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




 
     SOUNDING THE ALARM: THE PUBLIC HEALTH THREATS OF E	CIGARETTES

=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 25, 2019

                               __________

                           Serial No. 116-65
                           
                           
   [GRAPHIC(S) 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 
47-351 PDF            WASHINGTON : 2022                        
                        
                        
                        

                    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...........................................  3 
Hon. Brett Guthrie, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................  5
    Prepared statement...........................................  6 
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...........................................  12

                               Witnesses

Norman E. Sharpless, M.D., Acting Commissioner, Food and Drug 
  Administration................................................. 13
    Prepared statement........................................... 16 
    Answers to submitted questions...............................119
Anne Schuchat, M.D., Principal Deputy Director, Centers for 
  Disease Control and Prevention................................. 29
    Prepared statement........................................... 31
    Answers to submitted questions...............................139
Joneigh S. Khaldun, M.D., Chief Deputy Director for Health and 
  Chief Medical Executive, Michigan Department of Health and 
  Human Services................................................. 72
    Prepared statement........................................... 72
    Answers to submitted questions...............................151 
Elizabeth Cuervo Tilson, M.D., State Health Director and Chief 
  Medical Officer, North Carolina Department of Health and Human 
  Services....................................................... 78
    Prepared statement........................................... 80
    Answers to submitted questions...............................157
Lee Norman, M.D., Secretary, Kansas Department Of Health and 
  Environment....................................................90
    Prepared statement...........................................92
    Answers to submitted questions..............................165
Monica Bharel, M.D., Commissioner, Massachusetts Department of 
  Public Health................................................. 94
    Prepared statement.......................................... 96
    Answers to submitted questions..............................168

                           Submitted Material

Article of September 22, 2019, ``GOP allies warn vaping ban will 
  sink Trump in 2020,'' by Alayna Treene, submitted by Ms. 
  DeGette........................................................112
Article of September 19, 2019, ``White House abruptly cancels 
  meeting with vaping advocates,'' by Daniel Lippman and Dan 
  Diamond, submitted by Ms. DeGette..............................115
Article of September 19, 2019, ``White House cancels pro-vaping 
  meeting as illness cases rise,'' by Jennifer Jacobs, submitted 
  by Ms. DeGette................................................ 116


     SOUNDING THE ALARM: THE PUBLIC HEALTH THREATS OF E-CIGARETTES

                              ----------                              


                     WEDNESDAY, SEPTEMBER 25, 2019

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:01 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), Burgess, 
McKinley, Griffith, Brooks, Duncan, and Walden (ex officio).
    Staff present: Kevin Barstow, Chief Oversight Counsel; 
Jesseca Boyer, Professional Staff Member; Jeffrey C. Carroll, 
Staff Director; Manmeet Dhindsa, Counsel; Evan Gilbert, Deputy 
Press Secretary; Waverly Gordon, Deputy Chief Counsel; Tiffany 
Guarascio, Deputy Staff Director; Judy Harvey, Counsel; Stephen 
Holland, Health Counsel; Chris Knauer, Oversight Staff 
Director; Jourdan Lewis, Policy Analyst; Alivia Roberts, Press 
Assistant; Andrew Souvall, Director of Communications, Outreach 
and Member Services; Benjamin Tabor, Staff Assistant; Kimberlee 
Trzeciak, Chief Health Advisor; Jennifer Barblan, Minority 
Chief Counsel, Oversight and Investigations; Mike Bloomquist, 
Minority Staff Director; S. K. Bowen, Minority Press Assistant; 
Diane Cutler, Minority Detailee, Oversight and Investigations; 
Jordan Davis, Minority Senior Advisor; Margaret Tucker Fogarty, 
Minority Legislative Clerk/Press Assistant; Brittany Havens, 
Minority Professional Staff, Oversight and Investigations; 
Peter Kielty, Minority General Counsel; Bijan Koohmaraie, 
Minority Deputy Chief Counsel, Consumer Protection and 
Commerce; Ryan Long, Minority Deputy Staff Director; Brannon 
Rains, Minority Legislative Clerk; Kristen Seum, Minority 
Counsel, Health; and Alan Slobodin, Minority Chief 
Investigative Counsel, Oversight and Investigations.
    Ms. DeGette. The Subcommittee on Oversight and 
Investigations hearing will now to come to order. Today, the 
committee is holding a hearing entitled, ``Sounding the Alarm: 
The Public Health Threats of E-Cigarettes.'' The purpose of 
today's hearing is to examine the public health impacts and 
regulatory authorities related to e-cigarette manufacturing, 
sales, and use.
    The Chair now recognizes herself for purposes of an opening 
statement.

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

    Our country is facing a serious public health epidemic, one 
that is causing severe harm. This hearing will examine the 
cause of that epidemic, the uncontrolled and rising use of e-
cigarettes. As life-threatening illnesses sweep the country and 
the use of e-cigarette products by young people soars, we must 
act to protect the American people from the myths and the 
misunderstanding about these products.
    First, the data is now clear. Over the past several years, 
we have seen an acceptably high proportion of young people 
facing nicotine addiction. This year alone, more than 27 
percent of high schoolers report they are using e-cigarettes or 
vaping, as it is also known. From 2011 to 2015, there was a 900 
percent increase, a 900 percent increase in youth vaping, and 
from 2017 to today, the use, the rate of high school use 
doubled.
    The vaping epidemic and its impact are personal to me. My 
home state of Colorado has the unfortunate distinction of 
leading the country in teen vaping. A major factor contributing 
to the continued dramatic rise of e-cigarette use among teens 
is the inundation of flavored products. Recent data from the 
Centers for Disease Control and Prevention indicate that 60 
percent of students using e-cigarettes within the last month 
cited using popular fruit, menthol, or mint flavors.
    Young people turning to e-cigarettes also may have the 
false assumption that these products are safe or relatively 
harmless. But contrary to many manufacturers' claims, e-
cigarettes pose risks to young people and can lead to 
addiction, harm brain development, affect respiratory health, 
and can lead to heart disease. Additionally, e-cigarette use 
increases the risk of youth turning to conventional cigarettes.
    As much as we do know, the more troubling concern maybe how 
much we don't know about these products. For example, in some 
cases, we don't even know what chemicals and toxins are being 
inhaled when vaping. In a very real sense, the e-cigarette 
industry has launched a massive public health experiment in our 
country, of which its outcomes and consequences remain unknown.
    A recent spate of serious vaping illnesses epitomizes just 
how much we are in the dark about these products. These 
illnesses, numbering 530 so far and increasing daily, have led 
to hospitalizations, potential long-term health complications, 
and several deaths.
    While CDC and FDA are here today, and I want to thank both 
witnesses and they will provide more information about the 
status of the investigation and what products may be the 
culprit; no specific causes of the illnesses have yet been 
determined. With these agencies engaged and in collaboration 
with state partners, I have confidence that the root cause of 
this outbreak will eventually be identified.
    But even if the cause is isolated to a product sold on the 
streets or the use of THC, we must keep in mind that branded e-
cigarettes sold in stores are not harmless. This brings me to 
my next concern. Given the potential risks associated with 
these products, it would be reasonable to assume that the e-
cigarettes have been closely reviewed and approved by the FDA. 
But they haven't. E-cigarette products are only on the market 
today because FDA is temporarily giving them a pass by 
exercising its enforcement discretion.
    Let me be clear, no e-cigarette currently on the market in 
the United States today has been fully reviewed by FDA for its 
impact on public health. FDA needs to do its job, examine these 
products, and tell the public what the risks are. Can they even 
be legally sold: If so, how? In other words, FDA must go 
forward with conducting its repeatedly delayed premarket 
reviews for all e-cigarette products and determine whether the 
sale of the sale of the product is ``appropriate for the 
protection of public health.''
    Now after years of the delays around the regulation of e-
cigarettes, the administration recently announced that the FDA 
would prioritize enforcement and clear the shelves of non-
tobacco flavored e-cigarette products pending review. I am 
encouraged by this recent action, but FDA needs to provide 
additional details and a timeline for action. We have to ensure 
that this policy will be implemented and enforced in a 
reasonable way. In the meantime, nothing is stopping 
manufacturers from submitting their applications to FDA today. 
The burden is on the cigarette companies to demonstrate that 
these products meet the FDA's health standards.
    And regardless of the administration's recent announcement, 
legislation action is not off the table. I and others have 
introduced bills to tackle this public health priority, 
including Chairman Pallone, who has been a steadfast leader on 
these issues. States on the front lines of the youth epidemic 
have also been taking action on e-cigarettes. We are going to 
hear some of their plans today.
    Now, the industry has been swift to rail against efforts to 
restrict the products, claiming they assist adult smokers in 
quitting traditional cigarettes. That evidence, however, is far 
from conclusive, and FDA has not approved e-cigarettes for 
cessation purposes. Any benefit to adult smokers has to be 
weighed against the generation of young people for which vaping 
represents an on-ramp to use.
    [The prepared statement of Ms. DeGette follows:]

                Prepared Statement of Hon. Diana DeGette

    Our country is facing a serious public health epidemic, one 
that is causing severe harm. Today's hearing will examine the 
cause of that epidemic-the uncontrolled and rising use of e-
cigarettes.
    As life-threatening illnesses sweep the country, and use of 
e-cigarette products by young people soar, we must act to 
protect the American people from the myths and misunderstanding 
about these products.
    First, the data is now clear. Over the past several years, 
we've seen an unacceptably high proportion of young people 
facing nicotine addiction.
    This year, more than 27 percent of high schoolers report 
they are currently using e-cigarettes, or ``vaping," as it's 
also known.
    From 2011 to 2015, there was a 900 percent increase in 
youth vaping, and from 2017 to today, the rate of high school 
use doubled.
    The vaping epidemic and its impact is personal to me: my 
home state of Colorado has the unfortunate distinction of 
leading the nation in the rate of teen vaping.
    A major factor contributing to the continued dramatic rise 
of e-cigarette use among teens is the inundation of flavored 
products. Recent data from the Centers for Disease Control and 
Prevention indicate that 60 percent of students using e-
cigarettes within the past month cited using popular fruit, 
menthol, or mint flavors.
    Young people turning to e-cigarettes also may have the 
false assumption that these products are safe or relatively 
harmless.
    But contrary to many manufacturers' claims, e-cigarettes 
pose risks to young people and can lead to addiction, harm 
brain development, affect respiratory health, and can lead to 
heart disease. Additionally, e-cigarette use increases the risk 
of youth turning to conventional cigarettes.
    As much as we do know, the more troubling concern may be 
how much we don't know about these products. For example, in 
some cases, we don't even know what chemicals and toxins are 
being inhaled when vaping.
    In a very real sense, the e-cigarette industry has launched 
a massive public health experiment on our country, of which its 
outcomes and consequences remain unknown.
    A recent spate of serious vaping illnesses epitomizes just 
how much we are in the dark about these products. These 
illnesses, numbering 530 so far, and increasing daily, have led 
to hospitalizations, potential long-term health complications, 
and several deaths.
    While CDC and FDA are here today and will provide more 
information about the status of the investigation, and what 
products may be the culprit, no specific cause of the illnesses 
has been determined yet.
    With these agencies engaged and in collaboration with state 
partners, I have confidence that the root cause of this 
outbreak eventually will be identified.
    But even if the cause is isolated to a product sold on the 
streets, or use of THC, we must keep in mind that branded e-
cigarettes sold in stores are not harmless.
    This brings me to my next concern-given the potential risks 
associated with these products, it would be reasonable to 
assume that e-cigarettes have been closely reviewed and 
approved by FDA.But they haven't been. E-cigarette products are 
only on the market today because FDA is temporarily giving them 
a pass by exercising its enforcement discretion.
    Let me be clear, no e-cigarette currently on the market in 
the United States has been fully reviewed by FDA for its impact 
on public health.
    FDA needs to do its job, examine these products, and tell 
the public what the risks are, and how-or if-they can be 
legally sold.
    In other words, FDA must go forward with conducting its 
repeatedly delayed premarket reviews for all e-cigarettes 
products and determine whether the sale of the product is 
[quote] ``appropriate for the protection of public health."
    After years of dithering and delays around the regulation 
of e-cigarettes, the Administration recently announced that FDA 
would prioritize enforcement and clear the shelves of non-
tobacco flavored e-cigarette products pending review.
    This recent action is an encouraging first step. But FDA 
has yet to provide additional details or a timeline for action. 
We must ensure this policy will be implemented and enforced in 
a timely and effective manner.
    In the meantime, nothing is stopping manufacturers from 
submitting their applications to FDA today. The burden is on e-
cigarette companies to demonstrate that these products meet 
FDA's health standard.
    And regardless of the Administration's recent announcement, 
legislative action is not off the table. I and others have 
introduced bills to tackle this public health priority, 
including Chairman Pallone, who has been a steadfast leader on 
these issues.
    States on the front lines of the youth epidemic have also 
been stepping up to take action on e-cigarettes. We'll hear 
some of their plans and ongoing efforts on today's second 
panel.
    The industry has been swift to rail against efforts to 
restrict their products, claiming that they assist adult 
smokers in quitting traditional cigarettes. The evidence, 
however, is far from conclusive and FDA has not approved e-
cigarettes for cessation purposes.
    Any potential benefit to adult smokers must be weighed 
against the generation of young people for which vaping 
represents today's ``on ramp" to tobacco use.
    We can and we must do more to ensure we are not sacrificing 
today's young people to a lifetime of nicotine addiction.
    I thank the witnesses for their service, and look forward 
to hearing about how we can work together to address this 
critical public health issue.

    Ms. DeGette. I want to thank the witnesses for being here 
today, for their service, and I look forward to hearing how we 
can work together to address this very serious public health 
issue. And I will yield to Mr. Guthrie from Kentucky.

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

    Mr.Guthrie. Thank you, Chair DeGette, for holding this 
hearing. And before I get started on my opening statement, I 
want to say I know a lot of our members are going to have to be 
going back and forth. For whatever reason, this committee 
scheduled two important subcommittee hearings at the same time.
    And so, we have drug pricing upstairs; I think everybody 
agrees it is an important issue for the country, and this is an 
important issue for the country as well, and a lot of members 
here are membership of that subcommittee. So, I apologize that 
we are going to be in and out; that is where we are.
    And I want to say that I am deeply concerned about the 
growing outbreak of lung illness associated with vaping and e-
cigarette use as well as the marketing of e-cigarettes to kids. 
We need to understand the causes of this vaping illness and 
ensure that e-cigarettes are not marketed to kids. It is also 
important that we understand the health implications of vaping 
and e-cigarette use more broadly, whether an adult is vaping 
THC derived from marijuana, nicotine, or another substance.
    So far, the available evidence of the 553 reported cases of 
lung illness and eight deaths does not point to a conclusive 
cause. But the test samples overwhelmingly suggest an 
involvement of illicit e-cigarette devices, the psychoactive 
ingredient in marijuana called THC, and other black market 
products. For example, according to the Centers for Disease 
Control, most patients who have experienced these lung 
illnesses have reported a history of using e-cigarettes 
products containing marijuana or THC. However, some have 
reported using products that contain THC marijuana with 
nicotine, while others have reported only using products with 
nicotine.
    Separate from the outbreak of lung illnesses, according to 
the U.S. Food and Drug Administration, the United States has a 
youth e-cigarette epidemic. The most recent data from the 
National Youth Tobacco Survey show that 27-1/2 percent of 
youths reported using e-cigarettes compared with 20.8 in 2018. 
The rate was only 11.3 percent just three years ago.
    These trends are unacceptable. The marketing of e-cigarette 
products to children must be stopped, and youth access to e-
cigarette products must be blocked more effectively. This 
epidemic is already driving legislation and regulatory 
responses.
    Last September, the FDA issued more than 1,300 warning 
letters and fines to brick and mortar retailers who illegally 
sold e-cigarette products to minors, and five warning letters 
to e-cigarette manufacturers about their plans to address youth 
access of their products. Eighteen states have increased the 
legal age to purchase tobacco products to 21. Michigan, New 
York, and the District of Columbia have issued a proposed 
regulation to ban flavored e-cigarettes.
    On September 11th, 2019, the Trump administration announced 
that the FDA would finalize a compliance policy to prioritize 
enforcement against the marketing of unauthorized non-tobacco 
flavored e-cigarettes including, mint and menthol e-cigarettes. 
While these responses are aimed at reducing the attraction of 
e-cigarettes to youth, wide bans will almost certainly create 
black markets. In that vein, we will also need a response to an 
increased black market demand for flavored pods and to address 
the growing trade in illicit cannabis marijuana vaping 
products.
    A New York Times article reported that a recent bust of a 
THC oil operation in Wisconsin revealed a very advanced, 
immature illicit market for marijuana vape cartridges and 
distribution of contaminated marijuana-based vape carts. I am 
told these illicit operations are using a tactic in other 
illegal drug operations. They are cutting their product with 
other substances, including some that could be dangerous.
    Public health advocates, for example, said a particular 
cutting agent, vitamin E acetate, is an oil that could cause 
breathing problems and lung inflammation if not heated fully 
during the vaping process. By using smaller amounts of the 
expensive THC, or marijuana, and diluting it with oils that 
cost much less, one can increase their profit by selling the 
product. For example, medium-grade THC can cost $4,000 a 
kilogram, but additives may cost pennies on the dollar. These 
operations rely on pen factories that buy empty vape cartridges 
and counterfeit packaging from Chinese factories and then fill 
them with THC liquid that they purchased from the United States 
market. Empty cartridges and packaging are also available to 
purchase on the internet.
    While federal and state authorities are working on an 
effective response against teen e-cigarette use, we must ensure 
that our youth is educated on the dangers of using e-
cigarettes. For example, in Massachusetts, Governor Baker's 
administration launched a campaign to combat teen vaping and e-
cigarette use in April 2019, and the Massachusetts Department 
of Public Health launched a campaign to highlight the use of 
vape pens and e-cigarettes in July 2018. These actions are 
commendable, and I look forward to seeing the results of these 
campaigns.
    With regard to adults trying to quit smoking, some studies 
suggest that e-cigarettes are less harmful than traditional 
cigarettes. According to the CDC, e-cigarettes have the 
potential benefit, cessation, from combustible cigarettes for 
adult smokers, but CDC cautions that e-cigarettes are not safe 
for youth, young adults, pregnant women, or adults who are not 
currently using tobacco products. Additional research should 
occur to look at the effectiveness.
    I want to thank our witnesses for being here on both panels 
today, and I really look forward to this important discussion. 
So, I will be back and forth between hearings, but that is 
where we are, and I yield back.
    [The prepared statement of Mr. Guthrie follows:]

                Prepared Statement of Hon. Brett Guthrie

    Chair DeGette, thank you for holding this hearing. I am 
deeply concerned about the ongoing outbreak of lung illness 
associated with vaping and e-cigarette use, as well as the 
marketing of e-cigarettes to kids. We need to understand the 
causes of this ``vaping illness," and ensure that e-cigarettes 
are not being marketed to kids. It is also important that we 
understand the health implications of vaping and e-cigarette 
use more broadly, whether an adult is vaping THC derived from 
marijuana, nicotine, or another substance.
    So far, the available evidence from the 530 reported cases 
of lung illness and eight deaths does not point to a conclusive 
cause, but the test samples overwhelmingly suggest involvement 
of illicit e-cigarette devices, the psychoactive ingredient in 
marijuana called THC, and/or other black-market products. For 
example, according to the Centers for Disease Control, most 
patients who have experienced these lung illnesses have 
reported a history of using e-cigarette products containing 
THC. However, some have reported using products that contain 
THC and nicotine, while others have reported only using 
products with nicotine.
    Separate from the outbreak of lung illness, according to 
the U.S. Food and Drug Administration, the United States has a 
youth e-cigarette epidemic. 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 rate was only 11.3 percent just three years ago. 
These trends are unacceptable. The marketing of e-cigarette 
products to children must be stopped, and youth access to e-
cigarette products must be blocked more effectively.
    This epidemic is already driving legislative and regulatory 
responses. Last September, the FDA issued more than 1,300 
warning letters and fines to brick-and-mortar retailers who 
illegally sold e-cigarette products to minors and five warning 
letters to e-cigarette manufacturers about their plans to 
address youth access use of their products. Eighteen states 
have increased the legal age to purchase tobacco products to 
21. Michigan, New York, and the District of Columbia have 
issued or proposed regulations to ban flavored e-cigarettes. On 
September 11, 2019, the Trump Administration announced that the 
FDA would finalize a compliance policy to prioritize 
enforcement against the marketing of unauthorized non-tobacco 
flavored e-cigarettes, including mint and menthol e-cigarettes.
    While these responses are aimed at reducing the attraction 
of e-cigarettes to youth, wide bans will almost certainly 
create black markets. In that vein, we will also need a 
response to an increased black market demand for flavored pods, 
and to address the growing trade in illicit cannabis vaping 
products. A New York Times article reported that a recent bust 
of a THC-oil operation in Wisconsin revealed a very advanced 
and mature illicit market for THC vape cartridges and 
distribution of contaminated THC-based vape carts.
    I am told that these illicit operations are using a tactic 
seen in other illegal drug operations: cutting their product 
with other substances, including some that could be dangerous. 
Public health advocates, for example, said a particular cutting 
agent, vitamin E acetate, is an oil that could cause breathing 
problems and lung inflammation if not heated fully during the 
vaping process.
    By using smaller amounts of the expensive THC and diluting 
it with oils that cost much less, one can increase their profit 
from selling the product. For example, medium-grade THC can 
cost $4,000 a kilogram, but additives may cost pennies on the 
dollar. These operations rely on ``pen factories" that buy 
empty vape cartridges and counterfeit packaging from Chinese 
factories, then fill them with THC liquid that they purchase 
from the United States market. Empty cartridges and packaging 
are also available to purchase on the internet.
    While federal and state authorities are working on an 
effective response against teen e-cigarette use, we must ensure 
that our youth is educated on the dangers of using e-
cigarettes. For example, in Massachusetts, Governor Baker's 
administration launched a campaign to combat teen vaping and e-
cigarette use in April 2019, and the Massachusetts Department 
of Public Health launched a campaign to highlight the dangers 
of vape pens and e-cigarettes in July 2018. These actions are 
commendable, and I look forward to seeing the results of these 
campaigns.
    With regard to adults trying to quit smoking, some studies 
suggest e-cigarettes are less harmful than traditional 
cigarettes. According to the CDC, e-cigarettes have the 
potential to benefit cessation from combustible cigarettes for 
adult smokers but the CDC cautions that e-cigarettes are not 
safe for youth, young adults, pregnant women, or adults who do 
not currently use tobacco products. Additional research should 
be continued into the effectiveness of e-cigarettes for smoking 
cessation and to understand long-term health effects.
    I thank our witnesses on both panels for being here today 
and being part of this important discussion I yield back.

    Ms.DeGette. I thank the gentleman. The Chair now recognizes 
the chairman of the full committee, Mr. Pallone, for 5 minutes 
for purposes of an opening statement.

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

    Mr. Pallone. Thank you. I want to thank Chairwoman DeGette 
for having this very important hearing today. We are examining 
the growing public health crisis involving e-cigarettes and the 
proliferation of these products amongst kids and teens, and I 
am deeply concerned about the recent outbreak of lung illnesses 
that have killed eight people and sickened more than 530 here 
in the U.S.
    I am also very frustrated by the fact that e-cigarette 
usage has reached epidemic proportions in recent years among 
kids. If you talk to any parent of a high school student, you 
know that our nation's e-cigarette problem is real and it is 
getting worse, and it is long past time for public health 
agencies to address vaping and e-cigarette usage in a 
meaningful way. I look forward to hearing about what the FDA 
and the CDC can tell us about how they are addressing these 
tragic mystery illnesses and their recent actions to combat 
youth e-cigarette use.
    But make no mistake, I firmly believe that many aspects of 
the youth vaping epidemic could have been addressed if the FDA 
had moved forward with reviewing all e-cigarettes on the market 
when it first had the chance two years ago. Instead, in July 
2017, FDA announced that it would delay the implementation of 
key provisions of the agency's final deeming rule, which 
ensured the agency would review all e-cigarette products on the 
market. That same day, I issued a statement expressing deep 
concerns that these delays would mean that e-cigarette products 
would continue to lack needed public health oversight for 
several years and risk continued exposure to a new generation.
    And here we are over two years later, and unfortunately, my 
concerns have come to fruition. Since that decision, youth e-
cigarette usage has skyrocketed. More than one in four high 
school students say they have used e-cigarettes in the past 30 
days. These products have been marketed and targeted to kids 
without our knowledge of the full public health consequences, 
and as a result, we could lose an entirely new generation to a 
lifetime of nicotine addiction.
    At the same time, hundreds of people throughout the country 
have developed unknown lung illnesses following the usage of 
vape products. In many instances, these products were 
manipulated beyond the product's intended use, but it still 
remains unclear what these products contain and how exactly 
they were manipulated.
    The lack of certainty on the root cause of these illnesses 
speaks to a larger problem. We do not know the full spectrum of 
health consequences associated with the use of e-cigarettes. 
Ten years ago, the Family Smoking Prevention and Tobacco 
Control Act was signed into law after coming out of this 
committee. This law gave FDA the tools that it needed to 
effectively regulate all tobacco products. But, unfortunately, 
that is not happening. Therefore, it is critical that FDA and 
CDC explain today what actions they are taking and what more we 
can be doing to protect consumers.
    And I also look forward to hearing from states that have 
forged their own responses in the wake of an action at the 
federal level. The wide availability of flavored e-cigarette 
products clearly designed for kids' consumption are putting the 
interests of industry above the health of our kids. While I am 
pleased by the Administration's announcement that it plans to 
pull all flavored e-cigarette products from the market until 
they undergo full FDA review, I believe that ban should occur 
immediately. Above all else, we must get to the bottom of what 
is causing these lung illnesses, and we must ensure that vape 
products are kept out of the hands of our kids.
    At the same time, it has become clear to me that we must 
enact new comprehensive legislation; to fully address this 
growing youth epidemic. We must eliminate flavors, prohibit 
online sales that make it easy for kids to buy e-cigarettes, 
and ensure that these products are not being marketed to anyone 
underage. My legislation, the Reversing Youth Tobacco Epidemic 
Act, does each of these things while also raising the age to 21 
to buy tobacco products. It is my intention to move this 
critical legislation forward, and I hope that it will receive 
the strong bipartisan support that it deserves. It is long past 
time to address the public health risks associated with e-
cigarette use. We have to use every tool at our disposal to 
solve this crisis.
    And if I could just say, Madam Chair, although it is true 
as you mentioned that we do want to move legislation. I also 
think that it is very important for the Oversight and 
Investigations Subcommittee to find out what is happening, you 
know, what the agencies are doing, what is actually causing 
this epidemic, so I really appreciate the fact that you are 
having this hearing. I think we need to have this hearing. As 
much as I want to move forward with the legislation; we need to 
have this hearing first to get to the bottom of this. So thank 
you again. I yield back.
    [The prepared statement of Mr. Pallone follows:]

             Prepared Statement of Hon. Frank Pallone, Jr.

    We are here today to examine the growing public health 
crisis involving e-cigarettes, and the proliferation of these 
products among kids and teens.
    I am deeply concerned about the recent outbreak of lung 
illnesses that have killed eight people and sickened more than 
530 here in the United States. I am also exceedingly frustrated 
by the fact that e-cigarette usage has reached epidemic 
proportions in recent years among kids. If you talk to any 
parent of a high school student, you know that our nation's e-
cigarette problem is real--and getting worse. It is long past 
time for the public health agencies to address vaping and e-
cigarette usage in a meaningful way.
    I look forward to hearing about what the Food and Drug 
Administration (FDA) and the Centers for Disease Control and 
Prevention (CDC) can tell us about how they are addressing 
these tragic mystery illnesses and their recent actions to 
combat youth e-cigarette use. But make no mistake--I firmly 
believe that many aspects of the youth vaping epidemic could 
have been addressed if the FDA had moved forward with reviewing 
all e-cigarettes on the market when it first had the chance two 
years ago.
    Instead, in July 2017, FDA announced that it would delay 
implementation of key provisions of the agency's final deeming 
rule, which ensured the agency would review all e-cigarette 
products on the market. That same day I issued a statement 
expressing deep concerns that these delays would mean that e-
cigarette products would continue to lack needed public health 
oversight for several years and risk continued exposure to a 
new generation. Here we are over two years later, and 
unfortunately my concerns have come to fruition.
    Since that decision, youth e-cigarette usage has 
skyrocketed--more than one in four high school students say 
they have used e-cigarettes in the past 30 days. These products 
have been marketed and targeted to kids without our knowledge 
of the full public health consequences. As a result, we could 
lose an entire new generation to a lifetime of nicotine 
addiction.
    At the same time, hundreds of people throughout the country 
have developed unknown lung illnesses following the usage of 
vape products. In many instances these products were 
manipulated beyond the product's intended use, but it still 
remains unclear what these products contained and how exactly 
they were manipulated. The lack of certainty on the root cause 
of these illnesses speaks to a larger problem--we do not know 
the full spectrum of health consequences associated with the 
use of e-cigarettes.
    Ten years ago, the Family Smoking Prevention and Tobacco 
Control Act was signed into law after coming out of this 
Committee. This law gave FDA the tools that it needed to 
effectively regulate all tobacco products. Unfortunately, that 
is not happening. Therefore, it is critical FDA and CDC explain 
today what actions they are taking, and what more we can be 
doing to protect consumers. I also look forward to hearing from 
states that have forged their own responses in the wake of 
inaction at the federal level.
    The wide availability of flavored e-cigarette products, 
clearly designed for kids' consumption, are putting the 
interest of industry above the health of our kids. While I am 
pleased by the Administration's announcement that it plans to 
pull all flavored e-cigarette products from the market until 
they undergo full FDA review, I believe that ban should occur 
immediately.
    Above all else, we must get to the bottom of what is 
causing these lung illnesses, and we must ensure that vape 
products are kept out of the hands of our kids. At the same 
time, it has become clear to me that we must enact new, 
comprehensive legislation to fully address this growing youth 
epidemic. We must eliminate flavors, prohibit online sales that 
make it easy for kids to buy e-cigarettes, and ensure that 
these products are not being marketed to anyone underage. My 
legislation, the Reversing the Youth Tobacco Epidemic Act, does 
each of these things, while also raising the age to 21 to buy 
tobacco products.
    It is my intention to move this critical legislation 
forward, and I hope that it will receive the strong, bipartisan 
support that it deserves.
    It is long past time to address the public health risks 
associated with e-cigarette use. We must be using every tool at 
our disposal to solve this crisis
    Thank you to the witnesses for being here today and I yield 
back.

    Ms.DeGette. The Chairman yields back. The Chair now 
recognizes the ranking member of the full committee, Mr. 
Walden, for 5 minutes.

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

    Mr.Walden. Thank you, Madam Chair, and thanks for holding 
this hearing.
    Electronic cigarettes or e-cigarettes, the current outbreak 
of lung illnesses associated with e-cigarettes, and the youth 
vaping epidemic are a front and center health concern in the 
United States and particularly in my state of Oregon. In recent 
weeks, an as yet unidentified illness has killed seven people; 
sickened more than 500 across 38 states. As we will hear from 
Dr. Sharpless and Dr. Schuchat today, the investigation of the 
cause or causes of the illnesses is ongoing, but it appears to 
be vaping related. Many of the individuals who have gotten sick 
seem to have used black market products that contain THC.
    Earlier this month, public health officials in Oregon 
announced a person who died of severe respiratory illness in 
July had used an e-cigarette containing marijuana oil purchased 
from a licensed dispensary, meaning that the product sold in 
the store should have gone through a testing process regulated 
by the State of Oregon. It was the first death in the U.S. tied 
to a vaping product bought in a marijuana shop. Much is still 
unknown, however, including which dispensary sold the product 
and whether it was contaminated or whether something was added 
into the liquid into the device after the purchase.
    In July, an 18-year-old young man went to a hospital 
complaining of breathing problems. Within 48 hours, he was sent 
to the intensive care unit and diagnosed with acute respiratory 
distress syndrome, a condition associated with acute lung 
injury. He was connected to a breathing tube and placed in a 
medically-induced coma for a week. Later, the patient's mother 
found an e-cigarette cartridge with the label of a licensed 
company based in California that sells THC products. However, 
the cartridge later was found to be a counterfeit of that 
company's product.
    In North Carolina, five individuals bought the marijuana 
oils that made them sick, on the street, from unlicensed and 
likely illegal dealers. All five were hospitalized, three in 
intensive care. It took a battery of tests to figure out that 
all five had acute exogenous lipoid pneumonia, that is lung 
inflammation caused by breathing oil. Luckily, the individuals 
in New York and North Carolina survived, but not all have been 
so lucky, including the individual from Oregon who died.
    These cases of young, seemingly healthy young adults 
getting sick after vaping are piling up far too quickly. These 
cases are shining a light on the youth vaping epidemic in the 
United States. The most recent data from the National Youth 
Tobacco Survey is very troubling. About 27-1/2 percent of youth 
reported using e-cigarettes in 2019 compared to 20.8 percent in 
2018. That is an 11.3 percent jump in just three years.
    Given these trends in the administration, the Trump 
administration, the states, and this committee are right to 
look for solutions to curtail youth access to e-cigarettes. So, 
I appreciate the Trump administration's pursuit of an effective 
solution to the problem of youth access as well as the 
partnership between the administration and the states to 
investigate these outbreaks of lung illnesses.
    However, there is another overlay to the e-cigarette 
problem, and that is counterfeit products including counterfeit 
THC products. Bootleg THC cartridges are becoming too common on 
the market, with vendors advertising counterfeit and bootleg 
products on social media platforms such as Snapchat and 
Instagram. And according to press reports, the states that 
appear to be most inundated with counterfeit THC products are 
states where recreational marijuana is legal.
    According to the California Department of Public Health, 
there were 28 potential cases of acute lung disease among 
people who had recently vaped cannabis products. In August, the 
California Department of Public Health reported a cluster of at 
least seven healthy kids in Kings County, California, all 
admitted to hospitals with symptoms of severe lung disease and 
all seven were linked to THC vapes that had been purchased from 
the black market. Lab tests conducted by a third-party testing 
company showed common contaminants in the counterfeit vapes, 
including pesticides, a fungicide that, when vaporized converts 
into a substance used as a chemical weapon by the French during 
the first war, World War I.
    In addition to the ongoing work, we need a full 
investigation into counterfeit THC cartridges, Madam Chair, as 
well as the vaping and cannabis black markets. That needs to be 
part of this investigation. So, let's get a full set of facts 
to ensure we get it right when we move forward on policy 
solutions. I appreciate the witnesses who are going to testify 
today and others who have weighed in and echo the comments of 
the top Republican on the subcommittee, Mr. Guthrie.
    Unfortunately, we have two very important subcommittees 
that the majority decided to schedule, one on top of the other, 
one on prescription drugs that begins in about eight minutes 
upstairs on a very partisan bill, and this one. So, sorry, but 
we will be going back and forth as we work on both of these 
issues, and I yield back.
    [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 current outbreak of 
lung illnesses associated with e-cigarettes, and the youth 
vaping epidemic are a front-and-center health concern in the 
United States, and particularly my home state of Oregon.
    In recent weeks, an as-yet unidentified lung illness has 
killed seven people and sickened more than 500 across at least 
38 states. As we will hear from Dr. Sharpless and Dr. Schuchat 
today, the investigation into the cause or causes of this 
illness is ongoing, but it appears to be vaping-related. Many 
of the individuals who have gotten sick seem to have used 
black-market products containing THC.
    Earlier this month, public health officials in Oregon 
announced that a person who died in July of a severe 
respiratory illness had used an e-cigarette containing 
marijuana oil purchased from a licensed dispensary, meaning 
that the products sold in the store should have gone through a 
testing process regulated by the state. It was the first death 
in the U.S. tied to a vaping product bought at a marijuana 
shop. Much is still unknown, however, including which 
dispensary sold the product, and whether it was contaminated or 
whether something was added into the liquid in the device after 
purchase.
    In July, an 18-year-old male went to the hospital 
complaining of breathing problems. Within 48 hours, he was sent 
to the Intensive Care Unit and diagnosed with acute respiratory 
distress syndrome, a condition associated with acute lung 
injury. He was connected to a breathing tube and placed in a 
medically induced coma for one week. Later, the patient's 
mother found an e-cigarette cartridge with the label of a 
licensed company based in California that sells THC products. 
The cartridge was later found to be a counterfeit of the 
company's product.
    In North Carolina, five individuals bought the marijuana 
oils that made them sick "on the street" from unlicensed and 
likely illegal dealers. All five were hospitalized, three in 
intensive care. It took a battery of tests to figure out that 
all five had acute exogenous lipid pneumonia--lung inflammation 
caused by breathing oil.
    Luckily, the individuals in New York and North Carolina 
survived, but not all have been so lucky, including the 
individual who died in Oregon. These cases of young, seemingly 
healthy young adults getting sick after vaping are piling up 
too quickly.
    These cases are shining a light on the youth vaping 
epidemic in the United States. The most recent data from the 
National Youth Tobacco Survey is very troubling. 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 Administration, the states, and 
this Committee are right to look for solutions to curtail youth 
access to e-cigarettes. I appreciate the Trump Administration's 
pursuit of an effective solution to the problem of youth 
access, as well as the partnership between the Administration 
and the states to investigate this outbreak of lung illnesses.
    However, there is another overlay to the e-cigarette 
problem: counterfeit products, including counterfeit THC 
products. Bootleg THC cartridges are becoming more common on 
the market, with vendors advertising counterfeit and bootleg 
products on social media platforms, such as Snapchat and 
Instagram. According to press reports, the states that appear 
to be the most inundated with counterfeit THC products are in 
states where recreational marijuana is legal.
    According to the California Department of Public Health, 
there have been 28 potential cases of acute lung disease among 
people who had recently vaped cannabis products. In August, the 
California Department of Public Health reported a "cluster" of 
at least seven healthy adults in Kings County, California, all 
admitted to hospitals with symptoms of severe lung disease. All 
seven of these cases were linked to THC vapes that had been 
purchased from the black market. Lab tests conducted by a 
third-party testing company showed common contaminants in 
counterfeit vapes including pesticides, and a fungicide when 
vaporized that converts into a substance used as a chemical 
weapon by the French army during World War I.
    In addition to the ongoing work, we need a full 
investigation into counterfeit THC cartridges, as well as the 
vaping and cannabis black markets. Let's get a full set of 
facts to ensure we get it right on the policy solutions.
    I look forward to listening to the testimony of the 
witnesses and working in a bipartisan fashion on solving this 
problem.

    Ms.DeGette. The gentleman yields back. The Chair now asks 
unanimous consent that Members' written opening statements be 
made a part of the record. Without objection, so ordered.
    I would like to now introduce our first panel of witnesses 
for today's hearing, Dr. Norman E. Sharpless, M.D., Acting 
Commissioner of the Food and Drug Administration and Dr. Anne 
Schuchat, M.D., the Principal Deputy Director, Centers for 
Disease Control and Prevention. I want to thank both of you for 
appearing before the subcommittee today. I know you have both 
appeared before this committee before and it is great to see 
you. You are aware, I know, that this committee holds an 
investigative hearing and when it does so, it has the practice 
of taking testimony under oath. Do you have any objections to 
testifying under oath?
    Let the record reflect the witnesses have responded no.
    The Chair then advises that under the rules of the House 
and the rules of the Committee, you are entitled to be 
accompanied by counsel. Do either of you desire to be 
accompanied by counsel?
    Let the record reflect the witnesses have responded no.
    So if you would, please rise and raise your right hands so 
you may be sworn in.
    [Witnesses sworn.]
    Ms.DeGette. You may be seated.
     Let the record reflect the witnesses have responded 
affirmatively, and you are now under oath and subject to the 
penalties set forth in Title 18 Section 1001 of the United 
States Code.
    The Chair now will recognize our witnesses for a 5-minute 
summary of their written statements. In front of each of you is 
a microphone and a series of lights. The light will turn yellow 
when you have a minute left and red to indicate your time has 
come to an end.
    Dr. Sharpless, you are now recognized for 5 minutes.

             STATEMENT OF NORMAN E. SHARPLESS, M.D.

    Dr.Sharpless. Good morning, Chairwoman DeGette, Ranking 
Member Guthrie, and members of the subcommittee. Thank you for 
the opportunity to be here today to discuss the regulation of 
electronic nicotine delivery systems or ENDS, and the agency's 
role in the ongoing investigation into lung injuries 
experienced by individuals who use vaping products.
    As you know, prior to coming to the FDA, I was director of 
the National Cancer Institute, and I'm a longtime cancer 
doctor. My experience treating patients has informed all of my 
work at the agency, including the issues before the committee 
today. We are here to discuss two top priority issues. First, 
the ongoing investigation into the cause of the lung injury 
associated with the use of vaping products, and second, the 
FDA's ongoing efforts to address an epidemic of youth use of 
ENDS products, including the administration's recent 
announcement about our intention to issue a policy that would 
address ongoing marketing of flavored ENDS products.
    Let me start by discussing the vaping illness outbreak. 
Working with state partners, CDC and FDA have been 
investigating an outbreak of severe lung injury associated with 
the use of vaping products. Most cases have reported the recent 
use of vaping products containing THC, the psychoactive 
ingredient in marijuana. Although these cases seem similar, it 
is not clear if they have a common cause or if they have 
different pathogenesis with similar presentations. The 
investigation has not identified any specific substance or 
product that is linked to all cases.
     Let me outline the main components of our investigation. 
FDA's Office of Emergency Operations has activated an Incident 
Management Group to coordinate across the agency and work 
alongside CDC's Incident Management System. FDA's regulatory 
field force is playing a critical role in fact-gathering 
analysis. With state health departments we are collecting 
samples for analysis at our Forensic Chemistry Center. The FCC 
is using state-of-the-art methods to assess the presence of a 
broad range of chemicals in these products, including nicotine, 
THC, and other cannabinoids, opioids, cutting agents, and other 
additives, pesticides, and toxins.
    Additionally, we are working with Customs and Border 
Protection to identify illicit vaping products at the 
international mail facilities. FDA's Office of Criminal 
Investigations is focused on identifying the products that are 
making people ill and following the supply chain to the source. 
FDA is not pursuing actions associated with personal use of any 
vaping products; our interest is in the suppliers. But to be 
clear, if we determine that someone is manufacturing or 
distributing illicit adulterated vaping products that caused 
illness or death for personal profit, we would consider that to 
be a criminal act. Because many of the products associated with 
the cases contain THC oils, we have engaged the DEA to help 
with our investigation.
    Now, let me turn to the FDA's efforts to address the 
disturbing rate of ENDS use by children. This summer, working 
with CDC, the agency received preliminary data from the 2019 
National Youth Tobacco Survey or NYTS. Despite strong 
compliance and education strategies, the 2019 data indicate 
another alarming increase in youth use of ENDS products.
    FDA's response to the 2018 NYTS data was aggressive and 
multipronged. We stepped up compliance and enforcement efforts 
by issuing warning letters and civil money penalties for 
retailers for sales of ENDS to minors. We collaborated with the 
Federal Trade Commission to remove kid-appealing products from 
the market and pursued ENDS manufacturers employing unlawful 
online posts by social media influencers. Most recently, 
earlier this month, we issued a warning letter to Juul Labs, 
Incorporated, for marketing unauthorized modified-risk tobacco 
products, including at a presentation to children given at a 
school.
    We also expanded our efforts to educate youth about the 
dangers of e-cigarette use. Our youth e-cigarette prevention 
campaign, the Real Cost campaign, is a comprehensive effort 
targeting nearly 10.7 million youth aged 12 to 17. Despite 
these significant efforts, the 2019 NYTS preliminary data as 
well as another study supported by NIDA demonstrate a continued 
rise in the disturbing rate of youth e-cigarette, use 
especially through the use of non-tobacco flavors. In 
particular, these data show that more than a quarter of high 
school students were current e-cigarette users in 2019, and 
youth e-cigarette users cited fruit and menthol/mint flavors as 
being the most popular.
    In short, these data indicate the FDA must do more. That's 
why the President announced his support for the FDA's intention 
to soon finalize a compliance policy related to flavored ENDS. 
This policy would prioritize FDA's enforcement of premarket 
authorization requirements for non-tobacco flavors. FDA is not 
banning flavors as it has been described in some news outlets. 
Rather, FDA intends to enforce existing law that limits the 
marketing of such products.
    This policy would not mean that flavored e-cigarettes could 
never be marketed. If a company can show through an application 
to FDA that a specific product meets the standards set forth by 
Congress, then the FDA would authorize that ENDS product for 
sale. FDA intends to prioritize enforcement actions such that 
flavored e-cigarette products will be expected to exit the 
market unless and until manufacturers of these products provide 
scientific evidence demonstrating that marketing their products 
is appropriate for the protection of the public health.
    I want to assure the subcommittee that I am firmly 
committed to employing all the tools at FDA's disposal to 
tackle these important problems. We will not rest until we have 
answers to the questions in the investigation and until we've 
dramatically reduced the access and appeal of e-cigarettes to 
children. Thank you.
    [The prepared statement of Dr. Sharpless follows:]
    Ms.DeGette. Thank you, Dr. Sharpless.
    Dr. Schuchat, you are now recognized for 5 minutes.

                STATEMENT OF ANNE SCHUCHAT, M.D.

    Dr.Schuchat. Thank you, Chairwoman DeGette and Ranking 
Member Guthrie and members of the subcommittee. I'm happy to 
have the chance to update you about our ongoing investigation 
of lung injury as well as what we're doing related to the youth 
epidemic of e-cigarette use. I want to tell you what we know 
and what we don't know, what we're doing about the lack of 
knowledge, and also what we're doing about the youth e-
cigarette problem.
    I want to make four key points. First, since the first time 
we learned of these cases of lung injury, CDC has been working 
24/7, hand in hand with the state and local public health as 
well as the FDA to get to the bottom of it. Secondly, our 
ability to do this type of investigation relies on a critical 
underlying public health infrastructure including data systems 
that need modernization and a trained public health workforce 
including a data-savvy public health workforce.
    Third, CDC has made important recommendations to the public 
already including the comment that while this investigation is 
ongoing people who are concerned about health risks should 
consider refraining from using e-cigarette products or vaping. 
People should not acquire products off the street and should 
not modify these further, beyond what was intended by the 
manufacturers. Adults who use e-cigarettes or vaping products 
because they have quit cigarette smoking should not return to 
smoking cigarettes.
    And, fourthly, this outbreak reinforces the need to address 
the broader epidemic of cigarette use among youth. What we know 
so far is that this epidemic is striking young people. Half of 
the cases are under 25. About three in four are male, but those 
numbers are changing as we get more data. We are getting new 
cases reported every day and I expect this week's numbers to be 
hundreds higher than what we reported last week.
    What we don't know unfortunately is the cause. We know that 
most of the reported cases with information available so far 
describe e-cigarette use containing THC or THC and nicotine e-
cigarette use. But no single product, brand, substance, or 
additive has been identified with all cases at this point. It 
may be that there is one cause or that there are many causes 
and there may be complex root causes.
    CDC is working vigorously together with the states to 
respond. We've dispatched our disease detectives to assist some 
of the state and local public health. We've been coordinating 
case definition, data collection, and analysis. We've issued 
clinical guidance and we're working with the clinical community 
to update that as new information becomes available. We 
activated Our Emergency Operations Center as we do for various 
public health emergencies and we are coordinating and convening 
the public health and clinical community as well as doing 
frequent media telebriefs to keep the public informed as well. 
We're working closely with the FDA on the traceback of products 
that people have used.
    And while our laboratory is not testing the patient 
products that are collected--that's the FDA's role at this 
point--our tobacco lab is working to develop assays to test the 
aerosols produced from some of the products. There are 
challenges with this response. The investigation includes 
trying to gather information about exposures to potentially 
illicit products and so some respondents may not be totally 
forthcoming. State laws vary regarding THC and cannabis use 
that can also complicate the data collection challenges.
    E-cigarettes or vaping are part of a marketplace that is 
very wide and diverse. As you've heard, a multitude of product 
varieties and different substances can be used with the 
devices. There are also the issue of counterfeiting or black 
market products. Public health data collection for its response 
is relying on antiquated and fragmented systems that need 
modernization. The disease, unfortunately, is moving faster 
than our data systems at this point and that is a barrier to 
our getting to quick answers.
    Let me turn briefly to what we're doing about the youth 
vaping issue or the youth e-cigarette use. We know that youth 
are much more likely than adults to use e-cigarettes. CDC has 
been messaging about our concerns with youth e-cigarette use 
since 2013 when we got the initial data about the alarming 
increase from 2011 to 2012 in youth use of e-cigarettes, so we 
have been at this and we continue to be at this in terms of our 
concerns.
    Finally, CDC is dedicated to working around the clock 
together with FDA and state and local health officials to 
identify the cause or causes of this outbreak and we will 
continue to keep Congress updated. Thank you.
    [The prepared statement of Dr. Schuchat follows:]
    Ms.DeGette. Thank you so much, Doctor. It is now time for 
members of the committee to ask questions and the chair will 
recognize herself for 5 minutes.
    So, in 2015, the CDC stated, ``Youth, young adults, 
pregnant women, as well as adults who do not currently use 
tobacco products should not use e-cigarettes.'' I think that 
was also echoed by you, Dr. Sharpless.
    So my question is, Dr. Schuchat, does the CDC believe that 
e-cigarette products are safe?
    Dr.Schuchat. We are really concerned about the use of e-
cigarette products among youth, pregnant women, young adults, 
and those who are not using tobacco products.
    Ms.DeGette. I mean even somebody who is not using, who is 
not smoking or using e-cigarettes now, it is not like they are 
safe for people to use; isn't that right?
    Dr.Schuchat. The aerosol that e-cigarettes produce can have 
a lot of potentially harmful substances. We have a lot to learn 
about both short-term and long-term effects.
    Ms.DeGette. So your answer is yes, it is not; or no, it is 
not safe; yes, it is safe?
    Dr.Schuchat. Right.
    Ms.DeGette. What is it?
    Dr.Schuchat. It is they are not safe for----
    Ms.DeGette. For those categories.
    Dr.Schuchat. For those categories.
    Ms.DeGette. Are they safe for other people?
    Dr.Schuchat. We are focused on those categories because 
there's the most data about them and particularly for those 
with the developing brain.
    Ms.DeGette. So we don't know if they are safe for the other 
people?
    Dr.Schuchat. Right.
    Ms.DeGette. OK.
    Dr.Schuchat. But we also are quite concerned about people 
going back to smoking cigarettes----
    Ms.DeGette. Right.
    Dr.Schuchat1 [continuing].And we don't want them to do 
that.
    Ms.DeGette. OK. Is it true that youth are more likely than 
adults to use these unsafe products?
    Dr.Schuchat. That's correct.
    Ms.DeGette. Now, Dr. Sharpless, the 2009 Tobacco Control 
Act gave the FDA the authority to put e-cigarettes under its 
regulatory authority which the FDA did in the 2016 deeming 
rule; is that right?
    Dr.Sharpless. That's correct.
    Ms.DeGette. And in 2017, the administration extended the 
compliance deadline by four years for companies to submit 
materials to the FDA for review of the public health risks of 
e-cigarette products; is that right?
    Dr.Sharpless. That's correct.
    Ms.DeGette. And is it accurate to say that e-cigarette 
products are only on the market because the FDA has exercised 
its enforcement discretion to allow them to remain on the 
market and not because the products have been reviewed by the 
FDA?
    Dr.Sharpless. All ENDS products currently on the market are 
illegal. They have not been reviewed by the FDA.
    Ms.DeGette. OK. And in fact your testimony says, ``No ENDS 
product in the United States is on the market legally,'' right?
    Dr.Sharpless. Correct.
    Ms.DeGette. OK. And so, you also agree with the CDC that e-
cigarette products are not safe; is that right?
    Dr.Sharpless. E-cigarette products are not safe. They are 
not without harm.
    Ms.DeGette. OK, so here is my concern. Both FDA and CDC 
says e-cigarettes are not safe. We are seeing an explosion of 
young people using the products and now we are seeing serious 
illnesses around the country, but FDA still allows these 
products to stay on the market even though they haven't 
undergone a full market review. So I think time is of the 
essence and I would like to ask you, Dr. Sharpless, when does 
the FDA intend to use its regulatory authority to assess the 
health impact of these products?
    Dr.Sharpless. I agree with you, I think time is of the 
essence. I think the context of the history is perhaps 
important. In 2017, when that light regulatory touch was taken, 
the data at that time showed that youth use of those products 
was sort of leveling off or going down and, therefore, I think 
the FDA being a science-driven organization opted for that 
policy at the time. Then what happened as you've described is 
this epidemic of youth use.
    Ms.DeGette. Right.
    Dr.Sharpless. And now we've accelerated our timeline. We've 
stepped up enforcement. We've stepped up education. And I can 
tell you, we are on this problem----
    Ms.DeGette. So what is your timeline?
    Dr.Sharpless. The next major development will be the 
finalizing of its compliance guidance which will have the 
effect of removing non-tobacco flavors from the market and we 
expect that to be weeks.
    Ms.DeGette. OK. And then what are you going to do after 
that?
    Dr.Sharpless. So typically when a guidance is finalized it 
has 30 days to go into effect or some period along those lines, 
and then we apply an enforcement strategy which we have----
    Ms.DeGette. So is the flavor strategy the only thing the 
FDA intends to do?
    Dr.Sharpless. I can't speak to, you know, a guidance in 
process, but it is certainly the major target of that effort.
    Ms.DeGette. And why is that? Do you think that that is 
going to solve the youth vaping epidemic?
    Dr.Sharpless. No, we do not believe that any single policy 
or process will solve the vaping epidemic. It's a combination 
of enforcement and education and multiple policy things that 
we're doing.
    Ms.DeGette. And are you continuing to review these products 
to see if they are inherently safe or unsafe?
    Dr.Sharpless. So all products, ENDS products, will have to 
submit an application to the FDA by May 2020.
    Ms.DeGette. OK.
    Dr.Sharpless. And so very soon everything should be coming 
in, but flavors would be removed from the market sooner than 
that because of our concerns about the youth epidemic of use.
    Ms.DeGette. OK, just one last question. How far is the FDA 
prepared to go to protect the health and well-being of young 
people if it determines that these are unsafe?
    Dr.Sharpless. The FDA is a science-driven organization. If 
the data support more aggressive measures, then we will take 
those.
    Ms.DeGette. How far?
    Dr.Sharpless. We could ban all flavors, for example.
    Ms.DeGette. Thank you. I now recognize the ranking member 
for 5 minutes.
    Mr.Guthrie. Thank you very much. I thank you both for being 
here, we appreciate it, your testimony is informative.
    Dr. Schuchat, you said that in all the 530 cases, or all 
the cases you have data for, there is no consistent, you 
haven't found like this is the cause, these are the things that 
we found or the thing that we found. Is there a trend line that 
is developing in what you are seeing?
    Dr.Schuchat. The data are coming in, really, literally, as 
we speak. We believe that most people who have exposure 
histories that we've gathered describe using either THC e-
cigarettes or THC e-cigarettes and nicotine e-cigarettes. There 
are very few that used only nicotine e-cigarettes.
    But I think it's important to say that what people say they 
used may not be fully descriptive of what the problem is. It 
may be as you heard, a cutting agent. It may be something 
together, something related to the device and how the device 
changed whatever product they used, and they may not really 
know what was in the product they got.
    Mr.Guthrie. It has been reported over 80, or 80 percent of 
the cases the person reported they used THC.
    Dr.Schuchat. That's right. That was in the report from 
Illinois and Wisconsin about the first 53 cases and those 
numbers are from about 40 people. But that trend is continuing 
as we get additional data. I think it's also important to 
recognize there may be a particular problematic source in the 
Midwest and a different one in California, and I think we 
really need to be on top of this investigation.
    Mr.Guthrie. Absolutely.
    Dr.Schuchat. And make sure that we understand all of the 
causes.
    Mr.Guthrie. When you say people are doing THC and nicotine 
is that they have nicotine e-cigarettes and THC, or they're not 
combining THC and nicotine?
    Dr.Schuchat. Right, separate products.
    Mr.Guthrie. Two separate products, OK.
    Dr.Schuchat. But one individual might have many different 
products that are being tested. So it's a very complex 
investigation and understanding exposure versus causality is 
something that we're really trying to get to.
    Mr.Guthrie. And I think we are looking at--we have the 
specific lung injuries we are looking at in this hearing. I 
know a lot of people are talking about the flavored and just 
the general growth in e-cigarettes which we need to address, 
but also the THC or the marijuana that we are needing to 
addressing.
    Some states have made it illegal. I think Massachusetts 
just said they are going to pull back the flavors, but I don't 
know they announced they are going to undo their marijuana 
policies and move them forward. And in your written testimony, 
you said that e-cigarettes or vaping products containing THC--
and many patients in this outbreak suggest the need to 
understand the health effects of increasing marijuana use in 
the U.S. That was in your testimony.
    What concerns does the CDC have about the effects of brains 
on teenagers who vape products containing THC?
    Dr.Schuchat. You know, the adolescent brain is still 
developing. In fact, brains develop all the way through about 
age 25. So whether it's nicotine or marijuana, I think we 
really want to know the effects that occur. There's animal data 
to suggest some concerns and there's behavioral data. But this 
is one of the reasons that there's a focus for the e-cigarette 
issue on avoiding use in adolescents and young adults. We don't 
know as much as we need to know about both short-and long-term 
effects, and there are harms associated with nicotine in the 
adolescent brain, as well as marijuana.
    Mr.Guthrie. Dr. Sharpless, what does FDA think of the 
effect of the brain and THC and vaping?
    Dr.Sharpless. We, as Dr. Schuchat said, there is animal 
data and some human data to suggest that the developing brain 
is sensitive to these kinds of chemicals and there are large 
ongoing prospective trials that the NIH is funding to address 
these questions, so I think we'll know more. But our current 
recommendation is that children should not be exposed to high 
doses of nicotine or THC for a long period of time. It's a bad 
thing.
    Mr.Guthrie. Thank you. And, Dr. Sharpless, CDC's written 
testimony states that product information from the outbreak 
cases will be shared with the FDA to help FDA assess which of 
the products fall within FDA's regulatory authority. Has CDC 
shared such product information with the FDA?
    Dr.Sharpless. We are sharing information continuously both 
with CDC and states and also now with the DEA. I think, you 
know, one of the things that we're doing that is important is 
we are getting these samples from the states that are linked to 
the cases and taking them to our lab and testing them directly 
to see what they contain.
    Mr.Guthrie. Are you seeing a trend? I know there has not 
been a consistent----
    Dr.Sharpless. We've received about 300 samples. We've 
tested about 150. I would say the answer's about 70 percent are 
THC products. The rest are nicotine products or something else. 
A significant fraction of the THC products, like maybe half of 
them, are contaminated with a vitamin E acetate as you 
mentioned, which is a skin oil that has no business being in a 
pulmonary product and we believe is added as a cutting agent as 
you mentioned.
    Mr.Guthrie. Can you know if, or can you tell if the 150 you 
have tested were secondhand or bootlegged or were they actual 
commercially purchased; can you tell that?
    Dr.Sharpless. That's difficult to ascertain. Some of the 
products, particularly the nicotine products, are things you 
could buy at a store and appear to be manufactured products, 
but many of them are clearly illicit products.
    Mr.Guthrie. Thank you. Well, my time has expired, and I 
will yield back.
    Ms.DeGette. Dr. Sharpless, you said those oils don't have 
any place in people's lungs. Can you explain why you said that?
    Dr.Sharpless. Sure. Vitamin E acetate is a skin oil. It's 
used for sort of, you know, wound healing in the skin. It's an 
oily goo. And it is--we have looked. There is virtually no 
pulmonary toxicologic literature on the use of this product as 
an inhaled substance. You know, an oily thing, the lung is not 
the gut. An oily substance in the lung is not going to be 
easily cleared and could cause a thing like lipoid pneumonia 
which has been seen in some of the cases.
    Ms.DeGette. I had a--I am sorry to say this.
    Mr.Guthrie. Go ahead.
    Ms.DeGette. But I had a pediatric pulmonologist in Denver 
tell me that what happens with this oil is it settles in kids' 
lungs and it impairs the development of their lungs and she has 
even seen kids whose lungs are like the lungs of 80-year-olds, 
and that is never going to resolve itself. That is going to be 
what happens. That is why we are so worried.
    The Chair now recognizes the gentleman from Massachusetts, 
the vice chair of this subcommittee, for 5 minutes.
    Mr.Kennedy. Thank you, Madam Chair. And I want to thank you 
for calling this important hearing. Thank our witnesses for 
being here.
    Yesterday, Massachusetts Governor Charlie Baker announced a 
public health emergency in a 4-month ban on the sale of all 
vaping products. To date, we know that at least nine people 
have died and 530 have been diagnosed nationwide. Back home in 
Massachusetts, there are at least 61 possible cases and yet we 
don't know concretely why. We don't know whether it is the 
nicotine products or the THC products. We don't know if there 
is additives that are responsible or if it is parts of the 
device that are causing the illness. We don't know if the 
products can be traced back to black market sales or over-the-
counter purchases.
    So building off of what the chair just asked, Dr. 
Sharpless, help me answer some of those questions. How is it--
what do we know and how is it that we don't know more?
    Dr.Sharpless. Regarding the vaping lung injury?
    Mr.Kennedy. I am sorry?
    Dr.Sharpless. Regarding the vaping lung injury?
    Mr.Kennedy. Yes.
    Dr.Sharpless. Yes. I think, you know, the first cases were 
really appreciated in July, so it's still a relatively new 
entity. I think the progress and the federal cooperation has 
been pretty good. We now have a rigorous case definition. We've 
begun to test a lot of the products both and interview the 
cases. And as I said, we've started a criminal investigation 
for, to learn more and I think we will gather more information 
quickly. I don't know if Dr. Schuchat wants to comment as well?
    Mr.Kennedy. So how did we get to the point where we are 
backtracking on this rather than actually putting in place the 
right consumer protections from the front end if you are 
telling me that vitamin E shouldn't be an inhalant and is 
coating people's lungs to the extent that children's lungs look 
like the lungs of an 80-year-old? Where was the regulatory 
failure to allow that to happen in the first place?
    Dr.Sharpless. We believe that adulterating a THC product 
would be an illicit activity. It would be illegal, and tough to 
regulate, you know, illicit drug dealers effectively. I mean 
that is people who are cutting their product to sell it for 
greater profit.
    Mr.Kennedy. And so you are saying that with regards to 
those specific cases with vitamin E acetate or an oil in it 
that you have no evidence that any of that is actually an 
approved commercial sale?
    Dr.Sharpless. No. Vitamin E acetate is not approved for 
inhaled use. I should be clear though that it's only present in 
about half of the THC products. We have a lot of cases that are 
not associated with vitamin E acetate.
    Mr.Kennedy. Right.
    Dr.Sharpless. We don't know if it causes anything or is 
just a marker for adulteration or, you know, is sort of a 
marker for a bad product.
    Mr.Kennedy. And so how, to both of you, how do we get to a 
point where we have got now a widely used consumer, series of 
consumer products that are getting 530 people sick, and 
understanding that it is somewhat new here, but there was 
clearly a massive regulatory failure that allowed for this to 
happen was there not?
    Dr.Sharpless. I believe, speaking about, not to conflate 
the two issues, but speaking about the epidemic of youth use of 
e-cigarettes, in retrospect, the FDA should have acted sooner. 
We should have been regulating these devices sooner. Since I've 
been at the agency, we've greatly accelerated the date. We've 
put out a bunch of education campaigns. We've announced new 
policies like the PMTA guidance that will help people submit 
these applications and now we are open for business to receive 
these applications. But we're going to catch up.
    Mr.Kennedy. Doctor?
    Dr.Schuchat. I would just say I'm extremely frustrated with 
the pace of our investigation. I wish we had answers already. 
I'm concerned that we may----
    Mr.Kennedy. So if you are frustrated with the pace of the 
investigation, what can speed up the pace of that 
investigation?
    Dr.Schuchat. Well, I think we have more than a hundred 
people working on this and the states are also making this a 
top priority. I think the FDA and DEA doing product sourcing 
can help. But I actually think there may a very complex set of 
root causes here that are going to be difficult for us to 
address as a nation and we need to take it very seriously.
    Mr.Kennedy. Like what?
    Dr.Schuchat. Well, I think if there's a set of supply 
chains that are completely underground that are adulterating 
products that in ways that are just experimental and are 
building on top of a population that is addicted to e-cigarette 
use as young people through the past few years, that we have a 
very vulnerable population and very challenging supply chain to 
address.
    Mr.Kennedy. And were none of those questions posed 
throughout any aspect of the regulatory process before these 
products were approved?
    Dr.Schuchat. I don't----
    Mr.Kennedy. Nobody thought that there would be a 
possibility of diversion or illicit use or that there could be 
implications here that we are going to have adverse health 
impacts?
    Dr.Schuchat. So, as you know the THC containing issues are 
really regulated at the state level, not at the federal level 
and I guess I would let the FDA describe that. CDC's not a 
regulatory agency.
    Mr.Kennedy. Understood.
    Dr.Schuchat. But we have been raising the alarm about e-
cigarettes and youth since 2013 when we first saw the rise. We 
also support state and local health departments to exert 
tobacco control comprehensive approaches.
    Mr.Kennedy. Dr. Sharpless, I will let you finish.
    Dr.Sharpless. Yes, so I think as Dr. Schuchat said, THC is 
a Schedule I drug. It's illegal by federal law but is being 
tolerated in some of the states. There's a state sovereignty 
issue. To the extent those products are reviewed and regulated, 
it generally occurs at the state level now.
    Mr.Kennedy. Right. And just very briefly though, it is not, 
as you said not all of these illnesses and death are linked 
squarely to THC; there is other issues here as well. And my 
concern is that if there is a failure in the regulatory and 
approval process on the front, it should have been easily 
foreseeable that some aspect of these would have been illicitly 
used or cut or otherwise.
    And so I want to understand where that process broke down 
so that we can make sure it doesn't happen again. I yield back. 
Thank you.
    Ms.DeGette. The Chair now recognizes the gentleman from 
West Virginia, Mr. McKinley, for 5 minutes.
    Mr.McKinley. Thank you, Madam Chair, and thank your panel. 
But I missed the earlier, your remarks, your earlier, because 
we do have another meeting going upstairs on prescription 
drugs. So you can see what has happened, the back and forth of 
this, so I apologize. That maybe your testimony might explain 
some of this, but I am trying to follow the chronology of this 
because from what I can gather from on the internet is that 
these cigarettes were introduced to the market around 2003, 
some said 2006. Can one of you confirm when these things came 
on?
    Dr.Schuchat. Yes, the e-cigarettes began to be marketed in 
2007, to my knowledge.
    Mr.McKinley. So back to you now, Doctor. If they have 
been--2007, again, I will accept your 2007. I have got 2003. 
But why has the FDA not come up with a final? Because I heard 
the chairman's remarks that I can't agree more with her 
concerns. I mean there is no light between the two of us on 
this. Why has the FDA not finalized some kind of determination 
that allows these things because they are still out there on a 
generally approved or how do you describe their permitted use?
    Dr.Sharpless. Sure. No ENDS products currently on the 
market are there legally. They are illegal. They----
    Mr.McKinley. I am sorry. I couldn't hear.
    Dr.Sharpless. They're illegal. They are not authorized to 
be sold. They're on the market through a policy of enforcement 
discretion where the FDA can prioritize the enforcement of its 
authorities. The history is, you know, e-cigarettes became 
deemed products subject to tobacco control like in 2016.
    Mr.McKinley. Well, you missed my point. I am sorry.
    Dr.Sharpless. Oh, I'm sorry.
    Mr.McKinley. If one of the byproducts of these are fine 
particles getting into people's lungs, we have had numbers of 
debates in this committee over the last 8 or 10 years about 
what is happening with the coal combustion, of particulate 
matter at 2.5 microns, but yet from what I understand, my 
research on this is that these e-cigarettes are introducing not 
only 2.5 microns but even less, smaller, and getting down in 
the lungs.
    So if we take action that are affecting and impacting the 
fossil fuel industry across America, why are we not finalizing 
and saying until we know more about the carcinogens, the heavy 
metals, and other things, cutting fluids or whatever its 
additives, why aren't we stopping this until your final 
determination? Why are these things still on the market if they 
are causing this kind of health risk----
    Dr.Sharpless. Sure.
    Mr.McKinley [continuing]. Twelve years after they were 
introduced?
    Doctor?
    Dr.Sharpless. I think the--we don't consider these products 
safe. They are harmful.
    Mr.McKinley. Excuse me?
    Dr.Sharpless. We do not consider these products safe. We 
think they have harm. We do not think, really, anyone should be 
using them other than people who are using them in place of 
combustible tobacco. I think it has to be said that combustible 
cigarettes are very----
    Mr.McKinley. But you know that is naive to think that that 
is what happening--children. Why aren't they just off the 
market until you make a final determination?
    Dr.Sharpless. So the drive at the FDA is to be guided by 
the science and what's good for the public health. We think 
that some small off ramp to allow addicted adult smokers off of 
it to transition from combustible cigarettes to another product 
is a public health value. But we really want to limit the 
ability of youth and children to get access to these products 
because the epidemic of youth use.
    Mr.McKinley. OK. Well, let me go up to the CDC. Would it be 
more beneficial to our youth and others if these cigarettes 
were taken off the market?
    Dr.Schuchat. We would like to make----
    Mr.McKinley. Now watch what I said. Should we take it off 
the market?
    Dr.Schuchat. We would like to make it possible for no youth 
to be----
    Mr.McKinley. I am sorry?
    Dr.Schuchat. We would like no youth to be using these 
products.
    Mr.McKinley. So why hasn't Congress worked on that?
    Dr.Schuchat. I'm sorry. Did you say why isn't Congress?
    Mr.McKinley. Yes. Why haven't----
    Dr.Schuchat. Well, we----
    Mr.McKinley. Why aren't they off the market? If you are 
saying they got a problem, you are thinking they should be 
better, why are they still out there? What is your opinion of 
why they are still out there if they are causing this kind of 
problem? If they are introducing particulate matter into our 
lungs that we are having such devastation with the coal 
industry and all fossil fuels, but yet we are allowing children 
to inhale it at a higher concentration level, let alone 
something that is up the stack a thousand feet up in the air, 
we are putting it directly into someone's lungs and we are 
saying that is OK.
    Dr.Sharpless. To be clear, Congressman, our plan is now to 
clear the market abruptly of characterizing flavors so that 
these kid-appealing products will be off the market as we 
finalize this guidance and implement this new policy.
    Mr.McKinley. I have run out of time. I yield back.
    Ms.DeGette. And don't worry, you can co-sponsor my bill to 
raise the smoking age to 21, if you haven't already.
    The Chair now will recognize Mr. Ruiz for 5 minutes for 
questioning.
    Mr.Ruiz. Thank you, Chair. There is a misleading notion 
when people say that it is safer than tobacco cigarettes that 
somehow it is safe. You said, and I believe you agree, and I 
wholeheartedly agree that vaping and e-cigarettes is not safe. 
In fact, there has been numerous scientific studies by 
different medical schools that have tried to elucidate whether 
or not vaping has any net public health benefit. And so far, 
the vast majority of researchers have concluded that they 
believe that there is more population-level harm than benefit 
with e-cigarettes.
    So on one hand, you both know that e-cigarettes has a very 
narrow benefit in that it helps tobacco smokers of cigarettes 
quit smoking, period. Not just to convert the market from 
tobacco to vaping for an industry's benefit, but it is to quit 
smoking and inhaling nicotine. There is no benefit to nicotine, 
period, but that is very narrow.
    Then the harm, the biggest harm here is that youth and 
young adult never-smokers, nonsmokers, people who have never 
touched a cigarette are starting to smoke nicotine through e-
cigarettes. These are new users. And there is even suspicion 
that there are more new users than there are those who are 
actually using e-cigarettes to stop smoking in general.
    So the benefit-harm, you can see, clearly the--in addition, 
there is a study from Pittsburgh that shows that those who are 
never-smokers who are now smoking and vaping, 47.7 percent of 
those youth and young adult smokers start smoking tobacco. 
Tobacco cigarettes. So you count those with never-smokers, 
compare those to those who are stopping to smoke, then that is 
why they are saying there is a net public health harm with this 
industry to begin with.
    Then there are other studies showing that vaping those e-
cigarettes still have volatile organic compounds that are still 
carcinogenic and cancer. And if you get a young adult who are 
more, have more propensity to be addicted, they have more 
propensity to stay smokers for a longer period of time 
therefore inhale benzene for a longer period of time, you can 
start to see that they can also acquire lung cancer and other 
types of cancers.
    And that is not to mention that the concentration of these 
pods, cute little pods that they do in USB cords, et cetera, 
have higher nicotine than tobacco, and you are starting to see 
reports in the emergency department of teenagers coming in with 
cardiac arrest and cardiac arrhythmias. I know, I am an 
emergency medicine physician.
    So where is the benefit of this industry to our nation's 
health except for that very small, narrow, tobacco smokers to 
get them to stop using tobacco and stop using e-cigarettes? So 
the best case scenario was that. The worst-case scenario is 
that new smokers, nonsmokers, and lifetime e-cigarette smokers 
which the e-cigarette industry and vaping industry would love 
to take tobacco smokers since they are large around the world 
and just simply buy our products because it is ``safer,'' i.e., 
the misnomer that it is safe.
    So we need to prevent the youth from getting their hands on 
there, and I am introducing legislation that will just do that 
to help increase the fines for first-time penalties for selling 
these to the youth. And I am also introducing legislation to do 
more research, more research on the long-term effects. So I 
would like to ask you, Dr. Schuchat, what are the secondhand 
smoke effects of vaping?
    Dr.Schuchat. You know, you've raised really critical issues 
that the aerosol that e-cigarettes can produce includes many 
toxic things and the direct and indirect effects are not fully 
understood, so the issue of additional research to really get 
at those long-term effects makes sense. And we absolutely share 
the concern about youth that no youth should be using e-
cigarettes and that it can open the door for many problems.
    Mr.Ruiz. I ran out of time.
    Ms.DeGette. The Chair now recognizes the gentleman from 
Virginia for 5 minutes.
    Mr.Griffith. Thank you, Madam Chairman. I appreciate it.
    Dr. Schuchat, you said earlier that there were a lot of 
different issues going on here and so I am going to touch on a 
couple different issues and I am going to jump around. So it 
may not always, one question may not lead to the next question. 
Let me start by just saying that there is an agency that is not 
here that I think has some issues that we need to look at and 
that is the DEA. Because for 20 years I have been for medicinal 
marijuana, but we have not been able to do adequate studies to 
find out what the benefits are. And if you can't find out the 
benefits you don't have any data on the harm.
    And so we really don't know, when you start adding THC into 
these vape products, we don't really know the long-term 
consequences of THC, particularly when you start as a youth. We 
know it is not good because the brain is developing as you 
said, Dr. Schuchat, until 25. As a part of that, the Virginia 
legislature this last year raised the age for all tobacco 
products to 21. So, you know, obviously the states can lead on 
that and Ms. DeGette mentioned that she has a bill that would 
do that at the federal level and that seems to be a proper step 
for youth.
    And in reality, Dr. Schuchat, I think you may have 
mentioned this yesterday as well, don't we really have two 
problems? We have these mysterious lung diseases and then we 
have the whole youth and flavor issues. And I bring that up in 
particular because my wife is a juvenile domestic relations 
district court judge and they are seeing all kinds of problems 
in the schools, because unlike a regular cigarette where the 
teacher can immediately identify what part of the classroom it 
is coming from, they are not getting that with the vape 
cigarette. They are just putting it in their pockets or 
whipping it out real quick when the teacher's back is turned. 
And they have no idea that vaping is going on in the classroom 
unless they actually catch them, which sometimes does happen. 
But am I correct? We are really talking about two different 
issues here today.
    Dr.Schuchat. Yes, there's two extremely important critical 
issues; where they overlap we don't know yet.
    Mr.Griffith. Right. Now one question that my colleague from 
West Virginia brought up and that is that e-cigarettes have 
been on the market for quite some time, 12 years at least, but 
the vaping illnesses seem to be new. So here is the question, 
and I would like a quick answer if I can get it because I have 
other things I want to ask about.
    Does the CDC or the FDA know if the current outbreak is a 
new phenomena or is it just that there is a new awareness and 
people started looking for these lung disorders from people who 
may have been vaping?
    Dr.Schuchat. Increasingly, the data suggests it is a new 
outbreak. There have been individual cases in the past, but 
nothing like what we have seen now.
    Mr.Griffith. And am I correct that the knockoffs, the 
illegal, imported many times pods is a relatively new 
development as well?
    Dr.Schuchat. Well, even the mod pods are relatively new, so 
knockoffs of mod pods would be new as well.
    Mr.Griffith. OK. And so previously we may not have had as 
much of the various chemicals being added in to dilute or have 
we?
    Dr.Schuchat. I don't actually know. I'm not----
    Mr.Griffith. Do you know, Dr. Sharpless?
    Dr.Schuchat. I don't have that knowledge.
    Dr.Sharpless. We are--we don't really know what the 
practices of adulterating these products have become. Other 
than that we know that when we test them we find signs of 
adulteration. That appears to be occurring, but whether that's 
new or an older practice, we can't say.
    Mr.Griffith. All right.
    Now, Dr. Sharpless, I'm aware that there are a number of 
vape products, or vapor products for sale in the U.S. that came 
onto the market after the FDA's August 8, 2016 deadline. That 
means they are already being sold illegally. What is the FDA 
doing right now to get those illegal products, many of which 
are compatible for use with legally sold products, off the 
market?
    Dr.Sharpless. When we identify products that are on the 
market after the period that you alluded, we act to remove them 
from the market by sending warning letters and other 
notifications. We've done that in a handful of instances or 
significant number of instances. It can be difficult to 
ascertain when something came on the market, so that makes it a 
little more tedious than you would have expected.
    Mr.Griffith. All right. Now I mean this as a friendly 
question. We can't control all the importation of illegal 
substances coming across our borders, currently. Do you have 
much hope that we are going to have much success with keeping 
imported, possibly tainted mods, pods, whatever the right 
terminology would be, coming across the border?
    And what I am trying to say is somebody else earlier said 
that you know, how come you all haven't stopped this? If we 
can't stop fentanyl, how are we going to stop pods for vaping?
    Dr.Sharpless. Congressman, I agree it's a very challenging 
issue. We have engaged the DEA to help, to discuss these topics 
and rely on their expertise. Our international mail facilities 
work with Customs and Border Protection to see what's coming in 
and we are doing fact-finding presently in the IMFs to find 
what vaping products are being sent to the United States and 
what are the characteristics.
    Mr.Griffith. All right. I think we will probably have more 
hearings. I appreciate your time. This is a serious issue. We 
are all very concerned about it, and I yield back.
    Ms.DeGette. The Chair now recognizes the chairman of the 
full committee, Mr. Pallone, for 5 minutes.
    Mr. Pallone. Thank you, Madam Chair.
    Earlier in September, the President announced that FDA 
intends to finalize the policy in the coming weeks to clear the 
market of flavored e-cigarettes until products undergo full 
premarket review. And while I certainly agree with the 
statement Dr. Sharpless made that we must act swiftly against 
flavored e-cigarette products, I am disappointed that it has 
taken so long to get to this point.
    E-cigarettes have been available for purchase for over a 
decade and it has been over three years since they were brought 
under the regulatory authority of FDA. And during this time, 
the e-cigarette market has dramatically expanded and has become 
more attractive and accessible to children and teens.E-
cigarette use amongst middle and high school students has risen 
sharply, with preliminary data released last week demonstrating 
that a third of twelfth graders are e-cigarette users.
    And I agree that the clearing the market of flavors could 
help reduce youth utilization of e-cigarettes and raising the 
minimum purchase age of tobacco to 21 could also help reduce 
youth access, but these steps in isolation aren't enough. It is 
my strong belief that Congress must take comprehensive action, 
and I now have some questions about FDA's guidance and our need 
to do more.
    So, first, let me start with Dr. Sharpless. It is my 
understanding that FDA intends to outline the Administration's 
policy to prohibit the sale of non-tobacco flavored products 
through guidance; is that correct? Yes or no.
    Dr.Sharpless. That is correct.
    Mr. Pallone. Dr. Sharpless, FDA guidance, in my opinion, 
lacks the permanence and legal force of a statute or a formal 
rule issued by the agency; is that correct?
    Dr.Sharpless. To be clear, we will--the guidance will just 
allow us, will describe how we're going to enforce existing 
law. So these products are illegal and we're just announcing 
how we're going to prioritize enforcement of existing law.
    Mr. Pallone. So, but do you disagree that the guidance 
lacks the permanence and legal force of a statute or a formal 
rule issue by the agency?
    Dr.Sharpless. Well, the products are illegal by the act of 
Congress, so guidance is merely to----
    Mr. Pallone. So you are saying that with the guidance you 
will now enforce the underlying law?
    Dr.Sharpless. Right. The guidance will describe our 
enforcement policies.
    Mr. Pallone. Well, what kind of steps can the FDA take to 
ensure that the industry is complying with this flavored 
tobacco prohibition, given what you just said?
    Dr.Sharpless. Sure. The FDA has experience with this kind 
of problem. Generally, we send warning letters to the 
legitimate retailers and manufacturers. They will come into 
compliance, usually, and then that will have a dramatic effect 
to the products on the market.
    Mr. Pallone. Well, I still don't understand how you force 
them to comply with the guidance.
    Dr.Sharpless. The way it works is we send a warning letter. 
It says that your product is no longer, you know, subject to 
enforcement discretion and at that time we expect it to be 
removed from the market, any flavored products.
    Mr. Pallone. And if they don't?
    Dr.Sharpless. Then we have a number of other activities 
that escalate, you know, further warning letters, civil money 
penalties we actually, and manufacturers we can seize through 
injunctions.
    Mr. Pallone. And you intend to impose those enforcement 
measures?
    Dr.Sharpless. What's that? I'm sorry.
    Mr. Pallone. You would impose those fines and those other 
enforcement measures?
    Dr.Sharpless. For manufacturers it's usually an injunction. 
Yes, but we would impose those, if needed.
    Mr. Pallone. OK. Let me--as the proposed flavored ban 
included mint and menthol flavored products, can you commit 
that these flavors will remain part of the compliance guidance 
when it is finalized?
    Dr.Sharpless. You know, I can't describe what's going to 
come out in a future, in a guidance we're working on, with 
certainty. I can tell you that the data suggests that mint and 
menthol are very popular with children, and if the intent of 
the policy is to----
    Mr. Pallone. But I mean you are not committed if that is 
going to be a part of the compliance when it is finalized?
    Dr.Sharpless. Well, the compliance guidance will be out in 
weeks and, you know, I think we will----
    Mr. Pallone. Well, it sounds like you are saying you are 
not committed to it, unfortunately. I just think the only way 
we can realistically verify that tobacco products both flavored 
and non-flavored don't flow to children is through direct, you 
know, this question is about face-to-face sales. I think the 
only way that you can verify that tobacco products, whether 
they are flavored or non-flavored, don't flow to kids is 
through direct face-to-face sales. And my bill would ban the 
sale to online and other, would ban online and other remote 
sales.
    So can you commit that any guidance banning the sale of the 
flavored e-cigarettes would extend to online and other remote 
sales?
    Dr.Sharpless. The guidance we envision would extend to all 
retail channels, so online and in-person sales.
    Mr. Pallone. OK. Now as I understand it, there are reports 
of as many as three million distinct e-cigarette products 
currently available for sale in the U.S. Does the FDA face any 
resource or capacity challenges in monitoring the e-cigarette 
market to be able to enforce the agency's existing authorities?
    Dr.Sharpless. So as you know, the Center for Tobacco 
Products at FDA is entirely funded off user fees. E-cigarette 
products do not pay a user fee, as I think contra distinction 
of other tobacco products. I think a user fee program for e-
cigarettes would be helpful to the FDA to enforce these 
activities that you described.
    Mr. Pallone. Are those user fees that you are receiving now 
available for monitoring e-cigarettes?
    Dr.Sharpless. We are using the appropriate monies for our 
activities related to tobacco products.
    Mr. Pallone. What about the user fees?
    Dr.Sharpless. I'm sorry, sir?
    Mr. Pallone. What I am trying to find out is if the money 
you are getting from user fees is available for monitoring e-
cigarettes or are you just using the money from appropriated 
sources?
    Dr.Sharpless. The money we're getting for user fees is 
available for the use of monitoring e-cigarettes.
    Mr. Pallone. All right. Thank you.
    Thank you, Madam Chair. Sorry to go over, but I, you know, 
this is such an important issue. I apologize for going over.
    Ms.DeGette. You are the Chairman. The Chair now recognizes 
the gentle lady from Indiana, Mrs. Brooks, for 5 minutes.
    Mrs.Brooks. Thank you, Madam Chairwoman. And thank you for 
hosting this incredibly important hearing.
    According to the Indiana State Department of Health and in 
a recent publication as Dr. Kris Box, the commissioner, stated, 
the numbers are staggering in Indiana as well. Nearly one in 
five high school students and one in twelve middle schoolers 
say they use e-cigarettes according to the 2018 Indiana Youth 
Tobacco Survey, and it is a 350 percent increase since 2012. 
She also writes that one e-cigarette can contain the same 
amount of nicotine as an entire pack of cigarettes? I think 
there is so much that is not known about e-cigarettes.
    And so my question for both of you given how little we know 
about e-cigarettes and long-term effects of e-cigarettes, what 
research or studies are currently underway to help educate 
everybody about the e-cigarettes? Dr. Sharpless, when do we 
expect the studies to be complete, what studies are underway, 
and same to you, Dr. Schuchat.
    Dr.Sharpless. Sure. There's a number of studies by a 
variety of federal agencies looking at the kind of composition 
of e-cigarettes and their use as a switcher cessation device 
type approaches from both NIH and FDA and other agencies. But, 
you know, these are still relatively new products and we don't 
have the long-term experience with them that we would like. The 
FDA has launched very vigorous education campaigns particularly 
targeting youth about the dangers of e-cigarettes including 
recent online, you know, ads and TV ads.
    Mrs.Brooks. My concern--and, Dr. Schuchat, anything else 
you would like to share about studies and research?
    Dr.Schuchat. Yes, CDC's just doing surveillance and 
monitoring. We're not doing research. We do test the aerosols 
and we're really, really focused right now on the lung injury 
outbreak and studies related to that.
    Mrs.Brooks. Well, in fact, right after Dr. Box issued this 
report and indicated that our Governor Holcomb at one of my 
high schools announced a two million dollar campaign to curb 
youth vaping at Fishers High School, talked about this, 
announced it at Fishers High School, a lung injury death 
happened to a young Hoosier within the week of this incident. 
And this has impacted 50 others in our state, nationwide over 
400 cases.
    My concern is, is that all of the research if we wait--the 
research being done on marijuana still isn't conclusive. We are 
still waiting on the federal government to really come up with 
conclusive studies to be finished on marijuana decades after we 
started it. Why do we think that this is going to be any 
different than that? Dr. Sharpless, why do we think the 
research is going to be any different and it is going to be 
done any faster, because more people are dying?
    Dr.Sharpless. No, I think I agree with you that this is 
going to be a tough topic to study. It's going to require a 
long-term effort. I think some data will be more easy to glean 
forthcoming, but the answer to the questions that we really 
want to know, like what's the safety of these products over 
years and decades, is going to take a while. In the interim, I 
think the FDA's charged with using existing science to come up 
with a regulatory framework that is best for the public good.
    Mrs.Brooks. So whether it is a surveillance or the 
investigations being done, is there a consistent substance, 
brand, or product identified in the cases so far?
    Dr. Schuchat?
    Dr.Schuchat. There's not yet a consistent one. And one of 
the reasons that we took action of making broad recommendations 
right now is it may take a while to get answers and we wanted 
to warn the public in the meantime.
    Mrs.Brooks. Dr. Sharpless, anything that you are, any 
different statement on that?
    Dr.Sharpless. I would agree that the majority of products 
as I mentioned are THC, but there's certainly some that are 
nicotine only and there's no particular brand or product or 
contaminant that we've identified in all cases.
    Mrs.Brooks. And in the studies that you are doing, how 
many, do we know if the individuals are reporting buying them 
at, the vaping products, at stores versus online or are they 
getting counterfeit or black market products on the street?
    Dr.Schuchat. I think anecdotally we see a lot of social 
sources, you know, not retail purchase but more, you know, from 
someone they know. So I think we're concerned about that in 
terms of what the ultimate supply chain may be.
    Mrs.Brooks. And do we know, have there been questions from 
them by those that are asking the questions whether or not they 
have modified after purchasing either the device or the 
product?
    Dr.Schuchat. They're a set of questions and I don't have 
yet the results of the interviews. The states on the next panel 
may have more information because they are actually doing the 
interviews with their patients.
    Mrs.Brooks. OK, thank you. I yield back.
    Ms.DeGette. The gentle lady yields back. The Chair now 
recognizes the gentle lady from Illinois, Ms. Schakowsky, for 5 
minutes.
    Ms.Schakowsky. Thank you. I understand that you are saying 
that we don't have any evidence or that the evidence is that 
this might help some smokers. But on the website smokefree.gov, 
which is part of the Department of Health and Human Services, 
it says, ``E-cigarettes are not approved by the FDA as a quit-
smoking aid. So far, the research shows there is limited 
evidence that e-cigarettes are effective for helping smokers 
quit. There are other proven safe and effective methods for 
quitting smoking.'' So that is the quote.
    So, clearly, e-cigarettes are not proving to provide 
smokers smoking cessation and it seems to me that, you know, if 
we are unable to limit cigarette use to existing smokers that 
we should just ban it. I don't understand why the default 
position right now should be to allow it continue in any shape 
or form. Dr. Schuchat, who I barely remember out of uniform, 
that we should be saying no right now, and then if there is a 
way to phase in some of it, OK.
    But meantime, people are dying including a person in my 
state. How many children are we going to allow to die before 
this is considered the emergency it is and we just say no? So I 
would like to hear from both of you.
    Dr.Sharpless. Sure. I'll start if you--mind. I agree with 
what you said. These are not approved cessation devices. The 
FDA does have other cessation approaches that are approved. The 
FDA is driven in its decision making by science for what's good 
for the public health. The argument against banning all e-
cigarettes is that we think in that instance there are people, 
millions of Americans using e-cigarettes today who may find no 
other source of nicotine that's gratifying, satisfying to them 
other than moving back to----
    Ms.Schakowsky. OK.
    But, Dr. Schuchat, you said that the aerosols have toxins 
in it. I mean, I understand what you are saying and maybe that 
is true. But in the meantime, we have an epidemic of people 
ending up in the hospital and eight people who are dead. Let me 
ask Dr. Schuchat to----
    Dr.Schuchat. Yes, what I would say, of course CDC doesn't 
have the regulatory authority but we have aggressively 
announced warnings and we want parents, teachers, state health 
departments, and clinicians to know about the dangers that this 
outbreak is associated with. Our recommendations say if you 
have concerns about health risks, we suggest you not use vaping 
or e-cigarettes at this time.
     Ms.Schakowsky. That is nice. That is nice, but--so, I want 
to ask another question. I understand, and we have heard from 
several media outlets, and I want to put some articles into the 
record that report that the White House is still planning to 
hold a listening session with several conservative think tanks 
and industry groups that are concerned that eliminating or 
banning any part of this would hurt the President's reelection. 
And so, it seems that no other, no public health groups are on 
the list and you were not invited, as I understand.
    Do you think that is appropriate that industry groups and 
organizations that support the President and support vaping 
should be in a meeting?
    Dr.Sharpless. I can't really comment on meetings the White 
House plans to take. I----
    Dr.Schuchat. Yes, CDC's a data-driven organization and 
we're gathering the data and alerting people about risks.
    Ms.Schakowsky. Well, I do want to ask that we put into the 
record some articles about this potential meeting. And let's 
hope that the whole idea----
    Ms.DeGette. Without objection, so ordered.
    [The information follows:]
    *********COMMITTEE INSERT**********
    Ms.Schakowsky. Thank you. And let's just hope that all of 
this is data-driven. But do you have any metrics at what point 
we say we are going to address this not just by education? Are 
we going to see an implementation of taking this away? Did you 
send the letter yet that you said is going out and what have 
the responses been? I don't feel a sense of urgency. I just 
don't feel a sense of urgency here.
    Dr.Sharpless. Congressman, we are very, have a strong sense 
of urgency at the FDA on this topic. You know, we sent the 
letter to the manufacturer I mentioned, to Juul Labs regarding 
their marketing practices. We also, this compliance guidance as 
we finalize it in a few weeks will have a dramatic effect on 
the marketing of flavored products and what's available to the 
American consumer today and I think will be really good for 
kids because we know flavors are particularly attractive to the 
young people.
    Ms.Schakowsky. OK, and they will be banned in a few weeks?
    Dr.Sharpless. They will be withdrawn from the market 
because we will exercise our, we will stop exercising 
enforcement discretion over those products.
    Ms.Schakowsky. And they will be banned?
    Dr.Sharpless. That will have the effect of removing them 
from the market. Yes, ma'am.
    Ms.Schakowsky. OK, I yield back. Thank you.
    Ms.DeGette. The Chair now recognizes the gentleman from 
South Carolina, Mr. Duncan, for 5 minutes.
    Mr.Duncan. Thank you, Madam Chair. You know, the use of e-
cigarettes is common among our youth and the reported deaths 
and illnesses that have been associated with that are 
incredibly worrisome. The issue as I see it isn't necessarily 
about vape or vaping products as much it is about how these 
devices are abused.
    I thank the witnesses for being here to help us understand 
the issue better so that we can hopefully find appropriate 
solutions, but I believe the immediate answer is for our youth 
to stop buying black market pods and stop trying to get high by 
lacing these pods with THC. That seems to be the common thread. 
I believe it is crucial though that we look further into the 
THC counterfeit black market products that people are buying 
and vaping. I understand these products have a short history, 
but we need to have all the facts before we can fully remedy 
the situation.
    So I am going to ask both witnesses here today, I 
understand that patients with reported lung illnesses have 
admitted to using e-cigarettes containing just THC, THC and 
nicotine, and just nicotine. But does CDC and/or the FDA 
believe that THC counterfeit black market vaping products pose 
a higher risk than legally sold, unadulterated nicotine 
cartridges used in e-cigarettes? Both witnesses.
    Dr.Schuchat. We're concerned about both right now and 
we're--it's an ongoing investigation about the lung injury 
outbreak. We're very concerned about e-cigarettes and youth on 
an ongoing basis because the trends are increasing.
    Mr.Duncan. OK.
    Dr. Sharpless?
    Dr.Sharpless. I agree with Dr. Schuchat's remarks. I think 
no single product has been linked to all the cases. When we 
test cases, products that are actually linked to cases in our 
lab, we find the majority are THC products but not all of them. 
There are certainly nicotine-only products as well.
    Mr.Duncan. Thank you for that. Are there any enforcement 
actions that CDC and FDA believe we should be taking against 
counterfeit manufacturers?
    Dr.Sharpless. A challenging issue for the FDA particularly 
around THC which provides some jurisdictional challenges, I 
think we can certainly try and enforce what comes in at the 
borders through the international mail facilities. When it is 
an FDA-regulated tobacco product we certainly have significant 
enforcement authorities. And as I said, we've engaged the DEA 
for their help on products that are more challenging for us 
jurisdictionally.
    Mr.Duncan. Yes. Dr. Schuchat?
    Dr.Schuchat. I really think this is an extremely 
challenging issue. I don't have the tools and I'm not sure what 
the tools are, but I think counterfeiting, and there clearly 
are a lot of dangerous products out there.
    Mr.Duncan. Yes. Given what little we know about these 
counterfeit products, what research or studies are currently 
underway to help us understand more? What are you all doing to 
help us understand more?
    Dr.Schuchat. Just briefly, the state and local public 
health are interviewing patients associated with the lung 
injury outbreak and identifying what they used, where they got 
it, how they used it, and providing that product information to 
FDA or as appropriate to DEA.
    Dr.Sharpless. We're taking the data we're getting from CDC 
and other datasets and integrating that and we have, you know, 
an across the agency effort involving all our scientists to 
think about, you know, what's the cause of this outbreak and 
what we could do to prevent further cases. And then I mentioned 
the extensive testing that we are doing in our criminal lab to, 
in our forensic chemistry lab to identify the components in the 
possible contaminants.
    Mr.Duncan. I think there needs to be a strong public 
service announcement, a marketing effort targeting the age 
groups of middle school and high school that are using these, 
even college and even young adults. Two weeks ago, the CDC put 
out a statement regarding whether users should consider not 
using e-cigarette products at all while the investigation is 
ongoing. Conversely, the FDA put out a statement urging 
consumers to avoid buying vaping products from the street and 
to refrain from using THC oil or modifying using any substance, 
adding any substance products purchased in the stores.
    Why have the CDC and FDA been putting out conflicting 
warnings and recommendations to the public?
    Dr.Schuchat. You know, I would say there's no light between 
the recommendations that the two agencies have been putting out 
and if it's interpreted as different we want to correct that.
    Dr.Schuchat. Yes, I would agree. I think we're in lockstep 
on this about the public health emergency here and the 
avoidance of these products by all parties except for those 
people who may be using them to not use combustible cigarettes. 
I think, you know, we do look at slightly different datasets 
and we, as data emerges in real time, we want to make it 
available to the public as quickly as possible because the 
public of import of this information.
     But I agree, we're in substantial agreement on----
    Mr.Duncan. Does it concern you at all that the federal 
health officials, public health officials are putting out 
conflicting statements and there will be confusion among those 
who are using e-cigarettes legally? Not the ones who are buying 
the black market, not the ones that are adding things to it, 
you know, the confusion over those that are legally using 
vaping products? Does that concern you at all?
    Dr.Schuchat. We strive for clear communication and want to 
do better.
    Dr.Sharpless. I would agree. We have constant communication 
and I think we will strive for very coordinated communication.
    Mr.Duncan. I think the message here today is stop putting 
THC products in legally purchased pods and stop buying black 
market pods. There is a health risk and is coating the lungs of 
our children, keeping the oxygen from making it into the system 
to provide oxygen to the brain. It is damaging the health of 
our kids and that is the message today. Stop doing this. I 
yield back.
    Ms.DeGette. The gentleman's time has expired. The Chair now 
recognizes the gentle lady from New Hampshire, Ms. Kuster, for 
5 minutes.
    Ms.Kuster. Thank you, Chairwoman DeGette, for holding this 
critical hearing and thank you to our witnesses for joining our 
committee while we seek answers from the public about this 
public health emergency. And I think you are hearing in a 
bipartisan way the research is really important, communication 
and transparency of the data to the American people. I can 
certainly say as a parent this is a very scary time in terms 
of, I personally don't think we should be holding out any of 
these products as ``safe'' to the public because we haven't had 
the research and we have not thoroughly tested them.
    Based on the data, just as we were on the precipice of 
minimizing tobacco's hold on our nation's youth, the tobacco 
industry has devised a new way to place our children once again 
in the crosshairs. As a result, e-cigarettes are now the most 
commonly used tobacco product among youth, surpassing the rate 
of youth use of conventional cigarettes 5 years ago in 2014. In 
fact, e-cigarette use among youth doubled from 2017 to 2019--
doubled--demonstrating this problem is only getting 
significantly worse.
    In my own home state of New Hampshire, the Department of 
Health and Human Services estimates that at least one quarter 
of all high school students use vaping products and that number 
is on the rise. Now you may know that our state is still in the 
throes of an opioid epidemic that began with misleading 
marketing and lack of regulatory oversight. My fear is that we 
are repeating those same mistakes and making way for a new 
generation grappling with addiction. And that is why I am proud 
to cosponsor the Reversing Youth Tobacco Epidemic Act of 2019, 
which includes numerous important provisions to curb the rise 
of youth tobacco use.
    And with that I want to ask a few questions. Dr. Schuchat, 
based on CDC's surveillance and research, what do you believe 
are the reasons that young people are smoking e-cigarettes at 
such alarming rates?
    Dr.Schuchat. We know that flavors are a principal 
attractant to young people. The latest generation of e-
cigarettes also are extremely high in nicotine content. They 
often include nicotine salts which are a little bit more 
palatable or less bitter and the flavors are, you know, really 
targeted at youth. So we think the addictiveness of the high 
nicotine level and the appeal of the flavors are key. We also 
think some of the companies have had youth-targeting ads.
    Ms.Kuster. And the marketing. According to the National 
Institute of Health, 81 percent of adolescents who have ever 
used tobacco products began with a flavored product. Dr. 
Schuchat, what more can you tell us about the contribution of 
flavors to this dramatic rise? And you have mentioned this, 
anything more to add?
    Dr.Schuchat. Yes, I think that we have seen a little bit of 
a shift in the most recent preliminary data with an increase in 
the menthol and mint flavors among what youth are using. So we 
do think flavors are a critical beginning to youth use and then 
the nicotine provides that addictive substance that keeps them 
going back.
    Ms.Kuster. Thank you.
    Dr. Sharpless, will you ensure that the newly announced 
federal policy to clear the shelves of flavored e-cigarette 
products will be effective?
    Dr.Sharpless. We believe this policy will have dramatic 
effects on the flavored products sold in the market today.
    Ms.Kuster. And does that include menthol and mint 
cigarettes will be cleared from the shelves?
    Dr.Sharpless. We are finalizing the policy and I don't want 
to prejudge the policy under preparation, but I can say that 
the data support mint and menthol being a significant problem, 
as Dr. Schuchat alluded that it's been very popular with 
children.
    Ms.Kuster. Thank you. Last year as part of the FDA's 
comprehensive plan for tobacco and nicotine regulation, the 
agency launched the Youth Tobacco Prevention Plan. Dr. 
Sharpless, what are the goals of this youth-focused plan and 
can you discuss the status of some of the efforts like the Real 
Cost campaign that FDA has or plans to implement?
    Dr.Sharpless. Thank you for the question. The FDA has a 
longstanding anti-tobacco campaign, educational campaign. 
Initially, we focused around combustible cigarettes, getting 
youth not to use that. We believe it's very successful in that 
regard that the campaign reaches 11 million kids, age 12 to 17, 
who are users of tobacco products or open to using tobacco 
products. In the last year or so we have really shifted that 
focus to e-cigarettes to catch up with this epidemic. This 
includes some new TV ads that are very, they really tested off 
the charts with the youth markets. They're strong ads to 
discourage youth use of e-cigarettes, to make sure kids are 
aware. You know, sometimes kids aren't even aware that some of 
these products contain nicotine, for example, so juuling has 
become verb in high school that is not really understood to be 
a dangerous product, necessarily. So there's really a lot of 
education effort devoted by the FDA towards this topic.
    Ms.Kuster. Well, in my view, manufacturers and retailers 
are creating a new generation of nicotine-addicted consumers at 
a time when our nation's youth face unique obstacles, now more 
than ever. So it is important we take action to constrain 
further reversals and protect our youth. And with that I yield 
back.
    Ms.DeGette. The Chair now recognizes the gentle lady from 
Florida, Ms. Castor, for 5 minutes.
    Ms.Castor. Well, thank you, Chairwoman DeGette. This is a 
very important hearing and thanks to our witnesses for being 
here.
    America has a serious and growing vaping problem. I have 
seen it firsthand. My two daughters are just a couple of years 
out of high school and I noticed a sea change in behavior among 
high school kids, middle school kids over the past decade and 
it reflects the research the yearly Florida Youth Tobacco 
Survey that is run by our Department of Health found that from 
2012 to 2018 there was a 361 percent increase of kids aged 11 
to 17 who had tried electronic vaping. Even worse, there has 
been a 582 percent increase in kids that currently use 
electronic vapes and 651 percent increase when the survey 
focused only on high school students. And on top of that, the 
survey also found that e-cigarettes are by far and away the 
most common form of youth smoking.
    So, clearly, this is a very serious public health problem. 
Do you determine an epidemic or an emergency, Dr. Schuchat?
    Dr.Schuchat. Yes, we are calling the youth use of e-
cigarettes an epidemic.
    Dr.Sharpless. As are we.
    Ms.Castor. OK. Dr. Sharpless, on September 10th in a post 
titled, ``How FDA is Regulating E-Cigarettes,'' you wrote that 
clearly some of the rapid rise in youth use of these products, 
meaning e-cigarettes, has resulted from irresponsible practices 
of the manufacturers who have targeted children in particular. 
Give us some examples of these insidious practices by Juul and 
other manufacturers.
    Dr.Sharpless. So on September 9th, we sent a letter to Juul 
Labs, Incorporated detailing their use of unauthorized 
marketing claims, the so-called modified risk tobacco product 
claims, so things like saying their product is essentially safe 
or much safer or 99 percent safer. Some of these were made in 
presentations to children and they----
    Ms.Castor. So they are just outright saying things that are 
untrue.
    Dr.Sharpless. There is no data to support those claims. 
There are no data to support those claims that I am aware of.
    Ms.Castor. So that is untrue.
    Dr. Schuchat? Yes.
    How are these manufacturers specifically targeting kids? 
What type of marketing are they using that really alarms you?
    Dr.Schuchat. Yes, we're aware of a lot of presence on 
social media and recruiting youth social influencers, you know, 
influential people, celebrities and so forth, to make this look 
cool or fun. And certainly as Dr. Sharpless mentions, a lot of 
youth aren't aware there's even nicotine in e-cigarettes, you 
know, flavor and water, that's what I thought I was getting.
    So I think we're seeing the kind of tactics that were used 
with cigarettes being used again. And we think we need to take 
really aggressive action to protect the young----
    Ms.Castor. Yes.
    So, Dr. Sharpless, you said in the--we need all the 
regulatory tools that have been mentioned here, but you said in 
your public relations campaign you are going to use TV ads. 
That is not going to do it. You know, you have heard, you know 
what they are using.
    Dr.Sharpless. Yes.
    Ms.Castor. They are on Instagram. They are on Snapchat. 
They are using these influencers. Don't you have plans for a 
more modern type of education campaign to really get to young 
people?
    Dr.Sharpless. I totally agree there's, this is a market 
that requires a lot of different channels to reach. We have 
done some of this, so with the Federal Trade Commission, for 
example, we took down some sites that were using these social 
media influencers that were sort hyping e-liquid products 
without disclosing they contained nicotine, which is a 
violation.
    Ms.Castor. Who were the public health influencers that you 
all are going to bring to bear, because these products, you are 
right, young people, they think they are cool. They think they 
are not so harmful. They think oh, that has happened somewhere 
else. It is not happening in my friend groups.
    Dr.Schuchat. In terms of public health, of course the 
Surgeon General's really been out there and our partners at 
state and local public health. I think there's a lot of kids 
behind me who might be influential as well.
    Ms.Castor. Really. You have got to get with the program 
here. This is, you are not going to be able to combat this with 
the same old ways to communicate to young people these days. 
You have got to get--you have got to bring the most modern 
techniques to bear. I don't think the Congress has all the 
answers in that either, so I really encourage you and I 
encourage the committee to move aggressively on this, otherwise 
other people are going to die and other young people are going 
to get hooked that they don't even--they think it is cool, they 
think it is not harmful, and now all of your, the evidence we 
have so far that is just not the case.
    So I will yield back my time and encourage you to be more 
hip. Thanks.
    Ms.DeGette. The gentle lady now--well, let's see--now 
recognizes the gentleman from Maryland, Mr. Sarbanes, for 5 
minutes.
    Mr.Sarbanes. Thank you, Madam Chair. I want to thank the 
witnesses for being here today.
    I would like you to speak, both of you, but maybe Dr. 
Schuchat to begin, on--map out for me, because I think this is 
horrifying what is happening and it is sort of we are playing 
the same reel over again that we saw with, you know, cigarettes 
before the tobacco settlement, with opioids before, now the 
heightened scrutiny that it is receiving and all the litigation 
that has ensued and presumably some kind of compensation that 
will come too late for many families and many communities.
    But even as we are dealing with those things, the after 
effects of those crises, those public health crises, we have a 
new one unfolding before our eyes. And you can just predict 
that we are going to be having hearings 10 years from now, 
looking back and picking up the pieces of a terrible public 
health crisis with incredible impacts on communities across the 
country. The fact that it is starting, its breeding ground is 
among children is what makes it even more horrifying, so there 
is a lot of discussion about how we need to better regulate 
this and addressing industry's practices and marketing and all 
the rest of it, which is important.
    But maybe you can map out the scenario of what the public 
health crisis could look like 10 years out, 5 years out, 10 
years out if we don't take really dramatic steps now to address 
this on what arguably is still kind of the front end of it, 
although we are kind of getting into the thing. Map that out 
for me, because in a way what I am asking you to do is put on 
the record a scenario that we can come back to. I don't want to 
have to do that, but that sadly we may find ourselves coming 
back to later and saying this was all predictable. So talk 
about that.
    Dr.Schuchat. We've been warning about e-cigarettes and 
youth since 2013 when we first saw the increase in our data 
from 2011 to 2012. But the industry has changed substantially 
since then and the products in this fourth generation of e-
cigarettes are much more risky even than the earlier ones in 
terms of nicotine level, flavors, the nicotine salts and the 
concealable product that make it really hard to know that 
anybody's using in class and so forth.
    So if these trends continue and we don't turn this tide, we 
have a generation addicted to nicotine with potentially the 
impacts on the adolescent brain or the developing brain that 
last for life in terms of memory, attention difficulties, 
learning problems, and the implications of that as adult 
workers. We have the potential to progression to cigarette 
smoking which we know is incredibly lethal in people who smoke 
and we have all the signs of that happening in terms of the 
last few years of data.
    The issue right now with the lung injury outbreak has 
people dying. It's not a question of 20 years from now. It's a 
question of now and the forces that have led to that we don't 
fully understand. Just as with the opioid epidemic, we didn't 
understand prescription drugs to heroin to fentanyl to 
analogues to stimulants. And so I think we have a lot of people 
getting addicted----
    Mr.Sarbanes. But one thing we have come to understand and 
we probably could have understood in the moment with the opioid 
crisis if we hadn't, in effect, had the wool pulled over our 
eyes by an industry with very effective marketing techniques, 
is how a whole industry can either affirmatively be trying to 
encourage dependency on their product or at a minimum turn a 
blind eye to alarming trends that are happening that they know 
are happening and look for sort of plausible deniability about 
their own responsibility. And I think we are seeing it all play 
again, same movie.
    So anyway, we are going to keep our focus on this. Thank 
you very much, Madam Chair, for convening the hearing. I yield 
back my time.
    Ms.DeGette. The Chair now recognizes the very patient 
gentle lady from New York, Ms. Clarke, for 5 minutes.
    Ms.Clarke. I thank you, Madam Chair, and I thank Ranking 
Member Guthrie, for convening this subcommittee hearing today 
on the threats of e-cigarettes. I would also like to welcome 
and thank our panelists for their expert testimony here today 
and for attending as we fight to protect the American people 
from the harmful effects of smoking, but more specifically e-
cigarettes and vaping.
    And I would like to jump right into my line of questioning. 
Dr. Schuchat, according to your testimony, as of September 19, 
2019 there were 530 confirmed cases of lung disease associated 
with e-cigarette use in 38 states and one territory. So far, at 
least nine people have died as a result and the overwhelming 
majority of these cases, 83 percent, of which the CDC has 
complete data are under the age of 35. These are young people. 
It is devastating that this disease has already taken nine 
lives that we know of and it is an obvious tragedy. I have also 
seen reports, however, of individuals currently still on life 
support or on respirators for days on end.
    So, Dr. Schuchat, what do you know about the potential 
long-term health effects about this pulmonary illness 
associated with e-cigarettes?
    Dr.Schuchat. We fear there may be long-term illness in a 
number of individuals. We're recommending individualized care 
for clinicians to follow patients after they're discharged and 
check pulmonary function tests and so forth. It's so new that 
the clinical course is probably variable and some improvement 
is being noted in a number of individuals when they get steroid 
treatment. But, you know, the issue of long-term effects is 
very serious because these are young people who were pretty 
much fine and may have a life that's quite altered if they 
recover.
    Ms.Clarke. Is it possible that there are cases that we have 
missed prior to the outbreak?
    Dr.Schuchat. Yes. We know there have been individual 
reports of serious lung injury following vaping or e-cigarette 
use in the past. We believe that something new is happening to 
cause these many cases that we're seeing now and we know that 
the states and clinicians are really looking backward and 
getting all the cases reviewed that they can.
     But new cases continue to occur, and that's one of the 
reasons we feel this sense of urgency to get the public health 
messages out so that we can prevent further cases.
    Ms.Clarke. Dr. Schuchat and Dr. Sharpless, you have both 
said that no single product, device, or component has been 
identified as the specific cause of these illnesses, but you 
have reported at least some of the illnesses have been traced 
to ``street'' products not sold by legitimate retailers. Dr. 
Sharpless, what authority does FDA have to take action against 
counterfeit or unregistered e-cigarette products?
    Dr.Sharpless. So for counterfeit tobacco products we have a 
range of authorities when we're able to identify them. This 
includes testing.
    Ms.Clarke. No, no, no. I mean the e-cigarettes.
    Dr.Sharpless. Yes. Well, so for when the products involve 
THC not a tobacco product, this is----
    Ms.Clarke. Generally speaking, e-cigarettes.
    Dr.Sharpless. So e-cigarettes as the FDA uses the term or 
FDA-regulated tobacco product and there we have----
    Ms.Clarke. OK.
    Dr.Sharpless [continuing]. The same authorities we have 
with other tobacco products.
    Ms.Clarke. OK. And so you do have the ability to take 
action against this?
    Dr.Sharpless. If it is a tobacco product we have 
significant authorities, yes.
    Ms.Clarke. I am sorry. You are parsing words here. We are 
here specifically about these e-cigarettes, right.
    Dr.Sharpless. I apologize for the lack of clarity. The FDA 
has significant authorities around tobacco products including 
e-cigarette nicotine delivery and the nicotine is a tobacco-
derived substance, so those products we have great, you know, 
strong authorities from the 2009 Tobacco Control Act as well as 
the deeming rule.
    THC and other, you know, things that might be vaped that 
are not nicotine are jurisdictionally more challenging. A 
substance like THC that is a Schedule I drug is some shared 
regulation between the FDA and the DEA, which is why we have 
been working with them on those sorts of products.
    Ms.Clarke. OK. Dr. Sharpless, to the extent that some of 
these products contributing to the illnesses may have been sold 
by registered retailers, what ability does the FDA have to 
order or recall or get these dangerous products off the 
shelves?
    Dr.Sharpless. So we can identify a manufacturer source. We 
can send warning letters and other measures, civil money 
penalties and that like, and even no tobacco sale order if we 
can identify a retailer that's selling a product that shouldn't 
be on the market.
    Ms.Clarke. And so have you already begun that process?
    Dr.Sharpless. Early days in this investigation, as I said 
right now our main focus is on testing the products, finding 
what they are and where they seem to come from, and then in 
many cases engage our----
    Ms.Clarke. But if people are losing their lives right now, 
wouldn't it be prudent to do a recall to, you know, a 
moratorium on sales, something that stops this until your 
testing is done?
    Dr.Sharpless. Well, let me--so that sounds a bit like a 
food outbreak, like what we would do if there were a bad food. 
But this is different in this way.
    Ms.Clarke. How is it different? People are dying.
    Dr.Sharpless. Well, many of these products are illicit so 
people are not forthcoming to----
    Ms.Clarke. Yes, but you know what you can do a process of 
elimination, right?
    Dr.Sharpless. We have better authorities about the illicit 
products that are sold through legitimate retailers, but many 
of these products are not that.
    Ms.Clarke. Thank you very much, Madam Chair. I yield back.
    Ms.DeGette. The Chair now recognizes the gentleman from New 
York, Mr. Tonko, for 5 minutes.
    Mr.Tonko. Thank you, Madam Chair, for the subcommittee 
hearing and thank you to our witnesses for appearing before the 
subcommittee.
    The 2016 final deeming rule issued by FDA brought e-
cigarettes within FDA's regulatory authority under the Tobacco 
Control Act, but FDA is not exercising that authority to its 
fullest extent and e-cigarettes only remain on the market today 
due to FDA's enforcement discretion. As has been well 
established this morning, teen use of e-cigarettes has 
skyrocketed over the past several years. In fact, the youth use 
rate of e-cigarettes surpassed conventional cigarette use some 
5 years ago.
    So, Dr. Sharpless, can you explain why FDA decided in 2017 
to extend the compliance deadlines for FDA review of the public 
health risks of these products?
    Dr.Sharpless. Sure. As part of a broader comprehensive 
strategy regarding tobacco in general, the FDA at that time 
looked at the data--we're a science-driven organization--and 
concluded that e-cigarette use among children from 2015 to 2017 
was going down or leveling off. That was before this explosion 
of youth use that we've now seen in the last two years. When 
the FDA began to appreciate this sort of rocket was taking off 
and we needed to be more engaged, we stepped up our enforcement 
education activities and now very broad policy activities that 
would have a major effect on the market.
    Mr.Tonko. Well, in retrospect, should the FDA have had 
acted more urgently?
    Dr.Sharpless. I believe in retrospect we should have acted 
more urgently.
    Mr.Tonko. OK. So if I understand you correctly, FDA decided 
to delay the compliance deadlines in 2017 because it was a 
brief decline in youth use rates in 2015 and there was a 
potential health benefit to some individual addicted adult 
smokers. So my question to you then is, now that we have a 
fuller understanding of the terrible epidemic that youth in 
this country are facing, have these considerations changed?
    Dr.Sharpless. The FDA has always been very clear that as 
new facts emerge and we get new data we will change our 
regulatory posture and I would argue have done so starting with 
the 2018 NYTS data, which was very concerning, and then the 
preliminary data we've seen from 2019 has really sounded the 
alarms for----
    Mr.Tonko. So if that is true then, how will FDA account for 
them in their eventual reviews of these products?
    Dr.Sharpless. Right. So we have moved up the date for PMTA 
submission, these premarket tobacco applications, so now to May 
2020. So all products on the market today are illegal. To be 
legally marketed they will have to come to the FDA and have a 
PMTA approved. In addition, our compliance policy that we 
announced, the President, you know, announced his support for 
recently, would have the effect of moving flavored products, 
which are particularly appealing to children, from the market 
very soon.
    Mr.Tonko. Well, Dr. Sharpless, we will hear on the second 
panel that Michigan has temporarily banned flavored products 
while Massachusetts has banned all vaping products for four 
months. There seems to be the recognition that we have a public 
health epidemic requiring some urgency from our regulatory 
agencies. So why has it taken a multistate outbreak of severe 
pulmonary illnesses and several deaths for this administration 
to take action to protect young people's health?
    Dr.Sharpless. Congressman, I would say the major point of 
data that is driving our compliance policy is the Youth Tobacco 
Survey, the NYTS, so this epidemic of youth use that we've 
identified for multiple datasets, not just the NYTS, showing 
youth use. And that is, I think, the sense of urgency is 
further injected by this other problem, the vaping lung 
injuries, but I think that, you know, the administration 
considers its duty to protect children a top priority and is 
really acting in response to the NYTS data.
    Mr.Tonko. Well, when FDA finally reviews these products it 
must assess whether they are ``appropriate for the protection 
of public health.'' So, Dr. Sharpless, will FDA ban them if it 
ultimately determines that the dangers of youth use outweigh 
any potential benefits to adult smokers?
    Dr.Sharpless. Certainly. We have issued guidances, or a 
guidance to industry about what the information is to be 
included in a PMTA. I think we've been very clear and we've 
already approved products through the PMTA process. And that's 
the sort of thing we consider is the benefit--the standard is 
what you mentioned. This product has to be good for the public 
health and if it's not it won't be authorized.
    Mr.Tonko. Well, I thank you for your responses. With all 
these new tobacco products flooding the market over the past 
few years, without a full understanding of the public health 
risks it is not surprising that we are in such a crisis 
situation today. And I have to echo my concerns over and over 
again how this administration has rejected science in many 
formats and ways and that is troublesome to me.
    So I would hope again that we approach this issue with all 
the science-based, evidence-based data at our fingertips and 
those data speak to us boldly and we should respond in public 
policy format so as to protect the lives of young people and 
all people across the board by sound policies. So with that I 
yield back, Madam Chair.
    Ms.DeGette. I thank the gentleman. The ranking member and I 
now will just ask a few closing questions.
    Mr. Guthrie, recognized.
    Mr.Guthrie. Thank you. Thanks, Chair, for doing a second 
round really quick.
    And based on something I heard earlier, and I saw this 
yesterday, I think I saw it. I don't remember if I heard it or 
read it, but somebody says if this was lettuce it would be off 
the market tomorrow. So, if you want to look at the equivalent, 
if somebody bought tainted lettuce at a grocery store you would 
trace back to where that came from and you would shut that 
whole supply line down.
    But if somebody bought tainted lettuce at a corner store, 
or if you drive through Kentucky people are on the side of the 
road selling their vegetables in the summertime, which is 
fantastic to get fresh vegetables, but if somebody is just out 
selling, you wouldn't go shut down all the supply line in the 
grocery stores because somebody bought tainted lettuce from 
somewhere that you can't trace, you can't figure exactly where 
it comes from. I think that would be more of the clue and I 
think if you could trace that you would shut it down, just is 
my guess on that.
    Dr.Sharpless. No, I agree with that characterization, 
Congressman Guthrie. I think the problem here is that we don't 
believe that the cases are being totally forthcoming with us in 
all instances of what they've been using and they're not eager 
to identify what products they've been using, and certainly a 
manufacturer is not eager to identify, to be known.
    In a food outbreak, the manufacturer has an interest in 
getting that food off the market. They don't want their product 
to get a bad reputation. But with an illicit substance it's 
very different from a food borne.
    Mr.Guthrie. It is a lot easier when it comes to a corporate 
chain because you can trace it as opposed to somebody's farm 
that just sold it to someone--it is hard to find. It is just 
harder to find that way.
    Dr.Sharpless. Correct.
    Mr.Guthrie. So, you said the National Youth Tobacco Survey 
is what you used to make some decision. And I have noticed it 
has increased greatly, but that information is relatively new, 
is it, maybe it came out in September or so? So you are using 
it to react to, and I think what you said given where we are 
now we should have reacted three years ago, but you are 
reacting to it now--now that you know, you are knowing the 
information today.
    Dr.Sharpless. Right. I think as new facts have emerged the 
FDA has changed its posture, so, you know, we're very clear 
that as we would continue to monitor the science and gather new 
data. The NYTS data from 2019 is still preliminary. We're 
working to get that data out with the CDC as quickly as 
possible, but I would say it's not the sole data source.
    So there's a study from NIDA and these state studies that 
have been referenced. And the fact that there's a striking 
epidemic of youth use e-cigarettes is, I think, 
noncontroversial.
    Mr.Guthrie. Absolutely.
    Dr.Sharpless. It's supported by many datasets.
    Mr.Guthrie. Good. And then one final thing, I was going to 
ask this in my previous questions. I was talking about THC 
previously in my questions. So, is the FDA involved in any 
federal investigation of vaping products containing THC and/or 
has the FDA declined to be involved in any federal 
investigation of vaping products with THC?
    Dr.Sharpless. So we have engaged heavily with the DEA, so 
we've had numerous joint calls and set up communication between 
our chemists and their chemists, our enforcement people and 
their enforcement people, our cybercrimes people, and their 
cybercrimes people. They have a number of ongoing 
investigations related to THC vaping products and they're 
sharing data on those with us. Our question is where are these 
products coming from and are they adulterated and of that 
nature. So I think there's good cooperation between the federal 
agencies related to THC.
    Mr.Guthrie. OK. I am going to use all my time, but I will 
finish with this. I was in your mail facility, the mail 
facility, our mail facility as Americans, at JFK Airport and 
your FDA group was there. It is amazing the things they are 
finding illicit. They were showing different tablets that were 
brand--that we would consider brand-name drugs today and how 
they copied the logos and the logos are off-center and things 
like that.
    So when you stand there and see the volume that your 
people, your brave people there going through some, dealing 
with fentanyl where they have to wear protective gear to find 
what is going through, they are there working, but it is an 
enormous task. We ask a lot of them, but we appreciate the 
effort that you guys do and what the CDC is doing as well and 
just all the work that you guys are doing.
    Dr.Sharpless. Thank you very much. But I'd like to say 
that's a real pride of the FDA, the IMFs, and have 
substantially increased their capacity thanks to the generous 
support of Congress in recent years.
    Mr.Guthrie. Thank you very much. I appreciate that and I 
yield back.
    Ms.DeGette. I thank the gentleman.
    Dr. Sharpless, I just want to clarify how this compliance 
policy of the FDA on the flavors is going to work, which is I 
understand it the same way it would work under the legislation 
that I have introduced. And that is you send out your order, 
then the companies are required to withdraw the flavored 
products. And then they can come and make an application with 
the FDA to try to show why they think that it is safe to market 
them; is that right?
    Dr.Sharpless. That's correct. Upon finalization, the 
guidance would then go into effect some period later. We would 
send out warning letters and other sorts of enforcement 
activity; pull the flavored products from the market. Anyone 
who thought that their product was good for the public health 
that could meet the standard can file a PMTA application at any 
time before May 2020, but at least by May 2020, and if the 
product can demonstrate a public health use then it would be 
authorized for sale.
    Ms.DeGette. And what would the criteria that would be used 
to allow that to happen?
    Dr.Sharpless. So the PMTA application, we've provided 
extensive guidance about what we expect industry to include on 
those. It's things like how is it manufactured, what are its 
components, nicotine levels, appeal to children, and use by 
specific populations, risks for addictions and diversions, and 
things like that.
    Ms.DeGette. But the reason why you are withdrawing it now 
is because there is substantial evidence that these flavors are 
appealing to teenagers and youths and getting them hooked on 
nicotine; is that right?
    Dr.Sharpless. That's correct. The data suggests that kids 
really like flavors. Nicotine is somewhat harsh straight and so 
flavors can mask that and make it more appealing to new users.
    Ms.DeGette. OK, so that is the evidence that would be used 
to counterweight any of the arguments.
    Dr.Sharpless. Right. And the evidence that's emerged from 
the NYTS studies and other studies is very strong that flavors 
drive a child to use.
    Ms.DeGette. OK. So I have got to say I haven't heard 
anything today to show why these products should be marketed. 
There is some anecdotal evidence that maybe it can help some 
existing adult smokers not smoke cigarettes, but other than 
that I haven't heard any reason why we shouldn't ban these 
flavors, why we shouldn't ban them, ban kids from being able to 
get this, and why we shouldn't aggressively pursue this from a 
public health perspective.
    But I think there has been some confusing questioning to 
both of our witnesses today implying maybe it is just illicit 
drugs or maybe it is just off-market vaping devices or 
whatever, so I, you know, you guys have the forum right now.
    I would like to ask each one of you to tell us what is your 
message to the parents of America regarding whether their kids 
should be using any form of e-cigarettes.
    Dr. Schuchat, we can start with you.
    Dr.Schuchat. We want parents to talk to their kids. They 
should not be using these products, e-cigarettes with nicotine 
or vaping products with other substances. We're very concerned. 
We have tip sheets for parents on how to talk to their kids 
about this. These are dangerous products for youth.
    Ms.DeGette. Dr. Sharpless?
    Dr.Sharpless. I think our message always, largely, agrees. 
We think that these products are unsafe for children whether 
they contain THC or nicotine and would not recommend their use. 
We really don't think anyone should be using e-cigarettes 
except for perhaps the person who's using it instead of a 
combustible cigarette because combustible cigarettes are really 
bad and we want to minimize their use as well.
    Ms.DeGette. Thank you. I want to thank both of our 
witnesses for participating today. You know the drill. Members 
will submit questions for the record, and I would ask each of 
the witnesses to agree to respond promptly to any of those 
questions should you receive any.
    With that, the subcommittee will dismiss Panel I. And after 
the second panel has been set, we will invite our witnesses to 
come. Thanks to both of you for coming today.
    [Whereupon, at 12:04 p.m., the subcommittee recessed, to 
reconvene at 12:10 p.m., the same day.]
    Ms.DeGette. I am now delighted to introduce our second 
panel of witnesses for today's hearing.
    Dr. Joneigh Khaldun who is a doctor, Chief Deputy Director 
for Health and Chief Medical Executive, Michigan Department of 
Health and Human Services; Dr. Elizabeth Cuervo Tilson, State 
Health Director and Chief Medical Officer of North Carolina 
Department of Health and Human Services; Dr. Lee Norman, 
Secretary of the Kansas Department of Health and Environment; 
and Dr. Monica Bharel. And Dr. Bharel is the Commissioner of 
the Massachusetts Department of Public Health.
    I want to thank all of you for appearing before the 
committee today. Now you are aware the committee is holding an 
investigative hearing and when we do so we have the practice of 
taking our testimony under oath. Do you have any objections to 
testifying under oath today?
    No. I will let the record reflect 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. Do any of you request to be accompanied 
by counsel today?
    No. Let the record reflect that the witnesses have stated 
no.
    If you would then, please rise and raise your right hand so 
you may be sworn in.
    [Witnesses sworn.]
    Ms.DeGette. Let the record reflect that the witnesses have 
responded in the affirmative and you are already seated. You 
are now under oath and subject to the penalties set forth in 
Title 18 Section 1001 of the United States Code.
    The Chair will now recognize our witnesses for a 5-minutes 
summary of their written statement. In front of you is the 
microphone and a series of lights. The light will turn yellow 
when you have 1-minute left, and red to indicate when your time 
has come to an end.
    And so let me please start with you, Dr. Khaldun. Welcome, 
and you are recognized for 5 minutes.

 STATEMENT OF JONEIGH S. KHALDUN, M.D., CHIEF DEPUTY DIRECTOR 
FOR HEALTH AND CHIEF MEDICAL EXECUTIVE, MICHIGAN DEPARTMENT OF 
HEALTH AND HUMAN SERVICES; ELIZABETH CUERVO TILSON, M.D., STATE 
   HEALTH DIRECTOR AND CHIEF MEDICAL OFFICER, NORTH CAROLINA 
  DEPARTMENT OF HEALTH AND HUMAN SERVICES; LEE NORMAN, M.D., 
 SECRETARY, KANSAS DEPARTMENT OF HEALTH AND ENVIRONMENT; AND, 
MONICA BHAREL, M.D., COMMISSIONER, MASSACHUSETTS DEPARTMENT OF 
                         PUBLIC HEALTH

               STATEMENT OF JONEIGH KHALDUN, M.D.

    Dr.Khaldun. Chair DeGette, Ranking Member Guthrie, and 
members of the subcommittee, thank you for the opportunity to 
speak with you today regarding the public health crisis of 
youth e-cigarette use.
    As the mother of three children, a practicing emergency 
medicine physician, and a state public health official, there's 
nothing more astounding than the fact that we have let an 
entire new generation of youth start using nicotine products. 
As a society, we let these e-cigarettes sneak onto the market 
without proper oversight or understanding of their health 
impacts. We can no longer stand idly by while this public 
health crisis ravages our communities.
    Nationwide, e-cigarette use among middle and high school 
students increased 900 percent between 2011 and 2015. The total 
number of children who are currently using e-cigarettes rose to 
an astonishing 3.6 million in 2018, 1.5 million more than the 
previous year. In some counties in Michigan, more than a third 
of high school students are using e-cigarettes. This epidemic 
can be attributed in large part to the appeal of flavored vapor 
products to youth as well as the advertising and promotional 
activities by companies that glamorize the use of nicotine 
products nationwide.
    Flavors such as strawberry milk, banana split, cotton 
candy, and gummy bear clearly target children and 
advertisements for vaping products are often visually appealing 
to children with pictures of candy on the packaging. Studies 
show that flavors are a major reason that youth start vaping. 
And even scarier, many young people use these products without 
understanding their contents or the fact that they have 
nicotine in them. I recently spoke with the parent of one my 
children's friends who was devastated that they found these 
products in their child's bedroom and they're now desperately 
trying to find resources for support for their child's 
addiction.
    Earlier this month, under the leadership of Governor 
Gretchen Whitmer, Michigan became the first state to announce a 
ban on the sale of all flavored nicotine vaping products. Our 
emergency rules also ban fraudulent or misleading advertising 
and disallow marketing of these products at the point of sale. 
This strong leadership is necessary given the significant toll 
this epidemic has taken on our society and particularly our 
youth. And I'm pleased that other states are taking similar 
action.
    In addition to this public health crisis of youth e-
cigarette use, as of September 20th we had 530 confirmed or 
probable cases of vaping-associated lung injury across the 
country and nine deaths. In Michigan, we know of 15 confirmed 
or probable cases of this illness and are investigating several 
more. During our investigation into these vaping illnesses, 
it's been heartbreaking to speak to families of young people 
who were otherwise healthy and are now barely clinging to life.
     There are key things we must do to fight this epidemic. 
First, we need strong, regulatory oversight over e-cigarettes. 
E-cigarettes should not be allowed on the market unless they 
are proven to be safe, and companies selling these products 
should not be allowed to market to youth or fraudulently market 
their products as safe.
    Second, more research is needed to understand the long-term 
health effects of e-cigarette use. Assertions that e-cigarette 
use is effective for smoking cessation are not scientifically 
proven and the FDA has not approved e-cigarettes as part of a 
smoking cessation program. E-cigarettes also can contain 
cancer-causing toxins. We need to make sure we fully understand 
the health impacts of these products before we allow them to be 
on the market.
    And, finally, we need to make sure there is sustained and 
increased funding for tobacco prevention education as well as 
funding for tobacco cessation efforts for youth and adults. 
Prevention efforts are a critical part of putting an end to 
this epidemic. The data around the epidemic of youth vaping is 
very clear and we must do more to properly regulate these 
products so no one, youth or adult, is harmed.
    Thank you for allowing me to participate in this 
subcommittee hearing today and I look forward to working with 
you.
    [The prepared statement of Dr. Khaldun follows:]
    Ms.DeGette. Thank you, Doctor.
    Dr. Tilson, you are now recognized for 5 minutes.

              STATEMENT OF ELIZABETH TILSON, M.D.

    Dr.Tilson. Chairman Pallone, Chair DeGette and Ranking 
Member Guthrie, and members of the subcommittee, thank you for 
the opportunity to testify today on the public health threats 
that e-cigarettes pose to our youth. My name is Dr. Elizabeth 
Cuervo Tilson and I serve as the state health director and 
chief medical officer for the North Carolina Department of 
Health and Human Services.
    As you know, in December of 2018, the U.S. Surgeon General 
called e-cigarette use among youth an epidemic. As a public 
health official, a pediatrician, and a preventive medicine 
physician, I see this epidemic playing out across our schools 
and our communities in North Carolina. Our most recent North 
Carolina Youth Tobacco Survey found that although combustible 
cigarette smoking was at a lowest ever recorded amongst high 
school students at 8.9 percent, e-cigarettes use increased 894 
percent since 2011. E-cigarettes have become the most commonly 
used tobacco product amongst youth in North Carolina and 
further concerns have now risen with the multistate 
investigation of severe lung illness associated with e-
cigarettes and vaping.
    But before I go on, let me put a face onto this epidemic. 
Luka is a teenager from High Point, North Carolina. As a high 
school freshman, Luka started using Juul as a way to fit in 
with his upperclassmen on football Friday nights. He quickly 
became addicted to the nicotine in the product even to the 
point of selling his clothes and other items to raise the $150 
a week he needed to support his nicotine addiction.
    Once a Boy Scout, an athlete, and an A-student, Luka let 
his grades fall and dropped out of extracurricular activities. 
Usually a well-behaved 15-year-old, Luka became irritable and 
angry, even throwing violent outbursts of rage. Finally, a 
nicotine-related seizure ended him up in the emergency 
department. At that point, Luka and his parents knew they had 
to do everything they could to get Luka the treatment he needed 
for his nicotine addiction. Luka participated in a nearly 40-
day substance use treatment program in California twice. 
Thankfully, he is now living substance-free.
    But Luka is not alone, and we've heard similar stories from 
across our state and our nation and we must act to protect our 
children. And let me be clear, e-cigarettes are not safe. 
Nicotine is the major psychoactive substance found in e-
cigarette solutions and is highly addictive. Youth and young 
adults are particularly at risk for the long-term effects due 
to the exposure of nicotine on their developing brain. Nicotine 
is related to seizures. Nicotine can cause harm to developing 
fetus. And there's emerging data that nicotine use through e-
cigarettes can, may increase their risk of emphysema, a form of 
long-term lung disease.
    Further, as the acute outbreak of severe lung illness 
associated with e-cigarette products, 36 cases have been 
reported in North Carolina almost all requiring 
hospitalizations, more than half requiring intensive care--
thankfully, we've had no deaths to date in North Carolina--and, 
currently, we have not identified the exact cause of this 
illness in our state.
    Some key factors identified that may be driving e-cigarette 
use among our youth include marketing strategies that appeal to 
youth; the delivery systems like the USB-like systems that are 
easy to conceal, used discreetly, and not recognized as adults 
as e-cigarettes; the use of flavors that attract youth to the 
products; and then the highly addictive nicotine which keeps 
them coming back.
    Youth use of e-cigarettes has challenged the resources of 
our state to address. Despite our 100 percent tobacco-free 
school policy, our school staff are finding e-cigarettes on 
school grounds, report that students' e-cigarette use is 
problematic contributing to learning disruptions, and do not 
think they have the resources to sufficiently address this new 
wave of tobacco products. We have insufficient resources to do 
evidence-based mass health promotion and media campaigns to 
compete with the e-cigarette and vaping messages. Our quit 
line, which is our telephone and web-based tobacco treatment 
program, is only resourced to serve about one-eighth of the 
number of our state tobacco users recommended by CDC best 
practices, and our local health departments are not structured 
or resourced to sustain a long-term response to this new 
outbreak.
    The e-cigarette epidemic among youth and young adults is a 
public health threat that will not be solved by one strategy, 
one policy, or a single federal agency or state. We'll need a 
comprehensive approach and utilize best practices and lessons 
learned from our success in combustible tobacco. Federal and 
state policies to consider include curbing advertising and 
marketing to youth, limiting youth access to e-cigarettes in 
retail and internet settings, reducing access to flavored 
tobacco products by youth, implementing price policies, and 
adding e-cigarettes to smoke-free indoor air policies.
    Increased funding should be allocated to further adopt and 
expand on CDC-recommended evidence-based state and local 
tobacco use prevention and cessation interventions including 
community interventions, mass reach health communications in 
mass media, evidence-based treatment and cessation 
interventions, surveillance and intervention, infrastructure, 
administration, and management. Thank you for the opportunity 
to share some of our experience with you and I applaud the 
subcommittee's work to help address this urgent public health 
issue.
    [The prepared statement of Dr. Tilson follows:]
    
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    Ms.DeGette. Thank you, Dr. Tilson. Thank you for putting a 
human face on this too.
    Dr. Norman, you are now recognized for 5 minutes.

                 STATEMENT OF LEE NORMAN, M.D.

    Dr.Norman. Good afternoon, Chair DeGette, Ranking Member 
Guthrie, and subcommittee members, and thank you for the 
opportunity to speak with you today. My name is Dr. Lee Norman 
and I am the Kansas Secretary of the Department of Health and 
Environment. I'm also the state health official and I'm an Army 
lieutenant colonel and the Army state surgeon of Kansas.
    I want to first give you a brief update as what we're 
seeing in Kansas. We now have ten hospitalizations confirmed 
from vaping and e-cigarette-related illnesses including two 
deaths in adults. That's an increase over the numbers that were 
quoted by the CDC from last week, and that was just a new adult 
added this week to that list. We have the same vaping patterns 
as seen around the country with these lung diseases and 
illnesses from the vaping solutions. Some have been nicotine 
only, some have been THC only, and some have been a combination 
of both including CBD oil.
    The final analysis is pending the return of the test 
results from the FDA, and what I just told you is of what we 
took by way of history from the deceased family members. 
Similar demographics as U.S. vaping patterns, two-thirds are in 
18 to 34-year-olds in Kansas, 16 percent are under the age of 
18, seventeen percent of users are under age 35, and three-
fourths of the users are male. In Kansas and nationwide, over 
one-half of all e-cigarette users also smoke combustible 
cigarettes while, of note, 80 percent of youths' first contact 
with nicotine is through vaping.
    What we are doing in Kansas, similar to my colleagues' 
intensive public health information campaign, we are working 
closely with the Department of Education on school programs for 
vape-free toolkits; intensive medical professional education 
and alerts; we are working with the FDA and CDC, of course, and 
our local municipalities to incorporate e-cigarettes into the 
state Indoor Clean Air Act.
    I want to comment briefly on the military because there's 
an ominous trend going on in smoking and e-cigarette use in the 
military. The military in aggregate right now is at its lowest 
rate of combustible cigarette use in modern history. But the 
new trend line especially due to vaping shows it to be on the 
rise. Now, alarmingly, e-cigarette users outnumber combustible 
cigarette smokers in military service members.
    In my 2017 to 2018 deployment in the Middle East, I saw 
vaping-related lung injury firsthand. This is an emerging 
military health protection issue. The hard-earned anti-tobacco 
gains are being quickly swept away by vaping and e-cigarettes. 
We need help at the state level regulating marketing. The 
flavors attract the youth, no question about it. Ninety-six 
percent of the youth who end up using tobacco started with 
flavored products. Joe Camel and the Marlboro Man taught us 
valuable lessons about the effectiveness of marketing to youth.
    We must together counter the effective industry marketing 
efforts. We must regulate sales. We shouldn't sell tobacco 
products to those less than 21 years of age. No internet sales 
of nicotine products. Regulating contents of vaping and e-
cigarette products is important. There is no consistent 
labeling of the products; there should be. We don't know what 
the offending substances are. We need to know what those are. 
We need time for the science to catch up with the epidemic of 
illnesses and death. We need to broaden the anti-smoking laws 
to include e-cigarettes. We need to support tobacco control and 
prevention funding.
    In summary, e-cigarettes are wildly efficient nicotine 
delivery systems designed to expose and addict youth to 
nicotine. Currently approved smoking cessation methods are not 
approved for those under 18. We must prevent addiction to 
nicotine. Vaping is effectively showing them the way to 
nicotine use and addiction. The U.S. Preventive Services Task 
Force and other professional research organizations say 
``insufficient evidence to support e-cigarettes as an effective 
tobacco cessation intervention.'' Other proven methods of 
cessation do exist.
    Given that we don't fully know the health effects of vaping 
solutions or oftentimes even the contents, we must apply 
consumer protection fundamentals to protect our citizens much 
as we would tainted meats or malfunctioning automobile airbags. 
I will welcome your questions, of course, later, and thank you 
very much for this opportunity.
    [The prepared statement of Dr. Norman follows:]
    
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    Ms.DeGette. Thank you, Dr. Norman.
    And now, Dr. Bharel, I am pleased to recognize you for 5 
minutes.

                STATEMENT OF MONICA BHAREL, M.D.

    Dr.Bharel. Thank you very much. Good afternoon, Chair 
DeGette, Ranking Member Guthrie, and members of the 
subcommittee. Thank you for the opportunity to provide 
testimony on this pressing issue today.
    As the Massachusetts Commissioner of Public Health, as a 
physician, and as a community member, I am extremely concerned 
about vaping especially among our youth. So thank you for--I 
commend you for shining a light on this crisis today.
    I'd like to take a few minutes to share with you today what 
we are seeing and what we are doing about this critical public 
health issue in Massachusetts. I'm proud that Massachusetts has 
a long history of being at the forefront of public health, and 
with the current vaping epidemic we're continuing to be 
proactive in our response based on evidence-based tobacco 
cessation and education programming. Last year, Massachusetts 
raised the minimum age to purchase tobacco products, including 
e-cigarettes, to 21. We also prohibited vaping where it's 
illegal to smoke, and became the first state in the nation to 
ban the sale of all tobacco products in pharmacies.
    Massachusetts has made significant progress in curbing both 
youth and adult tobacco use over the last few decades. Look 
back to 1996, our youth smoking rate in 1996 was 38 percent. 
Now that rate today is 6.4 percent and our adult smoking rate 
is one of the lowest in the nation at less than 14 percent. The 
cornerstone of our work has always been prevention. We have a 
strong cessation and prevention infrastructure and a network of 
community partners and dedicated advocates to help educate our 
communities on what we know. Unfortunately, this progress is 
now at risk. The industries are using the same old techniques 
to bring new products: cheap, sweet, and attractive to youth. 
And it's working in Massachusetts and across the country.
    We hear time and time again horror stories from children 
who are talking about the vaping in their bathrooms at school, 
who are too short of breath to participate in their sports 
activities, and children 11 and 12 years old who have to sleep 
with these devices underneath their pillows because they're so 
addicted they're waking up in the middle of night to use them. 
We know that in Massachusetts from our 2017 data that 40 
percent of high schoolers have tried these products and one in 
five, 20 percent, are using them regularly. And now we're 
confronted with the emergence of this serious vaping-related 
lung disease being seen across the country.
    2 weeks ago, I exercised my authority as Public Health 
Commissioner to mandate that physicians immediately begin 
reporting any unexplained vaping-associated pulmonary disease 
to us at the Department of Public Health. We immediately 
started to hear about cases, ten cases or more a day as we 
begin to ask for this reporting. We are now looking at 66 
reported cases to us and have already reported to the CDC three 
confirmed cases and two probable ones.
    What this tells me and what I'm afraid of is that this is 
just the tip of the iceberg in what we will see related to 
these e-cigarettes. We don't know what is causing these 
illnesses yet, but we want to act now to protect our children. 
And yesterday in Massachusetts we took a landmark step. Our 
governor, Governor Charlie Baker, declared a public health 
emergency in the commonwealth and put in place an immediate 4-
month ban on the sale of all vaping products, both nicotine and 
THC, both in retail and online.
    This ban on vaping product sales will enable our state to 
take a much-needed pause, to take a pause and gather more 
information and data to inform our next steps to protect our 
public's health. We can't stand by and watch the industry hook 
another generation on these deadly products. It's up to us to 
confront the facts, sound the alarm, and protect public health 
particularly in our youth. Our goal is simple. We do not want 
another generation of children to become addicted to nicotine. 
Thank you for commitment to your issue and I look forward to 
working with you. Thank you.
    [The prepared statement of Dr. Bharel follows:]
    
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    Ms.DeGette. Thank you so much, Doctor, and thanks to the 
entire panel. The Chair will now recognize herself for 5 
minutes for questioning.
    Last year, the Surgeon General declared the youth use of e-
cigarettes as an epidemic. Now you are from all around the 
country, I would guess you probably would agree with the 
Surgeon General. I think you can all answer.
    Dr. Khaldun?
    Dr.Khaldun. Yes, I would agree.
    Ms.DeGette. Dr. Tilson?
    Dr.Tilson. Yes, ma'am.
    Ms.DeGette. Dr. Norman?
    Dr.Norman. Agree.
    Ms.DeGette. Dr. Bharel?
    Dr.Bharel. Agree.
    Ms.DeGette. And, Dr. Norman, you said in your testimony, in 
your written testimony, our youth were poised to be the 
generation that ended smoking. That legacy is now in jeopardy. 
What do you think needs to be done to reverse this tide and the 
epidemic? Dr. Norman?
    Dr.Norman. Well, number one is that we are focusing today 
mostly on youth use of e-cigarettes. But one of the things that 
I think we cannot lose sight of is that these are so addictive 
we have to also think about smoking in general because this is 
an on-ramp to the use of e-cigarettes.
    Ms.DeGette. That is exactly right. That is right.
    Now I--so you might have heard me say to the previous panel 
I have sponsored legislation to increase the age to 21 for all 
of these products. And I was telling Mr. Guthrie that I have 
been--it is a bipartisan bill. We have bipartisan sponsorship. 
And in the Senate, the Senate Majority Leader Mr. McConnell has 
a companion bill.
    But, nonetheless, as I have been talking to people on both 
sides of the aisle and trying to get cosponsorship for my bill, 
people are reticent to cosponsor my bill because they say that 
if somebody is serving in the military they should be able to 
smoke and people over 18 can serve in the military. When I was 
listening to your testimony, Dr. Norman, I thought you would be 
the perfect person to give the answer to that. So what is the 
answer to that?
    Dr.Norman. I don't think we should allow smoking anywhere, 
but that's a public health expert talking.
    Ms.DeGette. Right.
    Dr.Norman. The military has a long history of even 
supporting smoking, to be honest, way back to the days when it 
was in C-rations, and they're available, nicotine and all 
products is available in very low cost. And I think that we 
need to accelerate the smoking cessation and vape protection.
    Ms.DeGette. Do you think that is a good idea that we are 
making that available to the military?
    Dr.Norman. No, I don't. There's nothing that would support 
that from a public health perspective.
    Ms.DeGette. And do you, and you said you think it is a good 
idea to raise the smoking age to 21.
    Dr.Norman. Yes, ma'am.
    Ms.DeGette. Do you think that even includes the military?
    Dr.Norman. Yes, ma'am.
    Ms.DeGette. And that is because of the risk to public 
health; is that right?
    Dr.Norman. Yes.
    Ms.DeGette. Now, so I want to ask each of you, I guess 
starting with you, Dr. Khaldun, what do you think the federal 
government could be doing more to protect children from e-
cigarettes?
    Dr.Khaldun. I think we really need to make sure that we 
don't allow this fraudulent marketing, this marketing to 
children saying that these products are safe. I think we need 
more evidence and data that they're actually, one, safe, and 
two, even effective for smoking cessation because that is not 
scientifically proven.
    Ms.DeGette. OK, thank you.
    Dr.Khaldun. So that is what I believe.
    Ms.DeGette. Yes, that is important.
    Dr. Tilson?
    Dr.Tilson. Yes, ma'am. As I mentioned in my comments, I 
think that we need to think about a comprehensive approach to 
tobacco control, same like we did with combustible. So 
combinations of a policy around marketing, around regulation, 
around limiting access to youth, around price policies, as well 
as we need to increase resources for states to be able to 
implement CDC's best practice recommendations for prevention 
and cessation.
    Ms.DeGette. Dr. Norman?
    Dr.Norman. I think it should--it hovers a lot around 
marketing. I think we need to make it less appealing. I think 
we need to regulate the availability to an older population and 
I think that we need to control what's the labeling of the 
products so people know what is actually in there.
    Ms.DeGette. Dr. Bharel?
    Dr.Bharel. When we passed Tobacco 21 in Massachusetts last 
year, it was based on the science of the developing brain. So 
whether someone can serve in the military at age 18 is a 
different question than whether or not someone should be using 
a tobacco product, because the brain continues to develop up to 
age 25 and we know that there can be damage to that and that's 
how we support tobacco being raised to 21 for all.
    Ms.DeGette. Oh, go ahead.
    Dr.Bharel. And I was just going to add that I support what 
the other panelists said around restriction of flavors, also 
restriction of nicotine content, and ad restrictions for it.
    Ms.DeGette. I just want to ask you one more question. You 
said that after you used your authority to require reporting 
reports skyrocket. Do you think that is going to happen in 
other states around the country as we get more and more 
reporting?
    Dr.Bharel. Yes, I do. And I think the reason for that is 
several. One is that clinicians have not been asking about 
vaping; teens have not been disclosing the use of these 
products. So as we increase awareness and we begin to ask and 
come forward, we'll see those cases. And also, there seems to 
be something going on in this current environment and that's 
why I said I'm worried that this is the tip of the iceberg and 
we'll see more not just acute things but chronic conditions as 
well.
    Ms.DeGette. Thank you very much. And I am now pleased to 
recognize the Ranking Member Mr. Guthrie for 5 minutes.
    Mr.Guthrie. Thank you very much. I am not here going to 
argue on the military. I agree that people 18 should not be 
smoking. But the principle, kind of, is if somebody is going to 
be old enough to wear the uniform, are they not allowed to make 
other decisions about that? And I think it is debatable. I am 
open to looking at it at your bill as well.
    And also, it was mentioned, I won't say who mentioned it, 
but mentioned that I was talking a lot about THC here. But it 
seems like there is a big move to ban nicotine, which we need 
to prevent nicotine, but there is other states all across the 
country and whatever giving more opportunities--I know they are 
not focusing on young people, but if you give opportunities for 
people to have access to marijuana it is going to get into the 
hands of younger people. And glad to see that you banned, Dr. 
Bharel, all forms of vaping, even THC.
    But I have a question and for all the witnesses, but, Dr. 
Norman, you kind of answered this in your statement so you 
don't really have to since you answered it. But in your state 
you reported cases of vaping associated with pulmonary illness 
and for each of you, how many cases have been reported in your 
state and can you provide a breakdown of how many of those 
cases involved E, but nicotine, THC, or both, and if it had 
THC, did it also have E acetate?
    Dr.Khaldun. Yes, so we in Michigan have had over 44 cases 
that have been reported to the Health Department. Fifteen of 
those are confirmed or probable cases. We have seen a mix, and 
again this is family members or patients who are self-
reporting, so we have some questions about what the actual 
truth may be, but this is self-reported. It's been THC, it's 
been nicotine, it's been both for some of them, so we don't 
again know what the exact substance is.
    Mr.Guthrie. OK.
    Dr.Khaldun. We have not in Michigan we don't test the 
products ourselves, we send it to the FDA lab for testing. And 
so at this point we do not know what other substances may be 
involved.
    Mr.Guthrie. OK.
    Dr.Tilson. Yes, sir. I'll share some of the data we have 
from North Carolina. So we have 36 cases reported so far. We're 
in the midst of investigating those cases, so for the 27 that 
we have the medical record information from, 75 percent of them 
have reported THC use, 17 percent have reported CBD, 45 percent 
have reported nicotine in flavors, and 37 percent have reported 
both THC and nicotine. Of the 16 that we've had the actual 
interviews for, 94 percent have revealed use of THC and 56 
percent have reported vaping nicotine.
    And we have been doing testing in our state lab as well as 
sending our samples to the FDA. We don't have our FDA reports 
back, same as the other states, but of what we found in our lab 
of the 41 that we have results from, 71 percent have had 
evidence of THC, half have had evidence of vitamin E, so only 
half and the other half haven't. As well as we found terpenes, 
nicotine, menthol, and glycerol as well in some of the other 
samples. So, a mixed bag of different findings.
    Mr.Guthrie. OK. You have already kind of talked about it, 
Dr. Norman.
    Dr. Bharel?
    Dr.Bharel. We've had, in Massachusetts we've had 66 cases 
that have been reported to us. Three have been confirmed by the 
CDC definition and two probable. The rest are currently under 
investigation. However, we do know that so far, the majority of 
them are under the age of 30 in terms of the suspects, and we 
also know that it is a mix. Some are THC only, some are 
nicotine only, and some are both THC and nicotine.
    Mr.Guthrie. And do you know if there are other oils if--do 
you know if there are other oils in that?
    Dr.Bharel. No, we're not doing our investigation of the 
actual materials. This is survey-based from both clinicians and 
individuals, so we aren't doing the actual testing in our lab.
    Mr.Guthrie. OK. Well, thanks a lot. And then all of you 
said that you were using the FDA; you are waiting on FDA 
results. How long does it take to get the results from the FDA 
and has the FDA told your state about the information they will 
share about your state's results and how do your results 
compare to the overall results they uncover?
    Dr.Khaldun. In Michigan I'm not actually aware of how long 
it will take the FDA to get those results back to us. We do 
have regular communications with the FDA and the CDC, but I am 
not aware of how long it will take to get those results back.
    Mr.Guthrie. OK.
    Dr.Tilson. Yes, sir. And I think this is a relatively new 
outbreak.
    Mr.Guthrie. Are you starting to get results back, I guess, 
have you got some results back so you know how long it is 
taking or you still waiting for--OK.
    Dr.Khaldun. I'm still waiting.
    Dr.Tilson. Yes, we have not gotten specific results back, 
but we have gotten communication from the FDA talking about 
what they have been finding and, again, haven't found in one 
specific additive. Have been telling us they've been finding a 
broad range of additives; not one substance seems to be 
identified. So we've been getting qualitative reports back from 
the FDA, but not the specific quantitative reports back.
    Mr.Guthrie. OK, thank you.
    Dr. Norman?
    Dr.Norman. Our first sample was sent in, in mid-August, and 
we haven't received any of the results back yet.
    Mr.Guthrie. Oh, OK.
    Dr.Bharel. Our information at this point is qualitative as 
well.
    Mr.Guthrie. OK. Well, thanks.
    So, getting back to the other. If you do just a search on 
the web, as amatter of fact, Chair DeGette was showing me a 
picture of a hoodie that, actually the cord of the hoodie is a 
vaping device. It just seems there is a lot of--I don't know if 
that is even legal. I don't know if that was an illicit side or 
what you can move forward, but obviously is marketing towards 
children, it appears, unless somebody who is an adult wants to 
do it at work and nobody knows they are doing it.
    People that I know that are going from cigarettes to vaping 
don't hide that they are vaping because they didn't hide that 
they were smoking, so moving forward. But there are a lot of 
illicit products. I would say more, and I am out of time, so I 
will turn it over to my friend from Massachusetts. But I was 
going to say what are your states are doing to move forward, 
but I will yield back to my friend.
    Mr.Kennedy. [presiding]. The acting chair thanks the 
gentleman and--yes, right--and recognizes the gentle lady from 
Illinois, Ms. Schakowsky, for 5 minutes.
    Ms.Schakowsky. Thank you. On August 23rd of this year, we 
learned that an Illinois resident died from the current 
outbreak of lung illness linked to e-cigarettes. The death is 
tragic, but the more I listen to what is the testimony I have 
heard today, it also seems to be preventable.
    And, Dr. Norman, your state has also suffered two deaths in 
recent weeks due to this illness. Do you believe, and anyone 
else can weigh in on this, do you believe that we could have 
prevented these deaths in this outbreak if the FDA had not 
delayed the Obama administration final rule that would have 
started e-cigarette regulation in 2018? And then that was 
postponed by this current administration.
    Ms.Schakowsky. And who was that question poised to?
    Ms.Schakowsky. And you, but anyone who wants to answer.
    Dr.Norman. OK. Well.
    Ms.Schakowsky. As well.
    Dr.Norman. We've been doing public health messaging for a 
long time and I really feel that in the state of Kansas, people 
and the potential users and users know it is not healthy to 
vape or to use e-cigarettes, so it's not out of lack of 
knowledge that people are starting and using e-cigarettes. And 
I do believe that whatever regulations can be propagated that 
would push towards restriction and less easy access to products 
and unregulated products, I think that's where the holy grail 
is.
    Ms.Schakowsky. So as my question was that actually it could 
have started in 2018. Would that have been effective? 
Regulation could have started. Wondered if anyone else wanted 
to weigh in.
    Yes, Doctor?
    Dr.Khaldun. I mean we saw across the country a 900 percent 
increase in students who were using vaping products between 
2011 and 2015, so it started a little bit earlier. I do know 
that there are youth in the state of Michigan who don't even 
know what's in these products they've been marketed to, so it 
is a possibility that that could have potentially prevented 
some of this, but I don't think we know for sure. Again, we 
don't know what the exact cause of these vaping-related 
illnesses are.
    Ms.Schakowsky. So we heard from Dr. Schuchat that the--not 
the accelerator, what do you call the--the what? Yes, the 
aerosol has toxic chemicals in it that we apparently know that. 
So do we, are we aware of everything that is in these? Have we 
done good research to know even how things like the aerosol 
could affect the health, anybody? Do we know?
    Dr.Norman. We learned last week on an FDA call that we have 
more information about what is in the vaping solution that goes 
in that end of the e-cigarette than what comes out in the 
aerosol, because there's certainly are changed by the process 
of the vaping.
    Ms.Schakowsky. So were you all here for the last panel?
    Dr.Norman. Yes.
    Ms.Schakowsky. OK, yes. So did you hear enough in terms of 
what is being done? Do you feel satisfied that going forward 
that we are going to make progress as fast as we could, as 
effectively as we could, from what you heard both from the FDA 
and the CDC? Let's start at that end.
    Dr.Khaldun. I think it's a complex investigation. I'm 
pleased that the FDA and CDC are providing support to our state 
and local governments, but I think collectively as a society we 
probably could have done more sooner. But I am pleased that the 
CDC and FDA are looking at this closely.
    Ms.Schakowsky. OK.
    Dr.Tilson. I would agree. I'm pleased with the proactive 
approach that CDC and FDA is taking, but I think we all 
acknowledge and I think the prior panel acknowledged that 
there's a lot more that we need to do and this is really an 
urgent public health crisis that we need to do a lot more and 
we need to do it quickly.
    Ms.Schakowsky. OK.
    Dr.Norman. Agree.
    Ms.Schakowsky. OK.
    Dr.Bharel. What I know is that we are seeing an alarming 
increase, as you mentioned earlier, in these vaping-associated 
pulmonary diseases, and in Massachusetts we put the temporary 
ban of all vaping products in place in order to take a pause, 
prevent further illness and death from this lung-associated 
disease, and be able to gather more data and information 
because there is so much that's unknown in this area.
    Ms.Schakowsky. So we are going to see an increase in the 
number of people, we are, that are addicted to nicotine right 
now. Is this something that is going to be alleviated even at 
this point? Are we going to see this increase going on as we go 
forward? Just yes or no.
    Dr.Khaldun. Yes. We do currently have youth who are 
addicted to nicotine and we need to help them address their 
addiction.
    Dr.Tilson. Yes, and we need a comprehensive, full steam 
ahead approach to address this.
    Dr.Norman. Yes, I think we're going to see a marked uptick.
    Dr.Bharel. Nicotine is highly addictive to youth and the 
way it's currently being marketed with the flavors and access 
we're going to see the problem continue to get worse.
    Ms.Schakowsky. Thank you. I yield back.
    Ms.DeGette. Thank you. The Chair now yields to Mr. Griffith 
from Virginia, 5 minutes.
    Mr.Griffith. Thank you very much, Madam Chair. Appreciate 
all of you all being here today, the information is very 
important to us.
    Dr. Tilson and Dr. Norman, because marijuana is not 
legalized in your states, do you believe youth are accurately 
reporting their use of products containing THC when they become 
sick?
    Dr.Tilson. Well, it's always hard to know exactly if people 
are being completely accurate. However, in both our medical 
records and our interviews, people are reporting that they are 
using THC up to 75 percent. So it's hard to know that 
everybody's reporting accurately, but a certain, a large 
percentage are reporting.
    Mr.Griffith. And the same question to you, Dr. Norman.
    Dr.Norman. I feel pretty certain that we don't always get 
the straight story and that's why we really do need to know the 
chemical analysis. I don't think that people are always honest 
with their medical history taken.
    Mr.Griffith. Yes. And are there--I understand the chemical 
analysis, but are there any other alternatives that you might 
use to increase the accuracy of the reporting?Either of you.
    Dr.Tilson. Well, we are testing their devices and what the 
solution is in the devices. So it's a combination of medical 
reports, interview, and then the testing of the actual liquid 
in the devices that we're using.
    Dr.Norman. Yes. I think that's the key piece that's 
missing. Our medical evaluations are pretty straightforward. 
The clinical care that's being provided is well understood. Our 
data gathering that we forward along to the CDC and the FDA is, 
I think, traditional of what we do in medicine and in public 
health, but we do need more of the analytics.
    Mr.Griffith. And just curious, because I know when we are 
doing polling data we ask the same question sometimes in two or 
three different ways so that we are trying to elicit a more 
accurate response. Do you all do that for this information as 
well, figure out different ways to ask something similar so 
that you can elicit a better response?
    Go ahead, Dr. Tilson.
    Dr.Tilson. Well, one, we're using the CDC reporting, making 
sure we're reporting the data elements of CDC so we can have a 
consistent reporting of different elements across the state and 
that our interviewers are pretty experienced in doing 
interviews with patients; so it is hard to know exactly that 
they're 100 percent accurate, but our interviews are pretty 
experienced in doing interviews with people.
    Mr.Griffith. I will take that as a yes. You are doing some 
interesting things, but each interviewer does it with their own 
style. You know, we talked about the street products and so 
forth. And in knowing that street products are contributing to 
the outbreak, what are your states' enforcement authorities and 
jurisdictions doing to crack down on the illicit street 
products that aren't from your commercial sellers? And anybody 
can answer that.
    Dr.Tilson. Yes, so a couple. So, one, within North Carolina 
tobacco sales are not licensed, so it's a little bit hard for 
us to really use that licensing data and to track within our 
license. And then with our illicit and unlicensed dealers and 
vendors, as was talked about earlier in this panel, it's hard 
to track those down.The investigation authority sits within our 
state bureau of investigation, our alcohol and law enforcement, 
so we've been starting to have conversations with them. If 
there was a complaint or us to be able to figure a signal, 
looks like it's coming from this geographic area or this store, 
then they can then go and then investigate that complaint. But 
right now, we don't have enough localizing data to really 
direct them.
    Mr.Griffith. Let me ask this and I'm going to start with 
you. And I'm sorry I was not here earlier. I was in another 
hearing. Dr. Bharel?
    Dr.Bharel. Yes, that's right.
    Mr.Griffith. Did I get that right? OK, thank you. I 
apologize.
    Dr.Bharel. No problem.
    Mr.Griffith. Do you all have a possession, is it illegal to 
possess a vaping device under the age of 18 in your state?
    Dr.Bharel. No. So the temporary ban that we put in place 
yesterday is around the sale.
    Mr.Griffith. OK.
    Dr.Bharel. So the temporary ban for four months is sale.
    Mr.Guthrie. Do any of you have a possession statute?
    Dr.Khaldun. Yes, in the state of Michigan, in June, we 
actually passed a law and updated the Youth Tobacco Act, so now 
it prohibits a minor from possessing or using a vapor or 
alternative nicotine product.
    Mr.Griffith. All right, I appreciate that.
    Let me ask Dr. Norman. You raised an issue earlier when you 
were talking about the FDA and they are testing what is going 
in, but you don't know if they are testing what is coming out. 
Is that correct?
    Dr.Norman. That's what we heard on the call with the FDA 
last week.
    Mr.Griffith. And you think it would be important and I 
would agree with that, but I don't want to put words in your 
mouth that we test the smoke that is coming out as well because 
the process is while the vaping is taking place could actually 
change some of those chemicals. And it could be that----
    Dr.Norman. Yes. I'm not an expert on the engineering that 
goes into the vaping devices and there's many different ones, 
but I think there's plenty of reason to believe that the 
ingredients that go in are not necessarily identical to the 
ingredients that come out.
    Mr.Griffith. And so the lung problems could actually be 
either or both. What is in it to begin with, what is coming out 
is the smoke, or a little combination of the two; is that 
correct?
    Dr.Norman. I don't know. I mean I really don't know the 
answer to that until we find out.
    Mr.Griffith. It is a reasonable guess though.
    Dr.Norman. A reasonable guess would be----
    Mr.Griffith. That it is some combination thereof and we 
need to know all the answers and not just half of them; is that 
what you are saying?
    Dr.Norman. Yes.
    Mr.Griffith. I appreciate it very much and I yield back.
    Ms.DeGette. I thank the gentleman. The Chair now recognizes 
the gentleman from Massachusetts for 5 minutes.
    Mr.Kennedy. Thank you, Madam Chair. Thank you to our 
witnesses. Thank you for your patience and your extensive 
testimony today. Dr. Bharel, wonderful to see you again and 
thank you for your leadership at the helm of our healthcare 
system in Massachusetts. Grateful that you are here.
    Yesterday, our governor, Governor Charlie Baker, declared a 
public health emergency and implemented an immediate ban on the 
sale of vaping products in Massachusetts. As patients sit in 
hospital rooms with a mysterious vaping-related illness and now 
businesses across our commonwealth shutter, this has clearly 
been, at least in my mind, a catastrophic regulatory failure.
    Dr. Bharel, to start with you, what should the FDA be doing 
immediately to support state efforts to contain this outbreak?
    Dr.Bharel. So there are several things that our federal 
partners could do. We could look at in Massachusetts we went to 
Tobacco 21, that would decrease access for young people. Flavor 
restrictions would also decrease access as well as 
understanding what is the content of these products, just like 
we do with tobacco products and testing the nicotine levels, as 
well as allowing us to limit advertising and put warnings on 
the products as well as in stores.
    Mr.Kennedy. And I wanted to see if you can clarify and walk 
me through this a bit, any of the witnesses here. Looking at 
the Acting Commissioner's testimony, he said that ``No ENDS 
product in the United States is on the market legally.'' For 
somebody that doesn't quite understand perhaps the term of the 
art there, it certainly seems like there is a legal market for 
these products; is there not?
    Doctor?
    Dr.Bharel. You know, and I can't speak to that specific 
thing.
    Mr.Kennedy. Yes.
    Dr.Bharel. What I do understand is that there are FDA 
nicotine replacement, FDA-approved nicotine replacement 
therapies available. And as a clinician that is what I would 
advise individuals to use, the FDA-approved such as the 
patches, the gums and the lozenges. And----
    Mr.Kennedy. Do you think the public is aware that there is 
products, that there are some of these products that does not, 
do not actually have FDA approval that are on the market?
    Dr.Bharel. I think that part of our education has to be 
around what approved cessation tools they are. And actually, as 
part of our temporary ban in Massachusetts we're doing an 
effort around enhanced education and access for these FDA-
approved nicotine replacement products.
    Mr.Kennedy. To any of our witnesses, do you have 
suggestions as to what the FDA should have done? We heard the 
Acting Commissioner acknowledge that in retrospect they should 
have been more active on the regulatory side for their upstream 
what should have been done to avoid where we are at the moment 
for people that are obviously patients that are sick, for 
businesses that are now shuttering or employees that might lose 
their jobs, for folks that are addicted to be forced into a 
black market for it, there is no part of the solution that is 
good at the moment.
    So how do we make sure we avoid this in the next round of 
whatever that might be? Doctor?
    Dr.Khaldun. Yes, as my colleagues have said, it's 
unfortunate that we don't exactly know what the substance or 
device is that's causing these vaping illnesses, so when you 
don't know it's kind of hard to say what you could have done to 
prevent it. But at the same time, I think their fraudulent 
marketing, the fact that a lot of adults and youth think that 
these products are effective, or don't know what's in the 
products, or that they're effective for smoking cessation is a 
problem. So I----
    Mr.Kennedy. Was it wise for the FDA to essentially allow 
for these products to hit the market without knowing the 
consequences of these products?
    Dr.Khaldun. I think that we could have potentially had 
stronger regulations sooner.
    Mr.Kennedy. Dr. Tilson?
    Dr.Tilson. I think these two issues too are related but 
somewhat conflated. So we have the problem with nicotine which 
we know is in there, and then we have the problem with what is 
in these substances with the vaping illness. I think we've 
known forever nicotine--not forever, but that nicotine is 
highly addictive. And I think the lessons learned in our 
combustible cigarette tobacco we should think about and be sure 
we're proactively applying those same lessons learned in a 
comprehensive approach when we're thinking about a product that 
has nicotine.
    Mr.Kennedy. Dr. Norman?
    Dr.Norman. About six years ago when I was the chief medical 
officer at the University of Kansas Health System, I outlawed 
vaping on our healthcare campus because it was that we had a 
no-tobacco policy. I got a certain amount of pushback for that 
because of the ostensible benefit for tobacco cessation. I 
didn't believe it then and I don't believe it now.
    I think looking in our rearview mirror, we would have 
benefited by having much tighter regulatory controls on the 
products that are the vaping devices and the vaping solutions. 
I think we deluded ourselves early on to think that this would 
maybe be a flash in the pan, a fad that would pass. But 
nicotine doesn't act that way. It's too addictive.
    Mr.Kennedy. Thank you all. I appreciate your testimony and 
I will yield back the final 5 seconds.
    Ms.DeGette. I thank the gentleman. I would advise the panel 
that there are some other members who would like to ask 
questions. They are upstairs at this other hearing and they 
can't get down.
    And so under the committee rules, members do have 10 
additional business days to submit questions and I suspect 
several members, including Dr. Ruiz, who is a medical doctor 
and cares a lot about these issues, they will want to ask you 
questions in writing. And if you don't mind, if you could 
please respond to those because this is an important public 
health issue.
    And I so appreciate all of you coming today. Your 
perspective from around the country being on the ground and 
what we can do, it is really vital to our consideration. And I 
hope you don't mind, I have decided to deputize all of you as 
our experts in assisting as we develop these policies. And with 
that, again, Members will have 10 additional days to ask 
questions. And I want to thank everybody and we probably will 
be having some more hearings, certainly some more 
investigation. With that the committee is adjourned.
    [Whereupon, at 12:59 p.m., the subcommittee was adjourned.]
    
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