[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
THE FEDERAL RESPONSE TO THE EPIDEMIC
OF E-CIGARETTE USE, ESPECIALLY AMONG
CHILDREN, AND THE FOOD AND DRUG
ADMINISTRATION'S COMPLIANCE POLICY
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HEARING
BEFORE THE
SUBCOMMITTEE ON ECONOMIC AND CONSUMER POLICY
OF THE
COMMITTEE ON OVERSIGHT
AND REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
DECEMBER 4, 2019
__________
Serial No. 116-74
__________
Printed for the use of the Committee on Oversight and Reform
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available on: http://www.govinfo.gov
http://www.oversight.house.gov or
http://www.docs.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
38-733 PDF WASHINGTON : 2020
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COMMITTEE ON OVERSIGHT AND REFORM
CAROLYN B. MALONEY, New York, Chairwoman
Eleanor Holmes Norton, District of Jim Jordan, Ohio, Ranking Minority
Columbia Member
Wm. Lacy Clay, Missouri Paul A. Gosar, Arizona
Stephen F. Lynch, Massachusetts Virginia Foxx, North Carolina
Jim Cooper, Tennessee Thomas Massie, Kentucky
Gerald E. Connolly, Virginia Mark Meadows, North Carolina
Raja Krishnamoorthi, Illinois Jody B. Hice, Georgia
Jamie Raskin, Maryland Glenn Grothman, Wisconsin
Harley Rouda, California James Comer, Kentucky
Katie Hill, California Michael Cloud, Texas
Debbie Wasserman Schultz, Florida Bob Gibbs, Ohio
John P. Sarbanes, Maryland Ralph Norman, South Carolina
Peter Welch, Vermont Clay Higgins, Louisiana
Jackie Speier, California Chip Roy, Texas
Robin L. Kelly, Illinois Carol D. Miller, West Virginia
Mark DeSaulnier, California Mark E. Green, Tennessee
Brenda L. Lawrence, Michigan Kelly Armstrong, North Dakota
Stacey E. Plaskett, Virgin Islands W. Gregory Steube, Florida
Ro Khanna, California Frank Keller, Pennsylvania
Jimmy Gomez, California
Alexandria Ocasio-Cortez, New York
Ayanna Pressley, Massachusetts
Rashida Tlaib, Michigan
David Rapallo, Staff Director
Richard Trumka, Subcommittee Staff Director
William Cunningham, Chief Counsel and Senior Policy Advisor
Joshua Zucker, Clerk
Christopher Hixon, Minority Staff Director
Contact Number: 202-225-5051
------
Subcommittee on Economic and Consumer Policy
Raja Krishnamoorthi, Illinois, Chairman
Mark DeSaulnier, California, Michael Cloud, Texas, Ranking
Katie Hill, California Minority Member
Ro Khanna, California Glenn Grothman, Wisconsin
Ayanna Pressley, Massachusetts James Comer, Kentucky
Rashida Tlaib, Michigan Chip Roy, Texas
Gerald E. Connolly, Virginia Carol D. Miller, West Virginia
C O N T E N T S
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Page
Hearing held on December 4, 2019................................. 1
Witness
Mitch Zeller, Director, Center for Tobacco Products, Food and
Drug Administration
Oral Statement............................................... 5
* The prepared statements for the above witness is available at:
https://docs.house.gov.
INDEX OF DOCUMENTS
----------
The document listed below, and pending Questions for the Record
responses will be available at: https://docs.house.gov.
* Response Letter from the FDA/OIRA; submitted by Chairman
Krishnamoorthi.
THE FEDERAL RESPONSE TO THE EPIDEMIC
OF E-CIGARETTE USE, ESPECIALLY AMONG
CHILDREN, AND THE FOOD AND DRUG
ADMINISTRATION'S COMPLIANCE POLICY
----------
Wednesday, December 4, 2019
House of Representatives,
Committee on Oversight and Reform,
Subcommittee on Economic and Consumer Policy,
Washington, D.C.
The subcommittee met, pursuant to notice, at 2:40 p.m., in
room 2154, Rayburn House Office Building, Hon. Raja
Krishnamoorthi (chairman of the subcommittee) presiding.
Present: Representatives Krishamoorthi, Maloney,
DeSaulnier, Khanna, Pressley, Tlaib, Connolly, Wasserman
Schultz, Sarbanes, Cloud, Grothman, Comer, and Miller.
Mr. Krishnamoorthi. The subcommittee will come to order.
Without objection, the chair is authorized to declare a recess
of the committee at any time.
This hearing is Examining the Federal Response to the
Epidemic of Youth E-Cigarette Use and FDA, Food and Drug
Administration Compliance Policy.
I now recognize myself for five minutes to give an opening
statement.
On September 11 of this year, the Administration released
deeply disturbing results from the National Youth Tobacco
Survey, otherwise known as the NYTS. The data confirmed our
fears that the youth vaping epidemic continues to grow to all-
time highs. Today, 5.3 million high school and middle school
students use e-cigarette, and the trends are alarming, both
among high school students as well as middle school students.
Here I show you two visuals. On your right we see that in
2017, roughly 12 percent of high schoolers were vaping, and in
2019, almost 28 percent of high schoolers are vaping, meaning
there is almost a 135 percent increase in vaping among high
schoolers.
On your left there is another visual, which is even more
disturbing. In 2017, 3.3 percent of middle schoolers were
vaping, and today it is almost 11 percent. That is a 218
percent rise in vaping among middle schoolers. As a parent of
three children, these statistics are extremely disturbing.
The NYTS data also shows that flavors are driving youth
vaping use. Seventy-two percent of youth who vape use flavors,
and 64 percent of all kids who vape use mint or menthol, which,
by the way, are Juul's most popular flavors. That makes sense,
because NYTS data also confirmed that Juul is the most popular
youth brand, with most kids who vape using it.
Armed with this data, the heads of America's public health
agencies convinced the President, at least temporarily, to do
the right thing. With data linking the alarmingly high youth
vaping rates to flavors, the President and the heads of HHS and
FDA announced their proposal on September 11 to essentially ban
flavored e-cigarettes, with the exception of tobacco-flavored
ones.
They put forward a sound and logical response to the
problem. As HHS Secretary Alex Azar pledged, quote, ``We
require that all flavors other than tobacco flavor be removed
from the market. This would include mint and menthol flavoring
as well as candy flavors, bubble gum flavor, fruit flavor, and
alcohol flavor.'' Secretary Azar explained that ``these
products are still getting to kids and we cannot let a whole
generation get addicted to them through mint and menthol and
other flavors,'' close quote.
During that same announcement, the President committed that
this bold flavor ban would be issued within the next, quote,
``couple of weeks,'' close quote. When the President made this
exciting announcement on September 11, I, and many members of
this committee, led the charge in commending him. A ban of all
flavored e-cigarettes would deter new youth users from starting
to vape. During a tumultuous time in our politics I frequently
referenced the President's announcement as bipartisanship at
its best. It was a move to protect and preserve the health of
American youth.
But while it is our privilege, or it was our privilege to
back the President when he took steps to strengthen public
health, it is also our responsibility to hold him and his
Administration accountable to their bold promises.
Unfortunately, almost three months after the President's
initial announcement, the flavor ban has not yet been
implemented. Reports illustrate that Big Tobacco lobbyists are
working to weaken the ban. There are indications, as well, that
the Administration is considering exempting menthol as well as
exempting vape shops. We sincerely hope these reports are
inaccurate.
In light of these allegations, we tried to find out what
was happening. We first wrote the FDA, asking it to finalize
and issue the flavor ban without exemptions. FDA did finalize
its guidance, but instead of publishing it, the FDA sent it to
the Office of Information and Regulatory Affairs, also known as
OIRA. That was concerning because OIRA often guts or
indefinitely delays agency action. By the way, OIRA is an
office within the Office of Management and Budget in the White
House, so you will hear that being referred to repeatedly
today. In fact, FDA had submitted an e-cigarette flavor ban to
OIRA once before, in 2016, and after a flood of industry
lobbying, OIRA eliminated that prior flavor ban altogether.
We then wrote OIRA, asking it to quickly complete its
review so the flavor ban wouldn't again fall victim to
lobbying. OIRA complied, but again, the guidance was not
published. Not publishing at that stage is highly unusual, so
the subcommittee wrote to both OIRA and the FDA to ascertain
which agency currently controlled the guidance. Neither
answered. So far neither FDA nor OIRA will clarify if the
guidance is with their office. However, we did get an update on
December 3--that would be two days ago--which is that OIRA has
said that it has completed its review, so we assume that the
guidance is now with the FDA again.
The American people deserve answers. Mr. Zeller, you are
the Director of FDA's Center for Tobacco Products. Today
parents across the country expect that you will provide them
with answers. Once we get those answers, we deserve immediate
implementation of a flavor ban with no exemptions.
And with that I now recognize my ranking member, Mr. Cloud,
for his opening statement. Thank you.
Mr. Cloud. Thank you, Mr. Chairman. Thank you, Mr. Zeller,
for being here today and participating what might not be the
most-watched hearing of the day, but certainly one of the more
important ones. Let me say, at the outset, thanks to the
chairman for the focus on this issue and the cooperative spirit
which, for the most part, we have been able to maintain on this
issue, even in today's polarized environment, in having
solutions-oriented discussion on this issue.
I know that we are especially united in our goal to end
teen vaping. This is an epidemic that is uniquely troubling
because it has caused harm in two ways, both fostering nicotine
dependency in youth and also the onset of increasingly fatal
lung injury. As a father, I can only imagine the agonizing
realization of understanding that your child has become
addicted to something they had no idea was even harmful, or the
pain of the devastating loss of losing a child or a loved one.
My sincere condolences to those who have lost loved ones to
this illness.
Over the last few months it has become obvious that
something is making users of vaping products sick. When we
think of the vaping epidemic, it is important to recognize that
there are tracks of concern, that each need attention and
require a tailored solution. There is the teen vaping epidemic
that has enveloped as many as 20 percent of our Nation's
teenagers, and then there is the issue of lung damage that,
according to the CDC, has tragically led to the deaths, thus
far, of 47 people in 25 states and the District of Columbia, as
well as 2,290 who have fallen ill to vape-related lung injury.
This aspect of the issue has affected all ages. Of those
hospitalized, 15 percent were under age Mr. Cleaver. 38 percent
were 18 to 24; 24 percent, 25 to 34; and 23 percent were 35
years and older.
This has been a complex issue, because while it is clear
that vaping products are hooking young people on nicotine, it
appears that tainted black market products seem likely to be
causing much of the lung injury. Some of the challenges in
dealing with these issues, of course, have been the rapidly
developing nature of this epidemic; the lack of reliable data
that definitively points to clear causes; counterfeit products
that blur the focus in understanding the origin of tainted
products; untraceable supply lines, particularly within the
black market; the lack of effective enforcement; and, of
course, the challenge we face, as legislators, in protecting
the public from harm while protecting their individual
liberties.
Thankfully, we have had some breakthrough in findings over
the last few weeks that bring some understanding to what is
causing lung injury. In the last update from CDC, vitamin E
acetate has been identified as a chemical of concern among
people who have gotten sick from vaping. THC has been present
in most of the recent samples tested. Vitamin E acetate has
been used as an additive, most notably as a thickening agent,
in THC e-cigarette products. These findings serve to suggest
that THC-containing e-cigarette products from nonregulated
sources are the most likely culprit for the recent outbreak of
lung injury.
News outlets, including the Associated Press and Wall
Street Journal have reported on the availability and pervasive
nature of vaping products that are tainted by bad actors. The
Wall Street Journal reports that there is a large market for
illegal and counterfeit vaping products online. These products
are often made by bad actors to resemble those from legitimate
manufacturers, but instead contain additives like pesticides.
The CDC has warned users not to buy any vaping products off
the street or online, and I am hopeful that the FDA and others
in public health entities at the Federal and state levels can
continue broadening our understanding of these recent cases of
pulmonary illness so they can be addressed appropriately.
Additionally, I would like to spend time today on this
hearing discussing on any progress the FDA has made on curbing
youth e-cigarette use. I do believe that the focus on this
issue in this committee has helped to bring awareness not just
to the misconceptions many youth have had toward the health
dangers associated with vaping but also to the public safety
issues that remain in the quagmire of the vaping product supply
chain.
Last, this committee considers solutions to those serious
problems I do hope will be appropriately balanced in protecting
the public, especially our teens, while protecting the rights
of consumers who still may find that vaping is a less-damaging
alternative to traditional smoking. And before closing I would
like to thank you, Mr. Zeller, for your testimony and being
here today, and, as always, I am grateful for the committee and
the chair and us being able to work together on this issue.
Thank you, Mr. Chairman. I yield back.
Mr. Krishnamoorthi. Thank you, Congressman Cloud. I now
want to recognize our new full committee chairwoman, Carolyn
Maloney. Congratulations. I look forward to working with her
under her leadership, and I welcome her here today. I know this
is an issue that she is very deeply concerned about. And now I
would like to recognize the chairwoman to say a few words at
this time.
Chairwoman Maloney. Thank you so much, Chairman
Krishnamoorthi, for holding this important hearing, and ranking
member for supporting it, and the entire subcommittee for your
work on addressing this epidemic.
E-cigarette manufacturers are luring a new generation of
Americans into a deadly, life-long addiction. The Centers for
Disease Control and Prevention found that tobacco use among
high school students has increased by nearly 40 percent in the
past year alone. Fueled by e-cigarette use, last year over 20
percent of teenagers reported e-cigarette use, a 78 percent
increase from the year before. We are facing a public health
crisis.
Thankfully, this subcommittee has stepped in to protect
children's health and hold this industry to account. Briefly,
it looked like we would have a very important, strong partner
in this fight, President Donald Trump. But he has broken his
promises, walking back his commitment to take quick, decisive
action to address youth vaping by imposing a flavor ban. It
looks like, once again, they are going to put profits over
people, and we will not allow this to happen.
I look forward to hearing your testimony and the
questioning of our witnesses, and I yield back. Thank you.
Mr. Krishnamoorthi. Thank you, Chairwoman. Now I would like
to recognize our witness. Today we are joined by Mr. Mitch
Zeller, the Director of the Center for Tobacco Products at the
Food and Drug Administration.
Sir, if you would please rise and raise your right hand, I
will begin by swearing you in.
[Witness sworn.]
Mr. Krishnamoorthi. Let the record show that the witness
answered in the affirmative.
Thank you, and I would like to invite you to give us your
opening statement. The microphones are sensitive so please
speak directly into them. Without objection, your written
statement will be made part of the record.
And with that, Director Zeller, you are now recognized for
five minutes.
STATEMENT OF MITCH ZELLER, DIRECTOR, CENTER FOR TOBACCO
PRODUCTS, FOOD AND DRUG ADMINISTRATION
Mr. Zeller. Thank you so much, Chairman Krishnamoorthi.
Thank you, Chairwoman Maloney. Congratulations on taking over
my old committee--I worked on this committee for four and a
half years, from the 1980's to the early 1990's, for one of the
subcommittees--to Ranking Member Cloud and to members of the
subcommittee, and thank you for the opportunity for being here
today.
And I want to begin by recognizing the subcommittee for its
work to examine the potential causes of the epidemic of youth
use of e-cigarettes. I am here today representing hundreds of
staff at the Food and Drug Administration who are working
tirelessly to prevent kids from starting to use any tobacco
product, including e-cigarettes.
I understand that the subcommittee and the public are
interested in the Administration's policy with respect to
flavored e-cigarettes, and I want to assure the subcommittee
that we are committed to doing everything that we can to
prevent kids from using tobacco products, and will continue to
develop a policy approach that aligns with that concern.
Recently, the Administration held a listening session on
the youth e-cigarette epidemic to help inform policy actions
going forward, and I will be happy to return to brief members
of the subcommittee, the full committee, and staff when updates
are available.
I would like to provide some background and an update on
FDA's efforts to regulate e-cigarettes. Our initial efforts
began more than a decade ago, long before the rise in youth use
of e-cigarettes and the multistate lung injury outbreak.
Between 2008 and 2010, FDA attempted to regulate e-cigarettes
as unapproved drug device combination products. Our action was
challenged and ultimately overturned in court.
In the decade since the Tobacco Control Act was passed,
FDA's Center for Tobacco Products, CTP, 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 kids on the dangers of tobacco use.
CTP has also expanded its focus and authorities to address
new challenges by products such as e-cigarettes. 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
8, 2016.
Protecting our Nation's youth from the dangers of tobacco
products is among FDA's most important responsibilities, and we
will continue to take aggressive steps to make sure tobacco
products are not being marketed or sold to kids.
Let me highlight some of the actions that we have taken to
help address the epidemic of youth use of e-cigarettes.
We have issued more than 10,000 warning letters and filed
over 1,600 civil money penalty complaints against online and
brick-and-mortar retailers for the illegal sale of e-cigarette
products to kids. 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 issued a warning letter to Juul Labs, informed by the
work of this subcommittee, for marketing unauthorized,
modified-risk tobacco products, including a presentation given
to youth at a school marketing Juul products as posing reduced
risk or harm compared to cigarette smoking.
We also issued a second letter to Juul expressing our
concern and requesting additional information about several
issued raised by this subcommittee regarding Juul's outreach
and marketing practices, including those targeted at students,
tribes, health insurers, and employers. Our letter notes that
despite commitments Juul has made to address the youth
epidemic, Juul products continue to represent a significant
proportion of the overall use of e-cigarettes by children.
Last year, we launched The Real Cost, youth e-cigarette
prevention campaign, which features hard-hitting ads on TV and
on digital and social media sites popular with teens, as well
as posters with e-cigarette prevention messages in every high
school across the Nation. And finally, we joined forces with
Scholastic to develop educational resources that have been
distributed to over a million middle and high school educators.
Yet despite these efforts, the youth vaping epidemic
continues to grow, and we know we need to do more.
As the subcommittee considers the issues related to e-
cigarette use, it is important to remember that no e-cigarette
product is lawfully on the market because none have obtained a
marketing authorization from FDA.
When we announced changes to our enforcement discretion
policy in August 2017, at the time the nationally
representative data suggested that youth use of e-cigarettes
had declined. However, as we all know, and as the chairman
pointed out in his opening remarks, last year the National
Youth Tobacco Survey, or NYTS, showed that from 2017 to 2018,
current e-cigarette use among high school students had
increased by 78 percent, and by 48 percent among middle school
students.
And last month we published the 2019 data, showing that
current e-cigarette use had risen to 27.5 percent among high
school students and 10.5 percent among middle school students.
As in previous years, the 2019 data 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 half of those in middle school used flavored e-
cigarettes.
We are committed top doing everything we can to prevent
kids from using tobacco products, and as I stated at the
outset, we will continue to develop a policy approach that
aligns with that concern.
I want to thank you for the opportunity to testify today,
and I would be happy to answer any questions that you have.
Mr. Krishnamoorthi. Thank you, Mr. Zeller. Thank you for
being here today. I would like to recognize myself for five
minutes of questions.
Mr. Zeller, you are aware that on September 11, HHS
Secretary Azar said the FDA was going to issue guidance
clearing the market of, quote, ``non-tobacco-flavored e-
cigarettes including mint and menthol products.'' Right?
Mr. Zeller. Yes.
Mr. Krishnamoorthi. And you are aware that Secretary Azar
announced the ban because, quote, ``the numbers from the NYTS
show a continued rise in the disturbing rates of youth e-
cigarette use, especially through the use of non-tobacco
flavors that appeal to kids.'' Correct?
Mr. Zeller. Correct.
Mr. Krishnamoorthi. And Secretary Azar further stated that,
quote, ``more than a quarter of high school students were
current e-cigarette users in 2019, and the overwhelming
majority of youth e-cigarette users,'' I think you said 75
percent of high schoolers, but ``the overwhelming majority of
youth e-cigarette users cited the use of popular fruit and
menthol or mint flavors.'' Right?
Mr. Zeller. That is correct.
Mr. Krishnamoorthi. The purpose of banning of, as you
Secretary Azar said, clearing the marketing of flavored e-
cigarettes was to decrease youth vaping. Right?
Mr. Zeller. That would be consistent with what the
secretary said, yes.
Mr. Krishnamoorthi. And there was urgency to this issue.
There was urgency. That is why the President said, on September
11, that FDA guidance and action would come in, quote, ``a
couple of weeks.'' Right?
Mr. Zeller. That is what was said.
Mr. Krishnamoorthi. And there was an urgency that was felt
at that time. Right?
Mr. Zeller. That is correct.
Mr. Krishnamoorthi. And on October 25, you stated that
FDA's work on the flavor guidance issue was, quote, ``a very,
very high priority, and we are trying to complete work on it as
quickly as possible.'' Right?
Mr. Zeller. I don't remember the date but yes, I said that.
Mr. Krishnamoorthi. Yes. You said that on October 25, to
The Hill.
But this guidance, this flavor guidance, has not yet been
published yet, has it?
Mr. Zeller. No.
Mr. Krishnamoorthi. According to a letter sent to me
yesterday by FDA and OIRA, FDA drafted guidance and sent it to
OIRA, an office within the OMB, as we talked about before, on
October 25. Correct?
Mr. Zeller. Yes, sir.
Mr. Krishnamoorthi. Just to be clear, FDA's guidance
document followed through on Secretary Azar's September 11
announcement that the FDA would clear the market of all non-
tobacco flavors. Right?
Mr. Zeller. I am not going to get into the substance of the
document that was submitted.
Mr. Krishnamoorthi. Okay. And on what basis are you not
getting into the substance?
Mr. Zeller. Because there has been no final decision made
on this policy. Because there are ongoing discussions that are
taking place, I am not going to be able to get into the
substance of what was in that document.
Mr. Krishnamoorthi. And who instructed you not to get into
the substance of it?
Mr. Zeller. This was based upon discussions internally at
the agency and it is standard practice when there is ongoing
policymaking that we don't talk publicly about what is under
consideration. I would be happy--as I said in my remarks, I
would be happy to come back and brief you and your staff when
there is a final decision and walk you through everything. But
this remains an open, ongoing set of discussions.
Mr. Krishnamoorthi. So according to FDA's letter sent to me
yesterday, the FDA OIRA letter sent to me yesterday, OIRA
concluded its review on November 4. Right?
Mr. Zeller. Correct.
Mr. Krishnamoorthi. Now did OIRA make any changes to the
initial guidance submitted by the FDA?
Mr. Zeller. Again, I can't go into the details of what
remains ongoing discussions.
Mr. Krishnamoorthi. Now you are familiar with something
called Executive Order 12866. Right?
Mr. Zeller. Yes, sir.
Mr. Krishnamoorthi. According to this catchy phrase, E.O.
12866, the FDA is not allowed to publish in the Federal
Register until OIRA has essentially completed its review.
Right?
Mr. Zeller. For things that are subject to the Executive
Order.
Mr. Krishnamoorthi. Correct. And this is one of them.
Mr. Zeller. This was a policy that, because of its
significance, we sent to OMB for review, yes.
Mr. Krishnamoorthi. And basically E.O. 12866 would apply.
It basically talks about the types of policies that would be
submitted to OIRA and then sent back to FDA. Right?
Mr. Zeller. Correct.
Mr. Krishnamoorthi. Okay. Now OIRA has marked the review,
quote/unquote, ``completed'' on its website. That means, Mr.
Zeller, the policy is now back with the FDA. Right?
Mr. Zeller. They completed their review on November 4, and
sent the document back to us, but there were still other
ongoing policy-related discussions going in parallel. But OIRA
did complete its review, as you stated, and sent it back to us
on November 4.
Mr. Krishnamoorthi. When you say there are policy
discussions ongoing, between who and who?
Mr. Zeller. There were parallel policy discussions going on
between FDA and the department and the White House.
Mr. Krishnamoorthi. So according to Executive Order 12866,
the FDA is not allowed to publish in the Federal Register until
OIRA has completed its review. Now that OIRA has completed its
review, the FDA can publish the guidance. Right?
Mr. Zeller. If the complete Executive branch review of the
policy was done, but there were still, as I said, in parallel,
other ongoing policy-related discussions going on, in addition
to the OIRA review of the guidance document that was sent.
Mr. Krishnamoorthi. So these parallel discussions, this
sounds like some kind of irregular channel of discussions,
independent of the standard submission of the guidance from FDA
to OIRA and back from OIRA to FDA. Is there some other review
that is happening right now that has nothing to do with OIRA or
FDA?
Mr. Zeller. There are ongoing policy-related discussions
between the agency, the department, and the White House about
what the policy should be.
Mr. Krishnamoorthi. Okay. So did OIRA really complete its
review, if they are still discussing with you this document?
Mr. Zeller. OIRA completed its review, but at other levels
within the department and the White House and the agency,
again, in parallel, there were discussions continuing about
what the policy should be, even though OIRA had completed its
review.
Mr. Krishnamoorthi. And who is part of those discussions at
the FDA?
Mr. Zeller. That would be the leadership of the agency, the
leadership of the department, and various parts of the White
House.
Mr. Krishnamoorthi. And that leadership includes you?
Mr. Zeller. I have been involved, I would say, peripherally
in those discussions. It has mostly been the leadership of the
agency.
Mr. Krishnamoorthi. And at the White House, who has the
leadership involved?
Mr. Zeller. I think it is various offices, from the
Domestic Policy Council to the Office of Management and Budget
and others. I have not been directly involved in discussions
with the White House.
Mr. Krishnamoorthi. So you would agree with me, sir--and
the White House Domestic Policy Council is headed by Joe
Grogan. Is that right?
Mr. Zeller. Correct.
Mr. Krishnamoorthi. You would agree with me that the FDA
should be regulating tobacco products, don't you?
Mr. Zeller. That is our job, yes.
Mr. Krishnamoorthi. It is not a waste of time. Right?
Mr. Zeller. It is one of the most important public health
things that a regulatory agency can do. It is something that I
have devoted the last 25 years of my life to.
Mr. Krishnamoorthi. That is why I am so concerned by your
prior answer that the White House Domestic Council, headed by
Joe Grogan, is part of these discussions, when Mr. Grogan said
it was, quote, ``a huge waste of time,'' close quote, for FDA
to regulate tobacco.
I am going to recognize others for questioning. Mr. Cloud,
you are recognized. I took a couple of extra minutes so why
don't we put some time on his clock.
Mr. Cloud. Thank you. Electronic cigarettes have been
available in the U.S. for a while now--you mentioned that--for
several years. Could you speak to why we are just now seeing
cases of this illness?
Mr. Zeller. I don't think that there is a definitive answer
to why only within the last, say, three or four months that we
have seen so many cases of pulmonary illness. There is a
working hypothesis, and the working hypothesis is that because
so many of these cases are associated with the vaping of THC,
that there may be something that was added to the product more
recently that is associated with the more recent rash and
increase in both injuries and deaths.
Mr. Cloud. Do we have a clear understanding? I mean, this
has been a developing issue, a rapidly developing issue, and
there are many sources, especially when it comes to teen
vaping, many of them getting them from their friends who are
old enough, supposedly, to buy them, and such. Do we have a
better understanding of the source of the vaping products that
are leading to illness yet?
Mr. Zeller. As you said in your opening remarks, Mr. Cloud,
it is important to differentiate between the epidemic levels of
kids' use of e-cigarettes where it is just a product that is
delivering nicotine versus some kind of vaping device, likely
bought off the street, possibly modified by the user, and
containing THC and these other compounds that are showing up
increasingly in the samples that we and the CDC have analyzed.
It is why the advice of the Federal Government is don't vape
THC. Don't buy these products. Be careful about what kind of
modifications you make to them. That is separate and apart from
the focus of your and the chairman's remarks about what to do
about kids' use of, I would say, more conventional e-
cigarettes.
Mr. Cloud. Right. And we have had some recent discoveries,
I guess, as far as what we think may be causing the illness.
Could you speak to that?
Mr. Zeller. Sure. We are working very closely with CDC
using our Forensic Chemistry Center, which is a really
sophisticated laboratory that FDA has to support law
enforcement action that the agency would take, when we get
samples from the states that have collected samples from
victims, patients, and forwarded them to us for analysis and to
CDC. And it is based upon the analysis of the samples, at a
chemistry level, that we are able to conclude it looks like in
roughly 80 percent of the cases that have been linked to
patients, THC has been identified. And in about three-quarters
of those cases a diluter known as vitamin E acetate, which is
an oil, has also been identified.
And because of some analysis of lung tissue, lung fluid
that CDC recently did within the last month or so, they were
able to conclude that THC and vitamin E acetate may be linked
to what is going on here. But both agencies have been very
clear to state publicly that there may be more than one cause.
But it is looking like some combination of THC with this
vitamin E acetate is playing a role in a number of these cases.
Mr. Cloud. And kind of what I was trying to ask before, but
when it comes down to those specific cases that are causing
injury, do we have a clear idea of which products and the
supply lines for those products yet? Have you been able to
trace any of that information back----
Mr. Zeller. We are using----
Mr. Cloud [continuing]. where it is most likely coming
from?
Mr. Zeller. I am sorry. We are using the resources of our
Office of Criminal Investigations, so we have boots on the
ground as we are trying to trace back the supply chain here. We
are not using the Office of Criminal Investigations' resources
to go after personal use or personal possession of these
products. It is who is the responsible party for putting these
THC products into the marketplace. And since this is a very
sensitive and ongoing investigation, the only thing that I can
report to the subcommittee is we are making progress.
But it is not like a romaine lettuce outbreak, where you
have responsible, lawful entities that want to get to the
bottom of what is causing the outbreak and would work with the
regulatory authorities to get to the bottom of it. It is a
challenge in doing this investigation. But our Office of
Criminal Investigations is making progress.
Mr. Cloud. Now you did mention some of the stuff the FDA
has done recently to help educate kids about the dangers, and I
think we have spent, what, $60 million on The Real Cost
campaign? You have highlighted some of those, if you want to
touch on those again. And is there anything else the FDA is
considering to help mitigate the dangers?
Mr. Zeller. I think that when it comes to addressing kids'
use of e-cigarettes, a comprehensive approach is required. We
are using as many of the regulatory, statutory, tools and
resources that we have. As you said, we have made a major
investment in a public education campaign, because what we have
learned from our research--and this is in real contrast to
kids' perceptions of the risks of combustible cigarettes. Kids
know that combustible cigarettes are dangerous. There are still
kids who are at risk of smoking, but they know that it is
dangerous.
By contrast, what we have learned from our research is that
a lot of kids are walking around thinking that e-cigarettes are
harmless. Amazingly, in some surveys, there are kids who don't
even know that there is nicotine in e-cigarettes.
So the most important think that we can do in our public
education efforts is to communicate to kids, and we know how to
do that from the work that we have done in The Real Cost
campaign, going back to the last five years, to communicate the
health consequences of vaping e-cigarettes, whether it is the
risk of becoming addicted to nicotine or the harmful compounds
that are present. So public education, compliance and
enforcement, the investment in regulatory science to better
understand the medium-and longer-term health consequences of e-
cigarettes are the tools that we have at our disposal that we
are trying to make the best use of.
Mr. Cloud. Okay. Thank you. I yield back.
Mr. Krishnamoorthi. Thank you, Mr. Cloud. I now recognize
Congresswoman Pressley for five minutes of questioning.
Ms. Pressley. Thank you, Mr. Chairman, for your continued
commitment to this issue. It is critical that we hold both Big
Tobacco and Big Vaping accountable for targeting young people
and for knowingly hooking generations of black and brown
Americans to nicotine. Our work to end the smoking epidemic is
not just simply a matter of public health. This is, and always
has been, an issue of racial justice.
Last week, my home state of Massachusetts became the first
in the Nation to place a permanent ban on flavored e-cigarette
and menthol cigarette products. This is important, because if
we are banning flavors we must ban all flavors, which includes
mint and menthol. To not do so would be discriminatory, since
menthol, in particular, has imposed a unique and deadly burden
on the black community.
We must clamp down on the production of menthol products
and not the individual possession of it, because there are real
intergenerational, traumatic consequences of broken windows
policing that has historically over-criminalized black and
brown communities, something I called for in my Peoples Justice
Guarantee resolution. We must be simultaneously attuned to both
public health and public safety to ensure that there are no
more Eric Garners.
For years, Big Tobacco companies disproportionately
targeted more tobacco ads and specifically more menthol tobacco
ads in black neighborhoods, in some instances, as many as 10
times more ads for menthol products. The CDC reports that
nearly nine out of 10 black smokers prefer menthol cigarettes.
So I think it is safe to say, Mr. Zeller, that the targeting
was effective. Correct?
Mr. Zeller. I would agree with that.
Ms. Pressley. So today, nearly 45 percent of black menthol
smokers say they would quit smoking if menthol cigarettes were
banned, and almost two-thirds of black smokers under 24 years
of age would do the same. A year ago, the FDA announced plans
to ban menthol cigarettes, saying that a ban was necessary
because menthol products, quote/unquote, ``disproportionately
and adversely affect underserved communities.''
So a year has passed and the FDA has not followed through
on this ban. Why is that, Mr. Zeller?
Mr. Zeller. As you said, Congresswoman, we went through an
advanced notice of proposed rulemaking on a variety of issues
related to flavors, including the presence of menthol in
cigarettes. And I would add to what you said, that one of the
public health concerns about mentholated cigarettes is not just
the disproportionate use of menthol cigarettes by African
Americans, but the role that menthol cigarettes plays in
attracting kids of any color to experimenting with cigarettes.
And we continue to review the comments and explore what the
regulatory options and policies should be, but I absolutely
hear you, and as center director share your concern, from a
public health perspective.
Ms. Pressley. I am sorry. So just to--reclaiming my time
for a moment, just in the interest of time. Just to be clear,
on the record, does the FDA plan to follow through with this
ban? Yes or no.
Mr. Zeller. I cannot give you a yes or no answer in an open
public hearing. All I can tell you is that we are continuing to
review all of the evidence related to flavors in all tobacco
products as we try to follow the regulatory science and come up
with the right policy.
Ms. Pressley. So previous attempts to ban menthol have been
overridden by the Office of Management and Budget. Why is that?
Mr. Zeller. You need to be more specific. I don't know what
you are referring to.
Ms. Pressley. Do you want me to restate the question?
Mr. Zeller. I don't understand what specific instance you
are referring to.
Ms. Pressley. Okay. I will move on. I think the point that
I really just reiterating, and I can't underscore enough
because we are talking about a life-and-death matter, is that
47,000 black people die every year from smoking-related
illness, making this the largest cause of preventable death
among black Americans, even more than gun violence or car
accidents. So we don't have more time. People are dying.
So in my final second I just want to go to a different line
for a moment. So e-cigarettes are not--are e-cigarettes
recognized as an effective smoking cessation aid or not?
Mr. Zeller. They are not approved by FDA as a cessation
aid.
Ms. Pressley. Okay. So e-cigarettes are not an effective
cessation device. Menthol e-cigarettes are not an offramp for
adult menthol smokers. They are an onramp to hooking a new
generation of smokers.
Mr. Zeller. Well, if we can go past the 20 seconds that you
have left, there is a public health balancing act that the
agency has to do with whatever policy emerges on flavors, and
it is balancing, well, are flavors helping adults successfully
transition off of cigarettes completely to e-cigarettes? What
role are flavors playing in that? And it is part of the
balancing that we need to do.
It is an easy call on the negative side of the ledger when
it comes to the role that flavors are playing in attracting
kids to experiment, especially kids who are walking around
thinking that these are harmless products.
But it is a balancing act because we have heard repeatedly
from former smokers that it was the presence of certain flavors
that helped them successfully transition completely away from
cigarettes.
Ms. Pressley. Thank you. I yield back.
Mr. Krishnamoorthi. Thank you, Congresswoman. I now
recognize Congressman Comer for five minutes of questions.
Mr. Comer. Thank you, Mr. Chairman. Mr. Zeller, nicotine
vaping products must submit pre-tobacco market applications.
Those applications must be submitted to the FDA by May 2020. It
is my understanding that there are millions of vaping products
sold that have registered with the FDA and are currently on the
market. It is also my understanding that only a fraction of
these products on the market today will have their pre-market
tobacco applications filed with the agency by May 2020. Do you
agree with that understanding?
Mr. Zeller. Mr. Comer, our door has been open for those
applications to come in ever since we asserted jurisdiction
over e-cigarettes three and a half years ago, and precious few
applications have come in.
Mr. Comer. Okay. What plans does the FDA have to remove
products from the market for which a pre-market tobacco
application has not been filed and/or to alert the public and
retailers as to which products can continue to be sold?
Mr. Zeller. If we are in a situation where a deadline has
come and gone, and there are currently marketed products that
failed to meet the deadline for getting those applications in,
then that would be at the top of our priority list for
enforcement action. We would monitor the marketplace. It would
likely start with a warning letter to the company, telling them
to remove the product from the market, and we could take
stepped-up enforcement action from them. And then it is up to
the manufacturer and the distributor to work with the retailers
to get those violative products off of the market.
Mr. Comer. Well, does the FDA plan to post a list in the
weeks after May 2020, when the deadline passes, setting forth
all those products for which a pre-market tobacco application
has been made? Do you plan on making a list?
Mr. Zeller. I will have to take that back to the center.
That is something that could be considered, and I will get back
to you as we think about that.
Mr. Comer. Okay. All right. Great. Sounds like a good idea.
So when we talk about all the counterfeit products, which
is where a lot of the problems occurred--I could say many of
the problems have occurred with the deaths, especially with the
THC products, many of which weren't 100 percent THC, many of
the products had no THC in it, or had all sorts of counterfeit
ingredients in it--what actions does the FDA plan to take
against these counterfeit suppliers?
Mr. Zeller. Let's draw a distinction between counterfeit
and illicit. So what we are talking about with whoever the
responsible party is for putting these THC products on the
market, these are illicit products. And as I said but can't
talk publicly about our investigation, we are making progress
in working back the supply chain to find the responsible
parties. When we find the responsible parties, we have a
variety of authorities at our disposal, but we are also working
in consultation with the Drug Enforcement Administration,
because there could be a role for DEA in this as well. It
starts with finding the responsible parties ,and that is the
phase of this investigation that we are in. But we are making
progress.
Mr. Comer. That is great. Thank you. I will close by saying
this. I think every stakeholder must do their part. Nobody
wants to see underaged youth use vaping products. No one wants
to see companies marketing to youth. But a lot of the future of
this depends on FDA's rules and regulations. When do you think
the FDA will finalize and publish the guidance on vaping
flavors, when we are talking about regulating the flavors, or a
flavor ban, as many have already alluded to up here?
Mr. Zeller. I can't give a definitive answer, other than to
say that the discussions that have been taking place continue
and FDA is committed to a policy that aligns with our public
health concerns about what is going on with kids and flavored
e-cigarettes.
Mr. Comer. Okay. All right. Thank you, Mr. Chairman. I
yield the balance of my time back.
Mr. Krishnamoorthi. Thank you. I just going to use the
balance of your time to ask another question about these
parallel discussions that are happening. You are tangentially--
you said you are tangentially related to these discussions. Who
at the FDA is part of these discussions directly?
Mr. Zeller. It is the leadership of the agency and the
commissioner's office.
Mr. Krishnamoorthi. So the acting commissioner is part of
these discussions?
Mr. Zeller. Yes, he is.
Mr. Krishnamoorthi. Okay. And then at the White House, who
is directing it from their end?
Mr. Zeller. I don't know.
Mr. Krishnamoorthi. Okay. I would like to recognize
Congressman Khanna for his five minutes of questioning.
Mr. Khanna. Thank you, Mr. Chairman. Mr. Zeller, you have
had a long career in regulating tobacco, working with David
Kessler in the 1990's, so I want to ask you questions based on
your expertise.
The tobacco survey results showed that 27.5 percent of high
school kids were using e-cigarettes and 64 percent of kids were
using mint or menthol. Do those numbers sound reasonable to
you?
Mr. Zeller. Yes, they do.
Mr. Khanna. And the data also showed that 72 percent of
high school users are using flavors, and most high school users
use Juul. Is that correct?
Mr. Zeller. Yes.
Mr. Khanna. So based on your entire career of regulating
tobacco, going back to your work for David Kessler, who I
admire, if you were making a recommendation to the President,
do you think that we should ban mint and menthol?
Mr. Zeller. My recommendation in this process has been to
follow the regulatory science and to come up with a policy that
most closely aligns with what those numbers show, which is that
we have an epidemic use of e-cigarettes by middle school and
high school kids. They disproportionately favor flavored
products, and the percentage of kids that are using e-
cigarettes more frequently is also increasing. I am not going
to go into the specifics of the policy, but I can tell you,
speaking on behalf of the Center for Tobacco Products, that our
recommendation has been that policy needs to align with that
science and that data.
Mr. Khanna. So do you think that banning mint and menthol
would align with that science and data?
Mr. Zeller. The only thing that I can say publicly is that
that is what was said on September 11 by the Administration. I
can't go into the specifics of the policy that is still under
consideration.
Mr. Khanna. But you could share your opinion. I mean, what
is your opinion. I mean, you have been dealing with the
regulation of tobacco for 20 years. If you were talking to
David Kessler and he said, ``Do you think mint and menthol
should be banned?'' what would you tell him?
Mr. Zeller. I will tell you what I would tell him, and that
is there was a second reputable national survey that came out
within the last month, called the Monitoring the Future Survey.
Reputable, been around for years. It measures 8th-, 10th-, and
12th-grade use of all kinds of products, licit and illicit. And
the survey instrument in the Monitoring the Future Survey
separates mint from menthol. It asks those questions
separately. The National Youth Tobacco Survey doesn't. Mint and
menthol are included in the same question.
So in the Monitoring the Future results, what we saw, from
an analysis that was done of kids who used Juul--but since the
majority of kids who use e-cigarettes use Juul, doing a sub-
analysis of just kids who use Juul is probably a good
indication of what is going on throughout the entire category.
And what that analysis showed, and that was published in
the Journal of the American Medical Association within the last
month, was that kids who use Juul are way more likely to use
the mint product than the menthol product. That was new
information, and that was information that has to be accounted
for, whether I was having a conversation with the former
commissioner, speaking under oath to the subcommittee----
Mr. Khanna. But we don't know whether, if they don't have
the mint option, whether they would just default to the menthol
option.
Mr. Zeller. That is correct, and that would have to be part
of the considerations.
Mr. Khanna. But you are not prepared here to make a
recommendation of your opinion, what you would recommend.
Mr. Zeller. The only thing that I can say publicly is that
that new information that came out in that survey had to be--
has to be factored into our thinking.
Mr. Khanna. Do you have any reason to suspect that politics
and electoral politics has gone into the decision making,
people advising the President that he could lose battleground
states if he banned vaping or banned flavors?
Mr. Zeller. No.
Mr. Khanna. Would you commit to resigning if you ever had
any indication that that was a consideration?
Mr. Zeller. I would commit to resigning if there was--if we
wound up with a fundamentally flawed policy, for whatever
reason----
Mr. Khanna. But if you had heard information that there was
political considerations, would you commit to resigning?
Mr. Zeller. I think it would depend upon what the outcome
of the policy was. I am talking about what the final policy is.
That is when I would consider a resignation, regardless of what
the considerations were that went into that. We have made a
recommendation as to what we think the policy should be. No
final decision has been made, and I will wait to see what that
final decision is.
Mr. Khanna. I am out of time.
Mr. Krishnamoorthi. Thank you, Congressman. Now I recognize
Congresswoman Miller for five minutes of questioning.
Mrs. Miller. Thank you, Chairman Krishnamoorthi and Ranking
Member Cloud, and thank you for being here today.
In our past three hearings, one issue that we all have
agreed upon is to keep e-cigarettes and vaping products out of
the hands of those who are underaged. I do feel that all of
these hearings have also illustrated the important role that e-
cigarettes can play in helping people quit smoking cigarettes.
It still seems as if it can be a vital tool in reduction and
should remain an option for those who do need it.
Can you discuss the proactive steps that both the CDC and
FDA have taken to prevent youth from accessing e-cigarettes?
Mr. Zeller. Yes, and thank you for the question. We are
responsible for enforcing the part of the law that establishes
a Federal minimum age of sale to all tobacco products,
including e-cigarettes, and for enforcing the law about illegal
marketing of e-cigarettes to kids.
And so through our Office of Compliance and Enforcement we
have issued over 10,000 warning letters and over 1,600 civil
money penalty complaints, and that is seeking a financial
payment to the Federal Government for repeat illegal sales at
the retail level to minors in our, what we call our compliance
check program. In addition, we have made a massive investment
in public education to complement the ongoing enforcement
actions.
I wish I could say that public education and compliance and
enforcement alone would be sufficient to reverse the trend that
we are seeing in the annual surveys, but it is not. More needs
to be done.
Unfortunately, we have had to use our enforcement resources
to go after companies that were remarkably selling e-liquids to
purposely resemble juice boxes. We did that in a collaboration
with the Federal Trade Commission, because those were also
violations of the Federal Trade Commission Act.
There is good news and there is bad news, but the good news
is when we sent the first 17 of those warning letters, just on
the issue of e-liquids that were purposely being marketed to
resemble juice boxes, cereal and candy, all 17 manufacturers
immediately reformulated their packaging. That was the good
news. The bad news is about a month later we were doing the
kind of monitoring and surveillance that we do online with the
techniques that we had, and we saw that there were a whole
bunch of online retailers that were still selling those
products. So we had to put out a whole additional batch of
warning letters to the online retailers that were continuing to
sell products that manufacturers had agreed to reformulate.
Mrs. Miller. That sort of leads me to my next question,
which is, what is being done? What enforcement efforts are
being done to get the illicit and illegal vape products off the
market now?
Mr. Zeller. Well, when are talking about the illicit
product, that is taking us into the realm of what is going on
with THC vaping, so that is separate.
Mrs. Miller. Excuse me, but will you please explain what
THC is?
Mr. Zeller. So THC--I can't give you the chemical name but
it is a chemical derivative of marijuana.
Mrs. Miller. So the people do know----
Mr. Zeller. There are a whole bunch of people who are
purchasing this completely illegal product to get high, and
what we have seen only in the last three, four, or five months
is something changed, something happened in how these products
were being manufactured, if you will, and sold, because we
weren't seeing the incidence of lung injury and death, even if
people had been vaping THC earlier than April or May of this
year.
Something changed earlier this year. The working hypothesis
is, well, it is a completely illegal enterprise to begin with,
and agents are being used to cut the THC to make it go further,
and the agents that are being used are oils. And if you inhale
oil into your lungs, that is a really bad thing and it can make
you very sick. And in all of the cases that the CDC has been
able to test lung fluid, they have found this vitamin E
acetate, this oil, present in every single sample.
Mrs. Miller. And that leads to probably my last question,
although I have more. Acetate is different than vitamin E oil,
so do we have two products being put together to, I mean, to
make vitamin E acetate?
Mr. Zeller. I can't answer that. I will have to get back to
you for the record on that. But it is an oil that is being
added as a diluter to stretch the THC.
Mrs. Miller. Okay. Thank you. I yield back.
Mr. Krishnamoorthi. Okay. Without objection, I would like
to have Congresswoman Wasserman Schultz and Congressman
Sarbanes permitted to join the subcommittee on the dais and be
recognized for questioning the witness as well, and I would
like, without objection, will enter this response letter from
the FDA as well as OIRA to my letter, and copying Mr. Cloud,
inquiring about the status of the flavor guidance.
Mr. Krishnamoorthi. With that I will now recognize
Congresswoman Tlaib for five minutes of questioning.
Ms. Tlaib. Thank you, Chairman. Thank you so much for being
here.
Mr. Zeller, yes or no, does the high nicotine content
contribute to youth use?
Mr. Zeller. I don't know if the high nicotine content
contributes to youth use.
Ms. Tlaib. How about nicotine salts?
Mr. Zeller. Let me elaborate. But the product that seems to
be the most popular with kids is very high in nicotine.
Ms. Tlaib. So nicotine salts as well?
Mr. Zeller. That is different. Nicotine salts may make it
easier for the nicotine to go down. It is part of our ongoing
investigation of Juul.
Ms. Tlaib. So yes or no. Do you believe that if nicotine
levels were capped at non-addictive or minimal-addictive levels
that it would help decrease youth use?
Mr. Zeller. That is something that we are certainly
considering for combustible cigarettes, and I will just leave
it at that.
Ms. Tlaib. Similarly, if nicotine salts were banned, would
that help decrease youth use?
Mr. Zeller. That I don't know, but we have an active,
ongoing investigation into the role of nicotine salts and the
nicotine levels.
Ms. Tlaib. And, Mr. Zeller, does FDA have the authority to
cap nicotine levels?
Mr. Zeller. Yes.
Ms. Tlaib. Yes or no. Does the FDA have the authority to
ban nicotine salts in e-cigarettes?
Mr. Zeller. Yes.
Ms. Tlaib. Will FDA commit to bringing these ideas to the
table?
Mr. Zeller. This is part of an ongoing investigation----
Ms. Tlaib. I know. I know.
Mr. Zeller [continuing]. that starts with gathering facts.
Ms. Tlaib. But those specific bans----
Mr. Zeller. We would be happy to come back and talk to you
when we are further along in the investigation so that we can
better understand the science, product design, how these
products work, and the public health impacts that they are
having.
Ms. Tlaib. Our chairman has taken a lead in--you know, he
sent a letter, and I think on September 5, outlining evidence
that we uncovered about Juul illegally marketing its products
in schools, a number of places that were directly to youth,
both as smoking cessation products and by claiming Juul was
safer than cigarettes, and so forth. And FDA partly responded
by issuing Juul a warning letter, declaring it had broken the
law by making modified risk claims.
Briefly, what led you to conclude that Juul had broken the
law?
Mr. Zeller. We had our own ongoing investigation of the
marketing practices of Juul. I would say that the information
that the subcommittee put on the record at its two-day hearing
in July gave us additional information and additional concerns
that the very specific examples that you just mentioned crossed
the line into what we called illegal modified risk health
claims, claims to either reduce exposure to toxins or to reduce
risk. And in that area we were able to assemble all the
evidence that we had, that you had provided on the public
record, and use it as the basis for a warning letter to the
company, separate and apart from an additional letter that went
to the company on the same day, making a massive request for
documents on other things that were being investigated.
Ms. Tlaib. Mr. Zeller, in your letter you all did ask them
to respond within 15 days. Did they?
Mr. Zeller. They responded by the end of the month. If they
missed the deadline it was only by a day or two.
Ms. Tlaib. And will you get us that response?
Mr. Zeller. I can discuss the outcome of that----
Ms. Tlaib. Well, you can't provide the response from Juul
to----
Mr. Zeller. Not while we--it is an ongoing investigation
that has not been closed. Were it to be closed, then I could
come back and brief you on everything that we have found. The
company responded. We are reviewing their response. If we close
that warning letter then I can come back and give you more
information.
Ms. Tlaib. How long can cases go by? I mean, can it be
years?
Mr. Zeller. It would not be years. Let's just say that a
voluminous amount of information was----
Ms. Tlaib. Sorry. I am a mom of two young boys and I am
just trying to make sure that we resolve this before, not only
juice boxes but we are going to have candy or suckers out there
with this stuff.
So FDA can punish companies for making illegal modified
risk claims. What are the maximum possible penalties the FDA is
permitted to impose, in situations like Juul?
Mr. Zeller. Let me just talk hypothetically about the
authorities that we have at our disposal, and they are both
civil and criminal. On the civil side, we can work with our
lawyers and the lawyers at the Justice Department, and there
can be seizures and injunctions to completely change the
behavior of the company that broke the law. There are other
instances where there can be massive fines to the Federal
Government. And then, working with the Justice Department, if
we think that there has been criminal activity then there could
be a criminal investigation and prosecution.
Ms. Tlaib. All right. Thank you so much. I yield the rest
of my time, Mr. Chair.
Mr. Krishnamoorthi. Thank you, Chair--thank you,
Congresswoman. Let me use the remaining time to further
explore, why are e-cigarettes so dangerous to youth?
Mr. Zeller. Two fundamental reasons. Our brains don't fully
develop until we are like 25 or 26 years old, and it is clear
that any exposure to nicotine in the still-developing
adolescent brain is harmful, regardless of what the other
hazards, chemicals in the vapor, in the liquid are. Just the
nicotine alone is reason enough to be concerned that no kid
should be experimenting with this product because of the
harmful impact of nicotine.
Then, when you add what is known about some of the harmful
compounds in the aerosol, those bring additional risks. When we
have the so-called harm reduction debate--is there a role for
this product to help addicted cigarette smokers completely
switch to e-cigarettes?--that is a completely different and
separate question, when we make a relative risk assessment of,
well, if you switch to e-cigarettes you will be exposing
yourself to fewer toxins. No kid should be initiating on any e-
cigarette product, and as I said earlier, kids are walking
around with this mindset that it is harmless, that it is water
vapor, and some of them don't even know that nicotine is
present.
Mr. Krishnamoorthi. I now recognize Congressman Grothman
for five minutes of questioning.
Mr. Grothman. Thank you. Maybe we are going to go over some
territory you have already covered, but you see the list behind
you, the number of middle school kids and high school kids who
are using these. Do you know how many of the people are using
these are using what I will call legal products that I could
pick up at my local convenience store, and the number that are
using illegal products, including THC?
Mr. Zeller. The data that the chairman has put up is use of
lawful e-cigarettes delivering nicotine. That is separate from
kids who are vaping and vaping THC.
Mr. Grothman. Okay. So I assume, though, that of, say, the
27 percent, some of those people are using THC.
Mr. Zeller. They could be, but this is----
Mr. Grothman. Almost always, I would assume. And is it your
belief--I mean, this is like the third hearing we have had on
this in this building--is it your belief that almost all, or
all of the hospitalizations that take place has come from
people who are using these THC cartridges?
Mr. Zeller. In the samples that we have analyzed, that have
been sent to us by the states, we are seeing THC in about 80
percent of them.
Mr. Grothman. Okay. I was glad recently to see a high
school in my district had some billboard or something or other
up, talking about the danger of combining e-cigarettes and THC.
As I understand it, when you put, or just these even legal
cigarettes, there are different amounts of nicotine from one
cigarette to the next. Right? You can buy a 10, you can buy a
50, whatever.
Mr. Zeller. Are you talking about cigarettes or e-
cigarettes?
Mr. Grothman. E-cigarettes. I am sorry.
Mr. Zeller. Yes. The nicotine content can vary.
Mr. Grothman. Okay. Do we know how many are sold at each of
the levels, you know, of 100 percent of the e-cigarettes that
are sold, how many are at a 50 or how many are at a 10 or
whatever?
Mr. Zeller. No, but what we do know is that Juul is the
highest nicotine product on the market, and kids who use e-
cigarettes are most likely to use Juul, and, therefore, they
are using the highest nicotine available.
Mr. Grothman. Juul only has high nicotine? I was under the
impression, from somebody I know, who stopped smoking, that you
can adjust and start at 40 and work to 20 or whatever. But you
are saying all Juul cigarettes----
Mr. Zeller. My understanding is that while there may be a
three percent nicotine Juul product out there, that the
overwhelming majority of the sales are the five percent, which
is an extraordinarily high level of nicotine per pod, per the
thing that you insert into the device.
Mr. Grothman. You sure of that?
Mr. Zeller. Yes.
Mr. Grothman. Okay. I was under the impression that people
who stopped smoking, kind of the whole purpose was to work your
way down from the top.
Mr. Zeller. If they are, they are not working their way
down with Juul. They could be working their way down to other
products that have lower nicotine levels.
Mr. Grothman. Okay. Are you worried that if you ban legal
e-cigarettes people will run to the illegal e-cigarettes, just
(a) with probably inferior product in there, and (b) with more
THC?
Mr. Zeller. We are not talking about a ban, Congressman. We
are talking about a policy to deal with currently marketed e-
cigarettes that haven't gotten a marketing authorization from
FDA, and what, of the currently marketed products, should
basically be put into a category where the only way that they
could be sold is if they go through a pre-market evaluation and
review process by FDA, because technically, none of these
products are lawfully on the market.
Mr. Grothman. Do you know people who have used e-cigarettes
and stopped smoking because of it?
Mr. Zeller. Yes, sir.
Mr. Grothman. Okay. And what is your opinion of that? I
mean, is that a good thing? A bad thing? Is it something we
should be discouraging? I mean, to me, it seems to me that is a
good thing. I mean, my whole life I am told, you know, smoking
takes seven years out of your life, blah-blah-blah-blah-blah.
All of a sudden we have something that is effective and we are,
you know, looking for ways to have less people use it.
Mr. Zeller. We have heard what I would say are compelling
but albeit anecdotal reports from individuals who said, ``It
was only because of e-cigarettes that I was able to get off of
cigarettes.'' E-cigarettes are not approved by the Food and
Drug Administration as a cessation aid. The United States
Preventive Services Task Force, Health Services Task Force, has
not recommended e-cigarettes as a cessation aid. There is a
regulatory pathway for this product to be authorized as a
cessation aid, if a company wants to go through the Center for
Drugs at FDA. It is why the leadership of the agency and the
department have been talking over the last year or more about
the onramp and the offramp and the balancing act.
Yes, there are anecdotal reports that some former smokers
have successfully transitioned completely to e-cigarettes. But
the onramp for kids is getting wider and wider and wider, and
our job, as regulators, is to figure out how to balance those
two use of the product. And the question for all of us, not
just for FDA, is at what price? At what price, as we balance
this technology, if e-cigarettes have become more and more of
an onramp for kids? And those are the things that we are
grappling with internally with the data.
Mr. Grothman. I just have one more question here, and
thanks for letting me go over. Is it possible that as less
kids, or have you found a way to ban e-cigarettes from kids,
what would happen, given that there is a little bit of a
natural inclination of kids to rebel, and instead of smoking e-
cigarettes they would smoke tobacco cigarettes?
Mr. Zeller. We have made such progress in reducing the
number of kids who smoke cigarettes. The numbers that are
coming out will report historically low rates of kids smoking
cigarettes. And kids are aware of the hazards of smoking
cigarettes.
I guess my concern, just speaking for myself, based upon
the data that I have seen, is that the kids who are most at
risk when it comes to experimenting with e-cigarettes are kids
who would have never thought twice about smoking a cigarette.
Mr. Krishnamoorthi. Thank you, Mr. Zeller. I now recognize
Congressman Connolly for five minutes of questioning.
Mr. Connolly. Thank you, Mr. Chairman, but if it is all
right I would like to yield to my good friend, Ms. Wasserman
Schultz, who was here before me.
Ms. Wasserman Schultz. Aw, go ahead.
Mr. Connolly. You sure?
Ms. Wasserman Schultz. Yes. I will go next.
Mr. Connolly. I am happy to--all right. Thank you. Give me
back my 15 seconds. I was trying to be gracious here, Mr.
Chairman.
So Mr. Zeller, welcome. I am going to ask a series of kind
of rapid-fire questions to establish just a record, if you
don't mind.
Did the compliance policy that FDA sent to OIRA on October
25 exempt vape shops?
Mr. Zeller. As I said to the chairman earlier, I can't get
into the details of the policy that remains under review.
Mr. Connolly. You can't even tell us, as a matter of fact,
it either did or did not include vape shops? Your view is that
is exempt from congressional scrutiny at a hearing?
Mr. Zeller. When there has not been a final decision made
yet on this policy, and it is clear that a final decision has
not yet been made, we don't discuss publicly what the
considerations are. I can--it has been accurately reported that
the agency submitted the guidance to OIRA. It has been
accurately reported, including on the OMB website, that OIRA
cleared the guidance. But as I said earlier to the chairman,
there are these parallel, ongoing policy-related discussions
going on.
Mr. Connolly. Mr. Chairman, I think that answer raises a
whole host of other questions about the jurisdiction of this
committee. And I would just say to you, Mr. Zeller, I think you
are treading on very thin ground with your answer.
Mr. Zeller. I appreciate that, sir.
Mr. Connolly. And we will revisit that as a committee.
FDA, however, does have the authority to regulate flavors.
Is that correct?
Mr. Zeller. That is correct. FDA has jurisdiction over any
device that could be used to deliver tobacco-derived nicotine.
Is that correct?
Mr. Zeller. That is correct. Different types of
authorities, but yes.
Mr. Connolly. Yes. FDA has jurisdiction over e-liquids. Is
that correct?
Mr. Zeller. As long as it is part of something that meets
the statutory definition of a tobacco product, yes.
Mr. Connolly. Correct. FDA even has jurisdiction over
nicotine-free e-liquids as a component or part of a tobacco
product if it is reasonably expected to be used for a tobacco
product. Is that correct?
Mr. Zeller. Exactly.
Mr. Connolly. That appears to cover the range of things
sold at a vape shop, so FDA certainly has the authority to
regulate flavors wherever they are sold, be it a gas station,
convenience store, or a vape shop, following that logic.
Mr. Zeller. Correct.
Mr. Connolly. That is correct. In fact, the Tobacco Control
Act prevents FDA from, quote, ``prohibiting the sale of any
tobacco product in face-to-face transactions by any specific
category of retail outlets.'' So FDA couldn't ban gas stations
from selling flavors while allowing vape shops to continue.
Could it?
Mr. Zeller. I think that is an accurate reading of the
statute.
Mr. Connolly. So I can't envision any way to exempt vape
shops from a flavor ban in light of those previous answers. You
are a lawyer, Mr. Zeller. Is there any legal way for a
hypothetical flavor ban to conceivably exempt vape shops?
Mr. Zeller. I think that your reading of an interpretation
of the statute is accurate, and I think that under the law we
would not be able to differentiate between types of retail
outlets.
Mr. Connolly. According to FDA and CDC's 2018 National
Youth Tobacco Survey, almost 15 percent of the kids reported
buying e-cigarettes from a vape shop, in the last 30 days,
compared to just 8.4 percent who bought them from a gas station
or a convenience store. So if the data shows that twice as many
underage kids buy e-cigarettes illegally at vape shops compared
to convenience stores, how would that support a hypothetical
plan that allows flavors in vape shops but bans them in gas
stations, when the numbers would suggest exactly the opposite
in terms of where the problem is?
Mr. Zeller. I think you are making a very good point.
Mr. Connolly. I think you are a good lawyer.
Mr. Zeller. Thank you, sir.
Mr. Connolly. Finally, a California study, published in
JAMA, showed that half of the vape shops did not check IDs in
youth, and 45 percent of the vape shops sold to youth. The
study found vape shops rates of sales to youth significantly
higher than other types of stores. If the goal is to keep kids
from vaping, how does that data support a hypothetical plan
that allows flavors in vape shops but bans them in gas stations
and convenience stores?
Mr. Zeller. As I have said in some of my earlier responses,
our job is to follow the regulatory science and to put forward
policy recommendations that align with the science, that do the
best possible job of protecting kids from the hazards of all
tobacco products, including e-cigarettes.
Mr. Connolly. Right. That is a very good, bureaucratic
answer, but I prefer it when you wear your lawyer's hat and
answer ``that is a very good question.''
Mr. Zeller. That was a very good question.
Mr. Connolly. Yes, I thought so. All right. Thank you. I
mean, we clearly do have a problem here, and we are going to
have to take cognizance of the actuality of the problem and
where kids are going, so that we can target effective
strategies to address it.
Mr. Zeller. I--Mr. Connolly, I agree, and while we have
chuckled in our exchange, that shouldn't belie the seriousness
with which we are taking this issue and trying to do the right
thing.
Mr. Connolly. Thank you.
Mr. Krishnamoorthi. Thank you. I now recognize
Congresswoman Wasserman Schultz for five minutes of
questioning.
Ms. Wasserman Schultz. Thank you, Mr. Chairman. When Dr.
Ann Schuchat of the CDC testified before this subcommittee on
September 24, I asked her about whether nonsmokers are being
drawn to e-cigarettes by their flavors, and she said that among
our young people, quote, ``flavors are pretty much always what
brings youth into starting use of e-cigarettes.'' She also
testified that for a flavor ban to be effective at keeping kids
off cigarettes, all flavors, including menthol, must be
included.
Mr. Zeller, do you agree with Dr. Schuchat's assessment
that in order to be effective a flavor ban must include
menthol?
Mr. Zeller. Again, I think much to the consternation of
this subcommittee I can't get into the specifics of the policy
that is under consideration. All I can tell you----
Ms. Wasserman Schultz. I wasn't asking about the specifics
of the policy under consideration. I am asking your opinion, if
you agree with Dr. Schuchat's assessment that in order to be
effective, a flavor ban must include menthol. You are not
prohibited in any way, shape, or form from offering your
opinion.
Mr. Zeller. As I said in an earlier response, one of the
things that we are trying to account for is the data that came
out in the Monitoring the Future Survey. That only came out
recently. And I will just repeat it very briefly.
Ms. Wasserman Schultz. Please briefly, because I am
familiar--I was here when you said it, and I don't need it
repeated.
Mr. Zeller. Okay. Then I won't repeat it, and I will just
cut to the chase and say we now have data that shows that for
kids who use Juul, they are far more likely to use mint than
menthol, far more likely. And how do we account for that, as we
are trying to make the right policy here to do the best job in
protecting kids?
Ms. Wasserman Schultz. Okay. So reclaiming my time, does
the idea of exempting menthol from a potential ban on e-
cigarette flavors originate from the FDA? That is an awfully
long pause.
Mr. Zeller. The issue of what the scope of the policy
should be, what it should include, was the subject and remains
the subject of ongoing discussions between----
Ms. Wasserman Schultz. Did the idea of exempting menthol
from a potential ban on e-cigarette flavors originate from the
FDA, or did it come from somewhere else?
Mr. Zeller. FDA put the science forward that I just
described to you.
Ms. Wasserman Schultz. That is not what I am asking you.
The idea to exempt menthol, was it an idea that was generated
by the FDA? Yes or no.
Mr. Zeller. Let me try to answer your question in a more
general and hypothetical way.
Ms. Wasserman Schultz. I have other questions for you and I
want an answer. It is not a trick question. Did the idea----
Mr. Zeller. The----
Ms. Wasserman Schultz.--to exempt menthol from a flavor ban
come from the FDA, or did it come from somewhere else?
Mr. Zeller. There were--there have been a variety of
options for the scope of this policy that have been under
discussion.
Ms. Wasserman Schultz. That--you are talking about options.
I am asking, the idea----
Mr. Zeller. Please let me finish.
Ms. Wasserman Schultz. I am trying to get a yes or no
question----
Mr. Zeller. The options----
Ms. Wasserman Schultz.--and you are obfuscating.
Mr. Zeller [continuing]. the options that FDA put on the
table for consideration, going to what the scope of this
guidance should be, went to the issue of menthol in or menthol
out. We put options----
Ms. Wasserman Schultz. But is that--did it come--did the
idea----
Mr. Zeller. If the--if--if----
Ms. Wasserman Schultz.--to exempt----
Mr. Zeller [continuing]. if the answer to your question is
who put the options on the table, menthol in or menthol out,
then the answer is yes, we put it on the table.
Ms. Wasserman Schultz. So it didn't come from somewhere
else. It wasn't an idea brought to you from the outside. It was
generated by the FDA. It was your idea, with no----
Mr. Zeller. At a point in time when all options were being
explored.
Ms. Wasserman Schultz. Okay. So there was influence from
the outside and it was not--you are not answering that this was
an idea that was exclusively generated by the FDA.
Mr. Zeller. I don't think that is what I said. When we
were----
Ms. Wasserman Schultz. I want to make sure I understand
what you are saying.
Mr. Zeller [continuing]. when we were identifying options,
we put a variety of options on the table for consideration that
included menthol in or menthol out.
Ms. Wasserman Schultz. Reclaiming my time. Mr. Chairman, we
are really going to have to make sure that the FDA understands
what they are required to answer when we ask them questions,
because Mr. Zeller is not complying with what is required of
him.
Do you have any reason to--on November 13, Dr. Schuchat
testified that the National Youth Tobacco Survey didn't
differentiate between menthol or mint, and we don't even know
if kids can differentiate menthol or mint. Do you have any
reason to believe that kids can differentiate between menthol
and mint flavors?
Mr. Zeller. I am aware of the literature that says kids may
not be able to differentiate between menthol and mint.
Ms. Wasserman Schultz. Okay. And menthol and mint e-
cigarettes, we know, may carry additional unique harms.
Pulegone is a cancer-causing agent present in mint plant oil.
Mr. Zeller, the FDA banned it as a food additive last year,
didn't it?
Mr. Zeller. Yes, it did.
Ms. Wasserman Schultz. And a recent study from Duke
University School of Medicine found extremely high levels of
pulegone in both menthol and mint e-liquids. It found a level
inhaled by menthol and mint e-cigarette users as much as 1,000
times higher than menthol cigarette users. Shouldn't we be
concerned about that?
Mr. Zeller. We have been looking into that science. We have
questions about the study that was done, but we are aware of
and we are looking at it.
Ms. Wasserman Schultz. You banned it as a food additive
last year, so I would think that you already have pretty good
science that it is dangerous. Correct?
Mr. Zeller. We are looking into the methodology and the
adequacy of that science.
Ms. Wasserman Schultz. Okay. That study came out on
September 16. We have heard that a decision to exempt menthol
may have been made by October 31. Were you aware of this study
on October 31 when you made that decision?
Mr. Zeller. I am not going to refer to any decision, but we
were aware of that study by October 31, yes.
Ms. Wasserman Schultz. When you were considering pulling
flavors and a revelation comes to light about dramatically high
levels of a cancer-causing agent in menthol e-liquids, wouldn't
that be a good reason to pull them from the market to determine
if they are safe?
Mr. Zeller. It would be part of the consideration that we
would make about what the scope of the guidance should be.
Ms. Wasserman Schultz. Okay. I yield back the balance of my
time. Thank you for your indulgence, Mr. Chairman.
Mr. Krishnamoorthi. Thank you, Congresswoman. Now I
recognize Congressman Sarbanes for five minutes of questioning.
Mr. Sarbanes. Thank you, Mr. Chairman and thanks for the
opportunity to waive on today. Mr. Zeller, thanks for being
here. As we have said now, many times, in September of this
year we saw the announcement from the Trump administration that
FDA would be releasing a compliance policy to ban all flavored
e-cigarette products including mint and menthol products. And
this would not be the first time that FDA moved forward with a
policy to ban e-cigarette flavors. Correct? Isn't it true that
a similar policy was crafted in 2015?
Mr. Zeller. I wouldn't call it ban, but it is a matter of
public record that there was a version of a regulation that
would have treated flavored products differently from
unflavored products.
Mr. Sarbanes. Restrictions would have been put on those. In
2015, when you were director of the FDA Center for Tobacco
Products, as you are today, were you involved in that
rulemaking process? I assume you were.
Mr. Zeller. Yes, sir.
Mr. Sarbanes. And we know that in October 2015, FDA sent
its flavor ban to the Office, to OIRA, for review, and OIRA has
an open-door policy, meaning it will meet with any lobbyist as
long as the rule is under review. We now know, as a matter of
fact, that OIRA met with over 100 industry lobbyists to discuss
the 2015 policy, and as a result, or I am not going to say
causation, but some correlation, at least, OIRA eliminated the
flavor ban policy. Were you satisfied with that result and
OIRA's justification back in 2015?
Mr. Zeller. I was prepared to explain the final policy. It
did not square with the policy that we put forward earlier in
the process.
Mr. Sarbanes. Okay. I am reading between the lines on that
answer. That was very diplomatic.
Now let's return to the 2019 flavor ban that was promised
in September, which, of course, was accompanied by these
startling figures from the National Youth Tobacco Survey,
showing that over a quarter of high school students now had
used e-cigarettes in 2019. Many had used the popular fruit,
mint, or menthol flavors. Despite those trends, the most recent
policy now seems doomed to the same fate as the 2015 policy.
Now that the current flavor guidance has left OIRA, the
President has taken at least one meeting on the topic. Do we
have any way of knowing whether the President or the White
House are meeting with industry lobbyists?
Mr. Zeller. That is a question you need to ask the White
House.
Mr. Sarbanes. Okay. So you don't know.
Mr. Zeller. I don't know.
Mr. Sarbanes. Of course, the Administration, which is the
least transparent in my memory, has eliminated the White House
visitor logs, so there is really no way to know who is showing
up there for these meetings and lobbying the President.
But even if that was public, that is not really the main
problem. The problem, and what I think people are fed up with
across the country, is that their government, this government
won't tackle important issues without getting permission from
special interest. I think that is what is playing out here. I
will just be very candid with you. I am not asking you to
comment on it.
We are facing a youth tobacco crisis. Two decades of
progress in reducing youth smoking is being reversed almost
overnight. The President promised to act quickly, promises to
do something to protect American kids from these dangerous
products, but as soon as he says he will take action, here come
the lobbyists, the influencers, and suddenly this particular
ban is in purgatory. It is not happening.
And the impression I get, and I think a lot of people in
the public, when they read a headline one day and then in 72
hours it is completely flipped around, is that the tobacco
industry lobbyists are calling the shots, and it is not public
health professionals. Unfortunately, it is not as it should be,
an agency like the FDA leaning in to protect consumers and
fulfilling its mission in every possible way, because of this
influence peddling that goes on.
So it is just another in a long list of examples of what is
broken about this place, and the public gets this. They may not
understand all of the intricacies of how influence flows
through the Executive branch, through Congress, et cetera, but
they can feel in their gut that policy is getting made up here
for a group of very powerful people and not for them.
We are going to have to fix this, in so many arenas, but
certainly when it comes to protecting the health of our kids.
And with that, Mr. Chairman, I yield back. Thank you for the
opportunity to waive on today.
Mr. Krishnamoorthi. Thank you, Congressman. Thank you all
for coming today. I just want to close with a couple of
remarks, which is that these figures are alarming, absolutely
alarming, and unacceptable. The FDA is charged, by the American
people, to stop this epidemic, and you are failing on the job.
We know what will stop it, and that is banning these flavored
e-cigarettes. We know it. Those flavored e-cigarettes are what
get kids to take up these e-cigarettes, and the nicotine is
what gets them hooked, for a life time of nicotine addiction.
And so for you to come in here and tell us you submitted
guidance to OIRA, OIRA concluded its review, and then for
parallel discussions to be happening, but for us to have zero
transparency into who is part of these discussions, how long
these discussions are going to happen, when this policy is
going to come out, is unacceptable. This is wrong. And the
parents of all these kids are still waiting for answers. And
the answers you provided today are not going to do.
So I suggest you go back to the FDA and you tell them that
the American public is up in arms about this youth e-cigarette
epidemic, and you tell the White House and you tell all those
who are part of these parallel, irregular, unusual, opaque
discussions that time is up. It is time to get their act
together and put this flavor ban out, immediately, without
delay, before another child gets hooked to these e-cigarettes,
before another middle schooler gets hooked to an e-cigarette,
and certainly before any high schooler or any child whose brain
is still developing to the age of 25 or 26, as you said, gets
hooked to an e-cigarette.
Without objection, all members will have five legislative
days within which to submit additional written questions for
the witnesses to the chair, which will be forwarded to the
witnesses for responses. I ask our witnesses to please respond
as promptly as you are able.
This hearing is adjourned.
[Whereupon, at 4:09 p.m., the subcommittee was adjourned.]
[all]