Grimmer--again that plays right into the FDA's hand--once you call these an NRT with the end play being to stop smoking---they fall squarely within the jusrisdiction of the FDA---game over if you call them an NRT.
Sun
Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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Grimmer--again that plays right into the FDA's hand--once you call these an NRT with the end play being to stop smoking---they fall squarely within the jusrisdiction of the FDA---game over if you call them an NRT.
Sun
Talking about precedents, I'm thinking of the ...... approval process, which was lightning fast!
The only problem is I don't think there are as many old and male e-cig smokers as there were making up the potential market for .......
But at least there are cases where the FDA has sped up the approval process. The question would be what does the FDA get out of a settlement offer?
If that is the case then this country no longer has critical thinkers or use what is in there right to question the authorty of all that governs in this country. The last time I checked that was suppose to be there job in the first place.
Then this governement has failed to give the rights to the people to have choice which to include persuit of happiness and the ability to decide what is better for each individual as long as nobody gets hurt in the proccess to include loss of life. Im beginning to wounder what this government truly stands for....is it really for the people or how much is to be gained on the bottom line. Just to let you I love this country and will die for it and we do have a lot of freedoms that most countries dont have...but we are on a downward slope of losing those freedoms..
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Talking about precedents, I'm thinking of the ...... approval process, which was lightning fast!
The only problem is I don't think there are as many old and male e-cig smokers as there were making up the potential market for .......
But at least there are cases where the FDA has sped up the approval process. The question would be what does the FDA get out of a settlement offer?
Double--what the FDA would get out of the proposed settlement I stated would be trying to save face when there is now a product that will show, when the data is in, that they turned their back on a device that simply works at getting people off cigarettes. But like I said---all parties would have to be reasonable and the advocacy groups against smoking allow for the FDA to act unreasonably. If the studies do indeed find the e-cig to be a safe product as we suspect, then there really is not any rational reason to not approve the e-cig so long as they are reasonably regulated and taxed of course.
Sun
this would be a good plan as long as they dont ban it from the market until test are done. we already know what's in them....
Grimmer -- it is a question of checks and balances--always has been. Judges are not suppose to legislate from the bench--but they often do. The Legislature makes the laws, the Executive branch enforces the laws and the Court's interpert the laws--that is the very basic foundation of the Seperation of Powers Doctrine framed in our Constitution.---three branches of Goverment, with each playing its own role.
Sun
but none exceeds the other
....believe me i agree these juices and devices need to tested from all manufatures.....IF the manufacture can afford the FDA testing then the suppliers will need to switch to a company that can afford it...then the suppliers need to be FDA registered....then be approved but there should not be a bann because already to many people use these ecigs and the FDA allowed the use of ecigs go for to long. then after 2 years of use then they want to ban them thre has to be a way to fight that. to allow test then aproval without a ban.
....believe me i agree these juices and devices need to tested from all manufatures.....IF the manufacture can afford the FDA testing then the suppliers will need to switch to a company that can afford it...then the suppliers need to be FDA registered....then be approved but there should not be a bann because already to many people use these ecigs and the FDA allowed the use of ecigs go for to long. then after 2 years of use then they want to ban them thre has to be a way to fight that. to allow test then aproval without a ban.
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Please READ paragraph 1.7 of this U.S. Government Document!!!!!!
http://www.atsdr.cdc.gov/toxprofiles/tp189-c1-b.pdf
Save a copy for your own records
http://www.atsdr.cdc.gov/toxprofiles/tp189-c1-b.pdf
Save a copy for your own records
This, to me is the catch 22. Like myself, most people appear to be moving to the PV devises as a means to get off the 4000 ingredients that tobacco uses to kill us. When I say I want to quit smoking, that translates to I want to quit smoking cigarettes. How bad is nicotine? I know there are some benefits.So I wouldn't consider this an NRT since these products are intended for use in smoking cessation efforts to help deal with withdrawal symptoms and cravings caused by the loss of nicotine from cigarettes. CRP would be a more appropriate designation for most people- cigarette replacement product. I too want to be able to complain about second hand smoke and smelly, smoky people (which I just started noticing the last couple days),
This is something that I have been wondering about for some time now (ie whether this is possible)
Bad as the headlines were, even the FDA report shows how much better these are compared to traditional cigarettes, so the 'logical' route would be for the FDA to work with e-cig manufacturers to reach a compromise solution such as you have suggested.
eg: FDA stipulates that if only previously FDA approved substances (and nicotine) are included, and 'spot-check' samples are tested, then they should be allowed to be sold (with strict guidelines as to marketing/packaging etc).
I think that's something that everyone should be able to live with.
Interesting, now the question is; how much PG are we ingesting in a day (not just in e-cigs, but in all the other products mentioned together)?
CoderGuy
Please know this- the FDA NDA and the accompanying approval process does not result in a class of products being approved- the process approves specific products proffered by the manufacturer. Nobody is going to front the amount of dollars necessary to go through the approval process without some sort of intellectual property protection, i.e. patents, trademarks, etc. Otherwise, they cannot be assured of getting a return on that investment. It appears that Ruyan and Njoy have US patents pending, do not know what the status of the other products or manufacturers is. I do know that various other importers and manufacturers have been unable to produce patents they claim to have or have pending.
Nobody in their right mind is going to fund an FDA approval process, estimated at tens of $$ millions, for a generic product. FDA approval is likely to be a windfall for one, maybe two, manufacturers and US importers.
So, the reality is, if the FDA prevails and if someone is able to get through the NDA process, there will be fewer products, at a much higher cost.
Also, if the predicate of the Nicotrol inhaler is used, there is the likelihood that an approved e-cigarette containing nicotine would start life as a prescriptive product.
Pfizer and its subsidiaries Pharmacia and Upjohn have never sought an Rx to OTC conversion and they don't plan to at this time.
Nobody in their right mind is going to fund an FDA approval process, estimated at tens of $$ millions, for a generic product. FDA approval is likely to be a windfall for one, maybe two, manufacturers and US importers.
So, the reality is, if the FDA prevails and if someone is able to get through the NDA process, there will be fewer products, at a much higher cost.
Also, if the predicate of the Nicotrol inhaler is used, there is the likelihood that an approved e-cigarette containing nicotine would start life as a prescriptive product.
Pfizer and its subsidiaries Pharmacia and Upjohn have never sought an Rx to OTC conversion and they don't plan to at this time.
To all of you who've made this thread such a great source of up-to-date information, THANKS!!!
And Sun - YOU DA MAN!!!!
Anyway, I'm thinking that we're actually headed in a good direction. The Chinese manufacturers are now seeking FDA approval because of all the hoopla. This means putting their product under the microscope on a continuous basis, which translates into a product we can trust.
Don't think for a minute that China doesn't care about our market here in the USA. Getting FDA approval would open the flood-gates for world-wide acceptance of the e-cig. This has the potential to become one of the largest commercial ventures in history, so getting the FDA stamp of approval is HUGE.
The result? We get to vape whenever and wherever we want, it would be regulated to insure a safer product, and gradually the public would come to accept it. The stigma associated with smoking would be gone, because there's no second-hand effects.
Would it be taxed? Sure, but not like tobacco. Without the claim that it's driving up health costs, loss of production and all the other excuses, they won't be able to tax it so hard. In fact, if we need prescriptions, they CAN'T put huge taxes on it.
All in all, I think we're gonna be OK. In the long run, this is a win/win situation. If the FDA wins, we eventually get a safe, regulated NRT. If the FDA loses, then the game's over right now, and the only thing we need to worry about is getting clean liquid. We win either way.
Just my 2 cents worth.... course you get what you pay for.
TC
And Sun - YOU DA MAN!!!!
Anyway, I'm thinking that we're actually headed in a good direction. The Chinese manufacturers are now seeking FDA approval because of all the hoopla. This means putting their product under the microscope on a continuous basis, which translates into a product we can trust.
Don't think for a minute that China doesn't care about our market here in the USA. Getting FDA approval would open the flood-gates for world-wide acceptance of the e-cig. This has the potential to become one of the largest commercial ventures in history, so getting the FDA stamp of approval is HUGE.
The result? We get to vape whenever and wherever we want, it would be regulated to insure a safer product, and gradually the public would come to accept it. The stigma associated with smoking would be gone, because there's no second-hand effects.
Would it be taxed? Sure, but not like tobacco. Without the claim that it's driving up health costs, loss of production and all the other excuses, they won't be able to tax it so hard. In fact, if we need prescriptions, they CAN'T put huge taxes on it.
All in all, I think we're gonna be OK. In the long run, this is a win/win situation. If the FDA wins, we eventually get a safe, regulated NRT. If the FDA loses, then the game's over right now, and the only thing we need to worry about is getting clean liquid. We win either way.
Just my 2 cents worth.... course you get what you pay for.
TC
You think the FDA will try to ban cellphones? Maybe do a study?
Maybe the FDA will try to ban cellphones too!
Surprise: Texting While Driving is Dangerous
PC World*-*Todd R. Weiss*-*3 hours ago
Shocking but true - another new study concludes that driving while texting on a cell phone or smartphone isn't safe - in fact, it can be 23 times more risky in leading to a crash than drivers who are not texting.
Texting while driving increases crash risk 23-fold*Computerworld
Texting While Driving Can Increase Crashes 23-Fold
Maybe the FDA will try to ban cellphones too!
Surprise: Texting While Driving is Dangerous
PC World*-*Todd R. Weiss*-*3 hours ago
Shocking but true - another new study concludes that driving while texting on a cell phone or smartphone isn't safe - in fact, it can be 23 times more risky in leading to a crash than drivers who are not texting.
Texting while driving increases crash risk 23-fold*Computerworld
Texting While Driving Can Increase Crashes 23-Fold
Could PVs ever be considered to be alternatives to cigarettes, instead of NRTs? Would the FDA ever even allow that to be a consideration, or are cigarettes and other tobacco products the only sanctioned non-drug "delivery device" that will ever be allowed?
Randy----Cigarettes and other traditional tobacco products have been protected from regulation since an Act of Congress in the 1930's. The e-cig could very well be approved as an alternative product other then cigarettes, with proper regulations under the guise of the FDA if applications are made and the manufactures go though the approval process. The FDA has the authority to place them on a fast track should they choose. If the FDA is truly acting in "the public interest" and the testing shows that the e-cig is "reasonably harmless" --then they should be approved. One the other hand, if the FDA's agenda is elsewhere---then the situation does not look good based at the moment on the facts that are currently available.
Sun
The Docket Sheet today showed no movement today. We await the second hearing requested by Judge Leon set of August 17th at 3PM.
Sun
Sun
Today the Docket Sheet no movement in the case. I would not be surprised that there are some additional filings with regards to studies before the Hearing.
Sun
Sun
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