The final countdown to August 8th - your FDA comments NEEDED

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bigdancehawk

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In case you are curious...


CASAA last night submitted a 53-page comment to the FDA on behalf of consumers regarding the Deeming Regulations.

Here's a link to their blog about it, which includes highlights, as well as a link to the PDF of the full 53-page comment:
CASAA: CASAA Submits Comment to FDA on Behalf of Consumers Regarding FDA Proposed Deeming Regulation

I'm on about page 30. It's powerful, persuasive and no punches are pulled, but.... It says the FDA was fundamentally wrong to deem e-cigarettes tobacco products under the current enabling statute, should give up the whole idea of "deeming" and go back to square one--tell Congress to pass new enabling legislation specific to e-cigarettes. I've been saying that too, but it surprised me to learn that's now CASAA's official position.
 

CabinetGuyScott

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for what it's worth.....


Comment:
i smoked for 40 years. i finally put them down successfully by switching to an e-cig. i may not ever be able to put that down even after weaning myself down to 0 nicotine content. the hand to mouth habit may be the hardest to break. i feel i would be dead now if it weren't for e-cigs. i used to try to go to sleep praying i didn't wake up anymore to the lung pain, light headedness and horrible health that i endured due to my inability to quit cigs. fast forward to now.

august 17th will be my 1 year smoke free. i am enjoying my life. have lost 50 lbs. can breathe, smell and enjoy physical activities just like a non-smoker. i want to live. i owe all these things to e-cigs. if i were in a position to make the decision yes/no on e-cigs knowing what i and countless others know, i couldn't live with myself knowing i took that hope away from someone. i am praying for divine guidance in this matter to whomever reads this.


This is one of the most powerful testimonials I have ever ever ... read... no, I feel as though I experienced this story.

All I can say is, thank you...
 

ethebull

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I had procrastinated far too long, but composed this a few hours ago. My submission -

I have been an e-cigarette user for just short of two years. I am a 55 year old man who began smoking cigarettes at age twenty. In the intervening 35 years, I tried to quit smoking many times. Nicotine gum got me to quit twice for 6 months and a year. Snus also was successful for two occasions of similar length, but my cravings for nicotine never ceased. I would inevitably have a social smoke and the cycle would return. E-cigs are an entirely different animal. They are The Solution for nicotine addicts like myself. I do not crave a cigarette. I have no interest in them. All of the pleasures of smoking are fully replaced by my ecig.

I have not had a cigarette since the day my first ecig kit arrived at my door. My experience in this is far from unique. I have communicated with thousands of ecig users on ecigarette.com who have also switched for good, after decades of trying to quit by other means. Drug therapies, nic patches and gum, and all the FDA sanctioned options, are a sad excuse to the affordable e-cigarette.

It is appalling to me that the FDA is choosing to regulate this wonderful lifesaving product, solely in the financial interests of big pharmaceutical and tobacco companies. You want to push the performance of the available products back to its infancy. My first kit of this first generation approach, gave me a taste of what an ecigarette could do. A "cig-a-like" was enough to give me hope, but would not have sustained my abstinence from smoking. With-in a week of using my toy ecig, I was frustrated by its short comings. - Lack of battery power and longevity, minimal delivery of vapor,... it had promise, but the internet gave me stories of products that could provide a much more satisfying vape. I've explored the gambit of improved vaping technology, and your regulations, as proposed, would have blunted this journey. I would be a current smoker if the FDA regulations currently proposed would have been in place two years ago.

I Do think the FDA should regulate. Please do so with public health as your primary concern, not the financial interests of the large corporations that seem to own you. There are only four ingredients in ecig liquid. PG, VG, Nicotine, and Flavor. REGULATE THOSE! NOTHING ELSE!! All current e-cigarette hardware works in the same basic way. There is a battery that heats a resistance-wire coil. The coil is in direct contact with e-liquid, and vapor is created. If your regulations allow for a variety of clever ways to maximize the consistency and safety of this process, then by all means regulate away! But the critical component to regulate is the liquid. PG and VG are widely available. Perhaps a bio test that insures safe inhalation for the two would be in order. Nicotine is a well known chemical. It has a lot of guilt by association. Cigarettes kill! We all know this, but nicotine is Not The Killer!! Regulate the purity of the nicotine. That would be appreciated!

The main thing that needs some overview and control here is the last ingredient. - Flavors. We do not need to limit the variety. Folks can market baby food flavors for all I care. Kids are not into ecigs for flavors. E-cigs simply are not cool. Look at the studies out there and it is clear. The flavors need to be looked into for safety and health. Are they safe to inhale? What is in them? This is something the FDA could regulate in a healthful and helpful way!

In closing, I write this submission for the benefit of future vapers. I own enough ecig hardware to get me through many many years. I have stock piled enough nicotine and flavors for the coming FDA apocalypse (as it is commonly referred to amongst vapers on the net). If the FDA's final rules follow the proposed guide lines, I will go to the black market for future needs. This is truly sad. I would like to believe that the FDA is there to support and encourage public heath and safe consumer goods, not to force someone like myself into a much more dangerous black market.

Please do what is best for current and future vapers, and potential ex- smokers. Please regulate for health and safety with no weight given to tax money or corporate greed.

Erik Ewald
 

2naphish

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This is one of the most powerful testimonials I have ever ever ... read... no, I feel as though I experienced this story.

All I can say is, thank you...

you are most welcome... that was from the heart. got to say your post also stopped me in tracks so to speak. you never know if someone really "gets it" when you write something you feel strongly about. if we are successful in the "right to vape" struggle perhaps there will be less and less people who will have to know these feelings... best to you and yours, <*}}}>{
 

madglee

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Good work, man. I should have had more balls and called them to task on the fact that they are owned by Big Pharma and Tobacco. Don't forget the American Lung Association promotes Chantix because they receive millions from Pfizer every year.
I had procrastinated far too long, but composed this a few hours ago. My submission -

I have been an e-cigarette user for just short of two years. I am a 55 year old man who began smoking cigarettes at age twenty. In the intervening 35 years, I tried to quit smoking many times. Nicotine gum got me to quit twice for 6 months and a year. Snus also was successful for two occasions of similar length, but my cravings for nicotine never ceased. I would inevitably have a social smoke and the cycle would return. E-cigs are an entirely different animal. They are The Solution for nicotine addicts like myself. I do not crave a cigarette. I have no interest in them. All of the pleasures of smoking are fully replaced by my ecig.

I have not had a cigarette since the day my first ecig kit arrived at my door. My experience in this is far from unique. I have communicated with thousands of ecig users on ecigarette.com who have also switched for good, after decades of trying to quit by other means. Drug therapies, nic patches and gum, and all the FDA sanctioned options, are a sad excuse to the affordable e-cigarette.

It is appalling to me that the FDA is choosing to regulate this wonderful lifesaving product, solely in the financial interests of big pharmaceutical and tobacco companies. You want to push the performance of the available products back to its infancy. My first kit of this first generation approach, gave me a taste of what an ecigarette could do. A "cig-a-like" was enough to give me hope, but would not have sustained my abstinence from smoking. With-in a week of using my toy ecig, I was frustrated by its short comings. - Lack of battery power and longevity, minimal delivery of vapor,... it had promise, but the internet gave me stories of products that could provide a much more satisfying vape. I've explored the gambit of improved vaping technology, and your regulations, as proposed, would have blunted this journey. I would be a current smoker if the FDA regulations currently proposed would have been in place two years ago.

I Do think the FDA should regulate. Please do so with public health as your primary concern, not the financial interests of the large corporations that seem to own you. There are only four ingredients in ecig liquid. PG, VG, Nicotine, and Flavor. REGULATE THOSE! NOTHING ELSE!! All current e-cigarette hardware works in the same basic way. There is a battery that heats a resistance-wire coil. The coil is in direct contact with e-liquid, and vapor is created. If your regulations allow for a variety of clever ways to maximize the consistency and safety of this process, then by all means regulate away! But the critical component to regulate is the liquid. PG and VG are widely available. Perhaps a bio test that insures safe inhalation for the two would be in order. Nicotine is a well known chemical. It has a lot of guilt by association. Cigarettes kill! We all know this, but nicotine is Not The Killer!! Regulate the purity of the nicotine. That would be appreciated!

The main thing that needs some overview and control here is the last ingredient. - Flavors. We do not need to limit the variety. Folks can market baby food flavors for all I care. Kids are not into ecigs for flavors. E-cigs simply are not cool. Look at the studies out there and it is clear. The flavors need to be looked into for safety and health. Are they safe to inhale? What is in them? This is something the FDA could regulate in a healthful and helpful way!

In closing, I write this submission for the benefit of future vapers. I own enough ecig hardware to get me through many many years. I have stock piled enough nicotine and flavors for the coming FDA apocalypse (as it is commonly referred to amongst vapers on the net). If the FDA's final rules follow the proposed guide lines, I will go to the black market for future needs. This is truly sad. I would like to believe that the FDA is there to support and encourage public heath and safe consumer goods, not to force someone like myself into a much more dangerous black market.

Please do what is best for current and future vapers, and potential ex- smokers. Please regulate for health and safety with no weight given to tax money or corporate greed.

Erik Ewald
 

Mowgli

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My comment submitted yesterday:

I started smoking as a teen in the 70's.

It started off as a fun rebellion but became a habit, then an intolerable nuisance, than an impossible to quit addiction.
I regularly smoked at least 25-30 cigarettes/day I tried to quit using hypnosis twice, the patch and/or nicotine gum countless times and cold turkey enough times to know that wouldn't work for me. All were unsuccessful for more than a few hours (usually) to a few days (at most). The few times that I managed to last more than a few hours I was cranky and miserable. I had a heart attack 2.5 years ago and only managed 17 days smoke-free just on fear alone. Fear for my life wasn't even enough to make me stay quit. I tried a few smokes and didn't drop dead so I got back up to 25-30/day within a week.

Last year I saw someone vaping and asked him about his e-cigarette. He told me he'd been smoke-free for 3 months using it. I tried an Njoy from the gas station and thought it was ok but it only lasted a few hours and I knew there would be something better available. I Googled and found a mall kiosk a few miles away. I tried and bought a rechargeable kit with assorted flavors and cut down to a few cigs per day immediately. I read continuously about vaping at ECF and other online forums and found a local vape shop offering more advanced systems and a countless variety of flavors. I visited and asked him to load a tank of his most popular flavor for me to try. I puffed an atomic fireball. I exclaimed "expletive deleted! That's an atomic fireball!" I bought all of his Fireball juice, a variety of fruit & candy flavors and a decent, variable voltage rechargeable ego battery kit. That was 3/28/2013. That was the day I completely switched from smoking to vaping. I haven't had a puff of smoke in over 16 months directly due to vaping candy, desert and fruit/berry flavored nicotine. I get the hand/mouth activity with the nicotine hit without the deadly smoke and associated mess.

I started at 24mg/ml for a few weeks, dropped to 18mg because I like the activity so I vape a lot and maintained that level for about a year. I lowered again to 12mg a few months ago so I can taste my flavors better. My latest blood work is better than my cardiologist's (he's 10 years younger and he jogs). I hike farther with less rest stops than before. When I smoked I couldn't take a deep breath without coughing. I can feel how much healthier I am and my blood work and stress test convinced my cardiologist. He's not a vaper but totally supports my switch.

I switch between about 3-5 flavors in different setups during the day. I have about 30 different flavors in my stock. I don't even keep menthol or tobacco in stock. I don't like those flavors. When I first quit smoking I thought I wanted tobacco flavored vapor but as I tried other flavors I realized I didn't even like tobacco. I was just used to it. The farther I am from smoking the better off I am.

I have helped other smokers to switch. My wife hasn't smoked in over a year. She still vapes a single sweet tobacco flavor that she likes out of about 5 that she tried. None of the 10+ other people I helped to switch even use tobacco flavors or straight menthol flavors. They enjoy mostly desserts, candy, custards and fruit/berries. I'd say the variety of available flavors is one of the top 3 reasons vaping has been successful for us. I can't imagine such a great reduced harm alternative disappearing from the marketplace. It's been a Godsend to my friends and I. We'll continue to vape no matter what but it would be tragic if current smokers don't get the same chance to quit that we had.

Thanks for reading
 

Churros4u

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Sent this earlier tonight ...

Comment Tracking Number: 1jy-8doq-z6wl (Also sent to CASAA)

To: FDA Center for Tobacco Products
RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38

My comment today is to ask for suitable and responsible regulations pertaining to e-cigarettes and the industry that has been created around them. I’m not opposed to having reasonable federal regulations of some kind, but they need to be made for the citizens protection and not simply for business protection of large corporations. Just because something may look like smoking, doesn’t mean it is smoking, or even contain tobacco, so why is this tobacco-less product being treated like a tobacco product. Only allowing for old technology based on useless, cumbersome products is going a bit too far.

I, like most vapers, do not believe that e-cigarettes or e-liquids should be sold to minors directly. There should be laws in place just as they are for smoking, drinking, driving and voting. I understand that some flavors/colors may be dangerous too; some things are only found out with time and research. That doesn’t mean banning everything in the beginning is fair or right … microwave popcorn hurt a lot of people (workers and consumers) but it is still on supermarket shelves! I feel that some regulations can be beneficial for the safety of all, but it seems as if most of these regulations put forth are only meant to stifle innovation and the right to a better quality product.

I started smoking when I was 12 years old and smoked about 1 to 1.5 packs a day for the better part of 30 years. I tried the other smoking cessations – patches, gum, Wellbutrin – but nothing helped me quit until I started vaping. It wasn’t just having the nicotine contained in e-liquids that helped me to get over all of the other chemicals in cigarettes, but more importantly, it was the psychological help from having something that I could do with my hands and mouth that really got me to stop smoking. That is something that everyone seems to forget about and that cannot be offered in any other smoking cessation on the market today. Another aspect was the capability of being a “dual user”. I smoked and vaped in combination for about a year. I decided to quit smoking and only vape, which led to a healthier environment for my family and pets. Yet another aspect that helped was being able to control the amount of nicotine I was getting. With gum and patches, there were only a few nicotine amounts to choose from, and with vaping, I can choose from several amounts to none at all. That allows me to wean myself from nicotine altogether at my own pace. After I started vaping full-time (about 2 years now), I was able to start a new weight loss plan and lost 95 lbs. That would have never been possible before because losing weight and the chemicals in cigarettes don’t match. So I’m even healthier than when I smoked.

Flavors are in everything from soda and cereal to chewing gum and alcohol. I still enjoy some tobacco flavors as well as dessert and fruity flavors – most humans do. I don’t feel that certain flavors only attract young kids … who doesn’t like the taste of cherry bubble gum or a blue raspberry slush. If adults didn’t also like these flavors, they wouldn’t be on the market. Taste-testing proves that! This is where the responsibility of adults has to take over so these items don’t get in the hands of children. The same should go for soda and desserts as too much of those in the hands of children can also have devastating consequences. The irony is that there is no regulation for those types items and yet they can be dangerous if over-consumed.

In the end, I don’t believe people will not stop using e-cigarettes if the current industry becomes illegal, but it will force a black market with damaging consequences for our justice system and citizenry. I can’t say whether I would go back to smoking cigarettes if I wasn’t able to get a truly good performing e-cigarette that matches my old smoking habit. I can say that I would probably resort to something else, whether it be smoking, drinking or prescription drugs – none of which I use now because I have a clean alternative that works for me and is, I believe, less damaging to my health, the health of other people and the environment. I have never heard of overdosing on vapor, killing someone while driving and vaping, or losing a battle with being a vaper. I can only ask that you take the scientific and social knowledge that you have gained, mixed with personal knowledge given by “vapers” who have responded to this call in order to come up with regulations that keep us safe and benefit all users, creators, vendors and citizens from the impacts of smoking.
 

dragonpuff

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My final comment:

This comment is in response to a comment by Dr. Stanton A. Glantz in which an article is attached titled, "E-Cigarette Makers Are in an Arms Race for Exotic Vapor Flavors."

As far as the article is concerned, it simply makes the case that e-cigarette companies are attempting to increase the number of flavors available to them, and that this will make them more appealing to children. To that end I must state that there is absolutely no evidence that flavors are attracting children to e-cigarettes. Several studies have been done showing that the vast majority of children who try e-cigarettes are already cigarette smokers. Given that cigarettes taste pretty awful in comparison, it is hard to make the argument that it is the flavor attracting them.

I must, however, address the statement in his attached letter, saying, "The FDA needs to resist the urge to focus entirely on youth and consider these effects on adults..." Alright, let's consider for a moment the effects of e-cigarettes on adults. Adult smokers who struggle to quit now have the option to switch to using a product that is monumentally safer (as proven in many studies thus far) yet offers a similar effect to that of cigarettes. The effect this product will have on adults is that it could cause them to switch to a much safer version of smoking, thereby saving countless lives in the process. Yes, I do believe that is something the FDA ought to consider.


:2cool:
 

bigdancehawk

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One hour and fifteen minutes left!! I want to make one more comment... but I feel like I've touched on everything already and I don't know what else to say... so...

Any special requests? :D Is there anything in particular anyone here wants me to write to the FDA about? I will write to them on the topic you choose, on the condition that you submit a comment on the same topic as well :D

OK, hotshot. :)

I feel threatened with exposure to harmful substances whenever I walk into a room where there are candles burning. Especially those scented candles. Only God knows what harmful substances I'm inhaling. Carbon dioxide for certain. I always flee the room, but those less enlightened remain. I pity them. Only the FDA can save them from all the unknown harms. Why do thoughtless people expose us to anything but nice, clean mountain air?

And some of those scents are alluring to children who could be tempted to eat the candles! Let's think of the children for a change!

I feel the same way and fear the same harm when I enter a room where they have those plug-in room deodorizers. Some of them have scents that might be harmful and children might eat those too! Yet, I can't seem to avoid them. They're in practically every public restroom.

And don't get me started on grocery stores. Yes, you know the ones. They spew the pleasant odors of baking bread and so forth into the very air we breathe to whet our appetites so we'll be tempted to buy more products--products loaded with gluten, flavors, preservatives, and other harmful substances. They are luring and tempting us like Pavlov's dogs. Those dirty capitalists, endangering our health to satisfy their endless greed!

I'm appalled that the FDA has failed to impose stringent regulations on these pervasive fumes, polluting the very air we breathe. For shame!
 

classwife

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Alexander Mundy

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In the nick of time

"Rightful liberty is unobstructed action according to our will within limits drawn around us by the equal rights of others. I do not add 'within the limits of the law' because law is often but the tyrant's will, and always so when it violates the rights of the individual." Thomas Jefferson

"FDA is aware that some tobacco products, such as e-cigarettes and certain cigars, are being marketed with characterizing flavors, and that these flavors can be especially attractive to youth. The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only. FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a "cigarette" as defined in section 900(3) of the FD&C Act and, consequently, subject to the prohibition against characterizing flavors, despite being labelled as a little cigar or other non-cigarette tobacco product."

Section 900(3) of the FD&C Act
3. Cigarette. The term 'cigarette'
A. means a product that
i is a tobacco product; and
ii meets the definition of the term 'cigarette' in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and
B. includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.

TITLE 15 -- COMMERCE AND TRADE CHAPTER 36– CIGARETTE LABELING AND ADVERTISING
1332. Definitions
1) The term "cigarette" means--
(A) any roll of tobacco wrapped in paper or in any substance not containing tobacco, and
(B) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described insubparagraph (A)

By definition a "cigarette"

is a tobacco product

AND

{ (A) any roll of tobacco wrapped in paper or in any substance not containing tobacco,

OR

(B) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described insubparagraph (A)}

AND

includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.

26 US Code 5702 - Definitions

(a) Cigar

“Cigar” means any roll of tobacco wrapped in leaf tobacco or in any substance containing tobacco (other than any roll of tobacco which is a cigarette within the meaning of subsection (b)(2)).

(b) Cigarette

“Cigarette” means—
(1) any roll of tobacco wrapped in paper or in any substance not containing tobacco, and
(2) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in paragraph (1).

If a product does no contain a "roll of tobacco" it is not defined in section 900(3) as a "cigarette"
If a product does not contain a "roll of tobacco" it is not defined in 26 US Code 5702 as a "Cigar".

A roll of tobacco is tobacco leaves that have been made into a cylinder.

E-cigarettes do not contain a "roll of tobacco" and therefore are not cigarettes or cigars so the prohibition against characterizing flavors established in the Tobacco Control Act does not apply to e-cigarettes.

Further, if legal terms should be changed to encompass e-cigarettes, the exclusion of "characterizing flavors" would reduce efficacy as a harm reduction strategy to what is possibly the greatest spotlight of hope for smokers. The efficacy of "characterizing flavors" is attested to by the fact that FDA approved NRT's come in "characterizing flavors" and not in "tobacco flavors" The pharmaceutical companies have spent millions to determine that "characterizing flavors" aid in harm reduction and are a benefit to society in such usage.

Do not let ideology get in the way of harm reduction for the millions of smokers whom could potentially be saved from prolonged illness or death from combustible cigarettes.
 
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