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?

FDA Misleading Report Strategy Backfires

Since the fall of 2008, the U.S. Food and Drug Administration (FDA) has been at war with the electronic cigarette (e-cigarette) industry. Claiming that the products are drug/device combination products that can be regulated by the agency under the Food Drug and Cosmetic Act, (FDCA), FDA began banning the import of e-cigarettes.

E-cigarettes are devices composed of a cartridge, a heating element, a battery, and electronics. When the user inhales, the device is activated and some of the liquid in the cartridge is vaporized, delivering a small amount of nicotine in a mist that has the appearance of smoke.

FDA's notices to the e-cigarette vendor Smoking Everywhere (SE) stated that SE's products "are intended to alter the structure or function of the body because they contain nicotine." Smoking Everywhere offered to revise labels and websites to satisfy FDA that "this product is intended solely for recreational use ... and not intended to effect the structure or function of the body and not intended to treat, cure, mitigate or treat a disease." FDA refused, and continued seizing products.

On April 28, 2009, SE brought suit against the FDA in the United States District Court for the District of Columbia. The suit challenged FDA’s authority to regulate and ban imports of e-cigarettes under the drug/device provisions of the FDCA. On May 15, 2009, Soterra, an Arizona company doing business as NJOY, joined SE as an intervenor-plaintiff, and NJOY filed its own complaint.

In June 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Act), giving the FDA statutory authority to for comprehensive regulation of the content, testing, development, manufacture, labeling, packaging, advertising, promotion, distribution, and sale of any "tobacco product."

In January 2010, the Honorable Richard E. Leon, Judge for the U.S. District Court, granted an injunction in favor of the plaintiffs, SE and NJOY, ordering FDA to refrain from seizing incoming shipments until the case has been decided. Judge Leon rejected FDA's argument that e-cigarettes should be regulated as a drug/device combination under the FDCA because the products are not sold with a therapeutic purpose. Judge Leon pointed out that, since the products contain nicotine derived from tobacco, they meet the definition of a tobacco product under the Tobacco Act.

Judge Leon's opinion pointed out that the FDA's purported public health concerns regarding e-cigarettes were not supported by the evidence. The court explained that advertising the products as a healthier alternative to smoking does not constitute a therapeutic claim. The Tobacco Act allows for "modified risk tobacco products" which are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products." Judge Leon pointed out that if the FDA did have concerns about public health, it could regulate the contents, labeling, and marketing of e-cigarettes under the Tobacco Act.

FDA chose, instead, to leave the products totally unregulated and filed an appeal. On March 31, 2010, the appeals court granted a stay pending appeal. The stay temporarily lifts the injunction, allowing FDA to resume seizing shipments of SE and NJOY products. In its brief filed on May 24, 2010, the FDA attempted to shore up its argument that the products are potentially dangerous by introducing as evidence findings announced in July 2009 regarding testing of 18 SE and NJOY cartridges in March.

The lab report noted that some Tobacco-Specific Impurities (TSIs) were "detected," along with Tobacco-Specific Nitrosamines (TSNAs), some of which can be carcinogenic. The FDA's press announcement stated, "A laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol [DEG], an ingredient used in antifreeze." The wording was calculated to convey the false impressions that e-cigarettes are more carcinogenic and more toxic than tobacco cigarette smoke.

This strategy played well in the press, convincing untold numbers of smokers to continue inhaling tar, carbon monoxide, particles of ash, heavy metals, and many more dangerous substances found in smoke, but absent from e-cigarettes. However, it was a strategic error on FDA's part to introduce the lab report into the court record.

NJOY's attorneys have taken advantage of this opening by analyzing the report authored by FDA scientist B.J. Westenberger and incorporating the results into the NJOY appeal brief filed with the court on June 23, 2010. The NJOY brief noted the following facts:

The amount of nicotine required to create a significant adverse effect is considerably higher than the levels Westenberger found in e-cigarettes.

The e-cigarette cartridge itself is neither ingested directly nor handled extensively,and thus the likelihood of significant exposure to DEG found only in the cartridge is therefore very low at best.

No tests were performed to confirm the presence of DEG in the vapor.

The TSNA levels were so low they could not even be quantified, and the TSI levels were less than the specification for the cartridge of the FDA-approved smoking cessation device, Nicotrol.

The evidence, moreover, demonstrates no harmful TSNAs or TSIs in the vapor that smokers actually inhale.

Links:

Smoking Everywhere Complaint:
http://www.casaa.org/files/smoking-everywhere---complaint.pdf

FDA's Brief in Opposition:
http://www.casaa.org/files/FDA%20brief%20in%20opposition.pdf

Judge Leon's Ruling:
http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf

Judge Leon's Opinion:
http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

FDA's Appeal:
http://www.casaa.org/files/FDA-Appeal-2010-05-24.pdf

FDA's Lab Report:
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

Exponent Analysis of FDA Report:
http://www.casaa.org/files/Exponent%20Response-to-the-FDA-Summary.pdf

Analysis of TSNAs in NJOY:
http://www.casaa.org/files/Study_TSNAs_in_NJOY_Vapor.pdf

NJOY Appeal Answer Brief:
http://www.casaa.org/files/NJOY%20Brief%20Ct.App..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.

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.