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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. Rathamar

    Rathamar Super Member Verified Member ECF Veteran

    Sep 15, 2013
    Mound - Minnesota, USA
    Did anyone else see this -
    FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

    Looks like the application date is moved until August 2022.

    The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

    Good news for once!
    • Like Like x 18
  2. trying

    trying Senior Member ECF Veteran

    Jun 11, 2010
    Now we are free to focus on the local regulations
    • Like Like x 4
  3. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    The fda sees no clear and present danger. State and local government should also take a pause.
    • Like Like x 5
  4. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    SE PA

    news. :thumbs:
    • Like Like x 6
  5. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    Imagine the celebrations in the vape shops and e liquid makers. If this sticks it's global news. The vape business should use this time to address standards and safety so the government has something to endorse instead of coming up with their own stuff.
    • Like Like x 7
  6. rwoodin

    rwoodin Senior Member ECF Veteran

    This is the best news I've heard for the vapor industry and community since the deeming regs, ever!:rickroll:
    • Like Like x 5
  7. zoiDman

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

    Supporting member
    Apr 16, 2010
    I always felt that if we could just Hold On Long Enough, that Reputable Science and Non-Rhetoric Policy thinking could prevail.

    Extending out these Compliant Dates sorely helps to get us to a Place where THR can be Evaluated more Objectively.
    • Like Like x 8
  8. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

    Jun 12, 2009
    NW Ohio US
    Not all 'good' but a rather new view from the new "FDA Commissioner Scott Gottlieb, M.D. "Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it's vital that we pursue this common ground."
    • Like Like x 13
  9. tj99959

    tj99959 ECF Guru ECF Veteran

    Aug 13, 2011
    With the way the industry is, there probably isn't a product being sold today that will still be available in 2022. That alone will save the industry billions.
    • Like Like x 1
  10. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    SE PA
    Except that those aspects of the Deeming for which the deadlines have already passed are unaffected by this, meaning that in principle, any product introduced after August of 2016 still requires a PMTA before it can be sold.

    The question of course is to what degree of enforcement we'll see regarding new products that are marketed without a PMTA...
    • Like Like x 4
  11. SteveS45

    SteveS45 Moved On ECF Veteran

    Jan 27, 2016
    Long Island, New York
    • Like Like x 7
  12. Hulamoon

    Hulamoon ECF Guru Verified Member ECF Veteran

    Supporting member
    May 6, 2012
    Waikiki Hawaii
    When did the grandfather date move up to Aug 2016? That element is pretty important as the 2007 date was what was sticking in my craw.[/QUOTE]
  13. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    FDA Commissioner Scott Gottlieb delays FDA’s vapor PMTA application deadline and vapor prohibition date from November 8, 2018 until August 8, 2022, vaguely endorses THR, calls for FDA to develop a new comprehensive plan for tobacco, nicotine, vapor and flavor product regulation
    FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
    Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
    FDA's New Plan for Tobacco and Nicotine Regulation

    Scott Gottlieb’s special announcement on tobacco/nicotine/vapor policy is at
    Center For Tobacco Announcement

    Gottlieb also said FDA CTP intends to:
    - maintain Deeming Rule’s sales ban on all new vapor products since August 8, 2016,
    - maintain Deeming Rule’s ban on truthful health claims by vapor manufacturers,
    - reevaluate Deeming Rule’s policies on vapor products, cigars and OTP,
    - promulgate regulations and final guidances for PMTA, MRTP and SE applications,
    - promulgate rules on "kid-appealing" flavors in tobacco/vapor products (after FDA and its funding recipients falsely claimed, since 2009, that flavorings are marketed to youth),
    - promulgate more rules and standards for ENDS (vapor products), and
    - mandate low nicotine cigarettes (which would increase harms for many/most smokers, and would create an enormous black market for cigarettes).

    News articles on FDA Commissioner Scott Gottlieb’s announcement are at
    FDA unveils plan for major changes to tobacco product regulations
    FDA aims to lower nicotine in cigarettes in bid to get smokers to quit
    Tobacco Shares Plunge After FDA Proposes Cut to Cigarette Nicotine
    FDA aims to cut nicotine in cigarettes, shift toward e-cigarettes
    British American Tobacco not surprised by FDA move to cut nicotine

    Altria responds to Scott Gottlieb’s announcement
    Press Release

    Clive Bates: Huge FDA announcement on future tobacco and nicotine strategy
    Huge FDA announcement on future tobacco and nicotine strategy
    • Like Like x 7
    • Useful Useful x 1
  14. Akrotiri

    Akrotiri Moved On

    Oct 4, 2016
    No you you didn't. In my thread which you hijacked some time ago(president trump just saved vaping) you were emphatic that the deeming laws were unavoidable and already codified into law.

    I was 100% correct. I graciously tried to inform ECF members that the deeming regs were not yet codified due to lack of legislative days in the federal register and were in fact invalidated by trumps second executive order.

    The thanks I got is that my IP address gets banned from ECF because of your trolling in my thread. I encourage everyone who reads this to read thru my thread "President Trump just saved vaping" to see how right I was and incorrect you were.

    Also, the FDA is directly investigating ECF. For further information regarding the progress and reasons for the investigation I require ECF to unblock my IP and an apology from those who derailed my thread . That is all.
    • Like Like x 2
  15. cookiebun

    cookiebun Ultra Member ECF Veteran

    Mar 6, 2011
    Central Ohio

    I'm all ears. Why would the FDA investigate ECF? :shock:
    • Like Like x 3
  16. Herrick

    Herrick Super Member ECF Veteran

    Oct 21, 2016
    So now all these vape companies have 5 years. How many of them will be able to afford the FDA hoop-jumping process in 2022?
    • Like Like x 2
  17. zoiDman

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

    Supporting member
    Apr 16, 2010
    If the FDA actually established Standards for PMTA, SE and MRTA approval, wouldn't this Substantially Reduce the cost of doing a successful PMTA, SE or MRTA?

    Too Earlier to say how all this is going to Play Out. But I am Hopefully Optimistic by the Tone and Direction the FDA says it wants to move in regarding "Tobacco Products".
    • Like Like x 7

    JUDGMENT AFFIRMED Ultra Member ECF Veteran

    Jul 24, 2012
    I recall reading that thread and it does appear that you were right Akrotiri. :thumbs::thumbs::thumbs::thumbs::thumbs::thumbs::thumbs:
    • Like Like x 1
  19. zoiDman

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

    Supporting member
    Apr 16, 2010
    I Hate to be the Big Black Fly in the Frosting Akrotiri. But Deeming is Still in Effect.

    Yes, the PMTA Filing Date has been Extended. And there were Positive Remarks made about reviewing the PMTA, SE, MRTA processes, but Deeming hasn't gone anywhere just yet.

    If you want someone to thank, Ironically that would probably be Judge Jackson.

    And this Didn't Happen. Or wasn't even close.

    • Like Like x 5
  20. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    There are a few items left to get for the stockpile (see below). Nothing announced today changes that plan. I probably won't delay the last purchases because I'd like to stop fretting about it.

    The plan appears to be to take the nicotine out of cigarettes and encourage smokers to get their nic fix from something lower risk, including vaping. It might work.

    The FDA is a revered institution around the world (deserved or not). All of a sudden vapers have the moral high ground, one of my favorite places.
    • Like Like x 6
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