This may not be the right forum for this, and it may have already been posted, but as a noob it's the only place I can post. If anyone can move it great. I wrote the FDA with a testimonial regarding e-cigs. It was first forwarded, and their reply is below.
Steve Nagy
Dear Cheryl:
Your email was forwarded to the Division of Drug Information, in the
FDA's Center for Drug Evaluation and Research.
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 FDA's Division of Pharmaceutical
Analysis analyzed the ingredients in a small sample of cartridges from
two leading brands of electronic cigarettes. In one sample, the FDA's
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.
Again, we appreciate the time that you have taken to contact us.
Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
This communication is consistent with 21CFR10.85(k) and constitutes an
informal communication that represents our best judgment at this time
but does not constitute an 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.
Cheryl,
Your email has been forwarded to the Center for Drug Evaluation and Research (CDER). Please forward all future inquiries regarding electronic cigarettes to "druginfo at fda dot hhs dot gov" (this is their email).
Sincerely,
Steve Nagy
Dear Cheryl:
Your email was forwarded to the Division of Drug Information, in the
FDA's Center for Drug Evaluation and Research.
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 FDA's Division of Pharmaceutical
Analysis analyzed the ingredients in a small sample of cartridges from
two leading brands of electronic cigarettes. In one sample, the FDA's
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.
Again, we appreciate the time that you have taken to contact us.
Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
This communication is consistent with 21CFR10.85(k) and constitutes an
informal communication that represents our best judgment at this time
but does not constitute an 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.
