Interesting legal arguments

[harmony gardens]

Lotus--the Judge has to make a determination based on the totality of the circumstances exactly what the "intended use" really is of an e-cig---not what is marketed, but rather what people are going to actually use them for. And we all for the most part, know that it is not to be able to smoke in a bar, rather it is to stop using harmful tobacco.

Sun

Wouldn't it be hard to determine? All claims are offered to suggest possible uses/benefits of a product, and any or all possible uses could be "intended uses" of a product, wouldn't they?

For instance, with the cheerios example,, someone could use cheerios as packing material, or as part of an arts and crafts project,,, the problem came in when the claim was made that it would lower cholesterol by a specific amount...

Each consumer could have a different intended use, and any or all of them could be valid.

 

[Sun Vaporer]

Wouldn't it be hard to determine? All claims are offered to suggest possible uses/benefits of a product, and any or all possible uses could be "intended uses" of a product, wouldn't they?

For instance, with the cheerios example,, someone could use cheerios as packing material, or as part of an arts and crafts project,,, the problem came in when the claim was made that it would lower cholesterol by a specific amount...

Each consumer could have a different intended use, and any or all of them could be valid.

Harmony--that is true--but the Court will look to the "real" indented use based on the facts. The facts readily show that people are using them just like myself as an alternative to the harmful effects of tobacco use.

I really is hard to deny that is the use.

Sun

 

[MVP]

I don't get it. So nothing can legally compete with cigarettes? They have a sanctioned monopoly on non-NRT nicotine delivery?

 

[CJsKee]

Lotus--the Judge has to make a determination based on the totality of the circumstances exactly what the "intended use" really is of an e-cig---not what is marketed, but rather what people are going to actually use them for. And we all for the most part, know that it is not to be able to smoke in a bar, rather it is to stop using harmful tobacco.

Sun

Sun...couldn't one say that the intended use is not to quit smoking, per se, as in NRTs, but for the "reduced harm" aspect. I know (but can't quote where) in the damn tobacco bill that there is a section for reduced harm products. Could the judge rule that ecigs fall in that category? This is if, in fact, they can be ruled to be tobacco products.

 

[harmony gardens]

I also think you could make a separate argument that the actual device, when used to vape nic free vapor, can replace the hand to mouth motion of smoking, while using the patch to replace the nicotine. Then a person could just continue to vape zero nic juice because they enjoy the act of smoking, but don't want the dangers.

Sort of like decafe coffee for caffeine addicts who want to avoid caffeine.

 

[LaceyUnderall]

Speaking only for myself, I know fully well that nicotine is addictive. And my e-cigs help me continue with that addiction. I have used the e-cigarette to stop smoking (meaning inhaling combustible tobacco), not to wean myself off of nicotine or to stop the habits associated with using a tobacco cigarette. I think that is their point.

And I think this is a most important statement that many simply do not understand.

Most, if not all, smokers know and accept what the positives and the negatives of smoking are for them. For those of us who are completely fine having a nicotine "addiction" for whatever reason, we have no intentions to ever stop using the ecig.

While this comment can unfortunately be taken way out of context and some anti-groups certainly will use it against whomever because that's what they do, I completely agree with you.

So can't the Judge rule that specific claims can no longer be made unless the manufacturers want to get approved as NRTs? Remember Cheerios? Still on the shelf. I love 'em!

Regulation is inevitable - and in my opinion a good thing if it's done within reason. I still see our best route is testing for purity (should've been done long ago!) and a "reduced harm" categorization which should be fairly easy to prove.

Add childproof caps, warning labels, age restrictions, etc., and the greater good should easily outweigh the risks.

+1 on that! I totally advocate a "reduced harm category" and believe there are a ton of products already on the market that should be in this category as well. I also think that some of the ridiculous restrictions on the NRT's should be lifted ie: Not sold next to cigarettes. Really? Shouldn't adults be given all of their nicotine options in one place? Would be huge I think!

 

[Duckies]

Given that they are going for the "we don't want people to quit nicotine" approach, they may want to try the green approach. Less cig butts, pollution of analog smoke, etc...

 

[Scaralouche]

but then there would be the question from the environmentalists about battery disposal, etc. are lithium batteries safe in landfills, unlike Ni-Cads or NiMHs?

 

[jen28f]

Given that they are going for the "we don't want people to quit nicotine" approach, they may want to try the green approach. Less cig butts, pollution of analog smoke, etc...

I agree with this. The reason I like ecigs better is not just because they are healthier, but so much cleaner. No ash, no ashtray, no burn holes in my shirts or bed...much safer for those who may fall asleep when smoking.
No butts littering, no smoke smell, no yellow stuff on the walls....
All in all this is as important, if not more so, than the health benefits to myself.

 

[Vocalek]

How do you determine the "intended use" of anything? By what the inventor/manufacturer/retailer state the intended use is. The intended use of paint is to decorate and protect surfaces. Some people inhale the fumes to get high. That doesn't change the original intended use of the product.

How many of bought your electronic cigarette on the basis of advertising material that told you to use them to quit smoking? The product descriptions that I saw promoted the benefit of being able to use them where smoking is banned. It was MY idea to try to use the product to quit smoking tobacco.

Another point: The greater good of the public. Is it better served by taking away this product, or by keeping it available? What will be gained, and what will be lost by each segment of the public? Is there anything else that can provide the benefit that might be taken away from that segment of the public?

Only tobacco smoking is as effective at providing the amount of nicotine we require. Banning electronic cigarettes would take away the only alternative that works for us. And as much as they FDA likes to yell that e-cigarettes have not been proven safe, the FDA failed to provide definitive proof that tobacco smoking is safer.

Ban them, and we have protected the children from buying and using these. There is a reasonable alternative and there is nothing unhealthy about it: Parental supervision.

Was there any other benefit that the FDA put forth associated with banning the devices? Oh yeah, to protect us users. Have they proved to the judge that we are being harmed and require their protection?

 

[Sun Vaporer]

How do you determine the "intended use" of anything? By what the inventor/manufacturer/retailer state the intended use is. The intended use of paint is to decorate and protect surfaces. Some people inhale the fumes to get high. That doesn't change the original intended use of the product.

How many of bought your electronic cigarette on the basis of advertising material that told you to use them to quit smoking? The product descriptions that I saw promoted the benefit of being able to use them where smoking is banned. It was MY idea to try to use the product to quit smoking tobacco.

Another point: The greater good of the public. Is it better served by taking away this product, or by keeping it available? What will be gained, and what will be lost by each segment of the public? Is there anything else that can provide the benefit that might be taken away from that segment of the public?

Only tobacco smoking is as effective at providing the amount of nicotine we require. Banning electronic cigarettes would take away the only alternative that works for us. And as much as they FDA likes to yell that e-cigarettes have not been proven safe, the FDA failed to provide definitive proof that tobacco smoking is safer.

Ban them, and we have protected the children from buying and using these. There is a reasonable alternative and there is nothing unhealthy about it: Parental supervision.

Was there any other benefit that the FDA put forth associated with banning the devices? Oh yeah, to protect us users. Have they proved to the judge that we are being harmed and require their protection?

Voc--the Law specifically addressses how you determine the intended use.


INTENDED USE
The FDA defines “Intended Use” as:
The term "intended uses" refers to the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. It may be shown by the offering or the using of the device, with the knowledge of such persons or their representatives, for a purpose for which it is neither labeled nor advertised. (21 CFR 801.4)

So no matter what the manufacture tries to market a product like the e-cig--the Court will input the actual and morst probable intended use based on the facts and not scam marketing.

Sun

 

[Vocalek]

Voc--the Law specifically addressses how you determine the intended use.


INTENDED USE
The FDA defines “Intended Use” as:
The term "intended uses" refers to the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. It may be shown by the offering or the using of the device, with the knowledge of such persons or their representatives, for a purpose for which it is neither labeled nor advertised. (21 CFR 801.4)

So no matter what the manufacture tries to market a product like the e-cig--the Court will input the actual and morst probable intended use based on the facts and not scam marketing.

Sun

We are speaking here of using this device for "smoking cessation" right?

Remember that the FDA definition of "smoking cessation" is that the patient stops using nicotine. None of the FDA NRTs are approved for long-term use. It was a selling point for approval when Pharma could show FDA that the levels of nicotine in an NRT user's body were lower than those achieved by smoking.

SE was naive enough to buy into the idea that all they needed to do was jump through a few hoops and FDA would approve their product for use in smoking cessation. FDA would never approve it unless and until SE designed the product in such a way that it would wean users all the way off nicotine.

NJOY took the stance that they had no intention, ever, of putting out a product intended for short-term use. And I believe them. From a business standpoint, it makes more sense to keep the customer coming back. NJOY even set up a program to automatically ship you cartridges every month, thereby setting themselves up with a steady stream of revenue.

 

[lotus14]

We are speaking here of using this device for "smoking cessation" right?

Remember that the FDA definition of "smoking cessation" is that the patient stops using nicotine. None of the FDA NRTs are approved for long-term use. It was a selling point for approval when Pharma could show FDA that the levels of nicotine in an NRT user's body were lower than those achieved by smoking.

SE was naive enough to buy into the idea that all they needed to do was jump through a few hoops and FDA would approve their product for use in smoking cessation. FDA would never approve it unless and until SE designed the product in such a way that it would wean users all the way off nicotine.

NJOY took the stance that they had no intention, ever, of putting out a product intended for short-term use. And I believe them. From a business standpoint, it makes more sense to keep the customer coming back. NJOY even set up a program to automatically ship you cartridges every month, thereby setting themselves up with a steady stream of revenue.

NO. Not smoking cessation! An safer alternative to smoking tobacco. The new law which gives the FDA regulatory power over cigarettes has a specific category for "reduced harm" products. The manufacturers need to get off their butts and prove these devices are significantly less harmful than cigarettes! How hard can that be?

If you want to cure your "disease" of nicotine addiction by using progressively lower nic content liquid, then fine, go for it! But the intended use of the e-cig for most of us is simply to have a safer alternative to cigarettes.

If the Judge finds that a "safer alternative" is their intended use then we will be in much better shape. Getting NRT approval could take a looong time.

 

[Vocalek]

Yes!

This invention is definitely NOT a "smoking cessation" product when you take a good look at the FDA definition. And "smoking cessation" was never the intended purpose. This is an alternative to smoking tobacco.

Unfortunately, a few vendors got a little carried away with thinking that it would be a great selling point that people are able to quit smoking tobacco altogether. (That's a good thing, right?) Unfortuantely, the FDA considers it a health claim.

The vendors could have gotten away with it if they had just included the verbiage you find on all the supplements (copied verbatim from one of my bottles):

"This statement has not been evaluated by the FDA. This product is not intended to diagnose treat, cure, or prevent any disease."

 

[TropicalBob]

Intended use doesn't ride on e-cigs being for smoking cessation, or an alternative to tobacco cigarettes. The intended use of e-cigs, according to the FDA's own comments, is not to cure the medical condition called nicotine addiction, but to "treat" it by providing nicotine to the addict. Thus the liquid that treats nicotine addiction is a "drug' to the FDA. The e-cig then becomes a medical device, per the FDA.

E-smoking further provides psychological and psysiological impacts to the user of the drug. That completes the definition under which the FDA asserts authority over our practice.

This has nothing to do with common sense, public good, marketing mistakes, taxes, etc.

The court case has everything to do with the intended use of e-cigs. And all the smoke screens in the world won't matter when the judge hands down the law. We are what we are .. and we will survive or die by truth and truth only. The court is weighing truth now.

 

[LaceyUnderall]

So....

Under that philosophy then TB, why is a can of soda not regulated as a "drug" and why is the can not a "drug delivery device"? Or a coffee cup not a "drug delivery device" and the coffee not a "drug"?

Technically, coffee and soda aid in the "treatment" of a medical condition called caffeine addiction.

Wonderful. I have a bottle of pure caffeine in my kitchen cabinet. So if I smoke that instead of nicotine, then all is fine and dandy?

 

[nitewriter]

For those of you who think a large majority of vapers use e-cigs to avoid the smoking bans, check out the numbers on this poll. http://www.e-cigarette-forum.com/forum/quitting/6470-e-cig-success-rate.html

 

[lotus14]

Intended use doesn't ride on e-cigs being for smoking cessation, or an alternative to tobacco cigarettes. The intended use of e-cigs, according to the FDA's own comments, is not to cure the medical condition called nicotine addiction, but to "treat" it by providing nicotine to the addict. Thus the liquid that treats nicotine addiction is a "drug' to the FDA. The e-cig then becomes a medical device, per the FDA.

E-smoking further provides psychological and psysiological impacts to the user of the drug. That completes the definition under which the FDA asserts authority over our practice.

This has nothing to do with common sense, public good, marketing mistakes, taxes, etc.

The court case has everything to do with the intended use of e-cigs. And all the smoke screens in the world won't matter when the judge hands down the law. We are what we are .. and we will survive or die by truth and truth only. The court is weighing truth now.

Yes, "The court case has everything to do with the intended use of e-cigs." E-cigs can be used as an alternative "reduced harm" device or as an NRT. Both uses provide nicotine to the addict but they are two very different intended uses!

The recent law created a distinct category for "reduced harm" products. The FDA has to abide by this law. The FDA WILL regulate the e-cig. The question is what standards will have to be met by the manufacturers and suppliers, and it's a BIG question.

 

[Randyrtx]

The recent law created a distinct category for "reduced harm" products. The FDA has to abide by this law. The FDA WILL regulate the e-cig. The question is what standards will have to be met by the manufacturers and suppliers, and it's a BIG question.

The question is, what needs to happen for e-cigs to be considered reduced harm products, rather than cessation products?

And what about e-liquids that contain nicotine derived from non-tobacco sources? Wouldn't those always be considered a drug?

Playing devils advocate here, as I certainly believe they should be considered reduced harm products and regulated as such. I have no more intention to give up vaping than I do to give up coffee.

 

[Webby]

Intended use doesn't ride on e-cigs being for smoking cessation, or an alternative to tobacco cigarettes. The intended use of e-cigs, according to the FDA's own comments, is not to cure the medical condition called nicotine addiction, but to "treat" it by providing nicotine to the addict. Thus the liquid that treats nicotine addiction is a "drug' to the FDA. The e-cig then becomes a medical device, per the FDA.

Riddle me this TB -

As a supplier, If I were to make the assumption that:

1) There are plenty of sources for e-liquid in the US and abroad

2) If banned, vapers are highly likely to find alternative means of getting their liquid (DIY, China, etc)

Could I then clear my store shelves of all but blank carts, attys, batts and chargers and fly free and clear of FDA seizures and any legal issues? After all, bongs are sold in most states and if I don't carry anything but blank carts and supplies there would be no nasty, dirty old nicotine juice on my site.

I can't own an M-16 machine gun - BUT, I can buy an AR-15 semi auto from my local gunsmith, order the hardware needed to convert it to full auto online, and a book on Amazon that tells me how to do it...