FDA and e-cigarettes: Your action needed now.

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Vocalek

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In answer to some questions I saw in earlier posts:

Yes, you can leave a comment, even if you are from a foreign country. One of the first comments left was from Dr. Riccardo Polosa, the Italian asthma specialist who conducted a clinical trial of using e-cigarettes for smoking reduction in people who did not want to quit altogether. (Over 20% of them did, to their own surprise.)

Hint: Compose your comment in a document, and then (if it is fewer than 2,000 chars), copy and paste it into the Comments field. The Web app times out while you are writing and it is maddening to lose work it took you an hour to enter. If it is longer than 2,000 chars) type "See attachment" into the comments field, and then upload your saved file.

I did a combination. I posted part of my comment into the Comments field as an "abstract" and uploaded the full file which was over 10,000 chars.

[See attachment]

Abstract:

The FDA should refrain from regulating e-cigarettes as tobacco products. There is no evidence that the products are in need of regulation beyond the safeguards that are already in place. Nobody is developing lung disease, heart attacks, strokes, or cancer from using e-cigarettes. There are fewer cases of nicotine poisoning with e-cigarette liquid (11) than with FDA-approved nicotine patches, gum, and lozenges (1,413.) There is no evidence that e-cigarettes are causing serious harm to either users or the general public.

In fact, smokers who switch to e-cigarettes report improvements in their health. Friends and family members are delighted that the people they worried about are no longer killing themselves with smoking.

If any e-cigarette manufacturer wants to be able to advertise that their products reduce health risks when compared with smoking, they can apply to the FDA’s Center for Drug Evaluation & Research (CDER) for fast-track approval as an innovative product for (1) Total abstinence from tobacco use, (2) reductions in consumption of tobacco, and (3) reductions in the harm associated with continued tobacco use. Given the powerfully positive effects on public health, the products should remain on the market during the approval process.

Telling smokers not to use low-risk alternatives is like telling passengers on the sinking Titanic not to use the lifeboats, because they haven’t been certified 100% safe by the Coast Guard. (“Just keep swimming!”) Regulating low-risk products by taking them off the market, reducing their effectiveness, or obfuscating their relative risks is like punching holes in those lifeboats. People are dying, folks. It’s time to get smart about helping smokers quit.

The full file contained my personal 45-year struggle to quit as well as critiques of the FDA's postings about e-cigarettes and smokeless tobacco.
 

davelog

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Submitted:

I was a 2-pack-a-day smoker for over 30 years, and had given up giving up well over a decade ago. Gum and patches did nothing for me, and attempting to quit cold turkey just alienated my family and friends because I was so irate all the time. I eventually stopped trying to quit just to keep the house harmonious.

In April of 2011, I had occasion to try an eGo electronic cigarette with 24mg e-liquid in it. It took exactly one 'hit' off the eGo to show me that there was actually something out there that could successfully satisfy my need for nicotine besides tobacco. The cigarette I out out to try that eGo was the last one I ever had, and more importantly, was the last one I ever _wanted_. I've been a non-smoker ever since that moment. I've been a _vaper_ ever since that moment.

In the year and a half and change since I made the switch, my lung function has drastically improved and my health is generally better. I have more energy so am now losing weight by exercising more. I don't smell like an ashtray any more, and my clothes no longer collect little burn-holes.

Back when I was a smoker, I couldn't go a half hour awake without a cigarette. As a long-term vaper, I now find I can go days without using my e-cig with no withdrawal effects. I'm still using 24mg nicotine e-juice, but I'm vaping less and less because I don't _need_ it like I needed cigarettes. From this, I personally do not believe that isolated nicotine is anywhere near as bad as it is when surrounded by its tobacco buddies.

To outlaw or regulate this amazing technology away from common use would be a criminal injustice to smokers everywhere. Electronic cigarettes changed my life - for the better, drastically - and I am by no means alone in this experience. PLEASE do the right thing and allow this life-saving technology to continue, flourish, and eventually eradicate the curse of smoking addiction across the world. Thank you.
 

JoAnnW

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This has been a major concern for me as well. Thanks for the reminder notice at the top of the site! I already had my comment saved to my computer so I did successfully submit it today.

I will be four months analog free tomorrow and I won't have anyone or organization try to take this away without a fight!
 

elfstone

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Got mine in too.

I am a 33 year old former smoker with a 20 pack-year history. I stopped smoking on January 4, 2012 after receiving my first electronic cigarette kit. I have been using these devices, or 'vaping' as it is referred to colloquially, ever since.

I have experienced no significant side effects. I have noted important improvements in my health - morning cough disappeared, effort tolerance improved, along with resting heart rate and blood pressure. I had a mild retinopathy attributed to HTN which since resolved.

There is a substantial body of evidence linking tars, CO, and other substances in cigarette smoke, but not nicotine, to health hazards. There is some safety evidence for nicotine use from pharma NRTs. There is evidence from the Swedish cohorts showing smokeless tobacco, even, to be significantly safer than smoking.

E-cigs vaporize a mix of propylene glycol, glycerine and nicotine with optional added food grade flavorings. No other potentially harmful chemicals have been detected at clinically significant level in e-cig liquids.

E-cigs have the potential to offer a harm reduced, attractive alternative to smoking for those smokers who cannot or do not want to cease their nicotine habit. They tackle both the supposed chemical dependence to nicotine and offer a pleasurable experience that pharm NRTs do not.

NRTs have a staggering fallure rate. Non-NRT smoking cessation meds have considerable side effects.

It stands to reason that research into e-cigs should be the main priority of an honest public health organization and large trials should be fast tracked. No one can honestly ignore or try to hinder e-cigs while at the same time considering extending NRT usage approvals.

There is no reason, however, to deem e-cigs as pharm products. They are consumer, non-tobacco, nicotine containing product. That's what they are. Deeming them as anything else is disingenuous.

Please regulate e-cigs on par with alcoholic beverages for safety standards and cleanliness alone.
 

Horseman9

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Just posted mine, wish Elfstone's had been up before I did - nice job there! I basically said the same things, you just did it better, LOL.

I also forgot to mention John Hopkins using nicotine to ease memory issues associated with Alzheimers patients. Maybe someone else can do that before comments are closed?
 
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crxess

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I put in my :2c:. Hopefully with inflation it will be worth more by the time they receive it.

60yrs old, smoked for 47, tried many times to quit with limited(read NO) success.

Aug. 6 2012 8:30 put out my last cigarette, picked up my first e-cig and never looked back.

5 months and many new PV toys later I have -0- desire to even touch a cigarette.

I did discover after all this, I was never addicted to Cigarettes and most probably are not. I was/am addicted to Nicotine. Use of the PV gives me control and allows me to adjust down that need according to my own personal needs. So far down from 24mg to 12mg and sometimes 6mg. ml.

ETA - not what I wrote them. Just what I lived
 
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jshamm

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May 9, 2012
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Your Comment Tracking Number: 1jx-833u-z5zw

I began smoking cigarettes when I was 18 years old. While I wanted to quit many times over the years, I inevitably only increased my addiction until I found myself a 34 year old man with a two pack a day habit. Over the course of those years I tried numerous methods to quit only to fail miserably and defeatedly each time. I had tried cold turkey, nicotine patches, lozenges, Chantix, cold turkey again and each time it became a power of wills I knew I would not win. I had resigned myself to be as smoker not because I wanted to be one but because I knew of no other way to be anymore.
In August 2010 I came across electronic cigarettes. Believing it to be more a lark, I ordered my first kit without any real sense of its usefulness. However, once I used the product I immediately knew I had found a replacement for those disgusting, expensive, and death-driven cigarettes. I haven’t once picked up, or felt the need for, a traditional cigarette since August 2010. While I have not used the electronic cigarette to quit nicotine, I have effectively given up cigarettes and am proud to say I have not looked back since.
My breathing is no longer labored; I can climb steps now without heaving and coughing; I know longer am embarrassed to be in close proximity to others and wonder about the stench of smoke clinging to my clothes; I can save money and provide more for my family. All of this was accomplished simply by switching to electronic cigarettes. I feel I have a chance again.
There are many of us out there who owe our future lives and health to the availability and continued use of electronic cigarettes. To dissuade or hinder our ability to access these products is not only detrimental and irresponsible to our health but also the health of future ex-smokers who could benefit from switching to electronic cigarettes.
I urge the FDA not to implement unnecessary regulations that can only hurt an industry that is attempting to save the lives of so many. There is a lot of misleading information regarding electronic cigarettes that has been proven false. What is known, and widely accepted, is the toxicity and cancer-causing agents found in a traditional cigarette. If banned, how many of us will go back to regular cigarettes? I am certain a large proportion would. If overregulated, how many small businesses who care about the craft and customers will close up shop only to be overtaken by large pharmaceutical companies and Big Tobacco? Again, I am sure a large proportion would.
I use electronic cigarettes as an alternative to smoking. I have no intention of quitting any time soon and to remove this much needed product from my arsenal is akin to tying both hands behind my back in my efforts to stay away from cigarettes.
 

DC2

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And this is just unproductive venting, but I'm so intensely, furiously, numbingly ......
Very well said aubergine, and I am quite sure all of us feel the same way.
I guess this is what is known as righteous indignation.

I hope we are all prepared to let loose a firestorm upon the FDA if they screw us.

We might be the largest, most passionate group they have ever screwed.
And I sincerely hope that they would be in for a lot more than they bargained for.
 
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