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Submission Date Moved to 8/8/2022

Discussion in 'FDA Regulations' started by Rathamar, Jul 28, 2017.

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  1. stols001

    stols001 Mistress of the Dark Nicotinic Arts Verified Member ECF Veteran

    Supporting member
    May 30, 2017
    Tucson, AZ
    Now I want to go!!!!! Moooom! Rossum says I can't go OUTSIDE!


    LOL, I think I will heed your advice for now, Rossum. Like I need more troubles.... :)

    Anna
     
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  2. SeniorBoy

    SeniorBoy VapeFight.com Founder Verified Member ECF Veteran

    Supporting member
    May 21, 2013
    Las Vegas, NV
    FYI. May have been posted by others. Bolded by yours truly:

    "President Donald Trump’s pick to head the U.S. Food and Drug Administration, Scott Gottlieb, will be in charge of implementing new rules governing the e-cigarette industry after serving for more than a year on the board of a company that sells vaping products. From March 2015 to May 2016, Gottlieb was a director of Kure Corp., a Charlotte, North Carolina-based firm that distributes e-juices and vaping pens in coffeehouse-style lounges known as vaporiums. He had a financial interest in the company as of March, according to financial and ethics disclosures, and promised to sell his stake if confirmed."

    Article dated 4/19/17 - Source

    EDIT: Disclosure by Dr. Gottlieb
     
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  3. stols001

    stols001 Mistress of the Dark Nicotinic Arts Verified Member ECF Veteran

    Supporting member
    May 30, 2017
    Tucson, AZ
    Yes, I think I saw that elsewhere in a news article, including the fact that Dr. Gottleib had cancer.... It kind of makes me conclude that he may be a former-smoker, current-vaper, and if so, good for him. I wish he'd pulled out his vape during the speech he gave, and started demonstrating it's features.

    I kid. This is all speculative, but it did make me think about that stuff. If e-cigging is going to be deemed by anyone, I'd be thrilled to have it be by someone who actually knows ANYTHING about vaping. Maybe why BT has been so... quiet-ish of late? (again, speculation).

    Anna
     
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  4. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    According to Wikipedia, he had Hodgkin's lymphoma. I'm not aware of any correlation between that and smoking.
     
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  5. stols001

    stols001 Mistress of the Dark Nicotinic Arts Verified Member ECF Veteran

    Supporting member
    May 30, 2017
    Tucson, AZ
    Nope, me neither. Thanks for the lookup. I still think it might make him very aware of what cancer is like on a visceral level....

    Anna
     
  6. Grego25

    Grego25 Senior Member ECF Veteran

    May 11, 2016
    I haven't been on ecf in a while & must have missed something. When was the date changed from 2007 to 2016? Last I saw the amendment was in the house


    Sent from my iPhone using Tapatalk
     
  7. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    It wasn't. The date that got changed was 2018 to 2022. That effectively allows products that were on the market prior to 8/8/2016 to remain on the market for an additional 4 years, but not in perpetuity, like Cole-Bishop would.
     
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  8. Grego25

    Grego25 Senior Member ECF Veteran

    May 11, 2016
    Thanks


    Sent from my iPhone using Tapatalk
     
  9. Verb

    Verb Ultra Member Verified Member ECF Veteran

    Apr 26, 2014
    Eastern, PA, USA
    I reason, the reason the FDA is not enforcing the 8/16 freeze on hardware sold without nicotine containing liquid, it opens them up to having to defend in court that zero nicotine vaping is tobacco use.

    I could see them coming down on liquids first to test the waters.
     
  10. zoiDman

    zoiDman My -0^10 = Nothing at All* ECF Veteran

    Supporting member
    Apr 16, 2010
    So-Cal
    I'm not sure how Opened that Door is anymore? Now that Judge Jackson ruled that the FDA was within it's Authority to apply "Intended Use" if there was a "Reasonable Expectation" that a piece of Hardware was going to be used with Nicotine derived from Tobacco.
     
  11. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    Under Gottlieb's four year delay, no new vapor products will be allowed to be lawfully marketed in the US unless/until FDA has approved a PMTA for them.
    So that claim by Gottlieb was obviously false.

    Ironically (or not), those who lobbied Congress to enact the TCA (from 2004-2009) also falsely claimed that the TCA would encourage the development of new low risk tobacco products (even though it banned all of them by imposing a grandfather date, and requiring FDA approval of a PMTA for any new product).

    Similarly, those who lobbied FDA to impose the Deeming Regulation (as well as FDA's Mitch Zeller) falsely claimed that the Deeming Regulation would encourae the development of new low risk tobacco and vapor products (even though the Deeming Reg would have banned >99.9% of vapor products in 2018 had Gottlieb not extended the deadline four more years).

    But Gottlieb's four year delay in the Deeming Regulation will encourage vapor manufacturers in other countries to develop new vapor products (that will be unlawfully sold in the US).
     
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  12. zoiDman

    zoiDman My -0^10 = Nothing at All* ECF Veteran

    Supporting member
    Apr 16, 2010
    So-Cal
    The TCA and the FDA's Deeming do many things. But encouraging the development of New low risk tobacco and vapor products is about the Last Thing that either do.

    Hard to believe a Lobbyist (or anyone for that matter) could even say they would with a Straight Face.
     
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  13. Verb

    Verb Ultra Member Verified Member ECF Veteran

    Apr 26, 2014
    Eastern, PA, USA
    But she also ruled the ability to argue for zero nicotine eLiquid and the equipment used to vape it has not been "made ripe" since no enforcement against it, for being sold as an unapproved tobacco product, has taken place.

    As soon as they try to bring open system hardware into the fold, the argument becomes ripe for a court challenge. Using a "never to be used with tobacco or its derivatives" label would be a good idea before bringing a challenge.

    I really wish a clear answer would have been provided to the judge when she rhetorically asked, what else would a person do with the device (other than consume a tobacco product).
     
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  14. sky4it

    sky4it Super Member ECF Veteran

    Nov 6, 2013
    Minnesota
    Kent:

    A question for you here. Am I to understand that nicotine and flavorings that were for sale prior to Aug 2016 now will have an extended date until August 2022 for approval by FDA? You know nicotine that you mix with flavoring sold by all these vendors? And flavorings also?

    If that is so this is a huge victory for vaping.
     
  15. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    I'm not Kent, but I'll throw two cents in anyway:

    I don't think that's necessarily a sure thing. The FDA could propose additional rules at any time; stuff like restricting the nicotine concentrations in products sold to consumers, banning diketones in anything intended for vaping, etc, etc. However, I would suppose we'd have some warning because they'd have to go through the rule-making process, which generally takes a few months at an absolute minimum.
     
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  16. Myrany

    Myrany Vaping Master Verified Member ECF Veteran

    Supporting member
    Apr 14, 2013
    Louisiana
    Also remember many of the flavorings we use were never intended for vaping to begin with. THey are food flavoring so would likely stay on the market regardless if not sold by a vape shop.

    Edit: I have always seen the nicotine as the real choke point the FDA could grab us by. PG, VG, Flavorings even batterys all have other uses non vaping related. Hardware can be improvised. Nicotine IS the sticker.
     
    • Like Like x 7
  17. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

    Jun 12, 2009
    NW Ohio US
    I was commenting 'nice job' to zoidman's post, but you should also look at Bill G's reply here, that contains zoidman's quote:

    Submission Date Moved to 8/8/2022

    IOW, that 'extended date' is for suppliers to submit PMTA's for approval. Not a small task for many suppliers.


    And thanks to Rossum for pinch hitting while I was away..... I agree with what he said as well.
     
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  18. sky4it

    sky4it Super Member ECF Veteran

    Nov 6, 2013
    Minnesota
    thanks Kent & Rossum.

    Rossum but there are no proposed rules on the table, at least not that I could discern from glancing the stuff over. In addition, it would only seem reasonable if they were going to regulate nicotine, a window of just a few months would seem predatory.

    The scope of this seems rather large, I would of thought the labs selling nicotine would have been out of business by august 2018 but now it seems to go on, which I think is huge news.

    Im more concerned about my favorite flavorings, you cant store the stuff beyond a year or two.

    Your the expert here Kent, you got an opinion? I will be just reading and listening.
     
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  19. zoiDman

    zoiDman My -0^10 = Nothing at All* ECF Veteran

    Supporting member
    Apr 16, 2010
    So-Cal
    I'm not Rossum.

    But this is what a ANPRM (Advanced Notice of Proposed Rule Making) does.
     
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  20. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    The regs that were finalized last year left some room for doubt. The stated that the FDA wasn't planning on to enforce against anything that wasn't a finished product, and the most common 100mg/ml nic base isn't, because nobody would vape it straight.

    I guess it depends on what your favorite flavorings are, but flavorings in general were way down the worry list because they easily pass the "What else would someone do with this product?" test.
     
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