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

[Territoo]

I just can't see the judge ruling in favor of the FDA. Lets face it, even though there were trace amounts of a carcinogen found the fact remains that this is a correctable issue. It is simply a matter of refinement and inspection. Many manufacturers in china are already resolving the issue presented by the FDA because they do not want to loose the US market. Also proposing that ecigs are a drug delivery device is no reason for a ban. Our country would crumble without drug delivery devices. Certainly Judge Leon is smart enough to see this. I hope.

What say makes sense, but making sense isn't what this case is about. It is simply whether or not ecigs are a drug/delivery device or a tobacco product. Its not about safety, ie the presence of carcinogens (which BTW are TSNAs, same or lower quantity found in approved NRT). Its not about cleanliness in manufacture which is a relative easy method to fix by registering w/ the FDA. It IS about it being a proposed drug delivery device which the FDA has full authority to ban since a NDA was never filed and no testing per FDA requirements has been done. Yes, we need drug delivery devices but the ones currently on the market, except for the ecig, have been FDA approved.

Now the kicker, even though by all odds the FDA will win this case based on current laws and policies, I'm holding out some small hope that Judge Leon sees the weakness of current laws/policies and is willing to establish some sort or precedent w/ this case.

 

[Sun Vaporer]

Due the the Labor Day Holiday today, the Court is closed and will reopen tommorrow.


Sun

 

[chayce]

E-cigs are technically drug delivery systems. So are forks. So are bottles. I can have a caffeine throat spray and the FDA won't bat an eye. Same with Caffeinated soap. Caffeine is a socially acceptable drug, nicotine is not. Between that and the amount of money big tobacco has riding on the banning of e-cigs it's no wonder these things are getting a fast track to a ban. This is the same FDA that took Cheerios to court for claiming to lower cholesterol. I can't wait until i need a prescription for a treadmill because it treats obesity.

 

[Sun Vaporer]

E-cigs are technically drug delivery systems. So are forks. So are bottles. I can have a caffeine throat spray and the FDA won't bat an eye. Same with Caffeinated soap. Caffeine is a socially acceptable drug, nicotine is not. Between that and the amount of money big tobacco has riding on the banning of e-cigs it's no wonder these things are getting a fast track to a ban. This is the same FDA that took Cheerios to court for claiming to lower cholesterol. I can't wait until i need a prescription for a treadmill because it treats obesity.

Chayce---as much as you want to come out swinging thinking the FDA is one big conspiricy theory---remember that SE and NJOY sued the FDA and this case has been sitting around waiting for 5 months for just a decision on a Motion for a Preliminary Injuction. So I do not see any fast track here.

And as for Cherrios---If you are going to make a health claim to gain market share, you better have the evidence to back it up, and General Mills conceded it did not. The days of selling "snake oil" remedies are long over.

Sun

 

[jvapor]

What say makes sense, but making sense isn't what this case is about. It is simply whether or not ecigs are a drug/delivery device or a tobacco product. Its not about safety, ie the presence of carcinogens (which BTW are TSNAs, same or lower quantity found in approved NRT). Its not about cleanliness in manufacture which is a relative easy method to fix by registering w/ the FDA. It IS about it being a proposed drug delivery device which the FDA has full authority to ban since a NDA was never filed and no testing per FDA requirements has been done. Yes, we need drug delivery devices but the ones currently on the market, except for the ecig, have been FDA approved.

Now the kicker, even though by all odds the FDA will win this case based on current laws and policies, I'm holding out some small hope that Judge Leon sees the weakness of current laws/policies and is willing to establish some sort or precedent w/ this case.

Well if it an issue of being a drug delivery device why don't manufacturers and sellers just ship them without nicotine? Then its just a vaporizer and not a drug delivery device. Ok now everyone can get their feathers ruffled at me here. If its about money, and I'm sure it is, then let them tax it. Just let me keep vaping rather than smoking.

 

[Sun Vaporer]

Well if it an issue of being a drug delivery device why don't manufacturers and sellers just ship them without nicotine? Then its just a vaporizer and not a drug delivery device. Ok now everyone can get their feathers ruffled at me here. If its about money, and I'm sure it is, then let them tax it. Just let me keep vaping rather than smoking.

J--because that is the same as shipping guns with blank bullets. The argument just does not fly. The intended use of the device is to use the nicotine cartridges---that is the way it is marketed and that is one of the paramount things that the FDA looks at.


Sun

 

[a2dcovert]

The FDA is operating within the parameters of their mission. They are well aware of what was taking place and they responded by the book. They saw an unknown product making unregistered claims. The unfounded claims to be a smoking cessation product labeled it as a drug. The e-cig was the delivery device so it was labeled a drug delivery device. It really is that black & white to them. The FDA is no stranger to this type of controversy.

 

[Sun Vaporer]

The FDA is operating within the parameters of their mission. They are well aware of what was taking place and they responded by the book. They saw an unknown product making unregistered claims. The unfounded claims to be a smoking cessation product labeled it as a drug. The e-cig was the delivery device so it was labeled a drug delivery device. It really is that black & white to them. The FDA is no stranger to this type of controversy.

A2d---Yes---it really is that simple when you cut out all the nonsense and look at it in the overall bigger picture.


Sun

 

[Sinless1]

I really don't get what the judge is taking so long for.

More than likely he is gonna default to the FDA. Since Njoy does business in other countries they will prob get thier product released to send out of the country. SE is another story they may end up losing all thier product

we had a shipment released from customs but not delivered. customs and usps can't seem to locate our package. I wonder what that means?

 

[Sun Vaporer]

I really don't get what the judge is taking so long for.

More than likely he is gonna default to the FDA. Since Njoy does business in other countries they will prob get thier product released to send out of the country. SE is another story they may end up losing all thier product

we had a shipment released from customs but not delivered. customs and usps can't seem to locate our package. I wonder what that means?

Sin--sounds like a reasonable take of the case.

Sun

 

[Sun Vaporer]

There was no movement on the Docket Sheet today. With the hoilday yesderday, that would be expected. Might see some action tommorrow. We will see.


Sun

 

[Territoo]

Probably will get a negative ruling on September 11. A little more salt in the wound of a day of mourning.

 

[JustMeAgain]

There was no movement on the Docket Sheet today. With the hoilday yesderday, that would be expected. Might see some action tommorrow. We will see.Sun

Sun,

I'm sure this is to be found somewhere...if so, my apologies for not finding it, but if the Judge decides in favor of the FDA, will this impact sales of product already in the US or will it pertain to future imports only? Also, will it have any immediate effect on US companies like Puresmoker or Johnson Creek?

 

[crazybry79]

Lets say the FDA does get its way, and bans the Ecig and related components.

What is the possibility one may import his/her own for personal use?

Would it be feasable to "re"market these as something similar? I dont know, Im shooting in the dark here, but like a "Vics Vapo rub" inhalor, or something of the like.

I understand the whole contraption may not be sold, what about peices? Batteries? - They're legal - yet a crafty person may make a bomb out of them. Other parts? ect?

 

[Sun Vaporer]

Sun,

I'm sure this is to be found somewhere...if so, my apologies for not finding it, but if the Judge decides in favor of the FDA, will this impact sales of product already in the US or will it pertain to future imports only? Also, will it have any immediate effect on US companies like Puresmoker or Johnson Creek?

JustMe---Should the FDA prevail, its impact will be immediate to all sales, be it domestic or international. The FDA has stated that it will step up its enforcement policys to include criminal prosectution for entities that will not heed to warnings.

Sun

 

[Sun Vaporer]

Lets say the FDA does get its way, and bans the Ecig and related components.

What is the possibility one may import his/her own for personal use?

Would it be feasable to "re"market these as something similar? I dont know, Im shooting in the dark here, but like a "Vics Vapo rub" inhalor, or something of the like.

I understand the whole contraption may not be sold, what about peices? Batteries? - They're legal - yet a crafty person may make a bomb out of them. Other parts? ect?

Crazy---Feasable? Yes---legal---No, should the FDA prevail.

Sun

 

[Cori]

I really don't get what the judge is taking so long for.

I too have to wonder why the judge is sitting on this for so long. I'm getting bad vibes here. Is this taking so long in order to give the FDA more ammo against ecigs, will they run more test and call it conclusive, or what? I'm not getting any warm fuzzy feelings about this, although I guess anything is possible.

 

[Vaporer]

Sun,

Unless they specifically use the word "possess" then it would be allowable to possess, make for personal use (in your home) a PV right?

There is a new thread, I'm sure you've seen, where CA bill SA 400 was reworded on Sept 2, 2009 to ban the sale, distribution etc...and it specifically by word states e-cigs and any device that can be used for the purpose of nicotine inhalation.
If Judge Leon lets the FDA have control of the liquid, this bill nails the coffin on devices, if I read it right, and puts the regulation of any device in this catagory in the hands of the FDA also.

This would be a horrible blow for us.

 

[Sun Vaporer]

Sun,

Unless they specifically use the word "possess" then it would be allowable to possess, make for personal use (in your home) a PV right?

There is a new thread, I'm sure you've seen, where CA bill SA 400 was reworded on Sept 2, 2009 to ban the sale, distribution etc...and it specifically by word states e-cigs and any device that can be used for the purpose of nicotine inhalation.
If Judge Leon lets the FDA have control of the liquid, this bill nails the coffin on devices, if I read it right, and puts the regulation of any device in this catagory in the hands of the FDA also.

This would be a horrible blow for us.

Vaporer--I would be a major set back to say the least, but it would ony affect the importation, sale, and marketing---not possession. That is not within the scope if this litigation.

Sun

 

[DC2]

They are messing with the wrong folks this time.
We have the truth on our side, and the passion of fighting for our very lives.

If they try to take us down, there WILL be hell to pay.
All we need is a focal point, and they would be stupid to give it to us.