My Letter back from the FDA

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ritalin

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Aug 23, 2009
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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?
 

whistlrr

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Sep 10, 2009
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Michigan's Knobbywristbone
"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?
 
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CrazyTerrie11

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Aug 10, 2009
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W. Valley/Phoenix Arizona USA
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!!!!!
 

Doctor Vapor

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Oct 9, 2009
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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.
 

quovadis

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Jul 5, 2009
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Tell her that your cartridges contain oxygen rather than carbon monoxide.

You see the response you got was out of the book...what's the point in contacting the FDA? Stop wasting your time.
They will do as they please...
The only way to get the FDA's attention is with a whole bunch of lawyers, doctors, lab reports, and empirical evidence.
It will then get national attention etc...
Do you have 50 million to spend on this ? No ...so enjoy vaping while we still can...

When they ban ecigs ..there's already a plan B in the works...

How many of us on the forum? A few thousand lost souls ? come on...
 

Vapen8

Senior Member
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Oct 25, 2009
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I wonder what chemicals I have volitized in a hot shower when shampooing or soaping up? Gee...I hope I'll be ok.
FDA= Government
Government= system of control
system= a body of function EG: we the people
I think we the people have officially lost the power to govern our government.
you should have written RJ Reynolds instead of the FDA, you would have at least been talking to a true authority of our government.
 

ritalin

Full Member
Aug 23, 2009
63
0
Tampa, FL
I wonder what chemicals I have volitized in a hot shower when shampooing or soaping up? Gee...I hope I'll be ok.

Maybe not!
Shower heads make a perfect home for bugs - health - 15 September 2009 - New Scientist
"Run your shower for a minute or so before you get in, otherwise you'll get a face full of bacteria." That's the advice of microbiologist Norman Pace, who has had the unenviable task of analysing the film of microbes that builds up within shower heads at 45 sites in the US.
Pace and his team from the University of Colorado, Boulder, found significant loads of nontuberculous mycobacteria (NTM), particularly Mycobacterium avium, at levels 100 times as high as those found in drinking water.
M. avium is responsible for a type of pulmonary disease more prevalent than TB in developed countries, cases of which have risen in parallel with the rise in showering, says Pace. "For most people, taking a shower is not dangerous, but if you are immune compromised, such as the elderly or pregnant, it could be," he says.
His advice is to not use shower heads made of plastic. "If it has little crusty deposits, throw the sucker away. Have a bath."
NTM expert Joseph Falkinham of Virginia Tech in Blacksburg says this type of data is needed to prepare a risk assessment, but we also need to know how many NTM of each species and type are needed to cause disease. "That is unknown for humans and not well established for laboratory animals either," he says.
 

Doubledot

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Aug 19, 2009
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The only way to get the FDA's attention is with a whole bunch of lawyers, doctors, lab reports, and empirical evidence.
It will then get national attention etc...

You have to lobby to do this = "grease money" and scratch my back - I'll scratch yours...

It is no different to the way things are done in third world countries. Just more obvious due to the desparity of wealth. Most of whom picked up from the USA. IMHO
 

crazybry79

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Sep 8, 2009
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......vaporized and inhaled by the user....

What about the vaporizer I use when Im sick?? That creates a vapor I inhale as well... now THATs a drug delivery device!

Oh wait.....it vapoizes WATER!! Another ingredient in antifreeze!8-o BANBANBANBAN!!!

Oh ya, thanx guys/gals for the 4 hour thing.....if the fda sees that, they'll REALLY have a boe-ner over that!!:lol:

OK...that was a cheap shot.....sorry :p
 

CrazyTerrie11

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Aug 10, 2009
445
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W. Valley/Phoenix Arizona USA
......vaporized and inhaled by the user....

What about the vaporizer I use when Im sick?? That creates a vapor I inhale as well... now THATs a drug delivery device!

Oh wait.....it vapoizes WATER!! Another ingredient in antifreeze!8-o BANBANBANBAN!!!

Oh ya, thanx guys/gals for the 4 hour thing.....if the fda sees that, they'll REALLY have a boe-ner over that!!:lol:

OK...that was a cheap shot.....sorry :p
I love your "Pauley Walnuts" avatar...
 
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