PMTAs - who is doing what?

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Ceejay0875

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[Sigh] I've never considered myself as an old lady... only pushing 55 this yr
Ah, wasn't referring to you dear, or anyone on this forum. buy all the yummy ice cream ya want! Was referring to a certain politician whose first name sounds a lot like "Nanny".
 

WorksForMe

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"Avail Vapor announced today that it has received its first premarket tobacco product application (PMTA) acceptance letter from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products. While the company would not say what flavors or how many flavors, it was confirmed that the mixed-berry flavored Mardi Gras was a submitted flavor."

Avail Earns PMTA Acceptance Letter From FDA for E-liquids

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zoiDman

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"Avail Vapor announced today that it has received its first premarket tobacco product application (PMTA) acceptance letter from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products. While the company would not say what flavors or how many flavors, it was confirmed that the mixed-berry flavored Mardi Gras was a submitted flavor."

Avail Earns PMTA Acceptance Letter From FDA for E-liquids

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Thank you for Posting this Works.

It will be Very Interesting to see How this one goes.
 

UncLeJunkLe

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"Avail Vapor announced today that it has received its first premarket tobacco product application (PMTA) acceptance letter from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products. While the company would not say what flavors or how many flavors, it was confirmed that the mixed-berry flavored Mardi Gras was a submitted flavor."

Avail Earns PMTA Acceptance Letter From FDA for E-liquids

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Not surprising seeing how Avail Vapor is owned (at least in part) by Altria, better known to smokers as Philip Morris.
 

WorksForMe

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Not surprising seeing how Avail Vapor is owned (at least in part) by Altria, better known to smokers as Philip Morris.

According to this article, that's no longer true.

"Avail founder and Chairman James Xu said the Giant Vapes deal was the result of Avail planning for its future, in part after ending its relationship last year with tobacco giant Altria, which had acquired a minority stake in Avail three years ago."

Chesterfield-based Avail eyes national reach with giant leap into e-commerce

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puffon

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    Just got this e-mail from Halo.
    Surprised, as large as Halo is, they are only submitting 3 flavors and no devices.
    I guess it's a start tho...

    upload_2020-8-12_16-29-36.png
     

    zoiDman

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    Just got this e-mail from Halo.
    Surprised, as large as Halo is, they are only submitting 3 flavors and no devices.
    I guess it's a start tho...
    upload_2020-8-12_16-29-36-png.901343

    Whereas I Don't believe that any Stand-Alone Bottled e-Liquid is going to get over the PMTA Bar the FDA sets, at least Halo By-Passed the entire "Children Loving" flavors Pitfall.
     
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    Spydro

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    [Sigh] I've never considered myself as an old lady... only pushing 55 this yr

    Way OT... but Surprise AZ is a name that brings back fond memories from the late 60's to late 90's. My ex MIL lived in Scottsdale from the late 60's until just before she passed (in Brentwood, CA 2011), and when her family all got together at her place there those 30 or so years my FIL, 3 BIL's and 2 of us SIL's sometimes perused the Magma Cotton Fields/Pheasant Club together in what at that time was NW Surprise.
     
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    Rossum

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    Just got this e-mail from Halo.
    Surprised, as large as Halo is, they are only submitting 3 flavors and no devices.
    I guess it's a start tho...

    View attachment 901343
    Hah! Halo's Turkish Tobacco was the very first e-liquid I ever vaped. However I got tired of it pretty quickly.

    at least Halo By-Passed the entire "Children Loving" flavors Pitfall.
    Way back when I first started vaping with Halo products, they didn't offer any sweet or fruity flavors at all. I realize that changed years ago though.

    Remember when some people around here thought that Halo would be the only e-liquid company able to muster the resources to file a PMTA?
     

    WorksForMe

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    Remember when some people around here thought that Halo would be the only e-liquid company able to muster the resources to file a PMTA?

    That doesn't appear to be the case, although it remains to be seen if any bottled e-liquids will get marketing orders from the FDA.

    Don't forget that Halo is only one of the brands produced by Nicopure Labs. They're a large company that sells e-liquid worldwide. I'm sure they will file more PMTAs than just the three announced by Halo.

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    zoiDman

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    ... I'm sure they will file many more PMTAs than just the three announced by Halo.

    They May. And they May Not.

    If things go Pear-Shaped with these 1st Three, I Can't see a company throwing More money down a Rat Hole for more PMTA's. Especially if there is a Fundamental Reason that the FDA round files their PMTA Application(s).

    There's also a Very Likely possibility that Leadership is going to change at HHS/FDA. And if that Change occurs, it is Not Going to be for the Better e-Cigarette wise.

    On the Other Hand, if it is Smooth Sailing with these Three PMTA's, then "Bridged-Data" could be used on Future Applications. Which would make the Cost and the Height of the FDA Bar lower to jump over.

    The current FDA could Fasttrack Legitimate PMTA applications. Knowing that they might Not be the ones who have the Ultimate Decision on future ones. Kinda like when an Exiting Governor signs pardons in the Last Days He/She is in office.

    All of it is just Hard to Say.

    Because Lots of Things are In Play Right Now. And it is Very Difficult to Tell exactly Which Way the Wind is Actually Blowing.
     
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    WorksForMe

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    There's also a Very Likely possibility that Leadership is going to change at HHS/FDA. And if that Change occurs, it is Not Going to be for the Better e-Cigarette wise.

    If the election in November causes a leadership change, I'd guess that the only things that will get approved are a few BT pod mods, but I try to stay optimistic.

    .
     

    zoiDman

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    Am I missing something? The PMTA applies to manufacturers and not to resellers, right?

    That is basically correct.

    A PMTA applies to a "Tobacco Product". Irregardless of Who Makes it or Who Sells it.

    Once a "Tobacco Product" has a Filled PMTA, it can remain on the US Market after Sept 9th pending review. And Anyone can Sell/Resell it as long as they can Sell Tobacco Products in the first place.

    But the Manufacture doesn't have to be the one who Files the PMTA. And it is thought that there might be a Few PMTA filled that are Funded and Prepared by a Distributor(s) or Group(s) of Resellers.

    Also, an OEM can sell a Non-PMTA-ed Tobacco product to Wholesalers/Distributors. Or sell Non-PMTA-ed products for the purpose of Export.

    But No One is going to be able to Sell a Non-PMTA-ed Directly to a Consumer in a US Market after Sept 9th.
     
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