The US Food and Drug Administration is considering the role of drug therapies to get kids to quit vapes and other nicotine products, with medical organizations and vaping groups weighing in during a public hearing Friday on how to address rising levels of e-cigarette use among youth.
There are no FDA-approved nicotine cessation products for e-cigarette users under 18.
“A few years ago, it would’ve been incredible to me that we would be here today discussing the potential for drug therapy to help addicted young people quit,” said FDA commissioner Dr. Scott Gottlieb, who commented on the importance of continuing key FDA operations, such as Friday’s hearing, despite the partial lapse in funding due to the federal government shutdown.
The agency announced in November that vaping had increased nearly 80% among high schoolers and 50% among middle schoolers since the year before. Experts worry that the devices could put kids’ developing brains at risk, get them hooked on nicotine early in life and be a gateway to smoking and other drugs. But, the long-term effects aren’t clear.
“The FDA has concluded that the level of addiction it is seeing among youthful e-cigarette users is so disturbing and so unprecedented that it needs to at least ask whether we need a solution that goes beyond what we ever did with cigarettes,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, previously told CNN.
‘Virtually no data’ on treating kids who are hooked
Medical experts say there is an urgent need for research on using therapies to treat kids who are addicted to nicotine. Many health care providers are already using some off-label, such as nicotine gum, but without solid data on how well they work and how best to use them in conjunction with counseling and other resources.
According to experts, most of what we know about nicotine addiction in teens, we know from cigarettes. But the technology and chemistry of vaping might pose an entirely different threat.
“These products deliver very high levels of nicotine, meaning that even brief experimentation is likely to put adolescents at risk for long-term dependence,” Dr. Susanne Tanski, former chair of the American Academy of Pediatrics Tobacco Consortium, told the FDA Friday.
“Clinicians urgently require new solutions to safely and effectively help stop them using these and all tobacco products for good,” said Tanski, also an associate professor of pediatrics at the Geisel School of Medicine at Dartmouth. “There is unfortunately virtually no data on how to treat an adolescent with e-cigarette dependence.”
But some in attendance think the FDA should have focused the hearing on preventing kids from picking up vapes in the first place.
“I believe FDA posed the wrong questions for today’s meeting,” said Lauren Lempert, a law and policy specialist for the Center for Tobacco Control Research and Education at the University of California, San Francisco.
Instead of debating the role of nicotine replacement and drug therapies, the agency “should be focusing on policies that will prevent youth initiation with e-cigarettes and addiction to nicotine,” Lempert told CNN in an e-mail ahead of the hearing.
In her statement to the FDA Friday, Tanski agreed.
“Preventing youth use in the first place should be FDA’s primary goal,” she said. “We must all recognize that if an adolescent has developed a nicotine addiction as a result of vaping, we’ve already failed.”
Could regulation go further?
Lempert said the FDA has a number of effective regulatory tools in its arsenal: It can demand pre-market review of e-cigarettes and tobacco products. It can regulate marketing and prohibit unauthorized claims by e-cig companies about health, safety, and smoking cessation. And it can ban all flavors.
Instead of requiring e-cigarettes to undergo FDA approval before they could be sold, the agency decided in 2017 that it would allow such products to stay on shelves until 2022 without pre-market review.
At the hearing, Gottlieb said requiring e-cigarettes to go down such a regulatory path could be “game-over for some of these products.” If the prevalence of youth vaping continues to rise, that could prompt the agency to take more extreme action, he said.
In November, Gottlieb proposed strengthening the agency’s policies against flavored e-cigarette products. These proposals could ultimately lead to their removal from shelves and websites that are accessible to minors. But the proposed changes do not include mint, menthol and tobacco flavors. Gottlieb said he wanted to leave the door open for adults who might use these products to quit smoking cigarettes, “but it can’t come at the expense of addicting a generation of kids on nicotine,” he previously told CNN.
Flavors are at the center of the regulatory debate: Some say they’re an important tool in getting adults to switch over from combustible cigarettes, while others want to ban them entirely because they appeal to kids and minimize how harmful and addictive vapes are perceived to be.
Mark Anton, executive director of industry group Smoke-Free Alternatives Trade Association, told CNN that his group shares the goal of preventing kids from using vapes but doesn’t think flavors should be the target.
“Flavors have been around for quite a long time,” he told CNN ahead of his presentation at the hearing. “You can’t just attribute [the recent spike in youth use] to a flavor.”
On the other side, health advocates say Gottlieb’s November proposal, in exempting some flavors, did not go far enough.
“There’s no evidence that adults need these flavors to quit smoking,” Bonnie Halpern-Felsher, founder and executive director of the Stanford Tobacco Prevention Toolkit, said at the hearing Friday.
Halpern-Felsher’s own research suggests that the majority of kids who have tried pod-based e-cigarettes started with one that was flavored.
“All flavors need to be eliminated,” she said.