FDA Deeming Regulation - What we know so far

[FXRich]

What concerns me is the fact that up until now the Vape industry has been very competitive which has kept the price for juice and hardware reasonable. But in 2 years if the FDA has its way there will be very little competition, and the expense to vape may be more than smoking, which will influence people to keep smoking. Just my opinion, and it don't mean much.

[Christopher]

Just now, FXRich said:

What concerns me is the fact that up until now the Vape industry has been very competitive which has kept the price for juice and hardware reasonable. But in 2 years if the FDA has its way there will be very little competition, and the expense to vape may be more than smoking, which will influence people to keep smoking. Just my opinion, and it don't mean much.

And your opinion is well founded. While we're still in the early phases if and when we apply from our initial applications for US made VT liquids the funding source will likely come from outside investors as the cost is ridiculously high. Especially if there are multiple application attempts, that has to be recuperated some how. Without a doubt, those selling liquid past the 3 year window will raise the prices. If there are few companies left, there's also the "why not" as there isn't any other option for the consumer. I'm not saying this is something Vapor Talk would do but heck, look at the table industry as a perfect example. The start up costs to get an Internet company of the ground is huge.

But as some have pointed there is still things passing through congress and a lot can happen in a couple of years. But it will go by quicker than people realize. Let's just hope the outcome is one we try to control rather than sitting back hoping those in the know take care of everything. (Psst come to my house, I got the good stuff)

Just now, Christopher said:

And your opinion is well founded. While we're still in the early phases if and when we apply from our initial applications for US made VT liquids the funding source will likely come from outside investors as the cost is ridiculously high. Especially if there are multiple application attempts, that has to be recuperated some how. Without a doubt, those selling liquid past the 3 year window will raise the prices. If there are few companies left, there's also the "why not" as there isn't any other option for the consumer. I'm not saying this is something Vapor Talk would do but heck, look at the table industry as a perfect example. The start up costs to get an Internet company of the ground is huge.

But as some have pointed there is still things passing through congress and a lot can happen in a couple of years. But it will go by quicker than people realize. Let's just hope the outcome is one we try to control rather than sitting back hoping those in the know take care of everything. (Psst come to my house, I got the good stuff)

EDIT: Just for future readers, my random quirks aren't a lack of taking this subject serious. Just that it's so ridiculous I often keep myself going with offbeat, crappy humor. 

[FXRich]

Just now, Christopher said:

EDIT: Just for future readers, my random quirks aren't a lack of taking this subject serious. Just that it's so ridiculous I often keep myself going with offbeat, crappy humor

Without humor this would be a crappy world.

[Bebop]

We will likely be mourning the "good ole days" sad to say.

 

but I agree with Christopher, the sad truth and the real tragedy is that this "regulation" will slow the progress of getting people smoke free.  Period.  Cost to the consumer will no longer be an incentive.  Effectiveness of the cig-a-like with regard to quitting will pale in comparison with the gear we have now.  There will be a lot more failure and some may even revert to analogs.  

 

I am am very proud of the fact that I am no longer pouring money in to the coffers of big tobacco. I'm proud of the great success I have had thanks to those before me who have shown me a way out of this trap.  And I'm proud of the fact that my wife and I have converted many people over to vaping with about a 95% success rate largely because I got the knowledge and had options to recommend to people based on their smoking habits.  

  I absolutely stand by sensible regulation designed to raise the standard of this industry. Of course we want it safe and we aren't trying to hook a new generation on an unhealthy lifestyle.  But I am sorry, this is not progress where it really matters - the effective reduction of smoking related disease.  This is a set back and frankly, a travesty for many people who will miss out on the benefits and opportunity offered by a well meaning community with a REAL solution to smoking related harm.  This is three steps forward and two steps back.

I hope I'm wrong.  I hope there is great success for future vapers.  But I can't help but feel a little like I've been scooped up and tossed back in to the waiting arms of big tobacco by association alone after I've worked so hard to get out of it's grasp.

:END RANT:.     

[Tam]

1 hour ago, Bebop said:

We will likely be mourning the "good ole days" sad to say.

 

but I agree with Christopher, the sad truth and the real tragedy is that this "regulation" will slow the progress of getting people smoke free.  Period.  Cost to the consumer will no longer be an incentive.  Effectiveness of the cig-a-like with regard to quitting will pale in comparison with the gear we have now.  There will be a lot more failure and some may even revert to analogs.  

 

I am am very proud of the fact that I am no longer pouring money in to the coffers of big tobacco. I'm proud of the great success I have had thanks to those before me who have shown me a way out of this trap.  And I'm proud of the fact that my wife and I have converted many people over to vaping with about a 95% success rate largely because I got the knowledge and had options to recommend to people based on their smoking habits.  

  I absolutely stand by sensible regulation designed to raise the standard of this industry. Of course we want it safe and we aren't trying to hook a new generation on an unhealthy lifestyle.  But I am sorry, this is not progress where it really matters - the effective reduction of smoking related disease.  This is a set back and frankly, a travesty for many people who will miss out on the benefits and opportunity offered by a well meaning community with a REAL solution to smoking related harm.  This is three steps forward and two steps back.

I hope I'm wrong.  I hope there is great success for future vapers.  But I can't help but feel a little like I've been scooped up and tossed back in to the waiting arms of big tobacco by association alone after I've worked so hard to get out of it's grasp.

:END RANT:.     

The UK is going forward and embracing vaping as the good thing it truly is while the US is doing just the opposite and vilifying it. I don't understand how so-called "intelligent" people can follow bad and biased research like sheep and make such unimaginably bad choices for regulation. I'm all for sensible regulation like not letting kids vape and setting a minimum age, making sure the quality of hardware and liquids are up to a certain standard... but this... this is not sensible at all. It's more a blatant attempt to wipe out an industry that has done so much good for so many people and instead set things up in favor of large companies that really don't have people's good health in mind but rather profits and greed.

[BirdDog]

10 hours ago, Bebop said:

We will likely be mourning the "good ole days" sad to say.

The users of Blue Foam and Pyramid Tea bags are probably rejoicing the comeback.

[Compenstine]

Lets not forget the paper clip manufacturers... You need those to fluff that poly-fill!

[Earthling789]

9 hours ago, Tam said:

The UK is going forward and embracing vaping as the good thing it truly is while the US is doing just the opposite and vilifying it. I don't understand how so-called "intelligent" people can follow bad and biased research like sheep and make such unimaginably bad choices for regulation. I'm all for sensible regulation like not letting kids vape and setting a minimum age, making sure the quality of hardware and liquids are up to a certain standard... but this... this is not sensible at all. It's more a blatant attempt to wipe out an industry that has done so much good for so many people and instead set things up in favor of large companies that really don't have people's good health in mind but rather profits and greed.

The UK is embracing it (as are other European countries) because they are not beholden to the Tobacco lobby and Tobacco taxes they same way our government is.  Sad, but true...  It has nothing to do with embracing biased research or "junk" science... it has to do with embracing the almighty tax dollar!

These regs are set to cause the failure of vaping, even through cigalikes.  We all know how expensive they are, and how inefficient they are at curbing the need for visible vapor and nicotine.  They cost as much as two packs of cigarettes and last less than what you'd get from one pack.  Nobody will ever succeed using cigalikes unless they were determined to quit cold-turkey anyway.  This is the design of these regulations... to kill vaping and prop-up Big Tobacco so they (government) can reap the rewards of tobacco taxes and tobacco settlement checks.  Even if vaping survives, government will continue to reap huge profits from applications, taxes, and settlement checks (now that all vaping is classified as tobacco-products).  Big Tobacco doesn't "win", but they certainly don't lose (since their product is "protected" and "preferred" by FDA stamp of approval).  The only losers are the American people.  The only winner is local/state/federal government.

[aufin]

I just don't see the govt. trying to totally "kill" vaping.  Vaping is too big and there's just too much money being passed around for govt. to ignore.  Regulate the crap out of vaping, yeah.  And, get their pound of flesh, Oh, Hell yeah.  But "kill" vaping, I don't think so.  Not only would the vaping community jump up and down yelling and screaming, and become a bunch of bootleggers, and "criminals" in the eyes of govt., but China has a pretty big stake in what's going on.  (That's not to say BT and BP wouldn't like to see vaping disappear)  If some of the articles I've read about vaping are correct, vaping is much bigger than just ex-smokers and active smokers, so I'm sure the money guys in govt. have run the numbers and what they have come up with is the Big Dollars they are, and would be missing out on were vaping to go away.  I see the vaping issue is just about the money...... the anti-smoker zealots, you'll never make them happy.  I think that making vaping go away would be a totally asinine move.  Yeah, I know, we're talking about the govt., and asinine moves are pretty common, but still, killing a money cow just doesn't make sense, and I'm pretty sure they know it, too.  I really don't think the govt. gives a rat's *** what we vapers do as long as we pay to play. I do see vaping being more expensive in the future.  I do see panic buying and shortages till everything settles down.  The govt. bastards just want what seems to be a pretty big (and undeserved) piece of what's going on.  I feel they're overstepping their authority, but what's new in this unconstitutional govt. we've seen these past few years?  (Hopefully that'll change in the near future, but that's a topic for another time and place).  I'm not saying I'm happy in the least little bit with what's going on, but tossing a few cents per ml tax on a bottle of juice to feed the govt. bears, I can live with.   I haven't seen any hard numbers tossed around about the sin tax on juices, so I'm probably in for a big surprise I won't be too happy about.  I've heard taxes are kinda like plucking live chickens:  See how many feathers you can grab at one time before the chicken starts screaming too bad.  That's the govt. way. 

Like someone once said, "that's my opinion, I could be wrong".

[cany]

FDA-funded study concludes e-cigs may not be so bad after all

[Earthling789]

Linked from the above article...  "E-cigs not as satisfying as the real thing, study finds", and this is likely one of the studies the FDA paid grant money for, and then utilized the study in their research to create the Deeming....

First of all, the "study" was conducted in 2014 (when the CE4 and eGo were the norm), and it was conducted by researchers at the Tobacco Center of Regulatory Science (TCORS) at Georgia State University.  It wasn't even a "study"... it was a SURVEY

• Survey details

• The researchers surveyed 5,717 U.S. adults in 2014, asking questions about their awareness of e-cigarettes, use of their products, and reasons for using traditional and novel tobacco products.
• Among the 144 former cigarette smokers who had tried e-cigarettes, nearly 30 percent (or 43 people) continued to use them as a satisfying alternative to regular cigarettes.
• But among the 585 smokers in the study, nearly 58 percent (or 337 people) reported they found e-cigarettes unsatisfying and stopped using them. 

Now, what I get from the numbers above... of 5717 people surveyed, only 144 were former smokers (2.5%), and 585 were active smokers (10.2%).  Starting there, the study is flawed because you're questions do not have enough base to formulate opinion.

Secondly... This is what I see from the data:

• 144 are former smokers, of which 30% actively use e-cigs as an alternative to smoking or cessation device.... and 70% have QUIT, possibly by using e-cigs as the tool to accomplish their task of quitting.
• 58% of the 585 active smokers reported they didn't like e-cigs... so, does that mean that 42% DID like them, used them, and quit smoking by using e-cigs??  Well, we don't know the whole story do we?  This is because the study is flawed and obviously bias to report only the negative, not the positive outcome.  They would likely say the same thing (people don't like them) if only 20% of the smokers said they were "unsatisfying".
• Isn't the FDA's own research showing that their "approved" cessation devices (pills/patches/gum/inhalers) only have a 20-25% success rate in smoking cessation/elimination?  This study alone proves (albeit with a small sample) that e-cig use has a higher rate of adaptation and success... but you'll not see that in an FDA report, will you?

This is the kind of junk science that we taxpayers need to be stop funding.  This is one of the main reasons I stopped doing research and chemical testing for labs in the early 90's...  All gov't funded research is bias, or at least has a bias (suggested outcome) before the testing begins.  Data numbers always support the bias, rather than the truth, and even when you point out the positive/truth to management, you are told "to focus on the results you are paid to find" or "you don't know what you're talking about"... Well, data doesn't lie... only people do!

[Compenstine]

Worth posting in both threads:

 

[Robinox]

On 5/10/2016 at 7:31 PM, cany said:

I cant afford to stock up on mods ETC this sucks

It's mods,  all the coils we'll need for our tanks, not to mention the eliquid. It is impossible to stock up because none of these products will last forever.  Frozen or not eliquid alone won't last more than 2 years. As a consumer we will be able to get vape products after August and beyond the two year mark but we won't have the variety and we will be paying a higher price + huge taxes like they have on cigarettes. It's a scary unknown ahead for all. 

[Jeffb]

On 5/13/2016 at 6:54 AM, Earthling789 said:

Linked from the above article...  "E-cigs not as satisfying as the real thing, study finds", and this is likely one of the studies the FDA paid grant money for, and then utilized the study in their research to create the Deeming....

First of all, the "study" was conducted in 2014 (when the CE4 and eGo were the norm), and it was conducted by researchers at the Tobacco Center of Regulatory Science (TCORS) at Georgia State University.  It wasn't even a "study"... it was a SURVEY

• Survey details

• The researchers surveyed 5,717 U.S. adults in 2014, asking questions about their awareness of e-cigarettes, use of their products, and reasons for using traditional and novel tobacco products.
• Among the 144 former cigarette smokers who had tried e-cigarettes, nearly 30 percent (or 43 people) continued to use them as a satisfying alternative to regular cigarettes.
• But among the 585 smokers in the study, nearly 58 percent (or 337 people) reported they found e-cigarettes unsatisfying and stopped using them. 

Now, what I get from the numbers above... of 5717 people surveyed, only 144 were former smokers (2.5%), and 585 were active smokers (10.2%).  Starting there, the study is flawed because you're questions do not have enough base to formulate opinion.

Secondly... This is what I see from the data:

• 144 are former smokers, of which 30% actively use e-cigs as an alternative to smoking or cessation device.... and 70% have QUIT, possibly by using e-cigs as the tool to accomplish their task of quitting.
• 58% of the 585 active smokers reported they didn't like e-cigs... so, does that mean that 42% DID like them, used them, and quit smoking by using e-cigs??  Well, we don't know the whole story do we?  This is because the study is flawed and obviously bias to report only the negative, not the positive outcome.  They would likely say the same thing (people don't like them) if only 20% of the smokers said they were "unsatisfying".
• Isn't the FDA's own research showing that their "approved" cessation devices (pills/patches/gum/inhalers) only have a 20-25% success rate in smoking cessation/elimination?  This study alone proves (albeit with a small sample) that e-cig use has a higher rate of adaptation and success... but you'll not see that in an FDA report, will you?

This is the kind of junk science that we taxpayers need to be stop funding.  This is one of the main reasons I stopped doing research and chemical testing for labs in the early 90's...  All gov't funded research is bias, or at least has a bias (suggested outcome) before the testing begins.  Data numbers always support the bias, rather than the truth, and even when you point out the positive/truth to management, you are told "to focus on the results you are paid to find" or "you don't know what you're talking about"... Well, data doesn't lie... only people do!

According to surveys, 51% of all surveys are made up

[Compenstine]

After watching the video I posted, I decided to put my flavors to the calculator. As the regs stand, it would cost me $8,428,000,000.00 to keep all the options for all the flavors offered. I would have to have this amount ready within the next 2 years. That is just one company with 49 flavors and this is not including the testing that would also need done on these flavors. I have seen numbers that say the Vape Industry in a 4 to 6 billion dollar a year industry as a whole... If you think these regs will not kill the industry? Please think again.

[FXRich]

Even if the price of juice goes up to $100 per 15ml bottle it won't mean anything, because after 2 years you won't be able to buy a refillable tank to put the juice in. They will probably declare that being able to change the coil makes them rebuildable. 

[Earthling789]

Today, I saw examples of true panic in the industry (retail)... 

I took my SO to tan at the local shop, which also has a small vape-shop, selling moderate and premium e-liquids and basic vaping equipment (eGo/Spinners, KPT/Nautilus style tanks, simple mods like the iStick, etc.)... they've already put up fire-sale prices on everything in the store.  The gal behind the counter said with the new regs, they were told to sell it off because they couldn't afford to continue to be in the business of vaping.    I know the owner well, and will try to reach out to him on Monday to INFORM him of the regs, and how they will not affect him as a retailer (directly), but after 8/8/18, he may have limited availability of products/liquids, and prices will obviously increase....

Another local mom-and-pop shop (actually the first shop I ever went into, and bought my first eGo's from) already has a "going out of business" sign in their window.  They were closed (it was late) when I saw the sign, but can only assume they too were horribly misinformed on these regs and decided to jump-ship before August rolls around

There is so much misinformation going around out here in the real world, and what amazes me is how those "in the business" such as retailers are not on top of the info through CASAA or any of the other vaping info outlets.... 

Yeah, the rest of us (consumers) are in an outrage, and there is some panic.... but it's not the end of the world (of vaping) YET...

12 hours ago, Robinox said:

It's mods,  all the coils we'll need for our tanks, not to mention the eliquid. It is impossible to stock up because none of these products will last forever.  Frozen or not eliquid alone won't last more than 2 years. As a consumer we will be able to get vape products after August and beyond the two year mark but we won't have the variety and we will be paying a higher price + huge taxes like they have on cigarettes. It's a scary unknown ahead for all. 

It's not a panic point yet... We are at Def-Con 3... where we need to be fully aware of our surroundings and act accordingly.  We need to be backing and supporting the vaping advocacy groups such as CASAA and communicating with our Congressmen.  We'll still be able to buy our mods, tanks, and coils... and yes, even e-liquids for another two years, at least!  There is no mention of taxation yet, even though we expect it to be coming (God knows how our government loves our tax dollars).  Taxes have to be set by local/state/federal legislative bodies.  The FDA has no power to tax any product or even suggest a tax rate. 

What I see happening on August 8th is ... nothing... it will be business as usual.  Sure, some companies will scale down or get out of the vaping industry all together, but the vast majority will continue to provide the mods/tanks/liquids on August 9th, and beyond... at least until 2018.  Will taxes be imposed on e-liquids by 2018?  Maybe?  But it won't happen anytime soon.

Now, all that being said... yes, I've placed an order for a couple of mods, and two new tanks... but I planned to buy them anyway.  Yes, maybe I bought them earlier than I would have if the FDA hadn't dropped their bomb, but I fully expect to be able to obtain my hardware and liquids (if I bought pre-made e-liquids) for at least another couple of years... and hopefully by that time, Congress will have slapped-down the FDA and changed the grandfather date to 2016 so all the current, existing products will be unaffected and fully available forever.

[Compenstine]

@Earthling789 Yes a lot can change in two years time. I'm not sure that it is a panic so much as it is throwing in the towel. A lot of vape shops were looking to cash in on the industry and are not willing to fight for change. The HR2058 is our best hope at the moment for some change. However this bill will stagnate the industry for many years to come. Congress now must slap the FDA down to really stop this from moving forward. It is very clear when you start adding up the cost for manufactures to make products to even put on the shelf to sell, that even retailers will not survive. It goes from a full store inventory to a small rack on a counter top. If even a small manufacture like my self is looking at having to pay 8.5 billion just to have no guarantee that the products can pass the PMTA, doors will close and close fast. I personally will hold out as long as I can and fight for the change, but it is an up hill battle.

[Robinox]

13 hours ago, Compenstine said:

After watching the video I posted, I decided to put my flavors to the calculator. As the regs stand, it would cost me $8,428,000,000.00 to keep all the options for all the flavors offered. I would have to have this amount ready within the next 2 years. That is just one company with 49 flavors and this is not including the testing that would also need done on these flavors. I have seen numbers that say the Vape Industry in a 4 to 6 billion dollar a year industry as a whole... If you think these regs will not kill the industry? Please think again.

Do you know if you would have to start filing the paperwork right away and if so do you have to pay when the papers are filed or later? If not can the vape shop owners put off filing and stay open for two years if they don't plan on filing in the first place, or will they have to close in August?

Edited May 15, 2016 by Robinox

[Compenstine]

Vape Shop owners, unless they are making e-liquid and/or building coils, are exempt. But, when the money is due is not clear as of yet. Myself being a manufacture would have 2 years to file. If I do not file in that two years time I would have to stop selling. If I were to file then I would have an additional year to sell or until I heard from the FDA stating that the App was approved or denied. If Denied I would have to stop selling at that point. In August the only thing I must do is change one thing on my labels stating that the nicotine in the product is addicting. Other than that, I'm already and have been following, all the regs that would come into play Aug 8th.

The bigger problem Vape Shop owners will face is lack of inventory. Like fighting a war. the FDA is cutting off the supply chain. With no inventory to sell they end up closing as well.

[Bebop]

Maybe that's part of the plan.  Scare the bejesus out of the retailers and watch them fold up themselves.  So far, the only thing I've noticed are signs going up at a couple shops saying "starting August - 21 I.D. Required" . That's it.  No other indications of panic.

 

I did, however, go online and buy two more evic vtc minis and a couple of samsungs and 4 more spare RBA decks.  And glass. Oh, and 2 more sub tank minis.   .   I'm not panicking.  I think of it as .......insurance.......

[Compenstine]

True panic will set in a few months before the 2 year deadline for registering. I'm not panicked, I'm angry. It is why I have not said much. That and looking for all the info I can on how this is going to play out so I can make plans. I have enough stuff to keep myself going for a very long time. It is others that I think about more than myself at this point.

[Jeffb]

Ecig business is a huge industry in China. Especially exporting to the USA. I wonder what they are going to do.

[cany]

1 minute ago, Jeffb said:

Ecig business is a huge industry in China. Especially exporting to the USA. I wonder what they are going to do.

From what Ive heard they are planning on fighting it

[Earthling789]

From what Ive heard they are planning on fighting it

The big players like kangertech are planning to fight along side and support with big $$, but many of the smaller players, as I understand, don't think it will affect them, or are planning to get a good run for two years, and bail out.

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