Former FDA chief: “I don’t see how” regulators keeps Juul, other e-cigarettes, on the market

WASHINGTON, D.C. — Leading vaping company Juul won't likely win regulatory approval to keep its e-cigarettes on the market, former Food and Drug Administration Commissioner David Kessler said in an interview Friday.

"I can't see how [Juul gets] approved," said Kessler, who spearheaded regulating the tobacco industry at the agency in the 1990s. "So they're going to face a cliff. Unless maybe somebody is enlightened enough to see that there is another pathway. But the current pathway they've set themselves on, I see significant roadblocks for them."

All e-cigarettes currently on the market will need to go through FDA review to stay on the market. The current deadline to submit applications is May 2020. The agency will weigh the "net public health benefit" in order to make its decision, meaning regulators will weigh the products' negative effects of getting minors hooked on nicotine against the benefits of helping adult smokers quit.

FDA spokesman Michael Felberbaum in an email said it would be "premature" for the agency to comment or speculate.

Juul has been largely blamed for fueling what regulators are calling an epidemic of teen vaping. Kessler said its use of nicotine salts has made it easier for kids to get hooked on e-cigarettes. Physicians have testified before Congress about how dangerous nicotine addiction is for developing brains, damaging some executive control functions and leaving teens more susceptible to developing other addictions later in life.

Nicotine salts make high concentrations of nicotine less harsh on the throat. They also deliver a faster and more intense hit than freebase nicotine that was used in e-cigarettes before Juul introduced the salts to the market in 2015. Kessler notes Juul isn't the only company that uses nicotine salts and he doesn't see how similar brands pass regulatory scrutiny.

"I don't see with the record that has been created today and with the explosion in youth use, that this is an industry that under the current model has any certainty," Kessler said in an interview with CNBC after speaking before the Food and Drug Law Institute's Tobacco and Nicotine Products Regulation and Policy Conference in Washington, D.C.

Kessler said it "remains to be seen" whether any e-cigarettes can survive the FDA review.

"I wouldn't want to bet on it," he told CNBC.

Kessler led the FDA from 1990 to 1997 under former presidents George Bush and Bill Clinton. He took on the tobacco industry and spearheaded the agency's efforts to regulate cigarettes. The agency's long-term strategy was to reduce the amount of nicotine in conventional cigarettes and move smokers to less harmful alternatives, Kessler said in his on stage.

Former FDA Commissioner Scott Gottlieb, who led the FDA from 2017 to 2019, got that strategy, Kessler said. Gottlieb in July 2017 unveiled a sweeping plan that would have done just what Kessler envisioned. He reversed course in September 2018 after receiving preliminary results of an annual federal survey that showed a huge spike in teen vaping.

"The industry blew it," Kessler told the audience. "The industry derailed that strategy. We can't even talk about that strategy."

Kessler called Juul "one of the great mess ups." He said if Juul thinks its products can help adult smokers stop smoking cigarettes, the company should come up with ways to reach those people while preventing its products from getting in the hands of kids.

One possibility includes selling its e-cigarettes like over-the-counter smoking cessation drugs that are sold behind the counter at pharmacies, he said.

Juul is trying to show regulators it's serious about preventing kids from accessing its products. The company is spending $100 million to install in stores a system it developed that requires store employees to scan a person's identification before selling them e-cigarettes. Juul also stopped selling its sweet flavors that were popular with kids in stores last year and stopped selling them altogether earlier this month.

Still, Kessler said the e-cigarette industry no longer has the trust of the public.

"I hope we can get to the point where people see this as potentially a safer product," Kessler told the crowd. "But in fact, I think that the actions over the last several years, in essence, I use the general you, whoever that is, you lost the trust of the American public."

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