E-Cigarette…Anyone Else?
Posted by
Armand RossettiJuly 24, 2009 10:00 AM
The FDA has alleged that one of several E-cigarette distributors in the United States, Smoking Everywhere, Inc. (SE), has marketed a product that is both an unapproved drug (nicotine) and an unapproved medical device (synthetic cigarette body).
The FDA made this determination after examining the product, several claims made about the product, and information that SE, itself, provided to the FDA. For further information, please read E-cigarette Anyone?
While class I medical devices (gauze pads, throat sticks and the like) do not necessarily need FDA approval, class II or III medical devices do require FDA clearance before legal marketing can occur. The FDA has classified the E-cigarette as a class III medical device, and as such that device must undergo the strictest FDA scrutiny before it can reach the marketplace.
Depending on the manufacturer and type, the cost of entry to use E-cigarettes can vary from $14.99 for the “disposable” version all the way up to more than $200.00 for reusable deluxe models. Complete “starter kits” with cartridges and batteries included have been advertized at around $100. While the $200.00 price tag might discourage younger users, the chic of it all and the curiosity to try an E-cigarette at the price of about three packs of cigarettes ($14.99) might entice a younger demographic to give it a try.
Most people who use E-cigarettes do so with the intention of cutting down on smoking, or with the anticipation being able to get a nicotine high while working indoors (no smoke = no ban). Other consumers use the device to quit smoking altogether. Cessation is possible because the nicotine concentrations in the cartridges can range from 16 mg all the way down to zero mg. The choice remains with the consumer.
There can be no dispute that well designed and well regulated E-cigarettes have a potential to aid smokers in reducing or eliminating their habits. And several manufacturers are heading in the direction of making the E-cigarette device as safe as possible.
However, E-cigarettes might also provide an avenue for further addiction. A first time E-Cigarette user with the handle, “Utada” recently posted an after purchase review on Amazon.com. Although Utada was going to give the SE distributed E-cigarette five (5) stars, Utada only gave the product three (3) stars because he or she felt that the product was addictive since it had nicotine.
But here's the catch. When Utada was smoking real cigarettes, she smoked only 5 or 6 a day. However, with the E-cigarette, Utada wound up smoking two cartridges a day (each cartridge being equal to 20 regular cigarettes). Utada continued her review by advising the purchase of “e-cig juice” an after market nicotine cartridge rejuvenator, which comes in different flavors. With e-cig juice (or E.LIQUID, as one example), Utada expected to save a lot of money. In fact, using e-cig juice to extend the life of the device, reduces the cost of “smoking” significantly to far less than $5.00+ a pack for 20 smokes (see below). But there is a potential health hazard in using an E-cigarette beyond the number of cycles that the manufacturer has built into the device; an example follows.
Recently, several complaints have surfaced about a burning taste that consumers experience after cycling the E-cigarette through a number of puffs. This phenomenon may or may not involve SE’s version of the E-cigarette, but it would be prudent to obtain more information from the manufacturer.
As one blogger illustrated, most E-cigarette devices contain a wick inside a filament that soaks up the liquid in the cylinder that contains nicotine. A battery powered filament then heats the liquid that finds its way to the wick to form a vapor. After a while, the wick dries out fairly easily and starts to burn forming “burnt e-liquid”). Thereafter, the residual E-liquid has a propensity to turn into a solid and begin to burn. That sequence is what creates an unwelcome taste, and a possible, device-related health hazard. With little regulation, the possibilities for serious health risks seem as endless as human creativity will permit.
For example, some ardent E-cigarette consumers have expressed concern that manufacturers may be using a cheap polyester material to make the filter portion of the cigarette. Polyester filters could turn out to be dangerous when burned and inhaled.
Moreover, E-cig liquid is sold in 15 milliliter bottles in several flavors and nicotine strengths for $14.99. According to one distributor, only 2 or 3 drops of the liquid will regenerate a cartridge. Since there are 20 drops per milliliter, that means that one 15 milliliter bottle contains from 100 to 150 cartridge refills, and one cartridge equals 20 cigarettes. Doing some simple math, like many young people are able to do, a cigarette equivalent could cost as little as $14.99 divided by 3000, or about half a cent (or 10 cents a pack). It’s a great way to beat the cigarette tax.
To reiterate, the E-cigarette is a device, nicotine is a drug, and the FDA will be regulating both. Therefore it is within the purview of the FDA to ensure the safety of the E-cigarette device and its delivery of a drug. Otherwise, problems associated with misuse and/or device alteration might abound
Bottom line: In the interest of consumer safety, the FDA should require all E-cigarette manufacturers list materials used in respective devices. In addition, the FDA should require E-cigarette manufacturers to conduct studies to determine whether any materials subject to heat during cycling, including polyester, might produce toxins. Smart manufacturers should be forthcoming with appropriate warnings and, lastly, all forms of nicotine, including E-cig juice should be FDA regulated.