FDA Game changer? - "Relax ... it's a ___ NJOY!" (NJOY to make a non-cigAlike/advanced system with a tank?)

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Jan 19, 2014
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H/t to Gato (del Jugo) who posted this elsewhere:

NJOY Aims to Bring Vaping National | ConvenienceStoreNews

The electronic cigarette manufacturer is preparing to debut a rechargeable
line of e-cigarette products and a "high vapor product" or a vapor-tank-mod (VTM),
according to Bonnie Herzog, managing director of tobacco, beverage and
consumer research at Wells Fargo Securities LLC.

What this means is that the FDA is now going to have to pay attention to at least one deep-pocketed maker of a non-cigAlike.

It also could mean that other BT/Big Vapor companies are going to start getting into the game. In fact, they'll have to, if they want a product that can withstand the tobacco act's (FSPTCA's) public health balancing test - cigAlikes aren't going to make it, because cigAlike users tend not to quit smoking tobacco cigarettes.

In addition to breaking open the door on a non-cigAlike, NJOY will probably have to - as part of this whole process - force the FDA to recognize that advanced (non-cigAlike) PVs really do help smokers quit, as opposed to letting the FDA swat all the evidence from Europe aside with the studies full of junk science/junk statistics that it's likely to fund (c.f. Grana et al., released a couple of months ago: New Study on Electronic Cigarettes by UCSF Researchers is Not Only Bogus Science, But is Also Dishonest

It will also will force the FDA to actually issue plausible regulations for advanced systems, instead of any number of options that it might have to kick out an application from a small manufacturer who might dare to file.

Although I can't post the link here, you might want to google: njoy presents relax site:youtube.com
(Be sure not to put any spaces before or after the colon. The YT video is called "NJOY Presents: Relax...It's Courtney Love!" )

"Relax ... it's a :censored: NJOY"

I'm not saying the US will be a perfect place to vape as a result of this. But it means that commercially-available vaping products will not necessarily be reduced to cigAlikes. (And eventually to nothing, because cigAlikes have a net negative impact on public health - if we assume that reduced tobacco cigarette smoking is of minimal reduced risk value to an individual, and also that cigAlikes reduce the likelihood of cessation. Which is precisely what the FDA and the CDC think.)

Finally, this will help slow the FDA down. Bill G. has suggested that they will be less likely to present the final proposed rule to any GOP-controlled congress. And proposed agency rules rarely survive Presidential changeovers, even if the same party remains in power. So if we're exceptionally fortunate, they may have to start all over again in 2017.

Other implications?

P.S.: I know this technically belongs in media. But it has tremendous significance for the FDA's proposed rule, because this is the first deep-pocketed firm that will now be able to throw its moneybags at the FDA in support of something besides a cigAlike.
 
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Katya

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Roger, please explain how this will "force the FDA to actually issue plausible regulations for advanced systems."

Most non-BT cigalike makers are introducing (or already offer) eGo-style battery + tank options (Mistic, Volt, Bloog, Apollo, Halo G6; even SmokeStik is considering upgrading). Why would Enjoy be more significant?

AFAIK, BT cigalike makers have no plans to upgrade.
 

aikanae1

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H/t to Gato (del Jugo) who posted this elsewhere:

NJOY Aims to Bring Vaping National | ConvenienceStoreNews

What this means is that the FDA is now going to have to pay attention to at least one deep-pocketed maker of a non-cigAlike.

It also could mean that other BT/Big Vapor companies are going to start getting into the game. In fact, they'll have to, if they want a product that can withstand the tobacco act's (FSPTCA's) public health balancing test - cigAlikes aren't going to make it, because cigAlike users tend not to quit smoking tobacco cigarettes.

In addition to breaking open the door on a non-cigAlike, NJOY will probably have to - as part of this whole process - force the FDA to recognize that advanced (non-cigAlike) PVs really do help smokers quit, as opposed to letting the FDA swat all the evidence from Europe aside with the studies full of junk science/junk statistics that it's likely to fund (c.f. Grana et al., released a couple of months ago: New Study on Electronic Cigarettes by UCSF Researchers is Not Only Bogus Science, But is Also Dishonest

It will also will force the FDA to actually issue plausible regulations for advanced systems, instead of any number of options that it might have to kick out an application from a small manufacturer who might dare to file.

Although I can't post the link here, you might want to google: njoy presents relax site:youtube.com
(Be sure not to put any spaces before or after the colon. The YT video is called "NJOY Presents: Relax...It's Courtney Love!" )

I'm not saying the US will be a perfect place to vape as a result of this. But it means that commercially-available vaping products will not necessarily be reduced to cigAlikes. (And eventually to nothing, because cigAlikes have a net negative impact on public health - if we assume that reduced tobacco cigarette smoking is of minimal reduced risk value to an individual, and also that cigAlikes reduce the likelihood of cessation. Which is precisely what the FDA and the CDC think.)

Finally, this will help slow the FDA down. Bill G. has suggested that they will be less likely to present the final proposed rule to any GOP-controlled congress. And proposed agency rules rarely survive Presidential changeovers, even if the same party remains in power. So if we're exceptionally fortunate, they may have to start all over again in 2017.

Other implications?

P.S.: I know this technically belongs in media. But it has tremendous significance for the FDA's proposed rule, because this is the first deep-pocketed firm that will now be able to throw its moneybags at the FDA in support of something besides a cigAlike.

A word of warning. Njoy is an "odd duck" in the field. Very difficult to out guess. Who would have seen this coming even 2 weeks ago? Yet I give credit to Weiss for keeping most of the awful bans out of the state and turning a couple in the legislature into vapers. Lobbying works. It's quite possible that Njoy has crunched the numbers enough that they see enough profit, with the predicted time available, to make the move even though it's a fail - or have some other larger game plan in mind. I don't think anyone can out guess them. Njoy is an interesting company to watch and it would be very interesting to see if they take on BT and BP. They just might. I will say no one knows. They are not "simple" to predict.

One other aspect is that if anyone has SE to nicotine for vaping, it will be NJoy. They are the first importers of Ruyan.
 
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Roger, please explain how this will "force the FDA to actually issue plausible regulations for advanced systems."

Most non-BT cigalike makers are introducing (or already offer) eGo-style battery + tank options (Mistic, Volt, Bloog, Apollo, Halo G6; even SmokeStik is considering upgrading). Why would Enjoy be more significant?

AFAIK, BT cigalike makers have no plans to upgrade.

These guys are big enough to fight the FDA. They can afford to do studies and drop millions in subsequent litigation. Maybe tens of millions on both.

And we'll see if BT feels forced to follow suit, because now they have a deep-pocketed competitor who won't be forced out by the FDA.

Before a player like NJOY in the VTM arena, BT might have entertained fantasies of being able to compete with cigAlikes (so long as those were around), and then having the field to themselves when cigAlikes got pulled because they attract too many dual users.

Now they have to at least consider that Herzog's prediction about the eventual dominance of vaping over analogs may indeed come to fruition, despite the best efforts of BP and the US Government-Industrial Tobacco Control Complex (which, as we all know, prefers tobacco cigarettes for many reasons).

That means there's a risk of BT ending up with nothing besides a rapidly-shrinking market for stinkies, unless they're willing to branch out beyond cigAlikes.

There may also be a broader entry path for new vapers, once the two-year window closes.
 
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Time to amend the "common misconceptions" thread.

Edit option is no longer available. I might post a follow-up. Let's see how this goes.

EDIT: I just looked at it again. The analysis of the 15 beliefs isn't changed by this news. There's a part of the introduction which may no longer be accurate - the statement about only cigAlikes being left. (But I'm in good company there, along with CASAA's press release.)
 
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Katya

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These guys are big enough to fight the FDA. They can afford to do studies and drop millions in subsequent litigation. Maybe tens of millions on both.

And we'll see if BT feels forced to follow suit, because now they have a deep-pocketed competitor who won't be forced out by the FDA.

I don't know... Even your article quotes Herzog as saying: '[...] If the robust growth of VTMs continues and is not ultimately hindered by the FDA regulations (snip)"
 

Katya

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Njoy has done such an admirable job of portraying themselves as a Big Tobacco lap dog that it's easy to lose sight of the fact that they're not actually BT-owned.

Indeed.

To continue Aikanae's duck analogy, NJOY is an animal that quacks like a duck, walks like a duck, but... ain't a duck. ;)
 
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I don't know... Even your article quotes Herzog as saying: '[...] If the robust growth of VTMs continues and is not ultimately hindered by the FDA regulations (snip)"

Can NJOY beat the FDA? You asked a $64 million dollar question. Or maybe a $640M question.

But we know that advanced devices make it possible for smokers to quit (and cigAlikes don't), right? So if that's true, they have the money to prove it via studies, and the patience plus the wallet needed to fight the FDA in court, then eventually they may very well win. It might take a long time. But there's a big prize.

Just imagine the effect of having a manufacturer who could legitimately label what they offer as a modified-risk tobacco product. Even if they can't advertise, we still know that a majority of tobacco cigarette smokers want to quit. (If you believe the ANTZ, on this particular point - and I do: they say it's 70%.)

I'm a firm believer in the idea that justice can prevail in the courts. If you have enough money to buy it.

Njoy has done such an admirable job of portraying themselves as a Big Tobacco lap dog that it's easy to lose sight of the fact that they're not actually BT-owned.

Think of all the smokers who can quit, if NJOY wins and the FDA loses. That's a lot of lives.
 
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aubergine

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My heart leapt when I read that. A small, very tentative leap, but still.
NJOY is capable of serious, skilled litigation - lots of experience there. They have an obvious high stake in this game. They have deep pockets. It doesn't matter if we're fond of 'em or not - if they win the battle to sell 'advanced', post-'07 equipment and liquid nicotine, so can your friendly neighborhood B&M, in principle, anyway, right?
Unless, once again, only they can afford to jump through the hoops. Would they fight to keep those costs down, or not [to discourage competition]? I suppose the latter. Still...
I'm feeling somewhat stupid on this one.
 
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