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The Vuse application for PMTA

Discussion in 'FDA Regulations' started by Stubby, Oct 12, 2019.

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  1. Stubby

    Stubby Ultra Member ECF Veteran

    Apr 22, 2009
    Madison, WI USA
    "The FDA’s premarket application process requires tobacco manufacturers provide not only information on the composition, design and manufacturing process, but also chemistry, toxicological and behavioral studies that demonstrate the product − when used − is appropriate for the protection of the public health.

    Reynolds said its submission contained more than 150,000 pages of documentation."

    Are there any open systems that have applied?

    Reynolds applies to FDA for premarket status for Vuse e-cigarette
    • Like Like x 1
  2. JD4x4

    JD4x4 Senior Member Verified Member ECF Veteran

    Jan 21, 2012
    No replies? I was looking for info on that myself.
    Seems to me that it would take just one of the new AIO/pod mfrs to certify with a flavorless e-liquid to break down the walls.. but admittedly I haven't had the time nor the stomach to scrutinize the PMTA in any detail.

    Any learned opinions here?
    • Like Like x 1
  3. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    According to a Wall St Journal article, JTI apparently submitted PMTAs for their Logic e-cigarettes in August,
    and NJOY is planning to submit PMTAs for some of its vapor products in January.

    Reynolds files for FDA review of Vuse e-cigarettes
    Tobacco giant gets a head start on rivals in seeking approval to keep vaping products on the market
    Reynolds Files for FDA Review of Vuse E-Cigarettes

    But after ten years since the TCA was enacted, the FDA has only approved two sets of PMTAs
    (for several SM's General Snus products, and recently for several PMI's IQOS products).
    FDA has also refused to officially review more than 400 PMTAs that were submitted.

    Since 2014, I have stated that the only PMTAs for vapor products that FDA will decide to officially review
    (next May) will be those submitted by Altria, Reynolds, Imperial, JTI and perhaps by NJOY and another large vape company (e.g. JUUL).

    On May 12, 2020, FDA will ban the sale of all nicotine vapor products that haven't submitted PMTAs (i.e. >99,9% of nicotine vapes now on the US market).
    • Informative Informative x 4
  4. JD4x4

    JD4x4 Senior Member Verified Member ECF Veteran

    Jan 21, 2012
    @Bill Godshall - Is the PMTA only for complete products? i.e. Only an AllInOne system or could a power unit with tank/coil be approved for say, a particular USP PG/VG/Nic solution?
    Typing that makes me think that it would have to be a "closed" AIO system. And that would mean absolutely limited choices going forward without blackmarket. :(

    I have to say that I actually would hate to be the guy at FDA discussing that, lol.

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