Comments Please on AAPHP Petitions to FDA

[THeGAMe]

Phil..

First, there is no official evidence that using a vape is less harmfull than smoking. With or without nic.

Next, Ill ask you if you use a non nic juice.
If not, Ill ask you to try a non or lessor nic content than you are currently using till you dont use it anymore.

Point being, if you use the vape, and all you are breathing in is a currently allowed substance deemed non harmfull by the FDA, AND it tastes the same, AND it doesnt change the way you feel when you use it...

Whats the diff if it had nic in it at all? No nic, no FDA problem.

 

[basic_atheist]

You can still add black market nic to them. Its better than the option to never be able to purchase a legal atty, batt, or cart again, or at least at a decent price..

Yaaay, finally some intelligence got here.

It's so frustrating I've even tried to joke about this issue to make me feel better. I near bout jumped on the paddy wagon to join the drug/device approach.

But now that you've mentioned it. You are absolutely correct! It's all about the nic and what's delivering it. Remove the nic and all you have is a good novelty fog toy, not a tobacco product, not a drug delivery system, just a nice conversation piece to use and pretend you're still smoking.

If we give the FDA a mere inch, they will have their lawyers stretching it out for miles. Foook Them!

Thanks TheGame. You brought me back to my senses!

Take out the nic! I can work with that.

 

[basic_atheist]

I'm sorry, but I thought this was totally uncalled for. We could just as easily put the shoe on the other foot and call the other side selfish for wanting to rush it into a category it clearly doesn't belong in for fear of losing what you enjoy too. I don't think we are being selfish for having our own opinions at all. And yes, I think some of my points show how this classification could hurt the industry, not just me.

Sorry, but some of us would rather argue for a better-fitting solution, then let the FDA bully us into curling up into a ball and admitting defeat...

Fear can drive us to make crazy, irrational decisions....

It's okay Firegirl. I understand. In fact, I've already forgiven her. It's hard to think straight when your pride and joy is being threatened. Later on I'll think in a new angle and find a solution. I always do. Even though sometimes it takes reading somebody else's thoughts to ignite a spark and steer you somewhere else.

I just hope she feels a little better now.

 

[ChipCurtis]

there is no official evidence that using a vape is less harmfull than smoking. With or without nic.

There will never be any "official" evidence if you only listen to what government agencies have to say about the e-cig. But there is evidence. What do you consider to be "official" evidence? From what source?

Here is some evidence:
FDA Study
Health New Zealand Study
Virginia Commonwealth University Study

Each of these studies draw different conclusions on different aspects of e-cigs, but if you read them, they all still still reach the same conclusion if this is the aspect of e-cigs that you are focusing on: That using a vape is less harmful than smoking.

But is that not "official" enough for you?

All 3 studies proved this. But each study's report to the media (and then the way the media slants things) resulted in only certain information getting out, which made e-cigs look bad.

 

[natura]

Originally Posted by maxx
As I mentioned earlier. The goals of the FDA and this petition are the same and inevitable.

I don't agree but I really do hope that you are right about this. Because if you are right the petition will be endorsed and acted on, and that is what I, as a vaper, very much want to happen.

And Max..Your more recent question
"They wouldn't need anyone's permission to do this, so why haven't they?"

The thing I FEAR MOST! That petition being used to get it labeled a medical device! The comments and the petition itself validate the THING FDA wants most.

(I can't help but wonder why the FDA would want to work with a group that opposes the VERY thing their trying hard NOT to accept. How did these two parties come together? Under what premise? WILL ALSO add here that I do believe our local ecf group believes the petition will play out as intended by them- I just haven't seen that out of the fda. FDA getting in contact with this group has a win win..no one opposes looks good for them-people oppose and write all the standard replies..it's almost like a treasure chest of validation for the desired classification)

This petition comes out after the Jan 10 2010 ruling..DOES not make sense! now to call them medical devices in order to petition them! to change classification!!

Oh the horror lol If it is just fodder for our side lol you have to top their fodder about the CHEERIOS!

 

[zelda]

I don't understand this either.
Whay aren't e-cigs being considered like hookahs? As far as I know hookahs are not classified as a tobacco product.

 

[River]

I know I said I would leave you to your own devices and let you make a hasty fear based decision on your own but I thought you may need to be reminded what a corrupt and incompetent foe you are deciding to give up to.

frontline: dangerous prescription: the fda: how independent is the fda? | PBS

CDRH Director Resigns on Corruption Allegations | The Sample | GenomeWeb

Corruption

Broken Government | Failure: FDA Failure To Ensure Drug Safety

Kerry Trueman: FDA = Failure to Do Anything

http://theherbdoc.com/ConsumerEducation/HealthNews/FDA/Codex6.htm


These guys can't keep us from being poisioned by food products, killed from dietary supplements, get drinks out of the market that are 10% caffeine 15% alcohol 20% untested herbs in a corn syrup base, are awash in payola and corruption scams and you are worried that vaping faces any real risk here?

Please, I'm begging here, don't roll over to these people. Sit tight and remember what came of the whole energy drink thing a few years ago. It was nothing but posturing and hyperbole to get energy drink manufacturers to back down. It did not work then and it won't work now.

In the end energy drink companies had to put caffeine sensitivity warnings on the can and stop making health claims and then the fda left them alone.

At this point in time the fda has even less of a reputation than they did then. Why compromise now?

Edit: Btw, thanks to Max for the Neville Chaimberlain pic of him triumphantly waving the Munich pact, awesome stuff!

 

[kristin]

If they get classified as a medical drug device, the Dems will reduce the cost for us with the healthcare bill.
.

ROFLMAO! Wow, you guys really are dreaming.

 

[kristin]

I'm sorry, but I thought this was totally uncalled for. We could just as easily put the shoe on the other foot and call the other side selfish for wanting to rush it into a category it clearly doesn't belong in for fear of losing what you enjoy too. I don't think we are being selfish for having our own opinions at all. And yes, I think some of my points show how this classification could hurt the industry, not just me.

Sorry, but some of us would rather argue for a better-fitting solution, then let the FDA bully us into curling up into a ball and admitting defeat...

Fear can drive us to make crazy, irrational decisions....

It's completely called for. People saying they will just use the black market or their stockpiles and refuse to support this attempt to keep ecigs available for everyone else is selfish and short sighted. It's not fear, it's logic, tactics and reason motivating me.

You are dangerously wrong and while you are sitting there, arguing for an option that is not even on the table, it'll be declared a drug delivery device and all hope of getting it classified as that 3rd option you want will be lost.

 

[kristin]

For you "no nic" proponents, 99% of new ecig users will not purchase a device with no nicotine. And even removing it won't stop legislation - propylene glycol has not been studied for longterm use. The FDA will still want it regulated, even as a placebo.

As far as all of the testimonials convincing the FDA that it's a drug delivery device - there is a difference between smoking cessation and nicotine cessation. These testimonials wil help us in our argument that it is an effective smoking REPLACEMENT for harm reduction purposes. The fact that people are saying they aren't intending to quit smoking is important.

 

[zelda]

I'm afraid you are dreaming if you think regulating e-cigs as tobacco products will help people.
I smoked for over 35 years and yes I would rather use this as a no nic option than be regulated as a tobacco product. The goal in my state is (supposedly) to stop smoking completely not provide other options for smokers. And they do this by raising taxes on tobacco products.
Once it is classified as tobacco product it will be treated just as a cigarette will.

 

[Firegrl]

It's completely called for. People saying they will just use the black market or their stockpiles and refuse to support this attempt to keep ecigs available for everyone else is selfish and short sighted. It's not fear, it's logic, tactics and reason motivating me.

You are dangerously wrong and while you are sitting there, arguing for an option that is not even on the table, it'll be declared a drug delivery device and all hope of getting it classified as that 3rd option you want will be lost.

Name calling over an opinion is never called for. It's just makes you, and the organization you represent, look bad. You are here to try and convince people to hop the fence and come over to your side. Don't think that tactic will work...

How about posting facts instead. But the problem is, neither side can really do that. Nobody here knows how this will definitely be resolved. The government, the FDA, etc. are constantly given facts and they ignore them 90% of the time and make their own decisions. You can tell everyone to sign this petition now, and you will fight to get the classification changed later. Do you know that will really work? I don't. Nobody can really present facts here to show how the government will resolve this. This isn't about our health or well-being and what's best for the American people, this is about money, plain and simple. You can say that the FDA won't directly benefit from this, but you don't really know what the FDA has their hand in.

All we are trying to do is present a different side. Some of us don't have the faith in the government/system that you guys seem to do anymore. I don't have faith that our voices will be heard and the correct classification will EVER be found. But in my OPINION, based on my experiences in political involvement, it's much harder to get something changed later on, then rally now and do it right the first time.

There is probably going to be absolutely NO win-win situation here for us at all as others have said previously in this thread. This is going to take YEARS to resolve either way we go. But disrespting each other and our valid opinions isn't going to solve anything either. It's just going to make us more divided...

 

[Oliver]

This petition comes out after the Jan 10 2010 ruling..DOES not make sense! now to call them medical devices in order to petition them! to change classification!!

Hang on, what do you think the Jan 10 2010 ruling was on?

I fear this is the centre of the confusion. All the ruling did was to grant an injunction to stop the FDA making seizures at the border: http://www.e-cigarette-forum.com/fo...s-fda-judge-leons-ruling-se-vs-fda-ruling.pdf

In other words, nothing has been yet ruled on in terms of e-cigs' status, and the FDA will still argue that it has the authority to regulate the e-cig as a medicinal device when this does go to court.

By trying to persuade the FDA to change it's own regulatory stance nothing is lost, and potentially everything gained. Arguments can still be made as to how e-cigs are to be regulated down the line.

On the tax issue, I don't get it. Sorry. If the government wanted to tax e-cigs highly, they could just get on with it, regardless of what category they're in.

Seriously, people, this is the best opportunity we've had as consumers to really change the game. Please at the very least make comments to the 2nd petition - to have the FDA rescind their press statements from last year.

Thanks,

SJ

 

[maxx]

On the tax issue, I don't get it. Sorry. If the government wanted to tax e-cigs highly, they could just get on with it, regardless of what category they're in.

SJ

Joe, that isn't correct. From WIKI:

An excise or excise tax (sometimes called a duty of excise or a special tax) may be defined broadly as an inland tax on the production or sale of a good,[1] or narrowly as a tax on a good produced within the country. Excises are distinguished from customs duties, which are taxes on importation. Excises, whether broadly defined or narrowly defined, are inland taxes, whereas customs duties are border taxes.

An excise is an indirect tax, meaning that the producer or seller who pays the tax to the government is expected to try to recover the tax by raising the price paid by the buyer (that is, to shift or pass on the tax). Excises are typically imposed in addition to another indirect tax such as a sales tax or VAT. In common terminology (but not necessarily in law) an excise is distinguished from a sales tax or VAT in three ways: (i) an excise typically applies to a narrower range of products; (ii) an excise is typically heavier, accounting for higher fractions (sometimes half or more) of the retail prices of the targeted products; and (iii) an excise is typically specific (so much per unit of measure; e.g. so many cents per gallon), whereas a sales tax or VAT is ad valorem, i.e. proportional to value (a percentage of the price in the case of a sales tax, or of value added in the case of a VAT).

Typical examples of excise duties are taxes on gasoline and other fuels, and taxes on tobacco and alcohol (sometimes referred to as sin taxes).

As long as E-cigs are not considered tobacco products, they are not excise taxed, which is the biggest part of all the taxes on tobacco. To tax e-cigs beyond the normal import, sales, etc tax would require new legislation. By moving E-cigs to tobacco products, the existing sin taxes already apply without new legislation. The minute the FDA rules that e-cigs are tobacco, they can be excise taxed.

 

[maxx]

OOPS...sorry. I forgot to add the WIKI link. BTW....good reading there about the "purpose" of an excise tax.

Excise - Wikipedia, the free encyclopedia

 

[Firegrl]

Joe, that isn't correct. From WIKI:



As long as E-cigs are not considered tobacco products, they are not excise taxed, which is the biggest part of all the taxes on tobacco. To tax e-cigs beyond the normal import, sales, etc tax would require new legislation. By moving E-cigs to tobacco products, the existing sin taxes already apply without new legislation. The minute the FDA rules that e-cigs are tobacco, they can be excise taxed.

Ah, thank you maxx. If you take a look at post #125 http://www.e-cigarette-forum.com/fo...lease-aaphp-petitions-fda-19.html#post1141208, you will see a link. I posted that link because that is who is responsible for collecting said taxes. They give the definition of tobacco products there as well. If you read the site, they refer to everything as "tobacco products", thus leaving me to believe that once ecigs are classified as such and lumped in with the rest, they will be subject to excise taxes....and they can start collecting almost immediately...

 

[zelda]

The FDA has already stated it does not have jurisdiction over e-cigs as tobacco products since they don't contain tobacco. It says it has jurisdiction because they are used to treat nicotine withdrawal and as such are a drug and delivery system.
The judge suggested the FDA treat them in a manner similar to tobacco products.

 

[5cardstud]

It's completely called for. People saying they will just use the black market or their stockpiles and refuse to support this attempt to keep ecigs available for everyone else is selfish and short sighted. It's not fear, it's logic, tactics and reason motivating me.

You are dangerously wrong and while you are sitting there, arguing for an option that is not even on the table, it'll be declared a drug delivery device and all hope of getting it classified as that 3rd option you want will be lost.

I was one of those people who don't care cause it won't affect me but after some soul searching I agree. There are people out there it does matter to and they're fellow vapers who will be affected. I do think there is only one choice either your for it and it gets regulated as tabacco or your against it and it gets regulated as a drug and banned. Now thats not hard to figure out. THERE IS NO THIRD CHOICE AT THIS TIME. Ps. they can tax it no matter how it's regulated.

 

[maxx]

Something else to consider on costs....and I know cost doesn't mean anything to some who are just looking at the health issue...this would place e-cigs in direct competition with analogs. When that happens, big tobacco will go to court....actually they will run...and claim that e-cigs have an unfair advantage in the market if they don't get the same sin taxes as cigarettes. And you know what....they would be absolutely right.

So even if the government wanted to give e-smokers a break on costs (yeah like that would really happen)...they could not legally do so. They cannot pick and choose which companies get a tax and which don't...when they are competing in the same marketplace. It is called capitalism.

No matter how you slice it....vaping will be just as expensive as smoking. If you got into vaping for health reasons, you don't care. If you got in for tax reasons....you are screwed.

 

[CES]

@ Maxx- Thanks for the definition of excise tax. - especially since i always think of tobacco taxes as sin taxes, it's good to know what they're supposed to be (I'm, for once, not being sarcastic about the thanks part).

The main points as i understand them are: Judge Leon granted an injunction, on the grounds that ecigs were essentially tobacco products, meaning that the FDA couldn't seize the products of two suppliers at the border at least until the full court case was completed. The FDA appealed . The appeals court put a stay on Judge Leon's ruling, until they could make a ruling about the FDA appeal. And we wait.

In the meantime, I've sent a letter directly to the appeals court.

IMO The AAPHP is hoping that if enough people respond the FDA will back off. Not likely, but worth a try. I think the FDA is using e-cigs as a distraction from the more important things they've been screwing up. The people who mentioned that we're not all that big of a deal are probably right. We aren't a very strong constituency yet, so we're easy to mess with, before we get strong. This way they can say they're doing something for public health, but not piss off anyone with power. So, I think trying to drum up some pressure on them seems worth a try to me.

But even more importantly, with the retraction petition, the FDA will know that people are aware that they are misrepresenting the research. The misrepresentation of research is what makes my blood boil. The kinda of crap the FDA is pulling is the stuff that would get me fired and banned from doing my research. So, yeah, i want them to know that people can see through it.

Lastly, although i think that most people's minds are made up, it's been interesting to see the difference in perspective.

Chris