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FDA protects cigarette from snus, instructs TPSAC to criticize/oppose Swedish Match's MRTP application, TPSAC does as told

Discussion in 'FDA Regulations' started by Bill Godshall, Apr 14, 2015.

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  1. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    A very sad development for THR occurred last week as FDA defended the false and misleading fear mongering warnings on smokeless tobacco products, and responded with hostility to Swedish Match's 100,000+ page MRTP application to truthfully say that snus is less hazardous than cigarettes.


    Obama’s conflicted FDA (whose CTP director Mitch Zeller lobbied for GlaxoSmithKline to ban truthful health claims about smokeless tobacco) instructs its advisory committee (which CTP stacked with THR opponents and CTP funding recipients) to criticize and oppose Swedish Match’s MRTP application to truthfully say snus is less hazardous than cigarettes; FDA touts negligible and hypothetical risks of snus, fails to admit any health benefits of switching from cigarettes to snus, fails to quantify or compare risks of snus to cigarette smoking.
    http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM441431.pdf
    April 9-10, 2015 ? Tobacco Products Scientific Advisory Committee Meeting Announcement
    FDA reviews bid to certify certain tobacco products as less dangerous - Winston-Salem Journal: Local Business
    FDA takes cautious tone in initial Swedish Match review | Reuters
    FDA questions evidence for lower-risk tobacco product - US News

    Meet the cancer doctor who wants the FDA to tell the truth about smokeless tobacco
    http://www.washingtonpost.com/blogs/wonkblog/wp/2015/04/08/meet-the-cancer-doctor-who-wants-the-fda-to-soften-tobacco-warnings/

    Brad Rodu: FDA must correct snus warnings
    http://rodutobaccotruth.blogspot.com/2015/04/fda-must-correct-snus-warnings.html

    Brian Lehrer reports on Swedish Match’s MRTP application for snus
    The Brian Lehrer Show: Can Tobacco be Relatively Safe? - WNYC

    FDA’s TPSAC follows CTP’s instructions, opposes Swedish Match’s MRTP application to truthfully inform tobacco users that snus is less hazardous than cigarettes.
    FDA Panel Opposes Dropping Warnings From Tobacco Pouch - ABC News
    FDA Advisory Committee Hesitates To Endorse Message of Safe Smokeless Tobacco | Medpage Today
    http://www.nytimes.com/2015/04/11/science/milder-warning-opposed-for-swedish-tobacco-item.html

    In two articles about Swedish Match’s MRTP application, NY Times reporter Sabrina Tavernise falsely claims smokeless tobacco health statements have been banned for 50 years (they were banned by FSPTCA in 2009), confuses and conflates smokeless tobacco warnings (mandated in 1986) with cigarette warnings (mandated in 1965), cites false claims of Big Pharma financed Matt Myers without disclosing conflicts of interest. http://www.nytimes.com/2015/04/09/health/swedish-company-asks-fda-to-remove-warnings-from-smokeless-tobacco-product.html
    http://www.nytimes.com/2015/04/11/science/milder-warning-opposed-for-swedish-tobacco-item.html

    NY Times editorial criticizes FDA’s conflict of interest for hiring dietary supplement lobbyist, but fails to acknowledge or criticize FDA for hiring conflicted GlaxoSmithKline lobbyist Mitch Zeller to head its Center for Tobacco Products.
    http://www.nytimes.com/2015/04/13/opinion/conflicts-of-interest-at-the-fda.html

    ACSH: FDA’s tobacco advisory panel is “dazed and confused” at best, clearly conflicted on snus
    FDA

    Is there anything like a lower risk tobacco product?
    Is There Anything Like A Lower-Risk Tobacco Product? - NASDAQ.com

    FDA funded UCSF prohibitionists lie about risks of smokeless tobacco to scare public, lobby for adult usage bans (to purportedly protect the children).
    https://tobacco.ucsf.edu/new-ucsf-report-smokeless-tobacco-sport-and-use-among-adolescents
    Smokeless Tobacco in Sport and Use Among Adolescents [eScholarship]
     
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  2. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    If FDA officially rejects Swedish Match's MRTP application (to truthfully claim that snus is less hazardous than cigarettes), the precedent will be set for FDA (unless some heads roll) to never approve ANY MRTP application for any noncombustible tobacco product (including for any e-cig if/when FDA issues a Final Rule for the Deeming regulation).

    While that may not matter to many/most vapers who use PVs and e-liquid (since all PVs and e-liquid would be banned by the Deeming Regulation), the same is not true for Big Tobacco companies that want to make MRTP claims for their smokeless tobacco, for their cigalike e-cigs (some of which may be approved to be marketed by FDA) and for their new heat-not-burn tobacco products.

    Also, if FDA rejects Swedish Match's MRTP application, the costs of submitting a Premarket Tobacco Application for an e-cigarette product (if/when FDA issues a Final Rule for the Deeming Reg/ban) will sharply increase.


    When criticizing the FDA's MRTP protocols and guidance (to FDA's IOM Cmte, to FDA's TPSAC, and to FDA), I called the FDA MRTP application process a
    "ten million dollar smokeless tobacco truth tax" (because that's what I estimated it would cost to submit a smokeless tobacco MRTP).

    Then Swedish Match submitted its 100,000+ page MRTP application, which probably cost the company about $10 million.

    But if FDA rejects SM's MRTP application, it would be more accurate to refer to FDA's MRTP process as a
    "permanent ban on truthful claims by manufacturers about risks of their tobacco products".
     
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  3. DC2

    DC2 Tootie Puffer Verified Member ECF Veteran

    Jun 21, 2009
    San Diego
    A sad day indeed.

    This shows the true colors of the FDA for those who didn't see them already.
    And it shows where things are headed for us.
     
    • Like Like x 1
  4. Stubby

    Stubby Ultra Member ECF Veteran

    Apr 22, 2009
    Madison, WI USA
    • Like Like x 2
  5. 2coils

    2coils Ultra Member Verified Member ECF Veteran

    Nov 29, 2012
    New Jersey
    If rejected, is a lawsuit a possibility? One would think if the application cost was 10 million, they would be willing to pursue legal avenues. If this is a plausible scenario, a positive outcome in court would help our cause, wouldn't it? It would be wonderful if the FDA could be called out by a judge for this bias. I know it is a lot of what if's, I am just curious what the recourse is here.
     
    • Like Like x 1
  6. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    I know several DC lawfirms that would be pleased to assist (for a fee) Swedish Match in suing the FDA.

    But those decisions will have to wait until FDA officially rejects SM's MRTP application (this summer).
     
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