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Speech | Virtual

Event Title
Remarks on New Strategies for Tobacco Policy and Therapeutic Nicotine Replacement
December 12, 2017


Remarks by Scott Gottlieb, MD
Commissioner of Food and Drugs
The Duke-Margolis Center for Health Policy
New Strategies for Tobacco Policy and Therapeutic Nicotine Replacement
Dec. 12, 2017
Washington, DC
(Remarks as prepared for delivery)
Good afternoon. It’s my honor to be here at Duke-Margolis today to discuss FDA’s current plans for public health improvement through tobacco regulatory policy. This is an ideal place to speak about the topic of tobacco regulation and public health, given FDA’s and Duke-Margolis’s mutual dedication to improving health by translating evidence-based policy solutions into practice.
I also appreciate the speaking invitation from Dr. Mark McClellan, who has been a colleague of mine for many years. During his tenure as FDA commissioner, when I was one of his senior advisors, Mark set a stellar example for me of the types of consequential policy reforms the FDA commissioner can inspire.
As I speak to you today, we’re approaching the 30th anniversary of the 1988 Surgeon General’s Report on smoking and health. We don’t hear as much about this report as we do about the landmark first-of-its-kind one in 1964 that warned about smoking’s health hazards. But Surgeon General C. Everett Koop’s 1988 report was likewise groundbreaking -- shattering the myth of smoking as a “bad habit” and presenting the science showing that cigarettes, and other forms of tobacco, are addicting.
The Surgeon General was confirming what was long known to the tobacco industry about the addictiveness of cigarettes.
Doctors were aware of the connection as well -- intuitively, from watching patients struggle to quit smoking and ultimately lose their lives after grueling battles with lung cancer, heart disease, or other smoking-related illness.
But it wasn’t until 1988 that the Surgeon General made the scientific determination that these products are addictive.
Today, I’ll talk about FDA’s updated plan for tobacco regulation, which I announced in July and that promises to save millions from premature morbidity and mortality from tobacco use.
In one sense, FDA’s tobacco regulatory plan borrows a page from the 1988 Surgeon General’s playbook, with nicotine—and the concept of addiction—as its centerpiece.
Our plan addresses addiction to combustible cigarettes, and takes other steps that, together, could alter the trajectory of addiction.
This trajectory is otherwise expected to cause more than 17 million premature deaths in the U.S. between 2014 and the middle of this century.  
While the understanding of cigarettes as addictive has held for 30 years, the modern tobacco landscape is far different from the marketplace of three decades ago.
In just the last few years, in fact, the market has greatly transformed and seen the emergence of new products. And the science, policy, and regulatory landscape has likewise evolved.
For one thing, there was FDA’s new authority to regulate tobacco, first established in 2009 under the Family Smoking Prevention and Tobacco Control Act. This authority was extended by the agency under the 2016 deeming rule to cover the wide variety of current—and future—tobacco products.
This broad authority sets the stage for FDA to encourage innovation in products that can help people quit smoking.
One example of such product innovation would be improvements in the technology of nicotine replacement products, also known as NRTs. These products have tremendous potential to save lives by empowering people to quit smoking, even if they don’t want to cut themselves off immediately and entirely from nicotine. 
It’s common knowledge today that cigarettes kill, yet people continue to smoke. The tragic fact is, one in two long-term smokers die prematurely from cigarette-caused disease. And tobacco remains the leading cause of preventable disease and death in the U.S., causing 480,000 premature deaths each year.
Why is that?
A principal reason people continue to smoke cigarettes—despite the dangers—is, in a word: nicotine. Beyond identifying cigarettes as addictive, the 1988 Surgeon General’s report also pegged nicotine as the culprit addictive substance. And since then, the connection has become scientifically undeniable.
Most adult smokers in the United States report they want to quit, and in 2015, more than half had made an attempt to quit in the last year. But nicotine—which a cigarette efficiently delivers through the lungs and to the brain in less than 10 seconds—pulls most people back in like a powerful magnet.
Only 7 percent of those in the 2015 survey who had made a recent quit attempt were successful.‎
Just this morning, FDA’s Center for Tobacco Products unveiled a smoking cessation education campaign called “Every Try Counts,” which recognizes nicotine’s powerful addictive potential.
The newly launched campaign is designed to encourage smokers to try to quit—even if they have tried unsuccessfully in the past.
Positive messages at convenience stores and other retail outlets, as well as ads that’ll appear on the radio and online, will encourage smokers to try again using messages such as: “Every time you put out a cigarette is a chance to try quitting again.”
“Every Try Counts” focuses on combustible cigarettes, with their toxic mix of more than 7,000 chemicals delivered by inhaling smoke. Products that deliver nicotine this way are responsible for the vast majority of tobacco-related morbidity and mortality in the United States. The campaign is just one example of how FDA is currently using its regulatory authority under the 2009 Tobacco Control Act to protect Americans from tobacco’s harms.
And it’s one action among several that FDA is taking under the comprehensive new plan I announced in July to move smokers away from deadly combustible cigarettes. 
While “Every Try Counts” focuses on helping adult smokers quit, many of FDA’s actions, including tobacco public education activities, are designed to protect the youth in this country from tobacco’s dangers. Almost all adult smokers—nearly 90 percent—started smoking by age 18. This is significant because we know adolescents’ brains are especially susceptible to being rewired to crave more nicotine. And youth also tend to lack a full appreciation of smoking’s health risks.
Although we’re encouraged that youth cigarette smoking has declined from years past, still, each day about 2,500 youth in this country smoke their first cigarette.
And teens’ overall use of tobacco and nicotine has remained relatively steady in recent years, thanks to the popularity of other products such as e-cigarettes and flavored little cigars.
It’s already illegal, under the Tobacco Control Act and the deeming regulation, to sell tobacco products to minors.
But FDA is taking additional steps to protect youth and young adults. And we’ll be pursuing additional enforcement actions against those who market tobacco products to kids.
Promising inroads have already been made with FDA’s public education campaigns: “The Real Cost,” “Fresh Empire,” and “This Free Life.” The first campaign of this kind, “The Real Cost,” seeks to educate at-risk teens about the harmful effects of tobacco use.
And a recent analysis found that the campaign’s cigarette prevention advertising stopped nearly 350,000 youth aged 11 to 18 from initiating smoking between 2014 and 2016.
To ensure that kids understand no tobacco product is safe, efforts are also underway that focus on the dangers of smokeless tobacco use, and we are expanding “The Real Cost” to specifically target youth use of e-cigarettes and other electronic nicotine delivery systems.
While FDA has made considerable progress, the agency must redouble its efforts to use all available tools and resources in the pursuit of two overarching goals: accelerate the decline in smoking that has occurred among adults, while keeping tobacco products out of kids’ hands and preventing future generations from becoming addicted in the first place.
Having told you about some recent and ongoing accomplishments, I’d now like to provide more detail about FDA’s comprehensive new framework itself.
The plan recognizes that nicotine creates and sustains addiction to cigarettes, but isn’t directly responsible for the morbidity and mortality from tobacco. It’s the delivery mechanism for nicotine that’s more directly linked to the product’s dangers.
In the case of cigarettes, the burning of tobacco and inhalation of resulting smoke particles render the products deadly.
On the opposite side of the risk spectrum, the FDA has approved Nicotine Replacement Therapies (NRTs) as safe and effective products in helping smokers quit.
Based on this understanding, the agency’s tobacco regulation plan focuses on minimizing addiction to the most harmful products while encouraging industry innovation in those products that could provide nicotine without the dire health consequences.
And there’s one constant to all of these efforts: Our actions are based on a rigorous scientific and regulatory foundation.
Out of the gate, FDA sees immense promise in lowering nicotine levels in combustible cigarettes to make them minimally or non-addictive. The benefits would be seen in life-years gained and pain and suffering avoided, as well as in health care costs saved.
This policy could prevent millions of deaths that would otherwise have occurred from the use of addictive cigarettes.
The Tobacco Control Act gives FDA the authority to set a product standard limiting the levels of nicotine in cigarettes. The agency’s Center for Tobacco Products will be issuing an advance notice of proposed rulemaking soon to seek input on this approach.
In parallel with this step to minimize the harms of the deadliest tobacco products, we’re encouraging innovation in products capable of delivering nicotine with less harm.
Importantly, FDA is bringing a more progressive perspective to medicinal nicotine products, including over-the-counter therapies such as nicotine gum and patches.
FDA supports development of new and better smoking cessation drug products, especially as the agency pursues the possibility of steeply reducing the permissible levels of nicotine in cigarettes.
To focus on therapeutic nicotine products for combustible tobacco product cessation, we’ve formed a Nicotine Steering Committee, which includes agency leaders from across FDA’s centers.
The formation of this committee reflects the need to critically examine the evolving science behind FDA’s evaluation of NRT safety and efficacy. Pivotal issues will include considering the types of safety and efficacy studies the agency should require and the way therapeutic nicotine products are used and labeled.
FDA has scheduled a public hearing for January 26th to hear from stakeholders on the approach for FDA’s evaluation of nicotine replacement therapies, and is also inviting related comments to be submitted. The upcoming public hearing is being held to obtain input on the most current science in this area and about FDA’s evaluation approach from a broad group of stakeholders, including the research and medical communities, tobacco and pharmaceutical industries, and other public health stakeholders.
Nicotine replacement therapies -- which supply controlled amounts of nicotine to ease withdrawal symptoms -- are used by some smokers who are trying to quit. FDA has approved two types of prescription NRT products—a nicotine nasal spray and nicotine inhaler—and three types of over-the-counter nicotine products—the gum, transdermal patch, and lozenge.
Most of these products have been approved for at least 20 years. The use of these approved products, while varying in their efficacy by type, is generally considered to double the likelihood of a successful quit attempt. There are also other FDA-approved non-nicotine therapeutic prescription drug agents.
The formulations and routes of administration of the approved NRT products have remained relatively unchanged for decades.
Over this time, however, research developments and changes to the regulatory landscape have led to changes in FDA’s recommendations for over-the-counter NRT labeling.
Specifically, the agency recommended in 2013 that two statements be removed from these products’ labeling as no longer necessary to ensure their safe use.
One statement warned consumers not to use an NRT product while still smoking or using any other nicotine-containing product. The other statement advised consumers to stop using the product at the end of the labeled duration of use.
Instead of the second statement, FDA recommended that consumers be advised to talk to their health care provider if they felt that longer use of the product would help them keep from smoking.
As the body of science surrounding NRT safety and efficacy continues to grow and evolve, the agency is considering what actions could increase access to, and use of, FDA-approved smoking cessation products.
FDA is committed to working with sponsors of NRT products—as well as any other products that can help more cigarette smokers quit—to bring innovative products to the marketplace.
During the January 26 public hearing, FDA welcomes feedback about public health, scientific, regulatory, and legal considerations related to NRTs. We’ve posed some specific questions of interest in a Federal Register notice published on November 30th.
One such question: Might there be ways to improve upon current delivery systems to yield new, potentially more effective over-the-counter NRT products?
Another question for consideration: Are there additional indications or regimens for over-the-counter NRT products that could be explored?
Some have called for additional labeling revisions— for example, to state  that using a longer-acting nicotine replacement therapy such as a patch with a faster-acting form such as a gum is safe and likely to improve quit rates in certain circumstances.
FDA is aware of literature supporting the efficacy of various combinations of NRT products. With sufficient evidence in a sponsor’s application, we could potentially approve a drug product with a dosing regimen combining therapeutic nicotine products.
These questions and additional examples of possible feedback topics are spelled out in the November 30th Federal Register notice, if you are interested in more detail.
Seeking public input—in the form of general comments, research results and other data, and additional information—is a mainstay of FDA’s process for developing effective science-based approaches for public health protection. The agency is also planning to seek public input soon on various tobacco topics through the rulemaking process. I want to at least highlight some of these important additional efforts.
We’re planning three Advance Notices of Proposed Rulemaking, or ANPRMs. I’ve already discussed the ANPRM on nicotine reduction.
A second advance notice of proposed rulemaking under development will seek input on the role of flavors in tobacco product use. Issues to be considered include: What role do menthol and other flavors play in attracting youth to start using tobacco? And, on the flip side, do certain flavors help adult cigarette smokers switch to potentially less harmful forms of nicotine products? A flavor might do both harm and good. FDA’s regulations will be based on their net impact on public health. 
Another advance notice of proposed rulemaking will seek public input on FDA’s regulatory stance regarding premium cigars.
Premium cigars are a topic of interest to stakeholders, with some supporting different legal and regulatory requirements for premium cigars compared to other tobacco products, including other types of cigars. FDA will seek comments and scientific input on various issues, including patterns of cigar use and resulting public health impacts.
In a broader context, the public dialogue between FDA and its stakeholders about nicotine and tobacco regulation represents a chance to reframe the debate about harm reduction that has sometimes seemed less than constructive.
In the shared public health objective of lessening the use of the most damaging tobacco products and enabling those who need or want nicotine to get it from less harmful products, we have an opportunity to engage in an important dialogue with stakeholders to improve public health.
In another step to support innovation and reduce the harms from tobacco products, FDA has revised its application deadlines for newly regulated tobacco products to August 8, 2021, for combustibles and August 8, 2022, for non-combustibles.
These extensions provide extra time for FDA to explore measures for making tobacco products less toxic, appealing, and addictive, and to pursue product safety standards such as those related to accidental child exposure to nicotine. And the extensions provide manufacturers more time to prepare higher-quality applications.
We’re using the time to get in place the rules and policies we need to make sure new products like electronic nicotine delivery systems are put through an appropriate series of regulatory gates.
To make the agency’s review process more efficient, predictable, and transparent, FDA plans to issue regulations outlining the information it expects in applications seeking FDA authorization to market tobacco products—namely, Premarket Tobacco Applications, or PMTAs; modified risk tobacco product applications; and reports to demonstrate substantial equivalence.
FDA is also working to finalize its guidance on how it intends to review PMTAs for electronic nicotine delivery systems, or ENDS.
The steps I’ve outlined are designed to work together, as a package, to bring FDA closer to its vision of definitively winning the battle against tobacco’s deadly consequences. In fulfilling our vital consumer protection role, we must foster product innovations in e-cigarettes or other noncombustible products if they support people in leaving combustibles behind. And we must do all we can with medicinal nicotine products to help more smokers quit.
As smokers are helped in quitting tobacco altogether or switching to less dangerous products, health gains will begin to appear quickly. These benefits will accelerate over time as future generations of kids are far less likely to become addicted to cigarettes, and suffer long-term health consequences.
In his Surgeon General’s report of three decades ago, Dr. Koop introduced the goal of a “smoke-free society.” Today we have the tools, the resolve, and the modern, multifaceted regulatory plan to make this vision a reality.
As we work with public health and other stakeholders to achieve this objective, I want to end by encouraging each of you to join in FDA’s public dialogue about nicotine—and participate with us in finally reversing tobacco’s deadly trajectory.
Thank you.
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