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Are e-cigarettes a bridge product to smoking, abstinence or neither? Sponsored by American Legacy

Dr. Nathan Cobb said that the preferred name for this product is Electronic Nicotine Delivery System (ENDS) since they do not fit the definition of a cigarette, which is tobacco rolled in paper. While there are many different products, they share several of the same components: a battery, heating element, filter that contains nicotine, flavorings and propylene gycol. As the user inhales and the propylene gycol is heated to 40 to 65 degrees centigrade and is drawn through the device, it vaporizes and carries the nicotine along with it. Propylene gycol is found in many food products and is generally considered as safe, however, in high doses, it can cause kidney and liver damage. There has been no research whether is it safe to be inhaled through the lungs or if there are dangerous products that are released as it is absorbed in the lining of the lungs, especially when if it is used frequently throughout the day and for long periods of time. Another concern is that there is no quality control and some companies are using other substances in the nicotine cartridge. The cartridge can be refilled with nicotine liquid which is sold in small amounts of about 1 gram, about the amount that would fill a shot glass. Because the product is not sold in a taper proof container, it should be kept away from pets and children because this amount could be a toxic or legal dose. Children could be particularly at risk since propylene gycol has a sweet taste that children may like. One teaspoon of nicotine is enough to kill a child.

Manufacturers of e-cigarettes claim that their product contains less harmful substances than cigarettes and that their product is more like a cigarette and not a nicotine replacement product, so the FDA does not have the authority to regulate this product. Unfortunately, until recently the FDA was barred by the Supreme Court from conducting any regulation of cigarettes, so there is no framework to evaluate tobacco products and health claims. As a nicotine delivery system, safety and efficacious issues need to be addressed which is difficult, since there is no single standard for ENDS. Questions of quality control, are there unintended consequences from the use, safety issues and is it really an alternative to smoking are all questions that need scientific research.

The FDA conducted a small pilot study comparing Njoy, Smoking Everywhere and the Nicotine Inhaler, a medicinal product available by prescription only. The nicotine cartridges were analyzed specifically for nicotine, tobacco smoke alkaloids, TSNA’s, and Diethylene gycol (DEG). For the two ENDS, it was found that the product delivered less nicotine than was stated on the package (Smoking Everywhere, 16mg stated vs. 5.98mg  found, Njoy, 18mg stated vs. 6.76mg found). One cartridge contained DEG which is not found in cigarettes and anabasine was detected in some cartridges, along with trace amounts ot TSNA’s, a cancer causing substance that is also found in tobacco products. Some 0 nicotine cartridges did contain nicotine. The FDA study had testing limitations, in there was limited chemical assessment, a machine was used to detect the amounts of nicotine inhaled which may be different than the way a human would inhale and it was not tested on humans to see if there were different biomarkers involved.

A report that is often quoted by manufacturers was funded by Runyan Ltd and was conducted by a private company, Health New Zealand. Their report has the same limitations as the one done by the FDA. Health New Zealand found that the cartridges contained TSNA’s, acetaldehyde, acetone, formaldehyde and polycyclic aromatic hydrocarbons (PAH’s) at lower levels than cigarettes but higher than nicotine replacement products that are FDA approved. Propylene gycol was declared virtually non-toxic but the effects of the electronic heating was not tested for long term toxicity. There are frameworks in place that where research could be done as to answer safety and quality control issues within a reasonable amount of time. If ENDS were to be found to be safe, there might still be risks that the users would need to be informed of but these can only be determined through adequate studies.

Besides the safety and quality control issues, there are behavioral issues that raise concerns. Is this a product that will wean smokers off cigarettes or will it be a bridge product that is used instead of cigarettes and prevents quit attempts? Will it entice former smokers to resume smoking? Will it serve as a gateway for new smokers?

The take away message from the panel is that currently it is impossible for a consumer to make an informed decision about ENDS and that the product should be banned until safety and efficacy studies are properly conducted.