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

[DC2]

Let's cut to the bottom line...

The decision to not inform CASAA about the new approach that is being taken effectively cuts the legs out from under CASAA and renders them not only ineffective, but possibly counterproductive.

The decision to not inform them may have been necessary, but it doesn't change that fact.

How am I supposed to support CASAA in their efforts if they are just as in the dark as I am?
Maybe CASAA should just shift their efforts to cheerleading and just stay out of the way?

 

[Sun Vaporer]

Left in the dark until just recently.
Unless this alternative approach was just taken up in the last few days?

Sounds to me though like it was not only taken up awhile back, but it is well underway.
I am assuming that it just came to your attention recently as well.

DC2----Let me explain something---Many Suppliers have consulted their Lawyers over this and many have been told that SE's approach was flawed. As a matter of fact most were told that SE's theory was flawed and wanted to do something about it.

These Suppliers are the little guys who were not going to enjoy the Stay issued to SE and njoy and did not feel that SE or njoy had their interests covered.

Funding was always the issue. Once the Appeals Court issued a Stay and they have lost shipment after shipment with the FDA's embargo, a few decided to step up and get into the game with their checkbooks.
They where told that the Appeals Court Stay was not good news from many Attorneys . So while the idea has been kicked around and Suppliers made calls, nothing really came to light till last week.

For them, it is either that our find another occupation. There is no unemployment benifits for the self-employed.

I will leave it at that.

Sun

 

[DC2]

DC2----Let me explain something---Many Suppliers have consulted their Lawyers over this and many have been told that SE's approach was flawed. As a matter of fact most were told that SE's theory was flawed and wanted to do something about it.

These Suppliers are the little guys who were not going to enjoy the Stay issued to SE and njoy and did not feel that SE or NJOY had their interests covered.

Funding was always the issue. Once the Appeals Court issued a Stay and they have lost shipment after shipment with the FDA's embargo, a few decided to step up and get into the came with their checkbooks.
They where told that the Appeals Court Stay was not good news from many Attorneys . So while the idea has been kicked around and Suppliers made calls, nothing really came to light till last week.

For them, it is either that our find another occupation. There is no unemployment benifits for the self-employed.

I will leave it at that.

Sun

So a long time ago they were being encouraged to implead into the current case, but rather than taking that route they are preparing to take another route instead. And the effort got a kickstart by the infusion of money, which is a very recent development.

Is there some way we can support them with our time or money?
Because I have the desire, and nowhere to aim it.

 

[Thulium]

Well you are on the Board and seem firm in your stances here. Read what you wrote about it. When you talk, are you not talking for CAASA? Thank god the Supplers did not post here.

I dislike it when my ability to express an opposing view is mistaken for a strongly held opinion, but I understand why it happens: My ADHD brain has a tendency to miss details so I don't tend to trust my first impression. To cope with this I am in the habit of "arguing from the other side" (aka "Playing Devil's THADvocate") in order to develop a deeper understanding of the underlying issues.

CASAA is a democratic association of consumer advocates. I don't speak for CASAA any more than a Senator speaks for the United States of America. That said, I understand that the "CASAA Board Member" under my alias here might confuse some people so I do try to remain impartial to the best of my ability.

I am not here to defend what these Suppliers do or do not do. I spelled
out an alternative theory of the case and dispelled the statement that any new litigation would not be feasible. Take it for what it is worth.

Hm. Even if you insist that I or Kristin "blasted" this alternate theory, I submit to you that I don't fully understand what this theory is so I withdraw my expressed opinion pending further review.

I don't think anyone made a statement that new litigation would not be feasible, I questioned the feasibility of a strategy that does not conform to the "tobacco or drug" paradigm the FDA and Congress have left us.

 

[D103]

The different standards for regulation of drugs/devices that the FDA has in place allow them to seize imports of unregulated drugs and they can be made illegal to sell without the FDA approval that will undoubtedly take years to accomplish. Tobacco products, on the other hand, have been specifically exempted from the FDA's import and sales restrictions.

Yes, the FDA can require tobacco companies to comply with various regulations and they could theoretically revoke the license from companies unwilling to comply (but no one would expect that to happen to Philip Morris, would we?)...but tobacco products will remain on the market in the intervening time between now and whenever the FDA actually makes tobacco regulations. On the other hand, the FDA can remove unapproved drugs from the market until they are approved.



There was not even any active ingredient in that thing! It was 2 pieces of plastic and some lubricant, yet the FDA was seizing the product from doctors 3 years after they were submitted for FDA approval.

I could see it being possible for e-cigs to survive without being legally defined as a tobacco product. In other countries like the UK, it seems possible that the e-cig might be okay in the hands of the medical regulators because they have adopted a harm reduction stance. In the United States, however, it is my considered opinion that the FDA is absolutely not suited to regulate the e-cig as a drug/device combo without first undergoing comprehensive reform, and the 450,000+ people who will die each year it takes for the FDA to figure out how to make e-cigs as ineffective as an NRT should not be made to wait.

I wish the companies you hint are submitting e-cigs to the FDA for approval all the best of luck and I honestly hope they are allowed to start selling their products soon. That doesn't make Judge Leon's ruling that e-cigs are NOT a drug device any less critical to the future of e-cigs. Therefore, I am not convinced that SE would have been better off trying to go through the FDA first, but I would be happy to be proven wrong.

Another question - somethig you said caught my eye and is very interesting. you said in your post: " Yes the FDA can require tobacco companies to comply with various regualtions and they could theoretically revoke the license from companies unwilling to comply (but no one would expect that to happen to Phillip Morris, would we?)"....and then you go on.
Now, while I agree with you I think a crucial word is missing; where you say "....revoke the license from companies unwilling to comply...." I would
add 'and/or UNABLE to comply....' As I am sure you are aware often times governmental regulation is actually the 'friend' of big business (despite their disingenuous protestations) in terms of eliminating the competition. My concern and question is if e-cigs are classified as an alternative tobacco product(which I am all for) 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?

 

[Sun Vaporer]

CASAA has not blasted anyone's public stance. 2 members of CASAA have questioned its feasibility and we don't expect an answer until the strategy is made public.

Well again Thulium, your posts certainly do not appear to welcome it. First you say CASAA should have been approched (do not know why as they have nothing to do with CASAA) and then you say you are only two of CASAA's board. Then you speak to how tobacco is the only way to go, and then attack that it is fantasy and not feasable.

The posts here all go to attacking and not embracing---that is all I have been doing is defending these attacks. So why not set the record straight so we can move on as you have 10 pages or so of posts that do not support what you are saying--maybe it is just a misunderstanding? I do not know. What I do know is I am tired of sitting here defending what others are trying to do for the good of e-cigs.

Sun

 

[Sun Vaporer]

Thulium--here is a starter for you--the theory of the case and a response--need more as there are pages of them:

Sun

Ladyraj, by that I mean that if SE and NJOY do win, the FDA is going to gain regulation over the e-cig as a "tobacco" product and will have the ability to greatly reduce the nicotine content. An e-cig yielding 4mg. of e-liquid is not going to do anything but "cut the legs out" from under the high effective ratio the e-cig currently enjoys thus rendering it an "approved failure". The tobacco legislation does not allow regulation to zero, but it leaves open the "amount" to be deemed reasonable to the FDA---and that will "bit us in the ...." when it comes to aligning the e-cig with tobacco—IMO, it is a fatal mistake.
　
　
Taking a different approach, an attack hitting the FDA head on with the e-cig for the purpose it currently employs is what is needed here.
　
　
I would contend that the definition of an e-cig is as follows:
　
　
The e-cig is an alternative way to use nicotine for recreational purposes and stop employing the use of cigarettes, which is one of the largest killing products ever put into commerce for use by consumers.
　
　
Is that an NRT triggering an intended use that has a therapeutic end point?---IMO, a resounding NO. An NRT is for a short duration of six months or less with an therapeutic end goal of total nicotine cessation.
　
　
To the contrary, I would contend that the e-cig has no end goal and is used purely for recreational purposes, so no FDA drug implications could be claimed.
　
　
As the theory of the case would go, absent a drug or a tobacco implication, the FDA would lack standing to regulate it as it is not a drug or a tobacco product.
　
　
The problem has been, IMO, that too much "sugar coating" has been going on and a lot of looking for loopholes with an approach that stamps the word "fear" all over the E-cig.
　
I would also contend that this fear of being labeled an NRT and a drug is the very problem that will lead the e-cig, at best, to "death by FDA regulation".
　
　
Instead, IMO, pit the FDA against exactly what the E-cig is as we know it and what the E-cig can do. Let the media play devil’s advocate with this type of Court case. You want to talk about winning "public approval" and the "Court of public perception" —a case framed like this in the Media will in fact spark the needed controversy as to how the e-cig should have a legitimate office when it comes to being a healthier alternative and saving lives. Lets call it for what it is IMO.



Remember, that the Court is sitting in equity and must balance the harms and take into account what is best for the public. I do not know a stronger case that can be made when weighing the healthier use of an e-cig against "death by cigarettes" should the FDA be allowed to ban the e-cig.

Bottom line here is that SE and NJOY need to get their act together and argue an "in the alternative" theory of the case.
　
Sun
　

A lot of wishful thinking. We don't have the luxury of demanding a third option. Our choices are "drug device" or "tobacco product." Period. Wishful thinking, hemming and hawing, will only get us placed into the "drug device" and probably banned altogether. And who will fund this fantasy campaign to become a reduced harm product before the government dumps it into the drug category?

As a tobacco product now, it will give us time to lobby to move it into reduced harm tobacco, once the studies and research is completed, yet keep it on the market until that happens.

Trying to force that hand now is what would end up biting us in the .....


To get into the reduced harm category will require PROOF, which is nearly impossible and as expensive and time-consuming as getting approval as a drug. It would have the same effect as having it declared a drug, as there is no concrete evidence at this time and studies are needed.

Do you folks not think that the FDA will be able to regulate the amount of nicotine allowed no matter WHAT category it is ultimately placed in? Do you really think that it will not be taxed no matter what and the government can vote for whatever rate they want to tax it? And if you think tobacco taxes are high, compare them to nicotine drug products. The cost of a highly taxed cigarette is just 35 cents each. The cost of a Nicotrol cartridge is $1.05 each. Being a tobacco product is CHEAPER even with the tax!

The only way to keep ecigs on the market NOW is as a tobacco product. Any other path will lead to indefinite removal from the market awaiting approvals.

Additonally, just because it is a tobacco product doesn't mean it will be affected by PACT and mail delivery. The law would have to be changed to add it, as it only applies to specific tobacco products at this time.

Finally, worrying about flavors is silly. Even if they ban flavors beyond tobacco & menthol, that will not include UNflavored. How and why would you ban NO flavor? Vendors can simply sell premixed flavor drops on the side, like Tasty Puff is sold for tobacco flavoring now. Easy fix.

 

[anim8r]

That's an interesting analogy but it falls apart because tofu is not made with an ingredient from meat. It would be more like substituting the coffee you drink with a caffeinated (or caffeine free) coffee flavored hot beverage--you know, something that was designed to look and taste just like coffee and provide the same physical effect (if caffeinated) without the toxins and carcinogens found in "the real thing"

Nicotine "can" be extracted from other sources. The fact that it is extracted from tobacco does not make it a tobacco product anymore than cyanide is a "plant" product. It is a compound. And at the moment, this compound is legal.

My particular e-cigs and liquids look and taste nothing like a real cigarette.

Well you know what they say about opinions... Everybody has one, but some are just wrong. The PACT act applies only to the specified products and e-cigarettes aren't specified--it doesn't matter if they are classified as tobacco or not.

Acts are easily updated. We'll see how long before it is "re-classified" in this act once it receives the NEW moniker of "tobacco product".

Tobacco bans? There is no such thing and congress has specifically told the FDA they can't ban tobacco--but the FDA can ban products containing nicotine that aren't tobacco products. Taxes? When a product is um, legal, it is subject to being taxed. I'm afraid you'll have to live with that because that's how things work in the real world. However, as Bill Godshall pointed out, most (if not all) states do not have a standing tax on tobacco products in general but rather tax specific tobacco products (which is some stores in some states sell "mini-cigars" that are cheaper than cigarettes because they aren't taxed the same).

You obviously live somewhere else. Smoking and tobacco use is banned at many goverment installations, work environments, bars, restaurants, etc. Internet sales is also banned on several tobacco products. It isn't nearly as big a stretch as some of you seem to think to place all of those bans on e-cigs.

Turn them into an unsavory alternative when compared to NRT's? Dude, NRT's make analogs seem savory. 8-o Ain't nothing they can do to e-cigs to make them unsavory compared to NRTs.

When you make them more expensive and a pain in the ... to purchase, "good" e-cigs will have a hard time competing on the open market. I only picked up on vaping because it was; easy to find, had dozens of flavor choices, a variety of hardware designs (many innovations invented by tons of actual users), and inexpensive. Take away one or two of these and I may not have tried it. And, like I said, this is just my opinion. You are certainly welcome to yours.

When did Big Tobacco become the nemesis? Tobacco companies aren't calling for the bans of e-cigarettes--tobacco companies want to sell them, actually.

At huge prices and with ......ed designs. Look at their previous attempts. Pathetic. The reason they will produce crappy products is the simple need to own the patents on their "unique" designs. In the meantime, we suffer since they'll be one of the only entities with the money, distribution, and the politicians available to get their products into stores imediately.

In case you hadn't noticed, it is the pharmaceutical companies like GlaxoSmithKline and Pfizer (makers of Nicotrol/Nicoderm/Nicorette and Chantix) who line the pockets of the FDA and anti-smoking prohibitionist nazis like John Banzhaf. (ASH Introduction)

I noticed. And agree they are also anti e-cig.

It is my opinion that getting it classified as a tobacco product will kill all of the bans that make e-cigs so much more difficult to purchase than other smoke-free tobacco products as an alternative to smoking cigarettes that kill people.

You know what they say about opinions

Time will tell.

That is just plain wrong. The FDA has expressed its full intention to regulate e-cigarettes as a drug which means they will not allow them to be SOLD at all unless and until they undergo years of research to prove that they are effective as a smoking cessation device and then only by prescription...and the FDA would be able to require the nicotine levels to be reduced to zero if they want, whereas they are specifically not allowed by law to require zero nicotine in tobacco.

Who said anything about the FDA allowing them to be sold.

I was saying, despite the FDA desires, they will be sold and used by Americans for many years (or even decades) to come.

Show me where batteries are illegal. Show me where fog machines (large, small, and the soon to be released ultra mini fogger kits) are illegal. Show me where nicotine is an illegal substance.

Bongs are still sold and legally.

People forget the inventive nature of corporations.

If the FDA creates a total ban on e-cigs, these companies will be forced to find an alternative use for atomizers that will make them legal in the US of A.

Same goes for all of the battery "holders". They will always remain legal. Current e-cig batteries (like the ego) would only need to be sold with silly interchangeable flashlight "heads" to remain legal. You'd simply have to get your atomizer (or mini-foggers) elsewhere.

And since nicotine is already legal. It will continue to be sold.

The FDA could only restrict sales of pre-mixed juice. There are no other "drugs" in 0 Nic juices.

This will give the companies plenty of time to submit sample premixed carts and juice to the FDA if they want to get their drugged liquid approved.

You will probably see an end to e-cig "kits", but that's about all.

As far as I'm concerned the FDA can try and chase the e-cig makers around for decades if they want.

 

[DC2]

I would question why this conversation is taking place here in this thread. Apparently Sun is a legal advisor for the CASAA organization. One would have hoped that this conversation would have taken place before it got to this point. So I don't really understand.

 

[Thulium]

Another question - somethig you said caught my eye and is very interesting. you said in your post: " Yes the FDA can require tobacco companies to comply with various regualtions and they could theoretically revoke the license from companies unwilling to comply (but no one would expect that to happen to Phillip Morris, would we?)"....and then you go on.
Now, while I agree with you I think a crucial word is missing; where you say "....revoke the license from companies unwilling to comply...." I would
add 'and/or UNABLE to comply....' As I am sure you are aware often times governmental regulation is actually the 'friend' of big business (despite their disingenuous protestations) in terms of eliminating the competition. My concern and question is if e-cigs are classified as an alternative tobacco product(which I am all for) 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?

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 :

Our mission is to ensure the availability of effective, affordable and reduced harm alternatives to smoking by increasing public awareness and education; to encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation; and to promote the benefits of reduced harm alternatives

(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.

 

[DC2]

And perhaps now that this discussion has taken place, CASAA can make it clear what their stance is on these issues as they affect all the rest of us. Until that time comes, I will need to stop repeating the arguments that have been made up to this point, and I will be unable to inform people what my opinion is since I no longer know what it is now.

I am left without any direction as to what to say when writing letters to various newspapers, legislators, judiciary, and any other organizations or peoples that we feel should be informed about our plight.

 

[DC2]

Bongs are still sold and legally.

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

 

[Sun Vaporer]

I would question why this conversation is taking place here in this thread. Apparently Sun is a legal advisor for the CASAA organization. One would have hoped that this conversation would have taken place before it got to this point. So I don't really understand.

Good question DC2--I post some information for members and end up defending it coming on 3 days. I do not know if they are speaking for CASAA or not---sounds like it demanding that these people should have told CASAA.

Bottom line--they are entitled to their opinion and it is the last time I will post information again about what is going on outside of the "vaccum" of this Fourm. I did not expect that but it is what it is.

Sun

 

[Mister]

CASAA decided to clearly lay out that they are only on board with "tobacco" and are aligned with SE and NJOY. Go read the posts. That is CASAA's right.

But to readily dismiss a new play because somehow it "had to be known to them" is absurd. The posts clearly show there is an issue there with staying the course and being closed minded to people that are actually going to fund litigation---Suppliers that we use---not SE or NJOY.

A little respect for those that step up is needed. Funny how that was not the case with Alliance but is the case here.

I have read the posts. It seems they must be open to interpretation because I have a different take on them.

I don't think anyone is dismissing a new play which they don't understand. OTOH, not much support or respect can be expected before people know more about how much someone is stepping up and what the play is.

 

[Sun Vaporer]

Kristin:
I've been following this thread for a while, and traveled way back into the earliest threads trying to bone up, and really have to say that to call SunV "cryptic" is somewhat... well...

He's been patiently and lucidly DEcrypting a raft of legalese in here for a long time, patiently responding to redundant questions, answering rude comments with straightforward and impersonal attempts to clarify confusion, and generally providing an invaluable service to those of us who are interested in trying to make sense of all this.

He's never claimed to be oracular, and when he opines he notes that he's opining.

I keep waiting for him to say, "Read the last damn 5000 posts, it's TFM.", but he doesn't.

And no, I don't know him from Adam, and for all I know he's wrong about everything, or a charlatan and a fraud, but I don't think so, and I don't sense that he's got any agenda besides doggedly trying to help fellow vapors stay informed about the damned federal debacle. Which IMHO is a good idea. And a hell of a lot of work.

So I'm sticking up for him here.

Aubergine---I came on here hours ago and was going to address your post. I apprecate your thoughts.

Thanks,


Sun

 

[markarich159]

In a thread I started when I first joined this forum back in July of 2009,( I believe I called it "a Pharmacists View" or something to that effect-in which I took some flack) I said, knowing how the FDA operates, the only chance e-cigs/e-liquids have of ever existing in the US Marketplace(side by side with already defined product categories like Cigarettes and NRT's) is for the FDA to create a completely NEW CATEGORY. This new category would have to treat e-cigs as a non-therapeutic, recreational entity. I have since, in other threads and forums, restated this opinion several times. I would call it NCNTNDD's(non-combustible, non-therapeutic, nicotine delivery devices) - I use the term "non-therapeutic" rather than "recreational" to avoid the tendency to associate these devices with "recreational drugs". If the initial marketing strategy of e-cigs in the US was not so "stealthy" and more above the table, legally speaking, this approach may have been swallowed or, at least, considered by the FDA. As it stands now, I don't think the FDA will ever be persuaded to consider this. BUT I still believe it is the only reasonable avenue, in the long term to keep the e-cig market viable in the US and, therefore, should be pursued diligently.

 

[Thulium]

Well again Thulium, your posts certainly do not appear to welcome it. First you say CASAA should have been approched (do not know why as they have nothing to do with CASAA) and then you say you are only two of CASAA's board. Then you speak to how tobacco is the only way to go, and then attack that it is fantasy and not feasable.

Let's be clear. I was not the one to "first" suggest that CASAA should have been informed. On the contrary, YOU are the one who stated that CASAA should have allied with these other companies but then when we asked how we might go about doing that you told us that we'll find out who they are after they've filed their suit. I don't think CASAA has a way to do what you suggest (ally with the new companies) unless you can also suggest a way for us to do it (tell us who the new companies are and/or outline the strategy rather than just say "No, there is another").

The posts here all go to attacking and not embracing---that is all I have been doing is defending these attacks. So why not set the record straight so we can move on as you have 10 pages or so of posts that do not support what you are saying--maybe it is just a misunderstanding? I do not know. What I do know is I am tired of sitting here defending what others are trying to do for the good of e-cigs.

Sun

Yes. Let's please set the record straight.

What is the new strategy and how does it fit within the framework you laid out for us? It is my understanding that the FDA can either regulate e-cigs as a tobacco product or as a drug. It appears that you are saying they DO have the ability to regulate electronic cigarettes as something that is neither a tobacco product nor a drug device. If it is neither, how can the FDA approve it? The FDA does not have regulatory control over nicotine products that aren't drugs, but they do have control over tobacco products...if e-cigs are neither, the FDA doesn't have regulatory control at all--which is actually the strategy that SE began with by not submitting their products to the FDA.

 

[Sun Vaporer]

In a thread I started when I first joined this forum back in July of 2009,( I believe I called it "a Pharmacists View" or something to that effect-in which I took some flack) I said, knowing how the FDA operates, the only chance e-cigs/e-liquids have of ever existing in the US Marketplace(side by side with already defined product categories like Cigarettes and NRT's) is for the FDA to create a completely NEW CATEGORY. This new category would have to treat e-cigs as a non-therapeutic, recreational entity. I have since, in other threads and forums, restated this opinion several times. I would call it NCNTNDD's(non-combustible, non-therapeutic, nicotine delivery devices) - I use the term "non-therapeutic" rather than "recreational" to avoid the tendency to associate these devices with "recreational drugs". If the initial marketing strategy of e-cigs in the US was not so "stealthy" and more above the table, legally speaking, this approach may have been swallowed or, at least, considered by the FDA. As it stands now, I don't think the FDA will ever be persuaded to consider this. BUT I still believe it is the only reasonable avenue, in the long term to keep the e-cig market viable in the US and, therefore, should be pursued diligently.

Sounds very productive Mark, and I will pass it on. I like your "NCNTNDD's"


Thanks,

Sun

 

[Sun Vaporer]

Thaluim--this is the theory that is being advanced. Let the FDA have fun with it. This is it.

Taking a different approach, an attack hitting the FDA head on with the e-cig for the purpose it currently employs is what is needed here.
　
　
I would contend that the definition of an e-cig is as follows:
　
　
The e-cig is an alternative way to use nicotine for recreational purposes and stop employing the use of cigarettes, which is one of the largest killing products ever put into commerce for use by consumers.
　
　
Is that an NRT triggering an intended use that has a therapeutic end point?---IMO, a resounding NO. An NRT is for a short duration of six months or less with an therapeutic end goal of total nicotine cessation.
　
　
To the contrary, I would contend that the e-cig has no end goal and is used purely for recreational purposes, so no FDA drug implications could be claimed.
　
　
As the theory of the case would go, absent a drug or a tobacco implication, the FDA would lack standing to regulate it as it is not a drug or a tobacco product.
　
　
The problem has been, IMO, that too much "sugar coating" has been going on and a lot of looking for loopholes with an approach that stamps the word "fear" all over the E-cig.
　
I would also contend that this fear of being labeled an NRT and a drug is the very problem that will lead the e-cig, at best, to "death by FDA regulation".
　
　
Instead, IMO, pit the FDA against exactly what the E-cig is as we know it and what the E-cig can do. Let the media play devil’s advocate with this type of Court case. You want to talk about winning "public approval" and the "Court of public perception" —a case framed like this in the Media will in fact spark the needed controversy as to how the e-cig should have a legitimate office when it comes to being a healthier alternative and saving lives. Lets call it for what it is IMO.



Remember, that the Court is sitting in equity and must balance the harms and take into account what is best for the public. I do not know a stronger case that can be made when weighing the healthier use of an e-cig against "death by cigarettes" should the FDA be allowed to ban the e-cig.

Sun

 

[Thulium]

Thaluim--this is the theory that is being advanced. Let the FDA have fun with it. This is it.


Taking a different approach, an attack hitting the FDA head on with the e-cig for the purpose it currently employs is what is needed here.

I would contend that the definition of an e-cig is as follows:
　
The e-cig is an alternative way to use nicotine for recreational purposes and stop employing the use of cigarettes, which is one of the largest killing products ever put into commerce for use by consumers.

Is that an NRT triggering an intended use that has a therapeutic end point?---IMO, a resounding NO. An NRT is for a short duration of six months or less with an therapeutic end goal of total nicotine cessation.

To the contrary, I would contend that the e-cig has no end goal and is used purely for recreational purposes, so no FDA drug implications could be claimed.

As the theory of the case would go, absent a drug or a tobacco implication, the FDA would lack standing to regulate it as it is not a drug or a tobacco product.

The problem has been, IMO, that too much "sugar coating" has been going on and a lot of looking for loopholes with an approach that stamps the word "fear" all over the E-cig.

I would also contend that this fear of being labeled an NRT and a drug is the very problem that will lead the e-cig, at best, to "death by FDA regulation".

Instead, IMO, pit the FDA against exactly what the E-cig is as we know it and what the E-cig can do. Let the media play devil’s advocate with this type of Court case. You want to talk about winning "public approval" and the "Court of public perception" —a case framed like this in the Media will in fact spark the needed controversy as to how the e-cig should have a legitimate office when it comes to being a healthier alternative and saving lives. Lets call it for what it is IMO.

Remember, that the Court is sitting in equity and must balance the harms and take into account what is best for the public. I do not know a stronger case that can be made when weighing the healthier use of an e-cig against "death by cigarettes" should the FDA be allowed to ban the e-cig.

Sun

Very interesting--this really does go to the theory that I supported a long time ago, but I called it Smoking Replacement (in contrast to Nicotine Replacement).



I really like analogies, so let me try one on for size: Basically the e-cigarette is a Square Peg. It has some things in common with the circles (tobacco) and some things in common with the triangles (drugs/devices), but Smoking Everywhere saw that it didn't really fit into either so they started selling it apart from FDA control. That is, until the FDA grabbed the peg and told SE that they had to make it fit in the triangle hole, but Judge Leon says it doesn't fit and while the AAPHP recommends simply making the round hole bigger, these new companies want the FDA to make a new hole. Is that about right?



This of course begs the question: Is it possible to rip someone, who is one, a 'new one'?

Following this logic, here is my stance: I support "widening the round hole" (placing e-cigarettes in the "tobacco" category) until I know what the new hole is going to look like.