Steve's Clean Smoking

The Power of an Informed Decision

At inLife, we believe that the power of an informed decision should be in the hands of the consumer.  That's why we want you to be informed and have all the available information available regarding your choice to use the electronic cigarette.  Below are links that we are aware of that speaks to the issue of the electronic cigarette.  inLife is adamant in our approach.  As mentioned throughout our website we are selling a product that is an alternative to tobacco products.  It is not sold as a cessation device.  It does not cure, mitigate any illness or condition nor does it offer any therapeutic benefit.   We do not sell our product to anyone who is under the legal age of smoking in their state of residency.  We encourage you to view our Products Warning and FDA statements found almost everywhere on our website and on the bottom of this page as well.

We welcome you to review the information on this link to educate yourself regarding what the experts are saying about the electronic cigarette.  inLife believes that you, as the consumer, should make your decision based on current medical information available.  You make the choice!

Comments by Dr. Michael Siegel, MD, MPH - A physician who specialized in preventive medicine and public health.  He is now a professor in the Social and Behavioral Sciences Department of Boston University School of Public Health.  He has 20 years of experience in tobacco control, primarily as a researcher. 

Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones

The FDA last week condemned electronic cigarettes on the basis that an FDA laboratory detected carcinogens (tobacco-specific nitrosamines) in the cartridges of several electronic cigarette manufacturers. The FDA held a press conference in which it attempted to scare electronic cigarette users into discontinuing e-cigarette use (and therefore a return to conventional cigarette smoking). In addition, a number of anti-smoking groups, including the Campaign for Tobacco-Free Kids and American Lung Association, have called for a ban on these products due to this carcinogen scare.

The FDA (and the anti-smoking groups), however, failed to do three important things:

First, they failed to disclose the levels of tobacco-specific nitrosamines that were detected in the electronic cigarette cartridges.

Second, they failed to test the control product (a nicotine inhaler) to determine the carcinogen level in that product.

Third, they failed to report the tobacco-specific nitrosamine levels in conventional tobacco products, including cigarettes.

Because of the FDA's and the anti-smoking groups' omissions, there is a need to get the rest of the story out there to the public. And here it is, in this table:

Maximum Tobacco-Specific Nitrosamine Levels in Various

Cigarettes and Nicotine-Delivery Products

(ng/g, except for nicotine gum and patch which are ng/patch or ng/gum piece)

Sources:

1.                Stepanov I, Jensen J, Hatsukami D, Hecht SS. Tobacco-specific nitrosamines in new tobacco products. Nicotine & Tobacco Research 2006; 8:309-313. (Link)

2.                Laugesen M. Safety Report on the Ruyan e-cigarette Cartridge and Inhaled Aerosol. Christchurch, New Zealand: Health New Zealand Ltd, 2008. (Link)

3.                Wahlberg I. Tobacco-specific Nitrosamines in Unburnt New Zealand Tobaccos. Report to Health New Zealand Ltd. Swedish Match, 2004. (Link)

As these data show, the level of tobacco-specific nitrosamines present in electronic cigarettes is at the trace level. It is measurable in parts per trillion (nanograms per gram). It is comparable to the nitrosamine levels in nicotine replacement products which are approved by the FDA.

In contrast, the level of tobacco-specific nitrosamines present in tobacco products are 300 to 1400 times higher. On a weight-for-weight basis, Marlboro has 1400 times higher the level of tobacco-specific nitrosamines than an electronic cigarette cartridge. And keep in mind that these represent the levels in the cartridges and cigarettes, not in the tobacco smoke or e-cigarette vapor which are directly inhaled. Because of the much higher temperatures generated in tobacco combustion compared to propylene glycol vaporization, the delivery of these carcinogens into the vapor is expected to be much lower than into the tobacco smoke.

Moreover, there are approximately 56 other carcinogens that have been identified to be present at high levels in tobacco smoke, while there are no other carcinogens that have been identified to be present in electronic cigarettes.

Based on these data, and upon knowledge that the conventional cigarette contains at least 10,000 other chemicals, including known toxins and carcinogens, while the electronic cigarette does not, there is exceedingly strong evidence that electronic cigarettes are much, much safer than conventional ones.

This does not mean that there are not issues that need to be addressed with electronic cigarettes. The diethylene glycol that was present in one cartridge tested suggests that more widespread and systematic testing should be done to identify the extent of this problem. Testing is also necessary to determine whether the diethylene glycol actually makes it into the e-cigarette vapor/mist. The problem should be able to be addressed easily, since high-grade propylene glycol - which is almost entirely free of diethylene glycol - is readily available.

Appropriate procedures also need to be in place, if they are not already, to ensure that electronic cigarettes are not available to minors.

However, what this calls for is the FDA working with the electronic cigarette manufacturers and distributors to study the product and address the identified problems. It does not call for the FDA to ban the product or pull it from the market.

This research is not the only work that has established that electronic cigarettes are much safer than conventional cigarettes. Research conducted by Dr. Murray Laugesen and Health New Zealand Ltd. reveals that the toxic emissions score for electronic cigarettes is much lower than that of conventional cigarettes. In fact, the toxic emissions score - which is a score based on the levels of 59 priority toxicants - was zero for electronic cigarettes. In contrast, it was 126 for Marlboro and it was no lower than 100 for any brand of conventional cigarette tested.

Note that the above study actually tested the electronic cigarette vapor. This is the most relevant test, because it determines what the user actually inhales. The study found no more than trace levels of any of the 59 priority toxicants.

The study concluded: "Ruyan® V8 nicotine e-cigarette users do not inhale smoke or smoke toxicants. The modest reductions recommended in 2008 by WHO's Tobacco Regulation committee for 9 major toxicants in cigarette smoke, in line with Articles 9 and 10 of the FCTC (WHO Framework Convention Tobacco Control treaty), are already far exceeded by the Ruyan® e-cigarette, as it is free of all accompanying smoke toxicants. Absolute safety does not exist for any drug, but relative to lethal tobacco smoke emissions, Ruyan e-cigarette emissions appear to be several magnitudes safer. E-cigarettes are akin to a medicinal nicotine inhalator in safety, dose, and addiction potential. E-cigarettes are cigarette substitutes. If they can take nicotine market share from cigarettes, and that is the big question, they will improve smoker and population health. They may also have a secondary role as medicinal nicotine inhaler quitting aids. Further trials of acceptability, addiction potential, clinical safety, and quitting efficacy are needed."

It should also be noted that there is preliminary research which provides laboratory evidence that electronic cigarettes are as effective as nicotine replacement products for short-term smoking cessation (i.e., these products have been shown to provide relief of cigarette cravings at a level comparable to nicotine replacement products). This research found that electronic cigarettes are actually preferable to a nicotine inhaler in terms of helpfulness, pleasantness, and ratings of whether the smoker would use the product and recommend the product. Given the overwhelming anecdotal evidence of the effectiveness of e-cigarettes for smoking cessation, formally studying the longer-term effectiveness of these products is a research priority.

Electronic cigarettes have the potential to be a life-saving intervention for millions of smokers. The FDA and the anti-smoking groups need to embrace this product and support the appropriate testing, not remove it abruptly from the market and sentence over a million e-cigarette users to disease and even death by a return to conventional cigarettes.

         http://tobaccoanalysis.blogspot.com/

A Copy of the Health New Zealand Report on the Ruyan Electronic Cigarette as referenced above by Dr. Siegel, MD, MPH.

http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf

More from Dr. Michael Siegel, MD, MPH

Independent Scientific Review Concludes that NJOY Electronic Cigarettes are Much Safer than Conventional Ones

Report Also Concludes that FDA Failed to Adequately Support Claims of Dangers of NJOY E-Cigarettes Compared to FDA-Approved Nicotine Replacement Products

A new scientific report - commissioned by NJOY and conducted by Exponent, Inc., a scientific consulting firm - reviewed the FDA report and other studies of electronic cigarettes and concluded that the FDA failed to provide evidence that NJOY products are more dangerous than any FDA-approved nicotine replacement products currently on the market. The report also concluded that the FDA report actually confirms that NJOY electronic cigarettes are much safer than conventional ones and should therefore be welcomed rather than cause for concern.

Exponent Inc. is a large engineering and scientific consulting firm with substantial expertise in the areas of toxicology and mechanistic biology, including chemical risk assessment. Exponent has extensive experience in the development of toxicity criteria and safety levels for chemicals. Its analyses have been incorporated into risk assessments conducted by OSHA and the EPA, and its scientists serve on a number of expert government panels.

The report made a number of important points, many of which I have been making over the past two weeks:

·                     "In the lots that were tested by the FDA, none of the key chemicals of concern in this study such as TSNAs and tobacco-associated impurities were able to be quantifiably measured in the liquid of NJOY's cartridges because they were all below the limits of quantification (LOQ)."

·                     "All of the tobacco-associated impurities found in the NJOY products were "present but at less than the level of the Nicotrol® inhaler [manufacturer] specification" according to the FDA report."

·                     "The chemical content of similar nicotine-containing FDA-approved products was not completely described with respect to the presence of tobacco-specific nitrosamines (TSNAs) and other tobacco-associated impurities that have also been found in nicotine replacement therapy (NRT) devices at similar, if not higher, levels."

·                     "Data presented in the report does not adequately support the opinion that users of NJOY products would actually be exposed to TSNAs and tobacco-specific impurities in the vapor phase during normal device use; and if exposed, that those levels would be a health concern as compared to other FDA-approved products."

·                     "The FDA-approved Nicotrol® inhaler was presented as a "control" for their studies, but was only used for some of the experiments. The device was never tested for the presence of the same "carcinogens and toxic chemicals" that were found in some of the e-cigarette cartridges. When it was indicated that the Nicotrol® inhaler device did contain some levels of tobacco associated impurities, it was never discussed in the report or even mentioned in the results section. These tobacco-specific impurities in the Nicotrol® inhaler were also not discussed in comparison to the values obtained for NJOY's or Smoke Everywhere's products. With respect to the TSNAs, the report did not mention that these substances are found in nicotine gum, the patch, nasal spray, and lozenges in concentrations that are at the very least similar to, or higher than those found in the NJOY cartridges (Stepanov et al. 2006; Osterdahl et al. 2004)."

·                     "Key carcinogenic and toxic chemicals that were found in the liquid phase were not examined in the vapor phase. From a human health exposure perspective, it would have been beneficial to determine if the same chemical constituents found in the liquid phase analysis were also found in the vapor phase, especially considering that the vapor phase is the pathway of exposure to the e-cigarette user."

The report concludes as follows:

1. "In summary, the report "Evaluation of e-cigarettes" suffers from several limitations, that taken together result in it failing to adequately support the FDA claims of potential adverse health consequences from the use of NJOY e-cigarette products tested as compared to other FDA-approved nicotine containing products."

2. "The detection of trace and non-measurable levels of TSNAs and tobacco-associated impurities in the liquid, rather than the vapor phase of NJOY's products, at levels that are many orders of magnitude below conventional cigarettes, and at or below FDA-approved nicotine containing products, should be considered as indicators of the regulatory acceptability of the NJOY products rather than reason for concern. When considering the relative potential health risks posed by these trace levels, it is worth noting that the approved NRTs, which have been shown to contain these substances, were not judged to contain levels sufficient to warrant toxicity information or reference to these substances in their own product literature."

This independent scientific report by an expert consulting firm in the area of toxicology and risk assessment confirms many of the critical points I have been making in commentaries over the past two weeks.

First, the FDA's presentation of its own laboratory results was very misleading because the Agency failed to mention the levels of the carcinogens that were detected in electronic cigarette cartridges (which were at trace levels) and failed to mention that these same carcinogens are also present (at similar trace levels) in FDA-approved nicotine replacement products.

Second, the FDA inexplicably failed to test the nicotine inhaler - which was the control device in the study - for the presence of the same carcinogens as in the electronic cigarettes. Such testing would likely have revealed the same trace levels of carcinogens, and would have nullified the FDA's and the anti-smoking groups' major points at the press conference.

Third, the FDA failed to compare the carcinogen levels in electronic cigarettes with those in real cigarettes which the FDA now approves. Such a comparison would have revealed that the real ones are 1400 times more dangerous. Thus, the FDA lab testing actually supports a conclusion that electronic cigarettes are much safer than the FDA-approved tobacco cigarettes and that electronic cigarettes should be embraced in the regulatory environment, rather than banned (as anti-smoking groups are widely calling for).

The Exponent report also notes that all of the NJOY electronic cigarette cartridges tested were negative for diethylene glycol. This suggests that propylene glycol cartridges that are derived from pharmaceutical grade propylene glycol are not a problem, and that the source of the problem with one electronic cigarette brand that contained diethylene glycol at a level of 1% is most likely the failure to use pharmaceutical grade propylene glycol, a problem that could (and should) be easily corrected.

The rest of the story is that an independent scientific expert report has now confirmed that - at least in the case of NJOY electronic cigarettes - there is no evidence that these products pose any increased health risks compared to FDA-approved nicotine replacement products and that they pose much less health risk than FDA-approved tobacco cigarettes.

Is it not inappropriate that while the FDA has had jurisdiction over both electronic cigarettes and tobacco cigarettes for the past several months, it has already held an alarmist press conference about the electronic ones, but has yet to put forward any warning to the public about the deadly real ones.

http://tobaccoanalysis.blogspot.com/

Comments by Dr. Elizabeth Whelan, Sc.D. MPH - President of the American Council on Science and Health.

Washington Times Op-Ed: Why are Anti-Smoking Groups Promoting Cigarette Smoking over Quitting?

An op-ed by Dr. Elizabeth Whelan - president of the American Council on Science and Health - in today's Washington Times asks why anti-smoking groups are promoting cigarette smoking over quitting by urging electronic cigarette users to return to the real cigarettes. Somehow, Dr. Whelan notes, anti-smoking groups seem to feel more comfortable with the idea of smokers using a product that we are familiar with, even though the product is responsible for what Dr. Whelan states are more than 450,000 deaths per year in the U.S.

Dr. Whelan writes: "At a time when the government is ostensibly trying to cut health costs, why is it trying to ban something that might help people quit smoking tobacco, perhaps the most devastating health problem in the U.S.? The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called "e-cigarette" -- claiming it was loaded with harmful "toxins" and "carcinogens." The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes -- better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S."

"In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk."

http://tobaccoanalysis.blogspot.com/

Comments by Dr. Brad Rodu, DDS, Professor of Medicine, Endowed Chair, Tobacco harm Reduction Research, University of Louisville

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."

http://rodutobaccotruth.blogspot.com

Comments by Dr. Joel Nitzkin, MD, MPH, DPA, Chair AAPHP Tobacco Control Task Force:

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."

Copy of FDA Evaluation of Electronic Cigarette, May 4, 2009

Copy of FDA Evaluation of Electronic Cigarette, May 4, 2009

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

Note: Neither Dr. Siegel, Dr. Whelan, Dr. Nitzkin nor Dr. Rodu endorse any particular brand of e-cigarettes.  These individuals are not paid spokespersons and they do not benefit financially from the electronic cigarette industry.  Their comments are their own opinions and are based upon the e-cigarette technology at large.  Their comments are not intended as an individual endorsement of inLife brand products nor our competitors.  However, they are strong advocates of this technology and they are making more and more health officials and providers aware of the benefits (in their professional opinion) that they provide.

inLife products have not been certified by the Food and Drug Administration or the Office of the Surgeon General to be used for smoking cessation purposes. To purchase inLife products or sign up a distributor, you must be the legal age of smoking or older in your state of residence.

Product Warning

Warning:  Nicotine is an addictive substance. This product has not been approved by the U.S. FDA as a cessation device and therefore should not be used to quit smoking. This product is not intended to diagnose, treat, cure, prevent or mitigate any disease or medical condition or offer any therapeutic benefit. Do not use this product if you are under the legal age of smoking or if you are sensitive to nicotine or inhalants. Do not use this product if you have or if you are at risk of having any respiratory conditions, heart disease, high blood pressure or diabetes. Consult your doctor before use if you have any medical conditions. Do not use this product if you are pregnant or nursing. Discontinue use of this product immediately if you experience symptoms such as nausea, dizziness, a weak or rapid heartbeat, vomiting, diarrhea or any other negative physical symptom.

If any of the aforementioned symptoms occur, seek medical attention immediately. KEEP THIS PRODUCT AWAY FROM CHILDREN AND PETS. Ingestion of the non-vaporized concentrated ingredients in the cartridge can be poisonous. Ingestion of certain pieces may present a choking hazard.