Please email the FDA at the following addy

[jodi]

I just send the following to: reglist@cdrh.fda.gov

"To whom it may concern:

Please do not take away another of our free choices by banning the use of these devices.

My sister's health has improved dramatically since she has stopped smoking tobacco and begun using a vaporizer. This has happened in only two months.

You will create a huge black market and criminalize millions of folks who only want to improve their health and that of the people around them.

Regards,

Jodi McMullen
Kingston, Oklahoma"

 

[tattbob]

It is done!!!

 

[~Gazoo~]

I do not know where that e-mail address came from--but these are the players and the e-mail addresses to the players that matter---

Email should be addressed to the following members of the FDA:

Janet Woodcock Janet.Woodcock@fda.hhs.gov and/or
Mary Hitch Mary.Hitch@fda.hhs.gov


That is the real deal---Sun

Thank you Sun..I agree!!

 

[dano]

May be late but I sent my message to the email address given.

"Ecigs are the greatest thing to ever happen to smokers. They are a healthier alternative to smoking. They don't stink or emit second hand smoke.
Do not shoot down this miraculous device that will save thousands of lives per year!"

 

[anagramit]

Sent my emails too.

 

[dano]

I just emailed ALL my state reps and senators. We should all do the same!

 

[HawaiiVapor808]

damn, i wrote them a letter and i forgot to post about it. anyway, I did it.

 

[suparstar11]

they seem like the best way to quit smoking. after I get one and feel the success I will send out the email! Cheers!

 

[bassn99]

Letter sent.
I have also written to the Fox Network in hopes of getting the media to really take a hard look at what is going on. Fox News seems to be one of the media outlets that is keeping an open mind. I would just like to see them investigate more.
As I am sure most of us are concerned about our health (or we wouldn't have converted to vapor) good or bad, I would like to know the real truth.

 

[MaDPimP]

better late than never:

To Whom It May Concern,

My name is and I am 24 years old. For at least the last 8 years I have been a heavy smoker. Over the years, I have tried on several occasions to quit smoking cigarette which I, and I feel fairly certain everyone on earth, know are harmful, deadly, and addictive. During this time I’ve seen doctors, been paid by my parents, tried lozenges, and tried the cold turkey approach to quit. The only thing all these methods had in common was: failure. No matter how hard I tried, no matter that it would cost me $100 to pay back my parents on top of the cost of cigarettes (a significant cost to a poor college student at the time), I simply could not stop.

Then a friend of mine told me about Electronic Cigarettes (E-Cigs). Admittedly I was skeptical at first. I mean come on, an electric stick that would vaporize nicotine? However, my interest was piqued and I began looking up information on the internet and was amazed at what I found. Not only were e-cigs real, but they were helping people stop smoking cigarettes!

I then began to find numerous reports from doctors and chemists about the health benefits of stopping smoking cigarettes and switching to e-cigs. I read real life testimonials from people who had smoked for 40+ years successfully and happily if not completely switching to e-cigs at least cutting their traditional tobacco smoking down to a fraction of what it once was. These people all went on and on about how much better they felt and happier they were after switching.

Needless to say, I decided to try them out and was remarkably pleased. I’ve had my e-cig now for almost 10 days and haven’t smoked a traditional cigarette since. Unlike my other experiences, with my e-cig I don’t have a need nor a want for cigarettes and I can’t foresee wanting one anytime in the near future as long as they are available. In my short time using them my life has improved dramatically. My clothes and hands no longer smell. People no longer stop and glare at me for hanging out in doorways while I smoke my cigarettes. And most importantly, from a health standpoint, I can breath, smell, and taste things better and no longer spend my mornings coughing up black tar like substances.

This brings me to the point of my letter today. I have anxiously followed the news story of the FDA’s current court case regarding E-cigs and as things begin to finally come to a head I feel its time to make my voice heard. While I realize that the gauntlet, so to speak, has apparently been thrown down, I am asking you as human beings and a responsible and reasonable governmental organization that you think carefully and considerately about what your next move will be in regards to e-cigs. I am not trying to say that there shouldn’t be controls/standards implemented. I am not claiming that the claims made regarding “smoking cessation” were necessarily appropriate or beyond reproach. I am simply asking that you take a look at the facts in the situation. Look at the many individuals this product has helped to avoid the known mortal danger posed by traditional cigarettes many of whom have tried the current available smoking cessation products and failed. Think about how many of those, including myself, would be forced back to the known and deadly embrace of traditional, tar and carcinogen filled cigarettes. If there is an alternative to this shouldn’t we as humane and concerned individuals give it a chance? Are we really forced with only the choice to quit or die? I should hope not.

In this great country of ours, we claim all people are free to the rights of life, liberty, and the pursuit of happiness. Let us not sully this reputation by depriving individuals of a longer life by using an alternative to a deadly product. Let us not disgrace ourselves by impinging on the rights of free citizens to use a substance that is legally protected in the manner they choose. And finally, let us not steal away the happiness that e-cigs have brought to not only myself but also to so many others by taking them away or making supplies if not impossible to find, scarce and unaffordable.

I would like to thank you for your time and hope that my humble opinions and beliefs will be taken into consideration.


Sincerely yours,

 

[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/keep-life-saving-electronic-cigarettes-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