[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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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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