It was classified as a cigarette by FDA for PMTA purposes and not as a vaping product.
If others knew this let me know and we can delete this. I didn’t know it. So let me explain how this came about. I went searching for info about their disassociating themselves from VTA who as we know has sued FDA. I found this:
– VAPOR TECHNOLOGY ASSOCIATION AND JUUL LABS PART WAYS
By pbusardo on 22 August 2019 in Recent News
"Yesterday, Juul Labs announced that it would not be renewing its membership with the Vapor Technology Association (VTA) citing the lawsuit that VTA recently filed against FDA and policy differences.
VTA is surprised by Juul’s stated opposition to the filing of VTA’s complaint against FDA because Juul recently opposed the efforts of the American Academy of Pediatrics to grossly accelerate the PMTA deadline in another lawsuit and sought similar relief in that federal lawsuit."
So, I read an Amicus Brief (Friend of the Court) submitted by Juul JLI (JLI as in Juul Labs Incorporated) in the above named lawsuit (Pediatrics v FDA). I found many things but will keep this short as possible. In the context of PMTAs:
(Quoting from the JLI Brief)
“JLI had already been at work on the necessary studies, and had gathered the required information, to the extent possible. To that end, JLI has dedicated 87 full-time employees to conducting the work necessary to, and to preparing, its PMTAs. The number of employees working on the PMTA process is expected to grow to more than 150 by the end of this year. JLI has already dedicated more than $50 million to preparing the applications, and it plans to spend a total of more than $125 million by the end of 2019.”
But what surprised me was this:*
(Again quoting the Brief)
“The IQOS Tobacco Heating System products are not ENDS products. Instead, as the FDA release cited in footnote 11 of Plaintiffs’ brief describes them, they are part of a device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol…Because of this composition, IQOS products “meet the definition of a cigarette in the Federal Food, Drug and Cosmetic Act.” Id. The manufacturer of the IQOS products did not need guidance from FDA for PMTAs for ENDS products, because they are not ENDS products. Moreover, it took FDA more than two years to complete its review of the application for the IQOS products. FDA announced its decision on April 30, 2019. Although, as just noted, FDA review did not involve an ENDS product.”