[Senate Hearing 118-670]
[From the U.S. Government Publishing Office]
______
S. Hrg. 118-670
COMBATTING THE YOUTH VAPING
EPIDEMIC BY ENHANCING ENFORCEMENT
AGAINST ILLEGAL E-CIGARETTES
=======================================================================
HEARING
before the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
__________
JUNE 12, 2024
__________
Serial No. J-118-69
__________
Printed for the use of the Committee on the Judiciary
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
www.judiciary.senate.gov
www.govinfo.gov
U.S. GOVERNMENT PUBLISHING OFFICE
50-512 WASHINGTON : 2025
COMMITTEE ON THE JUDICIARY
RICHARD J. DURBIN, Illinois, Chair
SHELDON WHITEHOUSE, Rhode Island LINDSEY O. GRAHAM, South Carolina,
AMY KLOBUCHAR, Minnesota Ranking Member
CHRISTOPHER A. COONS, Delaware CHARLES E. GRASSLEY, Iowa
RICHARD BLUMENTHAL, Connecticut JOHN CORNYN, Texas
MAZIE K. HIRONO, Hawaii MICHAEL S. LEE, Utah
CORY A. BOOKER, New Jersey TED CRUZ, Texas
ALEX PADILLA, California JOSH HAWLEY, Missouri
JON OSSOFF, Georgia TOM COTTON, Arkansas
PETER WELCH, Vermont JOHN KENNEDY, Louisiana
LAPHONZA BUTLER, California THOM TILLIS, North Carolina
MARSHA BLACKBURN, Tennessee
Joseph Zogby, Chief Counsel and Staff Director
Katherine Nikas, Republican Chief Counsel and Staff Director
C O N T E N T S
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OPENING STATEMENTS
Page
Durbin, Hon. Richard J........................................... 1
Tillis, Hon. Thom................................................ 3
WITNESSES
Abboud, Tony..................................................... 28
Prepared statement........................................... 42
Responses to written questions............................... 76
King, Brian A.................................................... 5
Prepared statement........................................... 45
Responses to written questions............................... 82
Rao, Arun G...................................................... 6
Prepared statement........................................... 53
Responses to written questions............................... 111
Richardson, Yolonda.............................................. 25
Prepared statement........................................... 58
Responses to written questions............................... 125
Shapiro, Josephine............................................... 31
Prepared statement........................................... 67
Spross, David.................................................... 26
Prepared statement........................................... 69
Responses to written questions............................... 128
Walley, Susan.................................................... 30
Prepared statement........................................... 72
Responses to written questions............................... 143
APPENDIX
Items submitted for the record................................... 41
COMBATTING THE YOUTH VAPING EPIDEMIC
BY ENHANCING ENFORCEMENT
AGAINST ILLEGAL E-CIGARETTES
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WEDNESDAY, JUNE 12, 2024
United States Senate,
Committee on the Judiciary,
Washington, DC.
The Committee met, pursuant to notice at 10 a.m., in Room
106, Dirksen Senate Office Building, Hon. Richard J. Durbin,
Chair of the Committee, presiding.
Present: Senators Durbin [presiding], Blumenthal, Booker,
Ossoff, Cornyn, Lee, Hawley, Tillis, and Blackburn.
OPENING STATEMENT OF HON. RICHARD J. DURBIN,
A U.S. SENATOR FROM THE STATE OF ILLINOIS
Chair Durbin. This hearing of the Senate Judiciary
Committee will come to order. Today the Committee will hear
from witnesses about the alarming level of youth e-cigarette
use, and examine how federal agencies have failed to enforce
the law designed to protect our children from a lifetime of
nicotine addiction. Let's turn to a video that shines light on
just how addictive these e-cigarettes are to children and why
today's hearing is so timely.
[Video is shown.]
Chair Durbin. Cigarettes are responsible for more than
480,000 deaths per year. These deaths touch virtually every
family in this country, including my own. This hearing is part
of my continued effort in Congress to stop these needless
deaths, particularly the addiction of children. We have made
progress and the tobacco giants have fought back. That's why
we're here today.
In the year 2000, 28 percent of high school students smoked
cigarettes. Thanks to the efforts of Congress and the public
health community, that number has declined to only 2 percent.
From 28 percent to 2 percent, of high school students today.
But anyone who thought Big Tobacco would accept this trend
and dissipate like a cloud of smoke was mistaken. Instead, they
rebranded and introduced new products known as e-cigarettes,
and they followed the same playbook. The exact same playbook
they successfully used to drive sales of Marlboro and Camel
cigarettes in the earlier years; target kids.
Thanks to the addictive nature of nicotine, these companies
knew, they've known a long time, if they could just hook a
child at a young age, they had a customer for life. It started
with JUUL, backed by $13 billion from tobacco giant, Altria, in
a partnership which the American Heart Association has
characterized as a match made in tobacco heaven. I would say
tobacco hell.
The company introduced flashy devices, kid-friendly
flavors, and advertisements featuring young, attractive people
that that unleashed a wave of nicotine addiction that then FDA
Commissioner Scott Gottlieb described in 2018 as an epidemic
with more than 5 million teens reported that they were using e-
cigarettes.
The FDA and the Justice Department has the tools to prevent
this epidemic. They have failed to use them. The Family Smoking
Prevention and Tobacco Control Act requires e-cigarette
companies to get FDA authorization before, before bringing
products to market. Authorization can only be granted if the
companies making the product first prove that their products
are, ``appropriate for the protection of public health.''
But for years, under both Democratic and Republican
administrations, FDA ignored its responsibility until public
health groups actually had to sue the agency to force it to do
its job and protect our kids. In that court case, the U.S.
District Court in Maryland found that the FDA was in fact
violating the Tobacco Control Act and ordered the agency to
complete its review of e-cigarette applications by September 9,
2021.
That was 33 months ago. Almost 3 years, FDA still has not
completed its review. Almost 3 years later, still has not
completed its review. After the court-ordered deadline passed
on September 9, 2021, FDA could have ordered every single
unauthorized e-cigarette off the market.
And that's what it should have done, and as the law clearly
intends. Instead, thousands of unauthorized e-cigarettes
flooded the markets. Flavors like: blue razz ice, strawberry
watermelon, bubblegum, and cotton candy designed and
effectively addicting millions of children in America.
Let me be clear, despite claims from Big Tobacco, there is
zero evidence that e-cigarettes and their fruity flavors are
targeted at adults. None, no evidence. In fact, the rate of e-
cigarette use is nearly twice as high for middle and high
school students as it is for adults.
Today, I'm releasing the findings from an NIH-funded
monitoring the future study, one of the country's preeminent
public health surveys. The researchers there estimate that 2.1
million children have picked up vaping since the Food and Drug
Administration missed its September 2021, court-imposed
deadline. 2.1 million new children addicted, and that's where
the Justice Department is supposed to step in.
FDA relies on Department of Justice to bring enforcement
actions for violations of the law. Sadly, the Justice
Department seems to have followed FDA's lead and has failed to
effectively crack down on illegal e-cigarettes.
To date, only 23--remember that number, 23--e-cigarette
brands have been authorized for sale in the United States. Yet,
there are more than 6,000 e-cigarette brands on the market
today. A trip to any gas station in America, convenience store,
or vape shop makes the scope of this illegal market clear.
I simply do not understand how the Food and Drug
Administration and our Department of Justice have permitted
thousands, thousands of products to remain on store shelves
when their manufacturers have not received authorization, or in
some cases even filed an application.
While these two agencies sit on their hands, during both
the Trump and Biden administrations, e-cigarette companies
addicted a new generation of children to nicotine, erasing the
hard work so many of us undertook to convince kids not to smoke
tobacco cigarettes and ultimately save their lives.
I'd like to thank Ranking Member Graham for working with me
on organizing the hearing. Unfortunately, he cannot be with us
today, but Senator Tillis of North Carolina will be serving as
a Ranking Member in his place. I now turn to Senator Tillis for
opening remarks.
OPENING STATEMENT OF HON. THOM TILLIS,
A U.S. SENATOR FROM THE STATE OF NORTH CAROLINA
Senator Tillis. Chairman Durbin, thank you for holding this
hearing. We're talking about a serious issue that impacts the
youth of our Nation, but it also threatens the legal tobacco
industry.
When the FDA banned legitimate flavored vapes, it opened
the doors to cheap Chinese knockoffs that flooded the market.
And even though these imported vapes are mostly illegal,
there's been little done in the way of enforcement. There's
been a 1,500 percent, a 15-time increase in kid-friendly
flavors sold from 2020 to 2023.
Among youth who reported e-cigarette use, more than 25
percent of them used it daily, and over \1/3\ used it at least
20 days a month. It's also worth noting that tobacco is my
State's oldest industry. North Carolina leads the country in
tobacco farming and manufacturing supporting over 27,000 jobs
in the State.
Nobody wants kids and teenagers using e-cigarettes,
especially illegal and counterfeit products that are being
dumped in the U.S. by China's State-controlled tobacco
monopoly, which is why I voted in favor of raising the age to
purchase tobacco products to 21.
While youth e-cigarette use has decreased by 60 percent
since 2019, the peak of 5.3 million according to the National
Youth Tobacco Survey, FDA's lack of guidance, lack of
transparency, and lack of enforcement has allowed the CCP and
organized crime to flood the U.S. with dangerous illicit vapes.
FDA's refusal to follow Congressional intent and implement
the Tobacco Control Act has led to disastrous consequences for
public health and American jobs. Now, conveniently, 2 days
before this hearing, the FDA has announced an inter-agency task
force to tackle this issue that has plagued our country for
years.
This thinly veiled political stunt comes 2\1/2\ years after
the Reagan-Udall Foundation report was released. With this very
recommendation, if the timing of the task force formation
wasn't evidence enough of how unserious the FDA is about
tackling the flood of illicit e-cigarettes in the U.S., FDA's
exclusion of CBP from the task force makes it crystal clear.
The FDA cannot create a functioning market of regulated
tobacco products through fines and warning letters alone. The
FDA must create a consistent, transparent, science-based review
process for reviewing applications for new tobacco products.
FDA's current process is broken. The FDA has currently
560,000 pending applications, including more than 557,000 for
e-cigarettes. To date, the FDA has only approved 1,000th of 1
percent of all e-cigarette applications that is received. In
fact, it's been more than 2 years since the FDA authorized a
new product, and the Center for Tobacco Products has never
authorized a new e-cigarette product under director King's
leadership.
The result of FDA's de facto ban on regulated, reduced-risk
alternatives for adult smokers is exactly what has caused the
convening of this Committee today; the youth vaping epidemic
and the lack of enforcement against illegal cigarettes.
Furthermore, it's worth mentioning today that there is also
a plague of illicit counterfeit THC vape products entering the
U.S. Much of this is related to Chinese imports, and many of
the health problems often associated with vaping actually stems
from fake, dirty THC vapes that contain dangerous additives.
We now see the Eastern Band of the Cherokee has decided to
start selling THC-based products in Western North Carolina
because they're within their sovereign territory. I have no
doubt that they are probably putting something on the shelf
that people think are safe, that are THC-based products, that
the behavioral health profession says is becoming one of the
leading causes of psychotic events, these supposedly legal
products that you could buy in North Carolina where THC
products are not technically allowed.
So I look forward to a robust conversation today, and maybe
we can get to a point to where we can bend the curve and hold
anyone out to dry, quite frankly, if we find evidence that they
are marketing to our Nation's youth. This is a major public
health threat. It's a major threat that I think is being
perpetrated, in large part, by China, and Mr. Chair, I
appreciate you convening the hearing today so that we can air
it.
Chair Durbin. Thank you, Senator Tillis. I'm glad that we
have a bipartisan motivation to meet today and get to the
bottom of this. Today's hearing includes two panels of
witnesses. Before I introduce the first panel, let me briefly
lay out the mechanics.
After I introduce and swear in the first panel, each will
have 5 minutes to provide opening statements. Then there's a
round of questions from the Senators. Each Senator will have 5
minutes. I ask them to please remain as close as possible to
their allotted time. Then, we'll turn to second panel. After I
introduce and swear them in, they'll each have 5 minutes
themselves.
I'll introduce the first panel. Now, on the first panel, we
will hear from Dr. Brian King, who serves as director of the
Center for Tobacco Products at the Food and Drug
Administration, and Arun Rao, who serves as deputy assistant
attorney general of the Consumer Protection Branch in the Civil
Division of the U.S. Department of Justice. Could the witnesses
please stand to be sworn in? Please raise your right hand.
[Witnesses are sworn in.]
Chair Durbin. Let the record reflect that both of the
witnesses have answered in the affirmative. I now give you an
opportunity for an opening statement. Dr. King, please proceed.
STATEMENT OF BRIAN KING, PHD, MPH, DIRECTOR, CENTER FOR TOBACCO
PRODUCTS, U.S. FOOD AND DRUG ADMINISTRATION, SILVER SPRING,
MARYLAND
Dr. King. Chair Durbin, Ranking Member Tillis, and Members
of the Committee, thanks for the opportunity to discuss FDA's
efforts to address unauthorized e-cigarettes. This morning, I'd
like to provide an update on how FDA is working in
collaboration with our federal partners on this critically
important public health issue.
Now, the bad news is that e-cigarettes have been the most
commonly used tobacco product among our Nation's youth since
2014, but the good news is that there's been more than a 60
percent decline in the number of middle and high school
students using e-cigarettes over the past 5 years, including
580,000 fewer high school students in 2023 alone.
But despite this progress, more work is definitely needed.
And for FDA's part, we're employing a comprehensive enforcement
approach in addition to other activities.
Chair Durbin. Dr. King, could you bring the microphone just
a little closer?
Dr. King. Is that better?
Chair Durbin. Yes. Thank you.
Dr. King. And I want to reinforce that we cannot do this
alone. An all-of-Government approach across the supply chain is
critical. With that goal in mind, FDA has been actively working
with colleagues across the Federal Government, including the
Department of Justice, Customs and Border Protection, the
Federal Trade Commission, and the U.S. Postal Inspection
Service.
And for FDA's part, I'd like to highlight some important
actions that we've taken to address unauthorized e-cigarettes.
At the manufacturer and distributor level, we've conducted
thousands of inspections resulting in nearly 900 warning
letters, and at the retailer level, we've issued over 550
warning letters.
Many recipients heed warning letters and take corrective
actions. But if they don't, we can escalate, and we've made
important strides in this space, including several first-of-
their-kind actions over the past 2 years.
For example, we've built cases to support the first
injunctions against e-cigarette manufacturers and distributors
in coordination with DOJ, which now number 8 complaints filed.
We've conducted the first seizure of an e-cigarette distributor
in coordination with DOJ and the U.S. Marshal service. We've
issued the first civil money penalties against e-cigarette
manufacturers, which now number nearly 60.
And at the retailer level, we've issued the first civil
money penalties for sales of illegal e-cigarettes, which now
number more than 100. And on imports, we participated in a
landmark joint operation with Customs and Border Protection
resulting in the seizure of more than $18 million worth of
unauthorized e-cigarettes.
And this work is in addition to our robust program to
prevent underage sales, for which we've conducted nearly 1.5
million inspections resulting in 138,000 warning letters,
33,000 civil money penalties, and 200 no-tobacco-sale orders
for a variety of tobacco products.
Now, I want to assure you that FDA is committed to taking
more of these escalated enforcement actions in conjunction with
our federal partners. But the road to get there is complicated
by several factors. FDA has received nearly 27 million pre-
market applications for e-cigarettes, which we are required by
law to review.
This combined with the rapidly evolving tobacco product
landscape presents an unprecedented time and resource challenge
that no other center at FDA has ever faced. There's also an
inequity in resources. We are a 100 percent funded by user
fees, which have not been updated to reflect the realities of
the tobacco product marketplace. We need Congress's support to
address this inequity, which we've included in the agency's
Fiscal Year 2025 budget proposal.
First, we seek authorization for FDA to collect user fees
from e-cigarette manufacturers, all of whom are currently
paying no fees, to increase the current collections by $114
million to account for the increased workload, and to index all
future collections for inflation.
Second, we seek to extend the agile hiring authorities of
the 21st Century's Cures Act to our center, to improve our
ability to recruit, to hire, and to retain personnel. We're the
only FDA center without such authority.
So in conclusion, FDA has taken important strides to
address unauthorized e-cigarettes, especially recently, but we
acknowledge there's more to do. And guided by our new 5-year
strategic plan, I'm confident that with Congressional support,
our critical all-of-Government approach will help us to achieve
our shared goals of removing unauthorized e-cigarettes from the
marketplace. And critically importantly, keeping these products
out of the hands of our Nation's youth.
We stand ready to partner with our federal colleagues,
including Congress, to explore additional opportunities to
optimize that enforcement, including the ability to better
identify and prevent the importation of unauthorized tobacco
products.
Thank you, and I look forward to answering your questions.
[The prepared statement of Dr. King appears as a submission
for the record.]
Chair Durbin. Thank you, Dr. King.
Mr. Rao.
STATEMENT OF ARUN RAO, DEPUTY ASSISTANT ATTORNEY GENERAL,
CONSUMER PROTECTION BRANCH, CIVIL DIVISION, UNITED STATES
DEPARTMENT OF JUSTICE, WASHINGTON, DC
Mr. Rao. Good morning, Chair Durbin, Senator Tillis, and
Members of the Committee.
Chair Durbin. Pull the microphone as close as you can.
Mr. Rao. Certainly. Is that better?
Chair Durbin. Yes. Thank you.
Mr. Rao. My name is Arun Rao, and I am the deputy assistant
attorney general for the Civil Division's Consumer Protection
Branch.
There is an urgent need to combat the illegal distribution
and sale of unauthorized electronic nicotine delivery systems,
or e-cigarettes, and I appreciate the opportunity to appear
before you today.
Safeguarding the well-being of our Nation's youth is a
paramount concern for the Department, especially in this area.
Illegal e-cigarettes are a significant public health risk to
Americans. They contribute to addiction and health issues, and
they pose a dire threat to youth who are often the primary
targets of aggressive marketing campaigns.
As you are aware, illegal e-cigarettes have flooded our
Nation. Many of these products originated from abroad, and in
particular from China. Tens of millions of e-cigarette
applications have been filed with FDA for authorization. Many
manufacturers have exploited the pre-market authorization
process.
For example, some have tried to evade FDA denial orders by
making minimal alterations to previously denied products, and
then filing another application with FDA. Some overseas
manufacturers routinely mis-declare shipments at port of entry
to evade import alerts, and retailers across the country
continue to manufacture their own products in individual
stores.
Taken together, these factors have made illegal e-
cigarettes all too accessible, allowing young people to obtain
them at brick-and-mortar retailers across the country and
online.
The Justice Department performs an important role in
supporting the FDA's efforts to ensure that illegal e-
cigarettes stay off the market. When manufacturers challenge
FDA orders denying their marketing applications, the civil
division defends the FDA's decisions in court. We've defended
the FDA in over 80 legal challenges filed by manufacturers.
While many of those matters have yet to be decided, we have
prevailed in more than a dozen cases, including in unanimous
decisions in seven courts of appeal. In a case in which we have
received a significant adverse decision in the Fifth Circuit,
the Department is seeking review from the Supreme Court.
The Department also plays an important role in enforcing
the Tobacco Control Act. For example, the FDA has pursued
monetary penalties against over 55 manufacturers and 100
retailers, and has sent warning letters to hundreds more.
Although the Department cannot impose penalties itself, we are
prepared to assist the FDA in collection actions to ensure
compliance. Additionally, we have partnered with the FDA in
significant enforcement actions. This includes the first
domestic seizure of unauthorized e-cigarettes, which included
more than 45,000 illegal e-cigarettes.
We also have the authority to bring civil injunction
actions in matters referred to the Department by the FDA. These
actions do not allow us to recover monetary penalties, limiting
their deterrent effect in some circumstances, but they are an
important tool. In appropriate cases, the Department has
secured injunctions against six entities, continues to litigate
against another, and just yesterday, filed a proposed consent
decree in our most recent case. We stand ready to act on
additional referrals in consultation with the FDA.
We recognize that illegal distribution and sale of e-
cigarettes is a complex and evolving problem that poses a grave
threat to public health and safety. It demands urgency. While
some progress has been made, there is still much work ahead of
us. That is why earlier this week, the Department and FDA
announced the creation of a multi-agency task force with the
sole purpose of addressing the threat posed by the sale of
illegal e-cigarettes.
The task force combines the expertise of multiple law
enforcement partners, including ATF, the U.S. Postal Inspection
Service, the U.S. Marshal Service, U.S. Customs and Border
Protection, as well as the Federal Trade Commission, to help
combat this problem through comprehensive enforcement
strategies, from seizing unlawful products to pursuing criminal
investigations and prosecutions under the Prevent All Cigarette
Trafficking Act, or the PACT Act.
We will use every tool available to bolster our efforts to
halt the illegal sale of unauthorized e-cigarettes. We also
stand ready to work with Congress in its legislative efforts,
to address this important issue. Congress has an important role
to play to ensure that the Department and FDA are able to
effectively pursue critical enforcement actions.
In closing, I want to express my gratitude for the
opportunity to testify. I am confident that working together,
we will make additional progress in the fight against the
illegal sale of unauthorized e-cigarettes, and will safeguard
the well-being of all Americans, and especially, our youth.
Thank you.
[The prepared statement of Mr. Rao appears as a submission
for the record.]
Chair Durbin. Thanks, Mr. Rao.
I'll ask a few questions. I'm going to make a statement,
which I hope you'll both listen to carefully. Under the Tobacco
Control Act, a manufacturer has the burden of proving to the
FDA, that its e-cigarette is, ``appropriate for the protection
of the public health,'' before it can enter the market.
In other words, unless the manufacturer meets its burden
and the FDA authorizes the product, it is illegal for that e-
cigarette to be sold in the United States. Dr. King, Mr. Rao,
is everything I've said so far accurate?
Dr. King. Yes, correct.
Mr. Rao. Yes.
Chair Durbin. To date, the FDA has authorized 23 e-
cigarette brands and no flavored cigarettes have been
authorized by the FDA.
[Poster is displayed.]
Chair Durbin. Take a look at this photo. It was taken by my
staff just a few days ago at a vape shop less than one mile
removed from the FDA's headquarters. It shows: Fat Boys Red
Bull Strawberry Vape, and VIHO Dragon Fruit Watermelon Vapes.
Right here is this so-called Elf Bar Watermelon Bubblegum Vape
purchased from that store, less than one mile away from the FDA
headquarters.
[Holds up vape product.]
Not a single one of these products has been authorized by
the FDA. None of them. These illegal products, clearly designed
for kids by their flavors, are being sold in FDA's shadow of
their building headquarters [points at poster and holds up vape
products]. Less than a mile from your headquarters. How is that
allowed to happen, Dr. King?
Dr. King. I'll reinforce that we do have a pre-market
paradigm for reviewing applications, and the sheer volume of
those applications, and the volume of the market, requires us
to prioritize our enforcement efforts.
Chair Durbin. That's what I really want to get to here. So
you're saying that if they're burden of proof on the
manufacturer under the law, they have to prove appropriate for
public health before they will be approved by the FDA? That
proof is not made, and yet these products are for going for
sale.
[Points at poster.]
You've completely fallen down on the job. Your
responsibility is to impose the burden of proof and not allow
the sale of these e-vape cigarettes to kids unless they're
approved by the FDA. Correct?
Dr. King. Correct.
Chair Durbin. So, let's hear the answer. Why are you doing
this.
Dr. King. I'll reinforce that the sheer volume of this
product landscape requires time to ensure that we conduct
scientifically defensible and legally defensible reviews of the
27 million applications.
Chair Durbin. It's not your burden, it's their burden. They
have to prove they're appropriate for public health. You don't
have to disprove it.
Dr. King. I'll reinforce that the applications are
substantial, and we have hundreds of scientists that are
working on a daily basis to review these applications. And
we've made good progress. We're 99 percent----
Chair Durbin. So, if I make a filing, if I file legal
briefs thick enough, I can go ahead and sell my product without
approval?
Dr. King. No, that's not accurate. But we want to make sure
we review the science that's submitted. And so there are some
applications that don't meet the initial bar. There are three
phases of review, and we can remove those applications earlier
if they don't have the necessary information. But if they
provide enough science for us to do a substantial review, we
have to take the time to scientifically review them. And that
does take time.
Chair Durbin. Mr. Rao, are these tobacco company lawyers
beating you to death to the point where you don't enforce the
law as it is written and I described it? Please use your
microphone.
Mr. Rao. Senator, this is obviously a very litigious
environment. We have been actively defending the FDA in courts
of appeal in district courts across the country----
Chair Durbin. Thirty three months. Thirty three months
since the Maryland court said you are required through the FDA
to get your job done, and nothing has happened. You call this
an urgent need. What is urgent about waiting almost 3 years and
doing nothing?
Mr. Rao. Senator, we share your concerns with respect to
the widespread prevalence of these illegal products, and we
take seriously our obligations to enforce aggressively in this
space.
Chair Durbin. I assume you're an attorney, are you not?
Mr. Rao. That's correct.
Chair Durbin. What does it mean when we say burden of
proof?
Mr. Rao. What needs to be established in a court.
Chair Durbin. Who has the responsibility of approving the
safety of this product now under American law?
Mr. Rao. In this case, it would be the manufacturers.
Chairman Durbin. Have they proven it with all these?
[Points at poster.]
Mr. Rao. I do not believe that's the case, no, they have
not.
Chair Durbin. So, what should we do as a Nation to say to
them you cannot in this situation openly defy the law and the
agencies, and sell your product anyway to children? What is it
we should do to stop them?
Mr. Rao. Senator, I think we should signal aggressive and--
aggressive enforcement in this space is a priority across the
executive branch. I think we should send that signal. I
appreciate the opportunity to lift up----
Chair Durbin. I'm sorry. I'm sorry. I'm against signals. Do
something. To announce 7 days before this hearing that you're
going to have real law enforcement and now get involved in
this. What in the hell have you been waiting for?
Mr. Rao. Senator, we have been acting on a number of
fronts. There's been the civil monetary penalty actions that
Dr. King referred to earlier, and the Department stands ready
to assist in collection actions in those matters. We have been
working with the U.S. Marshal Service and the FDA on seizures--
--
Chair Durbin. You're failing. You're failing. Within a mile
of the FDA headquarters is evidence that you're failing. What's
serious about this is not only the failure of the attorneys,
but the failure that is leading to addiction of children.
Mr. Rao. Senator, this is a multi-pronged approach, is
what's going to be required in this case. And again, that's why
we're working with multiple law enforcement partners, not just
the FDA, but also the Bureau of Alcohol, Tobacco and Firearms,
U.S. Postal Inspection Service.
We have had ongoing engagement with those agencies, looking
at potential additional enforcement actions, both criminal and
civil, that we can take using other authorities. And we are
optimistic that working with these partners, we're going to be
able to make progress.
Chair Durbin. Well, it's been quite a few years since I
finished my law school courses, but I do believe I understand
burden of proof. They have the burden of proof. They have
failed to meet it and sell their product regardless.
Our Government, Department of Justice, and FDA, standby and
say this is too complicated. It's not complicated. It's basic.
If they have the burden of proof and haven't met that. They're
violating the law. Correct?
Mr. Rao. Correct.
Chair Durbin. Enough said. Senator Tillis.
Senator Tillis. Mr. Rao, I'm not an attorney so I have a
habit of asking questions I don't know the answer to. And this
is one that I'm curious. If you take a look at the shelves that
are full there, [refers to poster.] you could leave this
hearing or you could view this hearing through a lens of
attacking Big Tobacco, and taking advantage of the youth
population, and try to get them addicted to nicotine. But it
seems to me that a lot of these products that were up there are
not being dumped on the market by Big Tobacco. Am I wrong?
Mr. Rao. Senator, there are a number of players in the
market, not just the large tobacco----
Senator Tillis. Let me just ask. We never totally solve
problems here. That's why we've been coming back every, you
know, every year for several hundred years to try and get
things right in this country. But if you really wanted to take
a big chunk out of the danger that our youth faces today, would
it be double down on Big Tobacco or in this?
Mr. Rao. Senator, I think----
Senator Tillis. If you actually pull that whole box
forward, I think that's what you're struggling with.
Mr. Rao. Okay. How about now? Senator, I think given the
complexity of the market, I think you have to take a multi-
pronged approach. We have to use all available tools----
Senator Tillis. I get all that. I get all that. But if
you're in a world--we've heard Mr. King say that the FDA is
stretched for resources. I think fee structures probably should
be modernized. That's not going to happen overnight. So if you
can only focus on one area that would have the biggest return.
I'm just asking, between Big Tobacco, which has been
characterized as one of the lead causes of this problem are
what's being dumped substantially from China, which of the two
would you try to solve first?
Mr. Rao. Senator, you know, we would work with the FDA on
determining the most effective use of our resources.
Senator Tillis. Well, Mr. King, let me move to you. I'm
assuming a lot of these applications you're being flooded with,
are they from the normal players or are they from other players
that are dumping products in the market?
Dr. King. It's all of the above.
Senator Tillis. But give me some rough idea of
stratification in terms of numbers the resources.
Dr. King. So, in terms of the big players, we do receive
applications, but we also receive from small entities as well,
including small manufacturers. Mom-and-pop shops and vape shops
are submitting applications as well.
Senator Tillis. Between the two of them, just intuitively,
Mr. King, which of the two do you think would be more risky in
terms of what's in the product? A big tobacco company that's a
perennial target, or mom-and-pop shops and import. Just
intuitively, which of the two do you think would represent the
most dangerous product?
Dr. King. It's dependent upon the information that's
supplied in the application to us and the science. And I cannot
make a sweeping generalization because there's no way----
Senator Tillis. So theres no way. You think that products
that have been researched, that are going through an industry
that's been heavily regulated are likely to be as dangerous as
products that are being dumped from companies that are
manufacturing it in China?
Dr. King. Again, I can't speak in broad generalizations----
Senator Tillis. Okay.
Dr. King [continuing]. But there is variability within
these products. It's a diverse landscape of different products
with different device types. And so, making those
generalizations is not consistent with the available scientific
evidence.
Senator Tillis. No, actually, I just think it's fascinating
that we haven't done the work to understand that. Because
you're not going to solve the whole problem. And it would seem
to me that it would be useful to actually figure out if you
were able to reduce the risk of one sector, then you would have
some idea of where the most dangerous products are and how they
are systematically coming to market. But apparently that's not
a factor. And I'm not going to go any further on that question.
Why 2 years after the report are we just hearing about this
task force, after the report recommendation?
Dr. King. We've been working systematically since the
release of the Reagan-Udall evaluation to address all 15
recommendations. And I publicly said, I welcome the evaluation.
That is accurate. And we've worked diligently to implement all
of them, including this.
But it's a variety of different actions. We've made
progress, we've been reporting quarterly on that progress. And
on the task force, it's multi-agency. And that takes time to
make sure we get the right folks to the table and we set the
foundation for more progress.
Senator Tillis. On the point that you're--and I'm just
trying to give you an opportunity to explain this, and Senator
Durbin has mentioned that, that you have responded to Senator
Durbin's questions that you have to review every application.
And so, are we saying that right now we're in a posture where
these products are given the benefit of the doubt pending
review?
Dr. King. No. There's no safe harbor----
Senator Tillis. Senator Durbin just said yes. So, [Senator
Tillis looks to Senator Durbin]. I'm just trying to make the
connection because I'm trying to understand why you think you
have to do the science, and I don't think you're suggesting
that because they've applied, that they can sell the market
until they've been disproven. Is that accurate?
Dr. King [continuing]. There is no safe harbor by simply
submitting an application. Anyone who does not have
authorization through the appropriate PMTA pathway or other
pathways is on the market unlawfully and risk of enforcement.
Senator Tillis. Okay. So just to be clear, if I can rob
Senator Durbin [points at poster.]--what the hell are we
talking about here then? [points at poster.] Is this legal? Is
it illegal? Is it subject to review and approval of an
application? I'm sorry to go over Senator Durbin, but I'm
trying to get an answer to your question, actually.
Dr. King. I can't go through every single product on that
chart, but I will tell you that it's a----
Senator Tillis. The point here is this is a shelf full of
potentially dangerous substances in a store in the shadow of
the FDA building. I'm just trying to figure out if any of this
is illegal or how in the hell it's legal. I mean, that seems
like a legitimate question, right?
Senator Durbin. Yes.
Dr. King. Okay. I'm happy to answer.
Senator Tillis. I mean, maybe we should go to the audience.
I'm just trying to get an answer to that. I'm trying to
understand why this is happening in North Carolina. I just
don't understand it.
Dr. King. No, I'd appreciate the opportunity to respond.
Senator Tillis. I'll come back to you in second round of
questions. You know, I do want to back up though and
understand. I used to dip tobacco, and then I went to a
nicotine pouch substance. And last September when the sales
went off, I told myself I was going to quit cold turkey, and I
got off of nicotine.
Now, I had that option to get off tobacco, that some people
could throw a baby out with the bath water and not have that
even for adult. This is something that lets people move off of
the cancer-causing substances in tobacco into something safer.
And then, ultimately, maybe for somebody like me, just quit.
So I hope as we're having this discussion that we recognize
if we take this stuff off the market and people are not going
to say, well, nicotine's not available anymore. I guess I'll
just stop. They're going to go back to a more harmful
substance, and we need to make sure that baby doesn't get
thrown out with the bath water.
Chair Durbin. Senator, the only thing I'll add is when you
start advertising flavor watermelon and bubble gum, you're not
talking about adults making conscious choices.
Senator Tillis. Yes, but I'm not aware of any--is there any
Big Tobacco company that has child flavors on the market today?
Dr. King. Yes.
Senator Tillis. And what are they?
Dr. King. There's a variety. We know that kids use fruit
and candy-flavored products, as well as mint, and other
flavors. And there are several Big Tobacco entities that are
manufacturing e-cigarettes with flavors that have been
documented to appeal to kids.
Chair Durbin. Senator Booker.
Senator Booker. Thank you very much, Mr. Chairman.
Gentlemen, thank you very much for being here. Everybody on
this panel knows the horrors of fentanyl analogs coming from
China flowing into our streets and doing untold harm, danger,
and death to Americans, and it is something that in bipartisan
ways we've tried to find ways of stopping that.
What is stunning to me about this business is as much as
focus is on American companies, there are all of these products
coming from other Nations that do not have the same levels of
scrutiny, and I believe don't have the kind of safety
precautions that are critically necessary.
Could you talk to me a little bit about the products that
are being sold in our stores, and corner grocery stores, in
bodegas, that come from other countries and the risks that they
pose to American citizens? Please, Dr. King.
Dr. King. Happy to answer. So we know e-cigarettes as a
general product class have lower risk than conventional
cigarettes, but that does not mean that they're safe. We know
the levels of toxicants are markedly lower, but we know that
the aerosol can contain harmful and potentially harmful
constituents. But it's a vast marketplace, and there's marked
variability across product types and brands.
Senator Booker. But be specific. Some of these products
that are coming from other countries like China, do they pose a
threat? Could they pose a threat?
Dr. King. I would say that any of the products, regardless
of whether they're coming from China or not, could. And that's
why we have a pre-market paradigm to review the scientific
evidence, to understand what is in the product itself, and to
make a determination based on the science whether they meet the
appropriate statute by law.
Senator Booker. And so, the safeguards and regulations, I
would imagine, are being subverted though by these knockoffs
that are often coming in from other countries. Is that correct?
Dr. King. Yes. Other countries and also domestically as
well. And the sheer volume of the marketplace is a key
challenge in this issue. And that's why I believe strongly that
an all-of-Government approach is key. And we're making
progress, getting the applications done, ramping up
enforcement. We need more resources and we need more people at
the table.
Senator Booker. And so that's a really important point that
I want to flush out a little bit more. In other words, there
could be products coming into our market from other nations
that pose a threat to Americans that are flooding our market in
many ways. But the challenge we have is the resources to do the
kind of law enforcement work that could stop some of these
knockoffs coming in. Is that what you're saying?
Dr. King. I agree. People and dollars resources, correct.
Senator Booker. Right. And the products that are being
marketed at a time where we are focused so much on, again, as I
think we should be, the safety of the products that are coming
through American companies. When you talk about law
enforcement, it's not just here, could more be done at the
point of the source of some of these products coming from other
nations?
Dr. King. It could be, but our current authorities are once
the products reach the border, we are working on some rules,
specifically rulemaking, around registration and listing, which
would allow us to engage further with international
manufacturers, particularly China, where the bulk of these
products are coming from.
But ultimately one of our inhibitors is being able to act,
you know, once it hits the border, which we are doing. But
again, if we had more resources and with the all-of-Government
approach, we can do a heck of a lot more.
Senator Booker. All right. Mr. Chairman, thank you very
much.
Chair Durbin. Senator Cornyn.
Senator Cornyn. So, from 2020 to 2023, 18.4 million vaping
products were sold per month. In September, 2023, there's been
a 1,500 percent increase in kid-friendly flavors sold from 2020
to 2023. My staff happened to stop by an Exxon station and
picked up a couple of examples of those products. One called
True Story. This one happens to be watermelon, bubble gum-
flavored. This one is called Tyson Heavyweight that is an
apple, melon berry.
Dr. King, those are clearly designed for consumption by
children. Correct?
Dr. King. I can't speak to the intent of the manufacturer,
but I can say that flavors do appeal to kids. 90 percent of
youth who use e-cigarettes use flavored varieties.
Senator Cornyn. And if you look at the warnings on these
products, it says this product can expose you to nicotine which
is an addictive substance. Correct, Dr. King?
Dr. King. A highly addictive drug.
Senator Cornyn. Highly addictive drug, known by the State
of California to cause birth defects or other reproductive
harm. This Tyson Mellon Berry warning says it can cause cancer.
So, let me just ask you, are any of these products safe to
consume?
[Holds up vape products.]
Dr. King. There's no e-cigarette that is safe. They have
lower risk than the general class.
Senator Cornyn. There's no e-cigarette that's safe at all.
And I realize the argument is that for people who are trying to
wean themselves, let's say from tobacco, some adults find some
of these products, maybe not these products, but some other
products useful to wean themselves.
Because as I understand, the two biggest problems with
smoking a cigarette, for example, is the products of combustion
and the nicotine, the products of combustion associated with
cancer according to the Surgeon General. And of course, if
you're vaping and not smoking, then really nicotine, which is
this addictive substance, is the problem.
So interestingly, both of these products say, ``For sale in
the United States only. Designed in the USA. Made in China.''
Same thing for the True Story, the watermelon bubble gum vaping
device manufactured in China, ``Sale only allowed in the United
States.'' To your knowledge, are these products available for
sale in China?
[Holds up vape products.]
Dr. King. I can't speak to if there is evading of the law,
but the Government of China currently has a law that prohibits
the sale of flavored e-cigarettes.
Senator Cornyn. So, you can't sell them in China, but you
can sell them in the United States, and essentially, victimize
and addict our children to these nicotine delivery devices,
which that's what they are. Aren't they?
Dr. King. They're nicotine delivery devices. That is
correct.
Senator Cornyn. Nicotine delivery device, a device designed
and sold to deliver an addictive substance called nicotine, as
well as other associated health risks. Let me just walk you
through, briefly, the FDA approval issues involving an American
company, JUUL.
About a year ago, the Center for Tobacco Products issued a
marketing denial order. Meant that JUUL wasn't able to sell its
products, but it filed suit during the litigation. The
marketing denial order was stayed and JUUL was able to continue
to legally sell its products.
Last week, the Center for Tobacco Products rescinded its
denial, which sounds like good news for JUUL, but my
understanding is the rescission of this order moves JUUL from
back to pending, neither approved nor denied, which means it's
no longer able to sell its products. So we have a situation
where the FDA denied JUUL, during which JUUL's e-cigarettes
were legal. Then the FDA rescinded its denial, and now JUUL e-
cigarettes are illegal.
Dr. King, this strikes me as a Kafkaesque situation for an
American company filing for approval and then finding
themselves in this maze of regulation and litigation.
Meanwhile, illegal Chinese vapes make $3 billion a year
advertising directly to American citizens. Is that accurate? Is
what I said accurate?
Dr. King. In general, yes.
Senator Cornyn. Thank you. Seems to me that we need some
legislation. I've got some that I tend to work on with my
colleagues here, Mr. Chairman, to try to address this problem
more directly and look forward to coming up with a legislative
response to what is an outrageous and unacceptable status quo.
Chair Durbin. I look forward to working with you, Senator.
Senator Ossoff.
Senator Ossoff. Thank you, Mr. Chairman. Thank you to our
witnesses.
Mr. Rao, Dr. King, no flavored vape or e-cigarette products
are currently FDA-approved. Is that correct?
Dr. King. That's correct. I mean, tobacco is a flavor. So,
no non-tobacco flavored e-cigarettes have been authorized.
Senator Ossoff. No non-tobacco flavored e-cigarettes,
therefore, other flavors have been authorized and under the
TCA. Is it correct, Mr. Rao, that they are therefore not legal
to sell in the United States?
Mr. Rao. That's correct.
Senator Ossoff. And yet they're widely sold in the United
States?
Mr. Rao. That's correct.
Senator Ossoff. Why?
Mr. Rao. Senator, as we have discussed, it's a complex
issue in terms of the legal landscape. We are taking
enforcement efforts on a number of vectors to try to address
the problem. Principally, the department has been engaged in
defense of the FDA's marketing denial orders in district
courts, in courts of appeal across the country. That has been
more than 80 cases to date, and we've prevailed in a dozen of
those.
In addition, we are working with the FDA and the U.S.
Marshal Services on domestic seizures. There was a seizure
earlier this year in Southern California in which 45,000
illegal cigarettes were seized. That's part of what we're doing
to try to combat this problem.
We recognize that there's more that can be done. We have
brought a number of civil injunction actions as well. But we,
as part of this task force that that has been previously
mentioned, we are looking to engage with law enforcement
partners across the executive branch to do more in this area.
Senator Ossoff. Thank you, Mr. Rao. So none of the non-
tobacco flavors, the flavors that are clearly in my view, meant
to appeal to kids are FDA-approved. None of them are legal to
sell in the United States. Flavored products are still
widespread in our communities.
In Georgia, a 2019 study found that 1-in-5 high school
students had vaped, often drawn in by flavors and bright
packaging. And because the products that some students are
accessing are unregulated and illegal, they're sometimes laced
with other drugs or contaminants.
Last March in Lee County in Southwest Georgia, a student
was hospitalized after using a vape reportedly laced with THC
and fentanyl. And a 13-year-old in Whitfield County, Georgia
suffered a stroke and paralysis after reportedly using a
brightly colored blueberry raspberry vape. The toxicology
report was positive for THC and PCP. How will the department
prioritize enforcement aimed specifically at those products
that are contaminated or which contain other deadly and illegal
drugs?
Mr. Rao. Senator, it's the highest priority for the
Department. We share your concerns regarding the health risks
with respect to vaping products that may contain additional
dangerous products, again, that often originate in China.
The Department has brought criminal actions against
individuals involved in the importation of counterfeit vaping
related items and we would look forward again to working with
the task force to, to bring more such actions going
Senator Ossoff. Mr. Rao, what's your candid message for
Georgia families right now who fear that their middle school or
high school student may unintentionally and inadvertently vape
and consume something like fentanyl or PCP?
Mr. Rao. I want to send the message that the executive
branch is taking a very aggressive approach to trying to combat
this problem using all available tools and working closely with
law enforcement partners to consider all potential avenues for
enforcement against this threat.
Senator Ossoff. What does it look like to work with, for
example, local law enforcement agencies in Georgia to make sure
that there's not fentanyl in e-cigarettes and vape products
that are being marketed to children?
Mr. Rao. Certainly, the Department and other law
enforcement partners would appreciate the opportunity to engage
with local law enforcement which has a----
Senator Ossoff. Are you doing it yet?
Mr. Rao. It's certainly something that our law enforcement
partners are constantly considering in terms of a potential
option and are always open to.
Senator Ossoff. It is not a trick question. Just so I
understand, so that I can be helpful in connecting your team
with the right local law enforcement agencies in Georgia. Are
you currently working directly with local law enforcement
agencies to identify, for example, fentanyl-laced vape pens in
Georgia or elsewhere in the country? Is that something that my
office can help facilitate that liaison between you and local
law enforcement in Georgia?
Mr. Rao. Yes. It's certainly something that we would
welcome facilitation on. I want to be sure that I'm, you know,
providing correct information and connecting you with the right
people. Again, you know, I know our law enforcement partners
constantly work with local law enforcement in all of their
matters and would welcome engagement from law enforcement
partners in Georgia to combat this issue.
Senator Ossoff. Thank you, Mr. Rao. Thank you, Dr. King.
Thanks.
Chair Durbin. Thanks, Senator Ossoff. Senator Blackburn.
Senator Blackburn. Thank you, Mr. Chairman. And we
appreciate you all being here.
Dr. King, I want to come to you first. And Senator Booker
was asking about the China-produced products that are coming
into our supply chain and the lack of verification around
those, and you kind of skirted that issue a little bit.
So, I'm going to give you the opportunity to submit in
writing to us, what is that pre-market paradigm, what is that
third party verification that you-all are using to make certain
that tainted products and illegal products are not in this
stream? Because you've not wanted to answer that question
fully.
Also, when you saw Senator Durbin's chart that Senator
Tillis held up, you couldn't say if there, things were being
safe harbored. So, let's get some clarification around that so
that we understand the extent of the problem that we're dealing
with. And you can just submit that in writing for the record.
That would be helpful.
Senator Blackburn. I also want to ask you, Dr. King, about
the role that social media is playing in this epidemic and see
what you are doing to address that. We know that TikTok,
Instagram are being used to market these illegal fruit and
dessert-flavored e-cigarettes to children. And any of us can go
into any market or any of these vape stores that are in our
State, and we see what is happening there.
So, I would think that one of the central tenets and
activities of the task force work should be looking at how
social media is being used to promote and to leverage these
products into the marketplace to children. Are you focused on
social media's role?
Dr. King. So, I'll say that we have authority over
remanufacturing, marketing, and sale. We do not have authority
to take action against individuals, but if that influencer is
connected to a manufacturer, we can take action. We have issued
warning letters in the past, and I will note that the Federal
Trade Commission will be on this interagency task force, and
they have key authorities in that space that will be useful as
part of a coordinated approach.
Senator Blackburn. Okay. So, you issue warning letters. So
then are you turning those entities over to DOJ so that they
can be a part of this? Are you turning them over to FTC so that
they can go after penalties and enforcement?
Dr. King. So we regularly engage with all of those agencies
even before the task force, but it depends on the merits of the
case. And so, if the case warrants that----
Senator Blackburn. Okay. How many have you turned----
Dr. King [continuing]. After the warning letters----
Senator Blackburn [continuing]. Over, and how many have
been penalized?
Dr. King [continuing]. We have escalated. So are you
speaking with regard to influencers specifically----
Senator Blackburn. Yes.
Dr. King [continuing]. Or any enforcement action against
any entity?
Senator Blackburn. Influencers. Social media is what we're
discussing.
Dr. King. Yes. So depending on the action, that would be
more appropriate through the Federal Trade Commission, not the
FDA.
Senator Blackburn. Yes, I said DOJ or the FTC. How many
have been shut down? See, this is a part of the problem. It is
if you're talking in circles, and we can't figure out what
you're doing to actually stem the flow of these products and to
bring people to account, and to hold them responsible for what
they are doing. And if you're issuing warning letters and
somebody gets that, but they know that DOJ and FTC is not going
to execute any type of accountability on them, then they're
going to delete that email warning, or they're going to crumple
that letter and throw it in the trash.
Dr. King. I will reinforce that a majority of those who
receive warning letters do heed and correct the violative
actions, and we have escalated our actions in the past 2 years
alone. We've issued the first injunctions against
manufacturers, the first civil money penalties against
manufacturers, the first civil money penalties against
retailers.
We definitely need more. I completely agree. But we need an
all-of-Government approach, and I'm hopeful the task force will
get us there. But we've set a solid foundation to move forward
further.
Senator Blackburn. Okay. And Mr. Rao, coming to you. What
about the new task force? Are you planning to use civil and
criminal penalties?
Mr. Rao. We are exploring all tools, Senator, both civil
and criminal. One aspect----
Senator Blackburn. Okay. So my time is running out. So
you're exploring, but this is an issue that's kind of gotten
away from you-all, and you've been slow to respond, and I think
it's disappointing to hear you kind of talk in circles about
what you are planning to do. But you haven't established a
plan, and you're not certain what your way forward is going to
be. Thank you, Mr. Chairman.
Chair Durbin. Thanks, Senator Blackburn. Senator Lee.
Senator Lee. Thank you, Mr. Chairman, and thanks to you for
joining us today.
Let me start off by saying that teen vaping is a problem.
It's a problem that our society needs to address. Those who try
to get kids hooked on nicotine should be ashamed of themselves.
Studies have shown that the use of e-cigarettes can easily
transition to marijuana and other drugs, especially among these
younger users.
My concern here is that the Federal Government has said
that it wants to be tough on tobacco. And in saying that, it's
issued a bunch of regulations for legal approval, only then to
sit on those applications for legal products in the U.S.
produced by U.S. companies, while turning a blind eye to
illegal Chinese imports.
Small businesses selling products are left with little to
no guidance as to what's legal and what's illicit. And this is
bad, and it's led to more teen vaping.
The FDA has publicly committed to clearing the backlog of
pending product applications by June 30 of this year. Many of
these applications have been pending for several years, even
though the deadline set by statute is 180 days. June 30 is in
less than 18 days, I wonder, I question whether they can get
that done by the June 30 deadline. I hope they can. But it
makes me wonder why it's taken this long.
Look, if we're going to establish a byzantine labyrinth of
federal regulations to make it more difficult to do this stuff,
then for heaven's sakes, at least make the regime work. The
worst thing you can do is set those up so as to choke out U.S.
producers who are trying to comply with the law, and then open
the floodgates so that the illegal Chinese products can move in
and be sold on unabated. So, I wonder about this backlog, and I
think the backlog is a significant problem.
Now, between 2019-2020, there was a 1,000 percent increase
in high school students' use of disposable e-cigarettes. That's
a very significant jump, and most of these e-cigarettes are
illegal flavored e-cigarettes from China aimed at children.
China's sales of e-cigarettes into the U.S. market generate an
estimated $3.5 billion annually.
And yet, despite all of this, despite the 1,000 percent
increase in teen usage of these illegal e-cigarettes, we've
seen little to no civil enforcement action taken by the
consumer protection branch of the Department of Justice against
these large Chinese importers. Mr. Rao, I'd like to know why.
Why is that?
Mr. Rao. Senator, we take very seriously the vast
widespread prevalence of the products that you've described.
And we have been working with our law enforcement partners,
including the U.S. Marshal Service on looking at seizures of
these products. There was a seizure----
Senator Lee. Hey, how many enforcement actions have you
brought?
Mr. Rao. Senator, we brought multiple enforcement actions,
civil injunctive enforcement actions. And again, we're also
looking at the use of criminal tools, as well as other
authorities, including the PACT Act.
Senator Lee. Okay. And some of those authorities that the
Department has access to or that the U.S. Government has access
to are civil and others are criminal. So, I have to ask the
question--I'll ask it to you, since no one from ATF is here,
why is it that ATF is not bringing more criminal enforcement
actions against the large Chinese importers?
I mean, are they too busy revoking the licensess of Federal
firearms, licensees based on paperwork violations so much so
that they've chosen to ignore those who are selling illegal
Chinese e-cigarettes to minors?
Mr. Rao. Senator, we're working closely with the ATF on the
use of the PACT Act. We are considering all available options
under that statute, and we're committed to working with them to
try to make additional headway in this area.
Senator Lee. Okay. Can you grasp my concern here, which is
that when we set up this very large net, a net you might call
it a dam, a barrier to entry that affects U.S. companies trying
to comply with the law, and then you subject them to a lengthy
licensing process, then they have to wait for years while
getting their products licensed.
Then you have Chinese manufacturers not making any effort
to comply with that law, not even making an effort to apply for
approval when those are flooding the market and the U.S.
manufacturers trying to comply with the law get nowhere. Can
you understand why that's a problem,
Mr. Rao. Senator, this is an extremely complex and rapidly
evolving area, and it is challenging in a number of levels. And
again, that's why we are eager to continue the work with our
law enforcement partners to try to address this going forward.
Senator Lee. Okay. Well, I hope they'll deal with it and
by, among other things, bring in enforcement actions. But also,
I hope that the folks at FDA can clear the backlog. Thank you.
Chair Durbin. Thanks, Senator Lee. Senator Blumenthal.
Senator Blumenthal. Thanks, Mr. Chairman, and thank you for
holding this hearing, and for your longstanding commitment to
stopping nicotine addiction and tobacco use, particularly among
our children.
This cause is a longstanding one for me. I helped lead
attorneys general in the 1990's to sue Big Tobacco and win a
major settlement. And progress has been made, but obviously,
not enough progress. And this hearing, I hope, will advance the
cause of preventing vaping use of e-cigarettes, particularly
flavored e-cigarettes, and bolster enforcement, which has been
sadly lacking by the Federal Government. Lagging and lacking.
Last week, the FDA rescinded its marketing denial orders
issued to JUUL Labs. This rescission means that JUUL's products
will remain on the market while the FDA continues its review of
JUUL's products. I'm concerned that the FDA's excision will
cause a surge in illegal e-cigarettes be sold and used by
vulnerable population and fueling the youth vaping epidemic.
I understand the FDA is in the midst of its review, but
leaving these products on the market when they have not met
statutory health standards is simply unacceptable and
dangerous. As Chair of the Permanent Subcommittee on
Investigation, I released a report in February, finding that
the regulatory efforts of the FDA, including extensions of
compliance deadlines and prioritizing enforcement of certain
types of e-cigarette products have failed to curtail
unauthorized e-cigarette products and prevent youth usage.
That is just one example of what we found in our
investigation on the Permanent Subcommittee on Investigations,
and that was set forth in the report. Obviously, I don't have
enough time even to scratch the surface of the report that we
produced, but I want to ask you, Dr. King, what evidence does
the FDA have to allow these products to remain on the market?
Aren't you concerned that this action will increase the use of
JUUL products, even though the FDA has yet to complete its
review? How can you leave them on the market?
Dr. King. As a scientist, myself, I'm committed to
following the science. And when I took this job, I vowed that,
and I'm continuing it now, and that includes this review.
As was noted in the release, we're doing a full substantive
review of the entire application. And I'll note that unless a
product has authorization, it's not on the market legally, and
therefore any product that does not have authorization has a
risk of enforcement. And I can't comment on specifics of any
individual product, but we have an important paradigm in place.
We've got to prioritize our resources accordingly, but we are
monitoring the use of products, including those that are
appealing to kids.
Senator Blumenthal. What are you doing to mitigate the
harms that JUUL is causing while you complete your review?
Dr. King. Well, part of it is the scientific review to make
sure that we're doing a robust review of the evidence,
including the toxicologic risks and various other risks at the
population as a whole. And concurrent to that, we're working on
enforcement and we're taking action.
Senator Blumenthal. When will your review be done?
Dr. King. I can't comment on the specifics of an
application, but I can tell you that we're working as
tirelessly as possible.
Senator Blumenthal. Well, that's the story of federal
enforcement here, and you're not the one who should be bearing
the brunt of the blame necessarily. But the history is a long
one, and it's filled with delay, and procrastination, and
failure to provide sufficient enforcement in a timely way.
Let me ask you, Mr. Rao. What provisions are you making for
attorney general enforcement as part of this renewed effort?
Mr. Rao. Senator, I think as part of what we're looking to
do going forward, is working with our federal law enforcement
partners to identify potential gaps or potential areas in which
additional support may be useful.
And, you know, as part of the regular discussions that
we're going to be having, we'll certainly look to identify ways
in which other agencies, whether attorney generals, whether
State law enforcement as Senator Ossoff mentioned earlier.
You know, I think, again, it's a difficult issue, and it
requires an all-of-Government approach. And so, we would
certainly welcome opportunities to engage with other law
enforcement partners, State and local.
Senator Blumenthal. Thank you. My time has expired. I thank
you both for your commitment to this cause. I think our view
and our role in the Congress is to provide additional impetus
and momentum. It's not personal. I respect your commitment and
your credentials, your lifelong work in this area, but I think
the Federal Government has continued to be less vigorous than
it should be.
Thanks, Mr. Chairman.
Chair Durbin. Thanks, Senator Blumenthal. We're going to
wrap up the panel. Senator Tillis has a question. I have one
before.
I've listened carefully, Mr. Rao, to your description of
this issue that we're considering today. You have said, and I
quote, ``It is the highest priority of the U.S Department of
Justice.'' You have said that it's an urgent issue. You have
said we need a very aggressive approach. You said we need to
use all available tools.
So, I'd like to issue a specific challenge to you. We're
going to give you the address of the store that has the
products here, and it's in Silver Spring, Maryland, within one
mile of FDA headquarters. You have announced this new
enforcement agency team that includes almost every law
enforcement agency of our Federal Government. I hate to pick on
one store, but I want you to prove to me that is urgent.
You're going to use all available tools and its highest
priorities. We know that they are selling illegal products to
children. We know that's happening, and it's happening across
this country. So, now I'm going to find out this agency task
force that has all the law enforcement agency, the Federal
Government is on the case.
My crack investigators here found this store, and they
found what they're selling to be illegal. Now, what are you
[poster is displayed and points at witness.] going to do about
it? What is U.S. Department of Justice going to do about it?
Anything? I hope you'll report back to the Committee what you
decide. Do you want to say something? You're welcome to.
Mr. Rao. Senator, again, I want to stress the Department's
commitment to this issue, and to pursuing enforcement without
fear or favor where the facts lead and where the law supports.
Chair Durbin. And I will tell you, my investigative team
here will be happy to work with you to identify the exact
address of this store, which I'm not going to read into the
record, but we'll give it to you so that we'll see what happens
a week or two from now. We'll check on the store and see how
they're doing. We'll see what the highest priority the
Department of Justice means. Senator Tillis.
Senator Tillis. Yes. You may be able to stop into that
Exxon that Senator Cornyn's staff went to also.
First off, Dr. King, it is very clear to me that you are
data-driven, science-driven, and I appreciate that. I'm trying
to get to common sense-driven here, and you've got to operate
within the context of the rules that we set here in Congress.
I understand that, and I'm not going to attack you, but it
just seems to me that you couldn't throw a rock and not hit
something. Like you see in Maryland. But right down here, I
know there's the Exxon right down here, you may have gotten it
there. Geek Bar was formed in China in 2015. They're
responsible for this one that has advertising--is this ``OMG
Blow-Pop?'' Oh, that's not focused on kids at all, right? The
language, the marketing on the box, now they're in China. This
one, however, is designed in the United States and manufactured
in China. It's called EB Design.
[Holds up vape products.]
They're business is labeled apparently headquartered in
California. Why aren't we going after them? If they're
contracting to get a product made in China that has labeled on
it, just sell it where it's legal in the United States. If in
fact it's illegal throughout the United States, why aren't we
at least able to go after any U.S.-based companies that are
involved in this supply chain that's poisoning our kids?
Dr. King. So, I'll reinforce that we have taken action
against that company. It's actually a progeny from the Elf Bar
product. We've done a series of blitzes since last April on a
monthly basis where we have issued warning letters to not only
the retailers, but also enhanced with civil money penalties.
And to your point around the data, that's what we're
following. We know Elf Bar and those progeny products are the
most commonly used product among kids, and that's where we
prioritize the resources.
I do want to make it clear though, when we follow the
science that the top two brands used among kids are Chinese
manufacturers, but number three and four are domestic. And so,
it's important that we follow the science and we'll continue to
have a nimble approach to our enforcement.
Senator Tillis. And what's the mix in those four then as a
stratification of their market share? The top two are from
China. The other two are from the U.S. What's the mix in terms
of the market share?
Dr. King. Higher market share is the U.S-based companies
and higher prominence among youth in terms of use is the
Chinese-based.
Senator Tillis. Thank you.
Chair Durbin. It's my understanding that you have a history
of finding retailers, but not manufacturers. Is that true?
Dr. King. We have initiated the first civil money penalties
against manufacturers within the past year, and I'm hopeful
we'll continue that in the future.
Chair Durbin. I hope so, too, because I not only want to go
after this store, but I'd like to go after the product
manufacturers that fill their shelves.
Dr. King. I agree completely. Comprehensive approach is
key. Agree completely.
Chair Durbin. I want to thank this first panel for
gathering, and Dr. King, and Mr. Rao, we're going to be back in
touch with you to see if you're using all available tools to
put these people out of business. Thank you very much.
Dr. King. Thank you.
Chair Durbin. We are now going to set up for the second
panel. Let me read briefly the biographies of the second panel.
Yolonda Richardson is president and CEO of the Campaign for
Tobacco-Free Kids organization that has fought for over 25
years to protect kids and save lives by working to reduce
tobacco use.
David Spross, executive director of the National
Association of Tobacco Outlets, a national trade association of
tobacco retailers. Tony Abboud, executive director of the Vapor
Technology Association, a national trade association dedicated
to protecting vaping and the alternative nicotine products
industry.
Dr. Susan Walley, chief of the Division of Hospital
Medicine at Children's National Hospital. She's an expert on
the prevention of youth tobacco use and tobacco-related
disease. Has served as chair of the American Academy of
Pediatrics, Section on Nicotine and Tobacco Prevention and
Treatment. And Josie Shapiro, a high school student from
Seattle, Washington. She's fought nicotine addiction after
picking up vaping as a teenager.
I'd also like to note for the record that we invited e-
cigarette manufacturers, Altria, R.J. Reynolds, Japan Tobacco
International, and Miracle Shenzhen Technology to send
representatives to testify at the hearing. None of them agreed
to do so.
So, I ask all the five witnesses to stand to be
administered the oath. Raise your right hand.
[Witnesses are sworn in.]
Chair Durbin. Let the record reflect that all five have
answered in the affirmative. And Ms. Richardson, you have 5
minutes. Please proceed.
STATEMENT OF YOLONDA RICHARDSON, PRESIDENT AND CEO, CAMPAIGN
FOR TOBACCO-FREE KIDS, WASHINGTON, DC
Ms. Richardson. Thank you so much, Chairman Durbin, Ranking
Member Tillis, Members of the Committee, thank you for inviting
me to testify today.
I am Yolonda Richardson, and I'm president and CEO of the
Campaign for Tobacco Free Kids. The Campaign is the leading
advocacy organization working to reduce tobacco use and its
deadly consequences in the United States and around the world.
The Campaign was and is a strong advocate for the Family
Smoking Prevention and Tobacco Control Act, which was the
landmark legislation that gave FDA the authority to regulate
tobacco products.
One of the most important tools that Congress gave FDA was
the authority to conduct pre-market reviews of new tobacco
products before they can be legally sold because of the Tobacco
Control Act decisions about which new products enter the market
are no longer supposed to be made by tobacco manufacturers
based on economic considerations, but rather, ultimately made
by FDA based on the need to protect public health after a
careful review of the scientific evidence.
Unfortunately, as you've heard this morning, pre-market
review has not been effectively applied to e-cigarettes. FDA
failed to assert its regulatory authority over e-cigarettes
until a substantial e-cigarette market had already formed, and
e-cigarettes had already become the most popular tobacco
product among youth.
FDA then further delayed implementation of the pre-market
review requirements of e-cigarettes, allowing these markets to
remain on the market for years. Only when the Campaign and
other public health groups successfully challenged the delay,
did FDA initiate pre-market review process in 2020, years after
these products were already on the market illegally?
Now that pre-market review has started, we are encouraged
that the FDA has appropriately applied the public health
standard as intended by the Tobacco Control Act. We agree with
FDA's determination that flavored products should not be
permitted because they increase the appeal and use of e-
cigarettes by youth.
Yet, as we've noted this morning, the process has been
slow, and several e-cigarette companies have flooded FDA with
pre-market applications for millions of products gumming up the
process. The result, thousands of e-cigarettes are still under
review, and there appears to be an unstated policy of not
taking enforcement action against products with pending
applications, including flavored e-cigarettes.
The large number of unauthorized e-cigarettes on the market
continue to present risk to public health. These products are
highly addictive, can expose users to harmful substances, and
have consistently been shown to appeal to youth. Appealing
flavors and addictive levels of nicotine is a dangerous
combination, which is why the FDA has rejected applications for
millions of flavored e-cigarettes.
Over the past year the FDA has taken some important
enforcement actions, but the current level of enforcement
activity has not proven to be sufficient. More and stronger
enforcement action is needed. The Campaign and 77 other
organizations recently sent a letter to FDA, the Department of
Justice, and Customs and Border Protection urging them to make
several changes.
I will quickly highlight for you some of the changes that
we proposed. First, the FDA must see greater monetary
penalties. FDA has been sticking penalties of only about
$20,000, which is too low to serve as a deterrent.
Second, the Department of Justice must prioritize tobacco
product enforcement, and act more quickly and aggressively when
violations are found. Despite widespread non-compliance, DOJ
has sought injunctions against only seven manufacturers today.
Third, Custom and Borders Protection and FDA must
prioritize and stop illegal importation of unauthorized
products. Many of the products you discussed early in the day
that are coming in from outside of the United States.
Fourth, the enforcement action must be brought against all
parties in the supply chain from manufacturers to wholesalers,
and distributors, down to retailers. Fifth, FDA must end the
broad exercise of enforcement discretion for products with a
pending application. These products are no more legal than
products for which no application was ever filed.
And lastly, FDA must complete its review of e-cigarettes.
FDA needs to move quickly to a true pre-market review process
where products are reviewed prior to entering the market rather
than the current post-market review.
We welcome this week's announcement about the creation of
the Multi-Agency Task Force, a whole-of-Government approach.
This could be important, but it must be immediately followed
with concrete and comprehensive enforcement actions. Federal
agencies should also coordinate closely with States and
localities on enforcement where appropriate.
Pre-market review has great potential to reduce youth e-
cigarettes, but without adequate enforcement, companies will
continue to flout FDA requirements and put young people at
risk.
Thank you, Mr. Chairman.
[The prepared statement of Ms. Richardson appears as a
submission for the record.]
Chair Durbin. Thank you, Ms. Richardson. Mr. Spross--did I
pronounce your name correctly?
Mr. Spross. You did, Senator.
Chair Durbin. Please proceed.
STATEMENT OF DAVID SPROSS, EXECUTIVE DIRECTOR, NATIONAL
ASSOCIATION OF TOBACCO OUTLETS, WINSTON-SALEM, NORTH CAROLINA
Mr. Spross. Good morning, Chairman Durbin, Ranking Member
Tillis, and Members of the Committee. I appreciate the
opportunity to join you today. I am David Spross and I serve as
the executive director of the National Association of Tobacco
Outlets, a national retail trade association that represents
more than 66,000 retail stores throughout the country.
At the outset, I want to clearly affirm our strong support
for a well-functioning regulatory system in which FDA oversight
leads to accelerated reductions in underage use and into
tobacco-related harm. NATO and our members are invested in this
system, and in these goals. Illicit markets are a major threat
to that goal, and thus, a threat to the responsible retail
community committing to operating within, not outside, the
legal system.
NATO members take compliance seriously. Our members include
licensed retailers who age verify their customers to prevent
sales to minors. We have also been regularly informing our
memberships of the brands FDA has targeted in its warning
letters and other enforcement actions to ensure our members
know in detail what products FDA is taking action against.
Today's hearing addresses a very important topic. The
marketplace is overrun by illicit and unregulated products, the
vast majority of which are flavored vapor products made in
China. To date, we have seen piecemeal enforcement that often
ignores the most egregious actors.
The task force announced this week is a good start for it
to be successful. The task force should use the full range of
enforcement tools, It has particularly focused on the worst
offenders, the largest manufacturers, and distributors of these
illicit products. With more aggressive enforcement action, we
believe order can be restored to this marketplace.
An effective regulatory system also requires a more
coherent compliance framework that clearly communicates FDA's
enforcement priorities. That is, the products that are once
immediately removed and the products that can remain on the
market. That information is critical to helping address the
marketplace chaos we see every day.
FDA has said that only 23 authorized vapor products are
legal. But we also understand that FDA is not currently
prioritizing enforcement against vapor products that have fully
complied with its 2016 deeming rule, and that have filed timely
PMTA applications, which remain pending before the agency.
FDA has repeatedly acknowledged that the removal of
products pending PMTA review would stimulate illicit market
activity and take potentially reduced harm products away from
smokers. Simply put, NATO members who are seeking to abide by
the law need greater clarity from the FDA. In addition, we
believe FDA must reform its PMTA process. In our view, the
process has fallen short of its intended purpose, and that is
why we've seen a flourishing illicit market.
To date, FDA has only authorized a small handful of small
smoke-free products despite millions of adult consumers seeking
better alternatives to smoking. As FDA and Dr. King have
acknowledged, smoke-free products are much less harmful than
cigarettes for smokers who want to switch. But with so few FDA-
authorized choices, consumer demand is now being met by Chinese
companies that want the FDA's regulatory system to fail.
Authorizing more products will help build a well-regulated
market.
In closing, NATO strongly supports solutions that reduce
underage use and deliver on tobacco harm reduction. We look
forward to working with the FDA, the task force, and this
Committee to address these issues.
Thank you very much.
[The prepared statement of Mr. Spross appears as a
submission for the record.]
Chair Durbin. Thank you, Mr. Spross.
Mr. Abboud.
STATEMENT OF TONY ABBOUD, EXECUTIVE DIRECTOR, VAPOR TECHNOLOGY
ASSOCIATION, CHICAGO, ILLINOIS
Mr. Abboud. Thank you, Chairman Durbin, Ranking Member
Tillis, and Members of the Committee for allowing me to testify
today and answer your questions on a topic that is crucial to
our public health. I hope that my opening statement and
responses to your questions will inform a balanced conversation
about tobacco policy in the United States that is rooted in the
science on e-cigarettes.
My name is Tony Abboud, and I'm the executive director of
the Vapor Technology Association. VTA is a trade association
that protects and promotes a vibrant U.S. vapor industry with
companies at every level of the distribution chain, including
manufacturers, distributors, suppliers, and mom-and pop-
retailers.
Discussions like the one we are having today are critical
to our members throughout the country. In informing our efforts
and our engagement with the esteemed Members of this Committee,
I hope I can serve as a useful and important resource for you
all.
Let us begin with the fact that youth vaping in the United
States has dramatically resolved from the peak of the JUUL
epidemic in 2019. Since then, youth vaping has plummeted 61
percent, largely due to the common-sense federal law raising
the age to buy tobacco products to 21, a law that VTA
championed with the White House and with Congress.
According to the CDC's National Youth Tobacco Survey, the
youth vaping rate now sits at the lowest level in more than a
decade, before e-cigarettes were even regulated by the FDA.
Even better now, only 4.4 percent of youth use e-cigarettes
regularly, and even fewer use them daily.
Interestingly, in that same CDC survey, youth have
consistently reported that flavors are not the reason they
first try an e-cigarette or the reason they currently use e-
cigarettes. Even more interesting, the dramatic rise in
flavored disposable vaping products since 2019 in this country
has corresponded with that dramatic decline in youth vaping.
But as dramatic as the decline in youth vaping has been,
VTA has not been satisfied and has been advocating on the Hill
for serious common-sense marketing and access restrictions to
further protect youth from e-cigarettes. Why is this important?
In February, Dr. Nancy Rigotti of Harvard Medical School wrote
in the New England Journal of Medicine. ``It is now time for
the medical community to add e-cigarettes to the smoking
cessation toolkit. U.S. public health agencies and medical
societies should reconsider their cautious positions on e-
cigarettes for smoking cessation. The evidence has brought e-
cigarettes to a tipping point. The burden of tobacco-related
disease is too big for potential solutions such as e-cigarettes
to be ignored.''
Further, last fall, the Medical University of South
Carolina published the largest clinical trial in the United
States, covering 4 years and 11 cities, finding that e-
cigarettes help people quit smoking better than the FDA-
approved medicines on the market, even if the individuals had
no intention of quitting. In other words, the mere availability
of these vaping products caused them to quit smoking.
Another study by Abigail Friedman from Yale, showed that
flavored e-cigarette restrictions result in a direct increase
in cigarette sales in those jurisdictions, which have limited
them. The authors warned any perceived public health benefits
of reducing flavored e-cigarettes may be offset by the public
health costs from e-cigarette sales.
The reason we are having this enforcement discussion today
is because U.S. tobacco regulation in the hands of this FDA is
broken. The FDA was supposed to implement the Tobacco Control
Act to allow Americans access to alternatives to cigarettes
that are less harmful. Instead, the FDA has done the exact
opposite. It has misused its power to impose a de facto ban on
flavored vaping products without reviewing the science.
Since passage of the Tobacco Control Act, the FDA has
authorized 16,000 combustible tobacco products and only a
handful of vaping products. In the past 2 years alone, this FDA
has not authorized a single vaping product or nicotine pouch
product like Zyn, but it has rushed 2,000 new combustible
products, including 821 new cigarettes to the market for
Americans to smoke.
The FDA has not done its job as a regulator, and now it
wants more funding to enforce the very actions which federal
courts have declared illegal and which are going for supreme
court review. To be clear, the FDA has repeatedly stated that
every single vaping product on the market is illegal regardless
of whether the company has a pending application. That means it
is enforcing prohibition. I contend you can give it all the
enforcement power in the world, but prohibition cannot be
enforced.
Instead of pursuing this failed regulatory policy, the FDA
must reverse course, make harm reduction its north star, and
authorize a wide variety of products that are less harmful
products. Filling the market with flavored products, which
American adult consumers are clearly demanding is the only way
to curb the illicit demand and give Americans what they need,
what they want, and what the law was intended for them to have.
Only then will half a million Americans who die from smoking
every year have a regulated choice and a fighting chance.
Thank you for the opportunity to testify. I look forward to
answering your questions and working with the Committee going
forward.
[The prepared statement of Mr. Abboud appears as a
submission for the record.]
Chair Durbin. Thanks, Mr. Abboud.
Dr. Walley.
STATEMENT OF SUSAN WALLEY, MD, MHCM, NCNTT, FAAP, IMMEDIATE
PAST CHAIR, SECTION ON NICOTINE AND TOBACCO PREVENTION AND
TREATMENT, AMERICAN ACADEMY OF PEDIATRICS, WASHINGTON, DC
Dr. Walley. Thank you, Chairman Durbin, Senator Tillis, and
Members of the Committee. My name is Dr. Susan Walley, and I
serve as the Division Chief of Hospital Medicine at Children's
National Hospital here in Washington, DC. I'm a pediatrician,
and an expert in adolescent tobacco use. I'm here today
representing the American Academy of Pediatrics, an
organization that represents 67,000 pediatrician members.
E-cigarettes are addictive and they are dangerous for
children. Unfortunately, we are here today because we're not
doing enough to protect our youth from a tobacco industry
intent on profiting off the use of these harmful and addictive
products among children.
Contrary to what you have heard today from the tobacco
industry, over 2 million children and adolescents currently use
e-cigarettes. The tobacco epidemic is not over while down from
its peak a few years ago, it is still a shockingly and
unacceptably high number. What's more? Over a quarter of youth
e-cigarette users use the products every day.
One of the primary reasons, as you have heard, children are
attracted to e-cigarettes is the sweet fruit candy and mint
flavors they come in. The flavors smell and taste great, and
they mask the harshness of tobacco. These products are also
often marketed with packaging that resembles candy and snack
food. As a pediatrician, I see all too frequently how nicotine
addiction takes hold in teenage patients who vape e-cigarettes.
The adolescent brain is more susceptible to nicotine
addiction. So, symptoms of dependence can appear in days to
weeks of first experimentation with e-cigarette use. When the
brain does not get the nicotine, it craves. Teens experience
unpleasant withdrawal symptoms such as irritability and
anxiety, which leads to continued use for many young people.
This is not just sporadic use, but consistent, frequent, and
dependent use.
Unfortunately, the trusted adults that teens usually rely
on; parents, teachers, and pediatricians like myself, have
limited options to assist in their quitting. I'm certified in
nicotine and tobacco treatment, which means I have special
training on how to help people, including children, quit using
tobacco products.
But pediatricians have found that helping adolescents stop
using e-cigarettes is exceedingly difficult due to the high
level of nicotine in these products, targeted marketing, and
easy access. Many of these children are very addicted, and we
have limited effective tools in our toolbox to help them
because youth tobacco cessation, treatment, particularly for e-
cigarettes, has had limited research funding.
So, our best strategy to avoid youth nicotine addiction is
to prevent the use of any tobacco products in the first place.
And we know the most effective way to stop youth e-cigarette
use is to get all flavored tobacco products off the market.
This is where we need the Food and Drug Administration's help.
To date, as you have heard, FDA has reviewed millions of e-
cigarette applications and has appropriately rejected the vast
majority of them. It is determined that no e-cigarettes that
are flavored are appropriate for the protection of public
health.
FDA has authorized only 23 e-cigarette products. These 23
products are sold under only three brands, and none of these
products come in a flavor other than tobacco. These are the
only products that are allowed to be legally sold in the United
States, but yet thousands of flavored e-cigarettes make their
way to the hands of children every day. And just like Senator
Tillis, I think we shopped at the same place, this OMG Blow-Pop
e-cigarette that I purchased within walking distance of a
school.
Today, 90 percent of youth e-cigarette users report using a
flavored product despite none of them being authorized by the
FDA. Simply put, this is unacceptable. The solution should
start where the problem starts; with the tobacco industry and
its supply chain.
Manufacturers should end the production of unauthorized e-
cigarettes. Distributors should stop distributing them.
Retailers like vape shops and convenience stores should stop
selling them to the public where they ultimately lie in the
hands of children.
But history has taught us that the tobacco industry and its
partners are unlikely to do the right thing on its own. That's
why we need the Federal Government to get these illegal
products off the market. We appreciate that the FDA recently
stepped up enforcement and is creating a multi-agency task
force with law enforcement partners to expand e-cigarette
enforcement.
Congress can also help by ensuring these enforcement
efforts have sufficient funding. We really need every relevant
partner to step up and make this a priority. Youth e-cigarette
use is still a very real problem, but it is a solvable problem,
and we have solutions. We just need the will to implement these
solutions.
America's pediatricians look forward to working with you to
ensure that our children grow up without the harms of tobacco
products. Thank you.
[The prepared statement of Dr. Walley appears as a
submission for the record.]
Chair Durbin. Thanks, Dr. Walley.
Ms. Shapiro.
STATEMENT OF JOSIE SHAPIRO, HIGH SCHOOL STUDENT, LINCOLN HIGH
SCHOOL, SEATTLE, WASHINGTON
Ms. Shapiro. Hi. My name is Josephine Shapiro. I am a high
school senior from Seattle, Washington, and I'm addicted to
nicotine because of e-cigarettes.
I grew up hating cigarettes and other commercial tobacco
products. I would cough as I walked by smokers trying to alert
them of the harm that they're doing to their bodies. I never
thought I would touch a cigarette or any other tobacco product.
As early as middle school, this started to change. My
friends started vaping in seventh grade. They thought vapes
were harmless because of the fun flavors and colorful
packaging. They wanted to be cool like the pretty girls they
saw vaping on social media, but they didn't realize they were
becoming addicted.
Vaping soon started to take over their lives. They would
leave class early to vape in the bathrooms or anywhere else
they could get away with it. It's easy to hide these products
in your sock or your bra, which makes it difficult for teachers
or parents to know when kids are vaping.
In ninth grade, I began to hang out with a new group who
used all sorts of e-cigarettes. The more I hung out with these
people, the more vaping became normal to me, and I had to try
it. The first flavor I tried was blueberry ice, but I tried
pretty much every flavor my friends had. I thought I was just
enjoying the flavors. But soon, my 14-year-old brain craved the
nicotine more and more. I promised myself I wouldn't buy my own
vape because I wasn't addicted if I was just hitting my
friends', right?
It wasn't long before I broke that promise to myself. I was
already addicted, and little did I know it was about to get
worse. These products are easy to get. You can ask someone
older than you to buy it, buy it off a friend, or go to a store
where they don't ID you.
Once I had my own vape, I would leave class to vape in the
bathrooms with my friends. I would get invited to lunch so
people could hit my vape, and all of a sudden, my entire circle
was centered around vaping. The hold nicotine had on my young
mind was intense and scary. I felt completely out of control,
helpless and alone, even though I knew I wasn't.
Vaping affected my mood, my ability to catch my breath, and
even my skin. I couldn't spend quality time with my friends
without thinking about when we were going to get our next hit.
I really miss the times when we could have fun without the
presence of nicotine.
One of the saddest things about vaping and nicotine
addiction is how it ruins relationships between friends and
families. I can't tell you how many ways it impacted my
friends, but let me tell you one example. One of my friends was
so addicted she would say things like, ``I'll just die at 20,
whatever.'' I watched her isolate herself from the rest of her
life, but as long as she had her vape, she said she was okay.
Vaping for her was not just an addiction, it was her
lifeline. We would skip class and activities to sit in her car
and vape. Then the vapes turned into cigarettes, and then the
cigarettes turned into other drugs.
My story is still ongoing today. Our story is still ongoing
today. As I look forward to all the wonderful things have ahead
of me, I'm still struggling to get over my nicotine addiction,
and I blame it all on the blueberry ice vape.
I've tried to quit vaping over and over again, but it's
really, really hard. Everything in my life is a trigger;
hanging out with friends, driving my car, going to the
bathroom, going into a convenience store, all of it makes me
want to vape. Honestly, I haven't been able to stay clean for
more than 2 months since I decided to quit. I feel terrible
about it.
My addiction consumes a lot of my life. It has impacts on
my physical and mental health. It makes me feel like I am less
than, but the reality is that my ambition and goals have been
suppressed by an industry that profits from me and my peers.
That's why I'm sharing my story today. I'm doing everything I
can to prevent young people from ever starting to vape or use
any tobacco product.
My story is mine, but I also tell it to protect the new
generations. I have two younger siblings and imagining them
with a blueberry ice vape breaks my heart. There are over 2
million kids who vape in the United States, and millions more
will go through the same thing if we do nothing.
From my perspective, we have to get rid of every single
flavored e-cigarette. Until then, kids will continue to use
these products, and they will continue to get addicted just
like me. Thank you.
[The prepared statement of Ms. Shapiro appears as a
submission for the record.]
Chair Durbin. Ms. Shapiro, thanks. It couldn't have been
easy for you to decide to do this, but it's important that you
did. To hear firsthand the story of what you've been facing
makes a real difference. I mean, to all of us. Dr. King is
still in the room. People representing the industry are still
in the room. They need to listen very carefully to what you had
to say. Stick with it. You can beat this. I know you can. You
have enough determination to be here today, and we're cheering
you on.
Dr. Walley, what about this argument that vaping is a good
way to stop tobacco use?
Dr. Walley. Thank you for the question, Senator Durbin. As
a trained nicotine and tobacco specialist, and a former medical
director of a tobacco consult service, you know, I understand
the devastation of an adult who has been smoking for 50 years
and has what we call like 100-pack history, where they smoke
two packs of cigarettes a day for 50 years, and so no one would
be more happy to see additional FDA-proven, safe, and effective
smoking cessation therapies.
The FDA has already approved safe and effective smoking
cessation therapies, and this is crucial that we as a medical
community and as a society, make sure that we provide the
access to those safe and effective FDA-approved smoking
cessation therapies.
Chair Durbin. So, Mr. Abboud, when you listen to Ms.
Shapiro talk about her addiction, what do you think as the head
of the association for vaping?
Mr. Abboud. Well, first of all, Senator, I think about her
as a parent of three teens and young adults. These are not new
issues for me, for my family, for any parents in the United
States.
Chair Durbin. Are your kids vaping?
Mr. Abboud. Some of them do vape, yes, and we talk about
this issue like we do all the other issues that teens have to
struggle with.
Chair Durbin. Do you encourage them to stop?
Mr. Abboud. Of course we do. Of course, we encourage them
to stop.
Chair Durbin. Well, doesn't that tell the whole story here?
You don't want your own kids doing this. Why do we want any
kids doing this?
Mr. Abboud. We don't want any kids doing this. This is why
we raised the age to 21 and we advocated for that. That's why
we've made this product illegal. That's also why we work hard
at doing the other things, making more common-sense regulations
to make sure that these products don't get into their hands
increasing things.
Chair Durbin. Mr. Spross, your retailers, what do they
think about this product? Do they just assume that since it's
going to be legally sold in the United States or apparent,
legally sold, they have no moral obligation to the kids that
are buying them?
Mr. Spross. Quite the opposite, Senator. We take a zero-
tolerance policy in terms of ensuring that our retailers are
trained to prevent sales to youth, whether that be through card
access or using the available tools that are out there through
the FDA website.
Chair Durbin. Do your retailers sell flavored products?
Mr. Spross. They do. And I would say, like I said in my
statement, yes, we've communicated the 23 products that have
been granted marketing orders. But we also, as I referenced,
there's been products that have filed timely PMTAs according to
the statutory deadlines. And those products are not in
receiving the enforcement right now.
Chair Durbin. Mr. Spross, I don't know if you were here
earlier, Mr. Abboud as well. We established that applying for
the PMTA is one thing, but there is a burden of proof by the
manufacturers as to the safety of their products. And that is
the one element that is clearly not being met by many of the
products that are on sale across America today. Do you
understand that distinction?
Mr. Spross. I do. What I would also add, just in terms of
the--if you can't sell it through licensed, regulated retail
shops where you are age-verifying to prevent youth from
purchasing the products, it will go into the illicit market.
And so, quite frankly, as I said in my statement,
authorizations are the key to this. There's 250,000
applications currently before the FDA that have been sitting
there, in some cases more than 4 years, and the time is now.
Chair Durbin. Do you understand the law says that they'll
continue to sit there until the manufacturer meets a burden of
proof?
Mr. Spross. Yes.
Chair Durbin. You can't go selling those in the meantime,
assuming that they've proven something that they haven't
proven. Do you understand that distinction?
Mr. Spross. I do, yes.
Chair Durbin. Mr. Abboud, what about that? I mean, you said
this is prohibition. Is it prohibition to say you have the
burden of proof that your product is safe for public health
before it can be sold in the United States?
Mr. Abboud. Yes. The problem, of course, Senator, is the
fact that the FDA created the regulations. They set the
deadlines for complying with the regulations they asked for and
received funding from this body for enforcing those
regulations. They changed the rules of the regulations and the
requirements after applications were submitted, and they did so
in a manner that did not involve any sort of public policy
oversight.
The net result was the mass removal of products from the
marketplace, and which of course, spawned this illicit
marketplace.
Chair Durbin. The original law, the Tobacco Control Act,
puts a burden of proof on the manufacturer to prove that their
product is safe for public health. Do you understand that
responsibility?
Mr. Abboud. I do. I do. And the Reagan----
Chair Durbin. And do you disagree with that? Do you think
that's not the case?
Mr. Abboud. But manufacturers need to know from the FDA
what is required to make that proof. And the Reagan-Udall
Foundation, which was an independent body that was asked for by
the commissioner, said that the agency has not told companies
what is required to prove APPH or how they are interpreting it.
And instead of responding to that criticism, the FDA waited
1 year and said nothing. They are not telling manufacturers
what they need to do to comply. And they're not even telling
retailers what products they're even reviewing, much less how
they're reviewing them.
Chair Durbin. Twenty-three of those manufacturers have been
approved. So, obviously, they knew what they needed to comply.
Mr. Abboud. Well, that's a little bit of a stretch,
Senator. Only because they're 23 is really basically only 8
devices, which is--and only a few, 5 of them, are on the market
today. That's not enough for 30 million smokers. That is not
enough of options.
Chair Durbin. I think the bottom line is if you want to
discourage your own children from using vaping products, we
ought to understand the danger of that product. And I think you
inherently do. Most parents would. Senator Tillis.
Senator Tillis. Thank you, Mr. Chair. I want to go back
to--I think it related to a question that you asked Dr. Walley.
But a part of what we don't want to do is to remove options
that are safe for alternatives to an otherwise--to an activity
that you as a physician, you wish they wouldn't even vape.
Right?
But there's a reason why there are nicotine lozenges.
There's a reason why there are nicotine pouches. They are
providing people with off ramps to habits that, hopefully, they
can quit. It's how I quit last year starting with pouch
tobacco, actually starting with rough cut tobacco, moving to
pouch spitless tobacco, then ultimately to a nicotine pouch.
And now I'm as of last September, I've never--I haven't touched
it since. And Josie, I wish you the same. I know it's not going
to be easy.
But let's not forget that these are healthier alternatives
in the hands of adults. What we're trying to do is remove it as
an option, easily accessible option to children. We'll have a
separate discussion maybe on another day about the ultimate
disposition, but we shouldn't lose that. And Mr. Abboud, when
we see these shelves of products, and I guess Dr. Walley, it
was the Senator Durbin staff that went to the vape shop--I
haven't been to one yet, but I will go--we're talking about an
illegal product here. We're talking about something that
shouldn't be on the shelves.
So, Mr. Spross, could you just, for the record, could you
submit communications from your association to your members
that say this is bad, don't do it.'' Just evidence that you've
already suggested that you're doing that, but that you are
universally communicating to anybody that's associated or any
other retailer will ask the same of others that they're saying
this is bad, get it off the shelves. It's not only illegal,
it's unhealthy. Can you submit that for the record?
[Holds up vape products.]
Mr. Spross. Yes. We communicate to our members anytime
there's an enforcement action against the products that are
deemed illegal by the FDA.
Senator Tillis. Mr. Abboud, your industry's future rest on
getting this right. And again, I've got to believe that you
don't see your future as successfully marketing to kids. That
is not a sustainable path for a credible, legitimate business
in the United States, probably nowhere, but certainly not in
the United States.
So, if you were waiving a wand and you were Dr. King, or
you were in charge of the Federal Government regulatory
agencies, or you were a Member of the U.S. Senate and wanted to
fix this problem, what would your suggestion be? Number one; do
you suggest that there is a problem? Is there a problem that
needs to be fixed? That's the first question. Otherwise, it
disqualifies the second one; is there a problem that exists
with youth vaping and a vector to more dangerous outcomes?
Mr. Abboud. There is definitely an issue that persists.
Senator Tillis. Now, you've got an opportunity to wave a
wand. What should we do?
Mr. Abboud. There's two, maybe three principal things that
we do. The first is that we implement serious marketing and
access restrictions. The kind that we've been meeting with
Members on the Hill about, and we've been recommending for
years. Unfortunately, this body has typically only wanted to
talk about banning flavors as if flavors was in itself the only
thing about marketing.
We know that youth are impacted by this issue. They say
they are impacted and attracted to vaping for many other
reasons other than vaping. We can get to those concerns, we can
get to access restrictions and do things that doesn't require
removing all of the products that adults are using.
The second thing is, from an FDA perspective, I think we've
clearly heard the testimonies today. This is a hot mess right
now, and there is no clear pathway out, particularly through
this PMTA process.
And you heard Director King say, well, we're going to try
to resolve these applications, but we have to worry about
litigation. Of course, they do, because they put themself in a
box now where they have rejected en masse all flavored vaping
applications. So they can't make any more decisions along those
lines without worrying about what the supreme court thinks.
But the answer is already in the Tobacco Control Act. They
could implement a tobacco product standard. They can move on it
aggressively. They could state what should and should not be in
the products, how products should and should not be
manufactured. They can lay out those standards that
manufacturers can comply with.
There won't be any black box questioning as to what happens
when an application goes in. It won't take 4 or 5 years for an
application to get resolved, and then we can move forward with
an actual regulated market.
But unless they make harm reduction their north star,
unless they say we believe in vaping products--and we want to
encourage them like they are doing in other countries--we are
going to persist in having an illicit market. It will just be a
purely black market, not sold through any of the legal or
regulated licensed and tax-paying retailers and distributors
that our entities represent.
Senator Tillis. Thank you.
Chair Durbin. Senator Blumenthal.
Senator Blumenthal. Thanks, Mr. Chairman. Mr. Abboud, the
reason why you don't want your kids to vape is because of the
health risk. Correct?
Mr. Abboud. What I want my kids is to be healthy, as
healthy as possible. And when they're suffering from a variety
of issues that many adolescents are dealing with, then we have
to address those as parents.
Senator Blumenthal. Well, I think you've just answered my
question. I have limited time, but I think the answer is yes.
And the health risks are; Number 1, nicotine addiction; Number
2, the substances that may be in the vaping material. We have
no idea what they are when they come from China. They may be as
harmful as the carcinogens in tobacco.
So, I respect you as a parent also of four children, that
you want your kids to be in good health, and vaping is bad for
their health. And I also respect your criticisms of federal
regulation. As the Chairman of the Permanent Subcommittee on
Investigation, I released a report in February that documented
the regulatory failures that have created the hot mess that we
have right now. It's on us, the Federal Government, as well as
on the vaping manufacturers.
But what we documented was the missed opportunities by
federal agencies to stem the tide of addiction. This years-long
investigation highlighted the shameless marketing tactics of
new e-cigarette companies like Puff Bar, and the half measures
by the FDA that allowed Puff Bar to build on the popularity and
addiction that JUUL caused, and the need for enhanced federal
enforcement.
Am I correct in believing that you would support additional
resources and stronger regulation?
Mr. Abboud. Senator, to the earlier point, I also don't
want my kids drinking alcohol or using cannabis in flavors of
all varieties. I know kids are going to try things and to do
things. I don't try to base our national public health policies
or my beliefs on those based upon what's popular.
Senator Blumenthal. Well, let's break down the question.
You were critical, very specifically, of the lack of resources.
Let's just talk about resources. Would you support additional
resources going to FDA and other enforcement agencies to better
enforce restrictions on sales of vaping products?
Mr. Abboud. I honestly don't think it's a resource issue.
The FDA has had resources for years. They just haven't used
them in a manner that's efficient and that is effective. For
example, they use a lot of resources to go out and do retail
inspections, and they talk about vape shops being a problem.
What we found from their data is that the vape shops have the
best compliance rate with respect to the underage sales to
youth.
Senator Blumenthal. Well, I want to, you know, just take
this back to the manufacturers and the retailers of these
products. Wouldn't you agree that they've marketed to the kids?
Mr. Abboud. I think there is some poor marketing, which is
why we've been advocating for marketing restrictions in this
country. But----
Senator Blumenthal. The plain fact is----
Mr. Abboud [continuing]. There's not enough resources----
Senator Blumenthal [continuing]. They've taken a page from
Big Tobacco's playbook, and----
Mr. Abboud. There are not enough resources to enforce their
way out of this without other laws that can help put
restrictions on that. Enforcing a prohibition is going to lead
to simply a black market. It will not work. So until----
Senator Blumenthal. That's the same argument that was used
about tobacco and some of those restrictions have worked,
restrictions on marketing to kids.
Mr. Abboud. No, we're fine with that.
Senator Blumenthal. It's no accident that the vaping
companies are buying--I'm sorry, that the tobacco companies are
buying the vaping manufacturers because they know how it's
done. They can market in the way that they did with Joe Camel
and the Marlboro Man to kids.
That's Big Tobacco's playbook, and the vaping companies are
using it relentlessly, purposefully, and tirelessly with the
huge resources that they have now more than ever, because the
Big Tobacco companies are buying them.
Mr. Abboud. And we'd love to work with you on marketing
restrictions. That is something that has been important to us
for a while. We just don't think more resources thrown at the
FDA in its current makeup and with its current direction is an
answer.
Senator Blumenthal. Well, my time has expired, but I just
make the point to you as a former attorney general for 20
years, if you don't have resources, you don't have enforcement.
Resources are absolutely necessary. It's the lifeblood of
enforcement. Thanks.
Chair Durbin. Thank you, Senator Blumenthal. And thanks to
the panel. I want to thank Dr. Walley. Bringing science into
this from the medical perspective is a critical element. Ms.
Shapiro, thank you as well. Stepping up and making clear the
battle that you're fighting. You're going to win that battle,
and your coming here today is an act of courage, personally and
politically. It makes a difference.
I thank all the members of the panel. Ms. Richardson, I'm
sorry we didn't get into Campaign for Tobacco-Free Kids and the
great work that's been done through that organization over the
years.
Mr. Spross, Mr. Abboud, thank you for joining us. We may
have some written questions coming your way by Wednesday, June
19, and if you could respond to them quickly, we would
appreciate that.
Chair Durbin. Senator Tillis, do you have any closing
remarks?
Senator Tillis. Yes. Just very briefly. Thank you all for
being here, and I believe that everybody wants to try and
produce a good outcome for the threat that our youth faces. I
can't imagine anybody on the panel would be pursuing others.
I mentioned earlier that I think we have to have a broader
discussion about vaping because it's now the delivery mechanism
of choice for THC derivatives. And Dr. Walley, I don't know if
you've seen the research, I've spoken with behavioral health
experts that say that we're seeing an increase in psychotic
responses to so-called legal drugs.
The Eastern Band of the Cherokee now are starting to sell
THC products in North Carolina. I mentioned it in my opening
comments. They're marketing things in their native tongue among
a community that has a higher instance of substance abuse than
the U.S. population as a whole. I don't know if these are
healthy products or not, but I do know that when we're talking
about vaping, we need to go beyond just nicotine delivery to a
broader issue.
And Josie, I'm sure that you know a lot of friends who
moved off of nicotine to THC or to these other hybrids that
they're creating. It's a broader problem that we need to fix.
And Mr. Abboud, as I said earlier, your entire industry's
future rests on getting it right. So, we hope that you-all can
suggest to us things that we can do to come forward and address
the fundamental issue and the longer-term threat of these
practices happening in my own State of North Carolina. Thank
you, Mr. Chair.
Chair Durbin. Thanks, Senator Tillis. The meeting----
Dr. Walley. Could I respond to that, or no?
Chair Durbin. Very briefly.
Dr. Walley. Okay. Senator Tillis, I wanted to first start
and just congratulate you on your quit journey because nicotine
is highly addictive. In terms of your specific question about
THC, we do know, of course, this is a panel, to talk about
tobacco. That there is significant co-use, and we certainly,
the American Academy of Pediatrics have resources and strong
concerns. Thank you.
Chair Durbin. Thanks very much to the panel and those who
attended this important and historic hearing. The meeting the
Senate Judiciary Committee stands adjourned.
[Whereupon, at 12 p.m., the hearing was adjourned.]
[Additional material submitted for the record follows.]
A P P E N D I X
Submitted by Chair Durbin:
Advancing Convenience & Fuel Retailing, (NACS), ``Combatting the
Youth Vaping Epidemic by Enhancing Enforcement Against Illegal
E-Cigarettes''................................................ 146
Altria Client Services, Enforcement Recomendations, letter....... 154
Altria Client Services, Enforcement Recomendations, letter to FDA 163
American Lung Association, statement............................. 174
Cherfilus-McCormick, U.S. Representative Sheila, letter.......... 177
Convenience Distribution Association (CDA), statement............ 179
National Association of Secondary School Principals (NASSP),
statement..................................................... 184
Marijuana and the Pediatric Population 2020 Pediatrics, statement 186
Monitoring The Future (MTF), Estimates Based on 2024 Surveys..... 197
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