FDA approves IQOS

[Topwater Elvis]

FDA permits sale of Philip Morris IQOS tobacco-heating alternative to cigarettes - Reuters

Heat not burn is approved, but, e cigs / vaping liquids containing nicotine is 'different'?

Nonsense...

 

[zoiDman]

I kinda figured this would happen Eventually.

Even though the FDA's Advisory Board voted to Not Approve the iqos.

 

[Rossum]

Heat not burn is approved, but, e cigs / vaping liquids containing nicotine is 'different'?

Has anyone bothered to submit a PMTA for any "e cigs / vaping liquids containing nicotine"?

 

[Rossum]

I kinda figured this would happen Eventually.
Even though the FDA's Advisory Board voted to Not Approve the IQOS.

PM/Altria submitted two applications, a PMTA and an MRTP. The PMTA is what has been approved. The MRTP is what the Advisory Board voted on, and it has not been approved.

 

[zoiDman]

PM/Altria submitted two applications, a PMTA and an MRTP. The PMTA is what has been approved. The MRTP is what the Advisory Board voted on, and it has not been approved.

Interesting. I thought that the advisory board had Voted No on Both applications.

But I might be Mistaken.

 

[zoiDman]

BTW - The FDA did pretty good in that it Only took them 2 Years to make a decision on the IQOS.

Not bad seeing that they were under a Statutory Deadline of 180 Days after submission of a PMTA Application.

 

[Topwater Elvis]

From the horses rump err mouth ---> FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway

 

[Topwater Elvis]

Has anyone bothered to submit a PMTA for any "e cigs / vaping liquids containing nicotine"?

From my understanding a few large manufactures have, zero response or contact in return.
The costs per product, still undefined processes & zero communication kinda prevents 99% from making attempt.

 

[stols001]

IDK if this is good or bad too soon to tell but I have to say despite my "mad love" for Phillip Morris I have heard a few tales of "This is what got me off cigarettes."

So I don't begrudge it. I think the device looks and sounds like a PITA in every way, but to each their own.

LOL on FDA jokes. That is so true. I remember back when the HIV drug makes were having fits because they were like "Look FDA, everyone's going to be dead until these are approved." They wound up getting fast-tracked.

I don't see that happening for ANY ecig product however. And the cost, well P and M can afford it but I bet it was LOT.

Anna

 

[Rossum]

I think the device looks and sounds like a PITA in every way

Why do you say that? I mean, OK, it needs to be cleaned with a cotton swab and some alcohol occasionally, but other than that? If I were using it exclusively, I'd probably do that once a day. It takes like two minutes.

 

[Letitia]

Grimm has a good 510 Report about this on yt. He also mentions the catch 22 the juice companies are facing.

 

[Letitia]

Why do you say that? I mean, OK, it needs to be cleaned with a cotton swab and some alcohol occasionally, but other than that? If I were using it exclusively, I'd probably do that once a day. It takes like two minutes.

Already do that with my drip tips. If it gets more people to quit smoking I'm for it. Just wish vaping was getting a fair break as well. They did forbid the marketing of OQOS as a safer alternative, guess smokers are more valuable due to more health issues. Go America

 

[Rossum]

They did forbid the marketing of OQOS as a safer alternative

The fact that the PMTA got approved does not preclude approval of the MRTP at some point in the future.

 

[somdcomputerguy]

I kinda figured this would happen Eventually.

Yep. FDA took their (Phillip Morris) money (quite a bit), and their own sweet time.

edit: I haven't read the article in Reuter's, and I probably won't, but I read this a few days ago - FDA Finally Approves PMI's Heated Tobacco Product IQOS - American Vaping Association

 

[stols001]

I think I base It on like some thread by some guy "Adventures with IQOS." He seemed to have a hard time and also need to recharge it every ten minutes. IDK maybe it's easier? But the impression I got was that it was a pain.
Anna

 

[Eskie]

I only see it competing in the vaping cigalike market. It's far too different than the style of vaping many on this forum use. If it helps get more people off cigarettes, great. As to safety, it likely is safer than cigarettes. I believe it may not be as safe as vaping, but the evidence one way or another isn't out there.

The fact it was approved based on lower levels of toxic chemicals produced versus smoking may well establish a basis for the approval of most vaping products. Can't have two different standards, it would smell of arbitrary and capricious, and make for a good court case.

That said, obtaining an MRTP on vaping products will be difficult without a helluva lot of money. I can see Juul going for it with Altria's money, but the smaller players will not be able to compete unless there's a real change in attitude and precedent to support such approvals. And that's OK, I can live with a PMTA. At least it's legitimately on the market even if the vape companies can't advertise them that way. The word will still spread.

 

[Rossum]

I think I base It on like some thread by some guy "Adventures with IQOS." He seemed to have a hard time and also need to recharge it every ten minutes. IDK maybe it's easier? But the impression I got was that it was a pain.
Anna

I don't have that impression, but I have to admit, I don't use mine very much.

 

[zoiDman]

... Can't have two different standards, it would smell of arbitrary and capricious, and make for a good court case.

...

Of course they Can. And Do.

Some Undefined and Non-Statutory Level(s) of Toxins is only Part of what the FDA uses in their Righteous Might to ensure the "Protection of Public Health" when it comes to Declaring an Edict on what Tobacco Products will or Will Not be sold in the USA.

This is the Uphill Battle that e-Cigarettes face...

(4) Basis for finding

For purposes of this section, the finding as to whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account-

(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

[USC02] 21 USC 387j: Application for review of certain tobacco products

And it resides at the Core of a piece of Legislation that is Fundamentally Reliant on Judicial Deference.

So a Manufactory can try to Jump over Arbitrarily set bars for Toxicity. And spend Millions and Millions on PPM Studies and 1 out of X Risk Analysis.

But if they Can't Satisfy some Ethereal Un-Quantified Values of both "A" and "B" in this portion of the FD&C Act above, its No Ticky - No Laundry.

 

[Eskie]

If testing shows equivalent or lower emissions denial on that basis would be arbitrary and capricious. If they publish requirements that do not reflect what they approved for IQOS they will have a problem. They would have to find some other rationale for denial other than toxic exposure. Certainly possible but there is at least one goal post now in place.

Let's hope teens take up trying IQOS. Then see how that plays out.

 

[Letitia]

Teens will try it just because it's there to try. These products are more for those to whom vaping isn't appealing or simply didn’t work out. If you don’t want to quit smoking but must IQOS is more likely to work.