"The IQOS Tobacco Heating System products are not ENDS products

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.”

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Yet heating liquid containing nicotine derived from tobacco to produce an “aerosol” needs a staff of 150 full time employees at a cost of $125 million to prepare applications for an undefined and non final set of regulatory requirements (PTMA) that in the ‘Brief’ Juul claims to not know how to comply with.

The Pediatrics Association could have sued for enforcement of the already illegal sales to minors. Instead, I believe they sued to facilitate the handover of the entire industry to Big Tobacco and Pharma by FDA. Then Gottlieb goes to Pfizer.

Am I a “conspiracy theorist?” Are conspiracies common among the corrupt? Yes.

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I have no idea as to conspiracy, I can’t nor want to crawl in their heads. But it stinks to high heaven.

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There’s a hell of a lot I want to hear about this that I am not hearing. Ok, you’re not lighting the damn thing on fire, that’s a plus, but what about the plethora of other chemicals BT has been injecting into this shit? I’m down to 2mg/ml of nicotine. No GD way am I going back to 24mg analogs.

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How does heating a cigarette only create a nicotine vapour?
Who decided that this would be a better idea than vaping as we know it?

Surely vaping just nicotine suspended in VG/PG is better than heating a cigarette…

It’s madness…

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One cm of tobacco that’s been drenched in glycerine and a whole plethora of chemicals, just smelling the pack makes me nauseous :nauseated_face:

image

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Are these special cigarettes then?? :thinking:

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Yes, they’re just 4.5 cm long and only one cm is tobacco. Very weird strips of tobacco and it feels icky.
I thought these thing would just contain regular tobacco but as you can see they don’t.
The bit with the red stripes is the filter and the bit above that is a hollow tube.
I found half a pack a while back.
The inside of the paper is tinfoil, I guess the heat is quite high so without the foil it would burn anyway.

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Well I guess special in the sense that they are bought to us by our ‘trustworthy friends’ Juul/Altria/ Phillip Morris and their best butt buddies at FDA. I can’t imagine a better way to get people back to smoking cigarettes, that is, unless they can get everything else banned along with them. I guess they have been available in other countries for awhile, but were just introduced into the US in Atlanta GA.
They are failures as long as nic vape products are available. Like Walt said the whole thing stinks.

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I cannot really find the price of these things, I saw one ad, 5 BP for one pack of 20 sticks.
The amount of tobacco in a pack of HEETS is equal to just over 3 cigarettes in a regular pack.
A 2 pack a day smoker would need how much?
If the nicotine content would be significantly higher it might work, however, according to this article here;

https://www.quora.com/How-much-nicotine-not-tobacco-is-in-one-IQOS-cigarette
That is not the case, so how many packs are needed to satisfy a heavy smoker?
Combine that with the shite they’ve added to it and you might have a product more lethal than the one it’s supposed to replace.
I saw that they ask 35 euro for a holder and 60 euro for the charger, n$ce.

And if you really can’t quit, they’ve got all the tools for you to help you out.

I was tempted to laugh when I read that but it’s too sad really.

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Great question.

Thank you @Jose

Once again my alarm bells sound because of what I didn’t know. Seems to me that if its soaked in glycerine then that is what is creating the “nicotine-containing aerosol” and not the tobacco.

I was quoting the court brief and was stunned that the IQOS did not have to undergo PTMA submission as a electronic nicotine delivery system (ENDS) and was instead ‘waived through’ as a new product that “meet[s] the definition of a cigarette," a much easier path to product approval.

I thought it had gained approval as a new form of vapor device and as far as I can tell so did most others. FDA has published what they call “regulatory pathways” each of which is different. Regulating the IQOS the same as a combustion cigarette doesn’t make a damned bit of sense to me, except that it has been a scam hidden in plain sight.

Juul/Altria did a 180 degree policy turn after the approval and Pediatrics lawsuit that moved the PTMA date back 27 months. After May 2020, they may be the only company left standing. That is why I also pointed to the enormous $125 million for approval applications.

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Looks like pipe tobacco… Weird

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Doesn’t smell like it though, I always loved the smell of pipe tobacco.

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Well, looks like a UK thing… Who would have thought…

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Amber HEETS (10 packs)

Each HEETS Amber label tobacco stick can be enjoyed for approximately 6 minutes, or 14 puffs, which is similar to that of a cigarette.

This box contains 10 packs of Amber HEETS, with each pack containing 20 tobacco sticks, made with specially selected tobacco.

20 hours of Puffing… For £50! :thinking:

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I’ll bet that if someone signed up for a “marketing study,” particularly in London or Manchester, you could get your very own IQOS system plus a couple of hundred pounds if you agree to give them your personal information and use their device for 30 days. Whatcha think my UK friends? :face_with_raised_eyebrow:

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Im in! :drooling_face:

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Be careful! While your first thought may be financial, they may actually mean ‘weight gain’! LMAO :wink:

Are you sure you need a couple of hundred extra pounds? :crazy_face: :laughing:

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Hell No! :laughing:

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