Electronic-cigarette industry leader Juul Labs is pulling out all the stops to ensure its pre-market tobacco application (PMTA) will be successful when it is finally submitted by the May 2020 deadline that all e-cig companies must meet.
Even though the positions it is taking often run contrary to its own interests, Juul undoubtedly believes it won't do any good to stand on principle if regulators don't allow its e-cig device to remain on the market. But it might not matter at this point.
Juul voluntarily stopped selling flavored pods, including mint, for its device. Image source: Juul Labs.
A substantial animus has built up against the e-cig maker at the U.S. Food and Drug Administration, which has cracked down most heavily on Juul because teenagers purportedly favor its device over most others. And last Monday, former FDA commission Scott Gottlieb told CNBC the time had likely come to remove the Juul device from the market: "It's very clear that Juul can't keep their products out of the hands of kids. It could be that this product can't exist on the market anymore."
Previously he only said he thought it would be difficult for Juul to make it through the regulatory approval process. Now he's calling for its e-cigs to be banned. When it finally submits it PMTA to the FDA for consideration, there's every reason to believe Juul's application will be stamped "dead on arrival."
Filled with teen angst
The e-cig industry and Juul in particular are under increasing pressure to keep their devices out of the hands of teens. In announcing it would voluntarily stop selling mint flavored Juulpods (the portion of the electronic cigarette that contains the nicotine-infused e-liquid), Juul cited data from the Centers for Disease Control and Prevention's 2019 National Youth Tobacco Survey showing a big increase in teen e-cig usage.
Over 5 million teens are reportedly using e-cigs, up from 3.6 million in 2018, with 1 million using them daily and 1.6 million using them as many as 20 times a month. Tellingly, Juul was cited as the most common brand they used.
Juul CEO K.C. Crosthwaite said in a statement, "These results are unacceptable, and that is why we must reset the vapor category in the U.S. and earn the trust of society by working ... to combat underage use. We will support the upcoming FDA flavor policy and will follow the PMTA process."
In reality, Juul has taken to supporting anything the FDA advocates these days in a bid to get its upcoming application approved.
Cutting all ties
In August, Juul announced it was distancing itself from the Vapor Technology Association, the industry trade group, saying it wouldn't renew its membership in the organization because it found itself on different sides of issues from the group.
Juul also said it wouldn't support the trade group's fight against a federal court ruling that led the FDA to impose the May 2020 deadline. And Juul supports banning e-cig flavors, which the trade group opposes because of the devastating impact it would have on retailers.
Most recently, Juul said it would stop making the mint pods for its Juul device, which are a favorite of teenagers, though it will still make menthol.
No way out
Yet going against its own interests and those of the industry probably won't help it. While it's unknown what kind of sway Gottlieb still has at the agency, his successor, Ned Sharpless, seems to have no love lost for Juul, either.
The FDA head also is director of the National Cancer Institute, and he lit up Juul in September for its marketing practices, saying, "Juul has ignored the law and, very concerningly, has made some of these statements in school to our nation's youth."
Even though the e-cig leader is prostrating itself before the regulatory agency, the sharp attacks against the company by current and former regulators are increasing. It and tobacco giant Altria (MO 0.49%) are also being investigated to see if the cigarette company had any influence in ousting Juul's CEO and installing one of cigarette company's former executives in the position.
It indicates that any path forward for Juul Labs is going to be difficult at best, with little to no hope this e-cig company can be revived.
