Deeming Regulations have been released!!!!

Z-Lee

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  • Apr 17, 2021
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    How dare you?? Bite your tongue little one!!

    Never in my 46 years old on this earth have i heard or read such blasphemous words :-x:-x

    There is and will only be one Solo in this world!!

    View attachment 959367
    What about this guy, though? :unsure:

    upload_2021-10-13_4-36-24.png
     

    mikepetro

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    Apparently, Vuse has been approved. I am shocked, I tell ya. :D
    "The demands the FDA places on companies filing these applications are so extraordinary difficult to meet that only those with huge resources and personnel — in terms of scientists, lawyers, researchers — are able to file successfully,”

    I am shocked that the first PMTA to pass was from BT. I didnt see that coming at all.

    BTW, I just got a heck of a deal on some ocean front property in Idaho!
     

    Bronze

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    "The demands the FDA places on companies filing these applications are so extraordinary difficult to meet that only those with huge resources and personnel — in terms of scientists, lawyers, researchers — are able to file successfully,”

    I am shocked that the first PMTA to pass was from BT. I didnt see that coming at all.

    BTW, I just got a heck of a deal on some ocean front property in Idaho!
    I still have ocean front property for sale in Iowa.
     

    Javichu

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    One thing that really troubles me.

    Ok so one life isn't worth more than another,i mean we can all agree with that.

    A 15 year old kid's life is worth exactly the same as a 40 year old man,so what really bothers me is all i hear and read about is the young people,the kids...the children.

    Already been proven that cigarettes kill...so when push comes to shove let the kids be addicted to nicotine,they won't be dying from vaping anytime soon.
    Seems they worried about kids getting addicted to nicotine but they totally cast aside the fact that vaping saves the lives of adults.

    Sure kids are addicted to nicotine,place the blame on the parents for not taking the time to educate them properly and also blame the stores that sell vaping products to minors but think of all the lives of adults that will be saved.

    All the articles,newspaper pieces and videos mention kids and children but why no mention of adults?
    Seems the life of an adult isn't worth anything,at least that is what their behavior and laws towards vaping is telling us.
     

    Z-Lee

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    If they legitimately follow through with this, it would turn the tide for the entire battle we face. Unfortunately, if you've noticed, they like to pick and choose what statements are applied where, to best fit their agenda. And by agenda, I mean line the right pockets.
     

    zoiDman

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    Is that the Opinion of the FDA? Or is that the Spin the NYT would like people to Believe?

    Because one would be a Net Benefit, Science Based Approach to Public Health Policy. And the Other is a Whitewashing by a Media Outlet who has Habitually Skewed the Truth when it comes to All Things e-Cigarette related.

    Not trying to be the Big Black Fly in the Wedding Cake Frosting. Just someone who puts Little Faith in the NYT as a Balanced and Unbiased News Organization.
     

    zoiDman

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    Is that the Opinion of the FDA? Or is that the Spin the NYT would like people to Believe?

    Because one would be a Net Benefit, Science Based Approach to Public Health Policy. And the Other is a Whitewashing by a Media Outlet who has Habitually Skewed the Truth when it comes to All Things e-Cigarette related.

    Not trying to be the Big Black Fly in the Wedding Cake Frosting. Just someone who puts Little Faith in the NYT as a Balanced and Unbiased News Organization.

    I did a Quick Search of the FDA to find the Exact Text of what was said. Here it is...

    "...

    Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes. The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.

    ..."

    FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency

    So now it is Time for Zeller to Demonstrate that what he is saying is true and what he means.

    And that Demonstration would be by Issuing a PMTA Authorization for a Similar Cigalike that Isn't made by a Multi-National BT Company.
     

    ShowMeTwice

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    @dreamvaper, @Z-Lee and @Javichu it was nice seeing y'all bring some needed levity to this thread. It was getting kinda stale. :D

    And I learned something new too. Dreamvaper is into spankings. Didn't know that about her. :lol:


    Ok, carry on then... where were y'all, oh yes, doom and gloom. Just teasing, maybe. ;)
     

    mikepetro

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    Is that the Opinion of the FDA? Or is that the Spin the NYT would like people to Believe?

    Because one would be a Net Benefit, Science Based Approach to Public Health Policy. And the Other is a Whitewashing by a Media Outlet who has Habitually Skewed the Truth when it comes to All Things e-Cigarette related.

    Not trying to be the Big Black Fly in the Wedding Cake Frosting. Just someone who puts Little Faith in the NYT as a Balanced and Unbiased News Organization.

    These were the words of the FDA. Media bias not at play.

    FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency

    "Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes. The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products."

    The whole paragraph echoes what we have been saying all along.


    ETA: @zoiDman Now I see that you found it as well.
     

    zoiDman

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    These were the words of the FDA. Media bias not at play.

    FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency

    "Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes. The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products."

    The whole paragraph echoes what we have been saying all along.


    ETA: @zoiDman Now I see that you found it as well.

    Yep... This is where the Rubber Meets the Road.

    Because there is Nothing really Spectacular/Innovative about a Vuse Solo. So Common Wisdom would say that Similar Products in that class should be Authorized Also.

    Even Non-BT ones.
     

    Z-Lee

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    @dreamvaper, @Z-Lee and @Javichu it was nice seeing y'all bring some needed levity to this thread. It was getting kinda stale. :D

    And I learned something new too. Dreamvaper is into spankings. Didn't know that about her. :lol:


    Ok, carry on then... where were y'all, oh yes, doom and gloom. Just teasing, maybe. ;)
    It's been brought to my attention on more than a few occasions that this forum's admin are not interested in "fun", which is why I'm no longer very active here. Glad to see you're still making your rounds though SMT. I do miss some of you.
     

    Z-Lee

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    provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.
    This little clause is their scapegoat. Enforcement of proper distribution has very little, if any, connection to the manufacturers. Sure, don't make products that look like popsicles and sing "My Little Pony" songs when you pull a cord. Derp.

    At any point in time, they can use that clause to claim that a manufacturer isn't doing it's part, which is part of the agreement, thus nullifying it.
     

    Z-Lee

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    Yep... This is where the Rubber Meets the Road.

    Because there is Nothing really Spectacular/Innovative about a Vuse Solo. So Common Wisdom would say that Similar Products in that class should be Authorized Also.

    Even Non-BT ones.
    But is that really what how they're looking at it? An even playing field for manufacturers? I very highly doubt it.
     

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