Monday, October 12, 2009

FDA Miscalculates Real Danger to Smokers

The FDA is at a loss.

It knows why people want to quit smoking tobacco cigarettes - exposure to first and second hand smoke is proven to cause numerous health problems, from heart disease to cancer.

Up until now, the only way thought to quit smoking was to cure nicotine addiction. Beat the nicotine cravings, beat the urge to smoke - or so the theory goes. Consequently, the term "smoking cessation" has become synonymous with curing nicotine addiction with the use of Nicotine Replacement Therapies or NRTs.

However, focusing solely on nicotine addiction has been proven to be ineffective.

FDA-approved medications are tested in clinical trials and the enthusiasm of participants, close monitoring and counseling may all inflate the success numbers found in those studies, according to a report released in a 2002 edition of Journal of the American Medical Association (Vol. 288, No. 10: 1260-1264). "These products are designed to help with the cravings associated with smoking, but not the behavioral aspects," stated co-author Professor Elizabeth Gilpin, of the University of California. The report also pointed out that NRTs were originally by prescription only, giving patients trying to quit access to a physician's support and behavioral counseling.(1)

In the 2006 study, "Nicotine replacement therapy for long-term smoking cessation: a meta-analysis," the authors wrote, "Due to relapse, the overall efficacy of NRT treatment in terms of additional ex-smokers declined from 10.7% over and above placebo (6.6% to 14.8%) after one year to 7.2% (3.8% to 11.3%) at an average of 4.3 years follow up. "

"Because the long-term benefit of NRT is modest," the study concluded, "tobacco dependence treatment might be better viewed as a chronic disorder, requiring repeated episodes of treatment."(2)

So, why the extraordinary failure rate?

What Nicotine Replacement Therapy and other medications designed to solely treat nicotine addiction fail to address is the basic human tendencies of habit and ritual. Smokers don't just crave the nicotine. The physical act of smoking becomes integrated into their everyday activities to the point where the smokers are essentially lost without it. They become loyal to their cigarette brand. They find just the right holder and the best lighter.

Certain activities trigger the desire to light up, mostly common activities such as morning coffee, driving or after a meal. Just as people may bite on pen caps, twirl their hair or chew their lip, the act of taking a cigarette out, fiddling with it, lighting it, the sensation of inhaling the smoke, the feel of the smoke at the back of the throat and seeing the smoke swirling in the air are all part of the comfort mechanism for a smoker. That comforting ritual and habit is far and away the greatest reason why treatments that focus solely on nicotine addiction fail. After a year, there shouldn't be any more cravings for nicotine. Ask smokers why they started up again and they'll most likely point to a stressful event or period that caused them to seek out the comforting ritual of smoking, giving them a sense of control over their stress, not the craving for nicotine.

Nicotine is already acknowledged by the FDA and medical professionals to be one of the safer ingredients in tobacco cigarettes, as it's commonly used medically to assist smokers in the attempt to quit. Therefore, the FDA and medical professionals must agree that the greater danger in cigarettes is contained in the actual smoke, the known source of the tar, ammonia, acetone, carbon monoxide and other toxins and carcinogens.(3) So, why isn't the urgency to improve the smoker's health focused on removing the exposure to smoke, rather than the addiction to nicotine? Up until now, there hasn't been any alternative.

Enter the Personal Vaporizer or "electronic cigarette," a device whose growing popularity has left the FDA at a loss of how to properly categorize it.

For the first time in history, there is a device which, when used in lieu of tobacco cigarettes, targets the smoker's ritual and habit instead of the nicotine addiction. Nicotine is still present in the electronic cigarette and smokers are still comforted by the look and feel, as if they are still smoking, but the component most lethal to tobacco cigarette smokers and bystanders - the smoke - is absent.

Unlike NRTs, the consumer decides when and if they will reduce or eliminate their nicotine intake. The nicotine liquid sold by reputable manufacturers is available in measured levels of nicotine content, chosen by the consumer to match their former tobacco use. It consists of water, propylene glycol, nicotine and flavoring. Propylene glycol, a substance which is generally recognized as safe and approved for human inhalation by the EPA (4), is often confused with diethylene glycol, which is a toxic ingredient found in tobacco cigarettes (and antifreeze.) Propylene glycol is actually FDA-approved for human consumption and is used as a base for consumable products such as imitation vanilla and toothpaste and is the same substance used to create theatrical fog.

In July 2009, the FDA announced that laboratory analysis of two brands of electronic cigarettes found traces (approximately 1%) of diethylene glycol in one cartridge and certain tobacco-specific toxins, which are also found in tobacco cigarettes and FDA-approved NRTs. (5) However, the agency's analysis was also quite positive in the fact that researchers did not find the dangerous levels of toxins and carcinogens, such as the tar, carbon monoxide, ammonia, etc., that is found in tobacco smoke.(6)

The FDA, however, objected to some manufacturers' claims that the electronic cigarette is a smoking cessation device - falling back on the now outdated view that smoking cessation must involve nicotine replacement therapy - and electronic cigarettes have not been proven effective as NRTs through the proper studies. Electronic cigarette companies countered that their products are not intended for use as an NRT smoking cessation device, but rather as a smokeless alternative - one that mimics the habits and rituals of tobacco smoking, without giving up the nicotine. An FDA rebuttal cited numerous reports, including testimonials on vendor web sites, that consumers were using the device as a way to quit smoking and that indicated "intended use." As all NRTs fall under FDA jurisdiction, electronic cigarettes, the agency maintained, must be tested and shown to be as effective as other medicinal drugs.

Another July 2009 press release stated, "The FDA has been examining and detaining shipments of e-cigarettes at the border and products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products." (7)

Most would agree that the FDA has some valid points. The nicotine liquid does need to be regulated for consistency in ingredients, labeling and safe packaging. Studies should be done for the long-term effects of its use. Laws should be passed limiting the use and sale to legal adults. However, in its zeal to gain control over the regulation of electronic cigarettes, the FDA insisted that the product be removed from the market altogether, rather than cautious use while the studies are being made. This caused a snowball of misinformation in the media and gave the general public the impression that electronic cigarettes have all of the same dangers of tobacco cigarettes, if not worse. These concerns have prompted several anti-smoking groups and legislators to call for a complete ban of electronic cigarettes, ignoring the undeniable fact that, in the absence of an alternative, most electronic cigarette owners will return to smoking deadly tobacco cigarettes.

Because the FDA is at a loss as to how to categorize electronic cigarettes as a smoking cessation device without classification as an NRT and furthermore, by insisting that a smoking cessation device must address nicotine addiction, many believe the agency has miscalculated the greater danger facing current tobacco smokers - the actual smoke.

1. ACS News Center, "Smoking Cessation Aids Use Increases, Success Rate Declines" American Cancer Society

2. Jean-François Etter and John A Stapleton, "Nicotine replacement therapy for long-term smoking cessation: a meta-analysisTobacco Control

5. U.S. Food and Drug Administration, FDA Warns of Health Risks Posed by E-Cigarettes FDA

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