Please email the FDA at the following addy

[Momof3]

Sent to all addys. Response finally came from DRUGINFO@fda.hhs.gov

Ms. XXX XXXXX:

Thank you for making your opinions 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 generally recognized among scientific
experts as safe and effective. Based upon our investigation 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 the amounts
of nicotine or the kinds and amounts of other chemicals that the various
brands of these products deliver to the user. 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,

Division of Drug Information 7
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 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.


Not safe. Should use "safe" approved methods. Think of the children!

Probably a form letter because my email said I wasn't interested in quitting, just smelling better and not burning my house down. To date this is the only response I've gotten and it's been over 6wks. How much $$$ are scientific experts going for these days?

 

[Scaralouche]

Sent. hopefully, not too late.

 

[lvlninety9]

Ok not to sound to much like a pessimist, but what good is writing to the FDA going to do? They already have sent out form letters stating their position on the matter and no amount of mass letter writing done by us is going to change their minds. Plain and simple the FDA does NOT CARE what we the people think. They only care about the one thing the majority of our government cares about and that's the "where's my cut" mentality. You want to swing the FDA you better be some kind of billionaire because unless someone is throwing out mass amounts of money to swing them our way they are just going to crap on every single letter that we send them. You want your voice to be heard then do it where it counts. Not at the FDA offices but with our senators and representatives. The FDA doesn't care what you think. They care about what they think. And from reading some of the response letters that were sent out from the FDA no one here is going to change their minds. We could even fill their offices to the brim with letters and all they will do is get out the shovels and pile them in the garbage.

 

[Mr Sinister]

That is true. The FDA does not care about you. The same FDA that okayed Flouride in drinking water because its good for you teeth. (there's a reason why your dentist tells you not to swallow it) Aspertame, that is pretty much a poison and now used as the main artificial sweetener in everything. And there is many more. So I am not convinced that the FDA does anything for the right reasons. I am also pretty sure the Big Tobacco companies are lobbying for their side because this product will take quite a few customers away. I do hope that this will go our way and I did send my e-mail, just know that our voices and even the reps voices fall on deaf ears when it comes the the FDA. Just my 2 cents.

 

[wegster]

Hi all, my partner has spoken with Jan Cummings of the FDA. Ms. Cummings has become very sympathetic to our cause. Even though she will not be involved in the decision making she requested that emails be sent to the following email address and she will then forward them to the FDA dicision makers. She would like for the subject line to say "Electronic Cigarette" then a well thought out email stating our side of why e-cigs should not be banned. She needs as many of these emails as soon as possible. Thank you for taking the time to consider sending the email, Kat
Please send emails to reglist@cdrh.fda.gov and remember the subject line needs to say only "electronic cigarettes"

Sent. I also sent mail to:
editors@sciam.com - Scientific AMerican, regarding their drivel article..
ashwebmaster@ash.org - ASH. Total joke, search their site, it's truly pathetic the guy claiming he's both a lawyer and professor :-/
engadget - web form :-/
jon.cooper@co.suffolk.ny.us - random LI politician

And a few TV stations...more to come, this is pissing me off.

 

[aditas]

I just emailed. However, judging from the reply just above it appears that they have made up their minds already. They claim that they expose youngsters to nicotine and they are not effective as smoking cessation devices. Both points easily refutable, but no amount of logic or argument will make them change their position.

We need different tactics.

 

[mintee]

Ugh, done and done, sorry I was so late to the party.

 

[kardjunkie]

I just emailed. However, judging from the reply just above it appears that they have made up their minds already. They claim that they expose youngsters to nicotine and they are not effective as smoking cessation devices. Both points easily refutable, but no amount of logic or argument will make them change their position.

We need different tactics.

Email in not effective tool. Snail mail, hand written to state senators and representatives is the way to go. Just my opinion talking to several green organizations who say this.

 

[duke118]

I sent my email for what good it will do. I should have asked the FDA when the reduced risk cigarette is coming out.You know since they have control over what ingredients go into cigarettes. I just want to know how these .......s sleep at night when they condemn millions to a horrible and slow death?Just my opinion.

 

[Webby]

Ok not to sound to much like a pessimist, but what good is writing to the FDA going to do? They already have sent out form letters stating their position on the matter and no amount of mass letter writing done by us is going to change their minds.

I'm afraid I have to agree. the time for letter writing was months ago and it should have been directed at the manufacturers, pushing them to give full disclosure to the FDA.

An optimist sees the cup half full, a pessimist sees it half empty.

I'm a realist.

I wanna know what's in the damn cup.

 

[ProtoType]

I'm afraid I have to agree. the time for letter writing was months ago and it should have been directed at the manufacturers, pushing them to give full disclosure to the FDA.

An optimist sees the cup half full, a pessimist sees it half empty.

I'm a realist.

I wanna know what's in the damn cup.

Haha funny quote. Nice.

 

[christihein]

FDA Report Supports Electronic Cigarette Claims​

Great News For inLife Independent Distributors

​

To Our Valued To: All Valued Independent Distributors:​

FOR IMMEDIATE RELEASE ​

​

FDA Report Validates Previous Scientific Data. Findings Verify Claims By Manufacturers That Electronic Cigarettes Are Safer Than the Leading Tobacco Brand Cigarette. ​

​

On July 22, 2009 the FDA released the results of its own independent study of the electronic cigarette. The findings verify previous test results (1) which validate the electronic cigarette is up to 1,400 times safer than the leading brand of cigarettes. This is GREAT news for Electronic Cigarette users. ​

Previous studies on the e-cig (verified by the FDA Report) only show that electronic cigarettes contain very low levels (8.2 ng/g) of Tobacco-Specific Nitrosamines versus 11,190 ng/g for the leading tobacco cigarette.​

Product

NNN

NNK

NAT

NAB

Total

Electronic cigarettes (2)

3.87

1.46

2.16

0.693

8.2

Camel (1)

3100

1400

2800

150

7450

Skoal (1)

4500

470

4100

220

9290

Marlboro (1)

4300

1800

4900

190

11,190

​

(1)Laugesen M. Safety Report on the Ruyan e-cigarette Cartridge and Inhaled Aerosol. Christchurch, New Zealand: Health New Zealand Ltd, 2008. ​

Perhaps even more important than the findings of the FDA is what the FDA did NOT find.

The test did not reveal any of the 60 other known carcinogens (shown below)2 that are found in traditional tobacco products nor stated any other new dangers or findings that could conclude that the electronic cigarette is dangerous.​

2 Known carcinogens found in tobacco cigarettes. (NOT found in Electronic Cigarettes) ​

​

Acetaldehyde Acetamide Acrylamide Acrylonitrile 2-Amino-3,4-dimethyl-3H-imidazo[4,5-f]quinoline (MeIQ) 3-Amino-1,4-dimethyl-5H-pyrido [4,3-b]indole (Trp-P-1) 2-Amino-l-methyl-6-phenyl-1H-imidazo [4,5-b]pyridine (PhlP) 2-Amino-6-methyldipyrido[1,2-a:3',2'-d]imidazole (Glu-P-1) 3-Amino-l-methyl-5H-pyrido {4,3-b]indole (Trp-P-2 2-Amino-3-methyl-9H-pyrido[2,3-b]indole (MeAaC) 2-Amino-9H-pyrido[2,3-b]indole (AaC) 4-Aminobiphenyl 2-Aminodipyrido[1,2-a:3',2'-d]imidazole (Glu-P-2) 0-Anisidine Arsenic Benz[a]anthracene Benzene Benzo[a]pyrene Benzofluoranthene Benzo[j]fluoranthene Benzo[k]fluoranthene Benzofuran Beryllium 1,3-Butadiene Cadmium Catechol (1,2-benzenediol) p-Chloroaniline Chloroform Cobalt p,p'-DDT Dibenz[a,h]acridine Dibenz[a,j]acridine Dibenz(a,h)anthracene 7H-Dibenzo[c,g]carbazole Dibenzo(a,e)pyrene Dibenzo(a,i)pyrene Dibenzo(a,h)pyrene Dibenzo(a,i)pyrene Dibenzo(a,l)pyrene 3,4-Dihydroxycinnam ic acid (caffeic acid) Ethylbenzene Ethylene oxide Formaldehyde Furan Glycidol Heptachlor Hydrazine Indeno[1,2,3-cd]pyrene IQ 92-Amino-3-methyl-3H-imidazo[4,5-f]quinoline) Isoprene Lead 5-Methyl-chrysene 2-Naphthylamine Nitrobenzene Nitrogen mustard Nitromethane 2-Nitropropane N-Nitrosodi-n-butylamine (NDBA) N-Nitrosodi-n-propylamine (NDPA) N-Nitrosodiethanolamine (NDELA) N-Nitrosodiethylamine (DEN) N-Nitrosodimethylamine (DMN) N-Nitrosoethylmethylamine (NEMA, MEN) 4-(N-Nitrosomethylamino)-1-(3-pyridinyl)-1-butanone (NNK) N'-Nitrosonornicotine (NNN) N-Nitrosopiperidine (NPIP, NPP) N-Nitrosopyrrolidine (NPYR, NPY) Polonium-210 (Radon 222) Propylene oxide Safrole Styrene Tetrachloroethylene o-Toluidine (2-methylaniline) Trichloroethylene Urethane (carbamic acid, ethyl ester) Vinyl acetate Vinyl chloride 4-Vinylcyclohexene 2,6-Xylidine (2,6-dimethylaniline) ​

Dr. Michael Siegel MD, Boston University states “The FDA and anti-smoking groups are comparing electronic cigarettes to a solution of spring-fresh Maine mountain stream water. What they need to compare electronic cigarettes to is something known as a Marlboro cigarette.”​

Dr. Siegel continues, “In addition, recent research conducted by Dr. Murray Laugesen and Health New Zealand, LTD. reveals that the toxic emissions score for electronic cigarettes is much lower than that of conventional cigarettes. In fact, the toxic emissions score - which is a score based on the levels of 59 priority toxicants was zero for electronic cigarettes. In contrast, it was 126 for Marlboro and it was no lower than 100 for any brand of conventional cigarette tested.”​

We are on the verge of a major paradigm shift in the Tobacco Industry. Be ready. When the TRUTH about the health advantages of electronic cigarettes versus their traditional counterparts is finally embraced by health officials and the media, a major shift to this amazing technology will create an amazing opportunity for the inLife Independent Distributor. Work with your downlines today to prepare for the potential growth that we believe is coming. ​

 

[TheLizinator]

I sent the following:

I would like to contribute my say in this debate regarding the electronic cigarette. I have been an avid smoker most of my life. I purchased an e-cigarette several months ago and cannot say enough about the blessing this device has been to my life.

I no longer find myself winded with physical exertion; I had found it difficult to take out the trash if you can believe this. I can run up a flight of stairs. I can taste, smell and feel sensations that had been deadened by constant smoking of cigarettes. The air in my home is clean--no more acrid smell of smoke, no build-up of tar on my walls or anything else in my home. My car is clean and smells fresh now. I no longer crave cigarettes and do not have to budget $7.25 a day for smoking. I feel liberated from a deplorable habit that affected not only me, but all those around me.

Please think about these things without preconceived notions about smoking. The electronic cigarette allows me to give up cigarettes without regret. This has been the first acceptable substitute for an addiction that diminished the quality of my life and took its toll on my health. This has been the first time I've felt the energy and vitality that smoking addiction had robbed from me and I do not intend to give it up without a fight. Anti-smoking advocates fail to understand the gravity of their proposal to ban this device. When it also frees former smokers from polluting their environment, why on earth they would oppose it I will never know.

Please forward this information to anyone who might be in a position to evaluate these devices and persuade them to understand the incredible opportunity they offer smokers to be free from an oppressive addiction.

Respectfully,

 

[blowinvapor]

I just want to say i enjoy my E-cigarette very much. I was a 20 year smoker,1 pack a day. I just want to say that it seems like a lot of people are using this device to actually quit smoking anything. However, I am one of those that does not want to quit smoking. I love the art of smoking, what can I say, blame it on Die Hard. I just enjoy doing it, its hard for me to just sit there with my hands folded on my lap or something. And the art of smoking just makes the stress go away and makes things all better.

I am just saying that i hope the government does not look at all the, ' how the E-Cigarette helped me quit smoking anything.... period ', posts and petitions and say "see almost everyone is using this as a stop smoking aid." Which is untrue in my case. I will use it forever, because i have no intentions of quitting. Those that do kick the habit of Nicotine, more power to you and congrats.. but i am not one of them and never will be. So its either vapor or smoke. I just pray i can use vapor forever.
Don't take me too seriously, i am just a scared e-smoker, wondering what the so called government 'of the people' is going to do.

 

[Debbie Lee]

Dear Debbie,



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.


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.


- -----------------------------------------------------------------------------------------------------------------------------------

From: Debbie [mailto:
Sent: Sunday, August 16, 2009 11:54 PM
To: CDRH Registration and Listing
Subject: ecig


I have smoked cigs for over 37 year's. I have been a user of the ecig now since May 1st of this year. I want to tell you how much better I feel. I started the ecig to see if i could stop smoking and also due to the claim's it was a safer way to quit. I tried the patch broke out and got a circle from it that bled. I tried the gum and only use them still when I cut down on the ecig although I get hiccup's from the gum. My caugh has gone completely away I can now sing again which has been one of my first love's and I have an incredible anount of energy.

One day I decided to smoke a marlboro ultra light cig. It was the 13th of May. Big mistake I got nauseated right away dizzy and cold sweat's then I threw up. That lasted for about 15 minute's. Once I felt better I went straght back to my high dose nicotine 24 mg ecig and was fine, and have never been dizzy nauseated or got the cold sweat's from my ecig.

While I was still smoking cigs they were natural American Cigs. Yeah right boy BIG TABACCO had me fooled because after sleeping all night then waking up getting ready for work then once I got in my car to drive to work is when I would light up. I would always get dizzy and nauseated and these were the light brand. I dragged on the ecig after waking up the first morning ha no dizziness no nausea YAY.

So there you have my testamony. Much safer for the enviroment and no second hand vape and please tell me you will stop the spin about the youth of our nation. It is so much easier for them to get yucky stinking cancer causing 4000 chemicals a cig .

You have to know that since you approved aspertame sweetner's and such other cancer causing chemical's that you all look evil and like you don't care about us you really want us to smoke cancer causing cigs ?. You really want us to use chantix to quit smoking? . Give me a break. This is all because you don't care for us cuz where is your profit from the ecig. You get profit from Phillip Morris, Big Pharm, and lets see American Lung association, um cancer association. Isn't it really all about the money.


You must think were all so naive to you. Look what you approved in bacon cosemetic's etc... ad infinitum.


So please reconsider the ban. We will take care of our kid's before you will TRUST ME ON THAT ONE !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!



I would never leave them alone with you guys or ASH!!!!!!!!!!!!!!

 

[Mikko]

Hi !
I'm a new member and can not make new thread, so i put this here:

Campaigning idea:
"I will not waste time with those who have made the calculation that it's better politics to kill this plan than improve it" , says Obama.

The Plan is to save 4 million people per year worldwide by changing
killing cigarettes to e cigarettes.

Mikko

 

[Krel]

Done and Double done from others I know

 

[JebGipson]

Just sent the e-mail here it is (except for my home adress at the end for any non e-mail correspondence and verification of citizenship if need be.)

To whom it may concern,
My name is Jeb S. Gipson a long time cigarette smoker, whom due to health issues attempted to quit several times to no avail. A few months ago I discovered a product known as the "electronic cigarette" which is essentially a nicotine vaporizer. My first thought was "what will they market next?", and I was not entirely pleased with the initial price of the product. But I decided to look up some product reviews to see if it was a viable alternative to smoking. After some research I found thousands of people had totally converted to this "electronic cigarette" that were chronic cigarette smokers (several pack's per day) and were happy and feeling healthier within a few weeks of the conversion! I then decided to lay out the funds for the "starter kit" and see if it satisfied me. After my purchase I was in fact ecstatic as I found a way to enjoy what felt and looked like a cigarette without actually "smoking". Within a week my doctor reported that my blood pressure is doing much better, my capacity has increased, and on top of it all my budget only took a hit from the initial spending for the kit. In comparison to what I was spending each month on cigarettes I am spending barely anything.

I can understand why the regulation of this product has been turned over to the FDA. And I must say I feel it is because nobody else wanted to get their hands dirty either way. Ban the product and hundreds of thousands of Americans will die each day from first and secondhand smoke. Don't ban the product and billions of dollars will be lost in tax revenue, employment and money spent on smoking cessation devices such as the patch and gum. And perhaps due to shady marketing techniques some will even consider this option to be in fact "good for you" in comparison to "not AS bad".

Cigarettes are a serious health issue, and yet they are legal, taxed and regulated. Alcohol causes serious health issues, and yet it is legal, taxed and strictly regulated. The electronic cigarette so far has been shown to not necessarily be "safe" but to be a healthier option than smoking. And yet there is a movement to ban the product before even any unbiased tests are done? All the testing I have seen done were funded by anti-smoking organizations, using shoddy techniques, quick answers and questionable resources.

Many of my fellow vaporizer fanatics do not feel that the product should be taxed, and I disagree the product should be taxed, perhaps not at the same level as cigarettes but as a luxury a certain tax should be lobbied. If this product was taxed and regulated then perhaps the question of negative financial effects would be eliminated.

Electronic cigarettes MAY have saved my life, I cannot look into the future but I do know I would have continued to smoke until the day I died if I had not discovered this miraculous little device. If the product is banned, then I feel it will condemn a countless number whom began smoking at a young age (such as myself) and tried to quit but found it nearly impossible TO DEATH. If the ban is signed, please think of the lives that will die along with this new product's industry, and the rights that we as Americans appreciate so very much that will be lost.

Sincerely,
Jeb S. Gipson
Born June 16th 1986 Legal Former Tobacco Consumer

 

[warbdan]

Here is what I sent to the FDA.
To Whom It May Concern:
I am writing in regards to the recent ban on the sale of electronic cigarettes in Oregon and talks of a ban on sales of these devices nationwide. I don't think this is a reasonable action for the FDA to be taking because as 15 year cigarette smoker and recent electronic cigarette user I can say the electronic cigarette is a life saver. In the past year I have been developing sleep apnea, sometimes I would wake up as many as 10-15 times per night gasping for my breath. I tried nicorette gum, nicotine patches, and quitting cold turkey to stop my cigarette smoking, to no avail. Then one day at work I heard someone mention electronic cigarettes. I laughed at first, but I decided when I got home I would look into them. Ordering one was the best decision I could have made. Since purchasing my electronic cigarette last month, I've only lost my breath ONCE. I can breathe better in general, I have more energy, I'm optimistic, and I just feel better overall! Taking these devices off the market would devastate my progress and the progress I'm sure has been made by countless others.

We may still be using nicotine, but at least we aren't huffing arsenic, cyanide, and God knows what else is in cigarette smoke. Please, do us justice. Regulate electronic cigarettes, but do NOT ban them. It's not fair or responsible to disrupt a whole market because of one incident(the testing of 18 cartridges and problems found in 1). If you found bacteria in one McDonald's hamburger, would you ban fast food?

Please, we beseech you to do the fair and responsible thing. Keep electronic cigarettes available to the American public. Regulate them as needed, test them when necessary, and let us use the product we have grown to love.
Sincerely,
Warren Bottoms

 

[LaceyUnderall]

warbdan -

You have probably heard that a particular anti-smoking advocate is calling for a ban of PV's in Kentucky?

There are a few threads you should look at if you are interested in getting together with other Kentuckians to make your voice heard....

http://www.e-cigarette-forum.com/forum/organizations-ability-listen/36767-kentucky.html

http://www.e-cigarette-forum.com/fo...alth-official-issues-e-cigarette-warning.html

http://www.e-cigarette-forum.com/fo...36323-potential-kentucky-ban-help-e-mail.html