This is disheartening, indeed.
"Get your facts first, and then you can distort them as much as you please."
-Mark Twain.
FDA Swedish Match submitting 100,000 page MRTP application for General Snus to FDA
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This is disheartening, indeed.
"Get your facts first, and then you can distort them as much as you please."
-Mark Twain.
- Apr 2, 2009
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Alexander wrote
That's why Mitch Zeller will soon be proposing (per his comment in today's webinar) a new fee structure for tobacco companies (and almost certainly e-cig companies if a Final Rule is issued for FDA's proposed deeming regulation) to fund FDA's implementation of the tobacco Control Act.
I can already hear Mitch saying that FDA needs more money to implement the many different regulations that it has decided to impose on tobacco products, and that it will need even more money to implement the deeming regulation and dozens of other new regulations that Mitch plans to propose.
And of course, its the consumers of FDA regulated tobacco products who pay for all of these FDA fees.
So the consumers not only have to pay all of the manufacturer's costs of developing/submitting all applications to FDA, but the consumers also have to pay all of the FDA's expenses (including CTP's 500+ employees, TPSAC, and CTP's grants to Stan Glantz, AHA and other e-cig prohibitionists who FDA now calls Centers for Tobacco Regulatory Science).
That's why Mitch Zeller will soon be proposing (per his comment in today's webinar) a new fee structure for tobacco companies (and almost certainly e-cig companies if a Final Rule is issued for FDA's proposed deeming regulation) to fund FDA's implementation of the tobacco Control Act.
I can already hear Mitch saying that FDA needs more money to implement the many different regulations that it has decided to impose on tobacco products, and that it will need even more money to implement the deeming regulation and dozens of other new regulations that Mitch plans to propose.
And of course, its the consumers of FDA regulated tobacco products who pay for all of these FDA fees.
So the consumers not only have to pay all of the manufacturer's costs of developing/submitting all applications to FDA, but the consumers also have to pay all of the FDA's expenses (including CTP's 500+ employees, TPSAC, and CTP's grants to Stan Glantz, AHA and other e-cig prohibitionists who FDA now calls Centers for Tobacco Regulatory Science).
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There is enough documentation that I really wonder if an effective class action suit could be started against the FDA for intentionally causing more harm to smokers due to their refusal to resonably examine less harmful products (I'm sure the wording could be better). But IMO there is no doubt they are contributing to needless illness and death of possibly millions, along with unneccessary health care costs.
And Zeller has the balls to wonder if smokers will switch? Last I heard, 70% want to quit yet less than 10% are able to do so for 6 months. Hmmm ... where's the "greater good" in that arguement?
I know class actions are insanely difficult and expensive and take years, but if they can do it against products that can harm I would think they can do it against federal agencies too. I know with Medicaid (federal regulations) a class action is about the only way to force a change. The individual isn't usually considered to have a "private right" against a federal regulation.
I also have little doubt that congress intended the modified risk category to result in less harmfull alternatives to cigarettes and that is the opposite of the way the FDA is applying the regulations.
And Zeller has the balls to wonder if smokers will switch? Last I heard, 70% want to quit yet less than 10% are able to do so for 6 months. Hmmm ... where's the "greater good" in that arguement?
I know class actions are insanely difficult and expensive and take years, but if they can do it against products that can harm I would think they can do it against federal agencies too. I know with Medicaid (federal regulations) a class action is about the only way to force a change. The individual isn't usually considered to have a "private right" against a federal regulation.
I also have little doubt that congress intended the modified risk category to result in less harmfull alternatives to cigarettes and that is the opposite of the way the FDA is applying the regulations.
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If I understand you - that you don't think Congress meant to eliminate modified risk alternatives - I'm not so sure. Waxman, who introduced the bill, may not have known enough about ecigs at the time, does so now and is against them - also several of the co-sponsors.
One guy who voted for HR 1268 was Eric Cantor. He won't be there next year. His possible 'heir' David Brat is libertarian leaning and has written against regulation.. from a interview with dailyprogress:
FRESH & LOCAL: A conversation with Dr. David Brat, part 2 - Star Exponent: Columnists
(not directly related to anything tobacco but just 'regulation' in general)
"Dr. Brat points out that government regulation now costs businesses $2 trillion annually, and that regulatory burden falls disproportionally on small businesses. This is a very big problem, not just for us, but for all small businesses."
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aik wrote
I'm not aware of any class action lawsuit that's been filed against the FDA (or any federal, state or local government agency), and I don't know if federal class action lawsuits (or state class actions) can even be filed against governmental agencies.
Besides, the goal of most class action lawsuits is to make lots of money for the lawfirm that files the class action suit.
But that's not why companies or citizens sue government agencies.
I'm not aware of any class action lawsuit that's been filed against the FDA (or any federal, state or local government agency), and I don't know if federal class action lawsuits (or state class actions) can even be filed against governmental agencies.
Besides, the goal of most class action lawsuits is to make lots of money for the lawfirm that files the class action suit.
But that's not why companies or citizens sue government agencies.
I'm not really "in the know"...
But my guess is you're WAY off... because it wont even actually be read... just skimmed over, the summaries of each section lightly reviewed.
Sure Zeller may claim it costs the FDA $33m ... but that doesn't mean it does.
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As corrupt as this thread (including OP) makes the FDA out to be, and for not only this thread, I can't understand why consumers would want vendors to go through FDA. I get that threats of breaking federal law would likely motivate most businesses, but again, this is a very corrupt process we, consumers, are talking about. Questionable at the very least.
Given what this thread is saying, if I as consumer has choice between FDA approved tobacco product or one that was from underground market, I'd take the one from underground market. If that same business was around before regulations went into effect, I'd take the underground market one(s) in a heartbeat and call that a very wise decision.
There is literally zero guarantee that an FDA approved product would be harmless. Why anyone, anywhere, would lose sight of this fact is beyond me.
Either FDA finds way to work with vendors/industry in a reasonable fashion (includes expenses to comply) or consumers will find another way to enjoy vaping. Not maybe find a way. Will find a way.
Millions for an application is ludicrous. I'd love to see both the paperwork and the justification for it. Until I do, I'm calling it as I see it, it is a corrupt process.
Given what this thread is saying, if I as consumer has choice between FDA approved tobacco product or one that was from underground market, I'd take the one from underground market. If that same business was around before regulations went into effect, I'd take the underground market one(s) in a heartbeat and call that a very wise decision.
There is literally zero guarantee that an FDA approved product would be harmless. Why anyone, anywhere, would lose sight of this fact is beyond me.
Either FDA finds way to work with vendors/industry in a reasonable fashion (includes expenses to comply) or consumers will find another way to enjoy vaping. Not maybe find a way. Will find a way.
Millions for an application is ludicrous. I'd love to see both the paperwork and the justification for it. Until I do, I'm calling it as I see it, it is a corrupt process.
I also get that a black market will be created and will do very well under this scenario. Corruption makes crime super duper easy.
There's quite a few Medicaid class action lawsuits at any time. Most of them involve state interpetation of federal regulation. I was thinking the states would be at a similar level as FDA since they are the ones writing and applying the law (it's not done by CMS although they may issue guidelines, but states don't have to follow them. CMS is "not an enforcement agency"). I know it's a wild thought. With Meicaid, it can take 7 to 9 years to eventually get to court (ugh) and no one ever gets money even when they win. The lawyers doing it usually come from a small group partially funded through national protection agencies (pro bono).
What if these regulations go through and there's an increase in cigarette sales? That's pretty counter to the original bill's intention. All the "gains" in smoking reduction since ecigs would be lost.
Has anyone heard rumblings about an extension? It seems the best strategy is find reasons to stall finalizing deeming although not for political reasons since I doubt a change in congress or administration would have an effect on industry interests. The main reason is so that the numbers switching to vaping increase.
Of this I've no doubt, and once again our government who are suppose to protect and work for us shall only create millions more criminals.
Perhaps Mars will be the answer..... I tire of our lizard overlords, lol.
Are you imagining people will have personal distillers for nicotine or there will be tons of people rebuilding old ego's or RBA's? I don't think most people build their own coils as it is and it's certanly not going to attract mainstream smokers to swith to vaping if there's that high of a learning curve required to start.
One thing with prohibition against alcohol and another herbal substance was that anyone could make/grow it and it was in a useable form. I don't think that's true for nicotine. It would require importation / underground labs that are not that easy to hide. When something needs to be smuggled in, the quality becomes variable and the price esculates possibly higher than taxes would do. The more demand and active a black market is, the criminal charges are also increased - the major players eventually are criminals willing to take the risk.
I can remember when most prescription drugs were available on line > 10 yrs ago direct from the manufacturers plant (India, Thailand, etc) with ease. They couldn't search all packages, right? Well eventually they figured out ways to stop almost all shipments. Scammers also got into it to such an extent it was nearly impossible to figure out which factories were legit and which weren't. There were forums like ECF comparing which ones were which. A lot of people got sugar pills. Some got nothing. Some just got notices of confiscated pkgs. All of them paid a MUCH higher price than if they used a legit prescription and those prices are high enough.
Did you watch Dallas Buyers Club? There was a time that the FDA tried to grab control of nutritional suppliments; they were considered "illegal" without FDA approval including things like protien and vitamin C (in massive doses). This is still a grey area if you were to hang out on some cancer and homeopathic/body building boards. They are always locating legit sources for suppliments that are not considered illegal, but aren't approved for sale in the US. It's not so easy and not something most would deal with or could afford to deal with.
The other route would be to go to the dark net, use a VPN / TOR. Again, not something the mainstream is willing or can do. There's a sizeable portion of ECF that won't even deal with FaceBook and many of those (IMO) are a target market for vaping > 45 with decades of smoking history.
Personally I think nicotine should be classed as a suppliment like vitamins. But that's not going to happen.
Well hopefully there's more substance than the article you linked to.
This is why I think most people should buy their friends who still smoke a beginner's kit and give them a shot while it's available. Then sign them up for a CASAA membership. They should also tell their non-smoking friends about vaping, display a pin or something. "We" are the best counter to the propoganda. Most people I know not involved with vaping find it hard to believe the FDA is so corrupt. Afterall, it brings into question how safe the medications they take daily are. I'll float over to the sunscreen ingredient example (I'm a skin cancer survivor so I know that issue intimately as well). I'm sure there are other examples.
Even if a fraction of ECF active registered members signed up with CASAA, their membership would be 10x's higher. Why people haven't is a good guess since I don't get it. But numbers count. The next step is to make sure b&m's are familar with CASAA and letting their customers know; it's not talking "politics" (the only comment I've heard not to tell customers). I think they should sign them up in the stores and all employees should be members if they want to continue working there.
2nd and 3rd generation vaping hardware is the category that's expected to double and triple in sales over the next few years. "We" need as much time as possible to take advantage of that.
I do most of that whenever i can, all the vendors up here that i deal with know anout casaa. Ty for the kind words.
I grabbed the one line that pointed toward more but it was pretty scant. Part 1 was too.
Still, Cantor voted for HR1268 and from a few other sources, Brat sounds more libertarian.... As you likely know, searching "Representative/Senator's name" and e-cigarettes, don't get you that far unless it's Harkin, Durbin, Waxman, Boxer, et al. Oh, you'll get some sites but they're 'split' with "..." lol.
What was interesting about the election is there were @40% more voting in this primary than the last one. And to oust a party leader with 55% of the vote is quite an accomplishment. No 'astroturfing' here
I like this, as you might expect.
"Brat seems to believe that most economists are motivated by philosophy rather than science: they're secretly utilitarians who believe that the goal of public policy is to produce the greatest good for the greatest number.
He thinks this leads them to wrongly assert that their preferred policies are "scientifically" the best policies, when in reality they're just the policies that a utilitarian would say are the best. "Economists from the beginning to the end, have engaged in normative, ethical and moral arguments which diverge greatly from the work of the 'true' science which they espouse," Brat writes."
http://www.vox.com/2014/6/10/5798708/brat-academic-research
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He's religious, but likes Atlas Shrugged on the economic aspects... and Adam Smith. I'd bet he'd support ecigs but one never knows until they state it. Also in favor of term limits, including his own if he's elected. Cato has some problems with his immigration stance.
"Brat seems to believe that most economists are motivated by philosophy rather than science: they're secretly utilitarians who believe that the goal of public policy is to produce the greatest good for the greatest number.
He thinks this leads them to wrongly assert that their preferred policies are "scientifically" the best policies, when in reality they're just the policies that a utilitarian would say are the best. "Economists from the beginning to the end, have engaged in normative, ethical and moral arguments which diverge greatly from the work of the 'true' science which they espouse," Brat writes."
http://www.vox.com/2014/6/10/5798708/brat-academic-research
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He's religious, but likes Atlas Shrugged on the economic aspects... and Adam Smith. I'd bet he'd support ecigs but one never knows until they state it. Also in favor of term limits, including his own if he's elected. Cato has some problems with his immigration stance.
I grabbed the one line that pointed toward more but it was pretty scant. Part 1 was too.
As you likely know, searching "Representative/Senator's name" and e-cigarettes, don't get you that far unless it's Harkin, Durbin, Waxman, Boxer, et al. Oh, you'll get some sites but they're 'split' with "..." lol.
What was interesting about the election is there were @40% more voting in this primary than the last one. And to oust a party leader with 55% of the vote is quite an accomplishment. No 'astroturfing' here
Pretty much anything I say about that is going to go off topic. Yes, it was a surprise. I'm sure Dem's cracked the champagne since TP canidates don't fair well. I bet they haven't even prepared a canidate to run since they never considered there was a possibility. I guess it's another faculty member from the same college.
This is what ticks me off is that Dem's are basing much of their opinion on TVECA and cigalikes. That's what their "investigative report" covered. I'm still appauled that no one seems to care about figures, growth, etc after 2012 per the Economic Impact. That's a problem. B&M sales were not included. I think those figures should be available now, so ....?
It's important to pay more attention to what they do than what's said. Look at the attendence at the HELP hearing. Vaping not a priority and when push comes to shove I wouldn't it past any side to throw us under the bus if the deal was right.
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I hear you loud and clear. I'd like to see more figures too. The new percentage smokers figures too. Don't know when that comes out. I think they (FDA, gov't) are seeing more positive results and trying to figure how best to spin it but the economics tell the story. cig sales down/ecig sale way up. After again, hearing Zeller today on the webinar, there's simply no way he'll come off his utilitarian "dual use/continued addiction is the most important factor' because it endangers greater numbers and the "public health" - which has no basis in reality, (pics or it didn't happen
... but only in his head of what he thinks is best.Zeller is realistic about his area of influence - regulation, and right now, he has the confidence that he has the Senate on his side. But in less than the 2 years until final rule, that may change, and he would become less confident. He again, mentioned the lawsuits which is what drove him away from his "home" (FDA) the last time. So that is, imo, a significant fear. He doesn't want to 'move' again.
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