AAPHP to the FDA - Talking points discussion for comments submissions
- Thread starter Bill Godshall
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Currently it is about 10 posts down from this one.
Here's the link, in case it disappears...
http://www.e-cigarette-forum.com/fo...4891-comments-please-aaphp-petitions-fda.html
Sorry to repeat this question but could someone please post what the comments cutoff dates are for these petitions? I did read that topic in the regulations.gov site FAQs, but did not see cutoff dates where those faqs said they should be. (Still anticipating embarrassment when I finally find out why I'm not seeing them lol. 
) As I tell ppl about the petitions I'd like to have some idea what time frame we're talkin!! Seems that would be very useful for everyone to know.
) As I tell ppl about the petitions I'd like to have some idea what time frame we're talkin!! Seems that would be very useful for everyone to know.
My Petition;
I am writing to urge the FDA to reclassify and regulate electronic cigarettes (nicotine vaporizers) as tobacco products.
I am addicted to analog cigarettes and have been so addicted for the last 24 years. I have tried many methods to break my habit, from patches & gum even to prescriptions of Chantix to no success. For many years I felt that I would never be able to stop smoking and would die as a result of my addiction.
The beginning of 2010 was a time of enlightenment and change for me. I first became aware and then became a user of nicotine vaporizers. I have noticed the following changes in my health:
Breathing is much easier and complete.
Sense of smell works again.
Coughing every morning is gone.
Lungs don't hurt.
Along with myself, hundreds of thousands of smokers already have significantly reduced their health risks by switching to e-cigarettes / nicotine vaporizers.
There is no reason for the FDA to not control and regulate E-Cigarettes / Nicotine Vaporizers, since e-cigarettes / nicotine vaporizers are derived from tobacco, the FDA can legally reclassify and regulate them as "tobacco products", instead of choosing to classify e-cigarettes / nicotine vaporizers as "drugs" or "devices", the FDA was/is attempting to ban the products.
By reclassifying e-cigarettes / nicotine vaporizers as tobacco products, the FDA would ban their sale to minors, would be able to establish other reasonable and responsible product regulations, would help to reduce (instead of maintain) cigarette consumption, and would save taxpayers money that FDA continues to waste, in lieu of SE vs. FDA, Federal Judge Richard Leon ruled that the FDA can regulate e-cigarettes as "tobacco products", but not as "drugs" or "devices".
A Ban of E-Cigarettes / Nicotine Vaporizers on the FDA's part could only be recognized as its support for the Analog Cigarette / Tobacco Industry. If FDA bans Nicotine Vaporizers you sign my death warrant from smoking.
I am writing to urge the FDA to reclassify and regulate electronic cigarettes (nicotine vaporizers) as tobacco products.
I am addicted to analog cigarettes and have been so addicted for the last 24 years. I have tried many methods to break my habit, from patches & gum even to prescriptions of Chantix to no success. For many years I felt that I would never be able to stop smoking and would die as a result of my addiction.
The beginning of 2010 was a time of enlightenment and change for me. I first became aware and then became a user of nicotine vaporizers. I have noticed the following changes in my health:
Breathing is much easier and complete.
Sense of smell works again.
Coughing every morning is gone.
Lungs don't hurt.
Along with myself, hundreds of thousands of smokers already have significantly reduced their health risks by switching to e-cigarettes / nicotine vaporizers.
There is no reason for the FDA to not control and regulate E-Cigarettes / Nicotine Vaporizers, since e-cigarettes / nicotine vaporizers are derived from tobacco, the FDA can legally reclassify and regulate them as "tobacco products", instead of choosing to classify e-cigarettes / nicotine vaporizers as "drugs" or "devices", the FDA was/is attempting to ban the products.
By reclassifying e-cigarettes / nicotine vaporizers as tobacco products, the FDA would ban their sale to minors, would be able to establish other reasonable and responsible product regulations, would help to reduce (instead of maintain) cigarette consumption, and would save taxpayers money that FDA continues to waste, in lieu of SE vs. FDA, Federal Judge Richard Leon ruled that the FDA can regulate e-cigarettes as "tobacco products", but not as "drugs" or "devices".
A Ban of E-Cigarettes / Nicotine Vaporizers on the FDA's part could only be recognized as its support for the Analog Cigarette / Tobacco Industry. If FDA bans Nicotine Vaporizers you sign my death warrant from smoking.
Both petitions signed, sealed and delivered!
Has anyone thought of starting a group of some kind to try to gather the e-cig forces if needed to act enmass in the future? One where everyone would be notified immediately and could act?
Has anyone thought of starting a group of some kind to try to gather the e-cig forces if needed to act enmass in the future? One where everyone would be notified immediately and could act?
To the physicians of AAPHP,
I wrote my thesis on the effect of various addictions in societal costs and the failure of the efforts to manage and/or control them. Research has eclipsed and dated aspects of that paper as well it should. One area I discussed was the failure of treatment to break the Rule of Thirds. Seventeen years later it is still the rule.
As researchers you know the impact of smoking tobacco on the health of the people not just in the U.S., but world-wide is cannot be calculated. The only drug that rivals tobacco is alcohol. The costs in dollars and lives by these two drugs dating from the beginning of the 20th century have wreaked greater destruction and human suffering than all the wars fought during that period.One example, the war in Vietnam resulted in roughly 40, 000 deaths over a ten year span. It is estimated that alcohol alone, on average, accounts for an equal number in traffic related fatalities in a single year. Where are the protesters?
The question we should be asking is,"What can be done as harm reduction of these two addictions?" For the drug alcohol no one has a satisfactory answer. There hasn't been one in 5000 years and despite our efforts the problem worsens.
On the deleterious effects of tobacco smoking we have an option to reduce harm. Pending controlled studies, this option may prove more effective than current methods of nicotine delivery. The option, is electronic cigarette, and like gum or pills is taken in self-administered doses. The physiological effects of nicotine are known and we have already accepted this effect as reasonable trade-off to elimination of the carcinogenics caused by smoking. Lead the way to encourage the research necessary toward scientific fact, not fiction, guided by the lobby of Big Tobacco. Their history of past manipulations and deception aimed at furthering their own interests at the public's expense is a matter of Congressional and public record. Let us not repeat history.
I wrote my thesis on the effect of various addictions in societal costs and the failure of the efforts to manage and/or control them. Research has eclipsed and dated aspects of that paper as well it should. One area I discussed was the failure of treatment to break the Rule of Thirds. Seventeen years later it is still the rule.
As researchers you know the impact of smoking tobacco on the health of the people not just in the U.S., but world-wide is cannot be calculated. The only drug that rivals tobacco is alcohol. The costs in dollars and lives by these two drugs dating from the beginning of the 20th century have wreaked greater destruction and human suffering than all the wars fought during that period.One example, the war in Vietnam resulted in roughly 40, 000 deaths over a ten year span. It is estimated that alcohol alone, on average, accounts for an equal number in traffic related fatalities in a single year. Where are the protesters?
The question we should be asking is,"What can be done as harm reduction of these two addictions?" For the drug alcohol no one has a satisfactory answer. There hasn't been one in 5000 years and despite our efforts the problem worsens.
On the deleterious effects of tobacco smoking we have an option to reduce harm. Pending controlled studies, this option may prove more effective than current methods of nicotine delivery. The option, is electronic cigarette, and like gum or pills is taken in self-administered doses. The physiological effects of nicotine are known and we have already accepted this effect as reasonable trade-off to elimination of the carcinogenics caused by smoking. Lead the way to encourage the research necessary toward scientific fact, not fiction, guided by the lobby of Big Tobacco. Their history of past manipulations and deception aimed at furthering their own interests at the public's expense is a matter of Congressional and public record. Let us not repeat history.
And where might that thread be? A link would be nice.
<EDIT BY SJ> Here you go: http://www.e-cigarette-forum.com/fo...4891-comments-please-aaphp-petitions-fda.html
I dont want to be argumentitive here but could someone explain:
or post a link to the explanation. I cannot imagine how anyone could wrangle up something like that. Vaporizers are not "derived" from any tobacco I know of. That would imply they were made from tobacco (and yes I know the definiton of derive.) It would be a stretch to say vaporizing derived from smoking but at least one could make the case.
Bizarre to say the least.
Last edited by a moderator:
The nicotine in the e-liquid is a by-product of tobacco because it is extracted from Tobacco. so therefore: a tobacco product.
Be sure and comment on the FDA petition and write down your tracking number, so we can make sure they post them like they are supposed to.
- Apr 2, 2009
- 5,171
- 13,288
- 66
There is no deadline for submitting comments on the AAPHP petitions, and people can submit multiple comments.
The FDA is very likely to give serious consideration to the first AAPHP petition (to reclassify and regulate e-cigarettes as tobacco) if/when the Appeals Court upholds (or fails to strike down) Judge Leon's ruling in SE v FDA (i.e. the FDA cannot regulate e-cigarettes as drugs or devices, and can only regulate them tobacco products).
The AAPHP petitions are also likely to receive some news coverage if/when the Appeals Court upholds (or fails to strike down) Judge Leon's ruling.
That's why it is important that many e-cigarette users submit comments to both AAPHP petitions describing your personal experience with e-cigarettes (and your previous experience with cigarettes).
The FDA is very likely to give serious consideration to the first AAPHP petition (to reclassify and regulate e-cigarettes as tobacco) if/when the Appeals Court upholds (or fails to strike down) Judge Leon's ruling in SE v FDA (i.e. the FDA cannot regulate e-cigarettes as drugs or devices, and can only regulate them tobacco products).
The AAPHP petitions are also likely to receive some news coverage if/when the Appeals Court upholds (or fails to strike down) Judge Leon's ruling.
That's why it is important that many e-cigarette users submit comments to both AAPHP petitions describing your personal experience with e-cigarettes (and your previous experience with cigarettes).
These comments are in support of petitions FDA-2010-P-0095-0001 and FDA-2010-P-0093-0001, submitted to the FDA on February 7, 2009.
I represent no one other than myself. I have not received, nor do I anticipate receiving, any financial or other consideration from any electronic cigarette enterprise, tobacco-related enterprise or pharmaceutical enterprise.
The Food and Drug Administration (FDA), according to its own statements, is responsible for:
· Protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nations food supply, cosmetics, dietary supplements, and products that give off radiation
· Regulating tobacco products
· Advancing the public health by helping to speed product innovations
· Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health
The FDA, in its actions to date concerning electronic cigarettes, and more specifically in its July 22, 2009 press conference on e-cigarettes, has demonstrated significant failure to carry out every one of these four responsibilities. Specifically:
1. The FDA has failed to protect the public health as a result of its actions clearly intended to keep electronic cigarettes off the market in what can only be seen as an attempt to expand its own powers while, at the same time, serving to protect, rather than regulate, the interests of the pharmaceutical and tobacco industries.
2. Rather than properly regulate, and that only within the bounds of regulations co-authored by the tobacco industry itself, the FDA is protecting the interests of that industry by attempting to prevent other, less expensive and less harmful, products from competing with it.
3. The FDA is stifling, rather than speeding, product innovations that have the clear potential to save millions of lives.
4. The FDA has attempted to inflame the public, rather than educate it, with inaccurate, incomplete, irrational information based not on science, but on some unstated FDA organizational objective that clearly has no relationship to science. This is manifestly evident in the July 22, 2009 FDA press conference and press release concerning e-cigarettes.
For these reasons, I am submitting these comments in support of the two AAPHP petitions to the FDA, namely FDA-2010-P-0095-0001 and FDA-2010-P-0093-0001. Electronic cigarettes should be properly classified by the FDA as Tobacco Products rather than as drug-device combinations. The FDA also needs to correct the incomplete, false and misleading information it provided to the public on July 22, 2009. If the FDA is concerned about embarrassment for changing its position, I can assure the FDA that such a change would be considerably less embarrassing than clinging to the untenable position it has thus far embraced. Finally, the FDA has a clear organizational and ethical responsibility to actively pursue and support tobacco harm reduction strategies.
The FDA is rightly expected to be a paragon of rational scientific thought and behavior, and, given its charter to protect the public, of ethical conduct. In most instances, this has been the case. However, the FDA press conference and press release of July 22, 2009 demonstrated abject failure to live up to these perfectly reasonable expectations. The announced conclusions were illogical, irrational and appalling for the transparent pretense they attempted to pass off as scientific rigor. Surely, every FDA scientist worthy of the name must have been deeply embarrassed by this spectacle.
In its descent into some unstated political or other misguided agenda, the FDA revealed an utter, and manifestly intentional, failure to find and consider information on the subject, information readily available in the scientific literature, the vast majority of which contains findings contrary to the FDAs unfounded conclusions and bizarre prejudice against e-cigarettes. I say intentional because I saw many letters to the FDA that directed the organizations attention to this literature prior to the press conference.
To exacerbate this woefully incomplete and groundless analysis, the FDA made the patently absurd choice not to make the obvious comparison with Nicotine Replacement Therapy (NRT) products, which are regulated at the much more stringent level of drugs. Even worse was the stunningly obtuse decision to evade comparison with tobacco cigarettes, whose delivery of harmful content exceeds that of e-cigarettes by several orders of magnitude.
The FDAs conduct in this matter is inexplicable in any rational or scientific context. Absent a reasonable explanation from the FDA, we are forced to the conclusion that the reasons for this conduct must lie elsewhere. Some of the most glaringly obvious candidates include the following:
1. As any, even casual, student of organizational behavior recognizes, organizations seek out and protect that which nourishes them and work to expand their scope to the maximum extent possible within the limits of their charters and outside controlling forces. In the case of the FDA, the primary source of such nourishment has been the pharmaceutical and medical device industries, and, subsequent to the FDA/Tobacco law, the tobacco industry, which co-authored the act. The maximum extent is determined empirically by exceeding perceived limits and then gauging the reaction.
2. It is not at all unusual for a regulatory agency, having worked closely with a regulated industry, to gradually, and by imperceptible steps, come to perceive that industry as a constituency rather than as merely a subject of regulation. The Federal Aviation Administration is a well-known example of this phenomenon. It would be easy to conclude, correctly or not, that the financial threat posed by electronic cigarettes to both the pharmaceutical and tobacco industries has had some bearing on the FDAs behavior.
3. There is some other intentionally unstated agenda driving the FDAs behavior in this matter, an agenda obviously more important to the FDA than its clear responsibilities for public health.
Regardless of the real reasons, the FDAs conduct is simply wrong.
Judge Leons ruling, in my opinion, clearly and correctly deals with the FDAs strange attempt to regulate e-cigarettes as medical devices, an attempt that would effectively result in keeping e-cigarettes off the market for years, if not forever. Given the complete lack of evidence of any harm and positive evidence that e-cigarettes are as safe as, and more effective than, current approved NRT products, this is unethical. The studies desired by the FDA on the basis of e-cigarettes being classed as medical devices are impracticable, given the size and time required to produce the demanded results. Worse, such studies would be unethical, given the necessary exposure of thousands of people to known harmful substances that are avoided in other arms of any such study.
In summary, the actions of the FDA regarding e-cigarettes are clearly in conflict with its own stated responsibilities and obviously harmful to the public health. Its justification for these actions is based on an analysis that even an 8th grade student would be embarrassed to call science. While I am surprised it has taken so long for some scientific organization to bring the FDA to task for these actions, I am very pleased that the subject petitions address the matter in a thorough and rigorous manner and provide clear, practical and science-based recommendations to redirect the FDA toward meeting its responsibilities.
Additionally, I wish to go on record with anecdotal evidence supporting the AAPHP petitions. I was a cigarette smoker for 45 years, at one point smoking 2 packs of unfiltered cigarettes per day. Numerous attempts over the years to quit all ended in failure. In later years, I tried NRT products, including patches, gum and lozenges. Those attempts, driven, I believe, more by faith in the products than by actual effectiveness, met with similar failure. Even a heart attack did not deter the habit for more than 2 weeks.
In early 2009, an Internet advertisement for electronic cigarettes caught my attention. Curious, I went to one of many Internet forums on the topic and reviewed the experiences of many who had tried the products. I was struck by the almost universal stories of how easily they had given up tobacco cigarettes with e-cigarettes as a substitute.
Concerned that this might be either a fad or a case of exchanging one serious problem for another (Fen-Phen came to mind), I researched the scientific and medical literature, something that the FDA, with all of its resources and sophistication, apparently failed to do. Finding that the e-cigarettes did, indeed, deliver nicotine in useful quantities, while delivering no, or in a few cases barely detectable, amounts of the hundreds of harmful substances delivered by smoked tobacco, I purchased an electronic cigarette kit.
On March 19, 2009, I smoked my last tobacco cigarette. On March 20, 2009, I was smoke-free and remain so to this date. The only two difficulties involved were, first, that there was some anticipatory anxiety over whether it would actually work and second, that I missed the taste for tobacco flavor to which I was habituated. Electronic cigarettes were somewhat fussy in use, but this was more than offset by the fact that they could be used practically anywhere without exposing others to smoke and without producing an unpleasant residual smell in the surroundings. My breathing improved noticeably within days.
After six weeks, I began using e-cigarette liquids containing progressively lower levels of nicotine. This caused some minor, but not insurmountable, discomfort. After three weeks of this weaning process, I was using a liquid containing no nicotine. On June 20, 2009 I stopped using the e-cigarette entirely.
Financially, the cost of using e-cigarettes was about half the cost of the tobacco cigarettes I would otherwise have purchased. Interestingly, it was also significantly less expensive than FDA approved NRT products.
I strongly urge the FDA to reclassify electronic cigarettes from a drug-device combination to a tobacco product and to follow the Harm Reduction recommendations provided in the petitions. I also strongly urge the FDA to publicly correct the strident and unsupportable stance against reclassification and harm reduction strategies it enunciated in its July 22, 2009 press conference and press release.
I represent no one other than myself. I have not received, nor do I anticipate receiving, any financial or other consideration from any electronic cigarette enterprise, tobacco-related enterprise or pharmaceutical enterprise.
The Food and Drug Administration (FDA), according to its own statements, is responsible for:
· Protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nations food supply, cosmetics, dietary supplements, and products that give off radiation
· Regulating tobacco products
· Advancing the public health by helping to speed product innovations
· Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health
The FDA, in its actions to date concerning electronic cigarettes, and more specifically in its July 22, 2009 press conference on e-cigarettes, has demonstrated significant failure to carry out every one of these four responsibilities. Specifically:
1. The FDA has failed to protect the public health as a result of its actions clearly intended to keep electronic cigarettes off the market in what can only be seen as an attempt to expand its own powers while, at the same time, serving to protect, rather than regulate, the interests of the pharmaceutical and tobacco industries.
2. Rather than properly regulate, and that only within the bounds of regulations co-authored by the tobacco industry itself, the FDA is protecting the interests of that industry by attempting to prevent other, less expensive and less harmful, products from competing with it.
3. The FDA is stifling, rather than speeding, product innovations that have the clear potential to save millions of lives.
4. The FDA has attempted to inflame the public, rather than educate it, with inaccurate, incomplete, irrational information based not on science, but on some unstated FDA organizational objective that clearly has no relationship to science. This is manifestly evident in the July 22, 2009 FDA press conference and press release concerning e-cigarettes.
For these reasons, I am submitting these comments in support of the two AAPHP petitions to the FDA, namely FDA-2010-P-0095-0001 and FDA-2010-P-0093-0001. Electronic cigarettes should be properly classified by the FDA as Tobacco Products rather than as drug-device combinations. The FDA also needs to correct the incomplete, false and misleading information it provided to the public on July 22, 2009. If the FDA is concerned about embarrassment for changing its position, I can assure the FDA that such a change would be considerably less embarrassing than clinging to the untenable position it has thus far embraced. Finally, the FDA has a clear organizational and ethical responsibility to actively pursue and support tobacco harm reduction strategies.
The FDA is rightly expected to be a paragon of rational scientific thought and behavior, and, given its charter to protect the public, of ethical conduct. In most instances, this has been the case. However, the FDA press conference and press release of July 22, 2009 demonstrated abject failure to live up to these perfectly reasonable expectations. The announced conclusions were illogical, irrational and appalling for the transparent pretense they attempted to pass off as scientific rigor. Surely, every FDA scientist worthy of the name must have been deeply embarrassed by this spectacle.
In its descent into some unstated political or other misguided agenda, the FDA revealed an utter, and manifestly intentional, failure to find and consider information on the subject, information readily available in the scientific literature, the vast majority of which contains findings contrary to the FDAs unfounded conclusions and bizarre prejudice against e-cigarettes. I say intentional because I saw many letters to the FDA that directed the organizations attention to this literature prior to the press conference.
To exacerbate this woefully incomplete and groundless analysis, the FDA made the patently absurd choice not to make the obvious comparison with Nicotine Replacement Therapy (NRT) products, which are regulated at the much more stringent level of drugs. Even worse was the stunningly obtuse decision to evade comparison with tobacco cigarettes, whose delivery of harmful content exceeds that of e-cigarettes by several orders of magnitude.
The FDAs conduct in this matter is inexplicable in any rational or scientific context. Absent a reasonable explanation from the FDA, we are forced to the conclusion that the reasons for this conduct must lie elsewhere. Some of the most glaringly obvious candidates include the following:
1. As any, even casual, student of organizational behavior recognizes, organizations seek out and protect that which nourishes them and work to expand their scope to the maximum extent possible within the limits of their charters and outside controlling forces. In the case of the FDA, the primary source of such nourishment has been the pharmaceutical and medical device industries, and, subsequent to the FDA/Tobacco law, the tobacco industry, which co-authored the act. The maximum extent is determined empirically by exceeding perceived limits and then gauging the reaction.
2. It is not at all unusual for a regulatory agency, having worked closely with a regulated industry, to gradually, and by imperceptible steps, come to perceive that industry as a constituency rather than as merely a subject of regulation. The Federal Aviation Administration is a well-known example of this phenomenon. It would be easy to conclude, correctly or not, that the financial threat posed by electronic cigarettes to both the pharmaceutical and tobacco industries has had some bearing on the FDAs behavior.
3. There is some other intentionally unstated agenda driving the FDAs behavior in this matter, an agenda obviously more important to the FDA than its clear responsibilities for public health.
Regardless of the real reasons, the FDAs conduct is simply wrong.
Judge Leons ruling, in my opinion, clearly and correctly deals with the FDAs strange attempt to regulate e-cigarettes as medical devices, an attempt that would effectively result in keeping e-cigarettes off the market for years, if not forever. Given the complete lack of evidence of any harm and positive evidence that e-cigarettes are as safe as, and more effective than, current approved NRT products, this is unethical. The studies desired by the FDA on the basis of e-cigarettes being classed as medical devices are impracticable, given the size and time required to produce the demanded results. Worse, such studies would be unethical, given the necessary exposure of thousands of people to known harmful substances that are avoided in other arms of any such study.
In summary, the actions of the FDA regarding e-cigarettes are clearly in conflict with its own stated responsibilities and obviously harmful to the public health. Its justification for these actions is based on an analysis that even an 8th grade student would be embarrassed to call science. While I am surprised it has taken so long for some scientific organization to bring the FDA to task for these actions, I am very pleased that the subject petitions address the matter in a thorough and rigorous manner and provide clear, practical and science-based recommendations to redirect the FDA toward meeting its responsibilities.
Additionally, I wish to go on record with anecdotal evidence supporting the AAPHP petitions. I was a cigarette smoker for 45 years, at one point smoking 2 packs of unfiltered cigarettes per day. Numerous attempts over the years to quit all ended in failure. In later years, I tried NRT products, including patches, gum and lozenges. Those attempts, driven, I believe, more by faith in the products than by actual effectiveness, met with similar failure. Even a heart attack did not deter the habit for more than 2 weeks.
In early 2009, an Internet advertisement for electronic cigarettes caught my attention. Curious, I went to one of many Internet forums on the topic and reviewed the experiences of many who had tried the products. I was struck by the almost universal stories of how easily they had given up tobacco cigarettes with e-cigarettes as a substitute.
Concerned that this might be either a fad or a case of exchanging one serious problem for another (Fen-Phen came to mind), I researched the scientific and medical literature, something that the FDA, with all of its resources and sophistication, apparently failed to do. Finding that the e-cigarettes did, indeed, deliver nicotine in useful quantities, while delivering no, or in a few cases barely detectable, amounts of the hundreds of harmful substances delivered by smoked tobacco, I purchased an electronic cigarette kit.
On March 19, 2009, I smoked my last tobacco cigarette. On March 20, 2009, I was smoke-free and remain so to this date. The only two difficulties involved were, first, that there was some anticipatory anxiety over whether it would actually work and second, that I missed the taste for tobacco flavor to which I was habituated. Electronic cigarettes were somewhat fussy in use, but this was more than offset by the fact that they could be used practically anywhere without exposing others to smoke and without producing an unpleasant residual smell in the surroundings. My breathing improved noticeably within days.
After six weeks, I began using e-cigarette liquids containing progressively lower levels of nicotine. This caused some minor, but not insurmountable, discomfort. After three weeks of this weaning process, I was using a liquid containing no nicotine. On June 20, 2009 I stopped using the e-cigarette entirely.
Financially, the cost of using e-cigarettes was about half the cost of the tobacco cigarettes I would otherwise have purchased. Interestingly, it was also significantly less expensive than FDA approved NRT products.
I strongly urge the FDA to reclassify electronic cigarettes from a drug-device combination to a tobacco product and to follow the Harm Reduction recommendations provided in the petitions. I also strongly urge the FDA to publicly correct the strident and unsupportable stance against reclassification and harm reduction strategies it enunciated in its July 22, 2009 press conference and press release.
These comments are in support of petitions FDA-2010-P-0095-0001 and FDA-2010-P-0093-0001, submitted to the FDA on February 7, 2009.
I represent no one other than myself. I have not received, nor do I anticipate receiving, any financial or other consideration from any electronic cigarette enterprise, tobacco-related enterprise or pharmaceutical enterprise.
The Food and Drug Administration (FDA), according to its own statements, is responsible for:
· Protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nations food supply, cosmetics, dietary supplements, and products that give off radiation
· Regulating tobacco products
· Advancing the public health by helping to speed product innovations
· Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health
The FDA, in its actions to date concerning electronic cigarettes, and more specifically in its July 22, 2009 press conference on e-cigarettes, has demonstrated significant failure to carry out every one of these four responsibilities. Specifically:
1. The FDA has failed to protect the public health as a result of its actions clearly intended to keep electronic cigarettes off the market in what can only be seen as an attempt to expand its own powers while, at the same time, serving to protect, rather than regulate, the interests of the pharmaceutical and tobacco industries.
2. Rather than properly regulate, and that only within the bounds of regulations co-authored by the tobacco industry itself, the FDA is protecting the interests of that industry by attempting to prevent other, less expensive and less harmful, products from competing with it.
3. The FDA is stifling, rather than speeding, product innovations that have the clear potential to save millions of lives.
4. The FDA has attempted to inflame the public, rather than educate it, with inaccurate, incomplete, irrational information based not on science, but on some unstated FDA organizational objective that clearly has no relationship to science. This is manifestly evident in the July 22, 2009 FDA press conference and press release concerning e-cigarettes.
For these reasons, I am submitting these comments in support of the two AAPHP petitions to the FDA, namely FDA-2010-P-0095-0001 and FDA-2010-P-0093-0001. Electronic cigarettes should be properly classified by the FDA as Tobacco Products rather than as drug-device combinations. The FDA also needs to correct the incomplete, false and misleading information it provided to the public on July 22, 2009. If the FDA is concerned about embarrassment for changing its position, I can assure the FDA that such a change would be considerably less embarrassing than clinging to the untenable position it has thus far embraced. Finally, the FDA has a clear organizational and ethical responsibility to actively pursue and support tobacco harm reduction strategies.
The FDA is rightly expected to be a paragon of rational scientific thought and behavior, and, given its charter to protect the public, of ethical conduct. In most instances, this has been the case. However, the FDA press conference and press release of July 22, 2009 demonstrated abject failure to live up to these perfectly reasonable expectations. The announced conclusions were illogical, irrational and appalling for the transparent pretense they attempted to pass off as scientific rigor. Surely, every FDA scientist worthy of the name must have been deeply embarrassed by this spectacle.
In its descent into some unstated political or other misguided agenda, the FDA revealed an utter, and manifestly intentional, failure to find and consider information on the subject, information readily available in the scientific literature, the vast majority of which contains findings contrary to the FDAs unfounded conclusions and bizarre prejudice against e-cigarettes. I say intentional because I saw many letters to the FDA that directed the organizations attention to this literature prior to the press conference.
To exacerbate this woefully incomplete and groundless analysis, the FDA made the patently absurd choice not to make the obvious comparison with Nicotine Replacement Therapy (NRT) products, which are regulated at the much more stringent level of drugs. Even worse was the stunningly obtuse decision to evade comparison with tobacco cigarettes, whose delivery of harmful content exceeds that of e-cigarettes by several orders of magnitude.
The FDAs conduct in this matter is inexplicable in any rational or scientific context. Absent a reasonable explanation from the FDA, we are forced to the conclusion that the reasons for this conduct must lie elsewhere. Some of the most glaringly obvious candidates include the following:
1. As any, even casual, student of organizational behavior recognizes, organizations seek out and protect that which nourishes them and work to expand their scope to the maximum extent possible within the limits of their charters and outside controlling forces. In the case of the FDA, the primary source of such nourishment has been the pharmaceutical and medical device industries, and, subsequent to the FDA/Tobacco law, the tobacco industry, which co-authored the act. The maximum extent is determined empirically by exceeding perceived limits and then gauging the reaction.
2. It is not at all unusual for a regulatory agency, having worked closely with a regulated industry, to gradually, and by imperceptible steps, come to perceive that industry as a constituency rather than as merely a subject of regulation. The Federal Aviation Administration is a well-known example of this phenomenon. It would be easy to conclude, correctly or not, that the financial threat posed by electronic cigarettes to both the pharmaceutical and tobacco industries has had some bearing on the FDAs behavior.
3. There is some other intentionally unstated agenda driving the FDAs behavior in this matter, an agenda obviously more important to the FDA than its clear responsibilities for public health.
Regardless of the real reasons, the FDAs conduct is simply wrong.
Judge Leons ruling, in my opinion, clearly and correctly deals with the FDAs strange attempt to regulate e-cigarettes as medical devices, an attempt that would effectively result in keeping e-cigarettes off the market for years, if not forever. Given the complete lack of evidence of any harm and positive evidence that e-cigarettes are as safe as, and more effective than, current approved NRT products, this is unethical. The studies desired by the FDA on the basis of e-cigarettes being classed as medical devices are impracticable, given the size and time required to produce the demanded results. Worse, such studies would be unethical, given the necessary exposure of thousands of people to known harmful substances that are avoided in other arms of any such study.
In summary, the actions of the FDA regarding e-cigarettes are clearly in conflict with its own stated responsibilities and obviously harmful to the public health. Its justification for these actions is based on an analysis that even an 8th grade student would be embarrassed to call science. While I am surprised it has taken so long for some scientific organization to bring the FDA to task for these actions, I am very pleased that the subject petitions address the matter in a thorough and rigorous manner and provide clear, practical and science-based recommendations to redirect the FDA toward meeting its responsibilities.
Additionally, I wish to go on record with anecdotal evidence supporting the AAPHP petitions. I was a cigarette smoker for 45 years, at one point smoking 2 packs of unfiltered cigarettes per day. Numerous attempts over the years to quit all ended in failure. In later years, I tried NRT products, including patches, gum and lozenges. Those attempts, driven, I believe, more by faith in the products than by actual effectiveness, met with similar failure. Even a heart attack did not deter the habit for more than 2 weeks.
In early 2009, an Internet advertisement for electronic cigarettes caught my attention. Curious, I went to one of many Internet forums on the topic and reviewed the experiences of many who had tried the products. I was struck by the almost universal stories of how easily they had given up tobacco cigarettes with e-cigarettes as a substitute.
Concerned that this might be either a fad or a case of exchanging one serious problem for another (Fen-Phen came to mind), I researched the scientific and medical literature, something that the FDA, with all of its resources and sophistication, apparently failed to do. Finding that the e-cigarettes did, indeed, deliver nicotine in useful quantities, while delivering no, or in a few cases barely detectable, amounts of the hundreds of harmful substances delivered by smoked tobacco, I purchased an electronic cigarette kit.
On March 19, 2009, I smoked my last tobacco cigarette. On March 20, 2009, I was smoke-free and remain so to this date. The only two difficulties involved were, first, that there was some anticipatory anxiety over whether it would actually work and second, that I missed the taste for tobacco flavor to which I was habituated. Electronic cigarettes were somewhat fussy in use, but this was more than offset by the fact that they could be used practically anywhere without exposing others to smoke and without producing an unpleasant residual smell in the surroundings. My breathing improved noticeably within days.
After six weeks, I began using e-cigarette liquids containing progressively lower levels of nicotine. This caused some minor, but not insurmountable, discomfort. After three weeks of this weaning process, I was using a liquid containing no nicotine. On June 20, 2009 I stopped using the e-cigarette entirely.
Financially, the cost of using e-cigarettes was about half the cost of the tobacco cigarettes I would otherwise have purchased. Interestingly, it was also significantly less expensive than FDA approved NRT products.
I strongly urge the FDA to reclassify electronic cigarettes from a drug-device combination to a tobacco product and to follow the Harm Reduction recommendations provided in the petitions. I also strongly urge the FDA to publicly correct the strident and unsupportable stance against reclassification and harm reduction strategies it enunciated in its July 22, 2009 press conference and press release.
I represent no one other than myself. I have not received, nor do I anticipate receiving, any financial or other consideration from any electronic cigarette enterprise, tobacco-related enterprise or pharmaceutical enterprise.
The Food and Drug Administration (FDA), according to its own statements, is responsible for:
· Protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nations food supply, cosmetics, dietary supplements, and products that give off radiation
· Regulating tobacco products
· Advancing the public health by helping to speed product innovations
· Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health
The FDA, in its actions to date concerning electronic cigarettes, and more specifically in its July 22, 2009 press conference on e-cigarettes, has demonstrated significant failure to carry out every one of these four responsibilities. Specifically:
1. The FDA has failed to protect the public health as a result of its actions clearly intended to keep electronic cigarettes off the market in what can only be seen as an attempt to expand its own powers while, at the same time, serving to protect, rather than regulate, the interests of the pharmaceutical and tobacco industries.
2. Rather than properly regulate, and that only within the bounds of regulations co-authored by the tobacco industry itself, the FDA is protecting the interests of that industry by attempting to prevent other, less expensive and less harmful, products from competing with it.
3. The FDA is stifling, rather than speeding, product innovations that have the clear potential to save millions of lives.
4. The FDA has attempted to inflame the public, rather than educate it, with inaccurate, incomplete, irrational information based not on science, but on some unstated FDA organizational objective that clearly has no relationship to science. This is manifestly evident in the July 22, 2009 FDA press conference and press release concerning e-cigarettes.
For these reasons, I am submitting these comments in support of the two AAPHP petitions to the FDA, namely FDA-2010-P-0095-0001 and FDA-2010-P-0093-0001. Electronic cigarettes should be properly classified by the FDA as Tobacco Products rather than as drug-device combinations. The FDA also needs to correct the incomplete, false and misleading information it provided to the public on July 22, 2009. If the FDA is concerned about embarrassment for changing its position, I can assure the FDA that such a change would be considerably less embarrassing than clinging to the untenable position it has thus far embraced. Finally, the FDA has a clear organizational and ethical responsibility to actively pursue and support tobacco harm reduction strategies.
The FDA is rightly expected to be a paragon of rational scientific thought and behavior, and, given its charter to protect the public, of ethical conduct. In most instances, this has been the case. However, the FDA press conference and press release of July 22, 2009 demonstrated abject failure to live up to these perfectly reasonable expectations. The announced conclusions were illogical, irrational and appalling for the transparent pretense they attempted to pass off as scientific rigor. Surely, every FDA scientist worthy of the name must have been deeply embarrassed by this spectacle.
In its descent into some unstated political or other misguided agenda, the FDA revealed an utter, and manifestly intentional, failure to find and consider information on the subject, information readily available in the scientific literature, the vast majority of which contains findings contrary to the FDAs unfounded conclusions and bizarre prejudice against e-cigarettes. I say intentional because I saw many letters to the FDA that directed the organizations attention to this literature prior to the press conference.
To exacerbate this woefully incomplete and groundless analysis, the FDA made the patently absurd choice not to make the obvious comparison with Nicotine Replacement Therapy (NRT) products, which are regulated at the much more stringent level of drugs. Even worse was the stunningly obtuse decision to evade comparison with tobacco cigarettes, whose delivery of harmful content exceeds that of e-cigarettes by several orders of magnitude.
The FDAs conduct in this matter is inexplicable in any rational or scientific context. Absent a reasonable explanation from the FDA, we are forced to the conclusion that the reasons for this conduct must lie elsewhere. Some of the most glaringly obvious candidates include the following:
1. As any, even casual, student of organizational behavior recognizes, organizations seek out and protect that which nourishes them and work to expand their scope to the maximum extent possible within the limits of their charters and outside controlling forces. In the case of the FDA, the primary source of such nourishment has been the pharmaceutical and medical device industries, and, subsequent to the FDA/Tobacco law, the tobacco industry, which co-authored the act. The maximum extent is determined empirically by exceeding perceived limits and then gauging the reaction.
2. It is not at all unusual for a regulatory agency, having worked closely with a regulated industry, to gradually, and by imperceptible steps, come to perceive that industry as a constituency rather than as merely a subject of regulation. The Federal Aviation Administration is a well-known example of this phenomenon. It would be easy to conclude, correctly or not, that the financial threat posed by electronic cigarettes to both the pharmaceutical and tobacco industries has had some bearing on the FDAs behavior.
3. There is some other intentionally unstated agenda driving the FDAs behavior in this matter, an agenda obviously more important to the FDA than its clear responsibilities for public health.
Regardless of the real reasons, the FDAs conduct is simply wrong.
Judge Leons ruling, in my opinion, clearly and correctly deals with the FDAs strange attempt to regulate e-cigarettes as medical devices, an attempt that would effectively result in keeping e-cigarettes off the market for years, if not forever. Given the complete lack of evidence of any harm and positive evidence that e-cigarettes are as safe as, and more effective than, current approved NRT products, this is unethical. The studies desired by the FDA on the basis of e-cigarettes being classed as medical devices are impracticable, given the size and time required to produce the demanded results. Worse, such studies would be unethical, given the necessary exposure of thousands of people to known harmful substances that are avoided in other arms of any such study.
In summary, the actions of the FDA regarding e-cigarettes are clearly in conflict with its own stated responsibilities and obviously harmful to the public health. Its justification for these actions is based on an analysis that even an 8th grade student would be embarrassed to call science. While I am surprised it has taken so long for some scientific organization to bring the FDA to task for these actions, I am very pleased that the subject petitions address the matter in a thorough and rigorous manner and provide clear, practical and science-based recommendations to redirect the FDA toward meeting its responsibilities.
Additionally, I wish to go on record with anecdotal evidence supporting the AAPHP petitions. I was a cigarette smoker for 45 years, at one point smoking 2 packs of unfiltered cigarettes per day. Numerous attempts over the years to quit all ended in failure. In later years, I tried NRT products, including patches, gum and lozenges. Those attempts, driven, I believe, more by faith in the products than by actual effectiveness, met with similar failure. Even a heart attack did not deter the habit for more than 2 weeks.
In early 2009, an Internet advertisement for electronic cigarettes caught my attention. Curious, I went to one of many Internet forums on the topic and reviewed the experiences of many who had tried the products. I was struck by the almost universal stories of how easily they had given up tobacco cigarettes with e-cigarettes as a substitute.
Concerned that this might be either a fad or a case of exchanging one serious problem for another (Fen-Phen came to mind), I researched the scientific and medical literature, something that the FDA, with all of its resources and sophistication, apparently failed to do. Finding that the e-cigarettes did, indeed, deliver nicotine in useful quantities, while delivering no, or in a few cases barely detectable, amounts of the hundreds of harmful substances delivered by smoked tobacco, I purchased an electronic cigarette kit.
On March 19, 2009, I smoked my last tobacco cigarette. On March 20, 2009, I was smoke-free and remain so to this date. The only two difficulties involved were, first, that there was some anticipatory anxiety over whether it would actually work and second, that I missed the taste for tobacco flavor to which I was habituated. Electronic cigarettes were somewhat fussy in use, but this was more than offset by the fact that they could be used practically anywhere without exposing others to smoke and without producing an unpleasant residual smell in the surroundings. My breathing improved noticeably within days.
After six weeks, I began using e-cigarette liquids containing progressively lower levels of nicotine. This caused some minor, but not insurmountable, discomfort. After three weeks of this weaning process, I was using a liquid containing no nicotine. On June 20, 2009 I stopped using the e-cigarette entirely.
Financially, the cost of using e-cigarettes was about half the cost of the tobacco cigarettes I would otherwise have purchased. Interestingly, it was also significantly less expensive than FDA approved NRT products.
I strongly urge the FDA to reclassify electronic cigarettes from a drug-device combination to a tobacco product and to follow the Harm Reduction recommendations provided in the petitions. I also strongly urge the FDA to publicly correct the strident and unsupportable stance against reclassification and harm reduction strategies it enunciated in its July 22, 2009 press conference and press release.
Yes I too. Twice. And I type like a cop so number 3 is highly unlikely. Using Vista with all updates so I think it IE8 ?
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For anyone having trouble with the site via Safari, maybe it would be a quick workaround to grab and use a portable browser. Here's no-installation-necessary portable FireFox:
Mac version
macupdate.com/info.php/id/20395
Windows version (more widely available; here's one source... 'course if you have Safari on Windows and are having problems, you could also just try IE instead)
portableapps.com/apps/internet/firefox_portable
Cookies note: The portable version will likely have cookies (and other privacy-related stuff, plus popups, etc.) turned off by default, so you should probably change that setting for the regulations.gov site. It wanted cookies for my regular (installed) FireFox browser anyway, before it would load and work properly.
OH and regardless of method used, best to copy and paste your ready-to-go comment somewhere else temporarily before hitting submit, just in case!
Mac version
macupdate.com/info.php/id/20395
Windows version (more widely available; here's one source... 'course if you have Safari on Windows and are having problems, you could also just try IE instead)
portableapps.com/apps/internet/firefox_portable
Cookies note: The portable version will likely have cookies (and other privacy-related stuff, plus popups, etc.) turned off by default, so you should probably change that setting for the regulations.gov site. It wanted cookies for my regular (installed) FireFox browser anyway, before it would load and work properly.
OH and regardless of method used, best to copy and paste your ready-to-go comment somewhere else temporarily before hitting submit, just in case!
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What happens to those of us who want to reduce nicotine to 0 but want to continue to vape? Where do we fit in?
Good question Rock Woman. I guess that depends on just what parts of the products the FDA ends up regulating and under which authority. If FDA wins the court case and regulates them as "unapproved drug delivery device combinations" under the Food, Drug, and Cosmetics act, they will no doubt want to make every part you can think of illegal to import and/or sell. If NJOY wins the FDA would only have authority to regulate them as tobacco products under the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act.") In that case, my guess would be that they might confine their regulations to the portion of the product that is actually derived from tobacco -- i.e., e-liquid that contains nicotine. It is hard to imagine how they would come up with justification for regulating the hardware, or why they would want to. So if that were the case, the zero-nic vapers would be in the clear.
BTW, welcome to ECF. You might also want to check out the activism group that was born on ECF, Consumer Advocates for Smoke Free Alternatives Association (CASAA) for more information on tobacco harm reduction, nicotine, e-cigarettes, and other smoke-free alternatives: CASAA | The Consumer Advocates for Smoke-Free Alternatives Association
BTW, welcome to ECF. You might also want to check out the activism group that was born on ECF, Consumer Advocates for Smoke Free Alternatives Association (CASAA) for more information on tobacco harm reduction, nicotine, e-cigarettes, and other smoke-free alternatives: CASAA | The Consumer Advocates for Smoke-Free Alternatives Association
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