Comments Please on AAPHP Petitions to FDA

[zelda]

Is this court case solely to decide whether they are drug and delivery devices?

 

[DC2]

Is this court case solely to decide whether they are drug and delivery devices?

The court case is to decide whether or not the FDA can continue to seize electronic cigarette shipments being sent to Smoking Everywhere and njoy. In order to determine that, the judge needs to decide if they are truly unapproved drug delivery devices, as the FDA claims.

If the courts decide they are unapproved drug delivery devices then the FDA has complete and total control over them. That will basically give them the green light to continue seizing shipments to any and all electronic cigarette suppliers, and to step up enforcement in other ways as well, such as fining suppliers until they close their doors.

 

[zelda]

I know the judge ruled against the FDA stopping shipments on Jan 14th but I thought the appeals court overturned that ruling on February 2nd and the FDA can still seize shipments.

 

[DC2]

I know the judge ruled against the FDA stopping shipments on Jan 14th but I thought the appeals court overturned that ruling on February 2nd and the FDA can still seize shipments.

Sort of, but not quite.

The appeals court issued a temporary administrative stay on the ruling, while they familiarize themselves with the case. Supposedly this is very common, and was to be expected. They basically put the injunction (to prevent the FDA from seizing shipments during the course of the trial) on hold until they are ready to rule on the appeal of that injunction.

So at this point the FDA can seize shipments until the appeals court rules, and can continue doing so during the course of the trial unless the appeals court rules against them.

They have not overturned the injunction, although the speculation is that when they rule on the appeal to overturn the injunction they will issue an opinion which will basically send the message as to how they will rule on an appeal of the case itself, which is still pending trial and has not even really started yet.

Judge Leon, in his ruling to grant the injunction during the course of the trial, basically gave an opinion that clearly indicates he is almost certainly going to come down on the side of Smoking Everywhere/NJoy when they finally get the trial underway. And the appeals court is supposedly going to issue a ruling which will give a clear indication on how they intend to rule on the appeal that will follow, regardless of which side loses and files that appeal.

 

[zelda]

Thanks. I was a bit mixed up on that.

 

[Mr_Phil]

Hi there TheGame... I responded within your questions in red. Have an awesome weekend.

Phil..

First, there is no official evidence that using a vape is less harmfull than smoking. With or without nic. I'm reading several different docs that point to it being less harmful. And, to be truthful, I know that I am currently undergoing the same changes I did when I quit back in the early 90's for a solid year. We won't go into the stupid attack that caused me to take up smoking again....... heh. So in this instance I don't need "official" evidence. If something comes out, I will be happy to read it and then make my decision. That's the great part of being an American. I am supposed to be free to make, and be responsible for, my own decisions concerning my body and health. Isn't that the same argument used by pro-choice and all other "lifestyle" choices?

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. Nope, I use a high nic content juice. LIke I said, I never intended to quit. I am in it selfishly to continue a lifestyle choice I have freely made. If I can do it with less social stigma and better health, that's great. My next letter to the FDA will be on my blog asking them why they are not regulating Big Macs and Banning Alcohol.

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. If you read my comments you'll see that my overwhelming anger is that I am supposed to be free to do as I damn well please so long as I don't infringe on your right to do the same. I don't want or need the FDA to be anything more than Advisory. For me it really isn't about nicotine or drug delivery.

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... pssst, don't tell that to the congressmen who write very specific loopholes into the tax code to benifit a very, very, narrow group of people. Those people coincidentally pay the folks who lobbied for the tax break and bankrolled said congresscrook in the first place. 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. Screwed without getting kissed 8-o

 

[natura]

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

When you read what is being argued w/details of case- you know there are precedence that will be set one way or another.


Info after the 10th
"A federal judge has ruled that electronic cigarettes cannot be regulated as drug delivery devices by the Food and Drug Administration (FDA). This decision has left the public health
community red-faced." from
http://www.themoneytimes.com/featur...-drug-delivery-devices-judge-id-10100513.html



"Judge Leon argued that the devices should be regulated in the same way as cigarettes. The judge also agreed with the distributors that e-cigarettes were not marketed as medical devices to help smokers quit, as the Food and Drug Administration had argued, but rather as safer substitutes to give users “the nicotine hit that smokers crave.”
NY times
http://www.nytimes.com/2010/01/15/business/15smoke.html

Smokey Joe- wish they had not tied the two together. Given much consideration to it and think about it still each day for that one. Thank You for addressing my post. Wondering how the FDA approached them -their angle w/eyes closed no judgements just facts of their contact.

 

[Unperson]

The FDA hasn't scared me to the level of stockpiling e-liquid; the comments in this post have.

Are we really running that scared? To the point of actually "asking" the FDA to apply specific regulations?

Besides, it's not the FDA you need to worry about. It's "Action on Smoking and Health" (A.S.H.) that has us all in a sniper scope. They're the ones attacking all our retail brethren and sending all the threatening letters to Amazon, E-Bay/Paypal, individual site providers, and the like.

Yes, the FDA are puppets for big business, but A.S.H. are the real nico-nazis.

 

[Mister]

Are we really running that scared? To the point of actually "asking" the FDA to apply specific regulations?

Besides, it's not the FDA you need to worry about. It's "Action on Smoking and Health" (A.S.H.) that has us all in a sniper scope. They're the ones attacking all our retail brethren and sending all the threatening letters to Amazon, E-Bay/Paypal, individual site providers, and the like.

Yes, the FDA are puppets for big business, but A.S.H. are the real nico-nazis.

Sigh. How many times will people post here without reading up on and understanding the current situation.

The FDA is already applying strong specific regulations which will completely kill off all our retail brethren if unchallenged. A.S.H. has already won if we do nothing. Big Tobacco and Big Pharm will be laughing all the way to the bank if we do nothing.

We are asking the FDA to Reclassify e-cigs to a much lower level of regulation which will not kill us off. We are NOT in a situation where they are unclassified and are asking them to classify and add regulations. We are asking them to apply less.

There are just three possibilities at the moment:

1) Keep our heads in the sand because we don't see how bad things already are and don't want to see it until we get chewed up.

2) Try to get e-cigs reclassified to a better place, which is what this petition is about.

3) Try to get e-cigs unclassified. As far as I know no one has an actual plan in progress to make this happen (as opposed to just ineffectively talking about it) because those who have spent the time and energy to actually do something about our problems recognize that it would be easier to get peace in the Middle East than to accomplish this.

 

[basic_atheist]

I assume these are the current Federal Excise Taxes...
TTB Tax and Fee Rate

[B]Tobacco Products          [/B][B]1000 units      [/B][B]Pack of 20[/B]
Small Cigarettes            $50.33          $1.01
Large Cigarettes           $105.69          $2.11
Small Cigars                $50.33          $1.01
 
[B]Tobacco Products              [/B][B]1 lb.       [/B][B]Tin or Pouch[/B]
Pipe Tobacco                 $2.8311        $0.1769
Chewing Tobacco              $0.5033        $0.0315
Snuff                        $1.51          $0.0944
Roll-your-own Tobacco       $24.78          $1.5488

As you can see, each tobacco product is taxed differently, and it looks to me like the less harmful products have a very low Federal Excise Tax imposed upon them.

Well, not exactly. That table brings up bad memories on RYO tobacco for me. The current sin tax you see now shows the aftermath attack that was made on them.

The sin tax for RYO right before that (if I recall correctly) was only $1.47 per pound. And at that time I was able to get Farm Fresh RYO tobacco without the other 4,000 chemicals added to them. I could get one whole pound for $27.00 and make 450 cigarettes. I would get 2 to 4 bags at a time for that price! I was in HOG HEAVEN and having a blast making my own. All of my filter tubes were FREE!

When I found out the sin tax was going to get jacked up to $24.78 / lb. I asked the owner what the damages was going to be. He ran the numbers over and over and over and could NOT go any cheaper than $55.00 per 8 oz. , which included the New Floor Tax. We discussed how unfair it was, because after the new tax the RYO tobacco was going to be slightly higher than a commercial carton of Marlboro's where I was getting them locally, AND I didn't have to roll them OR pay for shipping. I looked all around trying to find a cheaper RYO deal, but everybody else was having the same trouble, plus they didn't have the quality grade RYO I was getting from the other guy. Many of the small RYO suppliers began shutting down and tried to squeeze all they could get with their remaining stock before going offline. It was sad. I actually cried!

Needless to say, I was forced to go back to them GD commercial toxin sticks called Marlboro's.

Don't you see what happened? The FDA and BT caught wind of what smokers started doing with RYO. The suppliers were skipping the chemical additive processes by going Farmer Direct. So the FDA said, "Oh yeah? Well then, we'll see about that!". Both BT and the FDA had their .... buddies to do some weaseling amongst the suits in congress and ABRACADABRA... instant sin tax jack on RYO!

So I know what's going to happen price wise if you want nic juice to be regulated so we can keep it. It can, and perhaps WILL, happen overnight at the drop of a hat! Can anyone say, "Special sin tax delivery!" ? - I knew you could.

If nic juice becomes an "official" tobacco product, I'm pretty sure it's going to get the same treatment as RYO, or at least similar. BUT, it IS better to go with tobacco than drugs. - Yes, I said that. Don't pass out. LOL.

And you can bet your bottom dollar that the FDA and BT will do everything they can to keep cigarettes the top tobacco product on the market.

Prepare for Nicotine War people! It's going to be one hell of a show. Sign the petitions and bring your own popcorn. I know I can't buy it for you.

P.S.
I'm not joking this time.

 

[Oliver]

Here's another good reason to encourage the FDA to regulate e-cigs as tobacco:

http://www.e-cigarette-forum.com/fo...-ny-state-bill-banning-ecigs.html#post1145211

 

[basic_atheist]

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.

... And even though I commented on the petitions and agree that "tobacco" is the best choice for the market... Thinking business wise and quality availability there... I STILL have the black market in my sights for backup.

Happy now?... Or do I have to lick it too?

 

[basic_atheist]

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...

Personally I see myself as sitting on the fence waiting to jump on the first thing that works within reasonable parameters. I'm keeping an eye out on all directions and will take what works for me. If I have to, I will take something from one side and something else from the other side, then put them together to get what I need. Whatever I can afford... that's what I want. If the options are Low, Medium, and High, I usually go for Medium. Low might kill you. High might cause you to go bankrupt. The Middle is where I like to be, but sometimes that's not an option.

If I can find good PV hardware on the legal market at reasonable prices, then that's what I'll use. But, if the nic juice on the legal market begins to go sour due to high taxes, then I'll either make my own, or go down to the street corner and see Mr. Nic Man. Heck, his mary jane juice might not be that bad either.<- Just kidding on that last sentence.

 

[bobtow]

To all the people who demand another choice and refuse to budge on their insistance that there be more choices, Wake up there are only two choices Drug or Tobacco and the FDA don't give a darn what you wish. As for taxes! There will always be taxes. Your choice will be ecigs or analogs. As for flavors! Some of us already mix our own flavors. Buy no-flavor nic juice at our own level. Non nic flavors cannot be banned. This is a fight to be classified as legal tobacco product or a drug that will be regulated by prescription. How many non-smkoking doctors do you think will write prescriptions for what they see as a no no in their fight against a product they work all there lives to irradicate? As for those who see this a loss of liberty. From the moment we are born we lack liberty. How many times have your parents stopped you from having your own way? Grow up and look reality in the face. What you want will not always be what you get. Hell I bet you have bought products, that you had to make do with, because you could not afford your first choice. Life isn't perfect. Live with it.

 

[Unperson]

Please stop with the 'if you don't support our decision to get these classified as tobacco then you're ignorant or just plain stupid' logic.

Come on. The reason tobacco is so hated is not nicotine. Tobacco is ugly because of every other aspect associated with it (e.g., first / second-hand smoke, tar, chemicals, combustion hazards, the financial burden placed on society due to associated medical costs attributed with the above mentioned, etc.. Do you really think tobacco would really have the bad rep it has now if it only had nicotine?

Is nicotine a drug? Sure; so is caffeine which is largely ignored. Is nicotine addictive? Yes; so is alcohol, which is only regulated with an age check. Can nicotine kill you in high doses? Sure. You can also die from drinking too much water too quickly. Yes, you can OD from H²O (hyponatremia), so let's ban/tax water.

What does all this governmental interference really stem from? Do you think there is a man sitting behind a desk whom (without any outside pressure or self-motivated financial agenda) genuinely cares if you want to mildly and safely self-medicate yourself with an unremarkable stimulant?

It's just about money. They want to keep taking it from you and a lot of you are not only suggesting that we pay them, but we should beg them to take the money from us. E-cigs should not be lumped in with standard tobacco. Not because they don't have a relationship with them due to nicotine (which they do), but because tobacco has a bad reputation for many aspects that have nothing to do with nicotine.

I almost have to wonder if this petition was started by an FDA mole; if for no other reason than it's base logic sounds like typical governmental bureaucratic double-speak. "Huh? The government is going to tax us for something that has nothing to do with the reason the tax was put in place? Umm.. ..okay!"

Wait! I'm having a vision.. ..it's of people trapped on the top floors of a building on fire. They sense impending doom. They jump to their deaths to avoid the flames even though the flames won't reach them for hours. Brilliant!

NOTE: If you haven't made the connection yet, my forum name is "Unperson" (1984). That should be enough to kick-start those of you that are about to flame me for being a government conspiracy nut.

"Unperson" - An unperson is a person who has been "vaporized"; who has been not only killed by the state, but effectively erased from existence. Such a person would be written out of existing books, photographs, and articles so that no trace of their existence could be found in the historical record. The idea is that such a person would, according to the principles of doublethink, be forgotten completely (for it would be impossible to provide evidence of their existence), even by close friends and family members. Mentioning his or her name, or even speaking of their past existence, is thoughtcrime; the concept that the person may have existed at one time and has disappeared cannot be expressed in Newspeak. Compare to the Stalinist practice of erasing people from photographs after their execution. [Source]

 

[kristin]

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...

You see it as "name calling." I see it as pointing out a negative, misguided attitude.

We have posted plenty of facts. Some people just don't want to accept them as facts.

Look at the link Smokey Joe posted. They are attempting to outright ban the use and sale of ecigs in New York based on the fact that ecigs are neither a tobacco product nor an FDA approved drug delivery device. This will set a precendence. We don't have the luxury of time to get a third classification. We have to pick one and the only choice that will leave the door open for further lobbying and possible reclassification as a "reduced harm" product is to get them classified as tobacco products FOR NOW.

 

[kristin]

... And even though I commented on the petitions and agree that "tobacco" is the best choice for the market... Thinking business wise and quality availability there... I STILL have the black market in my sights for backup.

Happy now?... Or do I have to lick it too?

I sincerely apologize for singling you out with the quote. It was not my intention to focus on you in particular - just the similar attitude several people seemed to have.

 

[kristin]

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.

But it will be open to legislation and lobbying. If it's made a drug delivery device, we will lose all chance of getting it reclassified as a "reduced harm" product - which is the ultimate goal.

 

[kristin]

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.

And this is where we get the opportunity to argue the reduced harm angle. As a reduced harm product, they will DESERVE the tax breaks.

We won't have this opportunity if they are classified as drugs. As soon as they are drugs, Big Pharma will set whatever price they want.

 

[kristin]

So because it isn't mentioned we can assume there will be no taxes on e-cigs?

$7 for a pack of cigarettes = .35 cents per cigarette. Even cheaper if bought by the carton and in some states nearly 1/2 that.

$177 for a box of 168 Nicotrol carts = $1.05 per cart. 1 cart = 1 cigarette.

One is a heavily taxed tobacco product and one is priced as a drug delivery device.

Now which classification do you think will be more affordable?