Financial Contributions to cover things like Transportation, Hotel/Food, Rental Cars are quid pro quo for attracting a Speaker for an event like this FDA Workshop.
And would Not Raise an Eyebrow with anyone on a Speaking Circuit.
FDA FDA announces E-Cigarette workshop (DEC 2014)
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Financial Contributions to cover things like Transportation, Hotel/Food, Rental Cars are quid pro quo for attracting a Speaker for an event like this FDA Workshop.
And would Not Raise an Eyebrow with anyone on a Speaking Circuit.
- Apr 2, 2009
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Its telling that FDA chose to schedule this workshop after it proposed the Deeming Regulation (that would ban >99.9% of e-cig products and give the e-cig industry to Big tobacco) and after it closed the public comment period.
I'll be participating in the December 10/11 workshop, just as I've participated in the FDA's last ten so-called scientific events regarding THR, MRTP and e-cigs.
But I suspect that (as occurred at most of those previous FDA sponsored events) the agency will invite (and pay) many THR opponents to give lengthy presentations of junk science and repeat false and misleading fear mongering claims about e-cigs, while allowing THR advocates one or two minutes to tell the truth about e-cigs.
I'll be participating in the December 10/11 workshop, just as I've participated in the FDA's last ten so-called scientific events regarding THR, MRTP and e-cigs.
But I suspect that (as occurred at most of those previous FDA sponsored events) the agency will invite (and pay) many THR opponents to give lengthy presentations of junk science and repeat false and misleading fear mongering claims about e-cigs, while allowing THR advocates one or two minutes to tell the truth about e-cigs.
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Really, on the 'after' - any sensible agency would have done it well before and many times before.
Very Good to hear that you will be Participating in this Workshop. Because I know you Can/Will bring some Balance to it.
I actually think the 32 (or so) questions listed mostly relate to public health and I am glad the FDA is asking for scientific input on them. If they made the regulation without asking they'd just be pulling it out their ... (they may still do that)
I actually think this is a positive step. Looking at what materials might pose a risk in manufacture of attys, tanks, PVs and liquids. Looking at any interactions people should be aware of, odd effects of temperature and wattage with liquids. If this generates a couple of prelim studies in each of the question areas vapers as a whole will benefit. And as I said, asking scientists for the truth is better than asking regulators for the truth.
It certainly beats the alternative. They could've just as well announced they were imposing the deeming regs exactly as written.
I agree that a Workshop like this Can Be a Positive and Productive Step.
That is, IF Much of the Junk Science is Thrown Out which is being used to Support some Very Questionable Claims.
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- Apr 2, 2009
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Before congratulating the FDA for holding this forthcoming workshop and for allowing THR supporters to present, please remember that on December 17, 2012, more than a dozen e-cig consumers and supporters testified at a FDA public hearing about the many benefits of e-cigs, and how FDA approved drugs didn’t help them quit smoking
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal
Then in January 2013, e-cig consumers submitted more than 5,200 comments to the FDA’s Docket on Section 918 (accounting for >99% of docket submissions) informing the agency of the benefits of e-cigs, and urging the agency to not ban or unjustifiably regulate the products. But the FDA has only made 99 of these comments available to the public
Regulations.gov
http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html
Smokefree Pennsylvania submitted to FDA’s docket for Section 918 vast quantities of scientific and empirical evidence documenting that e-cigs and other noncombustible tobacco/nicotine products are far less hazardous than cigarettes and have helped many smokers quit smoking and reduce cigarette consumption, and that FDA approved nicotine gums, lozenges and patches have very low success rates for smoking cessation.
http://www.e-cigarette-forum.com/fo...mments-sec-918-tobacco-act-6.html#post8403639 and
http://www.e-cigarette-forum.com/fo...t-written-comments-sec-918-tobacco-act-7.html
But in April 2013, FDA sent a Report to Congress per Section 918 of TCA that contradicted and misrepresented the evidence provided to the agency on the health benefits of smokers switching to e-cigarettes or smokefree tobacco products, and on NRT’s dismal success rate for smoking and nicotine cessation at the 12/17/12 Section 918 public hearing, in >5,200 public comments submitted to agency’s dockets, at a 2/3/11 IOM MRTP meeting, at a 8/25/11 FDA MRTP meeting, and at many FDA TPSAC meetings.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
http://www.e-cigarette-forum.com/fo...ds-studies-reduced-risk-tobacco-products.html
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal
Then in January 2013, e-cig consumers submitted more than 5,200 comments to the FDA’s Docket on Section 918 (accounting for >99% of docket submissions) informing the agency of the benefits of e-cigs, and urging the agency to not ban or unjustifiably regulate the products. But the FDA has only made 99 of these comments available to the public
Regulations.gov
http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html
Smokefree Pennsylvania submitted to FDA’s docket for Section 918 vast quantities of scientific and empirical evidence documenting that e-cigs and other noncombustible tobacco/nicotine products are far less hazardous than cigarettes and have helped many smokers quit smoking and reduce cigarette consumption, and that FDA approved nicotine gums, lozenges and patches have very low success rates for smoking cessation.
http://www.e-cigarette-forum.com/fo...mments-sec-918-tobacco-act-6.html#post8403639 and
http://www.e-cigarette-forum.com/fo...t-written-comments-sec-918-tobacco-act-7.html
But in April 2013, FDA sent a Report to Congress per Section 918 of TCA that contradicted and misrepresented the evidence provided to the agency on the health benefits of smokers switching to e-cigarettes or smokefree tobacco products, and on NRT’s dismal success rate for smoking and nicotine cessation at the 12/17/12 Section 918 public hearing, in >5,200 public comments submitted to agency’s dockets, at a 2/3/11 IOM MRTP meeting, at a 8/25/11 FDA MRTP meeting, and at many FDA TPSAC meetings.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
http://www.e-cigarette-forum.com/fo...ds-studies-reduced-risk-tobacco-products.html
In other words: Beware of Bureaucrats, Regulators & ANTZ, bearing gifts.
I don't think anyone went so far as congratulating the FDA; the point was that this is not the worst of all possible case scenarios. The more appropriate terminology might be "damning with faint praise."
That's exactly it. When looking over the list of questions, you can tell they are really nitpicking at every single tiny little detail about vaping that may, possibly, potentially, lead to a (minor) danger which would "justify" the FDA exerting control over the market to protect us from ourselves.
But then Chantix kills hundreds of people and oh well, that's just collateral damage, no need to investigate anything there...
Being killed by Big Pharma is way better than potentially overdosing on nicotine and throwing up for an hour or two. And you get unlimited free Pfizer mouse pads in the afterlife.
I am (somewhat) pleased they appear to be putting science at forefront of their decision making process regarding eCig regulations. I realize if one has been around the block with the FDA, then the appearance (of being scientific oriented) is easy to downplay and/or be cynical about.
But as a consumer that was awaiting FDA action on eCigs (years ago) and as one who chose to comment, I feel insulted that they are doing this after collecting comments. Their proposed regulations showed up as rather clueless about eCigs and I really had no problem pointing that out in my comments. If they were being fair to the most important stakeholder (the consumer), they'd have another round of comments a good 3 to 6 months after this workshop. If not, the consumer is getting slighted, unless magically, actual science wins out as a result of this workshop.
It is an interesting development though.
But as a consumer that was awaiting FDA action on eCigs (years ago) and as one who chose to comment, I feel insulted that they are doing this after collecting comments. Their proposed regulations showed up as rather clueless about eCigs and I really had no problem pointing that out in my comments. If they were being fair to the most important stakeholder (the consumer), they'd have another round of comments a good 3 to 6 months after this workshop. If not, the consumer is getting slighted, unless magically, actual science wins out as a result of this workshop.
It is an interesting development though.
I don't think they'd hold this workshop if they weren't looking at a re-write in some order. They may be looking at writing stricter or more lenient or genuinely looking for more effective regulation. And if they do a significant re-write I believe there is some obligation (given the initial public comment) to seek further public comment [All of the above is vague memory and I do not live in the US so it could be .... about tit].
I agree. I think they want to rewrite the deeming so that it is more applicable to e-cigs, i.e. they want to write it so it's easier for them to really crack down.
As was mentioned previously, we'll know a lot more about their intentions when we see how they apportion the speaking time. If the only people allowed to speak at length are ANTZ groups and tobacco company spokesmen, it'll be pretty obvious the whole thing is a charade and not likely to change the equation to any appreciable degree. If, however, equal time (or something resembling it) is given to THR advocates and representatives of actual vaping companies, it may be a legitimate exercise with the potential to produce positive results. But I'm not holding my breath.
- Apr 2, 2009
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The lawyers at FDA know their deeming regulation is very likely to face legal challenges in federal court that (among other things) will correctly claim that FDA grossly misrepresented the scientific evidence on e-cigs in its proposed deeming regulation (and for the past five and half years).
By telling the court that it held a Public Workshop on the scientific evidence of e-cigs, and by showing the court the FDA's grossly distorted interpretation of the workshop (which of course will conclude that e-cigs pose a major public health threat especially for children, and must be regulated by the FDA to protect children and public health), the FDA hopes to survive a legal challenge (at least on the issue of scientific evidence).
By telling the court that it held a Public Workshop on the scientific evidence of e-cigs, and by showing the court the FDA's grossly distorted interpretation of the workshop (which of course will conclude that e-cigs pose a major public health threat especially for children, and must be regulated by the FDA to protect children and public health), the FDA hopes to survive a legal challenge (at least on the issue of scientific evidence).
Depending upon who they actually allow to participate, they might have a similar problem with that as they did with Judge Leon in July regarding the TPSAC/Jonathan Samet 'conflict of interest' deal.
Just in case someone missed it, Bill's last thoughts/post on "The lawyers at FDA know their deeming regulation is very likely to face legal challenges" is supported by this thread at:
http://www.e-cigarette-forum.com/fo...comments-fda-opposing-deeming-regulation.html
I think you (Bill) nailed it and Kent's point is also very interesting. My own "rub your crystal ball" is that a very very very small number of "tokens" may present but the majority will say exactly what the FDA wants them to say. Period! I hope I'm wrong but that's the way I see it.
With respect to the "public comment". That's a one hour time slot for everyone. Held the next day! A "dog and pony show" IMHO. (EDIT: Perhaps 2 minutes max for each speaker. /end edit. Again, I'm very cynical and hope I'm wrong.
http://www.e-cigarette-forum.com/fo...comments-fda-opposing-deeming-regulation.html
I think you (Bill) nailed it and Kent's point is also very interesting. My own "rub your crystal ball" is that a very very very small number of "tokens" may present but the majority will say exactly what the FDA wants them to say. Period! I hope I'm wrong but that's the way I see it.
With respect to the "public comment". That's a one hour time slot for everyone. Held the next day! A "dog and pony show" IMHO. (EDIT: Perhaps 2 minutes max for each speaker. /end edit. Again, I'm very cynical and hope I'm wrong.
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