[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]


                       VAPING IN AMERICA: E-CIGARETTE 
                    MANUFACTURERS' IMPACT ON PUBLIC HEALTH
=======================================================================

                                HEARING

                               BEFORE THE

                      SUBCOMMITTEE ON OVERSIGHT AND 
                              INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                               __________

                            FEBRUARY 5, 2020

                               __________

                           Serial No. 116-96
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

                   govinfo.gov/committee/house-energy
                        energycommerce.house.gov
                        
                              __________

                   U.S. GOVERNMENT PUBLISHING OFFICE                    
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                    COMMITTEE ON ENERGY AND COMMERCE

                     FRANK PALLONE, Jr., New Jersey
                                 Chairman
BOBBY L. RUSH, Illinois              GREG WALDEN, Oregon
ANNA G. ESHOO, California              Ranking Member
ELIOT L. ENGEL, New York             FRED UPTON, Michigan
DIANA DeGETTE, Colorado              JOHN SHIMKUS, Illinois
MIKE DOYLE, Pennsylvania             MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois             STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina    ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California          CATHY McMORRIS RODGERS, Washington
KATHY CASTOR, Florida                BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland           PETE OLSON, Texas
JERRY McNERNEY, California           DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont                 ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico            H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York                 GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice     BILL JOHNSON, Ohio
    Chair                            BILLY LONG, Missouri
DAVID LOEBSACK, Iowa                 LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon                BILL FLORES, Texas
JOSEPH P. KENNEDY III,               SUSAN W. BROOKS, Indiana
    Massachusetts                    MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California            RICHARD HUDSON, North Carolina
RAUL RUIZ, California                TIM WALBERG, Michigan
SCOTT H. PETERS, California          EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan             JEFF DUNCAN, South Carolina
MARC A. VEASEY, Texas                GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
                                 ------                                

                           Professional Staff

                   JEFFREY C. CARROLL, Staff Director
                TIFFANY GUARASCIO, Deputy Staff Director
                MIKE BLOOMQUIST, Minority Staff Director
              Subcommittee on Oversight and Investigations

                        DIANA DeGETTE, Colorado
                                  Chair
JAN SCHAKOWSKY, Illinois             BRETT GUTHRIE, Kentucky
JOSEPH P. KENNEDY III,                 Ranking Member
    Massachusetts, Vice Chair        MICHAEL C. BURGESS, Texas
RAUL RUIZ, California                DAVID B. McKINLEY, West Virginia
ANN M. KUSTER, New Hampshire         H. MORGAN GRIFFITH, Virginia
KATHY CASTOR, Florida                SUSAN W. BROOKS, Indiana
JOHN P. SARBANES, Maryland           MARKWAYNE MULLIN, Oklahoma
PAUL TONKO, New York                 JEFF DUNCAN, South Carolina
YVETTE D. CLARKE, New York           GREG WALDEN, Oregon (ex officio)
SCOTT H. PETERS, California
FRANK PALLONE, Jr., New Jersey (ex 
    officio)
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................     2
    Prepared statement...........................................     4
Hon. Brett Guthrie, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................     5
    Prepared statement...........................................     7
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     8
    Prepared statement...........................................     9
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................    10
    Prepared statement...........................................    11

                               Witnesses

K. C. Crosthwaite, CEO, JUUL Labs, Inc...........................
    Prepared statement...........................................    14
    Prepared statement...........................................    16
    Answers to submitted questions...............................   107
Ricardo Oberlander, President and CEO, Reynolds American, Inc....    21
    Prepared statement...........................................    23
    Answers to submitted questions...............................   125
Ryan Nivakoff, CEO, NJOY, LLC....................................    26
    Prepared statement...........................................    28
    Answers to submitted questions...............................   131
Antoine Blonde, President, Fontem U.S., Inc......................    32
    Prepared statement...........................................    34
    Answers to submitted questions...............................   136
Jerry Loftin, President, Logic Technology Development, LLC.......    38
    Prepared statement...........................................    40
    Answers to submitted questions...............................   140

                           Submitted Material

Report of E-Cigarette Use Among Youth and Young Adults: A Report 
  of the Surgeon General, submitted by Ms. DeGette \1\
Letter of February 3, 2020, to Ms. DeGette, et al., by Lori 
  Tremmel Freeman, CEO, MBA, National Association of County and 
  City Health Officials, submitted by Ms. DeGettee...............    84
Article ``Indian Journal of Medical and Paediatric Oncology," 
  submitted by Ms. DeGette.......................................    86
Article of January 31, 2020,``Teens Find a Big Loophole in the 
  New Flavored Vaping Ban, by Sheila Kaplan, The New York Times, 
  submitted by Ms. DeGette.......................................   101
Article of September 12, 2019, ``Europe's missing `vaping 
  sickness','' by Sarah Wheaton, Politico, submitted by Ms. 
  DeGette........................................................   103

----------
\1\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF02/
  20200205/110462/HHRG-116-IF02-20200205-SD005.pdf.

 
 VAPING IN AMERICA: E-CIGARETTE MANUFACTURERS' IMPACT ON PUBLIC HEALTH

                              ----------                              


                      WEDNESDAY, FEBRUARY 5, 2020

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:30 a.m., in 
the John D. Dingell Room 2123, Rayburn House Office Building, 
Hon. Diana DeGette (chairwoman of the subcommittee) presiding.
    Members present: Representatives DeGette, Schakowsky, 
Kennedy, Ruiz, Kuster, Castor, Sarbanes, Tonko, Clarke, Pallone 
(ex officio), Guthrie (subcommittee ranking member), McKinley, 
Griffith, Brooks, Duncan, and Walden (ex officio).
    Also present: Representative Shalala and Hudson.
    Staff present: Kevin Barstow, Chief Oversight Counsel; 
Jesseca Boyer, Professional Staff Member; Jeffrey C. Carroll, 
Staff Director; Dhindsa Manmeet, Counsel; Austin Flack, Staff 
Assistant; Waverly Gordon, Deputy Chief Counsel; Tiffany 
Guarascio, Deputy Staff Director; Judy Harvey, Counsel; Zach 
Kahan, Outreach and Member Service Coordinator; Chris Knauer, 
Oversight Staff Director; Joe Orlando, Executive Assistant; 
Kaitlyn Peel, Digital Director; Peter Rechter, Counsel; Alivia 
Roberts, Press Assistant; Tim Robinson, Chief Counsel; Emily 
Ryan, GAO Detailee; Benjamin Tabor, Staff Assistant; C. J. 
Young, Press Secretary; Jennifer Barblan, Minority Chief 
Counsel, Oversight and Investigations; Mike Bloomquist, 
Minority Staff Director; Diane Cutler, Minority Detailee, 
Oversight and Investigations; Jordan Davis, Minority Senior 
Advisor; Tyler Greenberg, Minority Staff Assistant; Brittany 
Havens, Minority Professional Staff, Oversight and 
Investigations; Peter Kielty, Minority General Counsel; Ryan 
Long, Minority Deputy Staff Director; Zach Roday, Minority 
Communications Director; Kristin Seum, Minority Counsel, 
Health; Kristen Shatynski, Minority Professional Staff Member, 
Health; and Alan Slobodin, Minority Chief Investigative 
Counsel, Oversight and Investigations.
    Ms. DeGette [presiding]. The Subcommittee on Oversight and 
Investigations hearing will now come to order.
    Today, the Subcommittee on Oversight and Investigations is 
holding a hearing entitled, ``Vaping in America: E-Cigarette 
Manufacturers' Impact on Public Health.'' The purpose of 
today's hearing is to examine the role of manufacturers in the 
marketing and use of e-cigarettes in the United States as well 
as the associated public health implications.
    The Chair now recognizes herself for the purposes of an 
opening statement.

 OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Today, we are 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 1 in 4 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 percent of his peers are 
using e-cigarettes.
    Now, as I have said before many times, this teen 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, e-
cigarettes pose risks 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, a fact also confirmed to me by the high 
school students.
    E-cigarette manufacturers have been negligent at best or 
intentional at worst in attracting young people to their 
products. Flavor options, concealable 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 vape--fully 
understand the health impact of e-cigarettes. What is worse is 
many of the young people actually believe that these products 
are safe or harmless, also confirmed 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 Congress decided to act. In December, 
Chairman Pallone, 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, to 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 
administration recently caved to industry influence. Despite 
the FDA's announcement last September that it intended to ban 
all non-tobacco- flavored e-cigarette products to address the 
rising youth use rate, the final policy issued in January 
includes exemptions and loopholes. Not only are menthol-
flavored e-cigarettes still allowed under the FDA's new 
guidelines, so are the fruity and sweet-flavored e-liquids and 
disposable e-cigarette products. These loopholes may lead to 
young people shifting to using menthol-flavored products or 
disposable e-cigarettes that remain on the market. In fact, 
there are reports that the shift is already happening.
    The kids at South told me that it is harder for them to get 
e-cigarettes at the gas station. Good news. The bad news is 
people are just going to these vape shops to get these 
products.
    While companies claim that the e-cigarettes have the 
potential to help adults who smoke combustible cigarettes, it 
is important that CDC cautions such as the health benefit would 
only apply if the smoker were able to quit completely. We know 
that a majority of adult e-cigarette users, however, are dual 
users, meaning they both smoke and 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 are using an e-cigarette, how many 
young people will start using those e-cigarettes and develop a 
lifelong nicotine addiction? We must ensure that we are not 
only attempting to solve one public health problem 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 am glad you gentlemen are here because 
the industry caused this mess, and the industry needs to be 
responsible for cleaning it up.
    Today, we are 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 are going to have a lot of questions. We are 
looking forward to this hearing.
    I know I went a little overtime, Mr. Guthrie, which I don't 
usually do. So, I am happy to give you another minute for your 
opening statement.
    [The prepared statement of Ms. DeGette follows:]

                Prepared Statement of Hon. Diana DeGette

    Today, we are 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, our 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 such 
products the year before.
    This week, I met with a group of high school students from 
my district. And while the most recent national survey found 
that one-in-four high school students are currently vaping, the 
students I met with tell me they believe the actual rate is 
much higher.
    In fact, one sophomore I met said he thinks more than 60 
percent of his peers are using e-cigarettes.
    As I have said many times before, this teen vaping epidemic 
is personal to me. No state has a higher percentage of its 
teens currently vaping than my state of Colorado.
    According to the Centers for Disease Control and Prevention 
(CDC), e-cigarettes pose risks to all users, but 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.
    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 begin using combustible cigarettes.
    E-cigarette manufacturers have been negligent, at best, or 
intentional, at worst, in attracting young people to their 
products.
    Flavor options, concealable 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 vape-fullyunderstand the health impacts of 
e-cigarettes.What's worse is that many young people actually 
believe these products are safe or harmless.
    That is simply 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 (FDA) gave 
them a temporary pass by exercising its enforcement discretion.
    No e-cigarette currently being sold in the United States 
has been fully reviewed by 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 young people are paying the price.
    That is why Congress decided to act.
    In December, Chairman Pallone, myself, as well as some of 
my other colleagues here today, took an important first step to 
raise the nationwide minimum age to buy any tobacco product--
including e-cigarettes-to 21.
    Clearly more needs to be done, such as advancing 
legislation I, Chairman Pallone, and others have introduced to 
tackle this public health priority.
    These efforts are all the more important given that the 
Administration recently caved to the industry influence.
    Despite the FDA's announcement last September that it 
intended to ban all non-tobacco-flavored e-cigarette products 
to address the rising youth use rate, the final policy issued 
in January includes exemptions and loopholes.
    Not only are menthol-flavored e-cigarettes still allowed 
under the FDA's new guidelines, but also too are the fruity and 
sweet-flavored e-liquids and disposable e-cigarette products.
    These loopholes may lead to young people shifting to using 
menthol-flavored products, or disposable e-cigarettes that 
remain on the market. In fact, there are reports that shift is 
already happening.
    While companies claim that their e-cigarettes have the 
potential to help adults who currently smoke combustible 
cigarettes, it is important to note that CDC cautions such a 
health benefit would only apply if the smoker is able to quit 
completely.
    We know that a majority of adult e-cigarette users, 
however, are "dual users," meaning they both smoke and vape, 
which could actually be more dangerous than using either 
product alone.
    The question now is: for every adult smoker who may quit 
smoking because they start using an e-cigarette, how many young 
people will start using e-cigarettes and develop a lifelong 
nicotine addiction?
    We must ensure we are not attempting to solve one public 
health problem 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.
    This industry caused this mess, and it needs to be 
responsible for cleaning it up.
    Today, we will hear from the companies responsible for 
these products. The executives here today represent the five 
companies with the largest e-cigarette market share in the 
country.
    Gentlemen, your industry ignited this fire. Now we all must 
put it out.
    I want to know how you intend to do it.
    I want to know what your company is doing today to prevent 
youth from getting their hands on your products.
    I want to know what your company will do if the youth 
vaping rate doesn't start to go down.
    And, I want to know how far your company is willing to go 
to help us fix this public health crisis that your industry has 
created.

    Ms. DeGette. And with that, I am pleased to recognize the 
ranking member of the subcommittee, Mr. Guthrie, for 5 
minutes--6 minutes.

 OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEATH OF KENTUCKY

    Mr. Guthrie. Six minutes. Well, thank you, Chair DeGette.
    I appreciate the opportunity to be here and appreciate all 
of our witnesses here this morning.
    I thank you for holding this important hearing, and I share 
your concern about youth vaping trends that have emerged in the 
United States in recent years.
    The U.S. Surgeon General has called e-cigarette use by 
youth an 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 
showed that 27.5 percent of youths--and, of course, you said 
that you think it is higher than that from your sample, there--
reported using these cigarettes compared with 20.8 percent in 
2018. We do know it is more, and the market has increased.
    The marketing of e-cigarette products to children must stop 
and youth access toe-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 have already made strides to curb youth access in 
tobacco since we last held a hearing in September. In December, 
as mentioned by the Chair, Congress passed, and President Trump 
signed into law, legislation to raise the legal age to purchase 
tobacco products, including e-cigarettes, from 18 to 21.
    On January the 2nd, 2020, FDA issued guidance, finalizing 
its enforcement policy regarding unauthorized flavored 
cartridge-based e-cigarettes that appeal to children, including 
fruit and mint. Under this policy, as of February the 6th, 
2020, tomorrow, companies must cease manufacturing, 
distribution, and sale of unauthorized flavored cartridge-based 
e-cigarette other than tobacco or menthol, or risk FDA 
enforcement action. This guidance also gives the FDA the 
ability to pivot 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 premarket tobacco 
product applications to FDA by May 12th, 2020, for deemed 
tobacco products, including e-cigarette products, that were on 
the market as of August the 8th, 2016. Through their 
applications, manufacturers or importers must demonstrate to 
the FDA, among other things, that 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 premarket 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 the e-cigarette 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 
bans and narrowing of what is legally available in the 
legitimate marketplace will almost certainly shift product use 
for existing users to other products that are still available.
    We must be vigilant in responding to this potential shift 
in utilization, which may result in an increase of black market 
or counterfeit demand for e-cigarette products. We must ensure 
that our efforts to protect our youth and the broader public 
health do not inadvertently create a bigger and more 
complicated problem.
     Though not directly related to today's hearing, I continue 
to be concerned about the lung injury outbreak associated with 
vaping and e-cigarette use. These illnesses have been closely 
associated with black market products and THC, a marijuana 
derivative. While the number of cases appear to have peaked 
when this subcommittee held its first e-cigarette hearing in 
September, we have since learned that, according to the Centers 
for Disease Control, an illness outbreak was strongly linked to 
vitamin E acetate and additive to THC or marijuana e-
cigarettes. We need to more clearly understand the cause of 
these illnesses.
    It is my understanding that the e-cigarette manufacturers 
have taken, and are continuing to take, their own actions to 
prevent youth access to their products. This hearing can serve 
as a constructive discussion for us to learn more about what 
these manufacturers are doing to prevent youth utilization of 
these cigarettes.
    Before I conclude, I would like to make a quick comment and 
recognize a subsidiary of Reynolds that is located in my 
district. It is Kentucky Bioprocessing. Kentucky Bioprocessing 
was founded in 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 it was a host for growing vaccines for Ebola, a 
population that was used in emergency situations in the 
previous Ebola outbreak, and is now working to address 
potential vaccines for the corona virus. I am glad that KBP is 
working on alternative uses for tobacco in order to better 
America's public health.
    I thank our witnesses for being here today and being part 
of this important discussion.
    And I yield back.
    [The prepared statement of Mr. Guthrie follows:]

                Prepared Statement of Hon. Brett Guthrie

    Chair DeGette, thank you for holding this important 
hearing. I share your concern about youth vaping trends that 
have emerged in the United States in recent years. The U.S. 
Surgeon General has called e-cigarette usage by youth an 
"epidemic," and warned that it threatens decades of progress 
toward ensuring that fewer young people use tobacco.
    The most recent data from the National Youth Tobacco Survey 
showed that 27.5 percent of youths reported using e-cigarettes, 
compared with 20.8 percent in 2018. 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 have already made strides to curb youth access to 
tobacco since we last held a hearing on this topic in 
September. In December, Congress passed and President Trump 
signed into law legislation to raise the legal age to purchase 
tobacco products, including e-cigarettes, from 18 to 21. On 
January 2, 2020, FDA issued guidance finalizing its enforcement 
policy regarding unauthorized flavored cartridge-based e-
cigarettes that appeal to children, including fruit and mint.
    Under this policy, as of February 6, 2020-tomorrow-
companies must cease manufacturing, distribution, and sale of 
unauthorized flavored cartridge-based e-cigarettes, other than 
tobacco or menthol, or risk FDA enforcement actions. This 
guidance also gives the FDA the ability to pivot 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 that the FDA should take, either alone or in 
conjunction with industry.
    Further, according to the FDA's new guidelines, 
manufacturers, like the ones before us today, must submit 
premarket tobacco product applications (PMTA) to FDA by May 12, 
2020, for deemed tobacco products, including e-cigarette 
products, that were on the market as of August 8, 2016. Through 
their applications, manufacturers or importers must demonstrate 
to FDA, among other things, that marketing of the new tobacco 
product(s) would be appropriate for the protection of the 
public health. As part of this determination, FDA must consider 
the risks 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 premarket applications by May 
12, any products for which an application is not submitted must 
be pulled from the market.
    These legal and regulatory developments will drastically 
change the e-cigarette 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 
bans and the narrowing of what is legally available in the 
legitimate marketplace will almost certainly shift product use 
for existing users to other products that are still available. 
We must be vigilant in responding to this potential shift in 
utilization, which may result in an increased black market or 
counterfeit demand for e-cigarette products. We must ensure 
that our efforts to protect our youth, and the broader public 
health, do not inadvertently create a bigger and more 
complicated problem.
    Though not directly relevant to today's hearing, I continue 
to be concerned about the lung injury outbreak associated with 
vaping and e-cigarette use. These illnesses have been closely 
associated with black market products and THC use. While the 
number of cases appear to have peaked when this Subcommittee 
held its first e-cigarette hearing in September, we have since 
learned that according to the Centers for Disease Control and 
Prevention (CDC) the illness outbreak was strongly linked to 
Vitamin E acetate, an additive in THC e-cigarettes. We need to 
more clearly understand the causes of these illnesses.
    It is my understanding that the e-cigarette manufacturers 
have taken and are continuing to take their own actions to 
prevent youth access to their products. This hearing can serve 
as a constructive discussion for us to learn more about what 
these manufacturers are doing to prevent youth utilization of 
e-cigarettes.
    Before I conclude, I would like to quickly recognize a 
subsidiary of Reynolds that is located in my district, Kentucky 
BioProcessing (KBP). KBP was very helpful with the development 
of the Ebola vaccine and is now working to address the 
coronavirus. I am glad that KBP is located in Owensboro, 
Kentucky, and doing great things for America's public health.
    I thank our witnesses for being here today and being part 
of this important discussion.

    Ms. DeGette. I thank the gentleman. The Chair now 
recognizes the chair of the full committee, Mr. Pallone, for 5 
minutes.

OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Madam Chair.
    I am pleased we are 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 are here to not only ask how this happened, 
but what is going to be done to reverse these dangerous new 
trends in tobacco use. While federal 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 is long past time that the Food and Drug Administration 
move forward with reviewing the health and safety risks 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 is 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 of 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 is why I am so disappointed that 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-cigarettes, and open tank systems mixed 
in vape shops. The President's announcement last month fell 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 
ban at all. And that is also why it is 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 ban, 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 garners 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 are doing to correct 
it. It is chilling to sit and watch as we are seeing history 
repeat itself. We have 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 it happens 
again. For that reason, I hope the 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 they didn't cause any addiction, 
that they actually were just bubble gum or cotton candy and 
that was it.
    It is the misleading marketing, in my opinion, that has 
caused this epidemic and made young people feel that there was 
absolutely no problem with vaping. And that is why all the 
gains that we made from trying to discourage tobacco use, 
cigarettes, putting the warnings, all that has evaporated now 
because we have this young generation that, until recently, 
just thought there was not a problem.
    And I am pleased to see that we have some younger people 
here in the audience today speaking out against this, not here 
necessarily, but outside and getting the public and the media 
more aware.
    Thank you, Madam Chair.
    [The prepared statement of Mr. Pallone follows:]

             Prepared Statement of Hon. Frank Pallone, Jr.

    I am pleased we are holding this hearing so that 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. 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. While federal 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 is long past time that the Food and Drug Administration 
move forward with reviewing the health and safety risks 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 is 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 of 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.
    That is why I am so disappointed that 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-cigarettes, and open tank systems mixed 
in vape shops.
    The President's announcement last month fell far short of 
the promises he made last year to address the youth tobacco 
epidemic.
    Don't be fooled-a so-called flavor ban that exempts menthol 
and vape shops is not a ban at all.
    And that is also why it is critical that we continue to 
move forward legislatively with a solution since this 
Administration will not.
    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 ban, it also bans certain non-face-
to-face sales and protects kids from predatory marketing.
    It is a comprehensive approach to end this epidemic, and I 
hope that it garners 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 are doing to correct 
it.
    It is chilling to sit and watch as we are seeing history 
repeat itself. We have been here before as the tobacco industry 
admitted to misleading millions of users on the safety of 
tobacco products.
    We cannot sit idly by as this happens again.
    For that reason, I hope the witnesses today are forthcoming 
and acknowledge the role they must play in reversing these 
dangerous and disturbing trends.
    Thank you and I yield back.

    Ms. DeGette. I thank the gentleman. The Chair now yields 5 
minutes to the ranking member of the full committee, Mr. 
Walden.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you very much, Madam Chair.
    And I, too, Mr. Chairman, am glad these young people are 
here. When I was a student body president in high school. I 
know it was a long time ago; I led the effort before the school 
board to get smoking out of the bathrooms. It wasn't legal 
there, but we actually created a smoking area outside, which 
was revolutionary. You had to have parental permission and all 
this other stuff, but we got it out of the bathrooms, because I 
hated smoking. I was the only one in my family that didn't 
smoke. And my, we have come a long way. So, stay involved in 
all of this.
     And, Mr. Guthrie, I would be curious, too. I am going over 
to the corona virus briefing for the House in a few minutes. 
So, I hope we can find out more about the work that is being 
done with the tobacco plant, because vaccines, and getting to 
them quicker, is something that we have all been working toward 
for a long time.
    So, Chair, thank you for holding this hearing.
    Electronic cigarettes or e-cigarettes, the long 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, 
EVALI.
    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 vaping 
products is strongly linked to the EVALI outbreak.
    While there is still more to learn about the EVALI and what 
causes it, we must remain vigilant about a separate, but 
equally alarming issue, the troubling statistics regarding e-
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 percent in 2018. It is a big jump from 11.3 
percent just three years ago.
    Given these trends, the Trump administration, the states, 
manufacturers, and all of you before us today in this 
Committee, are right to look for solutions to curb/stop youth 
access to e-cigarettes. I applaud the Trump administration's 
pursuit of a solution 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 U.S. Food and Drug Administration, FDA, 
issued guidance in January finalizing its enforcement policy 
regarding unauthorized flavored cartridge-based e-cigarettes 
that appeal to children, including fruit and mint. In addition 
to these two changes, the May deadline for manufacturers to 
submit the premarket tobacco product applications, PMTA, to FDA 
is quickly approaching, which will shift the industry's 
landscape even further.
    Now, while these are all promising steps, we remain 
concerned about the counterfeit and black market products that 
current e-cigarette users, including our youth, may 
increasingly turn to, when products they are currently using 
will no longer be available in the legal and legitimate 
marketplace.
    I am also concerned about the potential shifts of youth 
usage to other non-cartridge-based e-cigarettes, and I am 
interested in hearing from the companies today their thoughts 
on how we can prevent this from occurring.
    I would also like to note the irony of the Health 
Subcommittee of this full committee holding a hearing just two 
weeks ago that included bills to deschedule and decriminalize 
marijuana, much of which is smoke; 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 marijuana-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 descheduling or 
legalization of marijuana is, at best, inconsistent when 
considering long-term health outcomes and a lack of research 
and data.
    In addition to the committee's ongoing work, Chair DeGette, 
I hope you will invite the FDA to testify again once the PMTA 
deadline passes in May. I think we could really benefit----
    [The prepared statement of Mr. Walden follows:]

                 Prepared Statement of Hon. Greg Walden

    Chair DeGette, thank you for holding this hearing. 
Electronic cigarettes, or e-cigarettes, the lung illnesses 
associated with vaping, and the youth vaping epidemic are a 
major health concern in the United States, and particularly in 
my home state of Oregon, which unfortunately is one of the 27 
states where there was a confirmed death associated with the e-
cigarette, or vaping, product use-associated lung injury 
(EVALI).
    Since the Subcommittee's hearing in September with federal 
and state health officials, we have learned more about what 
caused the lung illnesses. According to the Centers for Disease 
Control and Prevention, laboratory data shows that vitamin E 
acetate, an additive in some THC-containing vaping products, is 
strongly linked to the EVALI outbreak.
    While there is still more to learn about EVALI and what 
causes it, we must remain vigilant about a separate, but 
equally alarming issue-the troubling statistics regarding e-
cigarette use among our youth. As Republican Leader Guthrie 
stated, the most recent data from the National Youth Tobacco 
Survey is alarming. About 27.5 percent of youth reported using 
e-cigarettes in 2019, compared with 20.8 percent in 2018. This 
is a big jump from 11.3 percent just three years ago.
    Given these trends, the Trump Administration, the states, 
manufacturers like the ones before us today, and this Committee 
are right to look for solutions to curb youth access to e-
cigarettes. I applaud the Trump Administration's pursuit of a 
solution 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 U.S. Food and Drug Administration (FDA) 
issued guidance in January finalizing its enforcement policy 
regarding unauthorized flavored cartridge-based e-cigarettes 
that appeal to children, including fruit and mint. In addition 
to these two changes, the May deadline for manufacturers to 
submit their premarket tobacco product applications (PMTA) to 
FDA is quickly approaching, which will shift the industry's 
landscape even further.
    While these are all promising steps, we remain concerned 
about the counterfeit and black-market products that current e-
cigarette users, including our youth, may increasingly turn to 
when products they currently use may no longer be available in 
the legitimate marketplace. I am also concerned about potential 
shifts in youth usage to other non-cartridge-based e-
cigarettes, and am interested in hearing from the companies 
today for their thoughts on how we can prevent this from 
occurring.
    I would also like to note the irony of the Health 
Subcommittee holding a hearing just two weeks ago that included 
bills about de-scheduling and de-criminalizing 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 access 
to marijuana, 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 de-
scheduling or legalization of marijuana, is at best 
inconsistent when considering long-term health outcomes and the 
lack of research and data.
    In addition to the Committee's ongoing work, I'd like to 
ask the Chair to invite FDA to testify again once the PMTA 
deadline passes in May. While we heard from FDA in September, 
it is critical to continue to hear from FDA as the issue 
evolves and as FDA begins to evaluate the manufacturers' PMTAs. 
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 PMTAs and accordingly remove their products from the 
market. We want to make sure FDA stands ready to address these 
issues as they arise to protect current e-cigarette users, but 
most importantly our youth.
    I want to thank the companies before us today for 
voluntarily agreeing to testify before the Subcommittee. While 
it is important to hear from these five companies and what they 
are doing to ensure that their products stay out of the hands 
of youth, they only represent a portion of the vaping industry, 
and one that is captured by the Administration's January 
guidance. This further underscores the importance for a more 
thorough examination of the industry writ large, as well as 
those manufacturing and selling counterfeit and black-market 
products.
    I look forward to listening to the testimony of the 
witnesses and working with our friends on the other side of the 
aisle to ensure that we make fully informed policy decisions to 
protect public health and our youth.
    I yield back.

    Ms. DeGette. We will.
    Mr. Walden. Excellent.
    While we heard from the FDA in September, it is critical 
for all of us to continue to hear from the FDA as the issue 
evolves and the FDA begins to evaluate manufacturers' PMTAs.
    We also need a full investigation to 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 PMTAs 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 for voluntarily 
coming here. It is important that we hear from you.
    And, Madam Chair, I appreciate you holding this hearing. I 
will have to go over to that corona virus for the Members, but 
we will be back and forth. And I yield back.
    Ms. DeGette. Take notes over there. OK?
    Mr. Walden. Yes, I will.
    Ms. DeGette. And I just want to say, I don't think there is 
anybody on this Committee that thinks marijuana should be 
legalized for people under 21.
    Mr. Walden. Here, here.
    Ms. DeGette. And in addition, I think everybody on this 
Committee will agree that we need to continue to do the 
research on that, too.
    Mr. Walden. Yes.
    Ms. DeGette. There has been woefully inadequate research.
    Mr. Walden. Fully agree.
    Ms. DeGette. In fact, we are planning to have a hearing on 
that sometime in the near future.
    Mr. Walden. Excellent. Thank you, Madam Chair.
    Ms. DeGette. The Chair would now ask unanimous consent that 
the members' written opening statements to be made part of the 
record. Without objection, so ordered.
    The Chair would also like to welcome Representative Shalala 
for joining us at the hearing today. Representative Shalala 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 they are not able to 
question witnesses. But I think we could all stipulate that she 
probably has more institutional knowledge about healthcare 
policy than anybody in this Congress. So, we are really happy 
to have you join us.
    I would now like to introduce our witnesses for today's 
hearing.
    Mr. K.C. Crosthwaite, CEO of JUUL, welcome.
    Mr. Ricardo Oberlander, who is the president and CEO of 
Reynolds America, Inc., welcome. Glad to have you.
    Mr. Ryan Nivakoff, CEO of NJOY, LLC.
    Mr. Antoine Blonde, who is president of Fontem U.S., is 
welcome.
    Mr. Jerry Loftin, who is the president of Logic Technology 
Development, LLC, and welcome to you, too, Mr. Loftin.
    Thanks to all of our witnesses for appearing today before 
the subcommittee.
    You are 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 are 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 no.
    If you would, then, please rise and raise your right hand, 
so that you may be sworn-in.
    [Witnesses sworn.]
    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 penalties set forth in Title 18, Section 1001, of the U.S. 
Code.
    The Chair will now recognize our witnesses for a 5-minute 
summary of their written statements.
    In front of each of you, there is 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 5 minutes have come to 
an end.
    And so now, Mr. Crosthwaite, I am delighted to recognize 
you for 5 minutes, please.

TESTIMONIES OF K.C. CROSTHWAITE, CEO, JUUL LABS, INC.; RICARDO 
 OBERLANDER, PRESIDENT AND CEO, REYNOLDS AMERICAN, INC.; RYAN 
  NIVAKOFF, CEO, NJOY, LLC; ANTOINE BLONDE, PRESIDENT, FONTEM 
      U.S., AND JERRY LOFTIN, PRESIDENT, LOGIC TECHNOLOGY 
                        DEVELOPMENT, LLC

                 TESTIMONY OF K.C. CROSTHWAITE

    Mr. Crosthwaite. Chair DeGette, Chairman Pallone, Ranking 
Members Guthrie and Walden, and other distinguished 
subcommittee members, my name K. C. Crosthwaite, and I am CEO 
of JUUL Labs, a position I assumed when I joined the company 
about four months ago.
    At JUUL Labs, our thousands of U.S. 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 of 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 contract, today, 21-plus is the law of the land, thanks 
to many of you on this Committee. Under FDA guidance, pod-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.
    At JUUL 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 
re-earn 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 cannot or will not quit, less 
harmful alternatives like vapor products should be available.
    Public health authorities agree that it is not the 
nicotine, but the burning of tobacco and smoke that causes 
disease and death. As the FDA noted in 2017, in a 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.'' End of 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. JUUL 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 JUUL products are able to successfully 
transition completely off of cigarettes. We will provide all of 
this research to the FDA through the PMTA 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 youth usage. If 
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 DeGette, 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 adults 
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 and I look forward to 
answering your questions.
    [The prepared statement of Mr. Crosthwaite follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. DeGette. Thank you so much.
    The Chair now recognizes Mr. Oberlander for 5 minutes for 
an opening statement.
    Actually, hold on for 1 minute. We are going to replace Mr. 
Crosthwaite's microphone, so you don't have to keep shifting 
back and forth all day.
    Thank you so much.
    Mr. Oberlander, you are now recognized for 5 minutes.

                TESTIMONY OF RICARDO OBERLANDER

    Mr. Oberlander. Chair DeGette, Ranking Member Guthrie, and 
members of the subcommittee, Chairman Pallone, Ranking Member 
Walden, and distinguished members, my name is Ricardo 
Oberlander. I am the president of Reynolds American, Inc.
    I appreciate this opportunity to share information about 
our company and to continue this important conversation today.
    Over a decade ago, Reynolds set a goal to transform the 
tobacco market 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 vaping 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 are as important as the products themselves. Our 
marketing is important. It is how we communicate with adult 
smokers about alternatives to combustible cigarettes.
    As detailed in our 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 
pose numerous restrictions on the content of our marketing and 
limit with whom we communicate.
    Our vapor brand is VUSE. Our consumer demographics confirm 
our focus on adults. Ninety-five percent of VUSE consumers are 
over 25 and 70 percent are over 35.
    With respect to youth vaping, when VUSE was the market 
leader through 2017, youth vaping rates actually declined. And 
the most recent National Youth Tobacco Survey results show that 
VUSE is not popular among youth. Thus, we have demonstrated, 
and continue to demonstrate, that it is possible to responsibly 
market alternative products and manufacture them under rigorous 
product stewardship standards.
    The increasing 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, and 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 and to adult consumers.
    Looking forward, FDA's premarket 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 PMTA submissions for our 
VUSE products.
    There are additional actions we encourage you to consider.
    First, transparency in the PMTA process is critical. We 
suggest FDA disclose which products have been submitted for 
PMTA approval. This will help retailers and the public know 
which vapor products are undergoing PMTA review and are 
eligible to remain on the market, 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 PMTA 
process, although thorough and welcome, would significantly 
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 
that vaping product are not safe and not for youth. We already 
include many such statements in 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 continued and expanded.
    In conclusion, we believe a level setting of the vapor 
market through the PMTA process will help address these serious 
issues facing us today. At the same time, it will foster the 
continued transformation of the tobacco category and 
significantly benefit public health.
    I thank the committee for the opportunity to share 
Reynolds' views about these important issues and reiterate our 
full commitment to cooperating with this Committee and FDA.
    [The prepared statement of Mr. Oberlander follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. DeGette. Thank you so much.
    Mr. Nivakoff, now you are recognized for 5 minutes, please.

                   TESTIMONY OF RYAN NIVAKOFF

    Mr. Nivakoff. Good morning, Chair DeGette, Chairman 
Pallone, Ranking Member Guthrie, Ranking Member Walden, and 
distinguished members of the subcommittee.
    My name is Ryan Nivakoff, and I am the CEO of NJOY. 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 NJOY's 
insights into this complex and vitally important conversation.
    By way of background, I joined NJOY for deeply personal 
reasons. As I am 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 well 
before her time and as my once-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 at NJOY 
nor other pioneers in 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, NJOY 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 as 
an opportunity for productive dialog to move forward together 
collectively to protect the public health.
    There are approximately 34 million Americans who still 
smoke combustible cigarettes and over a billion people 
worldwide. Those smokers face a greater than 50 percent chance 
of premature 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 healthcare 
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, NJOY 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, would be our undoing. We have 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 NJOY 
products. Indeed, in the most recent National Youth Tobacco 
Survey, NJOY's use 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 violation data 
consistently shows that NJOY's 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 3,300 violations, including electronic 
cigarettes, of which only 20 involved NJOY products, which is 
less than 1 percent. The following fiscal year, FDA recorded 
over 5,250 violations, only 28 of which involved NJOY products, 
barely one-half of 1 percent. And in the present fiscal year, 
NJOY products were involved in only eight violations of the 839 
recorded by FDA thus far, again, less than 1 percent.
    While NJOY will strive to continue to reduce this number 
even further, NJOY is proud of its track record of success thus 
far. To be clear, however, my goal is not to aggrandize NJOY'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 am 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 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.
    [The prepared statement of Mr. Nivakoff follows:]
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    Ms. DeGette. Thank you so much.
    I now recognize Mr. Blonde for 5 minutes for an opening 
statement.

                  TESTIMONY OF ANTOINE BLONDE

    Mr. Blonde. Chair DeGette, Chairman Pallone, Ranking Member 
Guthrie, members of the subcommittee, thank you for the 
opportunity to appear today before the House Committee on 
Energy and Commerce, Oversight and Investigations Subcommittee, 
to discuss the important issues regarding electronic nicotine 
delivery systems, ENDS, commonly referred to as e-cigarettes.
    My name is Antoine Blonde, and I am president of Fontem 
U.S. Incorporated. Fontem U.S. markets and sells the blu 
brands, which we acquired from another company in June 2015.
    As you are aware, Fontem has cooperated extensively with 
the committee's investigation since it began last August and 
provided several hundred pages of material in response to the 
committee's request for information.
    We believe the facts make clear that Fontem is a 
responsible actor in the e-cigarette marketplace, and we are 
committed to ensuring that our business practices are 
consistent with our objective of providing adult consumers only 
with the highest quality products and an enjoyable product 
experience.
    I would like to briefly address four points.
    First, Fontem believes, without equivocation that youth 
should not use any e-cigarette product. We share the 
subcommittee's view that preventing youth access to e-
cigarettes is an issue of critical importance. In this regard, 
Fontem does not, and has never, directed its marketing efforts 
for e-cigarettes to youth.
    Second, Fontem takes extensive steps to ensure that its e-
cigarettes sales channel reflects Fontem's commitment to youth 
access prevention. Fontem's e-cigarettes are sold through three 
main distribution channels: the traditional brick and mortar--
the convenience stores, the gas stations--ecommerce, and vape 
shops. In each distribution channel, Fontem takes steps to 
ensure that youth do not have access to blu products.
    Third, Fontem has invested extensively in its product 
stewardship program. Fontem is also committed to responsible 
product stewardship practices and ensuring product quality is 
thoughtfully integrated from product conception to consumer 
use.
    Fourth, Fontem's products have not been found by the U.S. 
Center for Disease Control to be involved in any of the 
incidents of respiratory illness it has investigated. We were 
deeply concerned by reports last year linking respiratory 
illnesses to the use of vaping products, and we joined calls 
for the CDC to investigate these instances as soon as possible.
    Vitamin E acetate is not, and has never been, an ingredient 
in blu products, and we are not aware of any Fontem product 
being referenced by the CDC as involving 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 THC, from unknown sources or in the black 
market. Of course, we will continue to monitor these 
developments very closely.
    These initiatives are some examples of Fontem's extensive 
efforts in the areas of youth access prevention and product 
quality. All of us at Fontem 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 Fontem U.S., we look forward to working 
with the Congress and FDA and continue doing so. And I am happy 
to answer any questions you will have.
    [The prepared statement of Mr. Blonde follows:]
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    Ms. DeGette. Thank you, Mr. Blonde. And I apologize for 
mispronouncing your name earlier.
    Mr. Loftin, you are now recognized for 5 minutes for an 
opening statement.

                   TESTIMONY OF JERRY LOFTIN

    Mr. Loftin. Chairman DeGette, Ranking Member Guthrie, and 
members of the subcommittee, thank you for inviting me to 
testify at this hearing.
    I am Jay Loftin, 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 
premarket tobacco applications accepted for substantive review 
by the FDA. That is Logic. Logic has consistently acted 
responsibly. Since we started, Logic has had numerous measures 
to deter youth access to ENDS.
    We share your concerns regarding unlawful products and 
those that intentionally target minors or are 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 have 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 was the right thing to do.
    We don't suggest that our products are cessation devices. 
We have not, and do not, use influencers to convince children 
or adults to try our products. We are not evangelists 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, Logic's product packaging and website 
have carried a warning clearly stating that our products 
contain nicotine which is addictive; our products are for 
adults only, and underage sale is prohibited. Purchases through 
our website have always been restricted to age-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 is the right thing to do, 
is different altogether.
    Logic isn't a brand that resonates with youth. Our online 
data shows that Logic's typical consumer looks much more like 
me than my adult children. This is not by chance. It is the 
result of the responsible steps that Logic has taken, such as 
only using people who are over the age of 30 in our consumer 
marketing materials.
    Was it difficult to stand by and watch others take a less 
responsible approach and see our competitors' businesses soar? 
Yes, it was. Their growth came at a great cost. It has 
tarnished the entire category, caused a serious youth uptake 
problem, and created doubt and fear in this country.
    Rather than treating counterfeit products as an excuse for 
the problems at hand, Logic has committed substantial resources 
towards eliminating them. For nearly four years, we have worked 
with the FDA, Homeland Security, CBP, and law enforcement to 
stop thousands of illegitimate sales of our products online and 
at retail.
    We have vocally and consistently called for the FDA to 
close the window that it had opened when it pushed the PMTA 
deadlines back, and for the FDA to immediately and robustly 
impose and enforce premarket regulatory requirements. The FDA 
has the authority to rid the market of products that are not 
appropriate for the protection of public health and to 
determine, based on science and evidence, including the 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 is 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 is why we don't 
agree with wholesale bans on flavors. That is why we believe in 
allowing the FDA to decide which products should be on the 
market through the PMTA 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.
     [The prepared statement of Mr. Loftin follows:]
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    Ms. DeGette. Thank you so much, Mr. Loftin.
    It is now time for the committee to ask questions, and the 
Chair will recognize herself for 5 minutes.
    People are confused when it comes to the health and safety 
of e-cigarettes, and I heard this the other day over at South 
High School. The U.S. Surgeon General has noted that young 
people try e-cigarettes, assuming that either they are less 
harmful than other tobacco products or even that they are 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.
    My first question is, isn't it true that nicotine is 
addictive? Mr. Crosthwaite?
    Mr. Crosthwaite. Yes, nicotine is addictive.
    Ms. DeGette. Mr. Oberlander?
    Mr. Oberlander. Nicotine is addictive.
    Ms. DeGette. Mr. Nivakoff?
    Mr. Nivakoff. Yes.
    Ms. DeGette. Mr. Blonde?
    Mr. Blonde. Yes.
    Ms. DeGette. Mr. Loftin?
    Mr. Loftin. Yes.
    Ms. DeGette. And isn't it true, then, that using the 
products each of your companies makes which contain nicotine 
could lead to nicotine addiction?
    Mr. Crosthwaite?
    Mr. Crosthwaite. Yes, nicotine is addictive.
    Ms. DeGette. And your products could lead to nicotine 
addiction, correct?
    Mr. Crosthwaite. Yes, they could.
    Ms. DeGette. Mr. Oberlander?
    Mr. Oberlander. Any product containing nicotine is 
addictive.
    Ms. DeGette. And your products that people use containing 
nicotine could cause people to become addicted, yes?
    Mr. Oberlander. Yes, they do.
    Ms. DeGette. Mr. Nivakoff?
    Mr. Nivakoff. Yes, ma'am.
    Ms. DeGette. Mr. Blonde?
    Mr. Blonde. Yes.
    Ms. DeGette. Mr. Loftin?
    Mr. Loftin. Yes.
    Ms. DeGette. And do you agree with the medical studies that 
show that nicotine can have 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. Crosthwaite?
    Mr. Crosthwaite. As part of our PMTA, we will have all of 
our studies submitted to be reviewed by the----
    Ms. DeGette. So, have you seen the studies that show that 
there are these issues that I just mentioned?
    Mr. Crosthwaite. I'm not familiar with the one you're 
referring to.
    Ms. DeGette. You don't know? So, do you maintain that 
nicotine causes no health consequences in people then?
    Mr. Crosthwaite. No, nicotine is addictive and----
    Ms. DeGette. And does it have health consequences?
    Mr. Crosthwaite. It can cause harm.
    Ms. DeGette. Yes.
    Mr. Oberlander, did you hear my question about the studies? 
What is your view?
    Mr. Oberlander. Yes, I did. Our scientific team actually 
monitors all the literature regarding----
    Ms. DeGette. So, would you agree that nicotine could cause 
respiratory health issues, blood pressure, heart rate, and 
brain development issues?
    Mr. Oberlander. As I said before, nicotine is addictive and 
tobacco products can cause harm.
    Ms. DeGette. Could they cause the harms I just talked 
about?
    Mr. Oberlander. I am not familiar with----
    Ms. DeGette. You don't know?
    Mr. Nivakoff, what about you?
    Mr. Nivakoff. I am not in a position to corroborate nor 
repudiate----
    Ms. DeGette. So, you don't know if it could cause those 
harms?
    Mr. Nivakoff. Nicotine can cause health issues. I am just 
not----
    Ms. DeGette. What health issues do you think----
    Mr. Nivakoff. I am just not in a position to corroborate--
--
    Ms. DeGette. Yes, what health issues do you think they 
could cause?
    Mr. Nivakoff. Nicotine can raise your blood pressure.
    Ms. DeGette. OK.
    Mr. Nivakoff. It can cause headaches.
    Ms. DeGette. OK. But you don't really know about any other 
things?
    Mr. Nivakoff. I am not aware of the studies that----
    Ms. DeGette. Even though you are the CEO of the company? 
OK.
    Mr. Blonde?
    Mr. Blonde. Nicotine is addictive and, as such, can cause 
harm.
    Ms. DeGette. OK. The harm, I find it fascinating no one 
really wants to talk about what that harm is. 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 could cause any of 
those harms?
    Mr. Blonde. I have no reason to doubt those studies, but I 
am not aware of them.
    Ms. DeGette. Thank you. Thank you very much.
    Mr. Loftin?
    Mr. Loftin. Nicotine is addictive and we put all the 
warning labels on our product.
    Ms. DeGette. I understand that. Do you think it could cause 
the harms that I am talking about?
    Mr. Loftin. We are going to leave that up to the FDA to 
decide through the PMTA process, the specifics of----
    Ms. DeGette. So, you are 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. Nivakoff, I was really moved by what you said about, 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 am 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 are 
addictive, but they are not going to cause 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 
will answer it. Do you agree with the CDC that there is no 
completely safe tobacco product, including e-cigarettes?
    Mr. Crosthwaite?
    Mr. Crosthwaite. Yes, our products are not without----
    Ms. DeGette. Mr. Oberlander?
    Mr. Oberlander. No tobacco product is safe.
    Ms. DeGette. Including your e-cigarettes?
    Mr. Oberlander. Including them.
    Ms. DeGette. Mr. Nivakoff?
    Mr. Nivakoff. Yes, ma'am, I agree.
    Ms. DeGette. Mr. Blonde?
    Mr. Blonde. I agree.
    Ms. DeGette. And, Mr. Loftin?
    Mr. Loftin. All tobacco products carry risk.
    Ms. DeGette. OK. One last question. Do you all agree that 
there is a youth vaping epidemic in this country and that 
people under 21 should not be using e-cigarettes, including 
your products?
    Mr. Crosthwaite?
    Mr. Crosthwaite. I completely agree.
    Ms. DeGette. Mr. Oberlander?
    Mr. Oberlander. Chair DeGette, one----
    Ms. DeGette. Mr. Nivakoff?
    Mr. Nivakoff. Yes, ma'am, I agree.
    Ms. DeGette. Mr. Blonde?
    Mr. Blonde. Absolutely.
    Ms. DeGette. Mr. Loftin?
    Mr. Loftin. I agree.
    Ms. DeGette. What did you want to say?
    Mr. Oberlander. One youth vaping is too many.
    Ms. DeGette. Thank you. Thank you very much. I appreciate 
all of you.
    And now, I recognize Mr. Guthrie for 5 minutes.
    Mr. Guthrie. 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, including newer 
flavored products such as Puff Bars or POSH.
    And this is directed to Mr. Blonde and Mr. Nivakoff. I want 
to make sure we all understand FDA's authorities. Is it correct 
that, under the Deeming Rule, FDA can currently remove products 
that enter the market after August the 8th, 2016?
    Mr. Nivakoff. Yes, sir, that is correct.
    Mr. Guthrie. It is correct?
    Mr. Blonde. It is correct.
    Mr. Guthrie. In fact, the FDA has used the authority, 
removing nearly 100 flavored products by EonSmoke from the 
market in October of 2019. So, to Mr. Blonde and Mr. Nivakoff, 
under the January enforcement guidance, what actions can FDA 
take against manufacturers of non-cartridge- based products, 
such as disposable products, if the FDA finds the manufacturers 
fail to keep them away from minors?
    Mr. Nivakoff. Who would you like to go first, sir?
    Mr. Guthrie. You can go first, yes.
    Mr. Nivakoff. I think what is sometimes lost 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 manufactured or marketed in a way that makes 
them attractive to youth.
    So, the products that you refer to, while I can't comment 
on their genesis, I can say that, to the extent that they 
create an increased level of youth use, the FDA has sweeping 
authority to remove them from the market summarily.
    Mr. Guthrie. So, since you answered that, I will ask Mr. 
Blonde to answer this second. You first and, then, second. So, 
what has your company--because they have disposable products 
where the others don't--what have you done to prevent 
disposable products from being unavailable to youth?
    Mr. Nivakoff. Historically, our disposable products have 
not contributed to really any statistically- meaningful level 
of youth use. Our historical practice to avoid youth use across 
the spectrum of our products has been avoiding, and in our case 
eliminating, all advertising activity that occurs outside of 
the confines of the physical premises of a licensed tobacco 
retailer. We have eliminated the 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, 
flavored 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 PMTA process to 
adjudicate whether or not flavors are appropriate for the 
protection of public health.
    Mr. Guthrie. OK. Mr. Blonde, I have another question to get 
to. Your company, to keep disposable products out of the hands 
of youth, what is your company doing?
    Mr. Blonde. As for all of our products, we keep all of our 
products outside of the hands of youth through a very robust 
youth access prevention program. And this is through our 
marketing practices. The use of all the means that we put in 
marketing are only related to adult consumers, and we are being 
very careful about that.
    We are using very strict labeling rules as well to make 
sure that our products are informative and appropriate for 
consumption for adult smokers only. And we engage very actively 
with our retailers/partners to make sure that not any product 
is being sold to a youth.
    Mr. Guthrie. Thank you.
    And some of the others, since you all answered, I just want 
to get to. What actions as your company, recent actions have 
your company taken to curb youth access to the products? And do 
you monitor access and how do you make sure youth aren't using 
them?
    And then, I think Mr. Loftin used the term they have 
controls in place. So, if you want to talk about what controls 
are in place each of you, the other two can kind of answer that 
question, to keep youth from having access to your product.
    Mr. Crosthwaite. 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 pulled back and 
stopped all of our product, our digital and broadcast/print 
advertising. When I saw the access that youth were getting to 
certain flavors, including the bars, we stopped shipping them 
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 identifications are scanned and bulk limit 
purchases are in place, so that transactions are only happening 
with adults in retail stores. It is an effort that we are 
focused on, and we know we must combat the underage access to 
e-vapor.
    Mr. Guthrie. Can I jump to Mr. Oberlander? And then, we 
will get to Mr. Loftin, hopefully.
    Mr. Oberlander. First of all, our communication has been 
directed to adult consumers 21-plus since the very beginning. 
Second, most of our engagement is one-to-one mission-based. 
Third, we are early supporters of Tobacco 21+. Fourth, we have 
age-gated protocols in process for all our online interactions; 
we have state-of-the-art stage-gating for online purchases. 
Fifth, we have enhanced our contractual policies and 
penalties----
    Mr. Guthrie. OK, I am out of time. But, with the indulgence 
of the chairman, Mr. Loftin, you said you have controls in 
place? So, you are going to give me a few seconds.
    Mr. Loftin. 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.
    Mr. Guthrie. Thank you very much.
    I yield back.
    Ms. DeGette. The Chair now recognizes the chairman of the 
full committee for 5 minutes, Mr. Pallone.
    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 have integrity and are 
responsible don't sell products which, after listening to Ms. 
DeGette's questions, you admit make people sick, and probably 
kill people. If you wanted to be men of integrity and 
responsible men, you would not be selling this product. You 
would do something else. So, I just want you to understand I am 
very upset by hearing this constant reference to your integrity 
and responsibility. It is 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 are not going to admit 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 and curiosity in e-cigarettes. That 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, e-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, JUUL's advertising was, and I quote, 
``widely distributed on social media channels frequented by 
youth, was amplified by hashtag extensions, and catalyzed by 
compensated influencers and affiliates.''
    So, my questions are all of you, Mr. Crosthwaite. I could 
ask the others, but I don't have enough time.
    Mr. Crosthwaite, at the time that JUUL used these tactics, 
were any controls in place to prevent the advertising and 
marketing activities from reaching young people? Briefly, if 
you could answer? Were there any controls or any efforts to 
prevent the advertising and marketing from reaching young 
people?
    Mr. Crosthwaite. Just to be clear, we do not do any of the 
social media programs today. They are not in place.
    Mr. Pallone. No, I am talking about when you started doing 
it.
    Mr. Crosthwaite. Yes, so, from my recollection, looking 
back in time, this company never had any intention to market to 
youth.
    Mr. Pallone. I know you are going to say you had no 
intention. I don't think anybody here is going to admit their 
intent was to market to youth. But what I am 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 can say no.
    Mr. Crosthwaite. It was before my time at the company and--
--
    Mr. Pallone. OK, it was before your time.
    Mr. Crosthwaite [continue]. We are not on social media.
    Mr. Pallone. JUUL has acknowledged that it was not able to 
prevent young people from engaging with its product on social 
media. So, I am not going to ask you that.
    But, in the November 2018 release announcing your action 
plan to address underage use of e-cigarettes, JUUL stated, and 
I quote it, ``User-generated social media posts involving JUUL 
products or our brand are proliferating across platforms and 
must be swiftly addressed.'' Unquote.
    So, Mr. Crosthwaite, what was the tipping point that led 
JUUL to decide that its marketing practices were a problem that 
needed to be addressed? I know you are going to say you didn't 
target young people, but your action plans state that at some 
point, you realized that the social media was causing that. So, 
what was the tipping point that led JUUL to decide that these 
marketing practices were a problem that you should address? At 
what point?
    Mr. Crosthwaite. Well, the company in the past has taken 
actions when youth data became available, and I believe it was 
in, my best recollection, 2018 the company stopped being on 
social media.
    Mr. Pallone. OK. 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, it is clear 
that your influence continues to be active through user-
generated content. As you indicated, 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. Crosthwaite, after years of marketing practices to 
attract young people, is it reasonable to say that JUUL's 
actions were too little too late? I mean, hasn't the train 
already left the station? Because now, you know, the social 
media is being used by the people themselves, not by yours. So, 
don't you think that taking this off the market or all social 
media was a little too late? Yes or no?
    Mr. Crosthwaite. Mr. Chairman, when I joined the 
organization, I knew more needed to be done. And that is why I 
took the steps that I took to combat this issue that we are 
facing.
    Mr. Pallone. OK. Last question, because I only have 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-cigarette advertising and marketing? 
Yes or no?
    Mr. Crosthwaite. No, the products should never be intended 
to be marketed to youth, and that is not the company's 
intention.
    Mr. Pallone. All right. Thank you.
    Thank you, Madam Chair.
    Ms. DeGette. The Chair now recognizes Mr. McKinley for 5 
minutes.
    Mr. McKinley. Thank you, Madam Chair.
    I want to go back to; there are number of studies that were 
done by the National Academies of Sciences, Engineering, and 
Medicine. As a result of all those studies, they have come to a 
conclusion that said that, included in the vaping products are 
heavy metals, ultrafine particles, and toxic and carcinogen 
materials, and ingredients. Do any of you deny that there are 
ultrafine particles? Let's just focus on the ultrafine 
particles, the particles in the fluids. Do any of you deny that 
these particles are there, despite the reports?
    Mr. Crosthwaite?
    Mr. Crosthwaite. Sorry, I am not familiar with the specific 
report that you are referring to, but I will tell you, for 
our----
    Mr. McKinley. It is just a conclusion. Really, specifically 
for your product, do you have ultrafine particles in your 
product?
    Mr. Crosthwaite. I am not familiar with the ultrafine 
particles that----
    Mr. McKinley. Ultrafine particles are defined as 1 micron, 
1 micron of materials. In a hearing earlier, they indicated 
that 1 micron exists in almost all, if not all, and maybe even 
larger. But the concern for young people--well, maybe for 
anyone--is 1 micron getting in someone's lungs can have some 
long-term, very deleterious effect. And if we are allowing 1 
micron to be in these fluids, it is going to be introduced to 
people's lungs in young people, old. Anyone that uses this 
product is going to have a health risk, a health problem with 
it. And they are saying that.
    So, you don't. Any of the rest of you acknowledge that, 
yes, maybe it is in there? Mr. Oberlander?
    Mr. Oberlander. If I can, I understand your concern, sir.
    Mr. McKinley. Use your microphone, please.
    Mr. Oberlander. Sorry. Can you hear me now?
    Ms. DeGette. Yes.
    Mr. Oberlander. OK, sorry.
    I understand your concern, sir, but we do believe that, 
actually, through the PMTA applications, we can actually 
provide the FDA with all the evidence in order to understand 
what is the level of exposure of chemicals that you have 
mentioned and other substances in order for the FDA to make a 
decision about the impact on public health.
    Mr. McKinley. OK. Apparently, I am not going to get quite 
the answer I am looking for--or just an answer. Just for people 
to understand, 1 micro, the science of a micron; most people 
wouldn't understand that, but 50 microns is below the naked 
eye. We are talking about 1/50th of a micron is going to be in 
your lungs; we are going to be introducing it. It is a 
millionth of a meter. We are talking about something extremely 
small. And at 1 micron getting into your lungs, you are going 
to have some long-term problems.
    When we have been debating the Clean Air Act and the issues 
on that, we allow up to two and a half. That is the limit we 
think that we can tolerate, the two and a half. But we are 
allowing this product to be down to 1 micron, significantly 
causing long-term healthcare risks.
    And so, I guess my concern is, not only are we allowing 
these small microns to get into our lungs, but we are also 
allowing people to introduce other cancerous materials that are 
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 is not tamper-resistant, but tamper-proof? So that 
people can't play with this and causing even more health 
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 is being put into aftermarket utilization. Are any of you 
doing anything to prevent the aftermarket introduction of THC 
and this vitamin E acetate? Any of you?
    Mr. Loftin. Congressman----
    Mr. McKinley. Mr. Loftin, please.
    Mr. Loftin. Yes, Congressman, we have pre-filled, sealed 
cartridges that they can't get in at this point.
    Mr. McKinley. OK. So, we have got one of you that has got a 
preventive.
    I have run out of time. I yield back. Thank you.
    Ms. DeGette. I thank the gentleman. The Chair now 
recognizes Ms. Schakowsky for 5 minutes.
    Ms. Schakowsky. Last September, President Trump promised to 
take action to take all of the non-tobacco-flavored products 
from the marketplace in response to the youth vaping epidemic. 
But he didn't. That is not true. Incredibly, the Trump 
administration caved to special interests and created 
exemptions for disposable e-cigarettes in every imaginable 
flavor and menthol-flavored e-cigarettes.
    So, Mr. Blonde, this carveout will allow, it is my 
understanding, that Fontem ``Vivid Vanilla'' and ``Cherry 
Blast''--these are disposable products, clearly not aimed at 
adults--to remain on the market. We will get back to that 
later.
    We already have reports of young people shifting to these 
fruit- and dessert-flavored disposable products. There was a 
headline in The New York Times last week that says, ``Teens 
Find a Big Loophole in the New Flavored Vaping Ban''.
    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 have heard discussions about what that problem 
can be and the microns. And I thank Mr. McKinley for that.
    Mr. Crosthwaite, JUUL cannot deny the role of its legacy in 
the epidemic. JUUL is literally a common verb now; ``JUULing'' 
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 or youth vaping epidemic.
    Mr. Loftin, yes or no, do you believe the administration's 
exemption for any disposable product will leave many mint, 
fruity, and other sweet cigarette products easily accessible to 
young people?
    Mr. Loftin. We were disappointed in the guidance. We 
thought it should have gone further and all companies and all 
products should have been a part of the PMTA process.
    Ms. Schakowsky. Mr. Nivakoff, NJOY recently decided to 
voluntarily stop selling all flavored disposable products, and 
that they are not available to youth. Do you believe there is a 
risk that they will simply turn to using the disposable 
flavored products?
    Mr. Nivakoff. As the data has demonstrated, NJOY 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 factually 
inaccurate because they haven't been using it, to begin with.
    Ms. Schakowsky. So, disposable e-cigarettes are attractive 
to youth because they cost less, can be easily hidden, and have 
an enticing range of flavors. Mr. Blonde, given what you have 
heard here today, will you join NJOY and commit to voluntarily 
suspending the sales of your disposable ``Vivid Vanilla'' and 
``Cherry Crush'' products?
    Mr. Blonde. Our disposable products have been on the market 
for about ten years, and as for other disposable products, 
these are widely obtained by very older consumers. We are not 
aware of any issue, current issue, caused by our disposable 
flavors.
    And the fact that the FDA excluded the disposables from the 
guidance, we will comply on completely, but on disposables, we 
do have 9 million vaporers in the U.S., 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 
the design in the last ten years.
    I am aware----
    Ms. Schakowsky. And you are not concerned that those are 
also used by kids, that they may be attracted by those names?
    Mr. Blonde. We don't have any issue.
    Ms. Schakowsky. No, you----
    Mr. Blonde. We don't have an issue right now on historical, 
and we are monitoring that very carefully.
    I have a concern, though. I have seen The New York Times 
articles 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, will be in 
some foam factors that will be very appealing to these----
    Ms. Schakowsky. My time has expired.
    I hear a lot of you relying on the Food and Drug 
Administration, and it seems to me that, as much as we want to 
have the data, that you ought to know--I was just shocked that 
you did not know about the reports about the content of your 
vaping products.
    And I will yield back.
    Ms. DeGette. I thank the gentle lady. The Chair now 
recognizes Mr. Duncan for 5 minutes.
    Mr. Duncan. 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 that we can all 
agree that the youth vaping epidemic is a serious problem. But 
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.
    E-cigarettes were developed as an alternative to tobacco 
products, tobacco products which can contain tar and other 
things that are damaging to the body. But you also have to ask 
yourself, if e-products are used, e-cigarette products are used 
in Europe and other places in the world, why they aren't seeing 
the uptick in health-related problems that we are seeing and 
the deaths that we are seeing here in the United States. These 
are rhetorical questions that we have to ask ourselves.
    And I want to reference, Madam Chair, a Politico article 
dated October of 2019 and submit it for the record.
    Ms. DeGette. Without objection.
    [The information appears at the conclusion of the hearing.]
    Mr. Duncan. In that article, it also references that the 
Trump administration is urging people to avoid buying 
unregulated vape products. And I think we can point to the 
unregulated vape products, the black market products, and the 
tampered-with products as the leading cause for the health 
problems. They are not seeing that in Europe.
    In fact, Constantine Vardavas, a European Respiratory 
Society Scientific Regulations Director within the EU says 
this, ``We have not seen anything like what we are seeing in 
the U.S. 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 benefitting 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 to the 
black market where they are 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 is 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 to 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 there are Customs Enforcement officers that 
are actually enforcing our customs laws. OK? We need to help 
them to identify and intercept black market e-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 are working alongside them to combat the influx of 
black market e-cigarettes? And I will start with Mr. 
Crosthwaite.
    Mr. Crosthwaite. Thank you.
    And first, our hearts go out to anyone who was hurt and 
impacted by the unfortunate EVALI 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 are right to call out the amount of illicit 
products that exist in the United States market.
    Mr. Duncan. Is it difficult for the CBP officers to detect 
a counterfeit product versus a legitimate product, if it is 
manufactured overseas?
    Mr. Crosthwaite. Yes. So, we have a brand protection 
organization within our company who works with law enforcement, 
Border Patrol, and other regulatory agencies, on education, 
awareness, and helping combat this issue.
    Mr. Duncan. Mr. Oberlander? Put your microphone on.
    Mr. Oberlander. Mr. Congressman, first of all, this is a 
very serious issue and I understand your concern. When the 
EVALI crisis broke out, we were very concerned about, I mean 
very sorry for the pain that actually the families of victims 
were going through. And then, we immediately contacted the FDA 
and the CDC, offering our help. We had, to my knowledge, no 
confirmed cases associated with our VUSE products. I mean 
associated with the victims of the EVALI crisis.
    Ms. DeGette. Can you move the microphone back up again? It 
is okay.
    Mr. Duncan. And in the essence of time, I am running out 
here.
    Mr. Oberlander. OK. And then, definitely, we have worked 
with enforcement agencies in order to curb illicit trade, which 
is a serious problem for this country.
    Mr. Duncan. Yes. I am out of time, guys. Let me just 
reiterate, we need to work with the Customs and Border Patrol 
and Immigration and Customs Enforcement agencies, and this 
Committee needs to work with them as well, even though we don't 
necessarily have jurisdiction, to figure out how we can stop 
the counterfeit products from coming into 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 is not a 
problem in Europe.
    And with that, I yield back.
    Ms. DeGette. The gentleman yields back. The Chair now 
recognizes Mr. Kennedy for 5 minutes.
    Mr. Kennedy. Thank you, Madam Chair, for holding this 
hearing.
    Thank you to our witnesses for being here.
    We have heard consistent testimony from all of you this 
morning saying these products were designed to help people 
transition off cigarettes, that they were not designed to 
market to children or youth, and that if you are not a smoker, 
you should not start.
    To echo some of the skepticism from my colleagues, some of 
these products are marketed for 99 cents. It seems pretty easy 
to get started.
    I had a youth council of high school students from my 
district over the course of the past several years. It was 
probably about four years ago when a high school student asked 
me if Congress was going to step in and regulate e-cigarettes 
because everyone in their school was smoking.
    It is a bit difficult for us, I think, to hear your concern 
for youth when there were systemic and systematic and strategic 
social media campaigns to get products in front of kids. It is 
very difficult for me to understand--and I am certain that all 
of you have followed this information--I can't imagine that 
your companies don't. I can't imagine that you would be a CEO 
if you didn't.
    But when Johns Hopkins says, from 2016 to 2018, the adult 
non- smokers that are now using e-cigarette products has 
doubled, that there are now 6 million people that you claim 
were not the targeted market audience for your products, but 
there are 6 million more customers that have come in that 
weren't the folks that supposedly, at least outwardly, people 
were marketing to. In a 2019 Youth Tobacco Survey, a quarter of 
high school students had vaped in the last 30 days. And yet, we 
are saying we are not marketing to them. I think it is pretty 
hard to say that the consequence of the products that you have 
injected, and the ways in which you have gone about your 
businesses, haven't marketed to kids.
    Mr. Crosthwaite, I understand that you are newly at the 
position. I understand that the previous executives might not 
have done things the way that you would have wanted and your 
company would have wanted, and certainly I would have wanted. 
So, we have seen a change there.
    But, respectfully, what are you going to do to fix it? You 
can stop advertising now. You can stop putting up some of these 
bars. And I appreciate that, but we have now created an 
epidemic that is going to be touching today a quarter of all 
high school students; that the bars that you put up--I disagree 
a bit with Mr. Duncan's formulation of this, but he is not 
wrong. We now step in to regulate; you create incentives for a 
black market. Kids are going to go someplace else. Your company 
is now old news, and they are off to the next one, because of 
an industry that you helped create. And there are 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 are 
before us saying, ``Yes, we are open for regulation.'' What are 
we going to 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 now putting in place, would you 
pledge at this moment not to purchase one of those companies or 
acquire one of those companies or engage in those product 
sales?
    Mr. Crosthwaite?
    Mr. Crosthwaite. We do not sell any of the----
    Mr. Kennedy. Will you not sell? Will you not? Will you 
pledge not to acquire a company that is engaged? You have put 
up bars, but there are new products out there from new 
companies that don't face that regulation. Would you pledge not 
to acquire such a company that engages in those practices?
    Mr. Crosthwaite. What we are focused on is submitting our 
PMTA. We have no plans at this time to----
    Mr. Kennedy. So, no plan?
    Mr. Oberlander?
    Mr. Oberlander. Could you repeat your question, please?
    Mr. Kennedy. Will you pledge not to acquire a company that 
does not currently abide by the practices that you say you 
abide by, as they increase their own market share?
    Mr. Oberlander. We are not focused on that----
    Mr. Kennedy. So, a second non-answer.
    Mr. Nivakoff?
    Mr. Nivakoff. I would fully pledge.
    Mr. Kennedy. Fully pledge?
    Mr. Blonde?
    Mr. Blonde. We don't have any intent to purchase any 
company.
    Mr. Kennedy. Mr. Loftin?
    Mr. Loftin. We have no intent, but we will honor that we 
will always market responsibly.
    Mr. Kennedy. 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. Crosthwaite?
    Mr. Crosthwaite. Congressman, 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.
    Mr. Kennedy. So, how do I trust what you say?
    Mr. Crosthwaite. My actions so far since I have joined 
support our recognition that more needs to be done. So, we have 
taken action and we recognize more needs to be done to turn 
this issue around. We have been successful in converting 
millions of adults away from the most harmful form of tobacco 
use, and also recognize that that is at risk if we don't 
continue to make progress.
    Mr. Kennedy. I yield back.
    Ms. DeGette. The Chair now recognizes Mr. Griffith for 5 
minutes.
    Mr. Griffith. Thank you very much, Madam Chair. I 
appreciate it.
    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, 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, EVALI outbreak. The use of 
vitamin E acetate in THC has been strongly linked to those lung 
illnesses. Is vitamin E acetate used in any of your brands' 
cartridges? We will start with you Mr. Crosthwaite.
    Mr. Crosthwaite. No, Congressman.
    Mr. Oberlander. No.
    Mr. Nivakoff. No, sir.
    Mr. Blonde. No, sir.
    Mr. Loftin. No, sir.
    Mr. Griffith. So, none of your companies sell anything that 
contains THC or is specifically designed to be used with THC 
products? Can I assume that to be correct?
    Mr. Crosthwaite. Correct, we do not.
    Mr. Oberlander. No, sir.
    Mr. Nivakoff. No, sir.
    Mr. Blonde. No, sir.
    Mr. Loftin. No, sir.
    Mr. Griffith. Now can your products be adulterated so they 
can be used with THC products, modified or changed? Do you 
know?
    Mr. Crosthwaite. Our products are not designed to be 
changed or modified. They are tamper-resistant.
    Mr. Oberlander. Our products are also designed to be 
tamper-resistant.
    Mr. Nivakoff. The same answer, sir.
    Mr. Blonde. Same answer, sir.
    Mr. Loftin. Our products are pre-sealed cartridges. They 
can't get in them.
    Mr. Griffith. And what steps do you have, or plan to take, 
to prevent somebody using your device with some kind of a 
knockoff product that could be used with one of your devices?
    Mr. Crosthwaite. 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.
    Mr. Oberlander. To my knowledge, at this point in time, we 
don't have any counterfeit or illicit products actually for our 
VUSE products.
    Mr. Griffith. Does anybody have a different answer?
    Mr. Oberlander. We closely monitor the market.
    Mr. Griffith. Thank you.
    Does anybody have a different answer? OK.
    It is interesting because I had some folks who own vape 
shops come in to see me recently, and what they said was, 
``Look, we want people to come in and inspect us. We want them 
to see that we're using the right products, that we're not 
selling anything that's contraband or has been smuggled into 
the country, or that has THC when it's not supposed to be 
there. We don't sell those products.''
    Would you all agree that it is 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 the street corner from some renegade company?
    Mr. Crosthwaite. Congressman, 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 alternatives to combustible 
cigarettes.
    Mr. Griffith. And does anybody else have a different answer 
or something they would like to add to that? Mr. Loftin?
    Mr. Loftin. At Logic, we don't believe it has gone far 
enough. We think all products and all companies should go 
through the same process.
    Mr. Griffith. All right. I appreciate that.
    And I also understand that some of you make a zero-nicotine 
product. Can you explain why and for what purpose a nicotine-
free EVP might serve us? That would be a vaping product, for 
those who are watching at home. No nicotine?
    Mr. Crosthwaite. We do not make that product.
    Mr. Griffith. You don't make that product? Do you all make 
that? Does anybody else make that product?
    Mr. Oberlander. At this point in time, we don't have it. We 
are considering it.
    Mr. Nivakoff. No, sir.
    Mr. Griffith. OK.
    Mr. Blonde. Yes, we do.
    Mr. Griffith. Tell me about it.
    Mr. Blonde. In some cases, some smokers have evolved their 
way of taking nicotine. And at blu, we want to offer a full 
range of nicotine.
    Mr. Griffith. And they still want to have the feel of 
having something in their mouth or something that they are 
breathing in? What causes that?
    Mr. Blonde. Yes, as in my opening statement, I mean, some 
of our adult consumers decide to keep their pleasurable 
experience with our products, but without nicotine.
    Mr. Griffith. Right.
    Mr. Loftin, do you all have a product like that?
    Mr. Loftin. No, sir.
    Mr. Griffith. Okay. Well, very good. My time is just about 
up, but I appreciate you----
    Ms. DeGette. Will the gentleman yield, please, the rest of 
his time?
    Mr. Griffith. I will yield you my 37 seconds, yes, ma'am.
    Ms. DeGette. Mr. Blonde, what percentage of your sales are 
the no-nicotine e-cigarettes?
    Mr. Blonde. I don't have a precise number, but it is quite 
low.
    Ms. DeGette. Quite low? Could you supplement your answers 
with the exact number?
    Mr. Blonde. I would be happy to.
    Mr. Griffith. I yield back.
    Ms. DeGette. The Chair now recognizes Ms. Castor for 5 
minutes.
    Ms. Castor. Thank you, Madam Chair, for calling this 
important hearing today. It has really highlighted how e-
cigarettes and vape manufacturers have enticed young people to 
their products.
    And I am particularly concerned about companies marketing 
through social media to target--it is an insidious use of 
social media to target young people. And it has continued to 
happen even after the harm has become clear to young people, 
the addictive nature, the impact on the developing brain, among 
other health impacts.
    Mr. Crosthwaite, prior to reforming your social media 
marketing efforts in November of 2018, a large number of the 
JUUL 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 JUUL should never be 
marketed to youth, but they were extensively marketing to youth 
in the past. I assumed that JUUL addressed its social media 
presence because it was concerned about how its social media 
activities did impact youth. Is that correct?
    Mr. Crosthwaite. Yes, it was before I joined the 
organization when the company stopped in social media activity. 
And what we are actually focused on today with social media is 
getting posts off. So, we look for posts that we think are 
inappropriate. We ask them to be taken down, so that the access 
to this type of information is not available.
    Ms. Castor. So, Mr. Blonde, you just heard Mr. Crosthwaite 
state that they have a strategy, a social media strategy, but 
he acknowledged that social media does impact youth use of the 
vapes. As a major player in the industry, Fontem continues to 
use social media as a marketing tool. On the one hand, you have 
said here today, boy, you have an access program, you are 
trying to do everything you can to discourage, but, on the 
other hand, you continue to actively market to youth through 
social media. Why do you do that?
    Mr. Blonde. We don't market to youth in any shape or form.
    Ms. Castor. Well, one aspect of Fontem's social media 
activity I am concerned about is the use of the social media 
influencers. Underage youth who may be blocked from your social 
media accounts can still 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 are trendy. 
Will you commit here today to end your use of influencers to 
market the vapes to young people?
    Mr. Blonde. We have currently stopped producing any content 
from those influencers.
    Ms. Castor. What have you done to actively, then, end the 
influencers' use, the use on YouTube, of all of those videos?
    Mr. Blonde. We have very strict measures as far as it 
pertains to social media. We believe social media is an 
accepted platform of communication for our adult smokers.
    Ms. Castor. I mean, what social media is and the use of the 
influencers now, it makes it very difficult to control the 
dissemination of the marketing information.
    Mr. Crosthwaite, do you think that 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?
    Mr. Crosthwaite. What I have been focused on as CEO, since 
I have joined, is taking every step I believe I can to minimize 
youth getting access to----
    Ms. Castor. Was that a yes or----
    Mr. Crosthwaite. We are not on social media. I stopped, 
actually, all of our advertising----
    Ms. Castor. You are the market leader now. What would you 
say to these other CEOs who are not going down the same path?
    Mr. Crosthwaite. I can just share what I have been focused 
on, which is addressing youth getting any real access to 
information that they should not. And that is why I have taken 
the steps I have as CEO.
    Ms. Castor. Mr. Loftin, do you use influencers?
    Mr. Loftin. We do not use influencers.
    Ms. Castor. Mr. Nivakoff?
    Mr. Nivakoff. No, ma'am, we do not use influencers.
    Ms. Castor. Mr. Oberlander?
    Mr. Oberlander. We do not use social influencers.
    Ms. Castor. So, Mr. Blonde, you are the odd man out here.
    Mr. Blonde. Again, I mean, the use of influencers, as I was 
going to say, the choice of influencers is making sure that all 
people that we are interacting to are above 25 and look above 
25.
    Ms. Castor. Well, that is not good enough in today's age of 
social media. You have got to be proactive and you have got to 
control. If you are saying, on the one hand, ``I am not going 
to market to youth,'' and then, on the other hand, you are 
allowing the dissemination of videos and influencers on those 
platforms, you are really being hypocritical and it 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.
    Ms. DeGette. The gentle lady from New Hampshire, Ms. 
Kuster, is recognized for 5 minutes.
    Ms. Kuster. Thank you, Chairwoman DeGette, 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 have come into our life with 
nicotine that is highly addictive.
    So, I want to just say, based on the data, that we are on 
the precipice of minimizing tobacco's hold on our nation's 
youth, but confronting alarming rates of youth nicotine use. As 
a result, e-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 Dr. Sue Tanski, 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 
twenties. A brain that is not exposed to psychotropic drugs 
such as nicotine during adolescence is less likely to develop 
an 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 
company 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 in another hearing 
before this Committee. Today's schools around the country warn 
students about the harms of nicotine, particularly on 
developing brains.
    Mr. Crosthwaite, JUUL offers a 5 percent nicotine content 
pod which the company claims releases an amount of nicotine 
similar to a pack of 20 cigarettes. Some young users report 
going through a single JUUL pod in three hours. To try to 
reduce their nicotine intake, these young people are now 
turning to combustible cigarettes to reduce their nicotine 
intake.
    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?
    Mr. Crosthwaite. Congresswoman, I share your concern about 
the amount of youth getting access to e-vapor. It is 
unacceptable and we must work to combat it.
    Ms. Kuster. What is it that you are doing about it today?
    Mr. Crosthwaite. So, since I have joined the company, about 
four months ago, we took action to address this issue. So, we 
stopped shipping, when I became CEO in November, our mint 
product, which at the time, we got the data that youth were 
getting access to mint, and that was 70 percent of our company 
at that timeframe.
    Ms. Kuster. Seventy percent going to youth for nicotine 
addiction?
    Mr. Crosthwaite. No, no. No, 70----
    Ms. Kuster. Seventy percent of your profits were from this 
product that youth were using. Is that the number you are 
trying to explain to us?
    Mr. Crosthwaite. No, just to clarify, when we stopped 
shipping mint in November, at that time, of all of our sales, 
that product was 70 percent of our business.
    Ms. Kuster. That is what I am trying to say. I mean, for 
the American people, 70 percent of your product was going to 
youth in our country. And four months ago, you stopped that 
practice?
    Mr. Crosthwaite. 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.
    Ms. Kuster. What about the other flavors that are currently 
on the market?
    Mr. Crosthwaite. So, today, we sell tobacco and menthol in 
the company.
    Ms. Kuster. Menthol e- cigarette?
    Mr. Crosthwaite. Yes, in the U.S. market.
    Ms. Kuster. And do you think that is getting access to 
youth?
    Mr. Crosthwaite. Well, we have paid very close attention to 
the data when we made the decision on mint.
    Ms. Kuster. Is there any reason not to take that off the 
market?
    Mr. Crosthwaite. Well, today, there are over 10 million 
Americans who use combustible menthol cigarettes.
    Ms. Kuster. How many youths?
    Mr. Crosthwaite. When we saw the data, menthol was not one 
of the leading flavors that youth were getting access to. The 
number was quite small.
    Ms. Kuster. How many youths?
    Mr. Crosthwaite. My recollection is I believe the number 
was a few percentage points, but I will have to refer back to 
the report specifically.
    Ms. Kuster. My time is up. I just want you to know mothers 
and fathers across this country are watching this hearing very 
carefully.
    Thank you.
    Ms. DeGette. The Chair now recognizes the ranking member of 
the full committee, Mr. Walden, for 5 minutes.
    Mr. Walden. Thank you again, Madam Chair, for having this 
hearing.
    As I mentioned in my opening statement, I am 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 JUUL 
products, in particular. I understand the FDA's Office of 
Criminal Investigations has several ongoing criminal 
investigations related to counterfeit JUUL 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?
    Mr. Crosthwaite. Counterfeit products are an issue. It is 
something we have been very focused on in the United States 
market, getting them off of the marketplace.
    Mr. Walden. All right. Mr. Oberlander?
    Mr. Oberlander. Mr. Congressman, at this point in time, we 
haven't seen any counterfeits of VUSE products, but we 
constantly monitor the markets, to my knowledge.
    Mr. Walden. All right.
    Mr. Nivakoff. We have not seen any reports of counterfeits 
for our products.
    Mr. Blonde. We don't see any counterfeit product.
    Mr. Loftin. We are very concerned about counterfeit and, in 
fact, I would love to share some of our results by working with 
FDA, Homeland Security, CBP, and local law enforcement, if you 
don't mind.
    Mr. Walden. All right. Yes, if you want, real quick.
    Mr. Loftin. Through the help of everyone that I just 
mentioned, and all the outside agencies, we closed a factory in 
China shipping in. We also had eight seizures last year just in 
the U.S. in 2019; $1.5 million dollars worth of products 
confiscated in Nassau County in New York; 681 cease and desist; 
1859 unauthorized online sellers.
    Mr. Walden. OK. All right. If I could get that from you? I 
have got a couple of other questions I want to get to. I 
appreciate you have answered the question well, but I would 
like to get the full dataset from you.
    Mr. Loftin. Absolutely.
    Mr. Walden. Mr. Crosthwaite, I want to go back to you to 
make sure I understood your answer to Ms. Kuster. Did you say 
70 percent of JUUL's profits come from youth mint use? I don't 
think that is what you were saying, right?
    Mr. Crosthwaite. No. No, Congressman. What I was saying is, 
when we saw the youth data that came out and that youth were 
getting access to mint, we stopped shipping that in the United 
States. And when we stopped shipping mint in the United States, 
at that time, it was 70 percent of what the company sold in the 
United States.
    Mr. Walden. To all users, not just youth?
    Mr. Crosthwaite. Correct.
    Mr. Walden. OK. All right. In just a few months, the entire 
industry is going to undergo yet another shift when the PMTA 
filing deadline passes after May 12th. Only products for which 
a PMTA has been submitted can remain on the market.
    So, the question I have is, how will a consumer retail 
store owner know which products are allowed on the market after 
this date and which ones should be removed? What kind of 
transparency should we be thinking of? Do we need to do 
something here, once that process is completed?
    Mr. Crosthwaite, or anybody, want to take that? Yes, go 
ahead.
    Mr. Crosthwaite. So, 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.
    Mr. Walden. Right.
    Mr. Crosthwaite. And, of course, whatever way we need to be 
communicating about our status in that process, we will do so.
    Mr. Walden. But to the retailers and to consumers----
    Mr. Crosthwaite. Right.
    Mr. Walden [continue]. How will they know things are left 
behind?
    Mr. Oberlander. Mr. Congressman, as I mentioned in my oral 
statement, it is paramount that actually, the FDA gives full 
transparency of all products that have submitted PMTAs. So, 
that retailers, enforcement agencies, and the FDA actually have 
full visibility about which products are eligible to remain in 
the market or not.
    Mr. Walden. OK. Gentlemen?
    Mr. Nivakoff. Sir, I can't speak to my competitors. 
However, our products are almost exclusively sold in highly 
compliant Tier 1 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.
    Mr. Walden. Got it.
    Mr. Blonde. We strongly encourage the what you call the 
PMTA process. We intend to submit our PMTA to the FDA by May. 
And I agree that we strongly support the fact of full 
transparency to make sure only reliable actors stay in the 
market.
    Mr. Walden. All right. Mr. Loftin?
    Mr. Loftin. We strongly agree with the PMTA process. In 
fact, we are in standard review and working with them right 
now.
    Mr. Walden. All right. Perfect.
    Now, this issue with cannabis, THC, whatever, vitamin E, 
what is the best thing we can do here to put a stop to that? 
Because that is some of where the lung injuries are occurring. 
In a state like Oregon, that has legalized everything, we are 
seeing this. Any of you want to weigh-in on what the best 
course of action for Congress to do to deal with that issue?
    Mr. Loftin. I think you add all products and all companies 
involved in that under the PMTA process as well.
    Mr. Walden. OK. Will that get at it?
    Mr. Oberlander. I believe the FDA has discretionary power, 
an enforcement power actually, to understand the root cause of 
the situation and actually go after the culprits in this 
crisis.
    Mr. Walden. All right.
    Mr. Crosthwaite. And the benefit of a PMTA process are you 
have preclinical, clinical, behavioral research. For us, for 
example, we will have a hundred scientific studies submitted, 
so the FDA can fully evaluate a product and determine if it is 
appropriate for the protection of public health.
    Mr. Walden. All right. My time had expired. Thank you, 
Madam Chair.
    Thank you to all of you for your testimony.
    Ms. DeGette. I thank the gentleman. The Chair now 
recognizes Mr. Ruiz for 5 minutes.
    Mr. Ruiz. 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 
is 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 am 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 am a doctor; I know that--and to make it clear for 
parents and teachers to identify vaping products.
    It would also prohibit the sales 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 and addict youth to 
their products, and we must stop it.
    Mr. Loftin, in your testimony you link thedramatic increase 
in youth usage of e-cigarettes to the combination of, quote, 
``irresponsible marketing and product characteristics'' of 
other e-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?
    Mr. Loftin. Sir, I am not here to talk about the other 
companies, but I will tell you it is based on irresponsible 
marketing----
    Mr. Ruiz. Like what?
    Mr. Loftin [continue]. Exciting colors----
    Mr. Ruiz. You don't have to name companies, but give me 
examples of irresponsible marketing.
    Mr. Loftin. Exciting colors, exciting shapes, exciting 
names, parties, all kinds of different things without warning 
labels. It is all about the atmosphere of having fun, and it 
shouldn't be marketed to youth.
    Mr. Ruiz. So, despite companies' 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. Crosthwaite, in your testimony, you state that JUUL 
has, quote, ``halted our broadcast, print, and 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?
    Mr. Crosthwaite. Congressman. I share your concern about 
youth getting access to e-vapor----
    Mr. Ruiz. Should they be held under the same standards as 
cigarettes?
    Mr. Crosthwaite. I took the steps in the company because I 
felt it was critical to limit any sort of awareness to tools 
like we were using.
    Mr. Ruiz. They are addictive products. Should they be held 
to the same standards as smoking cigarettes?
    Mr. Crosthwaite. I think the FDA is going to have complete 
oversight over marketing practices.
    Mr. Ruiz. OK.
    Mr. Crosthwaite. I chose to take the steps we did because I 
felt significant action needed to happen to address this issue.
    Mr. Ruiz. 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 
Fontem 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 home page of Fontem's 
website for its blu products features a promotion for a, quote, 
``Last chance flavor blowout'' to, quote, ``stock up on 
selected liquid pods flavors before they're gone,'' end quote. 
``Buy 10 products, get 15 free.''
    It is very obvious that those who sell this product have 
their profit in mind when they are 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. Blonde, it seems quite unabashed in its interest to 
cash in on flavors that FDA has been urging to take off the 
market. Don't you think it is irresponsible of your company to 
offload your remaining stock of flavors in a fire sale at the 
same time FDA is sounding the alarm on the appeal of these 
products to youth?
    Mr. Blonde. The sales on our website are very strictly 
controlled and only accessible to 21-plus adults.
    Mr. Ruiz. So, you are saying it wasn't your decision? You 
are not taking accountability for the fact that, while the FDA 
says let's remove flavors, you are trying to sell your flavors 
and market these flavors that Mr. Loftin said would be 
considered as an irresponsible act of marketing and 
characteristics of a product?
    Mr. Blonde. We have several promotions 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 they would be off the market.
    Mr. Ruiz. Clearly, flavors have been a target for youth. 
So, you can say the adults, but, clearly, it has been a cause 
for the youth epidemic.
    I yield back.
    Ms. DeGette. The gentleman yields back. The gentleman from 
Maryland, Mr. Sarbanes, is recognized for 5 minutes.
    Mr. Sarbanes. Thank you, Madam Chair.
    Thank you to the panel.
    So, I understand that 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 have now created the next 
great public health crisis, really of scandalous proportions.
    It is 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 have turned up yet, 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, et cetera, 
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 is 
something that your industry is going to have to live with. And 
unfortunately, it is something our youth are living with and 
will be with them 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 flavored e-cigarette products. Hooray. And public health 
experts were encouraged by that, and children's advocates and 
medical. In a way, we couldn't believe it, that the President 
was moving there; he was going to 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 e-cigarette products.
    So, the question I keep asking myself is, what happened? 
Why would the FDA, the agency that is tasked with regulating 
tobacco, and has as 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 
back their decision? And I just feel like it has got something 
to do with how money moves in Washington.
     So, there is a report from the American Public Media that 
talks about the multimillion-dollar campaign that JUUL launched 
to push back on the government's efforts to restrict vaping. 
JUUL hired an army of lobbyists, spending almost $3 million on 
lobbying the Federal Government, more than doubling its 
lobbying expenses from 2017 and 2018 combined. The Political 
Action Committee reported spending $200,000 for candidates and 
committees, and JUUL dramatically increased its spending in 
states to combat state-level efforts to restrict their 
products; reported 142 lobbyists registered in 48 states.
    Then, when the Citizens United case opened the floodgates 
on how dark money comes into our politics and into the 
policymaking apparatus up here, we saw companies like Reynolds 
American and JUUL invest--I think 35 percent owner of Altria--
using their deep pockets to influence the regulations. Reynolds 
American donated millions of dollars to dark money groups like 
Americans for Tax Reform, and Americans for Prosperity. Altria 
spent $295 million 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 frustrating because there is an inside game. 
And I just want to speak to that.
    I didn't give anybody any opportunity to respond and I have 
now used my time. But I think it is a real concern and it is 
something that we need to shine a light on because the American 
public is, frankly, tired of it.
    And I yield back.
    Ms. DeGette. The gentle lady from New York is recognized 
for 5 minutes, Ms. Clarke.
    Ms. Clarke. I thank you, Madam Chair.
    Gentlemen, over the past decade, our public health agencies 
have become increasingly concerned about the youth vaping 
rates, as 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 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. Nivakoff, is e-cigarette use among youth a national 
public health threat?
    Mr. Nivakoff. Yes, ma'am.
    Ms. Clarke. The nation's leading public health officials 
point to the attractiveness of fruity and sweet flavors, 
targeted marketing tactics, stealth design, and low cost in 
explaining the appeal of e-cigarettes to youth.
    Mr. Loftin, your testimony attributes the rise in youth use 
primarily to, quote, ``youth appeal of certain products that 
seem to intentionally target minors''. End quote. Mr. Loftin, 
which products do you believe intentionally target young 
people?
    Mr. Loftin. Congresswoman, I am not here to talk about the 
other companies, but I know it is irresponsible marketing with 
exciting flavors and colors and shapes and sizes that appeal to 
minors. And if they are doing that, they should stop.
    Ms. Clarke. Well, you are a 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 in their 
practices, it would seem to me that the industry would have 
that conversation.
    Mr. Crosthwaite, according to national survey data, nearly 
60 percent of high-schoolers and over half of middle-schoolers 
who vape report JUUL as their usual brand. Mr. Crosthwaite, why 
are so many young people drawn to your products?
    Mr. Crosthwaite. JUUL has had great success converting 
millions of adults who were using combustible cigarettes, and 
otherwise wouldn't have quit----
    Ms. Clarke. Hold on one moment. My question is, why are so 
many young people drawn to your product?
    Mr. Crosthwaite. And with that success with adults, and 
that social sourcing plays a role in how youths get access to 
e-vapor products. An unintended consequence of our success was 
youth getting access to JUUL.
    Ms. Clarke. So, how many young people do you estimate were 
drawn into this because of the adult population that you are 
quoting?
    Mr. Crosthwaite. So, when we saw the youth data that came 
out, clearly, those numbers are unacceptable and too high.
    Ms. Clarke. But what were those numbers?
    Mr. Crosthwaite. They are publicly available numbers that 
the government has----
    Ms. Clarke. You don't know what the numbers are, sir?
    Mr. Crosthwaite. The studies that came out were the 
Monitoring the Future Study that showed that youth were getting 
access to mint-flavored----
    Ms. Clarke. Yes, but do you know what the numbers are? What 
did your study indicate, sir?
    Mr. Crosthwaite. They all indicated that the youth use was 
just too high.
    Ms. Clarke. Mr. Oberlander, beyond pointing to the specific 
product, how did we get here? What caused more than 5 million 
youth to start vaping?
    Mr. Oberlander. Madam Clarke, first of all, I share your 
concern. And the most important point I would like to remind 
you----
    Ms. Clarke. Can you pull the microphone closer, sir?
    Mr. Oberlander. When VUSE was the market leader between 
2015-2017, youth vaping rates declined. In the National Youth 
Tobacco Survey from last year, it actually showed that less 
than 5 percent of the respondents claimed to have used VUSE. 
Additionally, our consumer demographics for our VUSE products 
indicate that 95 percent of our consumers of VUSE are actually 
25 and older, and 70 percent of them are 35 and older.
    Ms. Clarke. So, are you saying you just have no idea how 
these 5 million youths starting vaping, sir?
    Mr. Oberlander. Frankly, we don't research youth. We 
research----
    Ms. Clarke. You have no idea?
    Mr. Oberlander. Excuse me. We have only researched 21-and- 
plus individuals.
    Ms. Clarke. Turning back to you, Mr. Crosthwaite, in your 
testimony you mentioned that JUUL is, quote, ``combating the 
serious problem of underage use''. Yet, as discussed, youth use 
continues to increase and young people are still using your 
products in high numbers. You came to JUUL from big tobacco, 
which has not always been a stalwart of promoting public 
health. Why should we take your word for it when you say that 
JUUL is serious about combating youth use of e-cigarettes?
    Mr. Crosthwaite. I joined the company because I believe in 
the historic opportunity for adults to have another option to 
combustible cigarettes who otherwise wouldn't quit. I also 
recognized that it is at risk if we don't solve this problem. 
The youth use situation is unacceptable. And when I joined, I 
took action, and we are prepared to do more over time.
    Ms. Clarke. 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 that have contributed to our nation's youth 
vaping epidemic. Each of you, though you tried to differentiate 
what your companies are doing, are all collaborating in an 
industry that has drawn in, and will continue to draw in, young 
people unless you take affirmative actions or unless we do so.
    I yield back, Madam Chair.
    Ms. DeGette. The gentleman from New York, Mr. Tonko, is 
recognized for 5 minutes.
    Mr. Tonko. Thank you, Madam Chair.
    Mr. Crosthwaite, 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?
    Mr. Crosthwaite. The youth rates are unacceptable. And this 
whole opportunity for adults we recognize is at risk if we 
don't address this issue.
    Mr. Tonko. I think 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, or become 
addicted.
    Common sense and research show that flavored products are 
an on-ramp to youth e-cigarette use. According to an NIH and 
FDA national survey, nearly 80 percent of youth used the 
tobacco product because, and I quote, ``It comes in flavors I 
like.'' Industry claims that flavored e-cigarettes are 
important to help some adult smokers quit, though whether these 
flavors are necessary to help a person quit smoking is yet 
unproven.
    So, Mr. Crosthwaite, between November of 2018 and November 
of 2019, JUUL voluntarily removed all of its flavored products 
except tobacco and menthol from the U.S. market. Was the 
increasing youth use of non-tobacco flavored products a factor 
in this decision?
    Mr. Crosthwaite. So, when I joined the organization, and 
when we saw the data that youth were getting access to mint, it 
is that data that drove the decision I made, which was to take 
mint off the market for the company in November.
    Mr. Tonko. And at our subcommittee hearing last fall, then-
Acting FDA Commissioner Sharpless stated that the research is, 
and I quote, ``very strong that flavors draw a child to use''.
    Mr. Nivakoff, do you agree with FDA that fruity and minty 
flavors play a role in attracting our youth to e-cigarettes?
    Mr. Nivakoff. I think that NJOY's data overwhelmingly 
demonstrates that flavors did not drive youth to our products. 
NJOY 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 FDA 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.
    Mr. Tonko. Well, at the listening session that the White 
House held this past November, you 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?
    Mr. Nivakoff. Can you repeat that quote? I don't recall 
saying that, sir.
    Mr. Tonko. The quote from the White House listening session 
was, and I quote, ``Flavors are an issue. They are attractive 
to our youth.''
    Mr. Nivakoff. Are you certain that came from me? I might 
have been speaking colloquially about the industry, but I think 
the data clearly demonstrates that flavors with respect to 
NJOY'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 use.
    Mr. Tonko. Yes, 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.
    Mr. Nivakoff. Perhaps you could share the context because, 
out of context, I don't fully understand what the comment is. 
But, again, NJOY is the overwhelming market leader. Despite 
having the overwhelming majority of our revenue derived from 
flavors, we have the lowest rate of youth use by any measurable 
benchmark afforded by the Federal Government.
    Mr. Tonko. Again, the context was whether or not flavors 
are a driving force.
    So, we will move on. A recent study of e-cigarette use 
among U.S. youth found the use of mint and menthol-flavored e-
cigarettes increased sharply over the past three years. For 
JUUL, it was reported that its mint products contributed 70 
percent to its overall sales after it restricted the 
availability of its fruit flavors. I am concerned that FDA's 
action to temporarily restrict certain flavored e-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, Mr. Crosthwaite, given the similarities between mint 
and menthol, do you believe it is possible that youth using 
mint e-cigarette products may just switch to those menthol 
products?
    Mr. Crosthwaite. I think it is important the 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 
exists.
    Mr. Tonko. But do you think it is possible that youth using 
mint will switch to the menthol product?
    Mr. Crosthwaite. We know that the FDA is certainly going to 
track it. We are going to do the same.
    Mr. Tonko. And, Mr. Oberlander, the same question to you. 
Are you convinced that menthol won't just become the new mint 
in terms of popularity among youth?
    Mr. Oberlander. Tobacco and menthol flavors have not been 
perceived by the FDA--there is no research--to be popular 
amongst youth. However, we will continue to monitor the market, 
and we encourage the FDA to do the same.
    Mr. Tonko. Well, I am disturbed by what we know of youth 
behavior and their likelihood to merely shift from using fruity 
and mint-flavored e-cigarettes to menthol products. 
Unfortunately, I have not heard anything this morning to 
convince me this won't be the case.
    And with that, Madam Chair, I yield back.
    Ms. DeGette. I thank the gentleman. The ranking member and 
I will now each ask one last round of questions, and I will 
recognize the ranking member, Mr. Guthrie, for 5 minutes.
    Mr. Guthrie. Thank you for that.
    And again, thank you for being here.
    No doubt, e-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 keeping the Committee updated as you 
take actions to stop usage of these cigarettes?
    Mr. Crosthwaite?
    Mr. Crosthwaite. We are committed to combating access for 
youth getting to e-vapor and we are happy to keep you up-to-
speed on all of our actions.
    Mr. Guthrie. Thank you.
    Mr. Oberlander?
    Mr. Oberlander. Yes, we are committed.
    Mr. Guthrie. Mr. Nivakoff?
    Mr. Nivakoff. Yes, sir.
    Mr. Guthrie. Mr. Blonde?
    Mr. Blonde. Absolutely, sir.
    Mr. Guthrie. Mr. Loftin?
    Mr. Loftin. We are committed and helping in any way.
    Mr. Guthrie. And then, one final question. You have all 
submitted PMTAs or indicated you plan to submit PMTAs. And that 
is important because, in order to stay in the market, you have 
to submit PMTAs, 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 what information should be 
submitted and in what format. Do you think it would helpful for 
the FDA to finalize its regulation before May 6th? And if it 
doesn't do it sooner rather than later, what setback will that 
cause your process?
    Mr. Crosthwaite? We can just go down the aisle.
    Mr. Crosthwaite. We are preparing to submit our FDAs. We 
have opportunities to engage with our regulator and get 
feedback on the process.
    Mr. Guthrie. Even without the final regulation? Are you 
getting feedback on what you need to do without a final reg in 
place?
    Mr. Crosthwaite. We have our regulatory science 
organization that does engage with the FDA and to seek the 
appropriate information to make our filing.
    Mr. Guthrie. But would a final regulation be helpful?
    Mr. Crosthwaite. Sure. Any clarity is always helpful, but 
we are confident that we are going to submit a fulsome 
application.
    Mr. Guthrie. Mr. Oberlander?
    Mr. Oberlander. We have submitted the first set of PMTA 
applications for VUSE products, and we will actually comply 
with the May 12th deadline to submit all others.
    Mr. Guthrie. But without a final regulation in place, do 
you feel confident that you are able to----
    Mr. Oberlander. Continuous clarity/clarification about the 
process would be helpful for sure.
    Mr. Guthrie. Thank you.
    Mr. Nivakoff?
    Mr. Nivakoff. We think the current guidance is sufficient.
    Mr. Guthrie. So, are you going to submit without a final 
reg?
    Mr. Nivakoff. We do plan to submit before a final 
regulation is promulgated. Certainly, we would welcome any 
additional clarity, but we don't think it is a prerequisite.
    Mr. Guthrie. OK. Mr. Blonde?
    Mr. Blonde. We agree that we are in the process of 
finalizing our PMTA and submitting it date, and we encourage 
everybody, and all the actors in the market should do so.
    Mr. Guthrie. OK. Mr. Loftin?
    Mr. Loftin. We have already submitted our PMTAs. We are in 
standard review. We are working with them right now. We will 
work with them if any new regulations come up.
    Mr. Guthrie. Thank you.
    But my point is, I knew you had to move forward because 
there is not enough time, if you are not moving forward, to go 
from where we are today to have it by May 6. But I am sure, as 
the oversight committee of FDA, we would like to see that they 
have a final regulation as you are moving for approval. We 
think that is the way the process should work. But we certainly 
understand you can't wait for that to happen, but clarity is 
always important. And following the process, the way it should 
be followed is important to us as well.
    Thank you for being here. As I said, we absolutely must get 
e-cigarettes out of the hands of our youth, and we would like 
for you to update us as you put new controls in place, as Mr. 
Loftin said. You shared with us what you do, but, as you move 
forward, we would like to see that as well. Thank you.
    And I yield back.
    Ms. DeGette. Thank you. I thank the gentleman.
    I just have a couple of quick questions. One of the things 
that the kids at my roundtable earlier this week said is that 
people are just getting e-cigarettes online, now that the age 
has gone up to 21. Mr. Loftin, you said that you have very 
strict online protections before you will send them out; is 
that right?
    Mr. Loftin. Yes, ma'am, we have.
    Ms. DeGette. Could you submit; we could see?
    Mr. Loftin. We have already sent that to the committee 
staff.
    Ms. DeGette. OK.
    Mr. Loftin. But I would be glad to do it again as well.
    Ms. DeGette. OK. Great. Thank you.
    And do the rest of you all have very strict online 
protections? Mr. Blonde, you are nodding yes.
    Mr. Nivakoff?
    Mr. Nivakoff. Yes, we do.
    Ms. DeGette. Mr. Oberlander?
    Mr. Oberlander. Yes, we do.
    Ms. DeGette. And, Mr. Crosthwaite?
    Mr. Crosthwaite. Yes.
    Ms. DeGette. OK. Thank you.
    The second question that I had was, e-cigarettes are being 
marketed as a smoking cessation tool, but, partly because we 
haven't had a final guidance from the FDA, e-cigarettes are not 
approved by the FDA as a smoking cessation tool. Isn't that 
correct, Mr. Crosthwaite?
    Mr. Crosthwaite. Correct. We do not market today as a 
smoking cessation tool.
    Ms. DeGette. OK. But they are not approved by the FDA, is 
that right?
    Mr. Crosthwaite. Correct.
    Ms. DeGette. OK. The next question I have--and I want to 
commend all of you for now realizing the extent of the problem, 
5 million 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 smoking 
cessation programs or other programs to help kids get off of 
this highly-addictive substance? It is one thing just to say, 
``We are 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 seem to be nodding.
    Mr. Oberlander. Thank you. Chair DeGette, I think this is 
an important issue.
    Ms. DeGette. Yes.
    Mr. Oberlander. And at Reynolds American, we have a youth 
tobacco prevention program called ``Right Decisions Right 
Now''. We have put a significant amount of money behind it. And 
only last year, we had 800 employees actually contacting 
schools, I mean talking about the dangers, including vapor.
    Ms. DeGette. And so, you actually are trying to help kids 
get off of nicotine?
    Would that be accurate for JUUL as well, Mr. Crosthwaite?
    Mr. Crosthwaite. We are trying to make sure they don't get 
it in the first place, access prevention.
    Ms. DeGette. I understand.
    Mr. Crosthwaite. And the question you are raising is an 
important one, and we would be happy to engage----
    Ms. DeGette. So, you are not doing it? You don't have 
programs right now to try to help people get off of it?
    Mr. Crosthwaite. We are not doing programs, right?
    Ms. DeGette. Thank you.
    What about you, Mr. Nivakoff?
    Mr. Nivakoff. Ma'am, we would support any recommendations 
that the committee has.
    Ms. DeGette. Right, but you are not aware of any program 
you all have now?
    Mr. Nivakoff. No, ma'am. We don't think it is----
    Ms. DeGette. What about you, Mr. Blonde?
    Mr. Blonde. No, we don't currently have programs and we 
don't address these----
    Ms. DeGette. Would you be willing to consider something 
like that?
    Mr. Blonde. We are happy to collaborate with the Committee 
and talk to----
    Ms. DeGette. OK. Mr. Loftin?
    Mr. Loftin. We are very open to working through that as 
well with the committee.
    Ms. DeGette. You don't have any programs right now?
    Mr. Loftin. Nothing specific.
    Ms. DeGette. OK. I am going, to 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 all were extremely vague in 
your answers and seemed to say, well, you are doing studies 
right now. Because it has actually been established that 
nicotine itself has severe health risks.
    I have got two reports that I had the staff go get me while 
we were sitting here, and they are surveys of the medical 
research. And the Surgeon General says, ``Nicotine exposure 
during adolescence can cause addiction and harm the developing 
brain.'' So, these kids get addicted; then, they are addicted. 
But, then, it says, ``Nicotine can cross the placenta and has 
known effects on fetal and postnatal development. Therefore, 
nicotine delivered by e-cigarettes during pregnancy can result 
in multiple adverse consequences, including Sudden Infant Death 
Syndrome, and could result in altered corpus callosum, deficits 
in 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 in potentially harmful doses of 
heated and aerosolized constituents of e-cigarette liquids, 
including solvents, flavorants, 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 toxicants than combustible tobacco products.''
    The Indian Journal of Medical and Paediatric Oncology, 
which was in 2015--so, that was five years ago, when we already 
knew this stuff--says, ``Nicotine poses several health hazards, 
cardiovascular, respiratory, gastrointestinal disorders, 
decreased immune response, and ill impacts on reproductive 
health, cell proliferation, oxidative stress, apoptosis, DNA 
mutation,'' et cetera.
    I am going to 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 have one last question for you, Mr. Crosthwaite, and I 
appreciate that you have said that JUUL 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 an unacceptable level. 
So, here is my question to you: let's say the 2020 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?
    Mr. Crosthwaite. In just a few short months, we are going 
to 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 is 
the process we think is best to make that determination.
    Ms. DeGette. Well, I am glad you are going through that 
process. I am glad everybody is going through that process, but 
my question is: if the number of youth vaping doesn't go down, 
despite all of this, with the effort you have taken already, 
would you stop marketing your e-cigarettes until we figure out 
how to solve this epidemic?
    Mr. Crosthwaite. Well, I have stopped all of our broadcast, 
print, and digital marketing already.
    Ms. DeGette. OK. So, you are not prepared to go as far as 
what I am suggesting? Wouldn't that be fair to say?
    Mr. Crosthwaite. We have taken serious actions to address 
this issue, and we are prepared to do more as we go on.
    Ms. DeGette. OK, but stopping sales altogether until we 
figure it out, that is not what you are thinking about?
    Mr. Crosthwaite. We are trying to preserve this opportunity 
for the millions of adults while combating the underage issue 
that exists. And ultimately, we are going to make that filing--
--
    Ms. DeGette. I got you. You don't want to answer it. 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 of Medical 
and Paediatric Oncology I just referred to.
    We have the letter to the committee from the National 
Association of County and City Health Officials.
    We have The New York Times article that Congresswoman 
Schakowsky referred to, and the 2016 Surgeon General report on 
the dangers of nicotine.
    I would ask unanimous consent that all of those be put in 
the record. So ordered.
    [The information appears at the conclusion of the hearing.]
    Ms. DeGette. I also want to remind Members that, pursuant 
to the committee rules, they have ten 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.
    Ms. DeGette. And with that, the subcommittee is adjourned.
    [Whereupon, at 12:56 p.m., the subcommittee was adjourned.]
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