Aaphp Has Submitted Two Citizens Petitions To The Fda

[FTJoe]

I have a hard time with them regulating e-cigs as a tobacco product because then they would be classified AS a tobacco product; therefore, they would be subject to the same tabacco taxtation laws for each state. The price of juice would go through the roof!

Agreed...like it or not, in my opinion, juice should be under control of the FDA at least for a while just as all the other NRTs were (I think). Problem is, who's got the money for the phased studies? FDA I believe just reviews, so the reality is if they get control, it'll be wiped out until a study is done. IMHO.

[abitmorevodka]

Let me muddy the waters even more...

1. BE WARNED: If the FDA gains ANY regulation over these, the sky's the limit. That's how they operate. IF they don't ban them outright, they'll have to regulate production of everything which will raise the costs to unheard of levels, then they'll tax them on top of that. At some point, one will have to have a special license to sell any ecig products and they'll ban all flavors except tobacco (and I hate the tobacco flavors.)

2. So what if I'm addicted to nicotine as long as I'm not getting my "fix" by smoking regular cigarettes? Is a nicotine addiction any more harmful to the general welfare of society than a caffeine addiction? Why should nicotine be regulated when caffeine isn't?

3. What if I choose to vape no-nic liquid? (I often do.) Why should the FDA be concerned about that?

4. I'm against the under-18 thing on principle, however, I'd be willing to cede that. However, if a minor decides to smoke it won't be b/c of advertising or flavors, it's b/c of peer pressure. The whole "it's for the kids" thing is a ruse. If a minor is going to smoke, I'd much rather them use an ecig rather than a real cig. And they continue to smoke in spite of all the laws and regulations.

5. Are ecigs any more dangerous than anything else (FDA-approved, of course), in my medicine cabinet?

6. I've been a law-abiding, tax-paying citizen all of my life. If the FDA continues in this silly war against ecigs I will either be condemned to die of a tobacco-related disease (assuming I don't get hit by a concrete truck), OR I'll be forced to become a criminal when my only "crime" was trying to stop using regular cigarettes when all else had failed.

Teresa

[FTJoe]

1. BE WARNED: If the FDA gains ANY regulation over these, the sky's the limit. That's how they operate. IF they don't ban them outright, they'll have to regulate production of everything which will raise the costs to unheard of levels, then they'll tax them on top of that. At some point, one will have to have a special license to sell any ecig products and they'll ban all flavors except tobacco (and I hate the tobacco flavors.)

Agree on most points except tax, I doubt they would handle the tax.

2. So what if I'm addicted to nicotine as long as I'm not getting my "fix" by smoking regular cigarettes? Is a nicotine addiction any more harmful to the general welfare of society than a caffeine addiction? Why should nicotine be regulated when caffeine isn't?

I agree but you won't know until a study is done.

3. What if I choose to vape no-nic liquid? (I often do.) Why should the FDA be concerned about that?

Safety of the device and fluids are still in question. I think if the fluids were separated, nic and non-nic, that might help butyou would be asking the government to be reasonable. ;-)

4. I'm against the under-18 thing on principle, however, I'd be willing to cede that. However, if a minor decides to smoke it won't be b/c of advertising or flavors, it's b/c of peer pressure. The whole "it's for the kids" thing is a ruse. If a minor is going to smoke, I'd much rather them use an ecig rather than a real cig. And they continue to smoke in spite of all the laws and regulations.

Yes a ruse, but they will hang their hat on the stings that are finding kids buying these. And if studies aren't done, effects on "kids" will be unknown.

5. Are ecigs any more dangerous than anything else (FDA-approved, of course), in my medicine cabinet?

I agree with the point but you won't know until a study is done. Its not a matter of dangerous or not dangerous. Its a matter of being able to to determine labeling, who should take, who shouldn't, side effects, etc. That's basically what the FDA does, and for certain items, control via the law.

6. I've been a law-abiding, tax-paying citizen all of my life. If the FDA continues in this silly war against ecigs I will either be condemned to die of a tobacco-related disease (assuming I don't get hit by a concrete truck), OR I'll be forced to become a criminal when my only "crime" was trying to stop using regular cigarettes when all else had failed.

Sad but probably true.

[abitmorevodka]

While I agree with the spirit of the plan of the AAPHP, I can't get behind the letter of it. It is not a tobacco product, there is no tobbaco in it. Calling e-cigs a tobacco product because it contains nicotine is like calling Coke-A-Cola a fruit because it contains sugar. Thats a can of worms I don't think we can afford right now.

I'm with you, Doc. How many of us started using ecigs b/c of all the bans?

Besides, it's the government and right now it's currently on steroids. Give them an inch...

Teresa

[abitmorevodka]

Agree on most points except tax, I doubt they would handle the tax.

I agree but you won't know until a study is done.

Safety of the device and fluids are still in question. I think if the fluids were separated, nic and non-nic, that might help butyou would be asking the government to be reasonable. ;-)

Yes a ruse, but they will hang their hat on the stings that are finding kids buying these. And if studies aren't done, effects on "kids" will be unknown.

I agree with the point but you won't know until a study is done. Its not a matter of dangerous or not dangerous. Its a matter of being able to to determine labeling, who should take, who shouldn't, side effects, etc. That's basically what the FDA does, and for certain items, control via the law.

Sad but probably true.

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

Well, that's the point, isn't it? They're trying to regulate this without any studies being done. Not that they need anything like real science or even logic to regulate anything. (Look how the EPA just regulated carbon dioxide.) This would have been just another regulation passed if it hadn't been challenged. Nicotine's been around a long time, it's not like it's a new substance or drug. These studies cost a lot of money and take a long time. The cost of such and the burden of proof should be on the FDA.

I meant the federal government, of which the FDA is a part, all the way down to the states and a lot of local governments will jump on the tax bandwagon, and jump they will. First they demonize it (equate ecigs with eeeevil cigarettes!), then they tax it and most don't bother protesting it any more than they protested the latest tobacco tax increase.

I don't know if they should try to change the rules in the middle of the game. It sounds as if they had absolutely no proof in the trial. I don't know how they think taking this case before an appelate court will actually help them, unless they're just trying to bully they two companies into dropping the suit rather than face the legal expenses.

We're currently living under a soft tyranny and this is what happens. It's all very depressing...

[abitmorevodka]

Agreed...like it or not, in my opinion, juice should be under control of the FDA at least for a while just as all the other NRTs were (I think). Problem is, who's got the money for the phased studies? FDA I believe just reviews, so the reality is if they get control, it'll be wiped out until a study is done. IMHO.

Why would you not have a problem with them regulating production? (Just playing devil's advocate.) I feel the ecig community is fully capable of regulating itself. The companies themselves have a vested interest in producing a clean product. No one's more concerned about the safety than those of us who use the juice. If they regulate juice (and the costs to comply with FDA regs are enormous!), chances are it will be illegal to make your own or to buy some of the ingredients...

[FTJoe]

Why would you not have a problem with them regulating production? (Just playing devil's advocate.) I feel the ecig community is fully capable of regulating itself. The companies themselves have a vested interest in producing a clean product. No one's more concerned about the safety than those of us who use the juice. If they regulate juice (and the costs to comply with FDA regs are enormous!), chances are it will be illegal to make your own or to buy some of the ingredients...

Because in the idealized world in which I live, the FDA's charter is to protect us. I do not know what is in the juice, I want it tested. in this crazy perfect world, I want to be safe. The FDA, in their purest form is a good thing.

Unless pushed, this will be my second to last post on the subject. I'm trying to say in this really messed up, socialist/fascist state we are heading towards, I think we will all be out of luck soon. Obviously money is behind the FDA campaign. I don't believe its the FDA themselves, but money is going to our beloved politicians, and they are pushing as hard as they can against evil e-cigs through the FDA.

Again, most of what we use is from China, they are putting cadmium in toys, poison in baby formula and pet food. Will our US providers police themselves and make sure things are cool in their best interest? Yes. But...most of their product comes from China.

Stock up, find some DIY flavors and reduce to no nic. That is my advice.

[FTJoe]

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

Well, that's the point, isn't it? They're trying to regulate this without any studies being done. Not that they need anything like real science or even logic to regulate anything. (Look how the EPA just regulated carbon dioxide.) This would have been just another regulation passed if it hadn't been challenged. Nicotine's been around a long time, it's not like it's a new substance or drug. These studies cost a lot of money and take a long time. The cost of such and the burden of proof should be on the FDA.

That isn't how this works. I'm not even sure they are charged with regulating. Bottom line is they make sure things are safe. So they will not allow a "drug/drug delivery system" loose without seeing the studies. The burden to do that is not on them. I mix six household chemicals together and say it'll grow hair. The burden is not on them to prove it, the burden is on me to make sure no one here has a chance to drink ammonia until I submit studies on it. They really do need to know if pregnant women, folks taking anti-depressants, etc. should steer clear of something, even things that are good. They are basically about labeling, think of it that way, things have to have a label, who can take, who shouldn't. I know we hate them in regards to e-cigs, but they do a good job overall. If this was a fair world, we would know who was directing the FDA so we could campaign against them.

Last post because I fear I am getting people to rail against me (actually I don't care but I am trying to help), just trying to say if I were a hard core vaper and addicted to nic, in case things don't go right, STOCK UP NOW!! I hope it doesn't go there, but fear it will.

[abitmorevodka]

That isn't how this works. I'm not even sure they are charged with regulating. Bottom line is they make sure things are safe. So they will not allow a "drug/drug delivery system" loose without seeing the studies. The burden to do that is not on them. I mix six household chemicals together and say it'll grow hair. The burden is not on them to prove it, the burden is on me to make sure no one here has a chance to drink ammonia until I submit studies on it. They really do need to know if pregnant women, folks taking anti-depressants, etc. should steer clear of something, even things that are good. They are basically about labeling, think of it that way, things have to have a label, who can take, who shouldn't. I know we hate them in regards to e-cigs, but they do a good job overall. If this was a fair world, we would know who was directing the FDA so we could campaign against them.

Last post because I fear I am getting people to rail against me (actually I don't care but I am trying to help), just trying to say if I were a hard core vaper and addicted to nic, in case things don't go right, STOCK UP NOW!! I hope it doesn't go there, but fear it will.

Well I can discuss something with you, agree or disagree w/o railing on ya'. :-)

I say the burden of proof is on the FDA b/c they started making all these claims. Burden of proof is on the accuser, not the accused.

I'm actually with you on the fascist state. How 'bout a soft tyranny quickly moving towards a totalitarian state? :-) Never would've believed it...

Anyway, let's not forget personal responsibility. If you're pregnant or have other medical conditions, don't use it until you can find out what kind of effect it will or could have on you. Approval by the FDA takes many, many years and costs millions upon millions of dollars.

The FDA has become too big and too mired down in red tape to properly perform it's job. We'd be better off having some private organization doing random testing.

However, maybe we've become too mired in the details ourselves. There was a line in the very first post, something about the FDA siding with the tobacco companies over the health of smokers/vapers. THAT is a strong statement and position. Isn't that what it comes down to?

I'll just throw this idea out there. We're brainstorming, right? What if we totally divorced vaping from nicotine? Go to no-nic juice. (I don't know, some companies could still offer the nic juice and let THAT be regulated if necessary.) I think that might be an option that would rock them back on their heels. If one didn't want to smoke and vape, it would help immensely to be able to vape no-nic while wearing a patch or whatever. Nothing else addresses the hand-to-mouth and - let's face it - the "addiction" if you will to the smoke/vapor itself. No wonder they have such a dismal success rate. It's NOT all about the nicotine. I think we associate a lot of behavioral actions with the reward of getting the nicotine fix. Over time our brain doesn't separate them out. I might still be getting the nicotine, but the other "good" things aren't getting satisfied.

I'm 52 years old. I've tried it all. I've spent hundreds if not thousands of dollars on NRT drugs, methods, etc., etc.. I tried all three anti-depressants. I came close to committing suicide while on Chantix. Luckily, I asked myself WHY I was feeling that way. The only thing that had changed lately was I had started taking the Chantix, so I quit taking it. A few weeks later, the FDA came out with the Chantix warnings. I could have been dead before they came out with those warnings about their "approved" drug. So, this is extremely personal for me.

I don't want to see the industry have to go no-nic, but if that's what would save it, it would be better than no vaping industry at all. But maybe that's what it will come down to in court AND in the eye of the public: Who's best interest does the FDA have at heart? The tobacco and pharmaceutical industries or the American people?

Also, let me throw this out there... Since I started vaping, I not only don't eat as much (I think getting the flavors tells my brain I'm eating or something), but when I eat, I actually CRAVE salads and fresh fruit. I practically eat salad or fruit for every meal. So, vaping - at least for me - has led to a healthier lifestyle in several ways. I never experienced this when smoking cigs.

Wow, I "talked" a lot. I've been up a really long time, so sorry. Probably time to start thinking about going to bed. :-) Teresa

[FTJoe]

Well I can discuss something with you, agree or disagree w/o railing on ya'. :-)

Just wanted to say it is a healthy discussion and was worried more about others thinking I was being a jerk. The issue is you understand the risks but the FDA is here to a large extent for the people that don't. Do not underestimate the large number of ignorant and stupid people out there that require protection. And besides that, the otherwise smart people who are assuming there is no poison in the juice, heavy metals in the attys, nicotine levels are correct, etc. That assumption may be a bad one...

My example stands, they are here to make sure when I say buy this potion, it contains all natural ingredients and will regrow your hair it is safe and doesn't contain a natural poison, or even caffeine that is discouraged from pregnant women. If its something they are not sure of, it will not be sold until it is studied and labeled. I won't argue if they made false claims, that is a bunch of BS and I agree. All they need do, which is I assume why they are making the claims, is say this needs to be studied and labeled. The burden is not on them to prove anything, its on the people who sell it and make money to prove it does what it says and its safe. This also protects those people from lawsuits.

Apathy then anarchy - stock up, vaping equipment, food and ammo!! ;-)

[VapeFiend]

"...in contrast to claims made at the FDA's press conference, there is no evidence that e-cigarettes have ever harmed any user..."

What about the exploding battery mod incident? Was that a hoax?

And @abitmorevodka, I agree about the whole Chantix thing. Antidepressants and antianxiety medications usually cause more problems than they solve. I am NOT a doctor, but I work around these drugs and I know a heck of a lot about them from professional and personal experience. There are much better non-drug therapies for situations like depression and anxiety. I found some self help cds that worked for me. I know, self help tapes... but at least they don't have side effects like suicidal tendencies or panic attacks

My grandpa's doctor put him on Chantix to quit smoking, against my protests, but he seems to be doing well with it. He quit smoking a few weeks before me and he's totally jealous of the e-cig

[markarich159]

What about the exploding battery mod incident? Was that a hoax?

Actually, no. There were 2 confirmed incidents. One involved a person(I believe the mod was a BB) who had his jaw broken when the batteries discharged. The BB does have a vent(under the switch), so I'm not sure exactly how the injury occurred.

The other involved a person who almost had his eye taken out by an atomizer(luckily he was wearing glasses, which were blown off his head). This incident involved a Chuck. The batteries in the Chuck discharged and the atomizer exploded off the end and became a projectile(which hit his glasses). Also, the hot discharge gases through the atomizer, blackened half of the persons face(although no permanent burns). The Chuck is vented as well, so it's apparent the venting on the mods, at least in these 2 cases, was insufficient to handle a quick Li-ion battery discharge.

In both cases dual stacked Li-ion batteries were used(either 2 CR2's or CR123A's in series), and , also in both cases, there was an apparent level of user error involved as well. In the Chuck case, there is a suspicion that possibly non-rechargable batteries were accidentally placed into a charger then used(which, obviously would lead to a dangerous situation).

[Jaysee]

"...in contrast to claims made at the FDA's press conference, there is no evidence that e-cigarettes have ever harmed any user..."

What about the exploding battery mod incident? Was that a hoax?

And @abitmorevodka, I agree about the whole Chantix thing. Antidepressants and antianxiety medications usually cause more problems than they solve. I am NOT a doctor, but I work around these drugs and I know a heck of a lot about them from professional and personal experience. There are much better non-drug therapies for situations like depression and anxiety. I found some self help cds that worked for me. I know, self help tapes... but at least they don't have side effects like suicidal tendencies or panic attacks

My grandpa's doctor put him on Chantix to quit smoking, against my protests, but he seems to be doing well with it. He quit smoking a few weeks before me and he's totally jealous of the e-cig

I'm very to new to vaping so i haven't studied enough to know alot about the ban other than the fact that i don't want it to happen anywhere, that includes the uk.Just a reply to the chantix pills thing.Sence I've started using this ecig i have many pple at work ask me about it(witch i love to tell pple all about its workings n sutch )and i tell em and direct them here.Their have been a number of them who have told me stories of chantix users they know who have had side effects like depression, suicidal thoughts, and i think someone even said hearing things(not sure if that was chantix or something else)Anyway ive haven't heard of and side effects of vapeing and pple quit smoking very quickly (if they want to)doing it.I really hope they see what an amazing thing this is and how many pple will live because of vaping.Im 33 now and can now feel the efects that smoking has been taking on my body and the pple around me.I've been vapieng exclusively for 3 or so days (see banner below)after smoking sence i was about 12 or so and i just realized that i haven't coughed at all today.Shurely they will see how good this is.

[PiWright]

Well I tried to post my comment but they said there was a problem with the document ID. I will try again. If you are interested, (and so I can copy and paste it to the Regulations.gov site again at a later time), this is what I wrote...

It would be an inherently hypocritical stance for the FDA to ban the use of personal vaporizers for the consumption of nicotine without the ban of traditional cigarettes. My debate is not that nicotine is in anyway good for human consumption but that traditional burned cigarettes are far more harmful to the public at large. As it now stands the perception of those who have left tobacco for vaporizers of the FDA and it's continued attempts are ban personal vaporizers are negative in the extreme. First; because there is little regulation of the personal vaporizer industry it is not perceived as the tax cash cow that traditional cigarettes are. Second; continued attempts to ban and vilify the personal vaporizer underscore just how far the FDA has gotten into bed with Philip Morris by way of the Family Smoking Prevention and Tobacco Control Act. Third; the FDA cares more to shore up the interests of the pharmaceutical companies that provide nicotine replacement therapies like GlaxoSmithKline who now hold a seat on the Tobacco Products Scientific Advisory Committee. Fourth; that the FDA does not care about the heath or interests of the consumer because the consumer will breed more tax payers anyways, think about the food additives they allow like "caramel color" which is a by product of the fuel/oil process, and *Yellow 5 and Red 40 which are widely used artificial colorings that are linked to hyperactivity and behavior problems in children (*Sourced from Center for Science in Public Interest article: CSPI Urges FDA to Ban Artificial Food Dyes Linked to Behavior Problems). In the end where many real doctors have endorsed personal vaporizers as a way to reduce the risks associated with smoking and even quitting nicotine altogether where the FDA continues to seek ways to discourage, denigrate and outright ban the use of personal vaporizers.

Of course I ran too long and did not get enough space to post the benefits of personal vaporizers as compared and contrasted with tobacco but I can easily add that in a second post at a later time, although the real doctors comment at the end makes for a strong segue.

[amcnutt]

I am new to this whole arena, and I am sure not the first person to ask this, but how can they clasify the e-cigarette as anything? The only thing with nicotine in it is the e-liquid. What if you had a vaporizor and 0% nic. juice, how can the FDA touch that? I agree that nicotine can be classified as a tobacco product as it is a derivative of tobacco, but how can they ban the electronic product?