The FDA is trying to set up a framework for regulating e-cigarettes. Such grim statistics prompted the FDA to recently propose that the level of nicotine, the addictive substance that gets people hooked, permitted in products should be brought down, either suddenly or gradually over time, to eventually wean people off smoking. Since past year, FDA commissioner Scott Gottlieb and other federal officials have discussed e-cigarettes as a potential tool to ween adult smokers off cigarettes, although that benefit hasn't been proven.
"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said in an interview. The agency may also ban sales of some flavored e-cigarette products, which Gottlieb says are particularly appealing to underage users, and consider shortening a grace period that now gives e-cigarette companies until 2022 to apply for FDA approval.
"I certainly am in possession of evidence that warrants that", Gottlieb said, without disclosing the evidence.
The government agency has ordered five leading brands, including Juul, which has 72% of the market as of mid-August, according to Wells Fargo, as well as BAT's Vuse, Altria's MarkTen, Imperial's Blue E-cigs and Japan Tobacco's Logic, to submit plans within 60 days detailing how they will combat excessive teen use of their products.
Gottlieb announced a number of steps the agency plans to take as part of a broader crackdown on the sale and marketing of e-cigarettes to minors.
The Vapor Technology Association, which says it represents over 600 vaping manufacturers and distributors, also supports limiting teen access, but added that the new actions by the FDA ventured "into risky territory" by not being in the best interest of public health.
The agency will also be increasing federal enforcement actions on e-cig sales to minors in convenience stores and other retail sites, Gottlieb said, and would look closely at a practice called "straw purchases", in which adults visit web-based stores and buy in bulk to resell to minors.
Makers argue that e-cigarettes can help adult smokers transition away from burnt tobacco products.
Manufacturers say they've changed from the days of Joe Camel, he said.
"They come out with cherry flavored vodka and birthday cake flavored vodka".
He said "everything is on the table", including criminal charges.
"JUUL Labs will work proactively with FDA in response to its request. I think education is the answer to fixing the problem, just like how we have educated young people about alcohol and other tobacco products over the years", Delaney said. "Hindsight, and the data that's now available to us, fully reveal these trends". Today's effort notches up that action, becoming, said Gottlieb, the "largest ever coordinated initiative against violative sales in the history of the FDA". But spokeswoman Victoria Davis said "appropriate flavors play an important role in helping adult smokers switch".
While e-cigarettes are thought to be less harmful than regular cigarettes, it's still unclear of the impact of long-term use.
And the agency has issued more than 135 No-Tobacco-Sale Order Complaints, which, according to the FDA, "can result in retailers being prohibited from selling tobacco products for specified periods of time".
Investors in Juul's competitors appeared to welcome the FDA announcement.