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

[kgonepostl]

The instant case is not so much just about any one company, rather it is about the FDA and wheather or not it over exceeded its authority.

Sun

Yup, that's what I meant

[DoubleTrouble]

Thanks, Sun! I guess I can understand how 'safety' works to manipulate situations. It'd come back to how to interpret the Constitution.

Here's another argument, though, linking the Farm bill and fish, to e-cigs. From NewsMax:

WASHINGTON -- Some prominent Senate Democrats are fighting a bid by the U.S. catfish industry and its Southern allies on Capitol Hill to impose new inspections on fast-growing Vietnamese imports of the fish.

In a letter dated Wednesday, eight senators — inluding **** Durbin of Illinois and John Kerry of Massachusetts — warned Agriculture Secretary Tom Vilsack that he could spark a trade war if Asian fish are included in a new inspection regime that was pushed through Congress last year at the urging of U.S. producers.

The senators said it wasn't their intent to include the Vietnamese fish in the new system when it was passed in last year's massive farm bill. Doing so, they wrote, would serve as a "de facto ban on exports from key trading partners."

"Such action may prompt retaliatory measures against U.S. exports" of other products, the senators wrote in the letter, a copy of which was obtained by The Associated Press.

The domestic catfish industry, which is struggling against the cheaper imports, says better inspections are necessary to ensure safety.

The two things that catch my attention are safety, which you've just explained, and "de facto ban." Given that China is so closely tied to the US import/export scheme, wouldn't an FDA action to remove e-cigs from the market be the same thing?

[Sun Vaporer]

Today, NJOY filed leave of the Court to reply to the FDA’s reply again arguing that the e-cig is a tobacco product that the FDA does not have jurisdiction to control.



Sun

[tannerk]

FDA tries to reconcile its position with the text of the Tobacco Act by seizing on paragraphs (2) and (3) of the definition of "tobacco products," which distinguish between the term "‘tobacco product’ and [a drug, device, or combination]......... Even if there were some overlap between Chapter V and Chapter IX (there is not), a nicotine-containing product would still have to meet the longstanding definition of a "drug" or "device" before it could be regulated under chapter V...........

Sun

Sun, thanks for the update. Obviously the time line has changed and could easily take another month.

This makes a valid argument (imo). This does echo the arguments in NW case with one major difference - the new legislation. In your opinion, do you think it changes outlook on the verdict or is it still the same?

[Sun Vaporer]

Sun, thanks for the update. Obviously the time line has changed and could easily take another month.

This makes a valid argument (imo). This does echo the arguments in NW case with one major difference - the new legislation. In your opinion, do you think it changes outlook on the verdict or is it still the same?

Tannerk--NJOY really had to do something here as the FDA argued in their Reply Brief that their case sould be dismissed outright. Having said that, I really wish they would have taken this opportunity to breath some new life into their argument instead of going down the same old path that proofed fatal to Nicotine Water and Nicotine Lollypops.

Sun

[Bones]

What I find interesting is that in the Nicotine Water case, the manufacture went so far as to even but shavings of tobacco in the Water to in an attempt to have Nicotine Water deemed a "tobacco" product and not a "drug". That maneuver readily failed and Nicotine Water was banned.
Since the FDA consented to this filing, we may again see a Reply to this filing by the FDA before a ruling by Judge Leon.


Sun

Could this be because it was water that was the vehicle? - I have not had much patience for the "what about the children?" argument in relation to e-cigs - But - With bottled water I can see that point as valid - How would one explain to a child how to distinguish it from regular bottled water? Particularly if the child is too young to read - Seriously - Nicotin Water - That was just a silly idea! That should have been banned simply on the basis of it's ridiculousness and I'm sure that played a big part in it -

edit: - same thing goes for the lollypops - too child friendly -
An e-cig is easily identifiable to a child as a "NO-NO" item -

[Sun Vaporer]

Could this be because it was water that was the vehicle? - I have not had much patience for the "what about the children?" argument in relation to e-cigs - But - With bottled water I can see that point as valid - How would one explain to a child how to distinguish it from regular bottled water? Particularly if the child is too young to read - Seriously - Nicotin Water - That was just a silly idea! That should have been banned simply on the basis of it's ridiculousness and I'm sure that played a big part in it -

Bones--it was litigated and found that Nicotine was a "drug" subject to FDA regulation. That is also why Nicotine Pops where banned. Child use was never even mentioned in the case just as it is not being mentioned here. The Court takes on its face that "children" are the intended users of these product nor are the the main "risk" concerns with regards to saftey. The standard is applied to the "what whould be" legitiamte consumer---meaning us.

Note that there is a company going though the FDA approval process as we speak for a cigarette like shapped cartridge that holds a nicotine gel. That manufacture, unlike e-cigs, made the appropriate application and submitted the requisite studies. Its status is still pending.


Sun

[LaceyUnderall]

Note that there is a company going though the FDA approval process as we speak for a cigarette like shapped cartridge that holds a nicotine gel. That manufacture, unlike e-cigs, made the appropriate application and submitted the requisite studies. Its status is still pending.

Isn't this product designed for specifically quitting smoking?

[let,there,be,vaping]

Obviously the time line has changed and could easily take another month.

I really hope so!

[LaceyUnderall]

Lacey--You are talking about Nicogel I think and that is not it--this product is shaped like a cigarette and it made to "sip' instead of smoke. When and if it will be approved is not known, but at least is is going though the proper channels.


Sun

so it is ingested vs inhaled?

EDIT: No... wait... after looking at the video for Nicogel, that isn't what I am thinking about. I am thinking about what you are talking about and I can't find the link but it is floating around here somewhere and if I remember correctly, they are very clearly marketing it as an NRT.