The question is ‘What kind of regulation?’

Some opponents of electronic cigarettes have stated they believe those who manufacturer and sell electronic cigarettes are trying to skirt regulation by the FDA. They ask “why don’t they just go through the normal NRT process like the nicotine gum or patch?”. I will answer these questions from the perspective of one company who sells electronic cigarettes.

We are NOT opposed to regulation. In fact one of the reasons we helped form the Electronic Cigarette Association is because we believe there does need to be a certain level of regulation. This includes, among other things, how it is manufactured, how it can be marketed, proper warnings, and most certainly keeping it out of the hands of minors. Some of these regulations are easy to implement and others will take time and help from an agency such as the FDA.

We ARE opposed to becoming an NRT. We strongly believe that the electronic cigarette should be allowed to freely compete with tobacco cigarettes on the open market. As an NRT, a product must be sold in pharmacies either with or without a prescription. NRTs are often more expensive than tobacco cigarettes. NRTs come with a stop usage date…..hence the claims of “quit smoking” which is really “quit using nicotine”. Placing these restrictions on electronic cigarettes create an unfair advantage for those who sell tobacco cigarettes.

I suppose the question is; if adults can legally choose to smoke tobacco cigarettes for as long as they like, why can’t they legally choose to use electronic cigarettes for as long as they like? For those who want to make claims such as “the electronic cigarette helps you quit smoking”, then they should do the proper clinical trials to prove that, submit it to the FDA, and then go sell it in pharmacies as a quit smoking product.

We applaud Matt Salmon, President of the ECA, in this Reuters article when he said, “We understand that to protect the public, some form of regulation may be necessary, and we welcome that. Our goal, nevertheless, is to ensure committed adult smokers the freedom of a clear, better alternative and to prohibit sales to minors”.

On October 1st, we had reported in our blog post Tobacco Kills. E-Cigarettes, Not Sure. So Smoke Tobacco, Siobhan DeLancey, Press Officer at FDA, stated:

“There are no long-term studies on the health effects of just nicotine, minus the tobacco component. We know what smoking tobacco does to the body over the long term,” DeLancey said. “What we want to see are well-designed clinical studies. Personal reports are not enough,” DeLancey said.

A recently published study done in 1996 on the long term effects of inhaled nicotine is now available.

The Department of Medicine, University Hospital, Tronheim, Norway, found:

“Tobacco smoking has been reported to be associated with increased risk of cardiovascular disease and cancer, particularly of the lungs. In spite of extensive research on the health effects of tobacco smoking, the substances in tobacco smoke exerting these negative health effects are not completely known. Nicotine is the substance giving the subjective pleasure of smoking as well as inducing addiction. For the first time we report the effect on the rat of long-term (two years) inhalation of nicotine. The rats breathed in a chamber with nicotine at a concentration giving twice the plasma concentration found in heavy smokers. Nicotine was given for 20 h a day, five days a week during a two-year period. We could not find any increase in mortality, in atherosclerosis or frequency of tumors in these rats compared with controls. Particularly, there was no microscopic or macroscopic lung tumors nor any increase in pulmonary neuroendocrine cells. Throughout the study, however, the body weight of the nicotine exposed rats was reduced as compared with controls. In conclusion, our study does not indicate any harmful effect of nicotine when given in its pure form by inhalation.”

Please note this study was not done on the electronic cigarette. The e-Liquid in an electronic cigarette is not pure nicotine. The e-Liquid is generally comprised of propylene glycol, glycerin, nicotine, water, and flavorings. No long term studies have been done to show the electronic cigarette vapor is safe to humans. The product has been used worldwide for about 5 years and in the US for over 2 years. To date there are no reported serious side effects.

If you are now wondering about the propylene glycol, studies have been done on the inhalation of propylene glycol by the EPA and “the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol.” But again, please note that this was not a study of long term, direct inhalation of PG.

It is clear that in the current quest for public health, there is some serious misinformation going on. It appears that there is a clear lack of understanding between the differences of combustion and vaporization and that it is no longer the burden of the accuser to show proof that the electronic cigarette vapor is in fact dangerous.

One “public health” organization, who we will not name, hasn’t even updated their own research links page regarding scientific studies since 2005. Considering this, it is no wonder they are trapped in a bubble and not seeing the electronic cigarette for what it is and that is an alternative to something that kills over 400,000 Americans per year.

All we ask is that those in the public health sector keep an open mind to the technology, base decisions on the most current science available, and work with the electronic cigarette industry rather than against it, to make sure smokers have all the necessary information to make a decision for themselves.

The current studies and science on the electronic cigarette is not perfect, as it never is. And yes, more testing needs to be done. And yes, in the meantime this is an alternative to smoking tobacco which kills a good percentage of it’s users.

One thing has become evidently clear: Most people, including the “scientifically based public health organizations”, do not understand the difference between combustion and vaporization. While we can completely understand a typical person would not, we are baffled as to why those with concerns about second hand smoke do not understand the fundamental basics between smoke and vapor, which means, they simply do not understand the difference between combustion and vaporization.

The electronic cigarette uses a vaporizer. No fire is needed to power the vaporizer. A battery is used to power the vaporizer.

The electronic cigarette consists of three parts: The mouthpiece, the atomizer (or vaporizer) and a lithium ion battery. When the entire unit is assembled, the user creates an inhaling motion which activates the battery. The battery powers the vaporizer and the vaporizer heats the liquid housed in the mouthpiece. The liquid itself is composed of nicotine, propylene glycol and flavorings. Please note that the liquid does not have to contain nicotine and many eSmokers are currently using non-nicotine liquids in their electronic cigarettes.

Propylene glycol makes up between 75% and 89% of the products on the market. Propylene glycol is commonly found in products including and not limited to: Consumer products and food products, including and not limited to deodorants, pharmaceuticals, moisturizing lotions, toothpastes, inhalers and fat-free dairy products.

1. Affects to Users. The FDA recently studied two brands of electronic cigarette liquid (1) and the report noted that the two brands tested contained low amounts of nitrosamines which are also found in many products including nicotine replacement therapies such as the gum, the patch and the Nicotrol Inhaler. The Commit Lozenge is the only nicotine product that does not contain nitrosamines. (2) Nitrosamines are also found in meats purchased from the local grocery store and increase in toxicity levels based on the temperatures at which they are cooked. They can also be found in beer and are finally, injected into food products like bacon.

A peer review of the FDA study, noted that according to the manufacturer’s information of the Nicotrol Inhaler, the user receives more nicotine than with an electronic cigarette. (3) A further study found users of the electronic cigarette will receive 1/3 of the nicotine than with a tobacco cigarette. (4) Please remember, this is based on nicotine content in the liquid and there are a variety of nicotine levels available, including zero nicotine liquids.

The review of the FDA report also found, as the liquid is vaporized and not ingested, that the only impurities found in the inhaled vapor at trace levels were cotinine or β-nicotyrine and “There is no indication in the published scientific literature that cotinine or β-nicotyrine are carcinogenic or have toxicity ratings of concern.” (4) Further studies on the vapor produced by vaporization are currently underway to insure these findings can stand up to further peer review.

2. Affects to Bystanders. In September of 2006, the Environmental Protection Agency (EPA), determined that “the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol.” It was also noted that “A review of the available data has shown propylene glycol to be negative for carcinogenicity in studies [and] therefore, no further carcinogenic analysis is required.” (5)

Propylene glycol vapors and mists have been studied since the early 40’s on all types of specimens from monkeys, rats, human adults and human children. It IS the base ingredient in most anti-bacterial air products found in hospitals. (6) Also found was “Lacking any active ingredient or any gaseous products of combustion, the PG mist or ‘smoke’ is not harmful to bystanders. The ‘smoke’ or mist is not tobacco smoke, and not from combustion – no flame is lit – and is not defined as environmental tobacco smoke.”(4)

Philip Morris conducted a study on their tobacco cigarettes finding that combustion releases a minimum 4,000 by-products including Carbon Monoxide, Arsenic, Hydrogen Cyanide and Formaldehyde to just name some of the worst ones. (7) With vaporization, studies have shown that these chemicals are simply not present because a much higher rate of burning of 1000 degrees is needed, where the vaporizer of an electronic cigarette only reaches between 40 and 65 degrees. (4)(1)

To date, there is no evidence that nicotine is present in the vapor from liquids with or without nicotine. “Inhaled nicotine in cigarette smoke is over 98% absorbed, and so the exhaled mist of the e-cigarette is composed of propylene glycol, and probably contains almost no nicotine; and no CO.” (4) Again, further studies on the vapor produced by vaporization are currently underway to insure these findings can stand up to further peer review.

Another interesting study, for those with concern to Second Hand Smoke should review, is the burning of incense. One study notes “that incense use is associated with increased risk of squamous cell carcinomas in the respiratory tract, especially in the upper part. This association is consistent with a large number of studies identifying carcinogens in incense smoke, and given the widespread and sometimes involuntary exposure to smoke of burning incense, these findings carry significant public health implications”.(8)

While there are differences of opinion on the real damage that can be done by second hand smoke from combustion, there are also amazing studies that have been done on vaporization and confusing the two needs to stop. It is very clear that many of the local smoking ordinances that are popping up and include electronic cigarettes in the definition of “smoke”, are simply wrong, misguided and are not based on any scientific fact whatsoever.

Public health organization need to make the distinction between combustion and vaporization and stop referring to the vapor of an electronic cigarette as “smoke” or as the Non-Smokers Rights Association was quoted today in the Inland Daily Bulletin as saying: “Despite the insufficient amount of testing, Tegen said the organization believes the electronic cigarette should not be considered as a substitute for smoking tobacco cigarettes and is concerned about the risks of inhaling second-hand smoke from the electronic version.”

It’s not smoke Ms. Tegan. It’s VAPOR! There is a huge difference and if your organization would like to study this further, you might just see the electronic cigarette for what it truly is: Something that non-smokers can embrace so that smokers no longer bother them with their second hand smoke.

References:

1. http://www.e-cig.org/pdfs/2009-FDA-Evaluation-of-Ecigs-nJoy-and-SE-results.pdf
2. http://www.e-cig.org/pdfs/TSNA-Study-in-Smokeless-Tobacco-Products.pdf
3. http://www.e-cig.org/pdfs/Response-to-the-FDA-Summary.pdf
4. http://www.e-cig.org/pdfs/2008-NZ-Report.pdf
5. http://www.e-cig.org/pdfs/EPA-Approval-of-PG.pdf
6. http://www.e-cig.org/pdfs/1946-Synopsis-On-PG-As-Disinfection-Vapor.pdf
7. http://www.e-cig.org/pdfs/1999-PM-Component-Anaylis-Combustion.pdf
8. http://www.e-cig.org/pdfs/National-Institute-of-Health-Incense-Burning-Study.pdf

Matt Salmon, President of the Electronic Cigarette Association (ECA), today denounced a quotation attributed to him by Epiphany Media Group in a press release dated September 14, 2009. The falsely attributed quotation conveys the mistaken impression that some e-cigarette products have been approved by the FDA for consumer use. Salmon underscored the ECA’s commitment to abide by FDA regulations.

“It has come to my attention that a press release with false and misleading claims about e-cigarettes attributed to me was distributed without my knowledge or approval. I want to make it unequivocally clear that I have never made such statements or claims and they are patently false,” said Salmon.

The erroneous quotation, re-released on October 8, 2009, reads, “It is disheartening that the FDA issued a warning to the public against electronic cigarettes without conclusive data to support the claim.” The release goes onto say that Salmon indicated that “some of the companies that are part of the ECA such as inLife electronic cigarette product lines are approved by the FDA.”

“I don’t know of any electronic cigarette suppliers or manufacturers that have been approved by the FDA,” added Salmon. “All of our members send a warning card with every unit sold stating clearly that the product has not been approved by the FDA.”

The ECA’s policy is that member companies cannot make any health claims about their products or represent them as smoking cessation devices. E-cigarettes sold by these companies are marketed as simply an alternative to combustible tobacco smoking. Additionally, all members must ensure that they have taken precautions to prevent people under the legal smoking age from having access to their products.

“This requirement has been a long-standing policy of the ECA since its inception and we will take the necessary steps to enforce it,” Salmon concluded.

Visit www.ecassoc.org for more information about the ECA and its member companies.

You must be thinking, Really? Who would think that let alone say it out loud. Well here’s the answer:

“There are no long-term studies on the health effects of just nicotine, minus the tobacco component. We know what smoking tobacco does to the body over the long term,” DeLancey said. “What we want to see are well-designed clinical studies. Personal reports are not enough,” DeLancy said. [Siobhan DeLancey who is a FDA Spokesperson]

This quote is from the Users love ‘e-cigarettes,’ but FDA wants to take closer look article published on September 30th, 2009.

First, let’s discuss the title of the article. Users, for the most part, do love their e-cigarette. However the FDA doesn’t want to “take a closer look”, what they are fighting for in their current legal battle is to classify the e-cigarette as a new drug / medical device thus named a combination product. This means it would be pulled off the market and made illegal until someone spends the money on the FDA application and does clinical trials to prove that it helps people quit smoking. And after the millions have been spent and the years pass, they would bring it back to be sold in pharmacies either OTC or by prescription. It is hard to compete with tobacco when you can’t sell in gas stations, tobacco shops, or online.

Now let’s look at what DeLancey from the FDA said, “There are no long-term studies on the health effects of just nicotine, minus the tobacco component.” – For the most part this is true.

Next, “We know what smoking tobacco does to the body over the long term,” – Yes, we do. It kills a rather large percent of the users

Then, “What we want to see are well-designed clinical studies. Personal reports are not enough,” – I am unclear about how you do a clinical study to provide data about usage over the long term. A 25 year clinical study?

The article then quotes some e-smokers who are very happy with their e-cigarettes. DeLancey ends with, “I feel their pain,” she said. “We don’t know if this is any better for them.”

Two immediate thoughts come to mind:

1) Based on this argument, if e-cigarettes are put through clinical trials and they are shown to kill a large percent of the users, will the FDA approve them for sale just as cigarettes are allowed? If not, why do combustible cigarettes get a free pass. Monopoly?

2) If DeLancey is a 25 year smoker who has tried to quit 14 times without success, then maybe she does feel their pain. However if that was the case, she would probably want to make the decision of what is better for herself. Smokers can do research on the competing products [e-cigarettes vs tobacco cigarettes]. There is data available, even if incomplete, to make a decision for themselves. It is not the FDA’s job to make decisions for adult Americans. It is their job to make sure that consumers have the proper information to make that decision. We applaud efforts by the FDA to ensure companies are not improperly marketing their products. We also hope they will see the potential of this product as we do and begin working with the industry, not try to re-locate it to pharmaceutical land.

The American Legacy Foundation had an “open” discussion on electronic cigarettes on September 16th, 2009. Since their panel was all made up of those who have the same positions, we thought we would respond to some of the information they presented. For full disclosure, we sell electronic cigarettes. For further disclosure, American Legacy Foundation gets money from tobacco company settlements (although they will not give grants to anyone who accepts money from tobacco companies) and receives contributions from Pharmaceutical companies who make nicotine replacement products, specifically Pfizer.

If you want to watch the almost two hour panel discussion, click here. If you prefer, you can watch the excerpts below and read our responses. We attempted to ensure that any clips we provide are not taken out of context, although at times the context is obscure and contradictory, which you will find out for yourself if you watch the whole thing.

NOTE: You will often hear the panel reference ENDS or Electronic Nicotine Delivery Systems which is their renaming of the electronic cigarette.

They hope this will be a lively discussion? That would imply that some of the panel members disagreed on the major points. The discussion opens with:

And ends with:

The panel is enthusiastic about agreeing with each other, I’ll give them that. But as for the opposing views, it is clear that this panel all agree on the major issue of what the electronic cigarette should be; a FDA sanctioned, pharmaceutical Nicotine Replacement Therapy.

Here is a clip of Dr. David Abrams (who is the Executive Director of the Steven A. Schroeder National Institute for Tobacco Research and Policy Studies at the American Legacy Foundation® i.e. he works for the American Legacy Foundation) who raised questions about why the electronic cigarette companies haven’t gone the NRT route via the FDA:

First, let’s be clear; the FDA approval Dr. Abrams wants for the electronic cigarette is as an NRT for people to use to quit smoking. Therefore users would be required to eventually stop using the electronic cigarette altogether. That is one route. Another is to say that smoking is a legal activity and smokers should have the right to use electronic cigarettes as much as they have the right to smoke tobacco.

He also makes it sound very easy to get FDA approval as a NRT which is contrary to Tufts Center for the Study of Drug Development, Outlook 2009, available at http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2009.pdf which shows the average time to get approval of a new drug (which is what a new NRT would likely be classified as) is 8 years. In the meantime, they want the e-cigarette or ENDS pulled from the market and presumably smokers to go back to smoking tobacco.

This is not to mention the FDA fees associated with a new drug approval and the device approval fee. Assuming they want clinical trials, the total cost would be around 2 million not including any consulting, legal fees, and the actual cost of the testing and clinical trials. I am no expert in this field and may have overlooked some requirements or loopholes, but in any case it is extremely likely the cost is going to be more than 1 million dollars, which is out of the reach of almost all the electronic cigarette suppliers on the market right now. The electronic cigarette industry in America is predominantly small US based businesses. Yes, much of the hardware is made in China, but I challenge you to find an American retail industry that doesn’t have their products built overseas. And remember, this would all be in the name of testing a “new drug”, specifically inhaled nicotine.

If we get past the rights of smokers to choose an alternative and the time and cost associated with getting approval, we soon run into the real issue with making the electronic cigarette a nicotine replacement therapy (NRT); competing with tobacco. NRTs are sold only in pharmacies at costs outside of market influence. If you doubt this, price out some nicotine gum. So now we have a competing product with tobacco that can’t be sold where tobacco is sold, at a higher price, and with more restrictions. This will make it incredibly hard for the e-cigarette to properly compete with tobacco. Reputable e-cigarette suppliers are not asking for special treatment, but rather to have the opportunity to compete with tobacco fairly.

Lastly, there is no proof the electronic cigarette would be a good NRT. If marketers don’t make cessation claims, then why would they go through testing to try and prove something they don’t want to claim. The FDA doesn’t make Coke-a-Cola test their product for it’s effectiveness as a way to stop using caffeine. Why? Coke doesn’t want to make that claim.

Dr. David Abrams whose conclusion was that he wanted the electronic cigarette to be a NRT, at one point discusses how he believes the e-cigarette is actually a tobacco product. So I am actually not sure what he wants:

He states that all nicotine products contain traces of the same organic substances, but then reverts to a scare tactic that e-liquid may be using pesticide grade nicotine. What he doesn’t mention is that nicotine itself is a poison. Even pharmacological grade nicotine in proper doses would kill bugs. Again, the devil is in the dosage. Please note that tobacco cigarettes do not use pharmacological grade nicotine. With that said, I agree pharmacological grade nicotine should be used and in the majority of products on the market, it is being used. Current testing being done will show the actual levels of TSNAs and we will release it as soon as we have it.

This is not about zero regulation, it is about reasonable regulation. The industry is only “adversarial” because those with vested interests in competing industries are determined to take this product off the market. Those who are truly for public health should be more interested in the science behind the electronic cigarette, comparing it to tobacco cigarettes, and it’s future potential rather than with taking it off the market until someone pays the FDA.

More analysis of the American Legacy Foundations “Open” Discussion will be coming over the next week.

1) FDA smoke screen on e-cigarettes in Washington Times by Dr. Elizabeth Whelan, president of the American Council on Science and Health

2) American Association of Public Health Physicians writes on behalf of Electronic Cigarettes to the Incoming Director of the FDA by Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force and Kevin Sherin, MD, MPH, FACPM, FAAFP
President, American Association of Public Health Physicians

3) Disingenuousness of the FDA’s Press Conference is Concerning; FDA and Anti-Smoking Groups are Committing Medical Malpractice on a Massive Scale by Dr. Michael Siegel, Professor at the Boston University School of Public Health

4) FDA’s drug and e-cigarette warnings counterproductive by Jeff Stier, associate director, American Council on Science and Health

5) Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes” by Janci Chunn Lindsay, Ph.D. from Exponent Health Sciences

6) An Interview With David Sweanor on the E-Cigarette, Tobacco harm reduction, snus and other issues from E Cigarette Direct out of the UK

7) The FDA Crusade Against E-Cigarettes by Brad Rodu, Professor of Medicine at the University of Louisville, holds an endowed chair in tobacco harm reduction research, and a member of the James Graham Brown Cancer Center at U of L

8) Prominent Public Health Physicians and Tobacco Researchers Expose Double Standard in the FDA’s Recent Study of Electronic Cigarettes and Challenge the FDA’s Alarmist Attitude Toward the Devices by Dr. Michael Siegel, Professor at the Boston University School of Public Health and Joel L. Nitzkin, MD, MPH, DPA, Chair AAPHP Tobacco Control Task Force and Brad Rodu, Professor of Medicine at the University of Louisville

9) Electronic Cigarette Association Letter To Congress by Matt Salmom, former Congressmen and President of the ECA

10) American Lung Association Asserts that E-Cigarettes are Designed to Promote Cigarette Smoking; Can Anti-Smoking Groups’ Reasoning Get Any More Absurd? by Dr. Michael Siegel, Professor at the Boston University School of Public Health

The articles above do not necessarily represent Instead’s position or opinion and no opinions within these articles should be taken as claims to the health, safety, or use of the electronic cigarette. As we have stated many times in the past, the most healthy thing to do is to quit smoking, period. The electronic cigarette is an alternative for long time smokers who have not been able to quit. It is not healthy or safe, but simply an alternative to smoking tobacco cigarettes.

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.
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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!

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.