FDA FDA's leaked guidance for PMTAs confirm deeming reg would ban >99.9% of nicotine vapor products

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Elizabeth Baldwin

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Only if the aim is to monopolize the e-liquid/e-cig market.

These specific regulations are a perfect example of that aim.

However, some regulation (ie. Testing of individual components of flavourings, ie. specific chemicals) is necessary to ensure we are not consuming or breathing toxic substances.

I presume 99.9% of flavours are harmless and therefore should not require any further regulation.

But they aren't planning to leave the flavors alone! Flavors will be the first thing they do away with. Zeller has said that.

The FDA doesn't "partially" regulate something. They take full control.

They plan on regulating them just like cigarettes. With cigarettes the cigarette makers pay huge testing and application fees for every individual item. They rarely get anything "new" approved. And the FDA are deeming ecigs/vape gear/juices/nic as tobacco which means they'll fall in the same category. There's no flavors in traditional cigarettes. It's menthol and tobacco only... that's it. The FDA isn't going to make an exception for vaping either. Just listen to Zeller talk. They have to think of the children. :eek:

Cigarettes aren't safe at all yet the FDA has them under their authority! Their authority means nothing but control and eradication.
 

Elizabeth Baldwin

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Maybe it will be approved if we agree to include a warning such as "if your e-cig fires continuously for more than 4 hours, see your doctor" :facepalm:

If they can afford close to a million dollars per flavor, per strength it might, probably not, but it might get approved. But ask yourself if even if you had a million dollars to send in one application for one of your juices, would you pay that large of a fee taking a huge gamble that you'll be denied and lose all that money? The only ones who can afford to lose that kind of money is Big Tobacco!

There's no juice makers that I know, with the exception of Big Tobacco, that can afford such losses. Even the really good juice makers, who are well known, aren't going to be in that position. And let's say they could borrow the money, would they do that taking that sort of risk that their application probably would be denied? Most will close up shop and cut their losses. Heck, I'd say they all will except Big Tobacco.
 

B2L

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If they can afford close to a million dollars per flavor, per strength it might, probably not, but it might get approved. But ask yourself if even if you had a million dollars to send in one application for one of your juices, would you pay that large of a fee taking a huge gamble that you'll be denied and lose all that money? The only ones who can afford to lose that kind of money is Big Tobacco!

There's no juice makers that I know, with the exception of Big Tobacco, that can afford such losses. Even the really good juice makers, who are well known, aren't going to be in that position. And let's say they could borrow the money, would they do that taking that sort of risk that their application probably would be denied? Most will close up shop and cut their losses. Heck, I'd say they all will except Big Tobacco.

And think about who would end up paying that, the end consumer when a 30 ml bottle ends up costing an arm and a leg.

Affordable Care Act anyone?
 

zoiDman

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I originally posed this as a question - why it this bad, wouldnt it be good to have someone make sure the ingredients are safe? And every one that commented came on real strong trying to make me feel small for asking. But all you have done is show me that you are the ones that need to think about it a little more. Ask yourself, wait "just think about it", how could this go wrong? When big pharma or big tobacco take over (which sooner or later we all know its a possibility) what will they do to ejuice? Do we really want a product that we ingest to NOT be reviewed? To have no regulations?

Being the only voice asking the question with so many of you coming on quite strong to tell me I am wrong, kind of sucks. But when you say "just think about it", I actually AM just thinking about it, and I actually was just asking why you felt it would shut down the industry and the responses I got didnt quell my questions, they actually made me wonder why in the world, with everything we have seen happen with other industries, you believe that nothing untoward will happen in this one without regulations?

I can't argue with Much of what you have Concerns over. And I think if you Asked the Average Vaper (Outside of a Thread Venue like this) that Most would agree with you.

But what I think Many See is that it is Very Hard to grab a Double Edged Sword and to Not Cut your Hand.

For Me, when considering if FDA Regulations are "Good" or Bad", it comes down to do the Good Things outweigh the Bad things that Regulations may bring?

Yes. I do believe that there will be some Regulations that will Improve the e-Liquid Market. And there are going to be some Regulations that will have Little/No Effect on the Most Vapers. But there will Also be some Regulations that Can/Will have Devastating Ramifications to ALL Vapers.

So if I have to do a Pure Good/Bad assessment, and cast a Single Up/Down Vote on Regulations, that is a No Brainer (For Me). The Bad Things will Far Outweigh the Good things that what I have seen are Very Likely to be Implamented.

Doesn't Mean that there will not be Some Good Regulations, or that you are Wrong. Because you are Not. But in Totality, I see the coming Regulations as Doing Much More Harm than Good.
 

AndriaD

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I can't argue with Much of what you have Concerns over. And I think if you Asked the Average Vaper (Outside of a Thread Venue like this) that Most would agree with you.

But what I think Many See is that it is Very Hard to grab a Double Edged Sword and to Not Cut your Hand.

For Me, when considering if FDA Regulations are "Good" or Bad", it comes down to do the Good Things outweigh the Bad things that Regulations may bring?

Yes. I do believe that there will be some Regulations that will Improve the e-Liquid Market. And there are going to be some Regulations that will have Little/No Effect on the Most Vapers. But there will Also be some Regulations that Can/Will have Devastating Ramifications to ALL Vapers.

So if I have to do a Pure Good/Bad assessment, and cast a Single Up/Down Vote on Regulations, that is a No Brainer (For Me). The Bad Things will Far Outweigh the Good things that what I have seen are Very Likely to be Implamented.

Doesn't Mean that there will not be Some Good Regulations, or that you are Wrong. Because you are Not. But in Totality, I see the coming Regulations as Doing Much More Harm than Good.

This is exactly the analysis I've done, and come up with the same answer -- because the FDA isn't capable of "a little reasonable regulation." No, they have to freaking OWN it, so they can give it to their buddies at BP, and if BT benefits too, oh well, at least taxes will stay high.

In light of that.. I have to say NO REGULATIONS. The industry is doing just fine without them.

Andria
 

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ok, now just think about it...

I say we dont know what they put into ejuice
you say read their ingredients or you say just google it (like that would be an answer) would any company say we make this juice in a rat infested basement and use whatever we have on hand when we run out (including pee, and seman (like some young high boy wont really think thats funny), or even worse some kind of addicting drug)
you say all other ingredients are more expensive so why would they, people also said this of tobacco and we found out why they would - to make them more addictive, to keep the market base, etc

I say we dont know that they even know how to mix it right
you say recipes are not rocket science, but I still say we dont know if they know how to read them

I say, it might be a good thing that they are regulated
you say regulation is the killer of this business, you say we are adults and know how to look out for ourselves, but I still say having something that is ingested by people should at least be looked at by some regulating body to make sure they are actually using the ingredients they put on their bottles or that they are doing this in a clean way, or that they handle nicotine properly. We ar adults but we dont go visit all the companies to see how they make it and if their rooms are clean and proper procedures are used. We dont have machines in our homes to test ingredients to make sure they are what they put on the label.

I originally posed this as a question - why it this bad, wouldnt it be good to have someone make sure the ingredients are safe? And every one that commented came on real strong trying to make me feel small for asking. But all you have done is show me that you are the ones that need to think about it a little more. Ask yourself, wait "just think about it", how could this go wrong? When big pharma or big tobacco take over (which sooner or later we all know its a possibility) what will they do to ejuice? Do we really want a product that we ingest to NOT be reviewed? To have no regulations?

Being the only voice asking the question with so many of you coming on quite strong to tell me I am wrong, kind of sucks. But when you say "just think about it", I actually AM just thinking about it, and I actually was just asking why you felt it would shut down the industry and the responses I got didnt quell my questions, they actually made me wonder why in the world, with everything we have seen happen with other industries, you believe that nothing untoward will happen in this one without regulations?

The problem is that the deeming regulation by the FDA is not regulation as we normally think of it, as in setting reasonable standards for liquid, battery safety, etc (which wouldn't be a bad thing). What the deeming does as we suspect it is written is nothing less then prohibition. You may want to read this

FDA "regulation" of e-cigarettes would not actually be regulation

The deeming is prohibition via overbearing regulation. It would wipe out essentially everything on the market. Within two years (assuming the finale deeming is pretty much the same as the proposed deeming) there would be no legal vaping products sold in the USA.

Asking if some regulations would be a good thing is a good question. Unfortunately the question gets mixed with much of the anti-regulation rhetoric that shows up in these types of threads.
 
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Rossum

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The deeming is prohibition via overbearing regulation. It would wipe out essentially everything on the market. Within two years (assuming it is finale deeming is pretty much the same as the proposed deeming) there would be no legal vaping products sold in the USA.
Although I'm stridently anti-regulation, I believe that's not entirely correct. I expect there will be a handful of companies (BT, as well as BV) who will submit PMTAs for various products. The proposed deeming indicated that once those PMTAs are submitted, the products they cover can remain on the market until the FDA acts on the applications, which if history is any guide will probably take many more years. In the end, I also expect the FDA will approve at least some applications, if for no other reason than they don't wish to be seen as having banned vaping entirely. Of course that still kills the vaping market as we have come to know it, but saying there will be "no legal vaping products" is probably hyperbole.

Asking if some regulations would be a good thing is a good question.
How about we make it incumbent on those wish to regulate something to show examples of the harm their proposed regulations will ostensibly prevent? Seriously, where's the harm that vaping has caused?
 

englishmick

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I can't argue with Much of what you have Concerns over. And I think if you Asked the Average Vaper (Outside of a Thread Venue like this) that Most would agree with you.

But what I think Many See is that it is Very Hard to grab a Double Edged Sword and to Not Cut your Hand.

For Me, when considering if FDA Regulations are "Good" or Bad", it comes down to do the Good Things outweigh the Bad things that Regulations may bring?

Yes. I do believe that there will be some Regulations that will Improve the e-Liquid Market. And there are going to be some Regulations that will have Little/No Effect on the Most Vapers. But there will Also be some Regulations that Can/Will have Devastating Ramifications to ALL Vapers.

So if I have to do a Pure Good/Bad assessment, and cast a Single Up/Down Vote on Regulations, that is a No Brainer (For Me). The Bad Things will Far Outweigh the Good things that what I have seen are Very Likely to be Implamented.

Doesn't Mean that there will not be Some Good Regulations, or that you are Wrong. Because you are Not. But in Totality, I see the coming Regulations as Doing Much More Harm than Good.

I agree with all you said. The guys at the FDA are smart and they are professional regulators. I'm sure they are capable of writing regulations that would make vaping safer while allowing it to continue, and innovation to thrive.

But instead they wrote regulations that, if they go ahead as written, will close the industry down completely.

That didn't happen by accident, like they didn't realise what the effect of their regs would be. They had a goal and wrote regs to achieve that goal.

We could spend a fun afternoon debating why they chose that path. Who pulled their strings. Was it the politicians, or the politicians of one particular party, or the corporations, or the Freemasons. I'm going to duck out of that one though.
 

Stubby

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Although I'm stridently anti-regulation, I believe that's not entirely correct. I expect there will be a handful of companies (BT, as well as BV) who will submit PMTAs for various products. The proposed deeming indicated that once those PMTAs are submitted, the products they cover can remain on the market until the FDA acts on the applications, which if history is any guide will probably take many more years. In the end, I also expect the FDA will approve at least some applications, if for no other reason than they don't wish to be seen as having banned vaping entirely. Of course that still kills the vaping market as we have come to know it, but saying there will be "no legal vaping products" is probably hyperbole.


How about we make it incumbent on those wish to regulate something to show examples of the harm their proposed regulations will ostensibly prevent? Seriously, where's the harm that vaping has caused?
It is questionable if even big tobacco or big vape will be able to get something legally on the market, especially since the approval process is largely arbitrary. The PMTA is so burdensome they may not even try.

Theoretically the OMB is the stopgap on overburdensome regulation, but that remains to be seen.
 
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zoiDman

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It is questionable is even big tobacco or big vape will be able to get something legally on the market, especially since the approval process is largely arbitrary. The PMTA is so burdensome they may not even try.

...

This Doesn't play into well with the Concept that States and the Feds are missing out on Millions and Millions of Tobacco Tax Dollars.

Making it so even BT or BV can't be viable Players in a regulated e-Cigarette market Doesn't do anything to Change the Tobacco Tax Shortfall that States and the Feds are seeing.
 
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Kent C

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Whenever I buy something , I am not just forking over some money, I am also fronting a certain degree of trust/good faith. Businesses who aim to stay in the same know that.

I agree most of what you say, esp. the above. And I'd add, that just as there are some consumers who will find a way to harm themselves regardless of regulations or businesses aiming not to; And that you'll have some shady businesses looking to make a quick buck - and when the market gets that information, it will react - now with twitter, facebook and with ecigs - ECF and other forums - again, will react much quicker than ever before to expose bad stuff - we do it here daily. If a Cloupor melts down from the usb port - people know the same day or next and word spreads to the vape shops. If buttery flavors contain diacetyl - those concerned about it, learn almost immediately and adjust their buying habits.

IF we trusted only the gov't - the time lag on them getting the word out would be much greater AND just like there are idiots that misuse products and 'grab the fast buck' businesses, there are also (and I'd argue, even more) gov't officials who are just as inept and shady. People are people and people in gov't are just as liable (again, I'd argue moreso) to misuse their positions of power, which in many cases are protected from attack or prosecution, to the harm of businesses and consumers alike.

People who think that with gov't, they can 'know' that certain products are safe, don't understand the nature that our gov't has become, and delude themselves in this 'absolute knowledge' - that as you have pointed out, has no basis in reality in some of the products that have been 'approved' by gov't.

The reason the market is a better regulator, is the speed at which information flows - again, esp. now. And while many people will say that ECF is only a small percentage of vapers, which is true, the effect of word of mouth, written word in other forums, facebook, twitter, reddit - that info gets out to the rest of the world quicker. It's a 'decentralized' information collection immediate to consumers - a bottom up approach, vs. a 'centralized' approach involving all that has to happen before something 'official' comes down the pipe - much of which has nothing to do with safety and more with politics or money or control.

For those who know nothing of this, who get their cigalikes at the gas station and convenience stores, don't care about their own health (some would say) - they are still somewhat protected by the c-store participation in the market and quality adjustments and the choice of sales that we make here - goes to manufacturers, vendors, and trickle down to the c-stores and gas stations as well, either through our efforts or through the cigarette manufactures that make them.
 
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Jman8

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ok, now just think about it...

Responding to this post because I was once where you were on this forum. I haven't changed drastically, and do (still) think the original FDA proposal is rather tame IF you are one who thinks forbidding minors usage/purchasing is a good thing. I think it is a very normal position, and is why I see the original proposal as tame (relatively speaking).

I say we dont know what they put into ejuice
you say read their ingredients or you say just google it (like that would be an answer) would any company say we make this juice in a rat infested basement and use whatever we have on hand when we run out (including pee, and seman (like some young high boy wont really think thats funny), or even worse some kind of addicting drug)
you say all other ingredients are more expensive so why would they, people also said this of tobacco and we found out why they would - to make them more addictive, to keep the market base, etc

I say even in a heavily regulated market, people won't know (with certainty) what is put into eLiquid. They'll think they know. I grant that. But really just got to look at say Chantix which went through lots of vetting before it got to market. Had all ingredients listed. Had its product produced in labs that likely cost millions, if not billions, of dollars. So, I'm saying that even if you think you know the ingredients in product, you really don't know what's in there, and/or if it is actually safe. Chances are very good that if it is made of substances from this planet (or this universe), it'll carry with it a degree of harm. And that harm may not be realized until years after FDA approval.

So, I am one who is rather convinced that incidents of harm will go up after FDA intervention. Because people will think the ingredients being used are vetted for safety. That may be accurate / hard to argue against. But the key determination will be to compare incidents of harm prior to FDA involvement and after involvement.

I say we dont know that they even know how to mix it right
you say recipes are not rocket science, but I still say we dont know if they know how to read them

I see this as cynicism (at best). My cynical response is the best mixers in the world, in the best lab environment don't know if they know how to mix. But the consumers know what they like, and know if they want more, or less of whatever is mixed for them, hopefully chosen by them.

I say, it might be a good thing that they are regulated
you say regulation is the killer of this business, you say we are adults and know how to look out for ourselves, but I still say having something that is ingested by people should at least be looked at by some regulating body to make sure they are actually using the ingredients they put on their bottles or that they are doing this in a clean way, or that they handle nicotine properly. We ar adults but we dont go visit all the companies to see how they make it and if their rooms are clean and proper procedures are used. We dont have machines in our homes to test ingredients to make sure they are what they put on the label.

Already addressed above, I think sufficiently. Lemme know if you disagree.

I originally posed this as a question - why it this bad, wouldnt it be good to have someone make sure the ingredients are safe? And every one that commented came on real strong trying to make me feel small for asking. But all you have done is show me that you are the ones that need to think about it a little more. Ask yourself, wait "just think about it", how could this go wrong? When big pharma or big tobacco take over (which sooner or later we all know its a possibility) what will they do to ejuice? Do we really want a product that we ingest to NOT be reviewed? To have no regulations?

Who regulates the regulators? That would be my rhetorical response to what I see as a loaded question that I don't think has thought things through.

Where are these "safe ingredients" of which you speak? Please name, even one.

I honestly think anecdotal evidence for harms/safety of eCigs outweighs the scientific evidence now, and will be the case going forward. In this era where things are not being heavily regulated, and theoretically anything could be put in eLiquid, we are not noticing 'great harm' from eLiquid. Closer to 'non-existant' incidents. So, one then would be right to have a 'see I told you so' attitude if regulation does increase incidents of harm. I think it will. I do hope I'm mistaken, but because of anti-vaping sentiment, I think that even while a whole lots of "big whatever entities" will be appeased through heavily regulated market, that anti-vaping will still have purpose to second guess every thing that the vaping market still produces. I think they will influence people who have doubts about vaping and convince some (hard to say how many) that what they are using is inherently unsafe. Lawsuits will happen. Product recalls will happen. Incidents of harm will go up.

Being the only voice asking the question with so many of you coming on quite strong to tell me I am wrong, kind of sucks. But when you say "just think about it", I actually AM just thinking about it, and I actually was just asking why you felt it would shut down the industry and the responses I got didnt quell my questions, they actually made me wonder why in the world, with everything we have seen happen with other industries, you believe that nothing untoward will happen in this one without regulations?

I was doing this in original FDA thread. Me and from what I recall about 3 other people were going against the grain in that thread. A lot of what I said then I stand by. I for sure stand by the kids issue and still think it is the one regulation that drives them all. Perhaps even you disagree with this, which would tell me that perhaps you haven't thought this through as well as you think you have. But, perhaps that has nothing to do with what you are driving at.

A very key thing to understand from naysayers (or those who talk about FDA ban) is that they ONLY mean de facto ban, and not outright. Sometimes (rarely) they'll say or strongly imply 'outright ban' but they are probably basing that on some leaked info, such as "FDA will make emergency rule to eliminate flavors."

A de facto ban, IMO, is very likely under FDA regulations unless another branch of federal government steps in and tells the FDA you cannot charge more than say $1000 for businesses to get into this market. Instead, FDA is free to charge whatever it wants AND then after that is paid, FDA is still free to say, your application has been denied. Then if you realize the FDA lost in a MAJOR court battle from this particular industry, it would seem like they have incentive to deny a whole lot, just because (they are jerks). Thus, the fact that costs could be so prohibitive, that anyone thinking of getting into vaping business post FDA rule, ought to have a $100 million business loan, and then assurance from investor / loan types that the money may be spent on FDA applications which, very easily could be denied. Those with that existing capital will be taking a gamble. A gamble that could pay off (and net them billions of dollars down the road). Or a gamble that could cause them from what right now looks like they are primed to be around for at least another 10 years, but because FDA denied their application means they are no longer a viable player in the market.

Regardless of how 'safe' and 'proper' you think their production line is, or was.
 
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Kent C

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The fact that all of their "approved safe" products carry these warnings which have been determined through (assumedly) scientific trials

This is important - 'assumedly'. We should know by now, that those scientific studies that will be used will be from Glantz, Prue Talbot and a host of others who have either gotten gov't and even FDA grants AND from people who through the 'revolving door' for those in agreement, will end up with jobs at the FDA or other regulatory agencies...... And the studies by Hayek, Polosa, Burnstyn, Dr. F and a whole host of others will NOT be used, even when - with Burnstyn esp. addresses the outpoints and flawed methods used by the anti-vaping studies - no control on formaldehyde, overuse of smoking machines, using 'barbecued' coils that produce chemicals that are no part of the reality of vaping - even sub-ohming, won't take into account the Temp Control innovations developed by the market to eliminate burning and a whole host of other things that won't be included in the studies that determine the regulations.
 
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Kent C

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It is questionable is even big tobacco or big vape will be able to get something legally on the market, especially since the approval process is largely arbitrary. The PMTA is so burdensome they may not even try.

I think the probability of this is greater than most people think. It tends to go against their 'BT' arguments.
 
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Jman8

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It is questionable is even big tobacco or big vape will be able to get something legally on the market, especially since the approval process is largely arbitrary. The PMTA is so burdensome they may not even try.

Theoretically the OMB is the stopgap on overburdensome regulation, but that remains to be seen.

Agree with your take on this. It is prohibition in many real ways, regardless of the regulators. If industry regulators (non-government) were to prohibit products say with with diacetyl in them, then that is prohibition. Plain and simple.

So, while it is accurate to say that the FDA will allow some vaping products in the legal market, it is also accurate to say they will (very likely) prohibit a whole bunch of other things. And on the whole, compared to the under regulated market, it will be more prohibition, than not.

Though I'm fairly certain the FDA will allow product with diacetyl in it. How you like dem apples?
 
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roxynoodle

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This Doesn't play into well with the Concept that States and the Feds are missing out on Millions and Millions of Tobacco Tax Dollars.

Making it so even BT or BV can't be viable Players in a regulated e-Cigarette market Doesn't do anything to Change the Tobacco Tax Shortfall that States and the Feds are seeing.

Well, they've been slow to the starting gate, but I think:

1. It stops current smokers from having a good chance of quitting. Their current demonizing of vapor products IS working as many smokers believe tobacco is safer. And we know only 7% are able to quit via other methods.
2. The teen smoking rate will go back up most likely. New smokers must replace dead smokers.
3. They are banking on many current vapers to return to smoking. Certainly the dual users will.
 

Kent C

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I say even in a heavily regulated market, people won't know (with certainty) what is put into eLiquid. They'll think they know. I grant that. But really just got to look at say Chantix which went through lots of vetting before it got to market. Had all ingredients listed. Had its product produced in labs that likely cost millions, if not billions, of dollars. So, I'm saying that even if you think you know the ingredients in product, you really don't know what's in there, and/or if it is actually safe.

Great example - the 600+ suicides likely thought it was safe as well. And only one example of thousands - just look at all the trial lawyer ads trying to drum up business on class action suits.
 

zoiDman

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...

3. They are banking on many current vapers to return to smoking. Certainly the dual users will.

I dunno?

I have Always believed that if Vaping reached a Tax Basis of a PAD Smoker, that not too many Government Agencies would care if you Smoked or if you Vaped.

And would probably start Agreeing with Most of the Health Studies that have come out saying that Vaping is Viable Harm Reduction over Smoking.

I mean, at that point, why would the State or Federal Government Care? If they got the same amount of Federal Reserve Notes either way, why Wouldn't they Lean towards the thing that has Less Harm?
 

benjamind2013

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One of my good friends certainly fell victim to the demonising of vaping. He bought the studies about burnt silica wicks. Now he's back on the old sticks again!

Here in Australia I am told the aforementioned male genital cutting phenomenon is on the rise due to a "huge shift in thinking".

No it's because this country is full of ....ing ......s who believe everything that is spoon fed to them. For a really good example on double standards, in 2014 the Aussie government increased the penalty for female genital mutilation from 7 years to 21 years. Yet it seems nobody is interested in offering the same protection for males.
 
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roxynoodle

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I dunno?

I have Always believed that if Vaping reached a Tax Basis of a PAD Smoker, that not too many Government Agencies would care if you Smoked or if you Vaped.

And would probably start Agreeing with Most of the Health Studies that have come out saying that Vaping is Viable Harm Reduction over Smoking.

I mean, at that point, why would the State or Federal Government Care? If they got the same amount of Federal Reserve Notes either way, why Wouldn't they Lean towards the thing that has Less Harm?

You're being intelligent and rational, neither of which we can expect from the Govt or FDA.

My guess? Because its detrimental to BT and BP. It would solve the tax situation perhaps, but not those 2 big players unless they became heavily invested in producing better vape products themselves.
 
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