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 (http://link.springer.com/article/10.1007/s00204-013-1127-0), junk science (http://tobaccoanalysis.blogspot.com/2014/05/glantz-review-article-is-little-more.html), and unsubstantiated propaganda (http://tobaccoanalysis.blogspot.com/2014/03/new-study-on-electronic-cigarettes-by.html) from the tobacco control industry (TCI).
The evaluation of the health effects of ecigs in Section IV.B is particularly egregious, being wrought with deprecated information, inaccuracies, and prejudice. Conspicuously, this section does not reference the single most comprehensive review study to date on the risks posed by ecig use published by Burstyn (2013). This study reviewed more than 9000 observations of the chemistry of ecig aerosol and compared them against worst-case exposure scenarios. The results unequivocally indicate that the vast majority of predicted exposures are <<1% of Threshold Limit Values (TLV) for involuntary workplace exposures. The study concludes that “there was no evidence of potential for exposures of e-cigarette users to contaminants that are associated with risk to health at a level that would warrant attention if it were an involuntary workplace exposures by approaching half of TLV.” And further that “exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern.” This study 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.
Burstyn (2013): http://publichealth.drexel.edu/~/media/files/publichealth/ms08.pdf
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 (http://link.springer.com/article/10.1007/s00204-013-1127-0), junk science (http://tobaccoanalysis.blogspot.com/2014/05/glantz-review-article-is-little-more.html), and unsubstantiated propaganda (http://tobaccoanalysis.blogspot.com/2014/03/new-study-on-electronic-cigarettes-by.html) from the tobacco control industry (TCI).
The evaluation of the health effects of ecigs in Section IV.B is particularly egregious, being wrought with deprecated information, inaccuracies, and prejudice. Conspicuously, this section does not reference the single most comprehensive review study to date on the risks posed by ecig use published by Burstyn (2013). This study reviewed more than 9000 observations of the chemistry of ecig aerosol and compared them against worst-case exposure scenarios. The results unequivocally indicate that the vast majority of predicted exposures are <<1% of Threshold Limit Values (TLV) for involuntary workplace exposures. The study concludes that “there was no evidence of potential for exposures of e-cigarette users to contaminants that are associated with risk to health at a level that would warrant attention if it were an involuntary workplace exposures by approaching half of TLV.” And further that “exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern.” This study 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.
Burstyn (2013): http://publichealth.drexel.edu/~/media/files/publichealth/ms08.pdf
