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

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.

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