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Is Juul really fighting for survival?

Is Juul really fighting for survival?

Juul in jeopardy? That’s how the press is billing the FDA’s upcoming PMTA verdict, reports ECigIntelligence

 

The US press is calling it a “fight for survival” for Juul Labs, described by the Silicon Valley Business Journal as “the once high-flying e-cigarette company that became a public health villain to many”.

We’re not talking here about Juul’s recent $40m settlement with North Carolina over the state’s accusation of encouraging young people to vape – though that could clearly be a costly precedent indeed if other states press to cash in similarly.

And we’re not talking about the still rolling wave of copycat lawsuits against the company.

We’re not even talking (though we might) about the controversy over Juul apparently paying $51,000 to have a whole issue of the American Journal of Health Behavior given over to studies funded by the company and offering evidence that vaping helps smokers quit. An arrangement that reportedly provoked three members of the journal’s editorial board to resign.

Bigger than all these – what The Philadelphia Inquirer, among others, is talking up as a threat to the company’s continued existence – is the upcoming decision by the US Food and Drug Administration (FDA) on whether or not to grant Juul’s premarket tobacco product application (PMTA). A decision the hard-pressed FDA, yet to have a permanent commissioner appointed by the Biden administration, may struggle to deliver by September.

As ECigIntelligence reported in March, a number of senior Democrat politicians would like that application to be denied. Acting commissioner Janet Woodcock told a recent House of Representatives panel, however, that the FDA would base its decision on sound science, and that she couldn’t prejudge the application, which was still under review.

Eric Lindblom, a former FDA adviser on tobacco, told the Silicon Valley Business Journal: “The stakes are high. If the FDA blows it on this one, they will face public health lawsuits.”

Juul has made a concerted effort to clean up its act and its image since Kevin Crosthwaite replaced Kevin Burns as CEO in September 2019. It could be argued that Juul today is a very different company from Juul two years ago and that it has become a partial victim of its own success, lifting its head above the parapet to be shot at by media and regulators alike.

As Lindblom says: “The FDA has to evaluate this in a forward-looking way and can’t really punish Juul.” But as he adds, perhaps ominously: “It can certainly take into consideration how popular Juul is among youth.”

All of which may suggest the likelihood of restrictions and conditions – perhaps on such things as flavors and marketing, both of which Juul has already taken steps to address – rather than a full-on survival threat.

And, of course, it’s not all just about Juul. While Juul has become for many a symbol, even a synonym for vaping, and taken more than its share of public flak, the US e-cigarette industry is a lot more than one company. And it’s not just one company under pressure as the FDA aims to follow the science on PMTA submissions for more than 6m vapor products.

When as senior a Democrat as US senator Dianne Feinstein – who is no scientist but who has been mayor of San Francisco as well as chairing several Senate committees – is given space in the American Healthcare Journal to urge Congress to “address the youth vaping crisis” by banning flavored vaping products it’s not hard to see which way the wind is blowing.

 

What This Means:

Although one big door has closed with the Supreme Court decision not to review the Big Time Vapes case, other small cases focusing on specific issues of the regulation could potentially make it to court.

Legal experts, we spoke to believe that after the legal scrutiny undertaken against the FDA’s authority by some in the industry there is “widespread optimism” that the agency could eventually relent in its regulations.

 

ECigIntelligence (www.ECigIntelligence.com) is the leading provider of detailed global market and regulatory analysis, legal tracking, and quantitative data for the e-cigarette, heated tobacco, and combustible-alternatives sector worldwide.

 

We offer the necessary tools to navigate the complex market and regulatory landscape of this sector through independent, analytical and actionable data insights, in-depth country reports, regulatory trackers, and legal analysis. In addition, we offer customized research and consultancy support.

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