Contact the FDA - Before December 28th!!

[NanoVapor]

That felt good, to insult the FDA. Screw recommending what they should do, the only recommendation they hear is the ca-ching of a cash register opening.

Buncha numbnuts wearing Rolex's at the FDA: "Lets approve fentanyl patches, fentanyl is only the most horrific opiate to withdraw from, its also the most dangerous because of its highly selective mu1 receptor agonism and the inherent respiratory depression that results from that. Futhermore, lets allow the patches to contain enough lethal dosages of the drug to kill an entire family, and lets let the patient slap this loaded-revolver of chemical weaponry onto their skins surface and hope that the pharma company didint make an incredibly tiny mistake that could cause the entire dosage to leech out at once and cause a massive overdose that robs children of their parents and parents of their children.... good idea? This briefcase full of lobbyist cash says so!".

Thats just one of the almost endless streams of xxxxed up xxxx the FDA does. Dont even get me started on Zyban, I had to be hospitalized for attempted suicide from taking that ....-wannabe xxxx, it gave me severe bipolar episodes, and I mean SEVERE. Good call FDA!! Thanks.

 

[adama2006]

Submitted. Hope it helps, i'd hate to have to go back to smoking pure cancer with a dash of poison.

 

[Ericfixit]

Sent my letter.


Cc. my state rep and senators

 

[Angelz]

Done. Except the ban on flavors.

 

[GarrettW]

Got mine in.

in case you're curious... here's what it says. (comment tracking no. 80a71140)

I want to urge those making decisions on this matter to remember the core principles of liberty, and to carefully consider which measures are necessary to protect our underage citizens from tobacco and which reach beyond their intended purpose and infringe on our rights. It is my belief that individuals of a legal age should have the freedom to engage in harmful activities if doing so does not directly harm others against their will.

Regarding electronic cigarettes (more correctly known as personal vaporizers or PVs), please exercise restraint when considering regulations on this fledgling industry. The FDA's prior tests on such devices were very limited in scope and hardly scientific. Those results do not reflect the majority of products in the PV market. I would encourage the FDA to engage in more and better scientific studies to get real answers to all the possibly questionable aspects of these devices. Please allow these life-saving products to remain on the market while they are being more thoroughly evaluated. I believe if you investigate every angle in your research and resist the influence of tobacco's tax revenue, you will find very little evidence that PVs are harmful.
I have heard of countless people who were able to quit using traditional cigarettes using these when other methods didn't work, and it would be a mistake to crack down on these so heavily that they would be nearly unobtainable. It would certainly seem unconscionable to regulate PVs heavier than cigarettes, as cigarettes are MANY times more harmful than PVs would ever be (but I know you like the tax dollars from tobacco).
Also, please consider the research out there that shows nicotine to not be that addictive of a substance at all when administered without the MAOIs in tobacco.

Lastly, lumping PVs into this legislation is fallacious, as they are not tobacco products at all.
​

 

[DMertz99]

Even if the details never see the light of day, I'm certain the actual number of public comments (both pro and con) will be considered by the FDA.

I personnaly feel letters to the editor of our local and national newspapers would have a more direct impact on those considering legislation.

It's also interesting that NJoy was so willing to give in on the flavor issue.

(Why do I keep hearing that irritating "cha-ching" sound in the background?)

 

[ECGuy]

You know what struck me about this form? And says a lot about how politics are done in the US now.

1- Asked for a country. Why are we accepting comments from non US citizens?

2- Required "Organization" field. And the Submitter category

Again, why an organization field at all? Yet alone one that is required. This is a place for citizens to comment, individuals, yet individuals were one of many different categories to choose from and the option of "no organization, simply a citizen" was not offered.

That is because organizations run the politics. Organizations are the ones who comment, industry is the ones who comment, companies and corporations are the ones who comment.

It's sad. But good to see that we have at least three pages of posts here of people who commented. Sadly this is not a 300 page thread like it should be. I hope everyone commented. We may be ignored because we are not in the other categories and are simply citizens and not part of some organization that should be listened to, but we put in our voice.

Someday we'll actually get organized too.

 

[slybootz]

I submitted my letter.

However, I do not think they should try to ban flavorings for e-juice. Flavored analog cigs were banned because of their possible appeal to children. Analogs are tobacco products, with nicotine..... so?

E-cigs are an alternative to smoking analogs. The are an ALTERNATIVE way to get your nicotine fix, or it can be used to quit all together if you have the will(or won't)power. The FDA has no problem with Nicorette gum or nicotine lozenges that have flavors such as orange, mint, fruit chill, etc.... no reason why they should attack the e-juice flavors

 

[Tracey1]

That felt good.

 

[alexprobb]

My comment I've posted several days ago is not listed on that site
Regulations.gov
Can you find yours?

 

[tankueray]

Done.
I work for an agency that regulates health and safety. I've read many comments in my time. I hope that with that knowledge I crafted something worthwhile.

To those of you concerned about flavor, not an issue, we can make our own and they cannot ban baking supplies, or feed supplies, or drugstore supplies. The issue is the actual nicotine. I'm hoping that the worst that will happen is that we have to go to the pharmacy to pick some up.

But if you will notice, all of the NRTs on the market do not have a tobacco flavor, no?

Personal anecdotes are good, too much passion is not. Threats are stupid. I'm not going to knock anyone for making an passionate plea for their own health and that of their families, but only provide your own experience and do not provide the experience of others unless you are personally connected to them.

The way we do it is that all comments are read and compiled, then presented to the panel/commission/committee/whatever. We generally actually follow established law and not political influence (however most of the law was created by political influence.)

As I stood in front of my city council arguing against the smoking ban with well presented, scientific evidence - I knew I was fighting a losing battle because the council members all had conflicts of interest and there were Drs. willing to substantiate science that had been proven flawed.

We will see.

As an aside: I'm very good at what I do. A rule that was promulgated a few years ago actually quoted my comments in the FR notice. Granted, they were my comments, but were officially submitted by my agency, so they had more weight. But seeing my contribution in the official rule felt pretty damned good.

I said all of the normal things, didn't mention flavor as it's irrelevant, conceded that I would buy liquid from behind a pharmacy counter, recommended the accepted warning labels and all of the common sense that we seem to have here in this group.

A few things I didn't add because I didn't have the research: They mention the CDC estimate of cost and health effects - someone should point out that PVs put the cost on the user and will actually decrease the cost of healthcare. (Oooh healthcare! That's a big thing right now, isn't it?) And the FR notice is only asking for comments related to tobacco products, so technically we don't have a dog in this hunt, but I still feel that it is important to remind the FDA that these are not tobacco products.

There will eventually be something related specifically to PVs, probably as drug-delivery devices, and we will need to rally more strongly then. If someone with a brain is in the FDA related to this notice, they will disregard any comments on the regulation of PVs (because that's not what they're supposed to be doing here.) So, if in the final rule there is no mention of PVs, it's because they are conceding they are not tobacco products and will deal with that later. (So no one be offended if PVs aren't mentioned, it may be a good thing.)

IIRC, comment period will close on the 28th, they will have 60-90 days to compile and then present to the committee/whoever. A hearing will happen, many of these are webcast, sometimes they last all day! Discussions ensue, a final rule is concocted and then will probably be published around July. I get FR notices every day, I'll keep an eye out.

I don't come here often, but if I hear anything I'll chime in.

Another aside: many businesses in town are allowing PVs, no one seems to care. I have not been made aware of any city or state complaints related to them. For you all: most state agencies allow you to track complaints online now. You'll need to go to the web site of the agency that regulates indoor air quality and find somewhere where you can track the status of a complaint. Hopefully you'll be able to see submitted complaints by county and browse around. Alternatively, once you've determined the agency that regulates indoor air quality you could do a Public Information Act request for all the PV related complaints within a specified period of time. Just a suggestion, I can't actually do such things if I want any job security, but you! You're the internet! You can do anything!

 

[gcram399]

I wish the government would keep their greedy hands out of our business. All they want is the lobby cash from Tobacco Industry.

Anyhow, I posted my opinions.

George

 

[Cubiccube]

I really just want the FDA to do a real test of Personal Vaporizers(e-cigs) against an actual cigarette, not cessation drugs. I understand the need to make sure that these are safe, but the US allows tobacco manufacturers to sell cigarettes to people like me who have been addicted for years. Personally I had been smoking since I was 18, and have UNsuccessfully tried to quit 5 times over the last 11 years. After using a Vaporizer for 1 day, I had no interest in smoking ever again. Now I had just recently found out about theses devices, and am hearing that the FDA is moving to ban these wonderful devices. I honestly am dumbfounded.

How in the world can they honestly say that they want me to go back to cigarettes or the other stop smoking items that have a ridiculous fail rate? I as a full upstanding citizen of the United State, of sound mind, and the idea that I should be able to have freedom to make up my own mind, would like the FDA to step back take a breath and see what these devices are doing for smokers around the world.

I hope that these decisions are made with the best interest of the citizens of the United States in mind. There is no reason to keep a potentially life-saving product off the shelves without doing proper research first. Also if one of the issues is with the manufacturing process, I'm sure an entrepreneur would love to set up manufacturing jobs in the US.

Considering dangers of nicotine in high amounts, I would say that I understand a legal age limit should be introduced. Children should be protected from possibly dangerous drugs, until they reach the age of consent and become a responsible adult, such as is with alcohol and tobacco. Also I do not believe that Vaping(as it is called) or any of the devices or liquids used with vaping should be classified as tobacco use. Other than the fact that nicotine is extracted from a tobacco plant, the actual usage and makeup of the e-liquids is nothing like normal tobacco usages.

That is what I posted

 

[rtbob]

Since I started using E Cigs three months ago My lungs have totally cleared up. No more coughing up sputum all day long. I can use the stairs at work with out becoming short of breath. I have discontuned using my Albuterol inhaler.
I smoked for 31 years. I was unable to quit using patches, gum and most recently Chantix. The ECIG has saved me from a slow and agonizing death. It will save millions from such a future. Most of my patients have COPD. Once this disease reaches it's final stage it becomes impossible to wean the patient from the ventilator. I have pulled the tube from many people and watched them drown in their own secretions. Must this continue to be the fate of smokers? Or maybe we get lucky and die of cancer first. Please do not ban this safe alternative to smoking. It is my (and millions of other people) only hope.
Robert Kelly RRT

 

[BigJimW]

Done.
I work for an agency that regulates health and safety. I've read many comments in my time. I hope that with that knowledge I crafted something worthwhile.

To those of you concerned about flavor, not an issue, we can make our own and they cannot ban baking supplies, or feed supplies, or drugstore supplies. The issue is the actual nicotine. I'm hoping that the worst that will happen is that we have to go to the pharmacy to pick some up.

Nicotine is also not going to be a problem to get. Nicotine in of itself for research and lab use does not fall under FDA regulations, as it is not meant for human consumption, but research work. Nicotine is not illegal to own or sell as far as I am aware. Blip Labs is a good source for research grade nicotine in a PG suspension. It is only when it is added for human consumption (patch, gum, e-juice, etc) that the FDA gets their panties in a twist. Research grade nicotine is very easy to get, and does not fall under the FDA thumb. (I may be wrong here, so if I am, someone correct me). Research grade nic is just another chemical to be found in a laboratory. Nicotine itself has no regulations.

The big problem may actually lie in the electronics and hardware. We can make batteries and other hardware, but the atomizers will pose a problem.

 

[TokenVapor]

My wife and I left comments.

 

[navyboym]

I beleive the only regulation that should come of this is the prohibition of sale to minors. Most other regulations that come from the FDA will in the end result in less people vaping by either the lack of availability or increased cost. If vaping is the miricle that we hope and beleive to be, those two end results could ultimately end in more deaths suffered by people smoking analogs.

Sad state of the nation when the individual isn't free to choose what risk they wish to bare.

 

[MX5]

I got my post done, and here it is:

I have been smoking for 30 years!! Thanks to my personal vaporizer(e-cigarette) Even though it is nothing like a cigarette. I can now say I am a non-smoker! Finally, after trying everything on the market to stop smoking I have found the solution and you want to take that away from me?? Shame on the FDA for even considering banning this product.

The thing is, I don't want to quit smoking, I just want an alternative to smoking without harming myself and my loved ones any more than I have and the personal vaporizer is the answer for me. I have actually started feeling better by using my personal vaporizer!!!!!

Please consider your action in this matter, for all former cigarette smokers that now use the personal vaporizer and for all non-smokers that are subjected to 2nd hand smoke. Wouldn’t it be great for all of America to be Smoke Free? It could be with the Personal Vaporizer!!!

This is just the way I feel, I Love My Vapor King!!!!!!!!!!!

 

[Webby]

http://www.e-cigarette-forum.com/forum/casaa/57399-casaa-response-fda.html#post861465

 

[cmonkey]

Others were saying they didnt know what to tell the FDA, so I thought I'd post about what I told them.

Just a short anectode about being a smoker for 20 year, how gum, patches, and Chantix did not work to help me quit smoking cigarettes, but the e-cig helped me quit analogs after only 3 days of owning it. Also a short comment about how if the FDA and the US Government really, truly, sincerely, wants its citizens to stop smoking cigarettes, that it "will support the use of e-cigarettes as a replacement device."

I didn't mention any specific policies they should adopt, as I prefer the government not solve problems that dont really exist. Im sure they'll create a few thousand on their own, and we'll end up having to deal with them.

cmonkey

ps. I read an article somewhere, that at least a few congressmen, and senators are using personal vaporizers on capital hill, and that one of them had sent one to President Obama. Lets hope this has a positive influence.