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  1. Speeches by FDA Officials


Event Title
Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
June 28, 2017

Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drug Administration
July 28, 2017
White Oak, MD

(Remarks as prepared for delivery)

Tobacco use remains the leading cause of preventable disease and death in the United States. But much has changed in the landscape of tobacco product regulation and FDA’s ability to address this public health crisis.

For one, FDA has significant new regulatory authorities.  When I last served, FDA lacked the authority to regulate tobacco products as traditionally marketed.  Since that time, our statute has been amended to include an entire chapter of new authorities. And FDA has stood up a new Center for Tobacco Products that already has a number of important accomplishments.

There’s also been enormous change in the marketplace for tobacco products since I was last at FDA.  In just the last few years, we’ve seen the advent and adoption of new product categories that may be able to deliver nicotine without having to burn tobacco.

As a physician who cared for hospitalized cancer patients, and as a cancer survivor myself, I saw first-hand the impact of tobacco.  And I know all too well that it’s cigarettes that are the primary cause of tobacco-related disease and death.  What’s now clear is that FDA is at a unique moment in history, with profound new tools to address this devastating impact.

Addressing the addiction crises that are claiming young lives and hurting American families is our most pressing mandate at FDA.  In particular, examining the presence of nicotine in combustible cigarettes has to be part of a much broader strategy.  I’ve pledged a deep commitment to taking aggressive steps to address the epidemic of addiction to opioids. I view our opportunity to confront addiction to nicotine with the same obligation.  I’ll pursue efforts to reduce addiction to nicotine with the same vigor.

Yes, there’s been progress since the landmark 1964 Surgeon General’s Report on Smoking and Health, including significant reductions in adult and youth tobacco use.  But the 50th Anniversary Surgeon General’s Report in 2014 indicated that the death toll from cigarette smoking was 480,000 every year.  So at this rate, from the release of the 2014 Surgeon General’s Report just through the mid-21st century, 17,280,000 Americans will die avoidable premature deaths because of cigarette smoking.

The magnitude of these numbers is hard to fathom.  But I’m sure that every person in this room has had a friend or loved one made ill or worse because of tobacco use.  And as a doctor I can tell you that tobacco-caused diseases -- especially cancer and lung disease -- are extremely painful.

In addition to the devastating human toll of tobacco use, cigarette smoking also causes direct health care and lost productivity costs totaling nearly $300 billion a year.  So there are substantial financial costs to society as well.

There are two key facts about tobacco use that must be front and center in our thinking if we’re going to be serious about altering the current trajectory of preventable tobacco-related deaths. 

Fact One:  The overwhelming amount of the death and disease attributable to tobacco is caused by addiction to cigarettes.  Addiction causes long-term sustained use. But it’s exposure to the harmful chemicals that cause disease.  Cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users. 

And Fact Two:  Almost all adult smokers started smoking when they were kids.  Nearly 90 percent started smoking before the age of 18, and 95 percent by age 21.  If you make it to age 26 without smoking, the odds are overwhelmingly in your favor that you won’t become a smoker.  Only about 1 percent of cigarette smokers start at that point or later in their lives.

Congress gave FDA powerful tools to help reduce the harms caused by tobacco use when it passed the Family Smoking Prevention and Tobacco Control Act in 2009.  And it sent a strong signal by calling it the Family Smoking Prevention and Tobacco Control Act.  To put it simply:  it’s all about kids and families.  Congress made that clear in the law. And we take that responsibility very seriously.

FDA has made great progress protecting those who are the most vulnerable -- our children -- from tobacco’s harms. The Agency produces public education campaigns that have kept nearly 350,000 kids who would otherwise have started to smoke from smoking. We vigorously enforce the law that makes it illegal to sell tobacco products to kids.

But too many children still experiment with tobacco products.  Too many of these children will make the progression to regular smoking, and end up being addicted to cigarettes.  And too many people who are addicted to cigarettes today and want to quit are unable to do so.

We must do more to help these Americans and their families to lead healthier lives, and to avoid or break free from harmful cigarette addiction. 

The key lies in taking a new and comprehensive approach to the regulation of nicotine.

Why nicotine?

Because nicotine lives at the core of both the problem and, ultimately, the solution to the question of addiction, and the harm caused by combustible forms of tobacco.

Nicotine is astonishingly addictive.  And when nicotine is attached to cigarette smoke particles, it’s not only highly addictive, but an addictive chemical mix of disease and death.  One feature critical to cigarettes is the efficiency by which they deliver nicotine.  And inhalation is the key.  A cigarette can deliver the inhaled nicotine through the lungs and to the brain in less than 10 seconds, adding to its addictive potential.

But the nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.  Yes, it got them all addicted and kept them addicted for the long term.  And it got most of them addicted when they were still teenagers.  But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine. 

So we need to take a fresh look at nicotine itself, and how the addiction that it causes relates to the potential harm of its delivery mechanism. 

Nicotine is by no means a completely safe and benign compound.  But a family and population-focused approach to reducing tobacco-caused disease and death must start from the premise that, as far as nicotine is concerned, the problem isn’t just the nicotine.  The bigger problem is the delivery mechanism -- how the nicotine gets delivered.  Attach it to smoke particles created by burning cigarettes and the mechanism is deadly.  But attach the very same nicotine to a medicinal product without the other chemicals found in tobacco products and these therapeutic products have been found to be safe and effective by FDA in helping smokers quit. In fact, for nicotine replacement products such as gum, lozenges and patches, FDA doesn’t even require a doctor’s prescription for them.

So how can we take a new and comprehensive approach to nicotine?

For starters, given everything I just said about the vital role of the delivery mechanism, we must acknowledge that there’s a continuum of risk for nicotine delivery.  That continuum ranges from combustible cigarettes at one end, to medicinal nicotine products at the other.

We must also acknowledge the evidence that shows the majority of cigarette smokers are concerned about their health and about two-thirds of adult smokers have stated they want to quit. They know it’s hard, and they’ve probably tried many times to quit with over half of adult smokers making an attempt to quit each year.

And we must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution.  While there’s still much research to be done on these products and the risks that they may pose, they may also present benefits that we must consider.  FDA’s investment in regulatory science will eventually answer many of those benefit and risk questions.

Armed with the recognition of the risk continuum, and the reality that all roads lead back to cigarettes as the primary cause of the current problem, we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.

And that’s why today I’m directing our Center for Tobacco Products to develop a comprehensive nicotine regulatory plan premised on the need to confront and alter cigarette addiction.  I’ve followed the compelling discussion—both the public discourse and within the Agency—of FDA’s potential to render cigarettes minimally addictive or non-addictive by regulating their nicotine levels.  I’ve seen the science in this area and believe it holds much promise.  We intend to take a hard look at the existing published literature on this important topic and hear from stakeholders, which could provide the basis for regulatory action.  To begin this process, we will develop an Advance Notice of Proposed Rulemaking to identify the issues FDA would need to address to use our clear authority under the product standard provisions in the Tobacco Control Act to regulate nicotine in combustible cigarettes and render them minimally or non-addictive.

Cigarettes will likely remain incredibly toxic, what with the presence of over 7,000 chemicals in cigarette smoke.  But with a balanced regulatory approach, we may be able to reach a day when the most harmful products are no longer capable of addicting our kids.

I can tell you that FDA and others have done some preliminary analysis of the potential public health impacts if cigarettes could no longer create or sustain addiction.  The public health benefits at a population level kick in over time, as future generations of kids who may experiment with cigarettes find it far less likely to ever become addicted to nicotine, and to suffer the chronic diseases that they are at great risk of experiencing once addicted to combustible cigarettes. And those potential generational public health benefits could be staggering in terms of life years gained, and economic costs avoided.

I’ve also asked CTP to explore the potential for any adverse effects from reducing nicotine levels, especially the possibility of a black market for higher nicotine products.  And we need to understand what role, if any, the availability of newer forms of nicotine delivery may play in reducing those adverse effects.

We intend to consider these and other relevant questions as part of our public process. That process will be one of a series of new rulemakings that we will begin working on immediately. These rulemakings will address foundational regulatory elements for a modern and sustainable effort to regulate tobacco products. Our approach to making nicotine the center of our regulatory efforts needs to be accompanied by a firm foundation of rules and standards for newly-deemed products.

Among other things, we will advance rules that will lay out what needs to be in applications for Substantial Equivalence, Modified Risk Tobacco Product, and Pre-Market Tobacco Product applications; whether and how we would exempt premium cigars from regulation; how to possibly regulate kid-appealing flavors in products like Electronic Nicotine Delivery Systems, or ENDS; and whether we should ban menthol in cigarettes and flavors in cigarillos – factors that we know are a leading driver of youth smoking.

But the most substantial new undertaking is the one aimed at nicotine, and to start, an Advance Notice of Proposed Rulemaking to explore how we could reduce nicotine in combustible cigarettes. Looking at ways to reduce nicotine levels in cigarettes so that they are minimally or non-addictive, while not altering the nicotine content of noncombustible products such as e-cigarettes, is a cornerstone of our new and more comprehensive approach to effective tobacco regulation.  And Congress has made clear that FDA has this authority.  As I see it, taking the next step and addressing nicotine is not just within our authority; it’s an enormous public health opportunity and falls squarely within FDA’s mission.

But, as we move forward with this approach, we must also take a new and fresh look at the noncombustible side of the house.  And that is why part of CTP’s task is to reconsider aspects of the implementation of the final deeming rule with an eye towards fostering innovation where innovation could truly make a public health difference, and making sure we have the foundational regulations we need in place to make the entire program transparent, predictable, and sustainable for the long run.

One area of emphasis will be to make sure we have the foundational regulatory architecture to ensure proper oversight of ENDS.  This firm foundation will establish a series of proper regulatory gates. Part of this will be developing regulations that we have not yet pursued because the Agency’s tobacco program itself is so new.  To take one example, I have real concerns about kids’ use of e-cigarettes, and I know many others share those concerns, especially those products marketed with obviously kid-appealing flavors.  As soon as the FDA deeming rule went into effect last summer that extended our authority to include ENDS, cigars, and all other tobacco products, FDA started enforcing provisions that, for the first time under federal law, made it illegal to sell all those products to kids. 

We will re-double our efforts to protect kids from all nicotine-containing products. This has to include looking at the role of kid-appealing flavors, because kids shouldn’t be using any of these products.  So going forward I am asking the Center for Tobacco Products to develop an Advance Notice of Proposed Rulemaking to address the issue of flavored tobacco products and kids.  This will be just one of the new proposed rulemakings and policy actions we are committing to today, in order to start the process for defining how we intend to properly regulate the deemed products.

As we move forward, I also hope that we can all see the potential benefits to addicted cigarette smokers, in a properly regulated marketplace, of products capable of delivering nicotine without having to set tobacco on fire.  The prospective benefit may be even greater for the subset of current cigarette smokers who find themselves unable or unwilling to quit. 

It’s incumbent upon us as regulators to explore both the potential public health benefits and the risks of this new technology with an open mind.  And I can assure you, from my discussions with the leadership of the Center for Tobacco Products, that FDA is bringing just that mindset to the task at hand.

To give ourselves time to implement this framework, including through notice and comment rulemaking, I’m directing CTP to reconsider the various compliance policies associated with the deeming regulation.  This includes the policies relating to the compliance periods for premarket submissions for products on the market at the time the deeming rule took effect and for FDA’s review of those submissions.  Specifically, CTP will consider the language in the preamble that set forth timelines for submissions and raised concerns about products coming off the market before FDA had reached a decision.  Reconsideration of these policies is within FDA’s discretion, and we are exercising that discretion in a targeted way in order to lay the groundwork for a more strategic long-term approach to regulating tobacco products.

The question is this: If we lean in on nicotine regulation wholeheartedly, how do these compliance policies fit into our overall goal?  In a world where FDA is pursuing how to regulate nicotine levels in cigarettes, and combustible cigarettes are one day far less addictive, we can take the time to make sure we have in place the foundational elements of a robust and sustainable framework for regulating the non-combustible forms of nicotine delivery.  That means extending further some of the current compliance deadlines for newly deemed products, primarily electronic cigarettes and cigars, that were previously extended. All of the requirements for newly deemed products that have already gone into effect will continue to stay in force.  In a world where there is no mandated reduction in the levels of nicotine in noncombustible products, our compliance policies should account for changes that will move addicted smokers down that continuum of risk to these less harmful products.

We need to make sure we strike the right balance between FDA fulfilling its vital consumer protection role while also fostering innovation when it comes to potentially less harmful forms of nicotine delivery. This becomes especially true in a world where cigarettes are no longer capable of creating or sustaining addiction. 

These are questions that FDA must confront.

I am also directing CTP to explore other aspects of the current application review process.  In particular, I have asked CTP to consider whether its current plan, which is to review all of the so-called Provisional Substantial Equivalence products, is an effective use of its resources and whether it should continue to pursue the current approach to these reviews.   I have asked CTP to consider whether there is an approach that makes more sense, and whether by not reviewing some of those products, those review resources could be freed up for other purposes and greater clarity could be provided to the market. 

In addition, we’ll also be revising the so-called “sunset policy” through additional guidance so that existing products under review remain on the market. The current policy could have forced existing products off the market.  We’ll also be working to put in place a more comprehensive, transparent, and vigorous regulatory framework that will make our regulatory efforts more sustainable.

Finally, as I’ve noted, I’m also asking the Tobacco Center leadership to explore a process by which it could ask for new information related to the patterns of use and resulting public health impacts from so-called premium cigars.  The final deeming rule covers all cigars.  But I want the Center to consider opportunities it could provide to interested parties to develop and submit new information or data on this issue.  This will take the form of a new Advance Notice of Proposed Rulemaking, to develop a new administrative record to explore these questions. We will explore any new and different questions raised, and seriously consider any additional data submitted relevant to the appropriate regulatory status of premium cigars. 

The comprehensive framework for nicotine regulation I’ve laid out here is an FDA-wide imperative.  This means we must also work to have medicinal nicotine and other therapeutic products play a greater role in helping more smokers try to quit with help, to quit successfully, and to stay quit.  That’s why I’m also asking our Center for Drug Evaluation and Research to examine possible steps we can take to address the performance of medicinal nicotine products, including the speed with which the nicotine is delivered, and other possible innovations in treatments that could help more smokers use FDA-approved products to quit smoking.

The potential to improve product performance here is a significant public health opportunity.  And I hope sponsors will come in and talk with us about steps that can be considered under the safety and efficacy standard for products that are intended to help smokers quit.

I want to emphasize that all of the steps I’ve outlined today are intended to work together as a package deal.  One federal court recently upheld the Agency’s authority over newly deemed products.  Each component of this broader plan builds on the deeming rule and is part of an overall effort to reduce the adverse effects of cigarettes, create clearer guideposts for the regulation of all products, and account for the role of all noncombustible products.

As a comprehensive public health package, it’s really all or nothing.  For example, we cannot make certain accommodations on compliance deadlines or give ourselves the time to put in place foundational rules, or take a different approach to the sunset policy or the provisional applications, if we’re not also pursuing the regulation of nicotine in combustible cigarettes. It’s only in a world where we will work to eventually render cigarettes minimally addictive that we can take on some of the other challenges or provide the greater flexibility outlined here when it comes to e-cigarettes and any other noncombustible products. And we cannot pursue a plan to minimize the addictiveness and attractiveness of cigarettes if we can’t simultaneously take the time to adopt additional procedural and foundational policies and regulations that are critically important to achieving our goals.  That’s why it’s a package. And it’s why we need to pursue all of these measures together.

I’ve formalized this comprehensive plan in close collaboration with the leadership of FDA’s Center for Tobacco Products. I’m moving forward with their full support and the support of my senior team.

In closing, we truly find ourselves at a crossroads when it comes to efforts to reduce tobacco use.  We have the potential to improve the lives of tens of millions of currently addicted cigarette smokers, and future generations of kids.  But if we’re going to meaningfully improve the public health, we need to be willing to take a hard look at our entire approach to tobacco, to make sure we have the right regulatory gates in place to evaluate products, and to focus more squarely on the nicotine.  On the one hand, there’s the ongoing divisive debate around the pros and cons of e-cigarettes.  Precious little progress has been made as competing camps dig in on the benefits and risks of a harm reductionist approach to this new technology.  Both sides are convinced that they’re right, but we’ve seen little progress, and virtually no common ground.  On the other hand, there’s a pathway forward that reframes the debate around nicotine. 

Three things have changed more recently that together provide an extraordinary opportunity to use the tools of product regulation so that tobacco use, and principally cigarettes, will no longer be the leading killer of Americans. 

First, the entire spectrum of nicotine-delivering products is now regulated, from the most to the least harmful.  Second, regulatory science is providing an evidence-base to inform policy for regulating the addictiveness of the deadliest form of nicotine delivery.  And third, even with unanswered questions about benefits and risks, there are now different technologies to deliver nicotine, for those who need it, that doesn’t bring with it the deadly consequences of burning tobacco and inhaling the resulting smoke. 

I see a way to maximize the positive impact from these three more recent developments by taking the steps I’ve outlined here today to reduce or eliminate the ability of combustible cigarettes to be addictive while putting in place the foundational regulatory elements for a comprehensive and sustainable framework for properly regulating products that may pose less risk.  I see a pathway towards successfully altering the current trajectory I mentioned at the outset that, unchecked, will continue to destroy families by claiming the lives of tens of millions of Americans by century’s end.

To succeed, FDA must be strategic about how it uses its tobacco and drug authorities.  To succeed, participants from all sectors in the ongoing harm reduction debate need to take a step back and work together to reach greater common ground.  And that common ground is worth pursuing around the ultimate harm reduction policy where cigarettes may be no longer addictive.

Reframing shared objectives around the need to rethink nicotine is a start.  It could help all of us achieve the one public health goal I know we all share, and that’s to save the lives of current and future cigarette smokers.

On a personal note, I started my remarks by describing all that’s changed regarding tobacco product regulation since I last served at FDA.  In the three months since my return, I see an extraordinary public health opportunity to take the bold and far-reaching actions I’ve laid out here today.  To miss the opportunity to build on everything that FDA has accomplished since the enactment of the Tobacco Control Act would be irresponsible.  We have it within our grasp to use the tools of product regulation to dramatically reduce tobacco-caused disease and death.  I can think of no more impactful action FDA could possibly take on my watch to help American families.

Unless we change course, 5.6 million children alive today will die prematurely later in life from tobacco use.  A renewed focus on nicotine can help us to achieve a world where cigarettes no longer addict future generations of our kids; and where adults who still need or want nicotine can get it from alternative and less harmful sources.  FDA stands ready to do its share.

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