Policy Guidance Document Regarding E-Cigarettes

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yvilla

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Kristin, I fully rebutted Phi's argument centered on the combination product prohibiton, more than once, months back. I'm not going to do it again.

All I'm going to say at this point is that with this repeated argument, Phi demonstratres a singular failure to comprehend some fundamental concepts integral to and pervasive throughout the entire FDCA, and the FDA's historical and current carrying out of its regulatory powers under it. Those concepts are related to "active ingredients" versus "inactive ingredients", "intended use" "marketed", etc, etc.

Furthermore, he reads the combination product prohibition of the FSPTCA completely erroneously, counter to even the FDA's own understanding of it, as evidenced by their own draft guidance on this provision published soon after the law was passed.

So phooey!
 

PhiHalcyon

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yvilla,

The measure of responsibility associated with your assertions (if proven wrong) is many times greater than that associated with mine. So, for your sake, you had better hope it is I who am deluded in 'understanding' that neither big pharm nor Phillip Morris would have agreed to a tobacco Act that would fail to eliminate the single greatest threat to their respective markets (i.e., the electronic cigarette) that either of them have ever faced or encountered. Maybe they were both feeling a little generous, and mutually decided to share their spoils of the nicotine market with anyone who could scrape up a few grand to start a home-based e-cig business. Maybe the ingredients used in foods, drugs, and cosmetics, are not really articles regulated under the FDCA. Maybe I have been nothing but a deluded chicken-little (with a 165 IQ) who has been unnecessarily warning the e-cig community to prepare for the worst. OR, maybe you are wrong, and have become the irresponsible false-prophet-in-chief who is the blind one leading the blind; fostering confusion and misinformed outrage, while giving people nothing but a false and empty hope.

If you are so absolutely certain in your understanding as to be able to confidently dismiss any chance that you are wrong, then, when proven right by the higher courts, I will bow to your supreme intellect in awe. Otherwise, I will feel mighty darn sorry for you, the lot you have chosen, and for those who have trusted you to be sure about the assurances you have given.

Good luck.

Phi
 

yvilla

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you had better hope it is I who am deluded in 'understanding' that neither big pharm nor Phillip Morris would have agreed to a Tobacco Act that would fail to eliminate the single greatest threat to their respective markets (i.e., the electronic cigarette) that either of them have ever faced or encountered. Maybe they were both feeling a little generous, and mutually decided to share their spoils of the nicotine market with anyone who could scrape up a few grand to start a home-based e-cig business.

The essential flaw in that argument is that the FSPTCA was written, in majority part, long before, no, years before, electronic cigarettes were even a blip on BT and BP's radar.
 

DC2

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Maybe I have been nothing but a deluded chicken-little (with a 165 IQ) who has been unnecessarily warning the e-cig community to prepare for the worst. OR, maybe you are wrong, and have become the irresponsible false-prophet-in-chief who is the blind one leading the blind; fostering confusion and misinformed outrage, while giving people nothing but a false and empty hope.Phi
Dude, get over your IQ and your little foray into the logical journey that landed you here.
I have a 165 IQ as well and I think you're somewhat nuts.

Actually, I think you are a bit too much tied to logic that you can't see straight.
That doesn't mean, however, that you wont' be right.

But it's not like logic is going to rule the day here.

SERIOUSLY, if logic ruled the day, this conversation would not even be taking place.
Think about that for a few hours.
 
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PhiHalcyon

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We are talking about a case before the court, not the foibles of human history. And in this context, logic is an absolute necessity in deducing the intent of Congress. So if you want to pretend to play a meaningful role in this conversation, then articulating your deductions of that intent - rather than making psychological assements or philosophical statements - would do wonders for your credibility and usefulness.
 
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DC2

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We are talking about a case before the court, not the foibles of human history. And in this context, logic is an absolute necessity in deducing the intent of Congress. And if you want to pretend to play a meaningful role in this conversation, then articulating your deductions of that intent - rather than making psychological assements or philosophical statements would do wonders for your credibility and usefulness.
Judge Leon.

That is the extent I am willing to go to with my psychological assessments and philosophical statements.
I'm not really interested in doing a dance with someone who can't see past their own mind.

If I was, I would have stepped into this a long, long time ago.
 

DC2

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The law is what really rules. But those who brought us the e-cig felt otherwise. Not that I am complaining. Nonetheless, it is their disregard for the law that is the real cause of our current woes.
Disregard for what law?

You are implying that it is a drug delivery device if I am not mistaken.
Nobody here agrees with that.
 

PhiHalcyon

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Disregard for what law?

You are implying that it is a drug delivery device if I am not mistaken.
Nobody here agrees with that.

A complete ..... can see that the e-cig is a drug delivery device. This is not even in dispute. The only question is whether or not it is drug delivery device that is protected from being regulated as such as a legitimate tobacco product, or whether it is a prohibited form of tobacco product that is not protected.
 

mmsjs5

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And neither is what you have to say, when you can't consider that logic does not rule.
Do you not understand that if logic ruled, WE WOULDN'T BE HAVING THIS CONVERSATION?


I agree 100%.

Some people cannot function in illogical situations, so prefer to CREATE logic.

I have seen alot of instances that the law had nothing to do with it, only the pretense of having law was important.

So sorry that my IQ is definitely not 165, but felt I had to back up DC on this one.
 

Vocalek

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:laugh:

Yeah, logic has always prevailed, throughout history.

:img:

Like the logical plan the tobacco control community has for improving public health?

1. First we outlaw everything that is much safer than smokikng.
2. Next, we decrease the nicotine level in cigarettes to make them "less addictive"
3. Finally, we stand there with our mouths open wondering why there are still 40+ million smokers and why they are all developing lung disease twice as fast.
 
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PhiHalcyon

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I actually agree that the new Tobacco chapter of the FDCA is going to control here, but Phi simply doesn't understand it, or specifically the provision he's going on about, nor the underlying fundamental precepts of the FDCA in general, as I noted previously. :)

Yeah. Which explains why the FDA is seizing e-cig shipments, and has NEVER allowed ANY nicotinated non-tobacco product to go unregulated as a drug.
 
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