FDA Stuff ... Bottom Line?

[Obi Wan]

So is this the bottom line of it all ,,
The fda is officially saying e-cigs with nicotine are illegal and they are going to ban any sales and also stop any imports ?
and that they will remain illegal until someone does testing that they may or may not approve.
which could take months or years or never..

 

[Sun Vaporer]

So is this the bottom line of it all ,,
The fda is officially saying e-cigs with nicotine are illegal and they are going to ban any sales and also stop any imports ?
and that they will remain illegal until someone does testing that they may or may not approve.
which could take months or years or never..

We do not know the Scope of what the FDA will do yet--Sun

 

[Obi Wan]

this site is awesome and depressing at the same time..
depressing because so many of us found something that finally seems to help us quit smoking analogs..
and its awesome because its so interesting to read everything about this new invention.
but somewhere on almost every subject T-Bob comes in and gives it a shot of reality that seems to lead to the FACT that the fda could care less about our opinions and needs testing done for safety before they would even consider a certificate or approval.
which actually makes sense but we dont want these banned..
i just hope it doesnt take years,,but i sense a disturbance in the force and im losing optimism...

time for a beer...

 

[Kate]

Don't forget that nicotine eliquid is banned in Australia but the ban is not being enforced on personal use. That might be the line the FDA takes or they might only stop commercial shipments aimed at health and NRT sales.

Until they actually stop citizens from vaping then everything is conjecture.

 

[TropicalBob]

Walrus: Jason of Totally Wicked and Christian of Johnson Creek have been forum members for a long time, have taken smart suggestions made on this forum, and implemented them.

Any vial or bottle containing a poison needs to be child-proof AND tamper-proof, have adequate warnings of poison prominently displayed, have a place and time of manufacture on it along with a production line number, and have an ingredient list with the packaging. They have done much toward that direction.

There are dangers with e-liquid. Those need to be spelled out -- to consumers and for first reponders in case of poisoning.

Let's not give any authority an easy and logical reason to ban use of a liquid we all have come to need. Let's just make it -- provably -- safe.

 

[CandyGirl]

this site is awesome and depressing at the same time..
depressing because so many of us found something that finally seems to help us quit smoking analogs..
and its awesome because its so interesting to read everything about this new invention.
but somewhere on almost every subject T-Bob comes in and gives it a shot of reality that seems to lead to the FACT that the fda could care less about our opinions and needs testing done for safety before they would even consider a certificate or approval.
which actually makes sense but we dont want these banned..
i just hope it doesnt take years,,but i sense a disturbance in the force and im losing optimism...

time for a beer...

funny while i was reading your post i kept thinking "help us obi wan kenobe, you're our only hope". lol

 

[LaceyUnderall]

Boo--you have a good point. I would go further though and ask the question--"Is it economically feasible to cure cancer?" Cancer is a money maker from the Hospitals, the Doctors, and the Drugs. What would it be like if cancer was cured? Whould all of the Hospitals gladly be turned into Librarys. Would the Doctors love going back to delivering babies? And lets not forget about big Phama with their Chemo Drugs--they would enjoy taking one for the team and enjoy seeing their market vanish if cancer was cured?? IMO-----Sun

Bingo. Until the health care system is NOT focused on profit and is focused on health, these problems will continue.

There is no way the device can be labeled a drug delivery device. They are exactly similar to other vaporizers on the market and any lawyer could argue that one. The eliquid is another story. However, to really ban it? Well, it may be bumpy for awhile but our eliquids will prevail. We may have to make some concessions but the concept is here to stay.

If anyone doesn't believe me, then imagine the day that someone does attempt to take them away for good. What will you do? Will you sit there idly and not say anything? If so, you should not be on this forum. If you are on this forum, you should be prepared to speak up when that time comes.

We are citizens of mostly free countries and as adults, we have the right to smoke an alternative to something that profits the pharmaceutical and tobacco companies. Both of those industries have proven to kill their users. Show me a dead e-smoker.

 

[yvilla]

I thought only the companies who claim to be healthy or NRTs/quit smoking devices will be illegal to sell and market? Is it not these claims that raised the FDA's eyebrows in the first place? I was under the impression that making these 2 claims in particular is what classified them as a new drug, and only these companies would be affected.

It's been said many times, but I don't see how they could possibly regulate the devices themselves. I think it would be wise for all suppliers to begin importing and selling the kits and liquids separately.

Riddle, I agree that it may only be some ecigs and some companies that the FDA might target, and I just posted this on another thread, regarding the FDA's alleged condemnation of all ecigs as "drug delivery devices" for a "new drug":

Or, is [the argument that the FDA has no jurisdiction over ecigs] only no longer valid as applied to those marketing ecigs as NRT or smoking cessation devices? And conceivably still valid as applied to those who are very careful in their marketing?

This quote from another FDA representative is what I'm referring to:

"In the US, the Food and Drug Administration has "detained and refused" several brands of electronic cigarettes because they were considered unapproved new drugs and could not be legally marketed in the country, said press officer Christopher Kelly. He did not give more details, but said the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising."

eCig sales soar online: Sci-Tech: News: News24

Here is the original thread I posted that in, for its full context:

http://www.e-cigarette-forum.com/forum/e-cigarette-news/8645-smartfixx-excerpt-website.html

 

[tsb]

ummm, i'm very worried, i'm about to place a large order to try to become an independent reseller, but if i do place this order and they are seized by customs i'm gonna be out 10k for nothing. i really dont know what to do now. suggestions anyone?

 

[CandyGirl]

SPIN THE WHEEL!!! lol

 

[Sun Vaporer]

ummm, i'm very worried, i'm about to place a large order to try to become an independent reseller, but if i do place this order and they are seized by customs i'm gonna be out 10k for nothing. i really dont know what to do now. suggestions anyone?

TSB--nothing you can do about it now--business is risk, and you decided to take the risk in face of the climate that has been brewing for some time now--so just relax--I think you will make it under the wire this time around--but keep yourself apprised if you plan to stay in the game and order again---Sun

 

[TropicalBob]

If a government agency says it is illegal to sell or market a specific product -- that's a pretty good reason not to start a business selling that product. The FDA said that about e-cigs.

Now, no one will go house to house to confiscate e-cigs, so we can all keep vaping away, but selling and marketing might see greatly stepped up enforcement soon. More confiscations. More targeted companies. Short supply.

I'll depend on Lacey to keep me posted about this as she continues ordering ...

 

[Obi Wan]

If a government agency says it is illegal to sell or market a specific product -- that's a pretty good reason not to start a business selling that product. The FDA said that about e-cigs.

Now, no one will go house to house to confiscate e-cigs, so we can all keep vaping away, but selling and marketing might see greatly stepped up enforcement soon. More confiscations. More targeted companies. Short supply.

I'll depend on Lacey to keep me posted about this as she continues ordering ...

i agree its a risky time for anyone to invest or get involved in sales.
could be a great idea in the future if its done with fda approval.
hopefully the 10k order will get thru but i wouldnt risk to much in one order.
cant help wonder how bans and customs stopping deliveries will effect Steve at puresmoker..
there moving right now and i think we are all having fun following his adventure and hopeing they do good with there business..

and Candy Girl there isnt much i can do anymore because the dark side is strong right now and my force powers are weak from the evil power of budweiser,

 

[Obi Wan]

I think theres a limit to how many star wars references i can make before it goes from somewhat funny to not so funny,,but my wife is asleep now so im bored and addicted to reading and commenting on these pages.
but to many jedi comments is just to much, so ill try to control myself and just read,, lol

 

[Mohave]

Well thank God there are still some of those evil profit seeking risk taking businesses around, including pharmaceutical enterprises, since if there weren't then most of us over age 40 would be quite dead of prosaic and formerly commonplace nasty things such as tuberculosis and diphtheria, as the medical treatments which permit us to exist so much longer than our ancestors would not have been created without those enterprising profit seekers. Nobody can possibly take the enormous risk of research and development of new drugs, medical devices, and therapies, and undertake the multi-stage many years long approval process for such things without the possibility of patenting and exclusively marketing it in those rare cases in which they are successful bringing it to market. Under current circumstances, one should earnestly hope for a profit driven and very well financed e-cig enterprise.

Am I missing something here? I'd really like to be wrong, but is there really any evidence at all, or even a remotely realistic theoretical possibility, that anyone in this infant industry will be both able and willing to take this on before this potential new business is strangled in its crib by a regulatory umbilical cord? If someone does that (seeks to begin the process for FDA approval as a new drug) their business model will need to estimate that they will eventually have an exclusive right to sell a lot of the product at a very hefty price. Over the counter aspirin could not possibly be brought to market today under the suffocating umbrella of our ever helpful and protective non-profit altruistic government.

“Studies published in 2003 by Joseph DiMasi and colleagues estimated an average cost of approximately $800 million to bring a new drug to market,”[1][2] “while a 2006 study estimated the cost to be anywhere from $500 million to $2 billion.”[3]

“By 1998, it took an average of 7.3 years from the date of filing to approval.”[4]

Is there some reason to think there will be some alternate process used for this “new drug” which dramatically differs from that which others must overcome? I'd like to think so, but I'll be reluctant to become too wedded to e-cigs without some good reason to think so.

[1]DiMasi J. Pharmacoeconomics 20 Suppl 3: 1–10.
[2]DiMasi J, Hansen R, Grabowski H J Health Econ 22 (2): 151–85.
[3]Adams C, Brantner V. Health Aff (Millwood) 25 (2): 420–8.
[4]Regulation and Firm Size: FDA Impacts on Innovation. Rand Journal of Economics 21, no. 4: 497–517

Oh by the way, regarding the foaming at the mouth ideological ranting and raving, tobacco smoking has been around a hell of a lot longer (since before any modern written language existed) than any government or business, and neither had anything to do with creating that practice.

I think theres a limit to how many star wars references i can make before it goes from somewhat funny...

Nope, no Sir; there's no limit to that at all.

 

[booboo]

"Oh by the way, regarding the foaming at the mouth ideological ranting and raving, tobacco smoking has been around a hell of a lot longer (since before any modern written language existed) than any government or business, and neither had anything to do with creating that practice."


The point was not that the government had/has a right to intervene in smoking or whether smoking came before government or anything else. The point is, it's more than hypocritical and contradicts common sense for them to try and regulate this drug, when it is known, proven and factual the harm tobacco and cigarettes can do, study after study and millions of deaths prove it in black and white (they write it on the damn box for God's sake); and they are worried about this?????????? For them to have stood back and done nothing to protect us from that (besides the warning on the label), means they have no right to "protect" us from anything. Everything should then be legal and allowed at our own risk......

 

[Mohave]

Those "studies in black and white" which "prove" this and that are much more ambiguous than is popularly believed (e.g. Japan has both the greatest life expectancy and the highest rate of cigarette smoking, the small difference in life expectancy between lifelong heavy smokers and never-smokers in the US is almost entirely accounted for by demographic differences between the samples, etc.) and escalating levels of benevolent "protection" for our own good began in earnest as the "studies" were ginned up to justify same. One could hardly expect to suddenly be forcibly "protected" from a longstanding and very widespread cultural practice involving an indigenous natural product. But nevermind, we are probably on the same page in the end:

[therefore]...they have no right to "protect" us from anything. Everything should then be legal and allowed at our own risk......

That is a proposition I could enthusiasticly agree with, individual choice accompanied by a free flow of widely disseminated information, as would our national government for the first 100 years of it's existence, but today much of the public as a whole unfortunately does not. And this is the inevitable logical endpoint once one grants state authority over such matters, to be coercively helped and protected from onself according to criteria determined by others. And that horse left the barn when the limitation of enumerated powers circumscribing the scope and purpose of legitimate government authority gave way to a simple minded majoritarian version of resentment driven trailer-park populist democracy.

So here we are, right where we brought ourselves.

 

[Grody]

I just can't see e-cigs not being banned. Maybe they will come back, and with a prescription you can get a 10 ml bottle of 4mg juice for $50, but I think that it's more likely that the juice will be banned alogether, and we'll eventually just be able to buy weak, heavily taxed cartridges.

I'm in Canada, and if there's a ban here, I can't see it taking very long for them to shut down the small amount of suppliers here. If they ban it in the States, I can see all the western supplies online being sold out before most people even hear the news.

I hope I'm wrong, but I don't trust the government at all, and I don't trust the media to give smokers a fair shake. I'm paying almost $10/pack here, the places I can't smoke is constantly increasing, and as a smoker I'm depicted as a smelly, ugly, ignorant, walking plague, who's spreading death and disease to all I come in contact with.

Once my current orders are delivered, I'll have 900+ mls of liquid. About 600 mls are 36mg, but I'm not sure how long that will last me. I'm a 2 pack/day smoker and my smokes say they contain 1.1-2.4 mg of nicotine, (whatever that means.)

I'd like to have a years supply, which will give me time to wean off, find the black market, or learn how to make it myself. I'll keep a good supply of atomizers and batteries on hand as well, but it's the juice that I'm most concerned about. I just can't see them ever approving it to be sold in it's current form.

 

[Nuck]

Grody, assuming you smoke 2ml a day of 18mg (a decent hit) which seems to be average, your supplies should last well over 2 years which is apparently the shelf life of the nic juice. You should be fine.

The nic juice as it is currently sold will have to be controlled a bit better in terms of QC and packaging. I really don't expect a permanent ban in Canada for many, many reasons but all bets are off in the US.

 

[Grody]

I hope you're right Nuck, but I'm not going to take any chances.

As far as my juice supply goes;

Is 2ml of 18mg juice per day, based on the average e-smoker? But since the average smoker, I'm assuming, smokes a pack a day, and I smoke double that, wouldn't I need 4mls of 18mg?

I've gone through about 20mls of 18mg, and 10ml of 36mg juice since monday while still smoking a little under a pack a day. But a lot of that's been wasted because the Smoke51 cartridges stop working, and they're still full of juice. I end up washing out Pilot cartridges that are 3/4 full when I get a burnt taste in my mouth, etc.

I have a Screwdriver, and a few other e-cigs coming in the mail, along with a bunch of atomizers and batteries. I also ordered some empty 3, 6, and 10ml bottles. So hopefully once everything gets here, I can learn what works best, and then measure my liquid intake a lot better. I'm thinking that it might be good to have one e-cig going with 36mg, one with 18mg, and one with 8-10mg. Then I can alternate between them, using the low nic one when I just want to puff away but don't really need the nicotine, use the 36mg when I need a boost, and the 18mg when I just want to have a smoke.