Why are PV's being regulated in the 1st place. The juice with nicotine I can understand.

[Craymar]

Actually, I don't see how they can regulate anything but juice that contains nicotine or actual tobacco since without either of those it's just a vaporizer. Same as a fog machine, only smaller since fog machine work about the same way, even using PG to produce vapor that looks like smoke.
Regulating the battery, atomizer or carts. It like regulating and taxing matches, lighters and ashtrays. Trying to say it a drug delivery device would then mean those roll your on cigarette papers and the empty cigarette filter tube are drug delivery devices. Not everyone uses juice with nicotine.

 

[Dirgon]

The only thing you have to keep in mind with it is....

Big tobacco loses money for each smoker who switches to PVs

Big pharma loses money for each smoker who doesn't use their marginally successful products five to ten times in order to quit.

Big government loses tax income for each smoker who no longer buys the above listed products.

In a nutshell, that's probably why they're so up in arms against them.

 

[sqirl1]

you know I've wondered that myself. the cartridges may be questionable but I think if it were challenged in court the batteries would be safe for sure, especially if they were being sold as generic batteries without labeling them for a specific purpose. atomizers maybe or maybe not, I can't think of a separate purpose for them but I think when it comes down to it the batteries are likely considered.... well.... batteries.

 

[ChipCurtis]

As long as these details and distinctions that you bring up are all but lost on the average citizen (which they are), the anti-smoking zealots will continue to plow forward with their agenda. "If it looks like a duck, feels like a duck and quacks like a duck, it must be a duck."

 

[ckc]

I guess unless all starter kits are sold without nic the E-Cig itself will be classed as a drug device/ tobacco delivery device....(you know what i mean.)

 

[kristin]

Whether they have nicotine or not, they are being used as a "smoking cessation device" according to the FDA and that means the FDA wants to regulate them as a treatment for nicotine addiction, which then makes them drug delivery devices.

So, you could put pure water in them and it wouldn't matter. It all comes down to "intended use." So, if the battery, atomizer or cartridge is intended to be used in an e-cig, which they categorize as a smoking cessation treatment, the devices would fall under the same category.

 

[ec!gg]

That is a good point... All we can do is continue to fight back.

 

[mwa102464]

Intended use is a pretty open statement with these VAPORIZERS, there are plenty of people who use 0mg and enjoy vaporizing the flavors more than anything. I don't ever see this being regulated either, now once you add the Nicotine in it's a whole different story. I feel if anything is going to be regulated it will be the juice and the people making it will have to be certified and be under serious scrutiny by the FDA and governing bodies who will be overseeing this juice business, and all these overnight juice businesses that have been popping up will be going bye bye and only the bigger companies will be the ones to survive because they are into the profit by now and making enough money to pay for all the certs and keep up with all the Regs that the FDA and Govt will be putting in place soon.! just my 2c

 

[kristin]

Except it doesn't matter to the FDA how consumers are using them, what matters is how they are being advertized.

Even though the companies aren't calling them smoking cessation devices, because the company web sites had consumer testimonials claiming that it helped them "quit smoking" (even though it didn't help them quit nicotine) the FDA claimed in a federal court lawsuit (Smoking Everywhere et al vs. FDA) that the testimonials constituted "advertizing intent" and claimed they are drug delivery devices intended to "treat or mitigate a disease." Luckily, Judge Leon disagreed - for those 2 companies.

Look at the fact that they went after Cheerios, yogurt and cranberry juice for making "unsubstantiated health claims" and told them to cease and desist or they had to go through drug trials to continue to make those claims.

If you are selling a stick and claim it can help people quit smoking, the FDA could and would do the same thing.

But the nicotine does add to the equation (which is probably why they didn't just get "cease and desist" letters like the food companies.)

 

[sqirl1]

then what they need to do is start selling batteries as generic batteries with no advertised connection on the box to E-cigs. they could easily get away with selling them as generic hardware. as for the E-liquid, nothing that could be regulated other than nic is in that, so once again, sell it like its a generic flavoring liquid without the nicotine, if you want nicotine all you have to do is squeeze it out of a patch and mix it with the liquid yourself. the FDA cannot regulate the batteries for sure if its just advertised as an "all purpose KR808 battery" and sold at batteries plus or somewhere similar. Attys could be say something on the box like "fog machine heating element". if the FDA finds a way to ban E-cigs, this could be a good backup plan.

 

[rolygate]

Ahh... You are unfortunately making the mistake of thinking that this has some relation to logic, doing the right thing, or public health. It doesn't.

The only important factor is that the pharma industry will lose a lot of money if electronic cigarettes become popular. They have hundreds of millions of dollars available to try and ensure that doesn't happen. Their agents are working very hard to do their bidding and try to stop e-cigs taking a proportion of the cigarette market.

Pharma wants (a) e-cigarettes banned, or (b) if that is not possible, regulations brought in to make them as unattractive as possible. Almost all the opposition you see, of any kind and in any arena, is paid for by Pharma. Once you realise this, it becomes obvious that ways of 'wriggling out from under' are not going to be successful, as their intent is to crush the industry and community, and nothing less will be satisfactory to them. They will keep attacking in every way possible until/unless they are blocked from doing so. And that option does not seem to be available to us at this time (in the US), since it requires that e-cigs be given legal status as a general consumer product, not a pharmaceutical or a tobacco product.

Judge Leon has already ruled that e-cigs are a tobacco product, and this means they will, eventually, be regulated as tobacco. Although this frees us from the threat of pharmaceutical licensing, and thus in effect a ban, it also means we are now subject to tobacco laws. Eventually, these will start to bite. And since these laws are controlled by the FDA, who appear in some respects to be sympathetic to Pharma's agenda [please note careful legal language...], you can expect that the FDA will do all in their power to make e-cigs as unattractive as possible to consumers and potential consumers.

 

[Vocalek]

I'm wondering. The FDA just informed Star Scientific that their dissolvable tobacco products are not covered by the Tobacco Act.

"Not all tobacco products are currently subject to Chapter IX of the FDCA [Federal Food Drug & Cosmetic Act]. At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject to Chapter IX FDCA Section 901(b). Based upon the information in your submission, [ARIVA-BDL(TM) and Stonewall-BDL(TM) are] not currently subject to Chapter IX requirements."

This is very confusing. A year ago, the FDA sent Star Scientific this letter, signed by Lawrence Deyton: Letter to Industry on Dissolvable Smokeless Tobacco Products (Star Scientific, Inc)

Section 907(f) of the Federal Food, Drug, and Cosmetic Act requires the Tobacco Products Scientific Advisory Committee (TPSAC) to study “the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children” and provide us with a report and recommendations. CTP is concerned that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance and easily concealable size of many of these products. We are also concerned about the extent to which the high nicotine content and rapid dissolution of dissolvable tobacco products may facilitate initiation of tobacco use, nicotine dependence and addiction in adolescents, and may serve as a mechanism for inadvertent toxicity in children. The report and recommendations developed by the TPSAC should help CTP better understand these issues.

So last year they were smokeless tobacco and now suddenly they are not. I am wondering whether this is a ploy on the part of the FDA to claim that they do not have to regulate e-cigarettes under the Tobacco Act, as suggested by the Federal Courts. If FDA insists on defining the covered tobacco products very narrowly, they leave a regulation gap. Perhaps they are hoping this will convince the Courts or someone in power to given them permission to regulate e-cigarettes as a drug.

 

[sqirl1]

what I'M saying companies should do is sell all the components of E-cigs as if they were SOMETHING ELSE. if E-cig batteries were just sold as batteries-- that could be a battery to anything--- the FDA couldn't do anything about it. same with cartomizers and atomizers, in fact there ARE other purposes to these that they could be sold under the guise of, and here's an example: a friend of mine said he was going to get an atomizer and some generic PG and use that as a costume prop to make it look like smoke is coming out of a fake gun. ALL the E-cig companies have to do to make the batteries, atomizers, and cartridges safe is sell them as "portable mini fog machines" maybe put stuff like "great for costume props, parties, and Halloween decorations!" on the box. like somebody said earlier, it's allllllllll about intended use. the FDA can't regulate things that technically aren't intended for human consumption now can they?

 

[sqirl1]

I'm wondering. The FDA just informed Star Scientific that their dissolvable tobacco products are not covered by the Tobacco Act.

"Not all tobacco products are currently subject to Chapter IX of the FDCA [Federal Food Drug & Cosmetic Act]. At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject to Chapter IX FDCA Section 901(b). Based upon the information in your submission, [ARIVA-BDL(TM) and Stonewall-BDL(TM) are] not currently subject to Chapter IX requirements."

This is very confusing. A year ago, the FDA sent Star Scientific this letter, signed by Lawrence Deyton: Letter to Industry on Dissolvable Smokeless Tobacco Products (Star Scientific, Inc)



So last year they were smokeless tobacco and now suddenly they are not. I am wondering whether this is a ploy on the part of the FDA to claim that they do not have to regulate e-cigarettes under the Tobacco Act, as suggested by the Federal Courts. If FDA insists on defining the covered tobacco products very narrowly, they leave a regulation gap. Perhaps they are hoping this will convince the Courts or someone in power to given them permission to regulate e-cigarettes as a drug.

which won't work because the tobacco control act CLEARLY says any thing that has to do with tobacco is regulated as a tobacco product. the courts will probably just tell them to get ufkced

 

[Vocalek]

which won't work because the tobacco control act CLEARLY says any thing that has to do with tobacco is regulated as a tobacco product. the courts will probably just tell them to get ufkced

The courts won't get involved unless the FDA is sued for refusing to regulate the Star Scientific products. SS certainly won't do that.

Now keep in mind that the FDA is already ignoring the Federal Court's opinion that, in the absence of health claims, electronic cigarettes cannot be regulated as a drug or drug-device combination under the Food, Drug, and Costmetics Act. So even if some organization decides to sue FDA for regusing to regulate Star Scientific products under the Tobacco Act, the FDA can feel free to act in contempt of court as it has done so many times in the past. The FDA is above the courts and above the law (in the not-so-humble opinion of FDA leadership.)

 

[rothenbj]

I'm wondering. The FDA just informed Star Scientific that their dissolvable tobacco products are not covered by the Tobacco Act.

Elaine, that is the strangest, strangest announcement I have read lately. Hopefully Bill has some idea of what's going on there. I am inclined to be as suspect of their intentions as you. Perhaps a push back at the legislature to take these non-tobacco, nicotine products and reclassify them. I can see the Pharma lobby already working our elected representative on the issue. Do you hear the political contributions entering the register?

 

[Vocalek]

Quick, Jim. Get out your checkbook.

 

[sqirl1]

The courts won't get involved unless the FDA is sued for refusing to regulate the Star Scientific products. SS certainly won't do that.

Now keep in mind that the FDA is already ignoring the Federal Court's opinion that, in the absence of health claims, electronic cigarettes cannot be regulated as a drug or drug-device combination under the Food, Drug, and Costmetics Act. So even if some organization decides to sue FDA for regusing to regulate Star Scientific products under the Tobacco Act, the FDA can feel free to act in contempt of court as it has done so many times in the past. The FDA is above the courts and above the law (in the not-so-humble opinion of FDA leadership.)

well I just meant that if they try to regulate dissolvable tobacco as some kind of drug, there's NO WAY they'll at least technically be able to do that. the tobacco control act says so clearly that anything remotely derrived from tobacco is automatically a tobacco product. I think we need to start getting in touch with this federal judge and sending him some letters to DO SOMETHING about them acting in contempt of court. I think eventually everybody will be so ...... off at the FDA on a number of things (not just nicotine related issues) that the courts will have to stop dicking around and actually enforce their rulings. I remember what big pharma did to me when I was 15 (I'm going to turn 21 soon now)...... I have autism/ADD and I was forced to take adderall pretty much, and at one point I looked like I got out of a concentration camp because of that crap and always thought of killing myself. after what all those ADD drugs did to me I'll never trust the FDA or big pharma. then I read studies that nicotine can be helpful to treat those conditions so I got a vapor king, and I gotta tell you I feel more focused with nicotine than I ever did on adderall. I can't wait to see the day those corrupt fascists finally lose. supporting the industry that hurts them the most is my personal way of getting revenge, hopefully I can save some lives by converting some analog smokers in the process.

 

[rothenbj]

sgirl1, tell us how you really feel.

On a more serious note, the nicotine is helping your condition? That's really good to hear.

Elaine, I don't think my checkbook could influence anyone in comparison to the wheelbarrows BT and BP can deliver.

 

[MoonRose]

As much as everyone hates the idea, we really should be trying to get the BT companies on our side, because without them there is no nicotine. In all truth, we actually need the BT companies as much as they are going to be needing us as more and more people start turning to the use of electronic cigarettes and other smokeless tobacco products. Let's face it folks, the BT companies have the money that we don't have and could help us with lobbying. If there is a way to form some sort of partnership with them that benefits all of us, it's worth looking into. Just my worth.