There may be an easy answer to the FDA ban

[Sun Vaporer]

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]

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]

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.

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.

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?

 

[bizzyb0t]

I'm confused...

All the FDA can possibly ban is the nicotine juice... they can't ban the hardware, right? It seems that they couldn't ban personal vaporizers and non-nicotine juice.

So really all they'd have to do is have the nicojuice go through some sort of regulation but as far as the hardware and other juices, nothing would be different?

Someone correct me if I'm wrong but there's nothing stating that the e-cig has to be used for the inhalation of nicotine, right? Just like bongs don't have to be used for weed. The way I see it, the hardware is safe from any sort of ban. It could even be seen as a novelty item without nicotine.

 

[Sun Vaporer]

I'm confused...

All the FDA can possibly ban is the nicotine juice... they can't ban the hardware, right? It seems that they couldn't ban personal vaporizers and non-nicotine juice.

So really all they'd have to do is have the nicojuice go through some sort of regulation but as far as the hardware and other juices, nothing would be different?

Someone correct me if I'm wrong but there's nothing stating that the e-cig has to be used for the inhalation of nicotine, right? Just like bongs don't have to be used for weed. The way I see it, the hardware is safe from any sort of ban. It could even be seen as a novelty item without nicotine.

Bizzy--The Scope of what the FDA can mandate is broad and could be as narrow as waning lables and age restrictions like those now being advocated in the UK or as broad as banning the e-liquid for its contents as being a "new" drug and the e-cig itself as being a "drug delivery device. What they will do is open--when they will do it seems close at hand----Sun

 

[proton32060]

Being in health care I am somewhat familiar with what the FDA can and can not do. They can not declare e-cigarette nicotine a drug demanding it be under their jurisdiction easily. Doing so would open up an entire mine field since conventional cigarettes, cigars, smokeless tobacco, etc would also have to be included by necessity since they also contain the compound. This would force them to (from that point forward) regulate the sale and use of all products containing nicotine- which would include all forms of tobacco.

Their most likely path would be to stop the sale and distribution of the e-juice itself. The reasoning could be that conventional tobacco products have a low and relatively predictable dosage level in their normal use.
However, e-juice is formulated as opposed to grown in a tobacco leaf so the dosage can not be guaranteed not to exceed acceptable levels. Since the production of the e-juice sold in vials and contained in the e-cigarettes themselves has no oversight in its production they would probably ban it on that basis as potentially harmful.

However that is not the real issue here. The problem is many Left wing ideologues ( especially in California) have decided it is politically incorrect and unacceptable for people to smoke.
Even if it has no impact on anyone but the smoker himself.

This is the reason many California municipalities are trying to make it illegal to smoke outdoors or even inside the smokers own home. Oddly, these are the same people who by today’s headlines are pushing to have Marijuana legalized for sale in California. So according to the thinking of these people- it is okay to smoke marijuana where you wish but unacceptable to smoke tobacco. And they are equally opposed to a product that does not generate any smoke at all but looks vaguely similar to a cigarette in appearance. The hypocrisy of that position speaks for itself.

It may now be too late to avoid scrutiny of these products by the government. However both the manufacturers and many of the users brought this on themselves. The many flavors made for these products does allow the opposition to claim the goal is to recruit non-smokers. Also, the fact many of the units are made to look both from their appearance and their use as if the user is smoking is not helpful.
This is not an objective argument these people are using balanced with reason and facts. They don’t want you smoking in their presence or even to “look” like your smoking, even if it has no potential impact on them or their health. And that is all there is to it.

This has much more to do with their personal agenda as opposed to the product itself.

The sad part is these are infinitely safer as a delivery system for the user and his family than burning plant leaves and drawing the resulting combustion products into his lungs. The part the anti-smoking ideologues refuse to acknowledge and from my experience care very little about, is that there are some people who can not quit smoking regardless of the aids available. Many of these people have already tried every method their Doctors recommend to no avail.

Those are the people who may well be saved from the debilitating diseases tobacco inflicts on chronic users
If these products are banned these people will not quit using nicotine, they will simply go back to the far more destructive habit of smoking cigarettes or using smokeless tobacco. I have seen first hand what smokeless tobacco can do to the user. Oral cancer is probably the worst malignancy a person can experience.
If the patient survives he usually loses a large portion of his lower mandible, muscle, and lymphatic tissue in the head and neck area of the effected side. The disfigurement the surgery creates and the quality of life the user has afterwards is truly horrific.

Unfortunately, the “politically correct” agenda currently in vogue places little value on that aspect of these products and the misery they may well prevent. Granted, it is better not to use nicotine from any source, but if you have to use it these products are far more preferable and safer than tobacco.

While it may well be too late, if I were distributing these products I would institute these changes immediately.

1)Require proof of age for the sale of anything associated with these products..
2)Eliminate all the fancy flavors and only have tobacco. That would eliminate the potential criticism of making these products attractive to non-smokers.
3)Offer a progressively lower dosage of cartridges for those wanting to reduce or end their dependence on nicotine over the long term and eliminate their use of tobacco with its destructive side effects immediately..

Finally, if you use these products stay out of restaurants and other public no smoking areas with them. There are far more non-smokers than smokers in this country. And in spite of the fact these pose no threat to the people watching you use them- they don’t care.
This is not a rational argument- it is an emotional one and they will win in the end whether you are right or not.

These products only have one legitimate use. To give people who either can not or will not quit smoking an alternative to tobacco and the damage it causes. If they are used for that purpose and it is made clear by the manufacturers that is their intended purpose then maybe they will survive.

But I doubt it.

 

[Sun Vaporer]

Being in health care I am somewhat familiar with what the FDA can and can not do. They can not declare e-cigarette nicotine a drug demanding it be under their jurisdiction easily. Doing so would open up an entire mine field since conventional cigarettes, cigars, smokeless tobacco, etc would also have to be included by necessity since they also contain the compound. This would force them to (from that point forward) regulate the sale and use of all products containing nicotine- which would include all forms of tobacco.
.

Hold the phone there Proton--the FDA did it with Nicotine Water, without any attack on tobacco--and further please do not confuse the regulation of Tobaccco with the FDA--that is coming under the FDA's Control soon, but has not happened yet. You might what to take a look at the timeline plight of Nicotine Water with the FDA to get a better understanding---Sun

See Nicotine Water

 

[proton32060]

Sun Vapor,

You are entirely correct and I apologize. My post was based on classes I took 30 years ago in Dental School. At that time there were not any products like these are the one you described so there was never any discussion on that matter. Further, nicotine was treated in the same way as caffeine and alcohol. My how times have changed.

However- I still stand by the rest of my post. These products are by far the lesser of the evils regarding nicotine use.

 

[Sun Vaporer]

. My post was based on classes I took 30 years ago in Dental School. At that time there were not any products like these are the one you described so there was never any discussion on that matter. Further, nicotine was treated in the same way as caffeine and alcohol. My how times have changed.

However- I still stand by the rest of my post. These products are by far the lesser of the evils regarding nicotine use.

Proton--We are all getting an education that we really do not what with the FDA here. Seems that what works for us does not fit into their plans for a Smoke Free Generation. All they care about is Kids--not the people that got sold down the river years ago by Big Tobacco with all of their "light" cigarette claims--Sun

 

[bizzyb0t]

Bizzy--The Scope of what the FDA can mandate is broad and could be as narrow as waning lables and age restrictions like those now being advocated in the UK or as broad as banning the e-liquid for its contents as being a "new" drug and the e-cig itself as being a "drug delivery device. What they will do is open--when they will do it seems close at hand----Sun

That doesn't make any sense! They haven't banned "water tobacco pipes", other glass pipes. Those are all used for much more than tobacco. There's vaporizers (much larger than the e-cig) used to smoke weed. Those haven't been banned yet and most likely will never be banned. I don't see how the e-cig hardware could ever be deemed illegal. I can smoke weed off of an aluminum can, that doesn't make it a "drug delivery device" any more than the glass pipes can be banned because people use them mostly for smoking weed. I know this because I have two friends who own and run their own "smoke shops" and blow their own glass.

The more I read, the more I see that the FDA is targeting e-cigs in particular. Also, the more I read, the more I am beginning to see that there seems to be a motivating factor here for an outright ban as opposed to regulation for the liquid. As for the hardware, I don't see how they can justify banning it in the absence of nicotine juice.

 

[TropicalBob]

No need to speculate of the FDA's intentions. The FDA spokeswoman said a day or so ago that these are illegal to sell or market. For those wanting "chapter and verse," here's a repost of the e-mail that that the FDA repeatedly has sent suppliers of confiscated shipments. While it contains some legal phrases, it's very easy to understand the bottom line message:

Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action.

In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body.

The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained.

Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.

There is wiggle room in even that declarative FDA statement, but it's for manufacturers to find and exercise. The ball is in their court ...

 

[StratOvation]

"Please be aware that electronic cigarettes that we have reviewed are drug-device combinations"

Bizzy, The defining difference, as I see it is the FDA have reviewed
"Starter Kits" which include a known drug (Nicotine) in a new formulation
(PG solution) that is designed and marketed (as a single unit or kit) as a
means of treating nicotine addiction.
Hence, the carts and e-cig are joined at the hip and considered as a "new Drug", placing them squarely under the jurisdiction of the FDA.

 

[Oceaneco]

I believe the key term used in that statement by the FDA is "Treat". Any time something is used to "treat" a condition or symptom it is scrutinized by the FDA. Once they repackage these devices and no longer sell them with cartridges in the same box, they will then be okay to sell them. In fact, distributors must clearly stear clear of the word "smoking or tobacco" and completely stop manufacturing the ones that look like cigarettes. I also completely agree with Proton38060 on not trying to use these devices in places that smoking is prohibited. I know this is going to sound hipocritical, but I have actually used my e-cig in the ladies restroom and nobody knows any different (it's my dirty little secret). They do not smell and it does not harm anyone.