To the FDA:
I am writing regarding the proposed regulations of electronic nicotine delivery systems (“ENDS”). I do not refer to them as e-cigarettes, because they are not really in any way cigarettes. ENDS neither contain any leaf tobacco nor do they require combustion to be used. I hold a PhD, a JD and am a college professor. I am a 61 year-old male that smoked cigarettes from the age of about 15 until switching to ENDS about three years ago. I have seen significant health benefits, including measurably better pulmonary function. My adoption of ENDS was endorsed by my physician who measured the increased pulmonary function. After my exclusive adoption of ENDS and my cessation of cigarette smoking, my COPD improved to the point that I no longer require a daily inhaled medicine for treatment. My level of nicotine use has also declined, much as was found in this study: IJERPH | Free Full-Text | Characteristics, Perceived Side Effects and Benefits of Electronic Cigarette Use: A Worldwide Survey of More than 19,000 Consumers.
Over all the years I smoked cigarettes, the only effective help I found was in ENDS. I tried the cessation products you currently have approved without any measure of success. The patches made me ill and the chewing gum was simply disgusting; these items are also expensive ended up useless for me. I know they have helped some people, but from what I have read they are not a true hit and fail in most cases. Nicotine addiction is insidious; my personal belief is it may be amongst the worst of all possible addictions to overcome. I have come to grips with minimizing my nicotine usage as much as practicable and at least now with ENDS I do not endanger others with second-hand smoke and am far more welcome in other people’s company satisfying my addiction.
Initially, I believe it is important to note that your proposed regulation to prohibit sales to minors is appropriate and in line with the self-regulation of the ENDS industry to date. I also believe that using ENDS is likely not an overall positive health choice. Neither would be choosing to live in a highly polluted place, such as Beijing. It is to me principally an issue of mitigation, or tobacco harm reduction. Although ENDS may not be good for someone, they are better than cigarettes, cigars and other tobacco based products. Numerous studies have concluded the same. I cite the additional references that may be found at the following links: http://informahealthcare.com/doi/abs/10.3109/08958378.2013.793439 ; http://www.nature.com/srep/2014/140226/srep04133/full/srep04133.html ; http://publichealth.drexel.edu/~/media/Files/publichealth/ms08.ashx ; http://www.biomedcentral.com/1471-2458/14/18/abstract ; http://www.biomedcentral.com/content/pdf/1471-2458-11-786.pdf; http://goo.gl/LhEDoK.
The attractiveness of ENDS to minors is unfortunately a consequence of the nature of youth and prohibitions. As has been consistently shown in your own and other studies and surveys, young people will experiment with drugs, whether they contain nicotine, ..., alcohol or for that matter many other intoxicants. The most recent one I heard about was the use of Burt’s Bees Lip Balm Beezin Teens Reportedly Getting High By Rubbing Burt’s Bees On Eyelids - TIME. The fact that food flavoring is often added to nicotine solutions may make the product more attractive to youth, but no more than hard cider or other flavored alcoholic beverages that are openly marketed and advertised on television. Flavor is, however, also an important part of what made ENDS attractive to me and helped me get off of using cigarettes; see IJERPH | Free Full-Text | Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey. The ability to have different flavors helped greatly in overcoming the desire to use cigarettes. Incidentally, I stopped using cigarettes fully within ten days of starting with an ENDS.
I am also a proponent of labeling requirements. I mix my own e-liquids to control the level of nicotine and other ingredients as best as possible. I start with a plain nicotine base and add flavors and/or sweeteners to my taste. It keeps the cost down and provides more control over the end product. Most users of ENDS do not mix their own liquids, so labeling is surely an appropriate step. I do believe over-regulation may result in some harmful side effects; see http://......................./wp-content/uploads/2013/11/Clive-Bates-Regulation-When-Less-is-More-E-Cigarette-Summit.pdf.
Another issue is not health related directly, but indirectly. Tobacco and other sin taxes have become a significant source of revenue for many governmental entities. I am most fearful that your decision to regulate will result in governmental entities accessing this as an opportunity for additional taxation. One of the attractive aspects of the use of ENDS besides the lack of combustion, ashes, butts, and second-hand smoke, is the fact that the cost is currently below that of cigarettes. You are no doubt aware that tobacco taxation has been seriously regressive, as smoking rates are higher amongst the poor than the wealthy. If taxation of ENDS becomes wide spread, many lower income folks may well continue to smoke cigarettes, simply as a matter of cost.
My final comment relates to the note I received from the White House, and I quote:
“If the FDA finalizes the rule in its current form, electronic cigarettes manufacturers will need authorization to sell products not commercially marketed as of February 15, 2007 -- but this doesn't mean these products would be banned. Sections 905 and 910 describe the applications and reports manufacturers will need to submit to sell their products.
There will be two primary ways for tobacco products to obtain that authorization: either an application for "substantial equivalence," or an application for premarket approval.
"Substantial equivalence" would ask manufacturers to compare their products to another product that was already commercially marketed by February 15, 2007 or that was previously found by FDA to be substantially equivalent -- though we acknowledge this may be challenging for electronic cigarettes. Second would be the premarket tobacco application, where a manufacturer submits information to the FDA establishing it would be "appropriate for the protection of public health" to allow the product to be marketed.”
[FONT="]
Based upon my reading of the above, because what you and the White House refer to as electronic cigarettes were not in abundance in the market in 2007, the manufacturers of ENDS will have to undergo an expensive and time consuming process to continue to market their products beyond a little over a two-year window. This leads to the anomalous result that the most harmful of products traditional cigarettes remain exempt from additional regulation because they were broadly in the marketplace in 2007, while a less harmful product will need to undergo a high level of scrutiny. This seems to be a rather silly result. Please adjust your proposed regulation to allow the continued sale of ENDS without the additional burdens, while adopting both the age limit and labeling requirements. [/FONT]
[FONT="]Very truly yours, [/FONT]
[FONT="]Richard Mason, Reno, Nevada[/FONT]
The abbreviation for {OTHER STUFF} is what ECF dotted in my letter ...
I am writing regarding the proposed regulations of electronic nicotine delivery systems (“ENDS”). I do not refer to them as e-cigarettes, because they are not really in any way cigarettes. ENDS neither contain any leaf tobacco nor do they require combustion to be used. I hold a PhD, a JD and am a college professor. I am a 61 year-old male that smoked cigarettes from the age of about 15 until switching to ENDS about three years ago. I have seen significant health benefits, including measurably better pulmonary function. My adoption of ENDS was endorsed by my physician who measured the increased pulmonary function. After my exclusive adoption of ENDS and my cessation of cigarette smoking, my COPD improved to the point that I no longer require a daily inhaled medicine for treatment. My level of nicotine use has also declined, much as was found in this study: IJERPH | Free Full-Text | Characteristics, Perceived Side Effects and Benefits of Electronic Cigarette Use: A Worldwide Survey of More than 19,000 Consumers.
Over all the years I smoked cigarettes, the only effective help I found was in ENDS. I tried the cessation products you currently have approved without any measure of success. The patches made me ill and the chewing gum was simply disgusting; these items are also expensive ended up useless for me. I know they have helped some people, but from what I have read they are not a true hit and fail in most cases. Nicotine addiction is insidious; my personal belief is it may be amongst the worst of all possible addictions to overcome. I have come to grips with minimizing my nicotine usage as much as practicable and at least now with ENDS I do not endanger others with second-hand smoke and am far more welcome in other people’s company satisfying my addiction.
Initially, I believe it is important to note that your proposed regulation to prohibit sales to minors is appropriate and in line with the self-regulation of the ENDS industry to date. I also believe that using ENDS is likely not an overall positive health choice. Neither would be choosing to live in a highly polluted place, such as Beijing. It is to me principally an issue of mitigation, or tobacco harm reduction. Although ENDS may not be good for someone, they are better than cigarettes, cigars and other tobacco based products. Numerous studies have concluded the same. I cite the additional references that may be found at the following links: http://informahealthcare.com/doi/abs/10.3109/08958378.2013.793439 ; http://www.nature.com/srep/2014/140226/srep04133/full/srep04133.html ; http://publichealth.drexel.edu/~/media/Files/publichealth/ms08.ashx ; http://www.biomedcentral.com/1471-2458/14/18/abstract ; http://www.biomedcentral.com/content/pdf/1471-2458-11-786.pdf; http://goo.gl/LhEDoK.
The attractiveness of ENDS to minors is unfortunately a consequence of the nature of youth and prohibitions. As has been consistently shown in your own and other studies and surveys, young people will experiment with drugs, whether they contain nicotine, ..., alcohol or for that matter many other intoxicants. The most recent one I heard about was the use of Burt’s Bees Lip Balm Beezin Teens Reportedly Getting High By Rubbing Burt’s Bees On Eyelids - TIME. The fact that food flavoring is often added to nicotine solutions may make the product more attractive to youth, but no more than hard cider or other flavored alcoholic beverages that are openly marketed and advertised on television. Flavor is, however, also an important part of what made ENDS attractive to me and helped me get off of using cigarettes; see IJERPH | Free Full-Text | Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey. The ability to have different flavors helped greatly in overcoming the desire to use cigarettes. Incidentally, I stopped using cigarettes fully within ten days of starting with an ENDS.
I am also a proponent of labeling requirements. I mix my own e-liquids to control the level of nicotine and other ingredients as best as possible. I start with a plain nicotine base and add flavors and/or sweeteners to my taste. It keeps the cost down and provides more control over the end product. Most users of ENDS do not mix their own liquids, so labeling is surely an appropriate step. I do believe over-regulation may result in some harmful side effects; see http://......................./wp-content/uploads/2013/11/Clive-Bates-Regulation-When-Less-is-More-E-Cigarette-Summit.pdf.
Another issue is not health related directly, but indirectly. Tobacco and other sin taxes have become a significant source of revenue for many governmental entities. I am most fearful that your decision to regulate will result in governmental entities accessing this as an opportunity for additional taxation. One of the attractive aspects of the use of ENDS besides the lack of combustion, ashes, butts, and second-hand smoke, is the fact that the cost is currently below that of cigarettes. You are no doubt aware that tobacco taxation has been seriously regressive, as smoking rates are higher amongst the poor than the wealthy. If taxation of ENDS becomes wide spread, many lower income folks may well continue to smoke cigarettes, simply as a matter of cost.
My final comment relates to the note I received from the White House, and I quote:
“If the FDA finalizes the rule in its current form, electronic cigarettes manufacturers will need authorization to sell products not commercially marketed as of February 15, 2007 -- but this doesn't mean these products would be banned. Sections 905 and 910 describe the applications and reports manufacturers will need to submit to sell their products.
There will be two primary ways for tobacco products to obtain that authorization: either an application for "substantial equivalence," or an application for premarket approval.
"Substantial equivalence" would ask manufacturers to compare their products to another product that was already commercially marketed by February 15, 2007 or that was previously found by FDA to be substantially equivalent -- though we acknowledge this may be challenging for electronic cigarettes. Second would be the premarket tobacco application, where a manufacturer submits information to the FDA establishing it would be "appropriate for the protection of public health" to allow the product to be marketed.”
[FONT="]
Based upon my reading of the above, because what you and the White House refer to as electronic cigarettes were not in abundance in the market in 2007, the manufacturers of ENDS will have to undergo an expensive and time consuming process to continue to market their products beyond a little over a two-year window. This leads to the anomalous result that the most harmful of products traditional cigarettes remain exempt from additional regulation because they were broadly in the marketplace in 2007, while a less harmful product will need to undergo a high level of scrutiny. This seems to be a rather silly result. Please adjust your proposed regulation to allow the continued sale of ENDS without the additional burdens, while adopting both the age limit and labeling requirements. [/FONT]
[FONT="]Very truly yours, [/FONT]
[FONT="]Richard Mason, Reno, Nevada[/FONT]
The abbreviation for {OTHER STUFF} is what ECF dotted in my letter ...
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