Smoking Everywhere V. FDA Daily Docket Sheet Update

[greenie]

Originally Posted by SheerLuckHolmes

Summary

a) 654 posts by Sun Vaporer (our hero) "Today there was no movement on the Docket on any of the pending Motions."

b) 823 posts by BigJimW (our spiritual leader) "this is bull*****"

c) 237 posts by Legal ONE (our legal mouthpeice) {see Sun Vaporer's post but in many more legal words}..

d) 158 posts by Tropical Bob (our journalist) "Try snus, you'll like it and the FDA can't touch you"

e) 875 posts by eveyone else (We The People) "WTF is taking so long?!?!?!?!?!?!?!?!?!?!?!?"

State wide bans have little to do with this case. The state level actions are all happening due to BT and BP lobbying money to the state reps to write bann laws. MHO.

A great summary!

[TheKingOfKool]

can anybody tell me the case where they said nicotine didn't effect the structure of the body?

[Sun Vaporer]

Originally Posted by TheKingOfKool

can anybody tell me the case where they said nicotine didn't effect the structure of the body?

King--Here you go:

"although nicotine may stimulate the senses, it does not affect either
the structure or any function of the body." E.R. Squibb and Sons, Inc. v. Bowen, 870 F.2d 678, 683 (D.C. Cir. 1989) (citing Action on Smoking & Health v. Harris, 655 F.2d 236, 240 (D.C. Cir. 1980) for the above-stated proposition).


Sun

[Zaija]

Thank you very much SheerLuck, very informing.


As for you Sun, you are all over this, everything to a science, amazing!

[TheKingOfKool]

thanks sun

[PhiHalcyon]

Since the FDA has been given authority to regulate tobacco products, and the only practical source of nicotine is tobacco, the "question" of whether or not nicotine is a drug has been rendered irrelevant.

[Sun Vaporer]

Originally Posted by PhiHalcyon

Since the FDA has been given authority to regulate tobacco products, and the only practical source of nicotine is tobacco, the "question" of whether or not nicotine is a drug has been rendered irrelevant.

Not really Philhalcyon--re-read the pleadings in the instant case--if it is a drug, the e-cig is subject to much more scunity, approval, and regulations.


Sun

[PhiHalcyon]

Originally Posted by Sun Vaporer

Not really Philhalcyon--re-read the pleadings in the instant case--if it is a drug, the e-cig is subject to much more scunity, approval, and regulations.

It is true that the FDA has not yet completely fathomed the implications of the Tobacco Control Act, but one of those implications is that it cannot regulate a tobacco product as a drug product on the basis that it contains nicotine. On the other hand, there is no question as to whether or not it can regulate nicotine as a tobacco product.

[Sun Vaporer]

Originally Posted by PhiHalcyon

It is true that the FDA has not yet completely fathomed the implications of the Tobacco Control Act, but one of those implications is that it cannot regulate a tobacco product as a drug product on the basis that it contains nicotine. On the other hand, there is no question as to whether or not it can regulate nicotine as a tobacco product.

Ph--that distinction goes to the heart of the case--If Judge Leon finds that the e-cig is a drug and medical device combination, then the approval process will knock the e-cig off the market for years if not for good. If Judge Leon holds that it is not a drug, rather a tobacco like product, then the current legislation will foreclose the FDA from banning the e-cig. So it goes to the amount of regulation and if it will give rise to what constitutes a de-facto ban.


Sun

[PhiHalcyon]

Originally Posted by Sun Vaporer

Ph--that distinction goes to the heart of the case--If Judge Leon finds that the e-cig is a drug and medical device combination, then the approval process will knock the e-cig off the market for years if not for good. If Judge Leon holds that it is not a drug, rather a tobacco like product, then the current legislation will foreclose the FDA from banning the e-cig. So it goes to the amount of regulation and if it will give rise to what constitutes a de-facto ban.

I think that nicotine-containing e-liquid (apart from all labeling and advertising considerations) is clearly a modified risk tobacco product. Nonetheless, there is a very thin line between a modified risk tobacco product that is regulated as such, and a modified risk tobacco product that is regulated as a drug. And defining that line may well be what this case proves to be all about.

As for the prohibition on banning, please read post #2456 of this thread. (Page 246)