Comments Please on AAPHP Petitions to FDA

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5cardstud

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Perhaps those who have posted comments opposing the two AAPHP petitions can explain to the rest of us why they want the FDA to ban e-cigarettes (which will occur unless the FDA reclassifies and regulates e-cigarettes as tobacco products), and why they want the FDA to prevail in the SE v FDA lawsuit (which seeks to prevent the FDA from banning the products by classifying them as drugs/devices, and which seeks to require the FDA to regulate e-cigarettes as tobacco products).

The only reason that e-cigarettes have remained on the market for the past nine months is because Smoking Everywhere filed a lawsuit against the FDA claiming that the FDA abused its authority by classifying e-cigarettes as drugs/devices (in an attempt to ban the products), and because federal Judge Richard Leon ruled in favor of SE and against the FDA.

The AAPHP petitions seeks to achieve the same goal as the SE and njoy seek to achieve in court (and have already spent millions of dollars in legal fees).

Those who have posted notes opposing the AAPHP petitions are either lurkers who want the FDA to ban e-cigarettes, or are totally naive of federal drug and tobacco laws, FDA regulatory policies and procedures, the SE v FDA litigation and thousands of notes that have been posted on the ECF carefully explaining all of these things in great detail.
Ok you want an explination? Here it is. I have fought the tabacco addiction all my life and I have found a device that works. Now along comes someone who tells me hey we want to have the FDA regulate this device as a tabacco product. Not why just that you want it. I don't know you from adam and you want me to put my device in the hands of the FDA as a tabacco product thats against it in the first place Heck no I won't. This whole fiasco is because you people put the horse before thwe cart. Next time try to remember that alot of us people don't spend every waking minute on the e-cigarette battle and need to know the reason why you want us behind something or not behind it. Especially when someone wants to team our device with a product thats against our continued use, thats all we knew.
 

Vocalek

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Could we all please just take a deep breath and remember that we have a common goal here: To keep electronic cigarettes legally available.

All we are disagreeing about is the best method to accomplish this.

Those of us who have been around for a long time have seen some extremely underhanded things pulled by the FDA and other organizations that purportedly have public health in mind. They have misrepresented the facts and have urged lawmakers who don't understand any of it to pass laws they have been told will protect public health, when the opposite is true.

We know for a fact that FDA and other groups send folks in to read this forum so that they can fomet conflict and gather information to be used against us. So the old-timers tend to be a bit mistrustful of the newbies until we know where you really stand.

On the other hand, the newbies feel attacked when their motives are questioned, and rightfully so. Let's just put down the baseball bats, knives, and guns and talk.

Here is an article that provides some background: Are electronic or e-cigarettes good or bad? Another viewpoint Missouri Group Against Smoking Pollution
 

Kate51

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5cardstud, the only choices FDA has open by virtue of their POWER is classify e-cig as a "drug delivery device", or a "tobacco product", Nicotine is so far derived mainly from tobacco, that's real. The FDA HAS the authority to regulate them, Courtesy of Big Government, we don't WANT them to do anything, but they're going to and are trying very hard to do just that. So we must secure the least offensive Classification if we can possibly do that.
So whatever the outcome, would you go back to smoking cigarettes again when all imports of e-cigs are banned, all commercially available juices are banned, or will you wish you had understood the TWO choices we are up against here as real. I fought cigarette addiction my whole adult life as well, believe me there is a much better way. So far tobacco cigarettes are still on the market, available presently without a prescription, courtesy of Big Tobacco, so what about nicotine as a "drug" Courtesy of Big Pharma don't you understand.
Smokers have more choices than quitting or dying!
 

River

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I am having a major problem seeing what the upside is in having continued access to e-cigs when all my favorite flavors will be removed from the market and I will be required to pay a hefty sin tax for a product that does not take a toll on health that tobacco does.

My choices are to pay triple what i do now and have to make my own fruit and candy flavors or to have it banned and pay triple what I do now and make my own fruit and candy flavors???

Really? That's it?

How can any of you find this an acceptible compromise?
 

natura

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The paragraph you quote is citing the legal basis for the right of the public to come forward and make a request of the agency via petition to change a regulation or how it is implementing a regulation.

Here is a link to 21 CFR 5.10: CFR - Code of Federal Regulations Title 21

yes it is. Your petition follows that basic format citing g and h thus calling them drug devices

G ((g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.

(2) The term "counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.)

AND H

((h) The term "device" (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.)

As found here on FDA web site for definitions!
SEC. 201. [21 U.S.C. 321]
 

Firegrl

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Could we all please just take a deep breath and remember that we have a common goal here: To keep electronic cigarettes legally available.

I think you have to acknowledge that a lot of us have other concerns as well. To me, there will be NO point in keeping these things legal if they are so heavily taxed like all other tobacco products that nobody can afford them. These things are basically manufactured electronics, which I assume, would cost more to manufacture than a pack of analogs. If we start taxing these things like cigarettes, I can see the cost going through the roof. And what about flavorings? I previously posted the link about banning cigarette flavorings. If we lump these in with tobacco products, you KNOW the FDA is going to add ecig flavorings to the list "to protect the children". What is that going to do for businesses that ONLY sell liquids? Sure, there is not tons out there, but I'd like to keep these good people in business.

I'm sorry, but part of the reason I vape is because of the choices of flavors, models, etc. I have. Sure, some will continue to vape without flavors (I'm sure some will DIY liquid), but will they still be able to easily purchase nicotine liquid to do so? And everything is cheap right now. I'm personally sick and tired of the government taxing me to death because I enjoy something. The point is, I like that there are choices and advantages to ecigs and I don't think people will continue to switch if we take away those choices and tax it to death. And classifying it as a tobacco product will do just that. They will still be legal, but not as appealing and that will prevent people from trying it. I know it would have stopped me.
 

Kate51

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I am having a major problem seeing what the upside is in having continued access to e-cigs when all my favorite flavors will be removed from the market and I will be required to pay a hefty sin tax for a product that does not take a toll on health that tobacco does.

My choices are to pay triple what i do now and have to make my own fruit and candy flavors or to have it banned and pay triple what I do now and make my own fruit and candy flavors???

Really? That's it?

How can any of you find this an acceptible compromise?
How about no choice at all. Your Government has authority over all tobacco products. There's no "compromise" in that. HOW they want to extend their authority still has a little daylight left. As a Drug or as a Tobacco product.
 

5cardstud

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5cardstud, the only choices FDA has open by virtue of their POWER is classify e-cig as a "drug delivery device", or a "tobacco product", Nicotine is so far derived mainly from tobacco, that's real. The FDA HAS the authority to regulate them, Courtesy of Big Government, we don't WANT them to do anything, but they're going to and are trying very hard to do just that. So we must secure the least offensive Classification if we can possibly do that.
So whatever the outcome, would you go back to smoking cigarettes again when all imports of e-cigs are banned, all commercially available juices are banned, or will you wish you had understood the TWO choices we are up against here as real. I fought cigarette addiction my whole adult life as well, believe me there is a much better way. So far tobacco cigarettes are still on the market, available presently without a prescription, courtesy of Big Tobacco, so what about nicotine as a "drug" Courtesy of Big Pharma don't you understand.
Smokers have more choices than quitting or dying!
I know that NOW. It's really to bad we weren't informed before the comments please post. Thats my point. By the way I put this on another post but here is what Jonathan Foulds wrote to me in an e-mail. His thoughts on it are:
Heres's the weird thing you may want to pass on to e-cig manufacturers....
if they insert a thin sheet of tobacco leaf into the e-cigarette, and cover the outside with paper and claim it helps with the "flavor' it may make it easier for the product to get regulated as a tobacco product (cigarette). Clearly all that would be bogus, but if you look at the current legal definition of a cigarette it may help.
Jonathan
 

DC2

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I am having a major problem seeing what the upside is in having continued access to e-cigs when all my favorite flavors will be removed from the market and I will be required to pay a hefty sin tax for a product that does not take a toll on health that tobacco does.

My choices are to pay triple what i do now and have to make my own fruit and candy flavors or to have it banned and pay triple what I do now and make my own fruit and candy flavors???
As has been stated many times, classifying them as a tobacco product does not guarantee there will be no flavors, nor does it guarantee they will be taxed. Each tobacco product is regulated differently.

And if attempts were made to apply such restrictions to electronic cigarettes then we would obviously have something to fight at that point. Right now, however, our immediate fight is to keep electronic cigarettes available before it's too late.

Really? That's it?
Not a single one of us posting on this thread wants that to be it.
But right now, yes, that's it.
 

Firegrl

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I am having a major problem seeing what the upside is in having continued access to e-cigs when all my favorite flavors will be removed from the market and I will be required to pay a hefty sin tax for a product that does not take a toll on health that tobacco does.

My choices are to pay triple what i do now and have to make my own fruit and candy flavors or to have it banned and pay triple what I do now and make my own fruit and candy flavors???

Really? That's it?

How can any of you find this an acceptible compromise?

Ah, thank god. I thought I was the only one that felt this way. This is exactly how I feel. They are trying to comprimise here, but it's NOT a very good one and could end of preventing smokers from switching over. We want to be preaching about a better alternative, and classifying it in with other tobacco products will take away some of the things that make it better. Smokers KNOW they are killing themselves, but they still do it. Most are NOT going to switch just by saying "it's better for you". If ecigs get taxed and end up being MORE expensive and have no flavor choices, smokers are going to say "what's the point?". You have to admit the money and flavors are a BIG factor for people to switch because we have no CONFIRMED, tested, conclusive evidence of these being used long-term (10 + years) is not killing us either. Why switch if they are just as expensive, no flavor/choices, and it could still end up killing me? Take away these advantages, we will lose people from trying/switching, and we will lose more advocates for these things in the future....
 

DC2

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The people talking about how this is a bad thing are not offering any concrete alternative.

Rest assured, if an alternative was available that was better than classifying them as a tobacco product, every single one of us posting in this thread, and this entire forum, would be 1000% in favor of it.

The only viable alternative coming down the pike is a "reduced harm" category.
But it doesn't quite exist yet, although they are apparently working on it.
 

CES

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Rest assured, if an alternative was available that was better than classifying them as a tobacco product, every single one of us posting in this thread, and this entire forum, would be 1000% in favor of it.

The only viable alternative coming down the pike is a "reduced harm" category.
But it doesn't quite exist yet, although they are apparently working on it.

+1

I also hate having to choose the lesser of two evils (feels a lot like voting)
 

5cardstud

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Now that I understand this alittle better I believe there is no choice to be made. We have to back this attempt at regulating this as a tabacco product or give up our ease at buying and having it shipped to us. The FDA is (fact) going to regulate this product. If they do as a drug we're pretty much S.O.L. cause it will be banned. If they regulate it as a tabacco product (which is where nic juice comes from) we got action. It's pretty much a no brainer. Just wished I would have been up on it a little more.
 

Kobudo

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The people talking about how this is a bad thing are not offering any concrete alternative.

Rest assured, if an alternative was available that was better than classifying them as a tobacco product, every single one of us posting in this thread, and this entire forum, would be 1000% in favor of it.

The only viable alternative coming down the pike is a "reduced harm" category.
But it doesn't quite exist yet, although they are apparently working on it.

This would be great, and a third classification is what I mentioned in the response I submitted to the first AAPHP link as a recommended "second step" after classification as a tobacco product to ensure immediate assurance of continued availability. We all know that several ECF members have been able to wean themselves off nic, and continue to vape at 0 mg. We also know some of these members are vocally opposed to having their completely non-tobacco-related juices regulated as if they had nic derived from tobacco in them.
 

River

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The people talking about how this is a bad thing are not offering any concrete alternative.

Rest assured, if an alternative was available that was better than classifying them as a tobacco product, every single one of us posting in this thread, and this entire forum, would be 1000% in favor of it.

The only viable alternative coming down the pike is a "reduced harm" category.
But it doesn't quite exist yet, although they are apparently working on it.
I do have a concrete alternative. Let it be banned, at least then the 14 to 25 year old smoker demograhic would be interested in trying it. If we have to sacrifice legality to get the people most in danger out of harms way then so be it.

Silly alternative? Maybe but all I have seen so far is how ... backwards the whole process has been up til now. Take for example the banning of fruit favor tobacco which was only ever used by old people and menthol which is loved by young people being left untouched by regulation.

We are going to let the same sorts of people that made that decision make these decisions and the result will be the same sort of foolishness.
 
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5cardstud

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5card it did get a little confusing, but I came into this Thread from this one, so it made more sense to me I guess.
Cigarette companies have been getting away with murder for over a hundred years.
Ya I didn't. I logged on for the day and Blam there it was "comment" I looked for the why's and why not's but they weren't there. It's my fault though cause I been e-mailing back and forth with Dr. Foulds and he was talking about doing just that but I wasn't paying attention that day.
 

5cardstud

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I do have a concrete alternative. Let it be banned, at least then the 14 to 25 year old smoker demograhic would be interested in trying it. If we have to sacrifice legality to get the people most in danger out of harms way then so be it.

Silly alternative? Maybe but all I have seen so far is how ... backwards the whole process has been up til now. Take for example the banning of fruit favor tobacco which was only ever used by old people and menthol which is loved by young people being left untouched by regulation.

We are going to let the same sorts of people that made that decision make these decisions and the result will be the same sort of boondoggle.
I too personally don't care what they do it won't affect me but I'm thinking of all the people that it does matter to. I feel a responsibility to do what I can for the rest of the vapers in this world. Not meant as a slight. LOL
 

Firegrl

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The people talking about how this is a bad thing are not offering any concrete alternative.

Rest assured, if an alternative was available that was better than classifying them as a tobacco product, every single one of us posting in this thread, and this entire forum, would be 1000% in favor of it.

The only viable alternative coming down the pike is a "reduced harm" category.
But it doesn't quite exist yet, although they are apparently working on it.

Well, when I don't have to work all day to get no Medicare and Social Security when I retire, and don't have to bleed money for taxes, I will happily take the time to find an alternative.

You mention the "reduced harm" alternative. What's stopping us from trying to get that pushed through quicker? What could we, as citizens, do to help with that? Couldn't the AAPHP give out info on how to help, instead of spending all their efforts on possibly classifying something in the completely WRONG category? Part of an organization's responsibility is to educate... I personally think if we classify these things incorrectly the first time, it will be nearly impossible to try and reclassify later when a new/more relevant category is found.

And I don't see what the major emergency is. I kinda see some scare tactics going on in this thread. SIGN THIS NOW OR ECIGS WILL BE BANNED FOREVER! Um, I have read the current court battle, and altough they are trying to seize SOME shipments, it's VERY obvious that our approved vendors at the bottom of the forum are still receiving most, if not all, their shipments from China. Read the stock status updates they put up. And I'm sorry. The courts aren't very fast and neither is our government. We have the time to come up with a real solution, not a frickin' band-aid as we call it in the IT world.

It's just really disheartning to see scare tactics being used to make people panic and sign something that could really screw us down the road. My mom taught me to do something right the first time because fixing it could be hard, tiring, and 10x more work later on down the road.

And I ask again, why aren't we hearing from any of our vendors on this subject? This will affect them in more ways, but I don't hear anything from them....
 
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