Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[D103]

Sun Thanks for that last post 10:38pm 4/09/10 for some reason the sytem won't let me use the quote feature. Anyway, your post and all your other comments have really helped me. I know I am going to sound crazy here because I've gone back and forth myself but after carefully reading your posts it makes more sense to me. Initially I too was against the tobacco status - for numerous reasons and I too felt that was a set-up and a loser. I was then convinced otherwise by some very thought provoking comments and opinions by some very committed and intelligent persons who shared the rationale for the "tobacco product status" and I began to feel they were right; and I have posted so several times on this and other threads. However, the whole time it has felt extremely uncomfortable inside me (and I've learned over time to trust this) I was feeling as though the "tobacco status" choice was the only viable option to keeping e-cigs available because I am sure, and I think most agree, that if it is classified as a drug-delivery device that is basically a defacto-ban. You have made your position clear to me and it makes very good sense - granted I am no attorney, I am no politician, nor do I understand the intricacies of how the FDA works and still, the strategy you have explained makes the most sense to me and in my opinion is the truest representation of the product and technology. I am also heartened to know that there is money and legal representation working on this strategy and if there is anyway in which I can help please let me know. I am also glad that you indicated that this "tobacco product" strategy has been reviewed by several Federal Trial and Appellant Attorneys and 99% felt it was a loser. I recently ran it by some attorney friends of mine (granted no experts by any stretch) but they too felt it was not a sound strategy and would likely not prevail.
As a side note to anyone who has found the ongoing "debate" or bickering as distasteful and distracting I would respectfully disagree. For anyone who has followed the recent passage of healthcare reform (whether you agree with it or not, is not my point) but rather you watched legislation in action. It's messy, ugly, sometimes bloody, sometimes disgusting. I agreed with several newscasters who likened it to the making of sausage. You may like the end product, but have you ever seen it made?!?!? YECH
This action too is going to be the same (I'm not saying I think this right or desirable but that I recognize it truly is the way of things) this is going to be a fight, it is going to be bloody and ugly and no one is going to just go away quietly into the night. So while it may be more comfortable to just be warm and fuzzy and supportive (I like those things too) that's not what is going to get things done. I am comforted that we have fighters in our corner and I appreciate the candor and the passion - we will need all we can muster and then some.
And to Kristin, I do appreciate everything you do for the forum and the cause in general and I have no problem at all with you expresing yourself fervently - in fact I respect it and it makes it easier for me to trust you. Please keep doing what you are doing you are a fighter and I respect that.

And Sun, thanks again!

[anim8r]

Reduced harm would apply to tofu in your scenario if tofu was also considered harmful.

"Reduced harm" means that the product is similar to the dangerous product, may carry it's own risks, yet the risks are considerably less than the product it's intended to replace.

All foods that contain fat come with at least a small amount of risk.

The point I was making is that nicotine is not considered harmful, and so far, I can't find any proof that PG and food flavorings used in e-cigs are harmful if ingested.

It's the other junk in cigarettes that have been proven to be deadly, not the nicotine. Nicotine in cigarettes is legal to use. So is the nicotine in e-cigs.

So why would there be a need to define nicotine as a "new drug".

If you're saying the combination of nicotine, PG, and food flavorings make it a new drug substance, then so what? We simply mix our own liquids. Regardless of the bans, nicotine would remain legal to use. Double flavored 0-nic liquid would also be legal to purchase. The FDA doesn't come into my house and check if I'm mixing my own cocktails with the correct amounts of alcohol.

As far as the hardware is concerned... I have no worries the hardware will still be available for as long as there are vapers desiring to purchase and use them (I covered that in several other posts).

Your opinion is wrong about mailing ecigs. Sorry. Read the PACT Act. It only applies to specific tobacco products and ecigs are NOT on the list. It would take an act of congress to get them added.

We'll see how long that lasts. I am simply not that naive. The PACT Act was written while e-cigs were NOT clearly defined. A rewrite will be inevitably discussed (if not immediately) once the courts label e-cigs with the shiney new tag; "tobacco product".

I can't understand how anyone would think this isn't a possibility.

Have you read ANYTHING about this topic?

Yes.

The FDA WANTS it to be classified as a drug, effectively BANNING it immediately. Then it'll take years and millions of dollars to get it approved.

Nicotine is legal. So we all become mixers during the next phase. You can still buy PG, food flavorings, and nicotine. They are all legal. So are all of the remaining components. The only true threat to the market is the sale of full "kits". At worst, this is just an inconvenience.

So we take a small step back. At least we still get our flavors and hardware in almost the same fashion we do now.

As a tobacco product, it will at least stay available for us to use, it'll take a couple of years for the FDA to get standards established and give us time to prove it's reduced harm value.

We've already had time. And what's come of it so far? Conceding that it should be called a tobacco product? That's our reply? That is a giant leap in the wrong direction. That loses us a lot of ground, some of which we'll never get back. Junk science and baseless myths about e-cigs seem to be the rules of thought today. That will NOT change once e-cigs are recognized as tobacco products. It will get far worse.

Letting the FDA call the nicotine in our e-cigs a drug doesn't get them much to work with in the long run. It's already a recognized drug in several OTC products.

Thousands of people have already been ground testing this "new drug" for years. It's already progressed far beyond the initial testing phase and far more positive pressure can be applied from users and concerned family members for this "new drug" since we aren't seeing people keel over from its use. The exact opposite is true.

And, as I've stated before, there are many options left for companies (and all of us) to exploit in any proposed attempts at banning e-cigs.

Taxes are NOTHING. I've made this point several times:

A cigarette is 35 cents. A nicotine inhaler cartridge is $1.05.

Even with the taxes, ecigs will be CHEAPER AS TOBACCO PRODUCTS than if they get in the hands of the drug companies!!

Taxes on cigarettes is about 70-90 percent (depending on where you live). An equivolent tax would be hard to miss and not likely to be called "nothing" by most people.

And, once taxed... the taxes can only get higher.

Non-smokers don't care how much "tobacco products" are taxed. You won't find any sympathy from these people.

EDITED to add: Sorry, Thad, I missed your post before posting this. You already covered everything!

All I see is a lose/lose for vapers by labeling e-cigs as tobacco products.

I hold no animosity toward you or others that believe "tobacco product" is the right way to go. I just don't agree with you.

[lonercom]

Interesting debate all. I love it when smart, creative, talented and passionate people discuss important issues relevant to my life. God knows we don't see it enough in our elected officials.

I've always wondered why the E-cig community has not explored the vitamin and suppliment theory. I know this isn't an herb in the strictest sense but that whole arena is kind of a fuzzy area anyway.

[bobtow]

All foods that contain fat come with at least a small amount of risk.

The point I was making is that nicotine is not considered harmful, and so far, I can't find any proof that PG and food flavorings used in e-cigs are harmful if ingested.

It's the other junk in cigarettes that have been proven to be deadly, not the nicotine. Nicotine in cigarettes is legal to use. So is the nicotine in e-cigs.

So why would there be a need to define nicotine as a "new drug".

If you're saying the combination of nicotine, PG, and food flavorings make it a new drug substance, then so what? We simply mix our own liquids. Regardless of the bans, nicotine would remain legal to use. Double flavored 0-nic liquid would also be legal to purchase. The FDA doesn't come into my house and check if I'm mixing my own cocktails with the correct amounts of alcohol.

As far as the hardware is concerned... I have no worries the hardware will still be available for as long as there are vapers desiring to purchase and use them (I covered that in several other posts).




We'll see how long that lasts. I am simply not that naive. The PACT Act was written while e-cigs were NOT clearly defined. A rewrite will be inevitably discussed (if not immediately) once the courts label e-cigs with the shiney new tag; "tobacco product".

I can't understand how anyone would think this isn't a possibility.






Yes.





Nicotine is legal. So we all become mixers during the next phase. You can still buy PG, food flavorings, and nicotine. They are all legal. So are all of the remaining components. The only true threat to the market is the sale of full "kits". At worst, this is just an inconvenience.

So we take a small step back. At least we still get our flavors and hardware in almost the same fashion we do now.





We've already had time. And what's come of it so far? Conceding that it should be called a tobacco product? That's our reply? That is a giant leap in the wrong direction. That loses us a lot of ground, some of which we'll never get back. Junk science and baseless myths about e-cigs seem to be the rules of thought today. That will NOT change once e-cigs are recognized as tobacco products. It will get far worse.

Letting the FDA call the nicotine in our e-cigs a drug doesn't get them much to work with in the long run. It's already a recognized drug in several OTC products.

Thousands of people have already been ground testing this "new drug" for years. It's already progressed far beyond the initial testing phase and far more positive pressure can be applied from users and concerned family members for this "new drug" since we aren't seeing people keel over from its use. The exact opposite is true.

And, as I've stated before, there are many options left for companies (and all of us) to exploit in any proposed attempts at banning e-cigs.





Taxes on cigarettes is about 70-90 percent (depending on where you live). An equivolent tax would be hard to miss and not likely to be called "nothing" by most people.

And, once taxed... the taxes can only get higher.

Non-smokers don't care how much "tobacco products" are taxed. You won't find any sympathy from these people.






All I see is a lose/lose for vapers by labeling e-cigs as tobacco products.

I hold no animosity toward you or others that believe "tobacco product" is the right way to go. I just don't agree with you.

You are merely spinning your wheels. The tobacco option was noty picked by Kristin, it was imposed by the FDA. There were only two options offered. Eiother have ecig listed as a drug or a tobacco product. There were no other choices to fall back on. And to compare tofu to nicotinei is erronious. nicotine is considered a toxic substance. It has been established that 60 mg could kill. I would have likied to see the option that ecig would be recognized as a recreational substance, but the FDA does not give anyone that option.

[Sun Vaporer]

You are merely spinning your wheels. The tobacco option was noty picked by Kristin, it was imposed by the FDA. There were only two options offered. Eiother have ecig listed as a drug or a tobacco product. There were no other choices to fall back on. And to compare tofu to nicotinei is erronious. nicotine is considered a toxic substance. It has been established that 60 mg could kill. I would have likied to see the option that ecig would be recognized as a recreational substance, but the FDA does not give anyone that option.

Bob--the issue is "Does the FDA have jurisdiction over the e-cig". The "tobacco" option came from SE as at the time of filing suit, calling it a tobacco product would negate FDA jurisdiction. Back when this suit was filed the FDA did not have jurisdiction over tobacco at all. That changed in midstream last year when Congress gave the FDA jurisdiction to regulate but not ban tobacco products. SE decided to stay with their "tobacco" argument.

We have never been limited to "Drug" or "Tobacco"---to the contrary, SE boxed us into that. I contend as well as many Attorneys that I have spoke with that absent a therapeutic endpoint, that the FDA has a real issue in claiming the e-cig a new "drug" thereby negating its jurisdiction. You do not need "another option", rather you only need to establish that the e-cig does not fall under the jurisdiction of the FDA.


Sun

[anim8r]

You are merely spinning your wheels. The tobacco option was noty picked by Kristin, it was imposed by the FDA. There were only two options offered. Eiother have ecig listed as a drug or a tobacco product. There were no other choices to fall back on. And to compare tofu to nicotinei is erronious. nicotine is considered a toxic substance. It has been established that 60 mg could kill. I would have likied to see the option that ecig would be recognized as a recreational substance, but the FDA does not give anyone that option.

Good lord...

Everyone seems to be stuck on the tofu reference .

It was used in an analogy concerning harm reduction and was not a comparison to nicotine. It was simply an analogy comparing a low fat healthier item (Tofu) to a higher fat not-so-healthy item (Red Meat).

As in... An E-cig = usually a lower level and far cleaner (or healthier) form of nicotine delivery when compared to the higher content and far dirtier (not-so-healthy) form found in cigarette smoke.

That's all I was saying.


And sure, nicotine is a poison. But, I don't know of anyone that has been poisoned by an e-cig which makes that as close to a moot point as you can get (imo) when discussing electronic cigarette safety.


As far as the two choices go (if that's all we have), I simply prefer the drug tag over the tobacco tag and have stated my reasons why.

Very soon after e-cigs get recognized as either a tobacco product or as a drug, we will know exactly how close all of us are in our opinions on the matter.

[Thulium]

Bob--the issue is "Does the FDA have jurisdiction over the e-cig". The "tobacco" option came from SE as at the time of filing suit, calling it a tobacco product would negate FDA jurisdiction. Back when this suit was filed the FDA did not have jurisdiction over tobacco at all. That changed in midstream last year when Congress gave the FDA jurisdiction to regulate but not ban tobacco products. SE decided to stay with their "tobacco" argument.

We have never been limited to "Drug" or "Tobacco"---to the contrary, SE boxed us into that. I contend as well as many Attorneys that I have spoke with that absent a therapeutic endpoint, that the FDA has a real issue in claiming the e-cig a new "drug" thereby negating its jurisdiction. You do not need "another option", rather you only need to establish that the e-cig does not fall under the jurisdiction of the FDA.


Sun

You are confusing me, Sun. You started this discussion by saying that we would be in a better position if Smoking Everywhere had simply applied to the FDA in the first place--now you are saying that the e-cig is not under FDA jurisdiction. Which is it?

[Sun Vaporer]

You are confusing me, Sun. You started this discussion by saying that we would be in a better position if Smoking Everywhere had simply applied to the FDA in the first place--now you are saying that the e-cig is not under FDA jurisdiction. Which is it?

Yes--no tobacco, no drug. Under SE's theory, they would need to file. But that is SE. More then one can "carry the flag" Thulium and it does not have to be SE leading the way.


Sun

[Thulium]

Yes--no tobacco, no drug. Under SE's theory, they would need to file. But that is SE. More then one can "carry the flag" Thulium and it does not have to be SE leading the way.


Sun

I understand that it doesn't have to be SE leading the way... and it would certainly be my preference for it to be a different business.

What I don't understand is how you can say that the FDA doesn't have jurisdiction and then praise the unnamed businesses for having submitted an application to the FDA and chide SE for not applying to the FDA as you have done in this thread.

SE's "theory" is that they have consistently marketed their product for recreational use and since the FDA did not regulate tobacco at the time, SE did not need to apply for FDA approval. In fact, since the FDA has still not published the requirements for MRTPs, it seems like it would behoove SE specifically to NOT apply to the FDA so that their argument remains consistent.

You've said that certain other suppliers have already applied for FDA approval, yet you say they aren't under FDA jurisdiction. Why would you submit an application for approval to an agency that you don't believe has jurisdiction?

[Sun Vaporer]

I understand that it doesn't have to be SE leading the way... and it would certainly be my preference for it to be a different business.

What I don't understand is how you can say that the FDA doesn't have jurisdiction and then praise the unnamed businesses for having submitted an application to the FDA and chide SE for not applying to the FDA as you have done in this thread.

SE's "theory" is that they have consistently marketed their product for recreational use and since the FDA did not regulate tobacco at the time, SE did not need to apply for FDA approval. In fact, since the FDA has still not published the requirements for MRTPs, it seems like it would behoove SE specifically to NOT apply to the FDA so that their argument remains consistent.

You've said that certain other suppliers have already applied for FDA approval, yet you say they aren't under FDA jurisdiction. Why would you submit an application for approval to an agency that you don't believe has jurisdiction?

Thulium---there are some Suppliers here on this Forum that filed with the FDA but claimed their product was not a drug. There hope is a denial so they have standing to litigate. They did not have any products seized like SE or NJOY so that would be the only way they could get standing.---You need standing. That is why the FDA has not refused as that would give them standing to litigate.

Sun