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

[Ryedan]

I detest Microsoft Word, but have fired it up for this very special occasion. That is all.

You are a scholar and a gentleman (or gentlelady).

I use OpenOffice and for occasions like this one I just save the file as a '.doc'

 

[penguiness]

I submitted my comment and also sent the tracking number to CASAA.

 

[Aheadatime]

Although this might be too 'lawful' or 'annoyingly detailed so get away from me' for some of you, I figured I would post my first couple paragraphs here in the forums. They immediately bring the attention to the constitution, which you can simply follow up with your own story and all of the details that should be included in your letter (as made clear by the OP's website).

"To whom it may concern,

I've been informed of , and thus, took it upon myself to study, the deeming regulations proposed by the FDA in regards to electronic cigarettes (hereby referred to as "ecigs"). This letter is my written dissatisfaction with the regulations as they stand, and with the concept of regulatory actions and/or language in any way, shape, or form outside of age restrictions. First and foremost, I would like to bring to attention the 10th and 9th amendments to the Constitution of the United States, which is the very document all federal employees and associates are sworn to protect and serve.

The 10th amendment states, "The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people." Since there is no text within the constitution which authorizes the federal government to regulate, approve, disapprove, restrict, or bolster in any way devices, foods, liquids, or substances used willingly by individuals in any context whatsoever, in relation to health or otherwise, then by default, any regulatory language, decree, policy, law, statute, bill, act, or measure proposed by any agency within the United States which represents, is paid for by, supports, acts under, or relates to the federal government of the United States in any way whatsoever is unconstitutional.

The 9th amendment states, "The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people." Thus, any regulatory body, establishment, agency, administration, panel, or group or any sort whatsoever may not, by constitutional law, use any language within the constitution as a means to extend its legal reach into that which was not mentioned within the Constitution of the United States, which by default, was left for the States and the People to govern, regulate, and restrict. This includes the states' right and the individuals' right to regulate, approve, disapprove, restrict, or bolster in any way devices, foods, liquids, or substances used willingly by individuals in any context whatsoever."

 

[Megan Kogijiki Ratchford]

love this!!!!! Boom aheadatime!!!

although this might be too 'lawful' or 'annoyingly detailed so get away from me' for some of you, i figured i would post my first couple paragraphs here in the forums. They immediately bring the attention to the constitution, which you can simply follow up with your own story and all of the details that should be included in your letter (as made clear by the op's website).

"to whom it may concern,

i've been informed of , and thus, took it upon myself to study, the deeming regulations proposed by the fda in regards to electronic cigarettes (hereby referred to as "ecigs"). This letter is my written dissatisfaction with the regulations as they stand, and with the concept of regulatory actions and/or language in any way, shape, or form outside of age restrictions. First and foremost, i would like to bring to attention the 10th and 9th amendments to the constitution of the united states, which is the very document all federal employees and associates are sworn to protect and serve.

The 10th amendment states, "the powers not delegated to the united states by the constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people." since there is no text within the constitution which authorizes the federal government to regulate, approve, disapprove, restrict, or bolster in any way devices, foods, liquids, or substances used willingly by individuals in any context whatsoever, in relation to health or otherwise, then by default, any regulatory language, decree, policy, law, statute, bill, act, or measure proposed by any agency within the united states which represents, is paid for by, supports, acts under, or relates to the federal government of the united states in any way whatsoever is unconstitutional.

The 9th amendment states, "the enumeration in the constitution, of certain rights, shall not be construed to deny or disparage others retained by the people." thus, any regulatory body, establishment, agency, administration, panel, or group or any sort whatsoever may not, by constitutional law, use any language within the constitution as a means to extend its legal reach into that which was not mentioned within the constitution of the united states, which by default, was left for the states and the people to govern, regulate, and restrict. This includes the states' right and the individuals' right to regulate, approve, disapprove, restrict, or bolster in any way devices, foods, liquids, or substances used willingly by individuals in any context whatsoever."

 

[gopher_byrd]

I posted mine the same day as the CASAA posted the 4th Call to Action.

Come on people!!!

Is the rest of your life worth a few minutes submitting your comments???

I know mine is!!!

 

[muranternet]

Done, and sent copies to my congressman and senators.

I am writing to address my concerns regarding the upcoming FDA deeming proposal on tobacco products, specifically electronic cigarettes. The deeming proposal lacks sufficient backing research, as stated in the electronic cigarette section (IV.D.), yet seeks ambiguously broad regulatory powers over these devices. I also have significant concerns regarding the impact of the deeming proposal on small businesses, which includes most electronic cigarette businesses.

Some background: I was a pack a day smoker for over 25 years. I have attempted quitting with nicotine gum, patches, Chantix, and cold turkey. None of these worked. Chantix, in particular, caused mood swings so significant that I stopped taking it. I lost a personal friend to suicide shortly after he began Chantix therapy, so I suppose I was lucky in this regard. Today, I am smoke-free and have no desire to light a cigarette, and this happened immediately upon using a refillable electronic cigarette. I did not even intend to quit smoking at the time; it simply happened. From a personal standpoint, I find this remarkable and life-saving. I am still using electronic cigarettes and choosing the strength of my e-liquid to consistently reduce my dependence on nicotine.

The most significant problems with the proposal come from classifying electronic cigarettes as tobacco products. Electronic cigarettes and their liquids contain no tobacco. Nicotine is delivered via USP-grade propylene glycol and/or vegetable glycerine. The combustion of tobacco produces the myriad carcinogens and toxic byproducts that electronic cigarette users seek to avoid, while also eliminating the presence of these toxins in secondhand smoke.

Regarding insufficient research: in section IV.D. we read, "We do not currently have sufficient data about e-cigarettes and similar products to determine what effects they have on the public health." Variations of this statement appear in many anti-electronic cigarette articles that rely on fear of the unknown rather than science to promulgate an agenda. In truth there are studies of the chemicals present in the inert liquid, the inhaled vapor, and the expelled vapor. One peer-reviewed example is BMC Public Health | Full text | Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks. More studies are available and are ongoing. I believe in the need for research, but to infer that a product is dangerous without study is irresponsible.

The proposed reporting requirements are extended from existing rules governing large multinational tobacco conglomerates, including Philip Morris (Mark Ten) and Lorillard (Blu). While such companies can easily shoulder the expense of regulatory requirements, smaller manufacturers cannot, effectively eliminating small entrepreneurs from the picture and leaving large company disposables as the only alternative. Such disposables have a poor reputation among many electronic cigarette users due to poor liquid and hardware quality, bad flavor, and high customer expense over time. I should point out that I first tried disposable electronics from these manufacturers, and continued smoking for months thereafter due to my dissatisfaction.

Electronic cigarettes have transformed my life for the better, and I want others to have the same opportunity. Thank you for your time.

 

[300fury]

done!! This is the most important action we as vapers can take. Come on everybody , let your voice be heard!!!

 

[Megan Kogijiki Ratchford]

Done, and sent copies to my congressman and senators.

I feel like I need to go sit at the kid's table now...that is FREAKIN AWESOME!!!!

done!! This is the most important action we as vapers can take. Come on everybody , let your voice be heard!!!

Exactly right 300, thank you!!

 

[jumphour]

Okay, done. Submitted 3 paragraphs, and then sent tracking # to CASAA. I am so proud of the fact that I haven't had a cigarette in 3 weeks. I wrote about the things I've tried in the past and how they failed. And I talked about how e-cigs have filled the void that was left empty by the other methods, and how I didn't want the opportunities to come (health, happiness, etc.) to be taken away from me. Boy, I hope this all works out.

 

[zoiDman]

People should NOT WAIT to the Last Minute to make their Comments.

Websites can get Overloaded. e-Mail Boxes can get Full. And believe it or Not, people Forget dates.

Make your Comments Now.

 

[Megan Kogijiki Ratchford]

Okay, done. Submitted 3 paragraphs, and then sent tracking # to CASAA. I am so proud of the fact that I haven't had a cigarette in 3 weeks. I wrote about the things I've tried in the past and how they failed. And I talked about how e-cigs have filled the void that was left empty by the other methods, and how I didn't want the opportunities to come (health, happiness, etc.) to be taken away from me. Boy, I hope this all works out.

Well done! And congrats on making it three weeks, that is awesome!!

People should NOT WAIT to the Last Minute to make their Comments.

Websites can get Overloaded. e-Mail Boxes can get Full. And believe it or Not, people Forget dates.

Make your Comments Now.

Good safety tip Egon, don't forget everyone!!

 

[dragonpuff]

I just submitted this:

I am concerned about the requirement of premarket applications for any tobacco product developed after February 2007 in order to market said product. The vast majority of e-cigarettes currently on the market were developed very recently, and these requirements will remove all products until the premarket application is approved. The combined effect of lost revenue from said product and the cost of filing a premarket application will prevent most of these products from re-entering the marketplace entirely, as many e-cigarette manufacturers and sellers are small businesses who simply cannot foot the bill.

The consequences of this are multifaceted and devastating to the economy. Only large corporations will be able to market e-cigarettes, including major tobacco companies. The rest will not be able to bring their products to market, forcing thousands of businesses to close and lay off all of their employees.

I urge you to seriously consider allowing products to remain on the market while their applications are pending, and to instill significant cost-reduction measures for premarket applications from small businesses so that everyone can afford to bring their product to market.

Thank you for your consideration.

It's my 12th comment... or 11th, or 13th..... I have no idea how many comments I've submitted, I lost track

 

[parrothead60450]

I got mine in! Thanks for the nudge! Keep nudging! It is time folks!

 

[Megan Kogijiki Ratchford]

One of my favorite bits from my comment is: "Folks, vaping is widespread and successful, the cows have left the pasture, it's too late to close the gate. You are coming into unknown waters; here there be dragons and we will NOT be silent!!"

 

[sonicdsl]

Bringing to the front (again!)...

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)

 

[dragonpuff]

One of my favorite bits from my comment is: "Folks, vaping is widespread and successful, the cows have left the pasture, it's too late to close the gate. You are coming into unknown waters; here there be dragons and we will NOT be silent!!"

I love this! I want this on a plaque in my living room!

 

[KODIAK (TM)]

Just want to keep this "bumped".

And to all the seasoned vapers here... yes, many of us can probably circumvent any obstacle the FDA throws at us but... those that follow may not have the opportunity to quit tobacco like we did using a free and flourishing market. For most of them it will simply be out of their reach.

 

[Megan Kogijiki Ratchford]

I love this! I want this on a plaque in my living room!

Awwww, thanks!!

 

[Megan Kogijiki Ratchford]

Just want to keep this "bumped".

And to all the seasoned vapers here... yes, many of us can probably circumvent any obstacle the FDA throws at us but... those that follow may not have the opportunity to quit tobacco like we did using a free and flourishing market. For most of them it will simply be out of their reach.

Agreed...I am prepared for this to shut everything down for a year or two but the new folks who are just getting started...oh man, breaks my heart!

 

[dailywalker]

Done and I'm happy to help! I sent comment number as well