[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

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

                                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

                              ----------                              
                                                                   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.]

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