Now is the Time To Act! I am Serious! **updated**
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- Apr 2, 2009
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The courts won't rule e-cigarettes as tobacco products, nor will the FDA. But the Senate HELP Cmte could define e-cigarettes as tobacco products, which I'm still convinced is the only way to prevent the FDA from banning the products (as unapproved drugs or drug-devices).
Those who are have urged the FDA to ban e-cigarettes don't want them to be defined as tobacco products, as the tobacco product standards in the Kennedy FDA bill (while onerous) are not nearly as stringent as FDA drug-device standards.
Those who are have urged the FDA to ban e-cigarettes don't want them to be defined as tobacco products, as the tobacco product standards in the Kennedy FDA bill (while onerous) are not nearly as stringent as FDA drug-device standards.
- Apr 2, 2009
- 5,171
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Please urge the US Senate HELP Committee help_comments@help.senate.gov to prevent the FDA from banning these and other smokefree tobacco/nicotine products (while keeping deadly cigarettes on the market). Next Tuesday (May 19), the committee is scheduled to begin its markup (i.e. voting) on the Philip Morris negotiated and backed FDA tobacco bill S. 982, which is now posted at THOMAS (Library of Congress)
- - -
Electronic cigarette interview with Dr Adrian Payne
Interview by James Dunmore
E Cigarette Direct
May 15, 2009
E-Cigarette Interview with Dr Adrian Payne
Dr Adrian Payne is the Managing Director of Tobacco Horizons, a Tobacco Harm Reduction Consulting Agency. During a post-doctoral career spanning more than thirty years, he has worked for both tobacco and pharmecutical companies, often in the field of Tobacco Harm Reduction.
ECD: How harmful is the electronic cigarette when compared to a regular cigarette?
Adrian: Based on the safety profiling data on E-cigarettes that has been published so far, I think it’s reasonable to say that they are probably at least two, if not three, orders of magnitude less harmful than regular cigarettes. The key reason for this huge difference is that E-cigarettes don’t generate harmful tobacco smoke. But it’s important to understand that ‘no smoke’ doesn’t necessarily translate into ‘no harm’; it’s possible that some risks might emerge from studies into their long-term use.
However, it’s hard to imagine that any such risks would even begin to approach those of smoking cigarettes. Indeed, probably the issue of main concern with E-cigarettes is that children might ingest the E-cigarette cartridges. So along with the necessary internal quality control checks, it would seem sensible for the various manufacturers to use childproof packaging as a design feature.
ECD: Do we have any idea of the effect of heating up nicotine prior to inhaling it? How is the heating of nicotine by the electronic cigarette different to setting fire to tobacco and inhaling the resultant smoke?
Adrian: The end result of tobacco combustion and nicotine vaporisation is basically the same, i.e. generation of a nicotine-containing aerosol that can then be inhaled by the user. Both processes involve heat, but they are otherwise very different in that the aerosol generated by the E-cigarette does not contain within it the thousands of other chemicals, many of which are thought to be extremely harmful, that result from the combustion of tobacco. It’s true that concerns have been expressed about possible harmful effects of some of the chemical components other than nicotine in the E-cigarette aerosol, for example propylene-glycol. But based on current knowledge, these concerns seem vastly overplayed when compared to the risks of cigarette smoking.
ECD. One criticism that has been leveled at the e-cigarette is that it could encourage youngsters and other non-smokers to take up smoking. Are young people more likely to take up smoking with an electronic cigarette than with a regular cigarette?
Adrian: As a parent myself, I understand concerns that young people might be attracted to E-cigarettes and then move on to conventional cigarettes. But I’m not aware of any evidence that this is, or is even likely to be, the case. In the first place, E-cigarettes are not ‘pocket-money’ devices. Secondly, I don’t think anyone has raised the same concerns about pharmaceutical nicotine inhalators which, in the UK at least, are available over the counter. Similarly I’m not aware of any evidence of adult non-smokers using either E-cigarettes or pharmaceutical nicotine inhalators in any number as a gateway to smoking - if there were I’m sure we would have heard of it by now. Bad news travels fast!
ECD: You have worked with both the tobacco industries and the pharmaceutical industries. Do you think there is any justification in e-smokers’ beliefs that Philip Morris is interested in snuffing out alternatives to cigarettes via the Tobacco Bill it supports in the US? And are large pharmaceutical companies encouraging public health groups in America to campaign against the devices?
Adrian: To my knowledge, Philip Morris was involved in discussions on the Tobacco Bill it supports in the US long before the advent of E-smoking so I don’t think that these beliefs are justified in the case of E-cigarettes. But what I think are justified are the widely-held beliefs that if this Tobacco Bill is signed into law as currently drafted, E-cigarettes along with other innovative products would face an almost impossible task to get regulatory approval and would therefore be banned.
This would in effect freeze the market and divide it between regular cigarettes (for those who either want to smoke or partake in the quasi-smoking experience which E-cigarettes provide), smokeless tobacco products (less harmful than cigarettes, but a completely different consumer experience) and pharmaceutical nicotine products (for those want to quit smoking entirely or at minimum cut-down their consumption). So E-cigarettes are at risk of being caught in a regulatory trap, with consumers being denied the choice of a far safer product than regular cigarettes that might meet their smoking abstinence needs better than either smokeless tobacco or pharmaceutical nicotine products.
It would make a lot more sense if a separate regulatory category were to be carved out for cross-over products like E-cigarettes and I’d like to see the manufacturers of these products being more pro-active in this regard. I’m certain such a move would find support from those members of the public health community who see E-cigarettes as potential life-savers rather than as regulatory upstarts. Development and application of an appropriate regulatory package wouldn’t have to be done all at once; it could be incremental, thereby allowing the products to stay on the market in the meantime.
Certainly large pharmaceutical companies with interests in stop-smoking medicines provide very substantial financial support to some of the public health groups that are calling for E-cigarettes to be banned. Incidentally these are the very same public health groups that support the Tobacco Bill backed by Philip Morris. But I’m not aware of any evidence of specific encouragement from these pharmaceutical companies for those groups to take such an antagonistic position. Nor have I seen any position statements on E-cigarettes from the companies themselves. That doesn’t mean to say of course that they are not keeping a close eye on what is happening on the E-cigarette front - I’m sure they are!
ECD: The reaction in the UK seems to be that these devices might help, but that more research is needed. Should more research be done into electronic cigarettes before we allow them to be used by smokers?
Adrian: Well, it’s certainly good that some commentators think that E-cigarettes might help; current smoking prevalence rates are proving surprisingly stubborn to conventional public health interventions. Apart from the reduced harm aspect, E-cigarettes do offer that touchy-feely behavioural aspect of cigarettes that for the most part other alternative products don’t. When it comes to the need for more research, I agree with this, but it should not be at the expense of taking the products of the market in the meantime. If this were to be the case, it really would be a cruel irony if smokers who had switched to E-cigarettes were, as a result, forced to revert to smoking regular cigarettes.
ECD: Should health groups help to fund this expense, as they should also be un-biased. Also, should the e cigarette be taxed by the government to compensate for potential loss in revenue?
Adrian: At a time of economic crisis when many health groups are under financial pressure, the funding may have to come from elsewhere. But it would be entirely appropriate, if not essential, for health groups to be involved in the design of protocols and the undertaking and review of research to evaluate more fully the long-term potential of E-cigarettes as less harmful alternatives to cigarettes. Yes there might be a revenue loss from fewer cigarettes being smoked if E-cigarettes took off in a big way. But I’d hope that governments would use tax policy to steer smokers towards safer products rather than drive them away from them.
ECD: The current advice for smokers from bodies like ASH UK is that nicotine replacement aids should be used by smokers instead of electronic cigarettes. How effective are these aids in helping smokers give up over the long term?
Adrian: Nicotine replacement aids clearly work for some people, but overall these aids are much less effective than one might anticipate, especially over the long–term. For example, in a recent study they were found to be effective in only 1.6% of users, although this admittedly this was better than the 0.4% achieved with placebo treatment.
It’s of course feasible that the development of newer nicotine replacement aids that more closely reproduce the pharmacokinetic profile of the intake of nicotine from cigarettes might improve on this, and currently there is a lot of interest in testing this concept. But at the end of the day it seems the most important thing that helps smokers to give up is having the willpower to do so. If E-cigarettes prove over time to be an effective transition tool in enabling smokers thinking about quitting to develop and build on the willpower to help them do so, then it would be an obvious benefit. I’d hope that if this is the case, bodies like ASH UK would recognise it as such and respond positively by revising their advice accordingly.
ECD: Of course, e-cigarettes are not the only alternative to smoking. Snus is regarded as one of the safest alternatives and some experts we have interviewed believe it contains no measurable risk at all. In your opinion, has the banning of Snus caused the death of smokers in the UK?
Adrian: Times have changed since the EU ban on snus was originally imposed and even hard-line tobacco control advocates now acknowledge that snus is much safer than cigarettes. So the reasoning for maintaining the ban seems more political than scientific, especially given that some smokeless products that are potentially much more harmful than snus are legally on sale. Quite bizarre really!
Perhaps the best answer would be to replace the specific EU ban on snus with a comprehensive overhaul of EU tobacco and nicotine regulation. I’d hope that this would put all nicotine-containing products under the same regulatory umbrella, classify them according to risk, and ensure that consumers are informed accordingly so that they can self-regulate their risk.
To get back to your question, according to one study over 200,000 premature deaths might be avoided annually in just fifteen EU countries if smoking rates were as low as in Sweden, which is attributed in large part by many observers to the Swedish preference for snus instead of cigarettes. So intuitively, it’s very tempting to say ‘yes’. However, without snus having been on sale legally in the UK it’s not really possible to give a definite answer. This is because we don’t know what the UK consumer reaction might have been to snus being made available as an alternative to cigarettes.
It’s not sufficient to just put a less harmful product like snus on the shelves in the hope that consumers will buy it; it has to have consumer relevance and sufficient utility to stimulate trial and repeat purchase. The same is of course true for E-cigarettes and any other less harmful cigarette-alternative. This is where public health backing, rather than criticism, of the launch of such products can play a vital role in getting the message across to the consumer, even if these products originate from the tobacco industry.
ECD: Do you see parallels between Snus and E-Cigarettes?
Adrian: Absolutely, there are definite parallels here. Both products offer smokers nicotine-providing alternatives to cigarettes at a vastly reduced relative risk, primarily because of users not having to inhale tobacco smoke. Both products also offer the consumer some elements of the ritualistic aspects of smoking that medicines don’t. And Sweden offers a good example of how preferences have changed when consumers are given the choice. That doesn’t mean to say that either type of product would necessarily have a universal attraction for smokers. But even if only a small minority of smokers switched, the public health benefits could still be considerable.
A regrettable parallel is that the opposition of some to cigarette alternatives such as snus and E-cigarettes seems to be born out of an absolutist view that the use of tobacco products (or anything resembling them) should be eradicated from modern-day society. Prohibition didn’t work for alcohol in the US and I see no reason why it should work for tobacco either. Some detractors claim that making cigarette alternatives like snus and E-cigarettes available encourages dual-use in combination with cigarettes and thus delays quitting smoking. But the same criticism could equally well be directed towards medicinal nicotine products marketed to relieve cravings during temporary abstinence from smoking.
Finally, I’d say that the current controversy about both snus and E-cigarettes is indicative of the fact that current models of tobacco and nicotine regulation have outlived their usefulness. Urgent revision is required to help, rather than hinder, consumers being able to make healthier choices if they either don’t want to, or can’t, quit their nicotine dependence entirely. E-cigarettes and the voices of the many E-cigarette users world-wide could prove to be a powerful catalyst for change in this regard; as someone who has long had a passionate interest in tobacco harm reduction, I certainly hope so!
Many thanks to Dr Payne for sparing us the time for this interview.
- - -
"E-cigarette" firm claims pharma industry behind proposed ban
By C Shanti
TG Daily
May 14, 2009
http://www.tgdaily.com/content/view/42451/181/
A company marketing so-called e-cigarettes claims that a proposed ban on the products is being orchestrated behind the scenes by the pharmaceutical industry.
An "e-cigarette" is a product that typically uses a battery to vaporize a water based solution to supply nicotine to a "smoker" without any smoke or additional carcinogens and chemicals.
Ecigaretteschoice.com sells these devices and claims that Senator Frank Lautenberg (D-NJ) is trying to ban these products but alleged in a release that he has received over $100,000 from pharmaceutical companies that market products to help people stop smoking.
Senator Lautenberg wants the FDA to run testing on "e-cigarettes" to demonstrate they are safe."
Not all physicians are against "e-cigarettes", the vendor claimed. It said that Dr Joel L. Nitzkin, chair of the Tobacco Control Group for the American Association of Public Health Physicians is opposed to Senator Lautenberg's proposals.
Said ecigaretteschoice.com in a statement today: "Should we listen a non-medically licensed politician whose motives align themselves with the big pharmaceutical companies he protects, or should we listen to the health professionals that are all but screaming for us to actually pay attention to our country's real health issues?"
Dr Nitkin, said the statement, is convinced it's harmful to ban a product less dangerous than its traditional counterpart and put what amounts to a government seal of approval on the more dangerous product, that is to say a cigarette.
Senator Lautenberg wrote to the Food and Drug Administration earlier this year and asked it to take immediate action against manufacturers of electronic cigarettes. He wants the FDA to take the products off the market. He said that the World Health Organization said last year there is no scientific evidence to confirm the products safety and efficacy.
- - -
Electronic cigarette interview with Dr Adrian Payne
Interview by James Dunmore
E Cigarette Direct
May 15, 2009
E-Cigarette Interview with Dr Adrian Payne
Dr Adrian Payne is the Managing Director of Tobacco Horizons, a Tobacco Harm Reduction Consulting Agency. During a post-doctoral career spanning more than thirty years, he has worked for both tobacco and pharmecutical companies, often in the field of Tobacco Harm Reduction.
ECD: How harmful is the electronic cigarette when compared to a regular cigarette?
Adrian: Based on the safety profiling data on E-cigarettes that has been published so far, I think it’s reasonable to say that they are probably at least two, if not three, orders of magnitude less harmful than regular cigarettes. The key reason for this huge difference is that E-cigarettes don’t generate harmful tobacco smoke. But it’s important to understand that ‘no smoke’ doesn’t necessarily translate into ‘no harm’; it’s possible that some risks might emerge from studies into their long-term use.
However, it’s hard to imagine that any such risks would even begin to approach those of smoking cigarettes. Indeed, probably the issue of main concern with E-cigarettes is that children might ingest the E-cigarette cartridges. So along with the necessary internal quality control checks, it would seem sensible for the various manufacturers to use childproof packaging as a design feature.
ECD: Do we have any idea of the effect of heating up nicotine prior to inhaling it? How is the heating of nicotine by the electronic cigarette different to setting fire to tobacco and inhaling the resultant smoke?
Adrian: The end result of tobacco combustion and nicotine vaporisation is basically the same, i.e. generation of a nicotine-containing aerosol that can then be inhaled by the user. Both processes involve heat, but they are otherwise very different in that the aerosol generated by the E-cigarette does not contain within it the thousands of other chemicals, many of which are thought to be extremely harmful, that result from the combustion of tobacco. It’s true that concerns have been expressed about possible harmful effects of some of the chemical components other than nicotine in the E-cigarette aerosol, for example propylene-glycol. But based on current knowledge, these concerns seem vastly overplayed when compared to the risks of cigarette smoking.
ECD. One criticism that has been leveled at the e-cigarette is that it could encourage youngsters and other non-smokers to take up smoking. Are young people more likely to take up smoking with an electronic cigarette than with a regular cigarette?
Adrian: As a parent myself, I understand concerns that young people might be attracted to E-cigarettes and then move on to conventional cigarettes. But I’m not aware of any evidence that this is, or is even likely to be, the case. In the first place, E-cigarettes are not ‘pocket-money’ devices. Secondly, I don’t think anyone has raised the same concerns about pharmaceutical nicotine inhalators which, in the UK at least, are available over the counter. Similarly I’m not aware of any evidence of adult non-smokers using either E-cigarettes or pharmaceutical nicotine inhalators in any number as a gateway to smoking - if there were I’m sure we would have heard of it by now. Bad news travels fast!
ECD: You have worked with both the tobacco industries and the pharmaceutical industries. Do you think there is any justification in e-smokers’ beliefs that Philip Morris is interested in snuffing out alternatives to cigarettes via the Tobacco Bill it supports in the US? And are large pharmaceutical companies encouraging public health groups in America to campaign against the devices?
Adrian: To my knowledge, Philip Morris was involved in discussions on the Tobacco Bill it supports in the US long before the advent of E-smoking so I don’t think that these beliefs are justified in the case of E-cigarettes. But what I think are justified are the widely-held beliefs that if this Tobacco Bill is signed into law as currently drafted, E-cigarettes along with other innovative products would face an almost impossible task to get regulatory approval and would therefore be banned.
This would in effect freeze the market and divide it between regular cigarettes (for those who either want to smoke or partake in the quasi-smoking experience which E-cigarettes provide), smokeless tobacco products (less harmful than cigarettes, but a completely different consumer experience) and pharmaceutical nicotine products (for those want to quit smoking entirely or at minimum cut-down their consumption). So E-cigarettes are at risk of being caught in a regulatory trap, with consumers being denied the choice of a far safer product than regular cigarettes that might meet their smoking abstinence needs better than either smokeless tobacco or pharmaceutical nicotine products.
It would make a lot more sense if a separate regulatory category were to be carved out for cross-over products like E-cigarettes and I’d like to see the manufacturers of these products being more pro-active in this regard. I’m certain such a move would find support from those members of the public health community who see E-cigarettes as potential life-savers rather than as regulatory upstarts. Development and application of an appropriate regulatory package wouldn’t have to be done all at once; it could be incremental, thereby allowing the products to stay on the market in the meantime.
Certainly large pharmaceutical companies with interests in stop-smoking medicines provide very substantial financial support to some of the public health groups that are calling for E-cigarettes to be banned. Incidentally these are the very same public health groups that support the Tobacco Bill backed by Philip Morris. But I’m not aware of any evidence of specific encouragement from these pharmaceutical companies for those groups to take such an antagonistic position. Nor have I seen any position statements on E-cigarettes from the companies themselves. That doesn’t mean to say of course that they are not keeping a close eye on what is happening on the E-cigarette front - I’m sure they are!
ECD: The reaction in the UK seems to be that these devices might help, but that more research is needed. Should more research be done into electronic cigarettes before we allow them to be used by smokers?
Adrian: Well, it’s certainly good that some commentators think that E-cigarettes might help; current smoking prevalence rates are proving surprisingly stubborn to conventional public health interventions. Apart from the reduced harm aspect, E-cigarettes do offer that touchy-feely behavioural aspect of cigarettes that for the most part other alternative products don’t. When it comes to the need for more research, I agree with this, but it should not be at the expense of taking the products of the market in the meantime. If this were to be the case, it really would be a cruel irony if smokers who had switched to E-cigarettes were, as a result, forced to revert to smoking regular cigarettes.
ECD: Should health groups help to fund this expense, as they should also be un-biased. Also, should the e cigarette be taxed by the government to compensate for potential loss in revenue?
Adrian: At a time of economic crisis when many health groups are under financial pressure, the funding may have to come from elsewhere. But it would be entirely appropriate, if not essential, for health groups to be involved in the design of protocols and the undertaking and review of research to evaluate more fully the long-term potential of E-cigarettes as less harmful alternatives to cigarettes. Yes there might be a revenue loss from fewer cigarettes being smoked if E-cigarettes took off in a big way. But I’d hope that governments would use tax policy to steer smokers towards safer products rather than drive them away from them.
ECD: The current advice for smokers from bodies like ASH UK is that nicotine replacement aids should be used by smokers instead of electronic cigarettes. How effective are these aids in helping smokers give up over the long term?
Adrian: Nicotine replacement aids clearly work for some people, but overall these aids are much less effective than one might anticipate, especially over the long–term. For example, in a recent study they were found to be effective in only 1.6% of users, although this admittedly this was better than the 0.4% achieved with placebo treatment.
It’s of course feasible that the development of newer nicotine replacement aids that more closely reproduce the pharmacokinetic profile of the intake of nicotine from cigarettes might improve on this, and currently there is a lot of interest in testing this concept. But at the end of the day it seems the most important thing that helps smokers to give up is having the willpower to do so. If E-cigarettes prove over time to be an effective transition tool in enabling smokers thinking about quitting to develop and build on the willpower to help them do so, then it would be an obvious benefit. I’d hope that if this is the case, bodies like ASH UK would recognise it as such and respond positively by revising their advice accordingly.
ECD: Of course, e-cigarettes are not the only alternative to smoking. Snus is regarded as one of the safest alternatives and some experts we have interviewed believe it contains no measurable risk at all. In your opinion, has the banning of Snus caused the death of smokers in the UK?
Adrian: Times have changed since the EU ban on snus was originally imposed and even hard-line tobacco control advocates now acknowledge that snus is much safer than cigarettes. So the reasoning for maintaining the ban seems more political than scientific, especially given that some smokeless products that are potentially much more harmful than snus are legally on sale. Quite bizarre really!
Perhaps the best answer would be to replace the specific EU ban on snus with a comprehensive overhaul of EU tobacco and nicotine regulation. I’d hope that this would put all nicotine-containing products under the same regulatory umbrella, classify them according to risk, and ensure that consumers are informed accordingly so that they can self-regulate their risk.
To get back to your question, according to one study over 200,000 premature deaths might be avoided annually in just fifteen EU countries if smoking rates were as low as in Sweden, which is attributed in large part by many observers to the Swedish preference for snus instead of cigarettes. So intuitively, it’s very tempting to say ‘yes’. However, without snus having been on sale legally in the UK it’s not really possible to give a definite answer. This is because we don’t know what the UK consumer reaction might have been to snus being made available as an alternative to cigarettes.
It’s not sufficient to just put a less harmful product like snus on the shelves in the hope that consumers will buy it; it has to have consumer relevance and sufficient utility to stimulate trial and repeat purchase. The same is of course true for E-cigarettes and any other less harmful cigarette-alternative. This is where public health backing, rather than criticism, of the launch of such products can play a vital role in getting the message across to the consumer, even if these products originate from the tobacco industry.
ECD: Do you see parallels between Snus and E-Cigarettes?
Adrian: Absolutely, there are definite parallels here. Both products offer smokers nicotine-providing alternatives to cigarettes at a vastly reduced relative risk, primarily because of users not having to inhale tobacco smoke. Both products also offer the consumer some elements of the ritualistic aspects of smoking that medicines don’t. And Sweden offers a good example of how preferences have changed when consumers are given the choice. That doesn’t mean to say that either type of product would necessarily have a universal attraction for smokers. But even if only a small minority of smokers switched, the public health benefits could still be considerable.
A regrettable parallel is that the opposition of some to cigarette alternatives such as snus and E-cigarettes seems to be born out of an absolutist view that the use of tobacco products (or anything resembling them) should be eradicated from modern-day society. Prohibition didn’t work for alcohol in the US and I see no reason why it should work for tobacco either. Some detractors claim that making cigarette alternatives like snus and E-cigarettes available encourages dual-use in combination with cigarettes and thus delays quitting smoking. But the same criticism could equally well be directed towards medicinal nicotine products marketed to relieve cravings during temporary abstinence from smoking.
Finally, I’d say that the current controversy about both snus and E-cigarettes is indicative of the fact that current models of tobacco and nicotine regulation have outlived their usefulness. Urgent revision is required to help, rather than hinder, consumers being able to make healthier choices if they either don’t want to, or can’t, quit their nicotine dependence entirely. E-cigarettes and the voices of the many E-cigarette users world-wide could prove to be a powerful catalyst for change in this regard; as someone who has long had a passionate interest in tobacco harm reduction, I certainly hope so!
Many thanks to Dr Payne for sparing us the time for this interview.
- - -
"E-cigarette" firm claims pharma industry behind proposed ban
By C Shanti
TG Daily
May 14, 2009
http://www.tgdaily.com/content/view/42451/181/
A company marketing so-called e-cigarettes claims that a proposed ban on the products is being orchestrated behind the scenes by the pharmaceutical industry.
An "e-cigarette" is a product that typically uses a battery to vaporize a water based solution to supply nicotine to a "smoker" without any smoke or additional carcinogens and chemicals.
Ecigaretteschoice.com sells these devices and claims that Senator Frank Lautenberg (D-NJ) is trying to ban these products but alleged in a release that he has received over $100,000 from pharmaceutical companies that market products to help people stop smoking.
Senator Lautenberg wants the FDA to run testing on "e-cigarettes" to demonstrate they are safe."
Not all physicians are against "e-cigarettes", the vendor claimed. It said that Dr Joel L. Nitzkin, chair of the Tobacco Control Group for the American Association of Public Health Physicians is opposed to Senator Lautenberg's proposals.
Said ecigaretteschoice.com in a statement today: "Should we listen a non-medically licensed politician whose motives align themselves with the big pharmaceutical companies he protects, or should we listen to the health professionals that are all but screaming for us to actually pay attention to our country's real health issues?"
Dr Nitkin, said the statement, is convinced it's harmful to ban a product less dangerous than its traditional counterpart and put what amounts to a government seal of approval on the more dangerous product, that is to say a cigarette.
Senator Lautenberg wrote to the Food and Drug Administration earlier this year and asked it to take immediate action against manufacturers of electronic cigarettes. He wants the FDA to take the products off the market. He said that the World Health Organization said last year there is no scientific evidence to confirm the products safety and efficacy.
I think you just nailed it Lacey.
Love or hate Kennedy, Congress will tearfully applaud just about anything he proposes as it comes as his "dying wish"
Dear esteemed committee members,
I'm writing as a concerned American citizen and a former cigarette smoker -- pack or more per day for over 30 years. Two months ago I quit, abruptly, and I wasn't even planning or trying to! Another accidental quitter here! Yes, I used to rather rudely shush my doctors when they'd tell me I should quit, even when one of them said he detected signs of COPD. I didn't believe it.
But my lungs told a different story. I got tired of telling people I was "coming down with something" every time they remarked on my coughing; of lying awake at night hacking, unable to get to sleep; of awakening in the middle of the night coughing, only to put on my slippers and step out for a cigarette.
In March this year, I discovered e-cigarettes. What a difference! Like I said, I wasn't even trying to quit -- I was looking for a way to legally smoke in places I hadn't been allowed before. But since the day I received my first e-cig, I haven't been back to regular cigarettes, except for a very vexing 4-5 days when my battery charger went out on me. Oh, was I angry! For those few days, I went back to "analogs," and hated every second of it. Good thing my supplier wasn't local, or it might've gotten ugly!
Now, I no longer wheeze when I take a deep breath. The coughing is gone. My teeth are getting whiter. I am calmer overall.
Mesdames and Messieurs, I implore you to do whatever it takes to keep e-cigs available to us. If it means classifying e-cigs as a tobacco product rather than a "drug," do it. I know it hasn't been fully tested yet -- we're working on that. I'm one happy guinea pig. Believe me, e-cig users are uncommonly health-conscious, as you would note by visiting our online forum: Health and Medical Issues - e-cigarette-forum.com • The place for electronic cigarette reviews, news and chat
As a former cigarette smoker who had resigned herself to smoking till it killed her, I implore you not to take my e-cigs away. This is the ONLY way I'll stay off cigarettes for the foreseeable future.
Very respectfully,
I'm writing as a concerned American citizen and a former cigarette smoker -- pack or more per day for over 30 years. Two months ago I quit, abruptly, and I wasn't even planning or trying to! Another accidental quitter here! Yes, I used to rather rudely shush my doctors when they'd tell me I should quit, even when one of them said he detected signs of COPD. I didn't believe it.
But my lungs told a different story. I got tired of telling people I was "coming down with something" every time they remarked on my coughing; of lying awake at night hacking, unable to get to sleep; of awakening in the middle of the night coughing, only to put on my slippers and step out for a cigarette.
In March this year, I discovered e-cigarettes. What a difference! Like I said, I wasn't even trying to quit -- I was looking for a way to legally smoke in places I hadn't been allowed before. But since the day I received my first e-cig, I haven't been back to regular cigarettes, except for a very vexing 4-5 days when my battery charger went out on me. Oh, was I angry! For those few days, I went back to "analogs," and hated every second of it. Good thing my supplier wasn't local, or it might've gotten ugly!
Now, I no longer wheeze when I take a deep breath. The coughing is gone. My teeth are getting whiter. I am calmer overall.
Mesdames and Messieurs, I implore you to do whatever it takes to keep e-cigs available to us. If it means classifying e-cigs as a tobacco product rather than a "drug," do it. I know it hasn't been fully tested yet -- we're working on that. I'm one happy guinea pig. Believe me, e-cig users are uncommonly health-conscious, as you would note by visiting our online forum: Health and Medical Issues - e-cigarette-forum.com • The place for electronic cigarette reviews, news and chat
As a former cigarette smoker who had resigned herself to smoking till it killed her, I implore you not to take my e-cigs away. This is the ONLY way I'll stay off cigarettes for the foreseeable future.
Very respectfully,
OMG - I just became aware of what sounds like a wonderful alternative to real smoking which I am so addicted to and which is killing me - and see - that the government which is supposed to be serving me (we the people) is fascist already even in this realm. OMG
- Apr 2, 2009
- 5,171
- 13,288
- 67
I posted several notes describing details surrounding the Senate HELP markup session (on the Kennedy tobacco bill that occurred Tuesday and yesterday) at
http://www.e-cigarette-forum.com/fo...pproves-fda-tobacco-regulation-measure-7.html
http://www.e-cigarette-forum.com/fo...pproves-fda-tobacco-regulation-measure-7.html
I have already gotten the word out personally to many of my co-workers. Everyone asks me about my pen-style e-cig (801). Many of these same people have ordered ecigs for themselves and their spouses and/or family members who smoke. Most are having very good success with dumping the analogs. All are FOR ecig "legalization." None of them can understand the FDA / government actions.
Get out there and spread the word....send messages to congress and the FDA.
MacZapIt
http://vaporheads.collectivex.com/
Get out there and spread the word....send messages to congress and the FDA.
MacZapIt
http://vaporheads.collectivex.com/
Last edited:
The 'government' FDA actions are simple to understand. There's no tax infrastructure in place to tax e-cigs like there is for analog cigs. If everybody quit analogs overnight and switched to e-cigs, our corrupt government would lose billions in tobacco tax dollars and tax dollars from the pharmaceutical industry. Ever wonder why the sale of analog cigs has never been banned? Isn't it interesting that analog cigs continue to be sold legally and taxed to the point of insanity with all that's known about the adverse health effects from smoking them while e-cigs are being assaulted for what's not 'known' about the possible health effects. Follow the money.
I just wonder what it's going to take to motivate the people to take back this country?...
Robbie
I just wonder what it's going to take to motivate the people to take back this country?...
Robbie
- Apr 2, 2009
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Here are several news stories I helped generate about Senate Democrats falsely accusing Reynolds of target marketing their new smokefree spitfree tobacco products to minors during last week's HELP Cmte markup session. The WSJ article is objective, while the Dayton Daily News article quotes more harm reduction opponents (who say similar the same about e-cigarettes) repeating these false claims.
- - -
U.S. senators attack Reynolds' alternative
They propose amendment to FDA tobacco bill to ban dissolvable smokeless products
By Richard Craver
Winston-Salem Journal
May 26, 2009
U.S. senators attack Reynolds' alternative
Two U.S. senators are aiming to snuff out dissolvable smokeless-tobacco products before they can get a toehold in the U.S. market.
Their amendment to the proposed FDA regulation bill from Sen. Ted Kennedy, D-Mass., is stoking the debate regarding the viability and possible less-hazardous role of smokeless tobacco products.
U.S. Sens. Jeff Merkley, D-Ore., and Sherrod Brown, D-Ohio, have labeled as "tobacco candy" the three dissolvable products being test marketed by R.J. Reynolds Tobacco Co.
The senators say that the dissolvable products are aimed at getting youths hooked on tobacco and nicotine. They said that some of the products are sold in containers "designed to resemble cell phones."
"There is no doubt that smokeless tobacco products are aimed squarely at children," Brown said. "We have a responsibility to protect children from suggestive marketing and dangerous products."
Reynolds counters that the products -- a pellet (Camel Orbs), a twisted stick the size of a toothpick (Camel Sticks) and a filmlike strip for the tongue (Camel Strips) -- are aimed at adult consumers who want to use a tobacco product in places where they can no longer smoke by federal and state law.
Reynolds is plowing ahead with its smokeless-tobacco initiatives as part of what Susan Ivey, its chairwoman and chief executive, calls its transformation into becoming a "total tobacco company." The company is considered the industry leader in next-generation smokeless products.
In October, Reynolds introduced the dissolvable products in test markets in Columbus, Ohio, Indianapolis and Portland, Ore. The products are made of finely milled tobacco and come in flavor styles called "fresh" and "mellow." They last from two to three minutes for the strips, 10 to 15 minutes for the orbs and 20 to 30 minutes for the sticks.
The senators' amendment was approved last week by a 15-8 vote, mostly along party lines, in the Senate committee on Health, Education, Labor and Pension. Both North Carolina senators, Republican Richard Burr and Democrat Kay Hagan, voted against the amendment.
The Kennedy bill is expected to be dealt with in the Senate next week. Like the House version of the bill that was passed in April, it would impose restrictions on the marketing of cigarettes, cigars and smokeless tobacco and allow the FDA to regulate the content of cigarettes.
In March, Burr and Hagan introduced an alternative tobacco-regulation bill that has made little progress. Their bill would create a new federal agency within the U.S. Department of Health and Human Services to solely regulate tobacco instead of assigning the task to the FDA.
Burr and Hagan said that the massive recall of tainted peanut products and other problems at the FDA demonstrate that the agency is too "overburdened" to oversee such an important component of North Carolina's economy as tobacco. Burr has threatened to filibuster the Kennedy bill.
By introducing the amendment, the senators may be providing the means for scientifically proving whether smokeless products are less hazardous than cigarettes.
Such a definitive test in the United States, which would be under the auspices of the Tobacco Products Scientific Advisory committee, has been requested for years by advocates on both sides of the issue. A report would be presented within two years to the FDA if it is given oversight of the industry.
Julie Edwards, a spokeswoman for Merkley, said that unlike nicotine gum, which is meant to be used for a limited time with decreasing use of nicotine, "tobacco candy is meant to start or continue the addiction and may have even higher doses of nicotine than cigarettes."
"We are talking about a product that hasn't been strenuously studied but is assumed to carry many of the same risks as chewing tobacco -- including the risk of cancer."
Both Reynolds officials and some smokeless-tobacco advocates dispute Edwards' statement on higher doses of nicotine in smokeless products.
Tommy Payne, the executive vice president of public affairs for Reynolds, said that the senators' amendment is part of an "abstinence-only strategy that only provides three options for smokers -- cigarettes, nicotine replacement or quitting cold turkey."
"Our smokeless products are part of a strategy aimed at harm reduction that is backed by scientists and elements of the antismoking advocacy groups," Payne said.
"Their intent with the dissolvable study could be beneficial to our efforts if the science reveals what we believe it will."
Bill Godshall, the executive director of SmokeFree Pennsylvania, said that "many inaccurate and misleading claims were made about the least hazardous tobacco products" by senators and others at the markup session. He is an advocate of switching smokers to smokeless products for health benefits.
He said that efforts to diminish or snuff out the impact of smokeless products would keep those unable or unwilling to quit cigarettes hooked on their habit.
"The amendment's real intent was to poison and pre-empt passage of, and any objective discussion about, responsible tobacco harm-reduction amendments that can significantly reduce cigarette consumption and save the lives of millions of smokers," Godshall said.
"By repeatedly referring to Camel Orbs as candy, and by falsely accusing Reynolds of target marketing them to youth -- which if true, would be actionable violations of both the Master Settlement Agreement and state minimum-age sales laws -- the senators went over-the-top to protect Marlboro's lethal cigarette empire from harm-reduction market competition by Reynolds' far less hazardous smoke-free alternatives."
Richard Craver can be reached at 727-7376 or at rcraver@wsjournal.com.
- - -
Tobacco foes say new product a lure for minors
Maker of Camel Orbs says smokeless, dissolvable tobacco is hardly candy.
By Jessica Wehrman
Dayton Daily News
Sunday, May 24, 2009 9:34 PM
Tobacco foes say new product a lure for minors
WASHINGTON - Shelly Kiser of the American Lung Association in Ohio was all set to give a presentation on Camel Orbs - a dissolvable tobacco product slightly bigger than an Altoid mint - to the Ohio School Nurses Association. All she needed was a prop.
So Kiser, director of advocacy for her organization and no great fan of Camel Orbs, headed into a Columbus gas station earlier this year and asked for a container of Orbs.
They gave it to her for free.
For smokers long confined to standing outside in crummy weather to get their nicotine fix, Camel Orbs is an alternative that keeps users out of the elements.
For Sen. Sherrod Brown and public health advocates, its yet another diabolical strategy to get kids hooked on smoking.
Brown, D-Ohio, this week successfully added a measure calling for a quick Federal Drug Administration study of Orbs and other dissolvable tobacco products to a larger bill that would, for the first time, put tobacco products under FDA regulatory authority. The bill, with the amendment, passed the committee last week and now awaits full U.S. Senate approval. It passed the House in April.
Brown compares Orbs to candy, and said the fact that the products can be passed off as breath mints is another way to lure kids into becoming tobacco addicts at a young age.
"It is criminal to me that they market to children the way they do," he said.
But David Howard, a spokesman for R.J. Reynolds, said the product, like all tobacco products, is legal only for adults over the age of 18. The product is currently not available in the Dayton area.
R.J. Reynolds introduced Orbs in Columbus, Indianapolis and Portland, Ore., earlier this year, and the company said early feedback has been positive. Orbs, he said, "meet the societal expectation of no second-hand smoke, no spitting, and in the case of dissolvables, no litter."
He said theyre hardly candy. They are made of finely milled tobacco, and designed for adults.
"The bottom line is these are tobacco products," he said. "They are clearly marked as tobacco products, they are marketed as tobacco products and they carry the same warnings as tobacco products."
He said similar products - Ariva and Stonewall - have been on the market since earlier this decade with little protest.
Still, he said he welcomes Browns amendment and any study of their product.
Bill Godshall of a group called SmokeFree Pennsylvania counts himself as one of the defenders of Orbs. He compares the products to Nicorette or Commit Lozenges and cites studies indicating they are safer than cigarettes.
"What this comes down to is people fighting for the same market," he said.
But Brown cites studies indicating a single Orb has between 60 and 300 times the amount of tobacco contained in a single cigarette. And Greg Connolly, a professor of the practice of public health at Harvard University, calls Orb products "nicotine on training wheels."
R.J. Reynolds, Connolly said, "is just trying to expand the options for nicotine delivery products for the American public."
Smoking a cigarette for the first time, can be a deeply uncomfortable experience for a teenager, Connolly said. Theres the smoke, for one thing, as well as the coughing and the taste. By turning it into a mint-like product - in mint and cinnamon flavors - theyve made nicotine addiction a more pleasurable experience, he said.
Connolly said Browns amendment would allow the FDA to begin the studies necessary to take Orbs off the market. And unless the FDA starts regulating tobacco, he warns, the tobacco industry will continue to get more sophisticated in how it delivers nicotine. If that doesnt happen, he said, "the tobacco companies own the future."
Kiser said despite the fact that the products are only legal for adults, school nurses have reported finding packages of Orbs in the trash.
To her, theyre dangerous because they can be consumed in front of parents and teachers without the adults knowing whats going on.
"Unless a parent knows the exact shape of it, they wouldnt suspect anything," she said.
- - -
U.S. senators attack Reynolds' alternative
They propose amendment to FDA tobacco bill to ban dissolvable smokeless products
By Richard Craver
Winston-Salem Journal
May 26, 2009
U.S. senators attack Reynolds' alternative
Two U.S. senators are aiming to snuff out dissolvable smokeless-tobacco products before they can get a toehold in the U.S. market.
Their amendment to the proposed FDA regulation bill from Sen. Ted Kennedy, D-Mass., is stoking the debate regarding the viability and possible less-hazardous role of smokeless tobacco products.
U.S. Sens. Jeff Merkley, D-Ore., and Sherrod Brown, D-Ohio, have labeled as "tobacco candy" the three dissolvable products being test marketed by R.J. Reynolds Tobacco Co.
The senators say that the dissolvable products are aimed at getting youths hooked on tobacco and nicotine. They said that some of the products are sold in containers "designed to resemble cell phones."
"There is no doubt that smokeless tobacco products are aimed squarely at children," Brown said. "We have a responsibility to protect children from suggestive marketing and dangerous products."
Reynolds counters that the products -- a pellet (Camel Orbs), a twisted stick the size of a toothpick (Camel Sticks) and a filmlike strip for the tongue (Camel Strips) -- are aimed at adult consumers who want to use a tobacco product in places where they can no longer smoke by federal and state law.
Reynolds is plowing ahead with its smokeless-tobacco initiatives as part of what Susan Ivey, its chairwoman and chief executive, calls its transformation into becoming a "total tobacco company." The company is considered the industry leader in next-generation smokeless products.
In October, Reynolds introduced the dissolvable products in test markets in Columbus, Ohio, Indianapolis and Portland, Ore. The products are made of finely milled tobacco and come in flavor styles called "fresh" and "mellow." They last from two to three minutes for the strips, 10 to 15 minutes for the orbs and 20 to 30 minutes for the sticks.
The senators' amendment was approved last week by a 15-8 vote, mostly along party lines, in the Senate committee on Health, Education, Labor and Pension. Both North Carolina senators, Republican Richard Burr and Democrat Kay Hagan, voted against the amendment.
The Kennedy bill is expected to be dealt with in the Senate next week. Like the House version of the bill that was passed in April, it would impose restrictions on the marketing of cigarettes, cigars and smokeless tobacco and allow the FDA to regulate the content of cigarettes.
In March, Burr and Hagan introduced an alternative tobacco-regulation bill that has made little progress. Their bill would create a new federal agency within the U.S. Department of Health and Human Services to solely regulate tobacco instead of assigning the task to the FDA.
Burr and Hagan said that the massive recall of tainted peanut products and other problems at the FDA demonstrate that the agency is too "overburdened" to oversee such an important component of North Carolina's economy as tobacco. Burr has threatened to filibuster the Kennedy bill.
By introducing the amendment, the senators may be providing the means for scientifically proving whether smokeless products are less hazardous than cigarettes.
Such a definitive test in the United States, which would be under the auspices of the Tobacco Products Scientific Advisory committee, has been requested for years by advocates on both sides of the issue. A report would be presented within two years to the FDA if it is given oversight of the industry.
Julie Edwards, a spokeswoman for Merkley, said that unlike nicotine gum, which is meant to be used for a limited time with decreasing use of nicotine, "tobacco candy is meant to start or continue the addiction and may have even higher doses of nicotine than cigarettes."
"We are talking about a product that hasn't been strenuously studied but is assumed to carry many of the same risks as chewing tobacco -- including the risk of cancer."
Both Reynolds officials and some smokeless-tobacco advocates dispute Edwards' statement on higher doses of nicotine in smokeless products.
Tommy Payne, the executive vice president of public affairs for Reynolds, said that the senators' amendment is part of an "abstinence-only strategy that only provides three options for smokers -- cigarettes, nicotine replacement or quitting cold turkey."
"Our smokeless products are part of a strategy aimed at harm reduction that is backed by scientists and elements of the antismoking advocacy groups," Payne said.
"Their intent with the dissolvable study could be beneficial to our efforts if the science reveals what we believe it will."
Bill Godshall, the executive director of SmokeFree Pennsylvania, said that "many inaccurate and misleading claims were made about the least hazardous tobacco products" by senators and others at the markup session. He is an advocate of switching smokers to smokeless products for health benefits.
He said that efforts to diminish or snuff out the impact of smokeless products would keep those unable or unwilling to quit cigarettes hooked on their habit.
"The amendment's real intent was to poison and pre-empt passage of, and any objective discussion about, responsible tobacco harm-reduction amendments that can significantly reduce cigarette consumption and save the lives of millions of smokers," Godshall said.
"By repeatedly referring to Camel Orbs as candy, and by falsely accusing Reynolds of target marketing them to youth -- which if true, would be actionable violations of both the Master Settlement Agreement and state minimum-age sales laws -- the senators went over-the-top to protect Marlboro's lethal cigarette empire from harm-reduction market competition by Reynolds' far less hazardous smoke-free alternatives."
Richard Craver can be reached at 727-7376 or at rcraver@wsjournal.com.
- - -
Tobacco foes say new product a lure for minors
Maker of Camel Orbs says smokeless, dissolvable tobacco is hardly candy.
By Jessica Wehrman
Dayton Daily News
Sunday, May 24, 2009 9:34 PM
Tobacco foes say new product a lure for minors
WASHINGTON - Shelly Kiser of the American Lung Association in Ohio was all set to give a presentation on Camel Orbs - a dissolvable tobacco product slightly bigger than an Altoid mint - to the Ohio School Nurses Association. All she needed was a prop.
So Kiser, director of advocacy for her organization and no great fan of Camel Orbs, headed into a Columbus gas station earlier this year and asked for a container of Orbs.
They gave it to her for free.
For smokers long confined to standing outside in crummy weather to get their nicotine fix, Camel Orbs is an alternative that keeps users out of the elements.
For Sen. Sherrod Brown and public health advocates, its yet another diabolical strategy to get kids hooked on smoking.
Brown, D-Ohio, this week successfully added a measure calling for a quick Federal Drug Administration study of Orbs and other dissolvable tobacco products to a larger bill that would, for the first time, put tobacco products under FDA regulatory authority. The bill, with the amendment, passed the committee last week and now awaits full U.S. Senate approval. It passed the House in April.
Brown compares Orbs to candy, and said the fact that the products can be passed off as breath mints is another way to lure kids into becoming tobacco addicts at a young age.
"It is criminal to me that they market to children the way they do," he said.
But David Howard, a spokesman for R.J. Reynolds, said the product, like all tobacco products, is legal only for adults over the age of 18. The product is currently not available in the Dayton area.
R.J. Reynolds introduced Orbs in Columbus, Indianapolis and Portland, Ore., earlier this year, and the company said early feedback has been positive. Orbs, he said, "meet the societal expectation of no second-hand smoke, no spitting, and in the case of dissolvables, no litter."
He said theyre hardly candy. They are made of finely milled tobacco, and designed for adults.
"The bottom line is these are tobacco products," he said. "They are clearly marked as tobacco products, they are marketed as tobacco products and they carry the same warnings as tobacco products."
He said similar products - Ariva and Stonewall - have been on the market since earlier this decade with little protest.
Still, he said he welcomes Browns amendment and any study of their product.
Bill Godshall of a group called SmokeFree Pennsylvania counts himself as one of the defenders of Orbs. He compares the products to Nicorette or Commit Lozenges and cites studies indicating they are safer than cigarettes.
"What this comes down to is people fighting for the same market," he said.
But Brown cites studies indicating a single Orb has between 60 and 300 times the amount of tobacco contained in a single cigarette. And Greg Connolly, a professor of the practice of public health at Harvard University, calls Orb products "nicotine on training wheels."
R.J. Reynolds, Connolly said, "is just trying to expand the options for nicotine delivery products for the American public."
Smoking a cigarette for the first time, can be a deeply uncomfortable experience for a teenager, Connolly said. Theres the smoke, for one thing, as well as the coughing and the taste. By turning it into a mint-like product - in mint and cinnamon flavors - theyve made nicotine addiction a more pleasurable experience, he said.
Connolly said Browns amendment would allow the FDA to begin the studies necessary to take Orbs off the market. And unless the FDA starts regulating tobacco, he warns, the tobacco industry will continue to get more sophisticated in how it delivers nicotine. If that doesnt happen, he said, "the tobacco companies own the future."
Kiser said despite the fact that the products are only legal for adults, school nurses have reported finding packages of Orbs in the trash.
To her, theyre dangerous because they can be consumed in front of parents and teachers without the adults knowing whats going on.
"Unless a parent knows the exact shape of it, they wouldnt suspect anything," she said.
Bill, regardless of what happens, I am so glad we have you speaking out for our rights.
Thank you for all you do on our behalf!
Thank you for all you do on our behalf!
You can buy and sell anything in this country if u label it correctly. Someone needs to come up with alternative therapies and names for ecigs and uses for the juice. If manufacturers ship personal aromatherapy devices and oils the fda and others lose their angle.
Bottom line pharmacies, tobacco companies and government (taxes) stand to lose a lot of money if everyone quits smoking analogs.
Bottom line pharmacies, tobacco companies and government (taxes) stand to lose a lot of money if everyone quits smoking analogs.
Thanks for all you do, Bill. Just tell us how we can help you help us win!
~~Cheryl
~~Cheryl
- Apr 2, 2009
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Here's a news article from 2003 when the FDA banned nicotine water (which is now being marketed as a homeopathic remedy), and several months after the FDA banned a nicotine lozenge and a nicotine skin cream. CTFK, ACS, AHA, ALA petitioned the FDA back then to ban these far less hazardous alternatives to cigarettes. I'm still very concerned that we may see similar headlines in the near future announcing the FDA has banned electronic cigarettes (after Obama signs the FDA tobacco bill).
- - -
FDA calls nicotine water illegal drug, bars its sale
Company sought to market it as a diet supplement
AP, Chicago Tribune, 2002-07-03, via tobacco.org
http://www.chicagotribune.com/news/nationworld/chi-0207030163jul03.story
WASHINGTON -- Water laced with nicotine is billed as a
"refreshing break to the smoking habit," but the Food
and Drug Administration ruled Tuesday that it's also
illegal, ending a California company's bid to begin
selling bottles later this month.
The crackdown had been expected since the FDA ordered
nicotine-laced lollipops and lip balm off the market in
April, calling them unapproved drugs that had enough
nicotine to endanger children lured by their resemblance
to candy.
But NicoWater underwent additional scrutiny because
its maker was promoting the bottled water as a dietary
supplement, and the federal agency isn't allowed to
regulate supplements nearly as strictly as it does
medications.
Because nicotine is legally sold over the counter
in FDA-approved smoking-cessation aids, federal law
prohibits its sale as a dietary supplement, agency
lawyers concluded Tuesday. That means NicoWater can't
be sold.
The "FDA's decision underscores our commitment that
consumers be protected from drug products that have
not undergone our rigorous review process," said
Lester Crawford, the FDA acting commissioner.
The manufacturer, QT5 Inc., remained confident that
its water met the definition of a dietary supplement,
but couldn't immediately say if it will challenge
FDA's ruling, said spokesman Ed Haisha.
Anti-smoking activists had pushed the FDA to issue
the ruling, saying allowing nicotine-laced water
would have set a dangerous precedent opening the way
for nicotine to be added many products, including
ones children use.
"The FDA decision is important because it recognizes
nicotine as a powerful drug that needs to be regulated,"
said Matthew Myers of the Campaign for Tobacco-Free
Kids, co-author of a petition filed with FDA against
the products.
The FDA's attempt in the mid-1990s to regulate
cigarettes was stopped by the Supreme Court.
Now nicotine, the addictive ingredient in tobacco, is
popping up in more and more novel products, and the FDA's
reaction has been to deal with them in a patchwork way,
one at a time, after Myers' organization files complaints.
The agency does regulate products containing nicotine
that are marketed as drugs--meaning smoking-cessation
aids like nicotine gum and patches, which underwent
rigorous scientific studies before their sales were
allowed.
In April, the agency stopped pharmacists from
formulating their own nicotine-laced lollipops and
lip balm as alternatives to those products, ruling
they were unapproved drugs.
Haisha said NicoWater, which was to start selling in
retail stores later this month, was never intended
as a smoking-cessation aid but as a boost for smokers
when they can't light up.
"From a practical standpoint, you're on a plane from
New York to L.A., this is to keep you from clawing
the seat in front of you," he said.
He contended users would absorb less nicotine from
the water -- 2 milligrams or 4 milligrams of nicotine
per 16-ounce bottle -- than from nicotine gum. At
those levels, it was touted as having little
aftertaste.
Haisha wondered why anti-smoking activists opposed
a smokeless way of getting nicotine. "It's a way to
keep Susie in the back seat from getting any
secondhand smoke when mommy's driving her to
school."
- - -
FDA calls nicotine water illegal drug, bars its sale
Company sought to market it as a diet supplement
AP, Chicago Tribune, 2002-07-03, via tobacco.org
http://www.chicagotribune.com/news/nationworld/chi-0207030163jul03.story
WASHINGTON -- Water laced with nicotine is billed as a
"refreshing break to the smoking habit," but the Food
and Drug Administration ruled Tuesday that it's also
illegal, ending a California company's bid to begin
selling bottles later this month.
The crackdown had been expected since the FDA ordered
nicotine-laced lollipops and lip balm off the market in
April, calling them unapproved drugs that had enough
nicotine to endanger children lured by their resemblance
to candy.
But NicoWater underwent additional scrutiny because
its maker was promoting the bottled water as a dietary
supplement, and the federal agency isn't allowed to
regulate supplements nearly as strictly as it does
medications.
Because nicotine is legally sold over the counter
in FDA-approved smoking-cessation aids, federal law
prohibits its sale as a dietary supplement, agency
lawyers concluded Tuesday. That means NicoWater can't
be sold.
The "FDA's decision underscores our commitment that
consumers be protected from drug products that have
not undergone our rigorous review process," said
Lester Crawford, the FDA acting commissioner.
The manufacturer, QT5 Inc., remained confident that
its water met the definition of a dietary supplement,
but couldn't immediately say if it will challenge
FDA's ruling, said spokesman Ed Haisha.
Anti-smoking activists had pushed the FDA to issue
the ruling, saying allowing nicotine-laced water
would have set a dangerous precedent opening the way
for nicotine to be added many products, including
ones children use.
"The FDA decision is important because it recognizes
nicotine as a powerful drug that needs to be regulated,"
said Matthew Myers of the Campaign for Tobacco-Free
Kids, co-author of a petition filed with FDA against
the products.
The FDA's attempt in the mid-1990s to regulate
cigarettes was stopped by the Supreme Court.
Now nicotine, the addictive ingredient in tobacco, is
popping up in more and more novel products, and the FDA's
reaction has been to deal with them in a patchwork way,
one at a time, after Myers' organization files complaints.
The agency does regulate products containing nicotine
that are marketed as drugs--meaning smoking-cessation
aids like nicotine gum and patches, which underwent
rigorous scientific studies before their sales were
allowed.
In April, the agency stopped pharmacists from
formulating their own nicotine-laced lollipops and
lip balm as alternatives to those products, ruling
they were unapproved drugs.
Haisha said NicoWater, which was to start selling in
retail stores later this month, was never intended
as a smoking-cessation aid but as a boost for smokers
when they can't light up.
"From a practical standpoint, you're on a plane from
New York to L.A., this is to keep you from clawing
the seat in front of you," he said.
He contended users would absorb less nicotine from
the water -- 2 milligrams or 4 milligrams of nicotine
per 16-ounce bottle -- than from nicotine gum. At
those levels, it was touted as having little
aftertaste.
Haisha wondered why anti-smoking activists opposed
a smokeless way of getting nicotine. "It's a way to
keep Susie in the back seat from getting any
secondhand smoke when mommy's driving her to
school."
- Apr 2, 2009
- 5,171
- 13,288
- 67
Here's another 2002 article announcing the FDA ban of nicotine skin cream and a nicotine lozenge. I believe that the marketers of the nicotine lozenges referred to them as lozenges, and that CTFK referred to them as "lollipops" to falsely imply the products were being target marketed to youth, just as CTFK, Senators Merkley, Brown and other repeatedly referred to RJ Reynold's new tobacco lozenge product (Camel Orbs) as "tobacco candy" to falsely accuse Reynolds of target marketing them to youth last week during the Senate HELP Cmte markup of the FDA tobacco bill).
FDA: Nicotine Lollipops Sold on Web Illegal
Reuters, 2002-04-10, via tobacco.org
WASHINGTON (Reuters) - Nicotine lollipops and lip balms sold by
three pharmacies as aids to quit smoking are illegal, U.S.
regulators said on Wednesday as they warned the firms to stop
selling the products.
The Food and Drug Administration ruled the lollipops and lip balms
are unapproved drugs and therefore need to pass extensive tests to
show whether they are safe and effective.
"FDA is concerned about the health risk of these products," the
agency said in a statement.
Pharmacists had asserted the right to sell the products at stores
and over the Internet under federal rules that permit them to make
medicines easier to take, a practice known as compounding.
The FDA determined that the lollipops and lip balms violated those
rules because some were being sold without a doctor's prescription.
Also, the type of nicotine typically used, nicotine salicylate, is
not permitted in compounding.
In addition, the products did not have proper directions for use and failed to
carry adequate warnings against use by children, the FDA said.
The FDA sent warning letters to Bird's Hill Pharmacy based in
Needham, Massachusetts; Ashland Drug of Ashland, Mississippi; and
The Compounding Pharmacy of Aurora, Illinois. All three firms were
selling the nicotine products over the Internet, the FDA said.
In the letters, the FDA asked the firms to respond within 15 days.
Failure to stop selling the products could lead to further
regulatory action, such as seizure or an injunction.
Larry Frieders, owner of The Compounding Pharmacy, said he
immediately stopped selling the products after he received the FDA's warning on
Wednesday morning.
"I'm disappointed because I think the product we were making was
helping people," he said in an interview.
The lollipops are promoted as a tasty way to give up cigarettes, or
a means for smokers to get a nicotine fix in places where they
cannot light up a cigarette.
FDA: Nicotine Lollipops Sold on Web Illegal
Reuters, 2002-04-10, via tobacco.org
WASHINGTON (Reuters) - Nicotine lollipops and lip balms sold by
three pharmacies as aids to quit smoking are illegal, U.S.
regulators said on Wednesday as they warned the firms to stop
selling the products.
The Food and Drug Administration ruled the lollipops and lip balms
are unapproved drugs and therefore need to pass extensive tests to
show whether they are safe and effective.
"FDA is concerned about the health risk of these products," the
agency said in a statement.
Pharmacists had asserted the right to sell the products at stores
and over the Internet under federal rules that permit them to make
medicines easier to take, a practice known as compounding.
The FDA determined that the lollipops and lip balms violated those
rules because some were being sold without a doctor's prescription.
Also, the type of nicotine typically used, nicotine salicylate, is
not permitted in compounding.
In addition, the products did not have proper directions for use and failed to
carry adequate warnings against use by children, the FDA said.
The FDA sent warning letters to Bird's Hill Pharmacy based in
Needham, Massachusetts; Ashland Drug of Ashland, Mississippi; and
The Compounding Pharmacy of Aurora, Illinois. All three firms were
selling the nicotine products over the Internet, the FDA said.
In the letters, the FDA asked the firms to respond within 15 days.
Failure to stop selling the products could lead to further
regulatory action, such as seizure or an injunction.
Larry Frieders, owner of The Compounding Pharmacy, said he
immediately stopped selling the products after he received the FDA's warning on
Wednesday morning.
"I'm disappointed because I think the product we were making was
helping people," he said in an interview.
The lollipops are promoted as a tasty way to give up cigarettes, or
a means for smokers to get a nicotine fix in places where they
cannot light up a cigarette.
I share your pessimism, having followed this story and practice for almost 17 months. Just substitute "e-cig" for "nicotine water", "lollipops" and "lip balm" in your noted stories, and you'll be reading the ban on e-cigarettes before long.
Bill I support you and I support the cause.
But the assertion that RJ Reynold would not try to target kids, is dubious at best.
I support peoples right to smoke if they choose. Moreover, I see smokeless tobacco as the less of evils and therefore should be made widely available.
However, I dont buy that Big Tobacco cares who they get to smoke,chew or whatever. Is the primary intent of Orbs to get kids to use tobacco, I doubt it. Will it get some to start, yea I think so.
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Per Boston George's comment, please note that in 1998 Philip Morris, Reynolds, Lorillard, UST and other tobacco companies signed the Master Settlement Agreement with 46 State AGs that specifically prohibited any of the companies from advertising, promoting, sampling and any other marketing of tobacco to youth (with multimillion dollar fines against any manufacturer caught violating the MSA).
Also, all 50 states have laws that prohibit the sale of tobacco products to minors under 18 years.
And at least 10,000 times more youth smoke Philip Morris Marlboro cigarettes than use RJ Reynolds' Camel Orbs. But those facts didn't seem to concern any of the Senate Democrats who publicly accused (without providing any actual evidence) Reynolds of target marketing Camel Orbs (tobacco lozenges) to youth and repeatedly referrring to the products as "tobacco candy" during last week's US Senate Committee markup of FDA tobacco legislation.
All of the different tobacco products (except one) that were held up by Democrat Senators were made by RJ Reynolds, and all of the products (except one) that were held up by Democratic Senators were removed from the market more than two and half years ago.
And of course, none of the Senate Democrats pointed out that Camel Orbs and other smokeless tobacco products are far far less hazardous than Philip Morris' Marlboro cigarettes (which the legislation protects).
Also, all 50 states have laws that prohibit the sale of tobacco products to minors under 18 years.
And at least 10,000 times more youth smoke Philip Morris Marlboro cigarettes than use RJ Reynolds' Camel Orbs. But those facts didn't seem to concern any of the Senate Democrats who publicly accused (without providing any actual evidence) Reynolds of target marketing Camel Orbs (tobacco lozenges) to youth and repeatedly referrring to the products as "tobacco candy" during last week's US Senate Committee markup of FDA tobacco legislation.
All of the different tobacco products (except one) that were held up by Democrat Senators were made by RJ Reynolds, and all of the products (except one) that were held up by Democratic Senators were removed from the market more than two and half years ago.
And of course, none of the Senate Democrats pointed out that Camel Orbs and other smokeless tobacco products are far far less hazardous than Philip Morris' Marlboro cigarettes (which the legislation protects).
I'm not an RJR fan and this is why: Star Scientific developed a new curing process during preparation for marketing its dissolvables, Ariva and Stonewall. It obtained patents on its process, which virtually eliminated carcinogenic TSNAs.
In 2002, it brought its first product to market.
Good idea, RJR must have said. Let's do it. But it didn't pay Star a cent for Star's patented process when RJR is said to have begun using it. Star sued for patent infringement. RJR filed countering legal mumbo-jumbo. The whole mess was decided -- wildly incorrectly -- by a lower court judge, and then reversed in no uncertain language by the appeals court. It ate up eight years in the courts.
RJR appealed that reversal to the Supreme Court. On March 8 of this year, we read this:
Star will now present its case for damages to a Maryland jury. In its first quarter report recently released, Star lost $5.2-million. Not from lack of sales. Lawyers to fight RJR don't come cheap.
Will the jury please note that RJR just blessed America with Camel Orbs, Sticks and Strips, dissolvables called "tobacco candy" in Senate HELP committee hearings last week? Will the jury please note how these are virtually the same as Star Scientific's tobacco pellets? Will the jury please sock RJR with a multi-million dollar damage penalty and give the inventor and patent holder the justice he deserves?
Philip Morris isn't the only black-hat American tobacco company.
In 2002, it brought its first product to market.
Good idea, RJR must have said. Let's do it. But it didn't pay Star a cent for Star's patented process when RJR is said to have begun using it. Star sued for patent infringement. RJR filed countering legal mumbo-jumbo. The whole mess was decided -- wildly incorrectly -- by a lower court judge, and then reversed in no uncertain language by the appeals court. It ate up eight years in the courts.
RJR appealed that reversal to the Supreme Court. On March 8 of this year, we read this:
Star will now present its case for damages to a Maryland jury. In its first quarter report recently released, Star lost $5.2-million. Not from lack of sales. Lawyers to fight RJR don't come cheap.
Will the jury please note that RJR just blessed America with Camel Orbs, Sticks and Strips, dissolvables called "tobacco candy" in Senate HELP committee hearings last week? Will the jury please note how these are virtually the same as Star Scientific's tobacco pellets? Will the jury please sock RJR with a multi-million dollar damage penalty and give the inventor and patent holder the justice he deserves?
Philip Morris isn't the only black-hat American tobacco company.
- Status
