FDA Economic Impact Analysis

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zoiDman

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Also FDA proposed regulations make all comments about right to vape outdoors in public seem trivial.

Usage bans ought to be a lot easier to ram thru over the next 75 days.

Once Nicotine containing e-liquids are Legal Defined to be a "Tobacco Product", there is going to be No Need for Many Indoor Bans to be "ram thru". They will happen Automatically by Inclusion.

More Outdoor Bans? That is yet to be seen.
 

Jman8

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Once Nicotine containing e-Liquids are Legal Defined to be a "Tobacco Product", there is going to be No Need for Many Indoor Bans to be "ram thru". They will happen Automatically by Inclusion.

Not necessarily. Otherwise, a patch couldn't be worn indoors. Your assumption is lacking important considerations that are likely not relevant to this this thread, but I think you know that. One very important consideration is the vaper who vapes 0 nic.

More Outdoor Bans? That is yet to be seen.

Same goes with indoor bans. Both are occurring as I write this.
 

zoiDman

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Not necessarily. Otherwise, a patch couldn't be worn indoors. Your assumption is lacking important considerations that are likely not relevant to this this thread, but I think you know that. One very important consideration is the vaper who vapes 0 nic.



Same goes with indoor bans. Both are occurring as I write this.

And how Exactly does Anyone know if you are using a 0mg Nicotine e-Liquid when you Blow your Clouds inside a Restaurant or an Elevator?

I'm not going to argue with you that a 0mg is a Tobacco Product. Because Clearly it is Not. But how are you going to Adequately Convince a Policy Maker to make an Exclusion to a e-Cigarette Use Policy for 0mg?
 

DC2

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Not necessarily. Otherwise, a patch couldn't be worn indoors.
I think Zoidman is correct.

Any smoking bans that currently say "tobacco products" would seemingly then include electronic cigarettes as soon as the deeming regulations are passed.
I'm not sure how many smoking bans have that language in them, and I would think it is very few, but yeah.

Nicotine patches are not tobacco products, they are pharmaceutical products.
 

AgentAnia

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I think Zoidman is correct.

Any smoking bans that currently say "tobacco products" would seemingly then include electronic cigarettes as soon as the deeming regulations are passed.
I'm not sure how many smoking bans have that language in them, and I would think it is very few, but yeah.

Nicotine patches are not tobacco products, they are pharmaceutical products.

I'm going to split hairs here on the local usage bans (because frankly I'm too exhausted by deeming-induced anger and frustration to talk about economic impact analysis): Putting ecigs and vaping under the federal "tobacco products" umbrella won't necessarily change any local laws restricting smoking and vaping, because all of the local laws and ordinances I've read have quite explicitly defined "tobacco product" and what constitutes "smoking." So they have their definitions, the feds have theirs. Local ordinances have to be amended or new ordinances passed to cover vaping precisely because these definitions are already on the books. This process will continue. (Remember, the deemings aren't concerned with usage as such.)
 
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I think Zoidman is correct.
Any smoking bans that currently say "tobacco products" would seemingly then include electronic cigarettes as soon as the deeming regulations are passed.
I'm not sure how many smoking bans have that language in them, and I would think it is very few, but yeah.
Nicotine patches are not tobacco products, they are pharmaceutical products.

The deeming step is merely a procedural prerequisite. Anything derived from tobacco which is intended for recreational consumer ingestion is a "tobacco product." FDA action or lack thereof doesn't change this. Congress already made that decision when it passed the FSPTCA.

***

I guess I'm a little confused by this (larger) discussion. FDA is required to produce the economic analysis. But for what purposes are we interested in it, here at ECF - other than as an interesting topic of conversation?

I can think of three reasons:

1) To clarify that e-liquids and all equipment unique to vaping are now going to be regulated out of existence, due to compliance costs. We already knew that, right? (Well, almost all of us did.)

2) As fodder for comments. Is it relevant? If the FDA came out and said that approvaing a drip tip would cost $1B, would that matter for purposes of the comments? If so, would that be balanced against the alleged health benefits (for ex.: the savings in lives, because junk science like Dutra & Glantz allegedly shows that vaping leads to smoking cigarettes, and any vaping product that will pass the test must reduce the prevalence of cigarette smoking?). BTW, trust me - there will be plenty more where Dutra & Glantz came from. The CDC is doing a survey of 20K school kids, and the state of CA is going to survey 400,000. There will be ample junk science out there to argue that unregulated vaping will lead to millions of new tobacco cigarette smokers, regardless of the actual statistics on prevalence, or the plummeting sales of tobacco cigarettes (did that stop them from making the argument before?). 1M new cigarette smokers due to unregulated vaping, at $1M/life = $1T. That's an easy one for the FDA and CDC, isn't it? Glantz's pals at JAMA will have scores of papes published to prove it within a very short time. Or at BMJ, etc. Incidently there is also the argument that people won't quit, and will remain dual users (I'm sure they'll have that one ready, too. The irony being that cigAlikes are to blame - the very technology they intend to preserve. Oh well.)

3) As a basis for any future organizing/political action effort - i.e. to contact our elected rep.s, etc.?

Don't get me wrong. I think the economic impact of reducing the vaping industry to cigAlikes and putting all that money in BT's hands is dreadful to say the least.

I'm just trying to figure out how it helps us to be able to prove that.
 
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DC2

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Putting ecigs and vaping under the federal "tobacco products" umbrella won't necessarily change any local laws restricting smoking and vaping, because all of the local laws and ordinances I've read have quite explicitly defined "tobacco product" and what constitutes "smoking." So they have their definitions, the feds have theirs.
That's what I've seen too, but I was thinking it was possible their are some ordinances that have not defined "tobacco product" so specifically.
If any such exist, or if they have defined them as whatever the FDA defines as a tobacco product...
 

Kent C

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Hey Man...

I'm telling you. We are coming to the Point of the Sword here.

It's time someone with some Big Time Non-BT Lawyers step up and finds something. Anything.

See : http://www.e-cigarette-forum.com/fo...egulation-preserve-destroy-ecig-industry.html

I'm still with Smokey Joe on this one, in that I think that the FDA has all but enforced the idea that ecigs have no substantial equivalent before 2/2007.

However, this depends on where one looks and where one stops looking. It is still true that the vapor which is inhaled by users is created by bringing eliquid in close contact with an electrical coil where it is vaporized. Where the coil gets it's electricity can vary and where the eliquid comes from, how it gets to the coil and what path the vapor takes for inhaling can vary widely. But the essence is still "eliquid vaporized by and electric coil". If a good lawyer can make this case AND if the FDA hasn't already made up it's collective mind, then there's a possibility that most ecigs and ecig components could be grandfathered in. There may be details on Substantial Equivalency which I am unaware, but I don't doubt that a good lawyer could make this case, but my larger doubt, and I assume SJ's, is in the FDA accepting it.
 

zoiDman

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See : http://www.e-cigarette-forum.com/fo...egulation-preserve-destroy-ecig-industry.html

I'm still with Smokey Joe on this one, in that I think that the FDA has all but enforced the idea that ecigs have no substantial equivalent before 2/2007.

However, this depends on where one looks and where one stops looking. It is still true that the vapor which is inhaled by users is created by bringing eliquid in close contact with an electrical coil where it is vaporized. Where the coil gets it's electricity can vary and where the eliquid comes from, how it gets to the coil and what path the vapor takes for inhaling can vary widely. But the essence is still "eliquid vaporized by and electric coil". If a good lawyer can make this case AND if the FDA hasn't already made up it's collective mind, then there's a possibility that most ecigs and ecig components could be grandfathered in. There may be details on Substantial Equivalency which I am unaware, but I don't doubt that a good lawyer could make this case, but my larger doubt, and I assume SJ's, is in the FDA accepting it.

I would think that a Cig-a-like with a Atomizer and Cart would be a Great Candidate for a 2007 Substantial Equivalency. It would be One of the Avenues I would be Pursuing Legally.

And it would seem that with a Slight Relaxing to the guidelines, that some other Products could be Grandfathered in also.

I also think that if the Right Person could crawl up to the Right BT Ear, that it could be shown that BT could Actually make More Money/Profits by letting More e-Cigarette Products be available to Consumers than to Push Everything Back to the 2007 Dark Ages.

But More Importantly. What of e-Liquids?

Everyone seems to be Loading Up threads talking about Hardware. What of what is going on with e-Liquids. That's what People should be MOST Concerned with.
 

Jman8

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I think Zoidman is correct.

Any smoking bans that currently say "tobacco products" would seemingly then include electronic cigarettes as soon as the deeming regulations are passed.
I'm not sure how many smoking bans have that language in them, and I would think it is very few, but yeah.

Nicotine patches are not tobacco products, they are pharmaceutical products.

I'd say they are both. But if going with main point here, then outdoor bans will automatically be included as well.

As outdoor bans already exist, for eCigs, currently in the U.S., really not tough to make the point I'm making. And as I live in a state that sought to allow for indoor use, and currently does in many places I go, including restaurants, then really comes down to a state issue.

If cigarette smoking is banned in cars, then so will eCigs. If thirdhand smoke is an issue, then so will thirdhand vapor.

Original point was, this is seemingly all trivial now compared to FDA proposed regulations.

All FDA has to do in next 75 days is say publicly, "ya know, we are going to probably ban all flavors sooner than later" and suddenly it'll be very easy to ram usage bans of all sorts thru, with probably not much of a fight. Vapers will be tied up with the other, (seemingly) more important item.
 
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I would think that a Cig-a-like with a Atomizer and Cart would be a Great Candidate for a 2007 Substantial Equivalency. It would be One of the Avenues I would be Pursuing Legally. [...]

If you can find one, test the e-liquid and run studies on its effect on smoking cessation. It would have to be an identical product, down to the milimeter. The composition of the e-liquid would also have to be chemically identical.

[...]
Everyone seems to be Loading Up threads talking about Hardware. What of what is going on with e-Liquids. That's what People should be MOST Concerned with.

People are talking about equpment because it's already been established that every single e-liquid that contains nic. is going to require its own separate $1M-10M application. And that would include different quantities as well as nic strengths, perhaps even packaging (which might need to be evaluated on the grounds that it's either dangerous to small children who might drink it, or attractive to minors who will then use it as a gateway to tobacco cigarettes).

There has been talk of vendors getting together and submitting an application for high-concentration nic. base. The biggest problem with that is that FDA could reject it on the first day after the two-year window closes. Now you're looking at a huge investment in the application which may not see any returns ever - or at least not for years. Only BT/BV could afford that.

If you want e-liquid w/ nic in it from a commercial source after the 2-year window closes, you'd better break open a Blu cartridge and NJOY whatever :censored: it is that they're offering which FDA has approved.
 
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DaveP

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I think lots of us are headed toward vaping zero nic juice and maybe getting into mixing that at home. I'm working my way to zero nic, but it's nice to be able to order juice and not have to deal with maintaining PG and VG and all the flavors. I just hate to hear that juice vendors are beginning to leave the business because of the FDA regulations to come.

I forget the name of the vendor, but one announced in the last day or two that they were leaving the business and selling out due to the upcoming regulation being cost prohibitive.

I'm not sure how a zero nic ecig could be controlled. Of course, any employer can issue an office regulation that says you can't eat or drink at your desk. If they can do that, then they can ban ecig use inside even if it's zero nic.
 
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SeniorBoy

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Why yes, yes it does. So they figure about $334,000 per new product application. Then you need to add:

Annual Registration and Product Listing (I haven't nailed down a per vendor cost yet)

Ingredient Listing (seems to cost $200 per ingredient?)

Potentially Harmful Constituants Reporting (no actual cost, but they say "We will estimate the cost of compliance with testing and reporting when those regulations are promulgated; this cost includes not only the cost of submitting the required information, but also the cost of prerequisite product testing if such testing is not already conducted for other reasons. )

Misc Costs (where they throw everything else, and I haven't pulled any specific numbers from it yet)

Only good news seems to be that e-cigs vendors will not be required to pay a share of the quarterly user fees.

Please excuse me as I'm trying to wrap my head around the economic impact. Please don't hesitate to correct my understanding:

A vendors single ejuice is NOT affected by the above costs IF it was created and released to the marketplace in 2007 or earlier? Call it grandfathered? ALL other ejuice released after 2007 IS subject to these HUGE fees? Coorect?

I realize I'm simplifying this subwhat but I would appreciate some guidance. Thanks
 

zoiDman

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...

People are talking about equpment because it's already been established that every single e-liquid that contains nic. is going to require its own separate $1M-10M application. And that would include different quantities as well as nic strengths, perhaps even packaging (which might need to be evaluated on the grounds that it's either dangerous to small children who might drink it, or attractive to minors who will then use it as a gateway to tobacco cigarettes).

...

So do you get the Feeling that People have given up on e-Liquids as a Viable Fight? And have Resolved themselves to the thought that there will be No More Bottled e-Liquids. Or Perhaps, Bottled e-Liquids Only Sold by a Very Small amount of Entities like BT, NJoy or maybe Johnson Creek?
 

DC2

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So do you get the Feeling that People have given up on e-Liquids as a Viable Fight? And have Resolved themselves to the thought that there will be No More Bottled e-Liquids. Or Perhaps, Bottled e-Liquids Only Sold by a Very Small amount of Entities like BT, NJoy or maybe Johnson Creek?
I think people aren't talking about e-liquids so much because there isn't as much of a grey area there to argue about.
But when the time comes to act, I sure hope people start talking about it more.
 

zoiDman

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I think people aren't talking about e-liquids so much because there isn't as much of a grey area there to argue about.
But when the time comes to act, I sure hope people start talking about it more.

Oh they will be Talking about it Alright. I just hope it Isn't too Late by then?

What good is all this Hardware like Clearos and Carto Tanks and RBA's if one has Nothing to Fill them with.

BTW - Remember a Long Time Ago when I told you that there would be a Bigger Fight that would need to be Fought? And that it would make Much of the Petty Bickering about things like Indoor Vaping in Non-Smoking areas seem Trivial.

Are we there Yet?
 

Kent C

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I don't think 'Substantial Equivalency' is a path at all. In order to come under SE, there has to have been a 'predicate tobacco product' that existed prior to Feb. 11, 2007 that already had FDA approval - to which the grandfathered 'new product' would be substantially equivalent.

edit: see post 159
 
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patkin

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I'm going to split hairs here on the local usage bans (because frankly I'm too exhausted by deeming-induced anger and frustration to talk about economic impact analysis): Putting ecigs and vaping under the federal "tobacco products" umbrella won't necessarily change any local laws restricting smoking and vaping, because all of the local laws and ordinances I've read have quite explicitly defined "tobacco product" and what constitutes "smoking." So they have their definitions, the feds have theirs. Local ordinances have to be amended or new ordinances passed to cover vaping precisely because these definitions are already on the books. This process will continue. (Remember, the deemings aren't concerned with usage as such.)

I so sympathize. I'm going thru it too at the same time I have medical crap going on. This whole thing is even messin with my sleep. Here is a vid that helped me when considering the local implications:

https://www.youtube.com/watch?v=InSCNdJKa0I
 

DC2

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Oh they will be Talking about it Alright. I just hope it Isn't too Late by then?

What good is all this Hardware like Clearos and Carto Tanks and RBA's if one has Nothing to Fill them with.

BTW - Remember a Long Time Ago when I told you that there would be a Bigger Fight that would need to be Fought? And that it would make Much of the Petty Bickering about things like Indoor Vaping in Non-Smoking areas seem Trivial.

Are we there Yet?
Not that I disagreed with you, but yes we are there yet.
Most definitely.
 
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