Proposed FDA Rules

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CoalCreek

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It's long past time the FDA goes under the microscope publicly to see exactly what's making it tick. It smells like money over health and claims of ignorance won't cut it. I paid huge tobacco taxes and increased insurance costs for decades while smoking and was damned glad to be rid of that. They can get me back into their money flow, or make me a law-breaker, with a bunch of carefully placed words over time. They want my money until I'm dead and gone. It's not about health this time. It's about protecting the franchise(s). Gloves are off. Follow the money.
 

MTFogger

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Absolutely not. The propaganda machine never sleeps.

I also encourage anyone who thinks the initial regulations are okay to reconsider.

The current devices, liquids, etc. will all have to apply for FDA approval within two years. There is absolutely no guarantee that they will approve any of them. Since they are hammering the "flavors marketing to children" angle...they could simply enforce a de facto ban by not approving any flavored or colored liquids. Don't sit on your hands during the review period.

Raise some hell, people, or we are stuck with them as written.

Could not agree more. Everyone should send to the head of the FDA a simple email/letter stating that I like using (insert flavor) in my e-device and I'm (insert age). Enough with the children angle already.
 

msrfrog

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Welcome to the new world order.
A lot of people thing pro gun people are nuts. But this goes to show the gov. Has no limits on the control they want to impose on us. Censorship ,bans making legal things illegal where does it end? They just want to brainwash everyone with TV. Dumb down your thinking. Turn everyone into a tax paying compliant zombie.

Sent from my GT-N7000 using Tapatalk
 

Funk Dracula

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Well now...

Keep your eyes on the CASAA site for their lawyers to dissect the massive books worth of regulations for us further. Await the marching orders; it's get off of your ... time for realz. Especially vendors, they need to either put up, or get out.

We've got what, 75 days to raise hell?

phew....
 

tj99959

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    I think this is the most important area of concern. There a thousands of vendors selling ecigs.. what is the cost and time to get things "approved" will be the question. It's a foolish thing to begin with because they essentially all work the same. The potential problem is enormous and it could leave the vape shops options limited. Can you imagine the FDA sorting through tens of thousands of applications?
    It's going to be a problem.

    The only hoop the VENDOR would be facing is in house made liquids. It's the MANUFACTURER that is going to get hit.
    If the manufacturer can't make it, there is no need to worry about vendors selling it. So you can probably say goodby to your Bobas Bounty. Smaller e-liquid manufacturers will be the first to go.
     

    Botomline

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    It's not only important to realize that the FDA would be under no obligation to actually approve any devises submitted, they might actually require vendors to pay the cost of review (which could be prohibitive), approve/review each variation of device juice/, and any changes to approved products, including packaging changes. That will lead to expensive and very long product introduction cycles, raise the barrier for new products and force most out of the market. Our options will be severely limited and probably dominated by cig-a-likes that BT can stamp out by the thousands in limited flavors.

    While this might seem benign as written, the above is how it would probably be interpreted. I'm old, but still like my blueberry/banana in a variety of devices and RBA's.
     

    Sgt.Rock

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    unconstitutional?

    Which part of the constitution prohibits regulating e-cigarettes?

    Even if e-cigs WERE protected in our constitution, it wouldn't matter. The constitution is more of a 'suggestion' these days then anything.

    Swing-and-a-miss



    The correct question is which part of the constitution gives the government permission to regulate E-Cigs (or anything else for that matter)
     

    rolygate

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    It's worth pointing out that FDA regulations (or anything else similar) has no relation whatsoever to ecig safety, public safety, public health, protecting children, or anything else like that. It's all about money and nothing else.

    The smoking economy is worth over $1 trillion a year and will eventually take a massive hit from ecigs. How much is just a guess, but given time (20 or 30 years perhaps) then a 60% reduction in the smoking economy is very likely.

    What is the smoking economy? It's all the funds generated by smoking and all the people who depend on that money. The list is very long, and everyone in the chain has a financial interest in protecting smoking - otherwise their jobs disappear or they take big pay cuts. Everyone from State Attorneys General to 'public health' groups such as cancer orgs depends on smoking. National governments, State economies, and city budgets depend on the tax revenues to balance the books. The States are in the worst position of all as they depend on the immense MSA payments to stave off bankrupty - and those payments are already starting to slide (way ahead of the expected date these payments would react to shrinking cigarette sales caused by growing ecig sales).

    All laws banning ecigs, all regulations restricting ecigs, all legislation affecting ecigs, and all voices heard speaking against ecigs are created by or dependent on the smoking economy. Public health is irrelevant, it's all about the money, has always been about the money, and will always be about the money.

    Please don't be fooled into thinking that health is important - nothing is of less importance to regulators than your health. Please don't be fooled into thinking that science and evidence are important - these things are completely irrelevant to legislators. All they are concerned with is their mortgage, and the smoking economy pays that. Smoking and pharma are protected, and that's all there is to it.

    You need to vote for someone who will do something about it - or just suck it up, it's what you voted for.
     

    Vaslovik

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    All laws banning ecigs, all regulations restricting ecigs, all legislation affecting ecigs, and all voices heard speaking against ecigs are created by or dependent on the smoking economy. Public health is irrelevant, it's all about the money, has always been about the money, and will always be about the money.

    Absolutely! And you can bet your last buck that those dependent on the smoking economy are paying people to churn out endless and vile propaganda against vaping, especially on internet vaping forums, like this one. It's all about corporate profits in the end, and who they pay off.
     

    kristin

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    As far as the "samples", I'm pretty sure that means giving away whole devices or bottles containing nicotine, like those given away at vapng events or during promotions. (I remember getting free cigarette samples handed out at college bars and music events back in the 80's.)

    A sample bar (really a "tester bar") in a store is not the same thing and if it IS prohibited, non-nicotine testers could be provided instead. But my guess is that the "samples" being prohibited are not the same as the store "testers" that remain in the store. The FDA is more concerned about controlling how the product is being distributed and keeping them from minors than testers in a store, which can card before allowing people to sample or even ban anyone under 18 from the store. Ultimately, testers don't leave the store, so they don't have the risk of getting into the hands of minors.

    As far as anything else in the rules, I haven't seen them yet. CASAA will review them ASAP and issue a CTA for the public comments.
     

    CabinetGuyScott

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    The pharmaceutical industry doesn't care about smoking cessation drugs except as an indicator to how their real smoking-related markets will react.

    Yes, NRTs and psychoactive drugs for smoking cessation are a ~$5 billion annual global market, but this is chump change compared to the main channels: (1) sick smoker treatment drugs and (2) the boost to general drug sales caused by smokers. Smoking creates at least 10% of pharma's gross income and it could even be as high as 15% or 20%.

    1. The sick smoker drugs are immensely profitable as a near-monopoly situation exists: chemotherapy drugs, COPD drugs, cardiac drugs, vascular drugs etc. All these will take a 60% hit eventually although there is a long timelag in this market.

    2. There is an enormous boost to general drug sales caused by smokers: diabetes, cholesterol, bronchitis and blood pressure drugs are examples. This is because a smoker is >40% more likely to be diabetic. The same applies to other conditions many drugs are sold to treat. These conditions can't be cured so the customers are permanent. Smokers will always need inhalers, diabetes meds etc. This market reacts faster than for example the chemotherapy drugs market.

    In addition there are other income channels such as OTC meds that are boosted by smoking.

    These huge income channels (possibly worth $200bn a year), plus the close integration of pharma with the legislative and regulatory systems, are the reasons why pharma is the strongest and most effective opponent of THR products such as ecigs. It's why they fund a range of front groups to promote their agenda: ban/restrict ecigs, in order to protect their income by protecting smoking. It's why cancer 'health' orgs are in the strange position of protecting and promoting cancer by helping to block ecigs - these groups are controlled by pharma. They pay the CEO $1m a year to keep the faith, so don't expect any honest 'cancer health' orgs anytime soon. They all need to protect smoking, it's the gravy train that pays all their mortgages.

    [edit]
    And I suppose it's worth adding that the reason why this is allowed is because anything connected to smoking is essentially a free-fire zone: smokers are considered already dead or addicts without rights. Industries can profit from smokers or restrict smokers in ways that would be impossible in other market areas. Smokers are basically considered to be an already-dead tax and profit source. Smokers have no rights, and ex-smokers have no rights either.


    So very well said Roly!!

    You make it easy to understand why the drug companies are at the forefront of this war to protect smoking.

    Btw, I used this post to create a blog entry, that is easy to "facebook" out to my social network.

    :thumb:
     

    wheezal

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    Don't forget this:

    "Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold."

    FDA proposes first regulations for e-cigarettes


    this doesn't worry me at all. having worked in "vice" industries before that have this rule, the backlog of applications is so immense, they never get around to reviewing anyone's applications. and as long as a vendor submits, they can still operate. by the time the regulatory body gets to the app, the rules will have changed, or something on the app needs to change.

    even, after years of waiting, they finally get to the review portion of the application, it wont be an insta-ban. the offending vendor will be given numerous warnings and opportunities to fix the issues that they are cited for. then the re-application goes right back to the bottom of the pile.

    take the casino industry, there are casino's and managers that have technically been operating for decades without licenses because their applications just haven't gotten reviewed yet. the backlog of people submitting overwhelms the paltry number of regulators that are charged with reviewing the apps.
     

    Funk Dracula

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    CASAA will review them ASAP and issue a CTA for the public comments.

    Yup. Thanks for the update.

    No point in us consumers freaking out speculating from browsed first impressions by others, other than it's bad on general principle (but we were expecting nothing less).

    Patiently awaiting for CASAA to read this over and get back with a CTA. I bet Greg Conley of AVA will digest this and tell us like it is real soon. From his twitter feed it looks like he pulled an all-nighter for us already.

    Hoping CASAA and AVA are a solid united front on this.


    Edit: And of course anybody who hasn't joined CASAA I urge you to please do so. The numbers really count right about now. Become a CASAA Member
     
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