FDA Response

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Krakkan

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Well here is a response from 1 of the 100+ emails I sent the E-cig petition too lol. Pretty crappy email but here ya go for your viewing pleasure...

[FONT="]Dear Mr. Henry,[/FONT]

Thank you for making your opinions 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 generally recognized among scientific experts as safe and effective. Based upon our investigation 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 the amounts of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. 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 Service’s, 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 smoker’s chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting [URL="https://atlanta.securemail.hhs.gov/exchweb/bin/redir.asp?URL=http://www.smokefree.gov/"]www.smokefree.gov[/URL].

Again, we appreciate the time that you have taken to contact us.
Best regards,
Division of Drug Information 7
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 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.
 

ladyraj

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I just received the very same response! I guess everyone who wrote in will get the same form letter.:(

Have to love the disclaimer:

"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 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."

Sounds like one should ignore the statements made in the communication!
 
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DaMulta

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So, until Philip Morris comes out with their E-Cig they will have no evidence that it is a safer alternative. IMO.

If they opened it up they know that it could hit every gas station in the US. With no Sin Tax just sales tax ATM. All the smokers would really see this then, and their budgets which are already in trouble would fall to the floor.

You have to think about what Tob Tax pays for, and to think that is not coming in to play would be crazy not to think about. Behind doors you know that is being talked about.....

Not everyone wants to quit vapping, some want to quit the habit all together.....FDA is looking at this just as a way to quit then give it up......from what I have seen.
 

Krakkan

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So, until Philip Morris comes out with their E-Cig they will have no evidence that it is a safer alternative. IMO.

If they opened it up they know that it could hit every gas station in the US. With no Sin Tax just sales tax ATM. All the smokers would really see this then, and their budgets which are already in trouble would fall to the floor.

You have to think about what Tob Tax pays for, and to think that is not coming in to play would be crazy not to think about. Behind doors you know that is being talked about.....

Not everyone wants to quit vapping, some want to quit the habit all together.....FDA is looking at this just as a way to quit then give it up......from what I have seen.

Oh they are scared of losing their precious blood money for sure... Makes me insane to think they can say they are worried about safety when they are now putting a seal of approval on cigarettes..
 

Sun Vaporer

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"There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Service’s, 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 smoker’s 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.
"
That is the FDA's answer for us---use an apporved NRT---period.

Well at least they stated again what we already knew was their positon--use an approved NRT or you can still buy cigarettes??

Sun
 

Krakkan

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"There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Service’s, 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 smoker’s 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.
"
That is the FDA's answer for us---use an apporved NRT---period.

Well at least they stated again what we already knew was their positon--use an approved NRT or you can still buy cigarettes??

Sun

lol right seems like a smart group of people there -- wonder how many more people will die due to their negligence and greed -- long live the revolution :p
 

ashdaburned

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Jun 21, 2009
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Gotta love how they say proven methods of quitting tobacco. How can you call 12% effective? If you look through the studies, that is what they come up with. After 1 year only 10-20% of people are still smoke free. To me that does not sound very effective. (Those are the numbers that i got from what i understand of the reports from the FDA. If they are incorrect please inform me, and add a source.) Also if they are approving stuff that can cause suicidal behavior, (which attempting suicide in some places is illegal) then i wonder what smoke cessation product they have denied.
 

breakfastchef

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Feb 12, 2009
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Gotta love how they say proven methods of quitting tobacco. How can you call 12% effective?

I have read the figure of smoking cessation success rates at under 6%. E-cigs are 100% effective for me.

Regardless of the language in the form letter Krakkan received, I understand the premise of the FDA's position. While we are all pretty certain that vaping is significantly better than smoking analogs, we should all continue to questions the 'What if's' of our new habit. In essence, we really do not know the medium and long term effects of what we inhale. Sure, on the surface we are taking in 3,999 less toxins (a good thing), but e-liquid was an unknown concotion until a few years ago.

All of this begs the question of what happens to suppliers that are careful to present personal vaporizers as alternative smoking devices, not NRT devices. It would appear that the few bad apples that make health claims may have damaged the entire industry here in the U.S.
 

Krakkan

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I'm thinking the FDA is getting worried. In other words, testing the waters of an anti e-cig campaign. Given the more and more positive press the e-cig has been getting, the FDA is going to get egg in their face if they come down hard on e-cigs with nothing to back it up.

Maybe we need to push back maybe some news stories on their recent mass emails that showed they never read a comment from their public that pays for their paychecks
 

Schroedinger's cat

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I had written to the FDA about e-cigs about a month ago, and today I got the same exact letter that started this thread.
It's really a pity that the FDA has this attitude, because it is definitely impairing even my desire to use these instead of cigarettes.

Back in the fall, I had gone from 20 to 2 cigarettes a day in a very short time with the e-cig, but I fell off the wagon after my mother died. When I wanted to give the e-cig another try, I could not find the liquid in any of the flavors I liked (This was soon after the first news of an upcoming FDA ban spread, so I guess that the liquid went fast). Because I expect the liquid to become banned pretty soon, I am hesitant to give the e-cigs another try now, as I should invest in a better device (which is not cheap), but may become unable to find liquid pretty soon. Oh, well. I guess that I'll keep smoking the regular cigarettes, unless the upcoming firesafe ones will be too much even for me....
 

TropicalBob

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Oh my. Do keep in mind the 1,000 or more health-oriented groups that supported the Waxman/Kennedy bill in Congress that handed tobacco control over to the FDA, the letter from Sen. Lautenberg seeking an FDA ban on e-cigs, the support of the four major anti-tobacco groups for Lautenberg's letter, etc. The FDA would have a harder time explaining why e-cigs would be allowed than why they would be banned.

The FDA's answer is always the same: These are unproven new drug devices delivering an unapproved new drug cocktail that treats a known medical condition called nicotine addiction. No approvals have been sought from the FDA for the new drug cocktail. No approvals have been sought for the devices.

Big Pharma got approvals and provided clinical trials for all the nicotine products now on the market, the ones the FDA refers smokers to when quitting is the goal. There is not a single product approved for long-term, continued nicotine use, which is how these will be used. No tests for side effects, health impacts, effects on others in the vicinity. We know very little about the science of what we're doing. If any maker has proof, then submit it and attempt to get approval.

The FDA is awaiting only the judge's decision in the Smoking Everywhere lawsuit before acting across-the-board on e-cigs and e-liquid.

Note: This was written quickly in response to the last post on the first page about the FDA getting "worried".
 
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OckhamsRazor

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Jul 6, 2009
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Dear FDA,

It has recently come to our attention that you have ideas about banning the use of E-Cigarettes in the United States because it might cause young children to become more easily addicted to Nicotine. We applaud your efforts at keeping us all healthy and safe.

While we're on that subject, we would like to also bring up that high fat content is also a major problem in America. In addition, caffeine can be a real problem. Hi sucrose ingestion is once again, a major health issue. We look forward to the banning of nicotine ALONG with the banning of high fat food, sugar, and caffeine. It will be a joyous day when all of these proven, FDA approved, substances are removed from our daily lives for the sake of making a better, healthier America.

In fact, if you ONLY ban electronic cigarettes, we will have to take legal action over what is clearly a double standard. This would grieve us deeply, but justice must be done, and I'm sure your entirely patriotic attitude regarding freedom and justice for all will prevail in whatever decision you make.

Once again, let us not be on opposite sides of the courtroom.

Yours truly,
OckhamsRazor
 

tims

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The FDA lets real drugs be marketed with out ever testing them, they take the word of the drug makers so called trails. Only to later find out people are dieing from it, or got very sick from it and they never took action.

They can tax ecigs just as easy as real smokes, but what is really going on right now is. What obama said before he won, we will tax smokes into nothingness. They don't want people to stop smoking away, they collect all that tax from smokers, and right now it's the biggest tax item bar none.
 

Scaralouche

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It took a chemist like Ted Breaux to show the FDA and the world, for that matter, that absinthe is a safe adult beverage. Ancient bottles from before the 20th century were opened up and analyzed and proven to be harmless and not containing toxic amounts of the poison called thujone. A harmless drink was banned for over a hundred years because of ignorant hysteria. Who would have thought it was the opium being smoked and other drugs rather than little old absinthe?

I see the same thing happening with e-cigs. What we need is a Ted Breaux-like industry leader to step up and show what we vapers all know. I dont see what the manufacturers of e-cigs and liquid have to hide or lose in this? The longer they remain in the shadows, the worse it looks. I dont want to be stigmatized or villified for trying to not die doing something I enjoy.
 

Krakkan

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It took a chemist like Ted Breaux to show the FDA and the world, for that matter, that absinthe is a safe adult beverage. Ancient bottles from before the 20th century were opened up and analyzed and proven to be harmless and not containing toxic amounts of the poison called thujone. A harmless drink was banned for over a hundred years because of ignorant hysteria. Who would have thought it was the opium being smoked and other drugs rather than little old absinthe?

I see the same thing happening with e-cigs. What we need is a Ted Breaux-like industry leader to step up and show what we vapers all know. I dont see what the manufacturers of e-cigs and liquid have to hide or lose in this? The longer they remain in the shadows, the worse it looks. I dont want to be stigmatized or villified for trying to not die doing something I enjoy.

Very well said. Its sad but we are finally starting to organize and we do have some push now with the ECA's lobbying abilities but I still feel we are miles behind where we should be.
 

chad

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I know it sounds stupid and may be stupid (and I am being serious)
But why don't they buy/ask for a dse901 and various juices to run some freakin tests?

The stuff is available and out there. I know because I'm.....vaping on it right now!

The FDA's ability to test is suspect. Also, their ability to regulate is marginal at best. I don't think I want them to test PVs at all. A third-party tester is probably best.
 
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