The Food and Drug Administration is exploring ways to help wean teenagers off nicotine as huge numbers of middle and high school students use Juul and other e-cigarettes.
declare it an “epidemic” and Gottlieb demanding manufacturers to fix it. Juul, the market leader, suspended sales of its fruity flavors in stores ahead of the FDA effectively pulling these products from convenience stores and limiting them to age-restricted stores like vape shops.
Despite these efforts, anecdotal reports suggest some teenagers find themselves hooked on nicotine and unable to stop using e-cigarettes. Doctors treating kids don’t have much information on how to properly treat them since the cessation products available today, like nicotine patches and gums, are meant only for adults. The agency put out the call for insight months ago and is holding a rescheduled public hearing on Friday at its Silver Spring, Maryland headquarters.
“For these addicted young people, the reasons that they tried e-cigarettes may not matter anymore,” Gottlieb said in prepared remarks. “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.”
E-cigarettes are billed as a way to help smokers get their nicotine fix without all the toxins that come with smoking cigarettes. However, the surge in young people using e-cigarettes has enraged parents, teachers and now even regulators.
Gottlieb believes in e-cigarettes as a way to help adult smokers. But on Friday, he said the industry will face an “existential threat” if the number of teens using e-cigarettes does not decrease in this year’s survey data. If the trends don’t improve, he said, the conversation will shift from where fruity flavors can be sold to whether e-cigarettes can stay on the market.
Gottlieb again dangled the threat of reversing a decision that allowed e-cigarettes to stay on the market. Products that were on the market before Aug. 8, 2016, were supposed to start undergoing review this year until Gottlieb extended the deadline until Aug. 8, 2022, so manufacturers would have more time to file complete applications.
“It will be ‘game over’ for these products until they can successfully traverse the regulatory process,” Gottlieb said. “I think the stakes are that high. And would be a blow for all of the currently addicted adult smokers who, I believe, could potentially benefit from these products.”
Gottlieb met with executives from five major manufacturers in the fall and plans to send follow-up meeting requests to the leaders of Altria and Juul.
In December, Marlboro-maker Altria invested nearly $13 billion for a 35 percent stake in Juul. Two months earlier, Altria said it would voluntarily pull its flavors and pod-based products, saying these features, which Juul popularized, drove the surge in young people using e-cigarettes.
“I have real questions about whether there’s consistency,” Gottlieb told CNBC in an interview last week.
Juul in a statement said it’s moving “full steam ahead” on implementing the action plan it announced in November to prevent minors from using its products.
“We will be a transparent, engaged, and committed partner with FDA, state Attorneys General, local municipalities, and community organizations in the effort to combat underage use,” a spokesman said in a statement.
In the meantime, the FDA wants to find ways to stop teens from using e-cigarettes. Treatments for nicotine addiction on the market today are intended for adults, not minors. Pfizer’s Chantix, a prescription drug to help adult smokers quit, failed a clinical trial last year studying whether it worked for teen smokers.
Researchers, public health groups and vaping associations are slated to make presentations at Friday’s hearing, though one group is noticeably absent from the agenda: drugmakers. Everyone who requested to give a formal presentation or share comments during the open session made it onto the agenda, the FDA said, meaning drug companies did not ask to participate.