Thank you, Dr. Curry. It is indeed a pleasure and great honor to be with all of you today. The work that you do, building the scientific base of understanding nicotine and tobacco, is enormously important to all of our work the Food and Drug Administration’s Center for Tobacco Products. And on behalf of Food and Drug Administration Commissioner, Dr. Margaret Hamburg, I would like to extend a special thanks to each of you for being here today and to welcome those of you from outside the United States who travelled a long distance to come to Baltimore.
I’m sure it goes without saying, but for me and the members of my staff who are here today, we look forward to learning from your research and experience as we move to fulfill our mission to implement the Family Smoking Prevention & Tobacco Control Act.
Now, as you can imagine, as the person charged with implementing the FDA’s new authorities for tobacco product regulation, it is important for me to try to meet with as many relevant groups and organizations as I can.
But there are very few who have a greater appreciation and understanding of the complexities of tobacco science and its role in tobacco control policy than you, who are sitting in this room today.
It was just eight months ago -- this week -- that President Obama signed the Family Smoking Prevention & Tobacco Control Act.
And, if you remember, at the time it was characterized as a tremendous victory for public health advocates.
And, of course, it was.
But I think you and I know IT was much more than that: it was really a triumph for science.
Over the course of three generations -- from H.S. Diehl’s first studies of cigarette tar at (the University of) Minnesota, Ernst Wynder’s work on lung cancer risk and the work of epidemiologists Hammon and Horn for the American Cancer Society, UP through your work today -- science has redefined the role of tobacco in American life.
What Americans once regarded as a bad habit or, at worst, a vice, we came to recognize as an addiction with deadly consequences.
Thanks to your predecessors -- and thanks to you – America and the world know better, and countless men and women are living longer, healthier lives for it.
That’s true whether you work in academe, the government, or in the private sector.
And, I’m here to tell you that, with tobacco product regulation by the FDA now a reality, your work and the work of your colleagues has never been more vital to our nation’s health -- and to global health -- than it is right now.
With implementation of the Tobacco Control Act, the best available science drives our regulation of tobacco products. So today, and into the future, tobacco control is being driven by regulatory science; not political science.
It’s an historic advance and one that presents new challenges, and, in a very real sense, defines new opportunities and responsibilities for the nicotine and tobacco research community.
I say that not as a battle-scarred veteran of the tobacco wars, but as someone who has worked for more than 30 years helping to translate science into public health priorities and public health policy; and public health policy into action.
As a good number of you know, I take a lot of pride in the fact that, back in 1978, I helped set up the original Office on Smoking and Health at the Department of Health, Education and Welfare when I had the opportunity to meet Ernst Wynder, Dan Horn, John Banzhaff, John Pinney, and others. And I’m also very proud of the advances in smoking cessation I led while I was at the Department of Veterans Affairs over the last 12 years.
But when Commissioner Hamburg asked me to take on this mission, it was less because of my work on smoking and tobacco, than the fact that I’m a practicing physician, a researcher, that I’ve worked on Capitol Hill and have led several large public health programs in two cabinet departments … and that I’ve had a hand in shaping the federal responses to dangers ranging from HIV/AIDS, bioterrorism to pandemic flu.
In fact, Commissioner Hamburg and I first met when we were both at NIH and I was Chief of the HIV therapeutics research branch of NIAID in the late 1980’s and 1990s.
In many ways, that experience – crafting science-based, multi-pronged strategies to respond to HIV -- is proving itself to be more relevant to this field than any of the other work I’ve done.
So I come to this position not as a veteran of the tobacco wars, but as a clinician, a researcher and a public health practitioner.
And, one who believes the best way to overcome tough public health challenges isn’t by embracing one single solution.
No: Complex problems require multi-faceted, comprehensive approaches based on the best available science.
That’s good policy. And it’s fundamental to the FDA’s tobacco product regulation authority.
That’s really the beauty of the Family Smoking Prevention and Tobacco Control Act.
It enables us to take action and move ahead on tobacco product regulation on many levels:
Preventing tobacco use by young people. Making tobacco less appealing to kids at the same time we make it less available.
Expanding public awareness – and understanding – of the actual constituents in tobacco and tobacco smoke and the real-life consequences of using tobacco.
Motivating tobacco users to quit by providing them with reliable information about tobacco products. Developing working partnerships with the States to enhance their efforts to enforce the provisions of the Tobacco Control Act.
Using all of FDA’s enforcement tools to ensure compliance with the provisions of that law.
And using science-based regulation to reduce the devastating toll tobacco use has taken, and continues to take on American families.
Now, obviously the science standard that we will be using for tobacco product regulation will be different from the science standard used by FDA in regulating drugs and medical devices. The standard FDA uses there is based on safety and effectiveness of those products.
Clearly, that standard will never apply to tobacco products.
I still think Gro Brundtland put it better than anyone. You might remember how, back when she was director-general at the WHO, she made famous the point that cigarettes are the only consumer product which - when used as directed - kills its consumer.
So the Tobacco Control Act directs that we regulate tobacco using a public health and population health standard.
That’s why it calls on the FDA to move ahead on a number of fronts –through a variety of regulatory actions.
And, to fulfill our responsibility, the Act clearly spells out a series of specific regulatory actions that are aimed at multiple targets
- prevention of youth tobacco use,
- tobacco advertising and promotion,
- tobacco product warnings and
- standards for tobacco products appropriate to the protection of public health.
The Tobacco Control Act also gives FDA the authority to take other actions in the future based on the continual expansion of the science base related to tobacco products.
I would like to outline five key features of the Act for you:
First, the Act mandated a permanent ban on fruit, herb, or spice-flavored cigarettes. That’s been in effect since September.
I know I don’t need to explain why we moved on that as quickly as we did to prevent youth from getting addicted to tobacco products in the first place.
The best description I’ve heard is that candy and fruit-flavored cigarettes are as fundamental to the future of smoking as training wheels are to the future of bicycles.
But that’s not all.
The Act also gives FDA the authority to take action against other flavorings and ingredients – including menthol.
It also empowers us to establish conditions for marketing modified risk products, to determine whether new tobacco products can be marketed, to review claims of substantial equivalence, and to assess whether our regulatory actions, in fact, meet the public health and population health standards of the law.
And importantly, I want to emphasize that the Tobacco Control Act also allows FDA to put in place specific tobacco product standards. We will be able to set standards for levels of toxins or carcinogens, nicotine, and for other aspects of tobacco product design to protect the public health. Of course, I shouldn’t have to tell you we’ll need good science to tell us the best way to approach these regulatory standards.
Second, the Act requires the creation of a Tobacco Products Scientific Advisory Committee.
This is a science-based, science-driven panel that is tasked with many responsibilities under the Tobacco Control Act such as addressing the issue of menthol in cigarettes – including its use by children, use among racial and ethnic minorities, its effect on addiction, disease risk and other issues.
The Advisory Committee is also mandated to consider the public health impact of dissolvable tobacco products, including their potential attractiveness to young people. And the Committee has many other responsibilities.
The committee will have 12 members. There will be 9 voting members including one who represents federal, state or local government, and another voting member who represents the general public. There will also be three non-voting members, representing the tobacco industry, small tobacco manufacturers, and tobacco growers.
Let me take a minute and talk about the tobacco industry. It can not be easy for an industry to submit to new regulation for the first time. And the tobacco industry poses special challenges. The industry has a history of resistance to working with government agencies. And the industry may realistically perceive a serious threat to its long-term interest in FDA oversight.
Successful implementation of the Tobacco Control Act requires engagement with various components of the tobacco industry directly, fairly and with transparency.
The design of effective regulatory measures requires good understanding of the industry to be regulated. Already, input from a wide variety of companies, large and small, was helpful in establishing the system for industry registration with FDA and submission of listing of tobacco products.
So as I said the TPSAC will have 3 non-voting members representing the tobacco industry.
These members will be able to share the industry’s perspective on all our work together and FDA is looking forward to the full and open participation by these representatives.
Of the 9 voting members of TPSAC, at least seven voting members will be health care professionals who are experts and/or practitioners in areas ranging from oncology, to toxicology, to addiction, to public health.
In other words, the committee will hear every perspective on the issues. And, as Congress intended, science will have the strongest voice of all.
We received over 100 nominations for the nine voting members and right now we are working to get these and the non-voting slate finalized.
Third, the Act requires tobacco industry registration with the FDA and for FDA to establish Good Manufacturing Practices and to conduct biennial inspections of those businesses that manufacture tobacco products.
Fourth – and critically important – the Act requires manufacturers and importers to report their products’ ingredients, nicotine content, and any and all research on the health and physiological effects of the product’s use. Manufacturers must submit to the FDA any changes in the ingredients of their products and it also requires them to turn over documentation of their marketing practices and their effectiveness.
Fifth, the Act authorizes FDA to require new, larger, and more prominent health warnings on packages and in advertising. For cigarettes, the new packs and ads will have nine warning statements and, for the first time, the FDA will require these warning labels to include color graphics clearly depicting the negative health consequences of smoking. For smokeless tobacco, the new packs and ads will be required to bear one of four warning statements.
These aren’t suggestions; this is now federal law. And when this or any of the other requirements of the law aren’t being obeyed, FDA has the power to investigate and authority to enforce compliance – and, believe me, FDA will not be shy about applying that authority.
So, what have we done in the eight months since the Act was signed?
Well, as I said, we’ve enforced the law’s ban on flavored cigarettes. To date, FDA has issued 25 warning letters to firms that have violated this ban.
We issued the Final Guidances on Industry Registration with FDA, Submission of Tobacco Product Listing and on Ingredient Submission.
We have chartered the Tobacco Product Scientific Advisory Committee, and are working to finalize its members. It will have its first public meeting in the near future.
We have instituted the Congressionally-mandated collection of the tobacco industry user fees which funds the activities of the Center for Tobacco Products.
We’ve begun meeting with other Federal agencies and will soon meet with state and local officials to coordinate their involvement in further development of the science base for tobacco product regulation, enforcement and public education.
And, of course, we established the FDA Center for Tobacco Products.
But that’s just the start.
Over the next eight months the Tobacco Control Act provides that we will do the following:
Reissue the 1996 Rule that restricts tobacco sales and marketing to young people and contains restrictions on promotion and advertising of cigarettes and smokeless tobacco.
Enforce the requirement that tobacco products using terms like “light,” “low,” and “mild” may be sold only if applications are submitted for them and FDA issues an order permitting their sale – and we’re interested in whether other marketing tools like use of certain colors or numbers might be falsely suggesting to consumers that some products are safer than others.
And we will implement use of new warning labels on smokeless tobacco products.
The FDA Center for Tobacco Products is 6 months old this week. We hit the ground running and we accomplished a lot in that time, but it’s only a small fraction of the gains we intend to make over the coming months and years.
Gains that will mean longer, healthier lives for millions of Americans now, and for generations to come.
The Act laid out a series of very specific goals and deadlines.
And we will meet them.
But I want to be clear that as aggressive as we are and will continue to be, what we do at FDA is only part of the equation.
The public health movement that was solidified by Surgeon General Luther Terry’s report in 1964 did not end with the signing of the Tobacco Control Act last June.
FDA’s new role is only one piece in a large, and stunningly complex puzzle.
The success of our efforts will ultimately be determined by the quality of our science.
And that’s where YOU come in.
A moment ago I remarked that this new law offers both new challenges and responsibilities.
I think first and foremost among them is to give us, at FDA your best thinking about the research agenda we need, to achieve the gains we want.
From the workshop that was held yesterday I know you’re already doing that – and I invite you to do more.
We need you the researcher, the scientist to be a stakeholder, not a spectator.
We need to hear your voices – not only in settings like this – but every time we open a FDA docket asking for scientific information or a summary of research findings.
I know many of you are familiar with FDA dockets. For those of you who aren’t, when the FDA begins consideration of a rule or regulation we sometimes create what’s called a docket to collect public comments and research findings.
Not many people realize this, but contributing to a docket offers an opportunity to have direct impact on the regulatory process by contributing information, data, and research on important issues around tobacco product regulation and other matters related to implementing FDA’s responsibilities under the Act. For example, we recently published a docket notice and received comments on the use of tobacco marketing descriptors that may convey modified risk. And the Center for Tobacco Products will be opening dockets on a series of specific topics in order to solicit information, data, and research which will help us.
It’s an opportunity I hope you’ll take advantage of because we need the best available science, and you’re the men and women who can help provide it.
I do want to have time to take some questions, but I want to touch back on something I said earlier.
You might recall that I mentioned I was a practicing physician. What I neglected to tell you is that I still am.
In fact, when I took this position it was on the condition that I could continue to see my clinic patients at the Washington DC VA Medical Center. And I do.
Every Friday morning I go to the clinic and offer the best care I can to people who sacrificed and suffered more than most Americans can imagine.
Many of my patients are veterans living with HIV -- and as you likely know, Veterans smoke at a rate significantly higher than average.
And I make a point of telling each of them, who use tobacco that, if they take their HIV medicine, in all likelihood, it won’t be HIV that will kill them. No. It will be their tobacco use.
The first time I say this to one of my patients he/she look at me like I’m speaking a foreign language. It never occurs to most people with HIV infection that tobacco use could be more dangerous than their HIV.
But here is how I think of it. It is not because the health risks associated with tobacco have dramatically expanded, but because science succeeded in transforming HIV: making what was once an incurable, rapidly fatal disease into a chronic, but treatable condition.
When I went to NIH in 1987 few imagined that was possible in the space of a generation – let alone half a generation.
But thanks to the vigorous application of science we succeeded.
It was because we embraced a multipronged scientific and public health strategy.
It was because we saw the seamless connection between the researcher in the laboratory, the clinician in the clinic and the outreach and prevention worker in the community.
Yes, it was research on the pathogenesis of the HIV virus, it’s perturbation of the immune system and impact on the complex cytokine cascade, it was the development and testing of the nucleoside reverse transcriptase inhibitors and protease inhibitors, it was the long-term epidemiologic cohort studies and innovative treatment interventions combining new therapeutics, and it was also using a science-based public health approach … and more.
It was because we understood that while it was one war, that war had to be waged on many different fronts.
That’s why I’m so excited about by our work to implement this new law.
Because it’s grounded in that same belief in a multipronged approach -- in science applied vigorously … and is the goal of our regulatory science.
Today, for the first time ever, the FDA has the tools and FDA is a full partner with you and public health and science agencies to build a healthier future for America in which the disease, disability and death caused by tobacco can be relegated to the history books.
With your support, your vision, your commitment to nicotine and tobacco research, I pledge to you that we will write that history.
Thank you for your work and thank you for your attention this morning.