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CASAA - A Nod to Harm Reduction from FDA’s New Director, Scott Gottlieb

Discussion in 'FDA Regulations' started by noevilstar, May 20, 2017.

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  1. noevilstar

    noevilstar Senior Member<br>CASAA Board Member ECF Veteran

    Feb 10, 2013
    Union City, NJ
    On Monday, May 15th, Scott Gottlieb M.D. made his first remarks to agency staff as the new director of the Food and Drug Administration (FDA). Of particular interest are Dr. Gottlieb’s statements regarding the importance of reducing smoking rates. Specifically, we are encouraged by the new FDA director’s statement that, “we need to have the science base to explore the potential to move current smokers–unable or unwilling to quit–to less harmful products, if they can’t quit altogether.”

    This is, of course, a step in the right direction, and many will read this as a signal that under Dr. Gottlieb’s leadership the FDA is likely to embrace a harm reduction strategy for reducing the harms of smoking. But CASAA would be remiss if we didn’t point out that this statement is bookended by the familiar (and unhelpful) “tobacco-free” mantra. It is vital to remember that we are working to reduce the harm of smoking and, as shown by decades of research from Sweden, the UK, and here in the US, smoke-free tobacco and nicotine products are a significant part of the solution.

    CASAA strongly urges Dr. Gottlieb to consider that rather than redoubling efforts to achieve tobacco and nicotine cessation, the FDA should accept the decades of research currently available that supports the efficacy of harm reduction strategies. Just as harm reduction has proven beneficial in reducing rates of sexually transmitted diseases, overdoses from drug use, and injuries from everyday activities, evidence–more than enough evidence–exists to support a similar policy to be applied to tobacco.

    While it may seem like the airwaves and news feeds are populated with strange statements from our political leaders, we still live in a world where words matter. There should be little doubt that Dr. Gottlieb’s statement to FDA staff was thoroughly contemplated and delivered deliberately. We are hopeful that his reference to an archaic abstinence-only message of complete tobacco and nicotine cessation is a fading evolutionary remnant. We believe that the agency is long overdue in acknowledging this strategy and “quit or die” messaging has run its course.

    Suggesting that the ultimate goal of the FDA is to “help smokers become tobacco-free” betrays a central pillar of harm reduction and hamstrings the agency before serious policy change can begin. A “tobacco-free generation” borrows heavily from the lofty dream of a “drug-free America.” While those slogans may evoke strong feelings among puritans, they have never worked particularly well as policies in the real world.

    We are excited to see the changes that Dr. Gottlieb will bring to the FDA. We appreciate that he will need to overcome deep structural barriers, and a nod to harm reduction is a step in the right direction. At the same time, it is also a clear signal that we must redouble our efforts in demanding access to affordable, enjoyable, and effective low-risk tobacco and nicotine products.

    (A Nod to Harm Reduction from FDA’s New Director, Scott Gottlieb - CASAA)
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  2. zoiDman

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

    Supporting member
    Apr 16, 2010
    Thank You for posting this noevilstar.
  3. Stubby

    Stubby Ultra Member ECF Veteran

    Apr 22, 2009
    Madison, WI USA
    When Mitch Zeller came in he often talked about the continuum of risk with different tobacco products. He also openly admitted smokeless tobacco was significantly less harmful than cigarettes. He talked elegantly on the concept of harm reduction.

    What he actually did is go on a holy war against ST, and then set about to destroy the vaping world. The FDA is essentially trying to crush every low risk alternative to smoking via regulation.

    I think the thing to watch is if he replaces Zeller, and with whom. If it is just another prohibitionist I am not going to get my hopes up.
  4. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    It's pretty obvious the new administration is sympathetic to our cause, broadly. After that what are their options to modify or undo what the FDA has prepared for vapers? I don't know enough to make a list.
  5. Stubby

    Stubby Ultra Member ECF Veteran

    Apr 22, 2009
    Madison, WI USA
    I have never heard anyone in the administration say anything about vaping. They have been completely silent on the subject.
  6. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    Putting Gottlieb as head of the FDA is enccouraging. His affilliations and policy positions are favorable. As I wrote earlier, I don't know what his options are.
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