FDA Warns Against E-Cigarettes
The Food and Drug Administration is warning Americans not to use electronic cigarettes because they contain cancer-causing chemicals and other toxins which include a compound that is found in antifreeze. However, they did not ban the sale of these smoke-free devices.
The E-cigarettes and other similar products are sold online and also in scores of mall kiosks across the United States. These devices deliver nicotine in a puff of hot gas that feels like real smoke. (There are also nicotine-free versions of the E-cigarettes.) Now the FDA has tested two of these devices: Njoy products and the Smoking Everywhere devices. Michael Levy, who is an attorney and also the director of the FDA’s office of compliance in the division of drug evaluation and research, said, “The products we reviewed so far we found to be illegal.” However, the FDA has still no banned these devices because there is still pending litigation on the issue of the FDA’s jurisdiction over the E-cigarettes.
So why call a news conference on the issue? Joshua Sharfstein, M.D., and the FDA principal deputy commissioner, stated, “We felt it important that while there is litigation and we are considering options, there is no reason to be confused about FDA’s position on the issue.”
At this news conference, an FDA analyst, Benjamin Westenberger, described testing 19 different cartridges from the two brands of E-cigarettes at the St. Louis facility for the FDA. They found among these tests:
* All but one of the cartridges was marked as having no nicotine when they actually contained the addictive substance.
* The cartridges that were marked as having low, medium, or high amounts of nicotine actually have varying amounts of nicotine.
* One of the cartridges tested positive for having a toxic antifreeze ingredient, diethylene glycol.
* The devices were emitting “tobacco-specific nitrosamines which are human carcinogens.”
* The devices were also emitting tobacco-specific impurities that are suspected of being harmful to humans.
The FDA news conference also featured several experts that also issued strong warning against the use of E-cigarettes:
* Jonathan Winickoff, M.D., and who is the chairman of the American Academy of Pediatrics Tobacco Consortium, warned that these types of products seem to be tailor-made to be appealing to kids. He stated that the devices could get kids addicted to nicotine and eventually turn them into smokers.
* Matthew McKenna, M.D., and who is the director of the CDC’s Office of Smoking and Health, noted that the E-cigarettes can also be used in environments that are smoke-free and therefore weaken the health benefits of the antismoking efforts.
* Jonathan Samet, M.D., and who is also the director of the Institute for Global Health at the University of Southern California, warned that the E-cigarettes are nothing like the nicotine-delivery devices that are approved by the FDA to help people stop smoking. He also noted that he E-cigarettes have no proven benefits but have risks that are perfectly clear.
Since the year 2008, the FDA has been trying to prevent the E-cigarettes from entering the United States. To date, there have been approximately 50 shipments refused, but this has still not stopped the sale and distribution of the E-cigarettes. In March of 2009, Canada fully banned the use of these devices.
The makers and distributors of the E-cigarettes have argued that their devices are safer than smoking real cigarettes, thereby mitigating the harm of smoking. Some have even implied that their products have help people stop smoking tobacco products.
The FDA has rejected both of these claims because these devices can deliver doses of synthetic nicotine, and these agency sees them as unapproved drug-delivery devices with unknown safety. It has also not been proven whether these devices can safely help people quit smoking, while they have the clear potential to entice new smokers with their candy and fruit flavors offered.
The E-cigarettes come in many sizes and shapes. Many of them look like long cigarettes, while others can look like pipes or cigars. They still all work in basically the same way:
* Users inhale through a mouthpiece.
* Air flow triggers a sensor that will switch on a small heater that is battery-powered.
* The heater then vaporizes liquid nicotine in the small cartridge and also activates a light that is at the “lit” end of the e-cigarette. The users can also opt for a cartridge that is nicotine-free.
* The heater will also vaporize propylene glycol (PEG) in the cartridge. PEG is the ingredient in which the theatrical smoke is made from.
* The user then gets a puff of hot gas that feels very close to tobacco smoke.
* When the user exhales, there is a cloud of the PEG vapor that looks like smoke. The vapor will quickly dissipate.
* The E-cigarettes contain no tobacco products. Even the nicotine in the e-cigarettes is synthetic.
The devices usually retail for $100 to $200. The refill cartridge packs vary in price depending upon the nicotine content. There are also liquid do-it-yourself refills that are sold. Each refill cartridge is good for several uses.
The device makers say that they are not making any health claims for their products. Craig Youngblood, who is the president of the InLife e-cigarette company, and stated that since regular tobacco is very bad for you, something that assuages your habit of nicotine without the smoke must be less bad for you.
“In our product you have nicotine or no nicotine, PEG, and some flavoring. In cigarettes you have nicotine, PEG, and 4,000 chemicals and 43 carcinogens. I am proponent or harm reduction. People have rights and choices and should be allowed to make them.”
Other have seen these devices as being a sneaky way to get people hooked on nicotine. One of these such people is Michael Eriksen, ScD, and who is the director of the institute of public health at Atlanta’s Georgia State University and former director of CDC’s office of smoking and Health.
“I have seen no evidence that people switch from tobacco cigarettes to e-cigarettes or other smokeless tobacco products. If you look at how smokeless products are marketed, they are sold as something to use at times you can’t smoke. The implication is you will increase nicotine exposure, not reduce smoking,” stated Eriksen.
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The FDA is grasping at straws. None of the impurities detected are required substances of e-cigarettes. They are trying to make the devices look bad. They should solicit comments from the thousands of users that are happy with them and make every effort to have them quickly adopted by the rest of the smokers as a smoking alternative that is much safer.