Response from the FDA today.

[Grateful]

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.

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.

[jj2]

This is the carbon copy letter they send out.
Glad to see that you wrote them though. Everyone needs to at least once.

[kase]

How can you type that much and not say anything at all? LOL!

[e-pipeman]

It seems quite clear from this letter that the FDA do not intend to support those who choose to vape rather than smoke cigarettes. Given that cigarettes remain legal in the USA this seems a strange position to adopt. It is as if your government (or an agency thereof) would rather see you use a product (tobacco) that is manifestly harmful rather than a product (e-liquid) on which the jury is currently out. The fact that vaping may be less harmful than smoking tobacco is surely enough to suggest that the practice should not be actively discouraged. In a sense the argument "innocent until proven guilty" could well be applied here. To adopt the opposite position would seem to be unreasonable.

[Silence]

Unfortunately, In the United States Constitution nor in the Bill of Rights does it state that we are "Innocent until proven guilty". sux I know. More over, correct me if I am wrong but doesn't the FDA take forever to accomplish anything? And one last point: If I am correct, which I believe I am, the FDA must be able to prove that a product is harmful in order to control/ban it. And they are by no means obligated to do either. (i.e. McDonald's still operates here)... JMO

[mudmanc4]

Nothing like checking to see what the government decides is good for us hey ? Geeze, what a joke. whoa, don't take this wrong, I sincerely appreciate this thread, as well as suns thread on the updated docket.

Let us look at this from anther angle here, we as a society have gotten so accustomed to having someone else tell us what we can / can't do , what is / isn't good for us, and then regulating "it" by force legal or not, that we actually wait on them hand and foot . This , this is the real issue here. Nothing else.

Now there may be those out there that need someone to tell them not to eat there pens and pencils, they may get stuck somewhere uncomfortable ok, yet I am a firm believer that at a certain age, if you are unable to make a decision based on what you have learned thus far in your life, then you need to go get a book or something, maybe the cat in the hat or something of the likes.

I especially enjoyed the quote "Since these products have not been submitted to the FDA
for evaluation or approval " seriously, ok, next time i go into my garden and pick something, I'll be sure to "submitt " the thing to a political organization , so they cn tell me if I can legally consume it, when there may very well be a huge corporation that markets close to the same thing, that is taxed, this way I am consuming something "legally " .

#%$!@$!@#$!#$~#$!@#~$ !!!!!!!

[kno]

the diethlyne glycol was found among 2 leading brands? what brands were there?

also noted the nicotine cartridge levels to vary even when labeled the same -

solution:
USA Lab Manufactured E-Juice for PV's under strict controls to US/FDA standards

boom - problem solved

china cig, US juice = vape happy! no?

[flrailroader]

Correct me if i'm wrong but according to wikipedia DEG is used as a humectant in tobacco,which means the analogs that we used to smoke had DEG in them anyways.Also the US code of Federal Regulations ALLOWS no more than 0.2% of DEG in polyethylene glycol when the latter is used as a food additive.So DEG thats used in antifreeze and is toxic to humans is why the FDA's wants us to believe e-cigs are unsafe to us,but ALLOW'S up to 0.2% DEG in food additives.Does any body else find this outragous.

[flrailroader]

Oh yeah i forgot, we all know that analogs have NO carcinogins,nitrosamines,or nicotine in them.YEAH RIGHT.

[Kent C]

Oh jeez, another one.... If they'd quit getting letters maybe they'd forget about it.