Smoking Everywhere V. FDA Daily Docket Sheet Update

[Caesarea]

Bill, if I read what you have written correctly, it might not be an either or decision, but a both ways one?


C.

[Giantfan]

Thanks for the explanation Bill. What I am concluding from that, is these things will be approved as tobacco products, and big tobacco will jump all over it. I can see some positive things coming from this, but what do you think the negative things could be? (besides e cigarettes becoming more expensive and taxed)

[mirinuh]

It appears as if Congress would have to step in to tax the e-cigarette as the current definition of a tobacco product used by TTB and in the federal regs requires the presence of fibrous tobacco. I suspect they would try to do that, but that would take a little time. There could be a tax holiday for a period of time!

[quetzacoatl]

Originally Posted by Sun Vaporer

Quetz--If Judge Leon factors in any "moral" thoughts into his decision, that would be reversable error. His moral beliefs are irrelevent and he is bound to judge based on the law. So if his moral beliefs are a factor, you sure are not going to be reading about it in his ruling, although it may be hidden.


Sun

Certainly not, but having a moral dilemma would obviously give him more motivation to delay the ruling and to have his team do more research than is typical to attempt to legally justify his moral stance. I don't plan on seeing anything having to do with morality in the ruling, but I can't see him ruling our way without having been fighting a moral battle over it all these months.

The thing is, morality should not be thrown out the window when it comes to law in this country. That's how a lot of people fall through the cracks; we may never have a perfect legal system, but it would be a far better system if we relied on the facts of a case instead of interpreting something as absolute law.

The judge is there to judge the law itself, not only to decide whether the law applies to a legal situation. The only letter of the law that he is bound to go by is the Constitution, otherwise there would be no law in the United States that could be overturned by a judge.

[Sun Vaporer]

Originally Posted by quetzacoatl

Certainly not, but having a moral dilemma would obviously give him more motivation to delay the ruling and to have his team do more research than is typical to attempt to legally justify his moral stance. I don't plan on seeing anything having to do with morality in the ruling, but I can't see him ruling our way without having been fighting a moral battle over it all these months.

The thing is, morality should not be thrown out the window when it comes to law in this country. That's how a lot of people fall through the cracks; we may never have a perfect legal system, but it would be a far better system if we relied on the facts of a case instead of interpreting something as absolute law.

The judge is there to judge the law itself, not only to decide whether the law applies to a legal situation. The only letter of the law that he is bound to go by is the Constitution, otherwise there would be no law in the United States that could be overturned by a judge.

Quetz--that really is not the case if a Judge does not want to be reversed on appeal and is dong their charged position correctly. The Judge is bound by the president's set by the higher Courts.
　
　
Take your search and seizure cases–violating 4th amendment rights with an improper search leads to criminals' walking all the time as the evidence is rendered inadmissable. As immoral as that is to the victims, it is the law and the Judge is bound by the cases that are controlling.

The doctrine of Stare decisis mandates Judges are obliged to obey the precedents established by prior decisions. So I would not count on some moral "high ground" here. Just a ruling, which more then likely neither side is going to be happy with and cross-appeals will follow.
　
Sun

[Sun Vaporer]

Again--no movement--all we can do is keep checking the Docket Sheet. Will will know when we know is all I can say---never have scene anything quite like it on a request for a Prelimnary Injunction but here it is.


Sun

[TheIllustratedMan]

Originally Posted by Bill Godshall

But if the FDA redefines e-cigarettes as tobacco products (which could also resolve the pending e-cigarette litigation), e-cigarette marketers would not be permitted to make any "modified risk" or "reduced exposure" claims (other than claiming the products are smokefree alternatives to cigarettes) without FDA approval (which would require additional research).

Ruyan officials have informed me that the company is conducting clinical trials so it can apply for FDA approval as smoking cessation aid (like nicotine gum, lozenges, patches, inhalers). I think its possible that the FDA could simultaneously approve Ruyan e-cigarettes (and/or those made by other companies) as drug-delivery devices for smoking cessation, while also regulating other e-cigarettes as tobacco products.

This is something that I've kicked around myself. If you look at how nicotine is regulated, and how caffeine is regulated, you notice that each substance has two completely different regulatory categories depending on how it is being sold.

Nicotine, when contained in a tobacco product, is a recreational use substance. It has next to no regulation on it (something that is changing, but the point stands). When sold as an NRT, it is a drug used for treating a specific condition, and is regulated as such.

Similarly, caffeine, when in a soft or energy drink, is considered a food additive, and has next to no regulation on it. However, when placed into a pill and sold as a stimulant, it is considered a drug and is so regulated.

The electronic cigarette could most definitely fit into two completely different regulatory schemes depending on intention and actual use.

[PhiHalcyon]

Originally Posted by Bill Godshall

Regarding the new FDA tobacco law, the FDA could redefine e-cigarettes as tobacco products. I repeatedly urged Congress to do so, and have more recently urged the FDA to do so, as that would allow e-cigarettes to remain on the market (as the product was on the market in 2007) and to establish reasonable and responsible regulations for e-cigarette products.

But if the FDA redefines e-cigarettes as tobacco products (which could also resolve the pending e-cigarette litigation), e-cigarette marketers would not be permitted to make any "modified risk" or "reduced exposure" claims (other than claiming the products are smokefree alternatives to cigarettes) without FDA approval (which would require additional research).

Ruyan officials have informed me that the company is conducting clinical trials so it can apply for FDA approval as smoking cessation aid (like nicotine gum, lozenges, patches, inhalers). I think its possible that the FDA could simultaneously approve Ruyan e-cigarettes (and/or those made by other companies) as drug-delivery devices for smoking cessation, while also regulating other e-cigarettes as tobacco products.

The much advertised and talked about claims of ecig manufacturers, sellers, and users, about the reduced harm and risk benefits of the ecig make it highly improbable that the ecig could ever be realistically regulated as anything other than the modified risk tobacco product that it actually is. A short list of intended uses may enable it to pose as a drug product as well, but the ecig is, by its very nature, a modified risk tobacco product; and should therefore be regulated as such. Besides, any substantial equivalence claim using an ecig that was 'commercially marketed in the U.S. as of February 15, 2007' as a predicate tobacco product would be quite vulnerable to FDA claims of that ecig having been misbranded, adulterated, and/or otherwise not a legal tobacco product at the time it was introduced.

Nonetheless, your diplomatic sharing of your informed perspective, and your advocacy for the FDA's reasonable use of its new authority, are greatly welcome, respected, and appreciated.

[Webby]

[quote=MaDPimP;698804]

Originally Posted by danielwd

The price increase is one thing, but the way I figured it, on average about 50,000 dollars worth of stock is traded daily. Then yesterday, there was some millions of dollars traded. Awefully suspicious.
quote]


Naked short-selling anyone?

WebTV seemed to have an untapped niche cornered (especially with the elderly market who only wanted to surf and send email to their grandkids) but in 1997, Micro$oft spent $425m to buy it and successfully squash the technology.

Poor resolution, falling PC prices and other factors took the fall, but conventional wisdom at the time was that M$ simply crushed a competitor under it's deep-pocketed boot heel.

Today's technological advancements make it a moot point now, but it's difficult to ignore the possible similarities and current position jockeying of PM if a retreat is in the works.

What better way to silence an impetuous upstart like the e-cig industry than to buy the rights and simply NOT produce a marketable product?

From PM's standpoint, "oops - oh well. I guess it was a bad investment. Anyone got a light?"

[C2Girl]

What a great analogy Webby!
I was one of the folks who had webtv, just wanted to email and surf the web. And I can totally get the "hidden agenda" of PM.
I sure hope like h.e.l.l this does not happen....