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

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Megan Kogijiki Ratchford

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Bringing to the front again!

I am Honored to be among all of you who have spoken up. All of your comments are very important, the fact that we don't all agree on every point is irrelevant. ALL perspectives of vapers is the point and one I'm amazed and delighted to be part of. Thank you ALL!! :wub:

Dear ECF members and visitors,

On August 8th the FDA will close the comments on its proposed deeming regulation.

This regulation will profoundly affect the future of the industry, and as it currently stands, this means 99% of available products are likely to be removed from the market.

So far, not nearly enough vapers have submitted their testimonies to the FDA, and it is essential that all who wish to see vaping remain a viable alternative for smokers.

That means you.

It needn't take long to comment, and I've put a guide on vaping.com, based on CASAA's latest call to action.

Please spend a few minutes composing your own comment. And remember, this really is your final opportunity to have your voice heard before the rule is made. Your comment is important as, by law, it has to be considered as part of the rule-making process.

Many thanks,

Oliver (SJ)
 

classwife

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aikanae1

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ok, here's a couple more (I'm still writing them based on what I find from ANTZ)

Your Comment Tracking Number: 1jy-8dnb-rdf8

As a 45 year + smoker, I am a primary stakeholder in FDA's deeming regulation. I've tried patches, gum, acupuncture, hypnosis, and except for chantix (just once), more times than I can count. My 2 non-smoking ex-husbands probably have a better count. Nothing made much difference. Finally, quitting became so demoralizing and demeaning that I gave up on quitting.

I bought an electronic cigarette out of curiosity at a gas station. It was better than other products but didn't help much. Almost a year later I walked into a local vape shop and the staff helped me find an electronic cigarette customized to help me quit. The level of nicotine I needed was less than the daily dose in NRT's. I was missing the vapor. Maybe it's inhaling deeply. There's a lot to learn beyond nicotine addiction.

I remembered from "Quit Smoking" literature to change familiar flavors when quitting so I intentionally did not choose tobacco flavors. My taste buds were numb so all I could taste were strong, sweet flavors like gummy bears. No joke.

I firmly believe cigarette smoking should be discouraged and vaping is one more way to do that. What I see as the biggest health benefit is having parents and grandparents around to council kids against smoking without puffing on a cigarette while I'm doing it. I can smell if my teen has smoked now and before I couldn't. That is an immediate benefit - not something 20 years from now. Vapers can become militant non-smokers just as fast as ex-smokers do.

Vapers are also compelled to give other smokers the opportunity to quit like ex-alcoholics do with AA. That is how the electronic cigarette industry has grown so fast without advertising. Devices were designed to help smokers make a quit attempt which a corporation can't do as easily because quitting is a "limited growth market" (WSJ, Herzog, Wells Fargo Investments) which was a reason tobacco companies didn't buy into the market until after 2012. In fact, tobacco companies have contributed nothing towards developing products that help smokers quit - just as ineffective as pharmaceutical companies have been for all these years. Chantix is an example of a cure worse than the disease with thousands of deaths.

Just as cigars can be divided into 2 markets, so can electronic cigarettes. There is the phony tobacco company device that has changed little, standardized, sold everywhere for less than $30, most likely to promote dual use and most accessible to youth. If the FDA were worried about "renormalizing smoking" that is the device to target.

Instead the FDA is targeting 99% of unique products, some are manufactured in the USA including chipsets. These devices cost more than $100 and are designed to help smokers quit, avoiding dual use, customizable, sold in stand alone shops where screening is more effective and support thousands of small independent business'. One online retailer claimed to offer 10,000 unique products not including eliquids. These devices require more knowledge to operate so they are less available to youth exploration.

The OMD Economic Impact didn't even bother to collect figures on the electronic cigarette market and instead used a percentage of cigar sales - what do cigar sales have to do with ecigs? They also predicted the market would be reduced to 25 products and state that consumer choice would be limited but not necessarily the volume of sales. On what planet does that advice apply to?

The FDA has no idea what they are regulating nor does it seem like they care. I'd swear the bulk of the deeming regulations were written by industry lawyers and accountants since only the pharmaceutical and tobacco companies could see the value in the regulations, as "exciting" and it appears that TVECA (tobacco companies) had advance knowledge before regulations were published.

I understand the FDA is largely supported by application and filling fees which also make it appear to be an employee of the industries paying them and there's little reason to disagree when most of the regulations concern competition and marketplace control and little to do with valid (not imaginary) threats to public health.

If electronic cigarettes posed a risk for non-smokers wouldn't that be spotted as a trend over the last five years? Instead both youth and adult smoking rates have declined proving that is not a risk and ecigs are a benefit to public health.

The FDA risks undermining their credibility and loosing public trust by supporting deeming as it is written. When I read about how Sweden came to have the lowest smoking rates and realized I could have reduced my harm ten years ago, I wondered where I could send my medical bills for reimbursement for the damage done to my health from being mislead by the FDA and CDC. I can never fully trust these agencies again.

I know the FDA understands the continuum of risk for nicotine products and it's past time to tell the public the truth. I hope the FDA will do the right thing.

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

and I couldn't resist ...

Your Comment Tracking Number: 1jy-8dom-85f1

As a vaper I would like to urge the FDA to ban all flavors from all products for adults. To prevent kids from becoming addicted to coffee, it should taste like water. Adults should not have flavored alcohol and that should be made to taste like water - and there should be no difference between vodka, whisky, rum or scotch. Alcoholism is a serious disease and a frequent cause for life threatening car accidents. All of our insurance rates would go down immediately. The Senate should not be allowed to have a candy desk - yes, there is a candy desk in the senate!!! No wonder they are all wired up and can't focus on getting anything done. What kind of a role model does that provide for our children! Soda's should have no flavoring or no sugar and should taste the same as alcohol, er water. Food coloring isn't healthy either, I guess. I'm not sure what to do here but I bet the FDA does.

I expect this to happen before April of next year since this has been going on for far too long - at least two centuries! Where was the FDA in the 1800's when all of this started? The FDA should be doing a much better job. They should have predicted this when the FTSPCA act was signed, even if some of these products didn't exist yet - the FDA should have known that someday they would.

Thank you very much for reading.
 
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2naphish

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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.
 

sonicdsl

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Alexander Mundy

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"I hope our wisdom will grow with our power, and teach us, that the less we use our power the greater it will be." Thomas Jefferson

FDA has stated that it does not have enough scientific evidence to make a determination of the effectiveness, harm to the individual of, harm to society of, effect of flavorings, etc. concerning e-cigarettes. Why would a regulatory branch of our government attempt to regulate something that they cannot say is a problem?

FDA has stated that it needs to regulate e-cigarettes to make scientific determinations about them. FDA has also stated that it's actions must be based on science. This is not reflected in the deeming regulation. If it were the section regarding e-cigarettes would be short and to the point. Something like "We are requesting to have the power to regulate e-cigarettes. We will suggest in further regulation what action or non action to take based on our findings after lengthy peer reviewed scientific studies."

So why is the FDA attempting to regulate e-cigarettes? I believe that Maria Azzarelli, coordinator of the Southern Nevada Health District’s tobacco control program, hit the nail on the head “We’re very concerned that what [was] becoming passé — smoking — is now coming back.” I believe the FDA is being pressured to regulate e-cigarettes for this reason. Regulation because "It looks like smoking" is overstepping authority and tantamount to misfeasance.

The FDA will do irreparable harm to small business, but more importantly could do irreparable harm to an estimated 42.1 million smokers if FDA regulates these products in a manner in which it has presented in the deeming regulation.

There is a saying I learned that is appropriate. "Take a feather pillow outside and rip it open shaking all the feathers into the wind. Now put them all back." Do not flex FDA regulatory muscle because "it looks like smoking". Do the science first. No one will be able to put all the feathers back.
 

Katya

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As a vaper I would like to urge the FDA to ban all flavors from all products for adults. To prevent kids from becoming addicted to coffee, it should taste like water. Adults should not have flavored alcohol and that should be made to taste like water - and there should be no difference between vodka, whisky, rum or scotch. Alcoholism is a serious disease and a frequent cause for life threatening car accidents. All of our insurance rates would go down immediately. The Senate should not be allowed to have a candy desk - yes, there is a candy desk in the senate!!! No wonder they are all wired up and can't focus on getting anything done. What kind of a role model does that provide for our children! Soda's should have no flavoring or no sugar and should taste the same as alcohol, er water. Food coloring isn't healthy either, I guess. I'm not sure what to do here but I bet the FDA does.

I expect this to happen before April of next year since this has been going on for far too long - at least two centuries! Where was the FDA in the 1800's when all of this started? The FDA should be doing a much better job. They should have predicted this when the FTSPCA act was signed, even if some of these products didn't exist yet - the FDA should have known that someday they would.

Thank you very much for reading.

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cbrite

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Mine was submitted tonight. It took me a little longer to figure out how I wanted to comment. In the end, I took the personal approach and reminded them that our government needs to support small businesses not destroy their opportunities. Comment Tracking Number: 1jy-8doo-qz1u

I wish I would have thought to include my banner that showed them what vaping has done for me!!
 

WaynesWorld

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Thanks to several different authors and my personal interweaving my own personal view I submitted the below to the FDA:

July 24th, 2014
“FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38”

Dear FDA Center for Tobacco Products,

My wife and I are members of CASAA, we both had been smoking "regular" cigarettes for over 30yrs. When we switched
to e-cigarettes, I was smoking 2 packs a day, my wife was at 1 to 1 1/2 packs a day. Over the years, we had both tried to quit
a minimum of 12 different times using ALL the "Conventional" & "Approved" methods. Patches, Gum, Hypnotism, Quit
Line Support, Cold Turkey, Chantix ... NOTHING WORKED!!

We were both at our wits end, we wanted and needed to quit ... but had run out of options. That is UNTIL we discovered ecigarettes.
On December 6th, 2013 we both purchased a Blu “cigalike” e-cigarette in the hopes it would be the answer to our
quitting cigarettes for good ... but we soon found out that the “cigalike” e-cigarettes were not effective in totally quitting
cigarettes. Not giving up, we then purchased a simple evod e-cigarette starter kit on Monday February 3rd 2014. We put
aside our combustible, (regular), cigarettes and have not smoked since and have not felt the need to. Our health, breathing,
blood pressure and energy levels have improved tremendously!

If the only electronic cigarettes legally available are reduced to the cigarette lookalikes, (“Cigalikes”), produced by major
tobacco companies, I will NOT buy them, they DON'T work … Nor will I return to smoking again. I will simply purchase
products of my choice on the black market. Any collection of regulations which is designed to expose Americans to greater
harm than necessary, as I believe is the case with the FDA's proposed regulations under discussion, is unjust. Consequently,
I would find myself compelled by conscience to defy them.

I believe that e-cigarettes should not be sold to minors. Yes, there should be full packaging labels such as nicotine levels and
ingredients, just as I believe that tobacco cigarettes should have full ingredient labeling. I also believe that childproof caps
are necessary, but to completely gut an industry and give it back to those who lied to us for years, (Big Tobacco), is
completely insane!

To say that children are enticed by flavored e-liquids is a complete falsehood and a text book example of hypocrisy. Where's
your concern for the children when it comes to flavored liquor or beers. The last time I looked you can find that anywhere!
Supermarkets, Drug stores, even the local convenient stores have shelves loaded with such products. Non-tobacco flavored
e-liquids are the PRIME reason for our success in quitting cigarettes. We detest tobacco flavored e-liquids … fruit, sweet
and candy flavored e-liquid was, and is, the KEY to our successful quitting of cigarettes … PERIOD!!

The administration has repeatedly called for sound science and transparency of government. Yet, the regulatory
process being pursued by the FDA is based on misdirection and innuendo dressed up as science. The scientific basis
put forth by the FDA for proposing these devastating regulations is filled with inaccuracies and misstatements which
constitutes an arbitrary and capricious abuse of the FDA's regulatory authority and a breach of public trust. And it
would seem that Judge Richard Leon agrees.

The FDA actions will devastate an entire industry, eliminating 10's of thousands of jobs, with loss of millions to the
Government in income tax and unemployment benefits, and worst of all, it would place the safety of the vaping world
into the very hands of the industries that have continued to ruin our health with smoking and smoking cures … Big
Tobacco and Big Pharma. As a consumer, a vapor and an ex-smoker ... I am appalled by the FDA's and CDC's
actions in misleading and misinforming the American public to achieve it's own personal and financial agenda.
 

cclaplante

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Your Comment Tracking Number: 1jy-8doo-snec
Comment:
I grew up surrounded by smoking and picked up the habit after moving to college.

In the over 20 years that I smoked, I averaged a 1 to 1-1/2 packs of cigarettes a day.

I attempted to quit several times during the period that I smoked. NRT in the form of the nicotine patch was unsuccessful. I watched my wife deal with side effects from Chantix, and did not want to go that route.

I also tried to quit cold turkey on more than one occasion. Two months was the longest I made it.

In 2010 I tried an electronic cigarette for the first time. It was a reusable, cigarette style e-cig made by Greensmoke. I thought the concept was great, and there was a lot of potential for people looking for a less-harmful alternative to smoking tobacco.

I used this e-cig for a few weeks and reduced my tobacco intake dramatically - from 1/2-1 pack a day to just 2 or 3 cigarettes a day. Soon, however, I noticed an overall lack of satisfaction and during a particularly long day at work ran both batteries down and ended up buying a pack of smokes. So it goes.

One year ago, I decided to give the technology another chance and did some research online. I found a vape shop* just north of Boston, and tried out and took home an "advanced" electronic cigarette, or personal vaporizer, refillable in an almost unending array of flavors, and with a larger battery that lasted all day. *(one of a very few at the time, and now one of several shops that will be forced to close if this regulation passes as written)

Initially I did not have an interest in flavors other than tobacco, and for the first six months after I made The Switch I vaped almost exclusively tobacco flavors while I gradually reduced my nicotine intake. I say, "The Switch" because for me, it was just about that easy. Within 48 hours of picking up my bigger, more powerful e-cig I had smoked my last cigarette.

At the end of this month I will celebrate one year of being smoke free. Over the last several months, what began as a means to an end has morphed into a very intriguing hobby, which has also been a great diversion from a herniated disc that I've been dealing with since March. I've been creating my own e-juice flavors, (with all FDA approved ingredients) most of which are not tobacco flavored at all. Some don't even have nicotine in them.

I agree that children should not have access to e-liquid or vaporizing devices, but the regulations-as-written will destroy a lot of peoples lives. Thriving small business owners all over this country - many of which are folks who quit smoking because of e-cigs and are trying to help others to do the same.

And even more people who, like me, have been successful in putting down tobacco smoke in favor of flavorful vapor, which is orders of magnitude less harmful. What shall we do? Go back to smoking?

How can that be better?

It can't be. I've noticed the changes for the better since I quit smoking. I can breathe better and don't get winded as easy as before I quit. The "smoker's cough" has all but disappeared. I can smell and taste things again. Oh, not to mention the money I'm saving by not buying a $10 pack of smokes each day.

Why would you want to take that away?

-C
 
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