Nicotine and the Role of Science in Regulation February 23, 2018

Speech | In Person

• Speech by: Scott Gottlieb, M.D.

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Society for Research on Nicotine and Tobacco (SRNT)
Annual Meeting
“Nicotine and the Role of Science in Regulation”
Baltimore, MD

(Remarks as prepared for delivery)

It’s an honor to be here today to share our goals with you. The Society for Research on Nicotine and Tobacco is the premier research organization on the issues central to a re-examination of how FDA can best regulate tobacco and nicotine. 

Your agenda for this year’s meeting is proof that your membership is hard at work producing the science that’ll help inform policy as we collectively tackle the leading cause of preventable disease and death in the country – tobacco use.

Since returning to FDA, I’ve made clear that one of my top priorities is to combat addiction crises plaguing this country.

The opioid crisis is appropriately getting the full attention of FDA, and policymakers across federal and state governments.

But tobacco use is another troubling addiction crisis. And it’s responsible for about 480,000 deaths every year in this country.

Yesterday, you heard the Surgeon General talk about the intersection of these two issues – addiction – and how we can improve prevention and treatment efforts. And part of the way in which we’ll solve the tobacco crisis is by addressing the root issue of tobacco addiction: nicotine.

We’ve made a lot of progress since the landmark 1964 Surgeon General’s report on tobacco. We should celebrate that.

But you all know that our work is far from done.

Not only are many adults still trapped in a lifetime of addiction to nicotine. But each day, nearly 2,500 American kids under age 18 smoke their first cigarette. The power of addiction is what keeps users coming back to a product they know can kill them.

So how do we take the next step in confronting this crisis?

How do we go from making great strides in curtailing tobacco use to a monumental milestone in addressing the addiction?

The founders of SRNT did something very smart when they created this organization.

This easily could have been a society for just studying tobacco products. But the founders were ahead of their time and thinking about the big picture when they named it the Society for Research on Nicotine and Tobacco.

For the layman, it’s easy to lump nicotine and tobacco together. And that’s one of our challenges: we need to correct many of the misperceptions and confusion around nicotine, like the commonly held belief that nicotine causes cancer.

But the founders of SRNT knew that these issues, while closely related, needed to be studied and considered on their own as well. And as the FDA moves toward a new way of addressing our country’s addiction to tobacco, it’s the research on nicotine that will lead the way.

As most of you likely know, back in July, we announced a new, comprehensive regulatory plan for tobacco products. It focuses on the issue of nicotine and addiction.

As part of that plan, we committed to beginning a public dialogue about the cornerstone of our plan: potentially lowering nicotine levels in combustible cigarettes to minimally or non-addictive levels through use of the regulatory tool we have known as product standards.

And frankly, the folks here today are exactly the kind of people we had in mind when we envisioned who would contribute to the science underpinning that dialogue, and participate in the discussions we all need to have. 

Up until this point, we’ve reached a stalemate in the discussion about harm reduction. Well-intentioned people on both sides of the debate have dug in their heels. We’ve made little progress.

But I hope our July 28th announcement could be the nudge we all needed to re-frame that conversation.

By taking a step back, I think we’re able to clearly see that the current marketplace for tobacco products is fundamentally a marketplace for products delivering nicotine.

And with that bit of common ground re-established – and importantly, in the context of our new regulatory approach – we can start the dialogue anew. We can pursue it with some real goals and progress in mind. Both within the tobacco control community and throughout society more broadly.

Before I go further, let me first offer a brief recap of some highlights from the broad plan we announced last summer.

A key piece of our new approach is recognizing a greater awareness that nicotine – while highly addictive – is delivered through products on a continuum of risk. And given their combination of toxicity, addictiveness, prevalence, and effect on non-users, cigarettes are the category of tobacco product that causes the greatest public health burden.

On this, I think we all agree: cigarettes are designed to create and sustain addiction.

And addiction causes long-term, sustained use.

That lifetime of addiction almost always starts from experimentation as a youth. Almost 90 percent of adult smokers started smoking by the age of 18. And 95 percent by age 21.

Of those in this country who make it to age 26 without smoking; the odds plummet that you’ll become a smoker – only about 1 percent of cigarette smokers start at that age or later. 

That means that roughly 99 percent of smokers start smoking before their brains are done growing.  So how do we stop nicotine addiction from taking hold of youth? And how do we help adults who are currently addicted to nicotine finally quit?

To help answer those questions, we plan to soon issue an advance notice of proposed rulemaking (ANPRM). Through this process, we’ll ask questions aimed at developing a product standard that would limit the amount of nicotine in cigarettes; rendering cigarettes minimally or non-addictive.

Evidence shows that most cigarette smokers are concerned about their health. They’re interested in quitting, and they’ve tried to quit. By reducing cigarettes’ addictiveness, we could help addicted users quit more easily. And we can help keep those who are experimenting – especially young people – from becoming regular smokers. Moreover, with innovation around the availability of potentially less harmful tobacco products, we could reduce the risks for adults still seeking access to nicotine.

A product standard limiting the amount of nicotine – rendering cigarettes minimally or non-addictive – could help current smokers quit. And such an approach could prevent most future users from becoming addicted and proceeding to regular use.

Disrupting that progression is a game-changing approach.

It could save millions of lives.

And that’s not just a figure of speech.

At this time, I can’t provide any additional details on this approach and the details of our rule making process. I need to let that route unfold through an open, transparent process.

But I don’t think it’ll surprise this audience that we believe such a product standard could have a tremendous positive public health impact. And I don’t think I need to explain to this audience how monumental such a product standard could be. But I’ll just say that we have an article nearing publication that includes updated modeling statistics for the potential positive public health impact of such a standard.

And the results are significant.

In addition to the first step toward a proposed nicotine product standard, we also plan to issue two additional ANPRMs.

One will seek comment on the role that flavors – including menthol – play in initiation and cessation of tobacco products.

With regards to this issue, we recognize there’s a give-and-take. We’ve seen evidence that flavors may help some adult cigarette smokers switch to potentially less harmful forms of nicotine delivery. However, we also need to be wary of the role flavors, including menthol, play in attracting youth to initiate tobacco use – something we clearly want to avoid.

Like many complicated issues, it’s possible for both things to be true at the same time. I’ve talked to ex-smokers, who’ve told me that they quit cigarettes altogether, and that they now vape. And they’ve also told me it was the flavors that helped them make that transition off combustible cigarettes.

Now I know anecdotes aren’t data. And we plan to collect the data we need as part of our rule-making process. But these personal stories are important to me as we shape our overall approach to smoking cessation. And it’s important to me that we uphold FDA’s responsibility to consider both sides and to issue regulations based on the net impact on the public health.

The other ANPRM would seek additional comments and data related to premium cigars, an issue that continues to draw interest. Here, we plan to seek information on how we might define and regulate premium cigars, taking into consideration the health effects of these products and their patterns of use.

In addition to the three ANPRMs, we’ve also revised compliance deadlines for so-called deemed products on the market as of August 8, 2016.

Under these new deadlines, applications to market such newly-regulated combustible products -- such as cigars, pipe tobacco, and hookah -- would be submitted by August 8, 2021. And applications to market newly-regulated non-combustible products, such as electronic nicotine delivery systems or e-cigarettes, would be submitted by August 8, 2022.

The extra time provided by these deadlines will allow researchers to advance or finish their work. It will allow industry to ultimately submit more accurate and complete product applications. And it will give FDA time to develop and establish certain policies and foundational regulations.

For example, between now and 2021, FDA intends to explore developing additional product standards or other regulations for known public health risks, including battery safety issues for ENDS, and children’s exposure to liquid nicotine.

In that time, we also intend to issue several foundational rules outlining the information we expect to be included in Substantial Equivalence Reports, in Premarket Tobacco Applications, and in Modified Risk Tobacco Applications.

We also intend to finalize guidance on premarket tobacco applications for ENDS products.

While much of the media coverage of our plan has understandably focused on the nicotine product standard and our efforts directed at the most harmful end of the continuum of risk, we’re also committed to making improvements on the other end. This includes more progress on safe and effective cessation products such as nicotine gums, patches, and lozenges.

We recently formed the Nicotine Steering Committee.

It’s a collaboration between the Center for Tobacco Products, the Center for Drug Evaluation and Research, and my office.

This new steering committee is charged with re-evaluating and modernizing the FDA’s approach to the development and regulation of nicotine replacement therapy products.

The work of the steering committee is an important component of our plan. Among adult smokers in the U.S., around 70 percent report that they want to quit. Nearly half try to quit each year, yet few succeed.

Currently, nicotine replacement therapy (NRT) products, such as nasal spray and inhaler NRTs, have been approved for prescription-only use; while gums, transdermal patches, and other pharmacological therapies have been approved for over-the-counter use. 

Using approved NRTs properly is considered to double the likelihood of a successful quit attempt, with variations between products. But most of the products have been approved for over 20 years. Since then, novel forms of nicotine delivery have been developed based on new technologies and innovations.

And so, the Nicotine Steering Committee will explore how FDA can best foster these innovations and develop them into FDA-approved therapies to help more smokers quit.

The committee recently held its first public meeting to discuss these issues and a few common themes emerged.

For example, on the topic of therapeutic product evaluation, there was discussion about considering criteria other than abstinence, such as “reduce to quit.”

Other issues that garnered discussion included using smoking cigarettes as the comparator, pharmacokinetic bracketing, concerns about the quantity and types of information needed before sponsors can study a product under an IND, broadening NRT indications, and flexibility on labeling.

This week, we opened a public docket to solicit comments on these, and other issues relevant to the work of the committee. 

For those who couldn’t attend the public meeting; the sessions were filmed. They’re available via webcast on our website.

I encourage you all to look at the materials and comment on the docket before April 16 to help FDA’s Nicotine Steering Committee advance the agency’s regulatory agenda.

The ANPRMs, committee meetings, and revised deadlines represent the regulatory side of our efforts. But the FDA is also engaged in campaign efforts to educate the public – particularly youth – about the dangers of tobacco products.

Although our understanding of harm reduction acknowledges that products fall on a continuum of risk, there’s one thing that all sides can agree on.

It’s that no youth should ever start using tobacco products.

To that point, CTP’s award-winning public education efforts will continue to be refreshed with new creative spots.

In just a few years, we’ve already seen encouraging public health benefits from these campaigns, which include “The Real Cost,” “Fresh Empire,” and “This Free Life.”

The FDA’s first public education campaign, “The Real Cost,” has prevented nearly 350,000 youth aged 11 to 18 nationwide from smoking from 2014 to 2016.

While our regulatory efforts work toward policies that decrease the appeal, toxicity and addictiveness of tobacco products, these public education efforts are out in the field. They’re creating awareness of the risks, and driving behavior change.

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. A few months ago, we launched “Hacked” -- a new ad under the “The Real Cost” umbrella.

“Hacked” is a first for the FDA. It’s currently running via online video and radio ads and appearing on platforms used by teens, including YouTube, Hulu and Spotify.

Later this year, we also plan to launch a full-scale campaign focused on youth use of e-cigarettes and other ENDS.

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 must re-double our efforts to prevent youth from ever initiating with them.

Our campaign efforts aren’t limited to preventing youth initiation. We also launched a new adult smoking cessation education campaign called “Every Try Counts.”

This campaign’s goal is to encourage cigarette smokers to quit by offering messages of support. To do this, the campaign is designed to reach smokers in some of the locations where they face a multitude of triggers and cigarette advertisements, such as gas stations and convenience stores.

“Every Try Counts” ads are now displayed in 35 counties across the U.S. And now, here is a closer look at the “Every Try Counts” campaign.

As you can see, these public education campaigns are informed by research; and creatively designed and executed.

Our public education efforts are a key complement to our regulatory efforts in preventing youth initiation and encouraging adult cessation.

I know that wasn’t quite a “brief” recap about our new regulatory plan. But I feel strongly that these efforts are crucial to our plan. Together, they form a cohesive package.

When done in concert, we believe our new approach will drastically shift the trajectory of tobacco-related disease and death in this country.

The FDA is working hard on these issues. Especially the three ANPRMs, which we expect to share with you soon.

In the interim, I hope we can seize the opportunity to have meaningful discussions about this big-picture approach to nicotine regulation and find common ground moving forward.

Although this is a new approach for FDA’s regulation of tobacco products, the idea of lowering nicotine in cigarettes itself is not a new concept.

Back in 1994, the well-known “Benningfield paper” by two prominent SRNT members, Drs. Neal Benowitz and Jack Henningfield, explored the implications of establishing a nicotine addiction threshold on tobacco regulation.

The “Benningfield paper” proposed a threshold for nicotine in cigarettes. It also foretold some of the important questions that should be asked about a potential nicotine standard.

In addition to the obvious question about determining what the exact nicotine level should be, such a standard would also raise questions about the potential for compensatory smoking behavior and whether to implement such a standard over a gradual period or all at once.

It could also raise questions on other potential unintended consequences, such as the likelihood of illicit trade in higher nicotine products.

In seeking a sustained dialogue on a comprehensive nicotine regulatory policy, we also must ask some other tough questions. 

After all, nicotine is not a completely benign compound. 

So how do we feel about long-term, sustained nicotine use?

What are the implications of using products that are potentially less harmful but still not safe?

How do we correct some of the misperceptions about nicotine safety? And what do we think about combination therapy and different indications, such as smoking reduction, for nicotine replacement therapies?

These are all important questions we need to be asking, and this is the exact time and place to start discussing the answers.

FDA will continue to explore these questions, and pursue data that can help better inform these discussions.

In that spirit, a few weeks ago, FDA published data concerning youth initiation on e-cigarettes. It showed that the e-cigs were the most commonly used tobacco product among kids.

I was struck by the response. I want to share it with you.

The social media response ranged from arguments that dismissed the youth use of e-cigs, to other arguments that tried to assert that e-cigs were not tobacco products. 

We need to ask ourselves if the e-cig industry is sustainable in the long run, as a viable option for adults, if it leads to a whole bunch of youth initiation on tobacco products. So, we need to do all we can, working together, to address the youth use.

At FDA, we will do our part. And as this industry matures, it must also bear an urgent responsibility to do more to prevent the youth use of these products. This responsibility comes not just out of being the right thing to do, but also out of key aspects of our statute, which are based on a net health benefit.

Even if the data ultimately shows that e-cigs may help reduce smoking rates among adults; the initiation of youth to tobacco products also is big factor in determining net health benefit.

As to the argument that e-cigs aren’t tobacco products; even though the nicotine is derived from tobacco, the determination that they are tobacco products was made fully and clearly a long time ago. The administrative record deeming e-cigs as tobacco products under the law is very strong. It’s part of the basis for the comprehensive plan we announced last July.

The deeming has already been upheld by the courts.

The people in this room are some of the world’s leading experts on nicotine and addiction. A conversation with a colleague during the coffee break may not seem like much in the moment. But it’s that dialogue among the field’s experts we’re hoping for.

The discussions we have here this week are an important part of the process for reconsidering nicotine. Once the ANPRM gets issued, we’re going to be seeking information about many of the specifics. But today, we can find common ground and engage in the philosophical debates that will guide the field’s thinking.

Tobacco control has changed a lot in the 24 years since publication of the Benningfield paper. But perhaps the most important thing is that the federal government now has the regulatory authority to undertake such a bold strategy.

In the past, research often ended at publication. But this type of provocative research no longer occurs in a vacuum.

Since the creation of the FDA’s Center for Tobacco Products in 2009, research in the field has real-world regulatory policy implications. The FDA is listening.

The groundbreaking research being done by all of you can strongly inform the policies and regulations we issue – and enforce – in this country.

The importance of this Society to our work cannot be understated. In fact, it’s written into our DNA.

When Congress drafted the Tobacco Control Act it valued SRNT so much that the law mandated that FDA consult with you on issues related to products for the treatment of tobacco dependence.  

New research findings being presented and discussed at this meeting will help inform our thinking on future policies, particularly the potential nicotine product standard.

This includes research on the effects of low nicotine content cigarettes on smokers with substance use and mental health disorders, nicotine abuse liability, perceptions about low nicotine cigarettes, and behavioral economics. These are all questions and research that we’d clearly want to consider.

Our regulatory thinking is guided by the best available science. And it’s the work of your membership that’s making important contributions to the science base that we rely on.

Research findings have been published addressing several important areas, such as the randomized trial to assess nicotine exposure, dependence, number of cigarettes smoked and compensatory behavior. Research on the effects of low nicotine content cigarettes on individuals who try smoking for the first time -- and the effects of a gradual versus immediate implementation of nicotine reductions -- were other key areas that were obviously important to our thinking.

The dissemination of your work and research only begins at peer-reviewed publication. Your efforts can literally be the source for a milestone policy in public health.

Participation in the regulatory process can also extend beyond conducting research.

In 2010, SRNT was a co-Petitioner on a Citizen’s Petition to FDA regarding regulation of over-the-counter NRT products.

The petition requested, among other things, that the comparison for NRTs should be cigarette smoking, that package labeling for NRTs should allow for combined use of NRT products, that labeling should be amended for NRTs to not limit use at 12 weeks, and that package labeling should be amended to not warn against continued smoking while using NRTs.

FDA listened to these issues. And several of the issues raised in the Citizen’s Petition directly resulted in change.

In response, FDA issued a notice announcing modifications to labeling of NRTs for over-the-counter use. The changes allowed, based on sponsor submissions, for modifications or deletions to be made to labeling statements regarding concomitant use of OTC NRT products with other nicotine-containing products.

The notice also allowed for modifications to labeling statements directing consumers to stop using the NRT product at the end of the recommend treatment period.

These are real-world, applicable examples of how the members of SRNT – by proactively engaging in the process – can use science-based evidence to contribute to regulatory policy.

By presenting FDA with the latest research on a topic, this organization was able to jumpstart policy change that will help smokers in this country who are trying to quit.

And as we move forward on the framework for the regulation of nicotine and tobacco, there are many more opportunities for science, your science, to inform policies that save lives.

For example, the same week of the Nicotine Steering Committee’s first public meeting last month on encouraging innovation in NRTs, we also held the Tobacco Product Scientific Advisory Committee’s public meeting on the modified risk tobacco product application by Philip Morris for its heated tobacco products. By law, these meetings are open to the public, and we encourage participation from all sectors, including the research community.

FDA is deeply committed to public participation in our regulatory processes.  Your research, your recommendations and your opinions do not fall on deaf ears.

The process for issuing rules and regulations is a participatory one. And we welcome and encourage your involvement.

Compared to other government agencies and centers, CTP is still a newer regulatory body. So, many of the policies we’ll enact in the next several years are foundational in nature and will pave the way for the future of tobacco regulation in this country.

We’re exploring new and exciting concepts, such as the nicotine product standard. But as I’ve mentioned many times before, our policies can only go as far as the science takes us.

So, my hope for you all today is that you continue the research you’ve been conducting for the last several decades; but take your findings a step further: from publication to participation.

When we issue proposed regulations, I hope you’ll submit your research to the docket as a comment.

When we hold public meetings, I hope you’ll share your ideas.

By actively engaging in the regulatory process, you can help ensure that your research has the power to save lives.

FDA is embarking on a path to solve the tobacco addiction crisis in this country. And your research guides that way.

Thank you all for having me here today.

And thank you for continuing to inform, support, and inspire our efforts to save lives from tobacco use in this country.