FDA So what might really happen with regulations/bans? Should we be stocking up?

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SmokinRabbit

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Mr. Zeller has been asked Numerous Times about e-liquids that are 0mg. Or the Possibility of a e-liquid that contains Nicotine that was Derived from some Other Sources besides Tobacco Plants. And his answers have been Consistent.

If an e-liquid contains No Nicotine from Tobacco Plants, the FDA does Not Have the Authority to Regulate it.

Good! :D
I won't pretend there aren't a ton of other implications to the regulations, but at least there is a glimmer of hope for good flavor...


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zoiDman

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Good! :D
I won't pretend there aren't a ton of other implications to the regulations, but at least there is a glimmer of hope for good flavor...

There is Always Hope when One Does Not Give Up.

But let me Interject one other thing relating to 0mg. If a Company Markets/Advertises a product for Human Consumption and or to be used in an e-Cigarette, there could be Problems.
 

dragonpuff

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We need to also keep in mind that even if only nicotine liquid were banned, since this is the key selling point that leads to vaping in the first place, sales will likely go down considerably over time. Most people who vape for nicotine will have to find other nicotine sources, and they will vape less or quit vaping completely. There will be far less new vapers, as it is no longer an effective substitute for smoking for most people (as most people are at least somewhat physically, not just habitually, addicted). As sales gradually drop over time, we will see less innovation of new products, less variety of products for sale, and fewer shops selling them. If nic liquid were banned completely for a long time, I predict that in as short as 10 years stores will be selling vaping equipment, including no nic liquid, on the side as a novelty product; they will expect few sales, and so they will have little variety in equipment and flavors. In other words, at that point you'll still have to DIY flavors, as fewer and fewer shops will be willing to put work into such a variety when hardly anyone is buying them.

So basically, as an individual, if you're concerned your best bet is to learn DIY, no matter what. If you vape nicotine, stock up if you can afford to - there's plenty of advice around here on where to buy bulk nicotine liquid and how to store it.
 

zoiDman

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We need to also keep in mind that even if only nicotine liquid were banned, since this is the key selling point that leads to vaping in the first place, sales will likely go down considerably over time. Most people who vape for nicotine will have to find other nicotine sources, and they will vape less or quit vaping completely. There will be far less new vapers, as it is no longer an effective substitute for smoking for most people (as most people are at least somewhat physically, not just habitually, addicted). As sales gradually drop over time, we will see less innovation of new products, less variety of products for sale, and fewer shops selling them. If nic liquid were banned completely for a long time, I predict that in as short as 10 years stores will be selling vaping equipment, including no nic liquid, on the side as a novelty product; they will expect few sales, and so they will have little variety in equipment and flavors. In other words, at that point you'll still have to DIY flavors, as fewer and fewer shops will be willing to put work into such a variety when hardly anyone is buying them.

So basically, as an individual, if you're concerned your best bet is to learn DIY, no matter what. If you vape nicotine, stock up if you can afford to - there's plenty of advice around here on where to buy bulk nicotine liquid and how to store it.

If the FDA attempted to Ban Nicotine in e-Cigarettes (which they are Not going to do), then this would be something that would be Pursuable in the Courts. Because the FDA does Not have the Authority to do so,

Limits on FDA’s authority
FDA cannot:

Ban certain specified classes of tobacco products – Sec. 907 of the FDCA
Require the reduction of nicotine yields to zero – Sec. 907 of the FDCA
Require prescriptions to purchase tobacco products – Sec. 906 of the FDCA
Ban face-to-face tobacco sales in any particular category of retail outlet – Sec. 906 of the FDCA

The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in certain specific respects. It also prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FDCA relating to specified areas.

Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet

Not saying that the FDA can not set the Compliance Bar so High that Only a select few can be viable in the coming e-Cigarette/e-Liquid market. Or require e-Liquids to be Sold in a Form that Most e-Cigarette users Aren't Going to like.

But the FDA Isn't Going to Ban Nicotine in e-Liquids.

It Isn't a Win for Anyone. BT or Tax Revenues or Consumers.
 

SmokinRabbit

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Interestingly enough, there's been a surge in my area of non-nicotine disposables. A year ago it was harder to find a zero nicotine ecig in a gas station. Now, not only do all the locals ones have them, they have a selection of them.

Only reason I know is my hub was using the occasional disposable when he didn't want to bother family members with a cigar, and he always wanted 0 nicotine. They got easier and easier to find in the last year.


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dragonpuff

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If the FDA attempted to Ban Nicotine in e-Cigarettes (which they are Not going to do), then this would be something that would be Pursuable in the Courts. Because the FDA does Not have the Authority to do so,

Limits on FDA’s authority
FDA cannot:

Ban certain specified classes of tobacco products – Sec. 907 of the FDCA
Require the reduction of nicotine yields to zero – Sec. 907 of the FDCA
Require prescriptions to purchase tobacco products – Sec. 906 of the FDCA
Ban face-to-face tobacco sales in any particular category of retail outlet – Sec. 906 of the FDCA

The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in certain specific respects. It also prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FDCA relating to specified areas.

Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet

Not saying that the FDA can not set the Compliance Bar so High that Only a select few can be viable in the coming e-Cigarette/e-Liquid market. Or require e-Liquids to be Sold in a Form that Most e-Cigarette users Aren't Going to like.

But the FDA Isn't Going to Ban Nicotine in e-Liquids.

It Isn't a Win for Anyone. BT or Tax Revenues or Consumers.

What I meant was "if", as a hypothetical worst case scenario. Even so, while they can't ban nicotine outright, it is within their power to strictly limit the amount of nicotine to the point where it is no longer effective for the vast majority of people (e.g. they can't reduce nicotine to zero, but technically they can reduce it to a paltry 3mg or so). Or they could simply continue with a de facto ban on liquid (e.g. everything must be preapproved, but approval is rarely given) as outlined in the deeming. Or, as DC2 noted, they can restrict all liquid to tamper-free cartridges. The effect on sales and availability of equipment associated with refillable liquid will be nearly as drastic under those circumstances as in my hypothetical ban scenario.
 

zoiDman

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What I meant was "if", as a hypothetical worst case scenario. Even so, while they can't ban nicotine outright, it is within their power to strictly limit the amount of nicotine to the point where it is no longer effective for the vast majority of people (e.g. they can't reduce nicotine to zero, but technically they can reduce it to a paltry 3mg or so). Or they could simply continue with a de facto ban on liquid (e.g. everything must be preapproved, but approval is rarely given) as outlined in the deeming. Or, as DC2 noted, they can restrict all liquid to tamper-free cartridges. The effect on sales and availability of equipment associated with refillable liquid will be nearly as drastic under those circumstances as in my hypothetical ban scenario.

I can Agree that what the FDA will do to e-Liquids will be, for the Most Part, a de facto Ban on Small Vendors. Even some Mid-Sized ones. Leaving Only BB and of course, BT.

But what would be the Benefit, to Any Party Involved, of a Reduction of Nicotine to the 3mg Level that you Mentioned?

It doesn't Help an OEM Sell their Products. It Doesn't Help a State or the Feds from Generating Tax Revenues. And it Sure as Heck is going to Help Someone get off Analogs. Or Stay Off Analogs.

So why would the FDA Consider something like this?
 

dragonpuff

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I can Agree that what the FDA will do to e-Liquids will be, for the Most Part, a de facto Ban on Small Vendors. Even some Mid-Sized ones. Leaving Only BB and of course, BT.

But what would be the Benefit, to Any Party Involved, of a Reduction of Nicotine to the 3mg Level that you Mentioned?

It doesn't Help an OEM Sell their Products. It Doesn't Help a State or the Feds from Generating Tax Revenues. And it Sure as Heck is going to Help Someone get off Analogs. Or Stay Off Analogs.

So why would the FDA Consider something like this?

Think about it. They've been talking about lowering the nicotine content in cigarettes for years, in an effort to "reduce addiction" (not that it will help with that, but whatever). Obviously that would be difficult to do, partly because it involves modifying a plant and partly because tobacco companies don't like it. But with e-liquid, it's very easy to lower nicotine levels, and there are few corporate interests blocking that. If ANTZ and others believe reducing nicotine levels would reduce addiction to the horrible, evil e-cigarettes (think of the children!!), then the question is not why would they do it - the question is, what's stopping them?

Why would the FDA do that? For the same reasons they want e-cigs banned: if e-cigarettes are made less effective, then tobacco and pharmaceutical companies (especially GSK, who they seem to be in bed with) won't have to worry as much about their profits being cut into.
 

DC2

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I can Agree that what the FDA will do to e-Liquids will be, for the Most Part, a de facto Ban on Small Vendors. Even some Mid-Sized ones. Leaving Only BB and of course, BT.

But what would be the Benefit, to Any Party Involved, of a Reduction of Nicotine to the 3mg Level that you Mentioned?

It doesn't Help an OEM Sell their Products. It Doesn't Help a State or the Feds from Generating Tax Revenues. And it Sure as Heck is going to Help Someone get off Analogs. Or Stay Off Analogs.

So why would the FDA Consider something like this?
Ignoring for the moment that we disagree on whether more taxes can be generated by vaping as opposed to keeping people smoking...
If nicotine was reduced to 3mg strength, everyone would have to buy more e-liquid, which would generate more tax revenue.
 

zoiDman

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Think about it. They've been talking about lowering the nicotine content in cigarettes for years, in an effort to "reduce addiction" (not that it will help with that, but whatever). Obviously that would be difficult to do, partly because it involves modifying a plant and partly because tobacco companies don't like it. But with e-liquid, it's very easy to lower nicotine levels, and there are few corporate interests blocking that. If ANTZ and others believe reducing nicotine levels would reduce addiction to the horrible, evil e-cigarettes (think of the children!!), then the question is not why would they do it - the question is, what's stopping them?

Why would the FDA do that? For the same reasons they want e-cigs banned: if e-cigarettes are made less effective, then tobacco and pharmaceutical companies (especially GSK, who they seem to be in bed with) won't have to worry as much about their profits being cut into.

It's a Possibility.

But I think that the Cap on e-Liquids will be more around 18mg. Maybe as High as 24mg.

BT has Dumped a Boat load of Money to get into the e-Cigarette Market. And I don't think they would have if there was even the Remote Possibility that e-Liquids Nicotine would be Limited to something so Low as less than 12mg.

Because the Success rate of Switching starts to Drop Off Very Fast if a Smoker can not choose an e-Liquid that is 12mg or More. I fear Pre-Filled Cartos Much More than I Fear Nicotine Levels being in the Single Digits.

But I guess we will have to Wait and See.
 

zoiDman

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Ignoring for the moment that we disagree on whether more taxes can be generated by vaping as opposed to keeping people smoking...
If nicotine was reduced to 3mg strength, everyone would have to buy more e-liquid, which would generate more tax revenue.

I don't think this this can be Said for Everyone. Let alone the Majority of Current e-Cigarette users. 3mg Isn't going to Cut it for Most People. And the Success Rate of Switching to e-Cigarettes would Go Way Down.

Believe it or Not, BT doesn't worry about Existing Smokers. Smokers do what they do. Feed the Addiction. BT's Main Emphasis is Getting New Smoker. Because Smokers have a Bad Habit of Dying Earlier than they Should. So you Always need New Smokers.

Setting the Nicotine Level to 3mg would Greatly reduce the Amount of People who would Switch. And that is Not Good for Business in the Short Term. And Devastating in the Long Term.
 

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I think it bears repeating that liquid solutions with various concentrations of nicotine have been manufactured and sold for quite some time, long before 2007, and have been used in nicotine gum, patches, etc. Thus, it may be that these liquids must be grandfathered under the express provisions of the enabling statute. But I have not been able to determine how long liquids with specific levels of nicotine have been sold, how they were marketed and sold, to whom or for what purposes other than NRT. However, that information is certainly in the possession of those who make the stuff. If they were exclusively marketed and sold as "drug products," then they would probably not fall within the definition of "tobacco products," and thus might not qualify for grandfathering.

I agree with you. This has been my issue since the FDA considered "e-cigs" a tobacco product. My point is WHY are they considered a tobacco product when the same nicotine is used in NRT's? My thoughts back in March was to consider it a "drug" under the FDA that way we could have been covered because the FDA already approved NRT nicotine. Maybe I was naïve. Flavoring?- they have fruit chill in Nicorette. Is the issue nicotine, hardware or flavorings? If the nicotine used in a NRT is already FDA approved then WHAT is the point? If e-liquid is considered a tobacco product then so should NRT. It's just a different delivery system. They are losing money. Period. Is this political?....You bet.
 

dragonpuff

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I really hope you're right Zoidman. Personally I notice a distinct difference in my mood and ability to focus when I drop from 24 to 18 for just a day, so I really hope the powers that be retain a vested interest in allowing the nic level to remain high (though I do have cognitive problems that are mitigated by nicotine)...

I do believe, though, that if regulations are stalled long enough for more science to be done, we will have less of an issue overall. They are already proving that nicotine is not dangerous or addictive unless assisted by other chemicals, so as this research continues and becomes more widely known, we will have less of an issue with regulations on nicotine if they happen later rather than sooner. Likewise, as more research is done on the safety of e-cigarettes, by 2020 or so there will be less perceived need to regulate them so strictly. ANTZ' arguments are already becoming paper thin - people are seeing that many of the ideas they propose just don't hold water. That's why they're becoming louder and more boisterous now. That is also why they're pushing for strict regulations now - because they know if they wait too long they'll be SOL.
 

dragonpuff

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I agree with you. This has been my issue since the FDA considered "e-cigs" a tobacco product. My point is WHY are they considered a tobacco product when the same nicotine is used in NRT's? My thoughts back in March was to consider it a "drug" under the FDA that way we could have been covered because the FDA already approved NRT nicotine. Maybe I was naïve. Flavoring?- they have fruit chill in Nicorette. Is the issue nicotine, hardware or flavorings? If the nicotine used in a NRT is already FDA approved then WHAT is the point? If e-liquid is considered a tobacco product then so should NRT. It's just a different delivery system. They are losing money. Period. Is this political?....You bet.

Back in 2009 they were trying to cram e-cigarettes into one category or the other - either a drug delivery device (i.e. medicine), or tobacco product. Many of us argued for tobacco product. Why would we do that? Because if it were classified as a drug, ALL e-cigs would be yanked from the market and have to EACH go through a strict FDA approval process just to be marketed. Each e-cig company would have to conduct their own clinical trials demonstrating efficacy (i.e. proof of smoking cessation) at their own expense, submit an application costing hundreds of thousands of dollars, wait for the FDA's approval, and then the e-cig would only be available by prescription for a number of years. They would then have to petition the FDA again to allow over the counter sales. It would have completely destroyed the industry as we know it.

So e-cigs were not classified as a medicine, but were still open to being classified as a tobacco product, which the FDA didn't have the authority to regulate. Then Obama signed the FSPTCA, giving authority over tobacco products to the FDA. Then, as you probably know, the FDA came up with their deeming regulations, which propose to classify e-cigs as tobacco products and subject them to the same regulation within. The fun thing about the deeming regs is that it's classic FDA fare - the premarket approval requirements are almost identical to what you would see for medical devices, except that upon approval the product would go straight to the market and not require a prescription. The deeming does not actually make sense for tobacco products, much less e-cigs.

Yes, nicorette is available over the counter, but for a while it was prescription only - same with the patch and other nicotine therapies. Keep in mind that each nicotine product is approved separately, regardless of whether it contains the same drug. That really is not the direction you want to take e-cigs. Our best bet is to fight against the current deeming, and against all the current propaganda.
 

zoiDman

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I really hope you're right Zoidman. Personally I notice a distinct difference in my mood and ability to focus when I drop from 24 to 18 for just a day, so I really hope the powers that be retain a vested interest in allowing the nic level to remain high (though I do have cognitive problems that are mitigated by nicotine)...

I do believe, though, that if regulations are stalled long enough for more science to be done, we will have less of an issue overall. They are already proving that nicotine is not dangerous or addictive unless assisted by other chemicals, so as this research continues and becomes more widely known, we will have less of an issue with regulations on nicotine if they happen later rather than sooner. Likewise, as more research is done on the safety of e-cigarettes, by 2020 or so there will be less perceived need to regulate them so strictly. ANTZ' arguments are already becoming paper thin - people are seeing that many of the ideas they propose just don't hold water. That's why they're becoming louder and more boisterous now. That is also why they're pushing for strict regulations now - because they know if they wait too long they'll be SOL.

I really Think that for Most People, and for Future people Trying e-Cigarettes for the 1st Time, that the Nicotine Levels that the FDA Sets will be OK.

If a Person uses 18mg and then wants to get the Same Amount of Nicotine per day with 3mg, then they would Need to use 6 Times the e-Liquid.

That mean 6x More Exposure to Flavorings/Sweeteners. 6x More Exposure to PG and VG. And 6x the Cost.

Whereas on Paper, one could argue that this Would be Great for Tax Revenue. When does the Market Decline when e-Liquid Costs go up 6 Times (before Taxes) per day?

The FDA can Accomplish what they wants @ 18 or 24mg Limits.

BT will be Happy. Tax Collectors will be Happy. Consumers, for the Most Part, will be Happy. And Smoker could have a Decent Chance of Switching.
 

zoiDman

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I agree with you. This has been my issue since the FDA considered "e-cigs" a tobacco product. My point is WHY are they considered a tobacco product when the same nicotine is used in NRT's? ...

Could it be the NRT is Not Designed to be Used Indefinitely?

Where as e-Cigarette Use may be?
 

Kent C

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What I meant was "if", as a hypothetical worst case scenario. Even so, while they can't ban nicotine outright, it is within their power to strictly limit the amount of nicotine to the point where it is no longer effective for the vast majority of people (e.g. they can't reduce nicotine to zero, but technically they can reduce it to a paltry 3mg or so). Or they could simply continue with a de facto ban on liquid (e.g. everything must be preapproved, but approval is rarely given) as outlined in the deeming. Or, as DC2 noted, they can restrict all liquid to tamper-free cartridges. The effect on sales and availability of equipment associated with refillable liquid will be nearly as drastic under those circumstances as in my hypothetical ban scenario.

Exactly. It will be a de facto ban as Bill has pointed out. One would think you wouldn't have to explain that :facepalm:
 

DC2

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I agree with you. This has been my issue since the FDA considered "e-cigs" a tobacco product. My point is WHY are they considered a tobacco product when the same nicotine is used in NRT's? My thoughts back in March was to consider it a "drug" under the FDA that way we could have been covered because the FDA already approved NRT nicotine. Maybe I was naïve. Flavoring?- they have fruit chill in Nicorette. Is the issue nicotine, hardware or flavorings? If the nicotine used in a NRT is already FDA approved then WHAT is the point? If e-liquid is considered a tobacco product then so should NRT. It's just a different delivery system. They are losing money. Period. Is this political?....You bet.
Anybody that wants to submit their electronic cigarette products to the FDA as drug delivery devices may do so.
And if accepted, those products (and those products ONLY) will NOT be considered a tobacco product, nor treated as such.

The problem is that gaining such approval is EXTREMELY expensive and takes years worth of studies.
Which is exactly the reason we all fought so hard to keep that from happening.

But like I said, if anyone wants to, they can try.
 
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