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.

 

[tmtowtdi]

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.

Heya Lacey - are you thinking of Aeros? Forum won't let me post a URL, but Google for "aeros smokeless cigarettes" for the website.

 

[LaceyUnderall]

Sun, there is no doubt that things were not done exactly right. The manufacturers in China did not fully understand the regulations of the US. Some suppliers have played within the rules and regulations and some have not.

There is also no doubt that the judge has an interesting task on his hands and all of us just speculate until the final judgment comes in. However, in both the SE and nJoy companies, they have very well put together product presentation, so thank god for that!

And a big thank you for your updates... if I haven't already

PS. I still think it is sunny by the way

 

[Bones]

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

yes - very true - I still think nicotine water is a very silly idea though

 

[LaceyUnderall]

Heya Lacey - are you thinking of Aeros? Forum won't let me post a URL, but Google for "aeros smokeless cigarettes" for the website.

Quit Smoking, Stop Smoking Or The New - Aeros Smokeless Cigarettes

No... but that is interesting as well and I will look into it more.

The thing I am thinking about looks like a clear plastic tube, the size of a roll your own and is full of gel... bubbles and all. You clip the end and sip the liquid. Kind of an odd idea, but whatever works I guess.

This aero though is interesting. Wow! It took them 3 years and sadly enough... it appears they are out of money and needing more to move forward: Quit Smoking, Stop Smoking Or The New - Aeros Smokeless Cigarettes They openly admit to no marketing experience which would make sense why they aren't mainstream.

This almost needs it's own thread. You should start one tmtowtdi. PM me and I will follow in to post your links for you.

 

[tmtowtdi]

This aero though is interesting. Wow! It took them 3 years and sadly enough... it appears they are out of money and needing more to move forward: They openly admit to no marketing experience which would make sense why they aren't mainstream.

This almost needs it's own thread. You should start one tmtowtdi. PM me and I will follow in to post your links for you.

Thanks Lacey, but I haven't got any more info on the Aeros than what's in the link. I saw a post somewhere in this forum (I think...) within the last few days that mentioned them and just happened to still have the link in my browser's history. If you managed to Google the site, you know as much about them as I do

 

[TheIllustratedMan]

OK Sun, I'm probably going to have to get you to explain slowly for me again, but...

The more I'm thinking and talking about this case specifically, it seems that the FDA is right. You have a new delivery mechanism for a known drug (nicotine), which under the law requires FDA approval to be marketed in the United States. Smoking Everywhere, NJOY, and other US distributors are violating this law, therefore cannot be allowed to operate. (I'm also under the impression that the FDA does not consider PVs tobacco products, which is the main crux of the case).
So, we're on a forum that is mostly users of this product, with some suppliers. The suppliers should be very worried about the outcome of this case, since it could entirely put them out of business. What about us users?
Does the FDA have the right to block personal importation? Assuming an FDA-leaning outcome to the case, you won't be able to market or sell PVs in the US. What about buying them? Basically, if a Chinese supplier maintains a Chinese website and I order from it for personal use, does the FDA have jurisdiction to block that transaction? I don't see this case covering that issue, since it's all about sales and marketing, though maybe that would still fall under sales. Just seems to me that the FDA has no control over a Chinese company, although they still may have control over imports.

Clarification?

 

[malyden]

Quit Smoking, Stop Smoking Or The New - Aeros Smokeless Cigarettes

No... but that is interesting as well and I will look into it more.

The thing I am thinking about looks like a clear plastic tube, the size of a roll your own and is full of gel... bubbles and all. You clip the end and sip the liquid. Kind of an odd idea, but whatever works I guess.

This aero though is interesting. Wow! It took them 3 years and sadly enough... it appears they are out of money and needing more to move forward: Quit Smoking, Stop Smoking Or The New - Aeros Smokeless Cigarettes They openly admit to no marketing experience which would make sense why they aren't mainstream.

This almost needs it's own thread. You should start one tmtowtdi. PM me and I will follow in to post your links for you.

Here's some older links from this forum about the Aeros:
http://www.e-cigarette-forum.com/forum/smokeless-tobacco/586-aeros-smokeless-cigarette.html

http://www.e-cigarette-forum.com/fo...-anyone-tried-aeros-smokeless-cigarettes.html

http://www.e-cigarette-forum.com/fo...-something-new-aeros-smokeless-cigarette.html

http://www.e-cigarette-forum.com/forum/law-e-cigarette/23676-1980s-e-cig.html#post417130

 

[Sun Vaporer]

OK Sun, I'm probably going to have to get you to explain slowly for me again, but...

The more I'm thinking and talking about this case specifically, it seems that the FDA is right. You have a new delivery mechanism for a known drug (nicotine), which under the law requires FDA approval to be marketed in the United States. Smoking Everywhere, NJOY, and other US distributors are violating this law, therefore cannot be allowed to operate. (I'm also under the impression that the FDA does not consider PVs tobacco products, which is the main crux of the case).
So, we're on a forum that is mostly users of this product, with some suppliers. The suppliers should be very worried about the outcome of this case, since it could entirely put them out of business. What about us users?
Does the FDA have the right to block personal importation? Assuming an FDA-leaning outcome to the case, you won't be able to market or sell PVs in the US. What about buying them? Basically, if a Chinese supplier maintains a Chinese website and I order from it for personal use, does the FDA have jurisdiction to block that transaction? I don't see this case covering that issue, since it's all about sales and marketing, though maybe that would still fall under sales. Just seems to me that the FDA has no control over a Chinese company, although they still may have control over imports.

Clarification?

TheIllustratedMan---A ban on e-cigs and e-liquid by the FDA would mean that the e-cig can not be Imported, Sold, or Marketed here. The importation into the United States by us, as consumers will be difficult at best.

I know we all think, "Well, if I order from China, just a small quanity, it is going to get through Customs---after all, the can not inspect every product going though Customs".

Here are the problems---First off, the Shipping Companies will refuse to ship. DHL already has done that and others will follow suit. These Shipping Companies have licences and they are not going to risk their licences on such a diminimus part of their business that the e-cig comprises. That license is way more valuable then that. Has anyone found a Shipper that would import items that are banned? The Shipping companies are going to self protect their interests just like DHL has already done. So their there is the first obstical.

Second there is the Payment System--Visa, Mastercard, Western Union, Bank Transfers, Paypal---again all licensed by the Fedreal Goverment. Are they going to be in the business of illicit conduct to risk thier licenses and subject themselfs to fines? There is the second obstical.

So for the consumer who wants to be ligitimate, the options are really going to be forclosed.

Remember, that the actual ownership of the e-cig is not in issue today and may never be. That is why stockpiling now so ownership rights are already vested is a wise move to hold yourself over till the air clears after apllications are made and approval processes are completed. Is there any gurantee that the e-cig as we know it will ever be approved? The short answer is no.

People should not readily assume it is just Big Tobacco and Big Pharma that have a interest in the e-cig and are willing to go though the approval process. As a matter of fact we have a member right here on this Forum working with a much larger industry as a "Counsultant" just using their e-cig. And getting payed well too I might add. Who that company and Member is, I am not at liberty to say.

So that is where we stand as consumers if the Court holds against the e-cig as we know it.

Sun

 

[Janetda]

I'm obviously new to all this (analog free for 3 weeks), But I don't see the point of this lawsuit at all. I get that maybe the FDA overstepped it's bounds by stopping the import because that's not what the FDA is suppose to do - but it sounds like it's already been established that nicjuice a drug and not legal to market and distribute it here in the States. Would they have preferred it if the DEA took the action? I'm failing to see why they challenged this in court at all. Seems to me that for the most part the authorities have been looking the other way when it comes to e-cigs and this court case is going to force a whole lot of sunshine where we might not want it....or am I missing some big picture thing, I often do.

 

[Sun Vaporer]

I'm obviously new to all this (analog free for 3 weeks), But I don't see the point of this lawsuit at all. I get that maybe the FDA overstepped it's bounds by stopping the import because that's not what the FDA is suppose to do - but it sounds like it's already been established that nicjuice a drug and not legal to market and distribute it here in the States. Would they have preferred it if the DEA took the action? I'm failing to see why they challenged this in court at all. Seems to me that for the most part the authorities have been looking the other way when it comes to e-cigs and this court case is going to force a whole lot of sunshine where we might not want it....or am I missing some big picture thing, I often do.

You make a good point Janet---but Agencies like the FDA actually what to be the Defendants in suits as the burden of proof is on the Plaintiff. In reality though, having not filed suit was not an option for SE and NJOY as their inventory was seized by Customs thereby shutting them down for the most part. All parties concerned I think really did not know that the e-cig would ever be anything more then a novelty at best. They underestimated the fact that the majority of people who smoke what a safer alternative----but then again the minute you use the word safer--you just fell in the trappings of one of the FDA's argument for the e-cig to be banned.

Sun