U.S. panel rejects Philip Morris claim iQOS device cuts disease risk

[5150sick]

https://www.reuters.com/article/us-...m-iqos-device-cuts-disease-risk-idUSKBN1FE2IQ

"IQOS is used by nearly 4 million people in 30 markets outside the United States but needs FDA authorization to be marketed in America.

The panel did conclude that the product exposes users to lower levels of harmful chemicals but said the company had not shown that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death. Philip Morris needs to show both in order to claim the product modifies the risk of cigarettes."

it would take at least a lifetime to show this.
That means we are all fucked too.

"Some panelists were concerned that not all the harmful or potentially harmful chemicals in cigarettes were significantly reduced in the iQOS aerosol. Philip Morris presented data showing an overall exposure reduction of about 95 percent."



3 BILLION dollars in data and testing, using ALL OF JAPAN (and 29 other areas) as a test market, 95 percent safer then smoking.

They STILL get REJECTED for a modified risk claim.

If anyone here still thinks that ANY vapor product from ANY company will get pre market approval under the FDA then you are either an idiot or BADLY misinformed on the subject. - 5150

 

[Rossum]

A "Modified Risk Approval" is different than a "Pre-Market Approval". The former allows the manufacturer to claim that the product is "safer" than some alternative. The latter allows the product to be sold, but without any such claim. I have little doubt that IQOS will receive a PMTA and will be allowed on the market in the US, just as I have little doubt that at least a few vape products will (those made by companies with sufficient resources to submit the onerous applications), but I don't think any "Modified Risk" application will ever be approved.

Swedish Match ended up in the same place for some of their Snus a few years ago -- MRTA was not approved, but PMTA was.

 

[pulsevape]

Sure would like to know the names of the people sitting on the "panel"....I just love the newspeak.....words like ..."expert" "proffesor" "panel"....they hold the same sway and mindless slavish obedience that 500 years ago terms like "king" "lord" "church" held for the peasants.

 

[5150sick]

A "Modified Risk Approval" is different than a "Pre-Market Approval". The former allows the manufacturer to claim that the product is "safer" than some alternative. The latter allows the product to be sold, but without any such claim. I have little doubt that IQOS will receive a PMTA and will be allowed on the market in the US, just as I have little doubt that at least a few vape products will (those made by companies with sufficient resources to submit the onerous applications), but I don't think any "Modified Risk" application will ever be approved.

Swedish Match ended up in the same place for some of their Snus a few years ago -- MRTA was not approved, but PMTA was.

We will see how the PTMA for this one goes.

I'd be willing to bet that Swedish Match spent at least 10 million to get through the PTMA process as well

I still don't see any vape company coming up with enough cash to get anything through this VERY EXPENSIVE process.

We have proof from the only one that ever got through that you have to be a pretty large player before FDA will even give you the time of day.

 

[5150sick]

This right here:

"The panel did conclude that the product exposes users to lower levels of harmful chemicals but said the company had not shown that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death. Philip Morris needs to show both in order to claim the product modifies the risk of cigarettes."

Means that NO PRODUCT will get a modified risk claim through in our lifetime

Because it's impossible for anybody to show that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death unless they follow lifelong users. For life.

 

[hellcatrydr]

That's a tobacco device.
.............................
IQOS is a sleek, penlike device that heats tobacco but does not ignite it - an approach Philip Morris says
produces far lower levels of carcinogens than regular cigarettes.
..........................
It's the same thing as an induction bud vaporizer. How is it relevant to vaping?

 

[5150sick]

That's a tobacco device. How is it relevant to vaping?

Because they spent 3 billion dollars proving that it is 95% safer then smoking but it still didn't get approved.

Who do you think is going to spend that kind of money getting a single vaping device rejected?

Also because it is impossible for any vape company to prove both of these in less then a lifetime:

"The panel did conclude that the product exposes users to lower levels of harmful chemicals but said the company had not shown that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death. Philip Morris needs to show both in order to claim the product modifies the risk of cigarettes."

The FDA is showing straight up that it is impossible to get a modified risk claim in this lifetime and someone is going to have to spend multiple millions of dollars to maybe (or maybe not) get any vaping device to stay on the shelf.

These two cases put together (Swedish match snus and IOQS) proves that FDA has no intention of allowing vaping as we know it to exist.

They want to steal vaping for pharma to be used as a "cessation device" which will be boring like the patch and gum and will fail 95% of the time.

 

[hellcatrydr]

I dunno papi...

iQQS sounds a lot closer to smoking than vaping does.

 

[5150sick]

I dunno papi...

iQQS sounds a lot closer to smoking than vaping does.

Doesn't matter the sound.

in order to get a modified risk claim you need to PROVE:

1) The product exposes users to lower levels of harmful chemicals
2) That lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death.

The first ones easy but the second one?

How could one prove this without following a group of lifelong vapers for life for comparison to lifelong smokers without taking a lifetime?

 

[hellcatrydr]

Doesn't matter the sound.

in order to get a modified risk claim you need to PROVE:

1) The product exposes users to lower levels of harmful chemicals
2) That lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death.

The first ones easy but the second one?

How could one prove this without following a group of lifelong vapers for life for comparison to lifelong smokers without taking a lifetime?

What does it matter what claims are FDA authorized?
$3B... That sounds like they're trying to clear it as a medical device. That would connect it to health insurance...
I don't really understand the licensing but the thing will still go on sale either way...
So it will be available to the public soon... with or without the claim, right?

Who cares if Phillip Morris can or can't officially claim iQQS is "better" than smoking???
If it is, word will get out just like it did with vaping.

Remember like 9 years ago... back in the day? It was a huuge forum etiquette no-no to even hint
that a vape could be a stop-smoking aid. Yet EVERY dam one of our lives were saved/extended by vaping... thatt was the unspeakable truth...

My point is the product will get out and word will spread, just like it did with vaping.
If it's better, people will know.
I frankly have my doubts about it compared to vaping. It's pretty close to smoking.

You do know this is not new tech, right? There are a bunch of bud devices out there that pioneered the design.

If they spent 3 Billion dollars on that thing, I hope that included liquor, hookers, & gov't graft.

Cause iQQS appears to be a Pax clone...

 

[hellcatrydr]

I would verry much like to see some of the math on the 3 billion dollar claim.

 

[5150sick]

Swedish Match is the only company to ever get a product on the market going through the FDA's PMTA process.
They had 30 years worth of data on their Snus from Sweden and cost them 10 million dollars.

We have what? Maybe 5 years worth of data on anything that we use that's worth vaping?
(I'm not using anything older then 2015/16 in my daily setups right now)

I would imagine companies like Blu, Vuse, Njoy could get a decades worth of data but that's a shitty 1st gen cigilike.

What company do you think will roll the dice and kick out $10 million on a far from sure thing?


To summarize: The only new "tobacco" product to get on the shelves after the FDA took over was Swedish Match Snus and it cost them $10 million to get on the shelf.
Vaping (that already don't sell tobacco) companies aren't going to kick out $10,000,000 to see if their product gains approval to be sold in the US.
They can sell in the UK all they want right now for $0

 

[Carambrda]

How could one prove this without following a group of lifelong vapers for life for comparison to lifelong smokers without taking a lifetime?

By writing an open letter to the FDA's Commissioner stating the fact that 15 year old kids in high school are being taught a reduced exposure to harmful substances and or toxins to the human body will cause a decline in health risk to humans?

 

[Carambrda]

Hope is a good thing, maybe the best of things, and no good thing ever dies.

 

[Rossum]

I'd be willing to bet that Swedish Match spent at least 10 million to get through the PTMA process as well

Yep.

Who do you think is going to spend that kind of money getting a single vaping device rejected?

Juul, for one. I think there will be others too. $10 million isn't really that much money to "invest" on the chance of having one of the few legal / "approved" vaping products available.