First thing's first ...
SJ, I am
completely behind your proposal to do something like the Robert West toolkit, as I've said right here (in #4, but I want your wonderful OP to be in this link):
http://www.e-cigarette-forum.com/fo...ore-effective-than-nrt-smoking-cessation.html
So my comments about NJOY should in no way be read as my saying that we can all relax now, even if I quoted that advertising line (I realize now that there could be a misunderstanding about that - it was only intended as a kind of humorous teaser.)
***
Sorry, how do we know this? Don't get me wrong, I think it's almost certainly correct, and it's certainly true of our sample when we carry out surveys, but has this actually been written up from population-level surveys? I hear what you're saying wrt Njoy commissioning the surveys, but I'm not sure how that helps given that we have anywhere between 50 and 125 days until the final rule is proposed.
If not, don't expect the FDA to accept it as true.
For what it's worth, I now reject the concept of Cigalikes (as sold in front-line retail) being a transitional device, helping turn people on to the "proof-of-concept" so they explore and find better devices. While this may have been true to some extent a couple of years ago, I view them now as being far more of a block to the VTM category than helping.
You're right that we don't really "know" about the relative cessation rates associated w/ cigAlikes and advanced devices, in the sense of being able to "prove" it.
My focus in saying that had to do with the applications that cigAlike manufactorers will have to submit -
not the comments for the FDA's deeming rule.
So what I was saying is:
If everything that we believe about cigAlikes and cessation is true, then the FDA will have legitimate grounds to reject cigAlike applications whenever it has the data, under the health effects balancing test in the tobacco act. I think we agree on this, because I've seen you say something very similar in another thread.
If the FDA wants to make life difficult for cigAlike applicants, it can wait to reject the cigAlike applications until the 2-year "window" closes. Because the applicants will then require
pre-market approval if they submit another application.
You may very well be right about this whole question of whether they're more helpful or harmful as part of the pathway to advanced devices. Are you saying that people who try cigAlikes may go back to smoking because they get the wrong impression about what vaping really is? I know that I've seen that myself - two smokers whom I know are going to require a lot more "work" on my part, before they are disabused of this incorrect impression about vaping.
CigAlikes are also a huge problem for us because of the way public health studies are often done - "ever vapers" are often included. This is probably how the Grana et al. junk letter resulted. We may recognize this as the headline "e-cigarettes don't help smokers quit":
http://media.jamanetwork.com/news-item/
e-cigarettes-not-associated-with-more-smokers-quitting-reduced-consumption/
(That headline wasn't as common in the UK as it was here in the US. It was a major media storm at the end of March. References to it are by no means gone. Link is split into two lines, but anyone who wants to leap into this cesspool of junk science can paste the 2-line link into their browser's address bar. Be sure to wear HAZMAT garb
***
[...] Can we say this is the final word [on predicates]?
[...]
I would posit that if the FDA PMTA proves too onerous for them, they may well decide to jump ship entirely and focus on Europe.....
So, game changer? Could be, but we'll have to wait and see.
Don't forget that Victory brands are out there too with an enormous market capitalisation buying up everything that moves, presumably following Warren Buffet's maxim. What their plan is is anyone's guess.
On the predicates thing - I provide periodic lip sevice (or is that finger service) to the idea, only because so much work appears to have been done to track down this Ruyan lead. I've said repeatedly that I think hope for this is remote. I was just trying to be nice
Europe is a huge question mark, "herding" the 28 "cats" (member states) into art. 18 is going to be messy at best. The UK market may be bigger than most in the EU, and there are those outstanding (cessation theraphy) applications to the MHRA by BAT and Nicolite. All I can say is that in terms of population and GDP, the potential US market is substantial, and there's only one critical regulatory agency to currently deal with. Federal supremacy law generally makes it tougher for the states to get into nitty-gritty stuff like packaging and labelling requirements, now that the FDA has put down its marker. So there are big potential economies of scale here on this side of the pond.
Granted, we have no idea what NJOY will do. That's why I put a question mark in this post topic. And I wasn't being squirrelly about that, as Erich von Däniken was in
Chariots of the Gods?
My bottom line here is that massively deep pockets are going to be required to pursue the new product pathway. Only BT and BV (big vapor) have it. And this is the first time so far as I know that any of them have formally announced that they're going to move forward with an advanced device.
Any BT/BV company - or any other firm - that's going to go all the way with this, will have to put serious money on the table, and be ready for a long spell of no sales if the FDA rejects their application, while the case winds its way through the courts. And they're going to have to put up a huge chunk of change in advance for the applications' studies: one per flavor and nic strength combination.
Are we talking about a mere $10M? (Hmm, sounds low.) $100M? $500M? More? I don't know.
It might be cheaper to buy Congress. Or Congress may have to be "bought" in addition. As we say here in the states -
"Would you like fries with that?"
***
As an aside, questions about whether I actually vape encouraged me to start this thread, which I had been meaning to post for a while anyway, and which is totally

...
I've been looking for what strikes me as the ideal mech (according to my own personal preferences, which may not be of any relevance to anyone else - i.e. YMMV):
http://www.e-cigarette-forum.com/fo...their-vapapocalypse-simplicity-longevity.html
Just for what little that may be worth - yes, I
do vape, even if I don't own a Provari
(Not the APV anyway. I could be talked into buying a tee shirt tho'
