FDA FDA Approves MRTP for IQOS

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Rossum

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iqos already had PMTA approval. Now they have an MRTP approval allowing them to make the following "Reduced Exposure" claim:

AVAILABLE EVIDENCE TO DATE:
  • The iqos system heats tobacco but does not burn it.
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
FDA Announcement:
FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information
 

zoiDman

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Someone is bound to ask: How is this relevant to vaping? Well, if someone wanted to invest the resources, it seems that a PMTA and even an MRTP for a vaping system is not longer out of the question.

I Don't think there were/are many reasonably informed Vaper's who thought that BT/BP/BV wouldn't receive a PMTA/MRTP or two.

But if No Open System Hardware, or Liquid e-Liquid, can achieve such Lofty FDA approval, is it Really going to be Vaping/DIY as We know it?
 

MLEJ

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"Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals."

Scientific studies (not funded by tobacco money) have shown that switching completely from conventional cigarettes to electronic cigarettes significantly reduces your body’s exposure to harmful or potentially harmful chemicals, too.

Guess that's less relevant to public health than tobacco, pharma, and M.S.A. money.
 

Rossum

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I Don't think there were/are many reasonably informed Vaper's who thought that BT/BP/BV wouldn't receive a PMTA/MRTP or two.
The PMTA for IQOS didn't surprise me at all. In fact, it took longer than I had expected for the FDA to grant that. However, the MRTP does surprise me, at least a bit. It was my senses that the FDA wanted the public to believe that all "tobacco products" we equally bad.

But if No Open System Hardware, or Liquid e-Liquid, can achieve such Lofty FDA approval, is it Really going to be Vaping/DIY as We know it?
I'm hopeful that if any vapor product gets an MRTP, that might just change public perception of all vapor products in small way.
 

Rossum

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Scientific studies (not funded by tobacco money) have shown that switching completely from conventional cigarettes to electronic cigarettes significantly reduces your body’s exposure to harmful or potentially harmful chemicals, too.
Absolutely, they have.

But our most benevolent government demands anyone wishing to make such a claim as part of their marketing strategy must jump though some very high flaming hoops first. In fact, these hoops are so high that one must buy a very expensive ladder in order to have any hope of reaching them. :(
 

zoiDman

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... It was my senses that the FDA wanted the public to believe that all "tobacco products" we equally bad.

I always kind thought the Opposite.

That the Concept of the MRTP was to make a Bright Line as to Bad Tobacco products on one side. And Not as Bad on the other.

It also was meant (IMO) as a Innovation Driver for BT to come up with something that Didn't Kill people as much.

But the Irony is that using that type of Common Sense approach is that e-Cigarettes should clearly fall in the Not as Bad side of the MRTP bright line. Something that I Don't think is going to Happen.

Or maybe more Specifically, something the FDA Doesn't want to Happen.
 

Katya

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However, the MRTP does surprise me, at least a bit. It was my senses that the FDA wanted the public to believe that all "tobacco products" we equally bad.

Maybe I'm too cynical, Rossum, but I always look for financial ties as the great motivator. Zeller used to be a consultant for GlaxoSmithKline (Nicorette) before President Obama appointed him head of Tobacco Control something or other. Big Pharma was making big bucks peddling their useless gums and lozenges, so they saw vaping as a great danger. I'm quite convinced that, had the BP invented e-cigs and could reap benefits from their sales, Zeller and the FDA would have approved vaping as a miraculous and life-saving HR product. ;)

Gottlieb had financial ties to e-cigs, so naturally he had a different perspective than Zeller. But the ANTZ knew it, and he was out sooner than anyone expected.

FDA Nominee Scott Gottlieb Should Recuse Himself from All Decisions Involving E-Cigarettes Given His Financial Interests in a Vape Shop Company

Dr. Hahn? No idea, all I know he's a good oncologist but he doesn't talk much, unlike Zeller and Gottlieb. During his Senate confirmation hearings he was vague, uttering statements like “I do not want to see another generation in this country become addicted to tobacco and nicotine, and I believe that we need to take aggressive action to stop that,” and “I look forward to hearing all of the data associated with this as a scientist and a researcher and a doctor. Seeing all the data and the complete set of data is important.”

So there. :D
 

MLEJ

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I always look for financial ties as the great motivator.
100% right. Always follow the money. The war on vaping has never for an instant been about public health. It's always been about pharma co. profits, tobacco co. competition, propping up the health care industry, and state Master Settlement Agreement payments. It's all about dollar signs, exclusively. There are plenty of other, similar instances besides vaping, too.

I'm quite convinced that, had the BP invented e-cigs and could reap benefits from their sales, Zeller and the FDA would have approved vaping as a miraculous and life-saving HR product.
The pharmaceutical and tobacco co. parent corporations should have bought up some vape liquid and/or hardware cos. Philip-Morris' parent Altria invested in JUUL. Any major company could have bought a dozen small e-liquid operation for what to them is a pittance. We'd be seeing bottles of flavored e-liquid in drug stores right next to the other smoking cessation products.
 

Mordacai

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@MLEJ, another contributing factor may be that apart from liquids. Everything else is produced by China.

As BT and BP have more than enough money to buy a controlling interest of shares in companies producing vaping hardware and consumables, if they so wished.

HNB seems a fad to me though, which will probably be more marketable to the younger age demographics. As it's supposed to be less harmful than smoking, but that's just really a marketing ploy as there's plenty of data to prove that it's still incredibly unhealthy.

One thing that I do remember is that many years ago I came across a statement made by Phillip Morris in a memo, it said that doubt is our product.

And HNB for those who do not possess the capacity for critical thinking, it certainly fits that criteria.
 

MLEJ

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@MLEJ, another contributing factor may be that apart from liquids. Everything else is produced by China.

As BT and BP have more than enough money to buy a controlling interest of shares in companies producing vaping hardware and consumables, if they so wished.
You're surely right about that. If they'd jumped on the opportunity with e-liquid and/or contracted to produce a simple pod kit a few years ago, there'd be a lot more happier and healthier people right now, though.
HNB seems a fad to me though, which will probably be more marketable to the younger age demographics. As it's supposed to be less harmful than smoking, but that's just really a marketing ploy as there's plenty of data to prove that it's still incredibly unhealthy.
Have you seen the price of the IQOS? And the cartridges or whatever they call them for it? They're insane. Unless the prices drop by a lot, there's no way it will succeed. That may be the plan; who knows?
Even if HNB does significantly reduce the risks of health issues relative to regular cigarettes -- which does seem reasonable, as smoke isn't inhaled -- claiming as they do that we don't know that vaping does the same is, at this point, simple dishonesty. As always, follow the money.
 

Rossum

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Have you seen the price of the IQOS? And the cartridges or whatever they call them for it? They're insane.
Costs are only insane relative to what we're used to paying for open-system vaping. I've been vaping long enough to remember when a decent mod, like a Provari or a REO cost more than an IQOS device does now, and the Heet sticks cost about what cigarettes do.

The other thing that IQOS has going for it that vaping doesn't is the full tobacco monty in terms of psychoactive effects, from the the minor alkaloids and such. It's a decidedly different "head" than vaping straight nicotine. Many (most?) vapers go through a period of withdrawal due to this when they switch. I can't say for sure because I had given up cigarettes years before I tried IQOS, but I suspect the transition from smoked tobacco to IQOS will be easier than the transition to vaping for many people.
 

MLEJ

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The other thing that IQOS has going for it that vaping doesn't is the full tobacco monty in terms of psychoactive effects, from the the minor alkaloids and such. It's a decidedly different "head" than vaping straight nicotine. Many (most?) vapers go through a period of withdrawal due to this when they switch.
i ordered some Whole Tobacco Alkaloid liquid for just that reason. It's expensive stuff, too. Hoping just a few drops in double-digit ml's of e-liquid will be enough.

Thanks for the other info.
 
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Mordacai

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I've also heard that the device has quesrionable reliability, if this is true it would be great for generating revenue. But not great for the users.

But where has a study been done regarding HNB and compared this to ciggarettes and tobacco, one which compares the compounds and their levels as we're still talking 1000's of compounds being produced. As I'm not aware of any studies yet myself, hopefully independent unbaiased researchers will perform this though.

But I recon that HNB is not going to be a savior for BT & BP like they think it will, as I can see that it will be almost as detrimental as smoking. But it will be more readily accepted initally due to the doubt about this new unknown technology.

At least with vaping we know that we have drastically reduced our chemical exposure and we also have evidence of a positive impact to health, whether it's others or our own. And that's what we need to concern ourselves with more than anything, and of course if other individuals show an interest we also need to be ambasadors for vaping and educate individuals.

And besides IQOS will always smell like tobacco, not a sweet shop, bakery or something else that is pleasant to us and for those around us.

And on a final note, we've all had experiences where we've been heckled by the general public about vaping and how dangerous it is and various other wildly unsubstantiated claims. A scene from Blazing Saddles comes to mind when I think on it, the scene where Gene Wilder's character is trying to explain about the local townsfolk.
 

Rossum

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i ordered some Whole Tobacco Alkaloid liquid for just that reason.
Yup. WTA helped me a lot early on, and I'll still drip a drop or two occasionally. But having also bought an IQOS a couple of years ago (out of sheer curiosity at a duty free shop in Europe on a business trip), I'll say that IMO, IQOS is a better substitute for tobacco than WTA liquid is.

Now mind you, my experience with IQOS was 4-1/2 years after I'd switched from smoking to vaping, so perhaps my judgement is off, but I think IQOS does something that even WTA doesn't.

All that said, I think it's been the better part of a year since I used mine, and I only ever used it on a very occasional basis.
 

Rossum

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And besides IQOS will always smell like tobacco, not a sweet shop, bakery or something else that is pleasant to us and for those around us.
It does smell a bit like tobacco, but that smell is at least an order of magnitude less than combustible tobacco. I've used mine indoors, both at home and in my office, and nobody ever said a word about the smell.
 
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Katya

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i ordered some Whole Tobacco Alkaloid liquid for just that reason. It's expensive stuff, too. Hoping just a few drops in double-digit ml's of e-liquid will be enough.

Thanks for the other info.

Where did you get yours, if I may ask? I used to get mine from Aroma Juice, but they closed shop, unfortunately. They made the only acceptable WTAs, in my experience, and I was very sad to see them go. Invented by our own ECF chemist @DVap.

That said, WTAs never scratched my itch like Swedish snus and Ariva and Stonewall dissolvable tobacco do. All I got from WTA eliquids was a nice, relaxed feeling. But it worked wonders for others.

Keep us posted, will you?
 
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Katya

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But I recon that HNB is not going to be a savior for BT & BP like they think it will, as I can see that it will be almost as detrimental as smoking. But it will be more readily accepted initally due to the doubt about this new unknown technology.

I'm also curious about that. A very similar product, albeit probably less refined, was introduced in 2009 under the name Ploom. Curiously, also invented by the same two Stanford grads who gave us JUUL. It was a total failure. I really hope that iQos is better than Ploom. ;)

The Ploom is Here.
 

MLEJ

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Where did you get yours, if I may ask? I used to get mine from Aroma Juice, but they closed shop, unfortunately. They made the only acceptable WTAs, in my experience, and I was very sad to see them go. Invented by our own ECF chemist @DVap.
mothersmilkwta.com/

Just got it yesterday, vaping it right now. So far, i'm not feeling any different than when vaping regular freebase nic liquids, but it may take some time to have an effect just as vaping's effect takes longer than smoking's (for me, at least). Gonna have to feel a noticeable impact before spending that kind of money again.

i ordered from Aroma just before it died. Got the auto-receipt email, never got an order shipped email, checked the website a week later & saw it was down, phoned to see if the order would ship or make sure my credit card wasn't billed, left a message and never got a reply. My card wasn't billed far as i can tell. It's a shame they were driven out of business, and they won't be alone.

Ariva and Stonewall dissolvable tobacco
It's amazing what a person can learn here. Never heard of such a thing before. Something else to check out...
 
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