The Ecig: A Nicotine Replacement Product?

[PhiHalcyon]

SEC. 918. DRUG PRODUCTS USED TO TREAT tobacco DEPENDENCE.
(a) IN GENERAL.—The Secretary shall—(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 506; (2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and (3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.

Section 918(a) (of the new tobacco product chapter of the FDCA) makes it unmistakably clear that Congress considers nicotine replacement products that are used for 'craving relief', 'smoking cessation', and 'relapse prevention', to be chapter V drug products used for the treatment of tobacco dependence.

Some nicotine replacement products (such as nicotine gum and nicotine lozenges) deliver nicotine via a non-tobacco excipient. Other NRPs (such as nicotine patches and the Nicotrol inhaler) deliver nicotine via a non-tobacco device. Thus, aside from the question of intended use, nicotine replacement products are products which deliver nicotine - in lieu of a tobacco product - via a non-tobacco excipient and/or a non-tobacco device. And in this respect, the e-cig (in being a non-tobacco device that delivers nicotine via a non-tobacco excipient) is a nicotine replacement product.

A manufacturer/importer may claim that its nicotine replacement product is not intended to be used for what Congress considers to be the therapeutic purposes of 'craving relief', 'smoking cessation', and/or 'relapse prevention'; but, if this was true, then what is it intended to be used for? Is it not self-evident that nicotine replacement products - by their very nature - are intended to relieve nicotine cravings in furtherance of the objective of ceasing and/or avoiding the use of tobacco? Is this not the reason why nicotine is taken out of tobacco and added to a non-tobacco excipient in the first place?

Even if the use of questionable disclaimers - and the avoidance of making therapeutic claims - would be sufficient to prevent the e-cig from being classified as a drug/device product on the basis of therapeutic intent, the very act of adding nicotine to their novel, smoke-simulating, non-tobacco excipient solutions demonstrates an intent of manufacturers to affect the structure or functions of the bodies (and brains) of those who will consume their product. Furthermore, it is this clear and undeniable intent (inherent in adding nicotine to a non-tobacco article or product) that is the rock-solid reason why NO nicotinated non-tobacco article or product has EVER escaped the drug-division domain of the FDA.

Congress may have adopted an expansive definition of the term 'tobacco product', but it also counter-balanced that definition with a definition of what is NOT a 'tobacco product': Section 201(rr)(2), "The term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g)." And if the inherent therapeutic intent of nicotine replacement products is not enough to render the e-liquid/e-cig product a drug/device combination, then the undeniable intent inherent in adding nicotine to e-liquid is. Therefore, e-liquid (like every other nicotinated non-tobacco product) shall be regulated as a drug; and the e-cig, a device intended to be used with that drug. For, as Congress demands in the very next paragraph: Section 201(rr)(3), "The products described in paragraph (2) shall be subject to chapter V of this Act."



Note: This post marks the end of my contribution to the task of predicting the ruling that will matter.

 

[Janetda]

Well Phil, I don't know about anyone else, but I really like to smoke. I simply wanted to try these things and lo and behold, I liked them better than regular cigarettes. I don't really give a crap about the health benefits. If I was that worried about my health I would have quit smoking regular cigarettes years ago. I vape because I enjoy it. For me it was like changing brands. It was that simple.

This is about the act of smoking. The antis involved aren't really concerned about nicotine or the health concerns or benefits. They use that because they can't just say we don't want people to smoke. For them it's the act of smoking something that they find wrong. The question really is, do we have the right to smoke for enjoyment? Yes, nicotine goes along with it, but IMO you are confusing the main issue.

 

[Thulium]

A manufacturer/importer may claim that its nicotine replacement product is not intended to be used for what Congress considers to be the therapeutic purposes of 'craving relief', 'smoking cessation', and/or 'relapse prevention'; but, if this was true, then what is it intended to be used for?

From Judge Leon's opinion:

Smoking Everywhere describes "electronic cigarettes" as "an alternative to traditional smoked tobacco products" that is "designed to replicate the adult experience of smoking without combustion or the use of cancerous by-products." ​

​

Is it not self-evident circular logic that nicotine replacement products - by their very nature - are intended to relieve nicotine cravings in furtherance of the objective of ceasing and/or avoiding the use of tobacco?

Fixed it for you.

Electronic cigarettes simulate the experience of smoking, and while some utilize nicotine to recreate the physical sensation of smoking, it is optional. How can you call something a "nicotine replacement product" if the nicotine is optional?

Is this not the reason why nicotine is taken out of tobacco and added to a non-tobacco excipient in the first place?

Not necessarilly. Is caffeine taken out of coffee and added to a non-coffee product "in furtherance of the ceasing and/or avoiding the use of" caffeine? Note that caffeine products are regulated by the FDA as a drug when they are marketed for the treatment of a specific ailment (No-Doz for drowsiness, Excedrin for pain relief, etc.), but caffeinated productsare generally regulated as a food item (for "recreational" use) in all other cases.

Even if the use of questionable disclaimers - and the avoidance of making therapeutic claims - would be sufficient to prevent the e-cig from being classified as a drug/device product on the basis of therapeutic intent, the very act of adding nicotine to their novel, smoke-simulating, non-tobacco excipient solutions demonstrates an intent of manufacturers to affect the structure or functions of the bodies (and brains) of those who will consume their product.

Judge Leon doesn't agree:

That electronic cigarettes are devices for delivering nicotine and are intended to have the same effect on the structure and function of the body as cigarettes is hardly a basis for classifying electronic cigarettes as a drug-device combination, thereby excluding them from the definition of "tobacco product." If it were, then traditional cigarettes would be excluded as well. Indeed, any tobacco product containing nicotine and claiming to have some pharmacological effect would be excluded. Because this result would effectively dismantle the existing regulatory wall Congress erected between tobacco products and drug-device combinations, I can easily infer that Congress did not intend tobacco products to be drugs merely because they deliver nicotine.​

​

 

[rothenbj]

Well before this thread breaks out into the rhetorical tennis match I expect will develope, I gave up vaping an ecig.

I decided to pursue an acting career and have turned my chuck into a personal theater smoke machine.

 

[PhiHalcyon]

Well Phil, I don't know about anyone else, but I really like to smoke. I simply wanted to try these things and lo and behold, I liked them better than regular cigarettes. I don't really give a crap about the health benefits. If I was that worried about my health I would have quit smoking regular cigarettes years ago. I vape because I enjoy it. For me it was like changing brands. It was that simple.

This is about the act of smoking. The antis involved aren't really concerned about nicotine or the health concerns or benefits. They use that because they can't just say we don't want people to smoke. For them it's the act of smoking something that they find wrong. The question really is, do we have the right to smoke for enjoyment? Yes, nicotine goes along with it, but IMO you are confusing the main issue.

The 'main issue' is the will and intent of Congress; not why you switched to the e-cig, or what the antis think, say, or believe. And as Section 918(a) shows, Congress considers nicotine replacement products to be drugs used to treat tobacco dependence - not despite the fact, but because they, as Judge Leon put it, "are intended to have the same effect on the structure and function of the body as cigarettes." Had tobacco not naturally contained nicotine, but been added by tobacco product manufacturers, do you really believe that the Supreme Court decision in Brown would have been the same as it was? Hell no.

The only thing that saved tobacco products from FDA regulation at the time of the Brown case was the fact that CONGRESS intended tobacco products to continue to be sold; and yet, if regulated by the FDA as drugs and devices, they, as a result of being too harmful to have any therapeutic value, would need to be banned. In Section 907(d)(3)(A) of the Tobacco Act, Congress played off of this principle by continuing and clarifying its intent that tobacco products continue to be sold by prohibiting the FDA from banning "all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products."

If there is any doubt that the above classes of tobacco products represent the totality of tobacco product classes that Congress intended to be regulable as tobacco products ...

SEC. 919. USER FEES.
(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF TOBACCO PRODUCTS.—
(A) IN GENERAL.—The total user fees assessed and collected under subsection (a) each fiscal year with respect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year.
(B) APPLICABLE PERCENTAGE.—
(i) IN GENERAL.—For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accordance with clause (ii):
(I) Cigarettes.
(II) Cigars, including small cigars and cigars other than small cigars.
(III) Snuff.
(IV) Chewing tobacco.
(V) Pipe tobacco.
(VI) Roll-your-own tobacco.

There are no provisions for adding additional 'classes' of tobacco products. Therefore, if nicotinated non-tobacco products (i.e., nicotine replacement products) that are intended for recreational pleasure (rather than nicotine craving relief in furtherance of the objective of ceasing and/or avoiding the use of tobacco), are to be regulable as tobacco products, then apparently Congress does not believe that the manufacturers of such products should be required to pay their fair share of user fees.

Worse yet ...

Section 901(b) APPLICABILITY.---This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.

For whatever reason, Congress did not see it fit to make cigars and pipe tobacco immediately subject to FDA regulation; but, more importantly, if Congress intended that some nicotinated non-tobacco products be regulable as tobacco products, then, despite the fact that it clearly intends nicotine replacement products intended to relieve nicotine cravings in furtherance of the objective of ceasing and/or avoiding the use of tobacco to be regulated as chapter V drugs, it apparently considers nicotine replacement products intended for recreational pleasure to not, at this time, be regulated at all.

Consequently, the choice before the Court is: Did Congress intend that all nicotinated non-tobacco products be regulated as chapter V nicotine replacement products (either on the basis of explicit or implicit therapeutic intent, or on the basis of the manufacturer's intent clearly demonstrated in its adding of nicotine to its product); or, did Congress intend that some nicotinated non-tobacco products (at this time) not be regulated at all? And if it is the latter (as patently absurd as such a notion is), then WHY (in the event that the FDA seeks to issue a regulation making some nicotinated non-tobacco products subject to regulation as tobacco products) did Congress not make provisions for the manufacturers of nicotinated non-tobacco products to pay their fair share of user fees (in the same way that it did for manufacturers of cigars and pipe tobacco - who are not currently required to pay)?


Grab a can of snus, and jump off the caboose, of this runaway train of e-cig madness. For, the legal bridge ahead is nothing but a mirage.

 

[rothenbj]

So glad you cleared that up for use your honor.

 

[Janetda]

Phi,

You've gone round and round with this in the other thread, with much smarter people than me. I get that you REALLY think you're right. That's cool man, we all want to be right. But seriously, if your argument comes down to Congress didn't specifically state that e-cigs should be taxed therefore they must be a drug...I just don't know what to say to that. You have to let go of the NRT argument, because e-cigs are not NRTs. They are alternative cigarettes that allow me to take or leave the nicotine. If they took the nicotine out of regular cigarettes, would that make them any less a cigarette or any less taxable? I don't think so.

And for the love of God, PLEASE if you write any more about this, could at least speak like a person and not a lawyer. I'm just not smart enough to read through all your para-legaleeze.

 

[PhiHalcyon]

Janet,

As far as me wanting to be right ... I just recently celebrated my first full year of analog-free e-cig use, and would therefore strongly prefer that I was wrong. For, even though I have joined the crowd that uses snus in addition to the e-cig, I not only enjoy my vaping habit, but I also still consider the e-cig to be instrumental in keeping me away from smoking again. Nonetheless, there simply is no credible basis to believe that the e-cig/e-liquid product will escape being regulated as a drug/device combination. I sincerely wish that there was, but there is not. So, in direct contradiction to your accusation, it is not I - but those who vainly persist in denying the inevitable - who have the I-want-to-be-right-so-bad issue.

As for your mischaracterization of my argument ... I was referring to the user fees that tobacco product manufacturers must pay to fund the new tobacco product division of the FDA. Since Congress made no provision for manufacturers of nicotinated non-tobacco products to pay this user fee (either now, or in the future), Congress obviously did not intend for nicotinated non-tobacco products to be regulable as tobacco products. Furthermore, the reason why this is the case is that there is no such thing as a nicotinated non-tobacco product that is not regulable as a drug. For, as I pointed out in my OP, the very act of a manufacturer adding nicotine to a non-tobacco product demonstrates an intent to affect the structure or functions of the bodies and brains of those who will consume that product; and this is all that is needed to render a product a drug under 201(g) of the FDCA. Whether or not we sincerely consider ourselves to be using the e-cig for what Congress considers to be the therapeutic purpose of nicotine craving relief in furtherance of the objective of ceasing and/or avoiding smoking is irrelevant.

Nonetheless, I would not worry too much. For, I am absolutely certain that we will be able to replace the e-cig with something else when the time comes.

 

[Thulium]

Since Congress made no provision for manufacturers of nicotinated the very act of a manufacturer adding nicotine to a non-tobacco product demonstrates an intent to affect the structure or functions of the bodies and brains of those who will consume that product; and this is all that is needed to render a product a drug under 201(g) of the FDCA.

Judge Leon says you are wrong:

That electronic cigarettes are devices for delivering nicotine and are intended to have the same effect on the structure and function of the body as cigarettes is hardly a basis for classifying electronic cigarettes as a drug-device combination, thereby excluding them from the definition of "tobacco product." If it were, then traditional cigarettes would be excluded as well. Indeed, any tobacco product containing nicotine and claiming to have some pharmacological effect would be excluded. Because this result would effectively dismantle the existing regulatory wall Congress erected between tobacco products and drug-device combinations, I can easily infer that Congress did not intend tobacco products to be drugs merely because they deliver nicotine.​

​

 

[rothenbj]

Your argument is fine, until you remove the nic from the liquid. Now you have a product that contains nothing that is regulated under ethical drug regulation. I personally can live with snus and nic free vapor easily. The snus gives me the alkaloids that, to me, are more important than the nic. The PV handles the hand to mouth habit plus the incredible flavors.

 

[Mac]

It's people like you who continue to harp on this absurd notion that e-cigs should be illegal who keep the rich rich and the poor poor while keeping smokers dead. I hope you are proud of yourself and welcome to my ignore bin.

 

[Mac]

Why don't you just admit that you work for whatever anti group, BP or tobacco company thats funding your little tirades, count your blood money and call it a day?

 

[Mac]

Urban Dictionary: sell

 

[PhiHalcyon]

Judge Leon says you are wrong:

That electronic cigarettes are devices for delivering nicotine and are intended to have the same effect on the structure and function of the body as cigarettes is hardly a basis for classifying electronic cigarettes as a drug-device combination, thereby excluding them from the definition of "tobacco product." If it were, then traditional cigarettes would be excluded as well. Indeed, any tobacco product containing nicotine and claiming to have some pharmacological effect would be excluded. Because this result would effectively dismantle the existing regulatory wall Congress erected between tobacco products and drug-device combinations, I can easily infer that Congress did not intend tobacco products to be drugs merely because they deliver nicotine.​

​

I do not blame you for being tempted to take comfort in Judge Leon's ruling, but his thinking here is not exactly new to me. On 10-6-09 (better than 90 days before Judge Leon's ruling), I said this:

Since the FDA was given authority to regulate the nicotine-yield of tobacco products, (but explicitly prohibited from requiring a nicotine-yield of zero), then neither the presence of nicotine in a tobacco product, nor any implied intent of the presence of nicotine in a tobacco product, can be used as the basis of classifying a tobacco product a drug. Otherwise, all tobacco products would be drugs ...
( http://www.e-cigarette-forum.com/fo...post625907.html?highlight=nicotine#post625907 )

Further supporting this line of thinking is:

SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
(a) IN GENERAL.—Tobacco products, including modified risk tobacco products for which an order has been issued in accordance with section 911, shall be regulated by the Secretary under this chapter and shall not be subject to the provisions of chapter V.

For, since tobacco naturally contains nicotine, and tobacco products, in general, are to not be subject to the provisions of chapter V, then Congress could not have intended for tobacco products to be classified as drugs/devices solely on the basis that they contain and deliver nicotine. Nonetheless, there are a few very real problems in trying to apply this logic to the e-cig:

Problem 1: Neither the e-cig, nor e-liquid, are tobacco products that contain and deliver nicotine. They are NON-tobacco products that contain and deliver nicotine.

Problem 2: E-liquid, unlike tobacco, does not naturally contain nicotine. The nicotine is added to it, and it is this adding of nicotine to e-liquid that unmistakably demonstrates an intent on the part of the manufacturer to affect the structure or function of the bodies and brains of those who will consume it.

Problem 3: Congress did not intend for nicotinated non-tobacco products to be regulable as tobacco products. Not only is this clear on the user-fee (and fixed number of tobacco product classes) basis that I pointed out earlier, but it is also firmly supported by the fourth paragraph of the definition of tobacco products: 201(rr)(4), A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). Which (with the exception of alcohol, meat, dairy, eggs, and produce products) includes virtually every imaginable article or product that is sold or suitable for human consumption.

Your argument is fine, until you remove the nic from the liquid. Now you have a product that contains nothing that is regulated under ethical drug regulation. I personally can live with snus and nic free vapor easily. The snus gives me the alkaloids that, to me, are more important than the nic. The PV handles the hand to mouth habit plus the incredible flavors.

I completely agree that a snus/nicotine-free e-cig combination would be an effective and acceptable plan to have to live with. And it sure would be mighty darn convenient for the e-cig hardware to stay readily available for this purpose. But, in not wanting to open up a whole new line of debate, I will simply say that I am not so confident that this will be the case. If you are right, then super; but if you are wrong, then there are alternate solutions. So I am not really that concerned about it.

It's people like you who continue to harp on this absurd notion that e-cigs should be illegal who keep the rich rich and the poor poor while keeping smokers dead. I hope you are proud of yourself and welcome to my ignore bin.

You are inappropriately construing my assessment of the law as being representative of my personal opinion of how things should be. They are NOT one and the same. The question I am addressing is not whether or not I personally believe that e-cigs should be illegal, but whether or not the e-cig is currently an unappoved drug/device product under the laws that someone other than me wrote.

 

[Thulium]

Problem 1: Neither the e-cig, nor e-liquid, are tobacco products that contain and deliver nicotine. They are NON-tobacco products that contain and deliver nicotine.

E-cigs and e-liquid have not yet been defined by law. Define them as tobacco products and this problem goes away.

Problem 2: E-liquid, unlike tobacco, does not naturally contain nicotine. The nicotine is added to it, and it is this adding of nicotine to e-liquid that unmistakably demonstrates an intent on the part of the manufacturer to affect the structure or function of the bodies and brains of those who will consume it.

You are equivocating. You are saying that e-liquid doesn't contain tobacco therefore when you add tobacco to it it is still not tobacco.

E-liquid DOES naturally contain nicotine...if the law says it does. Don't forget that NONE of these products have been defined by law, but Judge Leon ruled that electronic cigarette as defined by Smoking Everywhere can be considered a tobacco product. If Smoking Everywhere's definition of e-cigarette can pass muster, surely other products that have not been defined (e-liquid or "liquid tobacco" or simply "electronic cigarette refills" if thats what it takes) by any law thus far could be made tobacco products and thereby protected from ban.

I strongly disagree that the presence of nicotine demonstrates an intent to affect structure or function, and Judge Leon's opinion affirms this. The presence of nicotine demonstrates the intention of fully recreating the smoking experience in a smoke-free tobacco product. As you pointed out, the absence of nicotine does not preclude e-cigs from being considered a tobacco product so the fact that you can use substances other than liquid tobacco products in an electronic cigarettes does not preclude them from being a tobacco product.

Problem 3: Congress did not intend for nicotinated non-tobacco products to be regulable as tobacco products. Not only is this clear on the user-fee (and fixed number of tobacco product classes) basis that I pointed out earlier, but it is also firmly supported by the fourth paragraph of the definition of tobacco products: 201(rr)(4), A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). Which (with the exception of alcohol, meat, dairy, eggs, and produce products) includes virtually every imaginable article or product that is sold or suitable for human consumption.

Judge Leon ruled that electronic cigarettes CAN NOT be regulated as a drug because their clearly intended use is to perpetuate a nicotine addiction rather than treat it. Provisions for Modified Risk tobacco products along with Judge Leon's ruling as a guide make it possible for electronic cigarettes to be classified as a tobacco product, so unless you can get your favorite e-cigarette or e-liquid classified by law as a tobacco product, it can be made illegal.

I completely agree that a snus/nicotine-free e-cig combination would be an effective and acceptable plan to have to live with. And it sure would be mighty darn convenient for the e-cig hardware to stay readily available for this purpose. But, in not wanting to open up a whole new line of debate, I will simply say that I am not so confident that this will be the case. If you are right, then super; but if you are wrong, then there are alternate solutions. So I am not really that concerned about it.

I would be kinda/sorta okay with a snus + 0 nic or DIY combo...but fortunately, Smoking Everywhere has paved the legal path for electronic cigarettes to be legitimized as a smoke-free tobacco product.

Nicotine isn't used in electronic cigarettes to affect the structure or function of the body any more than it is used as such in traditional cigarettes. No, Nicotine is used in electronic cigarettes to affect the function of the e-cigarette to better replicate the smoking while significantly reducing the risk as allowed by Congress for tobacco products.

You are inappropriately construing my assessment of the law as being representative of my personal opinion of how things should be. They are NOT one and the same. The question I am addressing is not whether or not I personally believe that e-cigs should be illegal, but whether or not the e-cig is currently an unappoved drug/device product under the laws that someone other than me wrote.

And I appreciate that about you. However, you are neglecting to properly account for jurisprudence. Even though you see your interpretation of the law as the only one that is legitimate, legal precedent trumps an individual interpretation unless and until it is overturned. There were "laws" against discrimination before Jim Crow, but it was only when they were reinterpreted by the court and new laws were written that we began to actually do something about it.

If you are so convinced that courts will ultimately have to concede that e-cigs are a drug/device, then rather than giving the point to the opposition, take the (allegedly limited) opportunity to encase the e-cig's status into law NOW while we have Judge Leon's precedent to defend it. Then, if and when the law is challenged, we will have on our side the intent of the voters/legislators that e-cigs should be taxed and regulated as a tobacco product and a ban (even if you are right) is that much less likely.

 

[D103]

Obviously several candy bars should then be subject to FDA reclassification as "drug-delivery devices" since several have added significant amounts of caffeine ( an addictive drug) to their products and in fact outwardly promote these new products for their "amazing boost" in energy-clearly affecting the structure or functions of the bodies and brains of those consumers who choose to use these products. Also most "energy drinks" then should also be reclassified for the very same reason. I realize I am being sarcastic but the .......d up logic does apply. I believe their is a strong contingency of Public Health Physicians and Health Care workers who are pushing electronic cigarettes to be classified as a "Harm-Reduction" product and viable alternative to tobacco smoking. There are several very compelling reports on this at the Tobacco Harm-Reduction.org webpage and elsewhere on the web. I believe several are available on the
CASAA website as well

 

[victoria12]

its a very interesting thread..but i have to say that i'm also usng the e cig because i enjoy thiw type of smoking. I have also quit smoking regular cigarettes thx to e cigarette.

 

[PhiHalcyon]

Judge Leon ruled that electronic cigarettes CAN NOT be regulated as a drug because their clearly intended use is to perpetuate a nicotine addiction rather than treat it.

SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
(a) IN GENERAL.—The Secretary shall—(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 506; (2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and (3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.

As Section 918 above clearly shows, Congress sees nicotine replacement products as drugs used to treat tobacco dependence; NOT nicotine addiction. Nicotine replacement products are used to relieve cravings in furtherance of the cessation and/or avoidance of tobacco use, meaning that their extended use can still be understood as being a treatment. This is why the recreational-use-of-nicotine argument is no better than the tobacco-product argument.

I strongly disagree that the presence of nicotine demonstrates an intent to affect structure or function, and Judge Leon's opinion affirms this.

Why do you spend $15-35 for a $3 bottle of flavor extract? Nicotine. And for what? To relieve your cravings in furtherance of your objective to no longer smoke.


Anyway, sorry for the delay. Ever since the recent Appeals Court decision to grant the stay, I have not been able to focus on anything but making the imminent fate of the e-cig to be inconsequential. For, it is difficult to know exactly how things will unfold once the Appeals Court rules on the appeal - making now the very best time to ensure that the fate of the e-cig will have absolutely nothing to do with ours. And, fortunately, I have been at work on this for a while now.

 

[Thulium]

SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
(a) IN GENERAL.—The Secretary shall—(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 506; (2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and (3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.

As Section 918 above clearly shows, Congress sees nicotine replacement products as drugs used to treat tobacco dependence; NOT nicotine addiction. Nicotine replacement products are used to relieve cravings in furtherance of the cessation and/or avoidance of tobacco use, meaning that their extended use can still be understood as being a treatment. This is why the recreational-use-of-nicotine argument is no better than the tobacco-product argument.

I think your logic is working backwards. Just because Congress acknowledges the prolonged use of nicotine replacement therapy does not mean that all products containing nicotine are intended for therapeutic use.

Why do you spend $15-35 for a $3 bottle of flavor extract? Nicotine. And for what? To relieve your cravings in furtherance of your objective to no longer smoke.

I don't know about you, but that is certainly not the reason I buy e-liquid. ...and I never had the objective to no longer smoke--on the contrary, I buy e-liquid so that I can continue to enjoy the activity of inhaling the vapor of a tobacco product without the hazardous products of combustion found in traditional smoke vapor. The fact that this means I have stopped smoking cigarettes is a happy coincidence.

To say that the "objective" of e-cigarettes is to no longer smoke is like claiming the "objective" of Chantix is to make yourself miserable.

 

[noo]

I think the entire reasoning behind this argument, as well as what the FDA states is begging the question. Obviously, the presence of nicotine in these devices will give the users the anticipated results associated with nicotine use. Obviously, a "device" which delivers nicotine in a manner other than burning tobacco is an "alternate" nicotine delivery "device." Therefore, any product that contains nicotine must be intended as an "alternative" to tobacco delivery. The conclusion is implied by the premise!

Of course the great leap in reasoning here is stating that "all alternatives to tobacco must be intended as a means to cease tobacco use" as opposed to tobacco cessation being an ancillary effect of participating in a recreational activity. There IS a difference.

I don't understand how caffeine is frequently advertised - to children no less - in vague medical terms. Advertising alertness, insomnia relief, mood elevation and cognitive benefits does not make Red Bull a medical product, but the innate nature of the effects the E cig has on tobacco consumption does? In the same way, the FDA has not gone after high caffeine "herbal supplements" as a means to stop soda consumption, despite the fact that soda is addictive, contributes to obesity and is marketed to children.

I just don't think that the FDA has the authority to declare that tobacco is the only permissible means of consuming nicotine in a recreational manner. I think the SE/Njoy lawyers will make essentially the same argument I made above, and hopefully the appeals court will agree.