Teens addicted to electronic cigarettes have few treatment options to help them quit, and physicians treating nicotine-addicted kids have little information to guide them in helping their underage patients kick the e-cigarette habit, according to the FDA commissioner.
Scott Gottlieb, MD, was speaking Friday at the opening of a day-long public hearing, which was devoted to exploring the possible role of cessation therapies approved for adults to help youth who have become addicted to nicotine through the use of Juul and other vaping products.
“For these addicted young people, the reasons that they tried e-cigarettes may not matter anymore,” Gottlieb said. “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.”
He noted that while there is a tremendous amount of research on smoking cessation for adults, the treatment of nicotine addiction among adolescents and teens is not well understood.
“There is little information about how drug or behavioral interventions might support youth e-cigarette cessation, as well as youth tobacco use more generally,” he said.
Gottlieb cited 2018 National Youth Tobacco Survey (NYTS) figures that confirmed the epidemic rise in e-cigarette use among middle- and high school students between 2017 and 2018.
During this period, current e-cigarette use among high school students increased by 78% and current use among middle school students increased by 48%, with the total number of middle and high school students estimated to be current users rising to 3.6 million.
“I fear that the survey data that we’ll get for next year will show continued increases in youth use of e-cigarettes. We’ll be in the field between March and May with the 2019 National Youth Tobacco Survey. I’ll tell you this: If the youth use continues to rise, and we see significant increases in use in 2019, on top of the dramatic rise in 2018, the entire (e-cigarette) category will face an existential threat.”
The FDA gained regulatory authority over electronic cigarettes with the passage of the 2016 deeming rule, but the following year the agency announced that newly deemed e-cigarettes would be exempted from premarket review — essentially remaining unregulated — until 2022.
In his remarks on Friday, Gottlieb reiterated a previous threat to revisit the regulatory delay if e-cigarette companies do not engage in good faith efforts to prevent use of their products by youth.
Criticism of the FDA’s decision to delay regulatory oversight was a recurring theme at the hearing.
“Reversing these trends and ultimately eliminating youth e-cigarette use will take a multifacited approach, and strong tobacco control policies must take a primary role,” said Susanne Tanski, MD, speaking for the American Academy of Pediatrics. “While it is important to discuss how drug therapies can help adolescents who are already dependent on tobacco products, preventing youth use in the first place should be FDA’s primary goal. We have to recognize that if an adolescent has developed a nicotine addiction as a result of vaping, we have already failed.”
Tanski said FDA’s recently announced actions aimed at eliminating youth e-cigarette use “do not go far enough.”
“We urge much stronger action regarding e-cigarettes,” she said. “Strong tobacco control policy aimed at keeping these products away from adolescents may be more effective in achieving adolescent cessation than medical intervention. Indeed, it is likely that nothing FDA does to advance tobacco dependence treatment for adolescents will be as powerful or effective as addressing the availability of flavored e-cigarette products that are attracting and sustaining youth use.”