The head of the U.S. Food & Drug Administration (FDA) has threatened once again to ban e-cigarettes, warning JUUL Labs and other manufacturers that they face an “existential threat” if they don’t stop marketing their products to children and teens.
“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 category will face an existential threat,” FDA Commissioner Dr. Scott Gottlieb said last Friday at a public hearing convened to discuss the current epidemic of youth vaping.
“It will be game over for these products until they can successfully traverse the regulatory process,” he warned.
Many e-cigarettes deliver extremely high doses of nicotine in formulations that make the devices even more addictive than traditional cigarettes.
Unfortunately, teen vaping has more than doubled over the past two years, even as adult smoking has fallen to an all-time low. In fact, the U.S. Centers for Disease Control (CDC) estimates that 3.6 million high school and middle school students now use e-cigarettes.
According to NBC News, Gottlieb called out JULL Labs by name during last Friday’s hearing. The company’s trendy, USB-shaped vaporizers and flavored nicotine pods are seen as a major contributor to the surge in youth vaping.
“I find myself debating with tobacco makers and retailers the merits of selling fruity flavors in ways that remain easily accessible to kids,” Gottlieb said.
The FDA Commissioner made a similar threat last September. But a month later, several e-cigarette manufacturers provided the agency with detailed plans to keep their products away from minors. As a result, the FDA stopped short of a ban when it proposed new e-cigarette restrictions in November.
In threatening to revisit a ban, Gottlieb implied that JUUL and other e-cig manufacturers weren’t following through on their pledges.
“I have questions about whether they are living up to the very modest promises that they made,” he said. “It matters if the e-cig makers can’t honor even modest, voluntary commitments that they made to the FDA.
Officially, last Friday’s hearing was convened to discuss ways to help children and teens who have become hooked on e-cigarettes.
During her testimony, however, Susanne Tanski, a pediatrician and past chair of the American Academy of Pediatrics Tobacco Consortium, pointed to the lack of research on effective strategies for treating e-cigarette addiction and pressed the FDA to focus on prevention.
“We must all recognize that if an adolescent has developed a nicotine addiction as a result of vaping, we have already failed,” she said.
“FDA’s recently announced regulatory actions regarding e-cigarettes do not go far enough and we urge much stronger action,” she said. “Strong tobacco control policy aimed at keeping enticing products away from adolescents may be more effective in achieving adolescent cessation than medical interventions,” Tanski continued.
Lauren Lempert, a researcher at the University of California San Francisco’s Center for Tobacco Research and Education, agreed.
“FDA should fulfill its legal mandate and immediately pull from the market all e-cigarettes that have not been pre-approved,” she said.