FDA CASAA Call to Prepare re FDA Regulations Comments
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There is a large segment of the population who are not comfortable writing a letter from header to ending. Providing a document that they can cut and paste, including (put your story here) can make a difference between doing and not doing.
You can think what you want to about the situation however that won't change it nor are you in their shoes. So it doesn't make a difference what anyone thinks. It is what it is. They will instinctively alter any formatted comments to express their own thoughts so it's unlikely that it'll appear like a forum letter so that's not a worry either.
I tend to think that having the numbers submitting comments is worth it. I'm guessing this might diffuse some of the frustrations I read in the CASAA comments as well.
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My Thoughts are if a Person can make a Post to the ECF (or any Other Forum) or write an e-Mail, then they are More than Qualified to make a FDA Comment Submission.
I hope you don't change a thing in your letter. I found it to be intelligent, well reasoned and direct.
That is an excellent letter.
This brings up another subject; is it best to provide links to references / studies or should they be uploaded with the letter? I seem to recall a number of others appear to be uploading references. It seems to be that it would have a greater chance of being read if it was rather than a link. But I don't know for sure.
This brings up another subject; is it best to provide links to references / studies or should they be uploaded with the letter? I seem to recall a number of others appear to be uploading references. It seems to be that it would have a greater chance of being read if it was rather than a link. But I don't know for sure.
It sounds like that will be the next Call To Action that comes from CASAA...
CASAA: Fourth Call to to Action for FDA Proposed Regulations - Submit Comment
Like I said, it doesn't matter what anyone "thinks". The reality is they won't, and that'll be frustrating for them too.
I like to have a Positive Outlook on this.
I know that I have asked 5 People to make a FDA Submission. And 4 of them have done so. The Last will also. But She does Everything at the Last Minute. Habitually.
But I Know that NONE of them would have Made a Submission if I had Not Asked them.
So what is the Harm of Asking someone?
The Worst thing that can Happen is they Will Not. But that is what they were Going to do Anyway. So there is Nothing Lost.
I look at it like this.. and this is only for me, but.. If I do the foot work that is necessary to let my voice be hard, and that voice falls on ignorantly deaf ears, at least I did speak, and did what little I could do to protect what matters to me, and the blame falls on the ignorant regulators.. This way, at the very least, I do not share in the blame for the passage of such a ridiculous regulation. If however I do nothing, knowing I am benefiting from the lack of regulation, and knowing that I can at least state my opinion, then my inaction becomes my participation in the passage of the regulation by my inactivity. Again.. Ymmv 
btw, this is the body of my comment.. Hope it's actually read..lol (last name delete here)
Dear FDA Center for Tobacco Products
My name is Jerry and I am a citizen of the U.S.A. I wish to take this opportunity to express comment concerning the Deeming regulation currently under consideration as it pertains to E-cigarettes and Personal Vaporizers and their market and products from the point of the consumer.
For the sake of background, I started smoking tobacco cigarettes shortly after turning 18 years of age. It took nearly no time before I was addicted to all aspects of smoking tobacco cigarettes and I continued to do so for the following 20 years with an average consumption of about 2 packs of full flavor cigarettes a day. Though I admit that I have very limited medical knowledge, I still was extremely aware of all the aspects of being a hardcore smoker. After many different attempts to quit, including patches, gum, cold turkey, etc. I felt I was consigned to death by cigarette. Four years ago, a local shop opened that offered alternatives in the form of e-cigs.. They didn't market them to anyone but adult smokers, and they didn't market them as harmless.. BUT as a harm reduction... for me it worked tremendously. However, after about a year, I ended up picking up the tobacco pipe.. For me the nicotine delivery was adequate but I needed a more full bodies smoke presence to attach a comfortable satisfaction level.... The cig-a-like stuff that is currently available from those few big tobacco business are antiquated at best and simply useless at worst when it comes to keeping me from straying back to tobacco. I currently utilize a Mechanical mod unit with loose batteries and rebuildable atomizers
To this end, should such draconian regulations to the market that provides the products that saved my life and that are many many times less hazardous then any FDA approved cigarette out there, be instituted, I can assure you it will have only limited impact on my well being for I have no intentions of utilizing Big Tobacco's cig-a-like devices that for the most part don't get the job done, nor do I intend to stop vaping. I am quite a skilled DIY'er and already currently make my own ejuice blends and am capable of making my own modified devices to insure I can keep on vaping. Also, as the need may arise, I will not think twice to use whatever shadow market a ridiculous regulation of this nature will most assuredly create. I've always done my best to be a law abiding citizen, but frankly this regulation will force tens of thousands of good American citizens to do whatever they must to stay as healthy as they possibly can by whatever means is necessary. ANY government that would do that is not a government of, by, and FOR the people..
All of this said, I do believe that regulation that is truly for the best interests of consumers that USE them, is needed. I firmly agree with regulations that will restrict access to children, and I agree childproof caps are excellent regulations. Some regulations on the quality of the labs that produce the unflavored base nicotine that I use in my Ejuice blends would be great!
Regulations deeply limiting the type, number, quality and availability of both gear and premixed juices does nothing but hurt the hundreds of thousands of current users of personal vaporizers as well as ensures a more speedy death to the millions of smokers that find the standard FDA approved smoking cessation products useless for their addiction, but for whom could be saved from the coffin nail fby a FAR less harmful alternative..Regulations on flavors in premixed nicotine juice would be both futile and serves no real purpose. Not only will attempting to eliminate them likely create a black/shadow market for said types of premixed nicotine juices, as well as a huge over seas direct Market to consumers (neither of which the FDA can regulate at all), but frankly current ejuice manufacturers can simply leave out the nicotine all together and then it no long falls under a drug based product making it unregulated as anything more then a food product, designed to utilize whatever nicotine can be acquired and extracted at the end user level. Neither of these likelihoods are in the best interest of the consumers that are using this product. I, myself am easily capable of making my own flavored ejuices without nicotine for very very little money from ingredients readily available to any hobby store or my local grocer.
In closing, please consider all the ramifications of such regulation and think of the consumers well being over the consumers checkbooks and tax income.
Thank you for you time.
Respectfully,
Jerry
Proud member of the CASAA and a American Citizen
Dear FDA Center for Tobacco Products
My name is Jerry and I am a citizen of the U.S.A. I wish to take this opportunity to express comment concerning the Deeming regulation currently under consideration as it pertains to E-cigarettes and Personal Vaporizers and their market and products from the point of the consumer.
For the sake of background, I started smoking tobacco cigarettes shortly after turning 18 years of age. It took nearly no time before I was addicted to all aspects of smoking tobacco cigarettes and I continued to do so for the following 20 years with an average consumption of about 2 packs of full flavor cigarettes a day. Though I admit that I have very limited medical knowledge, I still was extremely aware of all the aspects of being a hardcore smoker. After many different attempts to quit, including patches, gum, cold turkey, etc. I felt I was consigned to death by cigarette. Four years ago, a local shop opened that offered alternatives in the form of e-cigs.. They didn't market them to anyone but adult smokers, and they didn't market them as harmless.. BUT as a harm reduction... for me it worked tremendously. However, after about a year, I ended up picking up the tobacco pipe.. For me the nicotine delivery was adequate but I needed a more full bodies smoke presence to attach a comfortable satisfaction level.... The cig-a-like stuff that is currently available from those few big tobacco business are antiquated at best and simply useless at worst when it comes to keeping me from straying back to tobacco. I currently utilize a Mechanical mod unit with loose batteries and rebuildable atomizers
To this end, should such draconian regulations to the market that provides the products that saved my life and that are many many times less hazardous then any FDA approved cigarette out there, be instituted, I can assure you it will have only limited impact on my well being for I have no intentions of utilizing Big Tobacco's cig-a-like devices that for the most part don't get the job done, nor do I intend to stop vaping. I am quite a skilled DIY'er and already currently make my own ejuice blends and am capable of making my own modified devices to insure I can keep on vaping. Also, as the need may arise, I will not think twice to use whatever shadow market a ridiculous regulation of this nature will most assuredly create. I've always done my best to be a law abiding citizen, but frankly this regulation will force tens of thousands of good American citizens to do whatever they must to stay as healthy as they possibly can by whatever means is necessary. ANY government that would do that is not a government of, by, and FOR the people..
All of this said, I do believe that regulation that is truly for the best interests of consumers that USE them, is needed. I firmly agree with regulations that will restrict access to children, and I agree childproof caps are excellent regulations. Some regulations on the quality of the labs that produce the unflavored base nicotine that I use in my Ejuice blends would be great!
Regulations deeply limiting the type, number, quality and availability of both gear and premixed juices does nothing but hurt the hundreds of thousands of current users of personal vaporizers as well as ensures a more speedy death to the millions of smokers that find the standard FDA approved smoking cessation products useless for their addiction, but for whom could be saved from the coffin nail fby a FAR less harmful alternative..Regulations on flavors in premixed nicotine juice would be both futile and serves no real purpose. Not only will attempting to eliminate them likely create a black/shadow market for said types of premixed nicotine juices, as well as a huge over seas direct Market to consumers (neither of which the FDA can regulate at all), but frankly current ejuice manufacturers can simply leave out the nicotine all together and then it no long falls under a drug based product making it unregulated as anything more then a food product, designed to utilize whatever nicotine can be acquired and extracted at the end user level. Neither of these likelihoods are in the best interest of the consumers that are using this product. I, myself am easily capable of making my own flavored ejuices without nicotine for very very little money from ingredients readily available to any hobby store or my local grocer.
In closing, please consider all the ramifications of such regulation and think of the consumers well being over the consumers checkbooks and tax income.
Thank you for you time.
Respectfully,
Jerry
Proud member of the CASAA and a American Citizen
I'll show you mine 
Dear FDA Center for Tobacco Products:
As a responsible, professional adult consumer of e-cigarettes and a member of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), it is my duty to convey my concerns to you about these misguided proposed regulations. While a large number of legislators, commercial corporations, and public agencies may have the power to shape the future of the e-cigarette industry, let my voice represent the viewpoint of an actual individual who will be directly influenced by any legislation which is passed. As a true stakeholder in this debate, I am appalled by the FDA's apparent lack of concern for the health detriment that the Proposed Rule will cause to individual consumers like myself.
The agency's willingness to pander to the Tobacco and Pharmaceutical industries under the guise of concern for public safety by enacting laws that would clearly benefit said industries while ignoring the actual health and well-being of myself and my fellow Americans is nothing short of outright abuse of the regulatory system. I urge you to take my following personal testimony into consideration before allowing such injustice to occur.
Prior to discovering e-cigarettes, I was a heavy smoker for 17 years. I had reached an all time high of about 2 packs per day. I tried my first puff of an e-cigarette 11 months and 22 days ago, and since that day, another combustible cigarette has not touched my lips.
I was not actively trying to quit smoking, and had resigned myself to the idea that I would remain a smoker until health issues or cost prohibited me from continuing. I had managed to quit once for about a month while I was still a teenager, but the experience was extremely harrowing and unsatisfying, and I hated that it added 15 pounds to my already overweight frame. This attempt was accomplished with the help of Nicorette gum. Needless to say, I resumed my habit in a moment of craving/weakness, convinced from then on that I would prefer to continue smoking rather than suffer through another attempt to quit.
Since I have taken up e-cigarettes instead of combustible cigarettes, my breathing has improved immensely and I've stopped wheezing and coughing. I felt so good that I was even inspired to improve my diet and begin exercising, and am proud to say that I've actually lost 30 pounds. Additionally, I have only experienced one slight cold in these 11+ months, and was feeling better in about 3 days rather than suffering with a lingering cough for weeks as I normally would have while still smoking.
I can attest that the variety of flavored e-liquids from various artisan manufacturers and the selection of cleverly designed and innovative e-cigarette devices that were readily available to me were a key to my embracing them as an alternative to tobacco cigarettes. Therefore, I would strongly caution that any legislation which would reduce the variety, innovation, availability, and reasonable pricing of these products would certainly have a negative impact on the willingness of other smokers to accept e-cigarettes as a viable, attractive alternative to combustible cigarettes.
In fact, I'm afraid to say that I can envision myself returning to regular cigarettes myself if I could no longer use my preferred device (Itaste VV battery with a Protank mini) and favorite e-liquid (pineapple shake flavored). If the options I actually enjoy are no longer available, I can't see myself trying to make do with poorly performing equipment and e-liquid flavors that I don't love. Alternately, I may find another way to continue my new lifestyle choice via the various black market products that will surely become widely available if the Proposed Rule is passed as drafted. I've also considered the possibility of learning to mix my own flavored e-liquids from the wealth of information available online. Somehow I doubt that the safety risks clearly inherent in these aforementioned courses of action would deter me or a large portion of my fellow e-cigarette users from attempting to continue to enjoy the satisfying experience that we have become accustomed to.
In closing, if your agency chooses to disregard the personal testimony and convictions of end users of these products (such as myself) and enacts these regulations that have been proposed, it will be clear to me that the FDA's agenda is not aligned with its purported commitment to protecting public health. The e-cigarette industry as it exists today was a godsend to me, and your unreasonable and non-scientifically-based attempt to regulate the smaller e-cigarette product vendors out of existence would be criminal in my eyes. If implemented, the only benefits of the proposed regulations will be to big tobacco companies and the manufacturers of pharmaceutical smoking cessation products, and that is completely unacceptable.
Sincerely,
(BooBoo888)
Dear FDA Center for Tobacco Products:
As a responsible, professional adult consumer of e-cigarettes and a member of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), it is my duty to convey my concerns to you about these misguided proposed regulations. While a large number of legislators, commercial corporations, and public agencies may have the power to shape the future of the e-cigarette industry, let my voice represent the viewpoint of an actual individual who will be directly influenced by any legislation which is passed. As a true stakeholder in this debate, I am appalled by the FDA's apparent lack of concern for the health detriment that the Proposed Rule will cause to individual consumers like myself.
The agency's willingness to pander to the Tobacco and Pharmaceutical industries under the guise of concern for public safety by enacting laws that would clearly benefit said industries while ignoring the actual health and well-being of myself and my fellow Americans is nothing short of outright abuse of the regulatory system. I urge you to take my following personal testimony into consideration before allowing such injustice to occur.
Prior to discovering e-cigarettes, I was a heavy smoker for 17 years. I had reached an all time high of about 2 packs per day. I tried my first puff of an e-cigarette 11 months and 22 days ago, and since that day, another combustible cigarette has not touched my lips.
I was not actively trying to quit smoking, and had resigned myself to the idea that I would remain a smoker until health issues or cost prohibited me from continuing. I had managed to quit once for about a month while I was still a teenager, but the experience was extremely harrowing and unsatisfying, and I hated that it added 15 pounds to my already overweight frame. This attempt was accomplished with the help of Nicorette gum. Needless to say, I resumed my habit in a moment of craving/weakness, convinced from then on that I would prefer to continue smoking rather than suffer through another attempt to quit.
Since I have taken up e-cigarettes instead of combustible cigarettes, my breathing has improved immensely and I've stopped wheezing and coughing. I felt so good that I was even inspired to improve my diet and begin exercising, and am proud to say that I've actually lost 30 pounds. Additionally, I have only experienced one slight cold in these 11+ months, and was feeling better in about 3 days rather than suffering with a lingering cough for weeks as I normally would have while still smoking.
I can attest that the variety of flavored e-liquids from various artisan manufacturers and the selection of cleverly designed and innovative e-cigarette devices that were readily available to me were a key to my embracing them as an alternative to tobacco cigarettes. Therefore, I would strongly caution that any legislation which would reduce the variety, innovation, availability, and reasonable pricing of these products would certainly have a negative impact on the willingness of other smokers to accept e-cigarettes as a viable, attractive alternative to combustible cigarettes.
In fact, I'm afraid to say that I can envision myself returning to regular cigarettes myself if I could no longer use my preferred device (Itaste VV battery with a Protank mini) and favorite e-liquid (pineapple shake flavored). If the options I actually enjoy are no longer available, I can't see myself trying to make do with poorly performing equipment and e-liquid flavors that I don't love. Alternately, I may find another way to continue my new lifestyle choice via the various black market products that will surely become widely available if the Proposed Rule is passed as drafted. I've also considered the possibility of learning to mix my own flavored e-liquids from the wealth of information available online. Somehow I doubt that the safety risks clearly inherent in these aforementioned courses of action would deter me or a large portion of my fellow e-cigarette users from attempting to continue to enjoy the satisfying experience that we have become accustomed to.
In closing, if your agency chooses to disregard the personal testimony and convictions of end users of these products (such as myself) and enacts these regulations that have been proposed, it will be clear to me that the FDA's agenda is not aligned with its purported commitment to protecting public health. The e-cigarette industry as it exists today was a godsend to me, and your unreasonable and non-scientifically-based attempt to regulate the smaller e-cigarette product vendors out of existence would be criminal in my eyes. If implemented, the only benefits of the proposed regulations will be to big tobacco companies and the manufacturers of pharmaceutical smoking cessation products, and that is completely unacceptable.
Sincerely,
(BooBoo888)
This is what this criminal (potential) sent to the FDA:
From: My name
To: FDA Center for Tobacco Products
RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38
24 July 2014
I am a consumer of electronic cigarettes (e-cigarettes or e-cigs) and a member of the Consumer Advocates for Smoke-free Alternatives Association (CASAA). Like millions of others we are the primary stakeholders whom these regulations will affect. As written these regulations will hurt me, the person you are trying to protect. The regulations will hurt me financially as well as physically. The regulations will drive up the costs of equipment and liquid to the point where I could not afford to use electronic cigarettes any longer which would affect me physically by most likely driving me to smoking again.
The FDA exists to protect me the consumer, but these regulations appear to protect large corporations not the consumer. There appears to be no consideration of us consumers in these regulations. The impact statement only considers impact on industry and the effects on the consumer are ignored by the FDA and the so called public health community.
I am 58 years old and smoked for over 40 years until I discovered e-cigarettes last December. In the past I tried the FDA approved devices such as gum and patches, but they did not work for me. Yes they provided nicotine, but that is not the whole picture. That picture also includes the physical routine of picking up a cigarette inhaling and exhaling the smoke. Since I have started using e-cigarettes the cigarette has been replaced with my advanced personal vaporizer and smoke with vapor.
I started my journey using the devices the size of a cigarette. They were OK, but they were not going to replace a cigarette for me. The battery only lasted 1 to 2 hours before needing to be charged. The cartridge containing the liquid would last only a little longer and really did not taste good. If I continued to use the cigarette sized devices it would cost more than smoking a real cigarette. They did do one thing well, that was to get me to research more advanced devices. When I purchased my first advanced device I went from smoking one pack a day to four cigarettes a day. Within two weeks it was zero cigarettes. I have been tobacco free for 7 months now all thanks to advanced electronic cigarettes.
The flavors available are also one thing that keeps me using e-cigs. If I could only vape tobacco flavor or menthol flavor I would probably return to smoking. Flavors are not used to market to minors, adults like flavor believe it or not. Yes, I agree that e-cigs should not be sold to minors at all.
My health has improved since I started using e-cigs. I used to wheeze and cough a lot and my wife would worry about me. Since I have started using e-cigs my wheezing and coughing have stopped. I recently went to a doctor for a check-up and he told me my lungs sound normal. Before e-cigs I would actively seek out elevators even for one change in floors. I recently had to work at a place in Singapore, on a business trip, where the elevator was out of order and the office I needed to go to was on the fifth floor. If I was still smoking I am sure I would have had to stop many times in that climb, but I was able to climb those 80 stairs without problems.
If these regulations go into effect without changes I see three choices for myself: return to smoking cigarettes, stop vaping, or start making my own liquids. I don't want to start smoking again, but that may happen with these regulations. Stopping use of electronic cigarettes, this is an option but not likely in my case. The most likely option would be for me to make my own liquid. I will purchase the needed ingredients prior to the implementation of the regulations in large enough quantities to last several years. I have already started to purchase purely mechanical devices that do not require anything more than batteries, wicking material, and resistance wire. I feel that a lot of current vapers will choose this option. I guess that would make me a criminal for trying to stay off cigarettes.
My life and millions of others lives have become part of a political game and we are just pawns. The power brokers in the big companies, government, and un-caring activists are moving the pieces with no concern for "We the People". The problem is this is not supposed to be a game. We are talking about the health and well-being of millions of people here. Please do not send me and millions of others back to cigarettes or turn us into criminals for trying to stay off cigarettes!
Just my
From: My name
To: FDA Center for Tobacco Products
RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38
24 July 2014
I am a consumer of electronic cigarettes (e-cigarettes or e-cigs) and a member of the Consumer Advocates for Smoke-free Alternatives Association (CASAA). Like millions of others we are the primary stakeholders whom these regulations will affect. As written these regulations will hurt me, the person you are trying to protect. The regulations will hurt me financially as well as physically. The regulations will drive up the costs of equipment and liquid to the point where I could not afford to use electronic cigarettes any longer which would affect me physically by most likely driving me to smoking again.
The FDA exists to protect me the consumer, but these regulations appear to protect large corporations not the consumer. There appears to be no consideration of us consumers in these regulations. The impact statement only considers impact on industry and the effects on the consumer are ignored by the FDA and the so called public health community.
I am 58 years old and smoked for over 40 years until I discovered e-cigarettes last December. In the past I tried the FDA approved devices such as gum and patches, but they did not work for me. Yes they provided nicotine, but that is not the whole picture. That picture also includes the physical routine of picking up a cigarette inhaling and exhaling the smoke. Since I have started using e-cigarettes the cigarette has been replaced with my advanced personal vaporizer and smoke with vapor.
I started my journey using the devices the size of a cigarette. They were OK, but they were not going to replace a cigarette for me. The battery only lasted 1 to 2 hours before needing to be charged. The cartridge containing the liquid would last only a little longer and really did not taste good. If I continued to use the cigarette sized devices it would cost more than smoking a real cigarette. They did do one thing well, that was to get me to research more advanced devices. When I purchased my first advanced device I went from smoking one pack a day to four cigarettes a day. Within two weeks it was zero cigarettes. I have been tobacco free for 7 months now all thanks to advanced electronic cigarettes.
The flavors available are also one thing that keeps me using e-cigs. If I could only vape tobacco flavor or menthol flavor I would probably return to smoking. Flavors are not used to market to minors, adults like flavor believe it or not. Yes, I agree that e-cigs should not be sold to minors at all.
My health has improved since I started using e-cigs. I used to wheeze and cough a lot and my wife would worry about me. Since I have started using e-cigs my wheezing and coughing have stopped. I recently went to a doctor for a check-up and he told me my lungs sound normal. Before e-cigs I would actively seek out elevators even for one change in floors. I recently had to work at a place in Singapore, on a business trip, where the elevator was out of order and the office I needed to go to was on the fifth floor. If I was still smoking I am sure I would have had to stop many times in that climb, but I was able to climb those 80 stairs without problems.
If these regulations go into effect without changes I see three choices for myself: return to smoking cigarettes, stop vaping, or start making my own liquids. I don't want to start smoking again, but that may happen with these regulations. Stopping use of electronic cigarettes, this is an option but not likely in my case. The most likely option would be for me to make my own liquid. I will purchase the needed ingredients prior to the implementation of the regulations in large enough quantities to last several years. I have already started to purchase purely mechanical devices that do not require anything more than batteries, wicking material, and resistance wire. I feel that a lot of current vapers will choose this option. I guess that would make me a criminal for trying to stay off cigarettes.
My life and millions of others lives have become part of a political game and we are just pawns. The power brokers in the big companies, government, and un-caring activists are moving the pieces with no concern for "We the People". The problem is this is not supposed to be a game. We are talking about the health and well-being of millions of people here. Please do not send me and millions of others back to cigarettes or turn us into criminals for trying to stay off cigarettes!
Just my
You all showed me yours, and I will show you mine 
It's long but it's strong!
(Note: I deleted some of my chantix experience for viewing here on ECF because it's graphic; the FDA needs to see that so they understand my experience.)
--------------------------------------------------------------------------------------------------------------
Dear FDA Representative,
I am writing to request that you seriously consider the impact of your proposed regulations of electronic cigarettes (e-cigarettes) on consumers, and that you make adjustments to these regulations in order to maximize their benefit to the public. I feel that these regulations were written without individual consumers in mind, when they are the people who will be impacted the most drastically. In the following paragraphs I will attempt to illustrate the impact of electronic cigarettes on the average consumer and how regulations can be modified to provide the greatest benefit to both individual consumers and public health as a whole.
I will begin by detailing my personal history of tobacco use. I first smoked at age 10 when my friend’s much older sister let me try her cigarette. At age 12 I became fully addicted to smoking and unable to pry myself from the habit, and I continued to smoke a pack per day for the next 18 years. I became fully aware of what I was doing to my health in my mid-twenties and began struggling to cut back and quit. The first time I quit smoking I used Chantix; this was when it was very new and the more severe side effects were as yet unknown. A month after I began taking it... <censored for ECF> ... needless to say, if my friends hadn’t found me at the time they did I may not have survived. I began smoking again a few days later. I felt deflated and defeated, having failed at the one thing I wanted the most at the time: to be smoke free. I did not give up.
My next few quit attempts I used patches, gum, and lozenges (I don’t remember in what order). I managed to quit twice, but only for a few days each. No matter what method I used, having been a heavy smoker I still had constant cravings that could not be satisfied. Every time I quit I had unbearable mood swings that impaired my ability to perform at work and caused me to lash out at the people I cared about the most. The consequences were too severe, and I stopped trying. My fourth attempt to quit was the “smoking gun,” as I called it: I tried electronic cigarettes. I managed to fully substitute these for tobacco and became completely smoke free in a matter of days. This lasted for three months. Unfortunately, I had many technical issues (batteries not working, liquid leaking, etc.) and eventually began smoking again. A few years later I tried a newer version of the electronic cigarette, and no longer had the technical issues I had with the old version. I still use electronic cigarettes, and I have now been completely smoke free since December 2013. I have finally achieved my goal.
The deeming FDA regulations specify that any technology available before 2007 will be grandfathered in and thus not requiring the lengthy approval process to be sold. As I stated earler, the older electronic cigarettes are littered with technical difficulties; as a result, many who have quit smoking using this technology have only been able to do so with the newer forms that will surely not be grandfathered in under those guidelines. The consequence of requiring individual approval for the newer forms will be drastic, effectively removing these devices from the market for years pending approval. I suspect that many will try to access these goods via the black market. This will lead to the technology becoming rather dangerous; these sellers will not be held to public scrutiny and will be less inclined to ensure the safety of their product lest they lose sales. There will be no accountability among these sellers. I predict that if electronic cigarettes in their current form are banned pending approval, we will see a sharp rise in black market e-cigarette-related injuries and poisonings from tainted nicotine liquid. This is a serious potential heath hazard that needs to be considered.
Many others will simply go back to smoking traditional cigarettes in order to get the amount of nicotine they are accustomed to, or attempt to smoke while using older e-cigarettes to keep from smoking too much. I personally will attempt dual use, as I see no other way out of this situation and I do not want to break the law. I would find it quite tragic to see an organization who is trying to protect public health by reducing smoking rates inadvertently drive many who have quit back to smoking. I urge you to seriously consider pushing the grandfather date forward before any other regulations are enforced.
Another issue that needs to be address is the use of flavors in electronic cigarettes and their potential encitement of children to use these devices. Personally I’m not sure why this even needs to be addressed: no one is out to ban flavors in alcohol, or for that matter in nicotine gum and lozenges. Children have long been attracted to smoking cigarettes for various reasons; this has not required sweet flavors (in fact, cigarettes taste rather disgusting, and youth often smoke regardless). That said, every study that has come out so far showing e-cigarette use by children showed that these same children had also smoked traditional cigarettes. There is clearly a much stronger link in the minds of children between cigarettes and e-cigarettes than there is between e-cigarettes and sweet flavors. I don’t believe restricting the types of flavors allowed in electronic cigarettes will make them any more or less attractive to youth. I feel that the usual restrictions of requiring clear warning labels and limiting the age of purchase to 18 or older will suffice.
Use of flavors in electronic cigarettes (by adults) serves an important purpose: it discourages smoking. The fact that electronic cigarettes taste so much better than the alternative is constant incentive to avoid smoking. Since taste is subjective, many different kinds of flavors must be available to make sure that anyone would rather use these than smoke. Many people I know who use electronic cigarettes and no longer smoke prefer them simply because they taste better. Also, you should keep in mind that the flavors used in electronic cigarettes are created by food flavoring oils, which are available everywhere and accessible by everyone. It is impossible to enforce a ban on flavors for electronic cigarette liquid, and I do not believe it is worth wasting the agency’s time and money in an attempt to do so.
Regarding nicotine use, it is imperative that you not overly restrict the amount of nicotine available in electronic cigarettes. As I stated earlier, the amount of nicotine present in other over-the-counter nicotine products was not sufficient to keep me from smoking. My current nicotine usage works well to keep me smoke free (my dose is considered “very high”), and many others have said the same. Since long-term nicotine use in other forms has been approved, there is no reason to believe that the nicotine in e-cigarettes is any different. If my dosage is lowered by regulation I will begin to smoke again in order to continue getting the same amount of nicotine. Restricting the allowed level of nicotine in electronic cigarettes will have the same effect to many as banning them outright. This technology needs to be protected, and it is crucial that its use as a nicotine delivery device be protected as well.
Finally, I want to briefly discuss the concern over dual use. In my experience, having known many people who smoke, individuals who engage in dual use don’t actually have any intention to quit smoking. They simply want an alternative so they can “smoke” indoors and otherwise will continue to smoke. Those using electronic cigarettes who do intend to quit smoking often only use both simultaneously for a short time before giving up traditional cigarettes outright. In fact, one trend I see in electronic cigarettes are individuals who accidently quit smoking: people who buy an e-cigarette kit with no intention of quitting smoking and end up quitting without even trying. This was the case for myself and my mother; back in December when I bought an electronic cigarette kit, I intended just to try it, but I liked it so much that I no longer wanted to have a cigarette after that. My mother was astonished at my success and got herself a kit; she unexpectedly quit within a week. I think quitting smoking by accident is indeed a new phenomenon.
I have covered many points in this letter, and if you have made it this far I appreciate you taking the time to read what I have to say. I understand that the deeming regulations are in place to ensure the safety of the public, and that scientific studies are still underway to understand the risks of electronic cigarettes. I believe, however, that we finally have a device that makes it possible, even easy, for people to quit smoking and never look back. Smoking cessation is so crucial to our well-being as a society that we should not allow unfounded fears of new technology to hold us back from a possible future where no one smokes tobacco cigarettes anymore. I urge you to consider the points detailed in this letter and re-examine the potential regulations in that light.
Sincerely,
A Concerned Citizen
It's long but it's strong!(Note: I deleted some of my chantix experience for viewing here on ECF because it's graphic; the FDA needs to see that so they understand my experience.)
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Dear FDA Representative,
I am writing to request that you seriously consider the impact of your proposed regulations of electronic cigarettes (e-cigarettes) on consumers, and that you make adjustments to these regulations in order to maximize their benefit to the public. I feel that these regulations were written without individual consumers in mind, when they are the people who will be impacted the most drastically. In the following paragraphs I will attempt to illustrate the impact of electronic cigarettes on the average consumer and how regulations can be modified to provide the greatest benefit to both individual consumers and public health as a whole.
I will begin by detailing my personal history of tobacco use. I first smoked at age 10 when my friend’s much older sister let me try her cigarette. At age 12 I became fully addicted to smoking and unable to pry myself from the habit, and I continued to smoke a pack per day for the next 18 years. I became fully aware of what I was doing to my health in my mid-twenties and began struggling to cut back and quit. The first time I quit smoking I used Chantix; this was when it was very new and the more severe side effects were as yet unknown. A month after I began taking it... <censored for ECF> ... needless to say, if my friends hadn’t found me at the time they did I may not have survived. I began smoking again a few days later. I felt deflated and defeated, having failed at the one thing I wanted the most at the time: to be smoke free. I did not give up.
My next few quit attempts I used patches, gum, and lozenges (I don’t remember in what order). I managed to quit twice, but only for a few days each. No matter what method I used, having been a heavy smoker I still had constant cravings that could not be satisfied. Every time I quit I had unbearable mood swings that impaired my ability to perform at work and caused me to lash out at the people I cared about the most. The consequences were too severe, and I stopped trying. My fourth attempt to quit was the “smoking gun,” as I called it: I tried electronic cigarettes. I managed to fully substitute these for tobacco and became completely smoke free in a matter of days. This lasted for three months. Unfortunately, I had many technical issues (batteries not working, liquid leaking, etc.) and eventually began smoking again. A few years later I tried a newer version of the electronic cigarette, and no longer had the technical issues I had with the old version. I still use electronic cigarettes, and I have now been completely smoke free since December 2013. I have finally achieved my goal.
The deeming FDA regulations specify that any technology available before 2007 will be grandfathered in and thus not requiring the lengthy approval process to be sold. As I stated earler, the older electronic cigarettes are littered with technical difficulties; as a result, many who have quit smoking using this technology have only been able to do so with the newer forms that will surely not be grandfathered in under those guidelines. The consequence of requiring individual approval for the newer forms will be drastic, effectively removing these devices from the market for years pending approval. I suspect that many will try to access these goods via the black market. This will lead to the technology becoming rather dangerous; these sellers will not be held to public scrutiny and will be less inclined to ensure the safety of their product lest they lose sales. There will be no accountability among these sellers. I predict that if electronic cigarettes in their current form are banned pending approval, we will see a sharp rise in black market e-cigarette-related injuries and poisonings from tainted nicotine liquid. This is a serious potential heath hazard that needs to be considered.
Many others will simply go back to smoking traditional cigarettes in order to get the amount of nicotine they are accustomed to, or attempt to smoke while using older e-cigarettes to keep from smoking too much. I personally will attempt dual use, as I see no other way out of this situation and I do not want to break the law. I would find it quite tragic to see an organization who is trying to protect public health by reducing smoking rates inadvertently drive many who have quit back to smoking. I urge you to seriously consider pushing the grandfather date forward before any other regulations are enforced.
Another issue that needs to be address is the use of flavors in electronic cigarettes and their potential encitement of children to use these devices. Personally I’m not sure why this even needs to be addressed: no one is out to ban flavors in alcohol, or for that matter in nicotine gum and lozenges. Children have long been attracted to smoking cigarettes for various reasons; this has not required sweet flavors (in fact, cigarettes taste rather disgusting, and youth often smoke regardless). That said, every study that has come out so far showing e-cigarette use by children showed that these same children had also smoked traditional cigarettes. There is clearly a much stronger link in the minds of children between cigarettes and e-cigarettes than there is between e-cigarettes and sweet flavors. I don’t believe restricting the types of flavors allowed in electronic cigarettes will make them any more or less attractive to youth. I feel that the usual restrictions of requiring clear warning labels and limiting the age of purchase to 18 or older will suffice.
Use of flavors in electronic cigarettes (by adults) serves an important purpose: it discourages smoking. The fact that electronic cigarettes taste so much better than the alternative is constant incentive to avoid smoking. Since taste is subjective, many different kinds of flavors must be available to make sure that anyone would rather use these than smoke. Many people I know who use electronic cigarettes and no longer smoke prefer them simply because they taste better. Also, you should keep in mind that the flavors used in electronic cigarettes are created by food flavoring oils, which are available everywhere and accessible by everyone. It is impossible to enforce a ban on flavors for electronic cigarette liquid, and I do not believe it is worth wasting the agency’s time and money in an attempt to do so.
Regarding nicotine use, it is imperative that you not overly restrict the amount of nicotine available in electronic cigarettes. As I stated earlier, the amount of nicotine present in other over-the-counter nicotine products was not sufficient to keep me from smoking. My current nicotine usage works well to keep me smoke free (my dose is considered “very high”), and many others have said the same. Since long-term nicotine use in other forms has been approved, there is no reason to believe that the nicotine in e-cigarettes is any different. If my dosage is lowered by regulation I will begin to smoke again in order to continue getting the same amount of nicotine. Restricting the allowed level of nicotine in electronic cigarettes will have the same effect to many as banning them outright. This technology needs to be protected, and it is crucial that its use as a nicotine delivery device be protected as well.
Finally, I want to briefly discuss the concern over dual use. In my experience, having known many people who smoke, individuals who engage in dual use don’t actually have any intention to quit smoking. They simply want an alternative so they can “smoke” indoors and otherwise will continue to smoke. Those using electronic cigarettes who do intend to quit smoking often only use both simultaneously for a short time before giving up traditional cigarettes outright. In fact, one trend I see in electronic cigarettes are individuals who accidently quit smoking: people who buy an e-cigarette kit with no intention of quitting smoking and end up quitting without even trying. This was the case for myself and my mother; back in December when I bought an electronic cigarette kit, I intended just to try it, but I liked it so much that I no longer wanted to have a cigarette after that. My mother was astonished at my success and got herself a kit; she unexpectedly quit within a week. I think quitting smoking by accident is indeed a new phenomenon.
I have covered many points in this letter, and if you have made it this far I appreciate you taking the time to read what I have to say. I understand that the deeming regulations are in place to ensure the safety of the public, and that scientific studies are still underway to understand the risks of electronic cigarettes. I believe, however, that we finally have a device that makes it possible, even easy, for people to quit smoking and never look back. Smoking cessation is so crucial to our well-being as a society that we should not allow unfounded fears of new technology to hold us back from a possible future where no one smokes tobacco cigarettes anymore. I urge you to consider the points detailed in this letter and re-examine the potential regulations in that light.
Sincerely,
A Concerned Citizen
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When trying to post on the FDA web site I had to cut my document down in size. Here is my document.
As a smoker of 47 years I would like to take time to share my experiences with you. I started smoking at age of 10 years old stealing my fathers camel non filtered cigarettes switching over to Marlboro and smoked for 47 years. At the age of 40 years old I had a massive heart attack while using the patch. On the way to the Hospital I had to be defibed two times and several other times while Dr. saved my life. After getting out of the hospital about three weeks later I was back on cigarettes and continued to smoke for the next 18 years. Then I had another heart attack December 2013 eight months ago. After which I was headed right back to cigarettes when I was introduced to Vaping. I have not smoked a cigarette since and plan not to. I started out at 12% nicotine and have reduced down to 2% nicotine. My plans are to be nicotine free by March of 2015 and free at last. I just recently had a heart Doctors appointment on the 14th of July 2014 and the Dr. told me that my lungs were not rattling and sounding much better. As a matter of fact I do not have to go back to him for a whole year and just so you know my first heart attack I received 2 stents then my last one I received 2 more. And yes I discussed my vaping with my doctor, we also talked about why the NRT’s did not work and what all I had tried which was hypnosis, patches, gum, lozenges all of them. He told me that he was glad vaping had gotten me away from smoking.
Ladies and Gentlemen what you are doing is nothing but political nonsense against the Vaping community. There are several States along with big tobacco companies, Big Pharmacy several health care systems, Universities and so on. I could go on for ever naming the entities that are losing billions of dollars since Vaping has arrived in the World. I have read your proposed regulations and through out the whole document you claim to be watching out for the better health of the people. And yet on the other hand you sit right there and state in your own document that while e-cigarettes are not completely safe they are 950 times better for the consumer than combustible cigarettes. And that secondhand vapor is far less harmful than combustible cigarette smoke. You all keep saying that Vaping could be a gateway to our youth smoking. It is my belief the only recourse on this matter is to remove the real problem and that is combustible cigarettes and any form of combustible tobacco from the World. You now have a valuable tool to use in what for decades you have been trying to do, which is to eliminate smoking altogether so step forward and use it. I will not sit here and tell you what my actions and recourse will be should you decide to either turn vaping over to big tobacco or to completely destroy it through regulations and taxation. Instead what I will tell you is every time I pass a smoker I will stop and tell him or her about vaping the good and what little bad there is. Mainly I will tell them the truth. And should a non smoker ask I will stop and discuss it with them also. Words have been twisted around so much that the public thinks that Vaping is just as harmful as or even more harmful than combustible cigarettes. These people that carry big titles should have their hands slapped for deceiving the public in such a way only to benefit off the backs of smokers and ex-smokers. One other note of interest you may want to know, If big tobacco is allowed to be the only producer of vaping products then I will start making my own accessories for I do have the knowledge and expertise to do so. Why would you trust something such as this industry to a company that has lied on numerous accounts and to the Supreme Court about combustible cigarettes?
Ladies and gentlemen moving on to the next topic of my discussion is the flavoring issue. I have been weaning myself off the nicotine for months now. Now that I am in my final stages of quitting, I have decided to stop using my tobacco flavor and move on to the candy and fruity flavors. This is a two fold feature that I feel is working for me. In the past when I have tried to quit smoking the first thing that happened was weight gain. By me utilizing the new flavors I have been able to curb the cravings of my new taste bud recovery, while also distracting myself from the need to have the tobacco taste. You have also commented that the flavors could be a gateway to youth smoking. I have stated above by eliminating combustible tobacco products altogether you eliminate the gateway effects to youth smoking combustible tobacco products. I therefore believe that by having the different flavors which are a vital part in using Vaping as a cessation tool to end smoking.
In conclusion I feel that what is really happening to this Industry is a political bout involving money issues. We do not need to let money be the determining factor when so many lives are at stake here. Not only in the United States but around the World as other countries are waiting to see what will be decided here in the United States. I am asking you to stand tall and tell the World we do care more about life than monetary values.
As a smoker of 47 years I would like to take time to share my experiences with you. I started smoking at age of 10 years old stealing my fathers camel non filtered cigarettes switching over to Marlboro and smoked for 47 years. At the age of 40 years old I had a massive heart attack while using the patch. On the way to the Hospital I had to be defibed two times and several other times while Dr. saved my life. After getting out of the hospital about three weeks later I was back on cigarettes and continued to smoke for the next 18 years. Then I had another heart attack December 2013 eight months ago. After which I was headed right back to cigarettes when I was introduced to Vaping. I have not smoked a cigarette since and plan not to. I started out at 12% nicotine and have reduced down to 2% nicotine. My plans are to be nicotine free by March of 2015 and free at last. I just recently had a heart Doctors appointment on the 14th of July 2014 and the Dr. told me that my lungs were not rattling and sounding much better. As a matter of fact I do not have to go back to him for a whole year and just so you know my first heart attack I received 2 stents then my last one I received 2 more. And yes I discussed my vaping with my doctor, we also talked about why the NRT’s did not work and what all I had tried which was hypnosis, patches, gum, lozenges all of them. He told me that he was glad vaping had gotten me away from smoking.
Ladies and Gentlemen what you are doing is nothing but political nonsense against the Vaping community. There are several States along with big tobacco companies, Big Pharmacy several health care systems, Universities and so on. I could go on for ever naming the entities that are losing billions of dollars since Vaping has arrived in the World. I have read your proposed regulations and through out the whole document you claim to be watching out for the better health of the people. And yet on the other hand you sit right there and state in your own document that while e-cigarettes are not completely safe they are 950 times better for the consumer than combustible cigarettes. And that secondhand vapor is far less harmful than combustible cigarette smoke. You all keep saying that Vaping could be a gateway to our youth smoking. It is my belief the only recourse on this matter is to remove the real problem and that is combustible cigarettes and any form of combustible tobacco from the World. You now have a valuable tool to use in what for decades you have been trying to do, which is to eliminate smoking altogether so step forward and use it. I will not sit here and tell you what my actions and recourse will be should you decide to either turn vaping over to big tobacco or to completely destroy it through regulations and taxation. Instead what I will tell you is every time I pass a smoker I will stop and tell him or her about vaping the good and what little bad there is. Mainly I will tell them the truth. And should a non smoker ask I will stop and discuss it with them also. Words have been twisted around so much that the public thinks that Vaping is just as harmful as or even more harmful than combustible cigarettes. These people that carry big titles should have their hands slapped for deceiving the public in such a way only to benefit off the backs of smokers and ex-smokers. One other note of interest you may want to know, If big tobacco is allowed to be the only producer of vaping products then I will start making my own accessories for I do have the knowledge and expertise to do so. Why would you trust something such as this industry to a company that has lied on numerous accounts and to the Supreme Court about combustible cigarettes?
Ladies and gentlemen moving on to the next topic of my discussion is the flavoring issue. I have been weaning myself off the nicotine for months now. Now that I am in my final stages of quitting, I have decided to stop using my tobacco flavor and move on to the candy and fruity flavors. This is a two fold feature that I feel is working for me. In the past when I have tried to quit smoking the first thing that happened was weight gain. By me utilizing the new flavors I have been able to curb the cravings of my new taste bud recovery, while also distracting myself from the need to have the tobacco taste. You have also commented that the flavors could be a gateway to youth smoking. I have stated above by eliminating combustible tobacco products altogether you eliminate the gateway effects to youth smoking combustible tobacco products. I therefore believe that by having the different flavors which are a vital part in using Vaping as a cessation tool to end smoking.
In conclusion I feel that what is really happening to this Industry is a political bout involving money issues. We do not need to let money be the determining factor when so many lives are at stake here. Not only in the United States but around the World as other countries are waiting to see what will be decided here in the United States. I am asking you to stand tall and tell the World we do care more about life than monetary values.
Very good. One letter addressed weight and obesity related illness imay even be a worse public health problem than tobacco. They are tied for first place in "preventable illness" and medical costs.
I'm all in favor of what each informed adult decides is in his own best interests. How could it be otherwise? I smoked for almost 50 years and I derived considerable enjoyment from it and I knew exactlyi what was at risk. Now, I get even more enjoyment from vaping. It works perfectly for me, but not entirely for you. So, why can't you be exactly like me?
The fourth call to action was announced today!Honestly, I have yet to write my draft, mainly because I was hoping for some answers to my questions first... but no matter! I am a recent college grad, which means four things: 1) I am a well trained writer; 2) I can figure out things as I go with minimal advisement (i.e. no answers to my questions); 3) I am excellent at putting things off til the last second, working under a tight deadline, and making it look like I've spent months on it; and 4) I'm currently unemployed! I have plenty of time to write this today!
As for dual use, I do agree that it's mainly a concern because the goal of Mitch Zeller and his peeps is to eliminate smoking entirely, making it effectively history. That's a lofty goal, but they might wanna slow down a tad because we, as a society, are nowhere near that yet. Furthermore, from what I can tell, dual users are a minority in the vaping community; it appears (we need real studies on this, not the garbage smoking = vaping = not-really-quitting studies I keep seeing...) the majority of smokers who begin vaping quit smoking, many of them surprisingly quickly. So even if dual use were a real concern, it is at best a marginal one and ought not to have such a drastic affect on policy making that it makes it harder for vapers to really quit. That would mean going backward and creating more smokers out of those who have otherwise quit.
I think I'm going to include a variation of that last paragraph in my draft.
Nice post. But that would be "effect."
(Please don't hurt me.)
Ouch!You got me
Well, at least you may derive some small comfort from knowing that I read the entire thing.
EDIT to make it sound more like, LOL, you know, uh, British.
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I am always comforted when I find that my posts are being read and liked, it makes me post more
That reminds me...
Those of you who are still submitting comments to the FDA: It would be best to follow the rules of grammar, syntax, punctuation, and spelling as closely as possible when making your comments. Speak professionally as much as you can. The more you do so, the more your comments will be taken seriously by those who read them.
Think of it like applying for a job: the better your cover letter and resume look, the more likely you are to get an interview. That is what you want here, for your comment to be noticed and taken seriously.
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