There may be an easy answer to the FDA ban

[Sun Vaporer]

Originally Posted by rlorange

Well Sun sounds like you have done a lot more research about the FDA than me. I guess the FDA is different to our TGA. In spite of what they can or can't do versus our TGA I still feel that they might no go that far... even if they can..

Rlorange--One thing I can tell you without a doubt about the FDA--when they make a statment about a product or drug and confirm, as they did yesterday, that the item in question is illegal to sell and market, and they have an ongoing investigation----that means that they are about to act. They have given up their ability to deny they knew of the product and any inherent risk that they precive is now in their lap because they have spoke. Their mission is a charge of saftey. Just think about the ramifcations if they do not act now after the statements they have advanced. For whatever reason, they have decided to comment on the record. Being on the record means action is close at hand. The only questions now are what will be the scope of their action and how quick is "quick" ---Sun

[TropicalBob]

Here's the part that is beginning to trouble me: The HUGE tobacco tax increases go into effect April 1 (April Fool on us!). We are two weeks away from that date and the FDA is issuing statements about e-smoking's illegalities.

What would a ban now or in the next month imply about tobacco, alternatives to tobacco and taxes?

I am NOT one of those who thinks the FDA decision on e-smoking will be predicated on retaining present tobacco taxes. That really is not their concern. Their concern is public safety of food and drug supplies. That's a big job, without side concerns thrown in.

But ... if they ban e-smoking now, the U.S. will appear to have followed Hong Kong's initiative: Pass a tobacco tax, then ban a product that evades those taxes.

Frankly, I think the FDA is caught by the timing of the SCHIF implementation. And I'm not at all sure what they'll do. Maybe, just maybe, they don't give a damn about how their action appears to the public. Still, a ban now would be terrible timing.

[Programmer]

Originally Posted by TropicalBob

Pass a tobacco tax, then ban a product that evades those taxes.

Perhaps 'avoids' would have been a slightly better term.

I'm quite sure you didn't mean that eventually I should be taxed just because I _used_ to be a smoker. When they catch up with the unintended consequences, I mean.

[StratOvation]

I have to disagree with ya Leaford....In my opinon, It is the similarity to cessation devices paired with the foolish marketing stratagies of a few e-cig manufaturers that has invited FDA involvement in the first place.
The similarities and claims imply that e-cigs will be held to the same R&D, Manufacturing, Labeling, Packaging and distribution standards that all currently available/approved cessation devices are held to.

Any e-cig manufacturer that anticipated marketing their product as a cessation device in the US, and failed to follow existing developmental protocols accepted by the FDA, simply got their horse ahead of their cart and unfortunately, It is nearly impossible to recover from such a blatant oversight.

[bri1270]

I am NOT one of those who thinks the FDA decision on e-smoking will be predicated on retaining present tobacco taxes. That really is not their concern. Their concern is public safety of food and drug supplies. That's a big job, without side concerns thrown in.

Bob, I have to disagree. First of all, if public safety was in fact the FDA's primary concern, wouldn't tobacco products have been regulated for a long time now? And why are they not regulated? Why has big tobacco been able to avoid regulation, and not had to divulge exactly what's in their products? It's only since Philip Morris hopped on the band wagon with the government that they even have a fighting chance of regulation. I can't get past the fact that the FDA is a government organization/bureaucracy ultimately run by politicians. Politicians pander to lobbies, and tobacco is an enormous lobby. Follow the money - Always follow the money.

I don't find the timing coincidental at all.

[TropicalBob]

Bri, the FDA has nothing to do with tobacco or its regulation. A bill in Congress would give it that authority, but that bill is not law -- and the FDA cannot regulate tobacco or tobacco products. So start there. What it CAN do is regulate drugs. And e-liquid is a drug.

The Philip Morris endorsement of the bill to give FDA authority over tobacco is a blatant power play to "freeze" present sales proportions, where PM is the leader. That bill will also make it extremely difficult to introduce new products -- think, e-cig. No other Big Tobacco company supports that bill, and PM is laughing all the way to the bill bank.

E-cigs are not tobacco products. Those are carefully defined in law. If e-cigs were, they would not be attracting FDA attention. As much as some might wish otherwise, e-cigs do not fit the legal definition of a tobacco product. Using an extracted nicotine in a chemical concoction for inhalation does not make these tobacco products. They are drug delivery products for nicotine addicts.

Do not prescribe too many ulterior motives to the FDA's involvement. It has a job to do: protect American consumers from hazardous/dangerous food and drug products. It sometimes fails. Those are big categories of responsibility and there aren't people to police every food or drug.

This much is almost a given: If ONE company had registered and properly presented evidence that e-smoking is safe and efficient when used as intended, backed by required scientific proof, then approval would be likely. If these had been invented by Big Pharma, the tests would have been done, approval would have been granted .. and, yes, we'd be paying more for a regulated product.

BUT AT LEAST IT WOULD BE LEGAL. That is not the case now because of the way these were marketed to American consumers.

[StratOvation]

I think a realistic, short-term, best case scenario to hope for is... The FDA will take into account the mutitude of potential health benefits that e-cigs/liqiuds provide as an alternative to tobacco cigs and allow the continued US distribution of e-cigs while they complete their investigation.
Possibly with some interim restrictions/regulations. ie. Warning labels, child proof containers or nicotine concentration limits.

They have used this approach in the past. Remeber the NSAID controversy back in 2005 with Vioxx and Bextra being recalled? The FDA determined that all NSAIDs possesed an inherent danger of increasing the chance of heart/pulmanary complications, But the list of Health benefits were so extensive they did not want to see patients suffering from chronic pain be deprived of them. So a compromise was made to change the labeling, ensuring anyone taking an NSAID was well aware of the potential risks involved.
Currently there are multiple NSAIDs available over the counter and via Rx,
Not because they are Deemed "Safe" by the FDA, but because the FDA deemed the benefits to outweigh the inherent risks.

Personaly, I am not aware of any reported cases of an acute exspoure attributable to responsible use of e-cigs or e-liquid that have resulted in a serious illness , injury or death. Is anyone else?
I could imagine a much quicker, more restrictive FDA response if there were such cases reported.

Mike

[leaford]

Originally Posted by StratOvation

I have to disagree with ya Leaford....In my opinon, It is the similarity to cessation devices paired with the foolish marketing stratagies of a few e-cig manufaturers that has invited FDA involvement in the first place.

Maybe, maybe not, but I was refering to the approval process. There's a rule that allows a new device to skip one of the steps in the approval process, pre-market notification, if it is "substantially similar" to an already approved device. So, in that regard, being similar to existing devices does make approval easier. But it only skips over one step, that's all.

Originally Posted by TropicalBob

Do not prescribe too many ulterior motives to the FDA's involvement. It has a job to do: protect American consumers from hazardous/dangerous food and drug products. It sometimes fails. Those are big categories of responsibility and there aren't people to police every food or drug.

This much is almost a given: If ONE company had registered and properly presented evidence that e-smoking is safe and efficient when used as intended, backed by required scientific proof, then approval would be likely. If these had been invented by Big Pharma, the tests would have been done, approval would have been granted .. and, yes, we'd be paying more for a regulated product.

BUT AT LEAST IT WOULD BE LEGAL. That is not the case now because of the way these were marketed to American consumers.

I agree. And our best hope is that Ruyan, or maybe Njoy, or even (yeah, right) Smoking Everywhere, SOMEBODY with deep pockets and a lot at stake, steps up and does the proper studies here in the US.

Originally Posted by StratOvation

I think a realistic, short-term, best case scenario to hope for is... The FDA will take into account the mutitude of potential health benefits that e-cigs/liqiuds provide as an alternative to tobacco cigs and allow the continued US distribution of e-cigs while they complete their investigation.
Possibly with some interim restrictions/regulations. ie. Warning labels, child proof containers or nicotine concentration limits.

I think that's a much more realistic scenario than most of the things being floated here. Not likely, but at least possible, and something we can try to influence through public awareness of our hobby and its benefits.

[snap6cat]

Please no more patches. Personally I find them very EXPENSIVE. If it comes to that I may have to get cigs. at least I can buy them, I just don't want to. I want the juice! Vapor is sweet and kinder to me.

David

[Madmax]

What happened to the New Zealand study done. Does it not count for anything. I realize that was specific to Ruyan. Maybe i missed something but did this get discredited?