FDA Personally unworried about the regulations

[UncloudedThinking]

The deeming regs are a problem because they are wrong. They are inappropriate. It is unacceptable for FDA to enact a regulatory scheme that offers the easiest path to approval to the most dangerous products and the hardest path to approval to the least risky products.

Further, they are wrong because they give such a massive advantage to large corporations that all of the small business will have to close. It is unacceptable to let BT have the industry.

And most importantly they are wrong because they are bad for public health. cigalikes may work for some people but they don't work for everyone. There are A LOT of people that are unsuccessful with cigalikes that succeed with second generation devices. If the deeming regs are enacted as they are the potential of vapor products to obsolete cigarettes will be severely undercut. The number of lives that can be saved will be much lower.

I hear people talk about how they will get around the deeming regs if they are enacted but believe that is a selfish view. If you aren't going to fight for this for yourself you should do it for the millions of people who still smoke.

The 2014 Surgeon Generals report on smoking estimates that 5.6 Million American children alive today will go on to die of smoking related illness. We have a chance to seriously change that. But not if we sit back and do nothing while FDA makes on of the worst mistakes in public health history.

 

[dragonpuff]

I am a dual user .... who has broken the addiction to smoking. How do I know this? Because I've gone cold turkey in my life for longer than any vaper has quit smoking via vaping.

So, cigalikes do work.

Sigh...

Saying that they worked for you is not the same as saying that they work for people in general. They do not.

I don't know how much you smoked (or still do...), but as for me, cigalikes only served to help me cut back and got me into vaping. They absolutely did not help me quit. They may work for some people, but they do not generally work for a heavy smoker trying to achieve a complete abstinence from smoking. In other words, they are the least likely to work for those people who have the hardest time quitting. This is why older studies on vaping show a low success rate for smoking abstinence, while newer studies are showing higher rates. Many of these newer studies are using ego style setups, which are far more effective. In other words, the proof is in the pudding.

 

[Oliver]

If there are requirements for pre-market registrations, then it is (remotely) similar to PMTA requirements.

Currently no one that I am aware of actually knows anything substantial about PMTA, and instead uses it as ultimate bogeyman for 'end of vaping as we know it.'

I recall numerous threads before (and after) EU decision on vaping as 'end of vaping.' One would think from rhetoric going into that and immediate aftermath that it would be literally impossible to obtain any vaping products in the EU at this point. If you are one of the lucky few that can get them, then that would be unbelievably surprising, based on those past threads.

Immediate aftermath? As I said in the post, the regulations don't come into force for another 18 months. At that point, most e-cigarette products currently on the market will be removed. It's bad - very bad. Please don't get me wrong - but it's going to be worse in some countries than in others.

My assertion that PMTA is not remotely similar to the requirements for EU member states holds up, I think. Like this:

The TPD is full of vague language, and it's up to member states to interpret these - either through careful deliberation and then "transposition" into the legislation (e.g. UK), or through "gazetting" (the direct application of the TPD language into the national law), and then modification through court battles.

So, in some countries, you may have a relatively liberal interpretation, but in others, you'll have something restrictive. This is all playing out right now in each member state. I, for example, met with the UK department of health last week to explain the product varieties to them, and was very impressed with their expressed desire to get this right. The UK gov has expressed its desire to be seen as a leading light on the issue across Europe - the history as to how this has been achieved is complex, but one day I'll write the book - it's a fascinating topic.

So, regarding the PMTA, and I wish I could share more here - but the work required to submit a PMTA application far exceeds anything 99% of the industry can achieve. I love this idea that the initial applicants will shoulder the financial burden of the process, and it will then become far easier for anyone else to ride on their coat-tails. Not going to happen.

You need to see the way the wind's blowing here - the process will be iterative, and will end up with GMP standards for production of e-liquid. Very few companies will be able to achieve this. The net result is going to be that e-liquid is produced by few, and at a cost that is unreasonable.

And that's before we even get onto the devices.

 

[jpargana]

I just do not see it having the massively negative impact everyone fears. Big tobacco at this point is all too heavily invested in E-cigs, there are way to many large corporations (you know, the people running this country) that are invested in this marketplace for these regulations to actually start tearing down or destroying the ecig market. They are going to wind up with some regulation, how can you expect them not to be? I am by no means a governmental advocate, or in support of any of this (barring the regulations that might help clean up the POS products, and harmful liquids that sneak there way over here) But come on, all the doom and gloom for what I personally feel is no reason.

Big Tobacco has not being investing in what we could call a "proper" E-Cig.

They have been investing in outdated, uneffective "cig-alike" technology - the kind of "E-Cigs" many of us found at some point or the other to be lacking - lacking in vapour, lacking in power, lacking in flavour... and then we either moved on to more effective 2nd and 3rd generation devices, or reverted to smoking.

I know many people who have tried, and failed, with the 1st generation devices, some years ago - I myself have lend them some Ego Dura sets at that time. I was lucky to stand, until 2nd generation Egos appeared.

Those people returned to smoking instead.
Those people have now returned to vaping, with "proper" gear.

Those who supported the new European TPD had the nerve to tell us that it will not "ban e-cigarettes". It will "only" ban 2nd/3rd generation "vaporizers", rebuildable atomizers and refills. Cig-alikes with sealed cartos - to "protect the children" - and proprietary batteries (electronic encryption, so that battery A will only work with atomizer A) - to protect the business - will still be available. And will be properly sold by BT, of course.

How is this NOT a de-facto ban on vaping, as we know it? How is this NOT giving a little hand to BT (On a Tobacco Directive !!), when you get rid of the most effective tobacco competition, leaving only the weakest gadgets available - and even those, are to be sold by BT?

You know what this reminds me of? The "tobacco flavourings ban" in the USA (for the 'childrun'), with that little exception of menthol, wich is "only" used by almost half of 'the childrun' !!

 

[SolRayz]

Nothing productive ever comes from government intrusion. It seems that they do nothing but bully, intimidate, lie, and/or annoy average people into accepting lower qualities of life with addition of a tax or two. Reading through some of the FDA proposed legislation is extrememly boring and lame and at times based on outdated info that is no longer relevant in 2014. The FDA is in over its head with everything else its responsible for, so to expect anything good, relevant, or beneficial, to come out of this has been agency, is laughable at best. The fact that it has taken them this long, to get there $h!t together, is more proof how completely incompetant they are, much like most of the fed.

The mere fact that they even have the nerve to even discuss ecigs, while regular cancer killing cigarettes continue to be sold nation wide for 50+ years, and even in pharmacies of all places, destroys any credibility and any legitamacy in my book.

 

[jpargana]

Nothing productive ever comes from government intrusion. It seems that they do nothing but bully, intimidate, lie, and/or annoy average people into accepting lower qualities of life with addition of a tax or two. Reading through some of the FDA proposed legislation is extrememly boring and lame and at times based on outdated info that is no longer relevant in 2014. The FDA is in over its head with everything else its responsible for, so to expect anything good, relevant, or beneficial, to come out of this has been agency, is laughable at best. The fact that it has taken them this long, to get there $h!t together, is more proof how completely incompetant they are, much like most of the fed.

The mere fact that they even have the nerve to even discuss ecigs, while regular cancer killing cigarettes continue to be sold nation wide for 50+ years, and even in pharmacies of all places, destroys any credibility and any legitamacy in my book.

This !!!

What really annoyed me, by reading some of the fantasies contained in the new TPD, is realizing that we may be about to lose vaping, by regulatory power of some people who know nothing about vaping, mixed with other people who understand the menace of vaping all too well - so well, that they want to get rid of it.

In the mean time, real people below their ivory towers is about to lose the freedom to choose an healthier life style. Real people's lifes and health may/will suffer because of poorly designed laws - from strictly an health perspective, I mean. It was very well designed from an economical view - to ensure people will keep smoking, securing the gravy train for BT, BP and BG !!

 

[zoiDman]

Well he's mentioned being a dual user in about 70 posts since October 2013. But you are right - there are 'many people' who don't know that he is. However, it is not likely anyone here who has paid even the least amount of attention to his posts in these sub forums. One, because he mentions it quite a bit and two, you may have mentioned it more than he has.

On a Forum this size, I can Guarantee that there are Many People who Do Not Know that Jman8 still Smokes.

If a Person says an e-Cigarette Works, I think knowing that the Person who says it Hasn’t Quit Cigarettes is pertinent. And gives some Perspective to the reader.

Just like if a Person says that they are Not Worried about future FDA Regulations. Many will Scratch their Head and wonder how can Someone not be Worried?

But if they know that the Person who Isn’t Worried still smokes Cigarettes, and uses a Cigalike similar to the Grandfather Cut Off Date, then they might have a Different Perspective than one who has who has Quit and uses an e-Cigarette that is Threatened by Regulations.

I’m not Going Back to Cigarettes. No Way. No How.

Maybe I would be Less Worried if I still Smoked? And the Only e-Cigarette I used was something that a Grandfather Clause might allow? And when the Regs come, and they are Bad, I would just Keep Smoking.

 

[stevegmu]

The funniest thing about the hatred and mass paranoia is that the FDA hasn't even done anything yet and no one even knows what regulations will end up enacted- even the FDA...

 

[WillyZee]

I am a dual user .... who has broken the addiction to smoking. How do I know this? Because I've gone cold turkey in my life for longer than any vaper has quit smoking via vaping.

So, cigalikes do work.

seems like Cigalikes have helped you cut down on your smoking ... however, they have not helped you quit smoking entirely.

 

[Oliver]

Well, when we did our last survey (N=10000) 12% of respondants were still smoking.

BUT - when they were asked how many cigarettes they'd reduced their smoking by, the average was 15 per day!!!

SO, 88% completely smokefree, 12% reduced by 15 cpd. This is a win, by any measure.

 

[zoiDman]

Well, when we did our last survey (N=10000) 12% of respondants were still smoking.

BUT - when they were asked how many cigarettes they'd reduced their smoking by, the average was 15 per day!!!

SO, 88% completely smokefree, 12% reduced by 15 cpd. This is a win, by any measure.

Absolutely!

Especially when you Consider that Many who are in that 88 Percentile, like Myself, have Tried Many Times and Many Methods to Quit and Nothing Work for more than a Short Period of Time.

What I Worry the Most About is that the FDA will Cap the Nicotine mg/ml level Too Low.

I couldn't Quit and Stay Quit without using 36mg/ml for the First 2 Months. I'm not Saying that Everyone was like me. But I know that there are Some who Just Couldn't Quit without going to the High End of the mg/ml scale.

 

[zoiDman]

BTW - It would be Interesting if there was a Follow Up survey on the 12% who have reduced there Smoking in 3 Months or so.

I wouldn't be Surprised to See if Many (if not the Majority) of them moved into the 88% Bracket.

And that the 12% Group was a Group that was Constantly in Flux. With New People Coming in who Still Smoked as People moved Out into the Non-Smoking Group.

Many People Don't Quit Smoking "Cold Turkey" using e-Cigarettes. But Ramp Down their Cigarette use over a certain amount of Time. Eventually becoming Smoke Free.

 

[Jman8]

Sigh...

Saying that they worked for you is not the same as saying that they work for people in general. They do not.

I don't know how much you smoked (or still do...), but as for me, cigalikes only served to help me cut back and got me into vaping. They absolutely did not help me quit. They may work for some people, but they do not generally work for a heavy smoker trying to achieve a complete abstinence from smoking. In other words, they are the least likely to work for those people who have the hardest time quitting. This is why older studies on vaping show a low success rate for smoking abstinence, while newer studies are showing higher rates. Many of these newer studies are using ego style setups, which are far more effective. In other words, the proof is in the pudding.

And my point is if they work for some people, as you have stated, then it is inaccurate to make the blanket statement of "they will not work" or "they do not work."

There will never be a product that works 100% of the time for all people. I grant that many, perhaps even most, eCig users who are seeking cessation will benefit more using larger devices. But again, I don't see the purpose in putting down cigalikes (to point of saying of they will not work) when another product, mods, has better chance of working for, as you have noted, a different type of smoker.

Btw, I smoked at level of 1 to 1.5 PAD. As a dual user, using only cigalike type devices, I currently smoke a pack a week, and in last 6 months have had 2 months where I smoked a pack a month, or less. Given my history with cold turkey and with my knowledge/experience of vaping, I believe I could cease smoking at any time, that I choose.

 

[Tangaroav]

I can understand that. What I can't understand is making a thread about their lack of concern.

I disagree with the op's opinion and views on regulations, I strongly disagree with those who seek to prevent his opinion from being posted.

 

[Kent C]

zoiDman:On a Forum this size, I can Guarantee that there are Many People who Do Not Know that Jman8 still Smokes.

No you can't. Did you take a survey? Anyway, I acknowledged that many in the forum don't know, they don't even know who jman8 IS. But people here do. Out of those 70 posts (actually 74) most of them where he's mentioned he's a dual user has happened in these 'news and campaign' forums in almost every post that is pertinent to any discussion of dual use. Again, if there are any regulars here who don't know that jman is dual user, it isn't because of him - it's their own inattention.


If a Person says an e-Cigarette Works, I think knowing that the Person who says it Hasn’t Quit Cigarettes is pertinent. And gives some Perspective to the reader.

Again, he's stated so, many times when no one even asked.

Just like if a Person says that they are Not Worried about future FDA Regulations. Many will Scratch their Head and wonder how can Someone not be Worried?



First, so what? That's the head scratchers problem. And secondly...

There are many reasons why someone might not be worried that has nothing to do with their using habits. Many gun advocates have been 'worried' about gun control, but with the current makeup of the House, there's little chance of anything coming down except perhaps by executive order, which would be immediately challenged. So some are not so worried.

Plus, some (with guns and ammo And with hardware and eliquid) have supplies that could last them quite a while or have resources to replenish. These people are also 'not so worried' about the deeming. They prepared for the worst at the earliest moment.

There are some people who by vaping or earlier methods who absolutely know they could quit nicotine and they just vape for fun or pleasure, where it is not the addiction that keeps them going.

And lastly, there are some who think that the FDA and gov't won't be able to pull off any great restriction or ban of these products either directly or through a black market - they're 'not concerned'. The fact that you are, doesn't immediately translate that everyone else is or should be. And to suppose that it is only because someone could easily go back to smoking, as the reason is rather short sighted.


But if they know that the Person who Isn’t Worried still smokes Cigarettes, and uses a Cigalike similar to the Grandfather Cut Off Date, then they might have a Different Perspective than one who has who has Quit and uses an e-Cigarette that is Threatened by Regulations.

Again, no one here should be so confused - he's made it clear, even when not asked. And... so what? if 'they' don't know?



I’m not Going Back to Cigarettes. No Way. No How.

Good! I'm not so sure myself. IF there's a total ban, I run out of supplies (not likely and there are SWAT teams, who I can't take out and there are no ecigs available, I'd go back to smoking. But then, I never intended to quit in the first place. It just happened and for all those who don't know by now, I'm not currently a dual user. I haven't had a cigarette in over 5 years.

Maybe I would be Less Worried if I still Smoked? And the Only e-Cigarette I used was something that a Grandfather Clause might allow? And when the Regs come, and they are Bad, I would just Keep Smoking.

Perhaps.

 

[Jman8]

Immediate aftermath? As I said in the post, the regulations don't come into force for another 18 months. At that point, most e-cigarette products currently on the market will be removed. It's bad - very bad. Please don't get me wrong - but it's going to be worse in some countries than in others.

My assertion that PMTA is not remotely similar to the requirements for EU member states holds up, I think. Like this:

The TPD is full of vague language, and it's up to member states to interpret these - either through careful deliberation and then "transposition" into the legislation (e.g. UK), or through "gazetting" (the direct application of the TPD language into the national law), and then modification through court battles.

So, in some countries, you may have a relatively liberal interpretation, but in others, you'll have something restrictive. This is all playing out right now in each member state. I, for example, met with the UK department of health last week to explain the product varieties to them, and was very impressed with their expressed desire to get this right. The UK gov has expressed its desire to be seen as a leading light on the issue across Europe - the history as to how this has been achieved is complex, but one day I'll write the book - it's a fascinating topic.

I concur that it is a fascinating topic. I look forward to your book

I find your meeting with UK dept. of health to be encouraging and reason to not be worried, even while there can still be a concern.

I find that pre-FDA deeming, here in the U.S., a similar process is already playing out. Some states have sought high restrictions on use of eCigs while others have done next to nothing in terms of restrictions.

So, regarding the PMTA, and I wish I could share more here - but the work required to submit a PMTA application far exceeds anything 99% of the industry can achieve. I love this idea that the initial applicants will shoulder the financial burden of the process, and it will then become far easier for anyone else to ride on their coat-tails. Not going to happen.

And this would be, for me, another area where we will have to wait and see. I agree that if the cost per product, per application is $330,000, that there is reason to be concerned.

But, I think black market will respond to whatever will be an obviously zealous approach should the $330K number be accurate with regards to minute product change. So, just to be clear if it is $330K for approval of 18 mg nic liquid and another $330K for 12 mg nic liquid of exact same flavor from same vendor, then yes, this will be a significant squeeze on the legal industry.

Those who think black market means inherent danger all the time for the consumer are people that I think either have never experienced the black market or are engaged in propaganda to create fear.

You need to see the way the wind's blowing here - the process will be iterative, and will end up with GMP standards for production of e-liquid. Very few companies will be able to achieve this. The net result is going to be that e-liquid is produced by few, and at a cost that is unreasonable.

And again, to deny the wind blowing in direction of underground market based on speculation on what legal market might become is I feel plausibly giving into fear mongering. And this is assuming that the fear mongering that 99% of all products will be gone, is entirely accurate.

If I truly believed that 99% of all products will be eliminated from existence (legal or otherwise), I could see reason to worry, but even then I would need to see more than speculation from our (biased) side. As much as wind appears to be blowing in a particular direction, I find much evidence right now to suggest it s blowing very slowly in that direction, which matters to a) black market operations, b) momentum/growth industry is experiencing, c) science weighing in to influence policy, d) technology advancing to muck up those that seek heavy regulation and e) politics of resistance, as may be embodied by politicians or as a possible platform.

 

[zoiDman]

I’m not Going Back to Cigarettes. No Way. No How.

Good! I'm not so sure myself. IF there's a total ban, I run out of supplies (not likely and there are SWAT teams, who I can't take out and there are no ecigs available, I'd go back to smoking. But then, I never intended to quit in the first place. It just happened and for all those who don't know by now, I'm not currently a dual user. I haven't had a cigarette in over 5 years.

Maybe I would be Less Worried if I still Smoked? And the Only e-Cigarette I used was something that a Grandfather Clause might allow? And when the Regs come, and they are Bad, I would just Keep Smoking.

Perhaps.

You know as well as I do that there will be No Complete Ban on e-Cigarettes.

But even if there was, the Last Thing I would want to see You do, or ANYONE, is go Back to Smoking.

 

[Kent C]

You know as well as I do that there will be No Complete Ban on e-Cigarettes.

But even if there was, the Last Thing I would want to see You do, or ANYONE, is go Back to Smoking.

Of course I know, but you're talking about people who don't know jman, don't know he's a dual user and I'm guessing wouldn't have a clue as to whether there would be a total ban or not. I've made my point - you're 'worrying' about other people who don't know that jman is a dual user has no application here in these particular threads, since anyone who comes here would know after about 3 of his posts, either from him or someone else complaining You were making a different point - I hope you succeeded.

 

[SeniorBoy]

On a Forum this size, I can Guarantee that there are Many People who Do Not Know that Jman8 still Smokes.

If a Person says an e-Cigarette Works, I think knowing that the Person who says it Hasn’t Quit Cigarettes is pertinent. And gives some Perspective to the reader.

Just like if a Person says that they are Not Worried about future FDA Regulations. Many will Scratch their Head and wonder how can Someone not be Worried?

But if they know that the Person who Isn’t Worried still smokes Cigarettes, and uses a Cigalike similar to the Grandfather Cut Off Date, then they might have a Different Perspective than one who has who has Quit and uses an e-Cigarette that is Threatened by Regulations.

I’m not Going Back to Cigarettes. No Way. No How.

Maybe I would be Less Worried if I still Smoked? And the Only e-Cigarette I used was something that a Grandfather Clause might allow? And when the Regs come, and they are Bad, I would just Keep Smoking.

That would be me so thank you! My bad, I should have read more of my NBF previous posts.

My NBF said: "You say they don't work. I find that inaccurate."

I never said "they don't work"! Of course they work for some folks and I frankly don't care what device anyone uses, as long as they either eliminate or cut back on stinkys.

My NBF said: "Arguably product in a future black market will be safer than current product in an unregulated market of a budding industry."

No argument required with your logic. That's a waste of bandwidth but of course this is a Forum so have at it and lets see how much "traction" you get with your assertion. Your talking apples and oranges with not a single piece of logic in your statement. Black markets don't appear until a given substance is regulated! You need BOTH circumstances (Regulated + Black market) in place before you make what I consider to be a specious and self serving comment. Using "future" vs "current" to use your words in case my thoughts need clarification. I'm not talking about counterfeit golf clubs or stolen inventory marked way down. Think controlled substances like "uppers' or "downers" as an example more closely related to juice.

On the other hand, if you wish to continue the discussion about black markets then lets assume for the sake of that discussion that the deeming is the law of the land and this produces a critical shortage of vaping supplies AND a black market has sprung up to fill this "demand" In this case by all means post your thoughts in this specific circumstance. All views are encouraged in this case. Until then...

Good luck and best wishes with Vinne in the alley and don't forget to bring cash.

 

[zoiDman]

Of course I know, but you're talking about people who don't know jman, don't know he's a dual user and I'm guessing wouldn't have a clue as to whether there would be a total ban or not. I've made my point - you're 'worrying' about other people who don't know that jman is a dual user has no application here in these particular threads, since anyone who comes here would know after about 3 of his posts, either from him or someone else complaining You were making a different point - I hope you succeeded.

My My. The Word "Worried" sure seems to be Being used a Lot Lately. LOL

I'm Not Worried about People Not Knowing that Jman8 still Smokes. Just Know that there will be Many who Read what he Post and Don't know that he Does.

This is what I posted...

In the Interest of Fairness, you should probably Also mention that you are a Dual-User.

Maybe it is just me? But I believe that the More you know about Someone, the Better you can Understand Ones POV or Motivations for what they Post.