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FDA is giving $1,000,000 to the IOM to demonize (er study) vaping

Discussion in 'FDA Regulations' started by Bill Godshall, Feb 26, 2016.

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  1. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    The FDA is giving $1,000,000 to the IOM purportedly "to conduct an in-depth evaluation of available evidence of health effects from e-cigarettes and recommendations for future federally funded research."
    Study on the Health Effects of Electronic Nicotine Delivery Systems and Priority Research - Federal Business Opportunities: Opportunities

    Looks like FDA wasn't pleased with, and plans to counter, the evaluation done by Public Health England.

    The last time FDA contracted with IOM to purportedly evaluate the scientific evidence on tobacco products five years ago, the IOM Committee rubber stamped FDA's deceitful default policy that "all tobacco products are as harmful as cigarettes" and recommended what evolved into FDA's MRTP Guidance that requires smokeless tobacco companies to spend
    millions (perhaps tens of millions) of dollars and obtain FDA permission before they can truthfully inform smokers that smokeless tobacco products are less harmful than cigarettes.

    After I urged the IOM Cmte to truthfully acknowledge (in its report) that smokeless tobacco products are far less harmful than cigarettes (during the public comment period of FDA's meeting with the IOM Cmte), former FDA CTP Director Lawrence Deyton instructed his funded IOM Cmte to NOT compare or differentiate the health risks of different tobacco products. The IOM Cmte did exactly what FDA's Deyton hired and instructed them to do.

    In its 2011 IOM MRTP report, Committee chair Jane Henney falsely claimed "“Right now there’s a shortage of scientific evidence on the health effects of modified risk tobacco products," while her committee's report failed to acknowledge the enormous body of scientific evidence confirming that smokefree tobacco products are far less hazardous than cigarettes. is external) is external)

    To date, Swedish Match is the only company that has submitted an MRTP application to FDA for its snus products (that FDA accepted for review), and is now awaiting FDA's decision.

    Below is my February 3, 2011 presentation to the IOM MRTP Cmte.


    I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable for past misdeeds, increase cigarette tax rates, fund tobacco education and smoking cessation services, and inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

    For disclosure, neither Smokefree Pennsylvania nor I have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.

    There appear to be three different types of modified risk or reduced exposure applications that will be submitted to the FDA via Section 911 of the FSPTCA:

    - those comparing a smokefree tobacco product to cigarettes,
    - those comparing a cigarette to other cigarettes, and
    - those comparing a smokefree product to other smokefree products.

    Existing scientific evidence indicates that all cigarettes pose similar morbidity and mortality risks, and that all smokeless tobacco products marketed in the US pose similar morbidity and mortality risks. So additional evidence is needed before one cigarette can be determined to be less hazardous than another, and more evidence is needed before one smokeless tobacco product can be determined to be less hazardous than another.

    In sharp contrast, many decades of scientific evidence confirms that daily use of smokefree tobacco products marketed in the US and Sweden pose about 99% fewer mortality risks than cigarette smoking, and that switching to smokefree tobacco products reduces a smoker’s mortality risks nearly as much as quitting all tobacco/nicotine. Nonsmokers are also exposed to less tobacco smoke when smokers switch to smokefree alternatives.

    Since >99% of all tobacco attributable deaths in the US are caused by the repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco products, it is vitally important for this committee to acknowledge these exponential differences of risk and encourage the FDA to incorporate this into the establishment of criteria for evaluating modified risk and reduced exposure tobacco product applications.

    In the absence of reduced risk marketing claims, population surveys confirm that several million smokers have already switched to smokeless tobacco products even though the vast majority of smokers inaccurately believe that smokeless tobacco is just as hazardous as cigarettes. So smokeless tobacco products have already saved more lives (of smokers) than could be offset even if every non-tobacco user in America begins to use smokeless tobacco.

    Even if many more non-tobacco users begin using smokeless tobacco products, the truthful marketing of smokefree tobacco products as lower risk or reduced exposure alternatives to cigarettes can only further reduce tobacco morbidity and mortality (to a meaningful degree).

    Therefore, this committee should encourage the FDA to not require new costly studies for a smokefree tobacco product to claim it is less hazardous than cigarettes. But reasonable post-market surveillance should be required.

    Requiring additional scientific studies for these types of modified risk or reduced exposure claims would be a “truth tax” for far less hazardous smokefree alternatives, would unfairly protect cigarettes from market competition by lower risk alternatives, and would threaten instead of improve public health.

    Once the FDA begins approving truthful modified risk or reduced exposure claims for smokeless tobacco products compared to cigarettes, the agency also will be prompted to evaluate and eliminate the 25 year old intentionally misleading Congressionally mandated warning on smokeless tobacco products and advertisements stating: “This product is not a safe alternative to cigarettes,” which has confused most smokers to believe that smokefree products are just as hazardous as cigarettes.

    Please remember that smokers have a human right to accurate and relevant health information and legal access to far less hazardous alternatives. The IOM and FDA should ensure that.

    Thank You,"
    • Like Like x 13
  2. nicnik

    nicnik Ultra Member ECF Veteran

    Apr 20, 2015
    Illinois, USA
    Thank you, Bill.
    • Like Like x 1
  3. DC2

    DC2 Tootie Puffer Verified Member ECF Veteran

    Jun 21, 2009
    San Diego
    This is what we face.
    And not enough of us care.

    That's about all I have to say after 6 years in this mess.

    Every damn one of us should care.
    And should make SURE our families and friends care too.
    • Like Like x 6
  4. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    Instead of another expensive study we could invite the Britsh public health people and the American public health people to meet at Bunker Hill in Massachusetts. We give them some muskets and cannons and let em have at it. I'm hopeful about the outcome because the Brits won there last time.
    • Like Like x 11
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