Fun reading, huh? I counted over a dozen lies and misleading statements in the first paragraph alone.
FDA FDA response to lawsuits.
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I fell asleep after the first paragraph - I am an insomniac but after many sleep-deprived nights I crash which is what happened last night. Will try again tonight and keep you posted.
If you 'liked' the last one get a load of this filing.
Here we have many of the organizations that profit off the backs of smokers hoping the court will protect their cash flow via repeating lies until they become 'truths.'
http://www.tobacco-on-trial.com/wp-content/uploaded/2016/08/2016-08-19-nicopurectfk.pdf
The Deeming Rule is a rational regulatory response to the public health issues associated with e-cigarettes
That one statement alone let's me know they are so far in left field that they are missing the whole event...
So then that would make the FDA response a drug.Hey sounds like it could be marketed as a tool to help insomniacs...
How freaking ironic.
I think their "response" should be taken off the market immediately.
And then they should be held in contempt of court for not providing a response.
And then they should all go to jail.
And then we win!!
All because Bea-FL fell asleep while reading it.
She will forever be remembered in the vaping world for her sacrifices.
Just remember Bea-FL about the whole intended use thingy.
You must insist that you read it precisely because you intended to use it to fall asleep.
Oh I would, I would. No tinketing, no DIY. Wouldn't want to wind up doing something illegal
Glad to be of help.
It's interesting that the Grandfather clause is the same date as vaping devices were arriving in the USA.
Why does the FDA not mention any of the positive reasons that vaping products have caused since 2007 in the US? Why do they not admit it's a dilemma to set up fair guidelines? Why is nicotine product use does not seem to be the issue that nicotine is with vaping devices?
Yes, I read all of the Nicopure case and find it's full of unproven untruths and unsupported statements?
Vaping Device came on the market for those who wanted to quit smoking but failed with other methods. It was not to appeal to kids. It did not have flavors created to attract children any more than Liquor! How do they explain the flavors of liquor, and the flavoring of childrens' medicine like cough syrups? Don't adults like candy and fruit flavors?
In the past, proplylene glycol was used as a base for inhaled respiratory treatments in hospitals. Can this medical use lwhich was researched be used towards the 10 (?) years of research?
Why do they have the right to test anything more that just the nicotine ? Most likely Proplyene glycol, glycerin, and food flavoring have already been tested for human consumption.
The FDA say any vaping hardware or non nicotine liquid can be included under the heading of Tobacco products just by association. WHAT???
The FDA says tobacco and vaping products are "gateways" to underage persons to use these products and become addicted. Wouldn't Peers be the biggest gateway? How many underage persons started smoking because their peers did? Probably more than just the items being on the market.
Are condoms a gateway to underage persons having sex? Were the benefits greater than the "gateway"?
This Nicopure document does not seem to address our points or the FDA's points clearly. I thought it would be more about taking each statement the FDA made and replying in a way that shows a valid point matching each of their's or at least addressing it with a question that they cannot answer in a reasonable manner. Reading this case seemed to give the FDA some more ammunition against vaping products . I hope someone can appeal their decision in a more direct and professional way. IMO
How many years of valid research can we find that take years off of their ruling. We do have scientific data. Probably not straight 10 years, but there is most likely that some can be used. Hopefully the appeal will contain our research data as well even propylene glycol used as a base for vaporized respiratory treatments.
CASAA and Bill Goodshal (sp) have some good documentation on research. New Zealand as well
Why does the FDA not mention any of the positive reasons that vaping products have caused since 2007 in the US? Why do they not admit it's a dilemma to set up fair guidelines? Why is nicotine product use does not seem to be the issue that nicotine is with vaping devices?
Yes, I read all of the Nicopure case and find it's full of unproven untruths and unsupported statements?
Vaping Device came on the market for those who wanted to quit smoking but failed with other methods. It was not to appeal to kids. It did not have flavors created to attract children any more than Liquor! How do they explain the flavors of liquor, and the flavoring of childrens' medicine like cough syrups? Don't adults like candy and fruit flavors?
In the past, proplylene glycol was used as a base for inhaled respiratory treatments in hospitals. Can this medical use lwhich was researched be used towards the 10 (?) years of research?
Why do they have the right to test anything more that just the nicotine ? Most likely Proplyene glycol, glycerin, and food flavoring have already been tested for human consumption.
The FDA say any vaping hardware or non nicotine liquid can be included under the heading of Tobacco products just by association. WHAT???
The FDA says tobacco and vaping products are "gateways" to underage persons to use these products and become addicted. Wouldn't Peers be the biggest gateway? How many underage persons started smoking because their peers did? Probably more than just the items being on the market.
Are condoms a gateway to underage persons having sex? Were the benefits greater than the "gateway"?
This Nicopure document does not seem to address our points or the FDA's points clearly. I thought it would be more about taking each statement the FDA made and replying in a way that shows a valid point matching each of their's or at least addressing it with a question that they cannot answer in a reasonable manner. Reading this case seemed to give the FDA some more ammunition against vaping products . I hope someone can appeal their decision in a more direct and professional way. IMO
How many years of valid research can we find that take years off of their ruling. We do have scientific data. Probably not straight 10 years, but there is most likely that some can be used. Hopefully the appeal will contain our research data as well even propylene glycol used as a base for vaporized respiratory treatments.
CASAA and Bill Goodshal (sp) have some good documentation on research. New Zealand as well
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Case in point is Operation Migration (OM) with which I have been closely involved for several years. It has nothing to do with vaping but shows the government stupidity. In this fiasco the government agency the US Fish & Wildlife Service (USFWS). Operation Migration has played a lead role in the reintroduction of endangered Whooping cranes into eastern North America. In the 1940s the species was reduced to just 15 birds. Between 2001 – 2015 OM pilots used ultralight aircraft and played the role of surrogate parents to guide captive-hatched and imprinted Whooping cranes along a planned migration route, which began in Wisconsin and ended in Florida.
By this year, thanks greatly to OM, there are several hundred whoopers in existence. Anyway, earlier this year USFWS decided that the aircraft-guided method was too “artificial” and that cranes missed early learning opportunities. It exercised its authority over the Endangered Species Act and ended the aircraft-guided reintroduction method. Never mind the volumes of scientific research and proof by experts in the field who showed USFWS they were wrong. It didnt matter.
IMO the problem here is that the government is involved. While it has created some good and honorable things (as a conservationist, the while National Park system comes to mind) IMO it's motivated by anything but sense.
Case in point is Operation Migration (OM) with which I have been closely involved for several years. It has nothing to do with vaping but shows the government stupidity. In this fiasco the government agency the US Fish & Wildlife Service (USFWS). Operation Migration has played a lead role in the reintroduction of endangered Whooping cranes into eastern North America. In the 1940s the species was reduced to just 15 birds. Between 2001 – 2015 OM pilots used ultralight aircraft and played the role of surrogate parents to guide captive-hatched and imprinted Whooping cranes along a planned migration route, which began in Wisconsin and ended in Florida.
By this year, thanks greatly to OM, there are several hundred whoopers in existence. Anyway, earlier this year USFWS decided that the aircraft-guided method was too “artificial” and that cranes missed early learning opportunities. It exercised its authority over the Endangered Species Act and ended the aircraft-guided reintroduction method. Never mind the volumes of scientific research and proof by experts in the field who showed USFWS they were wrong. It didnt matter.
The FDA may have really painted themselves into a corner with all of this. Since they can't deem vaping products as medical devices and if this tobacco deeming fails what will they do then? If they had tried to create a whole new category for vaping they may have been able to do anything they wished with vaping, maybe.
I really think the whole deeming vaping as a tobacco product is risky simply because the only thing linking vaping to tobacco is the nicotine and nicotine is sold over the counter and FDA approved for long term use and we're protected from the medical device category. I think we're in for a wild ride and who knows, maybe if the tobacco deeming fails they will then try to create a whole new category for vaping and squash it that way. Yes, I still hold on to the hope that we're gonna win this.
I really think the whole deeming vaping as a tobacco product is risky simply because the only thing linking vaping to tobacco is the nicotine and nicotine is sold over the counter and FDA approved for long term use and we're protected from the medical device category. I think we're in for a wild ride and who knows, maybe if the tobacco deeming fails they will then try to create a whole new category for vaping and squash it that way. Yes, I still hold on to the hope that we're gonna win this.
Okay I read through the PDF. It sucks as a sleep aid BTW. My thoughts on just some parts:
"FDA also referenced another study of 1,700 e-liquid exposures (from 2010 to 2013) showing that children …
FDA found, correctly, that the current evidence on these critical issues is inconclusive. Id. at 29028 (noting that ―long-term studies are not yet available to determine whether…youth and young adults [using e-cigarettes] are only experimenting with tobacco use, becoming established [e-cigarette] users or dual users, or transitioning to combusted products. In addition, there is not sufficient evidence to conclude that youth and young adults are using [e-cigarettes] as a means to quit smoking.
…other evidence is to the contrary‖ and citing studies showing that individuals who were smokers at the start of the study, and who reported ecigarette use at the end of the study, were more likely to still be smoking and to have unsuccessfully tried to stop smoking than smokers who had not used e-cigarettes)"
Part of my background is in scientific publishing which is worthless without proper references. Where are the references here?
"Contrary to Plaintiffs‘ contention, the APA does not require FDA to wait for conclusive evidence about e-cigarettes‘ adverse long-term effects before fulfilling the role that Congress assigned to it."
I think this is what will hurt the vaping industry the most. The fact that they can do what they are doing without any proof. They can do whatever they want because they can.
"FDA also referenced another study of 1,700 e-liquid exposures (from 2010 to 2013) showing that children …
FDA found, correctly, that the current evidence on these critical issues is inconclusive. Id. at 29028 (noting that ―long-term studies are not yet available to determine whether…youth and young adults [using e-cigarettes] are only experimenting with tobacco use, becoming established [e-cigarette] users or dual users, or transitioning to combusted products. In addition, there is not sufficient evidence to conclude that youth and young adults are using [e-cigarettes] as a means to quit smoking.
…other evidence is to the contrary‖ and citing studies showing that individuals who were smokers at the start of the study, and who reported ecigarette use at the end of the study, were more likely to still be smoking and to have unsuccessfully tried to stop smoking than smokers who had not used e-cigarettes)"
Part of my background is in scientific publishing which is worthless without proper references. Where are the references here?
"Contrary to Plaintiffs‘ contention, the APA does not require FDA to wait for conclusive evidence about e-cigarettes‘ adverse long-term effects before fulfilling the role that Congress assigned to it."
I think this is what will hurt the vaping industry the most. The fact that they can do what they are doing without any proof. They can do whatever they want because they can.
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Yeah, I've read parts of it, and meant to go over some bits later when I have more time. One thing I noticed right off the bat is that the citation is "omitted" for the bit about adolescent brain development and nicotine. Could that possibly be because the only study that even hints at that was a rodent study? hmm?
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