My Letter back from the FDA

[ritalin]

Several weeks ago I sent an email to the FDA requesting confirmation one way or another on customs holding shipments. I had recently read conflicting FDA quotes in regards to the matter. My first email was returned with the same scripted letter that has been posted in one form here or another. So I inquired again.

My second letter to the FDA

Thank you for your response,

However I still have a few questions. I should have made myself more clear. I intend to sell the product without nicotine, to my knowledge this is the only "drug" in the liquid. Will the same rules still apply if there is no "drug" in my device sold to the public? Will the same rules classify this no-nicotine e-cigarette as the "drug" delivery system and again bar it from importation?

Thank you,

Their response,

To clarify, regardless of whether the cartridges contain nicotine or not, they contain chemicals that are intended to be volatilized and inhaled by the user upon each inhalation through electronic cigarette articles. Based on various claims, statements, and representations of the products that we have reviewed, they suggest that these articles are intended to affect the structure or function of the body and to mitigate, treat, or prevent disease with or without nicotine. Therefore, they would require a new drug application, which we encourage manufacturers to submit.
To address your last question, FDA has detained and refused several importations of various brands of these "electronic" cigarettes, cigars, and pipes, and their components, and the agency continues to evaluate these products on a case-by-case basis.
Kristine Wollscheid
Compliance Officer
Food and Drug Administration
CDER/Office of Compliance
Division of New Drugs & Labeling Compliance
OTC Drugs Team
10903 New Hampshire Ave.
WO51-1333
Silver Spring, MD 20993

There were a few different ideas as to what she meant in her replay. So I inquired again.

Again thank you for your quick responce.

Please excuse me but I am still unsure of what you are saying here. I understand that the FDA's stance is that this is a drug/delivery device. Surely you are not saying that a devices "intended" use is determined strictly by the claims of some vendors. I would assume that the you mean to say that the other chemicals involved such as Propylene glycol and the food flavorings are considered drugs? The only other components of the e-cigarette liquid besides nicotine are already FDA approved as far as I am aware, or do you mean the idea that the device being sold as a placebo for a cigarette makes it a drug?

Thank you again,

Ill edit the post if I hear back from her again.
Your thoughts?

[Sun Vaporer]

I find this statement interesting:

"Therefore, they would require a new drug application, which we encourage manufacturers to submit."


I do not know if I have scene one that uses the "encourages" language---at least not that I have scene.


Sun

[nitewriter]

That is an interesting statement Sun.

On her first reply ritalin, I thought she was referring to the fact that some were selling them with Cialis.

[OutWest]

Some doctors suggest sucking on a lollipop whenever you want a cig. From what that letter says it tells me that all lollipops are drugs and need to go through the new drug approval process. *shaking head*

[whistlrr]

"regardless of whether the cartridges contain nicotine or not, they contain chemicals that are intended to be volatilized and inhaled by the user upon each inhalation through electronic cigarette articles."

Did the FDA ever approve hookahs bongs and water pipes?
what about steam inhaled from a boiling pot on a stove?
(Guess they'd better get to work on that too)

spoons are 'a delivery system' for all kinds of drugs, OTC and otherwise, when are we gonna need prescriptions for those?

lets not forget that caffeine is a chemical... shall we then have the FDA regulating cups while we're at it?

I mean, why stop here, why not regulate absolutely every fluid solid, etc, form that any and every way chemicals can even come in and then of course whatever and absolutely anything you can conceivably use to get any any of them in you in any form whatsoever, anything that can be used to get any of them into us, ever?


(Its 6am and I've not been able to sleep and I'm not sure if I'm not maybe making sense because of that or simply just because this whole situation is just so senseless)

my translation of what the FDA really said:
"we just don't want you to this at all, period, and we're just making it up as we go to see that you don't, and we're doing it just because we can"


..."volatilized and inhaled by the user" ...

why don't they put plain old air on hold and forbid us that too until Big Pharma can get their money from charging us prescriptions for it before we can even breathe and just be done with it?

[CrazyTerrie11]

Originally Posted by ritalin

Several weeks ago I sent an email to the FDA requesting confirmation one way or another on customs holding shipments. I had recently read conflicting FDA quotes in regards to the matter. My first email was returned with the same scripted letter that has been posted in one form here or another. So I inquired again.

My second letter to the FDA
Their response,
There were a few different ideas as to what she meant in her replay. So I inquired again.
Ill edit the post if I hear back from her again.
Your thoughts?

I HATE THE FDA!!!! Lets get real here....i mean have you heard the "side effects" of tons of drugs they "approve" ????? My P/V sure doesnt make me have thoughts of suicide or make me gain 10lbs or cause flu like symptoms....my god! How can they get away with this? It blows my mind how out of control and hypocritical they are and we cant do a damn thing about it. We need Erin Brokovich!!!!!

[CNubel]

Originally Posted by CrazyTerrie11

I HATE THE FDA!!!! Lets get real here....i mean have you heard the "side effects" of tons of drugs they "approve" ????? My P/V sure doesnt make me have thoughts of suicide or make me gain 10lbs or cause flu like symptoms....my god! How can they get away with this? It blows my mind how out of control and hypocritical they are and we cant do a damn thing about it. We need Erin Brokovich!!!!!

If your PV causes you to have an erection lasting longer than 4 hours, immediately call up a few good friends and have a party.

[CrazyTerrie11]

Originally Posted by CNubel

If your PV causes you to have an erection lasting longer than 4 hours, immediately call up a few good friends and have a party.

OMG!! Now thats funny..LMAO

BTW.......whats so wrong about a 4hour erection?? I thought that is what all us women were searching for...LOL

[CNubel]

Originally Posted by CrazyTerrie11

OMG!! Now thats funny..LMAO

BTW.......whats so wrong about a 4hour erection?? I thought that is what all us women were searching for...LOL

Don't remind me!! When I was 25, no problem. At 50...well, maybe not.

[Scottbee]

Originally Posted by CrazyTerrie11

OMG!! Now thats funny..LMAO

BTW.......whats so wrong about a 4hour erection?? I thought that is what all us women were searching for...LOL

Yeah... that's what you say.... but in reality, after 2.3 hours you want to dismount and watch Oprah. I know this to be true...