E-Cigarettes: Dialog on Flavors and Poisoning Issues

During the Public Hearings on a bill that would have banned flavored liquid for electronic cigarettes, one health advocate testified:

The problem is that a lethal dose of nicotine for children is 10 mg and one of those cartridges contains 500 to over 1000 mg.

In our follow-up thank you to the committee members who had voted against the measure we endeavored to correct the misinformation that came out during the hearing. Regarding this particular statement we wrote:

This is false. Cartridges contain nicotine that has been purified (pharmaceutical grade), not “pure nicotine.” A cartridge contains no more than one gram (1000 mg) of a liquid solution of water, propylene glycol and/or vegetable glycerin, flavoring, and (optionally) nicotine. The “high dose” cartridges typically contain less than 2% nicotine (20 mg.)

We received a response:

In that statement I was referring to the refill containers that are used to refill the cartridges in the e-cigarettes. The information I gave in the committee hearing is correct for the refill containers. The containers do not have child-proof caps and come in candy flavors. This bill would ban those.

The text below is the reply from one of the CASAA Board Members.

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I thank you for opening a dialog on these issues.

We are in agreement that nicotine is poisonous and should be kept out of reach of small children.

The information you gave the committee is not necessarily correct for containers of refill liquid. The total quantity of nicotine in a refill bottle depends on two factors: 1) what percent of the solution is nicotine and 2) the size of the bottle. Given the 2% figure that I mentioned in my email, you would need a 50 ml bottle of refill liquid to reach a total of 1,000 mg of nicotine (1000 divided by 20). That’s well above average size for a refill bottle. If the bottle contains zero-nicotine liquid, there would be zero mg of nicotine, regardless of how large the bottle is.

However, a discussion of how much of a toxic chemical is in a container is beside the point. Most households contain many different products that are poisonous – bleach, nail polish remover, aspirin, drain cleaner, children’s cough medicine, mouthwash – to name a few. Should legislation be passed to ban all poisonous substances? Or should parents be expected to keep all poisons out of reach of children and pets?

Most toddlers can’t read, therefore catchy flavor names would be lost on them. Many of the substances that poison children are rather unpleasant tasting.

As my colleague Kristin pointed out, many smokers who switched to electronic cigarettes have lost their taste for tobacco smoke. It is very likely that the more pleasant flavors assist in the process of extinguishing a taste for smoke. Many smokers who quit by using other methods report that they still have cravings to smoke, even years later. We who quit smoking by switching to a reduced-harm product are experiencing no cravings to smoke. This is an important point, so I am going to repeat it: We have no cravings to smoke! Thus, when a famous Pediatrician announces that kids will begin using e-cigarettes and then “graduate” to smoking, we find the idea ludicrous.

There is zero evidence that pleasant flavors are enticing young people to take up nicotine use via e-cigarettes. If pleasant flavors are what they are after, they can get those without nicotine in an e-cigarette. Better yet, they can buy real candy, real cookies, real bubble-gum or some other food source of pleasant flavors. Those products will cost a lot less than an electronic cigarette.

There is zero evidence that—for whatever reason—any significant number of young people are buying these products. I’m attaching a copy of the CASAA Position Statement on Electronic Cigarettes. It contains some statistics on the age and smoking experience of consumers, substantiated by references. I’m also attaching a copy of the CASAA document, “8 Biggest Electronic Cigarette Myths”. It provides a more detailed explanation of some of the points discussed here.

These products are working for people who had lost all hope of ever being able to quit smoking. I’m 65. I smoked for 45 of those years and tried the patch, gum, lozenges, prescription nicotine inhaler, counseling, hypnosis, Nicotine Anonymous, and prescription smoking cessation drugs. When treatment stopped, relapse began. I didn’t just try these products once. I tried over and over, even using different combinations. If the definition of insanity is doing the same thing over and over again, expecting a different result, then I must have been insane.

On March 27, I will have been smoke-free for two years. To me, that’s the answer to a prayer—quite literally.

There are now hundreds of thousands of former smokers like me who did everything we were told to do and could not quit. We have finally found something that works. Then along come the groups that are supposed to be in favor of smoking cessation—health departments across the country, US Health and Human Services agencies, American Lung Association, American Heart Association, American Cancer Society, Campaign for Tobacco-Free Kids, WHO, and the AMA—and all of them want to ban outright the product that finally, at long last, worked for us. And when that doesn’t work, they want to make the products less effective by such actions as banning pleasant-tasting flavors. It boggles our minds.

What we really find insulting is when these organizations tell us that we should try the “safe and effective” smoking cessation methods. What they seem to be saying is “We want you to go back to beating your head against the wall.”

Again, I greatly appreciate that you are willing to discuss these issues. If you have additional questions or would like to discuss anything related to improving smoking cessation rates, I am including my mobile phone number.

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The two documents mentioned above can be downloaded from the CASAA web site:

CASAA Position Statement on Electronic Cigarettes
http://www.casaa.org/files/Casaa%20Position%20Statement.pdf
8 Biggest Electronic Cigarette Myths
http://www.casaa.org/files/8%20Biggest%20Electronic%20Cigarette%20Myths%282%29.pdf

WHO Opinion Not More Important than Voter Experience

Recently, a member of the Consumer Avocates for Smoke-Free Alternatives Association (CASAA) who lives in New Jersey contacted me for help in responding to a letter he received from his State Senator Robert M. Gordon, District 38. The CASAA member--I'll call him "Tom" to protect his identity--had written to Senator Gordon to ask that the senator reconsider the inclusion of electronic cigarettes in indoor smoking bans.

About half of Senator Gordon's letter focused on the FDA's efforts to drive the products totally out of the marketplace. Senator Gordon appeared to be unaware that the FDA's July 2009 press conference regarding FDA's testing of 18 cartriodges was a carefully crafted "spin job".

Senator Gordon had bought into the idea that e-cigarettes cause cancer, because he had not learned that the FDA neglected to mention that it only detected 8 ng/g (parts per billion) of tobacco-specific nitrosamines ("carcinogens") in the e-cigarette liquid. The FDA-approved nicotine patch also contains 8 ng/g and 4-mg nicotine gum contains 2 ng/g in each piece. These products carry no cancer warnings because such miniscule quantities of nitrosamines carry no cancer risks. The FDA was purposely being misleading by referring to them as "carcinogens." Apparently Senator Gordon was also unaware that a pack of cigarettes typically contain over 100,000 ng/g.

He did know that the quantity of diethylene glycol (DEG) FDA detected in the liquid of one cartridge was 1%, but did not appear to understand the utter harmlessness of such a miniscule quantity. A 150-pound adult woud need to drink the liquid from 6804 cartridges in a single day to be poisoned. Two problems with this: (1) Consumers don't drink the liquid; they inhale the vapr. (2) The FDA did not find DEG or any other harmful chemical in any of the vapor tested. Dozens of labs have tested the liquid and the vapor, both before and after the FDA's test, and no other lab has ever detected DEG.

FACT: The FDA looked for, but did not find, any chemicals in the vapor in quantities that would endanger the health of users or bystanders. Thus there is no justification for lumping electronic cigarettes into laws that were intended to protect air quality.

So I helped Tom by reviewing his letter and supplying some links to research supporting Tom's statements. A few day's later, I noticed a statement in Senator Gordon's letter that was not addressed in Tom's reply: “I also came across a statement from the World Health Organization in 2008 which said that it does not consider e-cigarettes to be a legitimate therapy for smokers trying to quit.”

The person who made that statement on behalf of the WHO was pharmacologist Jack Henningfield, PhD, whose appointment to the FDA Tobacco Products Scientific Advisory Committee is being challenged for conflict of interest. Henningfield has performed consulting services for the pharmaceutical companies that manufacture the nicotine-cessation products. A continuing source of confusion between tobacco harm reduction advocates and the rest of the world is the pervasive belief that smoking = nicotine. Their definition of “quit smoking” is that you give up using nicotine. So when Henningfield says “smokers trying to quit,” he doesn’t mean smokers trying to quit inhaling smoke. He means smokers trying to quit using nicotine.

It is unfortunate that the vast majority of the public does not know that nicotine does not cause the smoking-related diseases—it’s the smoke!

E-cigarette users replace the nicotine that they used to get from smoking with vaporized nicotine that is not accompanied by the harmful components of smoke. Users who want to go on to reduce their nicotine intake can do so, but doing so is not required to enjoy the health improvements that come from eliminating smoke.

E-cigarettes are not intended to be therapy and they are not intended to treat nicotine addiction. Nicotine abstinence is unworkable for the majority of smokers. The proof lies in the 93% to 98% failure rate of the nicotine patch, gum, lozenges, and prescription inhalers that have contributed to Jack Henningfield's income.

All these products direct the user to reduce their nicotine intake to zero over the course of about 12 weeks. The fact that the failure rate for these products is so high is what keeps smokers coming back and buying more Nicoderm, Nicorette, and Nicotrol. It keeps the money flowing into the pharmaceutical companies’ coffers, into Jack Henningfield’s pockets, and the pockets of several other members of the FDA TPSAC. Unfortunately, it also keeps the consumers of these products relapsing back to smoking—and feeling guilty about it, when the true cause of the failure actually lies with the “experts” who insist on nicotine abstinence.

If men like Henningfield were truly concerned about the health of smokers, they would applaud any product or method that resulted in 80% of users being able to stop inhaling smoke. I believe they are much more concerned with their own wealth than with the health of smokers and the continued health of former smokers who rely on e-cigarettes or other reduced-harm alternatives such as snus to maintain their abstinence from smoking.

If men like Senator Gordon were truly concerned about the health of their constituents, they would stop to consider whether WHO's opinion is what really counts.

Legislators should place a much larger value on the experiences of the people who elected them, instead of relying on the unsupported opinions of self-proclaimed “experts.” Most of these "experts" have conducted no research on the products themselves and refuse to even talk to people who actually have used the products. I attempted to talk to Jack Henningfield at the Society for Research on Nicotine and Tobacco (SRNT) conference last year to explain how the products have helped so many of us. As soon as he heard the words “electronic cigarette” he couldn’t get away fast enough. He was downright rude about it.

My Way or the Die Way

An Open Letter to New York Assemblymember Linda Rosenthal:


“If I can do it, anyone can do it.”

In 1990, there were 43.8 million cigarette smokers in the U.S. Twenty years later, the number of cigarette smokers stands at 46 million. Ooops. Maybe it isn’t as easy to quit as you want to believe. Maybe all human beings do not have bodies that are exact duplicates of yours.

Do you inject insulin every day? No? Do you feel morally superior to those who do, simply because your pancreas works better than theirs? Of course not. Then why are you so smug about having quit smoking 20 years ago and so scornful of those who are not able to quit by using your method?

All of the FDA-approved “smoking cessation” products are based on a model of weaning smokers totally off nicotine. You used the patch. You may not be aware of the fact that the success rate for nicotine weaning products such as the patch, when used as directed, is only 7% at six months, 5% at one year, and down to 2% after two years. When treatment ends, relapse begins. Now here is an eye opener: 30% of the smokers who have stopped smoking altogether by using nicotine gum are still using the gum, years later. They managed to stop smoking only because they ignored the directions. Instead of practicing the recommended nicotine weaning therapy, they are practicing self-directed nicotine maintenance therapy.

Let’s talk about nicotine “addiction” for a moment. Have you ever heard of a motorist being charged with “Driving under the Influence of Nicotine”? No. And you never will. All of the drugs that result in a DUI charge (e.g., alcohol, marijuana, heroin, etc.) impair the driver’s ability to concentrate, pay attention, use good judgment, and react quickly.

What are the effects of nicotine? Here is what a meta-analysis revealed: “We found significant positive effects of nicotine or smoking on six domains: fine motor, alerting attention-accuracy and response time (RT), orienting attention-RT, short-term episodic memory-accuracy, and working memory-RT (effect size range = 0.16 to 0.44).” (Heishman SJ, Kleykamp SA & Singleton EG. 2010. Meta-analysis of the acute effects of nicotine and smoking on human performance. Psychopharmacology 210 (4): 453-469 http://www.ncbi.nlm.nih.gov/pubmed/20414766)

Nicotine also has positive effects on mood. Unlike drugs such as alcohol, it does not create a false state of euphoria. Instead, it helps to relieve depression and anxiety. If you don’t have depression and anxiety, it does not have much effect on your mood.

Think about this: If you were someone who had problems concentrating, remembering things, staying awake in boring situations, or who had a family or personal history of depression and/or anxiety, and nicotine was keeping the symptoms under control, what would happen to you if you stop using nicotine? Those symptoms would go out of control, wouldn’t they? All of these conditions are caused by imbalances in brain chemistry. And since none of these can be 100% controlled by sheer will-power, they would not be likely to magically go away on their own.

So just because you get along fine without nicotine does not mean that everyone is better off without it. Harmful effects of nicotine are trivial, on a par with the harmful effects of caffeine – a temporary increase in heart rate and blood pressure that normalizes 20 minutes later. Nicotine does not cause cancer, heart attacks, strokes, or lung disease. Smoke does. So doesn’t it make sense to help those who become dysfunctional without nicotine by changing the method that delivers their nicotine to something that does not involve inhaling tar, carbon monoxide, particles of partly burned paper and tobacco, and thousands of chemicals created solely by the process of combustion?

I smoked for 45 years and tried over and over again to stop. I used the patch 20 years ago, too. The difference between you and me is that you did not become dysfunctional after following the directions. I did, and stayed that way for 6 long, miserable months, during which I wanted to commit suicide. Antidepressant medication relieved the mood impairments to a large extent, but I was told there was nothing they could prescribe that would relive the cognitive impairments, and I was about to lose my job. The patch at that time was only available by prescription, so it was not a long-term maintenance option. But when it became available OTC, I tried that. However, I developed a nasty rash wherever I put the patch. When they finally began manufacturing Nicorette gum in pleasant flavors (instead of the original flavor that tasted like an ashtray), regular use of the gum helped me to reduce the number of tobacco cigarettes I smoked. Unfortunately, it has a tendency to upset my stomach if I chew more than 4 or 5 pieces a day. When I discovered the electronic cigarette, it was literally the answer to a prayer. I used to lie in bed at night, kept awake by the sound of my wheezing, and pray to God to send me a way to stop smoking without becoming dysfunctional. I switched over to inhaling vapor on March 27, 2009. The wheezing is gone, as is the “productive” morning cough.

If self-medicating to remain a functioning, productive member of society is somehow immoral, then I guess everyone who buys a double latte at Starbucks every morning, and everyone who pops some Advil when they pull a muscle should admit to being immoral. But IMHO it is immoral to take away a tool that can save the health and the lives of millions. I ask you to reflect on the information I have provided and then to consider amending A1468 to remove Section 2. Allow former smokers who rely on these products to remain abstinent from smoking. Do not deny continuing smokers access to an extremely effective tool that can save their health and their very lives. “Quit (my way) or die” is an inhumane stance.

Elaine Keller

WHO FCTC May Kill Millions of Smokers

It is shocking to read that the Parties to the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) want to prevent the use of two of the most effective methods for achieving smoking abstinence. (http://www.scoop.co.nz/stories/WO1011/S00426/tobacco-convention-agree-on-stronger-smoking-controls.htm)

Smoking prevalence rates have stagnated. The United States Centers for Disease Control and Prevention as stated: ““To further reduce disease and death from cigarette smoking, declines in cigarette smoking among adults must accelerate.” (CDC MMWR Vol. 59 / No. 35 http://www.cdc.gov/mmwr/PDF/wk/mm5935.pdf)

When used as directed to wean down and off nicotine, medicinal nicotine products have a success rate of 7% at 6 months, 5% at one year, and only 2% at 20 months. (Moore D, et al. Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis. BMJ 338:b1024 2009 http://www.bmj.com/content/338/bmj.b1024.full.pdf+html)

The main reason medicinal nicotine products are so ineffective is that they require sustained nicotine abstinence. As soon as treatment ends, relapse begins. Dr. Brad Rodu of the University of Louisville states, ““Given that the outcome measure for all smoking cessation trials in the U.S. is complete abstinence, it is no wonder that most cessation methods are deemed failures. For successful tobacco regulation, the FDA must break the public health community’s addiction to abstinence promotion.“ (http://rodutobaccotruth.blogspot.com/2010/10/noteworthy-news-from-norway-snus-is.html)

Let’s compare the success rate of medicinal nicotine to methods that do not require nicotine abstinence.

Dr. Karl Erik Lund compared quit rates, defined as the percentage of ever smokers who are now former smokers, among snus users and never users of snus in seven previously published Norwegian surveys. The results were published in Addiction magazine. (http://www.ncbi.nlm.nih.gov/pubmed/2088345)

Lund Survey No.	Quit Rate - Snus Users (%)	Quit Rate - Never Snus Users (%)
1	80	52
2	55	23
3	81	63
4	62	53
5	75	45
6	90	50
7	73	43

It is important to note that not all smokeless tobacco products are alike. Swedish snus is formulated to reduce cancer-causing nitrosamines. Studies show that the health risks associated with Swedish snus use are significantly lower than the health risks of continued smoking. An assessment by Gartner, et al published in Lancet found “There was little difference in health-adjusted life expectancy between smokers who quit all tobacco and smokers who switch to snus (difference of 0.1-0.3 years for men and 0.1-0.4 years for women). For net harm to occur, 14-25 ex-smokers would have to start using snus to offset the health gain from every smoker who switched to snus rather than continuing to smoke. Likewise, 14-25 people who have never smoked would need to start using snus to offset the health gain from every new tobacco user who used snus rather than smoking.” (http://www.ncbi.nlm.nih.gov/pubmed/17498798)

As for electronic cigarettes, most of the world-wide panic has been generated by a very misleading press conference held by the U.S. Food and Drug Administration regarding their testing of 18 electronic cigarette cartridges made by the two companies engaged in a lawsuit against the agency (a strong signal of bias).

The FDA failed to point out that the highest quantity of “carcinogens” detected in a cartridge is equal to the quantity in an FDA-approved nicotine patch (8 nanograms). The quantity of diethylene glycol detected was so miniscule that a 150 pound person would need to ingest the contents of 100,000 cartridges in a single day to be poisoned. So why all the panic? Electronic cigarettes are about as dangerous as FDA-approved nicotine products, which makes them several orders of magnitude safer than smoking.

Critics keep claiming that there is no proof that electronic cigarettes help people to stop smoking. If by “stop smoking” they mean “achieve total abstinence from nicotine” then the critics are correct. However, if what they mean by “stop smoking” is to stop inhaling smoke and to enjoy all the resulting health benefits, then the critics are wrong. Surveys of electronic cigarette users consistently show that a large majority of users are able to substitute the electronic cigarette for all of their smoked cigarettes.

Survey #	# Subjects	Quit Rate
Heavner K, et al. Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of ecigarette users, Tobacco Harm Reduction Yearbook 2010.	303	79%
Etter JF. Electronic cigarettes: a survey of users. BMC Public Health 2010, 10:231.	81	63%
The Consumer Advocates for Smoke-Free Alternatives Association, online survey of e-cigarette users.	2217	80%

Here is a summary of the success rates for the three methods of achieving smoking abstinence:

Method	Success Rates
NRT	Best Case: 10-15% As directed: 2-7%
Swedish Snus	55-90%
Electronic Cigarettes	63-80%

If the WHO FCTC succeeds in pushing electronic cigarettes and smokeless products such as Swedish snus off the market, they will have succeeded in making a significant contribution to the death of millions of smokers who could have quit smoking by switching to a safer source of nicotine.

Reality Faces Off Against Unfounded Fears

Compare and contrast reality with fears about electronic cigarettes voiced by people who have never seen one, never talked to anyone who used one, and never bothered to read the available studies.

The Fears - As reported in the Annals of Internal Medicine, Volume 153, Number 9, p. 607-609 (“E-Cigarettes: A Rapidly Growing Internet Phenomenon”):

We contend that the e-cigarette boom presents important public health concerns on at least 3 fronts. First, e-cigarettes may pose a risk as starter products for nonusers of tobacco. Although candy-flavored tobacco products and e-cigarettes were recently banned by the FDA in efforts to hinder marketing toward children, the posturing of e-cigarettes as “green” and “healthy” could deceptively lure adolescents. E-cigarettes also may represent a way for adolescents and adults to skirt smoke-free indoor air laws.

The Reality - As reported in Chapter 19 of the Tobacco Harm Reduction Yearbook 2010 (“Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users”):

All respondents previously smoked and 91% had attempted to stop smoking before trying ecigarettes. About half (55%) were 31-50, while 32% were >50 years old. Most (79%) of the respondents had been using e-cigarettes for <6 months and reported using them as a complete (79%) or partial (17%) replacement for, rather than in addition to (4%), cigarettes. The majority of respondents reported that their general health (91%), smoker’s cough (97%), ability to exercise (84%), and sense of smell (80%) and taste (73%) were better since using e-cigarettes and none reported that these were worse. Although people whose e-cigarette use completely replaced smoking were more likely to experience improvements in health and smoking caused symptoms, most people who substituted e-cigarettes for even some of their cigarettes experienced improvements.

Similar results were seen in two other surveys of users. J.F. Etter’s “Electronic cigarettes: a survey of users,” published in BMC Public Health reported, “Our results suggest that most people who buy these products are current and former smokers who use ecigarettes to help quit smoking, just as they would use NRT.” The median age was 37, ranging from 19 to 65 years. An unpublished survey conducted by the Consumer Advocates for Smoke-Free Alternatives Association (casaa.org) found that 50.9% of the 2,217 responders were between ages 30 and 49 years and 27.4% were older than 50 years, and 99.6% had been smokers.

Thus, reality certainly does not match the fears that e-cigarettes will be “starter products” geared towards adolescents and children. It is interesting that critics of e-cigarettes accuse manufacturers of offering flavors as a means of attracting children, but do not accuse the makers of Nicorette gum of luring children to their products via White Ice Mint, Cinnamon Surge, and Fruit Chill flavors.

Lastly, reality faces off against fear #3. E-cigarettes are not burned. Therefore they produce no smoke. Expressing fears that people will use them to “skirt smoke-free indoor air laws” is as ridiculous as fearing that children will purchase root beer as a means of defying laws against sales of alcohol to minors. Root beer isn’t an alcoholic beverage, and vapor isn’t air-polluting smoke.

Authors Yamin, Bitton, and Bates end their Annals of Internal Medicine essay with this statement: "Although the safety and efficacy of e-cigarettes is uncertain, we believe that clearly counseling patients against e-cigarette use, as well as other tobacco use, is prudent." Presumably, the authors would prefer that smokers stick with the FDA-approved smoking-cessation products that have a success rate that ranges from 2% to 7% when used as directed.

It is estimated that there are now a million former smokers who achieved their smoking abstinence by switching to e-cigarettes. It isn't at all prudent to recommend that they stop using e-cigarettes and risk relapse, nor is it prudent to steer current smokers away from a product that has a success rate that ranges from 63% to 80% based on the three surveys mentioned above.

FDA Can’t Handle the Truth

Recently the U.S. Food and Drug Administration (FDA) invited the public to submit suggestions to the Center for Tobacco Products for educational resources to be added to the training program for Tobacco Retailers. http://tobaccoideas.fda.gov/forums/76427-improving-fda-tobacco-retailer-communication-tools

I submitted the following suggestion on September 19, 2010.

Relative Risks

Provide printed information comparing risk of smoking-related diseases from cigarette smoke to reduced risk from switching to smokeless products.

After I submitted the suggestion, the following feedback was displayed: “Your suggestion is awaiting moderator approval.”

OK, it’s understandable that the FDA would want to make sure that off-topic or off-color suggestions are weeded out before displaying them to the rest of the word. Since my suggestion was submitted over the weekend, I waited until Monday to see my suggestion displayed so that others could vote upon it.

Returning to my specific suggestion at http://tobaccoideas.fda.gov/forums/76427-improving-fda-tobacco-retailer-communication-/suggestions/1070375-relative-risks I saw that the “Awaiting moderator approval” message was still displayed.

I noticed the following message on the page.

PLEASE NOTE: To review our comment policy, visit http://go.usa.gov/3jT. We will only post on-topic comments on communication tool suggestions for retailers.

I clicked the link to determine whether the suggestion I submitted met the FDA guidelines, which read as follows:

FDA Center for Tobacco Product’s Tobacco Ideas Web site allows and encourages public comments and votes. We expect that participants will treat each other with respect and abide by the Terms of Service. All comments posted to the Web site will be reviewed and approved by the administrator before posting. We will not allow comments that contain vulgar or profane language; personal attacks of any kind; or offensive terms that target specific ethnic, religious or racial groups. We will not allow comments that are clearly off topic, spam, or that promote services or endorsement of any financial, commercial or non-governmental agency. The appearance of comments and external links on this site does not constitute official endorsement on behalf of the U.S. Food and Drug Administration.

Was my suggestion “off topic”? I found the following description of the program for which the FDA was seeking suggestions. (http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/default.htm )

Break the Chain is FDA's new campaign to educate retailers and raise awareness about tobacco product regulations designed to protect kids from the dangers of tobacco use and its negative health impacts.

Medical research shows that 98-99% of the negative health impacts of tobacco use are caused by inhaling tobacco smoke. Tobacco retailers probably don’t know this. Like the rest of the American public, they have been misled into believing that the health risks of smokeless tobacco products are equal to the health risks of smoking. One of the government-required warning messages on smokeless products, “This product is not a safe alternative to smoking,” is interpreted by 85% of the public as “This product is no safer than smoking.”

Allowing the public to believe “you might as well smoke” perpetuates the worst of the negative health impacts of tobacco use. What if, however, smokers were provided with truthful information about relative risks so that they could make informed decisions?

In Sweden, providing the public with truthful information about the reduced health risks of using low-nitrosamine “snus” (a type of moist snuff) has led to Sweden enjoying the lowest smoking rates of any country in Europe. One study surveyed 6752 adult Swedes on tobacco use. They found that those who used snus were significantly less likely to start smoking. Among male smokers who later began using snus, 88% ceased daily smoking completely. Women using snus were significantly more likely to be able to stop smoking than those using nicotine patches or gum. "The main lesson of this study is that significant sections of the public would select a less harmful high-nicotine smokeless product over cigarettes and use it long term in place of smoking."
Ramstrom (2006) Role of snus in initiation and cessation of tobacco smoking in Sweden. Tobacco Control 2006;15:210-214. http://tobaccocontrol.bmj.com/content/15/3/210.abstract

But what effect does switching to Swedish snus have on health? Researchers reviewed the literature to identify studies that provided quantitative risk estimates associated with Swedish snus and cigarette smoking in a single population.

“Seven studies were identified that addressed eight health outcomes. Although few in number, these seven studies do provide quantitative evidence that, for certain health outcomes, the health risks associated with snus are lower than those associated with smoking. Specifically, this is true for lung cancer (based on one study), for oral cancer (based on one study), for gastric cancer (based on one study), for cardiovascular disease (based on three of four studies), and for all-cause mortality (based on one study).”
Roth (2005) Health risks of smoking compared to Swedish snus. Inhalation Toxicology. 2005 Dec 1;17(13):741-8. http://www.ncbi.nlm.nih.gov/pubmed/16195209

More recently, products have been bought to market that provide the look and feel of smoking without exposing the user or bystanders to the dangerous products of combustion. Instead of focusing on the huge potential of electronic cigarettes to reduce smoking-related disease, the FDA has chosen instead to exaggerate the importance of miniscule, harmless quantities of nitrosamines and utilize propaganda techniques to mislead the public into believing the products present "acute health risks."

So how could providing truthful information on relative risks of tobacco products to retailers protect kids from negative health impacts of tobacco use? Wouldn’t it lead to increased use of tobacco, resulting in increased negative health impacts?

If retailers were provided with documentation that switching to smokeless products reduces health risks, and if retailers informed smokers of the truth, odds are good that some smokers--perhaps many smokers--would make the switch, as happened in Sweden. There would be fewer adult smokers providing a role-model of smoking as a grown-up activity. If kids did learn this well-guarded secret, they would be less likely to start with or to progress to the much more harmful activity of smoking.

Two full business days have passed, and my suggestion still has not been published. On second thought, what did I expect?

Given the latest slogan coming out of the tobacco control community, “There is no safe form of tobacco,” it is doubtful that the FDA will ever agree to provide truthful information to the public. Admitting that some forms of tobacco are less harmful than others would expose the big, fat dirty lies for what they are.

Millions of smokers whose lives could have been saved by switching to safer alternatives have died over the past two decades as a result of the government-led disinformation campaign. Withholding the truth and engaging in misdirection are forms of lying, make no mistake. These lies kill people.

A Case of Legalized Extortion

I started to write this article in August, right after California Attorney General Edmund G. Brown Jr. announced a settlement with Sottera, the corporation that markets the NJOY electronic smoking alternatives. http://ag.ca.gov/newsalerts/release.php?id=1965 Unfortunately, I was sidetracked by more pressing issues, and I let the matter drop.

Recently, however, it became clear to me that this issue needs to be addressed when I read a forum entry that cited the settlement as proof that the company has been engaged in wrongdoing. The writer argued:

“Why would Sottera/NJOY settle/agree not to sell to minors and to discontinue advertising smoking cessation claims/health claims with the CA AG office (and pay $85,000 in fines) if they had not previously been caught doing so?”

I pointed out that a lawsuit constitutes an accusation, not legal proof, and that the most logical explanation for signing a settlement was that Sottera’s attorneys provided an estimate of what taking the case through the California court system would cost. The total was probably much higher than the $85,000 extorted by Brown. Were this the only legal battle Sottera faced, it might be worth while to go the distance. However, Sottera is engaged in a lengthy and costly legal battle with the U.S. Food and Drug Administration (FDA) in the Federal court system.

And it is this legal battle at the Federal level that is at the core of Brown’s suit. Late in 2008, the FDA began seizing incoming shipments of electronic cigarettes as unapproved new drugs. Smoking Everywhere filed suit against the FDA, asking for an injunction against product seizures. Sottera, which had also had large shipments seized, joined the suit as an Intervenor Plaintiff.

Apparently piqued at the audacity of the two companies for suing the FDA, the director of Action on Smoking and Health (ASH) decided to take matters into his own hands. He sent a letter to all 50 Attorneys General of each state, asking them to take legal action against Smoking Everywhere and NJOY

California’s Brown and Oregon Attorney General John Kroger apparently saw a PR opportunity and filed suit against both companies. The filings repeated the unfounded accusations from the ASH letter. Neither Attorney General bothered to conduct any type of investigation regarding the truthfulness of the accusations.

Had either AG even bothered to visit the NJOY web site, they would have seen that visitors are asked to verify that they are of legal smoking age before proceeding. The accusation that the products are targeted to non-smoking minors is further belied by text on the package of replacement cartridges:

"NJOY products are intended for use by those of legal smoking age and older, not by nonsmokers or children, nursing or pregnant women, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma."

Nevertheless, the California Consent Judgment requires Sottera to promise not to market its products to minors. It should be noted that the Consent Judgment stipulates, “The Parties enter into this Consent Judgment without a trial. It does not constitute evidence of an admission by the Defendant regarding any issue of law or fact alleged in the Complaint.” http://ag.ca.gov/cms_attachments/press/pdfs/n1965_sottera_consent_judgment.pdf

Bottom Line: Signing the Consent Agreement does not constitute an admission of guilt on the part of Sottera/NJOY.

Most of the other items stipulated in the Injunctive Relief section of the Consent Judgment involve Sottera promising to begin performing actions that it has been doing ever since the business started, or promising to stop doing things it never did in the first place.

“Defendant shall have and maintain a system for quality control of Covered Products to ensure that they are manufactured to appropriate specifications,” reads the Consent Judgment. “TESTED IN THE USA. GLOBALLY DISTRIBUTED. MADE IN CHINA,” reads the NJOY package text.

“Defendant shall not advertise Covered Products as smoking-cessation devices unless or until they have been approved by the Federal Food and Drug Administration as such under its authority to regulate drugs, devices, or tobacco products,” reads the Consent Judgment. “NJOY products are not a smoking cessation product and have not been tested as such,” reads the NJOY package text.

“Defendant shall not sell Covered Products containing vitamins or other substances intended to portray that using Covered Products will improve one’s health, without competent, reliable scientific evidence to support the implied health claim,” reads the Consent Judgment. This requirement is not too difficult for NJOY to implement, in view of the fact that the company has never sold cartridges containing anything other than propylene glycol, water, and flavoring, with optional nicotine.

Some of the provisions of the Settlement Agreement are downright absurd. The requirement, “Defendant shall not make claims about Covered Products having no tar without competent reliable scientific evidence to prove the claims,” illustrates ignorance of basic science. Numerous laboratories have tested the content of electronic cigarette vapor, but none has ever bothered to test for the presence of tar—for very good reason. Tar is created by the process of combustion. Nothing is burned in an electronic cigarette.

The most absurd requirement of all is “Defendant shall not make claims about Covered Products containing no tobacco without competent reliable scientific evidence to prove the claims.” It does not require a rocket scientist to look inside an electronic cigarette cartridge to verify that there is no tobacco present.

So what do you call it when the AG extracts a "fine" of $85,000 from a company that has committed no wrongdoing? Some would call that extortion. It adds insult to injury for the AG’s press release to malign the company by implying that wrongdoing has been committed in the past.

Unethical Soup

Dr. Michael Siegel has said, “When you write an op-ed, you essentially become an authority on the topic you are writing about and you take on the responsibility of researching the topic to make sure that you are providing accurate information.”

By perpetuating propaganda and demonstrating an unwillingness to gather the facts and to listen to her readers, the author of the blog Ethic Soup sets a poor example of ethical conduct. Sharon McEachern has consistently failed to provide accurate information on the topic of electronic cigarettes. Most of McEachern’s assertions are, as she admits, guess work. In her March 24, 2009 post she wrote, “So, if the marketers of the electronic cigarette want to help smokers quit, how come they don't conduct clinical studies and toxicity analyses? My guess is that they already have conducted these tests and not only do they not have evidence of safety, but probably have evidence that the opposite is true -- e-cigs are toxic and dangerous to one's health.”

Her guess is wrong. The original manufacturer of electronic cigarettes, Ruyan Group Limited, sponsored research conducted by Health New Zealand (NNZ) to study the safety and toxicity of its product. Health New Zealand’s October 2008, “Safety Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol” concluded “Ruyan® e-cigarette is designed to be a safe alternative to smoking. The various test results confirm this is the case. It is very safe relative to cigarettes, and also safe in absolute terms on all measurements we have applied.”

The American Cancer Society Cancer Action Network, the American Heart Assn., the American Lung Assn. and the Campaign for Tobacco-Free Kids urged the FDA to remove e-cigarettes from the market. But were these anti-tobacco groups—some of which have a mission to protect public health--really fearful that smokers would be harmed by the new products?

The truth lies well outside questions of health. “Is it Ethical to Re-create Smoking Culture?” McEachern asks in one of the post subheadings. She admits that anti-smoking groups fear that the e-cigarettes will bring back a "smoking culture" and that ex-smokers will “be lured back into the smoking trap.” This fear has proven to be unfounded. Two published surveys of electronic cigarette users have found that 100% were smokers when they turned to the electronic cigarette as an alternative.

In April 2009, HNZ presented the results of its research on e-cigarette safety and toxicity as a poster in Dublin at the 15th Annual Conference, Society for Research on Nicotine and Tobacco, (SRNT). Many employees of the health organizations calling for a ban on electronic cigarettes are members of SRNT. Nevertheless, the HNZ research either was not brought to the attention of the FDA, or the FDA knew of this research and purposely ignored it.

McEachern’s July 28, 2009 post gleefully reported on the FDA’s press conference announcing the results of testing that “found carcinogens and other toxic chemicals dangerous to humans.” By the time McEachern wrote her follow-up blog post on September 9, 2009, the FDA’s lab report had already been widely denounced as incomplete and misleading, due to the lack of a quantitative analysis of the so-called carcinogens and toxins. The truth is that the quantity of Tobacco-specific Nitrosamines (TSNAs) in electronic cigarette liquid is equivalent to the amount contained in FDA-approved nicotine replacement products. There are no warnings on a nicotine patch that it could cause cancer—because the quantity of “carcinogens” is too miniscule to present a danger.

Subsequent testing by an independent lab has revealed that there are no carcinogenic TSNAs present in the vapor. Furthermore, the amount of diethylene glycol (DEG) that FDA found in the liquid of one cartridge is thousands of times below the Minimal Risk Level. DEG has never been detected in the vaporized aerosol by any lab.

Nevertheless, McEachern continued to praise, as well as misquote, the FDA’s findings. She wrote, “As reported by Ethic Soup in past posts, the FDA and numerous health organizations have shown that e-cigarettes present an extensive variety of potential dangers to users (and maybe also to those around them) who inhale a mixture of nicotine -- both dangerous and addictive -- and propylene glycol which is an ingredient in antifreeze.”

To state that that “e-cigarettes present an extensive variety of potential dangers to users” is patently untrue.

Yes, of course, users inhale nicotine. The reason the FDA allows this addictive substance to be added to gum, lozenges, patches, and inhalers is so that smokers who crave the nicotine in cigarettes will find these “NRT” products to be an acceptable substitute for smoking. Initially, some smokers do, but when the NRT is discontinued, so is the smoking abstinence. In the final analysis, only 10% of NRT users achieve smoking cessation. The vast majority of smokers would never make the initial switch away from traditional cigarettes to an e-cigarette if the vapor contained no nicotine. But some e-cigarette consumers eventually do taper down to zero-nicotine liquid part of the time (35%) or all of the time (6%).

It was DEG, not propylene glycol (PG), that the FDA linked to antifreeze. At one time, ethylene glycol was the main ingredient in antifreeze, but many animals and children were being poisoned by the sweet-tasking liquid. Ethylene glycol has been replaced with PG because PG is non-toxic.

It’s a problem that I have to correct these factual errors in my blog. Had McEachern not cut herself off from the comments of her readers, we might have been able to help her separate fact from fiction via the comments section in her own blog. On the September 9 post, she allowed one comment.

She responded to the comment, “Hi Joey! Glad you responded to this post. I have several thoughts/questions to share. How do you know that e-cigarettes are 100 to 1,000 times less harmful than smoking tobacco cigarettes? Can you scientifically disprove that the following groups are all wrong about e-cigarettes being "poisonous?" --- American Cancer Society, American Heart Assn., American Lung Assn., the World Health Organization and the FDA.”

Apparently these are meant to be rhetorical questions, since McEachern immediately closed the comments option. Nevertheless, I do have answers.

We know that e-cigarettes are orders of magnitude less harmful for two reasons. First, we applied common sense. Smoke contains tar, carbon monoxide, heavy metals, and particles of ash. Vapor does not contain any of these. When any substance is burned, a chemical reaction takes place. In the case of tobacco, it has been found that 4,000 chemicals are generated, most of which are toxic and many of which are carcinogenic.

In contrast, vaporization is a physical process that changes the state of the substance from liquid to gas. No chemical changes take place. However, some substances have a higher vaporization temperature than others. Thus, some of the substances that are found in the liquid don’t always make it into the vapor.

Second, we observed the effect that switching to vapor had on our own health. Over 90% of users consistently report improved health across multiple surveys. In my own case, I have observed that I am no longer kept awake at night by the sound of my wheezing. I no longer cough up a gob of phlegm in the morning. Like many other e-cigarette consumers, I have now passed the one-year mark for being abstinent from smoking. My lungs couldn’t be happier.

Can I scientifically prove that the named groups are wrong about e-cigarettes being poisonous? If e-cigarettes are poisonous, why are users growing healthier? Shouldn’t they be dropping like flies? The named groups did not conduct any research of their own. They consistently refer to the FDA’s flawed report as “proof” that the products are dangerous. The FDA proved no such thing. Furthermore numerous tests by organizations other than FDA have found nothing poisonous or cancer-causing in the products. http://www.casaa.org/resources/lab.asp

U.S. District Court Judge Richard J. Leon wrote: “Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.”

I will leave the comments to this post open, allowing Ms. McEachern, the FDA, and any of the organizations and people she has admired in her blog posts about e-cigarettes to defend the ethics of using disinformation to sabotage the recovery of about a million former smokers and to prevent the recovery of millions more. Why work so hard to perpetuate smoking-related disease and death?

Smoke-Free Wisconsin and AMA

The Smoke-Free Wisconsin blog commented on the press release by the American Medical Association (AMA) announcing a resolution that called upon the U.S. Food and Drug Administration (FDA) to regulate electronic cigarettes as drug devices and called for a ban on e-cigaretes that are not FDA-approved. Of course, there are no e-cigarettes that are FDA-approved, so that amounts to a full ban. But wait, there's more. The resolution urged state legislators to ban sales of the products and ban their use in non-smoking areas.

Here's an extract from the Blog entry:

Folks who use e-cigarettes say they have quit smoking and have a "smoke-free" life. However you see the product, e-cigarettes do deliver nicotine, not unlike inhalers, lozenges, or gum. All cessation products are regulated by the FDA either as over-the-counter or by prescription.

The article contains a quote which is quite poignant:

“Because e-cigarettes have not been thoroughly tested, one cannot conclude that they are less harmful or less dangerous than conventional cigarettes,” said Dr. Langston. “The fact that they come in fruit and candy flavors gives them the potential to entice new nicotine users, especially teens.”

FDA regulation of e-cigarettes is something we can all support.

Actually, I can suppport reasonable regulation by the FDA, but not as drug delivery devices. I wonder about that "poignant" quote from Dr. Langston complaining that the products haven't been thoroughly tested. Then why did the AMA resolution also rescind a resolution passed last year supporting testing of the products as a smoking-cessation device. "They haven't been tested enough so let's ban them, and also let's oppose testing them."

I left the following as a comment on the Smoke-Free Wisconsin blog.

Yes, e-cigarettes do deliver nicotine, not unlike tobacco cigarette smoke. Unlike smoke, however, e-cigarette vapor does not deliver tar, CO, particles of ash, heavy metals and 4,000 chemical compounds that are created when tobacco is burned, many of which are carcinogenic or toxic. This isn’t rocket science. Even a lay person can figure out that smoke contains a lot more dangerous substances than vapor.

The true test of any drug’s safety comes after the drug is FDA-approved and can be prescribed for anyone who needs treatment. After the smoking-cessation drug Chantix was approved, there were cases reported of severe depression, anxiety, aggressive behavior, and suicides. FDA-approved Chantix is blamed for at least 78 deaths and over 3,000 serious injuries.

E-cigarettes have now been thoroughly tested by millions of users and zero serious injuries have been reported. In fact, those who have successfully replaced cigarette smoke with vaporized nicotine are experiencing improvements in their health: Reduction or elimination of wheezing and coughing, better stamina, better markers of cardiovascular health such as blood pressure and lipids.

The AMA should not be forcing those of us for whom nicotine abstinence is unworkable into a choice between relapsing to smoking or becoming criminals seeking e-cigarette supplies on a black market.

The FDA is now authorized to regulate tobacco products and should regulate e-cigarettes as a tobacco alternative to ensure that products have manufacturing quality controls in place, accurate labeling, and child-proof packaging.

I will be astonished if my comment is approved. However, I do invite Erich to leave comments here and begin a dialog for better understanding.

American Heart Association Prevents Smoking Abstinence

Excerpt from email received May 9, 2010

Helping people quit using tobacco is a top priority of the American Heart Association and we will continue to do all that we can to make sure that all people have access to safe and effective tobacco cessation therapies including pharmaceutical approaches as well as counseling. The U.S. Public Health Service has found that that the seven drugs approved by the U.S. Food and Drug Administration in combination with individual or group cessation counseling are the most effective way to help smokers quit.

Thank you and have a great day!

Copy of snail mail response

American Heart Association
National Service Center
1100 E. Campbell Rd, Suite 100
Richardson, TX 75081

Subject: American Heart Association Email - Sunday May 9, 2009

When did anti-smoking campaigns turn into anti-smoker campaigns? Until recently, I had no idea that the American Heart Association had changed its policies. It used to be that smoking, quite appropriately, was the enemy. Now it is all tobacco products – some of which could be very effective at reducing the smoking prevalence rate as well as the rate of smoking-related diseases and early deaths.

You know very well – or at least you should know – that many smokers cannot function well without adequate nicotine. Some smokers have been able to stop killing themselves with smoke by transferring to the nicotine provided by nicotine gum, but the dosage is inadequate for most. Some have been able to transfer to smokeless tobacco products. Unfortunately, too few have made this life and health-saving switch because 85% of the general public believes (erroneously) that these products are no less hazardous than smoking.

The nicotine products approved by the U.S. Food and Drug Administration for smoking cessation are only 10% effective. Electronic cigarettes allow the users to adjust their own dosage of nicotine, and these products are proving to be 80% effective at eliminating the habit of setting fire to tobacco cigarettes. A comparison of the number and quantity of toxins and carcinogens shows that these are much safer than tobacco smoking. Not only have their been no reports of serious adverse events in the 6 years the products have been available world-wide, but 90% of users are reporting that their health has improved since switching from smoke to vapor.

There is ample research to show that smoking has an adverse effect on cardiovascular health, but the morbidity rates for other forms of tobacco use are much, much lower. In fact, a person who continues smoking for just 30 more days and then becomes nicotine abstinent would do more damage to health than becoming smoking abstinent by switching to one of these reduced-harm products and using it for the rest of his or her (longer) life. So why isn't the American Heart Association's top priority "helping people quit smoking" rather than "helping people quit using tobacco"? Why is the new policy, “If you can’t stop using nicotine, we don’t care if you die”?

Helping people to quit smoking would be a much more easily attainable goal if health agencies and organizations such as yours would start telling the truth about the relative risks of tobacco products. Very few smokers know that health risks for smoking-related diseases can be reduced by up to 99% by switching to products such as reduced nitrosamine Swedish snus or electronic cigarettes.

If the public had not been misled into believing that all forms of tobacco use are equally harmful, more smokers would have made the effort to switch to a safer alternative. Think how much lower the smoking prevalence rate would be today if smokers had been given the whole truth and nothing but the truth. We might have achieved the Healthy People 2010 goal instead of missing it by a mile. Think of how many heart attacks and strokes could have been averted during the years when people were hoodwinked by misleading “safety” labels. Smokers and their loved ones should be outraged.

What is even more outrageous is the American Heart Association's goal of banning the only product that allows hundreds of thousands of former smokers to maintain their state of smoking abstinence. The American Heart Association's unachievable goal of nicotine abstinence works to prevent the achievable and more effective goal of smoking abstinence. The prevention of smoking abstinence is not in keeping with the mission of the American Heart Association. I find it shameful.

Thank you and you have a great day, too.

Lung Association Recommends Smoking

"Until the U.S. Food and Drug Administration (FDA) determines that e-cigarettes are safe for consumers, the American Lung Association urges consumers not to use these products." -- Letter from Charles D. Connor, President and CEO, American Lung Associatioon

Why is the head of the organization that is dedicated to lung health urging me to stop using the tool that has kept me smoke-free for over a year?

Does the American Lung Association (ALA) have any evidence that it is safer to inhale tobacco smoke?

It can’t be the carcinogen levels. A day’s supply (about 1 ml) of the 16 mg liquid contains 8 ng/g of TSNAs—about equal to the amount in an FDA-approved nicotine patch. Compare that to the whopping 11,190 ng/g of TSNAs in the most popular brand, Marlboro cigarettes.

It can’t be the number of toxins. In addition to the “chemical found in antifreeze,” conventional tobacco cigarettes contain arsenic used in rat poison, hydrogen cyanide used in gas chambers, formaldehyde used to embalm dead bodies, polonium radiation dosage equal to 300 chest X-rays in one year, and many more harmful substances that you will not find in the liquid or the vapor.

It can’t be the tar, carbon monoxide, and particulates. These are only found in smoke. If I go back to inhaling these substances along with my nicotine, I’m fairly certain that the wheezing that kept me awake at night and the productive morning cough will return. I also suspect that my recently regained ability to laugh out loud without triggering a coughing fit will disappear

I could understand the ALA taking the stance, “Until more is known, the American Lung Association cannot recommend the products.” However, in view of the known negative health consequences of inhaling smoke, it seems unethical to urge consumers not to use the products.

The ALA cannot ignore the fact that hundreds of thousands of users report that they are using the products as a complete replacement for their tobacco cigarettes. It also cannot ignore the fact that the health effects reported by users have been overwhelmingly positive. Not one serious adverse event has been reported. Meanwhile, 440,000 Americans per year die of smoking-related diseases.

We know that the FDA is not quick to pronounce any product “safe.” During those years, how much damage will be done to the lungs of the continuing smokers who heed the ALA advice?

Email Message to Public Citizen

I am confused. Your web site states "Public Citizen serves as the people’s voice in the nation’s capital."

And yet, we see your organization's name on the Amicus Brief filed on behalf of FDA in Smoking Everywhere versus FDA. Either your organization cares nothing for the health and welfare of the people, or you have been snookered.

Perhaps you fell for one or more of the many half-truths, unsupported fears, or outright lies you have been told about electronic cigarettes. Here are the facts, with sources cited:

Purpose - Electronic cigarettes were invented as a way to provide smokers who can't or won't quit with a substitute that is less hazardous than inhaling tobacco smoke. [1]

They were not invented as a way to outfox indoor smoking bans. They were invented in China. China doesn't have such bans.

They were not invented to be an NRT "smoking cessation" product. NRTs are purposely low-dose with the ultimate aim of "curing" nicotine addiction.

Target Market - Adult, committed smokers.[2] Ask the people/organizations claiming that electronic cigarettes are being marketed to children, "What percent of customers are under age 18?" I'd be willing to bet they can't do this, because they haven't bothered to actually investigate it. You can check the results of a survey (n=303) conducted by the University of Alberta [3] to learn that 55% of customers are between 30 and 50, and 32% are 51 years or older. All were previous smokers. In an ongoing survey (currently over 1,100 responses) being conducted by CASAA [4], we find 53.2% between 30 and 50, with another 29% age 51 years or older, and 84.5% smoked for 10 years or more.

Success Rate as Smoking Alternative - The University of Alberta Survey [3] shows that 79% are using them for a complete replacement for traditional tobacco cigarettes. An additional 17% are using them as a partial replacement, and only 4% use them in addition to tobacco cigarettes. The CASAA survey [4] shows that only 17.9% of users continue to smoke (some) tobacco cigarettes and that 75.2% report that they now use no smoked or smokeless tobacco products at all.

Toxicity - Based on number and quantities of harmful chemicals, electronic cigarettes appear to be at least 1,000 times less dangerous than tobacco smoke.

The FDA's press release concerning lab tests conducted on 18 cartridges gleefully announced that the products contain carcinogens and "a chemical used in antifreeze". If you read the actual lab report [5] you will find that no quantities are specified for the carcinogens -- Tobacco-Specific Nitrosamines (TSNAs).

You can, however, find in a report issued by Health New Zealand that a 16 mg. electronic cigarette cartridge contains 8 nanograms of TSNAs -- "This amount is extremely small, equal for example, to the amount reported to be present in a nicotine medicinal patch. (8 ng in 1g = eight parts per trillion)." [6]

To put this quantity in perspective, consider the fact that a pack of Marlboros contains 11,190 ng/g of TSNAs. [7]

Tobacco cigarettes also contain the "ingredient used in antifreeze." However, in addition, tobacco cigarettes contain arsenic used in rat poison, hydrogen cyanide used in gas chambers, formaldehyde used to embalm dead bodies, polonium radiation dosage equal to 300 chest X-rays in one year, and many more harmful substances that you will not find in electronic cigarette liquid or vapor.

No smoke - Electronic cigarettes use the process of vaporization, rather than combustion. Thus, the user does not inhale tar, carbon monoxide, or particulates. As you might guess (see next item), the lack of these substances as well as the extreme reduction in toxins and carcinogens appears to have a beneficial effect on the health of the users. Consider the bystanders as well. A tobacco cigarette remains lit, producing sidestream smoke. An electronic cigarette does not produce vapor until the user inhales, and the vapor does not go into the surrounding air until the user exhales. The vapor was also tested by Health New Zealand and pronounced to be "harmless, inhaled or exhaled." [8]

Beneficial Health Effects - The majority of University of Alberta survey [3] respondents reported that their general health (91%), smoker’s cough (97%), ability to exercise (84%), and sense of smell (80%) and taste (73%) were better since using e-cigarettes and none reported that these were worse. In the CASAA survey [4] 91.3% report better lung function/easier breathing and 80% report increased lung capacity. Over half report reduced coughing, increased stamina, and sleeping better.

Adverse Health Effects - The CASAA survey [4] asked respondents about adverse effrects, rated by frequency. Dry/sore throat (3.3%), Dry Skin (1%), and Increased Phlegm (1%) were reported as being experienced frequently. These symptoms can be annoying, but are by no means life-threatening.

In contrast, two of the drugs approved by FDA for smoking cessation have resulted in serious adverse effects including seizures, major depression, suicidal ideation, and deaths, and now carry an FDA "Black Box" warning. [9]

In his 32-page opinion [10] accompanying the injunction against FDA in the aforementioned federal case, Judge Leon wrote:

"I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public."

After considering the facts, I'm confident that you will agree that the public health dangers of electronic cigarettes have been greatly exaggerated by the FDA and the other organizations named in the Amicus Brief. As the surveys show, those who have switched to vaporized nicotine are enjoying the same kind of health benefits seen by those who quit all nicotine use. The real danger to public health lies with the possibility that FDA wins this case and immediately removes electronic cigarettes from the market. What will be the result?

In the CASAA survey [4], 72.2% indicate that it is likely or very likely that they will go back to smoking if electronic cigarettes become unavailable. Do you really want to be party to that end? Furthermore, consider the fact that the smoking prevalence rate has stagnated. Think of the over 40 million continuing smokers, who have tried over and over to quit, who might succeed at substituting vaporized nicotine for inhaling tobacco smoke--but not if the products are banned.

If you want to serve as "the people's voice," we are the people. We are being victimized by an overzealous government agency and non-profit organizations that claim they want to help people stop smoking. Instead, they are throwing all of their power and money into taking off the market the one product that finally worked for us. Look at both surveys. See how many products we tried in our attempts to quit. By insisting that "quit" means giving up all nicotine, these organizations are literally killing us with their "kindness."

Sincerely,

Elaine D. Keller, Board Member
The Consumer Advocates for Smoke-Free Alternatives Association (CASAA)
http://www.casaa.org

Sources:

[1] http://articles.latimes.com/2009/apr/25/world/fg-china-cigarettes25
[2] http://www.ecassoc.org/eca-letter-to-congress/
[3] http://tobaccoharmreduction.org/wpapers/011v1.pdf
[4] https://www.surveymonkey.com/sr.aspx?sm=HrpzL8PN5cP366RWhWvCTjggiZM_2b8yQJHfwE9UXRNhE_3d
[5] http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
[6] http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
[7] http://www.casaa.org/files/TSNA_Chart(1).pdf
[8] http://www.healthnz.co.nz/ECigsExhaledSmoke.htm
[9] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm
[10] http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

No Brainer

A Face Book poll called "The Smokeless Cigarette" has been created.


The question reads:

An artificial cigarette is invented that produces no first- or second-hand smoke; and 10000+ smokers try it, stop using tobacco, and stop wheezing and coughing. Should the invention be PULLED OFF THE MARKET until it can be proven safe and effective?

NO
YES

When put in this way, it sounds insane, doesn't it? It is utterly astonishing that the the American Lung Association joined with the Cancer Society, Heart Assn, and Campaign for Tobacco-Free Kids to prevail on the FDA to take electronic cigarettes off the market!

No doubt, they mean well, but they will cause untold harm if they get their way.

They say that electronic cigarettes have not been proven safe and effective. Well, more than 12,000 people have signed a petition asking the FDA to keep these available. Read some of the comments. You will see story after story. People are able to substitute inhaling vaporized nicotine from an electronic cigarette for some or all of their tobacco cigarettes. Many are reporting improved health. Even their doctors agree! You can see the petition and the signatures at http://www.thepetitionsite.com/1/kee...ttes-available,

So the users say that they ARE effective. Who would know better? As for safe, unless the CDC, FDA, AMA, ALA, ACS, AHA, etc, have been telling us big fat whoppers all these years about the dangers of tobacco smoking, just about ANYTHING would be safer to be using instead, no?

There are still 40+ million American smokers, many of whom would give up tobacco in an eye-blink if they knew that there is something out there that will allow them to do so without giving up being a productive, functioning, happy human being.

Smoking Cessation and Weight Gain

For years the medical establishment claimed that the weight gained with smoking cessation was a modest, relatively harmless 5 to 7 pounds. It's not that they were lying, but rather that their research wasn't covering all the bases. They were looking at cessation success rates, weight gain, and other factors after only 6 to 12 weeks.

When researchers took a look at weight gained after one year of continuous abstinence, the average weight gain was more like 13 pounds. In one study, a subgroup of patients gained in excess of 28 pounds over the course of a year.

The news goes from bad to worse. The National Heart Lung and Blood Institute (part of NIH), in its guidelines on obesity management admits: "Weight gain that accompanies smoking cessation so far has been relatively resistant to most dietary, behavioral, or physical activity interventions." [http://www.nhlbi.nih.gov/guidelines/obesity/e_txtbk/txgd/453.htm]

The Guidelines mention three treatments that reduce postcessation weight gain: Nicotine Replacement Therapy (NRT), phenylpropanolamine, and bupropion. Phenylpropanolamine was pulled off the market by the FDA several years ago due to concerns about stroke. It was one of the most effective weight loss drugs. Bupropion (Zyban) requires a prescription.

There are several forms of NRT that are available without prescription, including patches, gum, and lozenges. More recently, inhaled vaporized nicotine has become available using a new product from China, the "electronic cigarette." Many e-cigarette users bought the product to use in places and at times where smoking tobacco is illegal, and found--to their surprise--that they no longer needed to smoke tobacco. No weight gain has been reported while using the e-cigarette with a nicotine cartridge.