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

[Mister]

Sun, I can see how this approach could become much more visible to the public at large, and that is of course a huge advantage. The FDA wins things most easily when it can keep them out of the public eye.

How will the inevitable attacks based on nicotine be handled in this approach? Just maintain that it isn't a big deal? To me that is logical but it may be a hard sell in view of public perception. I think there's a lot of evidence that nicotine (in the amounts involved here) is not particularly dangerous. And there's even evidence that it is not in itself terribly addictive, that it becomes more addictive in cigarettes due to other chemicals which are not present in e-cigs. It might also be argued that the nicotine delivery should not be considered an issue at all since the same amounts of nicotine can readily be obtained by smoking. Do such arguments have a chance? Or do you think the nicotine problem can be handled some other way?

 

[anim8r]

Then why did the police recently confiscate them from all places selling them here where I live?

Beats me.

Water pipes are legal in San Diego.

Tell the people where you live they can buy replacements online.

Right here in the USA.

 

[DC2]

Beats me.

Tell the people where you live they can buy replacements online.

Right here in the USA.

My point being that they can stop the sale of them if they want to, and all it takes is for someone to want to. And while there is no incentive for anyone to care much about bongs, my personal opinion is that there will be plenty of people with a lot of money who are going to care if electronic cigarettes are still being sold if they are banned.

 

[D103]

That IS a good question.

Q: "What's to prevent the FDA from establishing new costly regulations, expense that Big tobacco is more than capable of absorbing, but an expense that would virtually wipe out the e-cig industry?"

A: You and me, buddy. This is why simply getting e-cigarettes classified as tobacco products is not the end of the work. I'll point to CASAA's mission statement :


(emphasis mine)

Regardless of how the electronic cigarette is ultimately regulated, there is no question that it will have to be regulated. The current free-for-all gray market is surviving on the good intentions of those involved, but it cannot last. Eventually the "bad" e-cig companies will include businesses that do much worse than overcharge for shipping and some agency will have to step in to ensure quality and safety controls are in place. Personally, I hope for less regulation rather than more, but in the end it is each of our individual responsibility and civil duty to make sure that regulations are reasonable.

In another thread people assumed that I somehow wanted e-cigs to be taxed because I was suggesting that tax reform was a possible way to get e-cigs encased in law as a tobacco product. The notion that I would WANT more taxes could not be farther from the truth! Politically, I am strongly in favor of a national flat tax and a radical downsizing of the IRS--but reducing taxes is not why I came here. I came here to help make sure that smoke-free alternatives like e-cigs remain available, affordable and are reasonably regulated to assure safety and effectiveness.

In a perfect world, we'd be able to let the FDA regulate them however they chose since the Agency was specifically created to assure safety and effectiveness over drugs and Congress thought it would be a good idea to get the same sort of safety and effectiveness out of tobacco products.... Unfortunately, the FDA has demonstrated throughout the course of its existence a complete inability to accomplish this so we are left with the task of convincing Congress to do what the FDA wont.

Of course you are right -- but I have to say that I am certainly less than confident of our (We the People) ability to stave off 'unfair/excessive' governmental regulation - especially considering our track record is less than impressive; and the fact that this is such a 'Hot' topic with formidable opposition - financially, politically and currently holding majority sentiment on their side - opposition which appear driven with a seeming collective conscience to "got to any lengths" including, disseminating false information, utilizing the bully pulpit to employ rash and unfounded scare tactics, and, in my opinion, seriously breach ethical boundaries.
But again, your points are well taken, 'one step at a time' - I guess I've always been one to try and look down the road for potential pitfalls.

 

[JerryRM]

No one here can deny that CASAA is an important ally and friend to the e-cig community. That being said, it appears to me that CASAA is offended at not being informed of any new actions being taken by suppliers against the FDA.

IMO, CASAA would be an important ally in any new legal proceeding, but it is up to the suppliers to decide if and when they want CASAA involved. Apparently, Sun has some insider information, but it is not his right or duty to pass that information on to anyone, public or private.

I have read page after page of Sun defending himself and I don't think he deserves to be treated like that. Day after day he has, at his own expense, kept us informed as to what is happening in the courts. Without Sun, we would be pretty much in the dark.

That's my two cents worth. Post flames if you like, I can take it.

 

[DC2]

No one here can deny that CASAA is an important ally and friend to the e-cig community. That being said, it appears to me that CASAA is offended at not being informed of any new actions being taken by suppliers against the FDA.

CASAA was formed to help represent us.
They can't do that very well if they are in the dark.

 

[Thulium]

No one here can deny that CASAA is an important ally and friend to the e-cig community. That being said, it appears to me that CASAA is offended at not being informed of any new actions being taken by suppliers against the FDA.

CASAA isn't offended by anything.

*I* am offended that CASAA is being falsely accused of siding with SE and Njoy and decrying the actions of other companies rather than joining them when the actions of the companies was not brought to our attention.

"We" aren't demanding that a business run their plan through us---"we" aren't demanding anything whatsoever. I do think it would have been appropriate to bring a new idea to the table for us to discuss BEFORE complaining that we aren't open to new ideas.

 

[Sun Vaporer]

Sun, I can see how this approach could become much more visible to the public at large, and that is of course a huge advantage. The FDA wins things most easily when it can keep them out of the public eye.

How will the inevitable attacks based on nicotine be handled in this approach? Just maintain that it isn't a big deal? To me that is logical but it may be a hard sell in view of public perception. I think there's a lot of evidence that nicotine (in the amounts involved here) is not particularly dangerous. And there's even evidence that it is not in itself terribly addictive, that it becomes more addictive in cigarettes due to other chemicals which are not present in e-cigs. It might also be argued that the nicotine delivery should not be considered an issue at all since the same amounts of nicotine can readily be obtained by smoking. Do such arguments have a chance? Or do you think the nicotine problem can be handled some other way?

Mister--as it stands right now, nicotine and caffeine are in the exact same catagory with the FDA and nicotine is not a Class substance. So it begs the question "what is the legal issue with nicotine" as a matter of law. You can market power drinks loaded with enough caffeine to kill a cow, so really what is the problem with products containing nicotine.

It always has bothered me that SE brought tobacco into the equation. The issue here is Nicotine, not tobacco.

Sun

 

[Sun Vaporer]

CASAA isn't offended by anything.

*I* am offended that CASAA is being falsely accused of siding with SE and Njoy and decrying the actions of other companies rather than joining them when the actions of the companies was not brought to our attention.

"We" aren't demanding that a business run their plan through us---"we" aren't demanding anything whatsoever. I do think it would have been appropriate to bring a new idea to the table for us to discuss BEFORE complaining that we aren't open to new ideas.

Thulium--was it not you who said that tobacco is the way to go here? Is that not SE's and NJOY's position? We are talking about the theory of the case, not the companies. If that is not your stance, what is your stance? And I would like to hear why you think or do not think we need a tobacco argument? Personally I do not think the tobacco theory is needed. What is your take?


Sun

 

[anim8r]

My point being that they can stop the sale of them if they want to, and all it takes is for someone to want to. And while there is no incentive for anyone to care much about bongs, my personal opinion is that there will be plenty of people with a lot of money who are going to care if electronic cigarettes are still being sold if they are banned.

And my point is... and lets not kid ourselves... Bongs are overwhelmingly used to smoke an illegal substance and yet... they are legal to purchase and own.

Nicotine, on the other hand, is a legal substance. So if bongs can be sold for "other" purposes, then a reasonable mind should see that the same logic would apply to our batteries, "mini foggers" or "atomizers intended for your 0-nic liquid enjoyment", and 0-nic carts.


The only thing I see ultimately at risk (if e-cigs are considered drug delivery systems) is the e'cig in full Kit form.

The batteries, atomizers, and carts can and will be sold legally... albeit in more 'creative' ways.

I put far more faith in businesses finding ways of skirting any and all of the FDA's possible regulations than I do for them beating any rules imposed on "tobacco products".

The term "Tobacco Product" will motivate multitudes of people to ban them in every way possible, including many of my co-workers--the same people who now congratulate me on my quitting cigarettes by using these nicotine inhalers.

Yup, the very same people that have welcomed my vaping will turn on this activity the instant it is known officially as a tobacco product. Count on it.

The term "Nicotine (or Drug) Delivery Device" sounds like something that is helpful or a treatment aide.


Terminology means everything when it comes to the e-cig's future.

IF it has to be labeled one of only two things, then I wholeheartedly prefer Nicotine Delivery Device when considering every possible outcome.


I leave it up to the juice makers if they want to submit fortified carts to the FDA for approval, but that decision wouldn't effect me one way or the other.

 

[DC2]

Thulium--was it not you who said that tobacco is the way to go here? Is that not SE's and NJOY's position? We are talking about the theory of the case, not the companies. If that is not your stance, what is your stance? And I would like to hear why you think or do not think we need a tobacco argument? Personally I do not think the tobacco theory is needed. What is your take?

I hate to speak for Thulium, but I believe his take is that he would love to support the new approach being taken by this group of suppliers, provided he understood how it would work and what the ramifications would be. And I'm pretty sure that is how every one of us would feel. I know that is how I feel, and I know I really want to know how CASAA feels about it, so I can understand whether or not to support them.

 

[DC2]

I put far more faith in businesses finding ways of skirting any and all of the FDA's possible regulations than I do for them beating any rules imposed on "tobacco products".

They would do so at their own risk and potentially at great monetary peril if they attempt to ignore a ban should the FDA rule these things to be drug delivery devices.

The FDA is already seizing product, and they have already indicated that if they get their way they may very well step up enforcement to include fining suppliers.

 

[Sun Vaporer]

I hate to speak for Thulium, but I believe his take is that he would love to support the new approach being taken by this group of suppliers, provided he understood how it would work and what the ramifications would be. And I'm pretty sure that is how every one of us would feel. I know it's how I feel.

DC2--I do not know all the details of how the case will be litigated, only what I posted. And Counsel usually does not disclose how they are going to play out a case. So we will just have to see how it unfolds I would imagine.


Sun

 

[Mister]

nicotine and caffeine are in the exact same catagory with the FDA and nicotine is not a Class substance

I didn't know that, it is very good news.

In Canada nicotine is specifically regulated by the Food and Drug Regulations (here's a link in case anyone wants it: http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._870.pdf) I believe the Canadian regulations have a specific loophole (Schedule F, nicotine exception (d)) which e-cigs could technically qualify under. The nicotine exemptions listed in Schedule F are part of what currently enables off the shelf sales of NRTs in Canada.

But with Health Canada's current stance it would require a court case to decide that issue. I've been trying to communicate with Health Canada to get a reaction regarding voluntarily complying with some other stipulations in order to get explicit agreement to using this exception. No luck so far.

 

[Thulium]

Thulium--was it not you who said that tobacco is the way to go here? Is that not SE's and NJOY's position? We are talking about the theory of the case, not the companies. If that is not your stance, what is your stance? And I would like to hear why you think or do not think we need a tobacco argument? Personally I do not think the tobacco theory is needed. What is your take?


Sun

What is my stance? As I said above, I support classifying electronic cigarettes as a tobacco product unless and until a more specific classification is available. That does not mean I am opposed to the creation of a more specific category, but it does imply that I would support other modified risk tobacco products the same way.

Why we need a tobacco argument? The FDA painted us into this corner when they insisted that SE's products be regulated as a drug device and the only other option offered was tobacco. To date, the ONLY nicotinated products intended for human consumption that have been allowed to remain on the market are either classified as tobacco products or are regulated by the FDA as smoking cessation medication. Since the intended use of e-cigarettes is more recreational than therapeutic, of the two currently available classifications, tobacco is more accurate than drug device.

Until recently, any discussion of another category was grouped under MRTPs--which by their name imply that they are a sub-category of tobacco products. It could be argued that MRTP's would be expected to not contain many of the ingredients in traditional tobacco products--so much so that something like Snus or dissolvables are hardly recognizable as tobacco. If smoke-free tobacco products can be classified as modified risk, certainly electronic cigarettes could be classified as a smoke-free tobacco product. ....The difficulty is that even the MRTP category is not available to us without many years of development and testing, and to be frank, we need e-cigs on the open market before then.

I think creating a new category is a FANTASTIC idea...but until it is realized, it would appear that we have only the alternatives the FDA has given us: Drug device or tobacco.

A new category doesn't prevent the FDA from seizing e-cigarettes as an unregulated new drug and device combination. Getting under the umbrella of protection afforded by tobacco is the only idea presented thus far that does not involve a de facto ban pending the creation and implementation of previously undefined regulations. That is, of course, unless you know of a way that a new category can be created before the FDA bans e-cigs as a drug?

 

[Sun Vaporer]

What is my stance? As I said above, I support classifying electronic cigarettes as a tobacco product unless and until a more specific classification is available. That does not mean I am opposed to the creation of a more specific category, but it does imply that I would support other modified risk tobacco products the same way.

Why we need a tobacco argument? The FDA painted us into this corner when they insisted that SE's products be regulated as a drug device and the only other option offered was tobacco. To date, the ONLY nicotinated products intended for human consumption that have been allowed to remain on the market are either classified as tobacco products or are regulated by the FDA as smoking cessation medication. Since the intended use of e-cigarettes is more recreational than therapeutic, of the two currently available classifications, tobacco is more accurate than drug device.

Until recently, any discussion of another category was grouped under MRTPs--which by their name imply that they are a sub-category of tobacco products. It could be argued that MRTP's would be expected to not contain many of the ingredients in traditional tobacco products--so much so that something like Snus or dissolvables are hardly recognizable as tobacco. If smoke-free tobacco products can be classified as modified risk, certainly electronic cigarettes could be classified as a smoke-free tobacco product. ....The difficulty is that even the MRTP category is not available to us without many years of development and testing, and to be frank, we need e-cigs on the open market before then.

I think creating a new category is a FANTASTIC idea...but until it is realized, it would appear that we have only the alternatives the FDA has given us: Drug device or tobacco.

A new category doesn't prevent the FDA from seizing e-cigarettes as an unregulated new drug and device combination. Getting under the umbrella of protection afforded by tobacco is the only idea presented thus far that does not involve a de facto ban pending the creation and implementation of previously undefined regulations. That is, of course, unless you know of a way that a new category can be created before the FDA bans e-cigs as a drug?

But why Tobacco? Nicotine stands on its own footing. Judge Leon ruled that if a product like Nicotine has no theraputic endpoint for using, then it can not be classifed as a drug. That part of his ruling does not even start to touch and concen tobacco. If it is not a drug, then the FDA has no jurisdiction to ban it.

So why do we need tobacco in the equation? Why can't the e-cig stand on its own as the FDA puts Caffeine and Nicotine in the same classification?


Sun

 

[anim8r]

They would do so at their own risk and potentially at great monetary peril if they attempt to ignore a ban should the FDA rule these things to be drug delivery devices.

The FDA is already seizing product, and they have already indicated that if they get their way they may very well step up enforcement to include fining suppliers.

And they have also released most shipments after holding them.

Bongs were seized in your home town even though they're legal to sell and own there.

Stuff happens.

If you've read my posts, you will deduce that these businesses will not be selling "e-cigs" or "drug delivery devices". The FDA will be chasing ghosts just like others chase after those that create and sell bongs.

The manufactures will be selling batteries, atomizers, etc. just like other devices that are used for other purposes are sold.

Right now they are listed as electronic cigarettes, personal vaporizers, etc. on the declarations documentation.

When companies start marketing their "mini flashlights" with interchangeable heads, then what justification can the FDA have for holding them?

Since when does the FDA have jurisdiction over batteries? or foggers?

Businesses will easily adapt to meet the demand (as seen so often in the past).
People are not so easily changed and word "tobacco" literally leaves a bad taste in their mouths.

Sorry, but I will never get excited over having a whopping two flavors to choose from, having to go outside for a "smoke" break again, or continuing to fight against the "for the children" tobacco legislature.

 

[kristin]

As we see now by how CASAA board directors responded in this thread, that they are not open to any new ideas anyway and want to stay the course and that they think the current course is a winner. Further they think that "tobacco" is the way to go and that nothing further needs to be done in the Court and that SE and NJOY have everything under control.

EXCUSE ME???

I think we HAVE demonstrated that we are open to other avenues. Had we been in the loop and thought it even feasible!!

That is an extremely unfair revision of the actual conversation we have been having, Sun.

We weren't even given the opportunity to know of another course of action. Without other suppliers to fund a go at the FDA, we were stuck with what we had - the SE vs FDA.

As I've already stated, by not telling us what was going on, these suppliers have put CASAA on the wrong side of the fence and that is THEIR doing.

CASAA had even put a call out to suppliers and given them their own private forum on the CASAA forum and we got no response!

Here CASAA is fighting for tobacco status because we felt it was the only option - which it IS without a strong financial backing and good lawyers - had we known there was a strong contingency of suppliers, we would have been backing them instead.

CASAA has ALWAYS backed a reduced harm classification. That has ALWAYS been the ultimate goal and without financial backing and attorneys, the tobacco product route was the only option.

Now you tell CASAA that the financial backing is there, yet they elected not to tell CASAA and allow CASAA to keep the course we were taking and that is somehow our refusal to look at other options?????

I'm so upset right now I could smoke.

 

[Sun Vaporer]

Kristin--please go back and read all of your posts about starting with the fantasy one. The one where you say we are stuck with Tobacco or Drug. You were not being open minded at all. You just dismissed it in short order. It really is hard to not look at your posts and say you kicked the idea to the curb. But if that is not your take, then that is fine too.

The Suppliers read your posts and their only comment was "we are really glad we did not post ourselves."


Sun

 

[JerryRM]

I'm so upset right now I could smoke.

Nothing is worth committing suicide over, Kristin. 8-o