PMTA For Juul
Juuls Labs files its PMT application to the U.S. Food and Drug Administration which will allow it to continue selling products in its core market
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by Dave Cross
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“We believe that vapour products can offer adult smokers an alternative to combustible cigarettes and, in so doing, reduce the harm associated with tobacco,” a Juul Labs spokesperson told Planet of the Vapes.
It was this simple pragmatic view that had the vaping community supporting Juul at the outset and hoping it succeeded. The company experienced a meteoric rise in fortunes as it delivered something truly unique to the alternative nicotine product market, but an article in the latest edition of Vapor Voice describes its progress as “the rise and fall of Juul Labs”.
Clearly Juul has not fallen far, rather it has stumbled over a continual stream of setbacks of its own design.
The high% salt nicotine pod addressed the convenience no other products of the time could match and the vibrant marketing made a niche product appear cool and original, but in doing so it opened the door to accusations of marketing to teens and the company made a succession of errors which resulted in becoming subsumed by the whole ‘teen epidemic’ nonsense.
Time and again, when faced with an issue, ex-CEO Kevin Burns said or did the absolute wrong thing. He alienated the vaping community, other independent companies in the sector, and never appeased the anti-vaping lobby. Some would say that he is personally responsible for the hostility to juice flavours that spreads from American coast to coast.
The PMTA, “includes comprehensive scientific evidence for the JUUL Device and JUULpods in Virginia Tobacco and Menthol flavours at nicotine concentrations of 5.0% and 3.0%, as well as information on its data-driven measures to address underage use of its products.”
But what about all of the other flavours that make vaping work for smokers switching away from tobacco harm? Juul pretty much helped kill them off in the States, culminating with the company willingly withdrawing the lot from sale – playing into the hands of every liar waving a pseudoscientific research paper.
A whole swathe of community goodwill disappeared down the drain at that point and Juul is going to have to work very hard to get it back.
“In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” said Juul Labs CEO K.C. Crosthwaite.
“Juul Labs has committed all necessary resources to deliver the best possible PMTA based on rigorous scientific research and data-driven measures to address underage use,” said Joe Murillo, Chief Regulatory Officer at Juul Labs. “We respect the PMTA process and believe it is the right forum to determine the role ENDS products can play in transitioning and completely switching adult smokers from combustible cigarettes to potentially less harmful alternative products while combating underage use.”
But where was this commitment to evidenced-based decision making when facing up to the statistically driven lie about a teen epidemic? Where was its rigorous scientific research to support the use of flavours in products, especially given the bright packets of nicotine gum that comes in a host of attractive flavours?
Juul’s statement reeks of appeasement for profit rather than commitment to reducing tobacco harm: “Late last year, the company, under Crosthwaite’s leadership, committed to resetting the vapor category and seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes. As part of that process, the company reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence.”
The company can’t comment on anything anymore without issuing caveats. It told POTV: “Nicotine is addictive and can cause certain harms to health. It would be best if no one used any nicotine product. Anyone who smokes should quit. Adult smokers who have not successfully quit should completely switch to potentially less harmful alternative nicotine products. Juul Labs does not want any non-nicotine users, especially those underage, to try our products, as they exist only to transition adult smokers away from combustible cigarettes.”
This is beginning to feel a lot like meeting someone at a party and them telling you how violent assault is a bad thing and they will take all reasonable steps to ensure that they do not hit you with fists or items of food. Juul are delivering a consistent message these days – but it isn’t one the vaping community cares for.
Will this matter?
Given the PMTA should be a simple matter of process for Juul, it can look forward to a quieter future serving its market and trying to convince smokers to adopt the product without advertising to them or promoting its products anywhere – a tough ask.
John Fell, principal at Ash Park, a financial analysis group, told Vapor Voice he thinks the company will now work to a far more conservative business model, operating with a reduced American market share and being a bit player in the rest of the world unless it manages to team up with another company to improve distribution.
With no promised streamlining of the PMTA process in evidence, the American vape market looks set to become a shadow of its former self as businesses are locked out of competing on a level playing field. Maybe this is what Juul are banking on?
All products that reduce tobacco related harm are to be welcomed – but Juul sure make it hard to like Juul.
Related:
- Cut Down To Size, Vapor Voice – [link]
- Juul Labs – [link]
- Premarket Tobacco Product Applications – [link]
Dave Cross
Journalist at POTVDave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous start-ups to develop content for their websites.
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