Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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my freaking head is spinning... The FDA is making claims on the "intended use". Which an abstract phrase. Intended use for me could be totally different than for someone else. i have a truck. Is my intended use for hauling or off roading?
I hope the Judge notices the non-concrete jarble the FDA is using to try and pull this out out their Arses....
In court it's FACTS.. Not hearsay(sp?) or opinion's !!!!!!!!!
I hope the Judge notices the non-concrete jarble the FDA is using to try and pull this out out their Arses....
In court it's FACTS.. Not hearsay(sp?) or opinion's !!!!!!!!!
Today the Docket sheet showed that Judge Leon granted the appearance of two counsel for SOTTERA, INC (njoy) to appear Pro Hac Vice (for this case and this case only as they are not admitted to practice law in this Federal Court). These again were a procedural entry and really has no bearing on the case. It is more of a "housekeeping" entry, as these Attorneys filed their motions with the Court back in May, but the Motions were never acted on.
It is interesting to note that in the FDA’s final Brief, they argue that the FDA's current position is that they are not, according to them, "banning" the e-cig, rather demanding that they go though the application and approval process before they "might" be put on the market.
This process can take years and a whole lot of money. That really constitutes a "defacto ban" in my book, due to the time and expense of the approval process on top of the fact that there is no guarantee that the FDA will ever approve it even after the application is submitted and the studies are done-----
Sun
It is interesting to note that in the FDA’s final Brief, they argue that the FDA's current position is that they are not, according to them, "banning" the e-cig, rather demanding that they go though the application and approval process before they "might" be put on the market.
This process can take years and a whole lot of money. That really constitutes a "defacto ban" in my book, due to the time and expense of the approval process on top of the fact that there is no guarantee that the FDA will ever approve it even after the application is submitted and the studies are done-----
Sun
Thank you for all your work and efforts to keep us informed. I check you updates every day...as do many.
Entirely correct and consistent with the "unapproved" and "misbranded" tags slapped on confiscated shipments. That's the way they will be stopped. Units and liquids are unapproved; device parts are misbranded. If FDA wins this one, it won't be only "big guys" being affected.
I am angry. Ebay has taken e-cigs off their site calling them a "Tobacco" product. They allow people to sell other nicotine products on their site. What I want to know is how they can ban the device itself if it contains no nicotine. In itself, it is only another electronic device. So without nicotine-it is not the Drug/device combination, that the FDA says it is. Does anyone else agree with me on this? I wonder if Ebay has this policy for "Electronics". As far as I know they don't. Any one with some input let me know. I did contact Ebay, (so did my entire family,lol). We are waiting for a statement on this issue.
The "big guys" are the wildcard, I think. PM was directly behind the conversion to FDA regulation and lobbied for the new law in order to lock in their market share. But if the FDA Gone Wild begins to impact on even cigarette sales, won't they bring in all their clout? I read somewhere about a new nicotine inhaler, presumably to boost sales when premium analogs go down.
Is there any way we can look at the big pharmaceutical companies for a "model?" It wasn't that long ago that the FDA began to regulate drug companies. And they too have "big guys." There's got to be a connection between lobbyists, billions of dollars, and nicotine delivery systems. China is huge, and could bring pressure given that the country really doesn't have private industry. Aren't these PVs a national product, then? And couldn't China become a "big guy?"
Is there any way we can look at the big pharmaceutical companies for a "model?" It wasn't that long ago that the FDA began to regulate drug companies. And they too have "big guys." There's got to be a connection between lobbyists, billions of dollars, and nicotine delivery systems. China is huge, and could bring pressure given that the country really doesn't have private industry. Aren't these PVs a national product, then? And couldn't China become a "big guy?"
Careful -- This issue about the device with no No-Nic is no longer on the table and it never even really was. Counsel for SE and NJOY do not dispute it and argue that the E-Cig is in fact a "tobacoo" product. For SE and NJOY, they want the whole package. Absent pleading that, which they did not, the issue in the case is waived---period--dead--done.
They must assume, absent the ability to sell the e-lquid cartridges with the e-cig, is not viable for them. So, as it is plead, this is an all or nothing deal.
Sun
Sun, do you mind my asking where exactly you predict the direction of this case going? What is your guess as to the Honorable Judge's decision? What would you choose on an objective basis?
I have faith in the free market myself, and hope the sentiment is shared by the Honorable Judge, but you never know... this nanny state philosophy has been so deeply rooted into our society I'm not sure what to expect from such an occasion as this.
I have faith in the free market myself, and hope the sentiment is shared by the Honorable Judge, but you never know... this nanny state philosophy has been so deeply rooted into our society I'm not sure what to expect from such an occasion as this.
Based on the pleading filed Eric, I do not see where SE and NJOY gave Judge Leon anything to hang his hat on. SE conceded most of the relevant points right out of the box as did NJOY. There simply is not much in the record for Judge Leon to find for them. If you compare the pleadings in the Nicotine Water case with this one, Nicotine water had a much better argument and still went down. There really is not anything for Judge Leon to grab onto based on what SE and NJOY plead.
Interesting to note that SE and NJOY are the Plainiff's, so the burden of prove rests with them. SE and NJOY really did not offer much prove of any kind in the filings. So it is an uphill battle to say the least------Sun
Hmm, with them specifically arguing it's a tobacco product, maybe Johnson's Creek's lawyers didn't think it looked good and that's why they don't use tobacco derived nicotine anymore. That way, the ruling in this case won't apply to JC.
They made the change so fast they don't even have a VG recipe ready - maybe to get the new product out before this ruling is made?
Just a stray thought...
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They made the change so fast they don't even have a VG recipe ready - maybe to get the new product out before this ruling is made?
Just a stray thought...
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Interesting that this received approval: Quit Smoking, Stop Smoking Or The New - Aeros Smokeless Cigarettes
Couldn't a ruling be made that yes the FDA can test it, but the product cannot be banned during the testing process? That seems a reasonable and fair ruling. I do not trust federal agencies because I believe they are influenced by big business and the FDA would have nepharious reasons for banning the sale of these products. Since this country has been so successful because of free enterprise I should think that squelching it would be a step in the wrong direction, and be unfair.
Juile ---the FDA does not test products. If a manufacture seeks to sell a product within the FDA's jurisdiction, the burden is on the manufacture to make application and provide the requiste studies to the FDA for approval.
The FDA stance is that drugs do not go onto the market for consumer consumption till after they are approved---not during the approval process to only later find out that it is harmful.
Sun
Julie, it doesn't work that way. The would-be marketer of a product that falls under the "drug" category must test and apply for approval from the FDA. It is not simple. It is not quick. It is not cheap. But the FDA does not test for product makers.
E-smoking does not have FDA approval for their stated intended purpose of treating nicotine addiction. Neither devices nor liquid has approval. That's the reason the FDA has halted shipments -- lack of approval for a "new drug" and "drug delivery device."
Note: I was writing as Sun was posting.
E-smoking does not have FDA approval for their stated intended purpose of treating nicotine addiction. Neither devices nor liquid has approval. That's the reason the FDA has halted shipments -- lack of approval for a "new drug" and "drug delivery device."
Note: I was writing as Sun was posting.
I have to chuckle at the FDAs stance on product testing at times. How many things have they approved only to yank later on because they turned out to be bad. You'd think that an agency tasked with consumer safety would at least do their own research instead of taking the word of an applicant.
The Docket sheet today showed no movement in the case--we await Judge Leon's ruling on the requested Preliminary Injuction flied by SE and NJOY--------
Sun
Sun
Thank you for explaining this to me, as I obviously misunderstood FDA involvement and the process of gaining approval.
This is just anbsolutely ridiculous. Nicotine is not a "new" drug and these are not "drug delivery systems," any more than nicotine in tobacco products is a "new" drug or cigarettes and cigars are "drug delivery systems." In the bill that passed, the exact chemical composition of nicotine was given and the bill states that the FDA cannot ban any tobacco product. Nicotine is a tobacco product. Their argument is ridiculous, and this just makes me furious.
I feel that the ecigarette industry has a right to sell their products and any ruling which would completely prohibit the sale of eproducts would be grossly unfair to the sellars of these products and would be a restriction of the free enterprise system established in this country, and a restriction on personal freedom in that our right to choose would be violated.
This is just anbsolutely ridiculous. Nicotine is not a "new" drug and these are not "drug delivery systems," any more than nicotine in tobacco products is a "new" drug or cigarettes and cigars are "drug delivery systems." In the bill that passed, the exact chemical composition of nicotine was given and the bill states that the FDA cannot ban any tobacco product. Nicotine is a tobacco product. Their argument is ridiculous, and this just makes me furious.
I feel that the ecigarette industry has a right to sell their products and any ruling which would completely prohibit the sale of eproducts would be grossly unfair to the sellars of these products and would be a restriction of the free enterprise system established in this country, and a restriction on personal freedom in that our right to choose would be violated.
I'm not sure you WANT to understand this, Julie, but the FDA's position is quite correct, given its charge. It regulates drugs and food in the U.S. (except meat, which is USDA). Nicotine is not new, but it's not nicotine you are vaping. You vaporize and inhale a whole concoction of chemicals mixed together with nicotine. And that formulation is new. Not nicotine per se, but the cocktail of chemicals we call e-liquid.
Now, that's where the FDA comes into the picture. The FDA's job is make sure that when some new drug concoction (which this is) is marketed, it's safe and efficient as directed for use. To know that, the FDA needs studies from those who want to sell the products, studies which will be reviewed by a panel of scientists for approval or rejection. E-smoking devices deliver a drug, so they are drug-delivery devices, which also require studies and approval to be certified as medical devices.
None of this has been done. And no approvals have been granted. That's why shipments have been stopped. That's why e-cigs and liquid face what Sun Vaporor aptly calls a "defacto ban." If proper procedures had been followed -- and they were not -- we might be legal at this time .. or we would not yet have heard of e-cigs. Either way, we wouldn't be in legal limbo, as we are now, awaiting the result of a shaky lawsuit.
This has nothing to do with personal freedom of choice. It has nothing to do with lack of taxation of our products. It has nothing to do with "free enterprise". It has nothing to do with comparing e-cigs to tobacco cigs. This forum has barked up so many wrong trees. This has everything to do with following the laws of the land, which were not followed in our case. Don't follow them -- as e-cig makers have chosen to do while selling to us -- and you'll face the wrath of FDA regulation, as is now the case.
Now, that's where the FDA comes into the picture. The FDA's job is make sure that when some new drug concoction (which this is) is marketed, it's safe and efficient as directed for use. To know that, the FDA needs studies from those who want to sell the products, studies which will be reviewed by a panel of scientists for approval or rejection. E-smoking devices deliver a drug, so they are drug-delivery devices, which also require studies and approval to be certified as medical devices.
None of this has been done. And no approvals have been granted. That's why shipments have been stopped. That's why e-cigs and liquid face what Sun Vaporor aptly calls a "defacto ban." If proper procedures had been followed -- and they were not -- we might be legal at this time .. or we would not yet have heard of e-cigs. Either way, we wouldn't be in legal limbo, as we are now, awaiting the result of a shaky lawsuit.
This has nothing to do with personal freedom of choice. It has nothing to do with lack of taxation of our products. It has nothing to do with "free enterprise". It has nothing to do with comparing e-cigs to tobacco cigs. This forum has barked up so many wrong trees. This has everything to do with following the laws of the land, which were not followed in our case. Don't follow them -- as e-cig makers have chosen to do while selling to us -- and you'll face the wrath of FDA regulation, as is now the case.
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