An idea for avoiding FDA approval or control

[Satire]

Had a little idea and thought I would share, comments welcome.

As we all know, any stop-smoking aid, NRT, drug delivery system, "tobacco alternative," etc is controllable by the FDA (and equivalent bodies in other governments). This requires years of safety-testing (for any of these), proof of effectiveness (for stop-smoking aids or NRTs), quality controls, and after all that there is still the lengthy process of getting approval to distribute that each supplier would have to go through. In addition to the years this would take, the price would most likely be greatly inflated (look at how much a pack of nicotine gum is and think about how many of these packs you could make at home with the amount of nicotine in a $20 bottle of eliquid and some gum).

Now this may seem inevitable, but from an objective point of view, the electronic device in your mouth is really just a fancy way to consume tobacco (or at least the desired parts of it), since all of the liquids are made from tobacco extracts with some flavors added. Tobacco products, including disolvables and others that contain tobacco extracts but no plant material, are notoriously uncontrolled (for adults) for any reason other than quality control standards. Similarly, fancy "tobacco" consumption devices are not controlled (take a look in your local head shop at all the crazy stuff used for "tobacco" consumption).

By this rationale, could one not say that this is just an alternative method of consuming tobacco, and thus fall into the same category? While this may conflict with the current statements that eliquid is "tobacco free," the fact remains that the liquids are made from tobacco (and many contain more from the tobacco than just the nicotine), and thus we are simply consuming tobacco, just because not everything from the plant is consumed doesn't make it any less of a tobacco product.

Declaring it as an alternative way to consume tobacco may not be the best marketing technique, but if the FDA get their hands on this stuff, all of the current suppliers are going out of business anyway because even if it does get approval, it will be produced by pharmaceutical companies and not some guy in his kitchen.

Any thoughts?

 

[TropicalBob]

I wish I could remember the exact thread -- or kept records like Kate -- but this came up and was rejected in either England or Australia. The government made a very clear distinction between nicotine derived from the combustion of tobacco and nicotine extracted as a chemical during processing. We use the chemical. We do not combust tobacco. We are not a tobacco product.

Other ruses tried in other countries, none of which worked: It's a food substance found in eggplant and potatoes (not food, authorities said); it's an insecticide (then it's not for human consumption).

Try as we might to skew reality, we are using an addictive drug, a poisonous substance, in an electronic delivery device made in China. There is really nothing definitive that can be said about the safety or health benefits of what we do. We "trust" we're doing the right thing.

Keep thinking.

 

[Rockbassray]

ok TB i think i got the answer.. The problem is that the juice " may " contain Nicotine, for those that want it.. and since the liquid is not " approved" yet... Would that mean we can use the device and juice without Nicotine? If so then we just slap a nicotine patch on our arm, and then vape from our e-cig.. and we are set .
I mean i dont think they are after the device as much as they are after the liquid that is in it... If we can simply learn to either enjoy the liquid Nicotine free or try to understand how the hell a government has regulations of what you do with your body? They do not own you in any way shape or form.. I understand the selling the portion they can regulate since it is in their country, but how free is anyone when compelte stranger from some organization says you cant do what you want.. but you can live freely in america? i really hate political government, right wing left wing.. corrupted people tryign to tell me what i can and can not do.. and then say " well then leave"... well doesnt matter where you go you will get that.. this world is nothing but an inslavment on the lower cash producing people... ... man i cant wait til aliens come to earth... they have my next order of e-cigs...

 

[Myk]

I agree. At least in the US, congress has told the FDA to stay out of tobacco. Saying this is tobacco may get it looked at for taxes but it would keep the FDA away from banning it.

From what I recently read the FDA turned it down from some company in late Nov. (as what I don't know) because it wasn't a form used in medicine (which makes me think as NRT).

Seems to me the government lets you grind tobacco to put up your nose, soak it in sugar and do other things so you can put it in your mouth, freebase it for cigarettes, flavor and cure it half a million ways for pipes and cigars. I don't see why extracting the "essence" and nicotine would be manufacturing a drug and under the FDA control.

It might kill the "smoke anywhere" claims to admit it's tobacco but I'd rather not vape everywhere than not vape anywhere.

The government made a very clear distinction between nicotine derived from the combustion of tobacco and nicotine extracted as a chemical during processing. We use the chemical. We do not combust tobacco. We are not a tobacco product.

You don't combust when you extract nicotine chewing or snorting either. They are still tobacco products.

If I sold my chew spit would that be a drug?

 

[cucurucho]

Rockbassray, here in New South Wales, Australia, the supply of nicotine liquid is outlawed. A state government official assured me, however, that selling and using the device with no nicotine in it would be perfectly acceptable. So using a patch and vaping nicotine free liquid would be fine if that works for you. But I don't think it would compare to vaping nicotine.

He also told me that if someone happened to miraculously have some nicotine liquid for personal use, that they would not get in trouble with the law. So I'm just going to continue vaping as I have been and ordering liquid from overseas (with a small risk of confiscation by customs). While it may be possible that the sale of liquid containing nicotine is banned in the US, there are always chinese suppliers

 

[Rockbassray]

Yes why dont we just all start Chewing then spit in 15Ml bottles and sell that.. LOL.

and here is another thought.. How the heck are they going to know you have Nicotine in the liquid?.. For example. you buy a 901 Kit with high nicotine in the carts. How are they going to know what the hell it is let alone if it has nicotine while being shipped across the US or world wide? they would have to open every single package to do that.. speaking of which.. i like to know if there is an invasion of privacy clause for items you purchase which are opened by Customs without your consent.

 

[Rockbassray]

Yes Cucur, i see and heard about the ban.. It is just another way for higher ups to take control. sit on it and find a way to make money. I think what will really happen is they will .. state selling Nicotine liquid is illegal.. which then they would have to say selling nicotine patch or gum is illegal.. i really dont see the difference.. it is like water.. Solid, liquid or gas... nicotine is Nicotine.. if you are going to ban one you have to ban all

 

[Satire]

Haha TB why must you be such a buzzkill
Even if chemically isolated nicotine is controlled, a crude extraction that still contains plenty of the other stuff from tobacco MUST be considered a tobacco product. I'm sure you are familiar with the dissolvables (for those not familiar see Ariva and Stonewall Official Site | Dissovable Tobacco | Smoke Free Tobacco and Chewing Tobacco - NEW Java Stonewall Dissolvable Tobacco Mints).

These are for sale in the US and are declared a tobacco product, and they are obviously just crude tobacco extracts with flavorings added and are not combusted (sound familiar?). It too is an addictive drug, a dangerous product, and is chemically extracted, yet it is not controlled because it comes from tobacco. If I dissolved one of these in some PG and smoked it in my e-cig would it suddenly stop being a tobacco product? If they both come from the same US tobacco and processed in the same way (note again, the eliquids are NOT made from pure nicotine, the lab test results show tons of stuff from tobacco, including some chemicals only found in tobacco, thus they are using crude tobacco extracts and not nicotine), how can they be proven different? Also the US government will have the final call on this, not the Aussies, and in the US legal system, technicalities (though this really isn't one, its just a fact) are well-monitored, and tobacco products, in all forms, are considered "tobacco" and nothing more.

 

[TropicalBob]

The liquid is the big problem, yes. But for what reason would anyone want the devices banned?

The biggie is that e-smoking will cause confusion for those enforcing no-smoking bans in public places. That's hard to argue with. Bar owners said it confuses patrons who want to smoke when they see an e-smoker exhaling large amounts of vapor. Is that a problem? It is if a smoker-patron then lights up a real cigarette because he/she saw someone else "smoking."

In reality, as many have pointed out, smoking is now unacceptable. Virtually everywhere. Victory over smoking is almost at hand for the antis. So don't expect them to welcome something that looks like the thing they just banished from public view.

But I think unwarranted intervention in a promising practice is damning more smokers to health problems down the road, by taking away something today that could help them. NRT is ineffective; e-smoking is superior.

What we need is compromised regulation that gives this technology a future, continues the help we e-smokers have already found, and assures all that this practice is safe and effective.

What we won't get is the status quo accepted.

 

[Rockbassray]

well put TB..

I think E-cigs are just to ahead of there time. Perhaps if place post a poster stating E-smoking allowed only!. ... but then again too much for too many people to do..

 

[TropicalBob]

They are "the future" today, Rockbassray. They look like something that might be used aboard the Starship Enterprise (and, in fact, could be!). If we don't kill this embryo, I'm sure it will mature into something valuable to smokers and others (for inhalation therapy).

As for dissolvable ... sorry, it's tobacco. I have been an avid user of Stonewall Java for about two years. I buy a five-pack of 20 every week. I'm using one now. E-smoking has never given me enough nicotine, so I use Stonewall and strong snus all the time. Stonewall's tobacco is 100% "Star-Cured Virginia tobacco" by Star Scientific. Bless 'em.

Very different from the extracted nicotine used in our liquid.

Dissolvables are natural; e-liquid is synthetic. No getting around it.

 

[Satire]

Perhaps I was mistaken about those dissolvables, I honestly didn't know what was in them I just assumed. Still, they have tobacco products made using tobacco extractions, and all tobacco is chemically treated in some way (including extractions), it doesn't make them any less of a tobacco product. That would be like saying coffee isn't a product of coffee beans because it is chemically extracted using a solvent (water).

Here is the Phillip Morris Patent Application for the products I was thinking of http://www.freepatentsonline.com/y2008/0149121.html

A consumable tobacco film strip adapted to dissolve in the oral cavity includes a tobacco component, a binder, a humectant, and optionally a flavorant. The tobacco component can include ground or powdered tobacco and/or a tobacco extract. Tobacco flavoring can be incorporated in the film strip by casting or extruding a mixture or the tobacco component may be added to a film strip after formation of the film. The film strips are adapted to dissolve and provide tobacco satisfaction.



rawr!

 

[TropicalBob]

Nothing is "extracted" in making dissolvables. They are compressed, powdered tobacco with a sweetener. That's it. No extraction of nicotine. We are not like that. Our e-liquids last saw tobacco somewhere in Cuba! This is not a natural product we use. It's a chemical concoction of untested ingredients of which nicotine is only one we crave. It's a drug. A highly addictive, toxic drug.

I posted this to a Ruyan supplier and it's probably worthy of dissecting in this interesting thread:

"With all the fuss now and fear of bans, it might turn out that only a true disposable like the Ruyan Jazz has any chance of approval. The device must be tamperproof. No taking anything apart. Everything must be sealed as a single unit and the e-cig thrown away when dry and/or dead. That kind of device might -- might -- have a chance at approval since it couldn't kill children or pets.

"I'm looking forward to some day trying the Jazz, but it needs to be cheaper still. If the specs are correct, it's equal to 4 or 5 packs of cigs, for $20 to $25. That's $5 a pack. Now, someone can toss around New York City prices if they want, but packs of cigarettes are about $3 where I live. Using a Jazz would be a significant increased expense for me."

 

[Satire]

Our friends at Phillip Morris disagree, sir. They have tobacco products with no tobacco leaves in it, and they do not seem to require extra approval for them. The flavorings and PG may be added, but it is a product made with tobacco extractions and therefore classified as a tobacco product, and tobacco is well tested and allowed for adult consumption in all forms, including inhalation and mouth absorption. Energy drinks are also "chemical concoctions" made from all kinds of crazy stuff and not safety tested, but since all the ingredients are not controlled, then the drink is ok to sell. I'm still failing to see any definitive line separating the eliquid from tobacco products.

Also, the eliquids DO have a legal obligation to put the same warnings as other tobacco products on their labels when they are sold commercially, so the suppliers need to get on their game about that, but if it isn't being sold (like if you made it for yourself or friends), and the liquid contains no illegal ingredients, I see no possibility of it being prosecutable. However it is legally required to put those warnings on it to make sure your customers are knowledgeable about the dangers of your product, so any supplier hoping to claim the "tobacco product" rationale might want to start adding these.

 

[TropicalBob]

What Philip Morris products are you referring to that are tobacco-free? Not the Heatbar, right? That uses tobacco.

I guess we could agree to disagree, but I'll bet no agency concludes e-liquid qualifies for tobacco product regulation. No matter how the liquid is framed. It's a chemical cocktail, not a tobacco product.

 

[yvilla]

Bob, its the new stuff coming out that Satire's referring to - a thin strip that dissolves in your mouth. It's linked to in the post above.

"Here is the Phillip Morris Patent Application for the products I was thinking of http://www.freepatentsonline.com/y2008/0149121.html"

 

[TropicalBob]

Those are the new dissolvables. I've only used the Star Scientific products. I look forward to those strips, toothpicks and tablets. But note that the strip is a tobacco product, not a nicotine delivery system. The entire patent makes reference to this;

The film strip of claim 1, wherein the tobacco component comprises ground or powdered tobacco with an average particle size of between about 100 nm and 1 mm.

Also note that I have been testing and using tobacco soaked in glycerine that I stuff into empty cartridges, allowing the glycerine to vaporize without the tobacco touching the atomizer. It works. It's a tobacco product. But it doesn't work as well as liquid nicotine solutions. And I have no idea how much nicotine I'm inhaling this way.

 

[Myk]

They are "the future" today, Rockbassray. They look like something that might be used aboard the Starship Enterprise (and, in fact, could be!).

I picture the non-cigarette looking e-cigs in a Star Wars (which I've never seen) like bar scene.

Our friends at Phillip Morris disagree, sir. They have tobacco products with no tobacco leaves in it, and they do not seem to require extra approval for them. The flavorings and PG may be added, but it is a product made with tobacco extractions and therefore classified as a tobacco product, and tobacco is well tested and allowed for adult consumption in all forms, including inhalation and mouth absorption. Energy drinks are also "chemical concoctions" made from all kinds of crazy stuff and not safety tested, but since all the ingredients are not controlled, then the drink is ok to sell. I'm still failing to see any definitive line separating the eliquid from tobacco products.

Also, the eliquids DO have a legal obligation to put the same warnings as other tobacco products on their labels when they are sold commercially, so the suppliers need to get on their game about that, but if it isn't being sold (like if you made it for yourself or friends), and the liquid contains no illegal ingredients, I see no possibility of it being prosecutable. However it is legally required to put those warnings on it to make sure your customers are knowledgeable about the dangers of your product, so any supplier hoping to claim the "tobacco product" rationale might want to start adding these.

I agree, caffeine added to a drink that it isn't natural to is not a drug. Caffeine tablets are.
Ginseng extracts are not drugs (and I've had some there were more potent than drinking tea).
They tried banning ephedra supplements as a drug because people used it to make .... and the ban was lifted, then it was brought back, now as far as I know it's a behind the counter type thing where they keep track of the purchasers.

 

[TropicalBob]

Good luck, guys. I see where you're coming from, but I surely don't think it will fly. Our nic liquid is not a tobacco product any more than Nicorette gum or a Big Pharma nicotine inhaler is. Every product containing nicotine will not qualify for tobacco regulation. Witness what happened with nic lip balm or water. We're in that boat.

Aside: I did a full search of the dissolvable patent for the word "nicotine". Not there. Interesting? Yep.

 

[halopunker]

If they are banning the cartridges just because of the nicotine...a Simple solution to this entire mess would be to have all the nicotine from the cartridges/device be removed.

Then leave it up to the consumer to actually add their own nicotine to their cocktail. But it's entirely too late to change how things have been operating so far.

I've been kicking around the idea of selling only juice/cartridges with 0 Nicotine in it...yet for some reason I don't think the idea will sell to too many customers.