Tobaccoless electronic ‘smokes’ are untested, unregulated

By Anne Aurand / The Bulletin

Published: April 25. 2013 4:00AM PST

Electronic cigarettes, purchased in various stores and online, are nicotine-delivering devices that look and function much like cigarettes. This $20 “pack,” which looks like a regular pack of cigarettes, contains a nicotine cartridge that looks like a traditional cigarette’s filter, a rechargeable battery that looks like the white length of a cigarette and a USB charger that connects the battery with an electronic device. This Njoy brand purchased at a local 7-Eleven came with a user guide that says the battery will last one to two days before recharging is needed. It recharges in about three hours. It says one cartridge delivers about the same “smoking satisfaction” as two packs of cigarettes. Cartridges can be replaced when the vapor drops below a satisfying level.

Looks like a cigarette
Electronic cigarettes, an alternative to the traditional tobacco cigarette, have grown in popularity, yet little is known about how safe they are or whether they effectively help smokers quit.

Electronic cigarettes, or e-cigarettes, are battery-powered nicotine delivery systems that look like and are used like traditional cigarettes.

Because they lack some of the toxins of tobacco smoke, such as carbon monoxide, the question has arisen as to whether they are a healthier alternative.

Some hypothesize that e-cigarettes might encourage smoking cessation by delivering smaller and smaller doses of nicotine while still providing the physical, behavioral ritual of smoking.

But clinical research has not answered these questions. One lab analysis found carcinogens and toxic chemicals in e-cigarettes, which are still unregulated by the Food and Drug Administration. It’s the unknowns that concern medical professionals.

Growth in popularity
A relatively new product, e-cigarettes were developed in China in 2004 and became widely available soon thereafter. Their use has grown in the U.S.

About 6 percent of all adults in the U.S. tried e-cigarettes in 2011, double the rate from 2010, according to a recent survey by the Centers for Disease Control and Prevention, published in February in the CDC journal Nicotine & Tobacco Research.

Of adult smokers, according to the survey, about 10 percent had tried e-cigarettes in 2010. In 2011, that increased to about 21 percent.

General awareness of e-cigarettes grew from about 40 to 60 percent of American adults between 2010 and 2011, according to the survey.

How they work
There are many brands and variations of e-cigarettes. A typical device has a chamber or cartridge that stores liquid nicotine (available in various concentrations), a solution of humectants (such as propylene glycol, which is involved in the vaporization process) and flavoring compounds. E-cigarettes come in flavors ranging from traditional tobacco and menthol to java and cherry.

There’s no lighter involved and no smoke is generated. Users puff like a normal cigarette, which activates a battery-operated electrical circuit that heats and vaporizes the nicotine and flavorings into a cloud of mist that is inhaled into the lungs.

Because they don’t emit smoke or an odor, they get used in nonsmoking establishments. Bill Robison, manager of the D & D Bar and Grill in downtown Bend, said the bar does not have any rules prohibiting their use inside.

“We have had people bring them in and use them but it’s infrequent,” he said. “There’s no smell. It hasn’t posed a problem.”

Some who use e-cigarettes say they feel like a healthier substitute for a real cigarette, and the vaporized nicotine feels gentler on the lungs than tobacco smoke.

Some marketers imply that the e-cigarette is a therapy for smoking cessation and some smokers use e-cigarettes as a weaning tool. Others use them instead of real cigarettes.

The World Health Organization doesn’t consider e-cigarettes a legitimate therapy for quitting, and medical professionals still tend to advise smokers to try well-studied nicotine replacement treatments such as patches, lozenges and gums.

Researchers are starting to look at the issue.

A six-month study of 40 smokers in Italy showed a decrease in cigarette smoking in participants who were given e-cigarettes. After 24 weeks, 22.5 percent of the participants had quit smoking. And, 32.5 percent of participants cut their smoking down about by 50 percent. The study was published in 2011 in BMC Public Health, a peer-reviewed journal from England.

Those who reported side effects from the e-cigarettes mostly noted dry cough and mouth and throat irritation, the study’s authors wrote, which might be associated with exposure to propylene glycol mist generated by the vaporizer. Propylene glycol is a low-toxicity compound widely used in food products and pharmaceuticals.

While the study suggested that e-cigarettes may help smokers reduce or quit smoking, large and carefully conducted randomized, controlled trials are needed to answer questions about the efficacy and safety of these devices, the authors concluded.

Such studies are being designed. One trial protocol, published in BMC Public Health in March, outlined a randomized controlled trial to take place in New Zealand, which will divide adult smokers who want to quit into groups that use e-cigarettes with nicotine, e-cigarettes without nicotine (placebos) and nicotine patches.

In an overview of the study, authors wrote: “The trial will inform international debate and policy on the regulation and availability of e-cigarettes.”

For now, Dr. Louis D’Avignon, a pulmonary specialist with Bend Memorial Clinic in Bend, said he’s more comfortable having patients use nicotine substitute products, such as patches or gum, which have been studied and regulated.

With e-cigarettes, concerns center on the unknown effects of other chemicals that may be inhaled, such as propylene glycol. And, lacking regulation, the ingredients in e-cigarettes vary widely, unlike gums and patches, which are standardized.

The FDA says on its website that it plans to soon begin regulating e-cigarettes “in a manner consistent with its mission of protecting the public health.” For the FDA to approve products, manufacturers would have to provide evidence of safety and efficacy.

If the FDA regulated and standardized e-cigarettes, and if research finds they are comparably safe, they might be a beneficial tool for smokers because unlike patches and gum, D’Avignon said, they fulfill an “experiential addiction” that accompanies a nicotine addiction — the physical ritual of holding and “smoking” a cigarette.

“It fills a psychological niche,” he said.

Safety concerns
No one fully understands long-term effects of e-cigarettes on the lungs, said D’Avignon, but he said they are probably less harmful to the lungs than a tobacco cigarette. He doesn’t advise people to use e-cigarettes but he doesn’t usually tell patients who use them to stop, either.

“It’s a matter of what’s the least harm,” he said. Although he added, lacking real data so far, “we can’t really talk about harm of these e-cigarettes.”

Nicotine is typically higher in traditional cigarettes than e-cigarettes, although the strength of nicotine in e-cigarettes is inconsistent and often unknown, D’Avignon said. (Some e-cigarettes claim to contain no nicotine.) Nicotine, which is addictive and can have some harmful effects on the vascular system, is not the most dangerous part of tobacco cigarettes.

Dr. David Gonzales, the co-director of the OHSU Smoking Cessation Center, Division of Pulmonary & Critical Care Medicine at Oregon Health & Science University, said some in the medical community say e-cigarettes may be better for smokers who won’t use the known medicines — products such as nicotine patches, gum, lozenges — to stop smoking.

“But that’s not the same as saying that it’s safe,” he said. “How not safe it might be is unknown.”

Everyone knows tobacco cigarettes are unsafe. But, not enough is known about these other products. So which is worse?

“There’s no good answer for that. It depends on which evil you’re talking about,” he said.

Nicotine by itself — like what’s used in lozenges and gum for smoking cessation therapy — doesn’t accelerate cancer growth the way nicotine combined with smoke does, he said.

In tobacco smoke, carbon monoxide is abundant and dangerous. E-cigarettes don’t appear to contain carbon monoxide. But they contain other chemicals that are vaporized and inhaled, which concerns Gonzales. Consider the products used for flavorings: “They don’t crush up raspberries. They came from a chemistry lab someplace,” he said. All these compounds are heated and vaporized. It’s difficult to know what’s being ingested and how the heat changes the various compounds, he said. He does not recommend people use them, he said.

In a lab analysis of e-cigarettes in 2009, the FDA’s Division of Pharmaceutical Analysis found carcinogens and toxic chemicals, such as diethylene glycol, a toxic chemical used in antifreeze, in one sample and compounds such as nitrosamines which are carcinogens, in other samples. (For more results of the

Generally, until products are submitted to the FDA for evaluation or approval, there’s no way of knowing the exact levels of nicotine inhaled, or what other chemicals the product might contain.

An advocacy group associated with the American Cancer Society, the Cancer Action Network, is calling for research and regulation.

Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a written statement, “The dramatic increase in both awareness and use of e-cigarettes adds even more urgency to the need for the FDA to regulate these products so it can determine what ingredients e-cigarettes contain, how they are being used and what effects they have on users.”

— Reporter: 541-383-0304,


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