Policy Guidance Document Regarding E-Cigarettes

[yvilla]

You know, DC, something just struck me - that didn't occur to me when Phi first presented his percentage of ingredients thesis six or more months ago.

It shows just what absurdity would result from an arbitrary percentage requirement that applied before a nicotine delivery product could be legally considered a "tobacco product", and just how divorced from common sense and real-world functionality Phi's notions are.

For if the fact that the inactive base ingredient comprises a much higher percentage of eliquid than the nicotine would keep the product from being considered a "tobacco product", then to be considered a "tobacco product" the product would necessarily be converted from a usable and relatively safe consumer product to a highly toxic and deadly product, that could not be sold as a consumer product and that no one would ever be able to use!

We all know that nicotine in pure form is deadly in minute quantities, and even in a 50% formulation. The no longer used and highly toxic pesticide known as Black Leaf 40 was 40% nicotine. We also all know that 7.5% nicotine is the level at which a nicotine containing product in the UK is legally considered a ""poison" and may not be sold. We also know that 3.6% nicotine liquid (or 36 mg) is the one considered "fierce" and is the highest concentration many think eliquid should be allowed to be sold for direct use (as opposed to mixing use). Some believe an even lower concentration cap should be imposed, such 2.4% or 1.6% (shudder).

So Phi's notion that the necessary and sensible high percentage of PG as the base for the nicotine in our eliquid should be a critical factor in the legal determination whether it is a "tobacco product" is, in a word, ludicrous.

 

[PhiHalcyon]

For if the fact that the inactive base ingredient comprises a much higher percentage of eliquid than the nicotine would keep the product from being considered a "tobacco product", then to be considered a "tobacco product" the product would necessarily be converted from a usable and relatively safe consumer product to a highly toxic and deadly product, that could not be sold as a consumer product and that no one would ever be able to use!

PRECISELY! Which is why paragraph 4 is sufficient to the purpose it was intended to serve. Nonetheless, the argument that I presented earlier today depended only on distinguishing a difference between a tobacco product sold in combination with an article or product regulated under the FDCA, and an article or product regulated under the FDCA sold in combination with a tobacco product. A distinction which must be able to be made if the purpose of paragraph 4 (as I have deduced it to be) is to be fulfilled.

*****

The draft guidance document that yvilla loves to refer to, and depend on so much, is nothing but a basic MINDMAP of possible interpretations to be used as a place to START in trying to understand what paragraph 4 REALLY means. It is therefore the LEAST authorative or dependable document that could have been written!!! After nearly a whole year since the Tobacco Act was passed (AND an extended public comment period that ended nearly six months ago), the FDA has STILL not released the FINAL guidance document that states what the FDA REALLY believes about the meaning of paragraph 4. In this context, and in this understanding of the facts, anyone who would put ANY confidence in the authority or dependability of the original draft guidance document (or in the understanding of anyone who would) is simply FOOLISH and NAIVE.

I was aware (from past engagements) that yvilla had committed this error in the past, but I had assumed that she had managed to move beyond such folly. This is the reason why my representation of her argument was inaccurate. Nonetheless, it is encumbent upon me to apologize for my misrepresentation of her beliefs, and I here now do.

I would have been sincerely THRILLED to have been nailed to the wall and proven wrong by yvilla's response to my argument. Unfortunately, I was left feeling disappointed and sorely under-challenged. I was hoping that her implied nicotine-wonderland-of-products-coming-our-way theory would be shown to have some real merit, but then, reality settled back in.

May the people prepare for what is to come.

 

[Drozd]

I would have been sincerely THRILLED to have been nailed to the wall and proven wrong by yvilla's response to my argument. .

In just about everyone else's view but yours she has proven you wrong...at this point most of us just think you're an embarrassment...

when I see you contribute to these threads I just sigh and think here he goes with his self important inflated ego and percieved superior intelligence again...

At this point just your ID applied to an argument completely invalidates that argument to me...sad really

 

[PhiHalcyon]

Drozd

You've got another thing coming if you don't believe that I will be vindicated, pal. But, I will let the Courts bring reality home for you, and anyone like you. For, I am now through here.

 

[kristin]

So, according to paragraph 4, a tobacco product mixed with “additives such as water, flavorants, binders, colorants, pH adjusters, buffering agents, fillers, disintegration aids, humectants, antioxidants, oral care ingredients, preservatives, additives derived from herbal or botanical sources, and mixtures thereof” would have to be classified a drug?

Hmmm...I guess someone should notify RJ Renyolds that their Camel Orbs, Strips and Sticks are actually drug delivery devices and not tobacco products.

 

[PhiHalcyon]

Non-tobacco additives in a tobacco product will not render it a drug, but adding nicotine to those additives to make it a tobacco product will make it a prohibited combination product.

 

[kristin]

ROFLMAO!!

You got peanut butter in my chocolate! No, you got chocolate in my peanut butter!

Give me a break.

 

[Drozd]

ROFLMAO!!

You got peanut butter in my chocolate! No, you got chocolate in my peanut butter!

Give me a break.

shh kristin...if you don't look him in the eye maybe he'll go away like he said he was going to...

quit baiting the troll

 

[PhiHalcyon]

You can laugh all you want. But it is the only way that the Tobacco Act can do what Congress intended - which is to not affect the regulatory order that existed prior to it. If paragraph 4 does not mean what I say it means, then all of the investment that big pharm has made into nicotine replacement products will have been in vain ... and they agreed to it! Good luck with that one.

 

[TexasRain104]

BRING IT ON!!!

I have taken down bigger...bader...more violent people!

 

[Drozd]

For, I am now through here.

you said you were through here...or are you a liar....or just talking and misinformed on yet something else....


Good day sir.....



I said good day...

 

[yvilla]

LOL.

Now two full briefs have been written after the passage of the FSTPCA, yet the FDA and all of its lawyers have STILL not seen that earth-shaking and automatic case-winning argument based on subsection 4 of 201(rr). My oh my, such bad lawyers (nine of them on this latest brief), to not have seen the light as Phi has seen it!

 

[PhiHalcyon]

yvilla,

If I was someone whose convictions required external reassurances (such as draft guidance documents or the absence/presence of arguments in briefs), then I would have never been able to endure through six months of one-against-all-others debate. Thus, even though you are relieved that the FDA has not yet attempted to rely on a paragraph 4 argument, I am not crushed, disappointed, or otherwise moved by it. So, rather than take solace in irrelevancies, perhaps you should take stock of the fact that you needed solace in the first place. I mean, you do realize that this is not all about you and me and egos and such, but about the ECF community's need to be accurately informed, right?

When I transformed from a well-complimented potential candidate who argued the reasons why we would or should win, to the one who sought to explain why we would surely lose, the cause of that transformation was paragraph 4. Up until I perceived paragraph 4 to be the bullet that would kill, it seemed like there was no way we could lose. For, according to the paragraph 1 definition of tobacco products, e-liquid was, after all, a tobacco product; and, as Congress had clearly stated, tobacco products are, in general, to be regulated as tobacco products under chapter IX; not as drugs under chapter V. This made it seem like there would be no difference at all between snus, cigarettes, and e-liquid - in terms of the requirement of therapeutic claims in order to be regulable as drugs/devices.

This is not, quite frankly, that difficult to see. So, in knowing that big pharm co-wrote and negotiated the Tobacco Act, do you really believe that big pharm's legal minds failed to see what so many of us have found to be relatively obvious? Certainly not. Which, of course, begs the question: How did big pharm's attorneys seek to assure that nicotine replacement products would not be afforded the same therapeutic claim requirement as all other tobacco products? And the answer is: Paragraph 4 as I have deduced it to mean. For, according to that deduced meaning, not only would all currently approved nicotine replacement products be prohibited under paragraph 4 (if attempted to be sold as tobacco products without any therapeutic claims), but so would virtually any other form of nicotine replacement product - including our much valued e-cig.

You try to make it seem like I am pretending to be smarter than the FDA's attorneys, but is it not you who have been pretending that big pharms' attorneys were blind and incompetent fools - as they sought to adequately protect their client's long-term interests? I realize you have much invested at this point, but what will your investment be worth when it becomes clear that big pharm's attorneys were not so foolish and incompetent after all?

 

[JustJulie]

So, Phi . . . if we agree with you, will you stop posting?

 

[yvilla]

I have not attempted to assess the FDA's strategies and understanding, but I will be surprised if the paragraph 4 prohibition is not brought up in next Monday's filing. For, in having been at work at understanding the logic and meaning of the Tobacco Act for many months, my take on the meaning of paragraph 4 is the only interpretation that does not open wide the door for big tobacco to essentially crush big pharm's hold on the 'safe' nicotine market. Which is simply not something that big pharm (who had the upper hand in the negotiations) would have ever signed on to.

If your take on subsection 4 is the only interpretation to save the day for the FDA/big pharm's position, then how on earth do you expect big pharm to carry out it's "plot" to win all via this provision if never so much as brought up before a court?

 

[Slickstick]

I just saw this thread for the first time and read it entirely EXCEPT....
I stopped reading his posts after page 8, But I still read everyone else's.
In the beginning it sounded like he had some sort of magic bullet up his sleeve so I kept reading.

I am sort of ashamed it took me so long to skip over his threads..

 

[Payne]

I just saw this thread for the first time and read it entirely EXCEPT....
I stopped reading his posts after page 8, But I still read everyone else's.
In the beginning it sounded like he had some sort of magic bullet up his sleeve so I kept reading.

I am sort of ashamed it took me so long to skip over his threads..

LOL, that's the same way I felt.

 

[Drozd]

yvilla,

If I was someone whose convictions required external reassurances then I would have never been able to endure through six months of one-against-all-others debate. .... I mean, you do realize that this is not all about you and me and egos and such, but about the ECF community's need to be accurately informed, right?

Words words word... I snipped this down to the only important part...
Hmmm...ever think that when it's 1 against all others in an argument....it's because that 1 is wrong.... and the only thing preventing that 1 from seeing that is their self important ego?...

you're right the ECF community needs to be accurately informed....which is why you should stop posting your 1 against all others opinion....because...well... it's wrong....

by the way did you miss the part that said that you were done here in this thread?.....LIAR....another gross inaccuracy from you..

 

[JustJulie]

I just saw this thread for the first time and read it entirely EXCEPT....
I stopped reading his posts after page 8, But I still read everyone else's.
In the beginning it sounded like he had some sort of magic bullet up his sleeve so I kept reading.

I am sort of ashamed it took me so long to skip over his threads..

It took you until the 8th page?

 

[PhiHalcyon]

If your take on subsection 4 is the only interpretation to save the day for the FDA/big pharm's position, then how on earth do you expect big pharm to carry out it's "plot" to win all via this provision if never so much as brought up before a court?

There is no 'plot'. It's not like big pharm just slipped paragraph 4 into the tobacco product definition while PM wasn't looking. What paragraph 4 is, is a means of guaranteeing that the regulatory division between tobacco products and nicotine drug products that already existed before the Tobacco Act would remain the same after the Tobacco Act. Therefore, there was no big plot. Just a simple commonsense objective for both parties to logically seek to ensure.