Remarks on the Regulation of Nicotine
October 18, 2017
Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Johns Hopkins Bloomberg School of Public Health
Public Discussion on The Regulation of Nicotine
October 19, 2017
(Remarks as prepared for delivery)
Before I begin, I’d like to thank the Bloomberg School of Public Health for inviting me here today. I’ve known Dr. Sharfstein for a long time. He’s played a key role in helping FDA advance its mission throughout his career. And he continues to be an important advisor to the agency. I’m grateful for the chance he gave me to come speak with you today.
In fact, I can think of few places more appropriate than a school of public health to talk about the FDA’s new approach to tobacco and nicotine regulation. As you pursue your education here, you’ll learn about the great achievements in public health – from epidemiologist John Snow and the pump handle, to the polio vaccine, to seat belts – and the challenging obstacles faced before we were able to succeed.
We have a similar opportunity in front of us right now to take a historically important step toward protecting public health from the number one cause of preventable disease and death in this country:Tobacco use.
Yes, we’ve made progress since the landmark Surgeon General’s Report on Smoking and Health in 1964. Our workplaces don’t resemble “Mad Men.” And you’d never see Ravens quarterback Joe Flacco hawking cigarettes on TV. But the 50th anniversary of the report showed that tobacco use, primarily smoking, still causes 480,000 deaths every year. At the current rate, from the release of that report in 2014 through the mid 21-st century, we’re on track for 17.28 million avoidable premature American deaths. I know it’s hard to wrap our heads around those kinds of numbers. But that’s equivalent to the entire populations of Maryland, Alabama and Missouri combined.
Before we can solve a public health issue of this magnitude, we have to ask ourselves the fundamental question that the father of epidemiology, John Snow, asked himself: What is the cause?
In this case, we already know the answer.
The overwhelming amount of tobacco-related disease and death in this country is caused by highly addictive cigarettes.
Cigarettes are designed to create and sustain addiction. Addiction causes long-term sustained use, which exposes users to the harmful and toxic mix of chemicals in tobacco and tobacco smoke that causes disease and death. Cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users.
Something that most of those people have in common is that they started smoking at an early age. Every day in the U.S., nearly 2,500 youth under age 18 smoke their first cigarette. Almost 90% of adult smokers started smoking by the age of 18, and 95% by age 21.
Of those in this country who make it to age 26 without smoking, the odds plummet that you will become a smoker. Only about 1% of cigarette smokers start at that age point or later in their lives.
So we know that smoking traditional combustible cigarettes causes most of the disease and death related to tobacco use. And most smokers get addicted in their youth. Then the question becomes: “How do we help those adults who are addicted quit, and how do we prevent youth from getting addicted in the first place?”
When I returned to the FDA, those were the questions I asked. In the time that I was gone, the tobacco landscape has changed dramatically – from passage of the Family Smoking Prevention and Tobacco Control Act, and creation of the FDA’s Center for Tobacco Products (CTP) itself, to the extraordinary rise in youth and adult use of e-cigarettes.
The truth of the matter is that much work remains. Adult smoking rates have declined. And teen use of cigarettes is down, but their overall use of tobacco products has remained largely the same due to increases in the use of e-cigarettes, other electronic nicotine delivery systems (ENDS), hookah and cigars. As regulators tasked with protecting the public health, I felt we needed to do more. So I put three charges to my FDA colleagues, and together we worked to address these challenges.
First, how can we use FDA’s new authorities to dramatically alter the trajectory of death and disease that smoking will cause, and prevent another generation of youth from becoming addicted to cigarettes?
Second, how can we implement the foundational rules to put our tobacco program on a strong footing to achieve its public health goals?
And third, how do we leverage new technology – including advances in medicinal nicotine products regulated as drugs – to ensure alternatives for adults who want access to nicotine, but want to quit cigarettes?
To pursue these goals, on July 28, I announced the FDA’s new comprehensive approach to regulating tobacco products. Our new approach places nicotine, and the issue of addiction, at the center of our efforts. The FDA is envisioning a world where cigarettes can no longer create or sustain addiction, and where adults who still need or want nicotine can get it from alternative and less harmful sources.
A centerpiece of this comprehensive regulatory plan is acknowledging that nicotine, while highly addictive, is delivered through products on a continuum of risk. And it’s the delivery mechanism – not the nicotine itself – that is truly the issue at-hand.
On one end of the spectrum, when nicotine is delivered through a medicinal product such as therapeutic gums, lozenges and patches, it’s been found so safe and effective the FDA doesn’t even require a prescription for them. However, it’s at the other end – the combustible cigarette – where nicotine’s delivery vehicle leads to incredible amounts of disease and death.
So, if this is our John Snow moment, then what is our pump handle?
To truly be a public health milestone along with the polio vaccine, we need something that will save as many lives as possible.
And if young people getting addicted to combustible cigarettes is the main culprit that sustains the cycle of cigarette-caused disease and death, then our answer is really rather simple – we need to lower the nicotine levels so that cigarettes are minimally or non-addictive.
Back in July, I said that we were doing some preliminary analysis of the potential public health benefits at a population level. And while we’re still working on updating those modeling statistics, I want to share with you, for the first time, some of the initial estimates we now have.
Over time, as future generations of kids who may experiment with cigarettes would find it far less likely to ever become addicted, we’re estimating that we could prevent up to 8 million or more tobacco-attributable deaths and more than 30 million individuals from being becoming regular cigarette smokers over the course of this century.
That is the staggering level of public health benefits we’re aiming for – imagine the life years gained, and the pain and suffering avoided.
Just imagine the impact this policy could have on treatment costs.
Currently, we spend about $300 billion each and every year on the direct and indirect costs associated with tobacco-related illnesses. In a world where cigarettes were minimally or non-addictive; the reduction in those overall costs would be enormous.
To take the first steps toward that vision, I’ve directed the FDA’s Center for Tobacco Products to issue an Advance Notice of Proposed Rulemaking to seek input on how we could reach the point where cigarettes could no longer create or sustain addiction.
The ANPRM will ask the important questions we’d need answered before implementing a nicotine product standard.
Perhaps most obviously, this would include asking what the right maximum level of nicotine in cigarettes should be.
But there are many other questions we’ll need answered, including ones about unintended effects such as, “will addicted smokers compensate by smoking more cigarettes?” and “will an illicit market for higher-nicotine cigarettes develop?” There are also questions about how manufacturers would comply with such a product standard and how the FDA would monitor and enforce it.
The ANPRM will be how we gather the information needed as we think about proposing a nicotine standard for combustible cigarettes.
Although a minimally or non-addictive cigarette is a key component of our approach to improving public health, it’s only one part of a comprehensive plan. I’ve also asked CTP to issue an ANPRM on flavors.
On this issue, we see two sides – on the one hand, we need to know the role that flavors, including menthol, play in attracting youth to initiate tobacco use. On the other hand, we also need to know whether or not and how certain flavors may help adult cigarette smokers switch to potentially less harmful forms of nicotine delivery; for example, when flavors are used in non-combustible products such as electronic nicotine delivery systems. It’s possible for flavors to do both harm and good, perhaps in different product types. FDA’s responsibility is to determine how they compare to each other and to issue regulations based on their net impact on the public health.
And this is where you come in. Rulemaking is a public, participatory process. As I have made clear since I arrived back at FDA, we’re here to have the tough conversations.
Some of that dialogue is about educating the public and correcting misperceptions about nicotine.
For example, a 2011 study by Legacy (now known as the Truth Initiative) found that only a third of smokers knew that nicotine patches, gums and lozenges do not cause cancer. And 93% of smokers didn’t know smoking while wearing the nicotine patch doesn’t cause heart attacks. So if we’re going to try to create a comprehensive nicotine regulatory policy that acknowledges the continuum of risk associated with nicotine delivery, then one of the challenges we all have confront are those misperceptions about nicotine’s safety.
Other aspects of the dialogue provide an opportunity to bridge the divide within the tobacco control and public health communities on issues related to harm reduction. The debate over the past decade on harm reduction and e-cigarettes has essentially reached a stalemate.
Our July 28 announcement is an opportunity to reframe that debate as we all search for common ground on the core issues related to nicotine, and face the reality that the marketplace for tobacco products is fundamentally a marketplace for products delivering nicotine.
At FDA we’ll let the science be our guide. We encourage the public to comment on our ANPRMs by submitting new information, new data, and substantive policy suggestions. As a science-based agency regulatory science will always be our North Star.
But our role in this comprehensive effort goes beyond issuing regulations. We also need to consider what we can do - in lieu of helping them quit completely – to encourage addicted smokers to switch to a potentially less harmful product.
Quitting cigarettes is still the preferred outcome.
That’s why we’re also looking at ways to encourage innovation for therapeutic nicotine products regulated as drugs.
In addition to encouraging innovation in drugs, we can also help smokers by enabling them to transition to less harmful tobacco products. So, to that end, we also need to foster innovation for new tobacco products that have the potential to make notable public health differences.
To facilitate that, we’ve revised the application deadlines for newly regulated tobacco products to August 8, 2021 for combustibles and August 8, 2022 for non-combustibles. Doing so allows FDA to pursue product standards – such as standards to address battery issues for electronic nicotine delivery systems and accidental child exposure to liquid nicotine – that we need in order to put these products through an appropriate series of regulatory gates to evaluate their risks and potential benefits. It also allows manufacturers the opportunity to prepare higher quality, more complete applications.
Our comprehensive regulatory plan is a package.
Each component – the nicotine product standard, the flavors ANPRM, extending the application deadlines – is integral to our plan.
As a package, the outcomes we desire will not come to fruition without all of the pieces working in concert.
While the pieces I’ve described represent regulatory aspects, the FDA is also engaged in education campaigns to inform the public – particularly youth – and young adults about the dangers of tobacco products. Because even within the scope of harm reduction, one thing all sides can agree on is that nobody, especially youth, should ever start using tobacco products – regardless of where the products fall on the continuum of risk.
To illustrate that point, in a minute, I’m going to share with you a never-before-seen ad aiming to educate youth about the harms associated with initiating e-cigarette use.
Although the FDA’s public education campaigns are still relatively new, we’re already seeing very encouraging public health benefits. Three of the campaigns – “The Real Cost,” “Fresh Empire” and “This Free Life” – aim to educate youth about the dangers of tobacco products in an original and engaging way that resonates with the target audience. I’m sure many of you have seen some of these ads and can attest to this.
But aside from being visually and creatively engaging, these ads are also incredibly effective. The FDA’s first public education campaign, “The Real Cost,” has prevented nearly 350,000 youth aged 11 to 18 nationwide from initiating smoking from 2014 to 2016.
Getting kids to think and act differently is the holy grail of behavior change advertising and a huge first step to benefit public health while FDA is moving to enact other policy interventions to decrease the appeal, toxicity and addictiveness of tobacco products soon.
And now, for the first time, we’re expanding “The Real Cost” to specifically target youth use of e-cigarettes and other ENDS through campaign advertising. Here is the first-ever public look at the e-cigarette spot we call “Hacked,” an ad under the “The Real Cost” umbrella that will begin running online next week.
This is an exciting and important start for our public education campaigns. Beginning next week, new campaign content – including online video and radio ads – will appear on platforms such as YouTube, Hulu, and Spotify, as well as on the campaign’s website.
In addition to these new digital materials, we’re also planning to launch a full-scale campaign focused on youth use of e-cigarettes and other ENDS in 2018. Because, while we fully recognize the potential some of these products may have in transitioning smokers away from the most harmful forms of tobacco use, we also have to re-double our efforts to prevent youth from ever initiating with them.
The tobacco marketplace is clearly evolving at a rapid pace, and as regulators, we need to evolve as well.
Our new comprehensive plan will allow us to use our understanding of nicotine to reduce use of the most harmful tobacco products, help more addicted smokers quit, and enable those who still need or want it to get their nicotine from a potentially less harmful product.
Just as we look back and wonder how the Don Drapers of the world smoked so much, we can hope that our children and grandchildren are one day puzzled by the addictive cigarettes of the 20th and early 21st centuries. Because unless we change course, 5.6 million children alive today will die prematurely later in life from tobacco use.
But this is our John Snow moment. We know the cause. And we know what we can do to prevent it. And by engaging with the people like those in this room, and working toward a common goal, we have the grand opportunity to save millions of lives and, in the process, achieve the greatest public health victory imaginable. Thank you.