ABOUT THE SPEAKER
Mitch Zeller - Health policy expert
Mitch Zeller leads the US Food and Drug Administration's efforts to reduce disease and death from tobacco use and bring previously unavailable information about its dangers to light.

Why you should listen

As director of the Center for Tobacco Products (CTP), Mitch Zeller, JD, is dedicated to carrying out CTP's charge to reduce the harm from all tobacco products across the entire population -- with a focus on how and why people start, stop or start using these products again.

Zeller became director of the FDA's Center for Tobacco Products in March 2013. The mission of CTP -- established by enactment of the 2009 Family Smoking Prevention and Tobacco Control Act -- is "to make tobacco-related death and disease part of America's past, not America's future, and, by doing so, ensure a healthier life for every American family."

A graduate of Dartmouth College and the American University Washington College of Law, Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest (CSPI). In 1988, Zeller left CSPI to become counsel to the Human Resources and Intergovernmental Relations Subcommittee of the House of Representatives Government Operations Committee, where he conducted oversight of enforcement of federal health and safety laws.
In 1993, Zeller joined the staff of then-FDA Commissioner Dr. David Kessler, MD. What began as a two-week assignment by Kessler in 1994 to examine the practices of the tobacco industry led to his serving as associate commissioner and director of FDA's first Office of Tobacco Programs. Instrumental in crafting the agency's 1996 tobacco regulations, Zeller also represented FDA before Congress, federal and state agencies. Zeller also served as an official US delegate to the World Health Organization (WHO) Working Group for the Framework Convention on Tobacco Control.

In 2000, Zeller left FDA to continue his work for tobacco control as executive vice president of the American Legacy Foundation. His responsibilities there included marketing, communications, strategic partnerships and creating the foundation's first Office of Policy and Government Relations. In 2002, Zeller joined Pinney Associates where, as senior vice president, he provided strategic planning and communications advice on domestic and global public health policy issues involving the treatment of tobacco dependence and the regulation of tobacco products and pharmaceuticals.

More profile about the speaker
Mitch Zeller | Speaker | TED.com
TEDxMidAtlantic

Mitch Zeller: The past, present and future of nicotine addiction

Filmed:
1,311,439 views

Tobacco use remains the leading cause of preventable disease and death in the United States, killing more people each year than alcohol, AIDS, car accidents, illegal drugs, murder and suicide combined. Follow health policy expert Mitch Zeller into the murky depths of the tobacco industry as he details the sordid history of nicotine addiction -- and invites us to imagine a world where policy change helps stop people from becoming addicted in the first place.
- Health policy expert
Mitch Zeller leads the US Food and Drug Administration's efforts to reduce disease and death from tobacco use and bring previously unavailable information about its dangers to light. Full bio

Double-click the English transcript below to play the video.

00:13
I'm going to tell you a story.
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I'm going to tell you a story
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about how the deadliest
consumer product imaginable
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came to be.
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It's the cigarette.
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The cigarette is the only consumer product
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that, when used as intended,
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will kill half of all long-term users
prematurely, later in life.
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But this is also a story
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about the work that we're doing
at the Food and Drug Administration,
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and specifically,
the work that we're doing
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to create the cigarette of the future,
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that is no longer capable
of creating or sustaining addiction.
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A lot of people think that
the tobacco problem or the smoking problem
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has been solved in the United States
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because of the great progress
that's been made
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over the last 40, 50 years,
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when it comes to both
consumption and prevalence.
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And it's true;
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smoking rates are at historic lows.
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It's true for both adults and for kids.
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And it's true that those
who continue to smoke
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are smoking far fewer cigarettes per day
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than at any time in history.
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But what if I told you
that tobacco use,
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primarily because of firsthand
and secondhand exposure
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to the smoke in cigarettes,
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remains the leading cause of completely
preventable disease and death
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in this country?
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Well, that's true.
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And what if I told you
that it's actually killing more people
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than we thought
to be the case ever before?
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That's true, too.
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Smoking kills more people each year
than alcohol, AIDS, car accidents,
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illegal drugs, murders
and suicides combined.
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Year in and year out.
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In 2014,
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Dr. Adams's predecessor released
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the 50th anniversary
Surgeon General's report
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on smoking and health.
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And that report upped the annual
death toll from smoking,
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because the list
of smoking-related illnesses
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got bigger.
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And so it is now conservatively estimated
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that smoking kills
480,000 Americans every year.
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These are completely preventable deaths.
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How do we wrap our heads around
a statistic like this?
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So much of what we've heard
at this conference
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is about individual experiences
and personal experiences.
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How do we deal with this
at a population level,
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when there are 480,000 moms,
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dads, sisters, brothers, aunts and uncles
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dying unnecessary deaths
every year from tobacco?
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And then what happens
when you think about this trajectory
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for the future?
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And just do the simple math:
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from the time of the 50th anniversary
Surgeon General's report five years ago,
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when this horrible statistic was raised,
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just through mid-century --
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that's more than 17 million
avoidable deaths in the United States
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from tobacco use,
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primarily because of cigarettes.
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The Surgeon General concluded
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that 5.6 million children
alive in the United States in 2014
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will die prematurely later in life
because of cigarettes.
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Five point six million children.
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So this is an enormous
public health problem for all of us
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but especially for us as regulators
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at the Food and Drug Administration
and the Center for Tobacco Products.
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What can we do about it?
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What can we do to reverse this trajectory
of disease and death?
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Well, we have an interesting guide
to help unravel issues
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like: How did the cigarette
as we know it come to be?
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What is the true nature
of the tobacco and cigarette business?
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How did the industry behave
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in the historically
unregulated marketplace?
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And our guide
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is previously secret internal documents
from the tobacco industry.
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Come with me
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in a tobacco industry
document time machine.
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Nineteen sixty-three
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was 25 years before the Surgeon General
was finally able to conclude
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that the nicotine
and cigarettes was addictive.
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That did not happen until
the Surgeon General's report in 1998.
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Nineteen sixty-three
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was one year before the first-ever
Surgeon General's report in 1964.
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I remember 1964.
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I don't remember
the Surgeon General's report,
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but I remember 1964.
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I was a kid growing up
in Brooklyn, New York.
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This was at a time
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when almost one in two adults
in the United States smoked.
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Both of my parents
were heavy smokers at the time.
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Tobacco use was so incredibly normalized
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that -- and this wasn't North Carolina,
Virginia or Kentucky,
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this was Brooklyn --
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we made ashtrays for our parents
in arts and crafts class.
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(Laughter)
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The ashtrays I made were pretty awful,
but they were ashtrays.
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(Laughter)
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So normalized that I remember seeing
a bowl of loose cigarettes in the foyer
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of our house and other houses
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as a welcoming gesture
when friends came over for a visit.
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OK, we're back in 1963.
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The top lawyer for Brown and Williamson,
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which was then the third-largest
cigarette company in the United States,
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wrote the following:
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"Nicotine is addictive.
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We are, then, in the business
of selling nicotine -- an addictive drug."
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It's a remarkable statement,
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as much for what it doesn't say
as for what it does say.
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He didn't say they were
in the cigarette business.
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He didn't say they were
in the tobacco business.
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He said they were in the business
of selling nicotine.
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Philip Morris in 1972:
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"The cigarette isn't a product,
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it's a package.
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The product is nicotine.
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The pack is a storage container
for a day's supply of nicotine.
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The cigarette, a dispenser
for a dose unit of nicotine."
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We'll come back to this
dose unit notion later.
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And R.J. Reynolds in 1972:
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"In a sense, the tobacco industry
may be thought of as being a specialized,
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highly ritualized and stylized segment
of the pharmaceutical industry.
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Tobacco products uniquely
contain and deliver nicotine,
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a potent drug with a variety
of physiological effects."
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At the time, and for many
decades, publicly,
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the industry completely denied addiction
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and completely denied causality.
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But they knew the true nature
of their business.
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And from time to time,
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there have been health scares
made public about cigarettes,
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going back many decades.
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How did the industry respond?
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And how did they respond
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in this historically
unregulated marketplace?
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Going back to the 1930s,
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it was with advertising
that heavily featured imagery of doctors
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and other health care professionals
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sending messages of reassurance.
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This is an ad for Lucky Strikes,
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the popular cigarette
of the time in the '30s:
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[20,679 physicians
say "Luckies are less irritating."
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Your throat protection
against irritation, against cough.]
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(Laughter)
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We laugh,
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but this was the kind of advertising
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that was there to send
a health message of reassurance.
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Fast-forward to 1950s, '60s and '70s.
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And here, again,
in the absence of regulation,
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what we're going to see
is modifications to the product
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and product design
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to respond to the health
concerns of the day.
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This is the Kent Micronite filter.
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And here, the innovation, if you will,
was the filtered cigarette.
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[Full smoking pleasure ...
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plus proof of the greatest
health protection ever.]
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What the smoker
of this product didn't know,
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what their doctor didn't know,
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what the government didn't know,
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is that this was a filter
that was lined with asbestos --
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(Gasps)
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so that when smokers
were smoking this filtered cigarette
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and still inhaling the chemicals and smoke
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that we know are associated
with cancer and lung disease
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and heart disease,
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they were also sucking down
asbestos fibers.
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(Gasps)
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In the 1960s and the 1970s,
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the so-called innovation
was the light cigarette.
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This is a typical brand
of the day called True.
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And this is after the Surgeon General's
reports have started coming out.
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And you see the look
of concern on her face.
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[Considering all I'd heard,
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I decided to either quit
or smoke True.
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I smoke True.]
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(Laughter)
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[The low tar, low nicotine cigarette.]
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And then it says, "Think about it."
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And then even below that
in the small print
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are tar numbers and nicotine numbers.
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What was a light cigarette?
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How did it work?
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This is an illustration
of the product modification
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known as "filter ventilation."
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That's not a real filter blown up.
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That's just a picture
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so that you could see the rows
of laser-perforated ventilation holes
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that were put on the filter.
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When you look at a real cigarette,
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it's harder to see.
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Every patent for this product shows
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that the ventilation holes
should be 12 millimeters
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from the lip end of the filter.
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How did it work?
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The cigarette got stuck into a machine.
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The machine started
puffing away on the cigarette
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and recording tar and nicotine levels.
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As the machine smoked,
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outside air came through
those ventilation holes
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and diluted the amount of smoke
that was coming through the cigarette.
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So as the machine smoked,
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there really was less tar
and nicotine being delivered
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compared to a regular cigarette.
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What the tobacco industry knew
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was that human beings
don't smoke like machines.
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How do human beings smoke this?
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Where do the fingers go?
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(Murmurs)
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Where do the lips go?
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I told you that the patent said
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that the holes are 12 millimeters
from the lip end.
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The smoker didn't even know
they were there,
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but between fingers and lips,
the holes get blocked.
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10:46
And when the holes get blocked,
it's no longer a light cigarette.
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Turns out that there's actually
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basically as much nicotine
inside a light cigarette
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as a regular cigarette.
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The difference was what's on the outside.
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But once you block what's on the outside,
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it's a regular cigarette.
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Congress put FDA in the business
of regulating tobacco products
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10 years ago this June.
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So you heard the statistics
at the beginning
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about the extraordinary contribution
to disease and death that cigarettes make.
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11:16
We've also been paying a lot of attention
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to how the cigarette works
as a drug-delivery device
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and the remarkable efficiency
with which it delivers nicotine.
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So let's take a look.
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When the smoker puffs on the cigarette,
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the nicotine from that puff
gets up into the brain
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in less than 10 seconds.
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Less than 10 seconds.
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Up in the brain,
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there are these things
called "nicotinic receptors."
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They're there ...
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waiting.
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They're waiting for, in the words
of that Philip Morris document,
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the next "dose unit of nicotine."
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The smoker that you see outside,
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huddled with other smokers,
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in the cold,
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in the wind,
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in the rain,
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is experiencing craving
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and may be experiencing
the symptoms of withdrawal.
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Those symptoms of withdrawal
are a chemical message
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that these receptors
are sending to the body,
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saying, "Feed me!"
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And a product that can deliver the drug
in less than 10 seconds
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turns out to be an incredibly efficient
and incredibly addictive product.
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We've spoken to so many
addiction treatment experts
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over the years.
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And the story I hear is the same
over and over again:
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"Long after I was able
to get somebody off of heroin
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or cocaine or crack cocaine,
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I can't get them to quit cigarettes."
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A large part of the explanation
is the 10-second thing.
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FDA has it within its regulatory reach
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to use the tools of product regulation
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to render cigarettes as we know them
minimally or nonaddictive.
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We're working on this.
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And this could have a profound
impact at a population level
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from this one policy.
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We did dynamic population-level
modeling a year ago,
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and we published the results
in "The New England Journal."
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13:19
And because of the generational
effect of this policy,
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which I'll explain in a minute,
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here's what we project out
through the end of the century:
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more than 33 million people
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who would otherwise have gone on
to become regular smokers won't,
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because the cigarette
that they'll be experimenting with
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13:34
can't create or sustain addiction.
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This would drive the adult smoking rate
down to less than one and a half percent.
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And these two things combined
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would result in the saving of more than
eight million cigarette-related deaths
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that would otherwise have occurred
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from the generational impact of this.
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Now, why am I saying "generational"?
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It's about kids.
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Ninety percent of adult smokers
started smoking when they were kids.
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Half of them became regular smokers
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before they were legally old enough
to buy a pack of cigarettes.
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Half of them became regular smokers
before they were 18 years old.
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Experimentation.
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Regular smoking.
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Addiction.
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Decades of smoking.
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And then the illness,
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and that's why we're talking
about a product
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14:23
that will kill half of all long-term users
prematurely later in life.
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The generational impact
of this nicotine-reduction policy
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is profound.
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Those old industry documents
had a word for young people.
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They were described as
"the replacement smokers."
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The replacement smokers
for addicted adult smokers
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14:44
who died or quit.
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Future generations of kids,
especially teens,
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are going to engage in risky behavior.
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14:52
We can't stop that.
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14:54
But what if the only cigarette
that they could get their hands on
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14:58
could no longer create
or sustain addiction?
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15:00
That's the public health
return on investment
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15:03
at a population level over time.
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15:07
Haven't said anything about e-cigarettes.
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But I have to say something
about e-cigarettes.
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15:11
(Laughter)
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We are dealing with an epidemic
of kids' use of e-cigarettes.
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15:15
And what troubles us the most,
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2159
15:17
in combination with the rising numbers
when it comes to prevalence,
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15:22
is frequency.
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15:23
Not only are more kids using e-cigarettes,
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15:26
but more kids are using e-cigarettes
20 or more days in the past 30 days
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15:30
than at any time since e-cigarettes
came onto the market.
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2777
15:32
And at FDA, we're doing
everything that we can
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15:35
using program and policy,
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1258
15:36
first to get the word out to kids
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1619
15:38
that this is not a harmless product
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2071
15:40
and to make sure that kids
aren't initiating and experimenting
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15:43
on any tobacco product,
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1160
15:44
whether combustion is present or not.
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1880
15:46
But think about e-cigarettes
in a properly regulated marketplace
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15:49
as something that could be of benefit
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15:51
to addicted adult cigarette smokers
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2120
15:53
who are trying to transition
away from cigarettes.
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2356
15:56
So, I'll leave you with this vision:
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16:01
imagine a world
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16:04
where the only cigarette
that future generations of kids
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16:06
could experiment with
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1161
16:07
could no longer create
or sustain addiction
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2238
16:10
because of a single policy.
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1737
16:12
Imagine a world
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1178
16:14
where health-concerned cigarette smokers,
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2686
16:17
especially if a policy goes into effect
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2896
16:20
that takes the nicotine levels down
to minimally or nonaddictive levels,
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3604
16:23
could transition to alternative
and less harmful forms
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2542
16:26
of nicotine delivery,
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1315
16:27
starting with FDA-approved
nicotine medications,
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2253
16:29
like the gum, patch and lozenge.
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1937
16:32
And finally,
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16:33
imagine a world and a properly
regulated marketplace,
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2849
16:36
whether it's e-cigarettes
or whatever the technology of the day,
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3214
16:40
it's not the product developers
and the marketers
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2301
16:42
who decide which products come to market
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1945
16:44
and what claims get made for them,
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1809
16:46
it's review scientists at FDA,
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2872
16:49
who look at applications
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16:50
and decide, using the standard
that Congress has entrusted us
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3674
16:54
to implement and enforce,
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2055
16:56
whether a particular product
should come to market,
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2833
16:59
because the marketing of that product
and the words of our law
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3238
17:02
would be appropriate for the protection
of the public health.
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17:06
These are the kinds
of powerful regulatory tools
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17:08
that are within our reach
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17:11
to deal with what remains
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17:13
the leading cause of completely
preventable disease and death
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17:16
in the country.
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1159
17:17
If we get this right,
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1267
17:19
that trajectory,
those 5.6 million kids,
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4589
17:24
is breakable.
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17:25
Thank you.
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17:26
(Applause)
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2713

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ABOUT THE SPEAKER
Mitch Zeller - Health policy expert
Mitch Zeller leads the US Food and Drug Administration's efforts to reduce disease and death from tobacco use and bring previously unavailable information about its dangers to light.

Why you should listen

As director of the Center for Tobacco Products (CTP), Mitch Zeller, JD, is dedicated to carrying out CTP's charge to reduce the harm from all tobacco products across the entire population -- with a focus on how and why people start, stop or start using these products again.

Zeller became director of the FDA's Center for Tobacco Products in March 2013. The mission of CTP -- established by enactment of the 2009 Family Smoking Prevention and Tobacco Control Act -- is "to make tobacco-related death and disease part of America's past, not America's future, and, by doing so, ensure a healthier life for every American family."

A graduate of Dartmouth College and the American University Washington College of Law, Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest (CSPI). In 1988, Zeller left CSPI to become counsel to the Human Resources and Intergovernmental Relations Subcommittee of the House of Representatives Government Operations Committee, where he conducted oversight of enforcement of federal health and safety laws.
In 1993, Zeller joined the staff of then-FDA Commissioner Dr. David Kessler, MD. What began as a two-week assignment by Kessler in 1994 to examine the practices of the tobacco industry led to his serving as associate commissioner and director of FDA's first Office of Tobacco Programs. Instrumental in crafting the agency's 1996 tobacco regulations, Zeller also represented FDA before Congress, federal and state agencies. Zeller also served as an official US delegate to the World Health Organization (WHO) Working Group for the Framework Convention on Tobacco Control.

In 2000, Zeller left FDA to continue his work for tobacco control as executive vice president of the American Legacy Foundation. His responsibilities there included marketing, communications, strategic partnerships and creating the foundation's first Office of Policy and Government Relations. In 2002, Zeller joined Pinney Associates where, as senior vice president, he provided strategic planning and communications advice on domestic and global public health policy issues involving the treatment of tobacco dependence and the regulation of tobacco products and pharmaceuticals.

More profile about the speaker
Mitch Zeller | Speaker | TED.com
THE ORIGINAL VIDEO ON TED.COM