The Ecig: A Nicotine Replacement Product?

[PhiHalcyon]

Arguing from the FDA's perspective has not exactly been a joyride, but now that I have taken the FDA argument as far as I can, I will now make the best appropriate counter-argument:


Even though Congress did not make pipe tobacco immediately subject to the provisions of Chapter IX, it did foresee the possibility of the FDA changing this via future regulation. Congress also prohibited the FDA from banning all pipe tobacco in the same way that it did for cigarettes and smokeless tobacco products.

Congress did not define pipe tobacco in the Tobacco Act, but it did define pipe tobacco in Section 5702 of the Internal Revenue Code: 5702(n) Pipe tobacco; The term ''pipe tobacco'' means any tobacco which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco to be smoked in a pipe.

It is a well-known fact that not all pipes enable the smoking of tobacco via the process of combustion. Some tobacco pipes enable the smoking of tobacco merely by drawing heated air through ground tobacco - causing some of the tobacco's constituents to be vaporized and inhaled (i.e., smoked).

The electronic cigarette takes the tobacco vaporizing pipe to the next logical step in the intelligent quest of smokers to seek to do what they enjoy doing - which is smoke tobacco - in the least harmful way possible. Rather than vaporizing many tobacco constituents - including harmful ones (like the tobacco vaporizing pipes do), the electronic cigarette vaporizes an highly purified tobacco extract.

The tobacco extract that is vaporized and inhaled (i.e., smoked) via the electronic cigarette consists of nicotine derived from tobacco and certain non-tobacco additives. And since these additives are not forbidden from being added to pipe tobacco, the tobacco extract smoked via the electronic cigarette is a liquid form of pipe tobacco that is a tobacco product as defined in Section 201(rr)(1) of the FDCA.

It is not surprising that the FDA would see the electronic cigarette as being a nicotine delivery device. It seen regular cigarettes in the same way. It is also understandable how the FDA may see the electronic cigarette as being a nicotine replacement product. But, the therapeutic uses that Congress recognized for nicotine replacement products (drugs used to treat tobacco dependence), are 'smoking cessation', 'relapse prevention', and 'craving relief' - none of which apply to the electronic cigarette as it is actually, and intended to be, used.

To say that the electronic cigarette is a product that is used for smoking cessation is to misunderstand what the electronic cigarette is. It is not a product that is used for smoking cessation; it is a product that is used for smoking purification. For, those who use the electronic cigarette are still smoking; they are just smoking in the purest and least harmful way possible.

To say that the electronic cigarette is a product that is used for relapse prevention is also invalid. For, those who use the electronic cigarette never stopped smoking in the first place. They just changed the way in which they smoke.

To say that the electronic cigarette is a product that is used for craving relief would be valid if those who used it were trying to quit smoking. But, as already pointed out, those who use the electronic cigarette are not trying to quit smoking. They want to smoke. They enjoy smoking. They just do not want to kill themselves and others in the process. So, they smoke in the purest and least harmful way ever developed, and that is with the electronic cigarette (aka, the tobacco extract vaporizing pipe).

 

[PhiHalcyon]

Since it was too late to edit my previous post, what follows is a clarified version of the above argument.

 

[PhiHalcyon]

Even though Congress did not make pipe tobacco immediately subject to the provisions of Chapter IX, it did foresee the possibility of the FDA changing this via future regulation. Congress also prohibited the FDA from banning all pipe tobacco in the same way that it did for cigarettes and smokeless tobacco. What Congress did not do was define pipe tobacco within the Tobacco Act. It has, however, defined pipe tobacco in Section 5702(n) of the Internal Revenue Code: Pipe tobacco; The term ''pipe tobacco'' means any tobacco which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco to be smoked in a pipe.

It is a well-known fact that not all pipes enable the smoking of tobacco via the process of combustion. Some tobacco pipes enable the smoking of tobacco merely by drawing heated air through it - causing some of the tobacco's constituents to be vaporized and inhaled (i.e., smoked) without any combustion. The electronic cigarette takes the tobacco vaporizing pipe to the next logical step. Instead of vaporizing the ground up leaves of tobacco (which eliminates all the by-products of combustion, but none of the harmful smoke constituents created via tobacco vaporization), the electronic cigarette is designed to heat and vaporize a substantially purified tobacco extract.

The tobacco extract that is heated, vaporized, and inhaled (i.e., smoked) via the electronic cigarette consists of tobacco extractives, and certain non-tobacco additives used for flavoring and dilution. None of these non-tobacco additives are prohibited from being adding to a tobacco product; and tobacco extractives are clearly a tobacco product as defined in Section 201(rr)(1) of the FDCA. Consequently, both the electronic cigarette, and the tobacco extract that it vaporizes, are clearly tobacco products; with tobacco extract being a liquid form of pipe tobacco, and the electronic cigarette a modern pipe.

It is not surprising that the FDA would see the electronic cigarette as being a nicotine delivery device. It seen regular cigarettes in the same way. It is also understandable how the FDA may confuse the electronic cigarette with being a nicotine replacement product. Nonetheless, the therapeutic uses that Congress has recognized for nicotine replacement products are: smoking cessation, relapse prevention, and craving relief. None of which apply to the electronic cigarette as actually and intended to be used.

To say that the electronic cigarette is used for smoking cessation is to fail to understand exactly what the electronic cigarette is. Rather than being used for smoking cessation, the electronic cigarette is used for the substantial purification of smoking. For, those who use the electronic cigarette are still participating in the bona fide act and practice of smoking. They are simply choosing to inhale a much cleaner smoke than is produced through the combustion and/or vaporization of cured tobacco leaves. Even when one smokes tobacco via the traditional means of combustion, the smoke that is inhaled consists of both the by-products of combustion and vaporization. And as the tobacco vaporizing pipes well demonstrate, combustion is not a necessary part of smoking tobacco. In fact, smoking tobacco via combustion is just a crude and dangerous means of smoking tobacco via vaporization. So, rather than the burning or combustion of tobacco, it is actually the vaporization of tobacco that is at the heart of what smoking is all about. And since it is the vaporization of a tobacco extract that is being smoked via the electronic cigarette (the cleanest form of smoking ever invented), to say that the electronic cigarette is used for relapse prevention is just as invalid as to say that it is used for smoking cessation. For, those who smoke via the electronic cigarette never stopped smoking in the first place.

Furthermore, to say that the electronic cigarette is used for craving relief would be valid if those who used it were trying to quit smoking. But, as already pointed out, those who use the electronic cigarette are not trying to quit smoking. They want to smoke. They enjoy smoking. They simply do not want to kill neither themselves nor others in the process. So, in not wanting to quit smoking, they make the admirable and responsible decision to smoke in the cleanest and least dangerous way that there is - which is with the tobacco-extract vaporizing pipe known as the electronic cigarette.

Consequently, since the electronic cigarette is not used for smoking cessation, relapse prevention, nor for therapeutic craving relief while attempting to quit smoking, the electronic cigarette is neither a nicotine replacement product as defined by Congress, nor a drug used to treat tobacco dependence. It is just a modern and intelligent tobacco-extract vaporizing pipe that is used as a cleaner way to smoke.

 

[Thulium]

Phi, the only problem I have with that stance is you seem to be more willing to be flexible with your definition of "smoke" than with your definition of "tobacco" when it is in fact "tobacco" and "tobacco product" that can be defined by law. Smoke is defined by nature as the gaseous products of combustion. Granted, there is a verb form of the word "smoke" that is encased in law, but I think it is a slippery slope to expand the definition of "smoke" to include vapor.

 

[PhiHalcyon]

Phi, the only problem I have with that stance is you seem to be more willing to be flexible with your definition of "smoke" than with your definition of "tobacco" when it is in fact "tobacco" and "tobacco product" that can be defined by law. Smoke is defined by nature as the gaseous products of combustion. Granted, there is a verb form of the word "smoke" that is encased in law, but I think it is a slippery slope to expand the definition of "smoke" to include vapor.

Since the legal availability of the e-cig as a tobacco product (if possible to achieve) would logically be more important than the question of where it can be used, I am not the least bit concerned about the slippery slope issue. Nonetheless, due to the composition of e-liquid and its resulting vapor, I would tend to agree with the virtually universal e-cig user opinion that we are NOT smoking. Consequently, that which is the closest we could have gotten to a winning argument does not even apply to the e-cig. For, since we are not smoking, we cannot argue that e-liquid is a form of pipe tobacco that is "suitable for use and likely to be offered to, or purchased by, consumers as tobacco to be smoked in a pipe"; and if we cannot argue that e-liquid is a form of pipe tobacco, then e-liquid - in having no tobacco product class in which it fits - cannot be classified as a tobacco product.

The definition of tobacco products is inclusive of both products that are regulable as tobacco products and products that are not regulable as tobacco products. And the primary line that separates them is the tobacco product classes that Congress has established. For it is only the tobacco products that Congress has intended to continue to be sold (i.e., those classified and prohibited from being banned) that are the tobacco products that were precluded by the Supreme Court from being regulated as drugs and devices. The secondary line that separates the tobacco products that are regulable as tobacco products from the tobacco products that are not regulable as tobacco products is the prohibition against marketing a tobacco product in combination with a non-tobacco article or product regulated under the FDCA.

Since the combination prohibition paragraph says nothing about how a combination product is intended to be used, it is difficult to decisively argue that e-liquid is not a prohibited combination product (even though I did take a crack at doing so in my attempted counter-argument). However, whether e-liquid is a prohibited combination product or not, the fact that it does not fit within any of the tobacco product classes that Congress has established is all that it takes to make it unregulable as a tobacco product.

The e-cig was specifically designed to be a nicotine replacement product in China (where they are not regulated as drugs); not to be a product that would be considered a tobacco product under U.S. law. So, the truth is that we have been introduced to an unapproved nicotine replacement product that has enabled us to break our bondage to cigarettes; educated us about the nature of our addiction(s); and provided us with a working example of what is possible and desirable in a safer smoking alternative.

Now we just need to take what we have learned from the e-cig; cast it into the matrix of the counter-argument that I presented; and pursue the rational non-futile objective of re-designing the e-cig into a legal tobacco product form. For, short of a miracle, the e-cig is likely to be going away for a while; and when it comes back (in big pharm/FDA-approved form), we may neither want nor recognize it.

 

[david_juan28]

E-cigarettes are the best alternatives. You can stay away from the health disorders.

 

[PhiHalcyon]

As already noted, my attempted counter-argument failed in the defense of the e-cig because the fact that we do not smoke e-liquid in a pipe means that e-liquid is not a liquid form of pipe tobacco; and because e-liquid does not fit within any of the other tobacco product classifications either. There is, nonetheless, another important reason why my attempted counter-argument was an inadequate defense of the e-cig, and that reason is the combination prohibition.

Since the prohibition against marketing a tobacco product in combination with a non-tobacco article or product regulated under the FDCA is in the fourth paragraph of the definition of tobacco products, it must be understood to pertain to products which are tobacco products under paragraph one. However, Congress did not declare prohibited combination products to not be tobacco products in the same way that it did in paragraph two for tobacco products that are drugs. Therefore, a prohibited combination product that is NOT marketed for therapeutic purposes (i.e., not regulated as a drug under chapter V) is simply a tobacco product that is prohibited from being sold.

The argument that e-liquid is excluded from the combination prohibition because it is not marketed as a food or flavor extract, but as a tobacco product, has been very tempting; but, the now clearly seen fact that defeats it is that it is AS tobacco products that combination products are prohibited! Therefore, even if it was possible to successfully argue that e-liquid is not marketed for the therapeutic purpose(s) of smoking cessation, craving relief, or relapse prevention, it would STILL be illegal to sell. For, the actual and intended effect of the combination prohibition is that any combination product that is not sold and regulated as a drug is prohibited from being sold.

The tobacco argument fails because e-liquid does not fit within any of the tobacco product classes that Congress has established and protected; and because e-liquid is a prohibited combination product. The recreational nicotine product argument fails because combination products are prohibited from being sold unless sold and regulated as drugs. Consequently, there is no winning argument for the e-cig ... even if we do smoke e-liquid in an electronic pipe.

 

[PhiHalcyon]

In conclusion, since all nicotinated non-tobacco products are tobacco products under paragraph one of the definition of tobacco products, but are prohibited combination products under paragraph four, no nicotinated non-tobacco product can be legally sold unless it is sold and regulated as an FDA-approved chapter V drug product.

This has been the regulatory reality for decades. And even though Judge Leon questioned whether this was a legitimate regulatory reality when he pointed out that some of the FDA's past actions had not been subject to judicial review, Congress has validated this regulatory reality with the combination prohibition - while simultaneously declaring that (in giving the FDA the authority to regulate tobacco products) it was neither affecting, limiting, nor expanding the FDA's chapter V authorities.

Prior to the Tobacco Act, nicotine replacement products were generally used to assist people in the transition from being a smoker to being a non-smoker. But Congress has now encouraged the FDA to consider approving the extended use of nicotine replacement products for the therapeutic purposes of craving relief and relapse prevention. Consequently, FDA-approved nicotine replacement products will not be limited to being sold only as a smoking cessation aid for graduated temporary use, but they will soon also be legitimately sold as we use the e-cig - which is as an extended-use smoking alternative.

What this Congressional encouragement/authorization assures is an intense competitive battle between the tobacco and pharmaceutical industries for the very lucrative, nicotine consumption market; and this battle is certain to result in a growing number of low-risk, nicotine delivery products from both camps. But as big tobacco seeks to push the definition of a classifiable tobacco product to the extremes, big pharm will attack (via its many shameless allies) any low-risk tobacco product that threatens its market share potential with ridiculous, hypocritical arguments like those now being spewed at dissolvables.

So, as e-liquid is now poised to be confirmed by the Courts to be an unapproved new drug product that is illegal to sell without prior FDA approval (and the e-cig a non-compliant/unapproved medical device); while big pharm's paid allies seek to attack any tobacco product that even remotely threatens to infringe on the low-risk nicotine market that big pharm has long considered to be its own; I deem the singlemost important task at hand to be learning to be self-sufficient makers of whatever "paragraph-one" tobacco product that we may prefer to enjoy. For, if paragraphs two through four do not damn our preferred products to the boneyard of worthy innovations that have been murdered by medicine-minded nannies, then big pharm's shameless 'save the children' alarmists will most probably seek to get them banned.