Former Food and Drug Administration (FDA) commissioner Scott Gottlieb expressed doubt that the scandal-laden Juul will ‘ever’ get approval from the agency he once headed up in a Friday interview.
‘Juul is in a hard spot to ever get their product approved,’ he said on a CNBC segment Friday.
After coming under fire dragging its heals on regulating e-cigarettes, the FDA proposed a regulatory pathway to market with a tight timeline for the products earlier this month.
But, before stepping down, Gottlieb launched a veritable war against Juul, whose slim, trendy devices and ad campaigns he – and other health officials – openly blame for driving the ‘teen vaping epidemic.’
In the Friday interview, Gottlieb said the company may be trying to wholly re-vamp its products to be ‘kid proof,’ but that the clock will likely run out before it succeeds.
Former FDA commissioner Scot Gottlieb said in a Friday CNBC interview that he doubts Juul will be able to get an approval-worthy application for its products ready for FDA review by the proposed, shortened deadline (file)
When the FDA first provided some rules to govern e-cigarettes, in 2016, it gave the companies that make the products just a few months to get their applications for approval together.
But it quickly changed its tune, giving a nice, long lead time to companies like Juul to submit the applications by August 2022.
That did not go over 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 kids,’ the groups said collectively in a statement.
The Maryland court agreed, ruling that the agency had indeed shirked its responsibility and needs to stop in to regulate e-cigarettes much sooner.
Volleying back, the FDA suggested giving e-cigarette-makers a deadline to submit their applications no sooner than 10 months, while the groups that filed suit pushed for a tight, 120-day deadline.
Either way, Gottlieb thinks Juul would be hard-pressed to clean up its act, so to speak, sufficiently to submit an approval application that might pass FDA muster – even in his own absence.
He ventured to guess that Juul would want to propose a new product that would be less enticing and accessible to children and teenagers.
‘But if applications are required to be due sooner, they won’t have time to do that.’
And the same products that are currently on the market are carrying such heavy public health baggage, implied Gottlieb, who is now a resident fellow at a venture capital firm and contributor to CNBC.
Juul is eager to shake the backlash its faced over accusations that its products are getting kids hooked on nicotine and, instead, retool its reputation for making an effective aid to help adults quit smoking.
But an application for the same product it now sells would be laden with ‘all of that historical use’ among teens and kids, he said in the Squawk Box interview.
Even after he stepped down from his leadership position at the FDA, Gottlieb has 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 company’s vice president of public policy, Tevi Troy.
As a result of Gottlieb’s dogged pursuit, Juul has had to pull its flavored e-liquid pods from shelves, deactivate its once popular Instagram account and is still mired in ongoing investigations into its advertising and marketing practices.
Tevi has shown no ill will toward his former collaborator, saying in a 2018 episode of Politico’s Pulse Check podcast, ‘I can’t really criticize what he’s done as FDA commissioner.
‘I don’t want my kids [or] anyone who’s not an adult smoker to use these products.’
A spokesperson for Juul conveyed confidence about whatever product the company will submit for FDA approval, in a statement sent to CNBC.
Spokesperson Ted Kwong said the company plans to submit ‘a comprehensive application to demonstrate the potential public health impact of Juul products, including the unprecedented rate at which our products are switching adult smokers from combustible use, which will be reviewed by FDA technical and scientific experts.’
But only time will tell.