WHO Opinion Not More Important than Voter Experience

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

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

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

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

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

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

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

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

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

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

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

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

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

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

My Way or the Die Way

An Open Letter to New York Assemblymember Linda Rosenthal:


“If I can do it, anyone can do it.”

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

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

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

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

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

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

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

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

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

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

Elaine Keller

WHO FCTC May Kill Millions of Smokers

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Reality Faces Off Against Unfounded Fears

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

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

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

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

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

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

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

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

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

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

Biological Basis of the Need for Nicotine

Nicotine is neither a nutrient nor a naturally occurring substance in the body. However, nicotine mimics the effects of acetylcholine (ACh) throughout the body, and ACh is a naturally-occurring substance. Although brain disorders can be caused by injury or strokes, most of them are caused by imbalances in neurotransmitters.

And nicotine appears to provide a corrective action for some of these imbalances.

Nicotine is being studied for treating Attention Deficit Disorder, chronic pain disorders, depression, anxiety, and memory impairments. It also works to prevent some of the nastier side-effects of medications used to treat schizophrenia. Nicotine prevents the build-up of alpha synuclean protein deposits in the brain which has implications for the prevention of dementia and Parkinson's Disease.

Many of the diseases that we used to call “mental” or “behavioral” we now know have a basis in biochemistry. There is still a tendency, I think, for people to hold those who have a brain disorder responsible for healing themselves. The “crazy people” should be able to “control themselves” better, the reasoning goes.

How many kids with true hyperactivity disorders were beaten for their misbehavior? And look how long we blamed those with stomach ulcers for being “too uptight” and "refusing" to relax — when in reality the cause of their disorder was a bacterial infection!

So I’m asking you to open yourself to the possiblity that feeling ill in the absence of nicotine and experiencing symptom improvement in the presence of nicotine is not necessarily a moral failing. It just might have a biological basis. This would explain why some folks need nicotine and others do quite well without it.

FDA Can’t Handle the Truth

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

I submitted the following suggestion on September 19, 2010.

Relative Risks

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

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

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

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

I noticed the following message on the page.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A Case of Legalized Extortion

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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