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Thread: USA FDA announces deeming regulation today

  1. #1
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    USA FDA announces deeming regulation today

    Something that really matters.

    Check out @GregTHR's Tweet: https://twitter.com/GregTHR/status/459182829801574400

  2. #2
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    First glance, not so bad. No sales to minors and warnings (meh).

    Admittedly it does create a framework to allow further rules, but given the direction change and the growth of industry over there, may not be too draconian.


    Cautiously optimistic. May set a reasonable precedent to be followed here.
    308hjute, Sponky and Browny like this.

  3. #3
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    Exactly.

    USA online sales matter much more in the scheme of things than anything here.

    Looks like a soft blow.

    Fingers crossed.
    Mick77 and 308hjute like this.

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    Problem with the US is they aren't banning the hardware or juices, but towns and cities are banning the act of vaping in public spaces.
    I don't know what is worse, not being able to buy gear locally(E: and having no policy in place to ban use), or not being able to actually USE it outside of your own property like in some USA towns and cities.
    Last edited by coopz; 24-04-14 at 03:57 PM.

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    Quote Originally Posted by coopz View Post
    Problem with the US is they aren't banning the hardware or juices, but towns and cities are banning the act of vaping in public spaces.
    I don't know what is worse, not being able to buy gear locally, or not being able to actually USE it outside of your own property.
    I suspect some of that may change once direction is given at a federal level.

  6. #6
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    Quote Originally Posted by coopz View Post
    Problem with the US is they aren't banning the hardware or juices, but towns and cities are banning the act of vaping in public spaces.
    I don't know what is worse, not being able to buy gear locally(E: and having no policy in place to ban use), or not being able to actually USE it outside of your own property like in some USA towns and cities.
    The nightmare scenario with the US has been the possible ban of online sales.
    Mick77 likes this.

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    "Companies would have to register the products and their ingredients with the FDA, but would have two years to do so.

    In the interim, they could continue selling their existing devices and introduce new products without regulators' approval. The new health warning labels would caution users against the danger of becoming addicted to nicotine."

    As per above comments, looks reasonable initially.

  8. #8
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    I'll be interested in what he has to say when he gets a copy of the Regs to dissect.
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    Quite a sensible approach thus far.....was nervous opening that article with one eye openeing thinking 'how bad are the proposed regs going to be'
    Supporting the freedom to purchase and use PV's in Australia!

  10. #10
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    Someone from the big 50k+ ECR reddit vaping forum broke it down.

    TLDR version: Two years after these regulations go into effect, any e-cigarette product then on the market containing nicotine or any e-cigarette product marketed to be used with nicotine will be BANNED if the manufacturer does not submit a costly application to the FDA. New products will not be permitted to enter the market without FDA approval. FDA is woefully and inadequately prepared to handle this.

    This is NOT good news and vendors and vapers should vehemently OPPOSE these regulations, as they will work to the benefit of large tobacco and e-cigarette companies with Wall Street investors that don't make the products used by 98% of this subreddit's users, while potentially shutting down hundreds or thousands of small and medium-sized businesses thanks to an extremely expensive, resource-heavy, and arbitrary system setup by the Family Smoking Prevention & Tobacco Control Act.

    This is actually worse than I expected.

    Two years after the regulation is written, e-cigarette companies will have to put in 'new tobacco product' applications for any product released to the market after February 25, 2007.*** This is not mere registration. This is a lengthy and expensive process. If you don't file an application, your product is banned. If you file an application and the FDA finds that your product shouldn't be on the market for one of a variety of reasons (including their favorite, 'You failed to submit adequate evidence of x, y, and z.'), it can be pulled from the market.

    After that 2 year date, any new e-cigarette product must be approved by the FDA before it goes to market. If the FDA does not approve your product, it cannot be brought to market. This is not a fast process, as evidenced by a Government Accountability Office report that was highly critical of huge delays that were and still are happening at the FDA Center for Tobacco Products. http://www.gao.gov/assets/660/657451.pdf

    For just a sample of what a "new tobacco product" application is like, see here. This a document from when the FDA refused to even file (let alone approve) four "new tobacco product" applications : http://www.fda.gov/downloads/Tobacco.../UCM389515.pdf

    Also see this snippet from a Lancet article (behind a paywall) by Dr. Lawrence Deyton, the former Director of the Center for Tobacco Products, in which the burden that will be put on e-cigarette and e-liquid companies is outlined: The burden is on the manufacturer to provide evidence that permitting the produc - Pastebin.com

    This is bad news for e-cigarette consumers. The chance of a flavor ban or an online sales ban from the start was never really an option. This prospect was here all along and is not positive.

    *** There is also something called "substantial equivalence" which is a smaller, but still expensive, loop to jump through. However, FDA guidance on substantial equivalence, and their past decisions on other applications, indicate that it would be a fruitless effort to prove substantial equivalence for a 2016 e-cig product vs. a 2007 product.

    Vapers should not only oppose this deeming regulation, but also support vendors that stick up for their businesses and consumers.

    (Going to edit this post a bit with some links as the night goes on)

    ~ Gregory J. Conley, JD, MBA Twitter: @GregTHR Bio: Gregory Conley | Heartland Institute (609) 947 - 8059
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