This is an email response I have just recieved from the FDA. I found some parts interesting. I have since replied thanking them for their response and offered to support what they need, being as how they cant seem to find any "studies" (I didn't say that part though lol)
Thank you for making your opinions known to the Agency. We appreciate your thoughts and suggestions regarding this issue.
At this time, we are not aware of any data establishing electronic cigarettes as safe and effective for their intended uses. Based upon our case by case 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 or their components has been approved by FDA. Therefore, the marketing of the products FDA has reviewed is not legal in the United States. 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 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 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.
We appreciate you understanding that the regulatory decisions are not made by the Division of Drug Information, but that are responsiblility is to convey the information to the public.
We hope that the above information clarifies any questions about electronic cigarettes.
Thank you for making your opinions known to the Agency. We appreciate your thoughts and suggestions regarding this issue.
At this time, we are not aware of any data establishing electronic cigarettes as safe and effective for their intended uses. Based upon our case by case 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 or their components has been approved by FDA. Therefore, the marketing of the products FDA has reviewed is not legal in the United States. 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 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 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.
We appreciate you understanding that the regulatory decisions are not made by the Division of Drug Information, but that are responsiblility is to convey the information to the public.
We hope that the above information clarifies any questions about electronic cigarettes.
