Over the past couple months there have been some opponents of electronic cigarettes coming out publicly and making many false or misleading statements about electronic cigarettes. These nay-sayers often use phrases such as “we just don’t know” to further their agenda against electronic smoking. On the flip side, there are some suppliers and supporters of e-cigarettes making statements that are also not entirely true to promote the product and gain public acceptance of the technology. So, below is an incomplete list of what we do and what we don’t know about electronic cigarettes.

Here’s what we DON’T know about electronic cigarettes:

1) We don’t know that they contain carcinogens. Some e-liquid may, but some may not. The FDA tested it and found that some do, but it wasn’t clear that they were found in the actual vapor. What was clear, was that when it was found, it was in trace levels.

2) We don’t know what the long term effects are of inhaling propylene glycol (or vegetable glycerin) may be. The EPA study on Propylene Glycol states, “A review of the available data has shown propylene glycol and dipropylene glycol to be negative for carcinogenicity in studies conducted up to the testing limit doses established by the Agency; therefore, no further carcinogenic analysis is required.” and “Upon reviewing the available toxicity information, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol.” With that said, we still can’t say for certain what the long term implications of inhaling propylene glycol are to the user.

3) We don’t know if electronic cigarettes can help someone stop smoking. We have argued many times on this blog that is is actually a poor stop smoking product because it allows the continuation of the smoking habit. It also continues to deliver nicotine which is addictive and one reason smokers keep smoking. Either way, there is no evidence that it is an effective quit smoking product.

4) We don’t know if this is eventually something kids will try. To date, there is no evidence that any kids have tried e-cigarettes especially those who have never smoked. We fully support making electronic cigarettes an adult only product.

Here’s what we DO know about electronic cigarettes:

1) The majority of the vapor produced consists of propylene glycol, glycerin and water. There is also generally some amount of nicotine in the vapor, unless zero nicotine e-liquid is used. This doesn’t mean there is nothing bad in the vapor, it just means that we do know what is in the majority of the vapor. Further testing is under way to find out all the trace elements.

2) There is no smoke produced because there is no combustion.

3) At least some smokers find e-smoking to be a decent alternative to smoking tobacco.

4) Electronic cigarettes have been on the worldwide market for approximately 7 years with no reports of major issues from the users. There have been reports of dry throat, headaches and other minor symptoms. This does not mean that there won’t be reports of more severe issues from users, but it does mean there haven’t been any yet.

5) To our knowledge, tobacco companies DO NOT make or sell any electronic cigarettes on the market. In the United States most are sold by smaller, start up businesses.

6) Burning tobacco is the cause of upwards of 400,000 deaths per year in the United States alone and electronic cigarettes are an alternative to it.

On Thursday, September 10, 2009, an ad-hoc group of electronic cigarette users, calling themselves the Alliance of Electronic Smokers, filed an amicus brief in the litigation against the FDA by two electronic cigarette suppliers.

Here is the information regarding their brief:

MOTION OF ALLIANCE OF ELECTRONIC SMOKERS FOR LEAVE TO PARTICIPATE AND FILE BRIEF AS AMICUS CURIAE

The Alliance of Electronic Smokers (AES), as an interested nonparty, respectfully moves the Court for leave to participate and file a brief as amicus curiae in this litigation in support of Plaintiff’s and Intervenor-Plaintiffs’ Motions for Preliminary Injunction.

ARGUMENT

As set forth in greater detail in the accompanying Brief of Amicus Curiae, AES is an ad hoc group consisting of current consumers of electronic cigarettes (e-cigarettes) that would like to preserve their current choice of tobacco products – a right that is being eliminated by the efforts of the U.S. Food and Drug Administration (FDA) improperly to exert regulatory authority over e-cigarettes. AES and its members are concerned that their right to choose a preferred vehicle for smoking pleasure could be infringed based on the outcome of the present case. Accordingly, AES and its members have significant interests in the outcome of this litigation. Moreover, AES believes that its perspective would be helpful to the Court in evaluating the merits of this matter. In particular, AES responds to points raised in the submissions by Action on Smoking and Health (ASH), which this court has granted permission to appear as amicus curiae. AES is including as Exhibit A hereto its proposed amicus brief with this motion.

Because the proposed brief responds to points raised in ASH’s previous submissions in this matter, AES believes its participation will not prejudice any party. Pursuant to Local Rule 7(m), undersigned counsel has conferred by telephone with counsel for the Plaintiff and Intervenor Plaintiff, and they do not oppose this Motion. Also, AES conferred with counsel for Defendants regarding their consent and, as of the time of this filing, was still waiting for a response.

BRIEF OF AMICUS CURAE

ALLIANCE OF ELECTRONIC SMOKERS

The Alliance of Electronic Smokers is an ad hoc group of adult smokers who use and enjoy electronic cigarettes (”e-cigarettes”) for recreational purposes and wish to continue to do so. E-cigarettes have been available to smokers since 2007 and, until recently, the U.S. Food and Drug Administration (”FDA”) had made no effort to restrict their use. We wish to bring several points to the Court’s attention, and to comment on various issues raised by amicus Action on Smoking and Health (”ASH”) in its recent filings:

I. THE NEW TOBACCO ACT

If FDA wishes to regulate e-cigarettes, it now has an avenue to do so—through the Family Smoking Prevention and Tobacco Control Act (“FSPTCA”), Public Law No: 111-31, H.R. 1256, 111th. Cong. (2009). FDA acknowledges that e-cigarettes would fit the statutory definition of a “tobacco product” under the FSPTCA. See Defendants’ Supplemental Brief In Opposition to Plaintiff’s and Intervenor’s Motions For A Preliminary Injunction, filed July 10, 2009, at 5 n.3. The FSPTCA reflects a legislative compromise. The Act allows FDA to regulate many elements of the production, labeling and advertising of “tobacco products,” while ensuring that nicotine cannot be banned for recreational use. FSPTCA Section 907(d)(3) (the Secretary may not “requir[e] the reduction of nicotine yields of a tobacco product to zero.”). Under section 901(b), FDA could regulate (but not ban) e-cigarettes following notice and comment rulemaking. Indeed, there is no statutory or other legal reason why FDA could not issue a notice promptly and complete this type of rulemaking in a matter of months.1

Congress recognized expressly in the FSPTCA that FDA did not previously have drug jurisdiction over tobacco products. FSPTCA, Sec. 2(7) & (12), Sec. 3 (1-7). The term “tobacco products” in the FSPTCA reflects the holding from the Supreme Court’s decision in FDA v. Brown & Williamson. 529 U.S. 120, 131, 158-59 (2000). In that case, the Supreme Court held that “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products.” 529 U.S. at 126. Just as it has in this case, the FDA argued in Brown &Williamson that tobacco products were within its drug jurisdiction because they are intended “to deliver the pharmacological effects of satisfying addiction, stimulation and tranquilization. . . .” 529 U.S. at 131. But the fact that tobacco products deliver nicotine with stimulative pharmacological effects did not convince the Supreme Court that FDA had jurisdiction to regulate tobacco as a drug as customarily marketed for tobacco pleasure. Id. at 158-59. Indeed, the Supreme Court only noted one possible exception to its conclusion that FDA lacked drug jurisdiction over tobacco products – “with respect to the well-established exception of when the manufacturer makes express claims of therapeutic benefit.” Id. at 158-59 (emphasis supplied). As the Plaintiff and Plaintiff-Intervenor have argued in this litigation, there are no such claims of “therapeutic benefit” in the record in this case; nothing in the record shows such products were offered to help smokers them quit smoking (i.e. for smoking cessation) or for any other medical purpose.

II. FDA’s PRIOR VIEWS ON BROWN & WILLIAMSON

Until recently, FDA agreed that the Brown & Williamson case precluded it from exercising drug jurisdiction over “tobacco products” offered for sale for non-therapeutic purposes, i.e. as customarily marketed for “tobacco pleasure.” Indeed, in 2003 FDA considered a citizen petition requesting that FDA classify as a drug a new non-cigarette “tobacco product” named “Ariva” – a tablet consisting of “cigalett” pieces of compressed powdered tobacco, mint flavoring and other ingredients.” Like e-cigarettes, Ariva’s labeling indicated that it would deliver nicotine to its users “When you can’t smoke,” and indicated that the product “contains nicotine, an addictive substance.” See Attachment A hereto, August 29, 2003, letter from John M. Taylor, III, Associate Commissioner for Regulatory Affairs, FDA, at 2 (emphasis added). The FDA concluded that it did not have drug jurisdiction over Ariva and explained very clearly that it viewed the Brown & Williamson decision to cover this new “tobacco product:”

The Court [in Brown & Williamson] concluded that FDA has no jurisdiction over “tobacco products as customarily marketed” because they simply do not fit within FDCA’s regulatory scheme. The Court recognized that “customarily marketed” tobacco products do not include products for which claims of therapeutic benefit, including “drug claims” or “health claims” are made.” . . . . FDA believes that, based on the information available to it at this time, it is precluded from asserting jurisdiction over Ariva as currently marketed because it is a “customarily marketed” tobacco product within the meaning of Brown & Williamson.

Id. at 2-3 (citations omitted and emphasis added).

III. RESPONSE TO ASH’S AMICUS ARGUMENTS

ASH has filed an amicus brief, and apparently has also sent the court a letter with a ten-page single spaced commentary on the August 17th hearing, dated August 24, 2009 (the “August 24 letter”). Notably, much of the amicus material is not relevant here or part of the administrative record compiled by FDA. For example, neither of the e-cigarette manufacturers acting as plaintiffs here have advertised or sell their products as delivery mechanisms for approved drugs with therapeutic effects, like Cialis or Viagra, as ASH’s August 24 letter misleadingly suggests. Similarly, ASH purports to identify certain other relevant products containing nicotine, but none are relevant here, because: (1) those products made specific claims about therapeutic purposes, (2) they predated the Supreme Court’s holding in Brown & Williamson; and/or (3) they were not ever the subject of a judicial challenge. Moreover, ASH failed to mention the one post-Brown & Williamson precedent that actually is relevant here – Ariva, as discussed above, another unconventional nicotine product for which FDA received citizen petitions requesting that it assert jurisdiction – a request that the FDA flatly rejected in 2003, finding that it lacked jurisdiction over “customarily marketed” tobacco products.

In addition, ASH cites Harris v. Action for Smoking & Health, 655 F.2d 236 (1980), a case it lost in the D.C. Circuit, to support its position that explicit manufacturer representations regarding drug claims are not necessary. To the contrary, however, in that case, the D.C. Court of Appeals actually affirmed the lower court’s holding that FDA’s refusal to assert jurisdiction over cigarettes as a “drug” was not arbitrary, capricious, or contrary to law.

Far from supporting ASH’s argument, Harris made clear that:

. . . the crux of FDA jurisdiction over drugs lay in manufacturers’ representations as revelatory of their intent . . . . Such an understanding has now been accepted as a matter of statutory interpretation.

655 F.2d 236, 238-39. And to the extent that manufacturer’s objectively manifested intent can be inferred, the D.C. Court of Appeals explained:

. . . consumers must use the product predominately and in fact nearly exclusively with the appropriate intent before the requisite statutory intent can be inferred.

655 F.2d at 240.2 That is certainly not the case here. There is no evidence to suggest that consumers have used e-cigarettes predominantly, much less nearly exclusively, for purposes of therapeutic benefit. Our choice to use e-cigarettes over traditional cigarettes is instead influenced by social stigmas and inconveniences associated with traditional smoking. But practical concerns are also important: the e-cigarette leaves no tar stains on the roof of our cars or in our homes, and does not leave our skin, breath, or clothes smelling like an ashtray. Also, we are able to “smoke” in places that traditional smoking is prohibited because second-hand smoke is not an issue. And the electronic cigarette gives the user the same smoking pleasure as traditional cigarettes, including by mimicking the physical activity of smoking.

E-cigarettes are very different from products offered to help smokers quit. The nicotine patch and gum for example are meant to gradually assist users to eliminate their nicotine addiction. Those products describe in detail how to eliminate nicotine addiction in multiple steps. E-cigarettes are not marketed for that purpose, and the product labeling does not include directions or any other statements concerning how to quit smoking.

There are other nontraditional nicotine products, such as “Snus” and dissolvable tobacco products such as Ariva, that have no purpose other than to deliver nicotine for recreation. By attempting to eliminate our access to the electronic cigarette, the FDA is depriving us of our right as consumers to make an informed choice to use vaporized nicotine products.

IV. CONCLUSION

The Alliance of Electronic Smokers respectfully requests that the Court consider the consumer as an intelligent force and provide consumers the right to choose to use and enjoy electronic cigarettes, or personal vaporizers, as a choice. Accordingly, for the reasons set forth in this case by Plaintiff Smoking Everywhere, Inc. and Plaintiff-Intervenor Sottera Inc. d/b/a NJOY, and for the additional reasons set forth herein, we urge the Court to hold that FDA lacks the authority to interfere with that choice, and to grant the requested preliminary injunctions.

1. In contrast, it takes, on average, approximately eight years to obtain FDA approval of a drug, from the initiation of clinical trials through the FDA approval process. See Tufts Center for the Study of Drug Development, Outlook 2009, available at http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2009.pdf (last visited September 8, 2009). During this time, the unapproved drug cannot be marketed or sold.

2. ASH also cites U.S. v Travia, 180 F. Supp. 2d 115 (D.D.C.2001) for the proposition that a written label is not required to infer a seller’s intent. But Travia is readily distinguishable – there, undercover agents presented evidence of oral representations made to customers about the purpose of the product sold, and the case had no bearing at all on tobacco products.
*****

For the pdf version click: Electronic Smokers Amicus Brief

Congrats to the Consumers who stood up for their rights to choose an alternative to a known killer! Every voice counts and every voice should be heard!

Anyone who does a bit of research on electronic cigarettes will soon find that there are a variety of types and sizes.  Some are better than others, but in general they all have their pros and cons.  Below is a list of some of the most popular types and their most common names along with what we believe to be their strengths and weaknesses.

Super Mini Cigarette (RN4088) – One of the smallest models on the market.  It is basically the same size as a regular cigarette. Pros: It’s small size makes it comfortable for many smokers to use.  Cons: It’s small size also makes it’s battery, atomizer, and cartridge pretty small so battery life is weak, it produces less vapor than others, and you will need to refill or change the cartridge more often.

Super Cigarette (DSE101, DSE103, RN4081) – Slightly larger than a regular cigarette, but still looks like a tobacco cigarette.  Pros: Most smokers find the size comfortable and it produces good vapor and has decent battery life.  Cons: The cartridge is a bit smaller than others so you will need to refill or change cartridges more often, although it’s cartridge is larger than the Super Mini Cigarette.

Mini Cigarette (DSE901, RN4075) – About the same girth as the Super Cigarette, but longer and has a tapered mouthpiece. Pros: Produces good vapor and has a good battery life.  Cons: Some smokers find the feel and design to be too different from a traditional cigarette and more like a small cigar.

Penstyle (DSE801, RN4072) – This was one of the first designs on the market.  It is quite a bit larger than a tobacco cigarette.  Pros:  It produces a lot of vapor and has a strong battery with a large cartridge.  Cons:  It is large an awkward to hold for many used to smoking a traditional (analogue) cigarette.

Screwdriver – As you guessed, this is shaped like a screwdriver.  It is basically just a really big battery.  Pros: Battery life is extended.  Cons:  It is very large and can be uncomfortable to hold.  Users have complained that they don’t like using them in public because they look strange.

Disposables – Disposable electronic cigarettes are all one piece with no rechargeable battery or refillable cartridge.  They come in different sizes, but are generally the same size as the Mini Cigarette.  Pros: Convenience.  Cons: They cartridges can’t be refilled, the batteries can’t be recharged.  Produces more waste.

The Instead Electronic Cigarette falls into the category of Super Cigarette.  We have tried models from every category and found that our electronic cigarette is a good balance of size, function, and vapor production.  We believe this model is the most satisfactory for long time smokers looking for an alternative to smoking tobacco cigarettes. To see our kits visit Electronic Cigarette Kits.

For a limited time, we are once again offering pre-filled electronic cigarette cartridges.  The cartridges fit the Instead Electronic Cigarette and come filled with your choice of e-liquid (various nicotine levels in tobacco or menthol flavors).  These cartridges, just like the empty electronic cigarette cartridges, can be refilled with e-liquid (once they are used up).  Pre-filled cartridges are approximately equivalent to 3 to 5 tobacco cigarettes.  Although we still believe the best e-smoking experience is with e-liquid, the pre-filled cartridges are convenient for those on the go.

Another new addition to our product line are the E-Cigarette Car Chargers.  This car charger works in conjunction with the small USB charger that comes with every Instead Electronic Cigarette Kit.  It converts your car’s cigarette lighter into a USB input to plug in your charger.  Another great idea for the e-smoker on the move.

Happy E-Smoking!

We have two competing products: The tobacco cigarette and the electronic cigarette. Both can deliver nicotine and facilitate the habit of smoking. But there are differences. The electronic cigarette is a reusable product. Cartridges can be filled over and over again. Batteries and atomizers last many uses. Obviously this is not the case with tobacco cigarettes. Let’s have a look at the difference in garbage produced between using 300 tobacco cigarettes and using 1 bottle of E-Liquid (approx. equivalent to 300 tobacco cigarettes by puff count):

Please note the e-cigarette cartridges are made of #2 plastic, which is generally recyclable. The glass bottle from e-smoking and the cardboard boxes from the tobacco cigarettes are also recyclable. This image shows the amount of garbage with no recycling, although we encourage everyone to recycle.

The intended use of a product is important not only from the perspective of categorization by the FDA but also to ensure the consumer is not misled by advertising. The FDA has been arguing that the intended use of the electronic cigarette is, or should be, to help people quit smoking. We do not believe this to be the case. We believe that this is another way to intake nicotine and participate in the action of smoking, without actually burning tobacco.

Many consumers who signed the electronic cigarette petition have stated that they have quit smoking with the electronic cigarette. However, these same consumers don’t state they have quit using nicotine, just that they have quit smoking. Smoking is not a disease according to the CDC, but nicotine addiction is, and there is no proof that electronic cigarettes help treat nicotine addiction. There is also no evidence that these consumers will not go back to smoking tobacco cigarettes.

It is a disservice to consumers to lead them to believe the electronic cigarette is a quit smoking product. There is no evidence as such. It continues the habit and the addiction to nicotine.

The intended use of the Instead Electronic Cigarette is to use it for the action of smoking. If you like to smoke, you may like the electronic cigarette. If you want to quit smoking, we recommend you go cold turkey or use a product that has been proven to help smokers quit.

August 29, 2009
Lawrence Deyton, MD
Incoming Director
FDA Center for Tobacco Products
Re: Don’t Write Off Current Smokers

Dear Dr. Deyton:
For the past half century, the American Association of Public Health Physicians (AAPHP) has served as the national voice of physician directors of state and local health departments and other like-minded physicians. We have long been involved with tobacco control, with the singular goal of doing everything in our power to reduce tobacco related illness and death.

As you assume leadership of the new FDA Center for Tobacco Products, we urge you to consider the actions FDA can take, within the powers granted by this new legislation, to rapidly and substantially reduce tobacco related illness and death in current adult smokers.

Unfortunately, FDA has not gotten off to a good start. FDA condemnation of electronic cigarettes, in its July 22 press conference, and FDA insistence that electronic cigarettes should be regulated as a drug/device combination rather than as a tobacco product makes no sense from a public health perspective. It flies in the face of FDA laboratory findings on other products already approved by FDA. If one looks at electronic cigarettes as a sentinel for all tobacco products less hazardous than conventional cigarettes – the outlook for FDA action reducing tobacco-related illness and death among current adult smokers is dismal.

With this in mind, we respectfully request your consideration of the following actions:

1. We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes.

2. We urge FDA to reclassify electronic cigarettes from a drug/device combination to a tobacco product. This will enable FDA to immediately regulate manufacturing and impose marketing restrictions during this initial period of FDA Tobacco Center development. This reclassification will eliminate pressure on the several hundred thousand current American users of electronic cigarettes to switch back to the much more hazardous conventional cigarettes.

This year, about 400,000 American adult cigarette smokers will die of a tobacco-related illness. Their second hand smoke will kill about 48,000 non-smokers. About 700 more will die in residential fires. Despite progress on other measures of tobacco use, per CDC estimates, this death count continues to inch up from year to year. In contrast, even though smokeless tobacco products represent about 20% of nicotine intake in the United States, the number of deaths per year from these products is too small for reliable estimates from the CDC.

Our (AAPHP) best estimate is that smokeless tobacco products currently cause about 700 cancer deaths per year in the United States. This is less than 1% of the more than 110,000 deaths that would occur each year if smokeless products carried the same mortality as conventional cigarettes.

This last week, Boffetta and Straif published a paper alleging evidence of an increased risk of fatal heart disease and stroke among smokeless tobacco users. This is a study sure to be referenced by those seeking evidence of the harmfulness of smokeless tobacco products. Unfortunately, this study suffers from major technical and ethical flaws, including failure to note in the abstract that they found no increased risk of non-fatal heart attack or stroke. Even worse, of the many studies reviewed, only two showed evidence of even a slight increase in risk of death – and these were the ones selected for the conclusion and abstract. That having been said, their allegations of a 13% increase in risk of fatal heart attack and 40% increase in risk of fatal stroke pale in comparison with the 180% to 300% increases in risk for men and women 35-64 years of age posed by smoking conventional cigarettes.

Contrary to prevailing conventional wisdom, virtually all the heart and lung disease from conventional cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion deep into the lung. Our best estimate (based on the work of Pankow et al and others) is that only about 2% of the cancer mortality from cigarettes is from the named carcinogens commonly found in tobacco products. Smokeless tobacco products carry little or no risk of heart disease and no risk of lung disease. They do not kill innocent bystanders and they do not burn down houses. The risk of cancer of any kind from smokeless products ranges from a high of about 5% of the risk of cancer posed by conventional cigarettes to a low well under 1% of the risk of cancer posed by conventional cigarettes. While definitive studies have not been done, we have reason to believe that tobacco products, such as electronic cigarettes, consisting of nicotine extracted from tobacco with only trace amounts of other chemical substances, should carry even less risk.

Most of the discussion to date around the new FDA/Tobacco bill has focused on reducing initiation of nicotine use by children and teens. The only discussion of current smokers has been limited to encouraging use of pharmaceutical products to aid cessation. This has been touted as doubling quit rates – but without mentioning that this doubling is from about 3% to about 5% per year. In other words, this option fails 95% of smokers willing to try it, even under study conditions with optimal counseling.

It should be possible to save the lives of 4 million or more of the 8 million adult American smokers who will otherwise die of a cigarette-related illness over the next twenty years. This could be done by making smokers aware of selected smokeless tobacco products (including but not limited to snus and electronic cigarettes) that promise to reduce the risk of tobacco-related illness by 99% or better for smokers who are unwilling or unable to quit. Rather than discouraging nicotine cessation, however, such an approach, even with no medical intervention, would be expected to triple the rate at which current smokers eventually discontinue their nicotine use.

Those writing the new FDA legislation endorsed a harm reduction component to current tobacco control programming, but in a most peculiar way. The law encourages cigarette manufacturers to develop “reduced exposure“ products and market them with no scientific proof that such reductions in exposure will reduce risk. The law then requires presumably new “scientific evidence” for smokeless products, already known to be of substantially lower risk. This makes no sense. The law encourages a harm reduction component to current tobacco control programming that might reduce tobacco-related cancer mortality by one or two percent; while actively discouraging switching to lower risk tobacco products that promise to lower total tobacco-related illness and death by 99% or better.

The secret to success, as we see it, will be to add an effective harm reduction component to current tobacco control programming while using the tools made available by this new law to prevent this new harm reduction
initiative from increasing the numbers of children and teens who initiate tobacco use.

Reconsidering the FDA stance on electronic cigarettes would be the most logical first step.

We look forward to working with FDA to use the powers granted by this new legislation to rapidly and substantially reduce tobacco-related illness and death, among both current and potential future tobacco users.

References:
The data on smoking attributable deaths on page 2 of this letter are from the Centers for Disease Control MMWR report of November 14, 2008. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm

The estimate that 20% of current nicotine consumption in the United States is from smokeless tobacco was generated by Mr. William Godshall, based on the formula utilized by Fagerstrom et al, when estimating 2002 nicotine consumption by type of tobacco product in multiple countries.

The discussion on risk of heart disease and stroke from smokeless tobacco products is from Paolo Boffetta and Kurt Straif : Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis. Published August 18, 2009. BMJ 2009; 339: b3060 [Abstract] [Full text]

The data on relative risk of fatal heart attack and stroke from smoking, in men and women 35-64 years of age, are data from the American Cancer Society as quoted in “Changes in cigarette-related disease risks and their implication for prevention and control.” Smoking and Tobacco Control Monograph 8. Bethesda, MD: US Department of Health and Human Services,
Public Health Service, National Institutes of Health, National Cancer Institute 1997;305-382. NIH Publication no. 97-1213.

The other references to the scientific literature that back-up the points made in this letter can be found on the Tobacco Issues page at the http://www.aaphp.org web site. There is an October 2008 “Resolution and White Paper on Tobacco Harm Reduction.” This paper, on pages 6 and 13, includes then-current CDC and AAPHP mortality projections. “The Myth of the Safe Cigarette,” is based on the paper by Pankow et al (http://cebp.aacrjournals.org/cgi/reprint/16/3/584 ) and others. It makes the case that conventional cigarettes cannot be made measurably safer. The exchange of correspondence with Zhu et al, from a paper published earlier this year, deals with the difference in quit rates, comparing conventional cigarettes to smokeless tobacco products.

Yours,
Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force
jln@jln-md.com
504 899 7893
Kevin Sherin, MD, MPH, FACPM, FAAFP
President, American Association of Public Health Physicians
ksherin@yahoo.com

Conflict of Interest Disclaimer: Neither of us, nor the American Association of Public Health Physicians, has received or anticipates receipt of any financial support from any tobacco product manufacturer or vendor, or any pharmaceutical firm making nicotine replacement products.

Visit American Association of Public Health Physicians writes on behalf of Electronic Cigarettes to the Incoming Director of the FDA to download the PDF version of the letter.

As noted in a previous about how the new tobacco legislation effects the electronic cigarette, we noted that in order for a product to be a drug it must be “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals”. And in order to be a new drug….it must be a drug.

So I contacted the Centers for Disease Control and Prevention (CDC) and asked if smoking was considered a disease. At first they just sent me all the statistics about how many people smoking kills. Then they got mad I kept asking. Then I eventually received this response:

“When reviewing responses related to tobacco use that were provided by CDC-INFO, we noticed your question asking if smoking is considered a disease. As noted by CDC-INFO, smoking is a primary risk factor for many diseases. Addiction to drugs, is viewed as a brain disease by the
National Institute on Drug Abuse (NIDA). For information about nicotine addiction, please visit NIDA’s Web site at
http://www.drugabuse.gov/ResearchReports/Nicotine/Nicotine.html and
http://www.drugabuse.gov/Infofacts/understand.html”

So, according to the CDC, smoking is not a disease, but rather it may put the user at risk of getting an actual disease. Apparently they believe that NIDA is correct and being addicted to nicotine is a disease. Thus, the electronic cigarette [e-liquid] as a new drug is one that is intended to diagnosis, cure, mitigate, treat, or prevent the addiction to nicotine. Curing nicotine addiction would involve not using nicotine anymore.

UPDATE: I recently found where Norman Edelman, M.D., Chief Medical Officer for the American Lung Association stated, “Smoking is widely recognized as a disease of nicotine addiction,”

This is why Snus or dissolvables are not Nicotine Replacement Therapy (NRT) products. They are not marketed as a way to quit smoking (quit using nicotine). They are marketed to be used indefinitely, i.e. to continue using nicotine.

The nicotine patch or gum is meant to ween the user off of nicotine until they no longer use it….thus curing them. There IS a stop usage date on NRT products.

Selling a consumer an electronic cigarette as a quit smoking device would mean it necessary to instruct the consumer to eventually move to zero nicotine e-liquid and/or to ultimately quit vaping altogether.

For those who think that the mere fact that there is a zero nicotine e-liquid available means it treats nicotine addiction; please note that there is zero nicotine Snus and even a zero nicotine patch that is apparently not an NRT, but yet does claim to help users quit smoking (quit using nicotine). Of course no drug, means no “new drug”, which means it isn’t a NRT.

If there is no stop usage date, then how can an electronic cigarette cure nicotine addiction? And how can continuing the action that got the user addicted to nicotine in the first place help cure their addiction? If smoking / vaping / using an electronic cigarette with zero nicotine is the cure, then so is smoking a zero nicotine tobacco cigarette. Oddly enough, these nicotine free cigarettes do claim to help the user quit smoking, but still they are not an NRT.

So we have products that contain nicotine, have no stop usage date, and make no quit smoking claims that are not NRTs (dissolvables, Snus)
We have products that contain no nicotine or any drugs, that do make quit smoking claims and they are not NRTs (zero nicotine patch, nicotine free cigarettes)
We have products that contain nicotine (or other drugs), have a stop usage date, and claim to help users quit smoking. These are NRTs (gum, patch, pills)

Which of these is most suitable for the electronic cigarette? To be classified as a new drug under the classification of a NRT, the product must 1) contain a drug and 2) have a stop using nicotine date or imply one with the claim of quitting smoking. Also, the American Lung Association states, “To be most effective, nicotine replacement products should be used in conjunction with a behavior change program.” (Update: we now link to the Archive.org page of the American Lung Association as it appears they recently took down this page) It is pretty obvious that electronic smoking is a continuation of the action of smoking, thus making it a rather ineffective NRT at best.

Most reputable e-cigarette suppliers don’t claim it helps anyone quit smoking and there is no proof that it does. I have yet to see any manufacturer or supplier recommending a stop usage date. It can come with nicotine or not.

So an e-cigarette that contains no nicotine (or any other drug) and makes no quit smoking claims should be labeled (and regulated) as an NRT? If so it would be the only product of it’s kind.

And with nicotine e-liquid and no stop usage date, we have a product that perpetuates nicotine addiction, not cures it. The upside? Nicotine alone kills very, very, very few people (if any) but inhaling burning tobacco kills hundreds of thousands.

The e-cigarette or electronic cigarette mimics smoking using vapor. It can contain tobacco products, but doesn’t necessarily need to. Some believe it helps people quit smoking, while others (such as Instead) believes it is not a quit smoking product. So where does it fit in? A tobacco product needs to contain tobacco. A new drug needs to cure, treat, diagnose, or mitigate a disease or condition.

There is no clear answer. But, when we look past the question of regulation, taxation, and ultimate control here is what we find:

A product that a decent percentage of smokers find to be a reasonable alternative to burning tobacco. Inhaling burning tobacco is known to cause cancer and a multitude of other problems for the user and potential for those near the user. Inhaling vapor from an e-cigarette has not been shown to cause issues for the user or by-standers. There may be unforeseen issues of inhaling propylene glycol or glycerin vapor in the long term, but there is no way to tell without decades of testing. In the mean time, inhaling burning tobacco would continue to kill. It is hard to believe that inhaling propylene glycol for 20 years would be worse than inhaling all the dangerous chemicals found in tobacco smoke for 20 years. Even if the FDA was correct and the vapor contained traces of TSNAs (which it didn’t…..it found those in the liquid), tobacco smoke contains these TSNAs in much, much higher levels.

So who should regulate it? The FDA thinks they should as an NRT (Nicotine Replacement Therapy). The issue is this; as an NRT it would need to be pulled from the market and submitted by a pharmaceutical company as a quit smoking product. The cost is in the tens of millions and the testing can go on for years. Even after it is approved, it can then only be sold in pharmacies either with or without a prescription. This is all assuming a pharmacy even sees the potential and submits the application. In the meantime, people keep burning tobacco at their regular rate and dieing.

If we skip into the future and do find electronic cigarettes sold in pharmacies, we will find tobacco cigarettes being sold in gas stations. We will likely find electronic cigarettes have now become more expensive than tobacco cigarettes (the pharmaceutical company would need to make back their tens of millions). We find at least some smokers disappointed that they didn’t quit using the e-cigarette as the package so boldly claims.

Now lets look at an alternative future, one where regulation has come in a different form such as via the tobacco bill or via the industry itself or via a newly created category. The product is sold in gas stations beside tobacco cigarettes. Companies compete to reduce their prices while consumers continue to demand innovation, safety, and function. There is competition. It is marketed as another way to smoke. Smokers freely use the e-cigarette instead of their tobacco cigarettes, whether completely or sporadically.

Which scenario is in the best interest of the smoker and of by-standers?

Electronic cigarettes are not safe. They are not healthy. But inhaling burning tobacco is known to carry a high risk of cancer.

It has been a busy few months! Our fight to keep the electronic cigarette from being seen as a quit smoking device by the FDA and anti-smoking groups continues. We have also been working hard to ensure that our supply of American Made E-Liquid is solid so we can provide our customers with better pricing!

Please note that while we may have been able to reduce our pricing on American Made E-Liquid and our Unique Stash Tin Electronic Cigarette Kits, this does not mean that we have cut back on our wonderful customer service! INSTEAD Electronic Cigarettes continues to grow by leaps and bounds as a company and hopes that our continued support of the industry will help the industry achieve it’s rightful place in the United States free market system.

Also, don’t forget to take a look at one of our newest products, the portable USB electronic cigarette battery charger. This charger can not only recharge your ecig batteries up to 18 times on the go, but it can also charge your iPhone. A must have for anyone who has portable USB devices.

Smokers have a choice! And that choice includes the Electronic Cigarette!