Former FDA commissioner calls for a full ban on pod-based e-cigarettes

Former Food and Drug Administration Commissioner Scott Gottlieb is done playing nice on e-cigarettes. He’s calling on the agency to ban all pod-based e-cigarettes, a move that would likely eliminate every product sold in the U.S. by companies like Juul and Njoy.

In a far-reaching and strikingly candid speech at Harvard University on Tuesday evening, the Trump appointee plans to rail against top e-cigarette makers for their role in what he calls the “travesty on top of a travesty” of youth vaping.

“Unless we’re able to change the current trajectory of tobacco-related disease, almost six million children alive today will die prematurely later in life from tobacco use,” Gottlieb will say, according to prepared remarks shared with STAT. “In my view, that requires us to sweep the market of all of the cartridge-based e-cigarette products in their entirety — Juul, Njoy, Blu, Vuse, and the others.”

Gottlieb, however, believes that open-tank vaping systems, such as those sold in dedicated adults-only vape shops, should still be able to stay on the market.

“We can preserve for adults the open-tank vaping systems that are sold in the adult vape shops,” Gottlieb says. “The kids just don’t like those big open-tank contraptions.”

His remarks come as the Trump administration continues to weigh a final regulation that could ban most flavored e-cigarettes. The administration has not formally unveiled its plan, but the policy is expected to carve out exemptions for tobacco and menthol flavored vapor products.

Gottlieb, who is now a resident fellow at the American Enterprise Institute and a special partner at the venture capital firm New Enterprise Associates, resigned from the FDA early this spring. But since his resignation he has made no bones about advocating for the FDA to pursue certain policies.

The remarks also come just days after a top Trump administration official claimed that the FDA’s efforts to regulate tobacco were a waste of time. Gottlieb, who not so subtly made his qualms with that statement known on Twitter, will largely reiterate those comments Tuesday.

“As a public health agency charged with the protection and promotion of the public health, FDA’s tobacco mission is an essential part of its overall obligation,” Gottlieb’s remarks state. “Addressing the leading cause of preventable death and disease in this nation — tobacco use — is among the most essential expressions of that mission.”

While Gottlieb’s policy prescription would likely put many of the top e-cigarette companies out of business, it would have a particularly devastating impact on Juul. Juul reportedly controls more roughly three quarters of the e-cigarette market and has been sharply criticized by some for fueling the popularity of vaping among young people. In response, the company has pulled most of its flavored products from the market, brought in a new CEO, and temporarily suspended all advertising earlier this year.

But Gottlieb isn’t pulling any punches in his criticism of the brand.

“At these levels of youth use, it can be judged that they’re not a responsible steward of their brand,” Gottlieb says. “There’s clear evidence that the manufacturers of Juul can’t, or perhaps won’t, keep their products out of the hands of children.”

Gottlieb also makes clear in his remarks that while he supports the Trump administration’s forthcoming ban on flavored products, he doesn’t think it will stem the tide of youth vaping.

“I fear that even if we fully remove the fruity flavors from the market, kids will continue to prefer the sleek Juul device and its high nicotine,” Gottlieb will say. “I’m concerned that a lot of currently addicted kids will just switch to the tobacco flavors.”

As FDA commissioner, Gottlieb championed a more activist role for the FDA in regulating tobacco issues. In 2017, he unveiled a sweeping tobacco control plan that most notably included reducing the level of nicotine in combustible tobacco to non-addictive levels. During his tenure he also cracked down on companies selling flavored tobacco targeted at youth and and stood up a massive anti-vaping campaign aimed at children.

But despite those actions, Gottlieb admitted Tuesday that he did not foresee Juul’s meteoric rise in popularity among children.

“What we didn’t envision in the summer of 2017 was Juul,” Gottlieb says. “I didn’t foresee how that product would be positioned in the kid marketplace, how it would appeal to children, and what a malignant presence it would become among American children.”

According to recently released FDA survey data, more than 5 million children are now using e-cigarettes, and the majority say they prefer Juul.

Megan Thielking contributed reporting.