Matt Salmon, former Congressmen and current President of The Electronic Cigarette Association responds to the FDA’s announcement regarding electronic cigarettes:

BOSTON, July 27 — The FDA recently went public with misleading information about the safety of electronic cigarettes and the marketing of the devices, not only using its clout but recruiting other prominent organizations to demonize a product that has great public health benefit potential.

A group of prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, challenge the FDA to provide the full quantitative data of the study upon which the FDA has based its warning against electronic cigarettes. They are concerned that the FDA’s disingenuous targeting of electronic cigarettes through a biased presentation of the scientific data has had significant negative impact upon the public perception of electronic cigarettes, when the best available evidence suggests that these have shown that the devices offer great potential to reduce serious health issues among traditional tobacco smokers.

In a July 22 news release, the FDA cited the detectable presence of carcinogens and “toxic chemicals” in a “small sample” of electronic cigarette cartridges as reason for alarm, singling out nitrosamines as particularly toxic. What the FDA fails to inform the public is that detectable amounts of carcinogens are also present in nicotine replacement products such as NicoDerm CQ and Nicorette gum, both approved by the FDA, and nitrosamines that can be also found in food items such bacon and beer. This double standard and alarmist attitude has had the significant and unfortunate effect of inducing hysteria among the public, discouraging tobacco smokers from using a product which is thought to be a significantly safer alternative to traditional tobacco.

Regrettably, the FDA has used biased reporting of this small and inconclusive study, the complete results of which have not been made public, to secure the vocal support of groups such as the American Academy of Pediatrics Tobacco Consortium, the Institute for Global Health, and the American Lung Association in their attack on electronic cigarettes. These researchers argue that it is absurd to consider taking electronic cigarettes off the market when it is the conventional ones which have been shown to be killing people. Further, the electronic cigarette community calls for accurate and fair reporting relative to the findings and statements of prominent medical professionals in favor of this new and important technology and challenges the media to tell the other side of the story.

“The FDA’s laboratory findings actually indicate that electronic cigarettes are much, much safer than conventional cigarettes,” says Dr. Michael Siegel. “The traces of carcinogens present are also present in nicotine replacement products. The FDA and the anti-smoking groups have fallen into a huge analytical trap as they have failed to ask the appropriate question. The question they are asking is: ‘Are electronic cigarettes safe?’ That is not the right question. The right question is: ‘Are electronic cigarettes much safer than traditional ones?’”

Dr. Rodu states, “The FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and the methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years. These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes.”

Dr. Joel Nitzkin speaking as individual states, “The newly adopted FDA/Tobacco legislation will give full FDA approval to currently marketed conventional cigarettes. The new law encourages cigarette companies to produce new “reduced exposure” cigarettes to be marketed as reduced exposure products, with no scientific evidence that such reductions in exposure will reduce risk of future tobacco related illness and death. In the context of these provisions of the newly adopted FDA/Tobacco bill — FDA should be encouraging, not maligning the manufacture and sale of electronic cigarettes, and working with manufacturers to assure the highest possible quality control.”

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For more information and interviews, contact:

Michael Siegel, MD, MPH
Professor
Department of Community Health Sciences
Boston University School of Public Health
617-638-5167
Email: mbsiegel@bu.edu

Joel L. Nitzkin, MD, MPH, DPA
Chair AAPHP Tobacco Control Task Force
Phone: 504 899 7893 or 800 598 2561
Fax: 504 899 7557
jln-md@mindspring.com
www.aaphp.org

Brad Rodu
Professor of Medicine
Endowed Chair, Tobacco Harm Reduction Research
University of Louisville
Phone: 502-561-7273
Email: brad.rodu@louisville.edu
http://rodutobaccotruth.blogspot.com

Electronic cigarettes are not healthy or safe. Anything that you inhale is probably not good for you….except for air…..except air in any major city in the world.

But lets compare the electronic cigarette to tobacco cigarettes. The tar, arsenic, carbon monoxide, and hydrogen cyanide in tobacco smoke is produced via combustion. The electronic cigarette produces vapor, not smoke. There have been some TSNAs (tobacco specific nitrosamines) found in some electronic cigarette liquid, but these are present in much greater quantities in tobacco cigarettes and are even found in low levels in FDA approved NRTs such as nicotine gum and the patch. More testing is needed to determine if TSNAs are actually present in the e-cigarette vapor, which is important as this is actually the method of intake, not the eliquid.

So is the electronic cigarette healthier than tobacco cigarettes? We can’t say yet without further testing. But consumers should have all the information and ask themselves questions like; if my cigarettes didn’t have tar, arsenic, carbon monoxide, and hydrogen cyanide would I rather smoke them? I think consumers can make this determination for themselves.

The problem with making specific claims about cigarettes or tobacco of any kind is two fold. First, it can give the impression that tobacco and specifically smoking, is in any way healthy, which it is not. Even relative marketing statements such as “healthier” and “safer” can give the idea that the e-cigarette is some how good for you, which it is not. Smoking is bad for you.

The second issue with making health or safety claims is that this gives the FDA a position to attempt to take the e-cigarette out of the hands of the long term smokers who use the electronic cigarette. Before you can make a health claim (or smoking cessation claim), you must have FDA approval. This means doing the testing they require and writing them a rather large check.

So it is important that marketers of the electronic cigarette walk that fine line of convincing long time, dedicated smokers to try an electronic cigarette and making claims that may lead them to believe that smoking is good, healthy, or safe in some way.

So what is our position at INSTEAD? We don’t consider the electronic cigarette a quit smoking device, as it is still “smoking” in effect. We also do not promote the e-cigarette as healthy because it is not healthy. We just think that of age people who choose the legal action of smoking should have the choice to smoke the electronic cigarette, which we believe has distinct advantages over traditional smoking. We do not make the determination of whether or not this is healthier for any particular smoker. We sell to adults and they can make that decision for themselves.

Visit the Instead Electronic Cigarette Store for kits, e-liquid, cartridges, and e-cigarette accessories!

Electronic Cigarette Set with US Made E-Liquid with: 2 x Batteries 2 x Atomizers 1 x USB / AC Battery Charger 1 x Carrying tin 1 x Travel pouch 1 x 15 ml bottle of American made E-Liquid (approximately 300 cigarettes worth) 5 x Empty cartridges

USB Passthrough + 2 Prefilled Cartomizers Kit with: 1 x USB Passthrough (acts as battery) 2 x Prefilled Cartomizers (worth 15 cigarettes each) 1 x Travel pouch

Portable Electronic Cigarette Battery Pack with: 1 x Portable lithium ion battery 1 x Cord to charge the battery pack from your computer 1 x Cord to charge the iPhones and iPods *Note: A USB e-cigarette charger is need to make this portable battery a e-cigarette battery charger, but luckily a USB charger comes with each Instead Kit! *Charge it from your computer, then charge an E-Cigarette battery up to 18 times on the go!

I’ve heard about the blind following of main stream media for sometime, but until now I didn’t realize how deep it ran. It runs deep.

Here are a few of the media head lines after the FDA press release on electronic cigarettes yesterday:
* Electronic cigarettes unsafe, linked to cancer – NOT TRUE – no cases or examples of electronic cigarettes causing cancer exist
* Health officials in the nation have said that the testing of two leading e-cigarette brands has shown that they contain cancer causing chemicals and other toxins, including a major compound used in antifreeze. – NOT TRUE – one cartridge from one company had diethylene glycol (DEG) in it, which is found in antifreeze
* FDA: E-cigarettes are as dangerous as tobacco cigarettes – NOT TRUE – this is crazy

Here is what they actually found:
* Out of 18 cartridges, 1 had diethylene glycol (DEG) in it at less than 1%. One.
* Tobacco specific nitrosamines (TSNA) and tobacco specific impurities were detected in both products at very low levels (taken from the FDA Electronic Cigarette Evaluation conclusion). Makes sense if the nicotine was taken from tobacco. Many FDA approved NRTs have Tobacco specific nitrosamines in them. Also, not all the samples contained TSNA.
* Since 100% of tobacco cigarettes contain multiple carcinogens and only 50% of the electronic cigarette cartridges tested contained detectable levels of carcinogens (and even then it was at “very low levels” according to the report), what is the FDA saying about it’s relative safety compared to tobacco cigarettes.

Here is what they did:
* They received the electronic cigarette test results back on May 4th, 2009.
* They postponed a scheduled press conference from May 5th, 2009 to July 23rd, 2009 at which time they released their findings.
* They tested 14 cartridges from Smoking Everywhere (including zero nicotine) and 4 from Njoy, but didn’t test zero nicotine from Njoy. The FDA has been sued by both these companies.
* They used the Nicotrol Inhaler as a “control” but didn’t test it for anything except nicotine.

For all you “journalists” here are some good questions to ask the FDA:
* Why was the report not released until now?
* Did you test any cartridges other than the 18 you published?
* Why didn’t you test the Nicotrol Inhaler for diethylene glycol or tobacco specific nitrosamines?
* Why didn’t you test the zero nicotine from Njoy?
* How many reported illness from electronic cigarettes have there been?
* How many reported deaths from electronic cigarettes have there been?
* Based on your testing, are electronic cigarettes safer and healthier than tobacco cigarettes to the user and the surrounding public? Or alternatively, are e-cigarette more dangerous or as dangerous as burning tobacco?
* Why was no American made e-liquid tested?

It is important to note for anyone who doesn’t know much about the electronic cigarettes, is that the e-liquid is a separate thing from the device. The e-liquid ingredient list can be reworked to make sure there are no cancer causing substances or even impurities. We need time and support to do this, not misleading press conferences. As an example, rather than propylene glycol (which is where many suspect the DEG came from), you can use food grade vegetable glycerin (VG) as the base. Another good question…..why didn’t the FDA test e-liquid with a VG base. This is a distinct advantage over tobacco cigarettes where it has been proven very difficult to make a combustible product safer or healthier.

Responsible suppliers and manufacturers in the industry are very concerned about the quality of the product and the safety of the users. But calling for a ban on electronic cigarettes because of this limited testing is like pulling all beer off the market because 1 bottle had a mouse in it.

So how did 1 sample with DEG and 5 samples with tobacco specific nitrosamines turn into “electronic cigarettes contain cancer causing antifreeze”? Presentation. Oh yeah….and lack of questions.

But why would the FDA want to skew public perception over the e-cigarette? Well, considering the very large $$$$ involved in NRTs (Nicotine Replacement Therapies) sold by the pharmaceutical and the fact that the FDA receives a lot of it’s funding through pharmaceutical companies, one could speculate that those selling competing products want total control over the market. Conspiracy theory? Maybe. But follow the money trail.

What the FDA wants to do is compare the electronic cigarette to nothing. Therefore, any issues with it are worse than nothing. They need to be compared to tobacco cigarettes. E-Cigarettes are used in the same fashion by the same group of people; tobacco smokers.

The FDA has told anyone with any adverse effects to report them by:
* Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

I agree. Those with adverse effects should report them. But the method by which they ask for feedback (the mock scientific data in press release form) makes it appear like the FDA wants issues to give them a reason to pull the e-cigarette off the market. For the sake of the thousands and thousands of e-smokers who find it a suitable alternative to burning tobacco, I hope this is not the case.

ON BEHALF OF NJOY, CEO Jack Leadbeater
July 23, 2009
NJOY RESPONSE TO FDA CONFERENCE CALL

NJOY’s products have been on the market since at least April 2007 with no reports of significant
adverse health consequences. We do not market our products to children, and indeed take
affirmative steps to ensure that our products are not sold to minors by requiring retailers to agree to where the product is placed and request verification of appropriate age as it pertains to each state law.

NJOY has been tested by an independent third-party laboratory, Exponent. This testing, as well
as our consultation with medical experts, gives us confidence that our products are appropriate
alternatives for traditional cigarettes for the committed smoker. We are therefore surprised the
FDA’s testing has resulted in the Agency suggesting that our products represent a health risk on
par with conventional cigarettes. We will provide more information on NJOY’s testing and the
results in the next few days.

The FDA’s report admits its conclusions don’t apply to all products.

* Broad statements were made on the call that Diethylene glycol (DEG) was detected in
the test samples, but the specific report shows that DEG was not found in NJOY’s
products.

* The results touted by FDA related to antifreeze are inapplicable to NJOY’s products (per
the FDA report) .

* FDA’s report simply shows that the products contain certain tobacco-specific impurities
(at much lower levels than conventional cigarettes, and this is something we are having
our experts compare in the reports conduct by NJOY and the FDA).

We find it interesting the FDA’s report is dated May fourth and is only now being released. The
FDA has not asked us to relabel our product, or to remove it from product shelves, at any point in the two years we have been in the market.

We remain willing to work with FDA to address the Agency’s concerns.

———————–

For more information, read How The FDA Misled The Public About Electronic Cigarettes which also includes a link to the actual FDA study.

At 3pm, 7/22/09, the FDA made an announcement to media regarding the status of the electronic cigarette. The call was headed by Judy Leon of the FDA Office of Public Affairs.

Due to the recent litigation between two electronic cigarette companies, Smoking Everywhere and nJoy, and the FDA, the FDA tested 18 cartridges from the two companies. From the testing done by the FDA on the electronic cigarette, it was noted that they found inconsistencies in the manufacturing process and that in some of the cartridges there were small amount traces of known carcinogens (Tobacco-Specific Nitrosamines) and Diethylene Glycol found in one cartridge from Smoking Everywhere, which is harmful to humans. What they also withheld from the announcement is that diethylene glycol is used for drying tobacco products and is found in tobacco products. They also failed to mention that Tobacco Specific Nitrosamines (TSNAs) are also found in the currently FDA approved NRT’s.

From the conclusions of these lab tests performed by one FDA lab, it was noted that the electronic cigarette cartridges differ from one manufacturer to another and therefore, quality control is of great concern to the FDA. We can’t disagree. The whole industry is already moving towards implementing better manufacturing processes.

The rest of the discussion was led by some heavy anti-smoking hitters in the public health industry. Jonathan Thomas of the Institute of Global Health, Dr. Jonathan Winickoff, Chair of the American Academy of Pediatrics and Dr. Matthew Mikenna of the CDC’s Office of Smoking and Health, all noted that their greatest concern is how the electronic cigarette is marketed and also how it has the ability to be a gateway to tobacco use.

The marketing concerns raised were that the ecig is marketed heavily to children through the enticing use of candy/fruit flavors and also that by putting “Adult Use Only” on a product such as the electronic cigarette, is a direct marketing tactic to children.

When asked if the electronic cigarette was a legal product to be sold in the US, Michael Levi, counsel for the FDA, noted that all of the products that have been held or seized have been new drug and drug delivery devices due to the marketing of them as smoking cessation devices. He also noted that in order to continue marketing them as NRT’s they would need the proper documentation and studies to sell them as such. He could not further comment due to the current litigation.

When further asked if anything has changed due to this call, if this announcement was actually to announce anything, Levi simply noted that the FDA wanted to make the public aware that the electronic cigarette is cause for concern based on the tests they had performed and that there was definitely a need for regulation to ensure that each and every product on the market is equal to what it says it is.

There is no doubt that the electronic cigarette needs to be regulated. But in what capacity and who is going to take on this huge task? It was very clear from the discussion that the FDA takes one stance: This is not a proven smoking cessation product and the only way they want to see this on the market is if it is.

It was clear from the lack of having any doctors/groups such as Dr. Joel Nitzkin, Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians or Dr. Michael Siegel of Tobacco Analysis, both prominent anti-smoking advocates but also FOR the electronic cigarette as a tobacco harm reduction strategy, that the FDA needs to be open to further discussions and also to acknowledge testing that has been done to date.

Hopefully, the FDA will not be blindsided by their defensive position due to their current litigation to see that even with the above testing on two of hundreds of different cartridges/liquids available on the market that there are a group of suppliers who do wish to be regulated, but regulated fairly.

It is interesting also that the doctors who were against the electronic cigarette and noting it as a “gateway to nicotine use”, did not voice any concerns regarding the recent overdose of nicotine by the 12 year old boy on a playground in the UK. A direct result of an anti-smoking group giving children nicotine without parental consent.

Or the fact that in another article today, Iayad Hasan, Director of the Cleveland Clinic Tobacco Treatment Center, declined the use of the ecig as a smoking cessation device because it does in fact leave the hand-to-mouth habit in tact and that does not aid in smoking cessation.

The facts are very clear. The electronic cigarette does need to be regulated. It does need quality control on the manufacturing side and it does need regulations for marketing. It is evidently clear that the electronic cigarette has helped thousands of tobacco cigarette users and it is equally clear that the Electronic Cigarette Association is needed now, more than ever. It is needed to implement standards. It is needed in order to keep the market free and open and not run by pharmaceutical and tobacco interests.

There are many things about e-smoking that are similar to traditional smoking but let’s not forget that it still isn’t actually smoking. Some argue that it is still smoking because the action of smoking is still present and although this is a valid argument, there is still no combustion, just vaporization. Thus, the term “vaping” has been introduced by many e-smokers.

Let’s first look at the similarities.

As mentioned above, electronic cigarettes allow the user to inhale and exhale a smoke like substance. This is important and why many smokers find the electronic cigarette to be a suitable alternative to tobacco. You can see the vapor go in and see it come out. You can even blow “vapor rings”.

Many electronic cigarettes look like traditional tobacco cigarettes. This is not true of all models, but of most. This adds to the smoking sensation and helps many smokers feel more comfortable with the product.

Electronic cigarettes deliver nicotine…..well most do. While it is true that you can easily use an e-cigarette with no nicotine at all, most are sold with nicotine. By the way, here is a pdf of research done on nicotine by M.A. Bozarth,* C.M. Pudiak, & R. KuoLee. Addiction Research Unit, Department of Psychology, University at Buffalo. As a side note, although nicotine is addictive, it has never shown to be cancer causing.

Now the differences.

Electronic cigarettes use vaporization, not combustion. Burning causes a chemical reaction that can produce many known cancer causing agents including tar.

The e-cigarette can be used over and over again. The cartridges are refillable using e-liquid and the battery is rechargeable. This is quite the opposite of a tobacco cigarette which is used up then tossed.

Tobacco cigarettes contain tobacco….obviously. This is not the case with electronic cigarettes. The liquid that is vaporized contains a base of propylene glycol or vegetable glycerin, water, nicotine (optional), and flavoring. Further testing of the vapor is underway to determine other compounds in the liquid and in the vapor.

It is common knowledge that smoking tobacco cigarettes causes cancer and may eventually lead to death. To date and to our knowledge, no cases of e-smoking related cancer have been reported. To date there are zero cases of e-smoking related deaths. Although there are limited studies (right now), if you would like some users opinions, visit the electronic cigarette petition.

Contrary to what many health organizations advocate, smokers do have rights…..they just don’t have the right to harm others. They do have the right to choose an alternative to a product that is sanctioned by the government and known to kill. We encourage any legal age smoker who is thinking to trying an electronic cigarette to do their research, compare the products, and make an informed decision for themselves.

We’ve been getting some questions about how one should go about cleaning their atomizer or even if they should.  The first thing to note is that you should not use any kind of liquid or solvent to clean an atomizer.  They are not meant to be submered in any kind of liquid.  This includes e-liquid.  The e-liquid is suppose to be contained within the cartridge a few millimeters from the atomizer.  When the atomizer element heats up, the heat vaporizes the e-liquid.  Although you may read about some users dripping the e-liquid directly onto the atomizer, this is not recommended.  It may work for a time, but inevitably it will cause the element to burn out.

Over time some eliquid may get onto the atomizer and build up.  The best way to clean it is simply to take the mouthpiece/cartridge off of the atomizer, leaving the atomizer screwed into the e-cigarette battery.  Then gently blow into the LED end of the battery.  This will activate the battery, which in turn will heat up the atomizer and any residual e-liquid will be vaporized.

Cleaning your atomizer in this fashion is not generally necessary.  Making sure your cartridge is full, but not “pooling” with e-liquid is the best way to ensure a long atomizer life on your electronic cigarette.

With many public health organizations and certain politicians making claims that electronic cigarettes are marketed to children, we decided to put together some numbers about the demographics of our customers. We do require all buyers to be of legal smoking age in order to purchase an electronic cigarette, but we wanted to answer the question if this product is more appealing to the young or the old.

Dealing with our customers on a regular basis has obviously given us some insight into the demographics of our e-cigarettes. Based on these interactions we are comfortable saying the majority of our customers are older smokers who have been smoking for a least 15 years. These seem to be the individuals who find the electronic cigarette a suitable smoking alternative after having tried to quit smoking with various methods over the years with no success.

But what do the number suggest? Although we are still working to put together the average age and the bell curve, we can easily pick out the mean age of our customers: 45 years old. That’s right, the mean year of birth for our customers is 1964. This was not surprising considering all the anecdotal evidence.

So who should use the electronic cigarette? That’s easy…..legal age smokers who have tried to quit smoking multiple times with no success. That’s it. Kids should not e-smoke. Non-smokers should not e-smoke. Pregnant women should not e-smoke. Anyone with any medical conditions should not e-smoke until they have talked to their doctors about it. Smoking, whether burning tobacco or the electronic cigarette, is an adult activity.