In a speech at FDA headquarters, Commissioner Scott Gottlieb said the FDA would also revisit its compliance policy that extended the dates for manufacturers of flavored e-cigarettes to submit applications for premarket authorization.
Gottlieb announced a number of steps the agency planned to take as part of a wider crackdown on the sale and marketing of e-cigarettes to children.
The agency issued 12 warning letters to companies that it says have deceptive marketing labels on e-liquids. “We cannot allow a whole new generation to become addicted to nicotine,” he said.
The FDA is giving the five top-selling e-cigarette brands – Juul Labs Inc., Vuse, MarkTen XL, Blu and Logic – 60 days to provide plans for how they will mitigate sales to minors.
In mid-September, the FDA has launched a vaping prevention campaign targeting 10 million youths who vape or are open to trying it, Gottlieb said. It will continue enforcement against retailers that sell to minors.
“We are very concerned that we could be addicting a whole generation of young people,” Gottlieb said. “We only have a narrow window of opportunity to address it.”
Instead of committing to regulate flavor, the FDA solicited more research on flavor’s role. Robin Koval, CEO of the anti-tobacco group Truth Initiative, said there is ample evidence that flavors attract teens.
Alternatives to cigarettes?
E-cigarettes are marketed as alternatives to traditional cigarettes because they can quell smokers’ urges for nicotine without cancer-causing tobacco.
Federal health officials and other health experts said there’s ample cause for concern about young people newly lured to nicotine and chemicals found in vaping juice. Vaping has not only usurped smoking tobacco among those under 20, it came along as youth smoking rates were declining and threatens to erase the health benefits from the gains.
Young adults who use e-cigarettes are more than four times as likely to begin smoking tobacco cigarettes within 18 months as their peers who do not vape, according to a study in December 2017 by the University of Pittsburgh Schools of the Health Sciences published in The American Journal of Medicine.
Juul CEO Kevin Burns said restricting flavors “will negatively impact current adult smokers” who want to switch from smoking to vaping. He said the company would support “reasonable regulation” to restrict advertising and the naming of flavors such as cotton candy and gummy bear that target children.
“The main reason people are able to switch away from tobacco is because of the flavors offered to them,” Kevin said. “If nobody uses it, why bother?”