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Thread: FDA opens comment periods on two issues regarding Substantial Equivalence Requirements

  1. #21
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    Elaine, this brings us to the subject of AVPs and zero nic liquid. I haven't bought an e cig "system" since '09 when I wasted a bundle on Blu. There I was buying nicotine laden cartridges and the hardware. I can't remember if they offered Zero nic back then since I only used them a couple weeks.

    I see no way that the FDA can make a case for regulating the use of flavored PG/VG or the device you vape that non-nicotine mixture in. The FDA has responsibility for drugs and now tobacco products which a 0 nic AVP is neither.

    With that in mind, I can only see a couple avenues that can take towards regulation. First, and obviously the preferred option, focus on liquid quality unless it's a system such as NJoy or Blu. The second could take any number of forms that would require pre-filled, proprietary nicquid dispensers.

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    What I'm seeing here this morning on other threads makes this all pretty near a moot point. Either the banks in some States or Visa itself as of 1/1/2014 dictates (not sure of law yet as no one will give a straight answer) is denying payment to any business selling vape gear.. period... not nicotine. One of the original OPs was for the purchase of bottles only. He was told payment would be blocked to any company selling components that went into the making of an ecig. It really doesn't matter what the FDA does anymore. While we're all thinking about them the move is to control finances... yeh, follow the money takes on a new meaning. I know I will be should my bank freeze MY funds arbitrarily.
    Last edited by patkin; 01-03-2014 at 07:48 PM.
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    Quote Originally Posted by patkin View Post
    What I'm seeing here this morning on other threads makes this all pretty near a moot point. Either the banks in some States or Visa itself as of 1/1/2014 dictates (not sure of law yet as no one will give a straight answer) is denying payment to any business selling vape gear.. period... not nicotine. One of the original OPs was for the purchase of bottles only. He was told payment would be blocked to any company selling components that went into the making of an ecig.
    Where are you seeing this?

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    I just talked with our...ugh......Governor's office and they checked with their legal staff and the legal staff was not aware of any Federal or State regulation going into effect January 1 to restricts buying vape liquid over the internet with Visa cards.....interesting that it is happening and nobody can explain it (not the bank, not Visa, and not State Governor's office & legal staff).....my search for answers continues...
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    PV Master ECF Veteran patkin's Avatar
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    Sorry... I didn't mean to hijack the thread. I'm just sooooo mad! My favorite juice vendor is in Kentucky so keeping my fingers crossed.

    rothenbj: these are the first two to trickle in

    Credit Card Company Refused To Process Transaction

    http://www.e-cigarette-forum.com/for...ape-shops.html
    Last edited by patkin; 01-03-2014 at 08:03 PM.
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    Thanks for the informative updates Tom.I quit worrying 5 years ago, as soon as I learned to order from China. However, I will still keep an eye out for the large groups of FDA e-cig police that will most probably be scouring our neighborhoods any minute now.
    I do agree that the citywide bans are the real problem and since no one here has mentioned sending briefcases full of money in with their letters and petitions, I expect the same level of success as we've already experienced.
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    Chuck

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    Quote Originally Posted by Vocalek View Post
    This current guidance does not apply to products that are not regulated yet as tobacco products. No doubt they will need to write a separate SE Guidance document to cover e-cigarettes, since they are very different from tobacco cigarettes. Our concern is that so far, the FDA has been very, very picky, sending back SE applications asking for more and more detailed information. "A coil is a coil is a coil" very likely will not cut it with tobacco regulators. If they follow the same pattern as this document, they will be asking for all of the metals that went into making a coil, design drawings, etc., and will want the new product to be identical in every way with the predicate product, unless the applicant can pony up proof that the new design does not present any changes in health risks.

    Tobacco companies might be able to absorb all these costly analyses, but those e-cigarette companies not owned by a tobacco company could be bankrupt by this process if it continues to be administered in this fashion.
    Here's an example of just how gritty it can become when having to jump through the FDA hoops. This is from the guidance document Vocalek linked to:

    In addition to the information requested in Section V.A. above, for 905(j) reports for
    products with different characteristics, but which you do not believe raise different
    questions of public health under 910(a)(3)(A)(ii), FDA may request additional data
    needed to make a substantial equivalence determination.

    Examples of additional data that may be requested include:

    Consumer Perception Studies - data comparing consumer perceptions with
    respect to the new tobacco product and the predicate that could affect
    initiation, cessation, frequency of use, patterns of use, smoking behavior, and
    perceptions of harm or addictiveness.

    Clinical data - data comparing the biomarkers of exposure and biomarkers of
    potential harm and human toxicity of the new tobacco product as compared to
    the predicate tobacco product and (if applicable) to a grandfathered tobacco
    product. Your report should include a summary of all studies conducted. In
    addition, your pivotal studies should be submitted and include: final approved
    study protocols, statistical analysis plans, any modifications to the study(ies),
    raw data, analysis platforms, and full reports.

    Yea, have fun providing that for a new flavor of e-juice. This is exactly what scares me and why I think big tobacco and big pharma will be helped by any regulation like this. Every e-juice manufacturer will have to hire engineers and scientists and lawyers just to market an e-juice and have a chance at it satisfying 905(j). If you want to market a tank or a mod, the same thing. At the very least it will have a chilling effect on the industry as a whole, greatly reducing the number of manufacturers of the various devices and juices that we now have available. And if you think people will just put stuff out there on the internet with some sort of "not intended for" language, keep in mind that when you run afoul of the federal government they can levy huge fines on you that you would have to fight in federal court. Attorneys well versed in federal laws are very expensive I'm sure. Sorry Tom, I think we're right to worry. I hope all of the vendors of various products are taking a serious look at this and getting involved in the public comment process.
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    No problem at all molimelight, Tom says everything is fine.
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    Quote Originally Posted by tombaker View Post
    If the FDA could ban analog tobacco they would.
    And that tells us a heck of a lot about their mind-set. We also know they would ban e-cigs if they could because they pretty much tried to do so. Since they WANT to ban this stuff but can't, the the next best thing in their mind is to make things as difficult as possible for the manufacturers. We can see this happening already with the absurd requirements they have for the analog manufacturers to prove substantial equivalence to grandfathered products. Yet you're telling us they would never do that to the manufacturers of e-cig products. Really?
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    Quote Originally Posted by retird View Post
    I just talked with our...ugh......Governor's office and they checked with their legal staff and the legal staff was not aware of any Federal or State regulation going into effect January 1 to restricts buying vape liquid over the internet with Visa cards.....interesting that it is happening and nobody can explain it (not the bank, not Visa, and not State Governor's office & legal staff).....my search for answers continues...
    You won't find it, because it does not exist. The original poster of the problem, has corrected their error.
    "Alright, so after looking into some things, it appears things are being worked out with the bank and they are going to check into why the error appeared and stated it may have been due to an issue on several vendors end in regards to how their CC processing is done. It appears that the issue is resolved and that I should be able to use my card as normal but definitely something to keep our eyes out for in the future if this happens with other peoples cards." Please refer to the original thread, as to not hijack this one any further.
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