Micro-comment #13 for FDA Deeming - re: Hajek review - Blogs - E-Cigarette Forum
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Micro-comment #13 for FDA Deeming - re: Hajek review

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by , 08-02-2014 at 07:00 AM (570 Views)
Docket ID: FDA-2014-N-0189; RIN: 0910-AG38

Electronic cigarettes are not tobacco products and should not be treated as such. Deeming them as tobacco is a grave error with deadly consequences for more than 40 million American smokers who will be denied access to an alternative that is more than 1,000 times safer than combustible tobacco.

The proposed deeming regulations would remove more than 99% of electronic cigarette (ecig) products from the market and deliver the entire ecig business into the hands of Big Tobacco, doing more damage to public health than any cigarette company ever accomplished. This is because many of its premises are constructed on faulty assumptions [1], junk science [2a, 2b], and unsubstantiated propaganda [3a, 3b] from the tobacco control.

In contrast to the dismal evaluation of the health effects of ecigs in Section IV, constructed entirely of deprecated information, inaccuracies, and prejudice, a recent publication [4] concludes “compared with cigarettes, EC are likely to be much less, if at all, harmful to users or bystanders.” Again in contrast to unsubstantiated propaganda from tobacco control groups uncritically parroted by the FDA deeming proposal and after a thorough review of the existing literature, the study clearly demonstrates that there is no evidence of ecig use by never-smoking adults or youth; and that ecigs help users quit smoking. This study itemizes each misconception and lie propagated by tobacco control and other ecig prohibitionists and debunks the unsubstantiated propaganda by comprehensive reviews of existing evidence. This study builds a compelling case that regulating ecigs as tobacco products is not warranted by the current evidence and, as such, should be mandatory reading for any professional and/or regulator with a serious and honest commitment to improving public health and reducing smoking rates.

The FDA has a mandate and a moral obligation to protect public health by actively seeking and critically reviewing all the available evidence, as well as funding additional research that will further improve our understanding of ecigs. Researchers who are not conflicted by any current or previous association with tobacco control, pharmaceuticals, or Big Tobacco should be supported and encouraged to pursue these studies. Continued improvement and innovation of electronic cigarettes is in the interest of public health, not snubbing them by deeming as tobacco products.

[1] http://link.springer.com/article/10....204-013-1127-0
[2a] http://tobaccoanalysis.blogspot.com/...ttle-more.html
[2b] http://www.bernd-mayer.com/pseudosci...arette-policy/
[3a] http://tobaccoanalysis.blogspot.com/...rettes-by.html
[3b] http://www.ecigarette-research.com/w...z-response-cvd
[4] Hajek et al. (2014) - Attached

** you can get the study here: http://onlinelibrary.wiley.com/doi/1...12659/abstract
LaraC and bigdancehawk like this.


  1. LaraC's Avatar
    DrMA, you are doing a wonderful job commenting to FDA. Absolutely wonderful!

    I've sent in two comments to FDA now...one with quite a bit of your "capricious and arbitrary" copy/pasted.

    The second I sent was a great deal of the "Conclusion" in Hajek et al's review of benefit/harm. I was happy to see that you've also used that study's ammunition. Your comments are extremely professional in tone and content. A pleasure to read, as are your ECF posts.

    I'm cynical enough about the economic factors at play (BT, BP, tax seeking governments) to think nothing rational or truly science based can possibly stop the juggernaut. But at least everyone who comments against the deeming proposals for e-cigs will have tried.

    Thanks for what you're doing.

    Laura (LaraC on ECF)
  2. DrMA's Avatar
    Thanks, LaraC. I'm glad you found use in my posts to help formulate your own comments.

    In my view, the only way we can win this thing is if we demonstrate to FDA that there are too many well-informed and politically active vapers to ignore; vapers who can see straight thru their BS and will not stand idly by and let FDA impose arbitrary and capricious rules based on conflicted and junk science, misinformation and conjecture.