Israeli Bans E-cigs------Health Ministry institutes complete ban on e-cigarettes following recent FDA press conference

[Vapinginmyboots]

No arguement from me there,,, but I'm kind of a dreamer, too. lol

Sigh,,, I'm too wrapped up in all this. I'm trying my best to be one of the voices, and extend my hand to everyone who's doing the same. We don't always agree on everything, but it's good to hang out with fellow travelers.

I too am wrapped up in this. We are the voices, and they are growing louder at least in the US and people are getting ...... at things. They are not getting ...... off about an e-cig ban, but about everything that is going on lately. We as individuals just want to be left alone! I dream of a day that our voices will be not only heard, but understood and acted upon, and I also dream of a day that the problem of "bans" on anything considered taboo will be unheard of and acted upon by our own personal responsibility and consequences of doing said "taboo" activity. A wish and a dream.

 

[Minimike]

The new law forbids the FDA to ban cigarettes.

I believe Israel, FDA, et al would have a different mindset if the manufacturers simply had their nicjuice analyzed independently and give the reports to the governments.

 

[kinabaloo]

There are probably more toxins inbibed by washing your hair or eating a packet of crisps.

Unless the initial testing showed a significant danger (it didnt), the FDA should be the one proving there is potential harm, as measured against common everyday activities.

They should only have the power to place a leaflet with their view inside the box.

The report showed that e-juice is safe by any reasonable measure. The announcements were very much at odds with the findings. And that's why their is so much distrust of the present regulatory system.

I would add though, on the report itself, that there was not a proper 'control' (the inhaler) that was fully disclosed.

Nothing is totally safe. That is a ridiculous measure, selectively applied for ulterior ends.

 

[TropicalBob]

BECAUSE THEY DID NOT HAVE ANY JURISDICTION OVER tobacco CIGARETTES UNTIL CONGRESS GAVE IT TO THEM RECENTLY.

Our e-cigs are not tobacco products. The FDA would not have considered them for regulation had they been a new cigarette. But they're a "drug delivery device" to the FDA. A new one. And that's where the FDA comes in.

Don't waste time and energy arguing common sense that these are healthier than cigarettes. We know that, intuitively and with all the intelligence we can apply to this. It doesn't matter. Repeat: It doesn't matter. This is not about health. It's about regulations -- ones there were not followed. It's futile to demand these be compared to tobacco cigarettes. E-cigs must stand alone before the regulatory judge.

Robbie: You do not want to know what the FDA will do to cigarettes and other tobacco products in the next two years. It's all spelled out. Costs to smokers will skyrocket far above today's levels. Purchases will be exclusively from local stores. The products you will be able to buy will suck. That is tobacco's future. And those who threw smokers out of all public places will turn increasingly to opposing smokeless products -- and electronic ones, too.

 

[jiuyueguizi]

Brazilian health authorities did the same.

Any link for the news that Brazil banned this product? thanks.

 

[Sun Vaporer]

Okay, but don't forget Bob that the FDA is doing nothing to ban the sale of cigarettes and these are known killers. They've also not done a 1 to 1 test of a regular cigarette against an ecig either. Why do you suppose that is?

Robbie

Robbie--you are looking at it upside down. The standard of review is not a comparison to known dangerous product like cigarettes, rather a new product that has to prove it is "reasonably safe" within the guidlines of FDA regulation. Trobcal Bob is correct in stating that the e-cig is not a tobbaco product!!! It does not fall within the santity of the Brown case or the 1930's legislation that was recently abolised by Congress.

Sun

 

[harmony gardens]

Don't waste time and energy arguing common sense that these are healthier than cigarettes. We know that, intuitively and with all the intelligence we can apply to this. It doesn't matter. Repeat: It doesn't matter. This is not about health. It's about regulations -- ones there were not followed. It's futile to demand these be compared to tobacco cigarettes. E-cigs must stand alone before the regulatory judge.

Ok Bob, You are right on again,,, so I'm wasting my breath, but the FDA scares me when they say that people are better off smoking than using an ecig. Regulation??? Bring it on!! I'm fighting an outright ban. If the industry could work with the FDA to deliver a "safer" product, that's still a worthy outcome.

I want to know this,,, is the FDA going to nix every vaping product it's asked to regulate???

If other NRT's can pass FDA standards, then they have the power to bless the ecig, too, provided the industry can find some standard to comply with. I guess it amounts to a bribery system, in a way. You get the ok by the FDA approved testers, and you get approval. That's the ball that's in the manufacturers court.

At the end of the day,,, as users,,, all we can say is that if they build it, we will come.

That's too sheepy for the people in this forum.

 

[trog100]

nothing in this world is %100 safe or can be proven to be... and above all why the f-ck should we have to prove it to be to some official bunch of w-nkers who dont know their .... from their elbow and who all have hidden agendas..

they will also keep moving the goal post to suit their agendas as and when required..

hypocritical self seeking w-nkers pandering to majority opinion..

rant over... he he he

trog

 

[Porphy]

The future of tobacco cigarette distribution.

Future of e-cigarette distribution.

 

[ubiratamuniz]

I do not see it that way at all, Jim. Not at all. All of the prior bans came well before the U.S. made any statement or took any action. You've just insulted Australia, Canada, Mexico, Brazil, Hong Kong...

Look, in your terms, this is like being pulled over in your car. The enforcement officer says "driver's license and proof of insurance." You say "I paid for this stinking car and my taxes pay your salary and paid for this highway. Hey, I'm so rich I'm self-insured. I don't need your stinkin' rules. I do as I damn well please."

Guess what will happen next?

There are regulations we all must follow. Failure to do so results in legal troubles. E-Cig makers had no license, no proof of insurance against product liability, and ignored calls to submit the products for approval after testing. They will pay for that arrogance.

Listen, free speech: You can down beat the U.S. all you want. But I won't join you in that chant.

no no no... his statement is correct about Brazil. Brazilian ban came after the FDA ban, and was openly advertised that the FDA ban was the inspiration...

Yeah, Brazilian authorities love to think stupidities like "if it is good for the US, it is good for us". They can't even think by themselves.

however I cannot state anything about the other countries...

Any link for the news that Brazil banned this product? thanks.

I have those only in Portuguese. Will they do?

Cigarro eletrônico será proibido no Brasil - INFO Online - (23/07/2009)

I must point in that particular news report the following information:

Um estudo feito pela FDA, agência americana equivalente à Anvisa, apontou que estes dispositivos são tão cancerígenos quanto um cigarro comum e recomendou que sua comercialização seja suspensa nos Estados Unidos, onde não há nenhuma regra que o proíba.

Translating to English:

"A study sponsored by FDA, the US health agency that is similar to our Anvisa, pointed out that these devices are as carcinogenous as an ordinary cigarette and recommended that its distribution be suspended in the United States, where there is no law to forbid it [explicitly]."

Another news story:
[FONT=Verdana, Arial, Helvetica, sans-serif]Artigos sobre Drogas - Site Antidrogas - Não jogue com a vida... - Cigarros eletrônicos contêm agente cancerígeno, diz FDA[/FONT]

Here's the link to the public inquiry text, as it came from ANVISA. BUT, it was poorly advertised, in fact it only came to press on the last day of the deadline, and the users from the Brazilian e-cig forum only knew about it AFTER the deadline...

Anvisa

Here's the link to discussion (in Portuguese) in our Brazilian forum.

Estão querendo barrar no Brasil.

All the articles above are in Portuguese. Put your translators to work...

 

[TropicalBob]

Stand corrected on Brazil. The other bans and/or regulations were prior to the FDA statements.

Porphy: Hilarious pix with a sad ring of truth about them.

 

[robbiehatfield]

Robbie--you are looking at it upside down. The standard of review is not a comparison to known dangerous product like cigarettes, rather a new product that has to prove it is "reasonably safe" within the guidlines of FDA regulation. Trobcal Bob is correct in stating that the e-cig is not a tobbaco product!!! It does not fall within the santity of the Brown case or the 1930's legislation that was recently abolised by Congress.

Sun

I'm not saying that you're technically wrong, but when the day is done, the ecig was designed to mimic smoking as close as is possible because the idea was to come up with a more healthy, viable way to enjoy smoking. In this context, it makes perfect sense to compare the two side by side as one approach is being touted as being a much safer way than the other to get a nicotine *fix*. Is it safer or isn't it?

It would also seem unfair to compare the horse and carriage to the car because of the vastly different way that both get the same job done, but this is ultimately what was done and the horse and buggy lost.

Robbie

 

[Sar]

... Our e-cigs are not tobacco products. The FDA would not have considered them for regulation had they been a new cigarette. But they're a "drug delivery device" to the FDA. A new one. And that's where the FDA comes in. ...

TBob, does FDA also consider nicotrol and nicotine patches to be drug delivery devices? If yes, e-cigs do not need to be any safer or "healthier" than those. As far as I know, that is the case already. If e-cigs can't be compared to nicotrol, what is the standard that e-cigs must meet?

We also know that FDA skewed the results of the study (summarized by Kinabaloo in his post, copy below). That can't be legal. Who polices FDA? They can't just fabricate conclusions to suit some agenda. What is the process to correct this? Is there some type of "internal affairs" process for FDA abuses? To whom does FDA answer to? We need to start contacting those people.

There are probably more toxins inbibed by washing your hair or eating a packet of crisps.

Unless the initial testing showed a significant danger (it didnt), the FDA should be the one proving there is potential harm, as measured against common everyday activities.

They should only have the power to place a leaflet with their view inside the box.

The report showed that e-juice is safe by any reasonable measure. The announcements were very much at odds with the findings. And that's why their is so much distrust of the present regulatory system.

I would add though, on the report itself, that there was not a proper 'control' (the inhaler) that was fully disclosed.

Nothing is totally safe. That is a ridiculous measure, selectively applied for ulterior ends.

 

[TropicalBob]

TBob, does FDA also consider nicotrol and nicotine patches to be drug delivery devices? If yes, e-cigs do not need to be any safer or "healthier" than those.

Yes, and that is true. Now, just show the FDA the clinical trials, as were done for Nicotrol and the patch, and prove e-cigs are as safe as those.

The whole problem with e-cigs at this time stems from the lack of testing and approvals needed to market a new drug in America. Big Pharma knows what is needed -- and complies. Our Chinese friends apparently were clueless (and they certainly should not have been!).

In no way would I defend FDA misinformation. It's shameful, but we have little recourse to answer it. This is not the first time the FDA has twisted facts and outright lied about tobacco products. Just research the history of warning labels for smokeless tobacco and nasal snuff. The distortions and lies will curl your hair.

I see no turnaround ahead, however. We're on a one-way street.

 

[Sar]

... The whole problem with e-cigs at this time stems from the lack of testing and approvals needed to market a new drug in America. Big Pharma knows what is needed -- and complies. Our Chinese friends apparently were clueless (and they certainly should not have been!). ...

Okay, so it was the responsibility of the Chinese to follow some type of process. But how would they even know what process to follow? I mean until now we didn't even know how would FDA classify the PV.

Also, if the rule is for the manufacturer to do testing and supply FDA with results, FDA is not following their own protocol on drug delivery devices either because they themselves did the testing. Why would they do that? And since they did do the test, can't we use the data to show that the devices are safe? There may be a way for scientists to force them to share the raw data that was used for analysis. We know it exists.

Lastly, if there is no way to move with the above, is there an option to remove PVs from the drug delivery device classification? Lets say the only thing that will be sold is the PV unit and no-nicotine flavored liquid. Call it mouth mister or tongue humidifier or such. Since the liquid would be composed of parts that are not considered unsafe or harmful or adictive, the PV can't be classified as drug delivery device becuase there is no drug delivered. If this could work, at least we would be able to save the hardware and no-nicotine liquid marketplace. (Nicotine would have to be do-your-own type of thing.)

 

[Our House]

Yes, and that is true. Now, just show the FDA the clinical trials, as were done for Nicotrol and the patch, and prove e-cigs are as safe as those.

TB,

What do you make of Spikey's recent finding that the Nicotrol inhaler had no nitrosamine stats because it was never even tested for them prior to FDA approval?

...Yet it was used as the control in an analysis looking to detect nitrosamines contained within ecigs?

...And that the nitrosamine information (which was never tested for in the first place; prior to FDA approval) for Nicotrol (the control) just happened to be OMITTED from the study?

I'm thinking that this fact alone renders the FDA's report findings invalid/deceitful/inadmissible/etc. and their press conference flat out defamatory. Do you agree?

 

[Vapinginmyboots]

Yes, and that is true. Now, just show the FDA the clinical trials, as were done for Nicotrol and the patch, and prove e-cigs are as safe as those.

The whole problem with e-cigs at this time stems from the lack of testing and approvals needed to market a new drug in America. Big Pharma knows what is needed -- and complies. Our Chinese friends apparently were clueless (and they certainly should not have been!).

In no way would I defend FDA misinformation. It's shameful, but we have little recourse to answer it. This is not the first time the FDA has twisted facts and outright lied about tobacco products. Just research the history of warning labels for smokeless tobacco and nasal snuff. The distortions and lies will curl your hair.

I see no turnaround ahead, however. We're on a one-way street.

I do tend to agree with your stance on the what the FDA is doing of late, TB. I have said before it is going to get ugly for vapers and have lost much hope for our beloved PVs. Isnt there some way to affect the FDA view of these, as in, get a large group of doctors on board or something and maybe have them mail them after seeing them get their hopelessly cig-addicted patients off cigs? Or are they only going to follow their own focus on banning these outright w/out input from us based on their own studies? I wonder if they will change course or not even listen.

 

[TropicalBob]

Also, if the rule is for the manufacturer to do testing and supply FDA with results, FDA is not following their own protocol on drug delivery devices either because they themselves did the testing. Why would they do that?

Again, it's the difference between tests and trials. The FDA can order independent lab testing of any product under its food and drug jurisdiction to determine its safety. It confiscated stuff from Njoy and SmokingEverywhere and then ordered the limited lab tests. Not unusual. A trial takes a long time and must prove safety and efficacy of the product in humans. Trials have been done on NRT products. Not on e-cigs (with the single outstanding exception of Ruyan's Health New Zealand trial, still pending peer review).

Many, many have suggested end runs around "drug delivery device" and "new drug". Only one voice counts. The FDA. You can label it Winky Dink if you like; it will be banned as a Winky Dink Electronic Cigarette. The time to sell these as anything other than an alternative to tobacco cigarettes is history. They might have passed legal muster if sold as a novelty. But noooooo. Claims for health were made. Claims for smoking cessation were made. And the FDA dutifully documented those claims -- which cannot be retracted, according to regulatory law, no matter how badly a manufacturer wants to say "oops, made a mistake saying that."

The archived Web pages lay out the lies.

 

[robbiehatfield]

Yes, and that is true. Now, just show the FDA the clinical trials, as were done for Nicotrol and the patch, and prove e-cigs are as safe as those.

The whole problem with e-cigs at this time stems from the lack of testing and approvals needed to market a new drug in America. Big Pharma knows what is needed -- and complies. Our Chinese friends apparently were clueless (and they certainly should not have been!).

In no way would I defend FDA misinformation. It's shameful, but we have little recourse to answer it. This is not the first time the FDA has twisted facts and outright lied about tobacco products. Just research the history of warning labels for smokeless tobacco and nasal snuff. The distortions and lies will curl your hair.

I see no turnaround ahead, however. We're on a one-way street.

I don't think ecigs need to be *as* safe as Nicotrol or the patch. On a scale of 1 to 10 with 10 being the most dangerous, if analogs are a 10, nicotrol and the patch are a 1, and ecigs are a 2, they're still a far safer and viable way to *smoke* than traditional cigarettes. This means that the bottom line is that everyone that switches from analogs to ecigs that hasn't done irreversible damage already may just save their own lives. To hell with all the BS as to what was originally claimed by the ecig manufacturers! This is about lives, not dotting i's and crossing t's! This is one of the main things wrong with this country today! We care more about semantics than the rule of logic..

Robbie

 

[sherid]

If you don't like cigarettes, don't buy them. Simple. No one is forcing you to do that, and we do not need any more BANS. God, I am so sick of that word.