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Juul May Have Hard Time Getting E-Cig Approved, Ex-FDA Chief Says

Drew Armstrong
Juul May Have Hard Time Getting E-Cig Approved, Ex-FDA Chief Says

(Bloomberg) -- The former commissioner of the Food and Drug Administration said he thinks Juul Labs Inc. will have a difficult time getting its e-cigarette approved under rules that will eventually force makers of the devices to go through government review to keep selling to consumers.

“Juul is going to be in a hard spot to ever get their product approved,” ex-Commissioner Scott Gottlieb, who stepped down from leading the agency earlier this year, said on CNBC Friday.

Altria Group Inc., which sells Marlboro cigarettes, bought a $12.8 billion stake in Juul last year. Shares of the tobacco company closed down 4.5% to $48 in New York, the lowest closing price since Jan. 30.

During his two-year tenure atop the FDA, Gottlieb initially took a cautious approach toward strictly regulating e-cigarettes, seeing them as a tool to help adult smokers quit. He evolved into a harsh critic, calling youth use an “epidemic” and said that Juul and other e-cigarettes had attracted previous nonsmokers.

To respond to a lawsuit claiming the agency failed to sufficiently regulate the products, the FDA has proposed giving manufacturers 10 months to submit applications to keep selling the nicotine devices.

Juul said it's working on its application to the FDA, which will include information on how the product can help existing smokers stop using cigarettes. ``We are confident adult smokers will not be left without a viable alternative to combustible cigarettes,'' said Juul spokesman Matt David.

Juul is popular with many young and underage people, and public health advocates have said that the company specifically targeted younger users. The company has pulled back on some marketing activities and has taken steps to make sure its product reaches only people of appropriate age. Juul’s website says that “We don’t want anyone who doesn’t smoke, or already use nicotine, to use Juul products.”

“We remain confident that Juul can successfully navigate the PMTA process,” Altria spokesman Steven Callahan said in an emailed statement. PMTA refers to the FDA’s premarket tobacco application rules. A federal judge said last month the FDA must speed up its implementation of the rules, though hasn’t made a final ruling on the agency’s proposal.

A spokesman for the FDA didn’t immediately provide a comment.

Government health officials are also researching the use of Juul as part of a regular survey that gauges youth tobacco use. The data they collect could have an impact on the likely review of the devices.

“If we see a further increase in overall use, and respondents report to using Juul mostly, then we think whatever Juul says, and whatever actions they point to that they have implemented, it won’t matter,” Ryan Tomkins, a stock analyst with Jefferies, said in a note to clients Friday.

(Adds Juul statement in sixth paragraph)

--With assistance from Janet Freund, Tiffany Kary and Anna Edney.

To contact the reporter on this story: Drew Armstrong in New York at darmstrong17@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett

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