FDA Center for Tobacco Products: Celebrating 10 Years of the Tobacco Control Act



we're celebrating the 10th 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 so 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 these products before so we had a lot of like logistical issues for example like where would we be where would our offices be where we'll be 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 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 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 the different researchers out there doing their own thing one of the things I think we've been very successful in the Office of Science and doing is being a facilitator to get better and integration across these researchers and and to really as a result create the synergy around tobacco science that just didn't exist 10 years ago so when I first came here I came directly from the advertising agency world and you know 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 our and science from an organization of one 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 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 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's is one of the challenges that that we are facing and I'm confident that we'll be able to be up to that task as well so deal with the change in the marketplace our past 10 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 in the market east cigarettes are what sometimes referred as vape products the challenge has been understanding these new products these novel products and understand them fully enough to understand how to best regulate them we went through a rulemaking process to expand our authority over the original products that Congress said we could regulate the original grant was cigarettes and smokeless tobacco basically and we went through something called the deeming rulemaking which took two and a half years and now we regulate every category of tobacco products that meets the definition of what is a tobacco product 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 the FDA has jurisdiction over these products we can establish requirements for them to help improve public health so 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 a thousand inquiries that were received in the first week we were able to hit the ground running when the rule began to go into effect as we confront whatever the 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 it's amazing how much we've accomplished I mean just the sheer volume of products we've had to deal with in the regular submissions like marketing applications and grant listings inspections you know that all of my staff neuroscience been involved in it's really remarkable and to really understand these products and understand how to meet our public health mission you know 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 you know mind blowing quite frankly last October we had our one millionth inspection that was completed and as a result of all the hard work working collaboration with the states we've issued tens of thousands of enforcement actions including warning letters and civil money penalties and over a hundred and fifty no tobacco sale orders 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 know through our evaluation that we had reached over 90% 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 or the real cost was the 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 dollars with a be in future health care costs that had been diverted because of the real cost 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 to policies through guidance and 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 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 lifelong smoker I've 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 in their future isn't very rewarding to me I think my staff stays super excited about it because the magnitude of impact that we can have and 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 have 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 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 when we look across the board at all of the issues and all 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 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 not addictive 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 can you imagine if there were a world where nicotine containing products were not addictive I think that would be a huge public health win I mean the hope is that we'll set policies that will really enable us to help adults find their off-ramp to leave cigarettes behind while preventing kids from taking an on-ramp and that's the delicate balance that we face from a policy standpoint and from a public education standpoint 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 you

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