Continued from previous page.
The FDA study has been faulted for a number of reasons, including but not limited to:
Why were only two e-cigarette brands tested?
There are hundreds of electronic cigarette manufacturers presently retailing products in the U.S. As one might expect, their products vary in degree of quality assurance and adherence to manufacturing best practices. Whatever the reason, two brands cannot be considered a representative sample. Further, independent tests conducted subsequent to the FDA report have identified a number of brands whose cartridges contain zero TSNAs.14
Why were FDA-approved, nicotine replacement therapies not tested as controls?
Perhaps, the answer is that these approved products (produced by major pharmaceutical companies) also contain trace amounts of the chemicals cited. For instance, “The maximum level of total TSNAs reported was 8.2 ng/g. This compares with a similar level of 8.0 ng in a nicotine patch, and it is orders of magnitude lower than TSNA levels in regular cigarettes.” Further, “electronic cigarettes contain only 0.07-0.2 per cent of the TSNAs present in cigarettes, a 500-fold to 1400-fold reduction in concentration.” The DEGs found in one sample account for the myth that electronic cigarettes contain anti-freeze. The most likely explanation for this single aberration is that the product in question utilized non-pharmaceutical-grade nicotine — something easily prevented by regulations requiring manufacturers to adhere to FDA-established nicotine quality standards.15
Why are the 8.0 ng/g of TSNAs found in nicotine patches acceptable to the FDA, while the 8.2 ng/g of TSNAs found in e-cigarettes unacceptable?
As the difference in TSNA levels is statistically insignificant, one can only conclude that the FDA applies a harsher standard to electronic cigarettes. This bias is indeed unfortunate as the technology has the potential to save the lives of millions of smokers worldwide. It is certainly ironic that misguided government agencies like Health Canada have banned the products in the interest of public safety.
The suspect methodologies employed by the FDA in their e-cig testing did not go unnoticed in the mainstream media:
But the agency has never presented evidence that the trace amounts actually cause any harm, and it has neglected to mention that similar traces of these chemicals have been found in other FDA-approved products, including nicotine patches and gum. The agency’s methodology and warnings have been lambasted in scientific journals by Dr. Polosa and other researchers, including Brad Rodu, a professor of medicine at the University of Louisville in Kentucky.” 16
Do e-cigarettes have side effects?
The short answer is “no.”
Given that electronic cigarettes are relatively new to the market, their health benefits, immediate side effects and long-term risks have not been fully determined. According to the World Health Organization (WHO), there is no sufficient peer reviewed research on the product to verify that e-cigarettes are an effective and safe nicotine replacement therapy. On the other hand, WHO does not rule out the possibility that the devices could be useful smoking cessation tools. It argues that safety claims should be backed by clinical studies and toxicity analysis. And while the WHO awaits the results of long-term clinical studies, smokers continue to die.17
…to a great extent they have based their reasoning on fear of the unknown rather than actual evidence.”
Laura Conzo Brady, eCigs HQ Editor
E-cigarette safety studies
A number of studies have been conducted to verify the safety of electronic cigarettes, with most providing remarkable results in e-cigs’ favor. For Instance, a study conducted by Health New Zealand in 2008 on the toxicity and carcinogenic levels of electronic cigarettes showed concentrations below harmful levels established by the WHO. The recorded nicotine dose was comparable to that of a medicinal nicotine-inhaler. The study concluded, “On the basis of findings to date, inhaling mist from the e-cigarette is rated several orders of magnitude (100 to 1000 times) less dangerous than smoking tobacco cigarettes.”18
A 2009 Health New Zealand Study found the e-cigarettes delivering nicotine were more effective in reducing tobacco withdrawal cravings than FDA-approved Nicorette Inhalers and e-cigarettes without nicotine. Further, they produced fewer side-effects than the inhaler while delivering approximately 1/10th the amount of nicotine contained in tobacco cigarettes. The study concluded that, “On the evidence to date, the e-cigarette appears to be akin to a medicinal nicotine inhalator in the safety of its emissions, and nicotine dose…E-cigarettes are cigarette substitutes. If they can wrest market share from cigarettes, they can improve smoker and population health. They may also have a more up-market role as medicinal nicotine inhaler to aid quitting.”19
A December 2010 research article by Dr. Zachary Kahn and Dr. Michael Siegel of the University of California at Berkeley and published in the Journal of Public Health Policy concluded that e-cigarettes have the potential to markedly improve the health of smokers who switch from tobacco cigarettes to electronic smoking products, “…electronic cigarettes show tremendous promise in the fight against tobacco-related morbidity and mortality. By dramatically expanding the potential for harm reduction strategies to achieve substantial health gains, they may fundamentally alter the tobacco harm reduction debate.”20
On August 25th, 2012, the European Society of Cardiology released the results of “the first clinical study of the acute effects of electronic cigarettes on cardiac function.” The findings were clear. According to Research Fellow at the Onassis Cardiac Surgery Center, Dr. Konstantinos Farsalinos, “Electronic cigarettes have no acute adverse effects on cardiac function.” He added, “considering the extreme hazards associated with cigarette smoking, currently available data suggest that electronic cigarettes are far less harmful and substituting tobacco with electronic cigarettes may be beneficial to health.”21
…medical researchers are proving with ever-greater frequency that e-cigarettes are definitively less harmful than tobacco cigarettes.”
Laura Conzo Brady, eCigs HQ Editor
While anti-smoking advocates, government regulators, and elected representatives have often cited the unknown effects of second-hand e-cigarette vapor as reason enough to restrict or ban the use of electronic smoking devices, to a great extent they have based their reasoning on fear of the unknown rather than actual evidence. A study published in the Journal of Inhalation Toxicology in October, 2012, entitled, “Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality” concluded that, “there are very low indoor air quality impacts from the use of an electronic cigarette based on the risk screening of measured emissions. It also indicates no apparent risk to human health from e-cigarette emissions based on the compounds analyzed.”22
Electronic cigarettes are much safer than tobacco cigarettes
It is with findings like these from across the globe, that medical researchers are proving with ever-greater frequency that e-cigarettes are definitively less harmful than tobacco cigarettes.
E-cigarettes produce a vapor composed of water, propylene glycol and nicotine, so e-cigarette users are not exposed to the thousands of toxic agents formed when tobacco is burned. Although laboratory studies have detected trace concentrations of some contaminants, this appears to be a small problem that is amenable to improvements in quality control and manufacturing that are likely with FDA regulation as tobacco products.” 23
If properly regulated rather than banned or unduly restricted, electronic cigarettes hold untold value in terms of both lives and healthcare costs. Judging by the thousands who have used them to successfully quit smoking, e-cigarettes are proving themselves to be the most effective form of nicotine replacement therapy currently available — or in the case of Canada — officially unavailable. These products have the potential to assist millions of tobacco users worldwide in their efforts to quit smoking.24
It is important to note that less-effective nicotine replacement therapies are already available in Canada using nicotine patches, gums, and inhalers that contain similar ingredients and produce health effects similar to e-cigarettes. This similarity is the basis that most petitions have adopted to argue for the reverse of the electronic smoking ban in Canada. However, the products are quite different in one crucial way; the Health Canada-approved methods of nicotine replacement therapies fail to wean smokers off cigarettes at a much higher rate.
Consider the following findings published in the American Journal of Preventive Medicine from April 2011:
The primary finding was that the 6-month point prevalence of smoking abstinence among the e-cigarette users in the sample was 31.0%… A large percentage of respondents reported a reduction in the number of cigarettes they smoked (66.8%) and almost half reported abstinence from smoking for a period of time (48.8%). Those respondents using e-cigarettes more than 20 times per day had a quit rate of 70.0%. Of respondents who were not smoking at 6 months, 34.3% were not using e-cigarettes or any nicotine-containing products at the time.” 25
