- Speech by
Norman E. "Ned" Sharpless,
Leadership RoleActing Commissioner of Food and Drugs - Food and Drug Administration
FDA White Oak campus
Thank you. Good afternoon and thank you for joining us today to discuss an incredibly important topic – youth tobacco cessation.
I hope you have had a productive morning and nice lunch and are refreshed and ready to continue this important dialogue.
It was an honor to be selected as Acting Commissioner of FDA and, over the past month, I’ve been familiarizing myself with FDA’s large portfolio.
My predecessor, Dr. Scott Gottlieb, made tobacco a top priority during his tenure here, and I remain committed that work.
Most notably, I intend to focus on keeping tobacco products out of the hands of America’s youth. There is no dispute that years of progress to combat youth use of tobacco – to prevent lifetimes of addiction to nicotine – is now threatened by an epidemic of e-cigarette use by kids.
As part of the Youth Tobacco Prevention Plan, FDA has used its authorities forcefully to prevent kids from getting their hands-on tobacco products, and we have focused particularly on this emerging threat of youth vaping.
Under my leadership at FDA, we will maintain this energy and focus.
These products are exposing a whole new generation to nicotine and the possibility of addiction.
Nicotine can also affect teen brain development and may have long-lasting effects on attention, learning, and memory.
In 2018, 3.6 million middle and high school students used e-cigarettes.
That is an increase of 1.5 million more youth exposed to nicotine through use of these products in 2018 versus 2017.
Emerging science also signals that teens who vape are more likely to start smoking cigarettes thereby potentially pushing them up the continuum of risk to the deadliest of products.
We can all agree this is a public health problem we must end.
Which is why our discussion here today is so important.
Our efforts to stop the epidemic of youth e-cigarette use must begin with prevention, but we must also put strategies in place now to help those who are already addicted or are on that path.
For young people who are currently hooked on e-cigarettes, we will support every effort to help them quit.
In fact, we specifically proposed to prioritize enforcement against flavors other than tobacco mint and menthol if sold in ways that pose the greatest threat to youth.
The FDA has taken a number of escalating regulatory actions to tackle the growing use of e-cigarettes among kids.
No child should be using any tobacco or nicotine-containing product and the FDA remains committed its Youth Tobacco Prevention Plan to ensure all tobacco products, including e-cigarettes, aren’t being marketed to, sold to or used by kids.
By coming together, undertaking vital research, and exploring treatment strategies to support youth cessation we can help stop this epidemic.
Which is why we need a broad coalition of dedicated researchers, doctors, public health professionals, and partners like yourselves to search for and provide the scientifically-sound treatment options and support to help them overcome their addiction to nicotine.
As you’ve already discussed today, treatment strategies and clinical trials are not one size fits all.
There are important differences between adult and youth treatment, and cessation of combustible use versus non-combustible use that we must study.
FDA is accepting research proposals to conduct clinical trials and further explore the potential development of drug therapies to support youth cessation.
To date, much of the research on youth tobacco cessation has been limited and focused on smoking, but we are determined to find solutions to address cessation of all types of tobacco, especially methods to help youth quit e-cigarettes.
Workshops like this one, and the scientific information we will gather together, will help us to provide the level of support kids and their families deserve.
I commend the Institute for Advanced Clinical Trials for Children and the Duke Clinical Research Institute for their leadership in this area.
We cannot and will not risk a generation of youth to a lifetime of nicotine addiction.
FDA has a significant public health responsibility and I’m proud to work with each and every one of you to accomplish our mission.
Thank you again for supporting our efforts.