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  1. Honorable Sen. [insert name here],

    I was very disappointed to see your letter (http://www.help.senate.gov/ranking/newsroom/press/senate-dems-fda-rule-is-critical-step-to-protecting-children-and-teens-from-tobacco-products-) cheering on the arbitrary and capricious FDA rule (Docket ID: FDA-2014-N-0189; RIN: 0910-AG38) "deeming" harmless, effective, smoke- & tobacco-free vapor technology as "tobacco products." This ruling, which will eliminate 99.99% of all vaping products on the market, is at odds with the overwhelming scientific consensus on the topic and an imminent threat to the health of the public.

    Recently, the Royal College of Physicians (RCP) published a 200-page systematic review of all high-quality evidence and concluded that vaping products are nearly harmless and effective. RCP also instructed all healthcare professionals to promote vaping as widely as possible in the interest of public health (https://www.rcplondon.ac.uk/news/promote-e-cigarettes-widely-substitute-smoking-says-new-rcp-report). The evidence summarized by RCP demonstrates that vaping not only helps smokers quit, but also prevents youth from ever starting, thus functioning in the real world as a vaccine against smoking. In the USA, two independent studies, one from Yale University (medicine.yale.edu/news/article.aspx?id=11459) and the other from Cornell University (weill.cornell.edu/news/news/2016/03/electronic-cigarette-age-restrictions-may-drive-teens-to-traditional-cigarettes.html), concluded that prohibiting access to nearly harmless vapor products causes youth to start and keep smoking instead.

    We The People who quit smoking with the help of vaping products have been anticipating this ruling for years, ever since disgraced, former FDA commissioner Margaret Hamburg (http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/) first banned vaping products in 2009. We are intimately familiar with all the scientific literature on this topic, as well as the political and financial motives underlying such bans (http://trenchreynolds.com/2014/08/16/why-the-states-bad-deals-with-tobacco-are-bad-for-vaping/). The 40 million American citizens who smoke deserve a chance to access the most effective substitute for smoking developed so far, regardless of the financial implications for tobacco-tax-dependent state and federal governments (https://youtu.be/zSq9iqal2cA).

    In the name of 9 million American ex-smoker vapers and 40 million current smokers, I urge you to review the evidence, dismiss self-serving propaganda from tobacco-tax-funded organizations and reconsider your position. Please also take steps to overturn the FDA deeming and hold to account those responsible for this grossly negligent public health malpractice.

    Sincerely,

    [The People]
  2. Submit your own here: http://www.regulations.gov/#!documentDetail%3bD=FDA-2014-N-1051-0001

    Other resources: http://www.e-cigarette-forum.com/forum/fda-regulations/626350-alert-deadline-11-59-tonight-fda-comments-swedish-matchs-mrtp-application-tpsac-consideration.html

    My comment (1jy-8fpw-yy0d):
    I strongly encourage FDA to swiftly approve the Modified Risk Tobacco Product Application submitted by Swedish Match North America for ten of its snus brands because smokeless tobacco products are far less hazardous alternatives to cigarettes, because hundreds of thousands of smokers in Sweden and Norway have quit smoking by switching to snus, and because the 1986 Comprehensive Smokeless Tobacco Education Act and the US DHHS have been deceiving the public to inaccurately believe that smokeless tobacco products are as hazardous as cigarettes for nearly three decades.

    On a scale of harm/risk from 1 to 100, on which FDA approved NRT products are 1 and cigarettes are 100, existing scientific and empirical evidence indicate that ALL noncombustible tobacco products marketed in the US are below 2, as all have very similar health/safety risk/benefit profiles as NRT products. Even in the absence of reduced risk marketing claims, population surveys found that several million smokers have already switched to smokeless tobacco products, despite numerous surveys finding that most smokers inaccurately believe smokeless products are as hazardous as cigarettes. So smokeless tobacco products have already saved more lives (of smokers) than could be offset even if every American non tobacco user begins to use smokeless tobacco.

    The intentional deceptive messaging on smokeless tobacco products constitutes gross public health malpractice and must stop. As long as FDA continues to post and maintain inaccurate and misleading information about electronic cigarettes, smokeless tobacco, and other smokefree tobacco products, the agency cannot be trusted to make any objective decisions about MRTP Applications, any other tobacco regulations, or any other public health issue.

    Instead of falsely claiming that all tobacco products are as hazardous as cigarettes, FDA must distinguish between these vastly different types of tobacco products and users. Public health benefits every time a cigarette smoker substitutes a smokefree tobacco product for a cigarette, and FDA needs to acknowledge this important fact. Thus, FDA also should correct or clarify ALL of the many inaccurate and misleading information about the health risks of different tobacco products, including those not explicitly covered in this MRTP application.
    Ipster, bigrobbie and nicnik like this.
  3. Have you noticed how many threads in the Legislation forum quickly degenerate into generic (and royally unhelpful) Liberals vs. Conservatives debates? I'm pretty much sick of it. I don't understand the compulsion some people have trying to convince me to choose between my right to vape and my right to have an abortion; between my right to own a gun and my right to be protected from greedy corporations; between my right to make the rules in my own bar and the right to have a social safety net...

    I don't swallow wholesale either the liberal or the conservative propaganda, nor do I subscribe to the fringe factions on either side. I think it's perfectly acceptable to demand that govt keeps their grabby paws off my vape, my gun, and my wife's womb, while at the same time demand they fight economic inequality by eliminating tax loopholes for the rich and corporations, creating a social safety net for the less fortunate, and ensuring access to affordable education and healthcare. I want freedom to raise my kids the way I see fit and I also want the sociopathic cockroaches in the financial sector reigned in and punished for crashing the economy.

    The vaping debate is not a Liberal or Conservative issue. The freedom to vape should not be diametrically opposed the opportunity to have a paid vacation from your employer. And framing it that way is the greatest accomplishment of the govt. I'm fairly certain the party lines have been drawn in such way to create the greatest amount of division among the population, by splitting up incongruent personal freedoms, economic, and political issues on either side of the divide. I wish there were a way to stop falling for this trick and demand govt acts in the interest of the people irrespective of party lines...

    None of this makes any sense really, I just needed to rant; and now I feel better... vape on!
    nicnik likes this.
  4. If it walks like a duck and quacks like a duck is probably some apparatchik lying thru his teeth in an effort to expand the spare of the public's rib that he's allowed to gnaw on.
    Ipster likes this.
  5. 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%2Fs00204-013-1127-0
    [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
    Tara Antonuccio and nicnik like this.
  6. 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%2Fs00204-013-1127-0
    [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
  7. 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, and sending the rest into extralegal markets. In the wake of historic declines in cigarette sales [1][2], Big Tobacco is not worried. They have already announced and celebrated the FDA-facilitated takeover of the entire ecig market [3][4][5]. In their Investor Day webcasts [4] Philip Morris effectively called FDA their “second pillar supporting our [...] business model.” Is this the image FDA and CTP want to project to the American public? A pillar of the Big Tobacco business model?

    The financial pressures to stop or reverse the expansion of the ecig market and preserve the status quo of the tobacco trade are not solely coming from Big Tobacco. Big Pharma has publicly exposed their financial interests in an anti-vaping ad campaign [6]. State governments are also publically facing the reality that ecigs have a very solid chance of causing them to default on $96 billion worth of tobacco bonds [7], by spelling the end of TMSA payments. The thought of losing tobacco tax revenue does not sit well with any branch of government. In this game of political and commercial interests, I and 40+ million American smokers have become the pawns; our health and lives not even an afterthought, while Big Tobacco, Big Pharma, Big Government, and so-called “public health” groups pursue the billions flowing from our pockets into theirs thru the tobacco gravy train. FDA has an opportunity to fulfill its mandate and moral obligation and stand by the true stakeholders in the tobacco debate – the 40+ million American smokers whose health is at stake; and the millions of consumers of ecig products who have accomplished the most significant step towards avoiding tobacco-related illness by quitting smoking and switching to vaping.

    Snubbing ecigs by deeming them as tobacco products would solidify FDA’s position as a pillar of the Big Tobacco business model at the expense of my health, public health, and the lives of all 40+ million American smokers.

    [1] http://files.shareholder.com/downloads/RAI/3345943209x0x771706/d581ea54-beb1-4997-ab94-d68abbd49348/2014-17_RAI_increases_2Q14_profitability.pdf
    [2] Reynolds American Inc.
    [3] PMI.com Press Release
    [4] Philip Morris Agenda
    [5] https://www.media-server.com/m/instances/8hjnb6wm/items/29n825fv/assets/75ngrwuk/0/file.pdf
    [6] http://www.amazon.co.uk/b?node=4933990031
    [7] Decline In Smoking & Tobacco Bonds | Spinfuel eMagazine
    bigrobbie likes this.
  8. 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 industry.

    On July 21, a federal judge from the US District Court of the District of Columbia [4] ruled that FDA erred in determining that the members of its Tobacco Products Science Advisory Committee (TPSAC) didn't have conflicts of interest; that the agency's appointment of those members was arbitrary and capricious, and tainted both the TPSAC and its work. In his memorandum opinion [4], the federal judge wrote "Conflicts of interest — whether actual or perceived — undermine the public's confidence in the agency's decision-making process and render its final product suspect, at best [...] and, at worst, untrustworthy."

    The evaluation of the health effects of ecigs in Section IV.B reflects the same uncritical acceptance of conflicted and junk science recognized by the court in the appointment of TPSAC. Following so shortly after the Vioxx scandal [5], these actions portray a pattern of biased and unethical behavior unbecoming a federal agency charged with protecting public health. Judge Leon’s opinion on TPSAC [4] further states that FDA must evaluate the credentials of its scientific advisors such that they do not present any actual or perceived conflicts of interest and are consistent with applicable ethics laws. I believe the same level of scrutiny applies to scientific literature reviewed and relied upon as part of regulatory decision-making, including the proposed deeming regulation (FDA-2014-N-0189); and that research originating from tobacco control groups, Big Pharma, or Big Tobacco are fatally and irreconcilably conflicted with respect to ecigs.

    In the spirit of Judge Leon’s ruling, the current version of the proposed deeming regulation is betrayed by numerous citations to gravely conflicted research throughout Section IV, which render it “at a minimum suspect, and, at worst, untrustworthy;” the very definition of arbitrary and capricious.

    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 and impacts of regulations. Researchers who are not conflicted by any current or previous association with tobacco control, Big Pharma, or Big Tobacco should be supported and encouraged to pursue these studies. I am attaching a list of known researchers who are fatally conflicted, have a proven track record of prejudice and scientific misconduct, and should not be allowed to participate in any decision-making process regarding ecigs (Attachment 1). Any publication or comment concerning ecigs authored or co-authored by any of these conflicted researchers should be summarily dismissed as “suspect” and “untrustworthy”. In addition, no further public funding should be awarded to researchers in Attachment 1 or their research groups.

    In contrast, Attachment 2 contains a letter by 53 scientists and researchers who have a track record of ethical and balanced scientific conduct, as well as the moral courage to stand against the dogma and propaganda emanating from tobacco control and evaluate ecigs based on their scientific merit and contribution to public health. The signatories to this letter (Attachment 2) embody the very essence of ethical scientific conduct and their input should be valued above all others’ and actively pursued thru reviewing their publications, awarding of research funding, and appointments to a new, balanced and respectable TPSAC.

    [noparse]
    [1] http://link.springer.com/article/10.1007%2Fs00204-013-1127-0
    [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] https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2011cv0440-82
    [5] http://www.naturalnews.com/002157.html
    [/noparse]

    Attachment 1: Conflicted researchers
    Attachment 2: Eligible researchers

    View attachment 360348
    View attachment 360349
  9. 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 industry.

    On July 21, a federal judge from the US District Court of the District of Columbia [4] ruled that FDA erred in determining that the members of its Tobacco Products Science Advisory Committee (TPSAC) didn't have conflicts of interest; that the agency's appointment of those members was arbitrary and capricious, and tainted both the TPSAC and its work. In his memorandum opinion [4], the federal judge wrote "Conflicts of interest — whether actual or perceived — undermine the public's confidence in the agency's decision-making process and render its final product suspect, at best [...] and, at worst, untrustworthy."

    The evaluation of the health effects of ecigs in Section IV.B reflects the same uncritical acceptance of conflicted and junk science recognized by the court in the appointment of TPSAC. Together, these actions portray a pattern of biased and unethical behavior unbecoming a federal agency charged with protecting public health. Judge Leon’s opinion on TPSAC [4] further states that FDA must evaluate the credentials of its scientific advisors such that they do not present any actual or perceived conflicts of interest and are consistent with applicable ethics laws. I believe the same level of scrutiny applies to scientific literature reviewed and relied upon as part of regulatory decision-making, including the proposed deeming regulation (FDA-2014-N-0189); and that research originating from tobacco control groups, Big Pharma, or Big Tobacco are fatally and irreconcilably conflicted with respect to ecigs.

    In the spirit of Judge Leon’s ruling, the current version of the proposed deeming regulation is betrayed by numerous citations to gravely conflicted research throughout Section IV, which render it “at a minimum suspect, and, at worst, untrustworthy;” the very definition of arbitrary and capricious.

    [1] http://link.springer.com/article/10.1007%2Fs00204-013-1127-0
    [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] https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2011cv0440-82
  10. 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 industry (TCI).

    The cost-benefit analysis forwarded by the FDA in regards to the deeming regulations is particularly egregious, because it overweighs hypothetical risks, while discounting real benefits. In a recent commentary, Clive Bates [4] 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 [5] 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)[6], who also discuss the enormous opportunity for appropriate, fact-based regulations to prevent “much misery and suffering” and save millions of lives.

    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 and impacts of regulations. Researchers who are not conflicted by any current or previous association with tobacco control, Big Pharma, 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%2Fs00204-013-1127-0
    [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] http://www.clivebates.com/?p=2257#more-2257
    [5] http://www.rstreet.org/wp-content/uploads/2014/06/RSTREET25.pdf
    [6] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3926346/
  11. Dear Stacy Deeble-Reynolds,

    I am writing to you in regard to the recent launch of the http://notsosafe.org/ website. This website appears to spread false and misleading claims regarding the contents of electronic vaporizers, also known as electronic cigarettes, or ecigs. I am deeply concerned that public money are being used to further a political agenda and that a public agency with a moral (if not 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 on the website is, in its entirety false, being backed up by demonstrated 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 tobacco control groups (TCG). 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.

    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. 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.”

    In addition, 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 current version of the notsosafe website.

    This kind of misinformation and propaganda do not reflect well on OCDE. Please remove the offending website and initiate an investigation to determine if any public funds were misused in the making and publishing it. Please also investigate the persons intellectually responsible for the uncritical acceptance of junk science, as they have no place in a department charged with overseeing the education of our youth.

    References:
    Burstyn (2013): http://publichealth.drexel.edu/~/media/files/publichealth/ms08.pdf
    Zyoud et al. (2014): http://www.biomedcentral.com/content/pdf/1471-2458-14-667.pdf
    Caro123 likes this.
  12. 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%2Fs00204-013-1127-0), 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).

    Research by tobacco control groups is fatally and irreparably conflicted by their interests in continued funding from the Tobacco Master Settlement Agreement (TMSA) and Big Pharma. The rise of ecigs threatens both these sources of funding. Siegel (2014) has discussed the lobbying efforts of Big Pharma against ecigs, and warned that these financial conflicts of interests must be acknowledged by tobacco control groups. Big Pharma has also recently launched a public anti-vaping ad campaign (http://www.amazon.co.uk/b?node=4933990031). Government funding is also a conflict of interest, since they also have a vested interest in continued tobacco payments (http://spinfuel.com/tobacco-bonds-electronic-cigarettes/). In a recent presentation, Prof. Peter Hajek (University of London, UK) expanded on the conflicts and motives that taint and bias much of the messaging of TCI. In light of this evidence, all research from tobacco control groups concerning ecigs should be summarily dismissed and all future funding from FDA suspended pending comprehensive investigations for academic misconduct.

    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, Big Pharma, 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.

    Siegel (2014): http://tobaccoanalysis.blogspot.de/2014/06/its-official-big-pharma-is-lobbying.html
    Peter Hajek presentation: http://gfn.net.co/downloads/2014/plenary1/peter%20hajek.pdf
    Peter Hajek video: http://youtu.be/IvDIF9izuMI
  13. 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%2Fs00204-013-1127-0), 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).

    Baseless conjecture spread by TCI and uncritically referenced by the proposed regulation 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, as well as FDA officials. 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 restricted 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 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.

    Farsalinos et al. (2013): http://www.mdpi.com/1660-4601/10/12/7272
    ASH Wales (2014): http://www.ashwales.org.uk/creo_files/upload/downloads/young_people_and_e-cigarettes_in_wales_final_march_2014.pdf
    ASH England (2014): http://www.ash.org.uk/files/documents/ASH_891.pdf
  14. 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%2Fs00204-013-1127-0), 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
  15. 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%2Fs00204-013-1127-0), 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).

    One of the most flagrant exaggerations perpetrated by TCI and unfortunately reiterated numerous times by this proposed regulation is in the assertion that little or nothing is known about ecigs, that health effects are completely unknown, and that very little research had been done on the subject. These statements are demonstrably false in light of the recent systematic literature review published by Zyoud et al (2014; http://www.biomedcentral.com/content/pdf/1471-2458-14-667.pdf). These authors 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. These authors also found that FDA was the most productive institution for articles related to ecigs.

    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 improving public health and reducing smoking rates. All ought to be critically reviewed, referenced, and thoroughly discussed by any evidence-based regulatory document related to ecigs. 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 current version of the proposed deeming regulation.

    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.
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