[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
AN EPIDEMIC CONTINUES:
YOUTH VAPING IN AMERICA
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HEARING
BEFORE THE
SUBCOMMITTEE ON ECONOMIC AND CONSUMER POLICY
OF THE
COMMITTEE ON OVERSIGHT
AND REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
__________
JUNE 23, 2021
__________
Serial No. 117-31
__________
Printed for the use of the Committee on Oversight and Reform
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available at: govinfo.gov
oversight.house.gov or
docs.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
44-984 PDF WASHINGTON : 2021
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COMMITTEE ON OVERSIGHT AND REFORM
CAROLYN B. MALONEY, New York, Chairwoman
Eleanor Holmes Norton, District of James Comer, Kentucky, Ranking
Columbia Minority Member
Stephen F. Lynch, Massachusetts Jim Jordan, Ohio
Jim Cooper, Tennessee Paul A. Gosar, Arizona
Gerald E. Connolly, Virginia Virginia Foxx, North Carolina
Raja Krishnamoorthi, Illinois Jody B. Hice, Georgia
Jamie Raskin, Maryland Glenn Grothman, Wisconsin
Ro Khanna, California Michael Cloud, Texas
Kweisi Mfume, Maryland Bob Gibbs, Ohio
Alexandria Ocasio-Cortez, New York Clay Higgins, Louisiana
Rashida Tlaib, Michigan Ralph Norman, South Carolina
Katie Porter, California Pete Sessions, Texas
Cori Bush, Missouri Fred Keller, Pennsylvania
Danny K. Davis, Illinois Andy Biggs, Arizona
Debbie Wasserman Schultz, Florida Andrew Clyde, Georgia
Peter Welch, Vermont Nancy Mace, South Carolina
Henry C. ``Hank'' Johnson, Jr., Scott Franklin, Florida
Georgia Jake LaTurner, Kansas
John P. Sarbanes, Maryland Pat Fallon, Texas
Jackie Speier, California Yvette Herrell, New Mexico
Robin L. Kelly, Illinois Byron Donalds, Florida
Brenda L. Lawrence, Michigan
Mark DeSaulnier, California
Jimmy Gomez, California
Ayanna Pressley, Massachusetts
Mike Quigley, Illinois
Russ Anello, Staff Director
Richard Trumka, Subcommittee Staff Director
Amy Stratton, Deputy Chief Clerk
Contact Number: 202-225-5051
Mark Marin, Minority Staff Director
------
Subcommittee on Economic and Consumer Policy
Raja Krishnamoorthi, Illinois, Chairman
Katie Porter, California, Michael Cloud, Texas, Ranking
Cori Bush, Missouri Minority Member
Jackie Speier, California Fred Keller, Pennsylvania
Henry C. "Hank" Johnson, Jr., Scott Franklin, Florida
Georgia Andrew Clyde, Georgia
Mark DeSaulnier, California Byron Donalds, Florida
Ayanna Pressley, Massachusetts
C O N T E N T S
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Page
Hearing held on June 23, 2021.................................... 1
Witnesses
The Honorable Richard J. Durbin, United States Senator
Oral Statement............................................... 5
Dr. Janet Woodcock, Acting Commissioner, Food and Drug
Administration
Oral Statement............................................... 8
Written opening statements and statements for the witnesses are
available on the U.S. House of Representatives Document
Repository at: docs.house.gov.
INDEX OF DOCUMENTS
----------
* Exhibit A - Document regarding JUUL Marketing Strategies;
submitted by Chairman Krishnamoorthi.
* Exhibit B - Document regarding JUUL Youth Advisory Council;
submitted by Chairman Krishnamoorthi.
* Exhibit C - JUUL internal email thread; submitted by Chairman
Krishnamoorthi.
* Questions for the Record: to Dr. Woodock; submitted by
Chairman Krishnamoorthi.
Documents entered into the record during this hearing and
Questions for the Record (QFR's) are available at:
docs.house.gov.
AN EPIDEMIC CONTINUES:
YOUTH VAPING IN AMERICA
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Wednesday, June 23, 2021
House of Representatives,
Committee on Oversight and Reform,
Subcommittee on Economic and Consumer Policy,
Washington, D.C.
The subcommittee met, pursuant to notice, at 10:01 a.m.,
2154 Rayburn House Office Building, Hon. Raja Krishnamoorthi
(chairman of the subcommittee) presiding.
Present: Representatives Krishnamoorthi, Porter, Bush,
Speier, Johnson, DeSaulnier, Cloud, Keller, and Clyde.
Also present: Representatives Wasserman Schultz, Maloney,
and Comer.
Mr. Krishnamoorthi. Thank you so much for joining us this
morning. We are starting on time.
So thank you, Mr. Cloud, the ranking member, for making
that happen as well. I now recognize myself for an opening
statement.
For the last year and a half, the deadly coronavirus
pandemic has gripped all aspects of American life. As we see
progress against the virus, we emerge with new insights about
other threats to public health.
It's time to reevaluate the public health threats that are
entirely within our ability to control. There was a youth
vaping epidemic in this country before the coronavirus, before
this subcommittee was even created, and before Acting
Commissioner Woodcock took the helm at FDA.
And the youth vaping epidemic, unfortunately, continues
today. More than 20 percent of high schoolers vape and five
percent of middle schoolers vape. Those are the same levels
that compelled the Surgeon General to first declare a youth
vaping epidemic three years ago in 2018.
For as long as this subcommittee has existed, we have been
investigating this epidemic. This is our fourth hearing on the
matter, and I sincerely hope it is our last because the
problems are solvable.
Our first in 2019 involved putting JUUL on trial, and
exposing the disturbing scope of the company's behavior, its
marketing to children, its attempted use of Native Americans as
experimental guinea pigs, and its responsibility for fueling
the youth vaping epidemic.
We presented evidence from our investigation to FDA and FDA
agreed that JUUL was breaking the law. It sent JUUL a warning
letter regarding its marketing practices and declared them
illegal.
Now JUUL's fate is, again, in your hands at the FDA. JUUL's
products and all e-cigarettes need FDA's approval for their
products to stay on the market through what is called the Pre-
Market Tobacco Application process, also known as the PMTA
process, and FDA's decisions are due by September.
JUUL's marketing to children was simply unacceptable. The
attorney general of North Carolina is taking JUUL to trial over
that as we speak.
But beyond marketing, JUUL hooked kids for three other
reasons. First, kids were attracted to the flavors JUUL
cigarettes came in. Second, kids got hooked because JUUL came
in nicotine levels much higher than anything else on the
market. And third, JUULs were easy to conceal from adults.
Companies copied JUUL's model. When you look at the list of
products that are on--that are the subject of PMTA
applications, there are many, many even now, in kid-friendly
flavors.
There are many that matches--match JUUL's high-nicotine
formulation, and many that match JUUL's concealability.
To the FDA, I would say this. No matter what your decision
is on JUUL's PMTA, you know that the problem does not end
there. To end the youth vaping epidemic, you'll have to deny
the applications for all products with the same characteristics
that made JUUL so popular with a generation of children.
Because we have watched in real time that whenever a
popular flavor is removed from the market, other flavored high-
nicotine products take their place.
So I say to Acting Commissioner Woodcock, I believe you
want to do the right thing, that you want to keep nicotine out
of the hands of children. When you decided to ban menthol
cigarettes, you took a strong action to strengthen public
health and racial equity.
When this subcommittee exposed the prevalence of toxic
heavy metals in baby foods, you made that issue a priority and
created the Closer to Zero initiative, and we are appreciative.
However, now FDA has the opportunity to step up and finish
the fight against the youth vaping epidemic. Don't let any
flavored products from any e-cigarette company stay on the
market, not mango and not menthol.
If you leave a single flavor on the market, kids will use
it, and that will not be because of the destruction that
occurred before you took the helm. It will be because of an
affirmative decision that you and the FDA make.
Don't make that decision. Don't let any flavored products
on the market. Don't let any high-nicotine products on the
market. Other countries cap nicotine at one-third of what is in
a JUUL. Those countries do not have anywhere near the youth
vaping epidemic problem that we have in this country.
Do these things, and in the next three months we can help
stamp out an epidemic. We saw this movie before with Big
Tobacco and the opioid epidemic. Let's not let it happen with
vapes. Have the courage to say no to Big Tobacco. The health of
the Nation depends on it.
Thank you. I now recognize Ranking Member Cloud for your
opening statement.
Mr. Cloud. Thank you, Mr. Chairman.
We have known for decades that cigarette smoking is
dangerous and linked to cancer and other illnesses. Smoking
causes 480,000 preventable deaths in America each year. That's
more than 1,300 deaths a day, and I cannot think of another
product on the market where 50 percent of its users want to
quit the product.
If you are under 21, you should definitely not use tobacco
or begin using vaping products or, for that matter, any other
drug or anything else nefarious you should put in your body.
It's really important to understand that especially for young
teens, if your bodies are still developing these products can
have an even outsized greater negative impact on your body as
you are--as you are growing and learning and those sort of
things.
Unfortunately, as we have covered in past hearings,
severely misguided marketing efforts contributed what has
become a vaping epidemic among teens in communities across our
Nation.
Social sourcing, coupled with nefarious counterfeit and
black market products, found their ways in the hands of far too
many teens and led to tragic and heartbreaking outcomes for far
too many families.
We made some progress with the passage of T-21, but there
is still more work to be done. There is some evidence--this is
a new industry, and some evidence is coming forth that may
lead--that vaping products could help with smoking cessation.
If that is true, I hope the FDA will take a good look at the
science based on it.
But we need to do everything we can to make sure that our
youth do not have access to these products. I share, along with
the chairman, our first role before being a Member of Congress
is that of a father, and we do not want to see a world where
kids have access to these sorts of products.
So, I want to thank you all for being here today. I want to
thank you for attending this hearing. I want to thank you also,
Dr. Woodcock, for appearing for us today.
I do hope that we will be able to have a good healthy
discussion, that we will be able to hear from you, but also
make sure we are not unduly influencing improperly a process
that is supposed to be evidence based and, hopefully, it will
be and that we will be able to do the right kind of--right kind
of science of being able to divide how we can protect our kids
yet if the science does point out that this is a smoking
cessation device that we will be able to have the right adults
have access to that product as well.
Thank you, Chairman, for this hearing. Thank you for your
passion on this topic, and I yield back.
Mr. Krishnamoorthi. I want to just applaud Mr. Cloud for
being part of the bipartisan and bicameral congressional Caucus
Against Youth Vaping, which myself, Senator Durbin, and others
are chairing. So, thank you so much, Mr. Cloud.
Now, Chairwoman Maloney, thank you for being with us and
thank you for your distinguished leadership of our committee. I
want to just recognize you for a brief opening statement as
well.
Chairwoman Maloney. Thank you.
Our nation's youth are experiencing a public health crisis.
According to data collected by FDA and CDC, more than 3 million
high school students and a half a million middle school
students use e-cigarettes, and according to the Office of the
Surgeon General, an estimated 5.6 million children in this
country will die early from a smoking-related illness if
cigarettes--could continue to be used at this rate.
That is one in every 13 young people alive today. These
numbers are horrifying. They threaten years of progress in
reducing youth tobacco use, and the e-cigarette industry is to
blame.
Companies like JUUL and Puff Bar knowingly and deliberately
pushed tobacco products onto our Nation's youth. They deployed
deceptive, dishonest tactics to get our young people hooked on
these products.
They even went so far as to promote their products
directly, in our Nation's schools. E-cigarette manufacturers
have acted with a complete disregard for the health of young
people across this country.
Their actions are appalling, and the Federal Government can
no longer allow this industry to foster youth addiction as a
long-term marketing strategy for its deadly products.
Our nation's regulatory agencies must take immediate action
to turn the tide on this crisis. FDA can build on the steps
it's taken so far by prohibiting the sale of remaining flavored
products, capping nicotine levels in e-cigarettes, and pulling
illegal products, like those sold by Puff Bar, off the market.
I strongly urge the agency to take these common sense
steps.
Let me conclude by commending the leadership of Chairman
Krishnamoorthi and the Subcommittee on Economic and Consumer
Policy. The subcommittee's investigation has brought to light
the dangerous practices of e-cigarette manufacturers across the
country, and it has underscored the urgent need for the Federal
Government to act on America's youth vaping epidemic.
Thank you for your leadership, Chairman Krishnamoorthi. I
look forward to hearing the testimony and from all of our
esteemed witnesses today.
And I yield back. Thank you for allowing me to be with you.
Mr. Krishnamoorthi. Thank you, Chairwoman Maloney. Thank
you for your distinguished leadership. Thank you for your
opening statement.
Now I would like to begin by introducing our first
panelist, someone I know very well, the distinguished senator
from my--from my own home state of Illinois.
For decades, Senator Dick Durbin has fought to protect all
Americans, including our society's most vulnerable, from the
dangers of tobacco and e-cigarettes. His work dates back to
leading the congressional effort to have smoking banned on
airplanes, a measure that went into full effect in 1990, more
than 30 years ago. Today, I am grateful to consider Senator
Durbin a champion and a partner in our shared effort to curb
youth vaping.
He is the Senate lead of the congressional caucus to end
the youth vaping epidemic. He is the Senate lead of our
legislation, the Tobacco Tax Equity Act, which will raise taxes
on all tobacco products for the first time in over a decade to
protect public health.
He is the Senate lead of the Prevent Act, legislation to
create youth vaping prevention programs in schools, and this is
just a small snippet of the work that Senator Durbin has
engaged in, in this space, for decades.
Senator Durbin, in his spare time, is the Majority Whip,
the chairman of the Senate Judiciary Committee, and a long-
standing dean of the congressional delegation from Illinois. We
are so fortunate to have him here today and thank him for his
participation.
Senator Durbin?
STATEMENT OF THE HONORABLE RICHARD J. DURBIN, UNITED STATES
SENATOR
Senator Durbin. Thanks, Chairman Krishnamoorthi and Ranking
Member Cloud, for allowing me to testify today on the youth
vaping epidemic and the role of the Food and Drug
Administration.
The campaign to reduce tobacco use and prevent our kids
from lifetime addiction is personal to me. My father died from
lung cancer. He was 53 years old. He smoked two packs of Camels
a day.
As a young high school student, I will never forget how he
struggled to breathe during my visits to the hospital in his
last days. Cigarettes are responsible for 480,000 deaths every
year in the United States. My family is, certainly, not the
only one who can tell this story.
So, ever since I came to Congress, starting in the House, I
have dedicated my career in public service to this fight,
holding the tobacco industry accountable for its lies and
deception, empowering families, schools, and health care
providers to prevent kids from this addiction, and working to
build and strengthen a regulatory framework that really does
focus on public health.
When last I testified before this subcommittee in July
2019--it seems so long ago--most of our focus was on the
skyrocketing rates of youth e-cigarettes, fueled by the kid-
friendly flavors, aggressive promotion, and high nicotine
concentration of the product.
Since that time, my office, this subcommittee, and the
public health community have shone a bright light on the
abusive tactics by JUUL that contributed to this foothold with
our children.
We now have uncovered the disgusting tactics used by this
company to addict our children on these e-cigarette products. I
am pleased our public health and antitrust regulators have
started to step in.
But what I want to focus today is the record of the FDA
over the last several years, and the opportunity that sits
before the agency today to correct its missteps in the past and
put public health and kids at the forefront of its mission.
Flavored e-cigarette products have exploded in popularity
among our kids, nearly 4 million now vaping, a 361 percent
increase in just eight years, when only 800,000 kids were
vaping.
One in five high school students use e-cigarettes. These
alarming trends are erasing the historic progress we have made
reducing youth tobacco use.
Who is the cop on the beat to whom we entrust our children?
It's the Food and Drug Administration, and this agency has been
timid and reluctant for way too long.
For years the FDA delay--delayed implementation of its
requirement that companies submit PMTA applications for review.
At the same time, the FDA allowed cigarettes to proliferate
essentially unregulated--e-cigarettes to proliferate
essentially unregulated--failing to enforce its own Deeming
Rule, which required that all new products entering the market
after August 8, 2016, undergo a public health review.
Since my last testimony, we had a glimmer of hope on that
day in September 2019 when President Trump promised to ban all
e-cigarette flavors.
As part of that, the FDA in January 2020 had a golden
opportunity to finally clear the market of these addictive kid-
friendly products, the vast majority of which were on the
market illegally.
But instead, the Food and Drug Administration took a half
measure, only partially clearing the market and leaving major
loopholes for this powerful industry.
The result? Kids migrated to these loopholes, to the
products that remained unregulated on the market, menthol-
flavored e-cigarettes and disposable vaping products. The use
of disposable e-cigarettes, one of the loopholes which the FDA
lost, which were exempted from the FDA's January 2020 action,
increased 1,000 percent last year.
Make no mistake, kids get it. If we don't take this
seriously across the board, they will find those loopholes and
continue their addiction.
And because the FDA allowed menthol-flavored cartridges
from JUUL and others to stay on the market, listen to this, the
use of these menthol-flavored JUUL products, cartridges,
increased from 11 percent to 62 percent of the market. Another
failure by the FDA.
Now we approach one of the biggest milestones in FDA
tobacco regulation history, and I worry the agency is going to
fail again.
After years of delay by administrations of both parties,
the FDA, under court order, under court order, finally required
e-cigarette and tobacco manufacturers to submit applications
for their vaping products on September 9, 2020.
This is the long awaited opportunity for the FDA to apply a
public health standard that Congress passed as long ago as 2009
in the Tobacco Control Act to evaluate whether a product can
stay on the market and whether it is, quote, ``appropriate for
the protection of public health.''
That is a high bar. It requires the FDA to balance the risk
of youth initiation with potential benefit of adult cessation.
And the burden is on the manufacturer. The burden is on the
manufacturer to show their products will not lead to youth use,
show their products do not harm the user, and to show they
actually help adults quit smoking.
Remember that claim made over and over again? Prove it. It
can't. They know they can't.
I am deeply troubled with what I have heard from the
response of the FDA to my letters. I fear they are going to
once again overvalue the unproven potential benefit of
cessation for adult smokers, while undervaluing the clear
evidence of what is happening to our kids.
Only four percent of adults use e-cigarettes. Twenty
percent of high school students. Kids who never would have
picked up a tobacco product are vaping.
It is simple. Any product with a history of increasing
youth use must be rejected by the Food and Drug Administration,
especially flavored products that we know hooks the kids.
This is the Super Bowl for the FDA's tobacco effort. I am
afraid they are not ready for prime time. I hope they prove me
wrong.
The FDA recently announced plans to ban menthol cigarettes,
an important public health action, and I want to commend the
acting commissioner who sits behind me on when she called me
with the news.
But just like that step, the time is now for FDA to take
meaningful action on how it applies public health standards to
e-cigarettes. We know FDA's after-the-fact enforcement, warning
letters, and perpetual game of whack-a-mole just doesn't work.
To put it bluntly, FDA slow walking and refusal to
forcefully act has enabled these e-cigarette companies to
addict a new generation of our kids.
It is time for the FDA to be a partner in public health,
not a partner to Big Vape, and take these products off the
market. As the subcommittee continues to examine the youth e-
cigarette epidemic and the role of FDA, I hope we prioritize
our kids.
Let me close with a personal note. It has been a few years,
but I once served in this House of Representatives, in this
building, in the House Appropriations Committee, and one day I
decided to offer an amendment on a Transportation Subcommittee
bill that I served on to ban smoking on flights of two hours or
less.
Why did I pick two hours? Because one of the leaders on the
Democratic side in the House Appropriations Committee, Martin
Sabo of Minneapolis, was a chain smoker. And I asked him once,
Martin, how long could you go without a cigarette? He said two
hours, and that is what I put in the first bill. Flights of two
hours or less, ban smoking.
What happened afterwards was incredible. Even with the
opposition of the House Republican and Democratic leadership, I
managed to get this to the floor, thanks to a man by the name
of Claude Pepper, who was chairman of the Rules Committee, and
basically ignored the Speaker's direction to give me a chance
on the floor.
How about that? I had Bill Young of Florida, a Republican,
as my co-sponsor. We went to the floor and we won. It shocked
everybody that we won.
Why did we win? Because it turned out the House of
Representatives was the biggest frequent flyer club in America,
and they were sick of smoking on airplanes.
Well, eventually, we banded it on all flights going beyond
two hours. I didn't know it at the time. I really didn't know
at the time. That was the tipping point.
At that point, people said to themselves, if it is unsafe,
if secondhand smoke is dangerous on an airplane, why is it safe
on a train, on a bus, in an office, in a restaurant, in a bar,
and the dominoes started to fall.
We are at a much different place in America today, because
as a junior member of the House of Representatives I tried
something that was considered politically impossible and it
worked.
You can do the same thing. You have that power at your
hands. I hope you will use it.
I know this hearing is an indication of your interest in
the subject. Not only give the FDA the tools, but make them use
it if they won't. Bring them around to the side of protecting
public health. You'll be glad you did.
Thanks for letting me testify today.
Mr. Krishnamoorthi. Thank you, Senator Durbin, for your
excellent remarks, and we very much appreciate your second
visit on this topic, hopefully your last.
Hopefully, this will be our last hearing, because now we
are going to adjourn this panel and invite Commissioner
Woodcock to come to the table and tell us how we are going to
get the FDA to do the right thing here.
So, thank you. Thank you, Senator.
Clerk, could you please play the video that has been
prepared for the public here?
[Video is shown.]
Mr. Krishnamoorthi. Thank you for playing that moving
video.
Good morning. We are now introducing panel two. We are
joined today by the Honorable Dr. Janet Woodcock.
Dr. Woodcock is the Acting Commissioner of the Food and
Drug Administration.
Commissioner, thank you for being with us today. I will
begin by swearing in the witness. If you would please rise and
raise your right hand.
Do you swear or affirm that the testimony you are about to
give is the truth, the whole truth, and nothing but the truth,
so help you God?
[Witness is sworn.]
Mr. Krishnamoorthi. Thank you. Let the record show that the
witness answered in the affirmative. Thank you, and please be
seated. The microphones are sensitive, so please speak directly
into them. Without objection, your written statement will be
made part of the record.
With that, Commissioner Woodcock, you are now recognized to
provide your testimony.
STATEMENT OF DR. JANET WOODCOCK, ACTING COMMISSIONER, FOOD AND
DRUG ADMINISTRATION
Dr. Woodcock. Thank you, and good morning, Chairman
Krishnamoorthi and Ranking Member Cloud. Thank you for the
opportunity to be here today.
This is a very important issue to me. I am here today
representing hundreds of staff at the FDA who are working every
day to prevent kids from using any tobacco products, including
e-cigarettes.
While I have only been in my current position for about six
months, I have been with the agency in various capacities for
over 30 years. While director of the FDA Center for Drugs, I
played a central role in the agency's initial attempts in the
early 2000's to regulate e-cigarettes under our drug and device
authorities.
Particularly, I was worried that flavors would entice
children to use these products and that would cause harm. The
issue, ultimately, was adjudicated in the 2010 Sottera court
case, where the D.C. District Court ruled that products made or
derived from tobacco could only be regulated under our tobacco
authorities.
And now, as acting commissioner, I am happy to continue to
work closely with my colleagues from the Center for Tobacco
Products. It is a new day and we now have a tremendous
opportunity and, indeed, a responsibility to keep and elevate
kids at the forefront of our efforts to prevent death and
disease from tobacco products.
With the September 9, 2020, premarket application deadline
behind us, we are taking steps to transform the tobacco
marketplace toward one where deemed new tobacco products on the
market, like e-cigarettes, will have undergone careful,
science-based review and oversight by FDA.
This is truly significant. We have received and initially
processed submissions that cover more than 6.5 million
products.
Congress granted us a vital public health tool with our
premarket review authorities, and I can assure you we intend to
use that authority to protect kids, and optimize public health
as directed in the statute.
We are working furiously on application review in order to
move on from sort of a Wild West, unregulated marketplace. We
will complete thorough evaluations to ensure that any products
that are granted marketing orders meet the statutory standard
of appropriate protection of the public health, as Senator
Durbin said, a high bar.
If data for a product do not clearly support that standard,
which includes an evaluation of the impact on youth initiation
and use, we will not issue a marketing order for that product.
At the end of the day, we are going to do everything we can
to end the epidemic of youth use and prevent another generation
of kids from becoming addicted to tobacco products.
Importantly, we are going beyond pre-market review. While
the 2020 National Youth Tobacco Survey showed an encouraging
and significant decline in youth e-cigarette use last year,
there are still 3.6 million middle and high schoolers who
currently use these products.
The epidemic of youth vaping threatens to undermine decades
of progress in reducing the impact of tobacco on public health.
So, we are also focusing our enforcement efforts against
any product where the manufacturer fails to take adequate
measures to prevent youth access and any product that is
targeted to youth, and we have been doing that.
For example, we have issued warning letters to companies
for illegally marketing unauthorized and kid-appealing tobacco
products, such as a backpack and sweatshirt with hidden pockets
to conceal e-cigarettes or those that resemble smart watches or
children's toys.
In addition, as of May 31, we have issued over 120 warning
letters to firms selling or distributing unauthorized
electronic nicotine delivery systems. That includes e-
cigarettes that did not submit premarket applications by the
September 9 deadline. Collectively, these companies have listed
a combined total of over 1.2 million products listed with the
FDA.
We are also expanding our critical public education efforts
through the Real Cost youth e-cigarette prevention campaign. We
are targeting over 10 million teens who have used or may use e-
cigarettes.
The most recent impact assessments of the Real Cost are
promising, indicating the various elements of the campaign have
received over 5 billion views and that 75 percent of youth are
aware and receptive to our ads.
Over time, increased exposure to the campaign is expected
to increase population level shifts and youth beliefs about e-
cigarettes.
As a science-based agency, we now support more than 145 e-
cigarette research projects. This research helps us better
understand and regulate these products and includes
investigation of use behaviors, addiction, and health effects.
We also continue our yearly surveys and studies we
undertake with Federal partners at CDC and NIH.
In closing, I give you my commitment and speak on behalf of
my colleagues at the agency that we will do all we can to
prevent kids from using tobacco products and to address the
current youth vaping epidemic.
We will do the hard work, we'll support innovative and
informative research, and make science-based data-driven
decisions as we follow through on this very important aspect of
our public health mission.
Thank you for the opportunity to testify. I appreciate the
subcommittee's efforts on support of the agency and your
efforts to protect kids, especially from the dangers of
tobacco, and I am happy to answer questions.
Thank you.
Mr. Krishnamoorthi. Thank you, Commissioner Woodcock. I now
recognize myself for questions. If you could please put the
first chart up.
Commissioner, I would like to start by directing you to the
NIH Monitoring the Future survey data published in 2019 and
2020.
[Chart.]
This is a chart showing that among a subset of almost 9,000
high schoolers, this NIH study found that the percentage who
said they have vaped in the past 30 days equaled 22.5 percent
in 2019 and 22 percent in 2020.
Now, back in May 2019, you described youth e-cigarette use
as a, quote, ``alarming problem.'' Do you consider--I assume
you continue to believe that sentiment, correct?
Can you repeat that? I think your mic is----
Dr. Woodcock. Yes, I do.
Mr. Krishnamoorthi. At the same meeting in 2019, you said,
quote, ``E-cigarette use among youth also increases the risk
that they will use combustible cigarettes,'' closed quote. You
still believe that, correct?
Dr. Woodcock. I believe that is the case.
Mr. Krishnamoorthi. According to FDA's website, quote,
``Nicotine exposure during adolescence can disrupt normal brain
development and may have long-lasting effects such as increased
impulsivity and mood disorders.''
You don't disagree, correct?
Dr. Woodcock. I don't disagree with that assessment. It is
very concerning.
Mr. Krishnamoorthi. Now, as you mentioned in your opening
statement, you have received millions of applications under the
PMTA standards, and one of the things that the FDA must assess
is, quote, ``the increased likelihood that those who do not use
tobacco products will start using such products.''
When youth who use e-cigarettes that might be subject to
the PMTA process have an increased likelihood of using other
tobacco products such as combustible cigarettes, that is a
problem under the PMTA standard, right?
Dr. Woodcock. Yes.
Mr. Krishnamoorthi. The PMTA standard also states that you
must consider the, quote/unquote, ``risks'' to, quote, ``people
who would use/propose new tobacco products under the PMTA.''
We just talked about the health risks to youth. I presume
that, again, those health risks, those significant long-term
health risks to youth, are, again, a problem under the PMTA
standard, right?
Dr. Woodcock. Absolutely. That is the harm bar. That is the
bar that has to be overcome by benefits in order to have a net
benefit in the public health.
Mr. Krishnamoorthi. Very good.
In your June 22 letter, so last night the good folks at FDA
sent me a letter late, saying, quote, ``The assessment of a new
product's likely impact on addiction, especially among youth,
is critical to determining whether allowing a new tobacco
product would be, quote, 'appropriate for the protection of the
public health.'"
And then the letter goes on to state, one of the issues
bearing on your assessment of addiction was, quote, ``the
levels of nicotine in the finished product,'' close quote.
I would like to now present you with some documents that
JUUL produced to our committee during this investigation.
I seek unanimous consent to enter Exhibits A, B, and C.
Without objection, so entered.
Mr. Krishnamoorthi. Clerk, can you please display the next
slide?
[Slide.]
Dr. Woodcock. Thank you.
Mr. Krishnamoorthi. This is a March 2016 JUUL document that
was produced as part of their document production to us on this
committee. It says, quote--this is an internal document from an
employee at JUUL.
It says, quote, ``Based on feedback from retailers,
customer service, and social media, many consumers feel that
five percent nicotine strength is too strong. Our current
nicotine level in pods is much higher than other e-
cigarettes.''
And by the way, as you know, this five percent strength is
the strength of current JUUL products. That was in 2016, five
years ago.
Now let us go to 2018 when 20 percent of high school
students and five percent of middle school students were
vaping. Can you please present the next slide, Rich?
[Slide.]
Mr. Krishnamoorthi. JUUL convened something called a Youth
Advisory Council to ask why so many children are using its
product. This is what Kim said. Kim said, ``Very high
concentration of nicotine.'' Then she had some other
interesting comments there.
I didn't put this up on a slide but Brett said, quote,
``Social acceptance to start addiction to nicotine'' keeps
them. Noah said, quote, ``Social to start, nicotine to stay.''
Besides this anecdotal evidence, Commissioner Woodcock,
there is objective data that even as late as 2020 the National
Youth Tobacco Survey that came out from the FDA shows an
increase in nicotine addiction.
According to FDA, almost 40 percent of high school users
are using an e-cigarette on 20 or more days out of the month.
That is every two of every three days. These numbers are up
from 2019 when that number was, roughly, 34 percent.
So, in your assessment of a new product's likely impact on
addiction, going back to the standard that you set forth in
your letter to me with regard to PMTA, you would be very
concerned about youth perceptions, as well as the reality of a
product's addictive qualities, correct?
Dr. Woodcock. Absolutely. That has to be in the forefront
of our assessment of harm--potential harm.
Mr. Krishnamoorthi. You would also be concerned about a
company's knowing decision to keep its nicotine levels high,
even in the face of internal employee as well as retailer
feedback that it is too high?
Dr. Woodcock. Obviously, for substances that can cause
addiction, exposure is very important, and higher exposure is a
problem.
Mr. Krishnamoorthi. And also you would be concerned about
youth data showing that it is hooking or addicting kids, right?
Dr. Woodcock. Absolutely.
Mr. Krishnamoorthi. When a company has such internal data
and continues to keep its nicotine levels high, does that fact
present evidence that the company intended to hook kids?
Dr. Woodcock. I guess that is--I am not a lawyer. So, that
is beyond my area of expertise. I would say that the facts of
the case show that this--these products had real dangers to
kids.
Mr. Krishnamoorthi. And the companies knew about the
dangers?
Dr. Woodcock. According to what you show here, absolutely.
Mr. Krishnamoorthi. In February 2020, FDA implemented a
new--we call it flavor ban. There is a very much--there is a
much longer title. You are familiar with that flavor ban,
correct?
Dr. Woodcock. Yes.
Mr. Krishnamoorthi. According to the policy, however, it
made two exemptions. First, it made an exemption for tobacco
and menthol flavors for JUUL and other cartridge-based devices,
and then, second, it made an exemption for all disposable e-
cigarettes to be in any flavor whatsoever.
Let us talk about menthol for a second, Commissioner. Can
you present the next slide?
[Slide.]
Mr. Krishnamoorthi. Forty-four percent of youth in 2019
used mint JUULs, and when mint was banned in February 2020
under your partial flavor ban, guess what? Forty-four point
five percent of youth used menthol JUUL.
So, we went from 44 percent of JUUL users using mint to
44.5 percent of JUUL users using menthol, and as Senator Durbin
said in his testimony, 62 percent of all users, regardless of
which company, ended up using menthol.
Now, Commissioner, this was before you became commissioner.
But I spent an entire hearing in December 2019 with your
colleague, Mitch Zeller, telling him that this was such a bad
idea to create an exemption for menthol.
I said this is exactly what's going to happen. People are
going to migrate from mint to menthol and that is what
happened.
Now, I was so pleased that you banned menthol combustible
cigarettes, which was the right thing to do. Will you pledge to
clear the market of menthol e-cigarettes?
Dr. Woodcock. Again, I can't prejudge our decisions. What I
can say is that menthol has additional properties,
pharmacologic properties, that I believe potentiate the effects
of nicotine addiction and make it harder to stop either vaping
or smoking. And so it is, to my mind, like actually having a
higher concentration of nicotine in your--whatever delivery
system.
Mr. Krishnamoorthi. Well, that is enlightening. It,
basically, heightens the addictive properties of the e-
cigarettes?
Dr. Woodcock. That is my belief, based on data. I don't
think it is totally settled, but evidence shows it is harder
for people who smoke menthol cigarettes to stop smoking, even
though they smoke fewer cigarettes. Those facts are compatible
with that hypothesis.
Mr. Krishnamoorthi. Let us talk about disposable e-
cigarettes.
According to the 2020 NYTS that you folks presented at the
FDA, in 2019 only 2.5 percent of high school students--I am
sorry, 2.5 percent of high school vapers used disposables.
But after FDA banned most flavors for cartridge devices but
allowed all flavors for disposables, guess what? Disposable use
surged to almost 27 percent in 2020. You don't dispute that
data, correct?
Dr. Woodcock. No.
Mr. Krishnamoorthi. The decision to exempt disposables,
again, was made before your time as commissioner. Exempting
disposable e-cigarettes was a huge mistake. Exempting them from
the flavor ban was a huge mistake.
I assume that you consider that problematic. Will you
pledge to close the disposables loophole in the flavor ban?
Dr. Woodcock. Again, I can't prejudge our decisions, which
are coming up very quickly. However, I think this switch to a
different alternative method of flavored cigarette rather than
staying with the, say, tobacco-flavored JUUL shows--is another
piece of evidence that the youth really prefers the flavors,
and that that is a really important factor for the youth in
sustaining their use of these products.
Mr. Krishnamoorthi. And, in fact, the percentage of youth
who use flavored e-cigarettes went up over the last year since
the partial flavor ban. Now it is up to 80 percent of youth use
flavored products, correct?
Dr. Woodcock. I can't remember all these numbers exactly.
But it is a very high number. I believe it is 80 percent. Yes.
Mr. Krishnamoorthi. Very good. Let me now recognize Ranking
Member Cloud. And I am sorry, I went--I think we forgot to turn
on the timer. So, we will give you some extra time here.
Mr. Cloud. It is a liberal five minutes.
[Laughter.]
Mr. Cloud. Thank you, again, for being here, and thank you,
Chair, for the important discussion on this topic. As we all
have agreed we don't want to see these in the hands of our kids
and we want to see what we can do to have it.
You mentioned that some progress has been made in 2020 and
that there has been some reduction in youth vaping according to
the data now, and granted on whatever topic we are talking
about, 2020 is a year that it is hard to really put any stock
in a lot of definite data.
So, I am curious to know why you think that happened. Did
the T-21 legislation that we passed have anything to do with
that? Was it some of the administrative actions that were
taken?
Also curious to know, as we are looking ahead, like we
said, 2020 is kind of a hard year to be definitive about when
it comes to data on any topic. But when we can expect to see
data that we can kind of see if those trends are moving in the
right direction, or if it was a blip because of COVID and all
those kinds of things?
What are your thoughts?
Dr. Woodcock. Well, the data from surveys should come out.
Hopefully, we will have some indication of that later this year
to give us another year of data, I think, because the survey
has already been conducted. So, the analysis must be done and
so forth.
I believe that the apparent decrease last year was probably
multi-factorial, and so it is hard to say what the contribution
of any given factor was to children. A lot of them were home.
They weren't suffering as much peer pressure. They were
very unhappy about not being around their peers. But a lot of
them were not in congregate situations. And we heard from the
film that you showed--we heard that peer pressure, and in this
finder, that peer pressure was a very important factor in some
of these kids using vaping products.
So, the ban on the T-21 I think is very helpful. FDA,
though, had to stop its compliance checks in the middle of the
pandemic because we used under-age children as part of the test
subjects along with a trained adult to go in and attempt to
purchase, and we couldn't send children into those
circumstances with COVID.
But I will say that even before, even when we had the limit
at 18, we saw thousands of cases where sales were made to
under-age, under 18, individuals. So, that's a problem out
there that those are--that those retail outlets still will sell
to underage individuals.
Mr. Cloud. There has been a--I am a little concerned about
the timing of this hearing. While I think it is a very
important topic that we cover and you to be here is great, just
because courts have frowned upon in the past Congress weighing
in while there is an agency investigating or reviewing a topic.
As a matter of fact, Pillsbury Company v. FTC held a
congressional investigation cannot be focused on intervening in
an agency's adjudicative function.
How are we going to make sure that today's hearing is
informative for us, informative for the American people, but
that your decisions are going to be evidence based? I noted
some of the comments you made talked about what you believed to
be the case but you didn't cite any data.
And I realize you have a team and a staff and you can't be
expected on every topic you cover to know everything, but how
are we going to ensure that as we move forward in this process
that it is going to be evidence-based?
Dr. Woodcock. Well, as I said, I cannot, in this hearing,
prejudge any decisions we will make or commit to any given
actions. The Congress has laid out in statute what the
statutory bar is for these--for this review program and the--
and it is a rather high bar. I don't think that is a matter of
dispute.
But, certainly, the agency scientists are hard at work at
evaluating these applications against the criteria that are
laid out in the statute, and that is the process that we will
follow.
Mr. Cloud. Are you--is there evidence coming to play that
shows that there is a use for adults--now, we are talking over
21--to use vaping products as a smoking cessation device? Is
there early evidence of that?
Dr. Woodcock. I think the studies are somewhat mixed, as
far as how effective vaping is.
Mr. Cloud. It is a new industry. So, I realize it is
developing.
Dr. Woodcock. No company has come to the FDA Center for
Drugs to go through the process of smoking cessation, right,
which would be a drug indication and is a different process you
would go through as a drug.
We have a number of cessation products on the market. They
have all been shown in clinical studies to help people stop
smoking, although the adherence to stopping smoking over years
may not be that good.
But these, including certain drugs, as well as different
nicotine products that people can use as nicotine replacement
and help stop smoking.
In all those cases, people are urged to also get counseling
or be in a program or something like that. That helps a lot of
people with smoking.
So, none of the vaping products have been through that kind
of process, which requires clinical trials to prove that you
can actually allow--get people to stop smoking. I think most--
--
Mr. Cloud. I think you could advertise it as that.
Dr. Woodcock. Pardon me?
Mr. Cloud. That they could advertise it as that kind of
product.
Dr. Woodcock. They would have claims. Then they would be a
drug and they could advertise, absolutely. But they would also
have to do toxicological studies on their products, inhaled
products, and so forth.
So, in the statute for tobacco products that we are
reviewing under says it also has a evidentiary statement in the
statute that says, you know, there should be studies that
should support the fact--the benefits, and those could be
clinical studies or other type of studies.
So the burden, as Senator Durbin said, is on the
manufacturer to show that by some studies and data that their
product has some public health benefit.
Mr. Cloud. I don't know if you would have this data handy.
If not, it would be--I would be very curious to have your team
look into it and see.
But, you know, as we--coming through this year with COVID-
19 that is a respiratory illness, and we know that it affected,
you know, particularly, seniors and other demographics
particularly hard.
But there were some cases where young people were
tremendously affected by it. Some died, while that was much
more rare than other segments of our population.
Have you all cross referenced that with vaping to see if
there was a connection to be susceptible? And then, you know,
in the past, we have covered this in a number of hearings so we
understood that there is a distinct difference even in the
effect of black market products versus others.
Not that you should have any of them. You know, that is
well established, I think, at least among us who are talking
about this issue.
Have you--have you found any sort of connection?
Dr. Woodcock. Yes, I don't think the data are available to
link COVID--severity of COVID or catching COVID by youth or
having a severe case with vaping practices. I can get back to
you.
We can look at what data might be available, but I do not
think those data are available. Youth use of COVID usually
wouldn't be in a medical record. I mean, the use of, excuse me,
of vaping wouldn't be in the medical record. And so that is--
then it is hard for people to make that connection.
Mr. Cloud. Right. OK. Well, thank you. I yield back. Thank
you, Chairman.
Mr. Krishnamoorthi. Thank you, Mr. Cloud.
Now I recognize Congresswoman Porter for five minutes.
Ms. Porter. Thank you very much, Mr. Chair.
Commissioner Woodcock, does the research clearly establish
that flavored e-cigarettes appeal to children?
Dr. Woodcock. Yes, I believe it does.
Ms. Porter. And in fact, the FDA banned non-disposable
flavored e-cigarettes except menthol in order to, quote,
``limit children's access to certain flavored e-cigarette
products we know are so appealing to them.''
Dr. Woodcock. Yes.
Ms. Porter. But we are having this hearing because
disposable flavored e-cigarettes and both disposable and non-
disposable menthol products are still on the market, and the
inevitable result of this is that e-cigarette use among high
school and middle school students is incredibly high, 3.6
million children youth vapers in 2020.
Dr. Woodcock, are--of those middle and high school kids who
smoked e-cigarettes, what percentage of them used flavored
products?
Dr. Woodcock. I believe that eight out of 10 use--e-
cigarette users report use of flavored products.
Ms. Porter. That is what I have, too, right about 80, 83
percent, and that was an all-time high. So, if any flavor other
than tobacco flavor of e-cigarette is left on the market, is it
likely to encourage youth to start vaping?
Dr. Woodcock. The statutory bar that we are talking about
is that harm, OK, the harm of----
Ms. Porter. Oh, reclaiming my time. I am going to get to
that balancing out.
Dr. Woodcock. OK.
Ms. Porter. So, I am going to let you do that balancing.
Dr. Woodcock. Yes.
Ms. Porter. So, you are going to have to balance. But what
we are balancing on the other side is I want to establish. Any
flavor of e-cigarette left on the market is likely to encourage
youth to start vaping. And we have to balance that against some
other things we are going to get to. Is that correct?
Dr. Woodcock. That is correct.
Ms. Porter. And if the FDA banned all flavored e-
cigarettes, would less kids continue to vape among those who
have started, in your opinion?
Dr. Woodcock. Well, I can't predict the future. I think
that might be likely. We also would have to, regardless, limit
advertising and sales in targeting children and other
practices.
Ms. Porter. Well, if they are not on the market, it is
tough to advertise that, right?
Dr. Woodcock. Well, yes.
Ms. Porter. So, to summarize, if kids have the choices of
any tasty flavor, they are going to go for it. And I am
speaking to you from experience here as a mom of three school-
aged kids.
If there were no watermelon snow cones, my kids are happy
with blue raspberry. No blue raspberry, they will take mango.
No mango, they will take strawberry. But if their only choice
was a brown tobacco-flavored snow cone, they are going to walk
away.
So right now, the FDA is analyzing what are called
premarket tobacco product applications, and in short, and this
is what you were hinting at, you have to decide whether or not
an e-cigarette can bring or keep a product on market, and in
doing that you have to do that only if it is appropriate for
the protection of public health. That is the standard.
And what this means is the FDA is required, as you were
saying, to balance youth vaping against any good that e-
cigarettes might do in getting adult smokers to quit tobacco
products.
Commissioner Woodcock, do you know what percentage of adult
smokers use e-cigarettes instead of traditional cigarettes?
Dr. Woodcock. No.
Ms. Porter. It is about 4.5 percent. So, we are talking
about a very small fraction of adult smokers, in general, use
e-cigarettes. And do you know of that small group of adult e-
cigarette smokers, do you know what percentage prefer menthol
or mango or if there is a blue raspberry over tobacco flavor?
Dr. Woodcock. No.
Ms. Porter. So, a study in Great Britain--we don't have the
study yet in the U.S.--found that 50 percent--56 percent of
adult vapers, people over 55, prefer tobacco. Do you know how
many kids like tobacco flavor?
Dr. Woodcock. I believe it is a very low percentage, but I
don't know the exact amount.
Ms. Porter. Yes, 1.1 percent of youth vapers. I mean, the
number of kids who like broccoli is many, many multiples of
that. So, it is really important, I think, that you have that
information as you go to do that.
The Surgeon General has said that there is zero real
evidence--scientific evidence--that proves e-cigarettes, in
general, help adults quit smoking. That is what the Surgeon
General has said.
You have testified that kids are drawn to flavored e-
cigarettes, based on the evidence, and as a mom of three
hopefully non-vaping kids, this is pretty personal for me.
The only way to protect our kids is to deny premarket
tobacco product applications for every flavored e-cigarette
other than tobacco flavor. Will you commit to doing that?
Dr. Woodcock. As I have said already, I can't prejudge the
scientific----
Ms. Porter. Reclaiming my time. Dr. Woodcock, you may not
be willing to do it. But I just want to make sure America
understands you have the authority to commit today to
preventing millions of kids from becoming addicted to vaping by
making the decision and the commitment today to us.
And if you don't make that decision today in this oversight
hearing, then the alternative is going to be years and years of
delay while Congress tries to pass a bill and millions,
millions more of kids getting addicted.
So, I appreciate--I hear you. You are not willing to make
that commitment to youth today. But I do want the American
people to understand you do have that power.
I yield back.
Mr. Krishnamoorthi. Thank you, Congresswoman Porter.
I now recognize Congressman Keller for five minutes.
Mr. Keller. Thank you, Mr. Chairman.
Youth vaping is an epidemic that puts the health of our
children at risk. Even after the Federal minimum age of the
sale of tobacco products was raised to 21 years old, and flavor
bans were enforced in 2019, in January 2020, the CDC found that
almost 20 percent of high school students vaped in the past 30
days. That is unacceptable. We need to focus on getting
disposable e-cigarettes out of the hands of our children.
While tobacco itself is not an illegal product, we must
ensure that guardrails are set in place for the overall health
and benefit of all Americans, especially those too young to
understand the danger.
These products are not subject to the same flavor guidance
as closed-system electronic nicotine delivery systems. We need
smart and targeted solutions for these problems.
So, Dr. Woodcock, I appreciate you being here today. Thank
you for that. And I just was wondering, could you give us an
update on what actions the FDA plans to take to protect the
health and safety of kids, while taking into account the mom
and pop or the small operations around the country that require
sensible regulations?
Dr. Woodcock. Well, according to the law and the court
order that we are under, by September 9 we will come to a
decision on these various applications that we have received,
and they have to meet the bar that we have been talking about
showing that, overall, having the product on the market is
appropriate to protect the health of the public, which is a
fair--fairly high bar, as we just heard.
So, we are--what we are doing is diligently working to get
through--we got applications for 6.5 million products and, of
course, some of them were from small businesses.
Now, we have given out a lot of assistance. We have a small
business assistance. We have tried to help. But under the
statute, these businesses must submit information that shows,
among other things, that their products meet this bar and are
appropriate for the protection of public health.
Mr. Keller. Great. And looking at disposable e-cigarettes,
you know, it is, clearly, a big part of the problem.
How can Congress and the FDA work together to keep our kids
safe? You know, is there something we could do to help
collaborate with the FDA? Some tools or things that we could do
to help--be helpful and work together?
Dr. Woodcock. Well, I think Congress has passed the
statute. We need to implement that statute. We are in the
process of doing that for the deemed products and, hopefully,
that will come to a conclusion very soon.
There are still--there are still problems. There are many
problems with addiction. We have the--also we have the group of
kids who are now addicted to nicotine that we probably need to
think about ways how can we assist them in recovery, getting
off of nicotine.
I think as the chairman said, there is evidence that early
exposure to various addictive products or drugs will act on the
brain in ways that may make it more difficult for these
individuals to stop those behaviors.
So, if we--if we can get to the end of this activity, in
addition, FDA hopes to get started again as the counties
become--you know, the pandemic subsides in the U.S. to
rigorously enforce the issues about sales to minors, because we
found a large number of retail outlets selling to under-age
people, even when that age was 18.
We do need to get our rule out about the T-21 that will
change the photo identity standard. So, I think there are many
additional things that can be done. But I think recovery is
something we should also think about.
Mr. Keller. Yes, absolutely. And I think we should be very
careful as we set policy forward. I know there has been a lot
of--a lot of talk across the Nation about recreational cannabis
or marijuana. I think we should be careful about that, too.
We are talking about addiction. And while we are talking
about making sure that our kids aren't exposed to this, I think
some of the policies that are being discussed by policymakers
on that front should also be taken into account, as we move
forward.
I know that is not what we are here to talk about today.
But I wanted to--addiction is a disease. It's not a character
flaw like it might have been thought about back in the 1970's,
and I think we need to be very serious and careful how we--how
we move forward on things that are, clearly, now not legal for
recreational use and I, certainly, wouldn't want to expand or I
don't think our government should be expanding those things so
that they would be available or more readily available to
people, then also potentially being able to get into the hands
of our kids.
So, I appreciate your time today.
Dr. Woodcock. Absolutely. You know, alcohol is probably one
of the worst substances and, of course, it is also widely
available as far as the toll of addiction on people.
Any substance that causes addiction--exposure is very
important, how prevalent it is, how----
Mr. Keller. I would say caffeine is probably one of the
most addictive drugs, isn't it?
Dr. Woodcock. They have got nothing on caffeine.
Mr. Krishnamoorthi. Be careful. Be careful, Mr. Keller. Be
careful.
[Laughter.]
Dr. Woodcock. Yes. They have--epidemiologists have tried
and tried, and I follow this and we have nothing on caffeine.
Mr. Keller. I know. I did read somewhere where that is,
like, the most addictive thing there is and because it is in so
many things.
But I appreciate your time. Thank you.
Mr. Krishnamoorthi. Congressman Keller, I was going to cut
your mic right about there.
[Laughter.]
Mr. Krishnamoorthi. But OK. Mr. Johnson--Congressman
Johnson, you are recognized for five minutes.
Mr. Johnson. OK. Thank you, Mr. Chairman.
Commissioner, the FDA has received over 6 million premarket
tobacco applications--tobacco product applications, or PMTAs. A
significant number of those PMTAs were submitted by vape shops,
which are required to submit a PMTA for every flavor that they
mix.
This means that a single small vape shop might have
applications for, say, 30,000 products. The multiplicity of
vape shop PMTAs are the overwhelming majority of the 6 million
PMTAs. Is that correct?
Dr. Woodcock. That is my understanding. Yes.
Mr. Johnson. And the FDA recently published the entire list
of PMTA applications, and this committee has whittled down that
list to the applicants who are most responsible for putting
these vaping products into the hands of our children.
And when you do it like that, the list of the PMTA
applicants goes down to about 44 companies, which is a much
more manageable number, which the committee will share with you
those 44 companies.
These are the pods and the disposables that are making
their way into high schools and middle schools.
Commissioner, the FDA is under court order to finish ruling
on applications by September 9th of 2021 but has signaled that
it will likely miss that deadline.
Can you commit today to ruling on all of those applications
from the 44 companies that create products that children are
most likely to use by that September 9th deadline?
Dr. Woodcock. Well, I cannot commit. I have to see the
list. I will tell you we have prioritized the--by market share
so that we have made sure that we are looking at the companies
with large market share that would have the most impact on----
Mr. Johnson. And how many of those companies have you
identified?
Dr. Woodcock. Well, I think there are only about five
companies that have the vast majority of the market share, and
then there is a very large number of small, as you said, vape
shops and other type of enterprises that constitute the rest.
Mr. Johnson. And can you name those five?
Dr. Woodcock. No. I am sorry. I can get back to you with
that information.
Mr. Johnson. Well, can you commit to ensuring that their
PMTA applications are all processed and ruled upon by the
September 9th deadline?
Dr. Woodcock. I will commit to do everything I can to make
sure that we have reviewed and finished all the high market
share company applications, because that will have the most
impact on this problem we are all mutually facing.
Mr. Johnson. Thank you. I would like to discuss further the
details of the PMTA review process. The possibility that a
company like Puff Bar might gain months of profit off children
because of a backlog at the FDA is troubling and unacceptable.
If you fail to rule on all PMTAs from the five companies
and the 44 companies with pod and disposable applications that
the committee has identified by the September deadline, will
you commit to pulling those products from the market until the
applications have been reviewed?
Dr. Woodcock. Technically, the products are currently only
marketed under enforcement discretion, and after the September
9th deadline, if they don't have an approved marketing
authorization, they are, again, only on the market under
enforcement discretion by the FDA.
Mr. Johnson. Thank you. Thank you.
JUUL dominates the prefilled pod market and its growth and
market share has driven the rise in youth vaping rates. And
yet, JUUL's PMTA application proposes lifting marketing
restrictions after just one year, even though JUUL is currently
on trial for marketing addictive and harmful products to
children.
JUUL has proven untrustworthy to continue selling its
products, and it has greatly contributed to the epidemic that
we face today.
So, Madam Secretary, how could--I mean, is the FDA
considering allowing JUUL products to be marketed again, or has
it already made a decision to ban that practice or to continue
to ban that practice?
Dr. Woodcock. Those--the products that we are reviewing
have to be subject to a marketing application. Something that
would be newly introduced into the market would have to go
through the review process, as I understand it.
Mr. Johnson. Has that happened yet?
Dr. Woodcock. Well, again, I can't discuss any single
action that we might take. But----
Mr. Johnson. All right. OK. Thank you.
Dr. Woodcock. Yes.
Mr. Johnson. If an application cannot prove with scientific
evidence that the product will not contribute to or increase
youth e-cigarette use, will you deny the PMTA application?
Dr. Woodcock. That is one bar, and it would have to have--
as the other prong of the evidence, it would have to have
extremely compelling evidence that it was uniquely positioned
to reduce people--to contribute to smoking cessation.
Mr. Krishnamoorthi. The gentleman's time has expired. Thank
you, Congressman Johnson.
I now call on Congressman Clyde for five minutes.
Mr. Clyde. I want to thank Chairman Krishnamoorthi and
Ranking Member Cloud for holding this hearing today.
This is my first hearing----
[Technical issue.]
Mr. Clyde. Are we--are we getting some feedback here?
Mr. Krishnamoorthi. Yes.
Mr. Clyde. OK. Great. Thank you.
Though this is my first hearing on vaping products, I
understand this is probably the fourth or fifth hearing in the
last couple of years on this exact same subject, and I think I
can speak for my colleagues on both sides of the aisle when I
say that no one wants children to have access to tobacco
products, including e-cigarettes and I want to thank the FDA
for cracking down on enforcement against companies who are
targeting children.
Dr. Woodcock, I understand that certain types of tobacco
products are inherently less risky than others. For example,
smokeless tobacco products are less risky than traditional
cigarettes.
Would you agree with that assessment?
Dr. Woodcock. That is the likely conclusion of scientific
evidence right now. It isn't definitive, but it is very
probable.
Mr. Clyde. OK. All right. Thank you.
Would you agree that marijuana is a more dangerous product
than tobacco?
Dr. Woodcock. I don't know that a direct comparison has
been made. I cannot answer that question.
Mr. Clyde. OK. Well, marijuana is, certainly, illegal right
now at the Federal level and tobacco is not. So, I would assume
that, based on that fact alone, that marijuana is a much more
dangerous product than tobacco.
Dr. Woodcock. Well, it depends on the tobacco. I mean,
cigarettes are the number-one cause--preventable cause of death
in the United States.
Mr. Clyde. OK.
Dr. Woodcock. So, when you take that figure into account,
the fact that marijuana, cannabis, is a Schedule I drug, it is
apples and oranges. There is a great deal of mortality and
morbidity from cigarette smoking, and that has been well
established.
Mr. Clyde. OK. Thank you.
While the health risks of tobacco is, certainly, a huge
concern for my Republican colleagues and I, I find it
interesting that all of my Democratic colleagues that were in
office last Congress voted in favor of H.R. 3884, the Marijuana
Opportunity Reinvestment and Expungement, or MORE Act of 2019,
which effectively would legalize marijuana on a Federal level,
and I think if my colleagues were truly concerned about the
youth smoking epidemic they would not have voted for the MORE
Act.
Further, I am concerned that our Chairman Krishnamoorthi
recently sent a letter to the FDA to you, Commissioner--Acting
Commissioner--asking to act to ban menthol cigarettes and e-
cigarettes, and I quote from the letter, ``The European Union
banned menthol cigarettes a year ago,'' and the very last line
of the letter says, ``If you allow menthol-flavored cigarette
sales to continue, you fail.''
That is really strong language. So, you know, this hearing
comes so soon after that letter being sent. That letter was
sent on April 21.
But I am concerned that the committee's goal of this
hearing is not to address the concern of youth vaping but to
strong arm the FDA, you, ma'am, into banning menthol cigarettes
and e-cigarettes.
So, Dr. Woodcock, is it true that the FDA is taking steps
to prevent children from using e-cigarettes?
Dr. Woodcock. Yes.
Mr. Clyde. Absolutely. Do you think that any of those steps
are hampering the adult use of e-cigarettes for those who want
to kick the habit of traditional cigarettes?
Dr. Woodcock. No.
Mr. Clyde. No. OK. All right. Great. So, we think e-
cigarettes are a safer alternative to traditional combustible
cigarettes, at least that is what the science currently says,
for those who are trying to quit smoking.
Do you believe that putting limitations on the amount of
nicotine in e-cigarette cartridges would hinder adults from
switching from the more dangerous combustible cigarettes to e-
cigarettes?
Dr. Woodcock. I don't think we have concluded our
deliberations on that particular factor.
Mr. Clyde. OK. All right. Then going back to the
decriminalizing of marijuana, with many states legalizing or
decriminalizing marijuana, what are the FDA's plans to quell
youth from participating in smoking marijuana?
Dr. Woodcock. I don't think the FDA regulates marijuana.
Mr. Clyde. So, you are not--there is no--there is no--
nothing that the FDA is doing in that regard?
Dr. Woodcock. Right now--currently, it is a Schedule I
drug.
Mr. Clyde. Right.
Dr. Woodcock. So, we would--we don't regulate it as a
medical product. For tobacco Congress passed a special law that
caused FDA to regulate tobacco products.
Mr. Clyde. OK.
Dr. Woodcock. So, generally, FDA regulates food and drugs,
medical products, devices.
Mr. Clyde. Does the FDA have any concern with the
legalization of marijuana?
Dr. Woodcock. Well, I think all in the biomedical community
are concerned about availability and managing availability of
any drugs that have the potential--you know, psychoactive drugs
and so forth. Yes.
Mr. Clyde. OK. All right.
Dr. Woodcock. And the potential impact on youth in
particular.
Mr. Clyde. Mm-hmm. I think it is a very, very dangerous
path to go down, the legalization of marijuana. So, thank you
very much.
And with that, I yield back.
Mr. Krishnamoorthi. Thank you. Thank you, Congressman
Clyde.
Now I recognize Congresswoman Bush for five minutes.
Ms. Bush. St. Louis and I thank you, Chairman, for
convening this critical hearing today. As a nurse, I know just
how important health is for our young adults, whose minds and
bodies are still growing every single day.
Vaping products by JUUL present an immediate threat to
adolescent health. Nearly two-thirds of JUUL users aged 15 to
24 don't even know that JUUL contains nicotine, which can
contribute to lung disease, heart disease, and partial brain
damage.
The FDA must take drastic steps to ban the uses of--usage
of JUUL products and minimize the negative impact on our youth.
Dr. Woodcock, Big Tobacco has a long history of twisting
science to meet its needs--its needs. I was dismayed to learn
that JUUL bought itself an entire issue of American Journal of
Health Behavior to bolster its application for FDA approval.
Twelve of the 13 papers in the Journal issue were either
written by either JUUL employees or their associates.
So, yes or no, do you agree that the FDA should take into
consideration the source of a supposedly scientific study
before giving weight to its findings?
Dr. Woodcock. FDA always takes into account the source.
Obviously, many of the studies of medical products are done by
the sponsors of the products, and there are many safeguards
that are put into place.
So, we look very carefully at validity of any data that
might be published.
Ms. Bush. So, because it was 12 of the 13 papers in one
journal, how can the FDA trust the scientific method and the
conclusions of the 12 scientists who were directly funded by
JUUL?
Dr. Woodcock. Well, I think we have many sources of
information, that only being one, and as we have been
discussing in this hearing, the statutory bar that the Congress
has put into place is a pretty high bar, and we must look at
all sources of evidence, and any evidence that is sponsored by
the company gets additional scrutiny.
Ms. Bush. OK. So, will the FDA take into consideration
these possible conflicts--like, look at it this way--these
conflicts of interest is what I call them--before giving any
weight to JUUL's scientific conclusions in their Premarket
Tobacco Product Application? Just a yes or no answer for that
one.
Dr. Woodcock. Yes.
Ms. Bush. OK. And will you consider Big Tobacco's history
of creating junk science to serve its needs while reviewing
JUUL's application, yes or no?
Dr. Woodcock. Yes.
Ms. Bush. OK. Thank you for those. Thank you. Thank you.
Thank you for that, Dr. Woodcock.
After many years of Big Tobacco lying to people about the
safety of its products, I will hope that the FDA will take
these--this cautious approach to research bought and paid for
by an e-cigarette company.
The U.S. saw a near 30 percent decline in youth vaping
rates in 2020. So, Dr. Woodcock, do you believe that additional
FDA regulations on vaping products will be effective in curbing
youth vaping rates even more?
Dr. Woodcock. I believe that we have to do something. I
mean, we can't continue with this epidemic. It is very
dangerous to children.
Ms. Bush. Yes. Yes, and that is--that was my next thing,
just the--considering the impact that these products have on
children, especially middle and high school children. Like, is
that a big part of the consideration, like, that group
specifically?
Dr. Woodcock. Absolutely. That is one of the statutory
standards that we have to look at, which is the potential for
harm, particularly children, in using these products.
Ms. Bush. Right. Well, yes, and because we know that--
because JUUL is really popular among teens--amongst teens, but
that research surveyed--the research only surveyed adult use of
its products.
And so, you know, as policymakers we must be equipped with
our current--with the current data, the accurate data about
vaping products to protect our health and the health and safety
of our--of our children.
And let me just ask, despite not having the answer to
everything that we want right now at this moment, but JUUL's
paid researchers concluded that e-cigarettes would save lives.
So, Commissioner, do you agree that the FDA should closely
evaluate these scientific claims from Big Tobacco regarding its
impact--its full impact on public health?
Dr. Woodcock. Absolutely, and I would reiterate that we
have other sources of information, including a lot of studies
we have sponsored under our programs.
Ms. Bush. OK. Thank you.
The information provided by JUUL does not meet the levels
of scientific rigor required by actual peer-reviewed studies.
So, if we don't know the potential harms of e-cigarettes, there
is not enough information available to predict their impact on
public health, especially our vulnerable youth.
But what we do know, is that e-cigarettes have hooked a
generation of young people on nicotine. The FDA has an
obligation to intervene and protect our children.
Thank you, and I yield back.
Mr. Krishnamoorthi. Thank you, Congresswoman Bush.
I would like to recognize our distinguished ranking member
of the full committee, Mr. Comer.
Mr. Comer. Thank you, Mr. Chair.
And, Dr. Woodcock, youth smoking cigarettes is at an all-
time low and their use of e-cigarettes has significantly
declined over the past couple of years as well.
Do you agree that the passage of T-21, which raised the
minimum age for tobacco purchases from 18 to 21, has
contributed to this downward trend?
Dr. Woodcock. I don't know. I would hope so. We have a lot
of data that many vape shops and other outlets continued to
sell to under-age use, even when it was at 18.
Mr. Comer. While overall youth use has declined for both
combustible and e-cigarettes, there has been an increase in
youths using flavored disposable e-cigarettes.
Other than sending warning letters to several companies
marketing flavored disposables in 2020, what has the FDA done
to prioritize clearing the market of these types of flavored
products, particularly those who have not submitted their PMTA?
Dr. Woodcock. Well, we have further actions that we can
take after a warning letter, though, to my knowledge, those
have not been taken yet.
Mr. Comer. Have you taken those actions yet?
Dr. Woodcock. No, not to my knowledge.
Mr. Comer. Prohibition didn't work for alcohol. Yet, many
of my colleagues argue that prohibition is not working for
marijuana.
Wouldn't it make more sense for the FDA to achieve the
intended health benefit by spending time and effort getting
more reduced harm nicotine products to market, and educating
smokers about the benefits of switching their nicotine source
while continuing to drive down smoking rates with education and
efforts to support total cessation?
Dr. Woodcock. Well, I believe the FDA is working in all
those areas to try and, you know, have campaign--anti-smoking
campaigns along with the CDC. Smoking is continuing to
decrease, combustible smoking, so that is very good.
We are very interested in additional smoking cessation
products, that there are quite a few of those on the market,
and other methods for recovering such as digital health methods
and so forth are under investigation.
So, hopefully, we can get addicted adult smokers off of
combustible cigarettes. That should be a goal.
Mr. Comer. OK. One of the biggest problems we face here is
not from the legitimate companies who have filed their PMTAs,
but from bad actors who are taking advantage of our current
regulations and selling vaping products containing vitamin E
acetate, found mostly in THC, not nicotine products in illicit
markets.
These illicit products have been known to cause serious
illness or death. My question, what steps is the FDA taking to
crack down on these kinds of illicit market e-cigarettes and
are imports from other countries like China playing a role in
these illicit markets?
Dr. Woodcock. Yes, and we, certainly, work with Customs and
Border Patrol. We have seized fraudulent products coming from
China, among other places. We make every attempt to keep these
from crossing our border.
We also, of course, do send warning letters, many of the
warning letters to companies who failed to submit applications.
They did then submit an application in response to that warning
letter.
Mr. Comer. That is one thing I want to remind everyone that
is paying attention to this hearing, that if they are flavored,
like the cotton candy brand and all that that has been banned,
if they are still on the market, those are illegal.
Dr. Woodcock. The----
Mr. Comer. Pods and stuff that are being sold, right?
Dr. Woodcock. Right. Right. The cartridge--the cartridge.
Yes.
Mr. Comer. The cartridge. Right.
What is the enforcement action process the FDA takes
against companies and individuals that sell illicit e-
cigarettes?
Dr. Woodcock. Well, our steps would be--these are illegally
on the market and so our steps would be a warning letter and
then potential other civil actions against them, including
injunction.
Mr. Comer. Do you know to date how many companies the FDA
has issued warnings to?
Dr. Woodcock. Yes, probably somewhere in my facts here. It
is quite a--it's a very large number of warning letters.
Mr. Comer. OK. Let me ask you this while you are--you can
get that answer to me. How many products has the FDA removed
from the market through enforcement action?
Dr. Woodcock. That I don't know. I can get back to you an
answer to that question.
Mr. Comer. OK. And I am about to run out of time, Mr.
Chairman. I have one more question.
I understand that the FDA has a very large number of
product reviews and applications which have been filed and are
subject to the September 9th deadline.
From a pragmatic standpoint, how and when might the FDA
communicate to the public and to the applicants about the
status of those products?
Dr. Woodcock. So, we have listed all the products that have
been submitted and made it through the initial, you know,
filing process and those are listed online, and they all have a
September 9th deadline under court order to be--for us to make
a marketing decision about them. Does that answer your
question?
Mr. Comer. Somewhat. I may have a followup or two, if you
don't mind, afterwards--after the hearing.
Dr. Woodcock. Certainly.
Mr. Comer. But my time has expired.
Mr. Chairman, I yield back.
Mr. Krishnamoorthi. Thank you, Mr. Comer.
And I just want to associate myself with the comments about
the enforcement actions. There is a perception and reality that
too many warning letters are sent and not enough enforcement
action is taken. So, that is something that I hope that you
will take under advisement.
Without objection, Congresswoman Wasserman Schultz shall be
permitted to join the subcommittee and participate in
questioning the witness.
Congresswoman Wasserman Schultz, you are recognized for
five minutes.
Ms. Wasserman Schultz. Thank you, Mr. Chairman. I
appreciate the opportunity to waive onto the committee today.
And Dr. Woodcock, it is a pleasure to be able to talk with
you. I know you know that youth e-cigarette usage remains at
epidemic levels, and I know I and my colleagues--many of my
colleagues here have worked hard through legislation and
repeated calls to the FDA for proactivity in science-based
policies.
In fact, my colleagues and I wrote to you on March 23
asking that the FDA end its enforcement exemptions for both
menthol and disposable e-cigarettes, and clear the market of
all flavored e-cigarettes until properly reviewed.
We also asked FDA to deny any premarket tobacco
applications for flavored e-cigarettes and deny authorizing the
marketing of any e-cigarette that poses an increased risk of
youth addiction.
I trust that we will be getting an answer and the
responsive actions are forthcoming. I certainly hope so. I look
forward to hearing back from you to that letter. I have several
questions though, concerning high nicotine content and how this
has worsened this crisis for our Nation's youth.
Dr. Woodcock, are you aware that jurisdictions like the
European Union, the U.K., and Israel capped the amount of
nicotine allowed in an e-cigarette at 20 milligrams per
milliliter?
Dr. Woodcock. Yes.
Ms. Wasserman Schultz. Do you agree that these countries
have helped reduce youth e-cigarette use by capping nicotine
levels?
Dr. Woodcock. It appears that way.
Ms. Wasserman Schultz. In the U.K., 94 percent of kids have
never vaped and only 1.8 percent of youth are using e-
cigarettes more than weekly. Because of the lower nicotine
levels, even JUUL isn't popular with kids in the UK.
In the U.S., there is no limit to nicotine levels in e-
cigarettes. JUUL has 59 milligrams per milliliter of nicotine,
three times the U.K. amount.
Yes or no, would fewer kids become addicted to e-cigarettes
if there were no e-cigarettes in the U.S. over 20 milligrams
per milliliter of nicotine?
Dr. Woodcock. Likely yes.
Ms. Wasserman Schultz. Likely yes. In reviewing PMTAs, will
you commit to considering how dangerous high-nicotine e-
cigarettes are to public health, compared to lower-nicotine e-
cigarettes?
Dr. Woodcock. That is, certainly, part of the statutory
framework. Yes.
Ms. Wasserman Schultz. OK. So, you are reviewing that?
Dr. Woodcock. Yes.
Ms. Wasserman Schultz. And the possibility exists that you
would lower the allowable level of nicotine?
Dr. Woodcock. Again, I can't comment on what actions we are
going to take. That----
Ms. Wasserman Schultz. Well, if you are reviewing the
possibility exists, presumably. The high nicotine levels in
JUUL and other e-cigarettes are leading to not just increased
youth vaping, but increased youth addiction.
Does the use of nicotine by adolescents have negative
health consequences?
Dr. Woodcock. Undoubtedly.
Ms. Wasserman Schultz. Over half of 18-to 24-year-olds who
vape never smoked cigarettes. Vaping introduced and hooked them
on nicotine. That is evidence of the products as an on ramp,
not an off ramp, to nicotine use, isn't it?
Dr. Woodcock. Yes.
Ms. Wasserman Schultz. The only reason to authorize a PMTA
for a high-nicotine tobacco product is if there is overwhelming
evidence that it is necessary for adult smokers to quit
smoking, and the product is not likely to be used by youth.
But that has not been the real-world experience of JUUL on
the market. First, adults don't use JUUL. Kids do. JUUL is the
preferred brand of just 5.6 percent of adult vapers but 41
percent of youth vapers, and while JUUL was helping to fuel an
epidemic of youth e-cigarette use, there was no discernible
decline in adult smoking rates.
Second, adult smokers don't need high-nicotine e-
cigarette--higher-nicotine e-cigarettes. In one study that JUUL
purchased, as Congresswoman Bush mentioned, they purchased it
for its PMTA.
Its researchers found that smokers transitioned away from
cigarettes to JUUL at the same rates, whether using JUUL's
three percent nicotine product or its five percent nicotine
product.
So, Dr. Woodcock, if that is true, there would be no reason
to approve their five percent product, correct?
Dr. Woodcock. The statutory requirement is that--the prong
about that it would help in some way protect the public health,
right, encouraging smokers to transition. So, there has to be
an incremental benefit there, right, in order to outweigh the
harms.
Ms. Wasserman Schultz. But, again, if researchers found
that smokers transitioned away from cigarettes to JUUL at the
same rates whether they were at three percent nicotine or five
percent nicotine in their products, then that would show that
there is no discernible difference and a lesser--a lower
nicotine level would be appropriate.
Dr. Woodcock. Those are the kind of data that need to be
evaluated. Absolutely. Yes.
Ms. Wasserman Schultz. OK. But that would seem, based on
what you just said, that--what the logical result should be. To
be clear, you should reject all of JUUL's products, all of
them, given what we know about how JUUL marketed and addicted
kids to their product.
And I encourage you to reject every PMT application for
products over 20 milligrams per milliliter. It is very clear
that there is a direct correlation to a precipitous drop in
youth vaping when you have a much lower--not 59 milliliters,
but 20, and that there is no discernible difference whether you
have a higher-nicotine product in the reduction in smoking by
adults.
So, that would seem to me, in the statutory framework that
is established by the FDA, to really result in those decisions
being made as a result of the evidence.
So, thank you, Mr. Chairman. I appreciate the indulgence. I
yield back.
Mr. Krishnamoorthi. Thank you, Congresswoman. I would like
to now recognize Congressman DeSaulnier for five minutes.
Mr. DeSaulnier. Thank you, Mr. Chairman, and thank you for
your attention to this issue and your passion for it. It is--as
you know, I feel very strongly that the actions of JUUL is
despicable.
Being from Northern California, I am proud of what we did,
both at the state level and local level, to partner with
legislators and local government around the country to really
make a significant positive impact on the public health issues
around smoking, and to see a San Francisco-based, Bay Area-
based company whose founders graduated from the School of
Design at Stanford, do what they did is, as I say, despicable,
and we shouldn't be talking about allowing them, from my view,
the ability to continue to market and distribute this product
to young people in particular, but we should be personally
holding them accountable.
But, Commissioner, in 2018, the Surgeon General declared a
youth vaping epidemic, 2018. Youth vaping rates in 2020 were
the same as in 2018. As we know--and we know what started it.
Between 2017 and 2018, the number of high school vapers doubled
from 12 percent to 29 percent. In the same period, JUUL's
market share grew from 29 percent to 76 percent.
In November 2018, the Center for Disease Control confirmed
the obvious, pointing to JUUL as the cause of this surge. Even
after taking away all of its flavors, except menthol and
tobacco, over a million children are still using JUUL, still
getting addicted to JUUL and a lifetime consequence of that.
It is still the most popular youth vaping brand, used by 40
percent--41 percent of youth vapers, and research shows that
many of these young people are unaware of the danger that they
are exposing themselves to.
So, Commissioner, do you agree that by the metrics I have
just mentioned we are still experiencing a youth vaping
epidemic?
Dr. Woodcock. Yes.
Mr. DeSaulnier. Do you agree that JUUL is the e-cigarette
company most responsible for creating this epidemic?
Dr. Woodcock. That is how it would appear.
Mr. DeSaulnier. In ruling on premarket tobacco product
applications, will you commit to considering past bad acts in
marketing to children and popularity with children when you go
through your decisionmaking process?
Dr. Woodcock. We have to adhere to the criteria laid out in
the legislation that Congress passed and we will do that. If
you are talking about the validity of data that is submitted to
us, we take a very close look at the validity of the data.
Mr. DeSaulnier. I appreciate that. If there are changes to
the statute that you think would help you to enforce the spirit
of the legislation, I would--I would greatly appreciate
communicating with you.
Do you agree that a nicotine product used by 41 percent of
youth vapers is hurting the overall public health for
generations to come?
Dr. Woodcock. Most likely it is hurting that generation. I
can't comment on generations to come, but it is definitely a
public health problem of significance.
Mr. DeSaulnier. Thank you, Doctor.
Do you trust the tobacco--the Tobacco Products Scientific
Advisory Committee and their advice?
Dr. Woodcock. Which--which advisory----
Mr. DeSaulnier. The Tobacco Products Scientific Advisory
Committee.
Dr. Woodcock. This is the FDA committee or----
Mr. DeSaulnier. Yes.
Dr. Woodcock. Likely I do. I am not familiar with this
committee. I am sorry. I'm kind of new to my job.
Mr. DeSaulnier. OK. I am happy to provide for the record
more information on that.
Dr. Woodcock. Certainly.
Mr. DeSaulnier. Madam Commissioner, I appreciate your
responsiveness and your succinctness.
JUUL hooked a nation of children in the light of day, but
it is asking the FDA to approve its product under shield of
darkness. This subcommittee has repeatedly asked JUUL for its
PMTA and JUUL has refused to provide it. JUUL knows the junk
science it has bought and paid for cannot withstand scrutiny.
If JUUL's PMTA was referred to the Tobacco Products
Scientific Advisory Committee, the application would be subject
to public scrutiny.
Do you have any comments on this, or on the trial in North
Carolina, if you are familiar with it, against JUUL for
creating a nicotine product for children?
The judge has already entered in a partial summary judgment
against JUUL and is instructing the jury that as a matter of
law, all of JUUL's social media posts or youth-oriented, quote/
unquote, ``evidence from that trial will be relevant to your
jury duty.''
Will you commit to gathering all documents from that case,
including expert reports?
Dr. Woodcock. Certainly. I think we should look at all
documents. But I can't comment, obviously, on any ongoing case.
Mr. DeSaulnier. Thank you, Commissioner. My time is up. I
yield back and I want to thank the chair again.
Mr. Krishnamoorthi. Hey, thank you so much, Congressman.
And now I would like to recognize Congresswoman Speier for
five minutes.
Ms. Speier. Mr. Chairman, thank you.
And Dr. Woodcock, great to see you, and in your role as
Acting Commissioner, you really were not involved in the
regulatory process before January 2021. So, I appreciate that.
But I am deeply concerned that this scandal that has been
promoted under a previous administration is going to, you know,
scar the lives of these children for the rest of their lives,
and all you hear about now are these double lung transplants on
13-and 14-year-olds and it's--you know, it takes my breath
away.
So, a Federal judge has ordered the FDA to speed up
regulations, ruling that the FDA has abdicated its regulatory
authority. Would you agree that he--that he was correct in that
regard?
Dr. Woodcock. As you said, I was not involved in these
previous discussions. But, currently, I am committed to getting
this done, if possible by the--by the date set by the court.
Ms. Speier. So, the previous administration at one point
said they were going to ban fruit flavors and then they
reversed themselves, and as a result, menthol JUUL pods were
increased by, like, a thousand percent among high school
students.
Was it a mistake to exempt disposables?
Dr. Woodcock. Yes, I wasn't involved in that decision at
all. You missed my oral testimony that----
Ms. Speier. Yes, I did. I was in a House Armed Services
Committee. I apologize.
Dr. Woodcock. That is, certainly, important. I was--I was
the instigator of the original Sottera lawsuit against the
original vapers on drug charges very early in 2000. That was
settled that--that we couldn't take drug charges because these
are tobacco products.
But so the subsequent actions after that from 2010 on I was
not involved in. And so, I mean, certainly, in retrospect it
seems, OK, the children switched over to disposables, right,
and although youth vaping has decreased in the past year, it
might be multi-factorial.
But there was, certainly, continued youth using of these
products at really unacceptable levels.
Ms. Speier. So, it appears that there are some companies
now that are just, basically, ignoring the requirements, Puff
Bar being one of them. Are you--based on their prior conduct,
are you prepared to reject their application?
Dr. Woodcock. Yes, I can't comment on individual----
Ms. Speier. How about this? If there are bad actors who
have previously shown that their conduct is violative or is
thumbing its nose to the government regulation, would that be
taken into account with their application?
Dr. Woodcock. It would be--it would definitely be taken
into account. Yes.
Ms. Speier. All right. Thank you.
You know, one of the biggest concerns is that these young
people don't appreciate there is nicotine in these e-
cigarettes. Do you think we need to improve the labeling
requirements for e-cigarettes, or should we just ban them
outright?
Dr. Woodcock. I think most likely we should make sure that
people are aware that--of the nicotine content. That would be
an extremely important thing to do.
As we discussed earlier, I really think we are going to
have to focus on recovery for teens, too, to get them off their
nicotine addiction. I don't know that the healthcare community
is well aware of how--what ways might work for youth who are
addicted to nicotine but not to cigarettes.
Ms. Speier. The amount of nicotine in an e-cigarette is--is
it 12 milligrams? Is that what I read somewhere?
Dr. Woodcock. There are various--there is various content
depending on----
Ms. Speier. So, how does that compare to a cigarette in
terms of the amount of nicotine?
Dr. Woodcock. I think there are some vaping products that
have extremely high content within them, up to maybe a whole
pack of cigarettes.
They wouldn't get that in one draw, but you--but they are
very high and I have heard from families whose children have
had very serious experiences after using these very high
nicotine products.
Ms. Speier. That is alarming. Thank you. I yield back.
Mr. Krishnamoorthi. Thank you. I just have one last
question.
Will you admit that the--or acknowledge that the flavor ban
exemptions that were created were just a fundamentally flawed
policy?
Dr. Woodcock. It would appear to have unintended
consequences that were very negative. Yes.
Mr. Krishnamoorthi. Negative consequences? So, you admit or
acknowledge, I should say--I mean, you were not the Acting
Commissioner at that point. But those flavor ban exemptions had
very negative consequences.
Dr. Woodcock. Correct.
Mr. Krishnamoorthi. Mr. Cloud, do you have one more
question?
Mr. Cloud. I can submit it for the record. Yes.
Mr. Krishnamoorthi. Well, thank you very much for your
testimony, and it was a marathon session and I really
appreciate your time.
Thank you again.
Dr. Woodcock. Thank you.
Mr. Krishnamoorthi. We are adjourned.
[Whereupon, at 10:50 a.m., the subcommittee was adjourned.]
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