Please email the FDA at the following addy
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I will tell you why--IMO--people should send their e-mails and hard copy letters to where it matters--the e-mail this person lists is for the REGISTRATION AND LISTING DEPARTMENT OF THE FDA. What to they have to do with our e-mails--Nothing--
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nations ability to prepare for and respond to public health emergencies.
Note: If you encounter an issue or wish to contact us regarding the Electronic Registration and Listing System (FURLS), please send an email to reglist@cdrh.fda.gov.
So no matter how well intentioned this individual is ---I would use the correct address to the right people:
Janet Woodcock Janet.Woodcock@fda.hhs.gov and/or
Mary Hitch Mary.Hitch@fda.hhs.gov
That is my take on it as you asked --but do as you will---Sun
Below is a response I received from one of Sun's addy's that I sent my letter too. Short & sweet!
see post 20 for letter.
Dear Gail ,
Thank you for your message to the Division of Drug Information at the Center for Drug Evaluation and Research (CDER), one of the five centers within the Food and Drug Administration (FDA).
Thank you very much for your comments. We certainly appreciate your time and effort spent in contacting us.
Best regards, see post 20 for letter.
Dear Gail ,
Thank you for your message to the Division of Drug Information at the Center for Drug Evaluation and Research (CDER), one of the five centers within the Food and Drug Administration (FDA).
Thank you very much for your comments. We certainly appreciate your time and effort spent in contacting us.
Drug Information BLS
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an 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.
Poetic - Just saw your request over at RTV.... so I thought I would give it a bump bump over here as well. THANK YOU for taking the initiative to do this!
This is an easy thing to do so those who haven't please send an email!
For those who have thank you!
I also emailed Janet Woodcock and Mary Hitch at the FDA a few days ago and this is the reply I received:
[/quote]
Thank you very much for writing. Of course FDA is interested in helping smokers stop; I certainly hope you are able to continue on this path. Janet Woodcock
[/unquote] 
Thank you very much for writing. Of course FDA is interested in helping smokers stop; I certainly hope you are able to continue on this path. Janet Woodcock
[/unquote] [/QUOTE]huh. well that is very interesting. The language would lead me to believe that there is some sympathy within her regarding the ecig.
One scenario: all nicotine ends up in the hands of the FDA and they are rational and they do see the ecig as a less harmful product and put it in it's own category. They have done surprising things before, like in the instance of the med for dying patients, I apologize the link is not handy right now... but after taking it away, they gave it back based on an argument that those who needed those meds were in great pain and suffering. They are allowed to way social aspects in their decisions and the ecig is definitely a case where social aspects would be considered.
Good work on sending the email. Per her response, you *know* she is not ignoring you and as we are all human we all know... once we hear from 2-3 people the same thing... we have a tendency to chew on it a bit more.
I have sent a letter to every email addy here and have the same letter saved.
I do think we can all make a difference and if we shout loud enough, maybe someone will hear us!
When the government was trying to pass a helmet law, Motorcyclists spoke out and it stopped the law (at least here in Wisconsin) I only wish people would have stood up for the seat belt law. It baffles my mind that I can't drive my car without a seat belt but people can ride a motorcycle without a helmet???
Oh well ... I am just tired of people trying to save me from myself!
I do think we can all make a difference and if we shout loud enough, maybe someone will hear us!
When the government was trying to pass a helmet law, Motorcyclists spoke out and it stopped the law (at least here in Wisconsin) I only wish people would have stood up for the seat belt law. It baffles my mind that I can't drive my car without a seat belt but people can ride a motorcycle without a helmet???
Oh well ... I am just tired of people trying to save me from myself!
Methinks you're guilty of waaaaay too big a stretch, Lacey. Wish it weren't so, but the FDA made its mind up long ago. It began stopping some shipments. It sent specific emails detailing its position -- these are drug delivery devices for a new drug to treat a medical condition called nicotine addiction. They are not approved. They are not legal to sell or import.
It held off on a press conference because SE sued the agency .. and there was no good reason to spell out the FDA specifics prior to a court ruling. But the press conference will be held, before long we're told by one supplier. And items to be given out at the press conference aren't done in a day. Video, graphics, text that must be passed through attorneys and others, etc. Those takes days or even weeks to get ready. They require a known position. The FDA knows what it will do. It has begun what it will do.
The FDA has banned e-cigs. It has told us so. All that remains is enforcement procedures .. and treating Sen. Lautenberg with due respect.
Janet Woodcock was no doubt referring to the numerous Nicotine Replacement Therapy products the FDA has approved. And the writer no doubt spelled out how the e-cig helps in quitting, along with a personal success story. Thus the response you view too positively.
As you know, because you got a copy, I wrote a long letter to Janet Woodcock. It contained the best arguments I could make to allow continued sales of e-products while studies are made. I got this:
Whee. And I'm sure that was written by a clerk. Sympathy? Don't bet on it. At least we'll all know before long: FDA position spelled out, court case decision, Senate vote.
Written and mailed to every addy I could find. Thanks to all of you for posting these addresses.
I have written a letter I'm intending to email to the FDA. I just thought that it may sound a little harsh in places and would like to know what ya'all think.
Thanks!
I am writing to you today in regard of the electronic cigarette and the possibility of it being removed from the market.
If a tobacco company were to introduce a new, groundbreaking cigarette that contained none of the tar or harmful chemicals in cigarettes, a product that would completely eliminate second-hand smoke and even reduce the danger of fire because it was battery operated, would that not be considered an amazing advance? Yet, it appears that since this product was not developed in more traditional channels, many will suffer, including the children who are the victims of that second-hand smoke, the ones so many tout as their main concern in their rallies against tobacco.
Personally, I have tried to give up the habit and have been unsuccessful despite many attempts. I think we are all well aware of the low success rate in the alternative options available, and I have, unfortunately, been one of the vast majority who have found no help whatsoever from these methods.
This product has the potential to help millions of people, to save millions of lives, yet it remains misunderstood by so many who are simply so blindly anti-tobacco that they fail to see that this is as close to a win-win situation as we may ever see.
There has been some concern that the electronic cigarette might make smoking although it is not truly smoking - more attractive to teenagers, an inadequate reason to withhold it from those who are already addicted to nicotine when sales could easily be monitored precisely as traditional cigarettes, making sales to those under 18 illegal.
I do not ask that the FDA blindly ignore the need for testing and consistency in these products, nor do I ask that they be allowed to be marketed as a smoking cessation device. I simply ask that until we have scientific information that it is, indeed, more dangerous than a product already in place, freely available to those of age, and used by millions on a daily basis, that it be accessible without restriction.
I suspect that those who must make this decision feel a degree personal responsibility involved in prohibiting a substitute that as far as anyone knows is a safer choice.
My plea is that the FDA chooses to exercise its powers wisely.
Respectfully,
Thanks!
I am writing to you today in regard of the electronic cigarette and the possibility of it being removed from the market.
If a tobacco company were to introduce a new, groundbreaking cigarette that contained none of the tar or harmful chemicals in cigarettes, a product that would completely eliminate second-hand smoke and even reduce the danger of fire because it was battery operated, would that not be considered an amazing advance? Yet, it appears that since this product was not developed in more traditional channels, many will suffer, including the children who are the victims of that second-hand smoke, the ones so many tout as their main concern in their rallies against tobacco.
Personally, I have tried to give up the habit and have been unsuccessful despite many attempts. I think we are all well aware of the low success rate in the alternative options available, and I have, unfortunately, been one of the vast majority who have found no help whatsoever from these methods.
This product has the potential to help millions of people, to save millions of lives, yet it remains misunderstood by so many who are simply so blindly anti-tobacco that they fail to see that this is as close to a win-win situation as we may ever see.
There has been some concern that the electronic cigarette might make smoking although it is not truly smoking - more attractive to teenagers, an inadequate reason to withhold it from those who are already addicted to nicotine when sales could easily be monitored precisely as traditional cigarettes, making sales to those under 18 illegal.
I do not ask that the FDA blindly ignore the need for testing and consistency in these products, nor do I ask that they be allowed to be marketed as a smoking cessation device. I simply ask that until we have scientific information that it is, indeed, more dangerous than a product already in place, freely available to those of age, and used by millions on a daily basis, that it be accessible without restriction.
I suspect that those who must make this decision feel a degree personal responsibility involved in prohibiting a substitute that as far as anyone knows is a safer choice.
My plea is that the FDA chooses to exercise its powers wisely.
Respectfully,
Well here's another reply from the FDA that I received. What do you think? currently investigating?
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research. We appreciate that you have taken the time to share your experiences with us.
At this time, there is little information that we can provide because we are currently investigating electronic cigarette products. Until there is evidence that these products are safe and effective, we continue to encourage consumers to consult their health care providers for recommendations for use of approved nicotine replacement therapies.
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.
xxxxx,
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research. We appreciate that you have taken the time to share your experiences with us.
At this time, there is little information that we can provide because we are currently investigating electronic cigarette products. Until there is evidence that these products are safe and effective, we continue to encourage consumers to consult their health care providers for recommendations for use of approved nicotine replacement therapies.
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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I just sent this to the FDA...
"I would like to know how you can possibly rationalize banning electronic cigarettes that contain and vaporize 3 basic ingredients (water, propolyne glycol, and nicotine) while allowing combustionable tobacco products that produce 4000+ chemicals, hundreds of which are proven to be carcinogens, and still claim your goal is to *protect* the American consumer? Do you realize how corrupt and foolish you look? From my perspective, the electronic cigarette is a revolutionary product spawned by innovation and deserving of accolades, not mindless banning!
Please also spare me any *legalise* replies, especially those that say that the electronic cigarette is designed to deliver nicotine to effect body structures as cigarettes and a great many smoking cessation products are designed to do that as well. FYI - Acohol is designed to effect body structures in the form of pleasure derived from being intoxicated and I have several family members that are addicted to this legal product to prove this!
When the day is done, the only real difference I can see between electronic cigarettes and all other forms of nicotine delivery is that the federal government benefits from ever increasing tax dollars extracted from those nicotine delivery products produced by big tobacco and the pharmaceutical industry. I really am looking forward to a straight answer from you in plain English that explains what it is you think you're doing here..."
Robbie
"I would like to know how you can possibly rationalize banning electronic cigarettes that contain and vaporize 3 basic ingredients (water, propolyne glycol, and nicotine) while allowing combustionable tobacco products that produce 4000+ chemicals, hundreds of which are proven to be carcinogens, and still claim your goal is to *protect* the American consumer? Do you realize how corrupt and foolish you look? From my perspective, the electronic cigarette is a revolutionary product spawned by innovation and deserving of accolades, not mindless banning!
Please also spare me any *legalise* replies, especially those that say that the electronic cigarette is designed to deliver nicotine to effect body structures as cigarettes and a great many smoking cessation products are designed to do that as well. FYI - Acohol is designed to effect body structures in the form of pleasure derived from being intoxicated and I have several family members that are addicted to this legal product to prove this!
When the day is done, the only real difference I can see between electronic cigarettes and all other forms of nicotine delivery is that the federal government benefits from ever increasing tax dollars extracted from those nicotine delivery products produced by big tobacco and the pharmaceutical industry. I really am looking forward to a straight answer from you in plain English that explains what it is you think you're doing here..."
Robbie
Sent the following to all 3 addresses.
"The FDA needs to reconsider this position. This product is helping thousands of people lower their consumption of tobacco cigarettes, if not outright quit. I was a 2.5 to 3 pack/day smoker for 37 years. Since I found the electronic cigarette I have totally quit tobacco cigarettes and even quit using nicotine (I make my own refill fluid with vegetable glycerin, distilled water, and food flavoring all of which are "generally recognized as safe". Nicotine itself is sold over the counter and in FLAVORS so this should not be an issue.
Regular tobacco cigarettes have supposedly been extensively tested and deemed HAZARDOUS yet are still sold with a warning lable. I do agree that testing for long term effects and quality control should be done, however, in the interim the ELECTRONIC CIGARETTE should be left on the market with a warning label that "long term effects are unknown" and sold only to ADULTS (as they already are).
If you should succeed in this BAN you will be DIRECTLY responsible for thousands returning to tobacco cigarettes since the current products available do not address the biggest need of the smoker and that is the actual physical act of smoking, i.e. the inhale, exhale, etc.
If the FDA is TRULY concerned with the health and welfare of American citizens they will gladly allow this product to continue to be purchased and used."
"The FDA needs to reconsider this position. This product is helping thousands of people lower their consumption of tobacco cigarettes, if not outright quit. I was a 2.5 to 3 pack/day smoker for 37 years. Since I found the electronic cigarette I have totally quit tobacco cigarettes and even quit using nicotine (I make my own refill fluid with vegetable glycerin, distilled water, and food flavoring all of which are "generally recognized as safe". Nicotine itself is sold over the counter and in FLAVORS so this should not be an issue.
Regular tobacco cigarettes have supposedly been extensively tested and deemed HAZARDOUS yet are still sold with a warning lable. I do agree that testing for long term effects and quality control should be done, however, in the interim the ELECTRONIC CIGARETTE should be left on the market with a warning label that "long term effects are unknown" and sold only to ADULTS (as they already are).
If you should succeed in this BAN you will be DIRECTLY responsible for thousands returning to tobacco cigarettes since the current products available do not address the biggest need of the smoker and that is the actual physical act of smoking, i.e. the inhale, exhale, etc.
If the FDA is TRULY concerned with the health and welfare of American citizens they will gladly allow this product to continue to be purchased and used."
Well, here's my reply from Janet Woodcock:
RE: FDA ban of the Electronic Cigarette
From: <img id="P___333230181" webimdisplaystyle="inline" style="display: none;"> Woodcock, Janet (Janet.Woodcock@fda.hhs.gov) Sent: Wed 5/27/09 1:17 PM To: Diane )
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RE: FDA ban of the Electronic Cigarette
From: <img id="P___333230181" webimdisplaystyle="inline" style="display: none;"> Woodcock, Janet (Janet.Woodcock@fda.hhs.gov) Sent: Wed 5/27/09 1:17 PM To: Diane )
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Thank you for writing. Janet Woodcock
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Thanks for the Update Dijohn and at least she responded without just hitting the "delete"----at least we know they are getting them--Sun
Done. Given it is looking like that there is no doubt this is going to be an FDA decision. Also e-mailed the American Lung Association concerning their outright stance on banning e-cigarettes with no reason given.
I am writing to express my support for the "fair" regulation of electronic cigarettes. My concern is that this product is becoming politically charged by opposing stances; thus, losing sight of the possible benefits of electronic cigarettes without due consideration.
I am a smoker of over 25+ years, I have tried quitting smoking using the patch, gum, lozenges, and Wellbutrin. For me, these aids did not work (e.g. panic attack like symptoms would soon set in and I would revert back to tobacco). I have been using the e-cigarette for the last 2-weeks and I have not felt the need to revert back to tobacco as of yet. Or should I say, when the withdrawal symptoms start to appear, I am able to over-come such symptoms by using the e-cigarette. I believe the key and my issue with other nicotine therapy substitutes (e.g. patch, etc.) is the fact that I am able to control the dose of nicotine and in a manner that satisfies the physiological aspects of smoking. Soon I should be over the initial "hump" and I can begin tapering off my nicotine use by using lower strengths of liquid.
I truly hope that any decisions being made by the FDA concerning these devices are for the right reasons. And, I really believe you should promote the testing of these devices as an alternative to other nicotine therapies. I do not believe an outright ban is appropriate at this time. I believe that this this addiction has a psychological side which is not being addressed by the traditional therapies.
I am writing to express my support for the "fair" regulation of electronic cigarettes. My concern is that this product is becoming politically charged by opposing stances; thus, losing sight of the possible benefits of electronic cigarettes without due consideration.
I am a smoker of over 25+ years, I have tried quitting smoking using the patch, gum, lozenges, and Wellbutrin. For me, these aids did not work (e.g. panic attack like symptoms would soon set in and I would revert back to tobacco). I have been using the e-cigarette for the last 2-weeks and I have not felt the need to revert back to tobacco as of yet. Or should I say, when the withdrawal symptoms start to appear, I am able to over-come such symptoms by using the e-cigarette. I believe the key and my issue with other nicotine therapy substitutes (e.g. patch, etc.) is the fact that I am able to control the dose of nicotine and in a manner that satisfies the physiological aspects of smoking. Soon I should be over the initial "hump" and I can begin tapering off my nicotine use by using lower strengths of liquid.
I truly hope that any decisions being made by the FDA concerning these devices are for the right reasons. And, I really believe you should promote the testing of these devices as an alternative to other nicotine therapies. I do not believe an outright ban is appropriate at this time. I believe that this this addiction has a psychological side which is not being addressed by the traditional therapies.
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