The FDA is aware of the gap and trying to fill it. The agency is preparing to yank e-cigarette flavors from the market while studying their safety and public health impact, and has announced new funding opportunities for researchers to study effective ways to treat nicotine addiction in youth and explore the development of drug therapies for 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,” Ned Sharpless, the acting FDA commissioner, said earlier this year.
The vaping lung disease that has sickened about 1,500 people and killed at least 33 has given urgency to efforts to stop youth vaping, although THC-containing vapes are responsible for much of the epidemic. The vaping industry argues that e-cigarettes help smokers stop using traditional cigarettes, but odorless vapes and their tantalizing flavors, like blue raspberry slushie and caramel candy, have created an influx of nicotine-addicted teenagers, and may come with other health hazards that are still poorly understood.
Vaping has caused tobacco use in teenagers to rise after a successful, decades-long campaign to stop minors from smoking cigarettes. More than 3.6 million youth reported vaping last year, and use among high schoolers rose from nearly 12 percent in 2017 to about 21 percent in 2018, according to government data.
“They came out with this product that has the capability of delivering nicotine in very high jolts … so the products are highly, highly addictive,” said Sharon Levy, the director of Boston Children’s Hospital’s adolescent substance use and addiction program.
Advocates want the FDA to ban all vape flavors, including menthol, which add to the allure of the products for young people. On Thursday, e-cigarette giant Juul suspended sales of its flavored pods — except for tobacco and menthol — pending FDA review.
Meanwhile, physicians are scrambling to design their own treatment plans — such as combining behavioral therapy with nicotine replacements , which doctors can currently prescribe to minors off-label.
“We desperately need some research immediately in this area” said Susanne Tanski, a pediatrician and past chair of the American Academy of Pediatrics Tobacco Consortium. She urges the FDA to “make this really quick. Fast track it. Because we’re in the middle of a bit of a public health crisis.”
Research should examine not only whether nicotine replacement therapies work for teen e-cigarette addiction, but the appropriate dosages, said Bonnie Halpern-Felsher, a professor of pediatrics , adolescent medicine at Stanford University.
Some teens don’t want their parents to know they vape, which makes it harder for physicians to treat them. And teenagers aren’t always aware they are addicted to e-cigarettes, and don’t understand the signs of withdrawal.
Studying potential drug therapies in minors is inherently difficult because parents might not want their children to participate in clinical trials, and researchers may be wary of studying an unapproved product in children.
FDA held a public hearing in January and a workshop in May on youth tobacco cessation that covered e-cigarettes, and is offering funds for research on youth tobacco initiation, use and cessation.
“It has become increasingly important to identify strategies to assisting youth who have become addicted to e-cigarettes with quitting the use of these products,” Brian King, a deputy director in the CDC’s Office on Smoking and Health, said in comments to POLITICO.
Behavioral counseling from providers can help prevent vaping and encourage teens to quit, according to King, as can mobile-based apps, but “more research is needed to identify potential medications, or other strategies, that are effective for tobacco product cessation among youth.”
The federal government runs a website on how to become a smoke-free teen, with links to a hotline, mobile-based apps and text messaging services offering tips on quitting. The American Academy of Pediatrics is working on guidance for doctors. And the Truth Initiative developed a text message program sending supportive messages and tips to young people who want to quit vaping, enrolling more than 54,000 users since its January launch.
“This is not an easy solution that you just give them a pill and then they stop using e-cigarettes” said Gary LeRoy, president of the American Academy of Family Physicians. Behavioral therapy is an important component of treatment, he said.
And the federal government needs to use its regulatory power to keep youth from starting to vape in the first place, said Jonathan P. Winickoff, a pediatrician and past chair of AAP’s Tobacco Consortium.
“The best cessation tool that you could use, that you could deploy to help kids across the country quit and get out of this vape epidemic, is to ban all flavored tobacco products,” he said.