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

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Oliver

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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.

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.
 

Elizabeth Baldwin

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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.

I totally agree. Many will try cigalikes and go right back to smoking if they don't find vaping quick enough.
 

Oliver

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I am familiar with that scenario. SJ, based on what he heard at SFATA, was quite certain that there are no predicate products comparable to what would be offered today (including cigAlikes). In fact I have yet to hear anyone say that they can estabish any type of proof regarding the existence of substantially equivalent predicate products even for modern cigAlikes. (By "any type of proof," I mean convince a court that the statute is satisfied, regardless of what the FDA says that it wants by way of docmentation.)

Therefore it logically follows that those of us who think that cigAlikes are going to come in, believe that this will be via the non-SE new product pathway. (Although they may survive only because the FDA fails to review the application, since pre-market approval is not reqired.)

Anyway I give up. Evidently we are talking past each other. Although I can't quite see how this is happening.

If anyone can, and would like to step in, I'd be grateful.

Please, let's take predicate products out of the equation. It's completely misleading. Even if it were proven that a Ruyan was sold prior to Feb 2007 in America (this IS the burden), then a 3 piece, completely redundant predicate would be the model.

The predicate of all two piece cigalikes is the KR-808D which wasn't released until well into 2008.

Can we say this is the final word?

I share Roger's belief that Njoy entering the VTM category is something of a game changer, however - it's unclear to me how they wish to proceed. This could be an almighty failure for them - for one, the supply chain as it currently stands simply isn't geared up to deal with them making a full-on entry into the category, so they are bootstrapping with internet sales only to begin with.

If they don't see sufficient interest in their product from their online sales (they may well not - the online space is a pretty hairy one for Njoy these days, despite their origins here), they may well dump it.

That said, don't forget the other part of the equation: Europe. The European market will be played very well by people like Njoy, who have much to gain from releasing a TPD qualifying product there. It's a complex picture, but Njoy could quite easily have the resources to dominate across Europe (each member state will be implementing the TPD themselves - not together. Think this through).

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.
 
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Gato del Jugo

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2coils

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Me and my mom quit using Green Smoke. Though, I was getting frustrated fast. Had I not found a better option, I may have went back to smoking! There has already been talk of the Cigalike market plateauing. Though they have come a long way, I believe they fall short for long term use. The craze and market boom I am sure had a lot to do with curiosity.
 

Gato del Jugo

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I have no idea what you mean since when I started my journey on cigalikes. They were horrible. I almost went back to smoking, then I discovered tanks and mods. That's been a while. I've watched my Mother try several different cigalikes and would go back to smoking each time due to poor performance, that is until I discovered vaping and she tried mine. Now she is deep into vaping after quitting a 50 year habit.

Honestly cigalikes are just garbage. Every one I've tried does not satisfy me, poor vapor, and the battery life is rediculous.

I know this has been said plenty of times before, but this is exactly why all these junky studies are showing such a high percentage of dual-use & quit-failure rate...


Include subjects using something like a ProVari or MVP, with a good topper filled with some decent juice that a particular smoker enjoys.. and that dual-use will plummet, just as the quit rate would skyrocket...
 

Bob Chill

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I noticed on the press release that there is a bottle of njoy liquid. I searched around and couldn't find much about it. I'm sure they'll stick to their small line of tobacco or menthol flavors. I'm pretty curious to know how much they are going to charge per ml.

Whether it's a complete gamble or they know something, it's nice to see a big company offer bottled juice and refillable tank.
 

wv2win

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........................

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.

......................................

Is there any doubt what will be best for vapers from the mid-term elections? We need the control of the Congress and the the control of the HELP committee to move out of the hands of the Senator Harkins and into the hands of a Senator Burr.

Vote wisely people.
 

Gato del Jugo

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I noticed on the press release that there is a bottle of njoy liquid. I searched around and couldn't find much about it. I'm sure they'll stick to their small line of tobacco or menthol flavors. I'm pretty curious to know how much they are going to charge per ml.

Whether it's a complete gamble or they know something, it's nice to see a big company offer bottled juice and refillable tank.

Dimitris, et al., discussed it on VP Live recently..

NJOY is also releasing 8 new juices.. but more of "adult" flavors, whatever that means (coffee?)...
 

Oliver

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2coils

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I noticed on the press release that there is a bottle of njoy liquid. I searched around and couldn't find much about it. I'm sure they'll stick to their small line of tobacco or menthol flavors. I'm pretty curious to know how much they are going to charge per ml.

Whether it's a complete gamble or they know something, it's nice to see a big company offer bottled juice and refillable tank.
I believe Dimitri mentioned, Njoy is going with an 8 "adult" flavor profile. Ie...coffee etc
 

Jman8

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Honestly cigalikes are just garbage. Every one I've tried does not satisfy me, poor vapor, and the battery life is rediculous.

I'm on a cigalike (V2) and been doing that for over 2 years. Plus am a PROUD dual-user. Always up for clarifying this and discussing it with the anti-cigalike crowd who routinely comes off snooty to me. I'm thinking there are for sure dual users who vape on big ol' mods and have not, by choice, given up smoking.

This cessation thing is nice and all, but come see me when you've quit for 8.5 years like I did when I went cold turkey.

I'm not against big ol' mod devices, why do some of you all have to continually vocalize disdain for cigalikes? Can't your device of choice simply be great for you without putting down the other offerings available?
 

Izan

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I ran across an ego sized disposable that is NOT a cigar.
More choices mean more choices....
Infinity_Black_5347941e7a6c8.jpg



cheers
I
 

2coils

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Jman, I get where you are coming from. I believe there is a place in the market for both. I even enjoy an Njoy from time to time! I believe from a TOTAL alternative point of view, the more "satisfying" the device (not just vapor production), the better shot of staying away from smokes. I do believe personally, the advanced systems are more satisfying! That does not mean the smaller devices are garbage.
 

Jman8

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BT had advance notice (TVECA) and seemed pleased with FDA's deeming - BT had some sort of arrangement going that would have simplified the process for them plus their prior experience with regulations. Either Njoy is part of that, or split off on their own directin or there's been a shift in FDA's position that we aren't aware of. I'm just saying that last one is an option, just like no one outside of BT knew what the deeming regs would be until they were public.

While I understand your point that when it comes to these specific proposed regulations, some companies appeared to have specific knowledge of what those would be. I'm yet to find anything in the proposed regulations that wasn't anticipated on ECF and elsewhere online going back to 2012, plausibly going back to 2010. SFATA was on top of this long before 2014. Mom and Pop vape store likely wasn't because managing that store was probably all they had time and resources for. I find it very hard to understand how any politically aware vaper, who's been in the game for more than a year could pretend like they had no idea some of these items would be proposed as regulatory framework by the FDA until 2014.

I tend to think the FDA considers nicotine is a drug and anything delivering it should be regulated as such. I think they have to follow court decision, but they don't have to agree with it and probably don't since medically, addiction is a disease and nicotine including harm reduction would be classed as treatment; not in the interest of public health policy.

In the recent hearing, FDA made it clear that they put larger public health policy above individual streams of potential THR. I think that is highly questionable and we know it is and will debate those who wish to take up FDA position as if that is authority on 'public health.' But until FDA sees their own science, they appear to be unmovable on this stance. Even after that scientific data comes in, I don't see them making great strides, but this whole discussion routinely shows up to me as individuals (who are politically aware) get this stuff in days, while it takes FDA, years to get it.

Why anyone would dispute nicotine is a drug is a bit bizarre to me. Why anyone would doubt that a regulator is going to want to regulate that is also a bit bizarre to me. But equally bizarre is that any regulator who thinks they can maximize control on it, and that control will automatically benefit public health. That may take decades for the regulator to realize how utterly unreasonable it was to seek maximal control on the substance.

Cigarettes were grandfathered in, clean and simple outside of FDA's decision making. This explains why it would be difficult for them to approve any tobacco type product as good for "public health" but could approve it for the individual as treatment. I think the FDA is struggling = turns it over to industry to write and FDA's role would be to make it fit within the law = a lot of murky policy decisions with little philosphy to back it up. However politicians seem to be eager to help make it worse.

Agree with this. It is the 'easy path' for regulator seeking maximal control. Yet, world don't work like that, and politicians come and go. I still think it is within our grasp to get eCigs grandfathered in. Not easy schmeasy, but easily worth trying given how proposed regulations were written plus given all agencies that could be involved going forward and given that regardless of what FDA does 4 years from now, that over the next 2 years, it'll all be allowed to stay on the market. Grandfathering just makes sense politically, unless you are of the ANTZ philosophy.
 

tombaker

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Please, let's take predicate products out of the equation. It's completely misleading. Even if it were proven that a Ruyan was sold prior to Feb 2007 in America (this IS the burden), then a 3 piece, completely redundant predicate would be the model.

The predicate of all two piece cigalikes is the KR-808D which wasn't released until well into 2008.

Can we say this is the final word?

I share Roger's belief that Njoy entering the VTM category is something of a game changer, however - it's unclear to me how they wish to proceed. This could be an almighty failure for them - for one, the supply chain as it currently stands simply isn't geared up to deal with them making a full-on entry into the category, so they are bootstrapping with internet sales only to begin with.

If they don't see sufficient interest in their product from their online sales (they may well not - the online space is a pretty hairy one for Njoy these days, despite their origins here), they may well dump it.

That said, don't forget the other part of the equation: Europe. The European market will be played very well by people like Njoy, who have much to gain from releasing a TPD qualifying product there. It's a complex picture, but Njoy could quite easily have the resources to dominate across Europe (each member state will be implementing the TPD themselves - not together. Think this through).

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.

I certainly believe that Cigalikes transition plenty of people into APV (I am not going with the rebranding of some of APV into VTM). Over the years cheap APV came about in mall shops, and Internet. So people can start with APV must more easily now.

But the sales numbers of E-Cigs are the majority of "users", and since we know that "users" are using Vaping to quit, I don't see how anyone can rightfully conclude the majority of the people completely transitioning is not coming in actuality from the majority of users. If APV was the majority, I would say the opposite.

Any survey based upon a user group like ECF is going to be biased to the user population with that user group. Back in the day if reading the forums I was, I would have concluded that everyone was overclocking their CPUs, and while the basic users were just buying a certain stepping of a Celeron, and running their dual channel at a higher speed, and getting the benefits of an easy multipler to the memory bus.....and the really Advanced users were using multiple fan,s Zalmann all copper heat sinks, or water-cooling............in actuality that survey on that forum would be entirely skewed. Intel ran the numbers, the real number of overclockers was so small they just ignored it. APV is not unlike overclockers. And ECF is not unlike Anandtech or Toms Hardware. And just like my ability to edit an autoexec.bat or a config.sys and system.ini once needed, those skills are outmoded by better products. Quad Core CPUs once cost 800 each, now they are on phones, you can buy off contract for 200, and the users have no care.

There is no differences between any KR808D and the most advanced APV of today. It boils down to a wicked E-Liquid against a DC coil. The rest is fluff and flair only. Yes they work much much better. But a 1940s Ford car, is still a car, as is a 2014 Ford, still just a car.

It may seem tragic or not glamorous, but it just a coil, and wicked E-Liquid. The end result is clear, its a cloud of vapor. What the FDA is concerned with is the end outcome going into the human. Its just vapor....yes.....Its just a tank holding liquid, still yes, no tank, poly fill....guess what, its still E-Liquid, a wick change only.

I am starting to think that the UK is a pretty different place than the USA as far as retailing of E-Cigs. They are selling Blu and Njoy, at Costco here. Thinks its about 5 dollars for the NJOY King 10 for like 50, if I recall correctly. They move stock fast so it should be the NJOY KING version 2 pretty soon. Every local corner market you can by Blu and V2 disposables, most smoke shops have the replacement Carts in stock.

Beside the differences between the UK and the current US market, It does not seem APV aficionados are keeping up with the leaders in E-Cigs (sticks batteries, Cig-alikes or whatever you want to call the majority of vapers) I am going to use V2 because I think they have the most diverse line, I could also use Apolloecigs, Halo, Blu and others. (I have Zero affiliation with V2 at all, including codes or links. I am a customer of them, my money flows to them, nothing in any form comes back to me, besides my purchases.....nuf said on that)

Everything below is on "stick" batteries, Cigalikes, you will over time the line has blurred between E-Cig and APV terminology.
1. V2 has been selling E-Liquid in bottles for well over a year.
2. All V2 products are classified as Refillable, (well actually see the last item)
3. The sell empty Carts specifically only for filling with E-Liquid
4. They sell in raw and Starter kicks, Clearomizers. They are top coil, with screw on caps, but are not rebuild-able.
5. They sell drip tips, in both metal and silicon.
6. The newest battery have power level indicators LEDs, and better regulation
6. Last month they started selling a IC controlled completely sealed, all liquid atomizer, with No Poly. This is not refillable.

I switched on my 3rd order to the tanks, and never went back to Polyfill. The newest option may put me back to fire and forget mode of of just replace the cart when done, the all liquid carts even have a fluid window. All that said....BLU is a better juice still.

NJOY (Sottera) has already proven it has the best lawyers in E-Cigs against the FDA. Thinking that they don't fully understand what they can do and not do against the FDA, is surely folly of the first class. If NJOY had not done what it did for all Vapers in the Sottera Win, the president established by the FDA could have become entrenched.

NJOY just dropped 75 Million on TV ad campaign paying for a top 10 song to boot. They are not leaving the USA....the UK must be really different, there is no way NJOY is turning tail on the USA leaving the market. And their lawyers have the drop on the FDA too.

In the end, E-Liquid is the E-Cig, and every Vaper or APV user all it doing the same thing....vaping E-Liqud....the cloud is the only thing that touches the consumer.....and the documentation of the E-Juice is the only significant thing that the FDA will require.

The FDA is not going to start checking the quality of regulated power sources....that's for UL to test.

Todays "sticks" still have the Automatic triggering option, a better system than manual (less burning of coils, easier) and the big difference is size. With an automatic E-Cig, I am hands free. With my Itaste VV, I have to use my hand always to hold, and trigger manually....making it less advanced, and less user friendly.

Sure, many people on ECF have switched, or started E-Cigs before the current crop.....but the current crop of E-Liquid Cig-Alikes has nearly full redefined what APV is......with only Mech MODs being clearly different enough.
Cheers
 

wv2win

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I'm not against big ol' mod devices, why do some of you all have to continually vocalize disdain for cigalikes?................

I would not say disdain but more like ineffective dislike. They have their place. But here is what I dislike about most cigalikes:

1. Lying marketing: one cart = 1 - 2 packs of analogs; batteries that last for 2 days; premium device, better than anything on the market, etc, etc

2. I personally have talked with about 50+ people locally who stated they tried vaping with a cigalike and due to the weak vapor, poor throat hit and weak battery that they went back to smoking. Some even called vaping another "stop smoking scam"

3. The fact that no cigalike company (until possibly now) has been willing to offer an "upgrade" product for those many dissatisfied with cigalike performance. In other words, they are more interested in just quick profits and have not been willing to put a little money into a better performing product.

4. If a cigalike provided an 10 hour battery with no battery drain issues (regulated), as well as a cart that lasted 10+ hours of hard use with no drop off in performance and a consistent vape for those 10 hours, I would be an advocate.

5. My biggest issue is that for every one person who successfully quits analogs with a cigalike, my strong guess is that 10 keep smoking and another 10 get smart and find a better product.
 

tombaker

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I ran across an ego sized disposable that is NOT a cigar.
More choices mean more choices....
Infinity_Black_5347941e7a6c8.jpg


cheers
I
Really wish that Janty was available in the US. They are one of the innovators, the Ego seems kinda popular. Plus the biggest reason I want them in the US, is they don't use Polycarbonate in their tanks, which is why my searches lead to their pages. Was looking for a re-brander of them available here, and could not find one.
 
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Kent C

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I'm on a cigalike (V2) and been doing that for over 2 years. Plus am a PROUD dual-user. Always up for clarifying this and discussing it with the anti-cigalike crowd who routinely comes off snooty to me. I'm thinking there are for sure dual users who vape on big ol' mods and have not, by choice, given up smoking.

This cessation thing is nice and all, but come see me when you've quit for 8.5 years like I did when I went cold turkey.

I'm not against big ol' mod devices, why do some of you all have to continually vocalize disdain for cigalikes? Can't your device of choice simply be great for you without putting down the other offerings available?

I'd tend to agree, but there was a time (2009-'10) when certain cigalikes - Blu, NJoy, SE (Smoking Everywhere) were truly ripping people off - they were way overpriced vs. other choices - some getting a 'monthly plan' (for refills) that they never signed up for, credit cards being assessed monthly, etc. And you didn't have to do the 'handholding' at the time for all those people who couldn't get them to work. :) To their credit, Jim Davis, TBob and a few others (and eventually me - usually pointing them to Jim D) did and it wasn't fun. This is where much of the 'disdain' comes from vets and likely the we've passed that along to others over time just by osmosis.
 
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