[Senate Hearing 116-470]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 116-470

                     EXAMINING THE RESPONSE TO LUNG
                        ILLNESS AND RISING YOUTH
                        ELECTRONIC CIGARETTE USE

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                                   ON

 EXAMINING THE RESPONSE TO LUNG ILLNESSES AND RISING YOUTH ELECTRONIC 
                             CIGARETTE USE

                               __________

                           NOVEMBER 13, 2019

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
                                
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                    U.S. GOVERNMENT PUBLISHING OFFICE                    
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
	  
		    LAMAR ALEXANDER, Tennessee, Chairman
  MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
  RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
  JOHNNY ISAKSON, Georgia			ROBERT P. CASEY, JR., Pennsylvania
  RAND PAUL, Kentucky			TAMMY BALDWIN, Wisconsin
  SUSAN M. COLLINS, Maine			CHRISTOPHER S. MURPHY, Connecticut
  BILL CASSIDY, M.D., Louisiana		ELIZABETH WARREN, Massachusetts
  PAT ROBERTS, Kansas			TIM KAINE, Virginia
  LISA MURKOWSKI, Alaska			MARGARET WOOD HASSAN, New Hampshire
  TIM SCOTT, South Carolina		TINA SMITH, Minnesota
  MITT ROMNEY, Utah			DOUG JONES, Alabama
  MIKE BRAUN, Indiana			JACKY ROSEN, Nevada


		 David P. Cleary, Republican Staff Director
	   Lindsey Ward Seidman, Republican Deputy Staff Director
		    Evan Schatz, Minority Staff Director
      John Righter, Minority Deputy Staff Director
      
      
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                      WEDNESDAY, NOVEMBER 13, 2019

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State 
  of Washington, Opening statement...............................     4

                               Witnesses

Zeller, Mitch, Director, Center for Tobacco Products, U.S. Food 
  and Drug Administration, Silver Spring, MD.....................     6
    Prepared statement...........................................     8
Schuchat, Anne, M.D., Principal Deputy Director, Centers for 
  Disease Control and Prevention, Atlanta, GA....................    14
    Prepared statement...........................................    16

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
    E-Cigarette Use Among Youth in the United States, 2019.......    53

 
                     EXAMINING THE RESPONSE TO LUNG
                        ILLNESS AND RISING YOUTH
                        ELECTRONIC CIGARETTE USE

                              ----------                              


                      Wednesday, November 13, 2019

                                        U.S. Senate
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:04 a.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Lamar 
Alexander, Chairman of the Committee, presiding.
    Present: Senators Alexander [presiding], Enzi, Burr, Paul, 
Collins, Cassidy, Murkowski, Romney, Murray, Casey, Baldwin, 
Murphy, Kaine, Hassan, Smith, Jones, and Rosen.

                 OPENING STATEMENT OF SENATOR ALEXANDER

    The Chairman. Good morning. The Committee on Health, 
Education, Labor, and Pensions will please come to order. I 
often suggest that Americans look at Washington, DC. as if you 
were looking at a split screen television. Today is a good 
example. On the one screen, you have the House of 
Representatives beginning public impeachment hearings into the 
President of the United States while on the other side you have 
a bipartisan group of Senators investigating a mysterious 
illness tied to e-cigarette use that has harmed more than 2,000 
Americans. With 39 of those who have died, at a time when as 
many as 1 in 10, Tennessee high school students, and 1 in 4 
high school students nationwide are using e-cigarettes, most of 
them illegally purchased.
    If you walk into a convenience store to buy aspirin you 
assume the Food and Drug Administration has said it is safe and 
effective. When you pick up a package of peanut butter 
crackers, you assume the FDA ensured it was packaged in a clean 
space. That is when you go and check out and you grab an apple 
from a basket on the counter, you would assume FDA has 
established rules for how it was grown. And so when you go to 
buy one of these, this is an e-cigarette, you would also assume 
that someone says that it is okay to buy it, but you would be 
wrong because this is an e-cigarette and the Food and Drug 
Administration has not used its authorities to say whether or 
not they are okay to be sold.
    Not a single e-cigarette or vaping product has been 
reviewed and cleared for sale by the Food and Drug 
Administration. According to data from FDA and the Centers for 
Disease Control and Prevention, over the last 2 years, 13.5 
million Americans, including over 5 million teenagers, have 
used e-cigarettes with about 1.6 million teenagers using e-
cigarettes frequently. Remember, e-cigarettes are tobacco 
products so legally it is illegal to sell tobacco products to 
persons under 18. In Tennessee, about 1 in 20 adults use e-
cigarettes some day or every day, and about 1 in 10 high school 
students used an e-cigarette in the last 30 days.
    According to CDC and FDA information, as many 1 in 4 high 
school students are using e-cigarettes. Over the last 6 months, 
there have been 2,051 Americans hurt, 39 have died, including 
two in Tennessee, from vaping-related lung illnesses, many from 
vaping with THC, the derivative of marijuana that makes people 
high. So here is what I would like to learn today. One, what 
have FDA and the CDC learned about the more than 2,000 
Americans who have gotten hurt from vaping. Second, 3 years 
after FDA said it had the authority to regulate e-cigarettes, 
why aren't there any rules in effect about what standards e-
cigarettes and vaping products need to meet? Three, what should 
FDA be doing to regulate and review these products? Four, there 
has been a 700 percent increase in the number of teenagers 
vaping since 2013.
    What has the FDA and CDC done about this surge of teenagers 
vaping? And fifth, how much of the $5.5 billion that the Center 
for Tobacco Products at FDA has received in user fees from the 
tobacco industry over the last decade has been spent on e-
cigarettes and vaping? These so-called e-cigarettes, which can 
turn a liquid containing nicotine into a vapor, can look like a 
pen, or a USB flash drive that you plug into your computer, or 
a regular cigarette. These are some of the pictures right here. 
Those are the devices that can be seen.
    Sometimes the liquid has a flavor, a mint or fruit flavor 
for example, that can be particularly appealing to younger 
people. To make this one work, this one here, there is a 
cartridge with liquid containing nicotine derived from tobacco, 
and it begins to operate automatically when you inhale it. In 
March of this year, doctors began to see patients with 
shortness of breath, chest pain, nausea, vomiting, and other 
symptoms, with no obvious cause.
    The common thread was that all the patients had used e-
cigarettes. On August 1, CDC, in coordination with FDA, began 
an investigation into this outbreak of vaping-related 
illnesses. While a large number of the cases involve THC, the 
derivative of marijuana that makes people high, Americans using 
e-cigarettes are inhaling something that is damaging their 
lungs and we need to find out what that is. Last Friday, the 
Centers for Disease Control announced the discovery of an 
additional ``very strong culprit,'' a form of vitamin E called 
Vitamin E acetate. According to CDC, inhaling Vitamin E acetate 
could harm your lungs. I look forward to hearing more about 
what CDC and FDA have found. In the middle of this outbreak of 
vaping-related illnesses and a 700 percent increase in the 
number of teenagers using e-cigarettes since 2013, I am 
concerned that the Center for Tobacco Products has received 
almost $5.5 billion in user fees and that there are no rules in 
effect yet to regulate e-cigarettes.
    This means that more than 8 million adults have used e-
cigarettes, many instead of smoking, that FDA has not said are 
okay to be sold. FDA has not always regulated tobacco products. 
In 2009, ten years ago, Congress passed the Family Smoking 
Prevention and Tobacco Control Act, giving the Center for 
Tobacco Products at FDA the authority to regulate tobacco 
products. I voted against this bill because I thought it did 
the right thing in the wrong way.
    I was concerned that FDA was already overwhelmed with 
ensuring the safety of our medicines and food supply and did 
not need the added burden of regulating tobacco. Nevertheless, 
Congress disagreed, and in 2009 Congress and the President gave 
the FDA the job of regulating tobacco products--ten years ago. 
By 2011, e-cigarettes were becoming widely used products, and 
the National Youth Tobacco Survey reported that teenagers were 
beginning to use e-cigarettes as well.
    Now here is--this shows the increase. So we see, that 
starts in 2011, 2009 was when tobacco products were regulated 
by the FDA, 2011 began the used survey of tobacco products. In 
2016, the FDA said that e-cigarettes were a part of tobacco 
products, regulated in the same way. And you can see in the red 
line at the top, the FDA and CDC figures that suggest that as 
many as 1 in 4 of high school students are using e-cigarettes. 
So it wasn't until 2016, 5 years after e-cigarettes were 
becoming widely used, that FDA announced it would begin 
regulating e-cigarettes as tobacco products. As a result, it 
has been illegal under Federal law to sell e-cigarettes to 
anyone under 18 since 2016.
    Despite the fact that FDA has been in charge of tobacco 
since 2009, has been tracking youth use of e-cigarettes since 
2011, declared it would begin to regulate e-cigarettes in 2016, 
there are no rules in effect for manufacturers of those vaping 
products. It was just earlier this year that FDA took the first 
step, the Agency proposed a rule in April and a second in 
September, to give manufacturers direction on what information 
FDA would need to review and authorize e-cigarettes. FDA needs 
to make these rules final so that manufacturers have clear 
standards and so consumers know that the e-cigarettes they are 
buying have met certain qualifications. The only reason e-
cigarettes are allowed to be sold at the convenience store is 
because FDA has decided to allow them to be sold while the 
Agency sets those standards.
    In addition, because it is already illegal to sell e-
cigarettes to those under 18. FDA has the authority to prevent 
online shops and stores from selling to teenagers. But parents, 
teachers, and principals are overwhelmed by the number of 
teenagers vaping--more than 5 million teenagers reported using 
an e-cigarette in the last 30 days, according to a recent 
National Youth Tobacco Survey.
    In just one year, 2013 to 2014, youth use of e-cigarettes 
tripled. Since 2014, the number of high school students using 
these products has more than doubled. I know the administration 
has been concerned about the number teenagers using e-
cigarettes and is working on a proposal to address flavored e-
cigarettes. A step Congress could take would be to pass 
Senators McConnell and Kaine's provision in our Lower Health 
Care Costs Act, which raises the minimum age for purchasing any 
tobacco product, including e-cigarettes, from 18 to 21.
    In conclusion, this is the reality, 13.5 million Americans, 
including more than 5 million teenagers, have reported using e-
cigarettes, with 1.6 million teenagers vaping regularly, and 
these products have not yet met any FDA rules or standards. And 
over the last 6 months, more than 2,000 Americans have gotten 
sick, and 39 have died, from lung illness related to vaping. 
This is an unacceptable situation that demands our attention 
and I look forward to hearing from our witnesses today.
    Senator Murray.

                  OPENING STATEMENT OF SENATOR MURRAY

    Senator Murray. Well, thank you, Mr. Chairman, for having 
this hearing and thank you to our witnesses for joining us 
today. Right now, families across the country are worried about 
the epidemic of lung injuries that are associated with e-
cigarettes or vaping products that, as the Chairman has said, 
has struck over 2,000 people, including 14 in Washington State, 
and claimed 39 lives. My heart goes out to all the victims and 
their families.
    I know all of my colleagues agree this is an urgent issue, 
and we are all very interested in what our witnesses today have 
to tell us about this crisis, and what steps we can take to 
stop it in its tracks and prevent similar outbreaks in the 
future. And beyond this new illness, families across the 
country are also deeply concerned about the continuing uptick 
in youth e-cigarette use. Again as the Chairman said, the 
latest data is showing us that 1 in 4 high school students and 
1 in 10 middle school students are using e-cigarettes. That is 
a really alarming increase and is fueled by companies' efforts 
to appeal to kids, threatens decades of work, and puts a 
generation of children at risk of nicotine addiction.
    For years, popular e-cigarette brands, like Juul, the brand 
we know most kids use, have appealed to kids through flavors 
like mint, menthol, and creme brulee and youth-savvy 
advertising, like campaigns with influencer personalities, 
among other tactics. While the communities across the country 
are treating nicotine addiction among kids like a public health 
crisis, e-cigarette companies have been treating it like a 
business plan. In fact, Juul reportedly not only knew how 
addictive and appealing its product would be for kids but used 
the addictiveness to market the product to retailers. One Juul 
pod can have as much nicotine as a pack of cigarettes and many 
kids don't even realize it. This crisis is spiraling out of 
control and it requires swift, bold action.
    For years, President Trump and his team have shown little 
interest in taking on the tobacco industry behind this epidemic 
and fighting for our children. His advisor Kellyanne Conway, 
recently and wrongly said the FDA has no jurisdiction over 
vaping and vape shops. Another of President Trump's leading 
voices on health care policy said he doesn't believe the FDA 
should even be regulating tobacco products and that the FDA's 
regulation of tobacco is, believe it or not, a ``huge waste of 
time.'' That is not merely alarming, it is dead wrong. But it 
is not just the Trump administration's words that should make 
families skeptical, it is putting our children's best interests 
ahead of tobacco companies' products and profits, it is the 
administration's actions.
    In 2017, the Trump administration delayed FDA oversight of 
existing e-cigarette products by four years. The decision, 
which former FDA Commissioner Gottlieb has since admitted was a 
mistake and a court has since ruled was unlawful, was a victory 
for companies like Juul, which were able to continue targeting 
our Nation's youth and selling flavored products that appealed 
to kids. In the years since the Trump administration decided to 
hit the snooze button on making sure e-cigarettes meet even the 
most basic standards, youth tobacco use has skyrocketed, driven 
by e-cigarette use which has more than doubled among high 
school students since 2017, and more than tripled among middle 
school students.
    While the Trump administration's decision to delay 
oversight of products already on the market has allowed this 
crisis to grow, its lackluster enforcement against new products 
coming to market illegally, has allowed it to fester, creating 
a wild west of vape products that are unregulated, and that can 
be incredibly dangerous in all sorts of ways, something the 
current epidemic of vaping-related illness has made all too 
clear. Between the crisis of rising youth tobacco use, and the 
alarming outbreak of vaping related illnesses, families are 
counting on us to act quickly and keep them safe.
    Washington State is one of several states that has already 
taken action by passing an emergency rule to ban flavored e-
cigarettes and raising the purchasing age for tobacco to 21. 
This Committee has also advanced legislation to raise the 
purchasing age to 21 nationally, but while we push for that 
step, there is still much more that needs to be done, including 
immediately clearing the market of all flavored e-cigarettes 
that have not undergone FDA review. Unfortunately, despite 
President Trump's recent promise to clear the market of non-
tobacco flavored e-cigarettes nationally, a promise that, for 
the first time, seemed to indicate this administration was 
taking the youth vaping epidemic seriously, reporting now 
suggests he may be walking away from that proposal altogether, 
or planning to bow to tobacco industry pressure with a watered-
down policy that could carve out vape shops, and leave menthol, 
a huge category of incredibly popular e-cigarette flavors, 
unaddressed. That would be a massive loophole, and absolutely 
unacceptable.
    In fact, new data released just last week showed us that 
youth use of mint and menthol e-cigarettes dramatically 
increased over the last year alone. We need swift, bold action, 
not delays and half-steps. And that doesn't just go for e-
cigarettes, but also for cigars, including kid-appealing 
flavored cigars, cigarettes, including menthol cigarettes, and 
other tobacco products. We need to continue investing in public 
health programs and preventive measures through CDC. And we 
need real progress on reducing the levels of nicotine in 
cigarettes, another policy the Trump administration promised 
but I am going to keep pushing for. And I am absolutely going 
to be pushing President Trump's new nominee to lead the FDA 
about his plans to fight tobacco use as well.
    Because our communities, our kids, cannot wait for the 
Trump administration to get its act together. Back in my home 
State of Washington, the La Conner school district recently 
filed a lawsuit against Juul for its role in the epidemic of 
youth tobacco use. Meanwhile, students at Jackson high school 
are encouraging their peers to take a pledge against vaping. 
And earlier this year, Madison, a young student from Ridgefield 
High School, testified in front of the state legislature about 
her own experience with e-cigarette addiction, and encouraged 
our lawmakers to take action.
    Leaders and advocates across the country are doing 
everything they can to respond to this crisis, and they deserve 
to know that we are doing everything we can too. That is why I 
am going to keep pushing for action on e-cigarettes and vaping, 
and I know there are Members on both sides of the aisle that 
want us to do more on this as well. So I hope we can take what 
we learn from this hearing and use it to continue working 
together, in a bipartisan way, on common sense steps to keep 
our kids, and our communities, safe.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murray. We have good 
attendance today. I am glad to see that. We have a vote at 11 
a.m., but we will continue the hearing right through the votes 
and we will alternate chairing the hearing so every Senator 
will have a chance to ask questions that they would like to 
ask. We appreciate our witnesses coming today and thank you for 
your willingness to serve our country in such important roles. 
We would ask you each to summarize your comments in about five 
minutes, which will allow more time for back and forth between 
you and Senators.
    First, we will hear from Mitch Zeller. Mr. Zeller is 
Director of the U.S. Food and Drug Administration Center for 
Tobacco Products. In this role, he leads FDA's effort to reduce 
tobacco related death and disease through research and 
regulation. He has worked on FDA related issues for more than 
30 years, joined the Agency in 1993, when he was the first 
Associate Commissioner and Director of the Office of Tobacco 
programs. He left FDA in 2000 and returned to lead the Center 
for Tobacco Products in 2013. He is a graduate of Dartmouth and 
has a J.D. from American University.
    Our second witness is Dr. Anne Schuchat. She is the 
Principal Deputy Director for the Center for Disease, Control 
and Prevention. She has held a variety of leadership roles 
there, including Acting Director, Director of the National 
Center for Immunization and Respiratory Diseases, and Chief of 
the Respiratory Diseases branch. Since joining CDC as an 
Epidemic Intelligence Service Officer in 1998, she has played 
key roles in its public health emergency responses, including 
the 2009 pandemic influenza response, the 2003 SARS outbreak, 
and the 2001 Anthrax attack.
    In 2008, she retired from the Commission Corps of the 
United States Public Health Service at the rank of Rear Admiral 
completing 30 years of service. She is a graduate of Swarthmore 
and received her M.D. from Dartmouth. We welcome both 
witnesses. Mr. Zeller let us begin with you.

    STATEMENT OF MITCH ZELLER, DIRECTOR, CENTER FOR TOBACCO 
 PRODUCTS, U.S. FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD

    Mr. Zeller. Good morning, Chairman Alexander, Ranking 
Member Murray, Members of the Committee, and thank you for the 
opportunity to be here today. I want to assure the Committee of 
the seriousness with which FDA takes its responsibilities on 
the public health issues that the Chairman and Ranking Member 
have already discussed.
    I am here today representing hundreds of staff at FDA who 
are working tirelessly to both prevent kids from starting to 
use any tobacco product, including e-cigarettes, and in 
collaboration with our colleagues at CDC, to get to the bottom 
through an investigation of what is causing these lung 
injuries. I will begin by discussing e-cigarette regulation and 
then provide an update on the lung injury investigation.
    FDA's initial efforts to regulate e-cigarettes began more 
than a decade ago, long before the rise in youth use and the 
multi-state lung injury outbreak. Between 2008 and 2010, FDA 
attempted to regulate e-cigarettes as unapproved drug device 
combination products. Our actions were challenged and 
ultimately overturned in court. In the decade since the Tobacco 
Control Act was passed, FDA has established a science-based 
approach to the regulation of tobacco products, vigorously 
enforced our authorities to target manufacturers and retailers 
that violate the law and designed innovative campaigns to 
educate youth on the dangers of tobacco use.
    The Tobacco Control Act provided FDA the authority to 
regulate e-cigarettes as tobacco products. Publication of the 
final deeming rule brought e-cigarettes under FDA's regulatory 
authority on August 8th, 2016. Let me highlight some of the 
actions that we have taken to address the epidemic of kids' use 
of e-cigarettes. We have issued more than 10,000 warning 
letters and filed more than 1,500 civil money penalty 
complaints against online and brick and mortar retailers for 
the illegal sale of e-cigarettes to kids. We have issued 
warning letters to six companies, notifying them of the need to 
remove more than 140 illegally marketed products from the 
market. We have issued warning letters that have resulted in 
the removal of dozens of e-liquid products that resemble kid 
friendly foods, like juice boxes, cereal, and candy.
    We have issued a warning letter to Juul labs for marketing 
unauthorized modified risk tobacco products. Last year, we 
launched the Real Cost Youth E-Cigarette Prevention Campaign, 
which features hard-hitting advertising on TV and on digital 
and social media sites popular among teens, as well as getting 
posters with e-cigarette prevention messages placed in every 
single public and private high school in the country. Finally, 
we joined forces with scholastic to develop educational 
resources that have been distributed to more than 1 million 
middle school and high school educators. Despite these efforts, 
the youth vaping epidemic continues to grow and we need to do 
more. As the Committee considers the issues related to e-
cigarette use, it is important to remember that no e-cigarette 
in the United States is on the market legally because none have 
obtained a marketing authorization from FDA.
    When we announced changes to our enforcement discretion 
policy in August 2017, at the time nationally representative 
data suggested that youth use of e-cigarettes had declined. 
However, as the Chairman and the Ranking Member pointed out and 
as we all know, last year with the release of the National 
Youth Tobacco Survey or NYTS, the results showed that between 
2017 and 2018 current e-cigarette use among high school 
students increased by 78 percent and by 48 percent among middle 
school students. Last week, we released the 2019 NYTS data 
showing that current e-cigarette had risen to 27.5 percent 
among high school students and 10.5 percent among middle school 
students. As in previous years, the 2019 NYTS shows a 
disturbing rate of youth use of flavored e-cigarettes.
    Among current exclusive e-cigarette users, nearly three-
quarters of those in high school and more than a half of those 
in middle school used flavored e-cigarettes. We are committed 
to doing everything that we can to prevent kids from using 
tobacco products and we will continue to develop a policy 
approach that aligns with that concern. Let me now turn to the 
lung injuries. FDA is deeply concerned by reports of injuries 
and deaths linked to use of vaping products and investigating 
this crisis is a top priority. On September 6th we activated an 
Incident Management Group or IMG to coordinate the Agency's 
investigation. The IMG is comprised of subject matter experts 
from across FDA dedicated to better understanding the 
relationship between any specific products or substances and 
the reported cases.
    Our labs have received over 1,000 samples from 25 states 
including 850 samples connected to patients. Samples associated 
with 69 of these patients have been examined. 80 percent of the 
69 linked cases involve THC products. 75 percent of the linked 
cases involving THC include products with vitamin E acetate as 
a diluent. I want to thank the Committee for the opportunity to 
appear today.
    We appreciate the Committee's support for the Agency and 
for our vital public health mission. And I am happy to answer 
any questions that you have. Thank you.
    [The prepared statement of Mr. Zeller follows:]
                   prepared statement of mitch zeller
                              Introduction
    Good morning, Chairman Alexander, Ranking Member Murray, and 
Members of the Committee. Thank you for the opportunity to be here 
today to discuss the Food and Drug Administration's (FDA or the Agency) 
regulation of electronic nicotine delivery systems, or ENDS, which 
include e-cigarettes, and the Agency's role in the ongoing 
investigation into vaping product use associated lung injury. I am 
Mitch Zeller, Director of the U.S. Food and Drug Administration's 
Center for Tobacco Products.

    I appreciate the opportunity to be here today to provide an update 
on FDA's regulation of ENDS, and to provide an update on FDA's efforts 
to investigate the illnesses associated with the use of vaping 
products.

    In my testimony I will begin with some background on FDA's tobacco 
product regulatory authorities. I will then address the history of our 
regulation of e-cigarettes and where we find ourselves today, 
confronting the epidemic levels of youth use of e-cigarettes. Finally, 
I will discuss FDA's role in the Federal and state investigation of the 
cases of lung injury.
                               Background
    Let me start with some background on our tobacco regulatory 
authorities.

    Tobacco use is the single largest preventable cause of disease and 
death in the United States. Each year, more than 480,000 people in the 
United States die prematurely from diseases caused by cigarette smoking 
and exposure to tobacco smoke. In 2009, Congress passed the Family 
Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which 
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to 
authorize FDA to oversee the manufacture, marketing, distribution, and 
sale of tobacco products and protect the public from the harmful 
effects of tobacco product use. This authority gave FDA comprehensive 
tools to protect the public from the harmful effects of tobacco use 
through science-based tobacco product regulation.

    Through premarket review, FDA evaluates new tobacco products based 
on applicable public health standards that include, for example, a 
consideration of the risks and benefits of the tobacco product to the 
population as a whole, including users and non-users. Similarly, when 
developing certain regulations such as product standards or 
restrictions on tobacco sales and advertising, the law requires FDA to 
apply a public health approach that considers the effect of the 
regulatory action on the population as a whole, not just on individual 
users, taking into account the likelihood of initiation and cessation 
of tobacco use.

    Under the statute, FDA had immediate authority to regulate 
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco. The Tobacco Control Act also authorized FDA to ``deem'' other 
``tobacco products'' (which include ``any product made or derived from 
tobacco that is intended for human consumption'' that is not a drug, 
device, or combination product under the FD&C Act, ``including any 
component, part, or accessory'' of that product) to be subject to the 
Agency's regulatory authority in Chapter IX of the FD&C Act.

    It's important to note FDA's initial efforts to regulate e-
cigarettes more than a decade ago, long before the rise in youth use 
and the multi-state lung injury outbreak. Between 2008 and 2010, FDA 
attempted to regulate e-cigarettes as unapproved drug/device 
combination products. FDA's action was challenged, and ultimately the 
U.S. Court of Appeals for the D.C. Circuit ruled that while FDA could 
choose to regulate e-cigarettes and other products ``made or derived 
from tobacco'' under its new tobacco authorities, it could not regulate 
these products under FDA's drug and device authority unless they were 
marketed for therapeutic purposes. Sottera, Inc. v. Food and Drug 
Administration, 627 F.3d 891 (D.C. Cir. 2010).

    Publication of the final deeming rule brought e-cigarettes under 
FDA's regulatory authority for tobacco products. That rule was issued 
on May 10, 2016, deeming additional products that meet the statutory 
definition of a ``tobacco product,'' except for accessories of such 
products, to be subject to FDA's regulatory authority. Deemed products 
include ENDS, cigars, pipe tobacco, nicotine gels, waterpipe (or 
hookah) tobacco, and any future tobacco products. The deeming rule, and 
FDA's regulation of these products, took effect on August 8, 2016.
               Regulatory Requirements for ENDS Products
    When the deeming rule took effect in August 2016, many of the 
regulatory and legal requirements that had been in place for 
manufacturers of cigarettes, smokeless tobacco, cigarette tobacco, and 
roll-your-own tobacco since 2009, as well as several new requirements 
specific to deemed products, became applicable to makers of e-
cigarettes and other ENDS products. These include:

          Registering domestic establishments and submitting 
        lists of products manufactured at those establishments, 
        including all labeling and representative samples of 
        advertisements;

          Submitting tobacco health documents;

          Submitting ingredient listings;

          Marketing new tobacco products only after FDA review; 
        and

          Marketing products with direct or implied claims of 
        reduced risk only if FDA confirms that scientific evidence 
        supports the claim and determines that providing a marketing 
        authorization for the product will, among other things, benefit 
        the health of the population as a whole.

    In addition, under the deeming rule, the following regulatory 
provisions also apply to deemed tobacco products, including ENDS 
products:

          Minimum age restriction (18 years or older) and 
        identification requirements to prevent sales to underage youth;

          Requirements to bear certain health warnings on 
        packages and advertisements (including certain ENDS components, 
        such as e-liquids) such as, ``WARNING: This product contains 
        nicotine. Nicotine is an addictive chemical.'' and

          Prohibition of vending machine sales, unless in a 
        facility that never admits youth.

    To provide time for industry to come into compliance with some of 
the new regulatory requirements triggered by the final deeming rule, 
FDA announced an enforcement policy with staggered timeframes. Some of 
the requirements, such as the Federal minimum age of purchase (18 years 
or older), were enforced immediately when the deeming rule took effect 
on August 8, 2016, while, through an exercise of enforcement 
discretion, FDA temporarily deferred enforcement of other provisions 
such as premarket review of ``new'' tobacco products.
                        Premarket Review of ENDS
    All deemed products, including ENDS, became subject to the 
premarket authorization requirements in the Tobacco Control Act on 
August 8, 2016. All ``new tobacco products'' are required to obtain 
authorization from FDA before they can be legally marketed. Pursuant to 
the Tobacco Control Act, a ``new tobacco product'' is one that was not 
commercially marketed as of February 15, 2007, or that was modified 
after February 15, 2007.

    FDA's initial compliance policy for premarket review stated that 
the Agency did not intend to enforce the requirements of premarket 
review against manufacturers of newly regulated new tobacco products 
that were on the market as of August 8, 2016, as long as they submitted 
marketing applications and received authorization within specific 
timeframes. As a result, FDA anticipated that many ENDS products would 
remain on the market without premarket authorization for up to three 
years.

    In July 2017, FDA announced a new comprehensive plan for tobacco 
and nicotine regulation that would serve as a multi-year roadmap in an 
effort to significantly reduce tobacco-related disease and death. The 
comprehensive plan was announced in part to afford the Agency time to 
explore other meaningful measures, beyond premarket review, to make 
combustible tobacco products less toxic, less appealing, and less 
addictive. One aspect of the plan involved striking a balance between 
conducting reasonable oversight through regulation and encouraging 
development of innovative tobacco products that may be less harmful 
than cigarettes. The Agency announced that it planned to issue an 
updated compliance policy to defer some enforcement timelines described 
in the preamble to the final deeming rule.

    Since that announcement, FDA has been hard at work on rules, 
guidances, and other communications that will help manufacturers 
develop higher quality applications, including the issuance of the 
following:

          Substantial Equivalence pathway proposed rule

          Premarket Tobacco Application for ENDS final guidance

          Premarket Tobacco Application proposed rule

          Vape shops final guidance

          Regular meetings with manufacturers to provide 
        guidance on premarket authorization processes

          Regular meetings with retailers on e-cigarette 
        policies of particular importance for retailers such as efforts 
        to prevent youth sales and the availability of free educational 
        resources for retailers to assist them in preventing youth 
        sales

          Draft guidance on Developing Nicotine Replacement 
        Therapy Drug Products

          Draft guidance on Nonclinical Testing of Orally 
        Inhaled Nicotine-Containing Drug Products Guidance for Industry

    The July 2017 announcement led to publication of the August 2017 
Compliance Policy, which was later the subject of litigation. In May 
2019, a U.S. District Court in Maryland vacated FDA's August 2017 
Compliance Policy. In July 2019, the court issued a further order 
directing FDA to require that applications for deemed ``new tobacco 
products'' such as e-cigarettes, cigars, pipe tobacco, and hookah 
tobacco, that were on the market as of August 8, 2016, be filed with 
FDA no later than May 12, 2020. The court order also provided for a 
one-year period during which products with timely filed applications 
might remain on the market pending FDA review, but subsequently 
clarified that its order does not restrict the Agency's authority to 
enforce the premarket review provisions against deemed products prior 
to May 12, 2020, or during the one-year review period.

    As the Committee considers the issues related to e-cigarette use 
today, it is important to remember that no ENDS product in the United 
States is on the market legally. To be legally marketed as a tobacco 
product, the product would need to obtain premarket authorization from 
the Agency. The product would undergo FDA scientific review, and 
(assuming that the product is being reviewed through the Premarket 
Tobacco Application pathway) the Agency would have to find that the 
product meets the applicable statutory standard for marketing--for 
example, that the product is appropriate for the protection of the 
public health. Alternatively, an ENDS product that is intended for 
therapeutic purposes (e.g., smoking cessation) would need to be 
reviewed and approved under FDA's drug authorities to be legally 
marketed as a drug. Currently, there is no FDA-authorized or FDA-
approved ENDS product on the market.
FDA's Aggressive Actions to Address the Youth Epidemic of ENDS Product 
                                  Use
    At the time FDA issued the August 2017 Compliance Policy to modify 
the enforcement discretion policies regarding premarket authorization, 
nationally representative data suggested that youth use of e-cigarettes 
had declined. \1\ While no level of youth use is acceptable, FDA took 
this directional data into consideration, along with the potential 
benefits some of these products might provide to some addicted 
individual adult smokers seeking to make a complete transition away 
from combustible cigarettes.
---------------------------------------------------------------------------
    \1\ Jamal A, Gentzke A, Hu SS, et al. Tobacco Use Among Middle and 
High School Students--United States, 2011-2016. MMWR Morb Mortal Wkly 
Rep 2017;66:597-603. https://www.cdc.gov/mmwr/volumes/66/wr/
mm6623a1.htm?s_cid=mm6623a1_w. The NYTS defines e-cigarettes as 
``battery-powered devices that provide nicotine and other additives to 
the user in the form of an aerosol.''

    The Agency was engaged in a public health balancing act. Given the 
then-existing evidence suggesting a decline in youth use, and with the 
potential for FDA to pursue other bold measures, in part by reducing 
the addictiveness of combustible cigarettes while temporarily delaying 
the likely immediate market exit of newly deemed tobacco products that 
could be potentially less harmful to individual users, FDA determined 
that the balancing of public health considerations argued in favor of a 
---------------------------------------------------------------------------
different comprehensive approach to nicotine and tobacco regulation.

    However, only a year after we announced the 2017 comprehensive 
plan, the National Youth Tobacco Survey (NYTS) in 2018 showed a new and 
significant increase in youth use of e-cigarettes. FDA collaborates 
with CDC to administer the survey to middle and high school students 
each year. The survey provides important data that allow us to 
understand current youth tobacco product use in a larger historical 
context.

    Between 2017 and 2018, current (past 30-day) e-cigarette use among 
high school students increased 78 percent, from 11.7 percent to 20.8 
percent. \2\ Current e-cigarette use among middle school students 
increased by 48 percent over the same time period, from 3.3 percent to 
4.9 percent. \3\ Moreover, evidence demonstrated that youth are 
especially attracted to flavored ENDS products. Data from the 2018 NYTS 
showed that, in just one year, current use of flavored e-cigarettes 
increased substantially among high school students who were current e-
cigarette users, from 60.9 percent in 2017 to 67.8 percent in 2018. \4\ 
In addition, the proportion of current e-cigarette users in high school 
who reported use on 20 or more days of the past 30 days increased from 
20.0 percent in 2017 to 27.7 percent in 2018.
---------------------------------------------------------------------------
    \2\ Id.
    \3\ Id.
    \4\ Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al., ``Notes from 
the Field: Increase in e-cigarette use and any tobacco product use 
among middle and high school students--United States, 2011-2018,'' 
Morbidity and Mortality Weekly, 67(45);1276-1277 (2018).

    FDA and CDC recently published 2019 NYTS data in the Journal of the 
American Medical Association (JAMA). \5\ Unfortunately, the data show 
that current e-cigarette use among youth has continued at its alarming 
increase, with 27.5 percent of high school students and 10.5 percent of 
middle school students reporting current use of e-cigarettes. The data 
also showed that more than five million U.S. middle and high school 
students are current e-cigarette users. Further, most of those middle 
and high school students who exclusively use e-cigarettes are using 
flavored products. And the survey shows that 34.2 percent of current 
high school e-cigarette users in 2019 are using the product frequently 
(use on 20 or more days in the last 30 days). In total, 1.6 million 
middle school and high school current e-cigarette users were frequent 
users, with nearly one million using e-cigarettes daily.
---------------------------------------------------------------------------
    \5\ https://jamanetwork.com/journals/jama/fullarticle/2755265.

    As in previous years, the 2019 NYTS shows a disturbing rate of 
youth use of non-tobacco flavored e-cigarettes. In particular, the data 
show that among current exclusive e-cigarette users, nearly three 
quarters of those in high school and more than half of those in middle 
school used flavored e-cigarettes. The most commonly reported flavors 
were fruit, menthol or mint (evaluated as a single category), and 
candy, desserts, or other sweets. \6\ Importantly, findings from 
another study, the 2019 Monitoring the Future (MTF) survey--also 
published in JAMA on November 5, 2019--give us a more granular picture 
of flavor preferences as they relate to this public health balancing 
act. These findings indicate that youth preference for menthol- and 
tobacco-flavored products is much lower than that for mint- and fruit-
flavored products. This recent analysis was limited to youth who 
indicated they had specifically used the JUUL brand.
---------------------------------------------------------------------------
    \6\ Cullen KA, Gentzke AS, Sawdey MD, et al., ``E-Cigarette Use 
Among Youth in the United States, 2019,'' JAMA.

    We are committed to doing everything we can to prevent kids from 
using tobacco products and will continue to develop a policy approach 
that aligns with that concern. Additionally, we are taking a number of 
---------------------------------------------------------------------------
other actions to help address the youth use epidemic:

          FDA has been holding retailers and manufacturers 
        accountable for marketing and sales practices that have led to 
        increased youth accessibility and appeal of e-cigarettes. For 
        example, since the effective date of the Deeming Rule in August 
        2016, FDA has issued more than 10,000 warning letters to, and 
        filed more than 1,500 civil money penalty complaints against, 
        retailers, both online and in brick-and-mortar retail stores, 
        for sales of ENDS and their components to youth.

          FDA has sent letters to over 100 companies seeking 
        information on over 130 brands, including ENDS products, to 
        determine whether those products were not marketed as of August 
        8, 2016, and therefore not subject to any previous FDA 
        compliance policy. To date, FDA has issued warning letters to 
        six ENDS companies notifying them of the need to remove a 
        combined total of more than 140 products from the market.

          The Agency has issued warning letters, many in 
        collaboration with the Federal Trade Commission (FTC), that 
        resulted in the removal of dozens of e-liquid products 
        resembling kid-friendly foods, such as juice boxes, cereal, and 
        candy.

          On September 9, 2019, FDA issued a warning letter \7\ 
        to JUUL Labs Inc. for marketing unauthorized modified risk 
        tobacco products by engaging in labeling, advertising, and/or 
        other activities directed to consumers, including a 
        presentation given to youth at a school, by marketing it for 
        reduced risk or harm from using the product compared to 
        cigarette smoking. Concurrently, the Agency issued a second 
        letter expressing its concern and requesting additional 
        information about several issues raised by Congress regarding 
        JUUL's outreach and marketing practices, including those 
        targeted at students, tribes, health insurers and employers.
---------------------------------------------------------------------------
    \7\ The warning letter is available at: https://www.fda.gov/news-
events/press-announcements/fda-warns-juul-labs-marketing-unauthorized-
modified-risk-tobacco-products-including-outreach-youth.

          FDA has also continued to invest in campaigns to 
        educate youth about the dangers of e-cigarette use. Last year, 
        FDA launched ``The Real Cost'' Youth E-Cigarette Prevention 
        Campaign \8\--a comprehensive effort targeting nearly 10.7 
        million youth, aged 12-17, who have used e-cigarettes or are 
        open to trying them. The campaign features hard-hitting 
        advertising on TV, digital and social media sites popular among 
        teens, as well as posters with e-cigarette prevention messages 
        in high schools across the Nation.
---------------------------------------------------------------------------
    \8\ More information is available at: https://www.fda.gov/tobacco-
products/real-cost-campaign.

          FDA joined forces with Scholastic to develop 
        educational resources for middle and high school teachers and 
        administrators. These materials have been distributed to more 
        than 1 million middle and high school educators. Our work with 
        Scholastic continues and more resources will be made available 
---------------------------------------------------------------------------
        in Spring 2020.

          The Agency also developed posters and resources for 
        doctors, youth groups, religious institutions, state and local 
        public health agencies, and others on the dangers of youth e-
        cigarette use and has worked to advance discussion and 
        understanding around how to help those kids who are already 
        addicted to e-cigarettes quit.

    We will continue to take vigorous actions aimed at ensuring e-
cigarettes and other tobacco products are not being marketed or sold to 
kids. In addition, we will continue to expand our public education 
efforts to get the word out to youth about the harms of e-cigarettes.
 Investing in Research to Learn More About the Health Impacts of ENDS 
                                Products
    FDA is funding several research projects assessing the health 
impact of e-cigarettes, including the FDA and NIH Population Assessment 
of Tobacco and Health (PATH) Study. The PATH Study is a national, 
longitudinal cohort study of almost 46,000 youth and adults in the 
United States that collected its first wave of data in 2013 and is 
following study participants over time to learn how and why people 
start using tobacco products, quit using them, and start using them 
again after they have quit, as well as how different tobacco products 
affect health (such as cardiovascular and respiratory health) over 
time. The PATH Study is tracking potential behavioral and health 
impacts, including collecting biospecimens to analyze for biomarkers of 
exposure and harm. \9\
---------------------------------------------------------------------------
    \9\ More information on the PATH Study can be found at https://
www.fda.gov/tobacco-products/research/fda-and-nih-study-population-
assessment-tobacco-and-health.

    In 2016, FDA awarded a contract to National Academy of Sciences, 
Engineering and Medicine (NASEM) to ``conduct an in-depth evaluation of 
the available evidence of health effects from electronic nicotine 
delivery systems (ENDS) and make recommendations for future federally 
funded research.'' This work included convening a multi-disciplinary 
committee of 13 members that met several times and holding an open 
meeting to obtain input from a wide range of stakeholders. The 
committee's methodology included: a comprehensive literature search and 
review; a quality assessment and evidence synthesis to assess causality 
for health effects; and an application of a framework for levels of 
evidence. Over 800 peer-reviewed scientific studies were evaluated and 
the consensus report, ``Public Health Consequences of E-Cigarettes,'' 
was released by NASEM in January 2018. \10\ Among the conclusions in 
the NASEM report is that teens who experiment with an e-cigarette are 
more likely to try conventional cigarettes compared to teens who never 
used an e-cigarette.
---------------------------------------------------------------------------
    \10\ More information can be found at http://nationalacademies.org/
hmd/Reports/2018/public-health-consequences-of-e-cigarettes.aspx.

    As noted in the NASEM report, assessing the long-term health 
effects of e-cigarettes is challenging given the range of devices and 
constituents. For example, products can vary widely in terms of device 
type, mechanism, ingredients and the characteristics of aerosol 
generation. Variables of ENDS that could affect health impact include 
factors such as: exposure to metals (including heavy metals), heating 
capacity, voltage, e-liquid substrates, nicotine concentration, flavors 
and flavoring ingredients, and use of other ingredients or contaminants 
with unknown inhalation effects. A specific ENDS product's health 
impact is also likely to be significantly affected by user behaviors 
(and we know that many ENDS users also use other tobacco products in 
addition to e-cigarettes, known as dual use or poly use). Assessing the 
short-term health effects is also challenging for these same reasons. 
To help understand the individual and population impact of ENDS, FDA is 
currently funding more than 115 studies assessing the short- and long-
term health effects of e-cigarettes including nicotine dependence, 
cardiovascular and pulmonary toxicity, potential carcinogenesis, 
effects of maternal use during pregnancy, and effects in the oral 
cavity. \11\
---------------------------------------------------------------------------
    \11\ More information can be found on the FDA website at https://
www.fda.gov/tobacco-products/research/ctp-supported-tobacco-regulatory-
research-projects.
---------------------------------------------------------------------------
   Investigation of Severe Respiratory Injury Associated with Vaping 
                                Products
    FDA is also deeply concerned by the recent outbreak of severe 
respiratory lung injuries and reported deaths that are linked to use of 
vaping products. Investigating this crisis is a top priority for FDA, 
and the Agency is working very closely with CDC and state officials. 
The Agency is committed to taking appropriate actions to protect the 
public as the facts emerge. FDA is not pursuing any actions associated 
with personal use of any vaping products; our interest is in the supply 
chain. Every day we are gathering more information, and every day we 
seek to use that information to better understand the relationship 
between any specific products or substances and the reported illnesses. 
To date, most patients have reported a history of using vaping products 
containing tetrahydrocannabinol (THC). Many patients have reported 
using products containing THC and products containing nicotine. Some 
have reported the use of e-cigarette products containing only nicotine. 
We are following all potential leads and are doing all we can to move 
this complex investigation forward.

    In recent months, this outbreak has possibly sickened, by the most 
recent CDC data, 2,051 people from 49 states, the District of Columbia, 
and one U.S. Territory. Sadly, 39 deaths have been confirmed in 24 
states and the District of Columbia. These illnesses do not appear to 
be due to infectious diseases, but rather appear to be associated with 
a chemical exposure from vaping products. Patients generally report a 
gradual start of symptoms including breathing difficulty, 
gastrointestinal symptoms, and/or chest pain before hospitalization. 
Many patients have reported recent use of vaping products containing 
THC. Although these cases seem similar, it is not clear if they have a 
common cause, or if they involve different diseases with similar 
presentations. The investigation has not identified any specific 
product or substance that is linked to all cases.

    On September 6, 2019, FDA activated an Incident Management Group 
(IMG) to coordinate FDA's activities for the investigation into these 
reports. The IMG is comprised of subject matter experts from numerous 
FDA centers and offices, such as clinicians, toxicologists, 
pharmacologists, epidemiologists, chemists, engineers, consumer safety 
and criminal investigators, and computational scientists. FDA is 
focused on better understanding whether there is a relationship between 
any specific products or substances and the reported cases. It is 
important to stress that identifying any compounds present in the 
samples is but one piece of the puzzle and will not necessarily answer 
questions about causality, which makes our ongoing work critical.

    FDA's work includes collecting critical details about the products 
or substances involved, where they were purchased and how they were 
being used and analyzing product samples. To date, FDA laboratories 
have received over 1,000 samples from 25 states for this investigation 
with roughly 850 of these samples connected to patients. Overall, 595 
of the samples collected from patients have undergone some level of 
testing. The Agency is also working to link samples with specific 
patients, directly linking 509 samples to 69 patients. Eighty percent 
of these include links to THC products and of these 75 percent of cases 
included products with vitamin E acetate as a diluent. Connecting the 
products and how they were used to specific patients is critically 
important to our investigation to determine, to the extent possible, 
the cause or causes of these injuries.

    FDA continues reaching out directly to the states that have 
submitted samples and is providing them high-level aggregate data in 
the form of status reports on preliminary analytical findings. 
Additionally, as the investigation continues to evolve, FDA and CDC are 
ensuring that information is shared seamlessly between the two 
agencies. FDA has assigned staff to CDC's Emergency Operations Center. 
Likewise, CDC has assigned staff to our IMG to facilitate 
collaboration. We continue to work closely on sample collection and 
joint testing plans for aerosol and e-liquid. The agencies also 
continue to share epidemiologic and product testing data to aid in 
linking of case patients to product testing results.

    Importantly, last week CDC reported on the first analysis of human 
lung fluid in 29 samples from individuals in 10 states. Vitamin E 
acetate was found in all 29 samples. THC was found in three samples 
from individuals who reported they only used a nicotine-containing 
vaping product. More work needs to be done to get to the bottom of what 
substance or substances is causing these illnesses and deaths, but 
these findings will help us get closer to the answers we and CDC are 
seeking.

    We are working to communicate with the public when we have 
information to share in a frequent and transparent way. FDA has warned 
consumers to avoid buying vaping products of any kind ``on the street'' 
and to refrain from vaping THC or modifying/adding any substances to 
products purchased in stores. FDA also encourages the public to submit 
detailed reports of any unexpected tobacco- or vaping-related product 
issues to FDA via the online Safety Reporting Portal, which can be 
found on our website (or at www.safetyreporting.hhs.gov).
                               Conclusion
    Thank you for the opportunity to testify today about FDA's tobacco 
product regulatory work and our efforts to investigate vaping product 
use associated lung injury. FDA is committed to the evolving 
investigation and to protecting and improving the public health.

    I am happy to answer any questions you may have.
                                 ______
                                 
    The Chairman. Thank you, Mr. Zeller. Dr. Schuchat, welcome.

 STATEMENT OF ANNE SCHUCHAT, M.D., PRINCIPAL DEPUTY DIRECTOR, 
    CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA

    Dr. Schuchat. Thank you, Chairman Alexander, Ranking Member 
Murray, and Members of the Committee. I am happy to have the 
chance to provide an update on our investigation of lung injury 
as well as our concerns related to the youth epidemic of e-
cigarette use. I want to make four key points. First, since we 
first learned of these cases of lung injury on August 1st, CDC 
has been working 24/7 hand-in-hand with state and local public 
health departments as well as the FDA to get to the bottom of 
it. Second, our ability to do this kind of investigation relies 
on critical underlying public health infrastructure, including 
data systems that need modernization and a trained and data 
savvy public health workforce.
    Third, CDC has made important recommendations to the public 
based on the investigation so far. CDC recommends that people 
do not use vaping products that contain THC. People should not 
acquire products from informal sources or the illicit market 
and should not modify further these products beyond what was 
intended by the manufacturers. While the investigation is 
ongoing, CDC recommends that persons consider refraining from 
use of all e-cigarettes or vaping products. Regardless of the 
investigation, e-cigarettes or vaping products should never be 
used by youth, young adults, or women who are pregnant. Adults 
who use e-cigarettes or vaping products because they have quit 
cigarette smoking shouldn't return to smoking cigarettes.
    Fourth, we must address the broader epidemic of e-cigarette 
use among youth. The epidemic of lung injury is striking young 
people. More than half of cases are under 25 years, about 15 
percent are under 18 years of age. About half of them need to 
be cared for in intensive care units. Fortunately, the new 
cases appear to be trending downward nationally, although some 
states remain hard hit. We continue to find that most patients 
report using THC containing products. Lab testing is providing 
important new information, but no single product, brand, 
substance, or additive has been identified in all of the cases 
at this point. It may be that there is one cause or that there 
are many problematic substances causing lung injury. And there 
may be complex root causes for this outbreak.
    CDC is working vigorously with states to respond. We 
dispatched our disease detectives to help state and local 
public health and we activated our emergency operation center--
our incident manager is coordinating a response. We have been 
holding frequent calls with public health, with clinicians, and 
briefings for the media in order to keep the public informed. 
Last Friday, we issued two key products in our morbidity and 
mortality weekly report. The Illinois study showed lung injury 
patients were significantly more likely than other people who 
vaped with THC to have acquired their products from friends or 
social sources, to use THC containing vaping products more than 
five times a day, and to use products that were labeled dank 
vapes, which is a class of largely counterfeit products of 
complex providence.
    In a separate report, we shared the results of CDC's 
initial lab testing of lung fluid from patients in 10 different 
states. That study found vitamin E acetate but no other oily 
adulterants were detected in all 29 patients tested. This is 
the first detection of a potential toxic chemical of concern in 
biologic samples from patients with lung injury. We are working 
closely with the FDA on the trace back of products that people 
use and on additional laboratory testing. We have made great 
progress, but there have been challenges with this response. 
State laws vary regarding THC and cannabis use and the 
investigation includes gathering information from people about 
potentially illicit products.
    E-cigarettes or vaping products are part of a complex, 
multi factorial marketplace. There are many different product 
varieties and different substances can be used with the 
devices. Counterfeiting or black market products can make 
analysis of some brands unreliable. Public health data 
collection for this response relied on antiquated and 
fragmented systems that need modernization. The outbreak 
unfortunately has moved faster than our data systems and that 
has been a barrier to our getting quick answers. Turning 
quickly to the epidemic of youth use of e-cigarettes.
    Youth are much more likely than adults to use e-cigarettes 
and flavors are a key part of that appeal. CDC has been 
messaging our concerns about e-cigarette use since 2013 when we 
got the initial data about the alarming increase from 2011 to 
2012. Recently, released data from 2019 show the problem is 
much worse now and continues to be of great concern.
    In conclusion, we are dedicated at CDC to working around 
the clock together with FDA and state and local health 
officials to stop this outbreak, address its root causes, and 
continue to focus on the concerning increase in youth use of e-
cigarettes. I look forward to your questions.
    [The prepared statement of Dr. Schuchat follows:]
                  prepared statement of anne schuchat
                              Introduction
    Good morning, Chairman Alexander, Ranking Member Murray, and 
Members of the Committee. I am Dr. Anne Schuchat, the Principal Deputy 
Director of the Centers for Disease Control and Prevention (CDC). Thank 
you for the opportunity to testify before the Committee regarding CDC's 
investigation into lung injury associated with using e-cigarettes or 
other vaping products, and for your continued commitment to support 
CDC's work to protect Americans.

    On August 1, 2019, Wisconsin first alerted CDC to a cluster of 
pulmonary injury among young adults that began in July 2019. Since that 
date, CDC has been putting its scientific expertise to use across 
epidemiologic, laboratory, and clinical realms to address this public 
health crisis. CDC's response efforts are committed to: identify and 
define the risk factors and the sources for e-cigarettes or other 
vaping product use associated lung injury (EVALI); detect and track 
confirmed and probable cases in the United States; communicate 
actionable recommendations to state, local, and clinical audiences; and 
establish laboratory procedures to assist with public health 
investigations and patient care. Throughout this investigation, CDC has 
been partnering with colleagues at the U.S. Food and Drug 
Administration (FDA), state and local health departments, and other 
public health and clinical stakeholders to gain a comprehensive 
understanding of EVALI and the potential cause or causes.

    As of November 5, 2019, there are 2051 confirmed and probable cases 
of EVALI reported by 49 states, Washington, DC, and the U.S. Virgin 
Islands. Most patients reported a gradual onset of difficulty 
breathing, shortness of breath, or chest pain before hospitalization. 
Some patients reported mild to moderate gastrointestinal illness. This 
lung condition is serious. As of November 5, 2019, 39 EVALI deaths have 
been confirmed in 24 states and Washington, DC, and we know that 
additional deaths remain under investigation by states. These tragic 
deaths reinforce the urgency of CDC's efforts, in close coordination 
with others, to identify the cause of this illness, provide 
recommendations to the public on how to prevent further illnesses and 
deaths from occurring, and to assist states to address this public 
health outbreak.

    EVALI presents our Nation with a new public health crisis. And as 
the Nation's health protection agency, CDC is leveraging its cutting-
edge science and expertise in public health preparedness to quickly and 
nimbly respond. As we do for other emergency investigations, CDC 
implemented an incident management structure in August 2019 and, on 
September 16, 2019, activated its Emergency Operations Center. Doing so 
has allowed CDC to dedicate more staff and resources to this 
investigation. To date, approximately 300 CDC staff have been engaged 
in response efforts, including CDC staff who have been deployed to 
assist state health departments in investigating lung injuries within 
their jurisdictions. We also have stood up an international team that 
is maintaining communication with our international public health 
partners.

    CDC is working 24/7 with FDA and state and local health officials 
to get at the root cause or causes of these lung injuries. CDC is in 
continuous discussions with states to determine ongoing and additional 
needs to assist in gathering data and information to monitor and 
identify what is leading to these lung injuries. CDC is collaborating 
with a wide range of partners to: facilitate sharing of information 
about the illnesses, and behaviors and use of e-cigarettes or other 
vaping products between state health departments and clinicians; 
analyze and link data to assist in investigations; conduct laboratory 
testing; coordinate national communication activities such as updates 
on the status of the investigation; provide public health and clinical 
recommendations; and provide information to states, healthcare 
providers, and the public.
                      Summary of the Epidemiology
    In responding to public health emergencies, CDC's first steps are 
to understand what is happening, establish where it is happening, and 
collect as rapidly as feasible relevant data to inform our next steps. 
For this response in particular, we are aggregating data from our 
epidemiologic investigation with findings from our laboratory testing 
of clinical and product samples, in collaboration with FDA, to help 
identify who is most at risk and the specific substances or ingredients 
that may be causing these lung injuries.

    The ongoing investigation into the cause or causes of EVALI is 
challenging for many reasons. First, the investigation spans almost all 
states and the U.S. Virgin Islands. Second, EVALI is a diagnosis of 
exclusion since, at present, no specific test or marker exists for its 
diagnosis in a patient. Third, this investigation is complicated by the 
diversity of the e-cigarettes or other vaping products in the 
marketplace. There are hundreds of products, and thousands of e-liquids 
used by people who use e-cigarettes or other vaping products. Fourth, 
people using these products may not know the ingredients in the liquid 
solutions, and chemicals may change when aerosolized in the e-
cigarettes or other vaping products. Moreover, many of the products and 
substances themselves can be modified by the distributer or the user. 
They can be obtained from brick and mortar stores, online retailers, on 
the street, through the internet, or through social sources. In 
addition, information about the use of e-cigarettes or other vaping 
products relies largely on self-reporting, and interviewees may be 
hesitant to share information about their use of substances such as 
THC.

    National data suggest that THC-containing products are playing an 
important role in this outbreak. Previously published reports from 
Illinois, Utah, and Wisconsin suggest that patients typically obtained 
their THC-containing vaping products through informal sources, such as 
friends or illicit in-person and online dealers, although local and 
regional differences in illicit THC supply and production seem to 
exist. CDC has regularly collected and shared information about the 
outbreak. On October 28, 2019, a report published in CDC's Morbidity 
and Mortality Weekly Report (MMWR) provided information on 867 EVALI 
patients with available data on substances used. Of these, 86 percent 
reported any use of THC-containing products in the three-months 
preceding symptom onset, and 64 percent reported any use of nicotine-
containing products in that period. For the same period, 52 percent 
reported use of both THC-containing products and nicotine-containing 
products, 34 percent reported exclusive use of THC-containing products, 
and 11 percent reported exclusive use of nicotine-containing products. 
Two percent of patients reported no use of THC- or nicotine-containing 
products in that period.

    This outbreak continues to disproportionately affect persons under 
the age of 35, highlighting the need to communicate the dangers of 
using e-cigarettes or other vaping products among youth and young 
adults, irrespective of the substances they are using in these 
products. In addition to the risk of severe lung injury, use of these 
products is also dangerous to young people because THC and nicotine 
both can have lasting adverse effects on brain development.
                    CDC's Collaboration with States
    CDC staff from across the agency currently are involved in the 
response to coordinate activities, develop resources, and provide 
assistance to states, public health partners, and clinicians around the 
Nation. In addition to those working on this response from agency 
headquarters, CDC staff also have been present on the ground within 
different states. As of November 2, 2019, CDC has deployed a total of 
22 staff to eight states to assist state health departments, at their 
request, in investigating these lung injuries. These staff members are 
in addition to the Epidemic Intelligence Service Officers and Career 
Epidemiology Field Officers who are already stationed in the state 
health departments. CDC also activated the Laboratory Response Network 
for Chemical Threats, which is a network of CDC, state, and local 
public health laboratories that provide critical laboratory testing 
support to the programs and providers who are responding to this 
outbreak.

    CDC is providing scientific expertise to assist state and local 
public health jurisdictions. To enhance collection and analysis of data 
about the products, ingredients, and compounds that may be responsible 
for this outbreak, early on CDC worked with states and the Council of 
State and Territorial Epidemiologists (CSTE) to develop a uniform 
report form for states to use to collect data on cases, and our agency 
has been partnering with states to compile those data. Again 
collaborating with states and CSTE, CDC recently revised the national 
data collection instrument to provide a more streamlined means for 
states to collect and report their data. CDC continues to work closely 
with states to explore additional quantitative and qualitative studies 
to increase our understanding of this outbreak and product use 
behaviors among EVALI patients.

    CDC's provision of assistance to states likewise extends to process 
improvements for sharing and analyzing case-associated data. For 
instance, CDC has implemented a data integration and management 
platform called DCIPHER (Data Collation and Integration for Public 
Health Event Response) for use in this outbreak response. This platform 
enables states to directly enter or import and view their data. In 
October 2019, CDC began piloting the use of DCIPHER with a subset of 
states and, as of November 2019, this platform is now available for use 
across all states.

    CDC also is leading outreach to states in collaboration with FDA to 
gather information on case-associated devices and substances to help 
build a more comprehensive picture of these incidents. CDC is gathering 
reports of the types and brands of e-cigarettes or other vaping 
products used, the substances used, any modifications of the products, 
and where the products and liquids were obtained.

    In October 2019, CDC expanded its laboratory testing in support of 
the lung injury outbreak to conduct analyses of aerosol emissions from 
case-associated e-cigarettes and other vaping products. Aerosol 
emissions testing will be conducted by CDC's Division of Laboratory 
Sciences, which will apply its over decade-long experience 
characterizing e-cigarette aerosol emissions to products associated 
with this outbreak. CDC's aerosol emissions testing complements FDA's 
testing of the case-associated e-liquids. When combined with 
epidemiologic and clinical laboratory data, the results found by 
testing case-associated product samples may provide insight into the 
nature of the chemical exposure or exposures contributing to EVALI.

    In addition, CDC continues to offer testing of states' pathologic 
specimens, including lung biopsy or autopsy specimens, associated with 
patients, as well as testing of bronchoalveolar lavage fluid (BAL), and 
any blood or urine samples that are paired with BAL fluid. CDC also 
expanded its laboratory testing to include cannabinoids, including THC, 
in case-associated urine samples. CDC developed and published clear 
guidance documents to assist public health laboratories, healthcare 
providers, pathologists, and others with specimen collection, storage, 
and submission to CDC for testing, which is posted on our website.

    Because of the variety of chemicals that are present in e-cigarette 
or other vaping product liquids and that may be added to these liquids, 
as well as the diversity of products in circulation, laboratory 
analyses are complex. Thus, despite CDC's enhanced laboratory capacity 
to assist in this outbreak, the identification of the cause or causes 
for EVALI may take considerable time and continuing effort.
                             CDC's Outreach
    CDC ensures that the findings from the investigation are provided 
in a timely manner to the public, healthcare providers, and others. 
These findings are then translated into evidence-based recommendations. 
CDC communicates regularly with consumers, clinicians, and public 
health professionals through scientific publications, web products, 
social media, traditional media, and other channels. As of November 1, 
2019, CDC has hosted seven national media telebriefings on the 
outbreak, joined by colleagues from the FDA and selected state health 
department investigators.

    Throughout this investigation, CDC has been dedicated to providing 
guidance and targeted communications to healthcare providers. On August 
16, 2019, CDC released a Clinician Outreach and Communication Activity 
(COCA) Clinical Action Alert describing this investigation and asking 
providers to report possible cases of EVALI to their state health 
departments. This was followed by a Health Alert Network (HAN) Health 
Advisory on August 30, 2019, with specific recommendations for 
clinicians, health officials, and the public. On September 6, 2019, CDC 
released additional information through several reports in the MMWR, 
including a summary from clinicians in North Carolina of clinical 
characteristics and e-cigarette or other vaping product use exposures 
among five cases in that state, as well as CDC guidance for public 
health officials, clinical providers, and the public about prevention, 
case identification, and reporting. On September 19, 2019, CDC 
conducted a follow-up COCA call with more than 2,500 clinicians in 
attendance, where we reviewed clinical features reported among cases, 
and provided CDC's recommendations for clinicians. On October 25, 2019, 
CDC published a factsheet for healthcare providers regarding evaluating 
and caring for patients with suspected EVALI.

    CDC's Lung Injury website houses information specifically for 
healthcare providers that is updated on a continual basis. For 
instance, we recently included information for healthcare providers 
that specifically relates to influenza. As noted on our website, during 
flu season, CDC recommends that healthcare providers should consider 
flu in all patients with suspected EVALI. We also note that antivirals 
should be considered in accordance with established guidelines and that 
decisions on initiation or discontinuation of treatment should be based 
on specific clinical features and, when appropriate, in consultation 
with specialists.
                               Challenges
    Despite all momentum gained and promising work underway across CDC, 
this investigation has posed a number of challenges. Public health runs 
on data. Protecting America's health requires reliable and up-to-date 
information to prevent, detect, and respond to health threats. Most 
public health data collection and reporting systems are antiquated and 
fragmented, making it challenging to assure timely, actionable 
information while continuing to safeguard patient privacy. This 
investigation is emblematic of a challenge to our agency's overall 
work, which requires rapid collection and analysis of public health 
data but is often reliant on paper-based systems and fax machines.

    Timely surveillance, particularly concerning newly emerging and 
rapidly evolving forms of tobacco products and cannabis use other than 
smoking (e.g., vaping, dabbing, edibles), in the United States is 
nascent. Although there have been contributory efforts to improve 
surveillance in recent years, this outbreak, against a background of 
limited estimates of baseline rates of use and use behaviors related to 
THC use in e-cigarettes or other vaping products highlights that data 
collection and analysis efforts have not kept up, either 
technologically or with the changing landscape of e-cigarette or other 
vaping product use. Another inherent challenge of this investigation is 
the complication introduced by the reporting of potentially illicit 
drug use from patients. State laws vary regarding THC and cannabis use, 
which may make standardized and consistent data collection challenging.

    Finally, the marketplace for e-cigarettes or other vaping products 
is wide and diverse, with a multitude of substances that can be used 
with the devices. This can complicate toxicology testing and the 
interpretation of results. Despite these challenges, CDC has taken 
positive steps to address the EVALI outbreak while also continuing to 
address the ongoing epidemic of e-cigarette use by youth in our Nation.
         CDC's Efforts to Address the Epidemic of E-cigarettes
    The EVALI outbreak comes at a time of epidemic-levels of e-
cigarette use by young people in the United States. E-cigarettes have 
been the most commonly used tobacco product among youth since 2014, and 
their significantly increased use has erased earlier progress in 
reducing overall tobacco product use among youth. Notably, e-cigarette 
use among high school students increased by 77.8 percent from 2017 to 
2018. Additionally, preliminary data from the 2019 National Youth 
Tobacco Survey (NYTS) demonstrate that more than a quarter of high 
school students reported e-cigarette use within the past 30 days.

    Flavors are one of many factors associated with youth use of 
tobacco. Specifically, flavors can increase the appeal of tobacco 
products to youth, promote youth initiation of tobacco products, and 
result in lifelong tobacco product use. Recent data published by FDA 
and CDC from the NYTS found that in 2018, 67.8 percent of high school 
students who reported using e-cigarettes within the past 30 days used 
flavored e-cigarettes. These data also indicated that during 2014 to 
2018, current use of flavored e-cigarettes increased among high school 
students.

    CDC is engaged in multi-faceted efforts to prevent and reduce use 
of all tobacco products, including e-cigarettes, among young people. In 
collaboration with our partners and other Federal agencies, CDC 
collects data and conducts research on youth use of tobacco products. 
For example, CDC and FDA jointly administer the NYTS, an annual survey 
to monitor national trends in the use of tobacco products among U.S. 
students in grades 6 through 12. This survey has been essential in 
identifying the extent and scope of the current youth e-cigarette 
epidemic in this country. CDC also complements its routine surveillance 
efforts with novel, rapid response monitoring that captures emerging 
trends concerning e-cigarettes, including through the use of sales data 
to monitor sub-annual changes in the United States e-cigarette 
marketplace. In addition, the Tobacco Laboratory in CDC's Environmental 
Health Laboratory provides critical laboratory science, including 
measuring harmful and addictive constituents in e-cigarette solutions 
and aerosol, and measuring chemicals in the blood and urine of people 
who use e-cigarettes or are exposed to secondhand aerosol.

    CDC has been at the forefront of this issue for many years. In 
2013, CDC published a report highlighting a doubling in youth e-
cigarettes use during 2011-2012, which initiated our efforts to warn 
the public, and others, about the health risks of e-cigarette use among 
U.S. youth. Since then, CDC has continued those efforts. For example, 
in 2016, CDC collaborated with the Surgeon General to release a Surgeon 
General's report entitled ``E-Cigarette Use Among Youth and Young 
Adults.'' This was the first comprehensive Federal report on e-
cigarettes among young people. Since then, CDC has continued to promote 
the findings of the report to educate parents, influencers of youth, 
and youth themselves. In response to compelling data about the sales 
and increased market share of JUUL, reports of widespread teen use of 
this and similar products, and mounting public concerns, CDC launched a 
partner initiative to expand the reach of CDC public health warnings. 
CDC developed plain-language infographics and social media posts for 
public health organizations and consumer audiences about e-cigarettes 
and has conducted back-to-school social media campaigns. CDC was the 
primary Federal agency that assisted the Office of the Surgeon General 
in writing and launching a December 2018 e-cigarette advisory to bring 
awareness to relevant audiences (teachers, parents, clinicians) about 
e-cigarette use by young people. CDC also developed promotional 
materials to support the release of the advisory.

    CDC provides funding and technical support to all 50 states, the 
District of Columbia, 8 U.S. territories, 12 tribal support 
organizations, and 8 national networks representing priority 
populations, which are essential for coordinating the public health 
response to prevent tobacco initiation among youth and young adults, 
promote quitting among youth and adults, eliminate secondhand exposure 
to smoke and e-cigarette emissions, and identify and eliminate tobacco-
related disparities. With funding from CDC, state and territorial 
health departments have taken a number of approaches to reduce youth 
access and exposure to e-cigarettes, including preparing nicotine 
health advisories and tobacco-free school toolkits, conducting 
surveillance of tobacco product use among youth, and creating and 
disseminating evidence-based educational materials to the public 
through social media and other mechanisms. CDC has ongoing work to 
prevent and reduce tobacco use, including e-cigarettes.
  CDC's Efforts to Understand the Harms Associated with Marijuana Use
    The exposure to vaping products containing THC in most patients in 
this outbreak underscores the need to better understand the health 
effects of increasing marijuana use in the United States and the 
changing marketplace as states continue to pursue legalization of 
marijuana for medical and nonmedical purposes. According to the 2018 
National Survey on Drug Use and Health, more than 43 million (16 
percent) Americans age 12 years or older reported using marijuana in 
the past year. Marijuana use among youth and young adults is 
particularly concerning given the potential risks to the developing 
brain. In 2018, one in eight youth, aged 12 to 17 years, and one in 
three aged 18 to 25 years reported marijuana use. Prolonged heavy 
marijuana use has been associated with a broad range of health effects, 
and health effects have also been documented in young people, in 
particular those that initiated marijuana use at an early age.

    CDC data indicate that many youth who use e-cigarettes also report 
using marijuana in vaping devices. For example, data from the 2016 
National Youth Tobacco Survey found that one-third of U.S. youth who 
have ever used an e-cigarette or other vaping product reported using 
marijuana in an e-cigarette or other vaping product, including 
approximately one-quarter of middle school users.

    CDC conducts limited surveillance, monitoring, technical 
assistance, and public education related to marijuana. For example, a 
small number of questions regarding marijuana use are included in the 
Youth Risk Behavior Survey (YRBS) and are being asked in a limited 
number of states through the Behavioral Risk Factor Surveillance System 
(BRFSS) and the Pregnancy Risk Assessment Monitoring System (PRAMS). In 
addition, CDC is providing informal technical assistance to state, 
local, tribal, and territorial officials when requested, with a focus 
on preventing harms, particularly in vulnerable populations such as 
youth, young adults, and pregnant women. CDC's marijuana webpage 
(www.cdc.gov/marijuana/) provides information on health effects, data 
and statistics, and offers resources and tools for the public. Finally, 
CDC collaborates with other Federal agencies on scientific workgroups 
to address emerging issues and work toward consensus on indicators and 
measures to monitor marijuana use and health effects.
  CDC Interim Outbreak Recommendations for Providers, States and the 
                                 Public
    CDC continues to refine recommendations based on data and 
scientific findings emerging from this complex outbreak. To date, no 
single compound or ingredient has emerged as the cause of EVALI, and 
there may be more than one cause. Because most EVALI patients report 
using THC-containing products before the onset of symptoms, CDC 
recommends that persons should not use e-cigarette, or vaping, products 
that contain THC. Persons should not buy any type of e-cigarettes or 
other vaping products, particularly those containing THC, off the 
street and should not modify or add any substances to e-cigarettes or 
other vaping products that are not intended by the manufacturer, 
including products purchased through retail establishments. In 
addition, because the specific compound or ingredient causing lung 
injury is not yet known, and while the investigation continues, persons 
should consider refraining from use of all e-cigarettes or other vaping 
products. Regardless of this investigation, e-cigarettes or other 
vaping products should never be used by youths, young adults, or women 
who are pregnant. Adults who are using e-cigarettes or other vaping 
products to quit smoking should not return to smoking; they should 
weigh all risks and benefits, and consider using FDA-approved 
medications. Updated information and recommendations related to this 
investigation are available at www.cdc.gov/lunginjury.
                               Conclusion
    CDC's foundation of public health work, including direct relations 
to state and local governments, is essential to our Nation's ability to 
respond to expected, unexpected, and unimaginable threats. CDC 
prioritizes sharing critical information with clinical providers, 
public health departments, laboratories, and the public to help prevent 
additional EVALI cases and to rapidly identify and treat affected 
individuals. We remain fully committed to investigating and analyzing 
data as quickly as possible and using cutting-edge science to inform 
evidence-based recommendations to protect the public from this health 
risk. CDC is working around the clock, together with state and local 
health officials and FDA colleagues, to identify the cause or causes of 
this outbreak and will continue to keep Congress, and the American 
public, up to date on our progress in this rapidly evolving 
investigation.
                                 ______
                                 
    The Chairman. Thank you, Dr. Schuchat. We will now begin a 
five-minute rounds of questions. My first question is what 
advice should I give Tennesseans? Dr. Schuchat, you repeated 
that CDC recommends don't buy any e-cigarette or vaping 
products off the street, don't modify--that would be the type 
of oil that you mentioned for example--don't modify the 
product. But the only way to assure, CDC says, that you are not 
at risk while the investigation continues is to consider 
refraining from use of all e-cigarettes or vaping. So is CDC's 
advice that one should not use e-cigarettes right now during 
the investigation?
    Dr. Schuchat. We are a data-driven organization and so our 
strongest recommendation right now is to avoid using e-
cigarette or vaping products that contain THC, and to avoid 
getting such products from informal sources like friends or 
dealers or online. But because about 10 percent of the cases of 
this very severe lung injury do not have a history of vaping 
THC, we continue to suggest that people consider refraining 
from use of all e-cigarettes or vaping products.
    The Chairman. Mr. Zeller, your--FDA's own website is 
similar in the respect that it says FDA warns the public to 
stop using THC, the derivative of marijuana that makes you 
high, and any vaping products off the street and oils like the 
acetate, but you don't go on to say that you should consider 
refraining from using any e-cigarettes during this period of 
time. And in fact, the FDA allows the sale of these e-
cigarettes because you delayed for several years the 
requirement that a manufacturer apply for standards. So which 
advice should Tennesseans follow the CDC's or the FDA's?
    Mr. Zeller. I believe our website is consistent with the 
CDC website and that it contains that second point about, 
during the pendency of this investigation, if you are concerned 
about any safety issues that you should consider refraining 
from using any e-cigarette or vaping product.
    The Chairman. Yes, but you said in your testimony that it 
was not legal to sell e-cigarettes but in fact, it is only 
legal to sell e-cigarettes in a convenience store, for example, 
because the FDA hasn't stopped it.
    Mr. Zeller. That is correct. That is a separate issue. 
These products remain on the market through a continuing 
exercise of what is known as enforcement discretion by the 
Agency. That is separate and apart from the public health 
advice to people concerned about what is going on with 
pulmonary illness and on that issue, I believe that our website 
is completely consistent with CDC's as is our messaging.
    The Chairman. Well, but it is--you are not saying to a 
convenience store that their selling e-cigarettes is illegal 
right now, right?
    Mr. Zeller. These products remain on the market through 
enforcement discretion. What is completely illegal is the sale 
of these products to anybody under the age of 18. And what I 
tried to say in my remarks is that we have been aggressively 
enforcing the youth access restrictions for e-cigarettes from 
the day that we gained regulatory authority over these 
products.
    The Chairman. Well, obviously, we are not making much 
progress with youth use. You list a number things you are doing 
and 1 in 4 of American high schoolers according to your 
statistics are using e-cigarettes. How much of the more than $5 
billion that you have collected from tobacco companies over the 
last 10 years have you used to discourage young people from 
using e-cigarettes?
    Mr. Zeller. The investment that we made in public education 
is a dollar figure that we can separate out for e-cigarettes. 
And from late 2017 through the end of next year we will wind up 
investing about $150 million in a massive multimedia public 
education campaign to get the word out to kids. Kids know that 
cigarettes are dangerous. We have made great progress in 
reducing kids use of conventional combustible cigarettes.
    What we have learned from our research is that most young 
people walk around thinking that e-cigarettes are harmless, 
that it is just a water vapor. There are surveys that show that 
kids don't even know that nicotine is present in the aerosol. 
We are working very hard to get the message out through paid 
advertising on TVs----
    The Chairman. One other, if I may so I could stay within my 
time. When do you expect the rules, the two rules that you have 
proposed, to be final?
    Mr. Zeller. We are going very hard to finalize them. The 
second of those rules, the rule for the pre-market tobacco 
application process, that is a proposed rule where the common 
period is still open through the end of the month but I can 
assure the Committee that completing these two final rules are 
the highest priorities of the Agency and the Department.
    The Chairman. Senator Murray.
    Senator Murray. Thank you, Mr. Chairman. Mr. Zeller, I was 
actually shocked that in a hearing that is focused in part on 
youthful vaping epidemic, your testimony, both written and oral 
here, made no mention of the administration's September 11th 
announcement that it intended to clear the market of all 
unauthorized non-tobacco flavored vaping products. It was made 
with a lot of fanfare and many of us have been publicly urging 
you to finalize it. Why is that not included in your testimony?
    Mr. Zeller. The only thing I can say, Senator Murray, is 
that we are committed to doing everything that we can to 
prevent kids from using any tobacco product including e-
cigarettes, and that we are continuing to develop a policy 
approach that aligns with that concern.
    Senator Murray. I appreciate that but the September 11th 
announcement was one we all listened to, we were attentive to, 
we have been pushing you on it, and yet here we are talking 
about the very topic and you didn't mention it in your remarks. 
I don't understand why.
    Mr. Zeller. I think that any questions that the Committee 
has about the announcement that the White House made and 
anything related to what remains a deliberative process on 
policy is best referred to the White House itself.
    Senator Murray. This is a White House decision?
    Mr. Zeller. I would refer the Committee to the White House 
if there are any questions about this ongoing deliberative 
process.
    Senator Murray. Okay. Are you committed to finalizing the 
flavor compliance policy that the administration announced, yes 
or no?
    Mr. Zeller. We are absolutely committed to coming up with a 
policy that aligns with this epidemic use of e-cigarettes by 
kids and that addresses this fundamental problem.
    Senator Murray. What is your timeline, when?
    Mr. Zeller. I can't give you a specific timeline, Senator, 
other than to say that the deliberative process continues.
    Senator Murray. You being told not to do this?
    Mr. Zeller. You are asking about the deliberative process 
and I really would refer you and the Committee to the White 
House to ask specific questions about where we are.
    Senator Murray. Okay. Dr. Schuchat, in September shortly 
after the administration's announcement, Representative Presley 
asked you, ``to be effective, do you agree that the flavor ban 
needs to include mint and menthol?'' Your answer was yes, and 
since then two things have happened. First, it has been 
reported this administration is dramatically weakening the 
policies, working on including by carving out those menthol 
products and covering only some retailers or walking away from 
the policy altogether.
    Second, DHARMA published CDC data demonstrating the 
increasing popularity of menthol and mint flavored e-cigarettes 
among youths while JAMA published data examining differences 
between mint and menthol attracting young people. So I want to 
ask you Representative Presley's question again. To fully 
protect kids, does this administration's ban of unauthorized 
flavors need to include mint and menthol products and cover 
everywhere that kids currently buy these products?
    Dr. Schuchat. We know that flavors are particularly 
attractive to youth. The CDC, FDA National Youth Tobacco Survey 
didn't differentiate menthol or mint. We don't even know if 
kids can differentiate menthol or mint. But the question that 
was asked was about menthol or mint and that was a very popular 
choice. The use of that flavoring increased after Juul took 
away the candy flavors. So the use of--we believe that kids are 
likely to use whatever flavor is left.
    Senator Murray. Yes. So does CDC's data actually suggest if 
a young person's preferred flavor e-cigarette is no longer 
available--for example, this administration bans fruit flavor 
but leaves menthol products on the market, kids will just 
simply switch to another flavor?
    Dr. Schuchat. Based on what we saw in 2018 to 2019, that is 
what we would expect.
    Senator Murray. Okay. Mr. Zeller, I know that FDA and CDC 
are working hard to identify the causes of the outbreak of the 
vaping related illnesses and contain this crisis. I want to 
underscore how important that work is for families everywhere. 
I am also very focused on how we could have prevented this 
outbreak in the first place because unfortunately the 
administration gave e-cigarette companies a free pass for four 
years to market many of these products with no FDA review. I 
want to ask could the national outbreak that has sickened 
thousands have been avoided or minimized if FDA had required 
pre-market authorization of e-cigarettes last year as the 
Agency originally envisioned?
    Mr. Zeller. I can understand why you are asking that 
question. I think it is a very difficult question to answer 
even in hindsight. Recall that the overwhelming majority of the 
cases of illness and death involved the use of THC. We are not 
saying that it is only THC related but it certainly seems to be 
overwhelmingly THC related.
    Senator Murray. I understand that. But do you think that 
the market for these vaping devices that are also now being 
used for marijuana would have existed in the way it has done 
today had it not been for FDA's delay?
    Mr. Zeller. I think that even under the original compliance 
policy that we had in the final deeming rule from 2016, these 
products would have remained on the market well into 2019 and 
that was under the original compliance policy. Again, I can't 
go back in a time machine and say how things would have been 
changed. We are a regulatory Agency that follows the regulatory 
science.
    As I said in my written and oral remarks, the decision that 
we made in 2017 to extend the deadlines was made at a time when 
kids use of e-cigarettes was in decline. We immediately 
revisited that policy a year later when we saw the spike, as 
the Chairman has pointed out in the chart, to revisit what 
those deadlines should be.
    Senator Murray. I can't help but think that the review of 
those products by FDA would have provided consumers with some 
pretty critical clarity. So it is--we are where we are, but it 
is really disconcerting.
    The Chairman. Thank you, Senator Murray. As I mentioned 
earlier, we have votes at 11 a.m., but we will continue the 
hearing through the votes so that Senators can have time to ask 
their questions. We have very good attendance today. So I would 
like to encourage Senators to stay within the five minutes for 
questions and answers.
    Senator Enzi.
    Senator Enzi. Thank you and thank you for holding this 
hearing. We are talking about vaping as the new crisis. I am 
still concerned about cigarettes. In 2009 when we passed the 
bill, I was really concerned to get three amendments. And one 
was increased fines. I don't know how that is working because--
the second requirement that I got in there was one that we 
would get a report three years after we passed it and every two 
years after that to see if we are making progress or not.
    We got a report once in 2013. So it makes it hard to know 
how we are doing on that and wouldn't give me much confidence 
in what we are doing with vaping. Can you commit, Mr. Zeller, 
to issuing a new report as soon as possible and meeting your 
statutory obligation to report to Congress every two years 
going forward?
    Mr. Zeller. Absolutely, Senator. We are working hard on 
updating and submitting the most recent report. And I can 
assure you on the enforcement authorities that you got into the 
underlying statute which gave the Agency an authority that it 
previously had never had, which is for the ultimate retailer 
that continues to break the law and sell to kids, thanks to the 
Family Smoking Prevention and Tobacco Control Act, we now have 
the ability for a retailer that has a certain number of 
violations in a specified period of time to go before an 
administrative law judge to seek something called a note 
tobacco sells order. And unfortunately, we have had to do this 
over 150 times to prevent retailers from selling any tobacco 
products of any kind for a specified period of time.
    Senator Enzi. Thank you. I won't take all the time to find 
that when that report could come out but I will be submitting 
that in writing. Another thing that I got in there was one 
where there had to be color graphic warning labels and the 
courts of course struck that down. They said that it was taken 
to court and the court said that it was an unabashed attempt to 
evoke emotion and perhaps embarrassment and browbeat consumers 
into quitting rather than purely factual, accurate, or 
uncontroversial information. Yes, the purpose of it was to get 
people to quit smoking and I think the reason it went to court 
is because it was working. So I congratulate you on an attempt 
to do color graphic warning labels.
    I think these warnings would be a good way to get people to 
stop smoking or vaping or never start. Can you explain the 
reasoning behind the choice to focus on highlighting the less 
known consequences of smoking like diabetes and bladder cancer 
rather than enhance awareness and remind smokers of the 
association between smoking and lung cancer, heart disease, or 
chronic obstructive pulmonary disease?
    Mr. Zeller. Thank you for the question, Senator Enzi. And 
yes, the focus of the new cigarette health warning proposed 
rule that we issued several months ago is focused on some of 
the lesser known but still very serious health consequences of 
smoking. We took that approach in the aftermath of the court 
case that ruled against the original final cigarette health 
warning rule, as you described in your statement, taking into 
account legal, constitutional, primarily First Amendment 
considerations as we researched and then drafted a new proposed 
rule that we intend to finalize by March of next year under a 
separate court order deadline.
    The focus is helping the public, adults and kids, 
understand that there are some lesser-known health consequences 
with cigarette smoking and that was a deliberate, strategic 
move on our part with an eye toward when this rule goes final, 
in the event that there is litigation, that this will give us 
the best chance of surviving that court challenge.
    These are all serious health conditions and they turn out 
to be lesser well-known than things like heart disease and lung 
cancer. And our research shows that the public is largely 
unaware that those can be linked to cigarette smoking.
    Senator Enzi. Thank you. I also am interested, of course, 
the testing is still ongoing but there is information on THC 
that is present in the majority of the samples the FDA has 
tested. Does the FDA have jurisdiction over THC products? And 
if so, what is the authority?
    Mr. Zeller. I think on a case-by-case basis when it comes 
down to the fact, if we were to take an action because of the 
presence of THC, it would be because the investigation has 
continued because we are going after the supply chain here. How 
did these products get onto the market in the first place? We 
are not looking at possession. We are not looking at personal 
use of these products. We have investigators on the ground to 
try to get at how did they get into the chain of distribution 
and commerce in the first place. If we can identify the 
responsible party--because with THC we are talking about an 
illicit compound.
    It is not like someone is going to step forward and say 
yes, I did it. If we can find the responsible party, if we can 
do the product analysis that shows that the THC is present with 
or without these oils that seem to be making it worse, then in 
theory we could use authorities that we have under the Food, 
Drug and Cosmetic Act. We are also working in consultation with 
the Justice Department and the Drug Enforcement Administration 
because THC is a controlled substance and there could be DEA 
authorities, but I don't want to speak for DEA. But we could 
act depending upon the facts under Food and Drug authorities.
    Senator Enzi. Thank you. I apologize for running over.
    The Chairman. Thank you, Senator Enzi.
    Senator Baldwin.
    [No response.]
    The Chairman. Senator Hassan.
    Senator Hassan. Well, thank you, Mr. Chairman and Ranking 
Member Murray for having this hearing and thank you to both of 
our witnesses and please pass on our thanks to the men and 
women you work with for their dedication to service. As other 
Senators have mentioned, recent national youth tobacco survey 
data shows an alarming rise in e-cigarette use among middle and 
high school students. And according to the CDC Youth Risk 
Behavior Survey, my State of New Hampshire has the highest 
percentage of high school students in the Nation reporting 
daily e-cigarette use. Millions of children are nicotine 
dependent because of e-cigarettes and the American Academy of 
Pediatrics estimates that only 4 percent of those kids are 
going to successfully quit. That is a stunning statistic.
    The devastating impact companies like Juul have had on 
children must be at the forefront of FDA's review of their pre-
market tobacco product applications in May. So Director Zeller, 
I have four questions for you I am hoping to get to in our four 
minutes. When the flavor ban was announced in September, Juul 
publicly stated that it would not lobby officials or attempt to 
influence the policy as it was developed. However, Juul 
executives recently told my staff that they have had, ``a 
number of conversations with FDA since the September 
announcement.'' Were you aware of or part of any of these 
conversations? And if so, what was discussed?
    Mr. Zeller. I am unaware of any policy related discussions 
between Juul and FDA.
    Senator Hassan. Any policy related. Have there been 
discussions between Juul and FDA that you are aware of?
    Mr. Zeller. We have been given a heads-up on personnel 
changes and things unrelated to policy.
    Senator Hassan. But in terms of policy, you are saying you 
are unaware?
    Mr. Zeller. I am unaware of any conversation.
    Senator Hassan. Okay. Given the importance of this issue. 
It is really concerning that you may not be aware of the full 
scope of conversations that Juul officials say have occurred 
with your staff. So I will follow-up in writing to request that 
you provide more information about what has been discussed in 
these meetings and with whom. Second question.
    A recent study in the Journal of the American Medical 
Association found that mint is the most popular e-cigarettes 
flavor among high school students. Earlier this month, former 
FDA Commissioner Scott Gottlieb predicted that if menthol is 
exempted from the flavor ban, Juul will simply rename their 
current mint flavor, which does contain some menthol, and sell 
it as menthol. So Director Zeller, how will FDA ensure that 
companies like Juul cannot game the flavor ban by, for example, 
reclassifying their mint flavor as a menthol product?
    Mr. Zeller. Senator, it is really difficult for me to get 
into a policy discussion when we remain in the deliberative 
process in creating the policy. So let me try this to speak 
hypothetically about product name change.
    Senator Hassan. Yes.
    Mr. Zeller. It turns out that under some litigation that 
went against the Agency, it may be possible for companies to 
change the names of products. In a world where we--again, 
hypothetically, in a world where we had a policy in place that 
tried to get at I think what is embedded in your question or 
any company to try to simply change the name of a product to be 
able to keep a product on the market that would otherwise have 
to be removed from the market, I will just say hypothetically 
in that situation FDA would be very concerned and would look at 
whatever authorities that we had to take action. But that is 
only a hypothetical----
    Senator Hassan. I understand it is a hypothetical. I 
understand the deliberative process argument but let me be 
clear what you are hearing from everybody up here is that we 
have children who are getting hooked on these products. There 
has been a lot of delay. We are looking for a strategy and we 
are looking for you guys to move through your deliberations.
    You have had plenty of time already and kids and people, 
Americans all over this country, are being hurt and they are 
going to be--they are addicted. And when the American Academy 
of Pediatrics tells me that only 4 percent of the kids who are 
now addicted to nicotine are going to be able to quit, your 
deliberative process needs to be as fast and strategic as it 
can be. The White House announced a policy back in September, 
but now we are being told they are still deliberating.
    We need you guys to focus on this. I have 25 seconds left 
but let me tell you what I want to get at in my last two 
questions, which is about the data that you all are collecting. 
Juul told my office that they regularly submit data on Juul 
purchasers to FDA. Of course, submitting purchaser data rather 
than user data means Juul does not submit data on youth e-
cigarette use.
    Will FDA require Juul to submit their user data, inclusive 
of youth users, rather than just purchase or data as part of 
their pre-market tobacco product application? And this also 
would be useful to get at the issue of diversion. Who is 
purchasing but then who is using?
    Mr. Zeller. A couple comments, Senator. First----
    The Chairman. Mr. Zeller, I am going to ask you to be 
succinct in your answer or give a written answer.
    Senator Hassan. Thank you.
    Mr. Zeller. Two points and then I will elaborate in 
writing. We have an active ongoing investigation of Juul. All 
aspects of advertising, marketing, and promotion of their 
products. So that is an ongoing investigation. Your question 
about the application process is a separate question and it is 
clear under the law that Congress wrote that as we review any 
application for any product, the impact on initiation, the 
impact on the likelihood that any non-user starting with kids 
would use the product, is a core component of how we would 
review any application for any new tobacco product.
    Senator Hassan. Thank you, and thank you, Mr. Chairman, for 
your indulgence.
    The Chairman. Thank you, Senator Hassan.
    Senator Burr.
    Senator Burr. Mr. Chairman, I start with the unanimous 
consent request to enter into the record the GMO study that 
Senator Hassan just referenced to. And I will note for my 
colleagues, this is the first time menthol has been broken out. 
They use Juul data to do it. It is referred to as monitoring 
the future of which menthol data in eighth graders was 1.7 
percent, 10th graders 2.4, 12th graders 3.8.
    The Chairman. So ordered.

    [The following information can be found on page 52.]

    Senator Burr. It is important to distinguish between 
menthol because the mint number is huge, the menthol number is 
not huge. There is not a mint product in combustibles and Mr. 
Zeller I think you will agree that when we did CTP, it was with 
the intent to bring less harmful products so that adults could 
choose to switch from combustibles to innovative products of 
which e-cigarettes were one of them.
    To maintain that there is the ability to go from a menthol 
combustible to a menthol non-combustible is an important health 
advantage to the American people to have reduced harm products. 
Now, Ms. Schuchat, I asked HHS for information related to the 
CDC's Youth. Tobacco Survey. September 13th, I asked for it to 
be a response by September 27th. I have not received it. Your 
staffs got that information. Will you promise me today I will 
have this next week?
    Dr. Schuchat. We have published that data. So that was in 
the--you just mentioned the monitoring the future data. The 
other report in JAMA of the same issue was the National Youth 
Tobacco----
    Senator Burr. I have got that JAMA report but specifically 
there is some information I have asked of HHS on the youth 
access.
    Dr. Schuchat. Yes, we will go back and get you that but 
just to expand on your comment, the question on the monitoring 
the future was, what is the usual--which Juul flavor do you use 
most often? So individuals could just give one choice, not 
multiple.
    Senator Burr. That is correct. April 10th, 2018 CDC made an 
initial announcement of an E. coli outbreak with an unknown 
source. Eight days later, the Agency determined the outbreak 
was linked to a specific product from a specific region, 
romaine lettuce, Yuma, Arizona. The CDC determined this link in 
part on interviews with those who had fallen ill and found that 
of 28 people 93 percent had eaten romaine lettuce in the last 
week. CDC acted swiftly and decisively in that.
    Now, we are at a point where 80 percent of patients use THC 
products and CDC just recently announced a form of vitamin E 
calling it a chemical of concern. That is based on CDC's 
determination based on 29 samples of similar number to the 
romaine lettuce investigation. What additional information does 
CDC need to make a determinative cause?
    Dr. Schuchat. We are extremely concerned about vitamin E 
acetate in the THC containing products but what we cannot say 
right now is whether there are other substances. There are 
about 10 percent of the patients with this very severe lung 
injury who did not use the THC.
    Senator Burr. You came to a single conclusion on Ebola--I 
mean an E. Coli. In a number of days, specifically with the 
same population, and I would only suggest to you that it is 
time to take the information you have got. And at least put out 
the warning a little more specific than maybe what you have. I 
have only got a minute left. I need to go to Mr. Zeller. Has 
the FDA inspected vape shops? And when I ask that question, I 
separate vape shops from traditional retail outlets.
    Mr. Zeller. Yes, we do.
    Senator Burr. How many have you inspected?
    Mr. Zeller. I will give you the exact number in writing. I 
don't know the exact number at the top of my head, but we----
    Senator Burr. Does FDA have authority to investigate them?
    Mr. Zeller. Yes, we do.
    Senator Burr. Okay. And when FDA deemed vapor products as 
tobacco products the Agency started to inspect vape shops. As 
FDA began to sound the alarm bell on children's use of these 
products, from 2017 2018 did CTP invest more money in 
inspection of retail facilities?
    Mr. Zeller. I will get you the annual numbers in writing. 
What we did----
    Senator Burr. Let me tell you the number. You actually 
decreased inspections from $48.4 million in 2017 to $44.3 
million in 2018. Did CTP conduct more inspections of retail 
facilities to determine whether they are selling products to 
youth?
    Mr. Zeller. My recollection is that the relative number of 
inspections stayed the same. What we had was a little bit of 
efficiency. These are contracts that we have at the state and 
local level and there were some efficiencies----
    Senator Burr. These are your responses to me. You had 
22,000 fewer inspections in 2018 than you did in 2017.
    Mr. Zeller. Senator, the point that I am trying to make is, 
when we got regulatory authority over e-cigarettes in the 
summer of 2016 for the first time, what we did with that 
existing contract mechanism was reprioritized where the 
inspectors would go to see if retailers would or would not sell 
the newly regulated products starting with these e-cigarettes 
to kids.
    Senator Burr. This one is an easy one. Did you increase or 
decrease the education campaign investment from 2017 to 2018?
    Mr. Zeller. From 2017 to 2018, our investment in the public 
education campaign has gone up considerably. From 2017 through 
the end of 2019, we will be investing roughly $65 million in 
that campaign and $85 million next year.
    Senator Burr. Let me tell you how you responded to me in a 
written response. You decreased your public education campaign 
investment by $72 million from 2017 to 2018. You can find that 
in question 14 of CTP's oversight letter that I received a 
response to on January 11th, 2019.
    Mr. Zeller. Senator, what I was referring to was the 
investment in the public education efforts for e-cigarettes, 
which has increased.
    Senator Burr. Okay. To my colleagues, it is important for 
us to be dealing with the same facts on these issues. I remind 
our colleagues, until Congress decides that tobacco is an 
illegal product, one of the responsibilities we have as Members 
of Congress is to protect the adults choice to use these 
products. That decision has not been made that it is an illegal 
product and we have done everything we can to try to bring 
reduced harm product to the marketplace. I think that is a good 
public health issue.
    Somebody will probably ask today, why don't more companies 
do pre-market tobacco applications? And the fact is that 
statutorily it requires CTP to review those in 180 days. 
Currently, there are three applications that may have been 
resolved but they are at 625 days. Six applications are at 589 
days. Four applications at 191 days. So when you ask why aren't 
companies willing to go out and do it? It is the lack of 
clarity of the pathway and it is the performance with a 
statutory requirement of 180 days that it is a black hole that 
you fall into.
    The Chairman. Senator Burr, we will have a second round of 
questions if you----
    Senator Burr. I thank the Chairman and I thank the Members 
for their indulgences. I yield the balance of my time.
    The Chairman. Okay. Thank you, Senator Burr.
    Senator Baldwin.
    Senator Baldwin. Thank you. Children's Hospital of 
Wisconsin was the first in the country to publicly identify 
what was at the time a mystery illness connected to vaping 
found in 8 teenagers who were hospitalized with seriously 
damaged lungs. In response, I requested that the CDC establish 
an Emergency Operation Center to investigate the cause of the 
outbreak and support states in their response. And I urged this 
Committee to hold a hearing on this matter. So I am pleased 
that we are here to discuss both the outbreak of this illness 
as well as the increasing number of children using e-
cigarettes. It is very clear that our work is far from over.
    Now that the CDC has detected one potential chemical of 
concern, the Committee I think should also hear from 
individuals who are on the front lines who can speak to the 
challenges of identifying, containing, and preventing 
outbreaks. And I expect we will learn more today that will 
indicate further action. At Children's Hospital of Wisconsin, 
many of the children with these injuries were hospitalized in 
intensive care units and they required supplemental oxygen or 
mechanical ventilation to breathe.
    Dr. Schuchat, can you tell us what is currently known about 
the long-term impact of these injuries, and especially what we 
might anticipate in terms of the impact on young people. And 
what resources does the Center for Disease Control and 
Prevention need to conduct further research on the longer-term 
impacts of this illness?
    Dr. Schuchat. Yes, thank you. And first just to say, we 
really applaud the clinicians in Wisconsin who sounded the 
alarm and got us going on the response. This is a very 
difficult injury that young people are suffering. You may have 
seen reports of the first reported lung transplant in a 17 year 
old in Michigan.
    Mr. Zeller. Double transplant.
    Dr. Schuchat. Double transplant. Thank you. So we know that 
some individuals will have very long term damage and not even 
be able to breathe without new lungs but we don't have the full 
story on the spectrum of illness or injury or how people will 
do. We have been working with the pulmonary specialty community 
to get guidelines out for follow-up so that everyone who is 
discharged from the hospital gets a regular follow-up including 
lung pulmonary function tests.
    Importantly, we are urging people to make sure that they 
focus on cessation and counseling while people are still in the 
hospital. There are tragically a few reports of readmission for 
worsening after discharge. In terms of the resources needed, 
this is a newly recognized syndrome in terms of this outbreak 
and so the full scope of research questions exist, not just the 
long-term outcome. The best way to treat it, the best way to 
track it.
    Right now we are using syndromic surveillance to try to 
find more automated ways to detect trends. We are worried about 
the impact that influenza may have on people who have suffered 
from this injury. Whether they are going to be new treatments 
needed or new challenges with diagnostics. So I think CDC, FDA, 
and NIH together joined in a meeting that tried to lay out a 
research agenda for the issue.
    Senator Baldwin. Okay. Mr. Zeller, I believe that the 
marketing practices of these vaping product makers have played 
a role in the popularity of these products, especially among 
youth. And a study of Juul's advertising efforts from Stanford 
University School of Medicine found that Juul's advertising 
imagery in its first six months on the market was patently 
youth-oriented, to quote from the article.
    That advertising was widely distributed on social media 
channels frequented by youth and was amplified by hashtag 
extensions and catalyzed by compensated influencers and 
affiliates. For too long FDA has failed to take action to crack 
down on the marketing aspect of this and advertising targeted 
at our Nation's young people. So can you explain why the FDA 
did not issue specific marketing guidance to e-cigarette 
manufacturers when these products first started coming to the 
market?
    Mr. Zeller. When e-cigarettes were first on the market, we 
didn't have regulatory authority over them. Since we got that 
regulatory authority which began in the summer of 2016, we have 
used all of our enforcement tools. We have issued warning 
letters for e-liquids that resemble kid friendly foods, like 
juice boxes, cereal, and candy. We have issued warning letters 
for paid social influencers where the connection to the company 
wasn't revealed and those statements lacked required warnings. 
We have issued a warning letter to Juul for unauthorized 
modified risk tobacco product claims. So we have tried to use 
all of the available tools that we had once we had the 
regulatory authority over these products.
    Senator Baldwin. Well, the warning letters are not the same 
as sort of a wider marketing guidance. I appreciate hearing you 
repeat what you had in your testimony, but the FDA has delayed 
taking real action. In September, it was announced that the 
administration or by the administration that you would be 
clearing the market of unauthorized non-tobacco flavored e-
cigarette products and it has been two months. So where is the 
policy?
    Mr. Zeller. I think----
    The Chairman. Mr. Zeller, I would like to ask you to make 
that succinct in writing.
    Mr. Zeller. I think any questions about the current state 
of policy really needs to be directed to the White House. We 
are in a deliberative process. The White House made an 
announcement in September and we are working to advance a 
policy consistent with taking steps to do everything that we 
can to protect kids from these products.
    The Chairman. Thank you, Senator Baldwin.
    Senator Paul.
    Senator Paul. They say politics is the art of looking for 
trouble, finding it everywhere, diagnosing it incorrectly, and 
applying the wrong remedies. I am afraid we could get into the 
same problem here in this discussion. The problem seems to be, 
and I have a great deal of sympathy, I have kids and I have 
warned them about, the vaping of illegal products, but it seems 
to be primarily deaths and horrific medical problems from 
vaping illegal products.
    What we are going to do in response to that is make more 
vaping illegal. It seems kind of counterintuitive. It seems 
like if you make more things illegal, maybe you get more people 
vaping illegal products and you have more problems. I think to 
have a complete picture here we ought to look at things in 
totality and it would have been nice to hear from somebody 
testifying about lives saved from vaping. You know, 480,000 
people die from smoking each year, 2,000 people are dying from 
vaping illegal products, and I don't want to discount that, we 
should do something about it, but I am not so sure making 
flavors illegal is actually going to make the problem better.
    It might make the problem worse. So we have to think about 
what we are doing here. And we really ought to ask the question 
and seriously look at, are lives being saved from vaping? I 
think there are estimates that hundreds of thousands of lives 
have been saved over the past 12 years from vaping instead of 
smoking. Now, you say well kids, is not a good idea to have 
kids vaping, for one reason or another. Yes, that is probably 
true, but it is already illegal for kids to vape. If you want 
to get more kids not to vape, well we may increase the penalty 
on people selling to kids. But to get rid of them, most adults 
are using the flavors as well.
    If you say well you are more likely to use the vaping 
flavors to get off of smoking, maybe you are more likely to 
stick with smoking if you ban flavors. So I just think--it is 
like so many things, we get off strung out on these things and 
we want to react, react, react really quickly, but nobody is 
really asking one important question, how many lives are being 
saved? The lives from smoking deaths dwarf any of the problem. 
It is a terrible problem we are having. I am not discounting it 
but it is a problem from illegal THC.
    We are going to make more things here legal. So we drive 
the flavors to the underground market. Maybe then people are 
going to cut the flavors with vitamin E as well. So I really 
just think like so many things we get going on this and we are 
probably going to end up doing the wrong thing. But if you want 
less kids to smoke, I would just increase the penalties on 
people selling the kids and you might have less kids smoking.
    But banning the flavors, you are going to affect the adult 
market also, and as a secondary consequence, you may also 
affect the amount of people that are able to convert from 
smoking to vaping and saving lives. I don't have a direct 
question but thank you.
    The Chairman. Thank you, Senator Paul.
    Senator, Kaine.
    Senator Kaine. Thank you, Mr. Chairman. And before I get to 
the questions, I was going to ask Mr. Zeller, I was not happy 
with your answer to Senator Murray's question about the 
pendency of the regulations after the September 11th 
announcement. The title of this hearing that we all know, 
Examining the Response to Lung Illnesses and Rising Youth 
Electronic E-Cigarette Use. You are the Director of the Center 
for Tobacco Products at the U.S. Food and Drug Administration.
    When you were asked by Senator Murray about the 
announcement that the administration made in September, you 
referred us to the White House. The White House won't send 
witnesses here. The White House is instructing witnesses to 
ignore subpoenas from Congress about testifying. You knew what 
the title was and you have the job. And I think we are entitled 
to an answer from you. I am not going to ask you about the 
deliberative process or details, but I want to just read this 
to you.
    This was the announcement that was made by the White House, 
September 11th, titled, Trump administration Combating Epidemic 
of Youth E-Cigarette Use With Plan to Clean Market of 
Unauthorized Non-tobacco Flavored E-Cigarette Products. First 
paragraph, today the Trump administration announced that as 
part of its ongoing work to tackle the epidemic of youth e-
cigarette use, the FDA intends--the FDA, your Agency--to 
finalize a compliance policy in the coming weeks that would 
prioritize the Agency's enforcement of the pre-market 
authorization requirements for non-tobacco flavored e-
cigarettes, including mint and menthol, clearing the market of 
unauthorized non-tobacco flavored e-cigarette products.
    A quote from Secretary Azar in this release, ``the Trump 
administration is making it clear that we intend to clear the 
market of flavored e-cigarettes to reverse the deeply 
concerning epidemic of youth e-cigarette use that is impacting 
children, families, schools, and communities. We will not stand 
idly by as these products become an on-ramp to combustible 
cigarettes or nicotine addiction for a generation of youth.''
    Is that still the Trump administration's intent to clear 
the market of flavored e-cigarettes to reverse the deeply 
concerning epidemic of youth e-cigarette use?
    Mr. Zeller. I understand your question, Senator Kaine, and 
the frustration about my inability to share more detailed 
information on----
    Senator Kaine. I am not asking about the details. I am not 
asking about the plan. I am not asking about the timing. The 
administration announced that your Agency, and you are the 
chief official over tobacco at this Agency, that it was the 
intent of the administration to issue regulations clearing the 
market of unauthorized flavored e-cigarettes. Is that still the 
intent of the administration?
    Mr. Zeller. All I can say Senator is that we are continuing 
to advance the policy to address----
    Senator Kaine. Let me ask you this. Do you know the answer 
to my question?
    Mr. Zeller. There is no final answer as of now.
    Senator Kaine. There is one of two options, you either 
don't know what the Trump administration intends, you don't 
know whether they will honor what they said we will do, or you 
know what the intent is and you are not telling me. Which is 
it? Do you not know or do you know and you are not telling me?
    Mr. Zeller. There is no final answer on the policy 
question. It is why we continue to have these discussions 
internally.
    Senator Kaine. That again, there may not be a final answer 
but the Trump administration announced its intent it was going 
to clear the market of these flavors. Do you have any reason to 
believe that the intent is now different?
    Mr. Zeller. Well, all I can refer you to Senator is as we 
continue to work on the policy to address the problem with 
kids' use of e-cigarettes----
    Senator Kaine. I am not asking about the total. I am asking 
about an announcement that was made about your Agency's actions 
and whether the intent that the administration announced is 
intent of the administration.
    Mr. Zeller. The goal remains----
    Senator Kaine. I do not like being playing games with. I do 
not like saying get somebody from the White House to answer the 
question when the White House will not send two witnesses to 
hearings like this. You are the person responsible. You should 
know the answer to this question because you knew what the 
title of the hearing was and you have the job. Let me move on 
now to another topic. I have a lot of folks who have spoken to 
me about this issue. I have got a student from Arlington, 
Nathan Robinson, who is here with one of his mentors.
    I have been told by kids in Virginia that they researched 
to see whether their e-cigarettes are harmful and as soon as 
they Google to get health information, then they are flooded 
with ads from companies trying to sell them e-cigarettes. I 
have school administrators who tell me we don't have a lot of 
experience in helping 14 year olds break addictions.
    The 17 year old that you mentioned, Dr. Schuchat, had a 
double lung transplant, the first that has been done for a 
vaping illness. The average life expectancy after a double lung 
transplant is seven years. That is the average life expectancy. 
We should get an answer to this question about whether the 
administration is going to honor the policy that they announced 
or not.
    Let me ask you this as I conclude. There is a proposal on 
the floor of the Senate that this Committee voted out as part 
of a comprehensive healthcare cost package to raise the age on 
all tobacco related products for every population in every 
corner of the United States to 21. Would that have a positive 
public health effect?
    Dr. Schuchat. Yes, we think that would.
    Senator Kaine. Thank you very much. I yield.
    Senator Collins [presiding]. Thank you, Senator Kaine. The 
Chairman has asked me to take over the hearing in his absence 
and as luck would have it, I am up next to do the questioning. 
And in any event, Mr. Zeller, and I am sorry that we are sort 
of blocked by the transcriber here, the dramatic increase that 
we are seeing in the use of e-cigarettes by our young people is 
threatening strides that we have made to reduce overall tobacco 
use.
    You quoted in your written testimony a study that was done 
by the National Academy of Sciences, Engineering and Medicine 
that concludes that teens who experiment with an e-cigarette 
are more likely more likely to try conventional cigarettes 
compared to teens who had never used e-cigarettes. Hasn't the 
rationale that has been given for e-cigarettes is that it will 
help people stop smoking and yet here we have a study that 
clearly states that teens who began using e-cigarettes are more 
likely to start smoking conventional cigarettes. Could you 
comment on that?
    Mr. Zeller. Sure and thank you for the question, Senator. 
It is part of--called the public health balancing act. When we 
look at what's going on with kids, any kids' use of any of 
these products, whatever the trajectory is going to be, goes on 
the negative side of the ledger. But pulmonary delivery of 
nicotine in a properly regulated marketplace is something that 
could potentially benefit some currently addicted cigarette 
smokers but only if they completely switch to the electronic 
cigarette. And our job as regulators as we look at 
applications, as we look at what is going on in the 
marketplace, is to do this public health balancing act. The 
imperative from a public health perspective is to not allow 
another generation of kids to become addicted to nicotine.
    Senator Collins. Well, that is exactly my fear not to 
mention the illnesses that we are seeing right now. Let me 
follow-up on a couple of other points that you made. In your 
written testimony, and again in your oral testimony, you said 
that it is important to remember that no e-cigarette product in 
the United States is on the market legally and that instead the 
FDA is exercising enforcement discretion. Given the harm that 
we are seeing and the high percentage of youths who are using 
it even in middle school and in high school, 27.5 percent you 
said today, why is the FDA exercising discretion?
    Mr. Zeller. As soon as we have a policy that we can come 
back to the Committee to talk about, we will be able to go into 
more detail about what the plans are. But your question is 
extremely well taken and we try to be as candid as possible 
about the state of the marketplace. From the day that we got 
regulatory authority over e-cigarettes starting in the summer 
of 2016, there was an exercise of enforcement discretion for 
the products currently on the market.
    If there is an e-cigarette that is not on the market, they 
are subject to the premarket review or if a company tried to 
put in these cigarette onto the market after that August 2016 
date, well, that is a violation of the law and we have taken 
enforcement action. So what we are talking about is the 
application of enforcement discretion to the products that were 
on the market as of that August 8th, 2016 cutoff date. And that 
is the policy that we are working on and when it is finalized, 
we would be happy to come back to the Committee and go into 
detail on that.
    Senator Collins. Given these very serious illnesses that we 
have seen in 49 states including Maine, why not ban refillable 
e-cigarettes? Wouldn't that help prevent situations where other 
teams are putting in oils or other dangerous substances like 
THC, or maybe they are not doing it, maybe criminals are doing 
it. But why allow them to be refillable?
    Mr. Zeller. Ultimately, for the products that have to come 
through a premarket review process, there is a court order 
deadline where whatever products remain on the market, these 
companies are going to have to file applications with the 
Agency by May of next year. What Senator Kaine was pressing on 
is well, where is the administration's policy now? What is the 
administration going to do about it? And what we are looking at 
is what are the steps that we can take to best protect kids. 
And it is two things. It is the alarming increase overall in 
kids use of e-cigarettes at the high school and middle school 
level and the increase in the popularity of flavored products.
    Senator Collins. My time has expired, but I just want to 
say to the Doctor who is representing the CDC that Jennifer 
Rhoades in Maine public radio hosted an informational panel in 
September on this very issue. And it was very disturbing 
because what she shared was her finding that students said, 
everyone vapes, that the official statistics are lower than the 
reality. It is not something that is certain kind of kid does, 
it is everywhere.
    Similarly Eileen King at the Maine School Management 
Association echoed that sentiment saying that vaping has 
exploded exponentially and that the adults, the teachers, the 
staff, the principle in general are ten steps behind the kids 
and even knowing that it is going on. So for the record, if you 
would respond since I am out of time, on what resources 
specifically are available to schools to highlight the dangers 
of vaping because until this latest spate of terrible 
illnesses, I believe based on students and teachers I have 
talked to, that they did not believe it was harmful and that is 
a real problem.
    Dr. Schuchat. We would be happy to submit for the record 
the family of materials because I agree with you. I hear 
exactly the same thing, that it is much worse than our 
statistics are telling us and moving very fast.
    Senator Collins. Thank you.
    Senator Smith.
    Senator Smith. Thank you, Senator Collins, and I am going 
to actually follow-up on the question that you just posed. I 
think it is a really important one. So in 2018, 1 in 4 11th 
graders in Minnesota reported using an e-cigarette in the last 
30 days. That is a 54 percent increase from 2018. So the 
anxiety and worry that you hear from all of us on this panel 
are really reflected in that data. When I asked teachers in 
Minnesota what keeps them up at night, they point to two 
things. One, the growing concerns about the mental health of 
their students as well as the exponential rise in teen vaping. 
And I think that these things are related.
    Here is a story. Claire Herring is a student at Hopkins 
High school in Minnetonka, Minnesota, and she turned to vaping, 
she told us, to deal with her mental health concerns. And she 
says that this isn't uncommon amongst her peers. In her words, 
she said other students are ``lost and they don't know what to 
do so they go for drugs and vaping is such an easy drug to 
get.'' And she is currently struggling to quit vaping.
    Now, Claire is not one of these young people who thinks 
that vaping is nothing but flavored water. She understands that 
she is addicted. She understands that she has a problem. So to 
follow-up on Senator Collins' question, what is the CDC and the 
FDA doing to help teens like Claire who are already addicted 
and struggling to figure out how to help themselves? Dr. 
Schuchat, would you like to go?
    Dr. Schuchat. Yes. I can begin and it is a real challenge. 
We don't have FDA-approved cessation tools for young people and 
it may not be that the things that work in adults work as well 
in younger people. We think that behavioral therapy is part of 
the picture but that more research is needed. And you know, the 
best thing here is to be very aggressive with prevention 
because it is so hard for people once they start. And I think 
in terms of the mental health issues, we realize that the 
Nation is facing a family of challenges for young people. We 
have seen rises in suicide in young people and we really need 
to do more.
    Senator Smith. Yes. That is for sure.
    Mr. Zeller. A few points, Senator Smith. First, we are 
making a massive investment in paid media and getting the word 
out to kids in school. So as I said in my remarks, working with 
students against destructive decisions, we got really snarky 
posters placed in every single bathroom of every single public 
and private high school in the entire country last year.
    That is where kids are going to Juul or to vape. We have 
also, working with scholastic, gotten much needed information 
into the hands of over a million middle school and high school 
administrators. But on the question of treatment, I agree with 
Dr. Schuchat, there is much more that needs to be done to help 
the teen that unfortunately has already become addicted and 
there are no FDA-approved drugs to treat nicotine addiction in 
teens.
    We convened two very important public meetings earlier in 
the year. One was a formal hearing to bring in researchers in 
the pharmaceutical industry to raise the issue of what role can 
drug therapy and counseling play in helping teens. And then we 
had a more focused scientific workshop in the spring on the 
same issue. But there is a gap here that needs to be addressed 
and we are doing everything that we can to do that.
    Senator Smith. Where are teens getting this idea that this 
is harmless?
    Mr. Zeller. Apparently, it is the mindset in the word of 
mouth. And that is what we found from our research and that is 
why our paid advertising is heavily focused on nicotine 
addiction and health consequences to break that, what we call, 
cost-free mentality that kids have that it is just a water 
vapor and it is harmless. It is anything but.
    Senator Smith. This is sort of a--I am having a here we go 
again moment because I mean, of course that was a message that 
big tobacco put out on cigarettes for many, many decades.
    I appreciate--I heard your testimony about the amount, 
about the dollars that you are spending on posters and 
bathrooms and with scholastic and all of that. And I mean 
certainly, that should be helpful. But my understanding is that 
Juul spent much, much, much, much more than that in the first 6 
months of 2019 to advertise as well. So, I mean I am concerned 
that we are just outgunned on this. Dr. Schuchat, do you want 
to say something about that?
    Dr. Schuchat. Just to say that we believe there has been a 
lot of social media marketing, peer influencer marketing, under 
the radar kinds of ploy----
    Senator Smith. Right. That we can't even tally.
    Dr. Schuchat. Yes, and that young people really don't know 
or were even surprised that there is nicotine in these e-
cigarettes. So I think there is a lot of work to do there 
because the wrong information has sort of set in, in terms of 
the understandings.
    Senator Smith. Right. I mean, it has been a long time since 
I have been a teenager but I remember clearly that I wasn't 
reading a lot of posters in the bathrooms. And I am not being 
dismissive of--I mean I am trying not to be dismissive but I am 
struggling to think about how we are going to combat this 
epidemic, as Senator Hassan said, that is going to have 
potentially lifelong challenges for these young people that are 
15, 16, 17 and becoming addicted to this. And it is very 
disheartening. I mean I can only assume that it is the White 
House that is pulling back the September 11th rule because it 
goes against the data that the FDA and the CDC has about the 
safety of these products. So it is very concerning to me.
    Senator Collins. Thank you.
    Senator Murkowski, and I want to salute you and Senator 
Durbin for introducing your legislation, which I was pleased to 
co-sponsor.
    Senator Murkowski. Well, thank you. It has been a year's 
long now to deal with the flavors and so to be sitting here 
today and to feel like we have made some headway in reducing 
the availability of these flavors out on the market, but then 
to have very conflicting signals now coming out from the FDA 
and the White House on whether or not menthol and mint are 
included in this, I think, is unfortunately an escape.
    When we are dealing with children and access to a highly 
addictive substance like nicotine for these underage 
individuals, the fact that we are even talking about giving 
that as a pass just I find mind-boggling and really very 
upsetting. You know, we have had some discussion about okay, is 
it that the kids really not appreciate that there is nicotine 
in these e-cigarettes? I asked, what is the level of labeling 
that is on e-cigs or on a vaping product? And I guess it is on 
the outside of the label. But if you are if you are that middle 
schooler and you are getting a refill in your cartridge or your 
pod, there is no label there. And again, the frustration here 
is you have kids who have seen advertised very clearly that 
these products are a cessation product.
    If it can be used to get me off nicotine, then surely it 
can't be that bad for me even if there is nicotine in it. So 
when we are talking about consistent messages to kids, I think 
you got to be pretty upfront and pretty direct. This harms you. 
This will addict you. This could ultimately kill you. I don't 
think we need to nuance the message here and I am just 
frustrated that we are still arguing over whether or not 
menthol or mint as a flavor in a nicotine based product is an 
attractant to kids or not an attractant.
    If it makes it taste that much better, they are going to be 
attracted to it. Let me ask a couple questions here because the 
statistics that you provided us, Dr. Schuchat, 80 percent of 
those that have been tested for the lung illnesses, 80 percent 
of those had THC contained within, 70 percent had this vitamin 
E. I guess I am a little concerned that if we get to this point 
where the sense is that the investigation and the deaths, the 
illnesses are linked to THC with the vitamin E additive, that 
somehow or other then we say, okay, crisis over, we shouldn't 
be putting THC in a vaping product, and certainly shouldn't be 
putting vitamin E in a vaping product.
    But beyond that, e-cigs and vaping products are not as bad 
and they are not going to kill you. Are you worried, and I 
guess this is directed to both of you, do you agree that even 
if the findings of the investigation do not implicate solely 
nicotine, that this should not be a distraction from the public 
health epidemic that we are facing which is this drastic rise 
in addiction to nicotine and e-cigarettes?
    Dr. Schuchat. Agree. There are two very disturbing 
epidemics going on. One is an outbreak of lung injury following 
e-cigarette or vaping product use that is pointing to THC 
containing cartridges in the vast majority. A second is this 
incredible skyrocketing rates of youth e-cigarette use and we 
know that the brain continues to develop until age 25 and 
nicotine is harmful for the developing brain. And the risk of 
these individuals being long-term addicted or going on to be 
addicted to other substances is very high. Two very, very 
disturbing emergencies.
    Mr. Zeller. Senator, we completely agree. It is really two 
separate issues. Kids should not be using any tobacco product, 
inhaling any of this stuff into their lungs. Everything that 
you are calling for in terms of the messaging directly to kids 
is exactly what we are doing in our paid advertising, talking 
directly to them about the presence of nicotine and that it can 
be addictive, talking direct directly to them about the 
presence of harmful compounds in the aerosol to try to break 
through what we call that cost-free mentality. Completely 
separate and apart from wherever the investigation takes us on 
the lung illnesses.
    Senator Murkowski. Just very quickly. Alaska is the one 
state where we have not seen illness and death. And that is 
good, no reported cases so far. In our state, retail marijuana 
is commercialized, it is tested by our state laboratories. So 
is the CDC providing any information to state regulatory 
bodies, whether it is Alaska or other states that have 
legalized on testing these products for these compounds that 
are a concern and then are there any barriers preventing 
Federal officials from working with our state marijuana labs on 
this topic?
    Dr. Schuchat. We are in close touch with the state health 
departments and their laboratories and are holding frequent 
calls and providing guidance. There are some challenges with 
shipment of specimens because of the scheduling of drugs.
    Senator Murkowski. Is that stopping any of the testing to 
your knowledge?
    Dr. Schuchat. I think it is just delaying it. I don't 
believe it is stopping it at this point, and Mr. Zeller can 
probably comment as well.
    Mr. Zeller. What I can add to that is, it is up to the 
states to send FDA the samples for testing. A number of states 
have. And when we complete our analysis, we then go back to 
each individual state with the results. So there really has 
been no issue in getting the samples to us and at least having 
us begin to do the chemistry work to be able to report back to 
them on a state-by-state basis. So it is like first in, first 
out. The first state that came to us is the first state that 
will get the results.
    Senator Murkowski. Thank you. Thank you, Madam Chair.
    Senator Collins. Thank you.
    Senator Rosen.
    Senator Rosen. Thank you. And I want to thank you for 
holding this timely hearing. I want to thank you for your 
efforts on this behalf. You know in Nevada we have had for lung 
related illnesses. Of course, greater than 2,000 cases across 
the Nation and 39 deaths. We must do something before these 
numbers continue to rise. But I want to build a little bit on 
what Senator Smith was talking about and talk about secondhand 
vaping.
    When e-cigarettes first appeared on the market, it wasn't 
uncommon, like Senator Smith said, to refer to it just as water 
vapor in reference to the puffs released into the air when 
exhaling. So according to a number of experts, including 
researchers at Nevada's Desert Research Institute, when the 
user of a vaping product exhales, they are actually releasing 
nicotine and other particulate matter into the air. Of course 
this can be especially harmful to children, particularly if 
their parent or caregiver believes that there is no negative 
impact from secondhand vaping smoke.
    Can you please elaborate on what you know about secondhand 
smoke in regards to vaping and what are your latest findings?
    Dr. Schuchat. The e-cigarette aerosol has a lot of 
different products or compounds in it. It can include heavy 
metals from the devices, things like lead, organic compounds, 
carcinogenic material, nicotine as you mentioned, and then what 
we call ultrafine particles that can be found deep in the lung. 
We are really at the beginning stage of understanding the 
aerosol effect in terms of secondhand smoke and there is a lot 
more that needs to be done.
    Senator Rosen. Do you think we could extrapolate from what 
we know from just regular cigarettes and the effects of second-
hand smoke?
    Dr. Schuchat. There are aspects that can be extrapolated 
and others that can't be. The combustible tobacco has a lot 
more toxins and harmful substance in it. But I think what our 
view is that e-cigarette aerosols may have fewer harmful 
substances, but that doesn't mean they don't have harmful 
substances.
    Senator Rosen. Thank you.
    Mr. Zeller. The only thing that I would add to that is that 
this is a major area of investment in research by both agencies 
to better understand both what is in the aerosol and then what 
is being delivered to the bystanders. And as soon as we get the 
answers to those questions, we will be in a better position to 
figure out what the potential harms are, what to say to 
consumers, and how to use that for regulatory policy purposes.
    Senator Rosen. Well, building on that, speaking about 
public health research, again researchers at Nevada's Desert 
Research Institute and University of Nevada Reno, they released 
information this summer about the aldehydes, right, such as 
formaldehyde, how they are absorbed into the lungs during 
vaping. These are chemicals widely known to cause cancer. So 
given that it appears that users of e-cigarettes assume they 
are inhaling some nicotine and flavored water, what is your 
understanding of the potential health risks of the aldehydes?
    Dr. Schuchat. In terms of the compounds, our principal 
message is that e-cigarettes should not be used by youth, young 
adults, or women who are pregnant, and the principal used 
really was intended to be for adults who are trying to quit 
smoking cigarettes. And that is where, the off-ramp 
conversation happens. The idea that they are harmless is wrong. 
The question about whether the aerosols and the various 
compounds cause harm directly or second hand is very much open.
    Mr. Zeller. I would add to that is that we have made 
formaldehyde the centerpiece of some of our paid advertising 
directly aimed at teens to make sure that they understand that 
the aerosol can contain formaldehyde which has been shown to be 
a cancer-causing agent.
    Senator Rosen. I suppose in the interest of time, my last 
question is, what in terms of funding for CDC or FDA, what do 
we need to help you with in funding or authorization to further 
expedite this research on vaping products, on the aldehydes, on 
secondhand smoke, on all of it?
    Mr. Zeller. I will go first. The administration's Fiscal 
Year 2020 request contained a request for $100 million 
additional for FDA for tobacco product regulation. And that is 
because with the existing dollars that we have had, we have 
either had to reallocate or reprioritized to do the right 
thing, whether it is compliance and enforcement, research, 
public education with the new and novel products like e-
cigarettes. So the administration believes that there is a role 
for an increase in budget to expand our programmatic work in 
those three critical areas.
    Senator Rosen. Thank you.
    Dr. Schuchat. There have been House and Senate bills that 
talked about increasing CDC's tobacco budget by $40 million and 
the public health data issues, the Data Saves Lives, by $100 
million per year. Those investments could help both the e-
cigarette epidemic and help us with future threats like this 
one where we could get out of the gate a little quicker and not 
take so long to understand what is going on. Ideally to predict 
a threat instead of react slowly.
    Senator Rosen. Thank you. I yield back.
    The Chairman [Presiding]. We have other Senators who would 
like to ask questions in a second round. And, let's see, 
Senator Cassidy, you may be next if you are ready, and then we 
will go to Senator Kaine. Senator Cassidy is always ready. The 
witnesses, you have been there for a long time as every--if you 
need a break for any reason. I think we will probably go 
another not more than half hour so it would be my----
    Mr. Zeller. We are good.
    The Chairman. Senator Cassidy.
    Senator Cassidy. Thank you both for attempting to address 
this issue. And I gather as--listening to Burr ask questions, 
he seemed to suggest that there has been some delay in 
determining what products might be responsible for this. But as 
I was reading about vitamin E acetate, it has oil in it, and I 
remember from medical school if you inhale oil, you do a lot of 
damage to your lungs. And that was mineral oil you were 
swallowing to clean out your bowels not a heated solution 
dispersing broadly. Do we really need to do a lot of study to 
tell people not to heat up oil and to inhale it into their 
lungs?
    Dr. Schuchat. We don't need to do a lot of studies for that 
question but I think there are many questions that remain. We 
don't know that there are other substances that are being 
either----
    Senator Cassidy. Are you imagining that it is non-oil-
based?
    Dr. Schuchat. There may be non-oil based. There has been a 
report of cobalt for instance from the device. So we think 
there is potentially a variety of products but I agree with you 
that vitamin E acetate, this oil in products that are being 
heated and inhaled is bad news.
    Senator Cassidy. Now, I think I remember reading although I 
was walking, couldn't find the article, that the British have 
really talented the vape to be, the electronic cigarette, to be 
a risk mitigation. I think I see something from CDC or I think 
from CDC of the risk mitigation aspect of this. Yes, you are 
getting nicotine, but you are not getting all these carcinogens 
that are associated with cigarette smoking.
    Assume that there is two aspects to this consideration, or 
at least two. First, the flavored cigarettes which induce young 
people to smoke cigarettes, become addicted, and remain as 
addicts for the rest of their life. Terrible, shouldn't happen. 
The second is what is the risk benefit ratio of using something 
which has potential for risk mitigation, reducing the risk of 
somebody smoking carcinogenic cigarettes for something which is 
less, balanced against the public health risk of people 
misusing them and inhaling cobalt and oil and whatever else. 
Would you all agree with that assessment?
    Dr. Schuchat. Just, briefly. The UK situation is quite 
different. They have a lower content of nicotine in the e-
cigarettes that are distributed there and they have a very 
aggressive sort of graphic label type of approach to warn the 
public. And they don't seem to have the youth epidemic that we 
are experiencing.
    Senator Cassidy. But that goes back to the youth epidemic 
not to the fact that it is risk mitigation.
    Dr. Schuchat. Right. They are really focusing the 
distribution of this lower nicotine content, e-cigarette, on 
adult cessation, but I think Mr. Zeller had more to say.
    Mr. Zeller. I agree with you Senator. It is a balancing act 
and Congress wrote that balancing act into the law with 
mandatory considerations. As we are looking at products on an 
application by application basis, we have to account for impact 
on initiation. Any initiation by kids goes on the negative side 
of the ledger. But to your point, what potential beneficial 
role can any of these alternative technologies play and that 
would go on the positive side of the ledger, but what we know 
with e-cigarettes is that the benefit comes only if you 
completely switch from cigarettes to e-cigarettes. The 
overwhelming majority of adults who are using e-cigarettes 
continue to smoke at least some conventional combustible 
cigarettes.
    Senator Cassidy. It doesn't make sense to me, I am just 
asking I am not arguing, that you have to make a complete 
transition because with cigarette smoking, I remember there is 
the 20 pack per day--again, I am having to remember this from 
school but one pack per day for 20 years however you get there. 
A half a pack times 40 years, two packs times 10 years, one 
pack times 20, but there is a threshold effect above which the 
effects of cigarette smoking and your risk for cancer 
escalates. So if we minimize that, it seems as if that would be 
risk mitigation, even if someone continues a smoke two real 
cigarettes a day.
    Mr. Zeller. Well, I will defer to Dr. Schuchat and others 
on what the science says about reduction. What we know from the 
available epidemiological data is the overwhelming majority of 
e-cigarette users continue to smoke cigarettes.
    Senator Cassidy. I get that but that is not my point.
    Mr. Zeller. I think that the science shows that whatever 
the potential public health benefit would be, would be lessened 
and reduced in the absence of----
    Senator Cassidy. I accept that as well but not entirely 
lost. Again, if there is a threshold effect above a certain 
point, your risk from cigarette disease increases dramatically, 
anything you do to substantially decrease that usage and 
therefore keep it below that threshold is beneficial.
    Mr. Zeller. I am unaware of the science that shows that we 
know the answer on a cigarettes per day basis. It is clear that 
duration of use, the length of time that you smoke, whatever 
the number of cigarettes, is definitely related to your risk of 
disease.
    Senator Cassidy. I am out of time. I thank you both. I 
yield back.
    The Chairman. Senator Kaine.
    Senator Kaine. Thank you, Mr. Chairman. Two items, data 
modernization and then the research on smoking cessation just 
to follow-up on the discussion that you're just having with 
Senator Cassidy. Maybe first, Dr. Schuchat, if you would, what 
is the current status of research and I know a number--much of 
it is international--but what is the current status of research 
on the smoking cessation effect of e-cigarette use among 
adults?
    Dr. Schuchat. Yes. The research so far is mixed. There have 
been three randomized control trials with somewhat different 
results. The most recent trial from the UK did find some 
benefit from e-cigarette use in adult cessation. It was coupled 
with behavioral counseling which we know is important and it 
was an earlier generation e-cigarette product.
    Senator Kaine. But it was a product that was compliant with 
the UK's rules about nicotine. And nicotine threshold in the UK 
is about a third of what the nicotine would be in the standard 
Juul that is available commercially, correct?
    Dr. Schuchat. Yes. That is right.
    Senator Kaine. But that one shows some positive effect if 
you couple it with behavioral therapy to try to reduce smoking. 
What about other studies?
    Dr. Schuchat. Well, the other studies didn't find the same 
effect. And the important things I don't believe there have 
been studies with the current generation of e-cigarette 
products that have the nicotine salts, which allows you to--
overcomes the harshness and allows for a much higher dose 
exposure. And we do think that higher dose exposure makes 
addiction more likely.
    Senator Kaine. Dr. Schuchat, I was out to vote. I don't--
did you talk about nicotine salts in the public testimony 
already?
    Dr. Schuchat. I don't believe so.
    Senator Kaine. Nicotine salts are a technological advance 
that Juul has put in place that takes the harshness of nicotine 
and by altering its pH balance reduces the harshness. And that 
together with flavoring is something that is an attractor to 
people who are using the product. Isn't that correct?
    Dr. Schuchat. Yes. That is right.
    Senator Kaine. Mr. Zeller, do you have anything else on the 
science of smoking cessation studies, the current state of 
affairs?
    Mr. Zeller. Two points. Important to emphasize that much of 
what has been published is on earlier generation products so 
this remains a moving target, but the official position of the 
U.S. Preventive Services Task Force is that e-cigarettes are 
not recognized as an effective cessation aid. And if there are 
cigarette smokers who are concerned about their health and 
interested in quitting, what they should be looking at is FDA 
approved by the prescription or over-the-counter drugs coupled 
with counseling of any kind, because if you couple the drug 
with the counseling you can double your chances of success.
    Senator Kaine. FDA has approved and number, six or seven if 
I remember correctly, of smoking cessation technologies that 
can be used----
    Mr. Zeller. Yes, including products that don't even require 
prescription. Nicotine gum, nicotine patches, nicotine lozenges 
available in pharmacies.
    Senator Kaine. Great. Thank you. Next issue, data 
modernization. The Lowering Health Care Costs Act that the 
Committee voted on a couple of months back included a piece of 
legislation that I introduced with Senator Isakson and King to 
modernize public health data infrastructure. The name of the 
piece of legislation was the Saving Lives Through Better Data 
Act and it included Section 405 of the Lowering Health Care 
Costs Act along with some other items dealing with data. If you 
could, and I just talked to Senator Isakson about this and he 
wanted me to ask about this, why is better public health data 
important to dealing with an epidemic like youth e-cigarette 
use?
    Dr. Schuchat. You can see how quickly the behaviors 
changed. When a new market entered the distribution, this rapid 
skyrocketing use of e-cigarettes. Public health has been very 
lead-footed both with the epidemic of e-cigarette use and with 
this lung injury. The public health departments are getting 
faxes and CDs from hospitals of medical records having to enter 
data multiple times. The systems between electronic medical 
records and the public health are not interoperable yet.
    The CDC is trying to integrate information from a variety 
of different systems. We think we can get modernization of 
public health that will give us more efficient use of people's 
time, more effective recognition of problems, and ideally get a 
public health workforce that can be predicting instead of 
reacting to health threats.
    Senator Kaine. Mr. Zeller, would you add anything to that?
    Mr. Zeller. Yes. From a regulatory standpoint, we are only 
as good as the available regulatory science. And one of our 
great challenges if not frustrations is that the research isn't 
rapid response enough. So in our grants, in our contracts, we 
try to build in a rapid response mechanism as the products 
continue to change. I will just say that it remains a work in 
progress.
    Senator Kaine. Thank you. Mr. Chairman, if I could, I would 
like to introduce for the record a letter from the Council on 
State and Territorial Epidemiologists focusing attention upon 
the data improvement aspects of the Lowering Health Care Costs 
Act and supporting those aspects of the bill.
    The Chairman. Thank you, Senator Kaine. Senator Murray and 
I hope the Lower Health Care Costs Act becomes law with your 
provision in it. We are working to do that.
    Senator Romney.
    Senator Romney. Thank you, Mr. Chairman and Ranking Member 
for holding this hearing, and thanks to our two witnesses for 
being here and testifying today. As you know, this is an issue 
that the entire Nation cares about. In particular in my State 
of Utah, the rate of vaping illness is of particular concern 
because it is six times the national average. And we have 
already lost one of our citizens to this vaping related 
illness. There are two obviously serious and somewhat related 
issues, one is of course the people who are subject to these 
terrible illnesses associated with vaping and the other is the 
epidemic of addiction among our young people.
    How did we get here? What did we get wrong? Because it is 
hard for me to imagine that there is a logical setting where we 
have what, over 5 million young people now addicted to 
nicotine. At the same time we are doing everything we can to 
stop smoking and we have been quite successful in reducing 
smoking and yet massive increase in addiction. And somehow, we 
don't do anything about it.
    What did we do wrong? What should we do differently? Is it 
your issue or is it our fault, by the way? I know it is 
tempting for me to join in blaming you all for not doing 
something to stop what happened. But should we have acted? Is 
there something we should have done or need to do now so that 
this doesn't continue to happen or happen in another way at 
another time?
    Mr. Zeller. I will start from the FDA and the regulatory 
perspective and then ask Dr. Schuchat to add from the CDC 
perspective. As I said in my oral remarks, we tried long before 
the epidemic of kids use of e-cigarettes and long before the 
outbreak of lung injuries to regulate e-cigarettes as 
unapproved combination drug device products, and we were sued, 
and we lost. And what the court said is in the absence of an e-
cigarette product basically making a drug claim, the only 
authority that FDA had to regulate e-cigarettes, because the 
nicotine in e-cigarettes is derived from tobacco, is under the 
tobacco authorities, the Tobacco Control Act.
    We went through a rulemaking process as the statute 
requires and didn't begin to have regulatory authority over e-
cigarettes until the summer of 2016, just a little over three 
years ago. So you could say that some of the things that had 
already been set in motion that led to what we all agree today 
is an epidemic level of kids use of e-cigarettes was occurring 
at a time when we were calling the marketplace for e-cigarettes 
before we got that regulatory authority, the Wild Wild West.
    There was absolutely no regulation. Since we have had the 
regulatory authority, we have worked very hard to use all the 
tools that we have from compliance and enforcement tools to 
massive investment in public education and research to get 
answers to all the important questions that the Committee is 
asking about just the basic product themselves and what is 
going on with kids.
    I would say it is a confluence of contributing factors, 
industry behavior at a time when there was no Federal 
regulation of these products, industry behavior that continued 
after we got that authority and we have tried to use our 
enforcement tools to go after the bad actors, and the mindset 
of kids. They walk around thinking that these are harmless 
products. A whole bunch of kids don't even know that nicotine 
is present. So I would say that it is a confluence of industry 
behavior and the mindset of kids and as regulators we are 
trying to use all the tools that we have to respond and to 
combat that.
    Senator Romney. Thank you.
    Dr. Schuchat. I agree but I would say there are three key 
factors that led us to where we are, that led to this 
skyrocketing of teenage use of e-cigarettes. The first is 
advertising and it didn't show up the way we are used to on 
Billboards or TV ads. It was social media, youth influencers, 
under the radar for us adults that really influenced kids to 
think it was cool to do this.
    The second thing was flavors, candy, fruit, things that 
were not at all in young people's minds associated with 
cigarettes or nicotine. And then the third is nicotine, one of 
the most addictive substances there is and with the newer 
generation products, the nicotine salts, the harshness that 
nicotine or tobacco products have was gone, and so the 
addiction could really take hold. Not addressing those three 
factors led us to where we are.
    Senator Romney. Thank you. I would note that in the words 
of the cartoon Pogo, we met the enemy and the enemy is us. And 
I am referring in some respects to those of us on this side of 
the room, which is we need to take action to provide authority 
for you to be able to regulate effectively these products. And 
at this stage as I understand, Senator Murkowski has put in 
place legislation or proposed legislation over a year ago to 
restrict flavors and yet we don't act. We talk about this 
epidemic among young people and wonder why you all haven't done 
something about flavors, but why haven't we done something 
about flavors.
    Senator Berkeley and I put together a piece of legislation 
that does four things. One, it makes these flavors illegal. 
Number two, it insists on close tanks, a closed system as 
opposed to one that people can add THC and other products to. 
Three, it puts a lot more money into advertising on social 
media and other media sources to go to kids.
    Finally, it pays for that advertising by putting an excise 
tax on nicotine just like the excise taxes on nicotine in 
cigarettes. If that legislation were to pass, my presumption is 
we would have a dramatic impact on reducing the number of kids 
that get addicted to nicotine. Do you agree? And a one-word 
answer is all you have got time for.
    Mr. Zeller. All I can say from the FDA perspective is we 
would be happy to work with you on that. I think that there is 
evidence based for the positive public health impact of the 
elements that you are describing there. We would be happy to 
work with you.
    Dr. Schuchat. Yes, I agree. And just to say that we think 
that tobacco control needs to be comprehensive, that Federal, 
state, and local efforts are needed, and that there is a 
history here of whack a mole that when we take care of a set of 
issues other issues emerge. So investment in monitoring that is 
modern so we can be on top of new threats that emerge.
    The Chairman. Thank you, Senator Romney.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman, and thank you for 
allowing a second round of questions. I had intended to ask 
about any expertise that had been developed relating to helping 
young people quit smoking, quit vaping, cease using nicotine. 
That has already been asked so I want to kind of explore a 
little bit further. If we are using adults perhaps as our best 
way of guessing, what these folks under 18 will experience, 
what percentage of the 5 million youths who are vaping nicotine 
products will become addicted to nicotine?
    Dr. Schuchat. I don't actually know that statistic. I don't 
know if you do?
    Mr. Zeller. We don't know that but there is an alarming 
trend that could be putting kids on the pathway to addiction 
from the annual National Youth Tobacco Survey results, and that 
is of the current e-cigarette users who are middle school or 
high school students, how many of them are so-called frequent 
users?
    Frequent uses defined as, did you use on 20 or more of the 
past 30 days? And unfortunately, the percentage of current e-
cigarette users in middle school and high school who are 
frequent users is rising. It is now a total of 1.6 million 
middle and high school kids in the 2019 NYTS data are frequent 
users, and almost 1 million of those 1.6 million used e-
cigarettes every single one of those days.
    Senator Baldwin. Okay, again using adults as our best 
source of information, our experience with adults, an adult who 
is trying to stop using nicotine, what information do we have 
about how often or how many times they try before they actually 
successfully cease using?
    Mr. Zeller. I will also from the FDA perspective because 
our center for drugs actually puts those products on the market 
as smoking cessation aids, but on the tobacco side, we also 
have had a paid media campaign called Every Try Counts where we 
are putting positive quit messages into gas stations and 
convenience stores because 96 percent of all the cigarettes 
that are sold in the United States are sold in gas stations and 
convenience stores. And what we are trying to do is to get the 
health concerned smoker who made a quit attempt in the past 12 
months but was unsuccessful to try again.
    Typically a smoker has to try, 10 or more times before they 
will ultimately succeed. And the real world Effectiveness rate 
of the FDA approved over-the-counter products, at least the 
nicotine gum, nicotine patches, nicotine lozenge, the real 
world effectiveness rate of these products is low. It is in the 
single digits.
    We need to get more smokers to be serious about making the 
quit attempt and we need to get the word out to them that it is 
often a matter of trying and trying again, and as Dr. Schuchat 
said earlier, then combining whatever drug you use, FDA 
approved drug that you use, with counseling of any kind, 
online, in person, group counseling because that can more than 
double your chances of succeeding.
    Senator Baldwin. It sounds like those should be the posters 
that are up in the middle school and high school bathrooms.
    Mr. Zeller. We need to know what will work with kids and 
that is what we are trying to get to the bottom of.
    Senator Baldwin. But we don't have a lot of time, right? We 
can't do a peer-reviewed study that takes, however long. We 
need to offer services to these children now. So support groups 
can be in school and that sort of thing.
    Mr. Zeller. We are. So there are online--so putting aside 
whether there is FDA-approved medications, there are a number 
of Government and online resources. And so through our youth 
prevention efforts, we have more than doubled the number of 
inquiries to an NCI website where kids can go for help in 
getting more information about quitting. But we still need to 
do more work on what are the products that we know will 
actually help them quit.
    Senator Baldwin. I am going to submit some additional 
questions for the record because the answers just beg other 
questions, but one that I will submit for the record, Dr. 
Schuchat, is you said in your testimony that the ongoing 
investigation into the lung injury presents a number of 
challenges to both public health agencies and health care 
providers, and I would be interested in getting more detailed 
information about what the CDC is sharing with state health 
departments and providers on best practices for identifying and 
treating the illness.
    Dr. Schuchat. I would be happy to submit that.
    Senator Baldwin. Thank you.
    The Chairman. Thank you, Senator Baldwin.
    Senator Murray.
    Senator Murray. Thank you. Mr. Zeller, I want to go back to 
you because I really am deeply troubled by the FDA's failure to 
complete key actions to protect the public health. We talked 
about the delay of the premarket review requirements for e-
cigarettes and the flavor policy but the Agency has dragged its 
feet on many other policies, graphic warning labels that 
Senator Enzi offered in the Tobacco Control Act, taking actual 
action on menthol cigarettes, implementing track and trace, a 
mandate that would actually deter illicit trade and bolster 
enforcement of key requirements.
    When this Committee worked to pass the law more than a 
decade ago it ensured the FDA had full authority to 
fundamentally remake the tobacco market. Can you tell us why 
these and other important provisions from the Tobacco Control 
Act have been so significantly delayed or not even started?
    Mr. Zeller. I think that a number of the items that you 
listed are things that we have been working on and that we 
share your concern about how much of a priority that they are. 
We have a completely stood up center with active, programmatic 
efforts in the major and most important programmatic areas, 
compliance and enforcement, public education, product review, 
regulatory science research, and then all the operations and 
management that goes with all of that. And we are ready for the 
applications for these products to come in. I think that the 
examples that you gave are important examples and happy to work 
with you and your staff to give you status reports on where 
each of those stand.
    Senator Murray. I appreciate that. But I just have to say, 
Mr. Chairman, first of all, thank you for having this hearing 
and thank you to both of you for coming and testifying but it 
just seems to me we need swift, bold, quick action on 
addressing these issues. So I am going to keep pressing the 
Trump administration which you have told us we have to talk to, 
including through the Acting FDA Commissioner and our new 
nominee should he be confirmed as well.
    We need to stop these delays and we need to deliver strong 
steps that have already been promised and I think that is 
critically important for this Committee to go really forcefully 
on. And I of course will continue to work with our colleagues 
on both sides of the aisle to do what we can to address this 
really critical crisis. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murray and I would 
emphasize to the witnesses and to the public, this is another 
one of our bipartisan hearings and I think you can see in the 
questions and attendance today the amount of interest in it. 
Let me follow-up with what Senator Romney and Senator Murray--
Senator Romney asked, what authority do you needed that you 
didn't have? Senator Murray talked about authority.
    Ms. Schuchat talked about three studies, I believe, the 
most promising of which in Great Britain showed was due to a 
lower level of nicotine in the e-cigarette. Do you agree, Mr. 
Zeller, that study suggested that a lower level of nicotine in 
the e-cigarette would be more effective in helping people to 
stop smoking?
    Mr. Zeller. I am not familiar with that study and I can't 
make that finding that a lower level of nicotine in the e-
cigarettes in the UK, given all the other factors that are 
present there, is a direct contributing factor to what is going 
on.
    The Chairman. Ms. Schuchat, did I characterize that 
correctly?
    Dr. Schuchat. Yes. Let me clarify. It was a randomized 
control trial comparing 20 milligrams per milliliter e-
cigarette with control. And so it wasn't showing that a lower 
was better than a higher, the products they were using were not 
as high nicotine content as the products that are in the market 
in the U.S.
    The Chairman. Well, in terms of authority, let me ask you, 
Mr. Zeller, do does the FDA have the authority to require lower 
nicotine levels in e-cigarettes?
    Mr. Zeller. Armed with the science to support it, yes.
    The Chairman. Yes. Does the FDA have the authority to 
require the kind of closed cartridge or tamper-proof cartridge 
that Senator Romney talked about in his legislation?
    Mr. Zeller. Yes. If the evidence was there to support it, 
we could use something called the product standard authority to 
put those kinds of provisions in place in the marketplace.
    The Chairman. Does the FDA have the authority to require a 
warning label to be on the device itself?
    Mr. Zeller. We already have done that. There is a mandatory 
nicotine addiction warning on all these products.
    The Chairman. Well, let's see. On this, you can put a 
warning label on this?
    Mr. Zeller. It would be on the package that product was 
sold in.
    The Chairman. Well, that is not what we are talking about. 
Have you got the authority to put a warning label on this 
itself?
    Mr. Zeller. That, I will need to get back to you for the 
record for something that would be inside the package. But 
there is a mandatory nicotine addiction warning on the labeling 
and the packaging for that product.
    The Chairman. The problem you run into was the First 
Amendment problem with your graphic?
    Mr. Zeller. That is correct.
    The Chairman. Graphic, which is different in the UK. They 
don't have a First Amendment if I remember, right?
    Mr. Zeller. Correct.
    The Chairman. Or much of one. Do you have the authority to 
regulate the size of these devices?
    Mr. Zeller. What do you mean by size?
    The Chairman. Well, some of them are this big, some of them 
are small, some--we have got a chart here with a bunch of them 
on----
    Mr. Zeller. That, I will need to consult with the Agency 
and get back to you on. It is possible that could be something 
under our products end authority, but I don't know and I don't 
want to misspeak so I will get back to you.
    The Chairman. Do you have the authority to regulate or ban 
certain flavors in e-cigarettes?
    Mr. Zeller. Yes, we do.
    The Chairman. Do you have the authority to spend more of 
the user fees that you get from the tobacco industry on finding 
more effective ways to encourage young people not to use e-
cigarettes?
    Mr. Zeller. We have done that. We have reallocated a 
sizable portion----
    The Chairman. But you don't need us to pass a law for you 
to do that, right?
    Mr. Zeller. No. But my point is that we have already done 
that on the public education side.
    The Chairman. I know you--but apparently it doesn't work 
because we have got 1 out of 4 high school students vaping.
    Mr. Zeller. I tried to make it clear that we have more work 
to do. But if the question is do, we know have----
    The Chairman. But what I am trying to make it clear is, do 
you have the authority within that more than $5 billion you 
have collected over the last 10 years to spend more of it on 
more effective ways to deal with young people?
    Mr. Zeller. Yes, we do.
    The Chairman. If I go through that level, while you want to 
get back to me on a couple of them, you appear to have the 
authority to lower nicotine level requirements to deal with 
close--to require closed tamper-proof cartridges. You may have 
the authority to put a label directly on a device or to 
regulate the size. You do have the authority to regulate 
flavors and you could spend more than you are currently 
spending, although you would have to spend less on something 
else, on focusing on more effective ways for young people. So 
there is a lot you could do and you could move the proposed 
regulations into final status more quickly, correct?
    Mr. Zeller. Yes. Yes, sir, and two points. First, 
finalizing those proposed rules is a huge priority. Second, how 
to use the broad authority that we have to address many of the 
product characteristics that you asked about is something that 
we are actively considering internally. And that is how to use 
the product standard authority which requires going through a 
rulemaking process to address various issues related to these.
    The Chairman. Well, I think you heard today some 
differences of opinion about attitudes toward tobacco, some, 
not much but some. I don't think you heard any about the 
importance of two things, one is getting to the bottom of this 
mysterious illness that you and the CDC are working on as 
quickly as we can. And two, dealing with the epidemic of young 
Americans, high school students who are vaping.
    We hope that the legislation that Senator Kaine and Senator 
McConnell, Senator Murray and I and others have, as part of our 
Lowering Health Care Costs Act, which passes Committee 20 to 3, 
will become law and move the age for the purchase of tobacco 
products up to 21. That should help. But in the meantime, it 
looks to me like you have a lot of authority to do more about 
e-cigarettes, especially for young people and that there is 
plenty of support on this Committee for you to do that.
    I want to thank both of you for coming today and for your 
professionalism. And there are a few follow-up questions as 
Senators had, particularly about the amount of spending that 
FDA does for young--on trying to persuade young people not to 
use vaping. The hearing record will remain open for 10 days. 
Members may submit additional information for the record within 
that time if they would like.
    The Chairman. We will meet again on Wednesday in this 
Committee, on November 20th, for hearing on the nomination of 
Dr. Stephen Hahn to serve as Commissioner of Food and Drugs. My 
guess is this subject will come up then again. Thank you for 
being here today.
    The Committee will stand adjourned.

                          ADDITIONAL MATERIAL

         E-Cigarette Use Among Youth in the United States, 2019
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    [Whereupon, at 12:22 p.m., the hearing was adjourned.]

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