0:00:01.143,0:00:02.801
I'm going to tell you a story.

0:00:04.048,0:00:05.439
I'm going to tell you a story

0:00:05.463,0:00:08.642
about how the deadliest[br]consumer product imaginable

0:00:08.666,0:00:09.816
came to be.

0:00:10.413,0:00:11.679
It's the cigarette.

0:00:12.572,0:00:15.104
The cigarette is the only consumer product

0:00:15.128,0:00:17.667
that, when used as intended,

0:00:17.691,0:00:21.500
will kill half of all long-term users[br]prematurely, later in life.

0:00:22.347,0:00:23.572
But this is also a story

0:00:23.596,0:00:27.022
about the work that we're doing[br]at the Food and Drug Administration,

0:00:27.046,0:00:29.450
and specifically,[br]the work that we're doing

0:00:29.474,0:00:32.625
to create the cigarette of the future,

0:00:32.649,0:00:37.069
that is no longer capable[br]of creating or sustaining addiction.

0:00:37.823,0:00:41.522
A lot of people think that[br]the tobacco problem or the smoking problem

0:00:41.546,0:00:43.284
has been solved in the United States

0:00:43.308,0:00:45.474
because of the great progress[br]that's been made

0:00:45.498,0:00:47.387
over the last 40, 50 years,

0:00:47.411,0:00:50.254
when it comes to both[br]consumption and prevalence.

0:00:50.278,0:00:51.436
And it's true;

0:00:52.205,0:00:55.236
smoking rates are at historic lows.

0:00:55.673,0:00:58.474
It's true for both adults and for kids.

0:00:59.339,0:01:02.125
And it's true that those[br]who continue to smoke

0:01:02.149,0:01:04.783
are smoking far fewer cigarettes per day

0:01:04.807,0:01:06.674
than at any time in history.

0:01:08.035,0:01:11.936
But what if I told you[br]that tobacco use,

0:01:11.960,0:01:15.268
primarily because of firsthand[br]and secondhand exposure

0:01:15.292,0:01:18.006
to the smoke in cigarettes,

0:01:18.030,0:01:21.788
remains the leading cause of completely[br]preventable disease and death

0:01:21.812,0:01:22.962
in this country?

0:01:24.196,0:01:25.396
Well, that's true.

0:01:26.988,0:01:30.948
And what if I told you[br]that it's actually killing more people

0:01:30.972,0:01:33.480
than we thought[br]to be the case ever before?

0:01:33.956,0:01:35.234
That's true, too.

0:01:36.903,0:01:40.990
Smoking kills more people each year[br]than alcohol, AIDS, car accidents,

0:01:41.014,0:01:44.196
illegal drugs, murders[br]and suicides combined.

0:01:45.154,0:01:46.554
Year in and year out.

0:01:47.979,0:01:49.874
In 2014,

0:01:51.177,0:01:52.871
Dr. Adams's predecessor released

0:01:52.895,0:01:55.315
the 50th anniversary[br]Surgeon General's report

0:01:55.339,0:01:56.806
on smoking and health.

0:01:58.133,0:02:01.863
And that report upped the annual[br]death toll from smoking,

0:02:01.887,0:02:04.537
because the list[br]of smoking-related illnesses

0:02:04.561,0:02:06.042
got bigger.

0:02:06.066,0:02:08.260
And so it is now conservatively estimated

0:02:08.284,0:02:12.937
that smoking kills[br]480,000 Americans every year.

0:02:13.414,0:02:16.318
These are completely preventable deaths.

0:02:16.811,0:02:20.033
How do we wrap our heads around[br]a statistic like this?

0:02:20.057,0:02:22.701
So much of what we've heard[br]at this conference

0:02:22.725,0:02:27.090
is about individual experiences[br]and personal experiences.

0:02:27.114,0:02:29.788
How do we deal with this[br]at a population level,

0:02:29.812,0:02:32.783
when there are 480,000 moms,

0:02:32.807,0:02:37.347
dads, sisters, brothers, aunts and uncles

0:02:37.371,0:02:40.746
dying unnecessary deaths[br]every year from tobacco?

0:02:42.329,0:02:45.424
And then what happens[br]when you think about this trajectory

0:02:45.448,0:02:46.706
for the future?

0:02:47.274,0:02:49.140
And just do the simple math:

0:02:49.831,0:02:54.498
from the time of the 50th anniversary[br]Surgeon General's report five years ago,

0:02:54.522,0:02:57.220
when this horrible statistic was raised,

0:02:57.244,0:02:58.991
just through mid-century --

0:02:59.857,0:03:05.347
that's more than 17 million[br]avoidable deaths in the United States

0:03:05.371,0:03:07.142
from tobacco use,

0:03:07.166,0:03:09.158
primarily because of cigarettes.

0:03:09.855,0:03:12.306
The Surgeon General concluded

0:03:12.330,0:03:19.285
that 5.6 million children[br]alive in the United States in 2014

0:03:19.309,0:03:23.737
will die prematurely later in life[br]because of cigarettes.

0:03:24.301,0:03:26.459
Five point six million children.

0:03:27.783,0:03:32.387
So this is an enormous[br]public health problem for all of us

0:03:32.411,0:03:34.708
but especially for us as regulators

0:03:34.732,0:03:38.387
at the Food and Drug Administration[br]and the Center for Tobacco Products.

0:03:38.411,0:03:40.011
What can we do about it?

0:03:40.752,0:03:45.363
What can we do to reverse this trajectory[br]of disease and death?

0:03:46.942,0:03:52.717
Well, we have an interesting guide[br]to help unravel issues

0:03:52.741,0:03:56.561
like: How did the cigarette[br]as we know it come to be?

0:03:56.942,0:04:01.023
What is the true nature[br]of the tobacco and cigarette business?

0:04:01.650,0:04:02.960
How did the industry behave

0:04:02.984,0:04:05.984
in the historically[br]unregulated marketplace?

0:04:06.325,0:04:08.047
And our guide

0:04:08.071,0:04:12.522
is previously secret internal documents[br]from the tobacco industry.

0:04:13.015,0:04:14.872
Come with me

0:04:14.896,0:04:17.697
in a tobacco industry[br]document time machine.

0:04:19.150,0:04:20.595
Nineteen sixty-three

0:04:21.612,0:04:27.265
was 25 years before the Surgeon General[br]was finally able to conclude

0:04:27.289,0:04:30.043
that the nicotine[br]and cigarettes was addictive.

0:04:30.067,0:04:34.173
That did not happen until[br]the Surgeon General's report in 1998.

0:04:35.062,0:04:37.427
Nineteen sixty-three

0:04:37.451,0:04:42.792
was one year before the first-ever[br]Surgeon General's report in 1964.

0:04:44.688,0:04:46.783
I remember 1964.

0:04:46.807,0:04:48.966
I don't remember[br]the Surgeon General's report,

0:04:48.990,0:04:50.323
but I remember 1964.

0:04:50.625,0:04:53.043
I was a kid growing up[br]in Brooklyn, New York.

0:04:53.532,0:04:55.222
This was at a time

0:04:55.246,0:04:59.287
when almost one in two adults[br]in the United States smoked.

0:05:00.094,0:05:03.257
Both of my parents[br]were heavy smokers at the time.

0:05:04.177,0:05:07.366
Tobacco use was so incredibly normalized

0:05:07.390,0:05:10.320
that -- and this wasn't North Carolina,[br]Virginia or Kentucky,

0:05:10.344,0:05:11.973
this was Brooklyn --

0:05:12.828,0:05:16.379
we made ashtrays for our parents[br]in arts and crafts class.

0:05:16.403,0:05:18.680
(Laughter)

0:05:19.970,0:05:22.883
The ashtrays I made were pretty awful,[br]but they were ashtrays.

0:05:22.907,0:05:24.573
(Laughter)

0:05:24.597,0:05:30.492
So normalized that I remember seeing[br]a bowl of loose cigarettes in the foyer

0:05:30.516,0:05:32.770
of our house and other houses

0:05:32.794,0:05:36.762
as a welcoming gesture[br]when friends came over for a visit.

0:05:37.609,0:05:40.702
OK, we're back in 1963.

0:05:41.204,0:05:43.172
The top lawyer for Brown and Williamson,

0:05:43.196,0:05:46.580
which was then the third-largest[br]cigarette company in the United States,

0:05:46.580,0:05:47.787
wrote the following:

0:05:47.811,0:05:49.001
"Nicotine is addictive.

0:05:49.025,0:05:52.548
We are, then, in the business[br]of selling nicotine -- an addictive drug."

0:05:53.184,0:05:54.524
It's a remarkable statement,

0:05:54.548,0:05:57.171
as much for what it doesn't say[br]as for what it does say.

0:05:57.195,0:05:59.560
He didn't say they were[br]in the cigarette business.

0:05:59.584,0:06:01.877
He didn't say they were[br]in the tobacco business.

0:06:01.901,0:06:04.543
He said they were in the business[br]of selling nicotine.

0:06:05.267,0:06:07.125
Philip Morris in 1972:

0:06:07.149,0:06:08.870
"The cigarette isn't a product,

0:06:08.894,0:06:10.346
it's a package.

0:06:10.712,0:06:12.312
The product is nicotine.

0:06:12.768,0:06:16.856
The pack is a storage container[br]for a day's supply of nicotine.

0:06:16.880,0:06:21.385
The cigarette, a dispenser[br]for a dose unit of nicotine."

0:06:22.055,0:06:24.891
We'll come back to this[br]dose unit notion later.

0:06:25.906,0:06:27.787
And R.J. Reynolds in 1972:

0:06:27.811,0:06:31.350
"In a sense, the tobacco industry[br]may be thought of as being a specialized,

0:06:31.374,0:06:35.120
highly ritualized and stylized segment[br]of the pharmaceutical industry.

0:06:35.144,0:06:38.002
Tobacco products uniquely[br]contain and deliver nicotine,

0:06:38.026,0:06:41.325
a potent drug with a variety[br]of physiological effects."

0:06:41.764,0:06:44.867
At the time, and for many[br]decades, publicly,

0:06:44.891,0:06:47.522
the industry completely denied addiction

0:06:47.546,0:06:49.679
and completely denied causality.

0:06:50.163,0:06:52.744
But they knew the true nature[br]of their business.

0:06:52.768,0:06:54.276
And from time to time,

0:06:54.300,0:06:57.941
there have been health scares[br]made public about cigarettes,

0:06:57.965,0:06:59.565
going back many decades.

0:06:59.989,0:07:01.923
How did the industry respond?

0:07:02.330,0:07:03.529
And how did they respond

0:07:03.553,0:07:06.633
in this historically[br]unregulated marketplace?

0:07:06.657,0:07:08.887
Going back to the 1930s,

0:07:08.911,0:07:13.990
it was with advertising[br]that heavily featured imagery of doctors

0:07:14.014,0:07:15.926
and other health care professionals

0:07:15.950,0:07:18.084
sending messages of reassurance.

0:07:18.617,0:07:20.252
This is an ad for Lucky Strikes,

0:07:20.276,0:07:22.688
the popular cigarette[br]of the time in the '30s:

0:07:22.712,0:07:27.010
[20,679 physicians[br]say "Luckies are less irritating."

0:07:27.322,0:07:31.524
Your throat protection[br]against irritation, against cough.]

0:07:31.548,0:07:33.990
(Laughter)

0:07:34.014,0:07:35.871
We laugh,

0:07:35.895,0:07:37.641
but this was the kind of advertising

0:07:37.665,0:07:40.656
that was there to send[br]a health message of reassurance.

0:07:40.680,0:07:44.196
Fast-forward to 1950s, '60s and '70s.

0:07:44.220,0:07:47.172
And here, again,[br]in the absence of regulation,

0:07:47.196,0:07:49.973
what we're going to see[br]is modifications to the product

0:07:49.997,0:07:51.695
and product design

0:07:51.719,0:07:54.404
to respond to the health[br]concerns of the day.

0:07:55.664,0:07:59.093
This is the Kent Micronite filter.

0:07:59.117,0:08:03.655
And here, the innovation, if you will,[br]was the filtered cigarette.

0:08:04.395,0:08:06.077
[Full smoking pleasure ...

0:08:06.101,0:08:09.013
plus proof of the greatest[br]health protection ever.]

0:08:10.244,0:08:13.172
What the smoker[br]of this product didn't know,

0:08:13.196,0:08:15.117
what their doctor didn't know,

0:08:15.141,0:08:17.300
what the government didn't know,

0:08:17.324,0:08:20.820
is that this was a filter[br]that was lined with asbestos --

0:08:20.844,0:08:21.900
(Gasps)

0:08:21.924,0:08:24.638
so that when smokers[br]were smoking this filtered cigarette

0:08:24.662,0:08:27.178
and still inhaling the chemicals and smoke

0:08:27.202,0:08:30.408
that we know are associated[br]with cancer and lung disease

0:08:30.432,0:08:31.641
and heart disease,

0:08:31.665,0:08:34.098
they were also sucking down[br]asbestos fibers.

0:08:34.112,0:08:35.112
(Gasps)

0:08:36.236,0:08:38.791
In the 1960s and the 1970s,

0:08:38.815,0:08:42.339
the so-called innovation[br]was the light cigarette.

0:08:43.490,0:08:46.969
This is a typical brand[br]of the day called True.

0:08:47.477,0:08:50.914
And this is after the Surgeon General's[br]reports have started coming out.

0:08:50.938,0:08:53.247
And you see the look[br]of concern on her face.

0:08:53.271,0:08:54.583
[Considering all I'd heard,

0:08:54.607,0:08:57.403
I decided to either quit[br]or smoke True.

0:08:57.427,0:08:58.833
I smoke True.]

0:08:58.857,0:09:00.395
(Laughter)

0:09:00.419,0:09:03.361
[The low tar, low nicotine cigarette.]

0:09:03.385,0:09:05.301
And then it says, "Think about it."

0:09:05.325,0:09:08.603
And then even below that[br]in the small print

0:09:08.627,0:09:11.507
are tar numbers and nicotine numbers.

0:09:12.333,0:09:14.452
What was a light cigarette?

0:09:15.474,0:09:16.942
How did it work?

0:09:18.474,0:09:21.172
This is an illustration[br]of the product modification

0:09:21.196,0:09:23.730
known as "filter ventilation."

0:09:24.128,0:09:25.787
That's not a real filter blown up.

0:09:25.811,0:09:27.001
That's just a picture

0:09:27.025,0:09:30.231
so that you could see the rows[br]of laser-perforated ventilation holes

0:09:30.255,0:09:31.611
that were put on the filter.

0:09:31.635,0:09:33.267
When you look at a real cigarette,

0:09:33.291,0:09:34.807
it's harder to see.

0:09:34.831,0:09:36.945
Every patent for this product shows

0:09:36.969,0:09:40.371
that the ventilation holes[br]should be 12 millimeters

0:09:40.395,0:09:42.164
from the lip end of the filter.

0:09:42.188,0:09:43.496
How did it work?

0:09:44.458,0:09:46.696
The cigarette got stuck into a machine.

0:09:47.950,0:09:50.291
The machine started[br]puffing away on the cigarette

0:09:50.315,0:09:52.752
and recording tar and nicotine levels.

0:09:53.061,0:09:54.791
As the machine smoked,

0:09:54.815,0:09:58.260
outside air came through[br]those ventilation holes

0:09:58.284,0:10:02.196
and diluted the amount of smoke[br]that was coming through the cigarette.

0:10:02.220,0:10:04.307
So as the machine smoked,

0:10:04.331,0:10:06.874
there really was less tar[br]and nicotine being delivered

0:10:06.898,0:10:08.745
compared to a regular cigarette.

0:10:09.975,0:10:11.760
What the tobacco industry knew

0:10:11.784,0:10:14.848
was that human beings[br]don't smoke like machines.

0:10:15.713,0:10:17.779
How do human beings smoke this?

0:10:18.816,0:10:20.416
Where do the fingers go?

0:10:20.440,0:10:21.680
(Murmurs)

0:10:21.704,0:10:23.104
Where do the lips go?

0:10:23.474,0:10:24.966
I told you that the patent said

0:10:24.990,0:10:28.014
that the holes are 12 millimeters[br]from the lip end.

0:10:28.038,0:10:30.276
The smoker didn't even know[br]they were there,

0:10:30.300,0:10:34.099
but between fingers and lips,[br]the holes get blocked.

0:10:34.505,0:10:38.219
And when the holes get blocked,[br]it's no longer a light cigarette.

0:10:38.807,0:10:40.339
Turns out that there's actually

0:10:40.363,0:10:43.069
basically as much nicotine[br]inside a light cigarette

0:10:43.093,0:10:44.299
as a regular cigarette.

0:10:44.323,0:10:46.289
The difference was what's on the outside.

0:10:46.313,0:10:49.559
But once you block what's on the outside,

0:10:49.583,0:10:51.130
it's a regular cigarette.

0:10:52.821,0:10:55.832
Congress put FDA in the business[br]of regulating tobacco products

0:10:55.856,0:10:57.331
10 years ago this June.

0:10:57.355,0:10:59.680
So you heard the statistics[br]at the beginning

0:10:59.704,0:11:04.364
about the extraordinary contribution[br]to disease and death that cigarettes make.

0:11:04.754,0:11:06.782
We've also been paying a lot of attention

0:11:06.806,0:11:10.666
to how the cigarette works[br]as a drug-delivery device

0:11:10.690,0:11:14.248
and the remarkable efficiency[br]with which it delivers nicotine.

0:11:14.272,0:11:15.672
So let's take a look.

0:11:16.844,0:11:19.605
When the smoker puffs on the cigarette,

0:11:19.629,0:11:22.836
the nicotine from that puff[br]gets up into the brain

0:11:22.860,0:11:24.669
in less than 10 seconds.

0:11:25.252,0:11:26.728
Less than 10 seconds.

0:11:27.300,0:11:29.029
Up in the brain,

0:11:29.053,0:11:31.918
there are these things[br]called "nicotinic receptors."

0:11:32.929,0:11:34.404
They're there ...

0:11:34.428,0:11:35.592
waiting.

0:11:35.945,0:11:39.207
They're waiting for, in the words[br]of that Philip Morris document,

0:11:39.231,0:11:41.297
the next "dose unit of nicotine."

0:11:43.252,0:11:45.918
The smoker that you see outside,

0:11:45.942,0:11:47.831
huddled with other smokers,

0:11:47.855,0:11:49.339
in the cold,

0:11:49.363,0:11:50.625
in the wind,

0:11:50.649,0:11:52.342
in the rain,

0:11:52.366,0:11:54.620
is experiencing craving

0:11:54.644,0:11:57.342
and may be experiencing[br]the symptoms of withdrawal.

0:11:58.564,0:12:02.125
Those symptoms of withdrawal[br]are a chemical message

0:12:02.149,0:12:04.289
that these receptors[br]are sending to the body,

0:12:04.313,0:12:05.869
saying, "Feed me!"

0:12:08.490,0:12:14.338
And a product that can deliver the drug[br]in less than 10 seconds

0:12:15.230,0:12:19.960
turns out to be an incredibly efficient[br]and incredibly addictive product.

0:12:21.379,0:12:24.466
We've spoken to so many[br]addiction treatment experts

0:12:24.490,0:12:25.640
over the years.

0:12:26.053,0:12:29.359
And the story I hear is the same[br]over and over again:

0:12:29.383,0:12:31.867
"Long after I was able[br]to get somebody off of heroin

0:12:31.891,0:12:34.605
or cocaine or crack cocaine,

0:12:34.629,0:12:36.677
I can't get them to quit cigarettes."

0:12:37.145,0:12:40.332
A large part of the explanation[br]is the 10-second thing.

0:12:42.081,0:12:45.835
FDA has it within its regulatory reach

0:12:45.859,0:12:48.233
to use the tools of product regulation

0:12:48.257,0:12:52.627
to render cigarettes as we know them[br]minimally or nonaddictive.

0:12:54.030,0:12:55.496
We're working on this.

0:12:56.046,0:13:00.092
And this could have a profound[br]impact at a population level

0:13:00.116,0:13:01.577
from this one policy.

0:13:02.124,0:13:04.587
We did dynamic population-level[br]modeling a year ago,

0:13:04.611,0:13:07.345
and we published the results[br]in "The New England Journal."

0:13:07.369,0:13:09.922
And because of the generational[br]effect of this policy,

0:13:09.946,0:13:11.437
which I'll explain in a minute,

0:13:11.461,0:13:14.268
here's what we project out[br]through the end of the century:

0:13:14.292,0:13:15.974
more than 33 million people

0:13:15.998,0:13:19.680
who would otherwise have gone on[br]to become regular smokers won't,

0:13:19.704,0:13:22.345
because the cigarette[br]that they'll be experimenting with

0:13:22.369,0:13:24.109
can't create or sustain addiction.

0:13:24.569,0:13:28.482
This would drive the adult smoking rate[br]down to less than one and a half percent.

0:13:29.450,0:13:31.333
And these two things combined

0:13:32.107,0:13:37.591
would result in the saving of more than[br]eight million cigarette-related deaths

0:13:37.615,0:13:39.844
that would otherwise have occurred

0:13:39.868,0:13:41.891
from the generational impact of this.

0:13:41.915,0:13:44.182
Now, why am I saying "generational"?

0:13:45.367,0:13:46.756
It's about kids.

0:13:48.090,0:13:51.408
Ninety percent of adult smokers[br]started smoking when they were kids.

0:13:52.121,0:13:54.224
Half of them became regular smokers

0:13:54.248,0:13:57.657
before they were legally old enough[br]to buy a pack of cigarettes.

0:13:58.287,0:14:01.466
Half of them became regular smokers[br]before they were 18 years old.

0:14:01.490,0:14:02.640
Experimentation.

0:14:03.212,0:14:04.362
Regular smoking.

0:14:04.728,0:14:05.878
Addiction.

0:14:06.522,0:14:07.863
Decades of smoking.

0:14:07.887,0:14:09.490
And then the illness,

0:14:09.514,0:14:11.661
and that's why we're talking[br]about a product

0:14:11.685,0:14:15.654
that will kill half of all long-term users[br]prematurely later in life.

0:14:16.880,0:14:20.186
The generational impact[br]of this nicotine-reduction policy

0:14:20.210,0:14:21.534
is profound.

0:14:22.817,0:14:25.742
Those old industry documents[br]had a word for young people.

0:14:26.323,0:14:29.276
They were described as[br]"the replacement smokers."

0:14:30.577,0:14:32.942
The replacement smokers[br]for addicted adult smokers

0:14:32.966,0:14:34.116
who died or quit.

0:14:34.533,0:14:38.303
Future generations of kids,[br]especially teens,

0:14:38.327,0:14:40.295
are going to engage in risky behavior.

0:14:40.319,0:14:41.586
We can't stop that.

0:14:42.010,0:14:46.011
But what if the only cigarette[br]that they could get their hands on

0:14:46.035,0:14:48.324
could no longer create[br]or sustain addiction?

0:14:48.839,0:14:51.450
That's the public health[br]return on investment

0:14:51.474,0:14:53.886
at a population level over time.

0:14:55.132,0:14:57.196
Haven't said anything about e-cigarettes.

0:14:57.521,0:14:59.727
But I have to say something[br]about e-cigarettes.

0:14:59.751,0:15:00.768
(Laughter)

0:15:00.792,0:15:03.664
We are dealing with an epidemic[br]of kids' use of e-cigarettes.

0:15:03.688,0:15:05.847
And what troubles us the most,

0:15:05.871,0:15:10.252
in combination with the rising numbers[br]when it comes to prevalence,

0:15:10.276,0:15:11.680
is frequency.

0:15:11.704,0:15:14.033
Not only are more kids using e-cigarettes,

0:15:14.057,0:15:18.137
but more kids are using e-cigarettes[br]20 or more days in the past 30 days

0:15:18.161,0:15:20.938
than at any time since e-cigarettes[br]came onto the market.

0:15:20.962,0:15:23.184
And at FDA, we're doing[br]everything that we can

0:15:23.208,0:15:24.466
using program and policy,

0:15:24.490,0:15:26.109
first to get the word out to kids

0:15:26.133,0:15:28.204
that this is not a harmless product

0:15:28.228,0:15:31.163
and to make sure that kids[br]aren't initiating and experimenting

0:15:31.187,0:15:32.347
on any tobacco product,

0:15:32.371,0:15:34.251
whether combustion is present or not.

0:15:34.569,0:15:37.690
But think about e-cigarettes[br]in a properly regulated marketplace

0:15:37.714,0:15:39.637
as something that could be of benefit

0:15:39.661,0:15:41.781
to addicted adult cigarette smokers

0:15:41.805,0:15:44.161
who are trying to transition[br]away from cigarettes.

0:15:44.185,0:15:47.716
So, I'll leave you with this vision:

0:15:49.748,0:15:51.399
imagine a world

0:15:52.077,0:15:54.749
where the only cigarette[br]that future generations of kids

0:15:54.773,0:15:55.934
could experiment with

0:15:55.958,0:15:58.196
could no longer create[br]or sustain addiction

0:15:58.220,0:15:59.957
because of a single policy.

0:16:00.585,0:16:01.763
Imagine a world

0:16:02.534,0:16:05.220
where health-concerned cigarette smokers,

0:16:05.244,0:16:08.140
especially if a policy goes into effect

0:16:08.164,0:16:11.768
that takes the nicotine levels down[br]to minimally or nonaddictive levels,

0:16:11.792,0:16:14.334
could transition to alternative[br]and less harmful forms

0:16:14.358,0:16:15.673
of nicotine delivery,

0:16:15.697,0:16:17.950
starting with FDA-approved[br]nicotine medications,

0:16:17.974,0:16:19.911
like the gum, patch and lozenge.

0:16:20.704,0:16:21.895
And finally,

0:16:21.919,0:16:24.768
imagine a world and a properly[br]regulated marketplace,

0:16:24.792,0:16:28.006
whether it's e-cigarettes[br]or whatever the technology of the day,

0:16:28.030,0:16:30.331
it's not the product developers[br]and the marketers

0:16:30.355,0:16:32.300
who decide which products come to market

0:16:32.324,0:16:34.133
and what claims get made for them,

0:16:34.157,0:16:37.029
it's review scientists at FDA,

0:16:37.053,0:16:38.633
who look at applications

0:16:38.657,0:16:42.331
and decide, using the standard[br]that Congress has entrusted us

0:16:42.355,0:16:44.410
to implement and enforce,

0:16:44.434,0:16:47.267
whether a particular product[br]should come to market,

0:16:47.291,0:16:50.529
because the marketing of that product[br]and the words of our law

0:16:50.553,0:16:53.725
would be appropriate for the protection[br]of the public health.

0:16:54.297,0:16:56.602
These are the kinds[br]of powerful regulatory tools

0:16:56.626,0:16:59.614
that are within our reach

0:16:59.638,0:17:01.014
to deal with what remains

0:17:01.038,0:17:04.291
the leading cause of completely[br]preventable disease and death

0:17:04.315,0:17:05.474
in the country.

0:17:05.498,0:17:06.765
If we get this right,

0:17:07.657,0:17:12.246
that trajectory,[br]those 5.6 million kids,

0:17:12.270,0:17:13.611
is breakable.

0:17:13.635,0:17:14.786
Thank you.

0:17:14.810,0:17:17.523
(Applause)