Comments Please on AAPHP Petitions to FDA

Status
Not open for further replies.

Mister

Super Member
ECF Veteran
Aug 3, 2009
523
27
Nanaimo BC Canada
I think a number of misconceptions have come into play on this thread and I'd like to address them.

1. That the FDA wants e-cigs regulated because they can then be taxed. This is a misconception. FDA regulation has nothing to do with taxation.

2. That e-cigs are currently unregulated and it would be better to keep them that way. This ship has sailed. The FDA has classified e-cigs, has decided to regulate them as drug delivery devices, and is only waiting for the court's decision in the current case before ramping up enforcement.

3. That the petition plays into the FDA's hand. It is actually the opposite. The FDA is fighting to retain its declared position that e-cigs are drug delivery devices. The petition goes against this FDA position.

4. That the petition plays into someone's big money. It does the exact opposite. The FDA's current position maintains the huge revenue streams of Big tobacco and Big Pharm. The petition seeks to reclassify e-cigs in a way which threatens huge amounts of BT and BP money. It may well be that BT/BP money is a large part of what's behind the FDA's current position.

5. That classification of e-cigs as a tobacco product somehow "tars us with the same brush" as smokers. Classification as a tobacco product is a legal issue of great importance. But it is not an issue which affects public perception. Public perception will be molded by the media from the top down and by us as vapers from the bottom up. Every non-smoking friend I have has endorsed (heartily in most cases) my use of an e-cig. That's where we'll win in the perception arena; the legal classification won't affect this.

6. That categorizing e-cigs as tobacco products is wrong because they aren't made of tobacco. "Tobacco products" is a category for the purpose of establishing what kind of regulation is appropriate, nothing more. When you consider all the toxic crap in a cigarette, "tobacco product" is a pretty good category to be in when you want a minimum of regulation! It is a reasonable category because e-cigs are primarily meant to be an alternative to smoking and because the most important ingredient used in an e-cig for most users is obtained from tobacco (nicotine.) To those who point out alternatives, please research the cost of obtaining nicotine from various sources. Tobacco is THE source of nicotine for all of our suppliers due to cost.

7. That the November election will have any impact on e-cigs. It won't. Politicians will not be motivated by the small number of existing vapers. They will be motivated by Big Tobacco and Big Pharm who both want e-cigs classified as drug delivery devices and most definitely do not want them regulated as tobacco products. An election won't make any difference to this.

8. That there is a third choice such as creating a new classification for e-cigs or reclassifying them to be unregulated aside from general consumer protection laws. The government, the FDA, the non-smoking population, the "quit or die" activist groups, and the large commercial interests involved will not agree to a reclassification of e-cigs from drug-delivery devices to an unregulated product. And there isn't anything near the required voter base to create a new classification, not to mention the BT and BP dollars which would fight any such attempt.

9. That classification as a tobacco product is in some other way inherently bad for vapers. E.g. that it automatically implies no candy or fruit flavors. There are no such automatic consequences. Restrictions on cigarettes are specific to cigarettes, not to all tobacco products. Once reclassified as tobacco products, any restrictions the FDA ends up trying to apply to e-cigs will be challengable independently of restrictions applied to cigarettes.

10. That reclassification of e-cigs as tobacco products somehow negatively impacts our existing e-cig vendors. It does not! But the existing classification as drug delivery devices hugely impacts them, it will pretty much kill all existing small vendors if not changed.

11. That reclassification to an over-the-counter drug might be preferable. That's exactly the kind of classification the FDA has already made. It will require years of testing and huge expenditures by existing e-cig vendors before we see their products again, something they (and we!) can't afford.

12. That technicalities such as classification of the hardware, which can be used with 0mg liquid, have an impact on the end result of all of this. They don't. We are in a fight against two groups: 1) Big Tobacco and Big Pharm, both with a huge financial interest in seeing e-cigs categorized as the FDA currently does, i.e. as drug delivery devices, and 2) Quit or Die mentalities who don't care whether e-cigs are actually safe. Both groups will base their final fight on the delivery of nicotine. They'll shift to fight the devices or the liquids according to what works best for them. Technicalities such as ability to deliver a non-harmful smoking experience won't slow them down.
 
Personally against it being classified as tobacco As it is not part of tobacco.
nicotine can be gained from other plants rather then tobacco.
Drug device? Come on probably possible but that's not what its used for.

If they wish to regulate all drug devices get rid of glass light bulbs any type of pipe hookah & rolling papers.

The FDA is Lined with PM & RJR lining there pockets. Due to so much loss. & knowing of more loss.

*Government is corrupt*
Yes these are my personal opinions & I will stand by it.
If they bann E-Cigs I will still be able to get everything 1 way or another.
They would have to stop all postal & mailing & cargo ships across the world.

But I will never pay more taxes & more taxes like they did to our cigarettes.
Hence why i Don't buy smokes in the USA... & it is perfectly legal.

*Yes Sadly I still smoke Analogs temporarily until I can get over some issues I have here*

Sorry but what i have read sofar I am 90% against.
I will be out of this country soon due to the way its being run. I would prefer live on the street & happy then Stressing over what I will be losing over & over.

Again we all have our own opinions thoughts etc. That is why we are individuals. & I do not mean any offence to anyone ever From how I word things. I am not perfect nor do I know it all.

I wish all of us Good Luck & hope we could win this war against the Gov...
 

LeftCatcher

Full Member
Mar 10, 2010
25
9
Atlanta, GA
LMFAO @ "quit or die activist's"
i think i'd chose death, to get away from them :p
thats death as in i'll keep doing what i'm doing and gun you down.
(seriously the only thing stopping me is about 1.6 million law enforcement officials that are PAID to care about there well-being)

all i know is since i started vaping, i haven't gotten ticketed, or arrested, or kicked out of any place for smoking. cause i didn't care, i lit up like it was 1936 and called'em fascists and communists the whole way.

i don't think that these petitions are for taxation, or by big tobacco
it's not about money, it's about the fact that to most non smokers, it looks offensive, it's not aesthetically pleasing to them.
cause even though theres no oder, or second hand carcinogens, and it affects them in no way, i've gotten ppl that can't stand that i can vape. all over the place, in stores, restaurants, the hospital (that was funny, a doctor and security told her to stuff it) etc.
thats who want's this "reclassification," they want it included in the banns
so they don't have to see it, and those kids that lost their parent(s) to tobacco related illness.
it's like they all want us to live loooong and boring lives.
well i'm sorry, i don't wanna cut my lawn, or only dress in business casual clothing and drive a miata cause it's the only affordable convertable sports car thats acceptable enough to park in my driveway (says the living establishment of many gated COMMUNities)
a want the right to walk down the street buck naked covered in green jello read'n playboy magazine, w/ a phat vape pipe. why? cause i may suddenly feel the need to, and this is freak'n america okay pal!
 
Sorry. I still cant agree to classify them as a tobacco product.

It isnt. Its new tech, and must be given its own classification. Even more so since you can use a ecig without nic. Much like the healthcare thing here in the US, it is stupid, and dangerous to our civil rights, to pass something now for the sake of getting something passed as opposed to doing it right the first time. Any other opinion, IMO, is very foolish and trusting of an entity not worthy of trust.

IMO, these petitions are a waste of time. The gov isnt listening. If they were they would know to .... out of our private lives and the choices we make. These people see an addict as a cash cow. Let that burn in...

Vote in November.

We need to clean house and send a message that we run this country, not them. Whats standing in the way is policy, not enlightenment.

I agree mostly. But I'm not so sure voting in November is going to make much of a hill of beans either. There's political puppets to convince you to bend the predetermined way... and then there's government regulation on something they don't want to understand, just get money out of it so the predetermined way will succeed... Guess what runs both?... M-O-N-E-Y

I see them all as wicked sneaky conniving dirty little back-stabbing SOB's that pretend they care about us, but really don't.
 
I get that some people want e-cigs classified as tobacco products to ensure they remain legal, but I can't get on board with that. They're not tobacco products. Just because the FDA doesn't currently have a classification that fits doesn't mean c-cigs need to be forced into an existing one. Whichever one you pick, it hands control of them to the FDA anyway.

If they were classified as tobacco products, they'd probably be seen as a societal evil and inevitably be heavily taxed by states and the federal government. Also there would be no flavors allowed beyond menthol and tobacco. The only benefit is they couldn't be outright banned. I think that's unlikely anyway.

Am I completely off base on all that?

No, you're pretty much on target. Some of those things might not happen immediately (like the flavors), but it will eventually.
 

Saerjin

Full Member
ECF Veteran
Feb 6, 2009
33
1
40
Pittsburgh, PA
My opinion may not amount for much but here are my thoughts.

If they want to classify it as a tobacco product I wouldn't mind. Simply because as long as I am still able to vape rather than smoke, I am willing to sacrifice taxes (if they even take it that far) for the ability to live a more enjoyable life.

As for smoking indoors? Well, out of respect I tend to go outside to vape either way. Considering a lot of people don't understand how this device works, I instead of avoiding confrontation for example at work. I just go outside and chat with co workers while vaping. Due to that a few have converted from my random small talk and them seeing me vape. Rather than trying to closet vape in the building.

In the end, yes it may suck either direction this may go. I just feel that as long as i'm able to continue using my device i'll be content.

What I don't understand is why would they make a fuss over the unit, rather than doing something more to the pure nicotine? What of the people who vape zero nic? These devices are the "Lighter" whereas the liquid nicotine is the cigarette...? Am I wrong to think of it that way?
 

CES

optimistic cynic
ECF Veteran
Verified Member
Jan 25, 2010
22,181
61,133
Birmingham, Al
Below is my comment on the first petition. I commented on the other a few days ago. I‘ve been reading and understand the fear and resentment that people have about being asked to comment on these petitions. I also felt a bit paranoid signing my name to anything associated with the government. But, I like being able to vape at work and to be able to vape openly. Since the FDA has already has e-cigs on the radar, silence isn’t an option. I don’t like that there are currently only two choices. But if we don’t speak up there will be no choices. We need to use all possible avenues, education of the general public, direct work with legislators, and our voices in any way that we can. Numbers and money are the only way we have to be heard- and I don’t have a lot of money.


I would like to share my experience with using an electronic cigarette (e-cigs) . I began using an e-cig in October 2009 as a method for allowing myself to continue to utilize nicotine without the harm associated with smoking combustible cigarettes. The harm reduction aspects, in my case, have been strong. My blood pressure (systolic and diastolic) has decreased 10 points, my hemoglobin has decreased to the middle of the normal range, and my ability to breathe deeply without coughing has also improved.
The FDA is charged with safety and protection, in the case of tobacco products, that charge is to assist in the known harm associated with smoking tobacco. The current actions of the FDA move to classify e-cigs as drug delivery devices is inconsistent with the charge, and would result in the potential for greater harm than allowing them to remain completely unregulated. If regulation is required for a product whose components are legal and all freely available to adults, then regulation as reduced harm tobacco products is a more appropriate course of action. Although e-cigs have not yet been well-studied, anecdotal evidence strongly suggests that people using e-cigs reduce or eliminate the amount of tobacco smoke they and those around them are subject to.
Classification of e-cigs as drug delivery devices would be a de facto ban, and I would likely return to smoking regular cigarettes.

Comment Tracking Number: 80ab8c13
 

leannebug

Vaping Master
ECF Veteran
Mar 5, 2010
4,694
561
the deep south
I have not decided yet to sign or not sign. Nor have I read the petition OR it's comments.
HOWEVER, what I did find interesting are the "comments" quoted here and thought to point something out.

QUESTION: from the comments posted here, I am assuming (yes I know what that makes me) that most of the 'comments' on the petition are; how much ecigs/vaping have helped them get off of cigarettes, helped them quit, etc, etc.
Does this not validate the point they are making? That the ecig should be classified in the drug category, because they are similar to other stop-smoking devices that are in that classification?

Who regulates nicotine inhalers? Nicotine gum? Patches? Pills (ie: Wellbutrin) Ok, so I know the last one, but honestly am not sure on the others.

If we praise the great ecig genie, and it's wonderous ability to stop us from smoking... then we are in fact proving their point. No?
 

Vocalek

CASAA Activist
Supporting Member
ECF Veteran
Why wasn't this explained at or on the page that asks for comments instead of just telling everyone they want to regulate as tabacco product please comment? What did they think everybodies comment would be without a little explaining as you have done here?

An excellent point. Those of us who have lived with the controversy surrounding our life-line for a year or more forget that newcomers may know nothing at all about the subject. In the future, when I put in a call to action of some kind, I will try to remember to provide some background.

I think it is too bad that in the redesign of ECF, the owners listened to one or two voices who complained that the "Campaigning" section was too close to the top of the main page. Now, it is so far down that most newcomers never get that far. I wouldn't be surprised if 50% of more of the folks who come here have no idea that their freedom to continue using this product hangs by a thread.
 

gowenrw

Full Member
Feb 22, 2010
9
0
Roselle, IL
Wow, the FDA regulations and the loophole laws around them are pretty absurd. I honestly don't know if it will help to classify the e-cigs as tobacco products or as drug devices. Technically both are correct. I mean Nicotine IS a drug and it IS derived from tobacco. But then Alcohol is also a drug... so is a beer .... a drug device?

The fact is that congress in its greedy tax income and tobacco lobbyist supporting way has tied the FDA's hands where real cigarettes are concerned or the FDA would have banned them long ago. To jump on that bandwagon and claim e-cigs are tobacco products just to take advantage of that same greed driven loophole seems wrong.

How it is that the nicotine gums and patches are able to be sold legally? They are not classified as tobacco products, are they? I thought they were sold as over the counter drugs and regulated by the FDA as such. I think if we are going to petition for anything it should be to get e-cigs classified that same way. This way the FDA is happy since they can regulate it (which is actually in all of our best interests BTW), and we are all happy since we can buy legally without using any legal loophole and without undue tobacco taxes.

Where is that petition? Ill sign it today.

--Richard
 

CES

optimistic cynic
ECF Veteran
Verified Member
Jan 25, 2010
22,181
61,133
Birmingham, Al
the drawback to classification as a drug device is "safe and effective". the studies to prove it aren't there, and it's a pretty big hoop to jump through. not necessarily because things are as safe as they appear to be, but because there are publications to show it. without the studies to show safety and effectiveness (anecdotes don't count, sorry, there are enough of them that they should), the FDA will continue to seize shipments and e-cigs will be driven underground. Ironically, people will mix their own juice, some won't do it very well, and, IMO, DIY juice made with pure nicotine ordered from scientific supply stores is where the greatest danger of harm is.
 

g123456e

Full Member
Jan 20, 2010
34
0
Kentucky
I think a number of misconceptions have come into play on this thread and I'd like to address them.

1. That the FDA wants e-cigs regulated because they can then be taxed. This is a misconception. FDA regulation has nothing to do with taxation.

2. That e-cigs are currently unregulated and it would be better to keep them that way. This ship has sailed. The FDA has classified e-cigs, has decided to regulate them as drug delivery devices, and is only waiting for the court's decision in the current case before ramping up enforcement.

3. That the petition plays into the FDA's hand. It is actually the opposite. The FDA is fighting to retain its declared position that e-cigs are drug delivery devices. The petition goes against this FDA position.

4. That the petition plays into someone's big money. It does the exact opposite. The FDA's current position maintains the huge revenue streams of Big Tobacco and Big Pharm. The petition seeks to reclassify e-cigs in a way which threatens huge amounts of BT and BP money. It may well be that BT/BP money is a large part of what's behind the FDA's current position.

5. That classification of e-cigs as a tobacco product somehow "tars us with the same brush" as smokers. Classification as a tobacco product is a legal issue of great importance. But it is not an issue which affects public perception. Public perception will be molded by the media from the top down and by us as vapers from the bottom up. Every non-smoking friend I have has endorsed (heartily in most cases) my use of an e-cig. That's where we'll win in the perception arena; the legal classification won't affect this.

6. That categorizing e-cigs as tobacco products is wrong because they aren't made of tobacco. "Tobacco products" is a category for the purpose of establishing what kind of regulation is appropriate, nothing more. When you consider all the toxic crap in a cigarette, "tobacco product" is a pretty good category to be in when you want a minimum of regulation! It is a reasonable category because e-cigs are primarily meant to be an alternative to smoking and because the most important ingredient used in an e-cig for most users is obtained from tobacco (nicotine.) To those who point out alternatives, please research the cost of obtaining nicotine from various sources. Tobacco is THE source of nicotine for all of our suppliers due to cost.

7. That the November election will have any impact on e-cigs. It won't. Politicians will not be motivated by the small number of existing vapers. They will be motivated by Big Tobacco and Big Pharm who both want e-cigs classified as drug delivery devices and most definitely do not want them regulated as tobacco products. An election won't make any difference to this.

8. That there is a third choice such as creating a new classification for e-cigs or reclassifying them to be unregulated aside from general consumer protection laws. The government, the FDA, the non-smoking population, the "quit or die" activist groups, and the large commercial interests involved will not agree to a reclassification of e-cigs from drug-delivery devices to an unregulated product. And there isn't anything near the required voter base to create a new classification, not to mention the BT and BP dollars which would fight any such attempt.

9. That classification as a tobacco product is in some other way inherently bad for vapers. E.g. that it automatically implies no candy or fruit flavors. There are no such automatic consequences. Restrictions on cigarettes are specific to cigarettes, not to all tobacco products. Once reclassified as tobacco products, any restrictions the FDA ends up trying to apply to e-cigs will be challengable independently of restrictions applied to cigarettes.

10. That reclassification of e-cigs as tobacco products somehow negatively impacts our existing e-cig vendors. It does not! But the existing classification as drug delivery devices hugely impacts them, it will pretty much kill all existing small vendors if not changed.

11. That reclassification to an over-the-counter drug might be preferable. That's exactly the kind of classification the FDA has already made. It will require years of testing and huge expenditures by existing e-cig vendors before we see their products again, something they (and we!) can't afford.

12. That technicalities such as classification of the hardware, which can be used with 0mg liquid, have an impact on the end result of all of this. They don't. We are in a fight against two groups: 1) Big Tobacco and Big Pharm, both with a huge financial interest in seeing e-cigs categorized as the FDA currently does, i.e. as drug delivery devices, and 2) Quit or Die mentalities who don't care whether e-cigs are actually safe. Both groups will base their final fight on the delivery of nicotine. They'll shift to fight the devices or the liquids according to what works best for them. Technicalities such as ability to deliver a non-harmful smoking experience won't slow them down.
I agree with Mister. I submitted a comment to both threads (even though I don't think the e-cig is a tobacco device) because I don't want to see it classified as a drug delivering device either, which it is now.

I have been researching for a couple of months but only vaping for a couple of weeks now and have already cut down to just a few real cigarettes a day. When I found this product, I was amazed at the possibility of it. It seemed too good to be true and thought it probably wouldn't be satisfying for me. I was wrong! It's a wonderful device that even if classified as a tobacco product initially, is better than being categorized as a drug delivering device. Yes, I would rather it be classified as it's "own device" but there is no entity petitioning that at present. Leaving it as a drug delivering device would take it out of the market completely until all necessary tests are done.
 

Krakkan

Unregistered Supplier
ECF Veteran
Feb 22, 2009
855
4
New Orleans, LA
www.truesmoker.com
Its Obvious half of the posters here have no idea how much work Bill has done for the E-Cig community I say we stand behind him 100% or you can virtually guarantee that E-cigs will be gone forever there has to be a compromise in this no matter what people think. You can't have your cake and eat it too.
 

Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
ECF Veteran
Apr 2, 2009
5,171
13,288
67
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.
 

Firegrl

Senior Member
ECF Veteran
Feb 3, 2010
151
0
Albuquerque, NM
www.geekgods.net
I've done a little research over the internet here and I completely agree that ecigs should NOT be classified as a tobacco product. It will completely destroy many of the things we have come to LOVE about ecigs. We need to find a new classification if no other classification fits. We can't just hammer the square peg into the round hole because we don't have the correct classification here....

Take this for example: TTBGov Tobacco FAQs. This talks about buying TOBACCO PRODUCTS over the internet, like we do 90% of our ecig equipment. This states that if a tobacco product is purchased over the internet, we would still have to pay any applicable fed tax AND state cigarette/excise tax. This would immediately cause ecigs to be included in the high analog taxes we were so happy to get rid of. No thanks. People have to remember that all tobacco products are taxed, not just cigarettes.

Another point someone mentioned above was about flavoring. Kiss that goodbye as well if these are classified as a tobacco product. Taking a look here Letter to Industry on Cigarettes Containing Certain Characterizing Flavors talks about flavoring in cigarettes, how it's not allowed, and how they can be seized and fines handed out.

"The removal from the market of cigarettes that contain certain characterizing flavors is an important step in FDA’s efforts to reduce the burden of illness and death caused by tobacco products."

Don't you think the FDA, if ecigs are classified as a tobacco product, would lump ecigs into this as well?

Oh, and I finally found the full classification description of tobacco products here: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:+26USC5702.

Uh, I don't know about anyone else, but ecigs DO NOT fit this classification. Our devices may contain nicotine, but they do not contain any tobacco whatsoever. From my understanding of the above classification, any tobacco product must contain some type of physical tobacco.

Sorry, but I agree with many others that this is NOT the appropriate solution.
 

Firegrl

Senior Member
ECF Veteran
Feb 3, 2010
151
0
Albuquerque, NM
www.geekgods.net
I think a number of misconceptions have come into play on this thread and I'd like to address them.

1. That the FDA wants e-cigs regulated because they can then be taxed. This is a misconception. FDA regulation has nothing to do with taxation.

2. That e-cigs are currently unregulated and it would be better to keep them that way. This ship has sailed. The FDA has classified e-cigs, has decided to regulate them as drug delivery devices, and is only waiting for the court's decision in the current case before ramping up enforcement.

3. That the petition plays into the FDA's hand. It is actually the opposite. The FDA is fighting to retain its declared position that e-cigs are drug delivery devices. The petition goes against this FDA position.

4. That the petition plays into someone's big money. It does the exact opposite. The FDA's current position maintains the huge revenue streams of Big Tobacco and Big Pharm. The petition seeks to reclassify e-cigs in a way which threatens huge amounts of BT and BP money. It may well be that BT/BP money is a large part of what's behind the FDA's current position.

5. That classification of e-cigs as a tobacco product somehow "tars us with the same brush" as smokers. Classification as a tobacco product is a legal issue of great importance. But it is not an issue which affects public perception. Public perception will be molded by the media from the top down and by us as vapers from the bottom up. Every non-smoking friend I have has endorsed (heartily in most cases) my use of an e-cig. That's where we'll win in the perception arena; the legal classification won't affect this.

6. That categorizing e-cigs as tobacco products is wrong because they aren't made of tobacco. "Tobacco products" is a category for the purpose of establishing what kind of regulation is appropriate, nothing more. When you consider all the toxic crap in a cigarette, "tobacco product" is a pretty good category to be in when you want a minimum of regulation! It is a reasonable category because e-cigs are primarily meant to be an alternative to smoking and because the most important ingredient used in an e-cig for most users is obtained from tobacco (nicotine.) To those who point out alternatives, please research the cost of obtaining nicotine from various sources. Tobacco is THE source of nicotine for all of our suppliers due to cost.

7. That the November election will have any impact on e-cigs. It won't. Politicians will not be motivated by the small number of existing vapers. They will be motivated by Big Tobacco and Big Pharm who both want e-cigs classified as drug delivery devices and most definitely do not want them regulated as tobacco products. An election won't make any difference to this.

8. That there is a third choice such as creating a new classification for e-cigs or reclassifying them to be unregulated aside from general consumer protection laws. The government, the FDA, the non-smoking population, the "quit or die" activist groups, and the large commercial interests involved will not agree to a reclassification of e-cigs from drug-delivery devices to an unregulated product. And there isn't anything near the required voter base to create a new classification, not to mention the BT and BP dollars which would fight any such attempt.

9. That classification as a tobacco product is in some other way inherently bad for vapers. E.g. that it automatically implies no candy or fruit flavors. There are no such automatic consequences. Restrictions on cigarettes are specific to cigarettes, not to all tobacco products. Once reclassified as tobacco products, any restrictions the FDA ends up trying to apply to e-cigs will be challengable independently of restrictions applied to cigarettes.

10. That reclassification of e-cigs as tobacco products somehow negatively impacts our existing e-cig vendors. It does not! But the existing classification as drug delivery devices hugely impacts them, it will pretty much kill all existing small vendors if not changed.

11. That reclassification to an over-the-counter drug might be preferable. That's exactly the kind of classification the FDA has already made. It will require years of testing and huge expenditures by existing e-cig vendors before we see their products again, something they (and we!) can't afford.

12. That technicalities such as classification of the hardware, which can be used with 0mg liquid, have an impact on the end result of all of this. They don't. We are in a fight against two groups: 1) Big Tobacco and Big Pharm, both with a huge financial interest in seeing e-cigs categorized as the FDA currently does, i.e. as drug delivery devices, and 2) Quit or Die mentalities who don't care whether e-cigs are actually safe. Both groups will base their final fight on the delivery of nicotine. They'll shift to fight the devices or the liquids according to what works best for them. Technicalities such as ability to deliver a non-harmful smoking experience won't slow them down.

What about this? Tobacco Product Fees

Looks like the FDA is making money off of cigarettes to me....

This would negatively impact our vendors and US. They get charged more money to manufacture, buy, etc. then that is going to be passed onto us.
 

natura

Ultra Member
ECF Veteran
Dec 5, 2009
1,281
3
USA-Western NY
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.
"Citizen Petition

The undersigned submits this petition under ___ (relevant statutory sections, if known) of the ___ (Federal Food, Drug, and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs under 21 CFR 5.10) to request the Commissioner of Food and Drugs to ___ (issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action)."

BY the above statements of why and how to petition the FDA-----BY signing I am saying "yes FDA your right"- this is as define by G and H ( I am NOT going to do that!)

Here are FDA's difinitions of G and H if you want to read them again!

As found here on FDA web site for definitions!
http://www.fda.gov/RegulatoryInform...FoodDrugandCosmeticActFDCAct/FDCActChaptersIa


Do not know about the rest of the vapor community BUT those definitions could include pratically anything! Why on
earth... would I WANT to say it belongs there when it has NOT been validated by anyone! (with the exception of perhaps the FDA who currently was told NO)

Better Question YET why on earth would you allow yourselves to be used by the FDA? Because you trust them?
I know you've worked long and hard. You asked why I am negative and it is because I do not trust the FDA. I do not want to sign a petition that CAN clearly be used against you and me! DO YOU NOT SEE they can be banned ...JUST BY USING documentation of your petition via public perception!
 
Last edited:

maxx

Ultra Member
ECF Veteran
Jan 23, 2010
1,269
3
PA, USA
www.omnimaxx.com
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.

You know what. You have done nothing but bad-mouth ECF members in this thread. You don't want comments or discussion. You want a cheering section. I obviously misunderstood what this thread was all about. My apologies for that error and I will move along.
 
Status
Not open for further replies.

Users who are viewing this thread