FDA and e-cigarettes: Your action needed now.

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Agorizer

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This CASAA blog post should help explain why e-cigarette users should be concerned about this: CASAA: CASAA testifies at FDA hearing

It's important to remember that while e-cigarettes that do not make smoking cessation claims will not be regulated as NRT, per the FSPTCA the FDA now has the power to regulate tobacco products. The category of "tobacco products" includes any product made of or derived from tobacco leaves and that is not approved by the FDA as a smoking cessation product. (This would probably not include non-nicotine solutions that make no treatment claims nor nicotine that is not derived from tobacco. However, most e-cigarette users today use e-cigarettes that contain nicotine from tobacco. The FDA would most likely require e-cigarette companies that claim an exemption as a non-tobacco nicotine product to prove that they are 100% tobacco nicotine-free. But this is just speculation.) The FDA is also tasked by Congress via FSPTCA to start looking into approving "modified risk" products.

So, the FDA has the power to proclaim whatever kind of regulations it sees fit upon e-cigarettes. However, at this time the FDA is considering allowing NRT to be used longer than the current 12-week recommended time. Big Pharma is lobbying for this, as well, which is why they have been working so hard behind the scenes to get e-cigarettes banned. E-cigarettes would be far more appealing as a long-term modified risk product than gums and patches and they know it. Unfortunately, the FDA is still intending to impose an end date (quit date) on NRT use, though longer than the current 12 weeks. We are arguing that there should be no end date - smokers should be encouraged to use smoke-free products as long as THEY deem necessary to remain smoke-free (as opposed to an arbitrary timeframe.) This would mean smokers would be using NRT essentially the same way most vapers use e-cigarettes - as an alternative to smoking rather than just as a way to nicotine abstinence. If the FDA approved NRT for such use, it's in our favor to argue that e-cigarettes should be regulated in the same way - as a modified risk product, rather than an NRT or a high-risk tobacco product - when they issue their deeming regulations on e-cigarettes. To put it very simply, as former smokers who quit by using a nicotine product long-term, we support long-term use of NRT because that would make it harder to argue against e-cigarettes also being used for the same intent. It basically opens the door for validation of e-cigarettes as a modified risk product.

Hope that helps.

Kristin, Thanks for the enlightenment on all of this. I *think* I understand most of the twists in their :evil: evil little minds finally. But, as far as I know, currant OTR NRTs aren't restricted or administered by a doctor. Who is minding/enforcing the "end date"? I can walk into (any of three that I can see from my car at any one moment) WalGreens and purchase as much Nic containing gum or patches as I please; for as long as I'm willing to pay the price--withOUT any "sin tax" applied. Who is going to enforce the end date, the pimple faced checkout kid? Unless I'm mistaken, if they called our juice NRT and just made the playing field level, we'd be golden.
Regarding "tobacco sourced" nic; could not smart guys in lab coats just synthesize it? Calls for "positivity" aside, I'm sure that they (those who just won't leave us alone) are gonna do whatever their monied masters tell them regardless of how many vapers they piss off/people they kill. Still, I commented thusly on the 15th:


What is done, or NOT done at this juncture regarding smokeless tobacco and "electronic cigarette" technology could not be more important. I beg you not to kill this infant in it's crib; and not to sentence perhaps millions of smokers to an early death by either denying them these less deadly means (and for many, much more successful means) of satisfying their habit, or, thru excessive taxation, remove one impetus for them to switch from what we ALL know is killing them! As a smoker for 30+ years, I know that the "e-cigarette" has likely prolonged my life, and certainly improved my health and stamina. No patch, gum, or other therapy ever came close to breaking my smoking habit. You have a chance to SAVE LIVES.....IF you ignore the monied interest of Big Pharma and the tendency of government to (attempt to) legislate private morality.
Please do the right thing. At best, you should exempt personal vaporizer (e-cig) technology from any "smoking" regulation---because it is not smoking! At most, you should treat it like any other NRT--allowing OTC sales to anyone old enough to buy a cigarette. In other words, keep the playing field level. Save lives. Do the right thing. Don't condemn nicotine users to a choice of bad, worse, and ineffective. Only educated users know how much (within recognized limits accepted by the industry) nicotine will keep them from going back to smoking. Don't apply arbitrary limits. Do the right thing. Save Lives. Please. Save MY life. Don't tax me back into the clutches of Big Tobacco. Do the right thing SAVE LIVES. This is your chance to make a lasting difference in millions of lives, or to dictate morality and enrich big business.
I started out a 1 1/2 year ago "vaping" 24mg/ml nicotine. I am now down to 14mg/ml. I hope to go lower. Perhaps even more importantly, I have got my father-a smoker of nearly 60 years- off of the cigarettes!! Without the currently available technology (including flavor choices), I couldn't have done it!
tracking # 1jx-8345-n6mg
 

godzilla93

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Comment submitted - at the last minute of course!

In case it could be of interest to anyone, here it is:

I started smoking at age 14. Born in 1975, I am now 37, and smoked an average of a pack of cigarettes a day for about twenty-two years, until I was finally able to quit tobacco completely when I switched to electronic cigarettes, in August 2012.
This was not my first attempt to quit: I made several attempts using nicotine patch—three serious attempts in the last decade. While the patch did help alleviate the immediate withdrawing symptoms (irritability, anxiety), it proved unsuccessful on the long run. Each time, I did relapse shortly after completing the prescribed process of gradual nicotine reduction—a process that I always followed to the letter.

I believe the problem was that the patch—as well as other similar forms of nicotine-reduction treatment (e.g., nicotine gums)—ignores, besides nicotine addiction, many important factors in the smoking compulsion: physical aspects of the smoking process—holding, sucking, inhaling/exhaling (which involves a certain degree of “throat hit,” heat, and taste); social aspects—smoking break, and other socialization opportunities; and finally, combining the two above, the pleasurable/recreational aspect of smoking.

In contrast, electronic cigarettes, in addition of supplying nicotine, also provide an effective, less harmful substitute in all these areas. Returning to my own experience, electronic cigarettes completely suppressed my craving for tobacco—I actually now find myself being quite repelled by the smell of cigarette smoke. Shortly after (and since) switching to electronic cigarettes, I have experienced noticeable improvements to my health: recovered sense of smell and taste, improved endurance (I now jog every morning for an hour, without shortness of breath, something I could not have achieved while smoking tobacco cigarettes), and drastic reduction of respiratory ailments (coughing, snoring, etc.).

My daily usage is now stabilized at an average of 3ml of nicotine liquid, at a concentration of 12mg/ml. I use a variety of delivery devices, and a variety of liquid flavors—including non-tobacco flavors. As of now, I am not considering reducing this usage: I made the informed—and, I believe, legitimate—decision to enjoy “vaping” as a legitimate recreational activity. In addition, I find that nicotine, as a mild stimulant—very much like caffeine in this regard—provides me with a sharpened focus for my creative, intellectual work. Yet I also feel that the ability to progressively reduce the nicotine dosage of the liquid used in electronic cigarettes could provide an effective way to stop using this substance if I decided to do so.

This is why, based on my first hand experience as well as my interactions with the vibrant community of electronic cigarette users, I believe any sensible regulation of electronic cigarettes should: 1) preserve the availability of a wide variety of flavorings (including “non-tobacco” flavors), as this variety is an essential part of the what make electronic cigarettes enjoyable, and thus effective, on the long run. 2) Similarly, preserve the availability of a wide variety of devices, as each smoker is different, and finding the right type of device(s) is an important part of a successful switch to electronic cigarettes (and off tobacco products). 3) Preserve the availability of a wide range of nicotine dosages—up to at least 18mg/ml: this will ensure that people starting with a high nicotine dependence would not be required to engaged in unsafe practice, such as, for example, the use of a patch or gums in addition to electronic cigarettes.

Finally, I strongly believe that any regulation of electronic cigarettes (as well as other tobacco-cessation products) should authorize the long-term use of nicotine. Indeed, there is, to the best of my knowledge, absolutely no proven ill-effect to the long-term use of nicotine (barring some very specific pre-existing conditions), and thus no rationale for barring someone an informed adult who would need (or choose) to do so. Furthermore, depriving the public of effective, safer alternative to tobacco on the basis of an unfounded (and vaguely moralizing) aversion for nicotine usage in itself (i.e., the “quit or die” approach, which by all accounts has proven highly ineffective) would be, from the standpoint of public health, dramatically counter-productive, and would effectively constitute a negation of the purpose of regulation agencies such as the FDA, which, I believe, is to promote and protect public health.

Thank you for your attention on this matter, which is of crucial importance to me, to the vibrant and expanding community of current electronic cigarette users, and, potentially, to the millions of smokers whose life expectancy could be dramatically increased by a switch to electronic cigarettes, should they remain available to the public.

Sincerely,
 

Gr8Scott

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Got mine in....all 2000 characters



I am a 45 year old male whom, until four months, ago smoked approximately 2 packs of cigarettes daily.

I watched my father die of lung cancer12 years ago due to the SMOKING of cigarettes.

My mother is now on oxygen 24/7 as a result of SMOKING cigarettes.

My myriad of attempts to quit smoking via transdermal, pharmaceutical, and all other means were transient and ultimately unsuccesful.

When I started electronic cigarettes, I truly was NOT looking to quit smoking. Despite the hazards, I considered myself a "confirmed" cigarette smoker who thoroughly enjoyed smoking. This is an important factor, considering how many people actually want to quit.

The electronic cigarette has TOTALLY replaced my desire to ever smoke again.I believe its presence and availability will save MANY lives, as its ability to emulate a tobacco cigarette is unparalleled anywhere today.

I can breathe easier. I am able to smell and taste again.When I encounter cigarette smoke publicly, it does not create an urgent desire to smoke a cigarette as it did at other times when I tried to quit.

A recent doctor's checkup and lab analysis revealed a dramatic improvement in my health. My blood pressure is perfect and the possibility of living without blood pressure control medications is now possible.

Draconian regulations, however well-meaning, that would inhibit the availability of electronic cigarettes would be the same as the FDA pronouncing a death sentence on millions of citizens of this country.

There should not be any time limit on using NRTs.

Innovative products such as e-cigarettes should not be made less effective by setting nicotine doses too low.

I emphatically urge the FDA to not propose the "deeming" regulation.

This would ban e-cigarettes, and would sharply increase the price and reduce accessibility of the products even if FDA exempted e-cigarettes from the most onerous provisions in Chapter IX.

Lastly,the FDA website should edit false info re: E-cigarettes and carcinogenesis.
 

TxTunesLady

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TrickyRicky71

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I love this forum! thanks for the heads up by email as i was able to get my comments in today 1-16-13 at 4:53 EST sorry for the long post but i though i would share with the forum.

First i would like to say i thought we were a free society based on capitalism and maybe the market place should let the e-cig industry grow or die, and maybe the Tobacco companies should be more innovative and maybe offer a zero nicotine cigarette which is available now in the e-liquid form. I smoked for over 20 yrs and successfully quit in 11/09 and to this day i hate the smell of cigarettes and the overall habit itself, until recently when i was researching the e-cig and its pros and cons as an alternative and even part of a smoking cessation program for my family members that smoke now. After days of researching on websites like http://www.e-cigarette-forum.com and reading various health reports i decided maybe i would try it out first. i bought a starter kit and the liquid with zero nicotine and it blew my mind away! I actually felt like i was smoking a cigarette as i enjoyed my favorite cup of coffee. i have now have 3 family members currently using an e-cig and have almost completely quit themselves. The liquid itself seems to made with the most natural ingredients of any tobacco related product i've seen and the fact that it is offered in many different strengths is fantastic and gives the consumer, again ,many more options than the traditional tobacco companies. Lets not forget the many different flavors of liquid available, from your normal tobacco and menthol blends to desert and nutty flavors its almost as much fun as wine tasting, again many more options to us consumers than any traditional tobacco company has to offer. Im also very interested on how the treatment of the zero nicotine liquid is gonna be treated as that shouldn't be included in any tobacco debates. Im very happy with all the members of http://www.e-cigarette-forum.com and all the stories i've read and how many analogs (cigarettes) have been avoided and it would be a crying shame if this industry is destroyed.
 

jazon1

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i think the only thing they can "regulate" could be the nic in out juices everything else could still be sold for other uses or no nic vaping which they can say nothing about. i thin everything on the market now would still be available just maybe not the juice with nic might just have to buy that over seas now or make your own should they ban it. personally i stocked up on a few letters of unflavored juice in dark airtight glass bottles and will store them in my freezer to make them last as long as possible to ride out anything that may happen.
 

mainevaper

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I got mine in. But... I dont see why everyone is so concerned. They state their objective right on the 1st page.



fda said:
a report to Congress examining how best to
regulate, promote, and encourage the development of ``innovative
products and treatments (including nicotine-based and non-nicotine-
based products and treatments)'' to better achieve the following three
goals: (1) Total abstinence from tobacco use, (2) reductions in
consumption of tobacco, and (3) reductions in the harm associated with
continued tobacco use.

It may be a good thing for the e-cig world.......

I'll be stocking up on bulk e liquid in the next couple weeks tho! ;)
Its not the devices that will get banned, or regulated, its the liquid, and most likely will need to be regulated to some degree. I for one would have no problem paying a few bucks more for a bottle of juice, to know it has been tested, and the label accurately describes whats in it. Jeez.. to quit smoking... I woulda paid thousands if I knew it was gonna work... I left that part out of my comment tho ;-)
 
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