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.
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[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
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Attachment 1: Conflicted researchers
Attachment 2: Eligible researchers
View attachment 360348
View attachment 360349
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.
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[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
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Attachment 1: Conflicted researchers
Attachment 2: Eligible researchers
View attachment 360348
View attachment 360349
