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George Mason’s Michael Marlow sends comment to FDA severely criticizing agency’s analysis of proposed deeming reg

Discussion in 'FDA Regulations' started by Bill Godshall, Jul 25, 2014.

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  1. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    George Mason’s Michael Marlow submits comment to FDA criticizing agency’s failures to develop cost-benefit analysis of its proposed deeming regulation, to quantify any of its stated public health benefits, to assess proposal’s costs of suppressing e-cig market, to consider that noncombustible tobacco/nicotine products pose far fewer risks than combustible tobacco products, and to acknowledge evidence that e-cigs help smokers quit.

    An truly excellent analysis and critique of FDA's proposed deeming regulation.
  2. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

    Jun 12, 2009
    NW Ohio US
    Marlow hits on all points and in a way that chastises the FDA on almost every point. Well worth the time to read.

    Some that got my attention:

    "The proposed rule pushes e-cigarette manufacturers
    to focus efforts toward developing new flavors, packaging, and other attributes unrelated to improved
    public health. The proposed rule might also promote combustible tobacco use because manufacturers
    will be unable to market e-cigarettes as safer alternatives or even state that they don’t contain tobacco. It
    is likely that fewer smokers will quit or reduce cigarette consumption. Public health will worsen to the
    extent that e-cigarettes are a safer alternative to tobacco cigarettes."

    And a good take on the consequences if the proposed deeming becomes the final rule:

    • Suppressing the e-cigarette market can be devastating to product innovation. Manufacturers
    will be unable to market their products as safer alternatives to cigarettes to smokers who are seeking
    harm reduction. The proposed rule pushes manufacturers to enlist other marketing angles,
    such as flavors, price, convenience, and appealing packaging. Public health worsens to the extent
    that manufacturers steer away from developing new products aimed at helping smokers reduce or
    quit smoking. In effect, the proposed rule removes much of the profit out of developing safer and
    more effective harm-reduction products and redirects resources toward other attributes unrelated
    to improved public health.

    • Suppressing the e-cigarette market is likely to promote FDA-approved NRT. This effect might
    improve public health if NRT is more effective than e-cigarettes in promoting lower consumption
    and quitting by smokers. However, as discussed above, the efficacy of NRT is debatable. Moreover,
    the literature suggests that smokers find e-cigarettes helpful. The FDA needs to explain why
    favoring the NRT industry promotes public health in light of this evidence.

    • The e-cigarette industry is likely to become less competitive as costs of bringing products
    to market and other costs rise. Limiting competition allows e-cigarette manufacturers to gain
    market power, thus raising prices, curbing consumption and limiting consumer choices. Larger
    firms carry an unfair advantage due to greater financial and legal resources, thus again limiting
    competition at the expense of consumers. Raising prices of e-cigarettes for smokers who might be
    interested in quitting is unlikely to promote public health when e-cigarettes are effective harm reduction

    There's much more, and again, worth taking the time to read it. Thanks Bill - might not have run into this elsewhere.
  3. dragonpuff

    dragonpuff Ultra Member Verified Member ECF Veteran

    I'm only halfway through reading this so far but it's incredible! I'm so glad this department at George Mason University took the time to analyze the situation and file a comprehensive report to the FDA :thumbs: we need institutions like this on our side!
  4. catlady60

    catlady60 Ultra Member Verified Member ECF Veteran

    Nov 14, 2013
    Nazareth, PA
    These facts point to a glaring conflict of interest the FDA would have to explain away disclose, evidence that BP has captured the FDA.
  5. SeniorBoy

    SeniorBoy Founder Verified Member ECF Veteran

    Supporting member
    May 21, 2013
    Las Vegas, NV
    Thanks Bill. Great find. Among the "take aways" from this well written and supported paper is that some vapers will return to smoking and deaths from smoking will rise if the deeming becomes the law of the land and NRT products remain an inferior solution compared to vaping.

    In many ways this reminds me of the:

    "The reputation of both the FDA and Merck lies in shambles today after evidence continues to surface that shows the FDA knowingly approved, promoted and refused to recall a dangerous drug that caused an untold number of fatalities among the American population: Vioxx. As readers of this website have long known, the FDA sees its job as promoting drugs and the financial interests of pharmaceutical companies, not in protecting the public health."

    Source: Reputation of the FDA in shambles after Vioxx scandal; calls for wholesale FDA reform gain momentum
  6. aubergine

    aubergine Ultra Member ECF Veteran

    Jan 22, 2010
    That's about the best opposition paper I've seen; spot on and excellent. I'm feeling less pessimistic lately (and unexpectedly) - might be in error but it just seems that there's a lot of well-prepared push-back from a lot of corners, more informed media pieces (that's a very low bar, but still) and ever-increasing 'normalization' of ecigs in the general public - that will count in Congress. The arguments on our side aren't exactly arcane - the appeal to common sense is all here. So, onward and upward. :)
  7. DrMA

    DrMA Ultra Member ECF Veteran

    Jan 26, 2013
    Seattle area
    Yes, here's that landmark study in The Lancet, which exposed the fact that Vioxx should've been banned by FDA 4 years prior to the voluntary withdrawal by Merck:

    The study concludes «The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarise the accumulating evidence need to be clarified.» Even in light of this evidence, repeatedly dismissed by FDA as "anecdotal" (sound familiar?), an FDA advisory panel voted that Vioxx should not be banned, in spite of the voluntary withdrawal by the manufacturer. This fits right into the long-running pattern of unethical behavior by FDA most recently exposed yet again by Judge Leon's ruling on the conflicts of interests of the TPSCA.
  8. nomore stinkies

    nomore stinkies Gee, Who did that? ECF Veteran

    Feb 23, 2014
    Bill, Excellent read. Can you tell us WHY they consider e cigarettes a tobacco product? I have read so many articles that state that they are not- including this one.

  9. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

    Jun 12, 2009
    NW Ohio US
    Pretty good explanation by Bill here:

    FDA Proposal For Deeming Regulation

    So while Judge Leon's 2010 ruling overturning the FDA's unlawful e-cig ban and the largely free market have enabled vapor products to significantly benefit the health of many smokers during the past several years, the FDA deeming regulation would not only halt, but would reverse all that progress because many vapers would return to cigarettes.

    To avoid losing another lawsuit, FDA might exempt e-cigarettes, cigars and other currently unregulated products from these 2007 and 2011 deadlines. But even if FDA changes these deadlines for newly regulated products, all e-cigarette products would be banned once Premarket Tobacco Applications are required for e-cigarettes.

    Basically, the FDA was stopped in banning ecigs directly, so the 'deeming' is the 'endaround', by merely "deeming" iow, lying or redefining ecigarettes to be 'tobacco products', despite the fact that the only characteristics that they have in common with the concept 'tobacco products' is that they are inhaled or puffed and appear to give off smoke (which they don't) and they contain nicotine (which they sometimes don't).

    This is analogous to "deeming" any four legged animal as a 'cat' even though it doesn't meow, purr, maintains an aloofness, likes to feed on birds, mice, chases laser dots and is the most photographed animal on the internet. :D
  10. Oliver

    Oliver ECF Founder, formerly SmokeyJoe Admin Verified Member ECF Veteran

    Possibly the best quote on this I've seen.
  11. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

    Jun 12, 2009
    NW Ohio US
  12. Anjaffm

    Anjaffm Dragon Lady ECF Veteran

    Supporting member
    Sep 12, 2013
    excellent find, Bill! :thumb:
  13. AndriaD

    AndriaD Reviewer / Blogger Verified Member ECF Veteran

    Jan 24, 2014
    I agree, really an excellent comment to the FDA on how stupid this deeming thing is. I just read it, and tweeted it -- lots of folks might not want to read something so long (reading is such HARD WORK, after all! :facepalm:) but some might read it and stand up and cheer alongside us!

  14. Stosh

    Stosh Vaping Master ECF Veteran

    Oct 2, 2010
    So the question is...did you copy and paste this into a FDA comment form? They deserve some sarcasm along with the serious entries.
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