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Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes
SILVER SPRING, Md., April 1, 2019 /PRNewswire/ -- As we continue to address the troubling epidemic of youth e-cigarette use, we've committed to employing a number of tools as part of our Youth Tobacco Prevention Plan to ensure no tobacco products are being marketed to, sold to, or used by kids. We've taken a series of escalating enforcement actions. We've launched public education campaigns to warn youth about the dangers of e-cigarette and other tobacco product use. And most recently, we advanced new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars.
But given the rise in youth e-cigarette use, we are faced with a challenging and troubling reality: We must not only seek to prevent youth from using tobacco in any form; we must also explore evidence-based approaches to address existing youth tobacco use and youth addiction to nicotine.
The need is clear. We've heard too many painful stories from parents of teenagers, pediatricians, and young people themselves; and, they reinforce what we all already know – for many young e-cigarette users, addiction has already taken hold. These young people are hooked on vaping, and their worried parents, physicians, and the public health community are searching for tools to help them quit.
Today, I want to update you on our latest efforts to help treat teen addiction to nicotine and announce a new workshop intended to help further examine the science and treatment strategies to support youth tobacco cessation.
In many therapeutic areas, including tobacco addiction and cessation, we know unique challenges exist when it comes to treating pediatric populations. Although there's a large body of research on adult smoking cessation, the methods to treat adolescents who're addicted to vaping are not well understood. There's little information about how drug or behavioral interventions might support youth e-cigarette and tobacco cessation. That's why, as part of ongoing efforts to examine the science and treatment strategies related to youth tobacco cessation, we held a public hearing in January on this topic that was invaluable in providing a range of perspectives on this important issue and announced new funding opportunities to support research on youth tobacco initiation, use and cessation that we are hopeful will help inform our regulatory policies.
Our efforts on this front have been helpful, but it's imperative that we continue the dialogue, especially with respect to e-cigarettes, which remain the most commonly used tobacco product among our nation's youth.
The most recent data show more than 3.6 million middle and high school students across the country were current (within the past 30 days) e-cigarette users in 2018. This is a dramatic increase of 1.5 million students from the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently, and they were using flavored e-cigarette products more often, than in 2017. This is particularly troubling given research shows kids using e-cigarettes are more likely to take up combustible cigarettes.
There's a large pool of nicotine users being created among school-age children who are using e-cigarettes and other tobacco products. And some portion of them are at risk of taking up cigarettes and becoming addicted to them. Youth e-cigarette and other tobacco product use also raises 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.
The rapid growth in the popularity of e-cigarettes among youth to epidemic levels necessitates we explore all options for how to address this public health concern. And our continued efforts 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.
To that end, the public scientific workshop that will be held May 15 will further discuss scientific understanding and treatment options for youth tobacco addiction and cessation, with a focus on e-cigarette cessation. The workshop will build on many of the scientific issues raised during the January public hearing. As part of our efforts to address this issue, we determined that holding both a public hearing and a scientific workshop would provide forums for gathering public input first, followed by robust scientific discussion with stakeholders. The workshop is being hosted in collaboration with the FDA by the Institute for Advanced Clinical Trials for Children and the Duke Clinical Research Institute, which have previously received grants to establish a Global Pediatric Clinical Trials Network to facilitate clinical trials of new drugs and devices for children in a range of therapeutic areas.
This workshop is intended to gather scientific information and stimulate discussion about the current science regarding youth tobacco use and addiction, and treatment strategies to support youth tobacco cessation. The workshop will include presentations and panel discussions relating to the unique factors impacting youth tobacco use and addiction and the challenges associated with youth tobacco cessation. For example, discussion is expected to include the basic science of tobacco addiction in adolescents, the current state of behavioral and pharmacotherapy cessation strategies in adolescents, and the development of strategies to generate robust evidence to address youth tobacco cessation.
When it comes to the treatment of nicotine addiction in youth, we want to explore how we can support the development of such therapies. We are hopeful this scientific workshop will help provide valuable information and input that the FDA can use to further address e-cigarette use among youth and help those who may already be addicted to these products through potential new therapies. We cannot risk a whole generation of kids getting addicted to nicotine. Prevention is a critical cornerstone of our efforts to reverse the alarming trend of rising youth use of novel products like e-cigarettes, but we must also put strategies in place now to help those who are already addicted quit.
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.
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SOURCE U.S. Food and Drug Administration