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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Over the past several months, we’ve continued to voice our concerns about the growing epidemic of youth e-cigarette use. Our public statements have expectedly prompted responses from industry and public health stakeholders on ways they and the FDA can further address these concerning trends. But we’ve also been inundated by a number of people asking for help in their fight against nicotine addiction in children and young adults. We’ve heard from parents worried about their child’s use of e-cigarettes, and asking for help for their child who they believe is already addicted to nicotine. Teens have also reached out following our public education campaign launch wanting information about how to quit their own use of e-cigarettes or how to get help for their friends. This is distressing. It highlights that while we take new steps to prevent initiation of youth on e-cigarettes, we must also help those who may already be addicted to these products.

Today, we’re announcing a public hearing, to be held Dec. 5, to discuss our efforts to eliminate youth e-cigarette use, with a focus on the potential role of drug therapies to support cessation among youth, and the issues impacting the development of such therapies for children. This hearing will also give us an opportunity to discuss the need for drug therapies to support youth cessation of other tobacco products, including combustible products, such as cigarettes or cigars, or smokeless tobacco products. All of these tobacco products pose serious dangers to teens’ and adolescents’ health.

That the FDA finds that we need to hold such a hearing ‒ to discuss ways to use drug therapies to treat teen addiction to nicotine ‒ underscores the deeply troubling nature of the public health problem that we’re confronting.

This hearing next month is part of our larger Youth Tobacco Prevention Plan. It will be an important opportunity to obtain input from across the medical and research fields, the pharmaceutical and tobacco industries, and public health stakeholders regarding approaches to eliminate youth e-cigarette use. This includes exploring potential drug therapies to support youth e-cigarette cessation, as part of broader treatment strategies, including behavioral interventions. If there is a need for new or different drug therapies when it comes to the treatment of nicotine addiction in kids, we want to explore how we can support the development of such therapies. For example, we’re interested in identifying the appropriate methods, study designs and measures for evaluating the safety and efficacy of drug therapies for youth e-cigarette cessation.

Unfortunately, the rapid growth in the popularity of e-cigarettes among youth to epidemic levels necessitates that we explore all options for how to address this public health concern. Since 2014, e-cigarettes have been the most commonly used tobacco products among youth, used by 1.73 million (11.7 percent) high school students and 390,000 (3.3 percent) middle school students in 2017. But according to new preliminary data from the 2018 National Youth Tobacco Survey, the number of high school and middle school-age children reporting use of e-cigarettes rose sharply. I reported on these numbers in an op-ed that I wrote with the Secretary of Health and Human Services. Other metrics that we track when it comes to kids and tobacco – such as the number of kids using traditional cigarettes, cigars or chewing tobacco – are also not moving in a favorable direction.

There’s a large pool of nicotine users that’s being created among school-age children by these products. And some portion of them are at risk of transitioning and risking addiction to cigarettes. Youth e-cigarette and other tobacco product use also raises a number of other health concerns, not only risk of addiction to nicotine early on in life, but potential harm to the developing adolescent brain, and exposure to chemicals known to have adverse health effects.

Despite these concerns about youth use of e-cigarettes and other tobacco products, research on youth tobacco-product cessation is limited and focused on smoking cessation. On that point we’re expanding our scientific priority areas to include support research on these topics through new funding opportunities. The specific areas we have identified include, for example, the development of data or methods to quantify the factors driving initiation and continuation of tobacco use among youth, as well as the understanding of youth attitudes toward e-cigarette and tobacco cessation; and the identification of youth tobacco users who may benefit from treatment with drugs intended for cessation. We’re also interested in the development of methods and study designs appropriate for the evaluation of behavioral or drug therapies for youth tobacco cessation.

We’re hopeful this hearing will serve as a valuable conduit to support the elimination of e-cigarette use among youth. No child should be using any tobacco or nicotine-containing product. We need to do everything possible to reverse the alarming trend of rising youth use of novel products like e-cigarettes, and to help kids who may already have become addicted.

We cannot risk a whole generation of kids getting addicted to nicotine. We must put strategies in place now to help those who are already addicted quit. We will take additional actions in the coming months to address the public health concern of youth e-cigarette and other tobacco product use with the goal of slowing and ultimately reversing these troubling trends.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.