MITCH ZELLER: We’re celebrating the tenth anniversary of the signing into law of the
Family Smoking Prevention and Tobacco Control Act.
We’re celebrating the making of history in 2009,
which gave powerful regulatory tools to the Food and Drug Administration
to use the tools of product regulation
to try to reduce the disease and death associated with tobacco use.
BEVERLY CHERNAIK: The Center was created by the Tobacco Control Act in 2009,
and it was really a very exciting, challenging time
because we were building a new FDA center from scratch.
And in addition, no one had ever regulated these products before.
So we had a lot of logistical issues, for example, where would we be,
where would our offices be,
where were we going to get computers
and phones and pencils and pens and things like that?
Also we needed personnel.
Fortunately, many people, including myself,
were very attracted to the Center because of its public health mission
and had kind of personal reasons for wanting to join the Center.
ANN SIMONEAU: Within days of the President signing the new law,
several of us were contacted by the Commissioner's Office
to come together to do the early steps of creating a new center.
We were all together in Building 51, I think it was the basement,
and the first thing we did was print out the new law.
MATT HOLMAN: When I first came to CTP, there was good tobacco research going on,
there has been for a long time, but there was very little integration.
You had different researchers out there doing their own thing.
One of the things I think we’ve been very successful in the Office of Science
in doing is being a facilitator to get better integration
across these researchers and to really, as a result, create this synergy
around tobacco science that just didn’t exist ten years ago.
KATHLEEN CROSBY: When I first came here,
I came directly from the advertising agency world.
And we had a really small team,
and I knew that we needed to build a team of professionals
that understood both the art and the science,
because at its core, advertising is the perfect blend of art and science.
JANELLE BARTH: And from an organization of 1 person to 800,
you really have to become very nimble.
An organization of 50 or 100 looks very different
and operates very differently than an organization of 800.
SIMONEAU: There was this camaraderie amongst all of the group
in which they were so dedicated to the public health mission of the Center
and knew what we were doing was so important for right now,
but also for generations to come.
ZELLER: We’re going to continue to grow.
We have to continue to grow
to meet the programmatic needs and demands that we have,
and being able to manage the continued growth of the Center
is one of the challenges that we are facing,
and I’m confident that we’ll be able to be up to that task as well.
HOLMAN: Dealing with the changes in the marketplace over the past ten years
has been a huge challenge, but I also think it presents an opportunity for us.
As most people know, we’ve seen new products come out on the market,
e-cigarettes or what is sometimes referred to as vape products.
The challenge has been understanding these new products,
these novel products, and understanding them fully enough
to understand how best to regulate them.
ZELLER: We went through a rulemaking process to expand our authority
over the original products that Congress said we could regulate,
and the original grant was cigarettes and smokeless tobacco basically,
and we went through something called the deeming rulemaking,
which took 2 1/2 years, and now we regulate
every category of tobacco products that meets the
definition of what is a tobacco product.
CHERNAIK: So this includes electronic cigarettes, cigars, pipes, hookah,
anything that meets the definition, as well as things that might be
created in the future that we haven't even thought about yet.
And what deeming did was it made them subject to the requirements of the law.
But one of the important things that it also did was
now that FDA has jurisdiction over these products,
we can establish requirements for them to help improve public health.
BARTH: The offices really do work together to make our announcements a success.
One of the examples that really stands out to me
is when we rolled out deeming, and, in particular,
there were volunteers from across all of the offices
that served in a call center with us.
They were the first-line volunteers answering the phone,
to answer the questions from over
1,000 inquiries that were received in the first week.
ZELLER: We were able to hit the ground running when the rule began to go into effect.
As we confront whatever the latest change in technology in the marketplace is,
or the latest thing that’s going on with kids’ uptake
of whatever the tobacco product is,
we are up to the task as long as we are in the game
and using the compliance tools, the research tools,
the communications tools, and the policy tools.
That’s what we do, and we’re good at it.
HOLMAN: It’s amazing how much we’ve accomplished.
I mean, just the sheer volume of products we’ve had to deal with
in the regulatory submissions, like marketing applications
and ingredient listings, inspections
that all of my staff in the Office of Science
has been involved in, it’s really remarkable.
And to really understand these products
and understand how to meet our public health mission,
understand the products well enough and how we should regulate them
to meet that mission
and to get where we’ve gotten in the past ten years
in that area is just mind-blowing, quite frankly.
SIMONEAU: Last October, we had our one-millionth inspection that was completed,
and as a result of all the hard work,
working in collaboration with the states, we've issued tens of thousands
of enforcement actions, including warning letters and civil money penalties,
and over 150 No-Tobacco-Sale Orders.
CROSBY: The first campaign that we’ve gotten to market is called “The Real Cost,”
and in the first two years that “The Real Cost” was in the market,
we knew through our evaluation that we had reached over 90 percent of kids,
effectively, at least 15 times every quarter of the year.
We know that we actively shaped and changed their attitudes and beliefs
towards tobacco products. We know that the independent effect of “The Real Cost”
was that nearly 350,000 kids who would have gone on to use tobacco
if “The Real Cost” wasn’t in market, didn’t.
Those children have an opportunity to lead a healthier life.
We’ve saved the nation over $31 billion, with a B,
in future healthcare costs that have been diverted
because of “The Real Cost.”
ZELLER: From award-winning public-education campaigns,
to a compliance and enforcement program that’s conducted over
1 million inspections of retailers,
to a regulatory science program that is
doing groundbreaking work with longitudinal studies
following tens of thousands of children and adults,
to policies through guidance and regulation
that are going to be the envy of regulatory authorities all around the world
if they had the same tools that we do.
BARTH: What I have found most personally rewarding about my work here
is that the opportunity to make a difference,
to reduce the death and disease caused by tobacco is so real.
My father is a life-long smoker.
I grew up watching him struggle with the addiction of nicotine.
I now have two young children,
and having the opportunity to make that difference
for the rest of America moving forward,
and especially for my kids and their future
is very rewarding to me.
HOLMAN: I think my staff stays super excited about it,
because the magnitude of impact that we can have in decreasing
the number of Americans who die or suffer chronic disease
from tobacco use is enormous.
And for me personally, I have family members who’ve died from lung cancer.
I have young children myself, I have nieces and nephews
who are at that age where they might pick up tobacco products,
and so to be able to have an impact on those people that I know personally
is a huge opportunity that I’m extremely grateful for.
CHERNAIK: My mother smoked for over 40 years
and she died of lung cancer.
My father never smoked but lived with my mother all those years
and he died of lung cancer.
Most of the people who came to the Center at the very beginning,
and I think many who still are coming to the Center,
do so because they are drawn
to the public health mission of the Center.
ZELLER: When we look across the board
at all of the issues and all of the tools and the resources that we have,
there’s one thing that we keep on coming back to.
It’s not just that tobacco use is the leading cause of
completely preventable disease and death in this country,
it’s that the primary contributor to that is cigarettes.
And we have it within our regulatory reach
to use regulatory tools and science
to transform the cigarette as we know it
by going through a rulemaking process
to render cigarettes minimally or nonaddictive.
And we’ve done some modeling out through the end of the century
to project what the population level impacts
of that one policy would be.
Many millions of lives would be saved
from this one policy if we get it right.
CHERNAIK: Can you imagine if there were a world where
nicotine-containing products were not addictive?
I think that would a huge public health win.
CROSBY: The hope is that we’ll set policies
that will really enable us to help adults
find their offramp to leave cigarettes behind
while preventing kids from taking an onramp.
And that’s the delicate balance that we face
from a policy standpoint and from a public-education standpoint.
ZELLER: It is so rewarding to see the passion and the commitment
and the dedication of everybody in the Center
to the public health mission of what we are about, which is
to do something about the leading cause of completely preventable
disease and death in the country and in the world.