FDA Common misconceptions about FDA regulations ( I hope CASAA will address at some point in the next few weeks)
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Only if it was derived in some way from tobacco (and by definition "synthetic" nic. would not be), or offered as a therapy (e.g. smoking cessation or for some other medical purpose). I suppose if you put it in a food or made a cosmetic out of it, that might be under their jurisdiction as well.
But the short answer is that recreational synthetic nic. cannot be touched by the FDA.
Maybe not immediately, but you can bet your bottom dollar that they would find some hole to cram it into. In their mind, synthetic for human consumption would probably fit perfectly into a pharmaceutical category and thus would need years of studies before it was legally allowed on the market. Or, it would be classified as what little synthetic there is currently, which is industrial because it's of inferior grade, and they or the EPA would shut it down.
Synthetic can currently be done, but it is much more expensive to produce than tobacco derived nicotine, and as I said of inferior quality. Unless someone comes up with a cheaper, cleaner way to do it, we'd better just concentrate on fighting what's in front of us.
Not to quibble but if any type of non-tobacco-derived nic. was sold as recreational e-liquid without any hint that it was about cessation or for any other medical use, I don't think the FDA would want to repeat Soterra again
They'd be massively ticked off, but completely helpless too.DEA? Hmm, IDK if they can regulate something w/ a different isomer if the synth. nic. came out that way.
Congress, however could and probably would act to extend the FDA's jurisdiction. THey just have to add the words "or nicotine" after "tobacco" in the FSPTCA act. It's a pretty trivial change. Some legislative staffer would do a global find-and-replace, it would be circulated for a couple days, and prob'ly go through both chambers w/o mark-up. The whole thing could get done in a week if congress was in session. It might get shoved into a sheaf of legislation that congratulated war heroes and named post offices.
Yep. There's no alternative to getting this stopped. Zero, zip, nada. It's vapapocalypse.
To be fair I didn't read his comment as partisan. More of a we know where we stand with this administration. We are by definition getting a new administration next election. Not necessarily a different party.
The cheapest way to manufacture nicotine in the long term would be to use a plant with as much nicotine in as the tobacco plant: Duboisia Hopwoodii, aka the Australian pituri plant.
But this approach is flawed because the legislators would quickly adjust the law to include all sources of nicotine (including synthetic). The purpose of the regulations is not to control ecigs and/or e-liquid or protect health, it is to prevent low-risk, difficult to tax alternatives to cigarettes eliminating smoking and the profitable diseases it causes. It's best to forget about such details in regulations, and concentrate on what they want to achieve.
They'll do what they need to do in order to achieve their goal, which is putting in place the most restrictions that can be achieved without a successful legal challenge.
The details are not really relevant until further down the road. If they can get away with what they hope for, then we will just have sealed disposables or minis with prefilled cartos, no refills, no web sales, no advertising, no flavors, no anything except a Blucig etc. All that will take a long time to implement and a lot of it will get challenged. Forget about cunning ways to evade the regulations, they will have all that covered once they get their ducks in a row. The black market will take over until such time as there are enough tens of millions of vapers to make a difference. The sooner the better.
But this approach is flawed because the legislators would quickly adjust the law to include all sources of nicotine (including synthetic). The purpose of the regulations is not to control ecigs and/or e-liquid or protect health, it is to prevent low-risk, difficult to tax alternatives to cigarettes eliminating smoking and the profitable diseases it causes. It's best to forget about such details in regulations, and concentrate on what they want to achieve.
They'll do what they need to do in order to achieve their goal, which is putting in place the most restrictions that can be achieved without a successful legal challenge.
The details are not really relevant until further down the road. If they can get away with what they hope for, then we will just have sealed disposables or minis with prefilled cartos, no refills, no web sales, no advertising, no flavors, no anything except a Blucig etc. All that will take a long time to implement and a lot of it will get challenged. Forget about cunning ways to evade the regulations, they will have all that covered once they get their ducks in a row. The black market will take over until such time as there are enough tens of millions of vapers to make a difference. The sooner the better.
I couldn't agree more. We still have to fight this thing tooth and nail.
If for no other reason, to delay the FDA's final rule for as long as we can. I don't want to step on whatever strategy CASAA will recommend, but it is still possible that the FDA may not present the final rule to congress before the Presidential changeover in Jan '17. (As a practical matter, they have to get it done by Sept or Oct '16). Generally, agency rules die if they don't go through that process before the end of a Presidency. As you may know, the US situation is not comparable to (say) the UK Minstries with their Permanent Secretaries (i.e. the mandarins who keep the fires burning during changes of gov't).
This scenario may unfold either because of the comments that we make which they are legally obligated to cognize (at least those which are factual in nature), and/or because of whatever pressure we can put on them via our elected representatives. Obviously the OMB did reject these rules once, so the situation in the executive branch is more complex than some would have it.
It's worth noting that there are two state Governers whom I mentioned earlier (Dayton of MN and Shumlin of VT) who have opposed the ANTZ. Shumlin even went so far as to say that vaping shouldn't be taxed if smokers are using it as a form of harm reduction. This again shows that political progress is possible.
The longer we can run out the clock, the better. Even your own ASH recently conceded that vaping isn't a gateway to smoking tobacco cigarettes. As time goes on, the science will become harder and harder to ignore. And - as you say - the number of vapers who have quit smoking will continue to grow.
The soution then is not to entertain any illusions about what the FDA will do with this proposed rule, should it become final - nor to (as you say) sit around and fantasize about some sort of panacea-like workaround. Instead we have to be clear about what the US Tobacco Control Government-Industrial Complex is trying to do, encourage as many smokers to switch as we can, and mobilize as much political support as is possible both within the established channels as well as via any other legitimate means that we can muster.
Every additional day that passes while vaping as we know it continues to exist will work to our advantage.
If for no other reason, to delay the FDA's final rule for as long as we can. I don't want to step on whatever strategy CASAA will recommend, but it is still possible that the FDA may not present the final rule to congress before the Presidential changeover in Jan '17. (As a practical matter, they have to get it done by Sept or Oct '16). Generally, agency rules die if they don't go through that process before the end of a Presidency. As you may know, the US situation is not comparable to (say) the UK Minstries with their Permanent Secretaries (i.e. the mandarins who keep the fires burning during changes of gov't).
This scenario may unfold either because of the comments that we make which they are legally obligated to cognize (at least those which are factual in nature), and/or because of whatever pressure we can put on them via our elected representatives. Obviously the OMB did reject these rules once, so the situation in the executive branch is more complex than some would have it.
It's worth noting that there are two state Governers whom I mentioned earlier (Dayton of MN and Shumlin of VT) who have opposed the ANTZ. Shumlin even went so far as to say that vaping shouldn't be taxed if smokers are using it as a form of harm reduction. This again shows that political progress is possible.
The longer we can run out the clock, the better. Even your own ASH recently conceded that vaping isn't a gateway to smoking tobacco cigarettes. As time goes on, the science will become harder and harder to ignore. And - as you say - the number of vapers who have quit smoking will continue to grow.
The soution then is not to entertain any illusions about what the FDA will do with this proposed rule, should it become final - nor to (as you say) sit around and fantasize about some sort of panacea-like workaround. Instead we have to be clear about what the US Tobacco Control Government-Industrial Complex is trying to do, encourage as many smokers to switch as we can, and mobilize as much political support as is possible both within the established channels as well as via any other legitimate means that we can muster.
Every additional day that passes while vaping as we know it continues to exist will work to our advantage.
Maxwell, Nice Dodging. You are putting together a list of misconceptions and realities, 14 of them. Now you don't want to address any of the inaccuracy and wrong information you are putting out.
Your views are not supported by statements by the manufacturers of Vaping. You are acting as if a roundtable days after has it all pegged, and denying all the significantly different opinions. Here on this discussion forum, Rodger, you don't want to hear any other view than your own. Fine, you can have at it.
I asked you specifically.
If everything is as you lay it out.
1. Why would the FDA wait so long before they can do anything. Why extend the 2 years. Why not say all applications are due now, that would cut the time down in half?
2. Explain the legal basis for restricting hardware that is used for items that are not nicotine based, because they could be used for something else. <---- Since you have refused so far, just realize that because there is no basis for banning such hardware, it REMOVES your entire statements that APV hardware is effected. ----> I am telling you are wrong. And so far you simply refuse to explain how you could be right on APV hardware, EVEN IF the FDA language is interpreted as you thing it is, the FDA can not ban personal vaporizers used for thing not related to nicotine. Explain the legal side you MUST be relaying on.
3. If you don't want to explain, its fine, this is your thread, just tell me you are not going to consider all views different than your own, and live in bliss of preaching to a finely picked and selected Choir of your choice. A wheel is used in a Mech MOD, so the FDA can ban all wheels now.....good luck with that logic, Maxwell.
Honestly it sounds like you've not read all of these regulations or you just can't comprehend the verbiage used in them!
Why would he need to prove these to you when all you have to do is go read it yourself. I can tell you it's in there! I'm not going to spell it out for you. I've read these regulations dozens of times. I totally agree with him. You are looking through rose-colored glasses. Sadly, that's what the FDA was hoping for...that most would see these as a mild regulation and not fight.
It's like a sheep! They have no idea when the slaughter is coming right up until the moment in which they lose their lives.
W.r.t. to hardware, for the umpteenth time ...
1) Language at the top of p.7 in the FDA's PDF which has been quoted in at least two or three different threads. "Component or part" of a tobacco product - it's part of the statute for heaven's sakes. You want legal authority? How about Congress?
2) What Mitch Zeller said here: FDA Deeming Teleconference 4/24/2014 - YouTube at 14:05 in answer to Greg Conley's Q - "intended or anticipated" use in a "covered tobacco product" quoted to you in at least two different threads.
3) What CASAA said in their press release: CASAA: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA - see this sentence: "Although the regulations do not openly ban the refillable devices that are preferred by experienced users, they impose a costly registration and approval process that would effectively eliminate them." also quoted to you in at least one if not two threads.
4) What attorney Azim Chowdhury says (quoted to you in this very thread in post #28
http://soundcloud.com/vp-live/smoke...adio-episode-2
And you keep asking the same question over and over and over again ... pretending that somehow this is the very first thread in which you've asked it.
No one is answering it, everyone is evading it, you ceaselessly and plaintively bleat. Nonsense!!
How many times do we have to go through this with you? Anyone who can stand it is invited to read this thread in which you pursue exactly the same strategy of repeating the same stuff until no one will listen: http://www.e-cigarette-forum.com/fo...rs-before-any-action-possible-under-regs.html
***
Do I know why the two-year rule is in place? I have no idea, and I do not care. I cannot see inside the FDA, and until some great investigative reporter breaks it wide open, I think it's entirely pointless to speculate.
If this is about the FDA's attitude towards vaping (i.e. you're arguing that they're somehow trying to cut vapers a break), then this is also a rather ridiculous positon for you to take. Zeller is running around the country telling interviewers like Judy Woodruff on the PBS News Hour that "tobacco products" kill 400,000 Americans a year, ergo we need to regulate vaping (i.e. implying that it's just another "tobacco product"). The FDA kept the bogus '09 study up on their web site for years, even though they knew it was garbage ("diethelyne glycol" etc.). They tried to ban vaping in 2009 completely. I'm sure there are other juicy tid-bits from Comm'r Hamburg's testimony or Zeller's statements. Or their backgrounds for that matter. (And then there's the long history that the FDA has of repeatedly denying that smokeless tobacco products have anything to do with harm reduction.)
So if that's where you're going with that - i.e. the 2-year period suggests that they have any particular attitude towards vapers - you don't have a leg to stand on.
Maybe OMB forced them to put in the two-year period, against their wishes. You don't know, and I don't know.
Well - actually we do know. The period would've been negative seven yearrs if they had gotten their way in 2009. Right?
***
I suppose you're going to go on some other thread and start with all this nonsense again. And then it will be just like we'd never discussed it. We'll have to start all over again from first principles.
Over, and over, and over again. Just like the movie "Groundhog Day." The constant mind-numbing repetition.
Endless dreary cycles of the same redundant infinitely-everlasting grind of permanent statis ... like the motion of a cursed gerbil on some kind of cosmic wheel ...
1) Language at the top of p.7 in the FDA's PDF which has been quoted in at least two or three different threads. "Component or part" of a tobacco product - it's part of the statute for heaven's sakes. You want legal authority? How about Congress?
2) What Mitch Zeller said here: FDA Deeming Teleconference 4/24/2014 - YouTube at 14:05 in answer to Greg Conley's Q - "intended or anticipated" use in a "covered tobacco product" quoted to you in at least two different threads.
3) What CASAA said in their press release: CASAA: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA - see this sentence: "Although the regulations do not openly ban the refillable devices that are preferred by experienced users, they impose a costly registration and approval process that would effectively eliminate them." also quoted to you in at least one if not two threads.
4) What attorney Azim Chowdhury says (quoted to you in this very thread in post #28
http://soundcloud.com/vp-live/smoke...adio-episode-2
And you keep asking the same question over and over and over again ... pretending that somehow this is the very first thread in which you've asked it.
No one is answering it, everyone is evading it, you ceaselessly and plaintively bleat. Nonsense!!
How many times do we have to go through this with you? Anyone who can stand it is invited to read this thread in which you pursue exactly the same strategy of repeating the same stuff until no one will listen: http://www.e-cigarette-forum.com/fo...rs-before-any-action-possible-under-regs.html
***
Do I know why the two-year rule is in place? I have no idea, and I do not care. I cannot see inside the FDA, and until some great investigative reporter breaks it wide open, I think it's entirely pointless to speculate.
If this is about the FDA's attitude towards vaping (i.e. you're arguing that they're somehow trying to cut vapers a break), then this is also a rather ridiculous positon for you to take. Zeller is running around the country telling interviewers like Judy Woodruff on the PBS News Hour that "tobacco products" kill 400,000 Americans a year, ergo we need to regulate vaping (i.e. implying that it's just another "tobacco product"). The FDA kept the bogus '09 study up on their web site for years, even though they knew it was garbage ("diethelyne glycol" etc.). They tried to ban vaping in 2009 completely. I'm sure there are other juicy tid-bits from Comm'r Hamburg's testimony or Zeller's statements. Or their backgrounds for that matter. (And then there's the long history that the FDA has of repeatedly denying that smokeless tobacco products have anything to do with harm reduction.)
So if that's where you're going with that - i.e. the 2-year period suggests that they have any particular attitude towards vapers - you don't have a leg to stand on.
Maybe OMB forced them to put in the two-year period, against their wishes. You don't know, and I don't know.
Well - actually we do know. The period would've been negative seven yearrs if they had gotten their way in 2009. Right?
***
I suppose you're going to go on some other thread and start with all this nonsense again. And then it will be just like we'd never discussed it. We'll have to start all over again from first principles.
Over, and over, and over again. Just like the movie "Groundhog Day." The constant mind-numbing repetition.
Endless dreary cycles of the same redundant infinitely-everlasting grind of permanent statis ... like the motion of a cursed gerbil on some kind of cosmic wheel ...
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Ditto Stosh.
Roger, your time would be better spent going wherever it's needed and adding precautions for the new members rather than this. Some people simply don't live in the same world we do.
Roger, your time would be better spent going wherever it's needed and adding precautions for the new members rather than this. Some people simply don't live in the same world we do.
I think it's time to stop the back and forth, here, and other threads. No more of this nonsense please, you've both made your points.
I'm sorry Roger, but I have to agree with Gary. I don't think wv's comments were out of line in the least. This administration is actively trying to control every aspect of our lives. The republicans are "supposed" to oppose big government. The democrats are currently demonstrating how far they want big government to go. No limit. They are putting vaping under their control because of the money. They, and the state governments will reap the taxes, and their friends (contributors) will get the privilege of being the producers that get the to make the money. You can bet your bippie that it won't be the Koch brothers...
@Roger_Lafayette - Thank you for the easy to understand and insightful analysis. CASAA is fortunate to have your services.
I believe their is a lot of confusion about the "substantially equivalent" issue so I hope it's ok to point folks to the following thread:
http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html
The .pdf link to the FDA document is in the first post. I hope folks spend the time to read the thread and the document which should help to eliminate a significant portion of the confusion. Certainly pages 34 and 35 from this FDA document spell out exactly what the realities will be for granting SE status. Unlikely to ever happen!
PS: Hope you like my signature!
I believe their is a lot of confusion about the "substantially equivalent" issue so I hope it's ok to point folks to the following thread:
http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html
The .pdf link to the FDA document is in the first post. I hope folks spend the time to read the thread and the document which should help to eliminate a significant portion of the confusion. Certainly pages 34 and 35 from this FDA document spell out exactly what the realities will be for granting SE status. Unlikely to ever happen!
PS: Hope you like my signature!
Right. The problem is Democrats like ... Gov. Dayton and Gov. Shumlin?
What I'm pointing to is that on ECF we have this double standard.
If a high-profile Democrat like Durbin goes after vaping, we hear people complain about Democrats.
If a Gov. like Dayton stops an indoor/outdoor vaping ban, or Shumlin stops a proposed vaping tax, then it seems their party is irrelevant.
Do you not see that in your own post that I quoted above, that you are also applying a double standard?
I don't see a single Republican elected official of any stature at all (let alone a Gov.) stepping forward to defend us.
I'm not in favor of what Durbin has done. Or the Obama administration's FDA and CDC directors/actions (the CDC is a somewhat less politicized agency). But I'm also against Gov. Christie's (NJ) and Gov. Kasich's (OH) tax proposals.
Does it matter to you that they are Republicans? Should it?
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@Roger_Lafayette - Thank you for the easy to understand and insightful analysis. CASAA is fortunate to have your services.
I believe their is a lot of confusion about the "substantially equivalent" issue so I hope it's ok to point folks to the following thread:
http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html
The .pdf link to the FDA document is in the first post. I hope folks spend the time to read the thread and the document which should help to eliminate a significant portion of the confusion. Certainly pages 34 and 35 from this FDA document spell out exactly what the realities will be for granting SE status. Unlikely to ever happen!
PS: Hope you like my signature!
Yes! Yes! Read the document, and the "deeming" document over and over with a critical eye, look for the phrases that just don't seem legit. Read them as if they were written by a sleazy used car salesman, they were...
Understanding what is being proposed, and the effects that it will have, both as written and in the ability it gives to the FDA to "adjust" the regulations in the future.- Status
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