The Food and Drug Administration last month held a press conference warning people of what they claim are the potential health risks and harmful effects associated with electronic cigarettes. Unfortunately, the study was extremely narrow in scope and included only limited data, failing to include a scientifically significant sample of e-cigarette products on the market or their users. They also failed to acknowledge the efforts on the part of electronic cigarette suppliers in our association to market their products solely as alternatives to adult smokers looking to avoid inhaling all the harmful toxins that come from combustible cigarettes.
If you aren’t familiar, e-cigarettes are electronic devices that deliver various levels of nicotine, depending on the desires of the users. These devices look and feel like a combustible cigarette and include a battery, a cartridge that delivers the nicotine, and an atomizer that creates a vapor to simulate the appearance and experience of smoking. So, smokers get the nicotine they crave but aren’t exposed to the hundreds of toxins that are known to shorten a smoker’s lifespan, giving the more than 1 million Americans who now use e-cigarettes a potential health advantage over those who continue to smoke combustible cigarettes. In addition to reducing the toxins from their habit, e-cigarette users enjoy having an alternative that they can use in the workplace and in public without violating any laws or policies, nor annoying or exposing non-smokers to tobacco smoke.
The Electronic Cigarette Association, which I represent, acknowledges the health risks of cigarette smoking and advocates that smokers quit. But we also recognize the struggles that many have in quitting and who are looking for a more convenient and better alternative to tobacco cigarettes. While some of our customers have reported using our devices to help them quit smoking by slowing reducing the nicotine delivery in our products, it is important to note that our member companies do not market their e-cigarettes as smoking cessation products nor make any such claims. The enormous response our members have received from more than 1 million Americans undoubtedly demonstrates that smokers unable to quit are desperately looking for an alternative to cigarettes.
Our member companies are extremely careful to market only to committed adult smokers who simply want an alternative to combustible cigarettes. In addition to eliminating the toxins from their habit, e-cigarette users enjoy having an alternative that they can use in the workplace and in public without violating any laws or policies and nor annoying or exposing non-smokers to tobacco smoke.
ECA was disappointed in the FDA study, particularly because it failed to follow its traditionally sound, scientific practices but instead issued misleading and narrow data without thoroughly testing the potential health benefits of e-cigarettes that potentially could save the lives of millions of Americans. I have attached with this letter a technical review and scientific analysis of the FDA’s report that was performed by scientists at Exponent. Among the limitations in the FDA study, Exponent found the following:
* The FDA failed to present standard protocols for proper study design with regards to the testing of the referenced control devices.
* The chemical content of similar nicotine-containing, FDA-approved products was not completely described with respect to the presence of tobacco-specific nitrosamines (TSNAs) and other tobacco-associated impurities that have also been found in nicotine replacement therapy devices at similar, if not higher, levels.
* In the lots tested by the FDA, none of the chemicals of concern in the study were able to be quantifiably measured in the liquid of the device’s cartridges.
* Data presented in the report does not adequately support the opinion that users of the products would actually be exposed to TSNA’s and tobacco-specific impurities in the vapor phase during normal use and if exposed, that those levels would be a health concern as compared to other FDA-approved products.
Given the limitations of this study, we encourage the FDA to take a more scientific approach and to work with members of the ECA before making any rash decisions to ban e-cigarettes altogether. Such a ban would leave smokers without an alternative to combustible cigarettes, which are clearly documented and known for their unhealthy and life-threatening results and which the FDA has no intention of banning. The enormous response our members have received from the more than 1 million Americans undoubtedly demonstrates that smokers unable to quit desperately are looking for an alternative to cigarettes.
We believe Americans should have a right to choose an alternative and our association is willing to work with Congress and the FDA to provide the necessary data to encourage reliable and extensive studies that we are confident will demonstrate the efficacy of choosing a product that will not deliver the harmful carcinogens found in cigarettes. We also want to work to ensure that manufactures agree not to make any health claims nor market these products to those younger than the legal smoking age. Our members are committed to following such guidelines and to giving smokers an alternative until they can make the commitment to quit smoking.
We do agree with the FDA, however; that E-Cigarettes should not be purchased or consumed by those under the legal age of smoking. We support any legislation, be it state or federal, that makes it illegal to sell e-cigarettes to children and those under the legal smoking age. We only market our products to committed long term smokers and would never want this to entice anyone who is not already addicted to nicotine to use our product.
Before any rash decisions are made on the future of e-cigarettes, the ECA asks that you encourage the FDA to conduct comprehensive, scientific studies. I would be happy to discuss this issue with you further. Please visit our website at www.ecassoc.org for more comprehensive information about our association and our product.