PMTAs - who is doing what?

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Territoo

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    If customs gets aggressive on Chinese shipments of filters and metal tubes, this might end up in the courts. However, I don't forsee anything but a small fraction of packages getting confiscated. FT sells a lot of non vape related products, and there are hundreds of Chinese vendors selling thousands of items. Just think of Ebay and Wish. Even in 2009, most items got through. It was the vendors of large shipments that had the problems. Now vendors either have a PMTA and get their shipments or don't.
     

    stols001

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    There is an FDA precedent for importation of medications from overseas. Basically, there is a "rule" that you are not going to get into legal issues from out of country sellers sending you three months or less of medication. Even if it's medication which is not FDA approved (although it can't be a scheduled substance.)

    If it is over 3 months personal supply they can legally prosecute that person as some sort of "dealer" or "reseller." Otherwise, the package is turned back and you are sent a letter that says don't be expecting your "whatever." It also encourages you to NOT do it while also noting it is not a crime and they cannot legally order you to stop.

    Depending on your seller, well, some will "guarantee" package arrival and will um, resend the medication (let's face it a lot of the time it's expired, sugar pills or whatever, they are losing little) unless you are able to identify the reputable drug companies which is EXTRAORDINARILY difficult as they are always changing their names.

    I was willing to do it for a MEDICATION I could not GET because it was not FDA approved here and totally harmless. I also NEVER went generic.

    I would have to go thorough an awful lot of vape gear before I were to get back into the "FDA Vape importation market." I also refuse to do it until I know the "rule" and the "law" because I break tanks like no one's business or I did so if I ordered 20 glass tanks and that is "too many" well ah, l would prefer not to be prosecuted for that.

    The US does what it can to dissuade and annoy sellers, for example they can and will (most likely) block fasttech's vape portion oft their site from the public that is fairly easy to do. They will also be vaguely threatening and etc. and offer up the kind of hassles FT won't want such as slowing down ALL packages more.

    There is plenty the good old USA can do an FDA can do to be a right pain in the rear and I think they can say if something is banned here it is banned from overseas in this sort of non technical but deeply annoying way.

    Good luck, I hope the FDA prove me wrong!

    Anna
     

    zoiDman

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    I just got an email from NN, they have filed and are helping their customers to file.

    I received an e-Mail also from Nude Nicotine.

    Nude Nicotine Regulatory Update

    My take on it is it is geared towards Commercial "Customers" seeking PMTA acceptance. And Not for End Users.

    But I could be wrong.
     

    rosesense

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    I received an e-Mail also from Nude Nicotine.

    Nude Nicotine Regulatory Update

    My take on it is it is geared towards Commercial "Customers" seeking PMTA acceptance. And Not for End Users.

    But I could be wrong.
    Yes, that is what they said. So their buyers/businesses who are filing could use their data.

    Why would an end user need/want to file a PMTA since they aren't selling.
     

    UncLeJunkLe

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    The US does what it can to dissuade and annoy sellers, for example they can and will (most likely) block Fasttech's vape portion oft their site from the public that is fairly easy to do.

    I doubt the US govt would block sites. There is still some constitutional integrity in the USA, little, but some. Even if they did block sites, you can just use a VPN/proxy to get around it. And they know this so even if they wanted to they would not bother. Would be a total waste of time because it's so easy to get around.
     

    HigherStateD

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    are they saying these 4 items are ready to go?PMTA Information
    Hrmm... That's what it seems to be saying. My question is, why would they have the yocan hive on the clearance page for non pmta compliance, as it's marketed as an alternative vape... So does that mean that isn't a loop hole?
     
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    WorksForMe

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    are they saying these 4 items are ready to go?PMTA Information

    That does appear to be what they're saying, but I'm not sure where they're getting their information. The Smok PMTA list I've seen doesn't include the kit on their site, and I haven't seen a list from Vaporesso. If they're a store you buy from, you could email them and ask about it.

    .
     

    zoiDman

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    are they saying these 4 items are ready to go?PMTA Information

    JMO...

    But a 230W Dual 18650 with a 510 Open System Atomizer Doesn't Sound like a very promising Candidate for a FDA PMTA.

    A Closed System Pod Mod, yeah I could see someone Roll'n the Dice on that.

    But I'm Not Sure how an OEM is going to convince the FDA/CTP how well a SMOK SCAR-18 can't be "Adulterated".
     

    Opinionated

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    That does appear to be what they're saying, but I'm not sure where they're getting their information. The Smok PMTA list I've seen doesn't include the kit on their site, and I haven't seen a list from Vaporesso. If they're a store you buy from, you could email them and ask about it.

    .

    I asked Vaporesso in their forum here and they never responded. I don't know that we will find out until post 9/9..
     

    low_tar_neil

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    zoiDman

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    A List of who has Submitted PMTA's published by the FDA would Help us. And I'm sure Retailers would Welcome it also.

    https://www.convenience.org/Media/D...tes_GR/Letter-to-FDA-on-PMTA-Transparency.pdf

    https://www.convenience.org/Media/D...CS/Industry-Letter-re-PMTA-List-(8-25-20).pdf

    "[Mitch Zeller, FDA/CTP Statement, Aug. 31st, 2020]

    ...

    In addition, we plan to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline, were on the market as of Aug. 8, 2016, and for which a premarket application is submitted by Sept. 9, 2020. However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed. We request your patience as we work through the appropriate processes to ensure the posted information is accurate and compliant with federal laws. In the interim, we encourage retailers and other interested parties to refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted.

    ... "

    FDA’s Preparations for the September 9 Submission Deadline
     

    zoiDman

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    They have 6 products listed on their PMTA page, I think these are the ones. Pmta » Vaporesso

    The Pod Mods I understand. And they seem Viable.

    But I truly wonder if Vaporesso is Submitting a serious PMTA for an Open System Mod Kit?

    I mean, How do you Evaluate Performance and or Potential Harm for a Mod Kit when you Don't even Know what the User is going to Put in the Tank?

    Or What Setting the User will set the Mod at?
     

    low_tar_neil

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    The Pod Mods I understand. And they seem Viable.

    But I truly wonder if Vaporesso is Submitting a serious PMTA for an Open System Mod Kit?

    I mean, How do you Evaluate Performance and or Potential Harm for a Mod Kit when you Don't even Know what the User is going to Put in the Tank?

    Or What Setting the User will set the Mod at?
    You can't but, you might assume that it buys you a year at the least
     
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