Docket ID: FDA-2014-N-0189; RIN: 0910-AG38
Electronic cigarettes (also known as e-cigarettes, e-cigs, or ecigs) 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 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 tobacco control groups (TCG).
The results of the Hajek et al. (2014) [4] and Farsalinos and Polosa (2014) [5] independently replicate the systematic review of existing laboratory and clinical research and unanimously conclude that “[c]urrently available evidence indicates that electronic cigarettes are by far a less harmful alternative to smoking and significant health benefits are expected in smokers who switch from tobacco to electronic cigarettes.”[5] Further, they demonstrate that there is no evidence of ecig use by never-smoking adults or youth and that ecigs help smokers quit.[4] These systematic and factual reviews build a compelling case that regulating ecigs as tobacco products is not warranted by the current evidence.
The dismal evaluation of ecigs forming the basis of the proposed deeming regulation is constructed entirely of deprecated information, inaccuracies, and prejudice. Virtually every assertion made in the document uncritically parrots unsubstantiated propaganda from TCG. FDA’s review of the literature suspiciously ignores the fact that all the hypothetical risks and malicious fear mongering advanced by TCG have been thoroughly debunked [6][7][8]. FDA should be aware that Drs. Farsalinos and Polosa are currently preparing the publication of another critique of TCG propaganda [9], which should dispel any shadow of a doubt that publications from TCG regarding ecigs are nothing more than academic misconduct and conflicted junk science and cannot be allowed to influence public health decisions.
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): http://onlinelibrary.wiley.com/doi/10.1111/add.12659/abstract
[5] Farsalinos and Polosa (2014): http://taw.sagepub.com/content/5/2/67
[6] http://mic.com/articles/87901/despite-the-alarming-studies-e-cigarettes-are-a-win-for-public-health
[7] http://online.wsj.com/articles/michael-b-siegel-the-e-cigarette-gateway-myth-1407283557
[8] Farsalinos KE, Polosa R. Youth tobacco use and electronic cigarettes. JAMA Pediatr. 2014 Aug 1;168(8):775. doi:10.1001/jamapediatrics.2014.727; http://archpedi.jamanetwork.com/article.aspx?articleid=1890731
[9] http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/2014/169-ecig-review
Electronic cigarettes (also known as e-cigarettes, e-cigs, or ecigs) 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 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 tobacco control groups (TCG).
The results of the Hajek et al. (2014) [4] and Farsalinos and Polosa (2014) [5] independently replicate the systematic review of existing laboratory and clinical research and unanimously conclude that “[c]urrently available evidence indicates that electronic cigarettes are by far a less harmful alternative to smoking and significant health benefits are expected in smokers who switch from tobacco to electronic cigarettes.”[5] Further, they demonstrate that there is no evidence of ecig use by never-smoking adults or youth and that ecigs help smokers quit.[4] These systematic and factual reviews build a compelling case that regulating ecigs as tobacco products is not warranted by the current evidence.
The dismal evaluation of ecigs forming the basis of the proposed deeming regulation is constructed entirely of deprecated information, inaccuracies, and prejudice. Virtually every assertion made in the document uncritically parrots unsubstantiated propaganda from TCG. FDA’s review of the literature suspiciously ignores the fact that all the hypothetical risks and malicious fear mongering advanced by TCG have been thoroughly debunked [6][7][8]. FDA should be aware that Drs. Farsalinos and Polosa are currently preparing the publication of another critique of TCG propaganda [9], which should dispel any shadow of a doubt that publications from TCG regarding ecigs are nothing more than academic misconduct and conflicted junk science and cannot be allowed to influence public health decisions.
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): http://onlinelibrary.wiley.com/doi/10.1111/add.12659/abstract
[5] Farsalinos and Polosa (2014): http://taw.sagepub.com/content/5/2/67
[6] http://mic.com/articles/87901/despite-the-alarming-studies-e-cigarettes-are-a-win-for-public-health
[7] http://online.wsj.com/articles/michael-b-siegel-the-e-cigarette-gateway-myth-1407283557
[8] Farsalinos KE, Polosa R. Youth tobacco use and electronic cigarettes. JAMA Pediatr. 2014 Aug 1;168(8):775. doi:10.1001/jamapediatrics.2014.727; http://archpedi.jamanetwork.com/article.aspx?articleid=1890731
[9] http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/2014/169-ecig-review
