Dear Ms. Owens:
The Consumer Advocates for Smoke-free Alternatives Association (CASAA) is pleased to be able to provide you with information regarding research on electronic cigarettes. CASAA is a non-profit organization that works to ensure the availability of reduced harm alternatives to smoking and to provide smokers and non-smokers alike with truthful information about such alternatives.
The document “E-cigarettes and Smoke-free Policies” posted on the Madison County Health Department web site (
http://www.madisoncountyhealthdept....cigarettes and Secondhand Smoke EH 112110.pdf) contains many inaccuracies. Only one of the sources (Trtchounian et al, 2010) describes the findings of research conducted on electronic cigarettes. The remaining sources include a press release, opinion pieces, and research conducted on smoke. This document appears to be based on a document of the same name produced by the Tobacco Policy Research Program at the University of Kentucky, so I am copying Ellen Hahn on this message as well.
Bullet points in the document regarding the FDA’s testing of 18 cartridges are based on an FDA press conference, rather than the on the laboratory report issued by the scientist who conducted the testing.
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
Inaccurate statements were lifted verbatim from the press release, e.g. “they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.” The truth of the matter is that the 8 nanograms of tobacco-specific nitrosamines (TSNAs) found in the liquid of a “high” dose cartridge are no more likely to cause cancer than the 8 nanograms of the very same TSNAs in a 21-mg Nicoderm patch. No TSNAs were detected in the vapor. There was only one potentially toxic chemical found, again in the liquid but not the vapor. However, the quantity of diethylene glycol (DEG) that the FDA measured was 0.01 ml -- thousands of times below the toxic level of 1 ml per kg. Screening for tobacco-specific impurities in the vapor was negative except for a non-toxic quantity of β-Nicotyrine.
When you compare the lab report to statements in the press release, it becomes obvious that the FDA found nothing in the e-cigarettes tested that would endanger health. However, the Agency used inflammatory wording in its press conference to make it appear as though the using an e-cigarette is more dangerous than continuing to smoke. That is egregious behavior on the part of officials of an Agency charged with protection of public health.
Henningfield and Zaatari might suspect that e-cigarettes emit carcinogens, but the scientists who actually studied the vapor have found no carcinogens--or any other harmful substance--in vapor. One such scientist is Dr. Murray Laugesen of Health New Zealand who has been studying e-cigarettes for over four years. He states, “Lacking any active ingredient or any gaseous products of combustion, the PG mist or ‘smoke’ is not harmful to bystanders.” More than one researcher has found that e-cigarette vapor contains only one-tenth the amount of nicotine as a puff of tobacco smoke, and most of the nicotine is absorbed by the user, rather than exhaled.
Slieman’s research was conducted on smoke residue. Including bullet points that imply Slieman’s study results are applicable to e-cigarette vapor is a gross misrepresentation of the science.
In 1990, there were 43.8 million smokers. Twenty years later that number stands at over 46 million smokers. The smoking prevalence statistics and the smoking cessation rates tell us quite clearly that a more effective approach is needed. In “Harm Reduction in Nicotine Addiction: Helping Smokers Who Can’t Quit”, a 2007 report by the Tobacco Advisory Group for the Royal College of Physicians, the authors discuss the relative harm of different nicotine products. They state that many lives could be saved and much morbidity prevented if we recommended that smokers substitute less hazardous alternatives for smoking.
All of the smoking cessation programs in existence today are based on the concept of imposing nicotine abstinence--an approach that does not work for the overwhelming majority of smokers. When used as directed, to wean down and off nicotine, the FDA-approved products have a 7% success rate at 6 months, dropping to 5% at one year, and only 2% after 20 months. (Moore D, Aveyard P, Connock, M, Wang D, Fry-Smith A, Barton P: Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis. BMJ 338:b1024 2009.)
The success rates reported in surveys of e-cigarette users indicate that the harm reduction approach is much more effective than the nicotine abstinence approach. In studies limited to a single product, success rates of 31% have been reported (Siegel, et al. Electronic Cigarettes as a Smoking-Cessation Tool: Results from an Online Survey. American Journal of Preventive Medicine.
http://www.ajpm-online.net/webfiles/images/journals/amepre/AMEPRE3013.pdf).
I’m sure you will agree that a 6-month point prevalence rate of smoking abstinence of 31% is superior to a 7% rate of smoking abstinence.
Now what happens if you don’t limit users to a single product, allow them to find the combination of hardware and liquid that works best for them, and provide advice and assistance by an online community of experienced users? Success rates soar. A survey of 270 e-cigarette consumers (303 before excluding possible duplicates) found that 100% smoked before starting to use the e-cigarette, 92% had tried to stop smoking—63% trying 4 or more times to do so, and 87% had tried pharmaceutical nicotine products. Only 1% reported that pharmaceutical products helped them to stop smoking permanently. How well did the e-cigarette work? Only 3% were using the product in addition to smoking, 15% were using them as a partial replacement for smoking, and an astonishing 82% were using them as a complete replacement for smoking.
Which would save more lives? If a range of 2% to 7% of smokers can quit nicotine altogether, or if a range of 31% to 82% of smoker are able to abstain from smoking but use a less hazardous alternative source of nicotine?
In the case of Smoking Everywhere and Sottera (dba NJOY) versus the U.S. Food and Drug Administration, the Honorable Richard J. Leon, of the U.S. District Court for the District of Columbia stated that the FDA failed to provide any evidence that the products have harmed anyone. Since that opinion was issued, millions more of the products have been sold; and to date there have been zero reports of any serious adverse event. Side effects reported are no different from those reported with use of FDA-approved nicotine products.
Both the lower court and the U.S. District Court of Appeals for the District of Columbia have issued opinions that, as long as vendors make no claims that electronic cigarettes can cure or treat a disease, the FDA cannot regulate the products as a drug or drug-delivery device combination under the Food Drug and Cosmetics Act. If electronic cigarettes are marketed without health claims, the FDA can use the authority granted under the Family Smoking Prevention and Tobacco Control Act to regulate e-cigarettes as tobacco products.
There is no evidence that vapor presents any sort of danger to bystanders. In fact the same surveys that report exceptional rates of smoking abstinence with e-cigarette use also report that more than 90% of users are experiencing health improvements. Given that fact, how could the vapor they exhale possibly endanger the health of bystanders?
When continuing smokers see electronic cigarette users staying in a nice, climate-controlled environment while they are exiled outside to the elements, this observation can serve as a powerful incentive. They may think, “Why not give e-cigarettes a try?” Many e-cigarette users at first had no intention of quitting smoking. But once they began using an e-cigarette, they no longer had any urge to smoke.
CASAA has revised “E-cigarettes and Smoke-free Policies” to provide a more accurate picture of the scientific facts about e-cigarettes. A copy is attached. I have sent a printed copy of this document to members of the Madison County Board of Health. Feel free to contact me with any questions you might have.
Very truly yours,
Elaine Keller
CASAA Vice President
CASAA | The Consumer Advocates for Smoke-Free Alternatives Association