-
I'm going to tell you a story.
-
I'm going to tell you a story
-
about how the deadliest
consumer product imaginable
-
came to be.
-
It's the cigarette.
-
The cigarette is the only consumer product
-
that when used as intended
-
will kill half of all long-term users
prematurely, later in life.
-
But this is also a story
-
about the work that we're doing
at the Food and Drug Administration.
-
And specifically,
the work that we're doing
-
to create the cigarette of the future
-
that is no longer capable
of creating or sustaining addiction.
-
A lot of people think that
the tobacco problem or the smoking problem
-
has been solved in the United States
-
because of the great progress
that's been made
-
over the last 40, 50 years,
-
when it comes to both
consumption and prevalence.
-
And it's true.
-
Smoking rates are at historic lows.
-
It's true for both adults and for kids.
-
And it's true that those
who continue to smoke
-
are smoking far fewer cigarettes per day
-
than at any time in history.
-
But what if I told you
-
that tobacco use,
-
primarily because of first-hand
and second-hand exposure
-
to the smoke in cigarettes,
-
remains the leading cause
of completely preventable
-
disease and death in this country.
-
Well, that's true.
-
And what if I told you
that it's actually killing more people
-
than we thought
to be the case ever before.
-
That's true too.
-
Smoking kills more people each year
-
than alcohol, AIDS, car accidents,
-
illegal drugs, murders
and suicides combined.
-
Year in and year out.
-
In 2014,
-
Dr. Adams' predecessor released
-
the 50th anniversary
Surgeon General's report
-
on smoking and health.
-
And that report
-
upped the annual death toll from smoking,
-
because the list
of smoking-related illnesses
-
got bigger.
-
And so it is now conservatively estimated
-
that smoking kills
480,000 Americans every year.
-
These are completely preventable deaths.
-
How do we wrap our heads around
a statistic like this?
-
So much of what we've heard
at this conference
-
is about individual experiences
and personal experiences.
-
How do we deal with this
at a population level,
-
when there are 480,000 moms,
-
dads, sisters, brothers, aunts and uncles
-
dying unnecessary deaths
every year from tobacco?
-
And then what happens
when you think about this trajectory
-
for the future?
-
And just do the simple math.
-
From the time of the 50th anniversary
Surgeon General's report
-
five years ago,
-
when this horrible statistic was raised,
-
just through mid-century.
-
That's more than 17 million
avoidable deaths
-
in the United States from tobacco use.
-
Primarily because of cigarettes.
-
The Surgeon General concluded
-
that 5.6 million children
-
alive in the United States in 2014
-
will die prematurely later in life
because of cigarettes.
-
5.6 million children.
-
So this is an enormous
public health problem for all of us,
-
but especially for us as regulators
-
at the Food and Drug Administration
and the Center for Tobacco Products.
-
What can we do about it?
-
What can we do to reverse this trajectory
-
of disease and death?
-
Well, we have an interesting guide
-
to help unravel issues
-
like, how did the cigarette
as we know it come to be?
-
What is the true nature
of the tobacco and cigarette business?
-
How did the industry behave
-
in the historically
unregulated marketplace?
-
And our guide
-
is previously secret internal documents
from the tobacco industry.
-
Come with me
-
in a tobacco industry
document time machine.
-
Nineteen sixty-three was 25 years
-
before the Surgeon General
was finally able to conclude
-
that the nicotine
and cigarettes was addictive.
-
That did not happen
-
until the Surgeon General's
report in 1998.
-
Nineteen sixty-three
-
was one year before the first ever
Surgeon General's report in 1964.
-
I remember 1964.
-
I don't remember
the Surgeon General's report,
-
but I remember 1964.
-
I was a kid, growing up
in Brooklyn, New York.
-
This was at a time
-
when almost one in two adults
in the United States smoked.
-
Both of my parents
were heavy smokers at the time.
-
Tobacco use was so incredibly normalized,
-
that -- and this wasn't North Carolina,
Virginia or Kentucky,
-
this was Brooklyn --
-
we made ashtrays for our parents
in arts and crafts class.
-
(Laughter)
-
The ashtrays I made were pretty awful,
but they were ashtrays.
-
(Laughter)
-
So normalized that I remember seeing
a bowl of loose cigarettes in the foyer
-
of our house and other houses
-
as a welcoming gesture
-
when friends came over for a visit.
-
OK, we're back in 1963.
-
The top lawyer for Brown and Williamson,
-
which was then the third largest
cigarette company in the United Sates,
-
wrote the following:
-
"Nicotine is addictive.
-
We are then in the business
of selling nicotine -- an addictive drug."
-
It's a remarkable statement,
-
as much for what it doesn't say
as for what it does say.
-
He didn't say they were
in the cigarette business.
-
He didn't say they were
in the tobacco business.
-
He said they were in the business
of selling nicotine.
-
Phillip Morris in 1972:
-
"The cigarette isn't a product,
-
it's a package.
-
The product is nicotine.
-
The pack is a storage container
for a day's supply of nicotine.
-
The cigarette, a dispenser
for a dose unit of nicotine."
-
We'll come back to this
dose unit notion later.
-
And R.J. Reynolds in 1972:
-
"In a sense, the tobacco industry
may be thought of as being a specialized,
-
highly ritualized and stylized segment
of the pharmaceutical industry.
-
Tobacco products uniquely
contain and deliver nicotine,
-
a potent drug with a variety
of physiological effects."
-
At the time, and for many
decades, publicly,
-
the industry completely denied addiction
-
and completely denied causality.
-
But they knew the true nature
of their business.
-
And from time to time,
-
there have been health scares
made public about cigarettes,
-
going back many decades.
-
How did the industry respond?
-
And how did they respond
-
in this historically
unregulated marketplace?
-
Going back to the 1930s,
-
it was with advertising
that heavily featured imagery of doctors
-
and other health care professionals
-
sending messages of reassurance.
-
This is an ad for "Lucky Strikes,"
-
a popular cigarette
of the time in the '30s:
-
"20,679 physicians
say "Luckies" are less irritating.
-
Your throat protection
against irritation, against cough."
-
(Laughter)
-
We laugh,
-
but this was the kind of advertising
-
that was there to send
a health message of reassurance.
-
Fast forward to 1950s, '60s and '70s.
-
And here, again,
in the absence of regulation,
-
what we're going to see
is modifications to the product
-
and product design,
-
to respond to the health
concerns of the day.
-
This is the "Kent" micronite filter.
-
And here, the innovation, if you will,
-
was the filtered cigarette.
-
"Full smoking pleasure.
-
Plus proof of the greatest
health protection ever."
-
What the smoker
of this product didn't know,
-
what their doctor didn't know,
-
what the government didn't know,
-
is that this was a filter
that was lined with asbestos.
-
So that when smokers
were smoking this filtered cigarette,
-
and still inhaling the chemicals in smoke
-
that we know are associated
with cancer and lung disease
-
and heart disease,
-
they were also sucking down
asbestos fibers.
-
In the 1960s and the 1970s,
-
the so-called innovation
was the light cigarette.
-
This is a typical brand
of the day called "True."
-
And this is after the Surgeon General's
reports have started coming out.
-
And you see the look
of concern on her face.
-
"Considering all I'd heard,
-
I decided to either quit
or smoke 'True.'
-
I smoke "True.'"
-
(Laughter)
-
"The low tar, low nicotine cigarette."
-
And then it says, "Think about it."
-
And then even below that
in the small print
-
are tar numbers and nicotine numbers.
-
What was a light cigarette?
-
How did it work?
-
This is an illustration
of the product modification
-
known as filter ventilation.
-
That's not a real filter blown up.
-
That's just a picture
-
so that you could see the rows
of laser-perforated ventilation holes
-
that were put on the filter.
-
When you look at a real cigarette,
-
it's harder to see.
-
Every patent for this product shows
-
that the ventilation holes
should be 12 millimeters
-
from the lip-end of the filter.
-
How did it work?
-
The cigarette got stuck into a machine.
-
The machine started
puffing away on the cigarette
-
and recording tar and nicotine levels.
-
As the machine smoked,
-
outside air came through
those ventilation holes
-
and diluted the amount of smoke
that was coming through the cigarette.
-
So as the machine smoked,
-
there really was less tar
and nicotine being delivered
-
compared to a regular cigarette.
-
What the tobacco industry knew
-
was that human beings
don't smoke like machines.
-
How do human beings smoke this?
-
Where do the fingers go?
-
Where do the lips go?
-
I told you that the patent said
-
that the holes are 12 millimeters
from the lip end.
-
The smoker didn't even know
they were there,
-
but between fingers and lips,
the holes get blocked.
-
And when the holes get blocked,
it's no longer a light cigarette.
-
Turns out that there's actually
-
basically as much nicotine
inside a light cigarette
-
as a regular cigarette.
-
The difference was what's on the outside.
-
But once you block what's on the outside,
-
it's a regular cigarette.
-
Congress put FDA in the business
of regulating tobacco products
-
10 years ago this June.
-
So you heard the statistics
at the beginning
-
about the extraordinary contribution
to disease and death that cigarettes make.
-
We've also been paying a lot of attention
-
to how the cigarette works
as a drug delivery device
-
and the remarkable efficiency
with which it delivers nicotine.
-
So let's take a look.
-
When the smoker puffs on the cigarette,
-
the nicotine from that puff
gets up into the brain
-
in less than 10 seconds.
-
Less than 10 seconds.
-
Up in the brain,
-
there are these things
called nicotinic receptors.
-
They're there, waiting.
-
They're waiting for, in the words
of that Phillip Morris document,
-
the next dose unit of nicotine.
-
The smoker that you see outside,
-
huddled with other smokers,
-
in the cold,
-
in the wind,
-
in the rain,
-
is experiencing craving.
-
And maybe experiencing
the symptoms of withdrawal.
-
Those symptoms of withdrawal
are a chemical message
-
that these receptors
are sending to the body, saying
-
"Feed me!"
-
And a product that can deliver the drug
-
in less than 10 seconds
-
turns out to be an incredibly efficient
and incredibly addictive product.
-
We've spoken to so many
addiction treatment experts
-
over the years.
-
And the story I hear is the same
over and over again.
-
"Long after I was able
to get somebody off of heroin,
-
or cocaine or crack cocaine,
-
I can't get them to quit cigarettes."
-
A large part of the explanation
is the 10-second thing.
-
FDA has it within its regulatory reach
-
to use the tools of product regulation
-
to render cigarettes as we know them
-
minimally or nonaddictive.
-
We're working on this.
-
And this could have a profound
impact at a population level
-
from this one policy.
-
We did dynamic population-level
modeling a year ago
-
and we published the result
in the New England Journal.
-
And because of the generational
effect of this policy,
-
which I'll explain in a minute,
-
here's what we project out
through the end of the century.
-
More than 33 million people
-
who would otherwise have gone on
to become regular smokers, won't.
-
Because the cigarette
that they'll be experimenting with
-
can't create or sustain addiction.
-
This would drive the adult smoking rate
down to less than 1,5 percent.
-
And these two things combined
-
would result in the saving
of more than eight million
-
cigarette-related deaths
that would otherwise have occurred.
-
From the generational impact of this.
-
Now, why am I saying generational?
-
It's about kids.
-
Ninety percent of adult smokers
started smoking when they were kids.
-
Half of them became regular smokers
-
before they were legally old enough
to buy a pack of cigarettes.
-
Half of them became regular smokers
before they were 18 years old.
-
Experimentation.
-
Regular smoking.
-
Addiction.
-
Decades of smoking.
-
And then the illness,
-
and that's why we're talking
about a product
-
that will kill half of all long-term users
prematurely later in life.
-
The generational impact
-
of this nicotine reduction
policy is profound.
-
Those old industry documents
had a word for young people.
-
They were described as
"the replacement smokers."
-
The replacement smokers
for addicted adult smokers
-
who died or quit.
-
Future generations of kids,
-
especially teens,
-
are going to engage in risky behavior.
-
We can't stop that.
-
But what if the only cigarette
that they could get their hands on
-
could no longer create
or sustain addiction?
-
That's the public health
return on investment
-
at a population level over time.
-
Haven't said anything about e-cigarettes.
-
But I have to say something
about e-cigarettes.
-
We are dealing with an epidemic
of kids' use of e-cigarettes,
-
and what troubles us the most
-
in combination with the rising numbers
when it comes to prevalence,
-
is frequency.
-
Not only are more kids using e-cigarettes,
-
but more kids are using e-cigarettes
20 or more days in the past 30 days
-
than at any time since e-cigarettes
came onto the market.
-
And at FDA. we're doing
everything that we can,
-
using program and policy,
-
first to get the word out to kids
-
that this is not a harmless product.
-
And to make sure that kids
aren't initiating and experimenting
-
on any tobacco product,
-
whether combustion is present or not.
-
But think about e-cigarettes
in a properly regulated marketplace
-
as something that could be of benefit
-
to addicted adult cigarette smokers
-
who are trying to transition
away from cigarettes.
-
So, I'll leave you with this vision.
-
Imagine a world
-
where the only cigarette
-
that future generations of kids
could experiment with
-
could no longer create
or sustain addiction,
-
because of a single policy.
-
Imagine a world
-
where health-concerned cigarette smokers,
-
especially if a policy goes into effect
-
that takes the nicotine levels down
to minimally or nonaddictive levels,
-
could transition to alternative
and less harmful forms
-
of nicotine delivery,
-
starting with FDA-approved
nicotine medications,
-
like the gum, patch and lozenge.
-
And finally,
-
imagine a world and a properly
regulated marketplace,
-
whether it's e-cigarettes
or whatever the technology of the day,
-
it's not the product developers
and the marketers
-
who decide which products come to market
-
and what claims get made for them.
-
It's review scientists at FDA,
-
who look at applications
-
and decide, using the standard
that Congress has entrusted us
-
to implement and enforce,
-
whether a particular product
should come to market,
-
because the marketing of that product
and the words of our law
-
would be appropriate for the protection
of the public health.
-
These are the kinds
of powerful regulatory tools
-
that are within our reach.
-
To deal with what remains
-
the leading cause of completely
preventable disease and death
-
in the country.
-
If we get this right,
-
that trajectory,
-
those 5.6 million kids,
-
is breakable.
-
Thank you.
-
(Applause)