The brouhaha began innocently enough, as a tweet from the former Food and Drug Administration Commissioner and vaping foe, Scott Gottlieb in response to a breaking news story that the FDA had accelerated the e-cigarette review deadline to just ten months. Soupwire covered it here: The End of Vaping as We Know It? FDA PMTA Deadline Moves Again – and small vaping companies and mom and pop vape shops felt the shudder from coast to coast.
Gottlieb wrote, “Rising youth use of ecigs (sic), esp JUUL, has forced FDA to repeatedly move up application deadline for entire segment. Could FDA let small vape shops pool data to more easily develop applications, like it’s doing for small stem cell investigators?”
According to Gottlieb’s post, “Our initial proposal to extend application deadlines for e-cigs was based on effort to give that segment time to comply at a moment when we sought to regulate nicotine in combustible products to render them minimally or non addictive to rapidly migrate smokers off cigarettes…our policy changed dramatically once we had evidence of the rampant youth use of e-cigs. We sought to restrict access to flavored products and move up the application deadline on all e-cigs. Today’s proposal to the court solidifies that policy pivot.”
Gottlieb then suggested that small vaping manufacturers could follow a common protocol and thereby pool their resources to file together for PMTA approval, which would “create a feasible path for small adult-only vape stores. It would separate them from mass market devices that were swept up by kids like Juul.”
Small vape shops banding together to gain FDA approval seems like a great idea, especially because not doing so will in all likelihood bankrupt most of them – the expense of gaining approval for just a single product will likely run in the hundreds of thousands of dollars.
Gottlieb continued, “It’s highly unfortunate JUUL’s market behavior helped put this entire category at risk but there’s no mistaking that the youth crisis was driven by JUUL, it’s parent company being Altria. Now that youth are initiated on e-cigs through JUUL they are migrating to other products.”
The problem, of course, is that this is all too little, too late. Gottlieb, who worked to put in place many of the current FDA regulations and rules, is no longer heading the FDA. And now that the agency has sped up the deadline to just ten months, the save the smaller vape shops’ proverbial goose, as they say, may already be cooked.
Vaping won’t be going away anytime soon – but the players left standing will most likely be those (ahem, JUUL) who are funded by the deep pockets of Big Tobacco. Yes, that’s the same JUUL that Gottlieb accused in the thread of marketing to kids and ruining vaping for everyone else.
Gregory Conley, President of the American Vaping Association responded to Gottlieb, “Open vapor manufacturers cannot afford it [FDA PMTA approval] and you did next to nothing to help them.”
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