Former FDA commissioner Scott Gottlieb expressed doubts about the fact that the Juul & # 39; scandal-laden ever & # 39; Get approval from the agency he once attended in a Friday meeting.
& # 39; Juul has a hard time ever getting his product approved, & # 39; he said one CNBC segment Friday.
After coming under fire by regulating e-cigarettes, the FDA proposed a regulatory path on the market with a tight timeline for the products earlier this month.
But before he resigned, Gottlieb launched a true war against Juul, whose slender, trendy devices and advertising campaigns openly blame him – and other health officials – for driving the & # 39; teen vaping epidemic & # 39 ;.
In the Friday conversation, Gottlieb said the company might be trying to & # 39; boxing & # 39; re-box its products, but the clock is probably up before it succeeds.
Former FDA commissioner Scot Gottlieb said in a CNBC interview on Friday that he doubts whether Juul will be able to prepare an approvable application for his products for FDA assessment with the proposed, shortened deadline (file)
When the FDA first issued a set of rules for e-cigarettes, in 2016 it gave the companies that make the products only a few months to get their applications together for approval.
But it quickly changed its tone, which resulted in a nice, long lead time for companies like Juul to submit applications by August 2022.
That did not go well with public health officials and organizations.
In 2018, dozens of groups, including the American Medical Association, Campaign for Tobacco-Free Kids, and the American Academy of Pediatrics, filed a lawsuit against the FDA, demanding immediate action to protect our children. the groups collectively in a statement.
The Maryland court agreed and ruled that the agency had indeed taken away its responsibility and had to stop regulating e-cigarettes earlier.
Recurringly, the FDA proposed to give e-cigarette manufacturers a deadline to submit their applications no earlier than 10 months, while the groups that filed a complaint insisted on a tight 120-day deadline.
Anyway, Gottlieb thinks Juul will have trouble clearing his act, so to speak, sufficient to submit an application for approval that can happen to the FDA – even in his own absence.
He dared to guess that Juul would like to propose a new product that would be less attractive and accessible to children and teenagers.
& # 39; But if applications have to be submitted earlier, they don't have time for that. & # 39;
And the same products currently on the market carry such heavy public health baggage, Gottlieb implied, who is now a resident of a venture capital company and contributes to CNBC.
Juul is eager to suppress the contradiction he has against allegations that his products make children addicted to nicotine and instead improve the company's reputation for effectively helping adults to quit smoking.
But an application for the same product that it now sells would be fraught with & # 39; all that historical usage & # 39; among teenagers and children, he said in the Squawk Box interview.
Even after he stepped out of his leadership position with the FDA, Gottlieb remained a curious crusader against e-cigarettes in general and Juul Labs in particular – despite his friendship and history of academic publishing partnership with the vice-president of government policy of the company, Tevi Troy.
As a result of the pursuit of Gottlieb & # 39; s, Juul had to take his flavored e-liquid pods off the shelves, deactivate the once-popular Instagram account and he is still entangled in constant research into his advertising and marketing practices.
Tevi has shown no bad will towards his former employee, and said in 2018 an episode of Politico's Pulse Check podcast, & # 39; I cannot really criticize what he did as an FDA Commissioner.
& # 39; I don't want my children (or someone who is not an adult smoker) to use these products. & # 39;
A Juul spokesperson expressed confidence about which product the company is submitting for approval by the FDA in a statement to CNBC.
Spokesman Ted Kwong said the company plans to submit a comprehensive application to demonstrate the potential impact of Juul products on public health, including the unprecedented rate at which our adult smokers switch to flammable use, which will be reviewed by FDA technical and scientific experts. & # 39;
But only time will tell.
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