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

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tA71ana

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I just submitted my comment...right under the wire.
I had to convert it to a .txt (I use Open Office) and I got a 'success' buit I hope its readable because something crazy happened to the formatting when going from .odf to .txt.
For whatever reason I was unable to preview it :(
The comment file is ok except that something happened to the wraparound.
But I got it in there - all 7212 characters......

Oh yeah - my tracking number is 1jy-8dor-bovn
 
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dragonpuff

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I just submitted my comment...right under the wire.
I had to convert it to a .txt (I use Open Office) and I got a 'success' buit I hope its readable because something crazy happened to the formatting when going from .odf to .txt.
For whatever reason I was unable to preview it :(
The comment file is ok except that something happened to the wraparound.
But I got it in there - all 7212 characters......

No matter how it turned out, they have to read it anyway :D so no worries
 

JustJulie

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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.

Basically, FDA has taken the position that it cannot exert regulatory jurisdiction over e-cigarettes (by deeming them as "tobacco products") without subjecting them to the whole host of provisions of of the Family Smoking Prevention and tobacco Control Act (TCA), the provisions of which would essentially destroy the industry with paperwork filings alone (none of which accomplish anything positive or beneficial for consumers).

Given that, our position is that if you can't exert jurisdiction without destroying that which you seek to regulate, then, no, you can't exert jurisdiction.
 

sonicdsl

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I just submitted my comment...right under the wire.
I had to convert it to a .txt (I use Open Office) and I got a 'success' buit I hope its readable because something crazy happened to the formatting when going from .odf to .txt.
For whatever reason I was unable to preview it :(
The comment file is ok except that something happened to the wraparound.
But I got it in there - all 7212 characters......

Oh yeah - my tracking number is 1jy-8dor-bovn

Heya tA71ana... I use Open Office too, and there is a function under "File" to Export to PDF. That's what I did with my comment.

For future reference :)
 

Rickajho

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Btw, right now I am going through this entire thread and collecting all the tracking numbers that people posted here in case they didn't send them to CASAA... if someone else already did this, then for the love of all that is holy please stop me!

In the best interest if your bitty fingers I have refrained from posting my tracking numbers on ECF. (But I have sent them to CASAA.)
 

bigdancehawk

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Here's one, just posted as we reach the final minutes:

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 forced to inhale. Carbon dioxide for certain. That's a well know fact. (Don't get me started on my next door neighbor's barbeque smoker--the smoke is almost enough to tempt me to eat a whole, deadly slab of ribs loaded with carcinogenic polycyclic aromatic hydrocarbons). The FDA has money for epidemiological studies, so why is there no research on those things? I always flee the area, but those less enlightened than I remain. I so pity them. Only the FDA can save them from all those known and unknown harms. If any activity or substance might prove harmful, it should be banned immediately pending further scientific inquiry. Why do thoughtless, selfish 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. So I always pee before leaving the house.

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, tempting and conditioning us like Pavlov's dogs. Not to mention the children. 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, tainting our lungs with the very air we breathe. For shame!

And now, e-cigarettes! Are you kidding? I feel my chest constricting at the mere thought of exposure to God knows what substances those ex-smokers are spewing in my face! They should never have smoked in the first place, so they deserve whatever fate may befall them. They're an affront to humanity and an imminent threat to my health, as well as the well being of all children everywhere. I ask--no, I beg you--force those ex-smokers out into the cold, the dark, the freezing rain, the stifling heat, and let them indulge their filthy habit there. Why can't they just quit their filthy nicotine habit altogether? What's wrong with them? Oh, well, at least the FDA can assure that the virtuous among us will be spared their nasty exhalations. They deserve exile to restricted smoking areas to inhale carcinogenic second hand smoke from the real cigarette smokers. At least the latter will soon die and we'll finally be rid of them for good.

As I patiently await the FDA's extermination of the former, group, I remain,

Yours truly.
bigdancehawk
 

Gato del Jugo

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Anybody notice that even though it's past midnight, it appears you can still submit a comment -- at least technically?

Doubt it would count, though, since stuff is electronically time-stamped...


Anyway, I'm glad this part is over.. I'm tired of writing.. Need a break..

Due to life interruptions, I only ended up submitting 9 comments, each covering a different topic.. But they were good ones, IMO.. :D


Thanks to all who submitted.. And keep in mind that this war is far from over, so keep fighting in any & every possible way you can! :headbang:
 

Rickajho

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Basically, FDA has taken the position that it cannot exert regulatory jurisdiction over e-cigarettes (by deeming them as "tobacco products") without subjecting them to the whole host of provisions of of the Family Smoking Prevention and Tobacco Control Act (TCA), the provisions of which would essentially destroy the industry with paperwork filings alone (none of which accomplish anything positive or beneficial for consumers).

Given that, our position is that if you can't exert jurisdiction without destroying that which you seek to regulate, then, no, you can't exert jurisdiction.

There's that. And is anyone else bothered by this one little thing on the Docket Summary page?

Priority: Economically Significant

Kinda puts their priorities regarding this proposal all in one tiny nutshell there, doesn't it?
 

tA71ana

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To Whom It May Concern:

This letter is in regard to the upcoming FDA Deeming Regulations, and the prohibition of Vaping products presently available on the market at this time.
I would like to begin with my personal story and how I feel Vaping has saved my life.

I began smoking tobacco cigarettes in the summer of 1972. Over the ensuing 40 years I developed Chronic Asthmatic Bronchitis from ongoing tobacco usage which went on to become COPD.
Even though I knew the habit was causing physical issues ancillary to the tobacco usage, I found it impossible to quit. I would awaken at night, quite literally gasping for breath and coughing until I vomited. I coughed regularly during the day as well; my voice was becoming raspy and my chest gurgled audibly with every breath.
Visits to the ER for breathing treatments, treatments administered at home, rescue inhalers and seemingly unending respiratory infections became the norm for me.
Over the years I tried the nicotine gum and patches multiple times to quit my tobacco usage, but to no avail.
Due to the fact that I have chronic Liver and Skin disease, I cannot take many drugs because of the side effects. Chantix, Wellbutrin and the like were totally out of the question for me.
I feared that I too, would be sentenced to the same fate as my Mother, who died at 71 of Oat – Cell Carcinoma of the Lungs (my Aunt, her Sister died of the same disease at 56, after having smoked Pall Mall unfiltereds for decades.).
One day, on a lark, I happened to peruse a blog thread (non – Vaping related) where the discussion happened to be about Electronic Cigarettes. Skeptical, I read on. One of the posters mentioned that she had tried E – Cigs and managed to kick a tobacco habit of 50 years plus. Intrigued, I heavily researched the hardware and flavored juice options that were available to me.
In the meatime, a friend of mine (who I didn't even realized vaped) gave me some of his used gear (as he had moved on to other vaping gear) and some tobacco – flavoured vape liquid that he no longer used.
I received the E – Cigs (two Joyetech 650 mAh batteries and cartomizers) and liquid on April 28th of 2012 and started vaping that very day.
I have not had a tobacco cigarette or cigarillo since.
I completely, absolutely and totally stopped smoking tobacco that day and have never returned to it.
Since I have started vaping I am no longer waking up in the night gasping for breath or coughing all day.
I no longer have the rattle in my chest, and my voice is clearer.
I still have COPD...the damage from my long – term tobacco usage is already done...but I feel that vaping has given me a choice between living longer or dying a tobacco – related death.
Since I have been vaping, my hair and clothes no longer smell of tobacco smoke.
My home no longer reeks of tobacco smoke.
I am not constantly stopping to “have a smoke” because since starting to vape I can go for many , many hours without having to vape at all.
I can actually taste my food now because I can smell again!

Now that you have heard my story, I would like to bring to your attention some other, larger issues in regards to vaping and the industry that has grown up around Vaping.
When I began vaping, I vaped tobacco – flavoured vapes. It was not long after that I discovered that I really didn't like tobacco flavours, so I moved onto fruit – flavoured vapes. Having a choice of flavours to choose from has helped me and many other Vapers continue to stay away from tobacco.
In addition, it is important for Vapers to have access to not only a range of flavours to choose from but differing nicotine (mg) levels as well. This makes it possible for a Vaper to “step down” their nicotine (mg) levels to zero (mg) if they would like to vape sans the nicotine or quit all together.

Another extremely important choice in Vaping is the hardware and delivery system used for it. Some Vapers prefer cigalikes (Personal vaporizers that look like tobacco cigarettes), some prefer devices with larger batteries (such as the Joyetech eGo) and some prefer APVs (Advanced Personal Vaporizers) with removable, rechargeble batteries, both regulated and non-regulated. Many Vapers (whether at home or out and about) may use some or all of the above at different times and in different situations or venues.
As far as delivery systems, Vapers prefer cartomizers, tanks, clearomizers and atomizers; again, most Vapers use some or all of these delivery systems depending on the device they are using.
It is essential that we have these choices because what works to keep one Vaper away from tobacco usage will not work for another Vaper.
As with many other things, “One Size Fits All” rarely ever works and Vaping is no exception.
Control of vaping hardware, delivery Systems and liquids by only a few large Corporations would not give us the choices we have presently and as seen in the past, all of these Corporations have included ingredients and chemicals in their products to make tobacco cigarettes and other associated products much more addictive and deadly.

I would like to now touch on the economics of Vaping and how prohibition of presently available products would have a deleterious effect on Vaping businesses.
It is not just the Consumers of vaping products that will be adversly affected by a prohibition of products presently available.
The businesses that have helped Vaping grow will be put out of business, causing a ripple effect outward, not only for the businesses but for all who are associated with it .
These businesses employ people who will find themselves thrown out of work, affecting the economic stability of their families.
Loss of Tax revenue will occur because these businesses pay taxes into their Local and State coffers, not to mention Federal taxes and having been thrown out of business, will not be contributing to the tax pool.
The Suppliers and Vendors of both hardware, delivery systems and liquids would also be facing the same issues.
Many Vaping businesses in the U.S. are Small Businesses and a prohibition of products presently available would be a heavy blow indeed , causing serious economic hardship to these businesses.
Potential bankruptcies are within the realm of possibility in this scenario.

If a prohibition on vaping products presently available were to occur, there is the distinct and likely possibilty that a Black Market would develop, resulting in unsafe Liquids and Hardware being sold, as well as potentiality for criminal conduct and underage access to occur.
As the situation is presently, Manufacturers and Sellers of both hardware and liquids are working dilligently within their own industries and with each other to insure safe products are available and preventing access to minors.

In closing, a prohibition on vaping products presently available will serve no one but a few very large Corporations. The Free Enterprise System (and the competition that is its lifeblood) that we hold dear in this Country is at the heart of this matter.
Adults who are legally allowed to smoke should also have the option to Vape and potentially save their own lives.

Sincerely,
 

bigdancehawk

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Basically, FDA has taken the position that it cannot exert regulatory jurisdiction over e-cigarettes (by deeming them as "tobacco products") without subjecting them to the whole host of provisions of of the Family Smoking Prevention and Tobacco Control Act (TCA), the provisions of which would essentially destroy the industry with paperwork filings alone (none of which accomplish anything positive or beneficial for consumers).

Given that, our position is that if you can't exert jurisdiction without destroying that which you seek to regulate, then, no, you can't exert jurisdiction.

Yep, I fully got that and I agree. It's bold, but it's correct. I can't imagine a regulatory agency saying that they're reluctant to exercise any and all powers granted to them but.... fingers and toes crossed....miracles can happen.
 

tA71ana

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Here's one, just posted as we reach the final minutes:

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 forced to inhale. Carbon dioxide for certain. That's a well know fact. (Don't get me started on my next door neighbor's barbeque smoker--the smoke is almost enough to tempt me to eat a whole, deadly slab of ribs loaded with carcinogenic polycyclic aromatic hydrocarbons). The FDA has money for epidemiological studies, so why is there no research on those things? I always flee the area, but those less enlightened than I remain. I so pity them. Only the FDA can save them from all those known and unknown harms. If any activity or substance might prove harmful, it should be banned immediately pending further scientific inquiry. Why do thoughtless, selfish 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. So I always pee before leaving the house.

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, tempting and conditioning us like Pavlov's dogs. Not to mention the children. 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, tainting our lungs with the very air we breathe. For shame!

And now, e-cigarettes! Are you kidding? I feel my chest constricting at the mere thought of exposure to God knows what substances those ex-smokers are spewing in my face! They should never have smoked in the first place, so they deserve whatever fate may befall them. They're an affront to humanity and an imminent threat to my health, as well as the well being of all children everywhere. I ask--no, I beg you--force those ex-smokers out into the cold, the dark, the freezing rain, the stifling heat, and let them indulge their filthy habit there. Why can't they just quit their filthy nicotine habit altogether? What's wrong with them? Oh, well, at least the FDA can assure that the virtuous among us will be spared their nasty exhalations. They deserve exile to restricted smoking areas to inhale carcinogenic second hand smoke from the real cigarette smokers. At least the latter will soon die and we'll finally be rid of them for good.

As I patiently await the FDA's extermination of the former, group, I remain,

Yours truly.
bigdancehawk

OMG this one had me cracking up, I almost choked on my coffee! LMAO
 

Rickajho

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Anybody notice that even though it's past midnight, it appears you can still submit a comment -- at least technically?

Doubt it would count, though, since stuff is electronically time-stamped...

Yeah, and it's till open. I even checked to see what time zone they were using: EST.

I wonder if they have to allow some kind of grace period, of sorts, if comments are still active and incoming?
 
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