Thought you might be interested.
Thank you for making your opinions and concerns known to the Agency. We appreciate your thoughts and experiences regarding electronic cigarette, cigar, and pipe products.
At this time, we are not aware of any data establishing electronic cigarettes, cigars, or pipes as safe and effective for their intended uses. Based upon our review of a number of these products, they are drug/device combinations that require approval by FDA before they may be legally marketed in the United States .
None of these so-called electronic cigarettes, cigars, and pipes, or their components has been approved by FDA. Therefore, the marketing of them in the United States is subject to enforcement action. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.
There may be a perception among some users that electronic cigarettes, cigars, or pipes are safer alternatives to conventional tobacco products. There may also be a perception that these products are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. The FDAs Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDAs analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. FDA also found varying levels of nicotine in cartridges labeled as containing the same level of nicotine as well as the presence of nicotine in cartridges labeled as containing no nicotine. These test results indicate that these products are manufactured under inadequate or non-existent controls.
FDA is concerned that electronic cigarettes, cigars, or pipes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.
There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Services, Treating Tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA-approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smokers chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting www.smokefree.gov.
Again, we appreciate the time that you have taken to contact us.
Best regards, kw
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
This communication is consistent with 21CFR10.85(k) and constitutes and informal communication that represents our best judgment at this time but does not constitute and advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
Thank you for making your opinions and concerns known to the Agency. We appreciate your thoughts and experiences regarding electronic cigarette, cigar, and pipe products.
At this time, we are not aware of any data establishing electronic cigarettes, cigars, or pipes as safe and effective for their intended uses. Based upon our review of a number of these products, they are drug/device combinations that require approval by FDA before they may be legally marketed in the United States .
None of these so-called electronic cigarettes, cigars, and pipes, or their components has been approved by FDA. Therefore, the marketing of them in the United States is subject to enforcement action. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.
There may be a perception among some users that electronic cigarettes, cigars, or pipes are safer alternatives to conventional tobacco products. There may also be a perception that these products are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. The FDAs Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDAs analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. FDA also found varying levels of nicotine in cartridges labeled as containing the same level of nicotine as well as the presence of nicotine in cartridges labeled as containing no nicotine. These test results indicate that these products are manufactured under inadequate or non-existent controls.
FDA is concerned that electronic cigarettes, cigars, or pipes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.
There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Services, Treating Tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA-approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smokers chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting www.smokefree.gov.
Again, we appreciate the time that you have taken to contact us.
Best regards,
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
This communication is consistent with 21CFR10.85(k) and constitutes and informal communication that represents our best judgment at this time but does not constitute and advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
