The Ecig: A Nicotine Replacement Product?

[PhiHalcyon]

Do people who have never used tobacco (and who therefore do not have the carefully-labeled disease of tobacco dependence) generally buy and use $50 packages of nicotinated gum, $30 bottles of nicotinated flavor extract, or any other high-priced nicotinated non-tobacco product? Of course not. For, they do not have the sort of cravings for nicotine that would motivate them to spend that much to relieve them. The fact that a person is motivated enough to pay the high price of a nicotinated non-tobacco product is therefore sufficient grounds to conclude that he or she is seeking to relieve his or her nicotine cravings - which are a symptom of tobacco dependence. The seeking of nicotine craving relief via a nicotinated non-tobacco product also implies the intent of a person with tobacco dependence to be trying to cease and/or avoid the use of tobacco; although this is not necessary to show in order for a nicotinated non-tobacco product to be considered as a drug used to treat the symptoms of tobacco dependence.

I find the carefully chosen label of tobacco dependence, and the carefully chosen therapeutic purpose of craving relief, to be designed to ensure that all nicotinated non-tobacco products are regulable as drugs. To believe otherwise is to conclude that Congress intended for some nicotinated non-tobacco products to not be regulable at all - for it sure didn't plan or intend for them to be regulable as tobacco products.

If anyone wants to put their hope in the tobacco product argument, or in the recreational nicotine use argument, then that is obviously their prerogative. But, personally, I abhor the very notion of hope in this particular situation. For, I do not want hope. I want certainty. Certainty that the amazing improvements in health, self-respect, and general enjoyment of life (that using the e-cig has brought) will neither be lost nor compromised. And the first step to establishing this certainty (no matter how difficult it may seem to willingly do) is to assume that the FDA will prevail in its bid against the e-cig.

Even though I have found the convincing of others (that the FDA was going to win) to be like trying to crack an egg that has proven to be made of solid rubber, I reluctantly accepted many months ago that the FDA was extraordinarily likely to win. And the logical consequence of this acceptance has been an unrelenting desire to create, devise, or discover a legal and effective means of preserving the benefits and satisfactions of the e-cig - so that the FDA win I seen as inevitable, would also be irrelevant.

This is not the time nor place for me to get into all the details of my efforts (nor to discuss the recent fundamentally important breakthrough that I have had), but I can honestly, confidently, and seriously say that I am now, finally, absolutely unafraid of what the ultimate fate of the e-cig will prove to be. Time will tell who was right about that fate; and anyone who thinks that there is a good fight to fight should by all means fight; but, in the meanwhile, I will be doing my best to ensure that even if we lose, that we will still be able to enjoyably keep our newfound freedom, health, and self-respect.

 

[noo]

You have done a lot of research on the topic, that is apparent, and I understand your desire to move forward. However, many of us are not ready to admit defeat yet.

I think a pertinent fact in the matter will be that congress DID leave exceptions in the relevant laws to allow for the recreational use of nicotine in the form of tobacco products, as well as reduced harm tobacco products. The law does specifically mention the exceptions considered, however the law was also written before the notion of an electronic cigarette was conceived. In my view, this at least deserves consideration and is open to legal interpretation in some regards. If you think of the nicotine liquid as the end result of removing the impurities from tobacco rather than the result of adding nicotine to PG, then this position becomes a bit more palatable

Hookah tobacco (she-sha), is granted an exception in the law, and is essentially the same thing as the E cig. The tobacco is soaked in flavor and glycerin for several weeks, and consumed by slowly heating and vaporing the resulting tincture. The only difference is that with the E-cig, the plant matter is removed to facillitate a more compact form factor. How is enjoying a hookah any different than the electronic cigarette? If the liquid is shipped with the tobacco still in it (to be filtered off by the user later) would the devices still be "drug combos?" Or would they be considered protected? If you soak some polyfilly in she-sha juice and smoke it with a hookah is it a drug combo then? The law is ambiguous in this regard it would seem, which is why a lot of people are hoping that common sense will prevail over a law which seems somewhat vague in its intentions.

 

[Thulium]

Do people who have never used tobacco (and who therefore do not have the carefully-labeled disease of tobacco dependence) generally buy and use $50 packages of nicotinated gum, $30 bottles of nicotinated flavor extract, or any other high-priced nicotinated non-tobacco product? Of course not.

But people who nearly never use tobacco (and who therefore do not have the carefully-labeled disease of tobacco dependence) occassionally buy and use $500 packages of cigars, $300 hookahs and accessories or any other high-priced nicotinated products that may or may not contain tobacco.

For, they do not have the sort of cravings for nicotine that would motivate them to spend that much to relieve them. The fact that a person is motivated enough to pay the high price of a nicotinated non-tobacco product is therefore sufficient grounds to conclude that he or she is seeking to relieve his or her nicotine cravings - which are a symptom of tobacco dependence. The seeking of nicotine craving relief via a nicotinated non-tobacco product also implies the intent of a person with tobacco dependence to be trying to cease and/or avoid the use of tobacco; although this is not necessary to show in order for a nicotinated non-tobacco product to be considered as a drug used to treat the symptoms of tobacco dependence.

As demonstrated above, this is a fallacious argument because not everyone who purchases or uses products containing nicotine (tobacco or otherwise) is a nicotine addict...and even if we were to assume that everyone who buys tobacco had a "tobacco dependence", it does not follow that the purchase of a nicotinated non-tobacco product necessarily carries the intention to avoid or stop using tobacco. Proof of this are the myriad folks right here like TropicalBob (and myself to a lesser extent) who use e-cigs and other smoke-free tobacco products with no intention whatsoever to cut down or stop using tobacco products.

On the contrary, I use electronic cigarettes and other smoke-free tobacco products because I don't want to stop enjoying tobacco products (namely nicotine)--instead I have chosen to reduce the harm I was previously exposing myself to in tobacco smoke.

I find the carefully chosen label of tobacco dependence, and the carefully chosen therapeutic purpose of craving relief, to be designed to ensure that all nicotinated non-tobacco products are regulable as drugs. To believe otherwise is to conclude that Congress intended for some nicotinated non-tobacco products to not be regulable at all - for it sure didn't plan or intend for them to be regulable as tobacco products.

Your reasoning is circular. You define e-cigs as a non-tobacco product and then assume that their intended purpose is to avoid tobacco, therefore you conclude that they are not a tobacco product.

If anyone wants to put their hope in the tobacco product argument, or in the recreational nicotine use argument, then that is obviously their prerogative. But, personally, I abhor the very notion of hope in this particular situation. For, I do not want hope. I want certainty. Certainty that the amazing improvements in health, self-respect, and general enjoyment of life (that using the e-cig has brought) will neither be lost nor compromised. And the first step to establishing this certainty (no matter how difficult it may seem to willingly do) is to assume that the FDA will prevail in its bid against the e-cig.

Even though I have found the convincing of others (that the FDA was going to win) to be like trying to crack an egg that has proven to be made of solid rubber, I reluctantly accepted many months ago that the FDA was extraordinarily likely to win. And the logical consequence of this acceptance has been an unrelenting desire to create, devise, or discover a legal and effective means of preserving the benefits and satisfactions of the e-cig - so that the FDA win I seen as inevitable, would also be irrelevant.

This is not the time nor place for me to get into all the details of my efforts (nor to discuss the recent fundamentally important breakthrough that I have had), but I can honestly, confidently, and seriously say that I am now, finally, absolutely unafraid of what the ultimate fate of the e-cig will prove to be. Time will tell who was right about that fate; and anyone who thinks that there is a good fight to fight should by all means fight; but, in the meanwhile, I will be doing my best to ensure that even if we lose, that we will still be able to enjoyably keep our newfound freedom, health, and self-respect.

Good luck with that. Although the "e-cig as a tobacco product" argument is not the ideal nor is it without its flaws, it is the option on the table that provides the greatest certainty that e-cigarettes will not be banned.

I do, however, welcome any ideas for something better. I just don't see the need to dismiss our current best strategy (agreeing with the American Association of Public Health Physicians) until the feasibility of a better alternative is known.

 

[PhiHalcyon]

I understand your desire to move forward.

It's not that I have a desire to move forward (beyond the e-cig). It's just that I loathe the spirit of fear and desperation - while anxiously waiting to see what the higher Courts will decide. It is easier to just take matters into my own hands and find a solution that is not in a state of jeapordy. If not for the immediate replacement of the e-cig (as now appears likely), then at least as an acceptable alternative should the need arise.

I think a pertinent fact in the matter will be that congress DID leave exceptions in the relevant laws to allow for the recreational use of nicotine in the form of tobacco products

Even though the use of tobacco products results in the non-therapeutic consumption of nicotine, I don't think that Congress' intent to allow tobacco products to continue to be sold can be fairly equated with an intent to allow the recreational use of nicotine. One must remember that the only thing that saved tobacco products from FDA regulation in the Brown case was that tobacco products - in having no therapeutic value that exceeded the dangers of their use - would have needed to be banned under the FDCA; and that this banning would have been contrary to Congress' intent that tobacco products continue to be sold. This logic does not apply to nicotinated non-tobacco products - which are safe enough to use for therapeutic purposes, and have never been precluded from FDA regulation either before or after Brown. Furthermore, the Supreme Court specifically avoided addressing the question of recreational versus therapeutic use of drugs; and, as far as I know, has never addressed this unregulated pharmacies-for-fun theory.

When, within the context of the definition of tobacco products, Congress prohibited marketing a tobacco product in combination with an article or product regulated under the FDCA, it's hard to conclude that it did so with an intent to allow nicotinated non-tobacco products to be sold for recreational use. For, had this been what it intended, then, by presumably excluding them from being regulated as tobacco products, it would have also had to intend that they would not be regulated at all.

I find it far more reasonable to conclude that a nicotinated non-tobacco product is, by its very nature, a nicotine replacement product (i.e., a relatively safe, non-tobacco means of delivering nicotine); that all such products were intended to be regulated as drugs; and that it is only when a nicotinated non-tobacco product is regulated as a drug that it is excluded from the prohibition against marketing a tobacco product in combination with an article or product regulated under the FDCA.

 

[noo]

I still see a giant loop hole with the entire hookah thing. Assuming that the physical devices themselves cannot be banned for use with 0 nic liquid, I would sell "oil sealed hookah tobbaco" that would essentially be a few grams of finely ground tobacco immersed in glycerine, water and flavor. I would develop a small, cheap "french press" device (a syringe with a pipe screen?) that would be used for "preparing" the tobacco for the hookah by pressing out the liquid.

It is well established that a solution of water and glycerin will extract flavor and nicotine from the tobacco, it is just a matter of calibrating the process out.

Bam, e-liquid that can never be illegal because it is sold with tobacco and has no additional nicotine added to it. Patent pending. Of course this would probably be way less healthy, as a bunch of the nasty stuff from the tobacco will probably make it into the final product. But it would be unquestionably legal in my estimation. Is anyone else starting to feel like Joseph Heller is writing the narrative here?

 

[rubberdux13]

hmmmmm.... pondering the advantages of renaming the "e-cigarette" to the
"e-hookah"....hmmmmm

 

[PhiHalcyon]

this is a fallacious argument because not everyone who purchases or uses products containing nicotine (tobacco or otherwise) is a nicotine addict...and even if we were to assume that everyone who buys tobacco had a "tobacco dependence", it does not follow that the purchase of a nicotinated non-tobacco product necessarily carries the intention to avoid or stop using tobacco.

It is not necessary to show that a person who purchases a nicotinated non-tobacco product is doing so for the purpose of ceasing and/or avoiding the use of tobacco. The therapeutic purpose of craving relief is all that is necessary to show. Furthermore, it is not necessary that it be shown that everyone who purchases a nicotinated non-tobacco product does so to relieve nicotine cravings. It is just necessary to show that, in general, those who purchase nicotinated non-tobacco products do so to relieve nicotine cravings. And it is precisely because of the impossibility of reasonably arguing otherwise that there is no such thing as a nicotinated non-tobacco product that is not regulable as a drug.

Your reasoning is circular. You define e-cigs as a non-tobacco product and then assume that their intended purpose is to avoid tobacco, therefore you conclude that they are not a tobacco product.

The question is not whether the e-cig can be understood to be a tobacco product, but whether or not Congress intended for nicotinated non-tobacco products to be regulable as tobacco products, or as nicotine replacement products. Since nicotinated non-tobacco products have never been precluded from being regulated as drugs; Congress prohibited the Tobacco Act from being construed in a manner that would change this; Congress prohibted marketing a tobacco product in combination with a non-tobacco article or product regulated under the FDCA; Congress made no provision for the FDA to add a new class of tobacco products besides the ones that it established; and nicotinated non-tobacco products are, by their very nature, nicotine replacement products; it is reasonable to conclude that Congress did NOT intend for nicotinated non-tobacco products to be regulable as tobacco products.

I just don't see the need to dismiss our current best strategy (agreeing with the American Association of Public Health Physicians) until the feasibility of a better alternative is known.

The AAPHP should be addressing its concerns to Congress, not the FDA; and trying to find a winning strategy to save the e-cig is to misunderstand the core objective in my opinion. Nonetheless, there is no winning strategy for the e-cig (as currently designed), IMO, except as a nicotine replacement product.

 

[ChipCurtis]

PhiHalcyon, by your reasoning, all coffee and coffee-related products (such as mugs and cups, coffee-makers, etc.) should be pulled from the market immediately.

What separates nicotine from caffiene in the scheme of things is simply the 30-year-long campaign against smoking, which was originally based on the actual damage that smoke (from combustion) does to your lungs. In other words, there is no FUD surrounding caffiene consumption in our society, so it's "okay".

The real problem with the e-cig for regulatory agencies is (1) the separation of nicotine from the tobacco leaf into a liquid, in combination with: (2) the "act" or imitation of smoking. This is a no-no for the anti's, even though there is no scientific evidence backing the idea that nicotine without smoke is more dangerous than caffiene.

 

[Kate51]

Excellent point, ChipCurtis. I'd take just as much offense to someone taking my coffee pot as I do threatening my PV! I'm sort of attached to both of them, and I have an attitude about that. And back-up resistance plan in place.

 

[ezmoose]

I like nicotine; I also like caffeine. I don't eat tobacco plants or coffee beans. I prefer to relieve my caffeine cravings through the use of a delivery device otherwise known as a coffee mug. Others relieve their caffeine cravings through soft drinks. I prefer to relieve my nicotine cravings through vaping versus smoking. I don’t care for sugar and fat too much. Others crave sugar and fat and relieve their cravings through junk food. Still others constantly crave sex and relieve their cravings though…

How something is classified has more to do with power, control, and taxation than my personal choice for partaking in it. Let’s hope the FDA doesn’t classify Big Macs as a delivery device; I doubt many would prefer biting live cows! lol

 

[rothenbj]

Excellent point, ChipCurtis. I'd take just as much offense to someone taking my coffee pot as I do threatening my PV! I'm sort of attached to both of them, and I have an attitude about that. And back-up resistance plan in place.

ChipCurtis has my vote on that truth. The anti science of today is no more accurate than the tobacco of a few decades ago, all of it at our expense. My un-scientific research has determined that cigarette addiction is a three pronged beast. The most addictive aspect is the tobacco alkaloids. Second to that is the hand to mouth habit which the PV addresses. The lowest portion of the addiction is the nicotine.

In seven months, I was able to reduce my cigarette consumption from two to three packs to a handful of cigarettes per day, toward the end of that seven months my cigarette consumption started to increase. Then I took TB's advice and found Swedish snus.

That was what I needed to remove cigarettes from the equation. Two months, no cigarettes, no desire and only two to for portions a day do it for me. I've lowered my PV nic to about 8mg and vapor casually during the day. I really see zero e liquid in the near future. Is the nic really that addicting? Not using my science.

Back up resistance? A bunker and an automatic? E Cig I mean, of course.

 

[noo]

I like nicotine; I also like caffeine. I don't eat tobacco plants or coffee beans. I prefer to relieve my caffeine cravings through the use of a delivery device otherwise known as a coffee mug. Others relieve their caffeine cravings through soft drinks. I prefer to relieve my nicotine cravings through vaping versus smoking. I don’t care for sugar and fat too much. Others crave sugar and fat and relieve their cravings through junk food. Still others constantly crave sex and relieve their cravings though…

How something is classified has more to do with power, control, and taxation than my personal choice for partaking in it. Let’s hope the FDA doesn’t classify Big Macs as a delivery device; I doubt many would prefer biting live cows! lol

Don't forget that suppliers of caffeinated products routinely make health claims concerning alertness, cognitive capacity, attention span, mood elevation etc... The claims often sound similar to the ADHD medicine I used to take.

Also, addictive caffeinated candy, gum, soda and mints are all marketed towards children, and have been identified as a major contributing factor to childhood obesity. Let us also not forget that obesity is the number 1 cause of lifestyle related mortality in the USA. Ahead of tobacco use.

Nothing about this process makes any sense.

 

[Kate51]

Let's just say, I'm ready for anything! Locked and loaded! Of course, the e-cig!!
You sound like you're doing great, Rothenbj! I'm still 'casually vaping' a little too much, but getting better at putting it down. My nic down too, so do feel good about that. Glad the snus is working for you.

 

[PhiHalcyon]

PhiHalcyon, by your reasoning, all coffee and coffee-related products (such as mugs and cups, coffee-makers, etc.) should be pulled from the market immediately.

HOW does the lack of intent on the part of Congress for nicotinated non-tobacco products to be regulated as tobacco products; the inescapable therapeutic intent of craving relief for any nicotinated non-tobacco product; and the intent of Congress for nicotine replacement products to be regulated as drugs used to treat tobacco dependence; result in the conclusion that coffee should be banned?!?

 

[Thulium]

HOW does the lack of intent on the part of Congress for nicotinated non-tobacco products to be regulated as tobacco products; the inescapable therapeutic intent of craving relief for any nicotinated non-tobacco product; and the intent of Congress for nicotine replacement products to be regulated as drugs used to treat tobacco dependence; result in the conclusion that coffee should be banned?!?

1. Considering that Congress wrote provisions for Modified Risk Tobacco Products, I don't think you can fairly say that Congress had no intention to regulate products designed to reduce the risk of traditional tobacco products.

2. How is it more an "inescapable therapeutic intent" to use nicotinated e-cigarettes than it is to use other modified risk tobacco products that also contain nicotine?

3. Although it is true that products marketed as "Nicotine Replacement Therapy" are obviously intended for therapeutic effect, how can you call something a "Nicotine Replacement Therapy" when the Nicotine is optional?? Do I need to get a new prescription for a 0-nic Nicotrol inhaler?

 

[PhiHalcyon]

1. Considering that Congress wrote provisions for Modified Risk Tobacco Products, I don't think you can fairly say that Congress had no intention to regulate products designed to reduce the risk of traditional tobacco products.

The Modified Risk provisions are not intended to establish a special class of tobacco products apart from the standard classes that Congress established (i.e., cigarettes, smokeless tobacco products, etc.), but are merely designed to force tobacco product manufacturers to prove the accuracy of any modified risk claims before they are permitted to make those claims.

2. How is it more an "inescapable therapeutic intent" to use nicotinated e-cigarettes than it is to use other modified risk tobacco products that also contain nicotine?

Neither the e-cig, nor e-liquid, fit within any of the tobacco product classes that Congress established.

3. Although it is true that products marketed as "Nicotine Replacement Therapy" are obviously intended for therapeutic effect, how can you call something a "Nicotine Replacement Therapy" when the Nicotine is optional??

Reminds of a crack dealer who sets up a lemonade stand, and then, when the police come to arrest him, asks, "How can you say that I am dealing crack when I am selling lemonade too?"

 

[Thulium]

The Modified Risk provisions are not intended to establish a special class of tobacco products apart from the standard classes that Congress established (i.e., cigarettes, smokeless tobacco products, etc.), but are merely designed to force tobacco product manufacturers to prove the accuracy of any modified risk claims before they are permitted to make those claims.'

Which makes it possible to make health claims about non-therapeutic use. Q.E.D.

Neither the e-cig, nor e-liquid, fit within any of the tobacco product classes that Congress established.

According to...YOU. According to the American Association of Public Health Physicians, e-cigarettes and e-liquid should be regulated as a tobacco product.

Reminds of a crack dealer who sets up a lemonade stand, and then, when the police come to arrest him, asks, "How can you say that I am dealing crack when I am selling lemonade too?"

You aren't good with analogies, are you? How does selling an electronic cigarette with nicotine relate to crack ....... the way an electronic cigarette without nicotine relates to lemonade??

It's more like selling regular and decaf Diet Coke and then YOU claiming it is a drug because the inclusion of caffeine "inescapably" means it is intended to help you stop drinking Coke.

 

[PhiHalcyon]

Which makes it possible to make health claims about non-therapeutic use. Q.E.D.

Whatever the hell that is supposed to mean.

According to...YOU. According to the American Association of Public Health Physicians, e-cigarettes and e-liquid should be regulated as a tobacco product.

Like I said earlier, the AAPHP should be addressing its concerns to Congress, not the FDA. For, the FDA does NOT have the authority to override the will of Congress; and Congress did NOT intend for nicotinated non-tobacco products to be regulated as tobacco products.

You aren't good with analogies, are you? How does selling an electronic cigarette with nicotine relate to crack ....... the way an electronic cigarette without nicotine relates to lemonade??

The analogy was perfectly valid. For, selling a non-drug product in addition to a drug product does not cancel the fact that you are selling a drug product.

It's more like selling regular and decaf Diet Coke and then YOU claiming it is a drug because the inclusion of caffeine "inescapably" means it is intended to help you stop drinking Coke.

Now THAT was a bad analogy.

 

[Thulium]

The analogy was perfectly valid. For, selling a non-drug product in addition to a drug product does not cancel the fact that you selling a drug product.

Isn't Diet Coke a drug product? Toxic and addictive drugs have been added to it, after all.



I think I'm done with this thread. I feel I understand your point of view and you have shown no willingness to consider alternate views.

 

[PhiHalcyon]

I feel I understand your point of view and you have shown no willingness to consider alternate views.

I am open to any view that is based on the law or the Constitution; for these are the things that the Court must base its decision on. Neither my personal opinion, nor yours, will have any relevance to how the Court decides. If it had been up to me, then I would have shifted the regulation of all nicotine products from chapter V to chapter IX, so that we would not need to have these absurd debates about what is a tobacco product, and what is a drug; and so innovative, low-risk products like the e-cig would be easier to bring to market for the good of public health. But this is not what Congress chose to do, and so we need to deal with the reality of what is - as it is; rather than as we think that it should be.