Fda Response Today, Possible Disagreements Within Agency

[zombie]

Whats up guys, and ladies,

After I completed my college speech regarding FDA deception, I sent an email asking/demanding explaniation of their outdated claims of no studies and antifreeze e-liquid. This is what I sent, and their response, albeit I was alittle tired when I sent it.

Also I had a 25 minute dicussion with the American Heart Association which consisted of my testimony and the factually findings we know now. I would recommend giving the American Heart Association a call along with U.S. House reps, and others.

I am a user of electronic cigarettes. I am well aware of your stance on them. I have done over 100 hours of research from independent universities, as well as findings from the FDA which have been found unanimously flawed.

Shame on those responsible for the efforts to ban the devices that helped save my life, or at the very least improve my over health. I know the facts and will work my *** off, to get the FACT out the the american public.

I realize that you may be a very nice person, by know means responsible for the decisions that have come from your office. The FDA needs to be fully funded from the government only or be disbanded, period. I will HELP the FDA! If it is not the profit insurrance company that everybody thinks it is.

Well I am going to breathe my antifreeze now, LOL

Have a good day.

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 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 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.

Sincerely,

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

kcd

[easilyamused]

i think it is BS that their main argument is and has always been that it could encourage young people to use nicotine... lets see, when i was a kid the guys were doing chew, i remember the girls always complaining that "he kissed me and i didnt even know he was chewing at the time" the guys thought this was funny.

I see the teens on the corner smoking, its like a social event for then, in fact in many ways smoking is a social event...

the local teens that i know dont want anything to do with e cigs, no matter what flavors they come it

[Nanna]

More to the point, if they are so afraid that e-cigarettes will lead people to smoking cigarettes about which there are known dangers, why don't they concentrate their efforts on banning cigarettes?

Oh. Yeah. Because they aren't allowed to do so.

[miatafrank]

They claim to not know of any scientific studies other than their own, but CASAA continues to send out links to all the studies that have been done to politicians every time there is a ban threat. The FDA would have to be living under a rock to not be aware of these studies, therefore it can only be concluded that they are ignoring any findings that disagree with their own.

[egoluvr]

I think it's all a bunch of crap- They want to put us vapers through hell so we'll be greatful when they take over the community and get the govertment to tax the crap out of everything. they want their share of the pie is all

[EiderDuck]

I would be interested to know how many FDA(stands for Forget Democracy Altogether)or(Fascists Destroying America) bigwigs are wined and dined(& Sixty..... fill in the rest, dare I say it?) by big tobacco CEO's to just look the other way as to what really they are doing to ppl by producing those analog's in the billions everyday. Money talk's... blah blah blah. Just another hot air gas bag.

Resistance is futile: We are trying to protect you... from yourself

Okay off my soapbox... for now