Micro-comment #13 for FDA Deeming - re: Hajek review

Published by DrMA in the blog DrMA's blog. Views: 109

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/10.1007/s00204-013-1127-0
[2a] http://tobaccoanalysis.blogspot.com/2014/05/glantz-review-article-is-little-more.html
[2b] http://www.bernd-mayer.com/pseudoscience-electronic-cigarette-policy/
[3a] http://tobaccoanalysis.blogspot.com/2014/03/new-study-on-electronic-cigarettes-by.html
[3b] http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/2014/166-glantz-response-cvd
[4] Hajek et al. (2014) - Attached

** you can get the study here: http://onlinelibrary.wiley.com/doi/10.1111/add.12659/abstract
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