My Letter back from the FDA

[CrazyTerrie11]

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...

Yeah....I'll take 2 hours. That should do it..LOL

[trog100]

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*

that pretty well sums it up.. if its taken into the body in any way.. its intention is to alter the body ether mentally or physically in any way.. by definition its a "drug"..

if its new its a new drug.. new drugs or a new use of old drugs all have to go thru the approval procedure..

simple definition of a drug... A substance that is used as a medicine or narcotic..

so a lollipop sold as a stop smoking plabeco would be a drug delivery device.. the drug/drugs would be whatever is in the lollipop..

its seems this entire thing has bugger all to do with nicotine.. its all down to the intended purpose of whatever is being taken into the body..

anything that isnt taken in solely for the purpose of nourishment is a "drug".. it dosnt matter what it is..

so under that definition.. e cig are illegal in the US.. they will remain so until they get approved.. i see no way around this one..

the situation we now seem to have seems to be in is one of enforcement... do they let everyone keep breaking the law or do they not..

they have already said e cigs are not legal to sell.. we are just too blind to see it.. so it now comes down to enforcement.. do they or dont they..

trog

[Luma]

They cant make money on the e-cig yet. That is the problem pure and simple. It is the same situation with MJ. They dont know how to regulate it, tax it, ect... It's all a matter of time.

[youtubecommercial]

They cant make money on the e-cig yet. That is the problem pure and simple. It is the same situation with MJ. They dont know how to regulate it, tax it, ect... It's all a matter of time.

I agree 100%

[catlvr]

They cant make money on the e-cig yet. That is the problem pure and simple. It is the same situation with MJ. They dont know how to regulate it, tax it, ect... It's all a matter of time.

Took the words right out of my mouth!

[trog100]

the real problem here is that you the amercan people have permitted the FDA to have too much power.. i know its cruel to say this but it is the simple truth..

basically they seem to have total control over anything you take into your body.. be it food or drug..

the only difference between the two seems to be the purpose you are taking it into your body for.. if its for nourishment its food.. if its to alter something ether mentally or physically its a drug..

they also get to decide which is which.. e cigs certainly aint food so that leaves the only other option.. they are a drug.. or at least whatever is in them is..

pf course under their simple definition even the lollipop used as a sweet to make little johnny happy is a drug..

frightening really aint it.. big brother has arrived and is well and truly established..

trog

[Ashhead]

As soon as we allow any gov agency to use "Federal" in thier name, instantly they have more power than the people they "serve".

[CrazyTerrie11]

the real problem here is that you the amercan people have permitted the FDA to have too much power.. i know its cruel to say this but it is the simple truth..

basically they seem to have total control over anything you take into your body.. be it food or drug..

the only difference between the two seems to be the purpose you are taking it into your body for.. if its for nourishment its food.. if its to alter something ether mentally or physically its a drug..

they also get to decide which is which.. e cigs certainly aint food so that leaves the only other option.. they are a drug.. or at least whatever is in them is..

pf course under their simple definition even the lollipop used as a sweet to make little johnny happy is a drug..

frightening really aint it.. big brother has arrived and is well and truly established..

trog

Darn it.....now there goes my chocolate.........LOL

[Sinless1]

Someone please tell me WHY?

Why are "WE THE PEOPLE" standing for this BS?
because a few people in the fda have an opinion that it's a drug delivery device or it may have risk or harm.
I'm sorry but i am well over 18 and do not need anyone's permission or opinion as to what i put in my body!
Why is it the fda has an opinion and the people react as if they just tore up the constitution and we don't have rights anymore

This mentality is what needs to change!
The only have power if WE THE PEOPLE give them power
We can Take it away also!

[quovadis]

I cannot even start to imagine the complexity of getting a new product to pass FDA if one is not a large pharmaceutical company.

I will always remember importing a grey market car in 2001, it took 6 years to federalize it with the DOT and EPA.
Car manufacturers accomplish this is in months.

It will take someone with really deep pockets to pass ONE e-cig model.
Not because they are safe or not safe, but because of government bureaucracy, testing and report procedure.

I don't know how many years this would take, but when they say "we encourage manufacturers to submit" they know it may involve a 10 year process.

Another point to consider is that you can only submit one type of e juice, with one type of atomizer and one type of battery.
These 3 will be tested together and homologated as one.
As soon as these 3 variables change (new juice, new atomizer, stronger battery), the test is void.

All these agencies that test and homologate products are a nightmare to work with.