[Senate Hearing 113-836]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 113-836

PROGRESS AND CHALLENGES: THE STATE OF TOBACCO USE AND REGULATION IN THE 
                             UNITED STATES

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

                                 HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                                   ON

EXAMINING THE STATE OF TOBACCO USE AND REGULATION IN THE UNITED STATES, 
                  FOCUSING ON PROGRESS AND CHALLENGES

                               __________

                              MAY 15, 2014

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
                                
                                
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                                


      Available via the World Wide Web: http://www.gpo.gov/fdsys/



                       U.S. GOVERNMENT PUBLISHING OFFICE
22-614 PDF                        WASHINGTON : 2017                       


_________________________________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government Publishing Office, 
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, 
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). 
E-mail, [email protected].  






          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       TOM HARKIN, Iowa, Chairman

BARBARA A. MIKULSKI, Maryland		LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington		MICHAEL B. ENZI, Wyoming
BERNARD SANDERS (I), Vermont		RICHARD BURR, North Carolina
ROBERT P. CASEY, JR., Pennsylvania	JOHNNY ISAKSON, Georgia
KAY R. HAGAN, North Carolina		RAND PAUL, Kentucky
AL FRANKEN, Minnesota			ORRIN G. HATCH, Utah
MICHAEL F. BENNET, Colorado	        PAT ROBERTS, Kansas
SHELDON WHITEHOUSE, Rhode Island	LISA MURKOWSKI, Alaska
TAMMY BALDWIN, Wisconsin	        MARK KIRK, Illinois
CHRISTOPHER S. MURPHY, Connecticut	TIM SCOTT, South Carolina
ELIZABETH WARREN, Massachusetts

                       Derek Miller, Staff Director

        Lauren McFerran, Deputy Staff Director and Chief Counsel

               David P. Cleary, Republican Staff Director

                                  (ii)


                            C O N T E N T S

                               __________

                               STATEMENTS

                         THURSDAY, MAY 15, 2014

                                                                   Page

                           Committee Members

Harkin, Hon. Tom, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Alexander, Hon. Lamar, a U.S. Senator from the State of 
  Tennessee, opening statement...................................     3
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................     4
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................     4

                               Witnesses

McAfee, Tim, M.D., MPH, Director, Office on Smoking and Health, 
  Centers for Disease Control and Prevention, Atlanta, GA........     6
    Prepared statement...........................................     8
Zeller, Mitch, J.D., Director, Center for Tobacco Products, U.S. 
  Food and Drug Administration, Silver Spring, MD................    13
    Prepared statement...........................................    14

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
  Response by Mitchell Zeller to questions of:
    Senator Harkin...............................................    41
    Senator Alexander............................................    42
    Senator Mikulski.............................................    48
    Senator Murkowski............................................    49
    Senator Roberts..............................................    50
    Senator Burr.................................................    52
    Senator Casey................................................    56

                                 (iii)

  

 
PROGRESS AND CHALLENGES: THE STATE OF TOBACCO USE AND REGULATION IN THE 
                             UNITED STATES

                              ----------                              


                         THURSDAY, MAY 15, 2014

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 3:35 p.m. in room 
SD-430, Dirksen Senate Office Building, Hon. Tom Harkin, 
chairman of the committee, presiding.
    Present: Senators Harkin, Alexander, Whitehouse, and Burr.

                  Opening Statement of Senator Harkin

    The Chairman. The committee on Health, Education, Labor, 
and Pensions will come to order.
    I thank everyone for their patience. We just had a whole 
lot of votes on the Senate floor.
    We have convened this hearing to examine the State of 
tobacco use and regulation in the United States, both the 
extraordinary public health efforts that have driven down 
tobacco use, and the enormous challenges that remain.
    Our Nation has made remarkable progress in the 50 years 
since the first Surgeon General's Report on Smoking and Health. 
In that time, the smoking rate has been cut by more than half, 
from 42 percent to 18 percent. We have learned what works, from 
smoke-free workplaces to access to free cessation services; 
from meaningful tobacco taxes to robust regulation; from media 
campaigns like the wildly successful Tips from a Former Smoker 
to commonsense marketing restrictions. So, we know what works.
    Yet, despite all these efforts and successes, tobacco use 
remains the leading preventable cause of death in the United 
States. Let me repeat that. Tobacco use remains the No. 1 
preventable cause of death in the United States.
    Right now, 16 million Americans are suffering from smoking-
caused illness, and 5.6 million kids alive today will 
ultimately die from smoking. Today, nearly 1 in 4 high school 
seniors smoke and, sadly, most young smokers become adult 
smokers.
    The problem is not just cigarettes. Last fall, the Centers 
for Disease Control and Prevention reported that the use of 
electronic cigarettes, or e-cigarettes--and I am going to have 
more to say about those after a bit because I have an array of 
them up here--among middle and high school students more than 
doubled in 1 year.
    It is because of statistics like these that public health 
efforts to combat tobacco have been among my top priorities 
since I came here. In responding to the hundreds of thousands 
who die every year due to tobacco use, in 1998 I introduced the 
first comprehensive, bipartisan bill--it was bipartisan--to 
give the FDA authority to regulate tobacco. It took a while, 
but that goal finally became a reality 5 years ago with passage 
of the Family Smoking Prevention and Tobacco Control Act. 
Today, we want to examine the implementation of that law to 
date.
    More recently, in light of the fact that some 3,500 
children try smoking for the first time each day, I authored 
provisions in the Affordable Care Act that ensure every 
American has access to tobacco cessation services without co-
pays or deductibles. Also, due to the provisions that I put in 
on the Prevention and Public Health Fund, we have invested more 
than $300 million in community-based public health efforts to 
curb tobacco use.
    And last month, confronted with the bleak prospect of a 
whole new generation becoming addicted to nicotine by way of e-
cigarettes, I joined with 10 of my colleagues to release an 
investigative report revealing that manufacturers are devoting 
massive resources to the marketing of e-cigarettes and their 
marketing strategies are expressly designed to appeal to kids. 
So I urge everyone to read that report.
    I want to just share one example of the many graphics it 
contains. That is this chart you see up here. It is an animated 
cartoon video game through which players earn e-cigarette 
coupons to redeem on Facebook. Kids play these games, then they 
get on Facebook and they can redeem coupons.
    Cartoons, video games, social media, candy flavors. The 
ones I have here, let us see, I have Gummy Bear, that is one; 
that appeals to adults, right, gummy bear? Then there is one, 
Rocket Pop that has a popsicle on the front of it; cotton candy 
concentrated nicotine. Now, I have another one here is Cran-
Apple, and I have a strawberry too. I did not want to leave out 
strawberry.
    It is the same thing we used to see with flavored 
cigarettes; same thing. So again, they are pulling out their 
stops to target children. It is absolutely shameful. Again, a 
throwback, a disgusting throwback, to Big Tobacco's playbook to 
promote traditional cigarettes to kids before restrictions were 
in place.
    I know that some believe that e-cigarettes are a promising 
alternative to cigarettes, but hopefully, we can all agree 
these products do not belong in the hands of kids. Keep in 
mind, this is a drug delivery device. It delivers nicotine. 
Nicotine is an addictive drug.
    I look forward to hearing more today from FDA about their 
new proposal to regulate these e-cigarettes and other tobacco 
products under the authority of the Family Smoking and 
Prevention Control Act.
    What is this one called? Cherry crush; I did not mean to 
leave that out either. Cherry crush, that is for the 
refillables. You can refill them.
    The e-cigarette phenomenon has created a regulatory black 
hole that has gone on too long. Today's hearing is Congress' 
first examination of that proposal, which has extraordinary 
consequences for public health.
    We are pleased today to have Dr. Tim McAfee of CDC's Office 
on Smoking and Health, and Mr. Mitch Zeller of FDA's Center for 
Tobacco Products to talk about the ongoing public health 
challenge posed by tobacco. They will also report on the 
important community-based and regulatory work in which those 
agencies are engaged.
    And now, I will turn to Senator Alexander for his opening 
statement.

                 Opening Statement of Senator Alexander

    Senator Alexander. Thanks, Mr. Chairman.
    Welcome to the witnesses.
    Congress passed the law to which Senator Harkin referred, 
the Family Smoking Prevention and Tobacco Control Act almost 5 
years ago, and it clearly was taking a position to discourage 
the use of tobacco products. What has happened since then, 
around 18 percent of adults still smoke cigarettes, but that is 
down from 20 percent in 2010. Smoking among youth continues to 
decline.
    Electronic cigarettes have grown rapidly. The number of 
adult smokers who tried e-cigarettes doubled between 2010 and 
2011. I am going to focus mostly on the so-called Deeming 
Regulation proposed 2 weeks ago by the FDA, but I did want to, 
first, read some statistics about the Center for Tobacco 
Products.
    FDA spent nearly 80 percent of the $1.8 billion in user 
fees collected, more than half of the spending, $868 million, 
occurred during fiscal year 2013.
    FDA has received only four premarket tobacco product 
applications, which would have to be filed for any novel 
product put on the market after February 2007 if deeming is 
finalized as it is. All four were rejected as incomplete. There 
are over 4,000 substantial equivalence applications pending for 
tobacco products. FDA has decided on 34 of the over 4,500 that 
the Agency received. I believe these statistics reflect a poor 
performance, and I think it is important to call that to your 
attention.
    Now, I appreciated being informed about the proposed 
regulation. I want to articulate my strong support for the 
alternative, exempting premium cigars from FDA regulation. I 
have some concerns about that, but I will followup with 
questions on how that works. The FDA regulations should fit the 
product and risk proposed by that product.
    Throughout the proposed regulations, FDA talks about a 
somewhat controversial idea of harm reduction. For the 42 
million Americans who currently smoke, FDA should enable 
companies to find creative ways to reduce the negative health 
effects of nicotine addiction, not regulate that innovation out 
of existence.
    Most of the discussion around the Deeming Regulation in 
tobacco seems to be about e-cigarettes, and I am here to 
listen. I understand there are competing points of view.
    Now, some public health experts, such as David Abrams at 
American Legacy Foundation, the largest nonprofit public health 
charity in the Nation devoted specifically to tobacco control, 
has said, ``This could be the single biggest opportunity that 
has come along in a century to make the cigarette obsolete.'' 
That is one view.
    On the other hand, CDC Director, Dr. Frieden, has been 
quoted as stating that, ``Many kids are starting out with e-
cigarettes and then going on to smoke conventional 
cigarettes.''
    So what I would like to understand is what research have we 
done to answer those questions. There are reports from 
countries overseas that some of these new products do not seem 
to be a gateway to traditional cigarette use, but we do not 
know that. We do not know that yet.
    The purpose of a hearing such as this, and I thank the 
chairman for calling this, is not to presuppose an answer, but 
to find from experts in our Government what their opinion is. 
And what I would like to know is which of those points of view 
you subscribe to.
    Here is what I think we all have agreement on. The 
regulations should be based on data and sound science. No. 2, 
no sales to anyone under 18. Any child beginning to use a 
tobacco or nicotine product is bad for public health. And No. 
3, manufacturers should register and list the products they 
make and ingredients they use with the FDA.
    After that, I think what we need to focus on is what is the 
research and what does it tell us?
    I look forward to the testimony. Thank you.
    The Chairman. Thank you, Senator Alexander.
    I know that Senator Whitehouse has to leave shortly and 
maybe Senator Burr; I do not know, but you wanted to make a 
short statement. I will recognize Senator Whitehouse.

                    Statement of Senator Whitehouse

    Senator Whitehouse. I appreciate the chairman recognizing 
me for 1 minute.
    We have two wonderful witnesses here from the FDA and from 
the CDC. But I wanted to make the point, as a Senator from 
Rhode Island, that there has been some very important corporate 
leadership in this area of reducing access to the No. 1 cause 
of preventable deaths, which is tobacco. And that comes from 
CVS Caremark, a company headquartered in Woonsocket, RI. They 
are a very significant pharmacy chain across the country.
    Larry Merlo, the CEO, and his management team, has made the 
decision to phaseout the sales of tobacco products by October 
1st of this year, and I think that is an important and 
commendable step. And I just wanted to have that be a part of 
the record of this hearing.
    The Chairman. Thank you very much, Senator Whitehouse.
    Senator Burr.

                       Statement of Senator Burr

    Senator Burr. Mr. Chairman, I never miss an opportunity to 
say something when given the opportunity, and since I feel like 
I have lived with this issue as long as anybody in Congress, 
now 20 years.
    And Mr. Zeller, thank you for the job you are doing over 
there. A newly created agency. Very, very tough to get up and 
run it.
    But Mr. Chairman. I can remember when opportunities for 
harm reduction were the goal, and it could not be achieved 
because the technology did not allow us to get there. I 
remember when R.J. Reynolds spent several decades and came out 
with a product that, I guess, was a precursor to some degree of 
the electronic cigarette, even though it operated differently, 
and Mr. Zeller, you might remember that.
    And there became a real opportunity for individuals to use 
a product that got what they were looking for without a 
combustible. And how quickly we have moved to a point where now 
harm reduction is no longer a goal and technology now allows us 
to get there. It allows us to field products, and trust me, Mr. 
Chairman, we can work out these things about flavors and all of 
this.
    But for God's sakes, let us not say we are not going to let 
technology play part of the process of taking more Americans 
off of using combustible tobacco products. And I look at the 
pool that was available to us when gum came out. We were 
ecstatic because this gave the ability for some people to break 
the cycle of combustible tobacco products for them.
    Then the patch came out. Not everybody could do the gum. 
Not everybody can do the patch. And now, we have electronic 
cigarettes. Rather than kill this before we know what we have 
got, and I am right with the chairman, let us do the science. I 
think Mr. Zeller is attempting to do that. I know the job that 
is in front. I know the statutory requirements. Let us let him 
do it.
    But let us not condemn where the technology has gone before 
we ever had an opportunity to see, in fact, what effect this 
can have on pulling people off of combustible tobacco products.
    So I hope the committee and I hope the FDA puts as much 
stock in harm reduction in how we get people off of something 
that is not as safe to a product that is safer. This is, for 
some people, not eliminating access. It is eliminating a 
product category. It has been for 20 years and nothing has 
changed today, and that is fine.
    But as long as I am a member of the committee, Mr. 
Chairman, I am going to fight for the American people to have a 
right to make a choice, and for Mr. Zeller to determine what 
those choices are going to be within reason. And I encourage 
you to continue the job you are doing.
    I hope that our policies reflect an opportunity for the 
American people to make a decision based upon what technology 
is available to choose a reduced harm product which, I think, 
many of the categories we see today are beginning to move 
toward.
    I thank the chairman.
    The Chairman. Thank you, Senator Burr.
    We will start with our first witness, Dr. Tim McAfee. He is 
the Director of CDC's Office on Smoking and Health within the 
National Center for Chronic Disease Prevention and Health 
Promotion. He directs all science, policy, and programming on 
tobacco control and prevention.
    Dr. McAfee is a family physician who practiced for more 
than a decade and served as a clinical faculty member at the 
University of Washington Family Medicine and School of Public 
Health.
    And Dr. McAfee also authored the World Health 
Organization's Tobacco Quit-Line Manual for low- and middle-
income countries. Thank you for being here, Dr. McAfee.
    And then after Dr. McAfee, we will recognize Mr. Mitch 
Zeller, who is the Director of the Center for Tobacco Products 
where he leads the FDA's efforts to reduce disease and death 
from tobacco use and to develop regulations for a variety of 
tobacco products.
    Mr. Zeller has been working on FDA issues for more than 30 
years. He served as Associate Commissioner and Director of 
FDA's first office of Tobacco Programs. And prior to rejoining 
the FDA in 2013, Mr. Zeller worked on tobacco control as 
executive vice president of the American Legacy Foundation, and 
as senior vice president at Pinney Associates. And we thank you 
for being here also, Mr. Zeller.
    Both of your statements will be made a part of the record 
in its entirety. And we would ask if you could just sum it up 
in just 5 minutes or so, we would appreciate it, and then we 
can get into a discussion.
    Dr. McAfee, welcome. Please proceed.

STATEMENT OF TIM McAFEE, M.D., MPH, DIRECTOR, OFFICE ON SMOKING 
    AND HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, 
                          ATLANTA, GA

    Dr. McAfee. Thank you very much, Chairman Harkin and 
Ranking Member Alexander, and members of the committee for 
their statements previously.
    It is an honor to provide this statement to you. I want to 
thank Chairman Harkin for his leadership and also recognize 
this committee's bipartisan history of support on tobacco 
control.
    As noted, my name is Dr. Tim McAfee, and I serve as the 
Director of the Office on Smoking and Health at the Centers for 
Disease Control and Prevention, and I am also a physician.
    Today, I will discuss, briefly, the past, present, and 
future of tobacco control drawing on findings and 
recommendations, primarily from the 50th Anniversary Surgeon 
General's Report on Tobacco and Health.
    Fifty years ago, half of the men and one-third of the women 
in this country smoked cigarettes. Tobacco companies could 
advertise everywhere, including TV, and school children carried 
lunch boxes with cigarette logos. Smoking was common in public 
places.
    Today, the landscape is already dramatically different. 
Adult cigarette smoking has fallen from 42 percent in 1965 down 
to 18 percent today. And tobacco prevention and control 
measures saved 8 million lives over the last 50 years.
    Today, half of our States prohibit smoking in worksites, 
restaurants, and bars. And on TV, we now see the real 
consequences of smoking through CDC's Tips from Former Smokers 
campaign. These hard-hitting ads show real people fighting 
serious disease and disability from smoking. In their first 
year, the ads led 1.6 million Americans to make a quit attempt, 
and over 100,000 to quit for good.
    Now, despite enormous progress, every day, over 3,000 
children under age 18 smoke their first cigarette. Smoking-
related deaths approach half a million a year in the United 
States, and another 16 million Americans suffer from serious 
smoking-related disease.
    The 2014 Surgeon General's report concluded that,

          ``The tobacco epidemic was initiated and has been 
        sustained by the aggressive strategies of the tobacco 
        industry, which deliberately misled the public on the 
        risks of smoking.''

    In addition to making their products powerfully addictive, 
the tobacco industry spends nearly $1 million an hour on 
promotions. They are developing products such as the fruit- and 
candy-flavored little cigars and electronic cigarettes. Little 
cigars, which are similar in size and shape to cigarettes, 
appeal even more to youth than adults because of their flavors 
and lower prices.
    Responses to our surveys showed cigar use among non-
Hispanic black students in 2012 is nearly double the rate 
observed in 2009. And cigarette use among all twelfth graders 
surged in recent years to levels that we have not seen in over 
a decade.
    And e-cigarettes are heavily marketed on TV and radio, and 
some marketing includes unproven health claims and themes 
proven to appeal to youth. As a result, nearly 1.8 million 
students in grade 6 through 12 reported trying an e-cigarette 
in 2012.
    There are now hundreds of e-cigarette products ranging from 
disposables that look like cigarettes to tank devices that are 
refillable, adjustable, and they allow for use of other drugs 
besides nicotine.
    FDA's deeming proposal could establish important regulatory 
requirements and allow for more comprehensive protections as we 
move forward. However, FDA regulation alone is insufficient and 
this process will take time. That is why many States and cities 
across the country are folding e-cigarettes into clean indoor 
air policies and enacting bans on e-cigarette sales to minors.
    Now, what are the many risks with e-cigarettes? The fact 
that e-cigarettes exist and are being marketed by some tobacco 
companies as being the same as cigarettes, but safer, is a 
dramatic shift. According to the Surgeon General's report, e-
cigarettes could be beneficial if they are completely 
substituted for burned tobacco and could assist in a rapid 
transition to a society with little or no use of burned tobacco 
products.
    As we consider these issues, we must not forget that burned 
tobacco products are overwhelmingly responsible for tobacco-
related death and disease. Yet today, cigarettes remain cheap, 
ubiquitous, and heavily marketed. They appeal to children, kill 
half of long-time users, and are addictive by design. If 
current rates of smoking continue 5.6 million American children 
under the age of 18 will die early because of smoking.
    Now, the good news is we know a great deal about what works 
and we also have a regulatory framework to accelerate our 
progress. The bad new is we are not doing enough of what works, 
like 100 percent smoke-free policies, higher prices, access to 
cessation treatments, hard-hitting media, and State-based 
tobacco control programs.
    The progress we have made is due to efforts from across our 
society including, as noted, from companies like CVS, which 
stopped selling tobacco products in October and the thousands 
of businesses that are helping their employees quit smoking.
    Working together, we can help Americans live longer, 
healthier lives. We can prevent 1 in 3 cancer deaths, save our 
economy $300 billion annually, and prevent half a million 
premature deaths a year.
    Thank you for the committee's attention to this important 
matter, and I am happy to answer any questions you may have.
    [The prepared statement of Dr. McAfee follows:]
              Prepared Statement of Tim McAfee, M.D., MPH
                                summary
    Fifty years ago, half of the men and a third of the women in this 
country smoked cigarettes. Tobacco companies advertised everywhere and 
smoking was common in almost all public places, including hospitals. 
Today, however, the landscape is different. Tobacco prevention and 
control measures have saved an estimated eight million lives over the 
last half-century.* In fact, the success of the tobacco-control 
movement constitutes one of the greatest public health achievements of 
the 20th century.
---------------------------------------------------------------------------
    * Holford TR, Meza R, Warner KE, Meernik C, Jeon J, Moolgavkar SH, 
Levy DT. Tobacco control and the reduction in smoking-related premature 
deaths in the United States, 1964-2012. JAMA: the Journal of the 
American Medical Association 2014.
---------------------------------------------------------------------------
    Despite enormous progress, the tobacco epidemic still rages on--in 
every community and in every corner of our country. The Surgeon General 
has concluded that combusted--or burned--tobacco products, such as 
cigarettes, cigars, and pipes, are overwhelmingly responsible for the 
burden of death and disease from tobacco use in the United States. And 
new, novel tobacco products pose challenges to research, surveillance, 
health policy, and regulation because they vary so widely in form, mode 
of use, contents, designs and emissions, potential health effects, and 
marketing claims.2
---------------------------------------------------------------------------
     Consequences of Smoking--50 Years of Progress: A Report of the 
Surgeon General. Atlanta (GA), Centers for Disease Control and 
Prevention (U.S.).
---------------------------------------------------------------------------
    To accelerate declines in tobacco use, the 2014 Surgeon General's 
Report emphasizes the effectiveness of comprehensive approaches to 
tobacco control that apply a mix of educational, clinical, regulatory, 
economic, and social strategies to: prevent initiation of tobacco among 
youth and young adults; promote quitting among adults and youth; 
eliminate exposure to secondhand smoke, and identify and eliminate 
tobacco-related disparities among population groups. While these 
evidence-based strategies are currently underutilized, CDC along with 
other Federal agencies, States and communities are taking steps to 
change that dynamic. Real progress in tobacco control will require 
commitment and effort across all sectors of our society including the 
business sector.
    If we end the tobacco-use epidemic, we can prevent one out of three 
cancer deaths in this country and save our economy nearly $300 billion 
a year in medical costs and economic losses.
---------------------------------------------------------------------------
     U.S. Department of Health and Human Services (2014). Let's Make 
the Next Generation Tobacco-Free: Your Guide to the 50th Anniversary 
Surgeon General's Report on Smoking and Health. Available at: http://
www.surgeongeneral.gov/library/reports/50-years-of-progress/. Accessed 
May 5, 2014.
---------------------------------------------------------------------------
                                 ______
                                 
    Chairman Harkin, Ranking Member Alexander, and members of the 
committee, it is an honor to provide this statement for today's hearing 
on progress in tobacco prevention and control. Fifty years ago, half of 
the men and a third of the women in this country smoked cigarettes. 
Tobacco companies advertised everywhere, and school children carried 
lunch boxes and wore baseball caps branded with cigarette logos. Except 
for churches and grade school classrooms, smoking was common in almost 
all public places, including hospitals.
    Today the landscape is different. Tobacco prevention and control 
measures have saved an estimated eight million lives over the last 
half-century.\1\ In fact, the success of the tobacco-control movement 
constitutes one of the greatest public health achievements of the 20th 
century. Adult smoking rates have fallen from about 43 percent in 1965 
to about 18 percent today.\2\ The latest surveys show that cigarette 
smoking rates among high school students are at the lowest in our 
history of measuring them. Most indoor workplaces are smoke-free and 
over half of States prohibit smoking in other indoor areas of public 
places such as restaurants, bars, and airports.\2\ Colleges and 
universities have embraced these policies, and many have adopted smoke-
free and tobacco-free campuses, indoors and out. Instead of images of 
glamorous people enjoying a cigarette, today we see the real health 
consequences of smoking through Tips from Former Smokers, the first 
federally funded anti-smoking national media campaign in the United 
States, which was initially established through the Prevention and 
Public Health Fund. These hard-hitting ads pull back the curtain to 
reveal real people fighting serious diseases and disabilities because 
they smoked, and in their first year led 1.6 million Americans to make 
a quit attempt and 100,000 quit for good.\3\
    However, we are far from the finish line. Despite enormous 
progress, the tobacco epidemic still rages on--in every community and 
in every corner of our country. Every day, more than 3,200 children 
under age 18 smoke their first cigarette, and another 2,100 youth and 
young adults who are occasional smokers become daily smokers.\2\ 
Smoking-related deaths now approach half a million a year in the United 
States, and another 16 million Americans have at least one serious 
smoking-related disease.\2\ One-third of all cancer deaths are caused 
by smoking, including the vast majority of lung cancers--the leading 
cause of cancer death in our Nation for both men and women.\2\
    Progress in reducing the disease and death caused by the tobacco 
epidemic has not been consistent across all populations. The burden of 
smoking now falls disproportionately on some of our most vulnerable 
populations--the poor, some racial and ethnic minorities, some members 
of the gay and lesbian community, and those living with mental illness 
and substance use disorders.\2\
    This entirely preventable public health tragedy did not occur by 
accident. The Surgeon General concluded that ``the tobacco epidemic was 
initiated and has been sustained by the aggressive strategies of the 
tobacco industry, which deliberately misled the public on the risks of 
smoking cigarettes.'' \2\ Today's cigarettes contain over 7,000 
chemicals and chemical compounds--over 70 of which are known to cause 
cancer.\4\ They are designed to addict their users quickly and heavily, 
speeding a jolt of nicotine to receptors in the brain in as little as 
10 seconds after the smoke is inhaled.\5\ The adolescent brain is 
especially sensitive to nicotine and teens become dependent on nicotine 
more quickly than adults.\6\ In fact, nicotine will cause three out of 
four teen smokers to become adult smokers--even though most say they 
plan to quit in a few years.\2\ Prevention and intervention in the teen 
and youth years is important because nearly 90 percent of adult smokers 
say they started before they were 18 years old.\2\
    In addition to making their products powerfully addictive, the 
tobacco industry spends $8 billion annually--nearly a million dollars 
an hour--to advertise and market cigarettes and smokeless tobacco.\2\ 
They outspend current State tobacco-control programs by a factor of 18-
to-1.\7\ In the United States, the tobacco industry recruits customers 
to consume over 14 billion packs of cigarettes a year.\8\ Marketing and 
glamorization of tobacco products remains widespread. Despite causal 
evidence that depictions of smoking in the movies lead to smoking 
initiation among young people, movies remain one of the largest 
unrestricted traditional media channels promoting smoking and tobacco 
use to youth. In fact, tobacco incidents in PG-13 rated top-grossing 
U.S. movies surged 98 percent from 2010 to 2012.\2\
    The Surgeon General concluded that combusted--or burned--tobacco 
products, such as cigarettes, cigars, and pipes, are overwhelmingly 
responsible for the burden of death and disease from tobacco use in the 
United States.\2\ Cigarettes carry the highest risk of addiction 
following initiation.\2\ This is due to cigarette designs that 
facilitate efficient and tolerable inhalation of nicotine-laden toxic 
smoke deep into the lung.\2\ In addition to cigarettes, there is an 
increasing array of combustible and noncombustible tobacco products on 
the market. New, novel tobacco products pose challenges to research, 
surveillance, health policy, and regulation because they vary so widely 
in form, mode of use, contents, designs and emissions, potential health 
effects, and marketing claims.\2\ Combustible product lines include 
fruit- and candy-flavored little cigars and cigarillos, which are about 
the same size and shape as cigarettes. These are of particular concern 
because their flavors and low pricing relative to cigarettes (largely 
attributable to differential tax treatment) are appealing to young 
people. In fact, research surveys have found that high school boys are 
smoking cigars at the same rate as cigarettes.\2\
    Noncombustible product lines include smokeless tobacco, dissolvable 
tobacco products, and the increasingly prevalent electronic nicotine 
delivery systems (ENDS). ENDS, including e-cigarettes, e-hookahs, 
hookah pens, vape pens, e-cigars, and others, are battery-powered 
devices that provide doses of nicotine and other constituents to the 
user in an aerosol. ENDS contain nicotine, which is addictive, toxic to 
developing fetuses, and may have lasting consequences for adolescent 
brain development.\2\ Potentially harmful constituents also have been 
documented in some ENDS, including: irritants, toxicants that can 
change genes, and other ingredients that have been shown to cause 
cancer in animals.\9\ ENDS are not ``safe,'' and because of the known 
risks associated with nicotine, the Surgeon General specifically 
cautions against their use by young people and pregnant women.\2\ ENDS 
could be less dangerous for the smoker to use than conventional 
cigarettes or other combusted tobacco products if and when used by 
established adult smokers as a complete substitution for cigarettes\2\ 
However, the consequences of long-term use of ENDS are unknown.
    In 1971, the tobacco companies stopped advertising cigarette and 
smokeless tobacco products on television and radio. This had a lasting 
impact on deglamorizing smoking.\10\ But now, electronic nicotine 
delivery systems are being heavily marketed on television and radio. 
The 2014 Surgeon General's Report observed that ENDS marketing ``has 
included claims of safety, use for smoking cessation, and statements 
that they are exempt from clean air policies that restrict smoking.'' 
Moreover, some ENDS marketing uses tactics which the Surgeon General 
has found lead to youth smoking:\5\ candy-flavored products; youth-
resonant themes such as rebellion, glamour, and sex; and celebrity 
endorsements and sports and music sponsorships. This is of concern 
because the Surgeon General has found that ``many changes in tobacco 
product form and marketing have been documented as efforts by the 
tobacco industry to contribute to tobacco use and addiction by 
fostering initiation among young people; making products easier and 
more acceptable to use; making and marketing products so as to address 
health concerns; and making and marketing products to perpetuate 
addiction through the use of alternate products, when smoking is not 
allowed or is socially unacceptable.'' \2\
    These actions appear to be successfully recruiting adult and youth 
ENDS users. Results from the HealthStyles survey suggest that adult e-
cigarette experimentation nearly doubled from 2010 (3.3 percent) to 
2011 (6.2 percent)\2\ In 2012, approximately 1.8 million students in 
grades 6-12 reported ever trying an e-cigarette.\11\ We do not yet know 
the long-term health effects that may result from use of ENDS, or the 
consequences of exposure to secondhand aerosol for bystanders. The 
recent Surgeon General's Report on smoking and health says that ENDS 
will cause harm if they:

     Encourage nonsmoking youth or adult non-smokers to start 
using them and become addicted to nicotine,
     Entice former smokers to relapse,
     Delay current smokers from trying to break their nicotine 
addiction altogether, or
     Encourage dual use of combustible tobacco products and 
electronic devices.\2\

    Additional risks include:

     The potential for ENDS to expose bystanders involuntarily 
to aerosolized nicotine, and
     Accidental poisonings resulting from ingestion or 
absorption through the skin of liquids containing high concentrations 
of nicotine.

    While we respond to the new challenges and opportunities presented 
by ENDS, we must remember that cigarettes and other combusted tobacco 
products are overwhelmingly responsible for the burden of tobacco-
related death and disease in the United States. Cigarettes remain 
cheap; ubiquitous; heavily marketed; appealing to children; 
``unreasonably dangerous, killing half of long-term users; and 
addictive by design.'' \2\ Every adult who dies prematurely from 
smoking in this country is replaced by two younger smokers who have 
been recruited to sustain the epidemic.\2\ In fact, if current rates of 
smoking by youth and young adults continue, 5.6 million American 
children under age 18 will ultimately die early because of smoking.\2\
    How do we accelerate the decline in the use of these deadly 
products? The good news is that we know a great deal about what works. 
The 2014 Surgeon General's Report emphasizes the effectiveness of 
comprehensive approaches to tobacco control that apply a mix of 
educational, clinical, regulatory, economic, and social strategies to:

    (1) prevent initiation of tobacco among youth and young adults,
    (2) promote quitting among adults and youth,
    (3) eliminate exposure to secondhand smoke, and
    (4) identify and eliminate tobacco-related disparities among 
population groups.

    Unfortunately, the Surgeon General concluded that these evidence-
based strategies are currently underutilized, but we are taking steps 
to change that dynamic:

     We know that a 10 percent increase in cigarette prices 
cuts consumption by 4 percent in adults, and by even more for youth.\6\ 
Yet many States have excise taxes of less than a dollar on a pack of 
cigarettes--and as a result, have higher smoking rates and higher 
medical costs to treat smoking-related disease relative to States with 
lower excise taxes. The fiscal year 2014 and fiscal year 2015 
President's Budgets propose a 94 cent per-pack increase in the Federal 
excise tax on cigarettes, which has the potential to prevent at least 
450,000 premature deaths of children alive today.
     We know that over half of current cigarette smokers want 
to quit and at least half will try to quit this year--the Affordable 
Care Act expanded access to smoking-cessation services and requires 
most insurance companies to cover cessation interventions. Integrating 
cessation help into behavioral health treatment will improve cessation 
rates, treatment retention, and outcomes for individuals with mental 
illness--a group disproportionately affected by tobacco use.
     We know that hard-hitting media campaigns such as CDC's 
Tips from Former Smokers have the potential to motivate even more 
smokers to quit successfully if they are sustained, as the Surgeon 
General recommends, at a high frequency for 10 years or more. The 
Affordable Care Act's Prevention and Public Health Fund supported the 
creation of this innovative campaign, which already has helped tens of 
thousands to quit smoking.
     We know that smoke-free policies protect nonsmokers from 
the dangers of secondhand smoke without harming businesses. Through the 
Office of the Assistant Secretary for Health's Tobacco-Free College 
Campus Initiative, the number of smoke-free campuses increased 73 
percent from 772 in 2012 to 1,343 in 2014. More work remains, as close 
to 90 million non-smokers, including over half of children between ages 
3 and 11--continue to be exposed to this known carcinogen. This year, 
41,000 Americans will die from a disease caused by this exposure.\2\
     We know that adequately funded, comprehensive, statewide 
tobacco control programs help inform tobacco-free social norms 
throughout communities and lower smoking rates and health care costs. 
CDC continues to invest in these State-based efforts through the 
National Tobacco Control Program. Yet States will spend less than 2 
percent of the more than $25 billion they receive in tobacco revenues 
this fiscal year on tobacco control.\5\
    At the Federal level, the work at the Food and Drug Administration 
to implement the landmark Family Smoking Prevention and Tobacco Control 
Act of 2009 is critical to further progress, and we are pleased to work 
in close partnership with FDA on the work described in its testimony 
today. CDC, FDA, and the National Institutes of Health are also 
partnering to fill critical research gaps.
    We also know that States and cities are taking action--implementing 
smoke-free indoor air policies, raising minimum age requirements for 
tobacco purchases, and putting policies into place to minimize 
potential harms of e-cigarettes. For example:

     Over half of States already prohibit e-cigarette sales to 
minors, as FDA is proposing in its deeming rule. Some are enforcing 
those policies through licensing requirements and penalties for 
violations.
     Three States prohibiting e-cigarette use in places where 
smoking is prohibited such as restaurants, bars, and worksites.

    As part of the National Prevention Council, agencies across the 
Federal Government are undertaking important commitments to promote 
tobacco-free living. For example, the Department of Housing and Urban 
Development is increasing access to smoke-free multi-unit housing for 
residents.\12\ Within the Department of Defense, efforts are underway 
to prevent and reduce tobacco use on DOD installations to promote 
health and mission readiness, help tobacco users quit, and lead by 
example for all workplaces. In addition, the U.S. Department of 
Veterans Affairs health care system provides evidence-based tobacco 
cessation counseling and FDA-approved medications for Veterans enrolled 
in care, including a national smoking cessation quitline and a mobile 
texting program, in collaboration with the National Cancer Institute. 
These and other initiatives have extended the reach of tobacco use 
treatment to Veterans nationally.
    CDC and the Department of Health and Human Services are committed 
to providing agencies with technical assistance and support as they 
implement these critical, but often challenging commitments. As 
resources permit, CDC is also committed to increasing the frequency of 
its high-impact Tips from Former Smokers campaign; conducting cutting-
edge research and surveillance to monitor the rapidly changing 
landscape of tobacco control; powering comprehensive tobacco control 
programs in States, tribes, and territories with resources and 
technical assistance, and expanding access to barrier-free tobacco-
cessation treatment, including through 1-800-QUIT-NOW.
    Real progress in tobacco control will require commitment and effort 
across all sectors of our society--not just local, State, and Federal 
agencies. One important partner will be the business community, and we 
are seeing some important movement in this sector. A striking example 
is the decision by CVS pharmacies to stop selling tobacco products in 
all their stores. Employee well-being and productivity also serve as 
motivators for business engagement. In addition to providing insurance 
coverage for smoking cessation, many large companies offer their 
employees free help to quit on the job, with cessation classes and 
support groups available throughout the work day. And smoking cessation 
as an important part of corporate wellness programs is spreading to 
smaller companies as well. Public health and tobacco-control 
stakeholders are working together with business leaders around the 
country to identify other opportunities for progress.
    If we end the tobacco-use epidemic, we can prevent one out of three 
cancer deaths in this country.\13\ We can prevent 480,000 premature 
deaths a year from smoking-related illnesses.\13\ We can prevent a 
third of heart disease cases, 80 percent of chronic obstructive 
pulmonary disease cases, and over 90 percent of lung cancer cases.\13\ 
We can keep 400,000 babies every year from being exposed to the 
chemicals in cigarette smoke before they are even born.\13\ We can save 
our economy nearly $300 billion a year in medical costs and economic 
losses.\13\ And we can help individual men and women live longer, 
healthier lives and avoid the pain and suffering that are a part of 
preventable diseases caused by smoking.
    Thank you.
                                Endnotes
    1. Holford TR, Meza R, Warner KE, Meernik C, Jeon J, Moolgavkar SH, 
Levy DT. Tobacco control and the reduction in smoking-related premature 
deaths in the United States, 1964-2012. JAMA: the Journal of the 
American Medical Association 2014.
    2. U.S. Department of Health and Human Services (2014). Reports of 
the Surgeon General. The Health Consequences of Smoking--50 Years of 
Progress: A Report of the Surgeon General. Atlanta (GA), Centers for 
Disease Control and Prevention (US).
    3. McAfee, Tim, et al (2013). Effect of the first federally funded 
US anti-smoking national media campaign. The Lancet. Published Online 
September 9, 2013. Available at: http://dx.doi.org/10.1016/S0140-
6736(13)61686-4. Accessed May 9, 2014.
    4. U.S. Department of Health and Human Services. How Tobacco Smoke 
Causes Disease--The Biology and Behavioral Basis for Smoking-
Attributable Disease: A Report of the Surgeon General. Atlanta (GA): 
U.S. Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Center for Chronic Disease Prevention 
and Health Promotion, Office on Smoking and Health, 2010.
    5. U.S. Department of Health and Human Services. The Health 
Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon 
General. Atlanta (GA): U.S. Department of Health and Human Services, 
Public Health Service, Centers for Disease Control, National Center for 
Chronic Disease Prevention and Health Promotion, Office on Smoking and 
Health, 1988. DHHS Publication No. (CDC) 88-8406.
    6. U.S. Department of Health and Human Services. Preventing Tobacco 
Use Among Youth and Young Adults: A Report of the Surgeon General. 
Atlanta (GA): U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, National Center for Chronic Disease 
Prevention and Health Promotion, Office on Smoking and Health, 2012.
    7. Campaign for Tobacco-Free Kids. Broken Promises to Our Children: 
The 1998 State Tobacco Settlement 15 Years Later. Washington: Campaign 
for Tobacco Free Kids, American Heart Association, American Cancer 
Society, Cancer Action Network, American Lung Association, and Robert 
Wood Johnson Foundation, 2013.
    8. Maxwell JC. The Maxwell Report: Year End & Fourth Quarter 2011 
Sales Estimates for the Cigarette Industry. Richmond (VA): John C. 
Maxwell, Jr., 2012
    9. Cobb, N. K., M. J. Byron, D. B. Abrams and P. G. Shields (2010). 
``Novel nicotine delivery systems and public health: the rise of the 
``e-cigarette''.'' Am J Public Health 100(12): 2340-42.
    10. Department of Health and Human Services (2000). Reducing 
Tobacco Use: A Report of the Surgeon General. Atlanta (GA): U.S. 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, National Center for Chronic Disease Prevention and 
Health Promotion, Office on Smoking and Health, 2000.
    11. CDC (2013). ``Notes from the field: electronic cigarette use 
among middle and high school students--United States, 2011-12.'' MMWR 
Morb Mortal Wkly Rep 62(35): 729-30.
    12. Department of Health and Human Services (2010). National 
prevention Council Action Plan. Available at: http://
www.surgeongeneral.gov/initiatives/prevention/2012-npc-action-plan.pdf. 
Accessed May 5, 2014.
    13. U.S. Department of Health and Human Services (2014). Let's Make 
the Next Generation Tobacco-Free: Your Guide to the 50th Anniversary 
Surgeon General's Report on Smoking and Health. Available at: http://
www.surgeongeneral.gov/library/reports/50-years-of-progress/. Accessed 
May 5, 2014.

    The Chairman. Thank you very much, Dr. McAfee.
    Mr. Zeller, please proceed.

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

    Mr. Zeller. Thank you, Chairman Harkin, Ranking Member 
Alexander, Senator Burr, other members of the committee for the 
opportunity to testify today.
    I am Mitch Zeller, Director of FDA Center for Tobacco 
Products, or CTP as we call it, and I am honored to be here 
today to discuss FDA's activities in implementing the Family 
Smoking Prevention and Tobacco Control Act since it was signed 
into law in June 2009.
    Next month, marks the 5-year anniversary of the Tobacco 
Control Act, a law that gave FDA comprehensive tools to protect 
the public from the harmful effects of tobacco use through 
science-based tobacco product regulation.
    Since the Act became law in 2009, we have made significant 
progress toward establishing a comprehensive, effective, and 
sustainable framework for tobacco product regulation.
    Our first priority was the creation of the Center for 
Tobacco Products, the first new center at FDA in 21 years. CTP 
has grown from a handful of employees in the fall of 2009 to 
nearly 500 employees today.
    During our startup phase, even as the Center was 
establishing itself, creating infrastructure, hiring 
appropriate personnel, we were required by law to meet more 
than 20 mandatory, statutory deadlines. We were also required 
to assess user fees, establish the Tobacco Products Scientific 
Advisory Committee, known as TPSAC, and refer initially issues 
to TPSAC for consideration, and the Center met nearly all of 
these many deadlines.
    CTP's main responsibilities include reviewing new product 
submissions, developing the science base for product 
regulation, enforcing the law, issuing regulations and guidance 
for industry, and educating the public about the risks 
associated with tobacco product use. And I would like to 
briefly touch on each of these.
    CTP is committed to carefully and thoroughly reviewing all 
tobacco product submissions in a consistent, transparent, 
predictable, and timely way. And we recently established 
performance measures that include timeframes for review of many 
of the submissions we receive.
    As a regulatory agency, we can only go as far as the 
regulatory science will take us. CTP funds and uses scientific 
research to better understand tobacco products, how the 
differences in products change the behavior of users and 
nonusers, and how to best reduce the harm from these products.
    We partner with the National Institutes of Health and the 
Centers for Disease Control and Prevention, as well as with 
FDA's own National Center for Toxicological Research to advance 
the regulatory science base.
    Vigorous enforcement of the Tobacco Control Act and 
implementing regulations is carried out through tobacco retail 
compliance check inspections, inspections of domestic 
manufacturers and imported tobacco products, and review of 
tobacco promotions, advertising, and labeling. CTP also 
provides compliance education and training to regulated 
industry.
    In February, we launched a national public education 
campaign called the Real Cost to prevent youth tobacco use and 
reduce the number of teens who become regular smokers. The 
campaign uses compelling facts and vivid imagery designed to 
change beliefs and behaviors over time, to educate youth about 
the dangers of tobacco use, and to encourage them to be 
tobacco-free.
    We have faced some challenges in the 5 years since CTP was 
created including the growing pains inherent in building a 
regulatory body from the ground up. We have worked through the 
logistical challenges of creating a brand new organizational 
structure, hiring qualified staff, developing the processes, 
procedures, and even the dedicated IT resources to carry out 
CTP's important regulatory functions.
    Regulating tobacco products is markedly different from 
other products traditionally regulated by FDA. Now, our 
responsibility is unprecedented. No other country has tasked a 
regulatory agency to evaluate new tobacco products before 
marketing based on public health criteria. And we have also had 
to create a tobacco retail compliance program that is unique 
even within FDA.
    Moving forward, we intend to sustain the momentum needed to 
achieve our goal of reducing the harms and risks associated 
with tobacco product use.
    I would like to close on a more personal note. After 13 
years out of Government, I returned to public service in March 
of last year to direct the Center for Tobacco Products. The 
main reason I returned to FDA was the public health opportunity 
to help use the product regulation tools Congress and the 
President granted the Agency in the Tobacco Control Act to help 
reduce the death and disease from tobacco use.
    The reality is that roughly 1 in 5 adults still smoke, and 
we will explore all available regulatory options to reduce the 
harm caused by tobacco products.
    But perhaps our greatest opportunity to overcome this 
pressing public health problem is to dramatically decrease the 
access and appeal of tobacco products to youth. We intend to 
use the many tools at our disposal to help make the next 
generation tobacco-free.
    I thank the committee for its efforts and I am pleased to 
answer any questions.
    Thank you.
    [The prepared statement of Mr. Zeller follows:]
              Prepared Statement of Mitchell Zeller, J.D.
                              introduction
    Mr. Chairman and members of the committee, I am Mitch Zeller, 
director of the Center for Tobacco Products (CTP) at the Food and Drug 
Administration (FDA or the Agency), which is part of the Department of 
Health and Human Services (HHS). Thank you for the opportunity to be 
here today to discuss FDA's activities in implementing the Family 
Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control 
Act), since it was signed into law on June 22, 2009.
    This January we marked 50 years since the first Surgeon General's 
Report on Smoking and Health, and how we've learned so much about 
tobacco use as the leading cause of preventable disease and death in 
this country. We've shifted the perception of smoking from an accepted 
national pastime to a discouraged threat to health--and more than 
halved smoking rates in this country. This year's Surgeon General's 
Report highlighted 50 years of progress in tobacco control and 
prevention, presented new data on the health consequences of tobacco 
use, and detailed initiatives that can end the tobacco epidemic in the 
United States.
    But the fact of the matter is, for all the progress we've made over 
these past five decades, tobacco-use remains the leading cause of 
avoidable death here in the United States and also around the world. 
Each year, more than 480,000 Americans lose their lives to tobacco-
related illness. This recent Surgeon General's Report also added new 
diseases to the list of those known to be caused by smoking: liver 
cancer, colorectal cancer, diabetes, and rheumatoid arthritis, as well 
as adding strokes caused by exposure to secondhand smoke. And each day 
in the United States, more than 3,200 youth under age 18 try their 
first cigarette and more than 700 youth under age 18 become daily 
smokers. If we fail to reverse these trends, 5.6 million American 
children who are alive today, will die prematurely due to smoking later 
in life.
                        the tobacco control act
    In 2009, the Congress passed, and the President signed, the Tobacco 
Control Act, which amended the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) to authorize FDA to oversee the manufacture, marketing, 
distribution, and sale of regulated tobacco products and protect the 
public from the harmful effects of tobacco product use. This new 
authority gave FDA comprehensive tools to protect the public from the 
harmful effects of tobacco use through science-based tobacco product 
regulation.
    FDA's traditional ``safe and effective'' standard for evaluating 
medical products does not apply to tobacco products. With limited 
exceptions, FDA evaluates new tobacco products based on a public health 
standard that considers the risks and benefits of the tobacco product 
to the population as a whole, including users and non-users. Similarly, 
when developing regulations, the law generally requires FDA to apply a 
public health approach that considers the effect of the regulatory 
action on the population as a whole, not just on individual users, 
taking into account initiation and cessation of tobacco use.
    Under the statute, FDA had immediate authority to regulate 
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco. The Tobacco Control Act also authorized FDA to deem other 
tobacco products to be subject to the Agency's regulatory authority in 
Chapter IX of the FD&C Act. On April 24, 2014, FDA issued a proposed 
rule (the ``proposed deeming rule'') to deem additional products that 
meet the statutory definition of a ``tobacco product'' (which includes 
``any product made or derived from tobacco that is intended for human 
consumption'' that is not a drug, device, or combination product under 
the FD&C Act) to be subject to FDA's regulatory authority.\1\ Under the 
proposed rule, products that would be ``deemed'' to be subject to FDA 
regulation, include currently unregulated marketed products, such as 
electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine 
gels, waterpipe (or hookah) tobacco, and dissolvables not already under 
the FDA's authority. Manufacturers of newly deemed tobacco products 
would be required, among other things, to:
---------------------------------------------------------------------------
    \1\ See FDA, ``News Release: FDA proposes to extend its tobacco 
authority to additional tobacco products, including e-cigarettes'' 
(April 24, 2014), available at http://www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm394667.htm.

     Register their establishments with FDA, report product and 
ingredient listings, and report harmful and potentially harmful 
constituents;
     Market new tobacco products only after FDA review;
     Make direct and implied claims of reduced risk only if FDA 
confirms that scientific evidence supports the claim and that marketing 
the product will promote public health; and
     Not distribute free samples.

    In addition, under the proposed rule, the following provisions 
would apply to newly ``deemed'' tobacco products:

     Minimum age and identification restrictions to prevent 
sales to underage youth;
     Requirements to bear certain health warnings; and
     Prohibition of vending machine sales, unless in a facility 
that never admits youth.

    Issuing the proposed deeming rule was an important step forward in 
regulating these products, and finalizing the rule after a thorough 
review of comments is a priority for the Agency. Products that are 
marketed for therapeutic purposes will continue to be regulated as 
medical products under the FDA's existing drug and device authorities 
in the FD&C Act.
    Between 2008 and 2010, FDA had previously attempted to address 
electronic cigarettes (e-cigarettes) as unapproved drug/device 
combination products. FDA's action was challenged, and ultimately the 
U.S. Court of Appeals for the D.C. Circuit ruled that while FDA could 
choose to regulate e-cigarettes and other products ``made or derived 
from tobacco'' under its new tobacco authorities, it could not regulate 
these products under FDA's drug and device authority. Sottera, Inc. v. 
Food and Drug Administration, 627 F.3d 891 (D.C. Cir. 2010). Finalizing 
the proposed deeming rule would bring these tobacco products under 
FDA's regulatory authority.
    FDA welcomes comment on all aspects of the proposed rule. We asked 
for comment on a number of specific issues, on which we look forward to 
receiving input, research, data and other information from the public 
to help inform the development of the Final Rule.
       accomplishments since enactment of the tobacco control act
    In the nearly 5 years since enactment of the Tobacco Control Act, 
FDA has made significant progress toward establishing a comprehensive, 
effective, and sustainable framework for tobacco product regulation 
that is designed to reduce the impact of tobacco on public health, to 
keep people, especially our Nation's youth, from starting to use 
tobacco, and to encourage consumers to quit. These major strides 
include, among other things:

     Establishing an initial framework for industry 
registration, product listing, and submission of information on 
ingredients and harmful and potentially harmful constituents (HPHCs) in 
tobacco products and tobacco smoke;
     Requiring cigarette, roll-your-own, and smokeless tobacco 
product manufacturers to seek FDA authorization before marketing a new 
product or making changes to existing products;
     Implementing and enforcing the FD&C Act's prohibition on 
the use of marketing terms for regulated tobacco products that imply 
reduced risk (such as ``light,'' ``mild,'' or ``low'') without FDA 
authorization;
     Developing a process for the review and evaluation of 
applications for new, modified risk claims, and substantially 
equivalent (SE) tobacco products;
     Implementing and enforcing the statutory ban on cigarettes 
with certain characterizing flavors;
     Increasing regulatory science capabilities through 
research to better understand regulated products and patterns of 
tobacco use;
     Restricting access and marketing of cigarettes and 
smokeless tobacco products to youth;
     Implementing a compliance and enforcement program to 
ensure industry compliance with regulatory requirements; and
     Establishing public education campaigns about the dangers 
of regulated tobacco products.

    These accomplishments demonstrate FDA's commitment to effectively 
regulate the manufacture, marketing, and distribution of tobacco 
products and to advance tobacco product regulations appropriate for the 
protection of public health.
              establishing the center for tobacco products
    FDA's first priority following the enactment of the Tobacco Control 
Act was creating the Center for Tobacco Products (CTP or the Center), 
FDA's first new center in 21 years. CTP oversees the implementation of 
the FDA tobacco program, and has been tasked with developing the 
scientific, regulatory, and public education infrastructure necessary 
to implement and track FDA's goals for meaningful product regulation 
that will help reduce the harms associated with tobacco products and 
prevent initiation of tobacco use (particularly among youth).
    From a handful of employees in the fall of 2009, the Center has 
grown to nearly 500 employees, including regulatory counsels, policy 
analysts, scientists, researchers, management officers, communications 
specialists, and other professionals who are designing and implementing 
a comprehensive program of tobacco product regulation. Key objectives 
involved in launching CTP have included recruiting management officials 
to lead the Center, hiring skilled staff, setting up necessary 
infrastructure and technology resources, and putting in place processes 
to meet statutory deadlines and directives.
    During its startup phase, FDA quickly established the foundation 
for meeting the many mandatory statutory deadlines included in the 
Tobacco Control Act. The law contains more than 20 statutory deadlines 
by which FDA was required to issue certain regulations, guidance 
documents, Reports to Congress, and a list of harmful and potentially 
harmful constituents, among other things. Most of these deadlines were 
in the first 3 years after the law went into effect. Therefore, even as 
the Center was establishing itself, creating infrastructure, and hiring 
appropriate personnel, it was required to develop a significant number 
of regulations and guidance documents on precedent-setting, complex 
issues. In addition, the Center was required to assess user fees, 
establish the Tobacco Products Scientific Advisory Committee (TPSAC), 
and refer to TPSAC the issue of the impact of the use of menthol in 
cigarettes on the public health, within its first year. The Center met 
nearly all of the more than 20 statutory deadlines.
    CTP undertakes four broad categories of activities in carrying out 
its responsibilities and authorities under the Tobacco Control Act:

     reviewing submissions for marketing new tobacco products 
and developing the science base for product regulation;
     enforcing statutory and regulatory requirements to ensure 
regulated industry and tobacco products are in compliance with the law;
     developing and issuing regulations and guidance for 
industry; and
     engaging in public education and outreach activities about 
the risks associated with tobacco product use, and promoting awareness 
of and compliance with the Tobacco Control Act.

    I will briefly describe some of CTP's accomplishments in each of 
these areas over the last 5 years, as well as note some of the 
challenges that we have faced in carrying out our responsibilities and 
authorities under the Tobacco Control Act.
                   the tobacco product review process
    The Tobacco Control Act requires manufacturers to seek FDA 
authorization before marketing a new tobacco product, including when 
modifying an existing product; the FD&C Act defines a ``new'' tobacco 
product as a product not commercially marketed in the United States as 
of February 15, 2007, or a product already on the market that is 
modified after that date. Products that were on the market on February 
15, 2007, and which have not been modified, can continue to be marketed 
without FDA authorization. This review process gives FDA the ability to 
help ensure that the marketing of any new product, including a modified 
product, is appropriate for the protection of public health and allows 
for greater awareness and understanding of the changes being made to 
tobacco products. There are three ways a new tobacco product, including 
an existing product that is modified, can obtain FDA authorization for 
distribution or retail sale: a premarket tobacco product application; 
an application demonstrating substantial equivalence (SE) to certain 
commercially marketed products; or an application for exemption from 
demonstrating SE.
     Premarket tobacco product applications: One pathway for a 
new tobacco product to receive market authorization is through the 
Premarket Tobacco Product Application (PMTA) process.\2\
---------------------------------------------------------------------------
    \2\ In September 2011, FDA issued a draft guidance document 
describing what the FD&C Act requires to be submitted in a new tobacco 
product application. The draft guidance also sought comment on the 
information to be included in the application that the agency would use 
to determine whether the marketing of a new tobacco product is 
appropriate for the protection of the public health, as determined with 
respect to the risks and benefits to the population as a whole, 
including users and non-users of tobacco products, and taking into 
account the impact on cessation and initiation.
---------------------------------------------------------------------------
     Demonstrating substantial equivalence to certain 
commercially marketed products: Demonstrating SE to a product already 
on the market is a second pathway to marketing authorization under 
specific circumstances. Under the SE pathway, whenever an existing 
tobacco product is modified, the manufacturer must submit a report with 
sufficient scientific data and information to FDA to demonstrate either 
that the product characteristics, as compared to the predicate product, 
are the same or that the tobacco product has different characteristics 
but does not raise different questions of public health.\3\ This means 
that products brought to market through this pathway should not present 
more harm to public health than a valid predicate tobacco product.
---------------------------------------------------------------------------
    \3\ Products that were first introduced or delivered for 
introduction into interstate commerce for commercial distribution 
between February 15, 2007, and March 22, 2011, and for which SE reports 
were submitted prior to March 23, 2011, can remain on the market unless 
FDA issues an order that they are ``not substantially equivalent 
(NSE).'' FDA refers to these SE reports as ``provisional.'' An SE 
report for a tobacco product submitted after March 22, 2011 is 
considered a ``regular'' report and the product covered by the 
application cannot be marketed unless FDA first issues an order finding 
the product substantially equivalent and in compliance with the FD&C 
Act. FDA issued a guidance document in January 2011 describing the 
content and data to be included in the report and the process for its 
review.
---------------------------------------------------------------------------
     Exemption from demonstrating substantial equivalence: The 
third pathway for new tobacco products is a request for an exemption 
from the SE requirements. This pathway is available for products 
modified by the addition or deletion of an additive or a change in the 
quantity of an existing additive, if FDA finds the modification of the 
product to be minor; FDA determines an SE report is not necessary to 
ensure that permitting the tobacco product to be marketed would be 
appropriate for the protection of public health; and an exemption is 
otherwise appropriate.\4\
---------------------------------------------------------------------------
    \4\ In July 2011, FDA issued a final rule on ``Exemptions from 
Substantial Equivalence Requirements'' that established the procedures 
for requesting an SE exemption.
---------------------------------------------------------------------------
    In addition to creating the pathways for marketing of new tobacco 
products, the statute directs FDA to evaluate and authorize marketing 
of modified risk tobacco products (MRTPs). MRTPs are tobacco products 
sold or distributed for use to reduce harm or the risk of tobacco-
related disease. These include products whose labeling or advertising 
represents (explicitly or implicitly) that the product is less harmful 
or presents a lower risk of tobacco-related disease than commercially 
marketed tobacco products, or that the product or its smoke contains a 
reduced level of, presents a reduced exposure to, or does not contain 
or is free of a substance.
    In order for a tobacco product to make claims that the product 
``presents a lower risk of disease,'' an applicant must show that the 
product will significantly reduce harm and the risk of tobacco-related 
disease to individual tobacco users and benefit the health of the 
population as a whole, taking into account both users and non-users of 
tobacco products.
    There is also a ``Special Rule'' for certain MRTPs, such as those 
that claim to ``present a reduced exposure to a substance.'' FDA may 
issue an order for such products if, among other things, the order 
would be appropriate to promote the public health; the claims for the 
product are limited to claims that the product does not contain or is 
free of a substance, contains a reduced level of a substance, or 
presents a reduced exposure to a substance; scientific evidence to 
satisfy the lower disease risk standards cannot be made available 
without conducting long-term epidemiological studies; and the available 
scientific evidence demonstrates that a measurable and substantial 
reduction in morbidity/mortality among individual users is reasonably 
likely in subsequent studies.
    FDA review of a new product, including a modified product, requires 
scientific and technical expertise in order to assess how the product 
design, ingredients, and other characteristics impact the public 
health.
    Substantial equivalence is one pathway manufacturers can use to 
seek permission to market a new tobacco product. The primary pathway, 
however, is through the filing of a new tobacco product application. As 
of May 1, 2014, FDA had not received any complete premarket 
applications for new tobacco products for which we can commence a 
scientific review.
    As of May 1, 2014, FDA had received a total of 4,580 submissions 
seeking to demonstrate SE to a predicate product, including 3,578 
``provisional'' submissions that were received before March 23, 2011, 
and apply SE to products currently marketed in the United States. The 
remaining 1,002 applications are ``regular'' submissions for products 
not currently on the market.
    FDA is committed to carefully and thoroughly reviewing all 
submissions in order to protect the public health as required by the 
FD&C Act. FDA is also committed to a consistent, transparent, and 
predictable review process and to completing reviews of all new product 
applications in a timely manner.
    CTP has prioritized the review of regular SE submissions and has 
made progress in each of the three key steps in the SE review process: 
(1) jurisdiction review; (2) administrative review; and (3) scientific 
review. As of May 1, 2014, CTP has completed the jurisdiction review of 
4,559 SE submissions and completed administrative review of 4,384 SE 
submissions and provided acknowledgment and, where appropriate, 
administrative advice and information letters to the applicants seeking 
information required for review. On March 24, 2014, CTP announced that 
we no longer have a backlog of regular SE reports awaiting review. CTP 
is starting review on regular SE reports as they are received. As of 
May 12, 2014, 257, or 25 percent of regular SE submissions have been 
resolved, either because CTP issued a determination (34 submissions) or 
because the submission was withdrawn (223 submissions). Fifty-seven 
percent of the Regular SE Report withdrawals reported to FDA were 
withdrawn after CTP issued an action letter which identified 
deficiencies in the submission.
    CTP has completed an initial evaluation of the 3,559 provisional SE 
reports to guide the order of review so that those products that remain 
on the market and present the highest likelihood of raising a different 
question of public health will be reviewed first. CTP has begun review 
of provisional SE reports and issued the first decisions on these 
reports on February 21, 2014. These decisions marked the first time 
that FDA used its authority under the Tobacco Control Act to order a 
manufacturer of currently available tobacco products to stop selling 
and distributing them.\5\ The products were found to be not 
substantially equivalent to predicate tobacco products, therefore under 
the Tobacco Control Act, they can no longer be sold or distributed in 
interstate commerce or imported into the United States.
---------------------------------------------------------------------------
    \5\ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm386707.htm.
---------------------------------------------------------------------------
    FDA has received 59 requests to consider certain products to be 
exempt from the SE requirements. To be considered for an exemption, 
requests must meet the requirements in the statute and regulations. CTP 
published a final regulation on the SE exemption pathway on July 5, 
2011. FDA has refused to accept 35 requests for SE exemption because 
they did not meet the statutory and regulatory requirements. The 
remaining 24 requests are under administrative, eligibility, or 
scientific review.
    There are many factors that can affect the timing of a 
determination by FDA, including the completeness of an application or 
whether there is a need for manufacturers to submit more information or 
provide an additional explanation so that FDA can complete its 
assessment. It is important to note that there was a wide range of 
quality in SE reports submitted thus far by the tobacco industry. In 
almost all cases, reports that have been submitted lack both 
information referenced in FDA guidance documents to facilitate FDA 
review and information required by statute for FDA to make its 
determination. Examples of some of the general issues that FDA is 
observing across multiple applicants include:

     Reports containing contradictory statements, particularly 
about whether the product characteristics were the same or different;
     Reports identifying a predicate product that does not meet 
the statutory requirement;
     Reports lacking information to completely understand 
product composition, including information about the tobacco blend used 
in the product;
     Reports missing specifications on components used in the 
manufacture of the finished product;
     Reports with HPHC measurements that were scientifically 
inadequate or did not include information needed to evaluate data 
quality; and
     Reports in which information on product design was 
incomplete, preventing a scientific assessment.

    In response to industry feedback, where possible, FDA has been 
taking steps that would streamline the SE review process, by:

     increasing opportunities for communication with industry 
by encouraging teleconferences between the assigned FDA regulatory 
project manager and the submitter;
     taking steps to facilitate quicker responses to questions;
     modifying the initial review for completeness to focus 
only on administrative issues, so that applicants can be notified more 
quickly about submission deficiencies;
     hosting webinars for tobacco manufacturers specifically to 
discuss the types of information that the Agency needs to complete the 
review of SE reports;
     issuing a September 2011 draft guidance document for 
public comment with responses to frequently asked questions about 
demonstrating SE of a new tobacco product; and
     launching a new section on the Agency's Web site, 
providing comprehensive information on the pathways available to 
legally market new tobacco products, including SE.

    In addition to streamlining the SE review process, FDA is taking 
other steps to improve the timeliness of product reviews. In fiscal 
year 2013, CTP increased the number of scientific staff by 38 percent, 
mostly to perform reviews. CTP plans to continue to hire many more 
scientists and expects the time required for review of SE submissions 
to get substantially shorter as CTP continues to improve the efficiency 
of its review process and as the quality of reports received from 
industry improves.
    In addition to hiring more scientific staff to perform reviews, 
last month, the Center established four performance measures that 
include timeframes for review of regular SE Reports, review of 
Exemption from SE Requests, review of MRTP Applications, and for 
responding to meeting requests. Beginning on October 1, 2014, all four 
measures will be implemented. The interim time between now and October 
1, 2014, will be used to develop tracking systems for monitoring 
progress in meeting the performance goals. As FDA gains more experience 
with reviewing provisional SE Reports, we intend to identify and 
implement performance standards for these submissions as well.
                       tobacco regulatory science
    CTP relies on the most current science to make regulatory decisions 
on tobacco products. The Center funds and uses scientific research to 
better understand tobacco products, how the differences in products 
change the behavior of users and non-users, how they cause death and 
disease, and how to best reduce the harm from these products.
    CTP has identified seven categories of research priorities:

     Product diversity--understanding the types of tobacco 
products and how their specific characteristics affect people's use of 
these products, as well as their attitudes, beliefs, and perceptions 
about these products.
     Addiction--understanding what effect different levels of 
nicotine and other factors have on addiction.
     Toxicity and carcinogenicity--understanding how changes in 
tobacco products affect their potential for harm and ways to reduce 
that harm.
     Health consequences--understanding the risks of different 
tobacco products.
     Communication--finding ways to effectively convey 
information about the risks of using tobacco and about CTP's role in 
regulating tobacco products.
     Marketing--understanding the impact of tobacco product 
marketing and public education on people's attitudes, beliefs, 
perceptions, and use.
     Economics and policy--estimating the economic impact of 
CTP's regulations; also understanding how CTP's actions change tobacco 
use and illness and death from tobacco use.

    CTP partners with other agencies, such as the National Institutes 
of Health (NIH) and Centers for Disease Control and Prevention (CDC), 
as well as with FDA's National Center for Toxicological Research, to 
continue to advance the regulatory science base. For example, CTP is 
partnering with NIH to support important research efforts, including:

     The Population Assessment of Tobacco and Health (PATH) 
Study: The PATH Study will help scientists learn how and why people 
start using tobacco, switch products, quit using tobacco, and start 
using it again after they've quit. By monitoring and assessing the 
behavioral and adverse health impacts of tobacco use in the United 
States, the PATH Study will add to the evidence base to inform 
regulatory decisions about the marketing, manufacture, and distribution 
of tobacco products. Because this is a longitudinal study following the 
same individuals, with appropriate consent, over years, FDA will be 
able to draw scientific conclusions on how users transition from the 
use of one product to another and from experimentation to regular use 
and how these choices impact the ultimate death and disease resulting 
from their use. The PATH survey went into the field in September 2013, 
the data will be available in the fall of 2015 for researchers by 
request, and the publicly available baseline survey dataset is expected 
in spring 2016. Any publicly released data will protect the identity of 
the participants.
     Tobacco Centers of Regulatory Science (TCORS): TCORS is a 
new research program designed to generate research to inform the 
regulation of tobacco products to protect public health. The program 
was initially funded in 2013 and will run up to 5 years. Essential 
elements of these centers include an overall focus on the high-priority 
tobacco regulatory program needs for CTP; three or more theoretically 
grounded, strong research projects with an integrative theme; the 
ability to respond quickly to emerging research questions through pilot 
projects; and a program for career development to train future 
generations of researchers in tobacco regulatory science.

    In addition, in response to the Court of Appeals decision on FDA's 
rule requiring that all cigarette packages bear one of nine new textual 
warnings and include color graphics depicting the negative health 
consequences of smoking, FDA is undertaking research to support a new 
rulemaking consistent with the Tobacco Control Act and actively working 
to move forward on this important issue.
                 compliance and enforcement activities
    Vigorous enforcement of the Tobacco Control Act and implementing 
regulations is carried out through tobacco retail compliance check 
inspections, inspections of domestic manufacturers and imported tobacco 
products, and surveillance and review of tobacco promotions, 
advertising, and labeling. CTP also provides compliance education and 
training to regulated industry.
    The FD&C Act instructs FDA to contract, where feasible, with the 
States, to carry out inspections of retailers in connection with the 
enforcement of the Tobacco Control Act; the retail inspection program 
provides a framework for a nationwide FDA enforcement strategy through 
the credentialing of more than 1,100 State and territorial officials 
and a comprehensive training program for these FDA-commissioned 
inspectors and program coordinators. CTP has awarded contracts for 
tobacco retail inspections in 48 States and territories, with awards 
totaling more than $93 million since the program began. Measurable 
accomplishments in the retail inspection program from 2009 through May 
1, 2014, include:

     Conducting more than 289,000 compliance check inspections 
of regulated tobacco retailers utilizing State and territorial 
contractors;
     Issuing over 14,800 warning letters to retail 
establishments where violations were found during compliance check 
inspections;
     Issuing over 1,430 CMP administrative actions to retail 
establishments where subsequent violations were found during followup 
compliance check inspections; and
     Developing an online searchable data base of retail 
compliance check inspection results.\6\
---------------------------------------------------------------------------
    \6\ See FDA, ``Compliance Check Inspections of Tobacco Product 
Retailers,'' available at http://www.accessdata.fda.gov/scripts/oce/
inspections/oce_insp_searching.cfm.

    Active and effective enforcement of tobacco laws and regulations 
governing the promotion, advertising, and labeling of tobacco products 
can help to protect the public health by preventing the sale and 
distribution of misbranded and adulterated tobacco products, including 
those with marketing and advertising materials that violate the 
requirements of the Tobacco Control Act. In this regard, FDA reviews 
and evaluates regulatory submissions that include tobacco product 
labeling, representative advertising, and consumer information 
materials; conducts routine monitoring of Web sites and publications 
that sell, distribute, promote, or advertise regulated tobacco 
products; and conducts surveillance of event promotion and sponsorship 
by tobacco manufacturers, distributors, or retailers.
    CTP has issued a number of letters to manufacturers requesting 
information regarding their marketing and advertising practices. For 
example, FDA has requested information on events that include the 
distribution of free samples of smokeless tobacco products, internet 
marketing activities, and other relevant information to determine 
compliance. From 2009 through May 1, 2014, FDA's promotion, 
advertising, and labeling compliance and enforcement program has:

     Monitored approximately 3,000 Web sites and more than 
74,000 publication issues where regulated tobacco products might be 
sold, distributed or advertised.
     Issued over 150 Warning Letters as a result of CTP's 
monitoring and surveillance of tobacco advertising, labeling, and other 
promotional activities; and
     Reviewed 38 smokeless tobacco warning plans and 13 
smokeless tobacco warning plan supplements.

    FDA conducts biennial inspections of registered tobacco product 
establishments that manufacture regulated tobacco products in the U.S. 
market. These inspections are designed to determine compliance with 
requirements of the FD&C Act, including establishment registration, 
product and ingredient listing, packaging, labeling, and advertising 
requirements, and marketing authorization for new or modified risk 
tobacco products. In the area of manufacturing compliance and 
enforcement, through May 1, 2014, FDA has:

     Conducted more than 120 inspections of registered tobacco 
product facilities;
     Conducted more than 20 investigations that included 
sponsorship events and distribution of free sample events; and
     Reviewed over 77,500 lines of imported tobacco products, 
completing over 1,100 field exams and more than 1,900 label exams, and 
refusing more than 70 entries, in collaboration with U.S. Customs and 
Border Patrol (CBP). We have also issued four import alerts that 
directed many of these reviews and exams.

    CTP also provides compliance education and training to regulated 
industry to ensure that those who must understand the law and 
regulations have the resources to do so. In 2011, FDA started hosting 
live webinars to help educate regulated industry and encourage 
compliance with Federal tobacco laws and regulations. Public webinars 
allow retailers and small businesses to watch and ask live questions. 
Each webinar addresses a specific subject, including published 
guidance, and many of the webinars are archived on the Center's Web 
site for future viewing. Industry can also suggest topics for future 
webinars.
    In addition, one of FDA's initial activities was to establish the 
Office of Small Business Assistance within CTP to assist small tobacco 
product manufacturers and retailers in complying with the Tobacco 
Control Act. The office has a dedicated Web page, e-mail address, and 
staff to assist small businesses with their questions, comments, and 
concerns.
         ``the real cost'' and other public education campaigns
    The Tobacco Control Act gives FDA the authority to educate the 
public about the dangers of regulated tobacco product use. To advance 
efforts to protect the public from the harmful effects of tobacco use, 
FDA is developing integrated, far-reaching, and evidence-based public 
education campaigns related to FDA's regulatory activities, including 
informing consumers about risks from tobacco use and preventing youth 
tobacco initiation, and promoting tobacco use cessation among youth.
    FDA has awarded multiple contracts for public education campaigns 
to conduct sustained, multi-media efforts that will enable FDA to 
educate the public, and vulnerable youth populations in particular, 
about the harms and risks of regulated tobacco products in order to 
help prevent youth initiation and encourage cessation. Specifically, 
these campaigns will equip the public with important facts about the 
health risks and addictiveness of regulated tobacco products and the 
HPHCs in regulated tobacco products.
    In February, we launched a national public education campaign to 
prevent youth tobacco use and reduce the number of kids ages 12 to 17 
who become regular smokers. ``The Real Cost'' campaign is the first of 
several planned tobacco education campaigns;\7\ it targets the 10 
million young people ages 12-17 who have never smoked a cigarette but 
are open to it as well as youth who are already experimenting with 
cigarettes and are at risk of escalating their use. ``The Real Cost'' 
campaign uses a comprehensive multimedia approach with compelling facts 
and vivid imagery designed to change beliefs and behaviors over 
time,\8\ educate youth about the dangers of tobacco use and to 
encourage them to be tobacco-free.\9\ Supported by the best available 
science, ``The Real Cost'' campaign will be evaluated to measure its 
effectiveness over time.
---------------------------------------------------------------------------
    \7\ Was not supplied.
    \8\ Was not supplied.
    \9\ See http://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/
PublicEducationCampaigns/TheRealCostCampaign/ucm384
305.htm.
---------------------------------------------------------------------------
    In addition, FDA is overseeing a variety of research and analytic 
activities to strengthen and inform public education initiatives and 
efforts. This includes awarding a contract to conduct rigorous outcome 
evaluations on the effectiveness of individual FDA tobacco-related 
public education campaigns, overall messaging, and related 
communications activities. This combination of establishing and 
evaluating evidence-based public education campaigns will enable the 
Agency to implement effective models for educating the public about the 
risks and dangers of regulated products, and will also complement 
public education initiatives by our partner agencies, including CDC, on 
tobacco-related issues.
      addressing challenges and advancing the tobacco control act
    Some of the challenges that we have faced in these early years are 
the growing pains inherent in building a regulatory body from the 
ground up. FDA has worked through the logistical challenges of creating 
a new organizational structure, recruiting and hiring qualified staff 
with applicable experience in a short timeframe, and developing the 
processes, procedures and dedicated information technology resources to 
carry out CTP's important regulatory functions.
    There are challenges intrinsic to the regulation of tobacco 
products, which are markedly different from other products 
traditionally regulated by FDA. For example, FDA has created and 
validated entirely new scientific testing procedures for the 
measurement of HPHCs in tobacco products and tobacco smoke, and 
developed metrics for the evaluation of product applications, including 
the SE applications now under review. The responsibility given to FDA's 
Center for Tobacco Products for the premarket public health review of 
tobacco product applications and reports is unprecedented. No other 
country's regulatory agency has been given the responsibility to 
evaluate new tobacco products before they are marketed and determine 
which products will be authorized for marketing based on public health 
criteria. FDA also established and implemented a tobacco retail 
compliance program that is unique even within the Agency. Tobacco 
product regulation also involves the regulation of an industry that is 
new to Federal product regulation and often unfamiliar with and 
continuing to learn what is expected in the regulatory process.
                               conclusion
    Moving forward, FDA will sustain the momentum needed to achieve its 
goals for reducing the harms and risks associated with tobacco product 
use. Despite the common misperception that decades of program and 
policy efforts have solved this problem, the reality is that tobacco 
use continues to be the leading cause of preventable death and disease 
in the United States. The total economic burden of cigarette smoking is 
estimated to be nearly $300 billion in annual health care and 
productivity costs. FDA will work to finalize the proposed deeming rule 
in a timely manner; expand the tobacco regulatory science base; 
continue to improve product review processes to enable the Center to 
make timely decisions; expand the compliance program to conduct 
enforcement in additional States; and develop and implement additional 
public education campaigns.
    In addition to the activities described above, FDA plans to explore 
the potential for tobacco product standards and is investing in 
research to support potential product standards to reduce product 
addictiveness, toxicity, and/or appeal.
    Roughly one in five adults still smoke. Those numbers are even 
higher in States like Kentucky and West Virginia, where smoking rates 
greatly exceed the national average.\10\ FDA cares greatly about the 43 
million addicted smokers, and one of our core goals is to reduce the 
harmfulness of tobacco products. We will explore all available 
regulatory science to do that.
---------------------------------------------------------------------------
    \10\ See CDC, ``Behavioral Risk Factor Surveillance System,'' at 
http://apps.nccd.cdc.gov/brfss/
list.asp?cat=TU&yr=2012&qkey=8161&state=All.
---------------------------------------------------------------------------
    Perhaps the greatest opportunity FDA has to overcome this pressing 
public health problem is to dramatically decrease the access and appeal 
of tobacco products to youth. Ninety percent of smokers start smoking 
by age 18, and 99 percent start by age 26; and despite years of steady 
progress, declines in the use of tobacco by youth and young adults have 
slowed for cigarette smoking and stalled for smokeless tobacco use.\11\ 
FDA intends to use the many tools at its disposal to continue the 
decline in tobacco use and to reinvigorate public determination to 
arrest the epidemic by making the next generation tobacco-free. The 
Agency remains committed to making tobacco-related death and disease 
part of America's past, not its future.
---------------------------------------------------------------------------
    \11\ U.S. Surgeon General, ``Preventing Tobacco Use Among Youth and 
Young Adults: A Report of the Surgeon General'' (2012), available at 
http://www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-
use/exec-summary.pdf.
---------------------------------------------------------------------------
    Thank you for the opportunity to testify today about FDA's 
accomplishments and challenges in the 5 years since enactment of the 
Tobacco Control Act. I am happy to answer questions you may have.

    The Chairman. Thank you very much, Mr. Zeller.
    Now, we will open rounds of 5 minute questions.
    Dr. McAfee, I will start with you. We both already 
mentioned the hard-hitting and incredibly effective Tips from a 
Former Smoker campaign created using resources from the 
Affordable Care Act's Prevention and Public Health Fund; I 
mentioned that in my statement.
    The outcomes of this campaign, at least what I have seen, 
have been extraordinary. You mentioned more calls to the quit 
lines. I think you said 1.6 million calls. More quit attempts 
mean ultimately more long-term quitters.
    Can you, again, just elaborate on CDC's work on this 
campaign? How did they decide on messages? What evidence do you 
have that your message is effective? And then last, is there a 
difference between the CDC media campaign, Tips from a Former 
Smoker, and FDA's media campaign, the Real Cost?
    Dr. McAfee. Thank you very much, and please feel free to, 
if I do not remember each one of the ones that you asked about, 
to refresh my memory.
    As you noted, Chairman Harkin, the campaign has been 
remarkably successful. The 1.6 million figure was actually the 
number of people who made a quit attempt because of the 
campaign just in the first year of the campaign. We also saw 
concurrently, we are now in our third year now, and we have 
also seen doublings in calls to the national 1-800-QUIT-NOW 
telephone number. And as much as fivefold increases in visits 
to the website of the campaign. So we are very excited by this. 
We are particularly excited about the very specific information 
about quit attempts that we saw with the campaign.
    We also saw increases in nonsmokers, millions of whom said 
that they had actually talked to a loved one who smoked and 
encouraged them to get help quitting.
    I think one of the reasons, however, that we were not 
surprised by these results is that we put a lot of work in up 
front. First, reviewing all the information from other 
countries' and other States' experiences that had done 
campaigns.
    And then working with literally thousands of smokers asking 
them, ``What would be most helpful to you to make a quit 
attempt a successful quit attempt?'' And we designed the 
campaign through several cycles of trying out our ideas and 
then checking back with smokers to see what they said. And they 
were very firm that this was the type of campaign that they 
wanted.
    We have also seen, 80 to 90 percent of smokers say that 
they have seen the ads. So we are feeling very, very strong 
about the response that we have had. I would just also mention 
that Terrie Hall from North Carolina, who died in September at 
53, was our real poster child. Of the 30 people, Americans, 
that stepped up, very difficult step to show, to put a face on 
what the harms of smoking will cause.
    In terms of your question about FDA and CDC.
    The Chairman. Yes, the two different approaches.
    Dr. McAfee. Yes. We are really in different swim lanes 
because the CDC program is focusing on adult smokers and 
encouraging them to quit. That is its laser focus. And the 
FDA's campaign, which Mr. Zeller can talk more about, but we 
are actually quite excited about the work that they have been 
doing, is also laser focused on youth in initiation and trying 
to keep experimenters from consolidating. So we are doing very 
different things.
    And the other thing to keep in mind is both campaigns 
combined represent, in terms of the amount of promotional 
effort that we are able to make, represents about 5 days out of 
a year of what the tobacco companies are spending, $8.5 
billion.
    The Chairman. You are talking about both combined?
    Dr. McAfee. Yes, both ours combined, both the FDA and CDC's 
campaign. Ours is----
    The Chairman. About 5 days out of----
    Dr. McAfee. Three hundred and sixty-five.
    The Chairman. Three hundred and sixty-five that would be 
funded by the tobacco companies.
    Dr. McAfee. Right.
    The Chairman. Mr. Zeller, in my brief time, again, just 
elaborate a little bit on the Real Cost.
    Mr. Zeller. Sure. Unfortunately, too many kids experiment 
with cigarettes each day for the first time, over 3,000 and 
over 700----
    The Chairman. A day?
    Mr. Zeller. Each day and each day, over 700 kids make the 
progression from experimentation to becoming regular smokers.
    The good news is compared to 20 years ago, those numbers 
are down. The bad news is those numbers are still 
unconscionably high from a public health perspective.
    There are 25 million 12- to 17-year-olds in our entire 
country and from the research that we did and we spent 2 years 
doing research before we launched the Real Cost campaign in 
February.
    What we came to understand is that there is about 10 
million of those 25 million teens who are at-risk. We call them 
being, literally, one party away from taking that first puff or 
they have already started to smoke a few cigarettes, and they 
are on that trajectory to becoming regular smokers. And from 
our research, we developed insights into how to communicate to 
these kids in ways that will breakthrough.
    The initial launch of the campaign is focused on the health 
consequences of smoking and addiction, but we do not talk to 
them like an adult lecturing a child about, ``Do not smoke and 
here are the long term risks.''
    It turns out that if you talk to at-risk kids about 
premature skin wrinkling or gum disease and tooth loss. And 
if--instead of talking to them about nicotine and addiction--
you talk to them about loss of control if they become addicted 
to cigarettes, that enables them to hit the pause button; that 
enables them to rethink their relationship with the cigarette. 
We also made a major investment in evaluation, so we will see 
how we are doing over time.
    It starts with building awareness. That will lead to 
changes in attitudes and belief, and then ultimately changes in 
behavioral intent and behavior. And we have made the investment 
in the evaluation to follow 8,000 of our target over the next 
couple of years to see how we are doing.
    The Chairman. Very good. Thank you both very much.
    Senator Alexander.
    Senator Alexander. Mr. Zeller, on one point, I think you 
are correct that premium cigars should be treated differently. 
I support the option and the regulation that would exempt 
premium cigars from FDA regulation. I introduced legislation 
like that some time ago. I believe people ought--adults--ought 
to be able to make their own choices.
    And I had a couple of questions, how would this price of 
$10 at retail work? What if one retailer sold a cigar at $9.99? 
What would that do?
    Mr. Zeller. Let me just clarify one thing, Senator. We have 
proposed regulatory options on cigars.
    Senator Alexander. Yes.
    Mr. Zeller. And one of the options is to exempt premium 
cigars.
    Senator Alexander. Right.
    Mr. Zeller. The other is to include them, and we are in a 
rulemaking period now, and we need to wait for all the comments 
to come in, and we will then consider our regulatory options, 
in large part, informed by the information that comes in.
    Senator Alexander. But you cannot comment on how it would 
work?
    Mr. Zeller. No. I just want to say, I do not want to 
prejudge what the outcome of the rulemaking would be.
    Senator Alexander. No, I was trying to prejudge it a little 
bit.
    Mr. Zeller. Which are free to do and I am not.
    Senator Alexander. Right. I understand.
    Mr. Zeller. But to your question about the price point, in 
the option that we laid out where premium cigars would be 
exempted, there would have to be a definition of premium 
cigars.
    Senator Alexander. Right.
    Mr. Zeller. So that we would know what is in.
    Senator Alexander. And if the price point seems to be, that 
might not work very well.
    Mr. Zeller. We have asked for comment on every aspect of 
the definition including the price point. And if people have a 
better way of us doing the price point than what we propose, 
which is $10 per cigar, we welcome information on the record. 
Absolutely.
    Senator Alexander. Are you open to considering extending 
the comment period?
    Mr. Zeller. We have received multiple requests----
    Senator Alexander. Yes.
    Mr. Zeller. For extensions of the comment period, which we 
are reviewing, literally, as we speak.
    Senator Alexander. I would encourage you to do that. I 
think it is more important to get this right, as you know very 
well, because of your background. This is an extensive, complex 
area.
    Let me ask you a broader question. Where do you come down 
on this difference of opinion on e-cigarettes? David Abrams at 
the American Legacy Foundation, ``The single biggest 
opportunity that has come along in a century to make the 
cigarette obsolete.'' That is one point of view.
    Dr. Frieden, ``Many kids are starting out with e-cigarettes 
and then going on to smoke conventional cigarettes.''
    Do we know enough to know yet what the impact of e-
cigarettes is?
    Mr. Zeller. I need to answer as a regulator. We have 
proposed to extend our jurisdiction over electronic cigarettes 
that meet the statutory definition of a tobacco product.
    We are also funding, literally, dozens of studies to answer 
all the questions that we have about e-cigarettes and right 
now, we have far more questions than answers about the safety 
of the product, about what is in the product, about what is in 
the vapor. We have questions about who is using the products 
and how they are being used. It is a very complicated subject.
    Senator Alexander. So you do not come down on either side 
yet as to whether it is tool; more important as a tool to help 
those who already smoke cigarettes to stop smoking or more 
dangerous as a tool to encourage kids to start smoking?
    Mr. Zeller. I think the only appropriate position for FDA 
to take at this point is they have the potential to do good and 
they have the potential to do harm. And we need answers to 
questions, which we are funding through research.
    Senator Alexander. When will you have enough answers to be 
able to make the kind of decisions that you are expected to 
make here?
    Mr. Zeller. The first step in the process is having 
regulatory authority over them. We do not need the answers to 
those questions to complete the deeming rulemaking that we 
launched several weeks ago.
    But going forward, in terms of figuring out what regulatory 
policies and approaches should be applied to e-cigarettes, when 
they come within our regulatory reach, we need answers to those 
questions. Let me give you an example of one of the studies 
that we are funding.
    We are spending a lot of money on what is called a 
longitudinal study following the same people over time. It is 
called the Population Assessment of Tobacco and Health and it 
is following, literally, tens of thousands of adolescents and 
adults. And over time, studies like that will begin to give us 
information that answers some of the behavioral questions: who 
is using the products, how they are being used.
    We then need additional studies on the products themselves, 
product safety. There are a series of questions that have been 
raised about these liquid nicotine products and exposure to the 
nicotine in these liquid nicotine products.
    When we have answers to those kinds of questions, we can 
figure out how to use the many regulatory tools that Congress 
has given the agency to figure out an appropriate regulatory 
framework to regulate e-cigarettes. But it starts with having 
the authority to regulate them, which is what the deeming 
proposal is all about.
    Senator Alexander. My time is up. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Alexander.
    Senator Burr.
    Senator Burr. Thank you, Mr. Chairman.
    Director Zeller, do you believe that some tobacco products 
present greater risks to individuals than other products?
    Mr. Zeller. Yes.
    Senator Burr. OK. On the continuum of risk, do you believe 
that noncombustible tobacco products are more likely to reduce 
harm than a smoked form of tobacco for individuals who would 
otherwise be using a conventional cigarette?
    Mr. Zeller. The answer is that it depends upon who was 
using the product and how they are being used. You can take any 
non-combusting product, whether it is a smokeless tobacco 
product, an e-cigarette, and it really depends upon who is 
using them and how they are being used.
    If we look at a subset of smokers who are otherwise unable 
or unwilling to quit, they are going to continue to smoke that 
pack of cigarettes. Half of them will die prematurely later in 
life from that decision. If we could get all of those people to 
completely switch all of their cigarettes for one of these 
noncombustible products, that would be good for public health.
    But our job as the regulator is to figure out what is going 
on at the population level, and it includes the much larger 
group of smokers--not like the first group I defined--a much 
larger group of smokers who are concerned about their health, 
and who are interested in quitting. And what happens instead of 
those people completely substituting with a noncombustible 
product, they start using both. And then along the way, they 
wind up being less interested in quitting.
    Then we would say, that might not be good for public health 
and our job is to figure out what the net is of all of those 
possible behaviors, including any initiation, which would not 
be good for public health, and then try to make regulatory 
policy on top of that.
    Senator Burr. Mitch, for the adult that chose Nicorette 5 
years ago, and they chewed the gum, and then they went out back 
and they had a cigarette. And they could not smoke at work, so 
they chewed the gum, and they went out back, and had a 
cigarette.
    Does that mean that Nicorette is not a useful tool for that 
individual? It is only a useful tool if that individual uses it 
to quit?
    Mr. Zeller. Yes. I would absolutely concede that any of 
these products, at an individual level, can do good.
    What is challenging for all of us dealing with the law that 
you gave us the responsibility to implement and enforce is the 
decisions that we have to make are not going to be made about 
what might be good for the theoretical individual. We have to 
have regulatory science to support decisions that inform what 
is happening at a population level.
    So, we have to look at all possible behaviors.
    Senator Burr. Yes, but if your trend line is this way, then 
the public health effect is better. You have less people using 
combustible products. You have more of those individuals that 
have either quit or they have gone to a reduced harm product 
that is good for public health.
    And let me just say for the record, CVS eliminated their 
cigarettes. CVS still sells patches, Nicorette gum, probably 
all of the pharmaceutical products--Chantix and others--that 
aid in eliminating or reducing the rate of smoking. It is not 
like they threw out the whole category.
    So take the retailer that sacrificed some large amount of 
sales, they still believe that risk reduction is an important 
thing for them to endorse. Would you agree?
    Mr. Zeller. I would answer it in this way, Senator. The 
products that you are referring to have been approved by FDA as 
safe and effective medications, and they have been on the 
market for over 30 years. There is a robust evidence base to 
know that those products work to help smokers stop smoking.
    They are actually not approved for reduction. They are only 
approved for abrupt cessation, but there is a robust evidence 
base that shows that when marketed to help smokers quit, and 
when used properly, people can succeed.
    By contrast, to go to the questions from Senator Alexander 
about what do you know and what you do not know, when it comes 
especially to e-cigarettes, there is a lot more that we need to 
know about the impact on reduction and the impact on cessation.
    Senator Burr. I agree with you totally. But can you point 
to any new innovation where we know right at the beginning 
everything about it and that we could come to an assessment? 
Now, I am hopeful that through your studies, you find this 
product is safe. We do not want an unsafe product out there 
that contributes to a different problem.
    But if you find that it is safe, are we going to say the 
same thing about e-cigarettes 10 years from now? ``Jeez, the 
body of evidence says that this did a tremendous thing to 
moving people off of combustible tobacco products.'' Is that 
not a good thing?
    Mr. Zeller. If we are going to regulate them as tobacco 
products, which is what the Tobacco Center has proposed to do, 
we have to find the claims that the new products are 
appropriate for the protection of the public health. That is 
not the safety and efficacy standard.
    Congress gave us a very different standard to use when 
using the tobacco authorities. And under the standard 
appropriate for the protection of the public health, it is that 
mix of behaviors that I was describing that we have to assess 
and then make regulatory policy based upon. It is complicated.
    Senator Burr. I certainly look forward to the science that 
is produced on this. I just caution you and our friends at CDC 
that if we kill technology and innovation, which is, in 
essence, what some are attempting to do with electronic 
cigarettes right at the beginning. ``Just stop it. No more. It 
should not be sold.'' Then innovation is not going to play a 
role in reducing the amount of Americans that smoke. It is just 
not.
    I think it is safe to say that when I look at diabetes 
today, I look at other things that we would consider a public 
health epidemic, innovation is going to give us the ability to 
do it. I do not think it is going to be by going out and 
eliminating whether they can go to McDonald's and buy a double 
cheeseburger, and the CDC is not proposing that.
    It is going to be innovation. It is going to be driving 
technology. It is going to be coming out with products that 
allow us to turn around the problem that they have.
    I think that is what we are talking about here, and I look 
forward to the work you are doing.
    Mr. Zeller. Thank you.
    Senator Burr. Thanks.
    The Chairman. Thank you, Senator Burr. We will start 
another round.
    Last month's proposal to expand FDA's authority to include 
more tobacco products marked an essential step forward. And 
while I was heartened by the release of this long-awaited 
proposal, I was also disappointed that the rule did not address 
some of the most egregious practices of e-cigarette 
manufacturers.
    I mentioned in my opening statement that last month, along 
with 10 of my colleagues, I released the finding of our 
investigation into the marketing practices of nine commonly 
sold e-cigarette brands. To say those findings were 
disheartening, I think for me, is an understatement.
    Among those findings, I know you will not be surprised to 
learn, that six of the companies reported that they market e-
cigarettes in flavors that appeal to children and teens. 
Flavors like cherry crush, and chocolate treat, and peachy 
keen, and great mint.
    Now, I would just say that anyone who claims that these 
products are not explicitly targeting kids is clearly blowing 
smoke. These are targeted to kids, not adults. I have some 
examples here.
    Here is one I pointed out earlier: Rocket Pop. In fact, I 
have a chart. I had it blown up so you can take a look at it. 
Rocket Pop. It has got a popsicle on front. Now, can anybody 
say that they are trying to market that to adults?
    The other one I have here, this is for that refill with 
pink spots is Gummy Bear. I do not think I have Gummy Bear, but 
it is there. Here is another one Cotton Candy. Here is for the 
refillables Cherry Crush. The one I had earlier was Apple 
Cranberry. Again, these are targeted to kids.
    Congress knew what it was doing based upon, I think, 
evidence that we had that they were using flavors in cigarettes 
to go after kids. Forget about the prospect of whether e-
cigarettes are good or bad for adults, and can this be a step 
towards cessation. We do not know all that yet, and that has 
got to be learned. But is it safe to say that, when you are 
talking about kids that maybe there ought to be some 
restriction on these to kids?
    Dr. McAfee or Mr. Zeller, I guess, why did FDA feel it was 
important to hold off on restrictions on e-cigarette flavors 
and marketing when they are clearly targeting kids? Why did FDA 
hold off on that on the flavors?
    Mr. Zeller. I appreciate the question and the perspective, 
Mr. Chairman, and we share the concerns about any marketing of 
any of the currently unregulated products like e-cigarettes 
that would have an appeal to kids.
    We need to have jurisdiction over them to do something 
about it, but in the preamble to the proposed deeming rule that 
would give us the authority to take regulatory action, we 
summed up all the evidence that we had about flavors. Then we 
asked a series of, what I think, are very profound and far-
reaching questions that we want comment from, from all points 
of view on what role the presence of flavors like this should 
play as an influence on the regulatory policies that the Agency 
will be in a position to make when deeming is final, and we 
have the ability to use all manner of tools.
    Technically, to ban flavors requires the issuance of 
something called a product standard under a different section 
of the statute; it is a separate rulemaking. But we need 
answers to the questions that we posed about what role should 
the flavors play in how these products are regulated.
    The Chairman. Let me take a different line. Does FDA have 
authority to regulate drug delivery devices?
    Mr. Zeller. FDA first tried to regulate e-cigarettes as 
drug delivery devices and we were struck down by the courts in 
the absence of a cessation claim.
    The very first action that FDA tried to take on e-
cigarettes back in 2008 and 2009, before the Family Smoking 
Prevention and Tobacco Control Act passed, was an enforcement 
action to prohibit the importation of e-cigarettes as 
unapproved drugs and devices. We were sued by an importer and 
the importer won in court. And in 2011, we had to announce that 
we would create a regulatory framework for e-cigarettes under 
these tobacco authorities in the absence of a cessation claim.
    The Chairman. I guess I do not understand it. Is nicotine 
generally recognized as a drug?
    Mr. Zeller. Yes.
    The Chairman. It is an addictive drug, is it not?
    Mr. Zeller. It is.
    The Chairman. Does not an e-cigarette deliver a nicotine 
vapor to your body?
    Mr. Zeller. We can make the assumption that it does. We 
need more information about that, but we can make the 
assumption that it does.
    The Chairman. I mean, you puff on it and you get nicotine. 
I mean, what else would you do? You do not throw it on the 
ground. It is put in there and you inhale it.
    Mr. Zeller. I can only tell you what----
    The Chairman. It is a delivery device.
    Mr. Zeller. I can only tell you what the courts ruled. We 
tried to regulate e-cigarettes in exactly that way and we were 
overruled by the courts.
    In the absence of a claim, a medicinal claim, a therapeutic 
claim, the courts told FDA, the only way that we could regulate 
nicotine containing e-cigarettes was under the tobacco 
authorities, and that is because of a statutory definition of a 
tobacco product. It has two parts, something that is either 
made or derived from tobacco, and the nicotine in e-cigarettes 
is derived from tobacco.
    The Chairman. Right.
    Mr. Zeller. And the courts said in the absence of a drug 
claim, the only way we could regulate tobacco-derived nicotine 
in these products was under the tobacco authorities.
    The Chairman. The reason I had all these out here today, 
just to show the proliferation of the devices that are going to 
kids. Here is one that is 800 puffs, delivers something that is 
a can-apple.
    It is interesting, they say on the back in fine print, it 
says--it is called an ``electronic hookah'',

          ``Electric hookah'' is not approved by the United 
        States Food and Drug Administration. You must be of 
        legal tobacco purchase age according to State law to 
        purchase and use these products. This product has not 
        been tested or proven to aid in smoking cessation and 
        the product contains nicotine, which is an addictive 
        and toxic substance and must not be used by pregnant or 
        nursing women and nonsmokers. Keep this product out of 
        reach of children.''

    But we know kids are getting them. They are buying them. 
They are proliferating among high school students. They are 
buying these fancy things here. They have a plug that goes into 
the wall. It looks like a computer plug. It has the little 
computer device that goes in there and you stick your thing in 
there and recharge it. They are rechargeable. I do not know 
what that costs. I am told this costs about $10 bucks and you 
get 800 puffs on $10 bucks. But these are all geared toward 
young people and I had that out just for show.
    I heard you say we need a longer comment period. I do not 
know about that. Something has got to be done about this.
    Mr. Zeller. Let me tell you other parts of the proposal 
that would address the issue of youth use of these products. We 
proposed extending the minimum age of sale that currently 
exists for cigarettes, smokeless tobacco, and roll your own to 
e-cigarettes. And so retailers who sold e-cigarettes to minors, 
if this proposal goes final, would be violating our regulations 
and Federal law.
    We have proposed to ban the sale of any of these products 
in vending machines to the degree that there are vending 
machine sales, unless it is in an adult-only establishment.
    And on the issue of nicotine and addiction, we have 
proposed a warning label on all of these products that explains 
to the public that they contain nicotine and that nicotine is 
addictive. The comment period is the public's opportunity to 
make suggestions for additional things that we should be 
thinking of doing when our rule goes final.
    The Chairman. That is interesting. This has a lot of that 
stuff I told you in fine print on the back, but none of this 
stuff does; nothing on it.
    Mr. Zeller. And that is because they are not currently 
regulated by FDA.
    The Chairman. But it is concentrated nicotine, an addictive 
drug. I went way over my time. I will yield.
    Senator Alexander. Thank you, Mr. Chairman. I have no more 
questions, and I have an appointment that I have to go to. But 
I certainly have no objection to your continuing.
    The Chairman. Do you mind if I continue?
    Senator Alexander. No, sir.
    The Chairman. OK. Thank you very much. I want to change 
things here a little bit.
    Dr. McAfee, one of the most startling findings of the 
recent Surgeon General's report was that cigarettes are more 
dangerous today than they were when the first Surgeon General's 
report on smoking was issued 50 years ago. That was startling.
    The report indicates that cigarette smokers today have a 
higher risk for lung cancer than smokers in 1964 despite 
smoking fewer cigarettes. And that some, if not all, of this 
increased risk is likely caused by changes in the composition 
and design of cigarettes.
    Can you explain ways in which these cigarettes are more 
dangerous?
    Dr. McAfee. Sure. I would add that the other thing that I 
think we have found very disturbing around this, in some ways, 
unexpected finding, is that it does raise concerns about the 
ability of innovation to automatically lead to improvements in 
public health without regulation, because over the last 50 
years, until the FDA got authority 4\1/2\ years ago, cigarettes 
were entirely unregulated.
    The remarkable thing that happened was that the innovations 
that were put in place by--apparently some of the innovations 
that were put in place that affected composition and design of 
cigarettes did not lead to fewer deaths. Most of the 
innovations appear to have been more driven for other purposes.
    And that the things that we have found, and a lot of this 
is basically driven by epidemiologic findings, is that despite 
the fact that we are smoking fewer cigarettes, a person who 
smokes in the United States is more likely to develop lung 
cancer than they were 30 or 40 years ago.
    The Chairman. I am sorry. Excuse me.
    Dr. McAfee. Sure. No problem. There has been a specific 
change that we absolutely think is related to changes in the 
design composition and that is that the type of cancer that 
people develop, the common lung cancer----
    Way back when I was in medical school the most common form 
of lung cancer was squamous cell carcinoma, which was found 
close-in to the main branchings of the lung. And over the last 
few decades, this has shifted to another kind of cancer called 
adenocarcinoma, which is located in the periphery of the lungs.
    And we believe that this is due, essentially, to the fact 
that cigarettes, over the last 30 or 40 years, have become 
easier to inhale due to changes in their design and 
composition. That may range from everything from the light, 
low, mild changes in the nature of their composition to design 
changes like ventilation holes in filters.
    We are not entirely sure what it was, but the Surgeon 
General determined that this change was related to design and 
composition changes.
    The Chairman. So the technology was used to make a 
cigarette that was easier to inhale and contain substances that 
were more dangerous?
    Dr. McAfee. Whether they contain more substances that were 
actually more dangerous or they literally just allowed the 
smoker to inhale them more deeply than they previously were 
inclined to do because the cigarettes 50 years ago were 
harsher.
    What we are viewing, what we are seeing in terms of the 
numbers is very large increases in the risk of lung cancer; 
larger in women than in men, but very large in both. Cigarettes 
have actually become--at least the way that cigarettes are 
being used and smoked in the United States--have become more 
dangerous, not less dangerous.
    The Chairman. Mr. Zeller, again, 5 years since we passed 
the Family Smoking Prevention and Tobacco Control Act. Again, I 
think a truly historic achievement for public health, but I 
know there have been some delays in implementing some 
provisions. But I also recognize that thanks to the ability of 
the FDA to regulate these products, strides have been made 
during that time. The Center for Tobacco Products has been, 
obviously, key. That is who is charged with this 
responsibility.
    What have been some of the best accomplishments, perhaps 
some of the biggest challenges confronting the Center for 
Tobacco Products?
    Mr. Zeller. In terms of accomplishments, it was no small 
task to start with literally 2 full-time employees at the end 
of September 2009--two--accompanied by about 20 other people 
who were temporarily on loan to this brand new Center. So it 
was no small task to literally build the Center into what it is 
today.
    It is a full-fledged, regulatory entity doing compliance 
and enforcement, doing public education, doing major work in 
terms of reviewing product applications, and overseeing 
investments in research because as I said in my remarks, we are 
a regulatory Agency. We can only go as far as the regulatory 
science will take us.
    The regulatory science informs all the decisions that we 
make on product applications, all the policies, guidances, 
regulations that we could be issuing.
    On the accomplishment side of the ledger, having a fully 
functioning Center that is doing all of that and that has 
launched the Real Cost campaign, and that is doing a massive 
nationwide enforcement of youth access laws, making a major 
investment in research, and making progress on the product 
review submissions, would be the short list of accomplishments.
    There have been challenges for the very same reason that we 
literally started from nothing in 2009, there were challenges 
with the product submissions. No question.
    We can look at it from both sides. There were problems with 
the submissions. Many of them were incomplete, but we have to 
own part of that as the regulator as well. It took us time to 
get up to speed. It took us time to hire all of the scientists, 
and especially chemists and engineers. We really needed some 
specialized science capability to do the best possible product 
reviews. But we have made extraordinary progress in dealing 
with the queue of applications.
    On the challenges side, it is what comes with literally 
starting from nothing, inheriting, as I said, over 20 
mandatory, statutory deadlines, and then doing the best 
possible job that we could with the product submissions.
    I can report that we have made extraordinary progress on 
the product submissions. There is a concept known as 
substantial equivalence. It is one of the pathways to market 
that companies can submit applications for. And for the queue 
of substantial equivalence applications for products not 
currently on the market, review of new applications can begin 
as soon as an application is received, and we could not have 
said that a year ago, 2 years ago, 3 years ago. There is more 
progress to be made, but I think that we are meeting some of 
the greatest challenges that we have faced.
    The Chairman. I appreciate that.
    Then let us talk a little bit about warning labels. One of 
the key provisions was calling for larger warning labels on 
cigarettes and smokeless tobacco products. The smokeless 
warning labels requirement, I guess, has been implemented. 
However, the specific graphic warning labels proposed by FDA, 
again, were struck down by a court, the U.S. Court of Appeals 
here for the D.C. Circuit on First Amendment grounds.
    After that decision, I wrote to Commissioner Hamburg urging 
FDA to move quickly to develop and implement a strong, new 
graphic warning labeling rule. Indeed, FDA's general authority 
to require graphic warning labels has been affirmed in the 
courts.
    So given the evidence that graphic warning labels encourage 
smokers to quit and prevent nonsmokers from starting to smoke, 
I am hoping this is a high priority for FDA.
    Is FDA going to propose a new set of cigarette warning 
labels that are designed to withstand a constitutional 
challenge?
    Mr. Zeller. The priority, and we are doing this, is getting 
the research done to inform our ability to write a new rule to 
survive the likely litigation that would come. Getting that 
research done is one of our highest priorities.
    And armed with the results of that research, and with 
paying attention to the court decisions that have come in, in 
reviewing our first attempt, which was struck down, will 
require some careful deliberations. And we will do that, just 
as soon as we can complete the research. But getting the 
research done to support a new, graphic warning label rule is a 
very high priority of the Center and the Agency.
    The Chairman. I wish we had some labels like I see in our 
neighboring country to the north in Canada. They have some 
pretty graphic and strong labels; full package on it. I guess 
they do not have a Constitution like we have that they have to 
worry about, but they are great warning labels.
    Does FDA plan to exercise its authority in the area of 
standards to require changes in cigarettes and other tobacco 
products, for example, limiting tar and nicotine levels to make 
them less addictive, less harmful, or less attractive?
    Mr. Zeller. Are you referring to the authority in the law 
known as Product Standards?
    The Chairman. That is right, product standards.
    Ms. Zeller. Product standards is one of the most powerful 
tools that Congress gave the agency in the Tobacco Control Act. 
It is the power with one exception. It is the power to ban or 
restrict the allowable levels of ingredients, constituents in 
the finished product.
    we have been saying publicly that we are investing in 
research to explore potential product standards in three areas, 
and this is as far as I can go publicly. We are supporting 
research to explore potential product standards in the areas of 
addiction, toxicity, and appeal. And armed with that 
information, we will then explore our regulatory options.
    The Chairman. Good. Good, good.
    My last question, Dr. McAfee, I want talk about cessation 
services. Last year, I wrote to Secretary Sebelius because I 
had a concern that many private health insurance plans were not 
covering tobacco cessation services that are recommended by the 
U.S. Preventive Services Task Force and required under 
provisions that I authored in the Affordable Care Act.
    Earlier this month, the Department issued guidance 
clarifying for insurers exactly what evidenced-based tobacco 
cessation services must be covered without co-pays or 
deductibles as the law requires. We know that a combination of 
medication and counseling is most effective at helping tobacco 
users quit.
    Could you elaborate on the role of cessation services in 
stemming the tide of tobacco use, and whether you expect this 
guidance to provide improved access to such services?
    And second, do you have any suggestions on the best way to 
increase the number of doctors who talk to their patients about 
quitting and increase the number of smokers who are covered 
under the cessation services?
    Dr. McAfee. Thank you very much, Chairman Harkin, for that 
question.
    It is a question that is near and dear to me because one of 
the things that I did prior to coming to CDC was to work very, 
very hard as a primary care doctor within an integrated 
healthcare system basically to try to figure out how we could 
mobilize the engine of healthcare to help our patients quit 
smoking. And this has proven to be something that has lots of 
very strong potential, but also lots of very strong challenges.
    And the potential is basically 75 percent of smokers see a 
doctor in a year, and doctors have a lot of respect, and they 
also are embedded in a system that increasingly knows how to 
adopt changes and influence behaviors.
    But on the flip side, there have been prodigious obstacles 
to moving forward around this including the lack of training 
that medical professionals get to help their patients, and then 
particularly the lack of coverage and capacity to be able to 
provide services without it seeming like something that they 
are doing just as, on top of everything else, as opposed to 
something that is integral to care.
    The short story that I learned from my decade of trying to 
do this is, yes, it is possible. It takes a lot of work. You 
have to make services accessible so that clinicians can refer 
people out to get deeper levels of service.
    We spent a lot of time trying to buildup services like the 
1-800-QUIT-NOW as an option for clinicians. And, you have to 
figure out ways that they can have the time, get reimbursed for 
it, et cetera, and then it really does work. You can actually 
drop prevalence at a population level.
    There were very, very exciting experiences in Massachusetts 
in Medicaid, for instance, where they were able to drop 
prevalence in just a few short years by major promotion of a 
good benefit.
    The exciting elements associated with the Affordable Care 
Act are really that it has, as you noted, embedded in it 
requirements about barrier-free coverage. There has been a 
devil in the details challenge around how that actually gets 
translated into language and guidance to health plans so that 
they are able to do that, encouraged to do that, required to do 
that.
    I do think that the guidance that HHS released last month 
gets a bit more specific around this. This is what the health 
plans actually were saying that would be helpful to them and 
that many of them will move. It will continue to be a process, 
but one that has hope.
    We have tried to integrate this in with the Tips from 
Former Smokers campaign and have gotten a lot of interest from 
healthcare organizations.
    The Chairman. I just guess I wish we had more emphasis, and 
I am going to be looking at this too, that people who are 
covered under the Affordable Care Act that see their doctors on 
prevention and wellness with no co-pays, no deductibles, they 
go in and get their annual checkup. That doctors have in their 
list of things that they do is to advise them on smoking if 
they smoke; to advise them on not only why they should quit, 
but how they should quit, what is available to them to help 
them; and refer them to the quit lines; refer them to other 
activities that they might do to cease. And then, if they need 
medication, or the patches, or the gum and stuff like that, to 
be able to advise them and get them on those. That is what I am 
hoping we do.
    Dr. McAfee. I strongly agree. We have actually done a 
pretty good job over the last 15 years, say, of getting it so 
that people are asked about their tobacco use status and given 
brief advice by physicians.
    But we still have a ways to go to try to make it so that 
particularly if people are interested, which most people are, 
that they can gain access to help everything from counseling 
right on the spot, to referral for counseling, or phone 
counseling, or Web counseling, and to medications. Just having 
it more embedded the way we treat hypertension, cholesterol, or 
the management of diabetes; having it just be part of service.
    The Chairman. I want to just add one more thing before I 
close up here, and that is the issue was raised earlier about 
premium cigars.
    Then I read somewhere about more and more kids are smoking, 
not what you think of as a cigar, but they are like little 
cigarettes, but they are cigars. They are wrapped in cigar 
paper and they are little, small cigars. And those are also, I 
think, being flavored too, if I am not mistaken. Yes, some of 
those are being flavored. So there is a clear distinction 
between that and premium cigars.
    And you said to me as you are working on a rule and how you 
define what a premium cigar is. I do not know what it is 
either, but I just hope that there is a clear delineation 
between those. Between that, which kids do not use, and which 
they cannot afford to buy, and they are too expensive, and the 
ones which they do get hooked on, those little cigarillos or 
whatever they are called.
    Mr. Zeller. And to point on flavors, one of the elements of 
our proposed definition for a premium cigar is that the only 
flavor that is in there is tobacco.
    The Chairman. Are there premium cigars with flavoring?
    Staff. Yes.
    The Chairman. Oh, there are premium cigars with flavoring.
    Mr. Zeller. We are proposing that the only flavor that can 
be in a premium cigar is tobacco, but we will welcome to take 
comments on that.
    The Chairman. Yes, I do not know that either. It is like 
that old saying, ``I know it when I see it.''
    Mr. Zeller. Right.
    The Chairman. You know a premium cigar when you see it, but 
it is hard to define.
    Mr. Zeller. It is hard for a regulator to take that 
approach, though.
    The Chairman. That is very true. I appreciate that.
    Dr. McAfee. If I could just add a word or two around that, 
I would want to make sure that we emphasized the reality that 
all cigars are dangerous. They all contain most of the same 
toxic substances.
    We are burning tobacco and that creates thousands of 
chemicals including around 70 or 80 carcinogens, most of those 
worrisome chemicals that are present in cigarettes are also 
present in cigars, including premium cigars. There may be some 
differences in how they are smoked, et cetera, but it is still 
a dangerous product and the question of how it should be 
regulated is different from the question of whether it should 
be regulated; whether they should be regulated.
    The Chairman. Got that.
    The other thing I just want to say is I had all this stuff 
on the e-cigarettes and, again, I'll just re-emphasize that the 
way they are being marketed, they are being marketed to kids 
and it is nicotine. Nicotine is an addictive drug. So they are 
marketing an addictive drug to kids, which gets them addicted 
on nicotine.
    If they cannot get a hold of one of these or one of those 
when they are addicted, they will get a hold of cigarettes. It 
just almost seems to me like this is almost like a gateway kind 
of an approach to cigarette smoking. So I urge you, I hope 
that----
    Again, I do not know about extending the comment period, 
whether that needs to be done, but I sure hope we do not kick 
this can down the road any more. We have got to get a handle on 
this one and start nipping this in the bud, this e-cigarettes 
stuff.
    What you do on it with adults, I am a little less clear on 
that, but for kids, as far as I am concerned, pretty clear what 
is happening here and how they are marketing it.
    Now, do either one of you have anything else that we have 
not asked, or covered that you would like to make for the 
record, or have us think about? Is there anything we have not 
asked or covered that you would like to add?
    Dr. McAfee. I would actually just like to followup a little 
bit on one of the things that you had said about e-cigarettes.
    I think one of the things that has been misunderstood about 
our findings last September at CDC is that there is some 
implication that we have to prove that children who use e-
cigarettes will progress in some large, dramatic fashion 
automatically to cigarettes, and we think that is a red 
herring.
    It is essentially related to what you just said. It is an 
important thing to find out, and we look forward to the 
findings from the pad, but the bottom line is for at least 
three reasons, children should not be using e-cigarettes.
    And we, as a society, there is no necessity for us to 
require marketing, sales, and product characteristics that will 
result in millions of kids experimenting with e-cigarettes. As 
you noted, nicotine is addictive.
    The other thing that we are worried about is even if kids 
were not to progress to cigarettes, we do not need to have e-
cigarettes to get kids to not smoke. We have plenty of other 
societal tools that have proven to be very effective. We can 
get youth-use down into low single digits doing stuff.
    It is egregious to suggest that somehow we need to have 
kids do this in order for adults to quit. And we are very 
worried because the Surgeon General's, this most recent Surgeon 
General's report, one of its findings around nicotine was that 
it is strongly suggestive that it has deleterious effects on 
the development of the adolescent brain. And this is not 
something that we need to, or should, fool around with.
    And then the last issue is, in fact, we are not saying that 
it is a gateway, but we have ample reason to be anxious and 
concerned that one of the results of millions of kids, if it 
becomes millions, playing around with e-cigarettes, especially 
if the reason that they are fooling around with e-cigarettes is 
because they are watching advertising and promotions that are 
renormalizing tobacco use, by making it sexy, glamorous, and 
using celebrity endorsements on television.
    This is a huge experiment and it is not fair to our 
children to ask them to pay a potential price around that for a 
hypothetical benefit to adult smokers. And we know the tactics 
that are being used in the process of marketing e-cigarettes, 
half a dozen characteristics of them that are very similar to 
the same things that a 2012 Surgeon General's report found, 
that the tobacco companies that had engaged in that caused kids 
to--that increased the chances that they would smoke 
cigarettes.
    We do not think that we can afford to or that there is any 
necessity to literally spend 5 or 10 years proving that a 13-
year-old using e-cigarettes will lead to them using cigarettes. 
It is just purely a bad idea.
    The Chairman. You are saying, basically, they are dangerous 
in and of themselves, whether they are a gateway or not.
    Dr. McAfee. Correct. Even the idea of a gateway, it is 
somewhat of a misnomer because a gateway in substance abuse 
treatment is that if you use one drug, it will lead to another 
drug. Like if you use marijuana, maybe it will cause you to use 
cocaine or heroin.
    This is the same drug. It is nicotine. It is just a 
different delivery device and the drug itself is intrinsically 
of concern in adolescents.
    The Chairman. Got it.
    Mr. Zeller.
    Mr. Zeller. Just one closing thought. Absolutely understand 
the concerns that you and Dr. McAfee have expressed about e-
cigarettes and especially the degree to which, any degree to 
which they are enticing kids.
    I will just leave you with one big picture thought. Let us 
not lose sight of the fact that this remains the leading cause 
of preventable death and disease in our country principally 
because of combusting cigarettes. And the opportunity that 
Congress has given the Center for Tobacco Products with the 
authorities and the resources that you have given us is an 
opportunity to make a serious dent in that death and disease 
toll.
    Now that we can add the tools of product regulation and the 
impact that product regulation can have to national 
comprehensive tobacco control efforts, let us not lose our 
focus on what that primary cause is for those now more than 
480,000 avoidable deaths each year, and that is primarily 
burning combusting cigarettes. And we need to redouble our 
efforts to focus on that.
    Dr. McAfee. And if I might just re-emphasize the very 
important point that Mitch Zeller made along these same lines, 
the Surgeon General's report really emphasized this point that 
we can argue, and we will, about how e-cigarettes should be 
regulated, velvet glove-iron fist, how should this happen, and 
which particular policies.
    But the safest thing that we can do, the biggest way that 
we can minimize their dangers and potentially maximize any 
potential benefits they have is,

          ``The impact of the noncombustible aerosolized forms 
        of nicotine delivery on population health is much more 
        likely to be beneficial in an environment where the 
        appeal, accessibility, promotion, and use of cigarettes 
        and other combusted tobacco products are being rapidly 
        reduced, especially among youth and young adults.''

    The Chairman. In other words, if e-cigarettes were marketed 
like the patch.
    Dr. McAfee. Or if cigarettes, if the appeal, accessibility, 
and promotion, and use of cigarettes were thumb-screwed in a 
more dramatic fashion.
    The Chairman. I am concerned about this approach now 
because I know there is a debate on whether e-cigarettes is a 
smoking cessation device or does it lead to youth to become 
more addicted to nicotine. I have seen a lot of back and forth 
on this.
    If you control the marketing so that e-cigarettes are 
simply marketed or sold under the same provisions like a patch 
or Nicorette gum, that is one thing. But that is not what is 
happening.
    Mr. Zeller. All I can say, Mr. Chairman, is that we tried 
that and the courts said no. We tried that.
    The Chairman. You tried to regulate e-cigarettes?
    Mr. Zeller. We tried to regulate e-cigarettes as unapproved 
drugs and devices, and we took an enforcement action, and we 
were sued, and the courts sided with the company that sued us 
and said, ``In the absence of a claim, a cessation claim,'' 
which would automatically make it subject to regulation by FDA 
under the safety and efficacy standard as a drug and device.
    In the absence of a cessation claim, the courts ruled that 
the only way that we could regulate e-cigarettes is under the 
tobacco authorities because the nicotine in these products is 
derived from tobacco and that is the regulatory framework that 
we are trying to create starting with the deeming proposal.
    The Chairman. I will have to think more about that. Just a 
moment.
    [Pause.]
    Yes, I guess you are right. The courts made a bad decision.
    Anyway, thank you both for all your leadership in this 
area. We just cannot let up on our efforts, and we have to 
figure out some way of getting a handle on these e-cigarettes, 
especially as it pertains to kids.
    I do not know whether I am for extending the deadline on it 
or not. I do not know. All I know is that there should be some 
really compelling reasons to extend the deadline beyond 75 
days. I do not know if there are or not; I have not seen that 
yet. Thank you all very much.
    I ask that the record be open for 10 days for other 
comments and suggestions from other members.
    Thank you again, for being so patient, for being here, and 
thanks for your leadership.
    Mr. Zeller. Thank you, Mr. Chairman.
    The Chairman. Appreciate it.
    Dr. McAfee. Thank you.
    The Chairman. Thank you. Thank you both.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

             Department of Health & Human Services,
                              Food and Drug Administration,
                                   Silver Spring, MD 20993,
                                                    March 27, 2015.
Hon. Lamar Alexander, Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC. 20510-6300.
    Dear Mr. Chairman: The Food and Drug Administration (FDA or the 
Agency) provided testimony at the May 15, 2014, hearing before the 
Committee on Health, Education, Labor, and Pensions entitled, 
``Progress and Challenges: The State of Tobacco Use and Regulation in 
the U.S.'' This is a response for the record to questions posed by 
several Committee Members to Mitchell Zeller, Director of FDA's Center 
for Tobacco Products.
    Please let us know if you have further questions.
            Sincerely,
                                   Thomas A. Kraus,
                    Associate Commissioner for Legislation.
                                 ______
                                 
 Response of the Food and Drug Administration to Questions of Senator 
Harkin, Senator Alexander, Senator Mikulski, Senator Murkowski, Senator 
                Roberts, Senator Burr, and Senator Casey
                             senator harkin
Deeming Rule
    On April 24th, FDA issued a long awaited draft rule asserting 
agency jurisdiction over additional tobacco products, including e-
cigarettes. This proposed ``deeming'' rule marked an essential step in 
FDA's implementation of the Family Smoking Prevention and Tobacco 
Control Act. While I know there have been a number of requests to 
lengthen the comment period and otherwise delay the issuance of a final 
rule, it is imperative to the public health that these regulations be 
finalized and strengthened. This is all the more important because, as 
drafted, the full force of the proposal would not come to bear for a 
full 2 years after it is finalized.
    Question 1. What steps can FDA take now to ensure issuance of a 
final rule within a year?
    Answer 1. The comment period for the proposed tobacco deeming rule 
closed on August 8, 2014. We are carefully considering all of the 
comments. FDA is also considering any data, research, and other 
information submitted to the docket. Finalizing the deeming rule is a 
priority for the Agency and we share your sense of urgency on this 
important matter.
Mislabeled Pipe Tobacco
    We tax different tobacco products at dramatically different rates 
in this country--while roll-your-own tobacco is taxed at the same rate 
of cigarettes, pipe tobacco is taxed at a much lower rate. Over the 
course of the last 5 years, we've seen ill-intended manufacturers take 
advantage of this disparity by relabeling roll-your-own tobacco as pipe 
tobacco--while making it clear to consumers that the product is 
intended for rolling into cigarettes. As a result, in 2012 GAO reported 
that annual sales of so-called pipe tobacco increased 869 percent 
between 2008 and 2011. The same report concluded that between 2009 and 
2011, the loss of tax revenues due to pipe tobacco masquerading as 
roll-your-own tobacco totaled as much as $492 million. I've authored 
legislation that would eliminate this problem by equalizing tax rates 
across tobacco products but FDA also has important tools.

    Question 2. What has FDA done to address the issue of mislabeled 
roll your own tobacco? Does FDA plan to take enforcement action, in 
addition to the August 2013 warning letters that you sent, against 
these companies under the misbranding provision of the Family Smoking 
Prevention and Tobacco Control Act, through which Congress gave the 
agency authority to address this issue?
    Answer 2. To ensure regulated industry and tobacco products are in 
compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), 
FDA conducts compliance check inspections of retailers; compliance 
reviews relating to tobacco product document submissions; routine 
surveillance of promotional activities of manufacturers, distributors, 
importers, and retailers; and inspections of manufacturers, among other 
activities. During the course of these compliance activities, if a 
tobacco product is promoted and sold as a product that is currently 
under FDA's jurisdiction (i.e., cigarettes, cigarette tobacco, roll-
your-own (RYO) tobacco, smokeless tobacco), FDA would determine whether 
the product complies with the requirements of the FD&C Act and would 
take an enforcement action if violations are found. Examples of 
violations contained in Warning Letters issued by FDA include 
violations of the prohibition on characterizing flavors other than 
tobacco or menthol and violations of the restrictions on modified-risk 
claims and descriptors. Even tobacco products that are labeled as pipe 
tobacco may be found to be in violation of the law, if the product, due 
to its labeling or promotion, meets the definition of cigarette tobacco 
or RYO tobacco in the FD&C Act.
    Pipe tobacco that is not promoted or sold as cigarette tobacco or 
RYO tobacco is currently not subject to Chapter IX of the FD&C Act.\1\
---------------------------------------------------------------------------
    \1\ Currently only cigarettes, cigarette tobacco, RYO tobacco, and 
smokeless tobacco are subject to Chapter IX of the FD&C Act. On April 
25, 2014, the Agency published the proposed rule entitled ``Deeming 
Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as 
Amended by the Family Smoking Prevention and Tobacco Control Act; 
Regulations on the Sale and Distribution of Tobacco Products and 
Required Warning Statements for Tobacco Products.'' Products that would 
be ``deemed'' to be subject to FDA regulation are those that meet the 
statutory definition of a tobacco product, including currently 
unregulated marketed products, such as e-cigarettes, cigars, pipe 
tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables 
not already under FDA's authority.
---------------------------------------------------------------------------
    As of September 30, 2014, FDA has issued 20 Warning Letters to 
firms for the sale and promotion of adulterated cigarette tobacco and 
RYO tobacco products labeled as pipe tobacco. FDA continues to take 
enforcement actions, as appropriate, to ensure continued compliance 
with the FD&C Act and FDA's implementing regulations. FDA's Warning 
Letters are available to the public on our Web site, www.fda.gov, which 
serves to educate the public and encourage voluntary compliance by 
regulated industry.
Tobacco Track and Trace
    The Family Smoking Prevention and Tobacco Control Act authorized 
the Secretary to ``require codes on the labels of tobacco products or 
other designs or devices for the purpose of tracking or tracing the 
tobacco product through the distribution system.''
    Question 3. What barriers do you see to the implementation of a 
Federal track and trace program for tobacco?
    Answer 3. CTP is taking a number of actions on issues related to 
illicit trade and track and trace. For example, CTP has hosted a number 
of listening sessions on track and trace and illicit trade with members 
of the tobacco industry; has consulted with colleagues from the Alcohol 
and Tobacco Tax and Trade Bureau (TTB), the Bureau of Alcohol, Tobacco, 
Firearms, and Explosives (BATF), and other Federal agencies; has helped 
the Centers for Disease Control and Prevention (CDC) plan special 
meetings of experts on illicit trade and track and trace, ''which 
included representatives from CTP and other Federal agencies; and has 
sponsored a major report from the Institute of Medicine (IOM), released 
in February 2015, on the characteristics of illicit trade markets 
throughout the world and the various initiatives that have been 
implemented to prevent and reduce illicit trade (including tracking-
and-tracing systems).
    Multiple agencies within HHS, including FDA and CDC, are working to 
address the issue of illicit trade at both the State and national 
levels. All of these actions will help to inform CTP's efforts to 
implement a track-and-trace system and to otherwise address illicit 
trade issues. The IOM report will be especially valuable by increasing 
our understanding of existing illicit trade characteristics and 
mechanisms and the effectiveness of various responses, and how an 
illicit trade in non-FDA-compliant tobacco products might differ, how 
track-and-trace technologies might prevent that type of illicit trade, 
and what other approaches are likely to be most effective. The IOM 
committee was also asked to identify research gaps and potential 
approaches to closing those gaps. Other challenges to implementing a 
new Federal track-and-trace system include making sure that it will 
work well with existing Federal, State, and local tobacco tax 
collection systems and with related recordkeeping and track-and-trace 
systems and procedures.
                           senator alexander
    Question 1a. To not be regulated by FDA, a premium cigar must have 
a price above $10 at retail--how does that work?
    Answer 1a. In the proposed deeming rule, FDA included two options 
for the categories of cigars that would be covered by the rule. The 
first option proposes to regulate all products that meet the definition 
of a tobacco product (except accessories of newly deemed tobacco 
products), and would include all cigars. The second option proposes 
defining a category of premium cigars that would not be subject to 
FDA's regulatory authority. FDA has proposed several criteria for a 
cigar to be considered a premium cigar and, therefore, exempt from the 
deeming regulation, should FDA select option 2 for the final rule. One 
of these criteria is that the cigar has a retail price (after any 
discounts or coupons) of no less than $10. If a retailer sells a cigar 
for less than $10 per cigar, the cigar would not be considered a 
premium cigar and would not be exempt from the deeming regulation, even 
if FDA selects option 2 for the final rule. FDA encouraged comments on 
all aspects of the proposed rule, including the proposed criteria for a 
premium cigar.

    Question 1b. If one retailer were to have a sale and sell cigars 
for $9.99,would that cigar manufacturer be in violation of the law and 
all cigars of that type be misbranded?
    Answer 1b. Under option 2 of the proposed rule, one of the criteria 
that a cigar would have to meet to be considered a premium cigar would 
be to have a retail price (after any discounts or coupons) of no less 
than $10. If the retail price of the cigar were less than $10, it would 
not be considered a premium cigar under this proposal. Therefore, the 
cigar would not be exempt from the deeming regulation, even if FDA were 
to select option 2 for the final rule; the cigar would be subject to 
regulation and would have to comply with the FD&C Act's requirements. 
We note that FDA specifically requested comment on this $10 price 
point, and we will consider all comments when finalizing the rule.

    Question 2. To avoid FDA regulation, a premium cigar must not have 
``characterizing flavors''. What does that mean? There is flavor 
information on the box? If the tobacco is aged in a whiskey barrel, is 
that a characterizing flavor? If Cigar Aficionado were to describe 
flavors in a cigar, would that affect whether the product qualifies for 
the exemption?
    Answer 2. The proposed criteria for a premium cigar under option 2 
of the proposed rule is intended to capture those products that, 
because of how they are used, may have less of a public health impact 
than other types of cigars. The preamble does not otherwise further 
define ``characterizing flavor'' for the purposes of this criteria. 
However, FDA solicited comments on all aspects of the proposed rule, 
including the proposed criteria for a premium cigar.

    Question 3. More broadly, given the thorough documentation of harms 
from smoking tobacco and addictive nature of nicotine in the proposed 
regulation, do you believe FDA can exempt any product that is made from 
or derived from tobacco from regulation given the mission of protecting 
the public health?
    Answer 3. FDA recognizes that all cigars are harmful and 
potentially addictive. At the same time, it has been suggested that 
different kinds of cigars may have the potential for varying effects on 
public health, based on possible differences in their effects on youth 
initiation and frequency of use by youth and young adults, among other 
factors. We published the proposed rule with two options (option 1 to 
include all cigars; option 2 to exempt premium cigars) for public 
comment to solicit information regarding such issues as disease risk, 
nicotine addiction, how premium cigars are used, and an appropriate 
definition for premium cigars, if needed, in order to determine whether 
it is appropriate to exempt premium cigars from the regulation. FDA 
will examine all of the available information in order to make the 
best-informed decision.

    Question 4. I'm here to learn about these new products, like 
electronic cigarettes, as they compare to products we know more about 
such as cigars, smokeless tobacco, and cigarettes. Mr. Zeller, you have 
written about the relative risks of different tobacco products for 
individuals. Could you share your thoughts about the continuum of risk 
related to tobacco products, and list some products such as traditional 
cigarettes, premium cigars, smokeless tobacco, and electronic 
cigarettes from most risky to least risky based on the data we have 
now?
    Answer 4. While FDA acknowledges that there may be products that 
contain lower levels of toxicants than cigarettes, many provisions in 
the Tobacco Control Act require FDA to make decisions after considering 
the risks and benefits to the population as a whole, including both 
users and non-users of tobacco products. The risk continuum is a 
relevant consideration as regulatory policy is developed; however, the 
variety of potential patterns of use render this a challenging 
assessment.
    There are distinctions in the hazards presented by various 
nicotine-delivering products. The view has been advanced by some that 
certain new non-combustible tobacco products (such as e-cigarettes) may 
be less hazardous, at least in certain respects, than combustible 
products, given the carcinogens in smoke and the dangers of secondhand 
smoke. The Department of Health and Human Services (HHS), including 
FDA, CDC, and NIH, are conducting studies that will assess 
addictiveness and the relative toxicities of e-cigarettes and other 
tobacco products. To the extent that scientific evidence demonstrates 
that certain products are indeed less harmful than others at an 
individual level, they could help reduce the overall death and disease 
toll from tobacco product use at a population level in the United 
States.
    Cigarette smoking is the major contributor to the death and disease 
attributable to tobacco use. The challenge for FDA, in considering 
currently regulated products and any additional products that would be 
deemed to be subject to the FD&C Act, is that regulatory policy under 
the Tobacco Control Act (TCA) must account for the net public health 
impacts at the population level. This includes impacts on initiation 
and cessation, and an evaluation of product harm.
    Ongoing research, both within HHS and elsewhere seeks to 
characterize whether emerging technologies, such as the e-cigarette, 
may have the potential to reduce the death and disease toll from 
overall tobacco product use, depending on who uses the products and how 
they are used.
    Much remains to be learned about the risks of e-cigarettes to 
health, as well as their possible benefits. E-cigarettes could be a 
detriment to public health. e-cigarettes have the potential to re-
normalize smoking, encourage youth to initiate smoking, and/or prompt 
users to continue or to escalate to cigarette use--in effect, reversing 
the meaningful progress tobacco control initiatives have achieved to 
date. Other reported e-cigarette risks include dermal exposure to 
nicotine, childhood poisoning events, and physical harm from defective 
products (such as exploding batteries). On the other hand, e-cigarettes 
could benefit public health if they encourage people who would 
otherwise not quit smoking to stop smoking altogether, while not 
encouraging youth or others to start use of tobacco products or 
encouraging former users to relapse back to tobacco use.

    Question 5. There is currently a backlog of over 4,000 
applications, and by some estimates, the deeming of cigars as tobacco 
products alone could lead to 5,000-10,000 additional applications being 
filed 2 years after the proposed regulation is finalized. How could you 
possibly handle such a workload?
    Answer 5. FDA has made significant progress in reviewing 
substantial equivalence (SE) reports for currently regulated products, 
and the Agency believes that this momentum will continue. The Agency 
has increased staffing, taken steps to streamline the SE review 
process, and established performance goals that include timeframes for 
review of regular\2\ SE reports and review of exemption from SE 
requests. We have been able to develop these performance goals because 
of increased capacity, efficiency, and knowledge of the scientific 
evidence needed to adequately review SE reports. As of September 30, 
2014, 45 percent of regular SE reports had been resolved by a final 
decision,\3\ either because FDA issued an Order letter (92 
submissions), a Refuse-to-Accept letter (6 submissions), or because the 
submission was withdrawn (361 submissions). FDA has issued a Scientific 
Advice and Information Request Letter or a Preliminary Finding Letter 
for 81 percent of the regular SE reports that are pending.
---------------------------------------------------------------------------
    \2\ SE reports received before March 23, 2011 for new products 
introduced to market between February 15, 2007, and March 22, 2011 are 
considered ``provisional,'' and the products covered by those reports 
can remain on the market unless FDA finds that they are ``not 
substantially equivalent.' '' The other category is ``regular'' SE 
reports (reports received on or after March 23, 2011). Products covered 
by ``regular'' reports cannot be marketed unless FDA first issues an 
order finding the product substantially equivalent and in compliance 
with the FD&C Act.
    \3\ Final decisions include refuse-to-accept letters, withdrawals 
by an applicant, substantially equivalent (SE) orders, and not 
substantially equivalent (NSE) orders.
---------------------------------------------------------------------------
    FDA continues to move forward with additional improvements to the 
tobacco product review program. We continue to hire and train new 
staff, develop better IT systems for tracking submissions, and address 
the scientific policy issues that result from developing a new 
regulatory review program. We will continue to advance our efforts to 
review and act on provisional SE reports while also working to meet the 
performance goals for regular SE reports and modified-risk tobacco 
product applications. We are committed to completing the review of 
provisional tobacco products.\4\
---------------------------------------------------------------------------
    \4\ If FDA issues an order that a tobacco product subject to a 
provisional SE report is NSE, the product may not be legally marketed 
and may be subject to enforcement action, including seizure.
---------------------------------------------------------------------------
    We intend to continue to build on this experience as we review 
premarket applications for newly deemed products. CTP is committed to a 
consistent, transparent, and predictable review process and to 
completing reviews in a timely manner.

    Question 6. FDA has tiered the 4,000 applications at the agency, 
which all are for products still in the market, into four tiers based 
on the potential risk to public health. For the product applications in 
the high-risk tier, representing the greatest potential risk to public 
health, can you provide a timeline for when the agency will complete 
its review and remove any products from the market if necessary?
    Answer 6. In June 2012, CTP established four Public Health Impact 
Tiers for provisional SE submissions, and in August 2012, CTP began 
assigning submissions to these tiers to prioritize scientific reviews 
for those products with the greatest potential to raise different 
questions of public health. Tier 1 includes submissions for products 
that have high potential for raising different questions of public 
health; Tier 2 is for products with moderate potential; Tier 3 is for 
products with low potential, and Tier 4 is for products with the lowest 
potential. Because FDA has been prioritizing the review of those 
provisional SE reports that are most likely to raise different 
questions of public health, the initial reviews likely will be more 
complicated and will have less predictable review timeframes. On 
February 21, 2014, FDA issued the first ``not substantially 
equivalent'' (NSE) orders for four provisional tobacco products 
currently on the market. These products can no longer be legally 
marketed. We continue to review provisional products and will act on 
these as these reviews are completed.

    Question 7. You propose not allowing electronic cigarettes to make 
claims that e-cigarettes may pose less risk than traditional 
cigarettes. A popular electronic cigarette company has a marketing 
campaign using phrases such as ``Friends don't let friends smoke'' and 
``Cigarettes, you've met your match.''Would these campaigns be 
considered in violation of the proposed deeming regulation? Why would 
we not want companies to market their products to smokers as a less 
harmful alternative to smoking, rather than forcing marketing to appeal 
to the whole population?
    Answer 7. The proposed deeming rule would extend FDA's tobacco 
product authorities (which currently apply to cigarettes, cigarette 
tobacco, RYO tobacco, and smokeless tobacco) to all other tobacco 
products, as defined in section 201(rr) of the FD&C Act, except the 
accessories of such other tobacco products, and potentially premium 
cigars (if FDA were to choose option 2 of the proposal). Such 
authorities include section 911 of the FD&C Act, which prohibits the 
introduction into interstate commerce of a ``modified-risk tobacco 
product'' without an FDA order in effect. A tobacco product is 
considered a modified-risk tobacco product under section 911(b) of the 
FD&C Act if its label, labeling, or advertising explicitly or 
implicitly represents that: (1) the product presents a lower risk of 
tobacco-related disease or is less harmful than one or more other 
commercially marketed tobacco products; (2) the product or its smoke 
contains a reduced level of a substance or presents a reduced exposure 
to a substance; or (3) the product or its smoke does not contain, or is 
free of, a substance. In addition, a tobacco product is considered a 
modified-risk tobacco product if its manufacturer takes any action 
directed to consumers, other than by means of the product's label, 
labeling or advertising, respecting the product that would be 
reasonably expected to result in consumers believing that the product 
or its smoke may present a lower risk of disease or is less harmful 
than other commercially marketed tobacco products, or presents a 
reduced exposure to, or does not contain or is free of, a substance. 
Modified-risk tobacco products that are introduced into interstate 
commerce without an appropriate FDA order in effect are adulterated 
under the FD&C Act.
    The modified-risk tobacco product provisions aim to ensure that 
modified-risk claims, including those about the relative harms of 
different products, are substantiated and supported by scientific 
evidence. As Congress found, unsubstantiated modified-risk claims are 
detrimental to the public health. We have seen this historically, with 
``light,'' ``low,'' and ``mild'' descriptors leading consumers to 
incorrectly believe that those products were safer. If the deeming rule 
is finalized as proposed, e-cigarette manufacturers would be eligible 
to file applications seeking authorization from FDA to market their 
products as modified-risk products under section 911 of the FD&C Act. 
CTP's review of electronic cigarette modified-risk claims would help to 
ensure that those claims are substantiated and not misleading. CTP 
would be able to issue modified-risk tobacco product orders to 
applicants that meet the criteria described under section 911 (g) of 
the FD&C Act.

    Question 8. I am concerned about the newly deemed products where 
substantial equivalence is not available because you believe that you 
cannot set a new grandfather date. All products, such as e-cigarettes, 
cigars, and water pipes will have to submit premarket new tobacco 
applications. My understanding is that no one has submitted a complete 
premarket new tobacco application, and the guidance outlines 
requirements for randomized controlled trials to prove impact on the 
public health. What data and scientific evidence does the agency have 
that these newly deemed products should be held to a different standard 
than those that were able to use the substantial equivalence pathway?
    Answer 8. Section 910 of the FD&C Act provides three pathways that 
new tobacco products can use to obtain marketing authorization: SE; 
premarket tobacco application (PMTA); or exemption from SE. The 
criteria for whether a product can use a particular pathway, and the 
standard for FDA authorization under each pathway, are set forth in the 
statute. With regard to those newly deemed products for which a PMTA is 
submitted, as noted in the preamble to the tobacco deeming proposed 
rule, it is possible that an applicant may not need to conduct any new 
nonclinical or clinical studies to support a PMTA application. FDA 
requested comments on this issue, as well as comments regarding the 
proposed compliance policy for substantial equivalence applications and 
PMTAs and other legal interpretations of the substantial equivalence 
grandfather provision that FDA should consider. FDA also requested 
comments as to what other information the Agency should consider to 
help expedite review of PMTAs for tobacco products that contain fewer 
or substantially lower levels of toxicants.

    Question 9. Would FDA work with Congress and support a legislative 
solution to allow FDA to set different substantial equivalence dates 
for newly deemed products if necessary?
    Answer 9. FDA is aware of new tobacco product categories that 
entered the marketplace after the February 15, 2007, reference date in 
the Tobacco Control Act, and that the SE pathway may not be available 
to these newer products. FDA included a question in the proposed 
deeming rule, requesting comment as to whether there are other legal 
interpretations of the SE reference date provision that FDA should 
consider.
    To address concerns that such products would immediately be removed 
from the market, FDA is proposing a compliance period of 24 months, 
following the effective date of a final rule, for submitting a 
marketing application under this pathway. FDA is also proposing a 24-
month compliance period for the submission of PMTAs. In addition, we 
proposed to continue the compliance policy, pending review of marketing 
applications, if those applications are submitted within the 24 months 
after the final rule's effective date. As a practical effect of these 
compliance periods, we would expect that most firms would continue 
marketing their tobacco products, pending FDA's review of their 
marketing applications.

    Question 10. If an electronic cigarette manufacturer files 
premarket tobacco applications for its products, but then a change is 
made to those products, say a new supplier is used, would the 
manufacturer have to re-file all new premarket tobacco applications? 
What changes will result in new tobacco product applications being 
filed if the substantial equivalence pathway is not available?
    Answer 10. All tobacco products that meet the definition of a ``new 
tobacco product'' under section 910 of the FD&C Act are required to 
undergo premarket review by FDA. However, FDA expects that not all 
PMTAs will require the same type or amount of data and information in 
order to satisfy the requirements of section 910 of the FD&C Act. In 
the proposed deeming regulation, we explain that we are seeking 
information as to how the Agency might streamline review of new product 
applications. We state in the proposed rule that in certain instances, 
we expect that FDA will be able to determine that a product meets the 
requirements of the FD&C Act using information that might be less 
burdensome for a manufacturer to gather and submit to FDA. For example, 
in some cases it is possible that an applicant may not need to conduct 
any new nonclinical or clinical studies. We are seeking comment on the 
types of information that manufacturers of certain categories of 
products could use to support their PMTAs.

    Question 11. Can you provide the total number of inspections of 
retail facilities, including how many have occurred on Native American 
reservations and how many have occurred off-reservation?
    Answer 11. As of September 30, 2014, over 346,000 FDA tobacco 
retail inspections have been conducted across 54 States and 
territories.
    Working with federally recognized tribes requires careful 
consideration of the legal and political framework that the United 
States has established with respect to Indian tribal governments, 
including Executive orders. FDA also follows the HHS Tribal 
Consultation Policy, which directs FDA to consult with tribes before 
any action is taken that will significantly affect tribes.
    CTP discussed its compliance and enforcement activities during a 
Tribal Consultation webinar held on June 16, 2014. Also on June 16, 
2014, CTP issued a Request for Proposal (RFP) for contracts with 
federally Recognized Indian Tribe government agencies to assist with 
inspections of retail establishments on Tribal lands, similar to the 
tobacco retail inspection program utilizing contracts with U.S. States 
and territories. CTP provided a technical assistance webinar for tribes 
to learn about the requirements of this RFP and how to submit a 
proposal. As of September 30, 2014, FDA awarded two contracts to tribes 
to conduct tobacco retail inspections within their jurisdictions.

    Question 12. Does the Center for Tobacco Products plan on approving 
one or more training programs for retailers so that retailers have a 
model to use to best comply with the law?
    Answer 12. Retailers are encouraged to implement a training program 
for their staff and to tailor their program to meet the needs of their 
employees and business, taking into consideration the size of their 
business and the products that they sell.
    FDA understands that some retailers have established various 
tobacco retailer training programs. The Agency does not currently 
approve any retailer training programs, however, FDA intends to 
promulgate regulations establishing standards for approved retailer 
training programs.
    The TCA established two schedules for the maximum civil money 
penalties that can be assessed for violations of regulations issued 
under section 906(d) of the FD&C Act, including violations of FDA 
regulations at 21 CFR part 1140--one schedule for retailers that do not 
have an approved training program and another schedule, with lower 
penalties, for retailers with an approved training program. In 
determining the amount of penalty the Agency will seek, CTP will use 
the lower schedule for all retailers, whether or not the retailer has 
implemented a training program, until regulations are developed that 
establish standards for retailer training programs.
    FDA has also issued a guidance entitled ``Guidance for Industry: 
Tobacco Retailer Training Programs,'' which is available at 
www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/
ucm218898.htm. This guidance contains examples of recommended elements 
that may be helpful to retailers in designing and implementing a 
training program.
    Currently, FDA develops compliance training materials for 
retailers, posts important information to its Web site, issues guidance 
documents, meets with and presents before stakeholders, and has 
established a comprehensive program for training on, and assistance 
with, the requirements of the TCA. In fiscal year 2014, CTP delivered 
five compliance training webinars for retailers and small businesses 
covering topics relevant to tobacco product businesses. In addition, 
FDA is developing a new retailer education campaign and will continue 
to provide easy-to-understand, free educational materials online and by 
direct mail that help tobacco retailers comply with the law. The 
campaign currently provides materials in English and Spanish and plans 
to expand to include additional languages in fiscal year 2015.

    Question 13. How is FDA utilizing the ``Minor Modification'' 
exemption to allow companies to make certain changes without review? 
What types of changes qualify for these exemptions? Will you consider 
permitting changes that are beneficial to the public health, such as 
reducing harmful and potentially harmful constituents, through this 
fast track process?
    Answer 13. Under section 905(j)(3)(A) of the FD&C Act ``[t]he 
Secretary may exempt [a tobacco product] from the requirements of this 
subsection relating to the demonstration that a tobacco product is 
substantially equivalent . . .'' In general, among other requirements, 
a new tobacco product may be found exempt from the requirements of SE, 
if the tobacco product is modified by adding or deleting a tobacco 
additive, or by increasing or decreasing the quantity of an existing 
additive, where that change constitutes a minor modification to the 
product. This requirement is found in section 903(j)(3) of the FD&C Act 
and at 21 CFR 1107.1(a). The term ``additive'' is defined in section 
900(1) of the FD&C Act:

          ``The term `additive' means any substance the intended use of 
        which results or may reasonably be expected to result, directly 
        or indirectly, in its becoming a component or otherwise 
        affecting the characteristic of any tobacco product (including 
        any substances intended for use as a flavoring or coloring or 
        in producing, manufacturing, packing, processing, preparing, 
        treating, packaging, transporting, or holding), except that 
        such term does not include tobacco or a pesticide chemical 
        residue in or on raw tobacco or a pesticide chemical.''

    Additionally, FD&C Act section 905(j)(3)(A)(ii) states that one of 
the criteria for finding a product exempt requires that the Secretary 
determine that ``a report under this subsection is not necessary to 
ensure that permitting the tobacco product to be marketed would be 
appropriate for protection of the public health . . .,'' and FD&C Act 
section 905(j)(3)(A)(iii) adds the requirement that the Secretary 
determine that an exemption is otherwise appropriate.
    FDA has issued regulations implementing this SE Exemption Pathway. 
When a product change meets the requirements in the statute as 
described above, FDA can exempt the product from the requirement to 
demonstrate SE. In this event, the manufacturer can implement the 
change after notifying FDA in accordance with section 905(j)(1)(A)(ii) 
of the FD&C Act.

    Question 14. FDA allows sampling of smokeless tobacco in age-
restricted facilities. What scientific evidence exists to support 
restricting similar sampling of newly deemed products, such as e-
cigarettes and cigars?
    Answer 14. Congress, by law, provided an exception only for 
smokeless tobacco in age-restricted facilities from the general rule 
banning free sampling. FDA believes that the free sample prohibition, 
as applied to newly deemed products, would eliminate a pathway for 
youth to access tobacco products, reducing youth initiation and, 
therefore, short-term and long-term morbidity and mortality resulting 
from use of these products. The IOM has stated that free samples of 
cigarettes ``encourage experimentation by minors with a risk-free and 
cost-free way to satisfy their curiosity'' (Institute of Medicine of 
the National Academies, ``Growing Up Tobacco Free: Preventing Nicotine 
Addiction in Children and Youths,'' 1994). Although the IOM was 
speaking in the context of cigarettes, the same rationale would apply 
to the proposed deemed products. In addition, the U.S. Court of Appeals 
for the Sixth Circuit previously recognized that FDA has provided 
``extensive'' evidence that free tobacco samples constitute an ``easily 
accessible source'' for youth (Discount Tobacco City & Lottery, Inc. v. 
United States, 674 F.3d 509, 541 (6th Cir. 2012) (citing 61 FR 44396 at 
44460, August 28, 1996), cert. denied, 133 S. Ct. 1966 (2013)).
    FDA solicited comments on all aspects of the tobacco deeming 
proposed rule, including data and information on how this restriction 
would reduce youth use of proposed deemed products.
                            senator mikulski
    Question 1. It is currently estimated that one in five deaths can 
be directly attributed to tobacco use. Smoking reduces life expectancy 
by at least 10 years and the CDC has said that tobacco use results in 
at least $133 billion worth of direct medical care costs each year. We 
have tried imposing taxes and educating--even scaring--the public about 
the harmful effects of tobacco use--but more needs to be done. As 
Director of the FDA's Center for Tobacco Products, what do you propose 
could be done to reduce tobacco use and address the tragic loss of life 
and unnecessary costs to taxpayers that result? Are you ready to try 
new actions?
    Answer 1. Despite decades of efforts by HHS to reduce tobacco use, 
it continues to be the leading cause of preventable disease and death 
in the United States. Since enactment of the TCA, FDA has made 
significant progress toward establishing a comprehensive, effective, 
and sustainable framework for tobacco product regulation. These 
accomplishments include:

     Establishing an initial framework for industry 
registration, product listing, and submission of information on 
ingredients and harmful and potentially harmful constituents in tobacco 
products and tobacco smoke;
     Implementing and enforcing the statutory ban on cigarettes 
with certain characterizing flavors;
     Restricting access and marketing of cigarettes and 
smokeless tobacco products to youth;
     Implementing and enforcing the requirement that cigarette, 
RYO, and smokeless tobacco product manufacturers seek FDA authorization 
before marketing a new product or making modifications to existing 
products;
     Implementing and enforcing the FD&C Act's prohibition on 
the use of marketing terms for regulated tobacco products that imply 
reduced risk (such as ``light,'' ``mild,'' or ``low'') without FDA 
authorization;
     Developing a process for the review and evaluation of 
applications for new tobacco products and modified-risk claims;
     Utilizing a science-based approach that addresses the 
public health issues raised by menthol cigarettes. FDA has taken 
several actions related to menthol, including: issuing an advance 
notice of proposed rulemaking seeking comments that may inform 
regulatory actions by FDA; requesting comment on the Agency-prepared 
report entitled ``Preliminary Scientific Evaluation of the Possible 
Public Health Effects of Menthol Versus Non-Menthol Cigarettes''; 
investing in research, such as on the effects of menthol in cigarettes 
and launching a youth education campaign that includes menthol-specific 
messages.
     Collaborating with CDC and NIH in pursuing a research 
agenda to better understand regulated products and patterns of tobacco 
use to inform the development of regulatory policy. This includes 
establishment of the Tobacco Centers of Regulatory Science, a program 
designed to generate research to inform the regulation of tobacco 
products, and the Population Assessment of Tobacco and Health study, or 
PATH, which is a collaborative study with NIH designed to measure 
tobacco use behaviors and health to inform product regulation. PATH is 
a longitudinal study that intends to follow tens of thousands of people 
age 12 and older in the United States, who use and do not use tobacco 
products.
     Implementing a compliance and enforcement program to 
ensure industry compliance with regulatory requirements, such as 
minimum age of sale in retail establishments throughout the United 
States; and
     Collaborating with CDC in establishing public education 
campaigns about the dangers of regulated tobacco products.

    CTP is well-positioned to build on the work of its first 5 years. 
In June 2014, we announced five strategic priorities designed to use 
the authorities in the TCA to have the greatest impact on the public 
health. CTP's strategic priorities are:

     Product Standards--This tool enables FDA to require 
changes to product content or design, including banning or restricting 
the allowable levels of harmful compounds in finished tobacco products.
     Comprehensive FDA-wide Nicotine Policy--We will help 
establish an integrated, FDA policy on nicotine-containing products 
that is public health-based and recognizes that it is not the nicotine 
that kills half of all long-term smokers, but the carcinogens and other 
toxins in tobacco smoke.
     Pre-and Post-Market Controls: Regulations and Product 
Reviews--We are developing rules and guidance for industry and 
improving the timeliness of product reviews.
     Compliance and Enforcement--We will continue to build the 
compliance and enforcement program for tobacco products, including any 
products deemed under CTP's jurisdiction.
     Public Education--We will collaborate with CDC to maximize 
HHS' efforts to educate at-risk audiences on the dangers of tobacco 
use.

    FDA shares your sense of urgency, and we are committed to taking 
bold and sustained action to reduce the death and disease caused by 
tobacco use.

    Question 2. The 50th anniversary Surgeon General's report found,

          ``The evidence is sufficient to conclude that the increased 
        risk of adenocarcinoma of the lung in smokers results from 
        changes in the design and composition of cigarettes since the 
        1950's.''

    FDA has had the authority since 2009 to require changes in all 
cigarettes to make them less deadly, make them less appealing to kids 
or to reduce the addictive levels in the product. What steps will FDA 
take to move forward with using this very important tool from the 
Tobacco Control Act to reduce the death and disease caused by 
cigarettes?
    Answer 2. Section 907 of the FD&C Act gives FDA the authority to 
issue tobacco product standards that are appropriate for the protection 
of the public health, through rulemaking. For example, FDA could issue 
a product standard that would reduce the harm, addictiveness, and/or 
appeal of tobacco products, if appropriate for the protection of the 
public health.
    CTP, with input from HHS, is exploring the potential for product 
standards in all three areas: addiction, toxicity, and appeal. CTP is 
also funding research to address issues related to potential product 
standards.
                           senator murkowski
    I am concerned about recent data published by CDC showing a huge 
spike in nicotine poisonings among small children related to e-
cigarettes. I understand from the American Academy of Pediatrics that 
even a teaspoon of the liquid nicotine used to refill an e-cigarette 
could be fatal if ingested by a small child. Yet, liquid nicotine is 
not required to be sold in childproof packages, and the proposed rule 
you put out last month makes no recommendations on child-proofing.
    Question 1. Is the FDA doing anything to prevent child nicotine 
poisoning? Is there a reason why the FDA did not include these 
precautions in its proposed rule?
    Answer 1. In the preamble to the proposed deeming rule, FDA 
included discussion regarding the recent increased incidence of child 
nicotine poisoning and the Agency's concerns regarding this issue. FDA 
considers the deeming rule to be a foundational regulation, which, when 
finalized, would allow the Agency to take further actions regarding 
critical issues, such as protecting children from liquid nicotine, 
related to the proposed deemed products. For example, FDA would have 
authority to issue tobacco product manufacturing practice regulations 
under section 906(e) of the FD&C Act. Such regulations could include 
requirements regarding the packaging and storage of a tobacco product 
such as liquid nicotine. In addition, under section 907 of the FD&C 
Act, FDA would have authority to issue a product standard with 
provisions related to components of tobacco products, such as liquid 
nicotine refill cartridges. Sections 906(d) and 907(a)(4)(B)(v) also 
afford FDA the authority to issue regulations restricting the sale and 
distribution of a tobacco product, if FDA determines that such a 
regulation would be appropriate for the protection of the public 
health.

    FDA Commissioner Margaret Hamburg wrote in a New York Times op-ed 
on May 12, 2014, the following,

          ``Much remains to be learned about the risks of e-cigarettes 
        to health, as well as their possible benefits, particularly for 
        those smokers who have not been able to quit using deadly 
        conventional cigarettes.''

    Question 2. Mr. Zeller, can you share your views on the various 
levels of perceived risk and potential benefit related to various 
tobacco products currently on the market?
    Answer 2. While FDA acknowledges that there may be products that 
contain lower levels of certain toxic chemicals than cigarettes, many 
provisions of the TCA require FDA to make decisions after considering 
the risks and benefits to the population as a whole, including both 
users and non-users. The risk continuum is a relevant consideration as 
we make regulatory policy. But the potential patterns of use make this 
a challenging assessment.
    There are distinctions in the hazards presented by various 
nicotine-delivering products. The view has been advanced by some that 
certain new non-combustible tobacco products (such as e-cigarettes) may 
be less hazardous, at least in certain respects, than combustible 
products, given the carcinogens in smoke and the dangers of secondhand 
smoke. HHS including FDA, CDC, and NIH, are conducting studies that 
will assess the addictiveness and the relative toxicities of e-
cigarettes and other tobacco products. To the extent that scientific 
evidence demonstrates that certain products are indeed less harmful 
than others at an individual level, they could help to reduce the 
overall death and disease toll from tobacco product use at a population 
level in the United States.
    Cigarette smoking is the major contributor to the death and disease 
attributable to tobacco use. The challenge for FDA, in considering 
currently regulated products and any additional products that would be 
deemed to be subject to the FD&C Act, is that regulatory policy under 
the TCA must account for the net public health impacts at the 
population level. This includes impacts on initiation and cessation, 
and an evaluation of product harm.
    Ongoing research, both within HHS and elsewhere, seeks to 
characterize whether emerging technologies such as the e-cigarette may 
have the potential to reduce the death and disease toll from overall 
tobacco product use, depending on who uses the products and how they 
are used. If such products result in minimal initiation by children and 
adolescents while significant numbers of smokers quit, then there is a 
potential for the net impact at the population level to be positive. 
If, on the other hand, there is significant initiation by young people, 
minimal quitting, or significant dual use of combustible and non-
combustible products, then the public health impact could be negative.
                            senator roberts
    Question 1. The Center for Tobacco Products is imposing fines for 
retailers that fail inspections, but they are imposing multiple fines 
and alleging multiple violations for a single inspection. This seems to 
be contrary to the provisions of the law establishing the Center for 
Tobacco Products which specifically states that retailers must be 
informed of all previous violations before being charged with an 
additional violation. In addition, it doesn't make sense with the 
penalty scale in the law that gradually increases fine amounts per 
violation. CTP's policy of counting one failed inspection as multiple 
violations could lead to a retailer losing his or her business or being 
hit with an unaffordable fine due to the actions of one bad employee 
without giving the retailer an opportunity to fix the problem. Can you 
explain how imposing multiple fines for a single inspection is 
consistent with the law?
    Answer 1. FDA charges a person with a violation at a particular 
retail outlet only after providing notice to the retailer of all 
previous violations identified by FDA at that outlet, as required under 
section 103(q)(l)(D) of the TCA. Further, TCA section 103(q)(l)(E) 
states that the maximum civil money penalties (CMPs) for multiple 
violations shall increase from one violation to the next violation, 
pursuant to the penalty schedule provided in the law.
    As noted in the June 2014 revised Guidance for Industry entitled 
``Civil Money Penalties for Tobacco Retailers: Responses to Frequently 
Asked Questions,'' the first time FDA identifies violation(s) at a 
retail outlet, its policy is to send a Warning Letter. CTP counts only 
one violation from the first inspection that finds one or more 
violations at an outlet, regardless of the number of violations that 
were noted and included in a Warning Letter. For any subsequent 
inspections, CTP may count any or all violations, and its general 
policy is to count each of them individually.
    If the respondent does not agree with the allegations in a CMP 
notice, wants to contest the amount of the CMP that FDA is seeking, or 
has other concerns related to the case, the party may file an answer. 
At that time, the respondent may request settlement discussions with 
FDA. Settlement discussions are often an efficient method of resolving 
a contested case. The respondent may present evidence and arguments as 
to why the party should not be liable for a CMP, or mitigating factors 
that should reduce the amount of the CMP. If the respondent and FDA do 
not agree on a settlement, the respondent may still have a hearing. If 
the respondent is not satisfied with the decision at a hearing, the 
respondent has a right to appeal the initial decision to the 
Departmental Appeals Board (DAB) by filing a notice of appeal with the 
DAB and the FDA Division of Dockets Management within 30 days of the 
relevant decision.
    In an effort to provide information to retailers and other 
interested stakeholders regarding the issuance of CMPs for violations 
of the FD&C Act requirements relating to tobacco products in retail 
outlets, FDA has issued two guidance documents (``Civil Money Penalties 
for Tobacco Retailers: Responses to Frequently Asked Questions'' and 
``Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco 
Retailers'') and has provided at least three compliance training 
webinars that covered the topic of CMPs.

    Question 2. The Family Smoking Prevention legislation was set up to 
create incentives for voluntary compliance by retailers by, for 
example, providing for a smaller set of penalties for retailers that 
have compliance programs that include using an approved training 
program. However, it is my understanding that CTP has not yet approved 
a single training program. I'm hearing from retailers that without that 
approval it is hard for them to justify the investment in training that 
they would like to make. Can you tell me when CTP will approve one or 
more training programs so that retailers know which ones they should 
use to best comply with the law?
    Answer 2. Retailers are encouraged to implement a training program 
for their staffs and to tailor their programs to meet the needs of 
their employees and businesses, taking into consideration the size of 
their businesses and the products they sell.
    FDA understands that some retailers have established various 
tobacco retailer training programs. FDA does not currently approve any 
retailer training program. FDA intends to promulgate regulations 
establishing standards for approved retailer training programs. The TCA 
also establishes two schedules for the maximum civil money penalties 
that can be assessed for violations of regulations issued under section 
906(d) of the FD&C Act, including violations of FDA regulations at 21 
CFR part 1140--one schedule for retailers that do not have an approved 
training program, and another with lower penalties for retailers with 
an approved training program. In determining the amount of the penalty 
the Agency will seek, CTP will use the lower schedule for all 
retailers, whether or not the retailer has implemented a training 
program, until regulations are developed that establish standards for 
retailer training programs. FDA has also issued a guidance entitled 
``Guidance for Industry: Tobacco Retailer Training Programs,'' which is 
available at www.fda.gov/TobaccoProducts/GuidanceCompliance Regulatory 
information/ucm218898.htm. This guidance contains examples of 
recommended elements that may be helpful to retailers when designing 
and implementing a training program.
    Currently, FDA develops compliance training materials for 
retailers, posts important information to its Web site, issues guidance 
documents, meets with and presents before stakeholders, and has 
established a comprehensive program for training on, and assistance 
with, the requirements of the Act. In fiscal year 2014, CTP delivered 
five compliance training webinars for retailers and small businesses 
covering topics relevant to tobacco product businesses. In addition, 
FDA is developing a new retailer education campaign and will continue 
to provide easy-to-understand, free educational materials online and by 
direct mail that help tobacco retailers comply with the law. The 
campaign currently provides materials in English and Spanish and plans 
to expand to include additional languages in fiscal year 2015.
                              senator burr
    Question 1. Do you believe that public health messaging with 
respect to tobacco products should be based on science and reflect the 
risk continuum of tobacco products?
    Answer 1. Yes, to ensure that public health messaging is effective, 
it should be grounded in solid science. To that end, FDA continues to 
collaborate with CDC and NIH, and invests in research in the 
development and evaluation of its public education efforts. At the same 
time, scientific consensus is not required prior to disseminating 
public health information.
    FDA also recognizes that there is a continuum of tobacco products 
with potential differences in risk, and the Agency will rely on sound 
science to demonstrate the public health impact of new FDA-regulated 
tobacco products. Many provisions of the TCA require FDA to make 
decisions after considering the risks and benefits to the population as 
a whole, including both users and non-users. A risk continuum is a 
relevant consideration as we make regulatory policy. But the potential 
patterns of use make this a challenging assessment. For example, in 
addition to understanding the adverse health impact of a particular 
product or regulatory action on tobacco product users, the Agency's 
actions include consideration of the impact on non-users (including 
youth) initiating tobacco use, the potential for delayed cessation, and 
the potential for former smokers to resume tobacco use.

    Question 2. What are the potential health benefits for individuals 
moving from smoking conventional cigarettes to forms of non-combustible 
tobacco products, including those with the goal of cessation as well as 
those who would otherwise be using a combustible tobacco product?
    Answer 2. FDA acknowledges that there may be products that contain 
lower levels of toxicants than cigarettes. HHS, including CDC, FDA, and 
NIH, are conducting studies that will assess the addictiveness and the 
relative toxicities of e-cigarettes and other tobacco products. 
However, under the TCA, FDA must make determinations about whether a 
particular regulatory action or the marketing of a particular product 
is appropriate for the protection of the public health based on a 
population health standard. This means that FDA must consider the risks 
and benefits to both users and non-users.
    Thus, in addition to understanding the impact for smokers who 
completely switch to a non-combustible tobacco product, the Agency 
needs to understand the impact on youth and others initiating tobacco 
use, smokers continuing to smoke while using the non-combustible 
product, the potential for delayed cessation of smoking, and the 
potential for former smokers to resume tobacco use. Products marketed 
for therapeutic purposes, such as FDA-approved smoking cessation 
products, would continue to be regulated under the safety and efficacy 
standard that currently exists for drugs and devices. They would not be 
regulated as tobacco products.

    Question 3. Will FDA take into consideration the scientific 
evidence comparing the health impact of vaping compared to combustible 
tobacco cigarettes? Please describe any scientific theory or current 
evidence that e-cigarettes are as hazardous as, or more hazardous than, 
combustible tobacco cigarettes.
    Answer 3. The tobacco marketplace is changing rapidly, with new 
types and brands of tobacco products increasing at a faster pace than 
ever before. The resulting prospect of consumers exploring and adopting 
use of new products is prompting tobacco control experts, scientists, 
and regulators to consider how to best evaluate, monitor, regulate, and 
communicate to the public about these products in order to protect the 
public health.
    E-cigarettes have become a significant source of nicotine in this 
new tobacco use environment. Awareness of e-cigarettes among U.S. 
adults doubled between 2009 and 2011. Adolescent use increased between 
2011 and 2014. According to the University of Michigan's Monitoring the 
Future study, in 2014, 9 percent of 8th graders reported using an e-
cigarette in the past 30 days, 16 percent of 10th graders, and 17 
percent of 12th graders.
    Much remains to be learned about the risks of e-cigarettes to 
health, as well as their possible benefits. E-cigarettes could be a 
detriment to public health. E-cigarettes have the potential to re-
normalize smoking, encourage youth to initiate smoking, and/or prompt 
users to continue or to escalate to cigarette use--in effect, reversing 
the meaningful progress tobacco control initiatives have achieved to 
date. Other reported e-cigarette risks include dermal exposure to 
nicotine, childhood poisoning events, and physical harm from defective 
products (such as exploding batteries). On the other hand, e-cigarettes 
could benefit public health if they encourage people who would 
otherwise not quit smoking to stop smoking altogether, while not 
encouraging youth or others to start use of tobacco products or 
encouraging former users to relapse back to tobacco use. Anecdotes 
illustrating both harms and benefits abound, but it is definitive 
scientific evidence that should drive the actions taken with respect to 
e-cigarettes.
    CTP has identified e-cigarettes as an immediate research priority 
area, and since 2012 has funded 50 research projects to better 
understand e-cigarette initiation, use, perceptions, dependence, and 
toxicity. Research to address e-cigarette knowledge gaps is being 
funded by grants administered through NIH and through internal FDA 
research. This ongoing and funded research is likely to provide 
characterization of some e-cigarette devices, e-liquids, and aerosols, 
and a better understanding of e-cigarette users, reasons for use, abuse 
liability, user perceptions, health effects, and topography. CTP 
comprehensively assesses e-cigarette use among U.S. youth and adults 
via the national tobacco surveillance systems in collaboration with the 
CDC (National Youth Tobacco Survey (NYTS) and National Adult Tobacco 
Survey (NATS)). CTP has also partnered with CDC's Pregnancy Risk Factor 
Surveillance System (PRAMS) to track the prevalence of e-cigarette use 
before, during and shortly after pregnancy, among women who have 
recently given birth. An analysis of the totality of the data will be 
needed to assess the impact of e-cigarettes on the public health.

    Question 4. Is there a potential public health benefit at the 
individual tobacco user level, as well as for the millions of 
individuals, who may be seeking to transition from tobacco products 
that present the greatest level of harm to products with a reduced or 
lesser level of harm?
    Answer 4. FDA recognizes that there is a continuum of tobacco 
products with potentially different toxicity profiles, and will rely on 
sound science to demonstrate the public health impact of new FDA-
regulated tobacco products. HHS, including CDC, FDA and NIH, are 
conducting studies that will assess the addictiveness and the relative 
toxicities of e-cigarettes and other tobacco products. Many provisions 
of the TCA require FDA to make decisions about what is appropriate for 
the protection of the public health after considering the risks and 
benefits to the population as a whole, including both users and non-
users. A risk continuum is a relevant consideration as we make 
regulatory policy. But the potential patterns of use make this a 
challenging assessment. For example, in addition to understanding the 
adverse health impact of a particular product on tobacco product users, 
the Agency's actions include consideration of the likely impact on 
youth or others initiating tobacco use, smokers continuing to smoke 
while using the product, the potential for delayed cessation of 
smoking, and the potential for former smokers to resume tobacco use.
    Much remains to be learned about the risks of e-cigarettes to 
health, as well as their possible benefits. E-cigarettes could be a 
detriment to public health. E-cigarettes have the potential to re-
normalize smoking, encourage youth to initiate smoking, and/or prompt 
users to continue or to escalate to cigarette use--in effect, reversing 
the meaningful progress tobacco control initiatives have achieved to 
date. Other reported e-cigarette risks include dermal exposure to 
nicotine, childhood poisoning events, and physical harm from defective 
products (such as exploding batteries). On the other hand, e-cigarettes 
could benefit public health if they encourage people who would 
otherwise not quit smoking to stop smoking altogether, while not 
encouraging youth or others to start use of tobacco products or 
encouraging former users to relapse back to tobacco use.

    Question 5. Is FDA committed to ensuring that the Agency's 
regulation of tobacco products will ensure that consumers have timely 
access to innovative products that present less harm to them than 
combustible tobacco cigarettes?
    Answer 5. FDA's proposed rule to extend its tobacco product 
authorities to additional products that meet the statutory definition 
of ``tobacco product'' demonstrates the Agency's sensitivity to the 
importance of innovation. FDA has proposed an extended compliance 
period for manufacturers of newly deemed products to submit their 
marketing applications. In addition, for products with applications 
submitted in that compliance period, FDA has indicated the Agency 's 
intent to continue the compliance period and not initiate enforcement 
action against products on the market for failing to have marketing 
authorization, pending FDA's review of the application.
    FDA has also specifically solicited suggestions on other actions/
approaches that the Agency could take to address this issue. The 
proposed deeming rule also acknowledges that there exists a continuum 
of nicotine-delivering products that may pose different levels of risk 
to the individual. We pose a series of questions in the rule, and 
sought comment on how this continuum should impact regulatory policy 
going forward, once the final rule is in effect.

    Question 6. FDA received seven modified-risk tobacco product 
pathway applications, but it is my understanding that FDA refused to 
accept six of these applications. Please provide FDA's reasoning for 
refusing to accept each of these six applications. How is FDA ensuring 
that applicants have clear guidance with respect to the requirements 
that need to be met in order for FDA to accept these applications for 
review?
    Answer 6. When FDA receives a modified-risk tobacco product (MRTP) 
application, it will first determine whether the application can be 
accepted and filed for substantive review. For example, if the 
application is for a product that is not a ``tobacco product,''or is 
for a tobacco product that is not currently regulated by FDA, or FDA is 
unable to review and process the application, the Agency may refuse to 
accept it. If the application is accepted, FDA will conduct a filing 
review to determine whether the application is complete, i.e., whether 
it contains all the items required under Section 911(d) of the FD&C 
Act. If the application is incomplete, FDA may refuse to file it. If 
the application is complete, FDA will file the application and begin a 
substantive review.
    As of September 30, 2014, FDA has received multiple MRTP 
applications. Ten of these applications have been filed by FDA and are 
currently undergoing scientific review. FDA issued refuse-to-accept 
letters for two applications and refuse-to-file letters for four 
applications, because they failed to include information required under 
the TCA and/or were about products that CTP does not currently 
regulate. One application was withdrawn by the applicant.
    A draft guidance was released for public comment in March 2012, 
containing information about submitting applications for MRTPs. The 
draft guidance addresses topics such as how to organize and submit an 
application, what scientific studies and analyses could be submitted, 
and what information could be collected through post-market 
surveillance and studies.\5\ FDA has also been meeting with individual 
manufacturers to discuss studies the manufacturers have proposed to 
demonstrate that marketing authorization for a product is appropriate 
under section 911 of the FD&C Act.
---------------------------------------------------------------------------
    \5\ ``Draft Guidance for Industry: Modified Risk Tobacco Product 
Applications.'' 77 Fed. Reg. 20026 (published for comments on April 3, 
2012).

    Question 7. By what date does FDA intend to finalize its draft 
guidance on modified-risk tobacco product requirements?
    Answer 7. FDA is currently reviewing comments on the draft guidance 
on MRTP applications, but is not able to provide a specific date for 
finalization.\6\ FDA is committed to helping industry better understand 
the tobacco product review process and the requirements in the law 
related to MRTP, and plans to continue meeting with stakeholders as 
needed to answer specific questions.
---------------------------------------------------------------------------
    \6\ Section 911(1)(l) of the FD&C Act directs FDA to issue 
regulations or guidance (or any combination thereof) on the scientific 
evidence required for assessment and ongoing review of modified-risk 
tobacco products. FDA issued this draft guidance in compliance with 
section 911(1)(l). See 77 FR 20026 at 20027 (April 3, 2012). 
http:www.gpo.gov/(dsys/pkg/FR-2012-04-03/pdf/2012-7908.pdf.

    Question 8. Last fall, GAO issued a report that found that as of 
late June 2013, CTP had made a final decision on only 6 of the 3,788 
substantial equivalent submissions, with the remaining submissions 
still undergoing CTP review. In this same report, GAO recommended that 
FDA establish performance measures that include timeframes for making 
decisions on new tobacco product submissions and monitor performance 
relative to those timeframes. Last month, GAO testified that as of 
December 31, 2013, CTP had made final decisions for only 30 of the 
4,490 SE submissions the agency had received. Will CTP set a 
performance target for provisional SE submissions to mitigate the 
current backlog of submissions? If so, please provide the performance 
goals and targets for clearing CTP's current backlog. If not, please 
explain why the Agency will not apply any performance metrics to these 
submissions.
    SE reports fall into two categories. One category is 
``provisional'' SE reports that apply to new products introduced to 
market between February 15, 2007, and March 22, 2011, and for which SE 
reports were submitted to FDA by March 22, 2011. These products can 
remain on the market unless FDA finds they are NSE. The other category 
is ``regular'' SE reports (reports for new products submitted after 
March 22, 2011). Tobacco products subject to a regular SE report may 
not be marketed unless FDA issues an order that the tobacco product is 
substantially equivalent and in compliance with the requirements of the 
FD&C Act. In April 2014, CTP established performance measures that 
include timeframes for review of regular SE reports. These performance 
measures were implemented on October 1, 2014.
    CTP has begun review of provisional SE reports and issued the first 
decisions on these reports on February 21, 2014. As provisional SE 
reports were submitted very early in the history of the review process, 
they were submitted before applicants had the knowledge and experience 
gained over the last few years. Thus, provisional SE reports are likely 
to be less well-organized, have many more deficiencies, and require a 
more complicated review by FDA than SE reports for regular products 
that are now being submitted. The potential for both large numbers of 
deficiencies and varying quality of provisional SE reports prevents FDA 
from predicting the time necessary for completing the initial review 
and for making a final decision. While it is important that FDA makes 
review decisions about tobacco products in a timely manner, it is 
absolutely critical that these marketing decisions are sound, grounded 
in the best available science, and made in accordance with applicable 
public health standards. Once FDA has had more experience addressing 
provisional SE reports, we expect to better understand the time that 
will be needed to review individual reports. At that time, we intend to 
set performance goals for provisional SE reports.

    Question 9. How does CTP propose to uphold its responsibility to 
review products in a timely manner given the potential impact the 
proposed deeming rule on CTP's current backlog of submissions? Will CTP 
establish performance goals and timelines to balance the current 
backlog of submissions with any additional workload as a result of the 
two options proposed with respect to cigars and other products under 
the proposed deeming rule? If so, please provide details.
    Answer 9. On March 24, 2014, CTP announced that we no longer have a 
backlog of regular SE reports awaiting review and that the Center is 
starting review on regular SE reports as they are received. As of 
September 30, 2014, 45 percent of regular SE reports had been resolved 
by a final decision\7\ either because FDA issued an Order letter, 
issued a Refuse-to-Accept letter or because the submission was 
withdrawn. FDA has issued a Scientific Advice and Information Request 
Letter or a Preliminary Finding Letter for 81 percent of the regular SE 
reports that are pending.
---------------------------------------------------------------------------
    \7\ Final decisions include Refuse-to-Accept letters, withdrawals 
by an applicant, substantially equivalent (SE) orders, not 
substantially equivalent (NSE) orders.
---------------------------------------------------------------------------
    CTP established four performance goals that include timeframes for 
review of regular SE reports, review of Exemption from SE requests, and 
review of MRTP applications (see tables below). Beginning on October I, 
2014, tracking of all goals was implemented.
Regulatory Performance Measures
    Substantial Equivalence Reports for products currently regulated by 
FDA (cigarettes, cigarette tobacco, smokeless tobacco, roll-your-own 
tobacco)

 
------------------------------------------------------------------------
                                                       Submission cohort
            Category               Performance goal      (In percent)
------------------------------------------------------------------------
Regular SE Reports..............  Finalize            Fiscal year 2015:
                                   jurisdiction and    50
                                   completeness       Fiscal year 2016:
                                   review (and issue   60
                                   letter as          Fiscal year 2017:
                                   appropriate)        70
                                   within 21 days of  Fiscal year 2018:
                                   FDA receipt of SE   80
                                   Report.
                                  Review and act on   Fiscal year 2015:
                                   an original SE      50
                                   Report within 90   Fiscal year 2016:
                                   days of FDA         60
                                   receipt.           Fiscal year 2017:
                                                       70
                                                      Fiscal year 2018:
                                                       80
Regular SE Report Resubmissions.  Review and act on   Fiscal year 2015:
                                   a SE Report         50
                                   resubmission       Fiscal year 2016:
                                   within 90 days of   60
                                   FDA receipt.       Fiscal year 2017:
                                                       70
                                                      Fiscal year 2018:
                                                       80
------------------------------------------------------------------------

    Exemption from SE Requests for products currently regulated by FDA 
(cigarettes, cigarette tobacco, smokeless tobacco, roll-your-own 
tobacco)

 
------------------------------------------------------------------------
                                                       Submission cohort
            Category               Performance goal      (In percent)
------------------------------------------------------------------------
Exemption from SE...............  Review and act on   Fiscal year 2015:
                                   a Request for       50
                                   Exemption from SE  Fiscal year 2016:
                                   within 60 days of   60
                                   FDA receipt.       Fiscal year 2017:
                                                       70
                                                      Fiscal year 2018:
                                                       80
------------------------------------------------------------------------

    Modified-Risk Tobacco Product Applications (MRTPA) for products 
currently regulated by FDA (cigarettes, cigarette tobacco, smokeless 
tobacco, roll-your-own tobacco)

 
------------------------------------------------------------------------
                                                       Submission cohort
            Category               Performance goal      (In percent)
------------------------------------------------------------------------
MRTPA...........................  Review and act on   Fiscal year 2015:
                                   a complete MRTP     50
                                   application        Fiscal year 2016:
                                   within 360 days     60
                                   of FDA receipt.    Fiscal year 2017:
                                                       70
                                                      Fiscal year 2018:
                                                       80
------------------------------------------------------------------------

    For purposes of the regulatory performance measures listed above:

     ``Review and act on'' means issuance of a letter (e.g., 
Scientific Advice and Information Letter, Preliminary Finding Letter, 
NSE or SE Order) after the review of an accepted regular SE report or 
resubmission; issuance of an order or letter after the review of an 
exemption from SE request; or the issuance of an order or letter after 
the complete review of a filed MRTP application. This timetable for 
MRTPs is FDA's best estimate, but it is based on limited information.
     ``Issue letter as appropriate'' means the issuance of an 
Acknowledgement Letter or Refuse-to-Accept Letter. If acknowledged, and 
the administrative review notes missing information, the information 
will be addressed during scientific review.
     Scientific Advice and Information Letter or Preliminary 
Finding Letter means a written communication, which lists deficiencies 
in an SE Report that precludes either further scientific review or 
issuance of an SE Order.

    FDA has made significant progress in reviewing SE reports for 
currently regulated products and this momentum will continue. The 
Center has increased staffing, taken steps to streamline the SE review 
process, and established the performance measures above that include 
timeframes for review of regular SE reports and review of exemption 
from SE requests. We have been able to develop these performance goals 
because of increased capacity, efficiency, and knowledge of the 
scientific evidence needed to adequately review SE reports.
    FDA plans to continue increasing staffing, strengthening our IT 
systems, and developing guidance and/or regulations to clarify 
submission requirements. As FDA and industry gain experience with 
submissions for these newly deemed products, we intend to identify and 
implement performance goals for these submissions.
    CTP is committed to a consistent, transparent, and predictable 
review process and to completing reviews in a timely manner.
                             senator casey
    Question 1. There are an increasing number of cases of children who 
have been poisoned from electronic cigarette refill vials. In April, 
the CDC warned that the number of calls to poison control centers for 
nicotine poisoning from electronic cigarettes has increased 
dramatically. More than half of these calls involved children age 5 or 
under. What, if any, steps does the FDA feel would be appropriate to 
address this issue? Does the FDA plan to begin collecting data on this 
matter or propose a regulation to require childproof refill vials if 
the current deeming regulation is approved?
    Answer 1. In the preamble to the proposed deeming rule, FDA 
included discussion regarding the recent increased incidence of child 
nicotine poisoning and the Agency's concerns regarding this issue. FDA 
considers the deeming rule to be a foundational regulation, which, when 
finalized, would allow the Agency to take further actions regarding 
critical issues, such as protecting children from liquid nicotine, 
related to the proposed deemed products. For example, FDA would have 
authority to issue tobacco product manufacturing practice regulations 
under section 906(e) of the FD&C Act. Such regulations could include 
requirements regarding the packaging and storage of tobacco product 
such as liquid nicotine. In addition, under section 907 of the FD&C 
Act, FDA would have authority to issue a product standard with 
provisions related to components of tobacco products, such as liquid 
nicotine refill cartridges. Sections 906(d) and 907(a)(4)(B)(v) also 
afford FDA the authority to issue regulations restricting the sale and 
distribution of a tobacco product, if FDA determines that such a 
regulation would be appropriate for the protection of the public 
health.

    Question 2. In your testimony, you discuss the partnerships the CTP 
has formed with organizations such as the NIH and the CDC to advance 
the regulatory science base for tobacco products. What, if any, impact 
did sequester cuts to institutions like the NIH and the CDC have on 
those efforts? Is there any research that is not being done or that is 
being delayed because of a lack of adequate funding?
    Answer 2. Congress designed CTP's financial structure to depend, in 
part, on carryover funding, so it made CTP's tobacco fees available 
until expended. This made it possible for FDA to limit the impact of 
sequestration in fiscal year 2013 on the TCA. FDA successfully worked 
with institutions such as NIH and CDC to ensure that activities funded 
with tobacco user fees were able to continue.

    [Whereupon, at 4:59 p.m., the hearing was adjourned.]