Monday, 15 December 2014

Dear Public Health Units across North America,


Dear Public Health Units across North America,
I am writing to you in regard to comments submitted to the FDA in Re: Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (Docket ID: FDA-2014-N-0189; RIN: 0910-AG38).
This comment appears to be nearly identical to others submitted by many county and city health departments throughout the US. Of greater alarm is the fact that your signature endorses a document that spreads false and misleading claims regarding the contents and risks of electronic vaporizers, also known as electronic cigarettes, or ecigs. I am deeply concerned that public money is being used to further a commercial and political agenda and that a public agency with a moral and legal obligation to protect public health would perpetrate such a malicious act designed to steer smokers away from an alternative that is more than 1000 times safer than combustible tobacco.

The information in the letter you submitted to FDA is, in its entirety, false, being backed up by demonstrated junk science [1] and unsubstantiated propaganda [2] from the tobacco control industry (TCI). It demonstrates malicious and willful ignorance and distinct lack of critical thinking from a public agency with respect to the state of science regarding ecigs. In addition it raises concern than an agency charged with protecting public health is instead pursuing the special interests of fringe groups or industry (as in Tobacco Control Industry). The uncritical parroting of industry messaging by public bodies is not only abhorrently immoral; it is gross public health malpractice with potentially dire consequences for 44 million American smokers.
Please refer to the single most comprehensive review study to date on the risks posed by ecig use published by Burstyn (2013) for an accurate and detailed assessment of the risks of ecigs. 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.”

Baseless conjecture spread by TCI and uncritically referenced in your letter alleges that flavors are solely intended to entice children and falsely claim that they cannot possibly be enjoyed by adults. Common sense dictates that such a claim would fail the straight-face test; but, paradoxically, and in spite of the evidence (Farsalinos et al. 2013) it keeps getting parroted by the media, FDA officials, and, now, your letter. The study by Farsalinos et al. (2013) surveyed 4618 participants, more than 90% of which were former smokers. Those surveyed overwhelmingly rated flavors as an important element contributing to their continued use and enjoyment of ecigs. This demonstrates beyond contestation that flavors are an important part of e-cigarettes’ success and pleasure perceived by adult users. This study also shows that flavors are marketed because there is a demand by adult users, and not for enticing children. Considering the fact that adoption of ecigs by youth is minimal and res  tricted to those who are already smokers (ASH England 2014 and ASH Wales 2014), any regulation that would restrict flavor choice would be inappropriate. It would cause harm to vapers, continued harm to smokers who would be denied the opportunity to switch to much safer ecigs, while no public health benefits would be observed in any other population.
The cost-benefit analysis forwarded by the FDA in regards to the deeming regulations and endorsed by your comment is particularly egregious, because it overweighs hypothetical risks, while discounting real benefits. In a recent commentary, Clive Bates [3] itemizes the risks associated with misguided regulations and quantifies that for every hypothetical risk from vaping, there is a more plausible benefit. These benefits are eloquently quantified by Joel Nitzkin (2014) in a policy study regarding ecigs, which proposes sensible approaches to ecig regulations. Another excellent summary of the risk-benefit proposition of regulating ecigs is presented by Saitta et al. (2014), who also discuss the enormous opportunity for appropriate, fact-based regulations to prevent “much misery and suffering” and save millions of lives.
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 – endorsed and repeated in your letter – is constructed entirely of deprecated information, inaccuracies, and prejudice. Virtually every assertion made in the document uncritically parrots unsubstantiated propaganda from TCI. FDA’s review of the literature suspiciously ignores the fact that all the hypothetical risks and malicious fear mongering advanced by TCI have been thoroughly debunked [6][7][8]. You should be aware that Drs. Farsalinos and Polosa are currently preparing the publication of another critique of TCI propaganda [9], which should dispel any shadow of a doubt that publications from TCI regarding ecigs are nothing more than academic misconduct and conflicted junk science and cannot be allowed to influence public health decisions.
Finally, Zyoud et al. (2014) searched for all available peer-reviewed literature on the subject of ecigs and retrieved 356 documents, among which 31.5% were original journal articles, 16% letters to the editor, 7.9% review articles, and 44.6% documents that were classified as other types of publications. The retrieved documents were published in 162 peer-reviewed journals, by scientists from 27 countries. All 356 documents discussed by Zyoud et al (2014) should be mandatory reading for any professional and/or regulator with a serious and honest commitment to disseminate accurate information, improve public health, and reduce smoking rate. All ought to be critically reviewed, referenced, and thoroughly discussed by any evidence-based information campaign published by a public agency. The critical review ought to be performed by qualified, impartial scientists with the motivation and ability to distinguish slanted junk science and deceptive inference from rigorous studies employing the scientific method, using appropriate analyses, and coming to defensible conclusions. None of these appear to apply to the letter you sent to FDA.

Calls to suppress, restrict, or ban electronic vaporizers are tantamount to the cold, calculated, and systematic murder of 44 million current American smokers, and 1.22 billion world-wide (Hanley 2014). Evidence presented by Nitzkin (2014) suggests that propaganda, lies, and misinformation regarding tobacco harm reduction (THR) perpetrated by TCI and disseminated by so-called “health” groups and public departments have already caused nearly 10 million unnecessary deaths related to smoking in the past 20 years alone (480,000 deaths per year × 20 years). Even under conservative assumptions regarding the success of THR initiatives using ecigs, Nitzkin (2014) estimates that up to 4.8 million American lives could be saved over the next 20 years. Nitkin (2014) concludes «[a] carefully structured Tobacco Harm Reduction (THR) initiative, with e-cigarettes as a prominent THR modality, added to current tobacco control programming, is the most feasible policy option likely to substantially reduce tobacco-attributable illness and death in the United States over the next 20 years.»
This kind of misinformation and propaganda do not reflect well on a public health agency. Please initiate an investigation into the persons intellectually responsible for the uncritical acceptance of junk science and shameless promotion of industry interests at the expense of public health, as they have no place in a department charged with protecting public health or the general interests of The Public.
Respectfully,
DRMA



References:
[5] Farsalinos and Polosa (2014): http://taw.sagepub.com/content/5/2/67
[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
Farsalinos et al. (2013): http://www.mdpi.com/1660-4601/10/12/7272

Similar Article by same Author:
http://vapefight.com/public-health-directors-lie-to-the-fda-about-vaping/

**By: DRMA : https://twitter.com/mihotep

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