    [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

                                  ----------

                               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

                                  ----------

                            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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