Juul e-cigarettes’ popularity among teens concerns schools, FDA

Food and Drug Administration Commissioner Scott Gottlieb supports this idea. As part of his sweeping plan to overhaul tobacco regulation, he wants to reduce the amount of nicotine in conventional cigarettes to minimally or non-addictive levels. In doing that, Gottlieb recognizes he needs to give people who are already hooked another less harmful option.

However, Gottlieb finds himself in a tougher position as more young people use Juul and other e-cigarettes.

Lawmakers, including Senate Minority Leader Chuck Schumer, have condemned Juul and pressed the FDA to do something to control youth use. Massachusetts opened an investigation into the company in July to see whether it violated state law in failing to prevent minors from buying its products.

“Any responsible party that wants to market products to adults needs to step up,” Gottlieb told CNBC in a July interview. “We have a window of opportunity to address this, and if the youth use continues, we’ll lose that opportunity.”

The rising popularity among teens doesn’t change Gottlieb’s mind in terms of the potential e-cigarettes can have to help adult smokers, but it does require the agency to ramp up its regulatory oversight, he said.

Earlier this year, the FDA requested information from Juul on how it markets its products to kids. It has received tens of thousands of pages of documents, Gottlieb said. The agency has also ordered a blitz to catch retailers illegally selling e-cigarettes to minors. In September, the FDA will launch its first campaign targeting youth e-cigarette use.

Eventually, Juul will need the FDA’s permission for its current products to stay on the market. E-cigarettes that were introduced before Aug. 8, 2016, were supposed to undergo review starting this year, but the agency extended the deadline until 2022. When that time comes, regulators will evaluate Juul and other e-cigarettes’ overall public health benefit, and having hoards of underage users will likely count against them.

“If these manufacturers don’t do more to address the youth use of products, they won’t be able to stay on the market,” Gottlieb said.

Manufacturers introducing new products after Aug. 8, 2016 must first apply with the FDA. So if Juul wants to add any new flavors or devices, it’ll need the FDA’s authorization.

Juul said it too believes “it is critically important to prevent minors from using e-cigarettes,” and it’s “committed” to keeping its products “out of the hands of young people.”