Firm wants e-cigarettes to be considered tobacco, not drug

[Satyr]

Source: Firm wants e-cigarettes to be considered tobacco, not drug | ScrippsNews

Electronic cigarettes don't contain tobacco or tar, but a Florida company is fighting for its high-tech substitutes to be identified as tobacco products, not drugs.
Why struggle to be grouped with a product vilified for killing millions of people each year? At least for Smoking Everywhere Inc., it would be a step up from having its product regulated as a drug.
Smoking Everywhere distributes e-cigarettes, which can't be lit and don't have tobacco. They are battery-operated and contain cartridges filled with nicotine, flavor and other chemicals. The steel tube that is made to look like a cigarette turns nicotine and water into a vapor that is inhaled.
Company representatives will be in Washington, D.C., on Aug. 17 for a hearing in federal district court to challenge the U.S. Food and Drug Administration, which wants e-cigarettes labeled as drug devices under its jurisdiction.
The FDA has not approved e-cigarettes as safe and has seized shipments being imported into the country.
Smoking Everywhere filed a lawsuit against the federal agency in April and sought a restraining order claiming that the FDA doesn't have the authority to control its products.
"It is an electronic cigarette, and a cigarette is not designed to stop someone from smoking ... so practically speaking, it would not fall under the definition of a drug," said Walt Linscott, a lawyer for Smoking Everywhere.
Smoking Everywhere and another e-cigarette company, njoy, which is a plaintiff in the suit, have had about 50 shipments confiscated by the FDA, Linscott said.
Smoking Everywhere imports all its cigarettes from China. With shipments not able to pass through U.S. Customs, its distributors will eventually run out, he said.
The FDA asserts it is protecting consumers. Right now, it's unclear how e-cigarettes would affect users' health, said Judy Leon, an FDA spokeswoman.
"It is important for the American people to know what is in electronic cigarettes in terms of the chemicals and the dose of nicotine," Leon said.
In a court filing, the FDA proposes that e-cigarettes fall in the category of drug devices as defined in the Federal Food, Drug and Cosmetic Act. They are designed, the FDA argues, to help in the treatment of nicotine addiction, which some medical experts have labeled a disease.
No matter how the companies market the product, e-cigarettes deliver nicotine, so the FDA has the authority to regulate them, Leon said. Smoking Everywhere claims that unlike nicotine gums and transdermal patches that the FDA regulates, its e-cigarettes are a safer alternative to smoking, not necessarily a means to quit smoking.
"A regular cigarette has no therapeutic value. ... It's not designed to provide a health benefit. It's quite the opposite," Linscott said.
David Drobes, a researcher who works in the Tobacco Research and Intervention Program at the Moffitt Cancer Center in Tampa, Fla.said that if e-cigarettes are not regulated now, the public may regret it later.
"If history proves anything, it is that companies that say they offer safer cigarettes really don't have the data to support that," he said, referring to light cigarettes advertised to have less tar and nicotine, claims that health advocates say are misleading.
The FDA announced July 22 that a laboratory analysis of e-cigarettes found that they contain carcinogens and toxic chemicals such as diethylene glycol, used in antifreeze.
Matt Salmon, president of the Electronic Cigarette Association, criticized the report as too narrow in scope and for not including a peer review.
"My personal feeling is that it was a lot more about public relations than public health," Salmon said.
(Distributed by Scripps Howard News Service ScrippsNews | current events, culture, commentary, community)
Must credit St. Petersburg Times

Am I the only person who sees a problem with this logic? First of all, E-cigarettes are not cigarettes. They don't contain tobacco! The FDA now has control over anything tobacco related. So, whether it's considered a drug delivery device or a tobacco product, the FDA is still going to be up our asses about e-cigs. My other problem here is if e-cigs are considered as tobacco products, they will be viewed no different by the non-smoking public than a regular analog cigarette. Inevitable "e-smoking" bans will ensue. SE is going to ruin it for everyone.

The FDA must be loving this!

 

[BOREMAN]

Source: Firm wants e-cigarettes to be considered tobacco, not drug | ScrippsNews





Am I the only person who sees a problem with this logic? First of all, E-cigarettes are not cigarettes. They don't contain tobacco! The FDA now has control over anything tobacco related. So, whether it's considered a drug delivery device or a tobacco product, the FDA is still going to be up our asses about e-cigs. My other problem here is if e-cigs are considered as tobacco products, they will be viewed no different by the non-smoking public than a regular analog cigarette. Inevitable "e-smoking" bans will ensue. SE is going to ruin it for everyone.

The FDA must be loving this!

And SE almost ruined my first e-smoking experience, as their product(s), IMO, SUCK ! ! ! ! Their idiots. Same with NJOY. Didnt liketheir product (NPRO) either ! ! ! !

 

[Hangtime]

They better consider jaggermiester ......, considering it is filtered through a derivative of the poppy plant. Almost forgot about hotdog buns. WTF!!

 

[kardjunkie]

The nicotine is extracted from tobacco, from my understanding, thus it is a tobacco product. The FDA will be up everyone's .... till some pays them large chunks of cash to approve them. Till then, we just order from the internet, US or China. SE and NJoy did both claim their products contained NO CARCINOGENS but they did. Its like the food labeling if less than .5 grams of trans fat the manufacture can claim 0 on their label but i dont think that applies here. Don't get me wrong, i think i should be able to run down to the gas station and pick 30ml of my favorite liquid. My health has gotten a lot better since I've cut analogs out but it comes down to this...Manufactures need to up front and honest what is in the liquid before and after its been vaporized and not have a bunch of people going around reselling them saying this and that, when actually there is no proof of it, yes i know the ruyan study but are we all just using it since its in our favor and throwing out the FDA's because it wasn't. We need third party, not affiliated with the manufacture or the FDA, ex. universities, non profit organizations, etc. And what we really need is someone pay the FDA, that is what they really want not being pulled into court. THEY WANT PAID

 

[opuscroakus]

Is it just me or is it some coincidence that the FDA spokeswomen named in the story, Judy Leon, has a remarkably similar name to the judges ruling on the case, Judge Richard Leon.

If I were a conspiracy theorist I would be all over this.

 

[Satyr]

The nicotine is extracted from tobacco, from my understanding, thus it is a tobacco product. The FDA will be up everyone's .... till some pays them large chunks of cash to approve them. Till then, we just order from the internet, US or China. SE and NJoy did both claim their products contained NO CARCINOGENS but they did. Its like the food labeling if less than .5 grams of trans fat the manufacture can claim 0 on their label but i dont think that applies here. Don't get me wrong, i think i should be able to run down to the gas station and pick 30ml of my favorite liquid. My health has gotten a lot better since I've cut analogs out but it comes down to this...Manufactures need to up front and honest what is in the liquid before and after its been vaporized and not have a bunch of people going around reselling them saying this and that, when actually there is no proof of it, yes i know the ruyan study but are we all just using it since its in our favor and throwing out the FDA's because it wasn't. We need third party, not affiliated with the manufacture or the FDA, ex. universities, non profit organizations, etc. And what we really need is someone pay the FDA, that is what they really want not being pulled into court. THEY WANT PAID

You are sort of contradicting yourself here. First you say that it should be studied and regulated by the FDA to make sure that these products are indeed safe for us or at least to prevent false claims. On some level, I tend to agree. However, you then state (and quite boldly at that) that someone needs to simply pay the FDA and skip this court stuff? Do you mean pay them to turn a blind eye? If so, that is the contradicting part. If that's not what you meant, perhaps you should clarify. Though, I'm sure the FDA is more than willing to play the game. It's not like they haven't before.

 

[kardjunkie]

You are sort of contradicting yourself here. First you say that it should be studied and regulated by the FDA to make sure that these products are indeed safe for us or at least to prevent false claims. On some level, I tend to agree.

The whole debate about FDA/e-cigs is kind of contradicting isn't it? The FDA regulating and controlling the tobacco industry when if a cigarette was put up to the FDA for approval it would never pass, right? but yet they get to regulate a product they would never approve. E-cigs as i am to believe, might be wrong, have about the same things as FDA aprroved devices, ex. gum, patch, etc., but the FDA says ecigs might be a health risk to us using it.

I never said i wanted the FDA to regulate, I just said it is a tobacco product. The nicotine is extracted from tobacco and thus a tobacco product or at least a by product of tobacco. My opinion, SE and NJoy are trying to get to be considered a tobacco product to stay alive. If they go the other rout a drug delivery system they are screwed.

I also said we need third party studies not FDA or manufacture paid studies. Universities are great for this. I said this for our use, the e-cig community, since the FDA has taken a stance they are a condemned products till they have been approved. The Ruyan paid study can only be taken so far also, every business does their best for their customer.

However, you then state (and quite boldly at that) that someone needs to simply pay the FDA and skip this court stuff? Do you mean pay them to turn a blind eye?

I mean pay them money just like the big pharmaceutical companies do get their products through clinical trials, not bribery. My understanding to get a drug through FDA approval you have to pay money to them for the clinical trials, case studies, and research. Maybe I'm wrong maybe and any body with absolutely no money can have a product go through the approval process.

Sorry if i was unclear or made no sense, might not have any. Read so much about it finally put my $.02 in. Just ranting about it and to be honest just sick of it. I have 3 weeks without a analog then 3 days with them and now another 1 week plus without them and I can tell myself i feel so much better without analogs. I can tell from my own body its better than analogs but that doesn't matter the FDA knows what is better for me than me right?

 

[Superstargoddess]

Well technically isn't nicotine and even caffeine considered a drug? I know that the more hardcore Straight Edge groups won't accept you if you do either. I would love to be Straight Edge since I do not drink or use illegal drugs, but even when I totally quit smoking and using a PV eventually, there is no way in hell that I can give up drinking Pepsi!

 

[EbenezerScrews]

These companies have to go the tobacco route because they won't be able to distribute drugs, if they are classified as such, which they will be...the could keep their business if they were selling "tobacco"...

This is all silliness, just hurry up and ban it so I can figure out a way around it, hahaha

 

[geeker]

This is all silliness, just hurry up and ban it so I can figure out a way around it, hahaha

*gasp* The HELL you say! *gasp* again

 

[Shan123]

Quoting Tropical Bob: "if I remove vitamin C from an orange and sell it as crystals to stir into a drink, the resulting drink isn't an orange or orange juice. If I remove carotenes from tomatoes and sell tablets of them in a health food store, I'm not selling a tomato product. E-liquid uses a chemical removed from tobacco and placed in a chemical concoction for vaporization. No tobacco. No smoke. How on earth is this a tobacco product?"

If you want 76 pages of history on this and a lot of explanation, read this thread:
http://www.e-cigarette-forum.com/fo...everywhere-vs-fda-off-topic-conversation.html

 

[Mac]

It is absurd. It is an absurity that we are all painfully aware of. When first released these things fell into a gray area of US law. The FDA (under political pressure from the pharm companies) said no, no gray area this is a medical device. As such you must follow our guidelines. To which SE responded oh no we don't we will sue you! We aren't treating illness we are giving smokers a better cigarette. Now talk to our lawyers. Then something even more absurd happened. Our idiotic president (traitor of a smoker that he is) signed a farce of legislation granting the FDA control over tobacco. Just like that the basis for SE's lawsuit vanished. As an act of desperation SE's attourney's changed their argument to : no no it's a cigarette now. It's a tobacco product now. Oddly enough, since what's right and wrong has nothing to do with this and the fact is that it is solely about the letter of the law this is SE's best argument. So now we all await our federal death sentence. End of story.

 

[grimmer255]

I dont know what category the ecig falls under. Nicotine is a drug but the main purpose of ecigs is used like a tobacco cigarette. So if nicotine is a drug and ecigs contain nicotine but is not used as NRT product but used like a tobacco cigarette, but ecigs contain no tobacco, then which category does ecigs fall under. jeesh........

 

[eric]

It's just so strange to me that this Tobacco bill was drafted at the same time electronic cigarettes hit the market, with the cut off date for new tobacco products deemed viable under their terms being one month prior to the introduction of electronic cigarettes here in the United States.

If electronic cigarettes are a drug delivery device because they provide a new means for nicotine users to get their fix, then straws should also be considered drug delivery devices as they provide a means for caffeine and alka-seltzer users to get theirs. If I want to vape nicotine-free PG, who are they to tell me I can't?

Something fishy is definitely going on.

So here is what I'm getting to: Electronic Cigarettes are themselves devices that create vapor from PG or VG based liquid. That is their intended use. Just as the intended use of a straw is to drink from, the intended use of Electronic Cigarettes is to inhale vapor from. Just as the case with a drink and a straw, with an electronic cigarette and PG-based liquid, the contents of said-liquid or drink are entirely based on the decision of the user, not the manufacturer.

E-liquid is really what this case should be about, not the device itself.

 

[Duckies]

Eric, I see where you are going, but that is a bad analogy. Yes, one can drink caffeine through straw, or they can drink milk, but the straw is not required.

PVs are required to vape PG whether it has nicotine in it or not.

Regardless, the FDA has already deemed them "drug delivery devices". The question in my mind is whether they will seperate homeopathic use (0-nic) from drug delivery use (nicotine).

 

[eric]

Eric, I see where you are going, but that is a bad analogy. Yes, one can drink caffeine through straw, or they can drink milk, but the straw is not required.

PVs are required to vape PG whether it has nicotine in it or not.

Regardless, the FDA has already deemed them "drug delivery devices". The question in my mind is whether they will seperate homeopathic use (0-nic) from drug delivery use (nicotine).

I don't see how this is a valid dismantling of the analogy... Because one delivery device applies to water-based liquid consumables while the other applies to water-based gas consumables, the analogy is null?

The basis for the analogy was not what consumables are being consumed, but that they are a means for delivery. Not to mention, the analogy only incorporated liquid caffeine products, and not milk.

The only difference between the straw and the PV is that the PV changes the physical composition of the PG or VG from liquid to suspended gas by means of heat. I suppose a better analogy would be using an ice cube tray to freeze your caffeine-infested (oh, what a vile drug!) liquid as it also changes the physical state of the liquid, except in this case from liquid to solid..

Edit: The straw is not required, but it is for the desired effect. The caffeine-bearing liquid is manufactured just as e-liquid is. Besides, you could inhale e-liquid in it's liquid state, but it'd be quite unpleasant.

The whole point of the analogy was simply this: You don't have to use drugs to utilize the device. PVs can be used to vape nicotine-free PG, just as straws can be used to drink caffeine-free soda. The intended use is broader for the devices than the intended use of the products. This is why the tobacco pipe/crack pipe arguments actually do hold sway in my opinion.

 

[Duckies]

The straw doesn't change the composition of the item (ie, water to ice or niquid to vapor).

 

[HighTech]

The straw doesn't change the composition of the item (ie, water to ice or niquid to vapor).

No, but a crack pipe does and they are sold in my corner mart. They are going to have a hard time making a ban on the hardware stick. They will go after the liquid mostly. Poppers were originally banned, subsequently changed, and are now freely available as a head cleaner...

 

[Duckies]

When you figure out how to get a fake rose into a PV, let me know.

 

[sherid]

I don't see how this is a valid dismantling of the analogy... Because one delivery device applies to water-based liquid consumables while the other applies to water-based gas consumables, the analogy is null?

The basis for the analogy was not what consumables are being consumed, but that they are a means for delivery. Not to mention, the analogy only incorporated liquid caffeine products, and not milk.

The only difference between the straw and the PV is that the PV changes the physical composition of the PG or VG from liquid to suspended gas by means of heat. I suppose a better analogy would be using an ice cube tray to freeze your caffeine-infested (oh, what a vile drug!) liquid as it also changes the physical state of the liquid, except in this case from liquid to solid..

Edit: The straw is not required, but it is for the desired effect. The caffeine-bearing liquid is manufactured just as e-liquid is. Besides, you could inhale e-liquid in it's liquid state, but it'd be quite unpleasant.

The whole point of the analogy was simply this: You don't have to use drugs to utilize the device. PVs can be used to vape nicotine-free PG, just as straws can be used to drink caffeine-free soda. The intended use is broader for the devices than the intended use of the products. This is why the tobacco pipe/crack pipe arguments actually do hold sway in my opinion.

It gets insane, doesn't it? The water glass and water that one uses to take Chantix or illegal drugs then is a drug delivery device. Should it be banned? Those cute little glass vases with fake roses inside that they sell at gas stations are infamous for their use as crack pipes, yet the vases are not banned.