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.

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

AAPHP Petitions to FDA on E-Cigarettes

The American Association of Public Health Physicians (AAPHP) has submitted two tobacco-related petitions to FDA. The first requested that FDA reclassify electronic cigarettes from a drug to a tobacco product. The second requested a follow-up press conference to correct errors and misinterpretations in their July 22, 2009 press conference. That press conference left many with the erroneous impressions that E-cigarettes might be more harmful than conventional cigarettes, that they are being marketed to teens, and that there is no information available to address these issues.

Dr. Joel L. Nitzkin, Chair of the AAPHP Tobacco Control Task Force, who has no financial relations ship with any tobacco-related or pharmaceutical enterprise, has addressed this issue because “the possibility exists to save the lives of 4 million of the 8 million adult American smokers who will otherwise die of a tobacco related illness over the next 20 years.”

As Dr. Nitzkin explains it, “Per our analysis, the only way we can achieve this huge public health benefit will be through addition of a harm reduction initiative to current tobacco control programming by which current smokers are informed of the differences in risk profile presented by different types of tobacco products. In that context, e-cigarettes appear to be the very-low-risk product likely to be acceptable to most current smokers. With strict FDA regulation of manufacturing and marketing -- it should be possible to achieve this public health benefit without increasing the numbers of teens initiating tobacco use. FDA regulation of this product as a drug would mean a de-facto ban until clinical trials not required of other tobacco products can be completed.”

The AAPHP notes that the provisions of the newly adopted FDA/Tobacco law will require that FDA grant full FDA approval to currently marketed conventional cigarettes, and that the Supreme Court is virtually sure to rule that FDA cannot prevent the cigarette manufacturers from informing smokers of the FDA approval. “Thus, the standard for comparison regarding the safety of alternate nicotine delivery products should not be the usual drug safety standards -- it should be in comparison with conventional cigarettes.”

The two petitions (about 20 pages each) plus a common set of attachments (303 pages) are posted on the tobacco issues page of our www.aaphp.org web site. The petitions, but not the attachments are accessible and available for comment on the www.regulations.gov web site. To access the petitions there, go to www.regulations.gov and type in the docket number in the Keyword field. The docket number for the petition to reclassify is FDA-2010-P-0095-0001. The docket number for the petition regarding the press conference is FDA-2010-P-0093-0001.

I urge readers of this blog to follow the directions in the paragraph above and leave positive comments for both petitions. Lives are at stake.

Electronic Cigarettes in the Military

The military should take a serious look at the electronic cigarette as a way of solving several problems. The military is reluctant to ban smoking because it helps troops remain alert and helps relieve stress. But it isn't the smoke that does it, it's the nicotine.

Tobacco smoking is an effective, but dangerous, way of getting sufficient nicotine. Currently available "nicotine replacement" products contain low levels of nicotine, by design, because the goal is to wean people totally off nicotine. With the e-cigarette, the user can control the amount of nicotine and take in enough to remain alert and relieve stress.

E-cigarettes deliver vaporized nicotine, without the tar, carbon monoxide, heavy metals, and multitude of toxins and carcinogens that tobacco smoke inflicts on its users. Over 13,000 people have signed the Electronic Cigarette Petition (http://www.thepetitionsite.com/1/kee...ttes-available). Users are reporting that they have been able to successfully substitute the e-cigarette for their tobacco cigarettes after trying every other method of quitting. They are also reporting greatly improved lung function and better blood pressure and cholesterol numbers.

There is every reason to expect that military personnel would see the same type of health improvements after switching to e-cigarettes, thus saving both the military and the VA substantial expenditures on tobacco-related illnesses.Since e-cigarettes deliver no side-stream smoke, and the exhaled vapor is non-toxic, there is no need to have people leave their work-station for "smoke breaks". Thus the military gains productivity improvements. E-cigarettes are battery operated, so there are no sparks and no fire hazard. One final benefit is that there will be fewer unsightly cigarette butts to deal with.

Guilt by Association

Nicotine has gained a reputation as a harmful substance through its association with tobacco. The reasoning goes:
* Tobacco is harmful to human health.
* Tobacco contains nicotine.
* Therefore, nicotine is harmful to human health.

Psychologically, this is very persuasive reasoning. But as the song says, “It ain’t necessarily so.” In terms of logic, this reasoning is a “fallacy of division.” Just because a fact is true about a thing does not prove that the fact is true for all of the parts of that thing. Wikipedia uses the example of a Boeing 747:

1. A Boeing 747 can fly unaided across the ocean.
2. A Boeing 747 has jet engines.
3. Therefore, one of its jet engines can fly unaided across the ocean.
http://en.wikipedia.org/wiki/Fallacy_of_division

The truth of the matter is that nicotine is not the really dangerous chemical in cigarettes. According to researchers at the University of Medicine and Dentistry New Jersey, “Cigarette smoke contains many harmful chemicals, and it is these, not nicotine, that are responsible for the heart attacks, cancer, and lung disease.”

Their Advice on using over-the-counter nicotine replacement therapy- patch, gum, or lozenge- to quit smoking can be downloaded from http://proyectovidanofume.org/pdf/ElsevierArticleJonathanEng.pdf