Please email the FDA at the following addy

[MaDPimP]

Heres what I got from the FDA:

Your message was forwarded to our Division of Drug Information, in the FDA's Center for Drug Evaluation and Research for response. We appreciate your comments.

The FDA considers electronic cigarettes to be unapproved products but we are willing to review any new drug application (NDA) that is submitted to us.

Please visit our website for information.

fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm

Best Regards,

BD
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

[danarmstrong]

I am a newbee to e cigs and have only used them for 2 weeks and have dramatically decreased my use of analogs.
I just sent the e mail to the FDA. I sure hope we can still purchase this product in the near future.

Thanks
Dan

[danarmstrong]

Just thought I would post this. I recieved it today from the FDA.

Dear Mr. Armstrong,

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.

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.


I hope we still have this option to smoking anologs in the future.

[catwoman19]

Just thought I would post this. I recieved it today from the FDA.

Dear Mr. Armstrong,

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.

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.


I hope we still have this option to smoking anologs in the future.

Hey Sun,
What do you thiink of this bull, they are sounding like they have already won the battle

[Vocalek]

Write him back. Ask him to provide the data that establishes that tobacco cigarettes, cigars, or pipes are safe and effective for their intended uses.

Thousands of comments left at the Electronic Cigarette Petition site are reporting improvements in lung function, blood pressure, heart rate, and other health parameters (http://www.thepetitionsite.com/1/kee...tes-available#). What data does the FDA possess that assures all these people that their health improvements will not "go up in smoke" if they relapse to tobacco because the FDA has made the electronic substitutes unavailable?

[Sparky400]

People might be getting tired of all the writing, but come on US-members, it's your future or lack there-of... these kinds of channels are often the most rewarding to follow, so I think it would be wise to do... and it's email this time too, so a bit easier then making snail-mail letters...

It is somewhat tiring to keep saying the pretty much the same thing over and over and over again. On the bright side, the folks who are writing letters frequently shouldn't have to change them much. I have used pretty much the same one a few times now..

Just thought I would post this. I recieved it today from the FDA.

Dear Mr. Armstrong,

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.

OMG!! I don't know whether to laugh or cry.. Do they have even have any data establishing what most people intend to use them for? Unless of course the government is deciding my intentions for me now too.

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.

Great, so I'm reminded now that I can't eat hotdogs, drink beer or cough syrup either. The FDA needs to remember that tax payers sign their paycheck. If they can't provide some perspective in their info they are not doing their job.

They should have just said it contains dihydrogen monoxide if they wanted to scare people. There is scientific data proving that 86% of the population supports a ban on that.

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.

This was the best part. I guess they need more scientific data or an anvil to fall on their head before they can remove this footer.

I am going to write a letter and ask all the volunteers on my mailing list (almost 100 people now) to do the same but not before I finish tearing this letter apart so they have some ammo.

[Thulium]

To whom it may concern:

I am writing in regards to the FDA's recent actions in regard to "electronic cigarettes". After 15+ years in various service industry professions, I have been smoking for some time and have attempted to quit using every Nicotine Replacement Therapy option with limited success. Although the FDA approved NRTs helped ease the physical craving, eventually the urge would still overcome and I'd find myself smoking again even while using nicotine polacrilex patches, gums, or lozenges. When I discovered electronic cigarettes at a Smoking Everywhere kiosk at the mall, I was immediately impressed at the very notion. By combining the known effects of low temperature vaporization and FDA approved ingredients, the electronic cigarette offers a replacement to not simply the nicotine but a replacement for the physical act of smoking which I found that I craved even when I did not physically crave the nicotine.

Electronic cigarettes are not nicotine replacement devices because they are helping me manage the urge to smoke even when I don't use nicotine. The purpose of the FDA is supposed to be to protect me from hazardous products, yet it appears you are attempting to ban a product that has not been shown to cause a single health problem. Products such as Chantix that have been linked to psychological disorders and side effects including suicidal tendencies are allowed to remain on the market despite their known adverse side effects and unknown long-term effects while the FDA attempts to ban electronic cigarettes because TRACE levels of carcinogens were found commensurate with approved products.

I have recently been elected to serve on the board of directors for an organization dedicated to preserving the ability to use smoking replacements like this, and I would like to know if the FDA is willing to work with us to assure that these types of products are regulated fairly. I have already reduced significantly the amount of cigarettes that I use and I plan to stop smoking entirely as long as I have access to cleaner options.

I urge you to consider that it is in fact the SMOKE produced by combustion of tobacco products that is the #1 cause of preventable deaths, and it is specifically the act of SMOKING that is re-created by these portable atomizers when used as intended as a Smoking Replacement device. President John F. Kennedy established the consumer's right to choose, President Ronald Reagan demonstrated through his own efforts to quit smoking that using a replacement product (in his case, Jelly Beans) and not necessarilly any pharmaceutical that is most critical to life-saving smoking cessation efforts.

I understand that there are concerns about e-cigarettes being sold to children. When I explained the issue to my 9 year old daughter, she immediately understood that it was better for her daddy and she is my inspiration to stop smoking with help from a harm reducing behavior replacement that allows me to titrate my nicotine use to whatever level I choose. According to the research that I have read, nicotine without the MAO inhibitors found in tobacco smoke is not particularly habit forming and there is no evidence whatsoever to suggest that someone who uses an electronic cigarette would "gateway" to other tobacco products--if there were we would have examples of this occurring with "candy flavored" nicotine polacrilex gums or lozenges that look like candy. If my 9 year old daughter can figure this out, certainly United States Food & Drug Association can see past corporate interests and help ensure that cleaner tobacco and nicotine options will save lives and should be protected if not encouraged.

Best regards,
Thad Marney

[edebran]

Done. I have only had a throw away type e cigarette and LOVED it. I will get my hands on a Joyce 510 ASAP. I would hate to see something stupid like an uneducated FDA ban destroy my new obsession.

[Cali]

I am, what is commonly becoming known as, an e-smoker. I have smoked since the age of 16 and am currently 32 years of age. I am a father, a son, a brother, and a hard working American citizen. I have tried several different methods over my lifetime to stop using cigarettes. I have tried the patches, the gums, the inhalers, and even the homeopathic remedies. The longest I have managed to go without a cigarette in my mouth has been a week at most.
I know that smoking is a leading cause of cancer and will eventually break my body down but the addiction had me in a vice that I simply could not free myself from. I woke up in the mornings coughing and unable to function properly as my body attempted to reject the toxins I inhaled with cigarettes. I would stand outside in freezing rain in order to smoke. Monetarily my addiction was costing me well over $150 a month.
I overheard a commercial for e-cigarettes on the radio one day and began researching the subject on the internet. After finding a great support community and asking more than a few questions, I decided to make the jump and hope these new devices could help me. I spent approximately $120 on a start-up kit and a few accessories that I felt would benefit me. That $120 bought enough supplies to last well over a month.
Once my package arrived I eagerly broke it open and began, unknown to me at the time, a journey towards a healthier lifestyle. I have yet to even crave a single cigarette since I became an e-smoker. My lungs are already rejecting the toxins I ingested with cigarettes as I can breathe easier in the mornings and I do not get as winded as I used to. My hair, clothes, skin, and breath all smell better due to not being infused with a disgusting smoke scent. My teeth have begun to shine better as they are not being stained by the thousands of chemicals I would inhale in a cigarette.
It has been well over three weeks now and I have not even considered touching a regular cigarette. I understand the want of our government to protect its citizens but there MUST be a middle ground. Without these wonderful devices I would still be inhaling carcinogens and taking precious time off of my lifespan. Not only do I thank the wonderful devices but my children do as well. I know that I have a much better chance at watching them grow into healthy adults and look forward to time with grandchildren now.
It may not seem like such a grandiose thing to the non-smokers in the world, but to those of us that have been able to put down the cigarettes we thank you for not banning or taxing them out of the average citizen's reach. I implore you to read these words and know that I am not a businessman trying to get rich. I am not a senator trying to get reelected. I am not government official trying to ensure the country gets its piece of the pie. I am simply a young man trying to live a healthier lifestyle.



This is a copy of the letter I sent in. I don't know if it's too late as I haven't seen any activity on this thread for a few months but I am a new member and I strongly believe that if we campaign in a grass roots effort we can achieve the goals of keeping these in production and within reach of the average citizen as far as cost is concerned