My letter to FDA. What do you all think?

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Canute

Unregistered Supplier
ECF Veteran
Dear Sir,

I am writing the following letter as a plea to prevent the banning of electronic cigarettes. After twenty four years of smoking one and half packs a day I have found what can only be described as a miracle in these devices. I have been using my personal vaporizer in lieu of regular cigarettes now for two weeks and found switching over to them as easy as switching brands. Prior to doing so I have done exhaustive research into their chemical composition in comparison to regular cigarettes and absolutely can not understand why the FDA would not be promoting these vehemently in order to assist the millions of Americans addicted to nicotine.

I would not for one single moment claim to believe that electronic cigarettes are healthy for you, however it seems to be common sense that they are clearly far better than standard cigarettes. If the FDA can provide scientific evidence showing that electronic cigarettes are more dangerous than standard cigarettes, then by all means continue with the ban. However, if they are shown to be equally as unhealthy, or less, then the FDA has a responsibility to millions of addicted Americans to support them in earnest. The fact is that even if they are equally harmful the benefits posed by the lack of fire danger, second hand smoke (both in terms of health and annoyance to non-smokers) and litter make them an invaluable aid.

After exhaustively attempting to researching the chemicals actually present in standard cigarettes it became quickly obvious to me that there were so many that researching them all became ludicrous. Though I do not have a P.H.D. in chemistry common sense dictates that the limited ingredients found in the typical e-liquids used in personal vaporizers could not possibly approach the harmful levels found in cigarettes.

I fully understand that great political pressure must be weighing upon the FDA from pharmaceutical companies marketing smoking cessation products as well as from the interests of tobacco manufacturers. I ask that the FDA understand the benefits posed by these devices and stand on the side of the citizens on this one.

The FDA mission statement begins with "The FDA is responsible for protecting the public health". If this is in fact the case then I would ask two simple questions to every person within the FDA with the required education to answer. I went from one and a half packs of Marlboro lights per day to puffing on a personal vaporizer filled with 16mg nicotine fluid. I have tried for ten years or more off and on to quit without success. Should I put this device down and return to my standard cigarettes? Will the FDA be confident enough that their answer is not based in financial special interests as to accept liability for the recommendation they provide?

Sincerely,
 

Dirtybutts

Super Member
ECF Veteran
Sep 25, 2009
344
1
West Point, New York
I love it! Well done, if anything they should not ban anyway because look at all the people that like to drink, or use a hooka it is a personal recreation chose that we have chosen I am not sure I keep sending them messages about how they have helped you kick smoking but instead make it know to them that this is no different than choosing a hobby for that matter..next thing ya know they will want to ban a certain brand os scissors because someone cut there finger while scrapbooking with them.
 

Canute

Unregistered Supplier
ECF Veteran
Ya know, Obama has supposedly been a smoker on and off over the years. I wonder if he even knows these things exist. Highly doubt he'd even take a stand one way or the other even if he did but it would be interesting to know. Maybe he might at least discretely push the FDA to get to the scientific bottom of the issue since he can relate to the addiction.
 

Pyrate

Senior Member
ECF Veteran
Sep 18, 2009
237
73
Las Vegas, Nevada
Ya know, Obama has supposedly been a smoker on and off over the years. I wonder if he even knows these things exist. Highly doubt he'd even take a stand one way or the other even if he did but it would be interesting to know. Maybe he might at least discretely push the FDA to get to the scientific bottom of the issue since he can relate to the addiction.


Thats true. I saw an interview with him where he said he has had difficulty quitting cigarettes.
Maybe someone should send him a link to these forums, a 510 Starter Kit and some Juice.
 

Dirtybutts

Super Member
ECF Veteran
Sep 25, 2009
344
1
West Point, New York
I love it! Well done, if anything they should not ban anyway because look at all the people that like to drink, or use a hooka it is a personal recreation chose that we have chosen I am not sure I keep sending them messages about how they have helped you kick smoking but instead make it know to them that this is no different than choosing a hobby for that matter..next thing ya know they will want to ban a certain brand os scissors because someone cut there finger while scrapbooking with them.


I realize now that this does not make very much sense....Damn ambian!
 

texasvol

Full Member
ECF Veteran
Oct 14, 2009
11
0
Texas
Here is the response that you're likely to get from the FDA. Please let us know if you receive anything different. Thanks!

Thank you for making your opinions and concerns known to the Agency. We appreciate your thoughts and experiences regarding electronic cigarette, cigar, and pipe products.

At this time, we are not aware of any data establishing electronic cigarettes, cigars, or pipes as safe and effective for their intended uses. Based upon our review of a number of these products, they are drug/device combinations that require approval by FDA before they may be legally marketed in the United States .

None of these so-called electronic cigarettes, cigars, and pipes, or their components has been approved by FDA. Therefore, the marketing of them in the United States is subject to enforcement action. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.

There may be a perception among some users that electronic cigarettes, cigars, or pipes are safer alternatives to conventional tobacco products. There may also be a perception that these products are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. FDA also found varying levels of nicotine in cartridges labeled as containing the same level of nicotine as well as the presence of nicotine in cartridges labeled as containing no nicotine. These test results indicate that these products are manufactured under inadequate or non-existent controls.

FDA is concerned that electronic cigarettes, cigars, or pipes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.

There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Service’s, Treating Tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA-approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smoker’s chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting [smokefree.gov]

Again, we appreciate the time that you have taken to contact us.



Best regards,
kw
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

This communication is consistent with 21CFR10.85(k) and constitutes and informal communication that represents our best judgment at this time but does not constitute and advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
 
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