarettes to the combination of quote

irresponsible marketing and product

characteristics of others see cigarettes

can you describe the marketing tactics

and product characteristics you think

are driving youth use including the

companies that are or were engaging in

these practices sir I'm not here to talk

about the other companies but I will

tell you it's based on irresponsible

marketing exciting what exciting don't

have to name companies but give me

examples any reversible market exciting

colors exciting shapes exciting names

parties all kinds of different things

without warning labels it's all about

the atmosphere of having fun and it

shouldn't be marketed to youth so

despite company's attempts to address

public concerns about their marketing we

know that youth continue to be targeted

in guidance published just last month

the FDA stated that e-cigarettes quote

continue to be marketed to minors

through a wide variety of media and

technology mr. cross wait in your

testimony you state that jewel has quote

halted our broadcast print and jitter

Digital product advertising do you

believe that the e-cigarette industry

should be subject to the same

advertising restrictions as combustible

cigarettes if not why not

congressman I share your concern about

youth getting access to eBay they be

held under the same standards as

cigarettes I took the steps that in the

company because I felt it was critical

to limit any sort of awareness to tools

like we were using their addictive

products should they be held to the same

standards as smoking cigarettes

I think the FDA is gonna have complete

oversight over marketing practices I

chose to take the steps we did because I

felt significant action needed to happen

to address this issue all right so we

know that e-cigarette manufacturers have

also marketed their products through

various promotions such as highlighting

the affordability and various flavors of

their products certain promotions caught

our eye after the FDA announced its

recent guidance Reynolds and Fontan

began online promotions to sell flavors

affected by the new policy Reynolds

website banner promotion for instance

stated quote last chance to buy vapor

flavor packs last chance to get your

flavored packs and the homepage of font

ends website for its blue products

feature promotion for a quote last

chance flavor blowout to quote stock up

on selected liquid pods flavors before

they're gone and quote buy 10 products

get 15 free it's very obvious that those

who sell this product have their profit

in mind when they're marketing to the

public not the public's health notably

both promotions excluded menthol and

tobacco flavors the two flavors excluded

by FDA's flavor guidance mr. blondie

seems quite unabashed in its interest to

cash in on flavors FDA has deemed urgent

to take off the market don't you think

it's irresponsible of your company to

offload your remaining stock of flavors

in a fire sell at the same time FDA is

sounding the alarm on the appeal of

these products to youth the sense of our

work

very strictly controlled and only

accessible to 21 plus adults so you're

saying it's it wasn't your decision

you're not taking accountability for the

fact that while the FDA says let's

remove flavors you're trying to sell

your flavors and market these flavors

that mr. Lofton said would be considered

as an irresponsible act of marketing and

characteristics of a product we have

several promotion on our website and

this one was dedicated to our other

consumers currently enjoying those

flavors and making sure that they could

stock them before clearly flavors has

been a target for youth so you can say

the adults but clearly it's been a cause

for the youth epidemic yield back

gentleman from Maryland mr. sarbanes

recognized for five minutes

thank you madam chair um thank you to

the panel so I I understand that the the

the premise of the product that you keep

pointing to largely is to cure cigarette

addiction and move people off of

cigarette addiction but when you look at

the societal impact it seems to me that

the cure here may be worse than the

disease because we've now created the

next great public health crisis really

of scandalous proportions and it doesn't

it's implausible that your companies

didn't pick up pretty quickly that youth

vaping was contributing significantly to

the profitability of the bottom line I

don't know what the various cases out

there turned up yeah but I know that in

years to come we will see emails and

memos and other things from the sales

force going back and forth to

headquarters etc talking about the great

opportunities to boost the numbers from

certain kinds of sales you knew it was

happening and it wasn't until this got

to crisis proportions and there was

a public outcry that the accountability

kicked in so that's something that your

industry is going to have to live with

and unfortunately if something our youth

are living with and we'll be with them

into the into the future I wanted to

talk a little bit about the FDA's

decision because originally you know FDA

announced that it would ban all flavor

cigarette products hooray and public

health experts were encouraged by that

children's advocates and medical in a

way we couldn't believe it that the

president was move in there he's gonna

push on the FDA to do it it sounded

almost too good to be true as a really

forceful response to the crisis and then

of course it turned out it was too good

to be true because when the policy

ultimately came down it was

significantly weakened with exempting

multiple cigarette products so the

question I keep asking myself is what

happened why would the FDA the agency

that's tasked with regulating tobacco

and has one of their key areas of focus

protecting America's youth and ensuring

a healthier life for every family this

is mission oriented stuff why would they

walk it back their decision and I just

feel like it's got something to do with

how money moves in Washington so there's

a report from the American public media

it talks about the multi-million dollar

campaign a jewel launched to push back

on the government's efforts to restrict

vaping fuel hired an army of lobbyists

spending almost three million dollars on

lobbying the federal government more

than doubling its lobbying expenses from

2017 and 2018 combined the political

action committee reported spending two

hundred thousand dollars for candidates

and committees

and jewel dramatically increased its

spending in states to combat state level

efforts to restrict their products

reported 142 lobbyists registered in 48

states then with the Citizens United

case opening the floodgates on how dark

money comes into our politics and into

the policy-making apparatus up here we

saw companies like Reynolds American and

jewel investor I think 35 percent owner

Altria using their deep pockets to

influence the regulations Reynolds

American donated millions of dollars to

dark money groups like Americans for Tax

Reform Americans for Prosperity Altria

spent 295 million dollars on lobbying

since 1998 more than ExxonMobil spent in

the same time period so the problem here

is that this culture of responding to

legitimate scrutiny around a public

health crisis responding by turning up

your lobbying and money influence on the

hill means that the priorities that the

public wants to see are continuing to be

frustrated because there's an inside

game and I just wanted to speak to that

today I didn't give anybody the

opportunity to respond and I'm now use

my time but I think it's a real concern

and it's something that we need to shine

a light on because American public is is

frankly tired of it and I yield back

lady from New York is recognized for

five minutes mr. Clark I thank you madam

chair

I'm gentleman over the past decade our

public health agencies have become

increasingly concerned about the youth

favoring races have all of us in 2013

the Centers for Disease Control and

Prevention first sounded the alarm on

the increasing use of e-cigarettes among

youth and in 2018 the Food and Drug

Administration

declared youth vaping and

an epidemic yet the number of young

people using e-cigarettes has continued

to grow

today more than 5 million young people

use e-cigarettes mr. Nava cough is

cigarette use among youth a national

public health threat yes ma'am

the nation's leading public health

officials point to the attractiveness of

fruity and sweet flavors targeted

marketing tactics stealth design and low

cost and explaining the appeal of

e-cigarettes to youth mr. Loftin your

testimony testimony attributes the rise

in youth used primarily to quote youth

appeal of certain products that seem to

intentionally target minors end quote is

the loft in which products do you

believe intentionally target young

people congressman I'm not here to talk

about the other companies but I know

it's irresponsible marketing with high

exciting flavors and colors and shapes

and sizes that appeal to minors and if

they're doing that they should stop well

part of an industry sir so I don't know

how much you all interact with each

other outside of being called here to

testify before us but the whole industry

is basically under scrutiny right now

and if you feel as though you have

colleagues that are unscrupulous and

their practices it would seem to me that

the industry would have that

conversation miss mr. cross wait

according to national survey data nearly

60% of high schoolers and over half of

middle schoolers who vape report Jul as

their usual brand mr. cross wait why are

so many young people drawn to your

products so the jewels had great success

converting millions of adults who were

using combustible cigarettes and

otherwise wouldn't have quit hold on one

moment my question is why are so many

young people drawn to your products and

with that success with adults and that's

social sourcing plays a role in how

youth get access to vapor products an

unintended consequence of our success

was youth getting access to jewel so how

many young people do you estimate were

drawn into this because of the the adult

population that that you're quoting so

when we saw the youth data that came out

who those numbers are unacceptable and

too high what were those numbers the

publicly available numbers that you

don't know what the numbers are sir the

studies that came out were the

monitoring the future study that showed

that youth were getting access to

two-minute yeah but do you know what the

numbers are what did your study

indicates there they all indicated that

the youth use which is too high mr.

overland

beyond pointing to the specific product

how do we how did we get here what

caused more than five million youth to

start vaping madam Clark first of all I

share your concern I think the most

important point I would like to remind

you that you pull the mic closer sir

when views was a market leader between

2015-2017 youth vaping rates declined in

the National Youth tobacco survey I mean

it's from last year actually show that

less than five percent of the

respondents claim to have used views

additionally our consumer demographics

for views products indicate that

ninety-five percent of our consumers of

views actually twenty five and older and

seventy percent of them so are you

saying you just have no idea how these

five million you started vaping sir yeah

like we we don't really search you you

have a reasonable idea

we have only researched 21 and plus

individuals turning back to you mr.

Crosswhite in your testimony you

mentioned that jewel is quote combating

the serious problem of unto Jake

underage use yet as discussed youth

could you you views continues to

increase and young people are still

using your products in high numbers you

came to jewel from Big Tobacco

which has not always been a stalwart of

moaning public-health why should we take

your word for it when you say that jewel

is serious about combating youth use of

e-cigarettes I joined the company

because I believe in the historic

opportunity for adults to have another

option two combustible cigarettes who

otherwise wouldn't quit I also recognize

that's at risk if we don't solve this

problem the youth usage situation is

unacceptable

and when I joined I took action and

we're prepared to do more over time so

as those responsible for perpetuating

the practices that have so enticed young

people to your products I believe that

your industry must be willing to take

ownership over your actions and that

have contributed to our nation's youth

vaping epidemic each of you though you

try to differentiate what your companies

are doing are all collaborating in an

industry that is drawn in and will

continue to draw in young people unless

you take affirmative actions and or

unless we do so I yield back madam chair

gentleman from New York mr. Tonko is

recognized for five minutes

thank you madam chair mr. cross wait for

every person that gets off of a

combustible cigarette how many will get

hooked or start using an e-cigarette in

other words the addiction that might

come to e-cigarettes for young people

how many are we willing to tolerate the

youth rates are unacceptable and this

whole opportunity for adults we

recognize is at risk if we don't address

this issue I think we there is that

tipping point I think we really need to

take that into consideration we do not

want our young people to be the victims

that will be addicted become addicted

common sense and research show that

flavored products are an on-ramp to

youth a cigarette use according to an

NIH and FDA national survey nearly 80

percent of youth used a tobacco product

because and I quote it comes in flavors

I like industry claims that flavored

East cigarettes are important to help

some adult smokers quit whether these

flavors are necessary to

a person quit smoking is yet unproven so

mr. cross wait between November of 18

and November of nineteen dual

voluntarily removed all of its flavored

products except tobacco and menthol from

the US market was the increasing youth

use of non tobacco flavored products a

factor in this decision so when I joined

the organization when we saw the data

that youth were getting access to men it

is that data that drove the decision I

made which was to take mint off the

market for the company in November and

at our subcommittee hearing last fall

then acting FDA Commissioner Sharples

stated that the research is and I quote

very strong that flavors drive a child

to use mr. nib akov do you agree with

FDA that fruity and minty flavors

play a role in attracting our youth to

e-cigarettes I think that end Joy's data

overwhelmingly demonstrates that flavors

did not drive youth to our products and

Joy's has the lowest rate of youth use

amongst the four major brands and has

overwhelmingly by a multiple of greater

than 30 the lowest rate of violations

with ft of retail inspections despite

the overwhelming majority of our revenue

previously being derived from flavors

albeit all flavors will be off the

market as of tomorrow

well at the listening session that the

White House held this past November it

told the president and I quote flavors

are an issue they are attractive to

youth so how does that coordinate or

respond to the answer you just gave now

can you repeat that quote I don't recall

saying that sir the quote from the White

House listening session was and I quote

flavors are an issue they are attractive

to our youth are you certain that came

from me I might be I might have been

speaking colloquially about the industry

but I think the data clearly

demonstrates that flavors with respect

to n Joy's distribution which is the

only thing over which I exercise control

have not been a driver of youth use as

we are overwhelmingly

the industry leader in avoiding

youth you yeah we I have a document here

that has the transcript of the listening

session that was held on November 22nd

and so that was a direct lift from that

transcript I perhaps you could share the

context because out of context I don't

fully understand what what the comment

is but again enjoy is the overwhelming

market leader despite having the

overwhelming majority of our revenue

derived from from flavours we have the

lowest rate of youth use by any

measurable benchmark afforded by the

federal government again the context was

whether or not

flavors are of driving force so we'll

move on a recent study of e-cigarette

use among US youth found the use of mint

and menthol flavored e-cigarettes

increased sharply over the past three

years for Jul it was reported that it's

mint products contributed 70 percent to

its overall sales after it restricted

the availability of its fruit flavors

I'm concerned that FDA's action to

temporarily restrict certain flavored

East cigarettes does not go far enough

because it exempts menthol products

FDA's website describes menthol as and I

quote a flavor additive with a minty

taste and aroma

so mister Crossway given the

similarities between mint and menthol do

you believe it's possible that youth

using minty cigarette products may just

switch to those of menthol products I

think it's important to note the

differences today we now have tobacco 21

as the law of the land and our menthol

product is actually very different than

our mint product it is a tobacco based

formulation that that exists but do you

think it's possible that youth using

mint will switch to the menthol product

we know that the FDA is certainly going

to track it we're gonna do the same and

Mister Oberlander the same question to

you are you convinced that menthol won't

just become the new mint in terms of

popularity among youth tobacco and

menthol flavors have been not perceived

by the FDA there is no research to be

popular amongst youth however we will

continue monitor the market and we

we need to do the same well I'm

disturbed by what we know of youth

behavior and their likelihood to merely

shift from using fruity and mint

flavored cigarettes to menthol products

unfortunately I've not heard anything

this morning to convince me this won't

be the case and with that madam chair I

yield back thank you gentlemen

the ranking member and I will now each

ask one last round of questions and I'll

recognize the ranking member mr. Guthrie

for five minutes thank you for that and

again thank you for being here no doubt

each cigarettes must get out of the

hands of our youth and I want to ask

each of you just to verify before we

break today are you committed to

stopping all youth access and will you

commit to keep the committee updated as

you take actions to stop usage of

e-cigarettes mr. cross way we are

committed to combating access for youth

getting to Ebay per and we're happy to

keep you up to speed on all of our

actions we are committed and helping in

any way and then one final question

you've all submitted PMT azor indicated

you plan to submit p.m. tas and that's

important because in order to stay on

the market you have to submit PM tas and

there seems to be a lot of products that

aren't that are on the market that

aren't going down that direction but

currently there is no final regulation

from FDA on the pmta process including

whatever information should be submitted

and in what format do you think it would

be helpful for the FDA to finalize this

regulation before May 6 and if it

doesn't do it sooner rather than later

what setback will that caused your

process mr. Crosswhite we can just go

down the aisle we are preparing to

submit our FDA's we have opportunities

to engage with our regulator and get

feedback on the process even without the

final regulation you're getting feedback

to what you need to do without a final

regan place we have our regulatory

science organization that does engage

with the fda and to seek the appropriate

information to make our filing what a

final regulation be helpful sure any

clarity is always helpful but we're

confident that we're going to submit a a

fulsome application mr. Ober lender we

have submitted the first set of PMT

applications for views broadly

and we were actually probably the meter

of deadline to submit all others without

a final regulation in place you feel

confident that you're able to continues

clarity clarification of what the

process will be helpful for sure we

think the current guidance is sufficient

so no final R you can submit without a

final reg so we do plan to submit before

a final regulations promulgated

certainly we would welcome any

additional clarity but we don't think

it's a prerequisite mr. Bandhu we could

agree that we already process of

finalizing elders here for PMT and

submitting in date and we encourage

everybody and all the marks actors that

newmarket should do so mr. Loftin we've

already submitted our PMT A's we're in

substantive review we're working with

them right now we will work with him if

any new regulations come up thanks for

my point is I knew you had to move

forward because there's not enough time

if you aren't moving forward to go from

where we are today to have it by May the

six but I'm sure as if the Oversight

Committee FDA we would like to see FDA

have a final regulation as you are

moving for approval we think that's the

way the process should work but we

certainly understand you can't wait for

that to happen but we would like to

clarity is always important and

following the process the way it should

be follows important to us as well

well thank you for being here and I said

we we absolutely must get these

cigarettes out of the hands of our youth

and we'd like for you to update us as

you put new I think controls in place as

mr. Loftin said as you you shared with

what you do but as you move forward we

would like to see that as well thank you

and I yield back

thank you I thank the gentleman I just

have a couple quick questions one of the

things that the kids at my roundtable

earlier this week said is that that

people are just getting a cigarette saan

line now that the age has gone up to 21

mr. Loftin you said that you have very

strict online protections in before

you'll send send them out is that right

yes ma'am could you submit those for the

record we have already sent that to the

committee staff but okay thank you did

the rest of you all have very strict

online protections Mr Bond a you're

nodding yes mr. never cause with You mr.

O'Brien derp yes mr. okay thank you

second question that I had was these

cigarettes are being marketed as a

smoking cessation tool but partly

because we haven't had a final guidance

from the FDA these cigarettes are not

approved by the FDA as a smoking

cessation tool isn't that correct mr.

Crosswhite correct we do not mark it

today as a smoking cessation okay but

but they're not approved by the FDA is

that right correct okay the next

question I have and and I want to

commend all of you for now realizing the

extent of the problem five million you

youth vaping and I want to commend you

all for trying to remove the marketing

but have you also tried to figure out

ways that you can help contribute to

assess smoking cessation programs or

other programs to help kids get off of

this highly addicted substance it's it's

one thing just say we're not going to

market to you anymore but we already

have millions of underage kids who have

gotten addicted what are we going to do

about that mr. Oberlander you you seem

to be nodding

thank you try to get I think this is an

important issue as Americans we have

used tobacco prevention program called

right the seasons right now a very

significant amount of money behind only

last year we have 800 employees actually

contacting schools I mean talking about

the dangers and so you actually help

kids get off of nicotine would that be

accurate for Jul as well mr. cross with

we're trying to make sure they don't get

it in the first place

I understand prevention and the question

you're raising is an important one and

we'd be happy to engage so you're not

doing you don't have programs right now

to try to help to help people get off of

it we're not doing programs you what

about you mister Niva cough ma'am we

would support any recommendations that

you're done you're not aware of any

program you all have now no ma'am we

don't we don't past you mr. blonde a no

we don't correct you have programs and

we don't address would you be willing

Dickens

or something like that we're happy to

collaborate with the committee and coach

mr. Lofton we're very open to working

through that as well with the committee

you don't have any programs right

nothing specific okay I was I'm gonna be

honest I was pleased that all of you

admitted under oath that nicotine is

addictive but I was extremely dismayed

when I asked you about the health

problems with nicotine that you were all

extremely vague in your answers and

seemed to say well you're doing Studies

right now because it's actually been

quite it's it's been established that

nicotine itself has severe health risks

a report I've got two reports that I had

the staff go get me while we were

sitting here and their surveys of the

medical research and the Surgeon General

says nicotine exposure during

adolescence can cause addiction and harm

the developing brain but then it said so

these these kids get addicted then

they're addicted nicotine can cross the

placenta and has known effects on fetal

and postnatal development therefore

nicotine development delivered by

e-cigarettes during pregnancy can result

in multiple adverse consequences

including sudden infant death syndrome

and could resort it result in altered

corpus callosum deficits and auditory

processing and obesity it goes on to say

e cigarettes can expose users to several

chemicals including nicotine carbonyl

compounds and volatile organic compounds

known to have adverse health effects the

health effects and potentially harmful

doses of heated and aerosolized

constituents of e-cigarette liquids

including solvents flavorings and

toxicants are not completely understood

and it goes on to say e cigarette

aerosol is not harmless water vapor

although it generally contains fewer

toxic instant combustible tobacco

products the Indian Journal of medical

and pediatric oncology which was in 2015

so that was five years ago when we

already knew this

says nicotine poses several health

hazards cardiovascular respiratory

gastrointestinal disorders decreased

immune response and ill impacts on

reproductive health cell proliferation

oxidative stress upon ptosis DNA

mutation etc and so I asked the staff

I'm gonna put these studies in the

record but I also asked the staff to

make a copy to give to each of you

because I think you need to be aware

that once these kids get addicted then

the nicotine is also going to have

lifelong impacts as long as they stay

addicted I one last question for you mr.

Krauss wait and I appreciate that you

have said that jewel needs to get it

right and I appreciate the turning the

page looking forward you said for

example when you saw the youth data on

the mint you quit shipping the mint

because it was it was an unacceptable

level so here's my question to you let's

say the 2020 youth National Youth

tobacco survey does not show a decline

in the rate of youth use of e-cigarettes

despite all of the efforts that you and

the other companies and Congress and the

administration in raising the age to 21

have taken would you then consider

suspending the sales of all of your

products until health officials can

figure out how we can stop this youth

vaping epidemic well in just a few short

months we're gonna have our pmta in with

the FDA who will have all of the

information to make the determination if

in fact our product is appropriate for

the protection of public health and that

that's the process we think is best to

make that determination I'm glad you're

going through that process I'm glad

everybody's going through that process

but my question is will if if the number

of youth vaping doesn't go down despite

all of this with the efforts you've

taken already would you stop marketing

your cigarettes until we figure out how

to solve this epidemic

make well I've stopped all of our

broadcast print and digital marketing ad

so you're not prepared to go as far as

what I'm suggesting

wouldn't that be fair to say we have

taken serious actions to address this

issue and we're prepared to do more as

we go on okay but stopping sales all

together until we figure it out that's

not what you're thinking about we're

trying to preserve this opportunity for

the millions of adults while combatting

underage issue that exists you know I

got you know one answer and I got you

but I do really want to thank you for

coming and I want to thank all of the

witnesses for their participation in

this hearing we have a number of

documents that we want to put into the

record we already put representative

Duncan's article into the record we have

the 2015 study from the Indian Journal

medical and pediatric oncology I just

referred to we have the letter to the

committee from the National Association

of the county and city health officials

we have the New York Times article that

congresswoman Schakowsky referred to and

this 2016 Surgeon General report on the

dangers of nicotine I'd ask unanimous

consent that all of those be put in the

record so ordered I also want to remain

mem remind members that pursuant to the

committee rules they have 10 business

days to submit additional questions for

the record to be answered by the

witnesses and if the witnesses could

answer those questions we would very

much appreciate it and with that the

subcommittee is adjourned

Comments

Popular posts from this blog

Rusk County Held Forum On Drug And Vaping Use By Teens

Morris County is taking a proactive

approach to vaping in schools and the

community tonight the Y's uh pressed

County coalition discussed what everyone

should know about vaping opioids and

other drugs during a community forum CBS

19's Chloe Bradford spoke to County

officials about how they were planning

to combat the issue veyts mods joules

and smoke juice also known as cigarettes

is trending with teens that's what we're

seeing the major increase in this

they've gotten away so much from the

smoking aspect of it to the vaping part

of it because it's a lot easier

concealed it's a lot easier to get away

with the CDC received more than 2700

reports of lung injuries because of

e-cigarettes or vaping as of this month

there has been 47 new cases 64 deaths

and more deaths are currently under

investigation

Russ County Sheriff Jeff prices more and

more teens are taking on this trend in

East Texas but the younger kids they

don't understand and they're not awa…

Are Kids Using Disposable E-cigarettes To Get Around The Vape Flavor Ban?

I'm male or GM a cover story it's a
startling headline this morning about
teens and vaping despite the new
flavored vaping bans
some kids are finding a way around it
Paula Faris is back with details about
this good morning again Paula Murray
Robyn good morning ladies yes these
teens are finding a loophole over 25% of
high schoolers used e-cigarettes last
year according to the CDC most of them
flavored but since the flavor ban many
teams are finding a way around it
they're turning to disposable flavored
cigarettes high school sophomores Nicki
McClure and Nate Albritton do almost
everything together classes studying
hanging out after school they even
started vaping together we were just
like let's just try it because like to
us everyone was doing it the best
friends from Paducah Kentucky say they
quickly became hooked and when flavored
Jules went off the market last year they
switched to puff bars a brand of
disposable e-cigarette when the ban came
disposable was like y…

Why I Quit Vaping|How To Quit E-Cigarette

hey guys welcome back to my youtube

channel where I have an even bigger even

grosser even more fucking disgusting

bruise on my leg every single video I

fall alot okay no but actually hey guys

what's up welcome back to my youtube

channel if you're new here hello welcome

to my youtube channel I like to use my

hands too much in my videos wow I'm

doing so well today tape

there's just tape so it took me over a

year over a freaking year to realize how

badly vaping was affecting me and the

title of this video is the vaping ruined

my life and this isn't clickbait bathing

literally ruined my life for six months

and it was absolutely terrifying and

absolutely horrible I wish that I could

have been smart and realized that vaping

was picking up my brain and making me go

crazy but it took me a freakin long time

to realize this baby had major physical

and psychological effects on me and made

me feel like I was going crazy I thought

that I was going mentally insane I

thought tha…