FDA TVECA post table of contents for Deeming Final Rule

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StormFinch

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Given everything the FDA wants in PMTA, it seems to me that it would take a year or more to prepare one, and the FDA's own estimate is that 5000 man hours are needed. So a two year "grace" period is probably the lowest they think is likely to withstand a court challenge.

Don't forget that that's 5000 man hours by an attorney versed in FDA applications. Try finding one of those that can just drop everything and work on your application. ;)
 

inspects

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Given everything the FDA wants in PMTA, it seems to me that it would take a year or more to prepare one, and the FDA's own estimate is that 5000 man hours are needed. So a two year "grace" period is probably the lowest they think is likely to withstand a court challenge.

Wholeheartedly agree...!
 
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Racehorse

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Killing vaping is about the only good choice of keeping that steady stream of money coming in.
Honestly, I think they are banking on us returning to smoking. Instead of taxing the heck out of vaping, they will demolish it

Well it is always interesting how different perspectives can be. I am just really not seeing the same scenario as you are. :dunno:

 

roxynoodle

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I first thought taxing the heck out of it was where they would go. But, now I think regulating it to nonexistance may be their end game (literally). They've been easily taxing cigarettes more and more, plus all the MSA money is at stake. They need us all to return to smoking, stop current smokers from quitting, and need new smokers to replace dead ones (those teens they are pretending to protect).

Let's hope I'm wrong.I do have a friend who calls me The Dark Entity.
 

Racehorse

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WATCH OUT.... THIS CAN HAPPEN TO YOU TOO if you DONT ACT NOW !

I said back in 2012, and I'll say it again: These things will be decided in the courts.

My advice is bring money $$, and lawyers............. and lots of both.

Already seen mucho regs and laws get passed.......sob stories to politicians, FDA doesn't work.
 

aikanae1

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Based on the OMB's first Economic Report, they seem to think transitioning from half a million products to 25 or so won't be much problem. After all, I guess we are just addicts and will accept nicotine in any form.

The SBA wrote an excellent letter of their concerns from a regulatory perspective. I don't see that any of their concerns were adressed. I don't think the SBA has enforcement, but they do have some weight. Their letter is a good read.

https://www.sba.gov/content/61114-d...d-family-smoking-prevention-and-tobacco-contr
 
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StormFinch

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Well it is always interesting how different perspectives can be. I am just really not seeing the same scenario as you are. :dunno:

Okay, let's try it this way. Google FDA and Pharmaceutical Industry and a good dozen articles will come up showing that, for the most part, the FDA is no longer funded by taxes, but by the various fees that the industries pay them. Back a year or two before they were given control over the tobacco industry, I believe they were 60% funded by pharma, and by 2010 they admitted that pharma fees alone paid for all administrative expenses pertaining to that particular industry, which includes personnel compensation and benefits, travel and transportation, rent, communications, contract services, equipment and supplies, etc; in other words, the whole enchilada. This effectively makes the FDA beholden not to the taxpayer, but to the companies it's supposed to be policing. Up until e-cigs showed up on everyone's radar, the NRT industry was predicted to have a continued increase in sales world wide. Although I have no idea what those sales are now doing in the U.S, since the introduction of e-cigarettes in France their NRT market dropped by almost 7% in 2013 and was predicted to stall completely by this year. Now, vaping has also harmed the tobacco industry, who is also paying the FDA exorbitant fees, to the tune of half the cigarette market in 8 years. Considering the fact that up until recently the tobacco and pharmaceutical industries had a weirdly symbiotic relationship with the quit/smoke merry-go-round, we're effectively harming two of the FDA's biggest customers, out of what, 3 if you include the food industry? On top of that, most pharmaceutical companies have a swinging door policy with the FDA; executives leave the FDA and immediately go to work for pharma, and now pharma's executives are leaving them and gaining positions within the FDA. Put plainly, the FDA doesn't care about taxes, federal or state, they care about the hand that feeds them.
 

Nuggit

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They very well might want to regulate us right out, that's how they got rid of all the "patent medicins" back in the day, that's why they started the FDAholes in the first place. To regulate folks right out of business, they aren't going after us, they are industry crushers. Big Government for the people, by the people my ....
We, vapers and vape industry needs to make the biggest stink possible for them. If it doesn't work, we need to black market em into changing. Like {other stuff}. I'm not endorsing Al Capone stuff, just make big GOV impotent.
Only the people can do that. It's a big task, but the founding fathers didn't want the Gov we have today either.
Freedom is not allways free.
I for one will get the business license to get nic and help the people out.
Call me a revolutionary.
Vape on, despite the burocrats.
Sorry for the errors, spell check is off kilter.
 
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Cam775

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....Edit: maybe you just had to file with the FDA that you were going to submit within the 2 year time frame.

Either way say goodby to the small vendor section here on ECF.
This is my understanding. They have 6 months to get the first submittal of information in and then 2 years to apply for approval. Does that mean that after that 6 months they're going to let ejuice makers continue making their products if they deem the ingredients harmful for inhalation? Many flavorings with cinnamon (for example) have a respiratory inhalation warning. Doesn't bother 99% of us, but if they wanted to be :censored: they could start pulling products as they please based on that.

I'm betting BT doesn't want to kill vaping because it's popular with young people, but they definitely want to be the sole providers of it! They will work with the FDA to have their products determined to be the only systems deemed "Safe"!:sneaky:
I've thought about this and I'm thinking they will make inferior products and crap juice available only. This will keep current smokers smoking because we all know crap cig-a-likes won't get the job done and future generations lighting up...no other options. @roxynoodle said it right, they need those "children they're protecting" to be lighting up and not have the option to vape. The media, via analysts have recently made the vaping industry front page news... **BILLION DOLLAR INDUSTRY WILL OVERTAKE SMOKING IN XX YEARS** and **TEEN SMOKING GOING DOWN WHILE TEEN VAPING SKYROCKETS** We've all seen those headlines and so have they (BT & BP), they're freaking out this industry will get too big to control here real quick...better get control while they can.
 

The Eciginator

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This is my understanding. They have 6 months to get the first submittal of information in and then 2 years to apply for approval. Does that mean that after that 6 months they're going to let ejuice makers continue making their products if they deem the ingredients harmful for inhalation? Many flavorings with cinnamon (for example) have a respiratory inhalation warning. Doesn't bother 99% of us, but if they wanted to be :censored: they could start pulling products as they please based on that.


I've thought about this and I'm thinking they will make inferior products and crap juice available only. This will keep current smokers smoking because we all know crap cig-a-likes won't get the job done and future generations lighting up...no other options. @roxynoodle said it right, they need those "children they're protecting" to be lighting up and not have the option to vape. The media, via analysts have recently made the vaping industry front page news... **BILLION DOLLAR INDUSTRY WILL OVERTAKE SMOKING IN XX YEARS** and **TEEN SMOKING GOING DOWN WHILE TEEN VAPING SKYROCKETS** We've all seen those headlines and so have they (BT & BP), they're freaking out this industry will get too big to control here real quick...better get control while they can.
Young folks love tech and candy, vaping gives them that as well as the addiction. BT doesn't care if they're burning it in paper tubes or a Vuze POS! As long as the next generation is hooked on BT products they're thrilled!:(
 

Katya

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On top of that, most pharmaceutical companies have a swinging door policy with the FDA; executives leave the FDA and immediately go to work for pharma, and now pharma's executives are leaving them and gaining positions within the FDA.

Right. Mitch Zeller himself served as an executive with Pinney Associates, a pharmaceutical consulting firm that does work for GlaxoSmithKline (BP, Big NRT
wink.gif
) before becoming FDA's director of the Center for Tobacco Products. I wonder what his next job is going to be? GSK, perhaps? Conflict of interest? Bah, humbug. Not in Washington.

I like this article:

http://tobaccoanalysis.blogspot.com/2014/06/its-official-big-pharma-is-lobbying.html

Heya, Stormy! Long time! Fancy seeing you here. :D
 

StormFinch

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They very well might want to regulate us right out, that's how they got rid of all the "patent medicins" back in the day, that's why they started the FDAholes in the first place. To regulate folks right out of business, they aren't going after us, they are industry crushers. Big Government for the people, by the people my ....
We, vapers and vape industry needs to make the biggest stink possible for them. If it doesn't work, we need to black market em into changing. Like {other stuff}. I'm not endorsing Al Capone stuff, just make big GOV impotent.
Only the people can do that. It's a big task, but the founding fathers didn't want the Gov we have today either.
Freedom is not allways free.
I for one will get the business license to get nic and help the people out.
Call me a revolutionary.
Vape on, despite the burocrats.
Sorry for the errors, spell check is off kilter.


Your post reminded me; not the FDA, but our government and big business of the time; the hemp industry was regulated right out of existence. Seems it threatened the wood industry, among others. In fact, sounds kind of familiar, some of us were even joking about vapor madness when the news sources were first starting their smear campaigns. ;)
 
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Cam775

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Young folks love tech and candy, vaping gives them that as well as the addiction. BT doesn't care if they're burning it in paper tubes or a Vuze POS! As long as the next generation is hooked on BT products they're thrilled!:(
Maybe. BT wants to control the market. How they'll do that, whether by squashing it or putting no money into R&D and just keeping the crap products they already have avaliable I don't know. But if they were going to compete for a part of the market they've had plenty of time and they have plenty of money to do so and they haven't...they've done this instead through the FDA. Just my thoughts.
 

Katya

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I first thought taxing the heck out of it was where they would go. But, now I think regulating it to nonexistance may be their end game (literally). They've been easily taxing cigarettes more and more, plus all the MSA money is at stake. They need us all to return to smoking, stop current smokers from quitting, and need new smokers to replace dead ones (those teens they are pretending to protect).

Let's hope I'm wrong.I do have a friend who calls me The Dark Entity.

Yeah. And prop up the Big Pharma and their (NRT) bottom line.

Too bad. I used to think that it was just about the lost revenue and that all they really wanted was to tax e-cigs like they are taxing cigarettes. But I'm beginning to see your point.
 

The Eciginator

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Maybe. BT wants to control the market. How they'll do that, whether by squashing it or putting no money into R&D and just keeping the crap products they already have avaliable I don't know. But if they were going to compete for a part of the market they've had plenty of time and they have plenty of money to do so and they haven't...they've done this instead through the FDA. Just my thoughts.
Well, someone who has never vaped anything better won't know it's crap! But they'll flock to it because the commercials are cool and the ridiculously high nic will take care of the rest!;)
 

StormFinch

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Right. Mitch Zeller himself served as an executive with Pinney Associates, a pharmaceutical consulting firm that does work for GlaxoSmithKline (BP, Big NRT
wink.gif
) before becoming FDA's director of the Center for Tobacco Products. I wonder what his next job is going to be? GSK, perhaps? Conflict of interest? Bah, humbug. Not in Washington.

I like this article:

http://tobaccoanalysis.blogspot.com/2014/06/its-official-big-pharma-is-lobbying.html

Heya, Stormy! Long time! Fancy seeing you here. :D

Bingo! And one of the short list candidates in the running for Hamburg's old position makes over half of his income from pharma research. It's just one hand washing the other.

Tweety! What's a sweet bird like you doing in a place like this? Never mind, I know the answer to that! ;) Ever feel like you just keep going through the same thing, over and over and over... :D
 

Katya

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Bingo! And one of the short list candidates in the running for Hamburg's old position makes over half of his income from pharma research. It's just one hand washing the other.

Tweety! What's a sweet bird like you doing in a place like this? Never mind, I know the answer to that! ;) Ever feel like you just keep going through the same thing, over and over and over... :D

Playing whack-a-mole with our legislators, over and over again... How long have we been doing this, Stormy? :facepalm:
 
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Nuggit

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Yes, stormfinch, they sure did. That's why cannabis has been so brutaly illegal. Hemp was their ticket. It's their sneaky way of getting what they want while keeping mainstream support. They have to move fast, and disseminate miss information and outright propaganda to the masses.
That's why we have seen posts along the lines that the majority will follow the lead if this is as bad as it looks and we can't get anything other than the latest version of the Vuse.
Our founding fathers were traitors for bucking the system of their time. We could take a lesson from them, buck the system, that's why we have an America to live in today, instead of being the next England. The more we let them run us, the more it's Government upon the people, instead of for the people. They count on the masses falling in line because they are more powerful than us. They got the guns, we got the numbers.
Can't let them run over us forever, bad precedent. Ultimate power, ultimately corrupts. There are more vapers than bureaucrats.
Rant over, for now. Vape on with pride!
 
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