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

American Lung Association Mission

“The American Lung Association is committed to helping all Americans who want to break their addiction to nicotine.” Apparently this means that the ALA is NOT committed to helping people who want to stop smoking tobacco, UNLESS they are willing to give up nicotine.

The mission of the American Lung Association is to save lives by improving lung health and preventing lung disease.

There is not a single word in that mission statement about nicotine prevention. Nicotine is being studied for use in treating a multitude of disorders and prevention of such terrible diseases as Parkinson’s. Scientists now suspect that smokers who can’t quit require nicotine to keep neurobiological problems under control.

Tens of thousands of smokers report being able to replace some or all of their smoked cigarettes with nicotine vapor inhaled by using an electronic cigarette. The vast majority of these folks state that they are no longer coughing, wheezing, and/or hacking up phlegm. That sounds like an IMPROVEMENT in lung health, doesn't it?

But the ALA wants electronic cigarettes banned.

Most of the e-cigarette users tried all of the FDA-approved nicotine replacement therapy (NRT) products, but were not able to quit smoking. This may be because the NRT products provide sub-therapeutic doses of nicotine. Perhaps one reason e-cigarettes succeeded where other products failed is because they provide enough nicotine to keep such conditions as depression, anxiety, and attention deficit disorder under control.

Still, the ALA wants electronic cigarettes banned.

Many, many e-cigarette users state that they will probably return to smoking tobacco if electronic cigarettes become unavailable.

Nevertheless, the ALA wants electronic cigarettes banned.

How many lives of e-cigarettee users will be cut short if the ALA gets it way? How many more lives might have been saved if e-cigarettes remained available and more smokers were able to substitute them for their tobacco cigarettes?

Would someone please explain how the campaign against electronic cigarettes helps the ALA fulfill its mission.

Pay Attention

In a 2008 letter to the editor of the medical journal, Schizophrenia Research, Yale University researchers Sacco, Creeden, Reuteunauer, and George stated, “We have found that cigarette smoking abstinence impairs and smoking reinstatement enhances spatial working memory and sustained attention.”

In a 2009 article in the journal Experimental and Clinical Psychopharmacology, researchers from Southern Illinois University said that nicotine replacement enhances spatial working memory and that this improvement is greatest in individuals with higher levels of depressive symptoms.

In a presentation at the Society for Neuroscience Annual Meeting in 2003, Alexandra Potter of the University of Vermont commented on the fact that youngsters with Attention Deficit Hyperactivity Disorder (ADHD) take up smoking at twice the rate noted that kids with ADHD take up smoking at twice the rate of other adolescents. "If these findings are substantiated," Dr. Potter said, "these cognitive improvements may explain the high rates of smoking initiation and maintenance in ADHD."

The bottom line is that for some smokers, there are only two ways they are able to maintain their brain’s abilities to sustain attention and remember what they have just seen moments before: Continue smoking or obtain adequate replacement of nicotine from other sources.

The patch, gum, and lozenges deliver nicotine at a much lower level than smoking. Many smokers have not been able to completely eliminate smoking using one of these Nicotine Replacement Therapy (NRT) products. The Central Sydney Area Health Service has achieved a 60% 3-month abstinence rate by combining products to replace more nicotine and provide more withdrawal relief. Other researchers have found combined therapies to be similarly more effective that one method of NRT.

Some people have—in many cases undiagnosed—chronic conditions for which nicotine is an effective treatment, and safer than many prescription medications. Yet, there seems to be a persistent antipathy toward using NRT on a long-term basis. The conditions are permanent. The treatment needs to be permanent.

The choice should not have to be between being a smoker or living in a permanent state of “brain fog.”

Long-term Nicotine Replacement

Tobacco smoking can cause serious damage. The smoker’s risks are greatly increased for heart attack, strokes, lung disease, and a variety of cancers. What about nicotine, the substance that keeps people coming back to tobacco? Isn’t that the source of tobacco’s harmfulness?
Smoking-related diseases are caused by the carcinogens, tar, particulates, and carbon monoxide in tobacco smoke, not the nicotine. A small percentage of smokers are able to give up nicotine with few ill-effects. Given the negative attitude seen toward smoking today, as well as the well-publicized health risks, it would seem reasonable to assume that those who can easily quit have already done so.

That leaves about 45 million U.S. smokers who experience depression, anxiety, cognitive impairments, and sleep disturbances so severe that they are unable to carry out their responsibilities whenever they totally abstain from nicotine. According to the smoking cessation propaganda, these “withdrawal symptoms” are supposed to disappear as soon as the nicotine is cleared out of the system—a couple of days to a week. But for many, these problems persist for months, and even years. Researchers are starting to find that many people with underlying conditions such as Attention Deficit Disorder, depression, anxiety, and other mental disorders, are keeping their conditions under control by self-medicating with nicotine.

These people could go to their doctors and receive prescriptions for anti-depressants, anti-anxiety medications, and/or amphetamines. But would they be better off?

According to one advertisement for an antidepressant medication, 70% of the people on antidepressants still experience symptoms. For some people, antidepressants trigger suicidal thoughts and/or behavior. Anti-anxiety medications are fine for temporary use during times of great stress, but they can be addictive and can cause dangerous side effects. Older adults who have high blood pressure are not good candidates for amphetamine-like medications. Furthermore, long-term use is discouraged by the FDA. Short-term treatment for a long-term problem is not a practical solution.

None of these medications causes cancer or lung disease, so a tobacco smoker might well be better off using them. But how do these medications compare with nicotine replacement products in terms of safety?

Nicotine, without the tobacco smoke, is a relatively benign drug. There may be a modest increase in heart rate and blood pressure, which poses a problem only for critically ill patients. When compared from a standpoint of safety, nicotine replacement therapy (NRT) would appear to pose fewer risks.

The question is whether society will allow people to medicate their conditions in the way that they find most effective. Chronic conditions call for long-term treatment.

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.