FDA Deeming updates PMTA deadlines delayed by three months

Discussion in 'FDA Regulations' started by Oliver, May 3, 2017.

Image has been removed.
URL has been removed.
Email address has been removed.
Media has been removed.
  1. Oliver

    Oliver ECF Founder, formerly SmokeyJoe Admin Verified Member ECF Veteran

    Dropping this here (via email):

    Subject: FDA Announces Information about Outstanding Compliance Deadlines related to Deeming Final Rule


    Good evening,



    The U.S. Food and Drug Administration is announcing information about the outstanding compliance deadlines related to the May 2016 final rule that extended the agency’s authority to additional tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.



    In lawsuits regarding the final rule, the FDA has stated that it will defer enforcement of all future compliance deadlines under the rule for electronic nicotine delivery systems (ENDS) such as e-cigarettes, cigars, and pipe tobacco for three months. In light of this, the FDA also intends to defer enforcement of all future compliance deadlines for all categories of newly regulated products for three months and plans to issue guidance describing its position in the near future.



    This concerns deadlines set for May 10, 2017, or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports.



    This does not apply to provisions of the final rule where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.



    This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.



    Please contact me with any questions.



    Lindsay R. Tobias
    Policy Analyst, Stakeholder Relations Office

    Center for Tobacco Products

    Office of the Center Director
    U.S. Food and Drug Administration
     
    oplholik, Rossum, halbgott and 5 others like this.
  2. WillyZee

    WillyZee Vaping Master Verified Member ECF Veteran

    Sep 23, 2013
    Toronto
    looks like they were expecting more PMTAs submitted than ... zero.

    I am curious if anyone knows of even one PMTA submitted ... juice or hardware?
     
    schismz likes this.
  3. tomzgreat

    tomzgreat Ultra Member Verified Member ECF Veteran

    Jun 5, 2009
    Chino California
    Sounds like the Trump Administration is halting Industry killing regulations for now.

    "This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court."
     
    schismz and WillyZee like this.
  4. zoiDman

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

    Supporting member
    Apr 16, 2010
    So-Cal
    These are Two of the Sweetest Words (regarding the FDA) that I have ever seen posted in my Entire Time on the ECF.

    New Leadership
     
  5. Oliver

    Oliver ECF Founder, formerly SmokeyJoe Admin Verified Member ECF Veteran

    Yes, there's quite a few PMTAs being submitted for juice and hardware.
     
  6. Oliver

    Oliver ECF Founder, formerly SmokeyJoe Admin Verified Member ECF Veteran

    Please note, they've not been submitted, but are going through the process of submission. There's quite a few steps. Some manufacturers are taking a "wait see" approach, engaging in the first part of the process but not committing to the very expensive parts until they have to.

    Jury's out as to whether any of them will be approved - but if you think hard about what's likely to happen, and use this blog post to inform your thinking, I reckon you can see where this is all heading.

    Short answer, we'll be able to get eliquid. Will it cost more and there be less choice? Probably. Will it gut the industry? Most likely.
     
    zoiDman likes this.
  7. Truthdog

    Truthdog Senior Member ECF Veteran

    Supporting member
    Jul 9, 2016
    Washington, DC
    Will any flavors be approved? Doubtful. Unless WE change it!


    Sent from my iPhone using Tapatalk
     
    LaraC and DC2 like this.
  8. WillyZee

    WillyZee Vaping Master Verified Member ECF Veteran

    Sep 23, 2013
    Toronto
    I'm basically asking if anyone has dropped down the cash on PMTAs ... and I'm curious who?

    I'm still thinking it's nobody ... both hardware and eLiquid.

    I also think BT has likely already submitted PMTAs on locked down pod systems (devices we won't see or even hear about until they are FDA approved).


    Sent via iPhone
     
    ENAUD, DC2, LaraC and 1 other person like this.

Share This Page