Regulating e cigarettes as drug delivery device?

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Rosa

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I think the problem is that cigarettes are protected by some old statute or something that says that they can never be attacked or regulated by the government or something like that (I can't remember the exact law). So, even though everybody agrees that they are deadly, nobody can do anything about it.

E-cigs, on the other hand, are not protected by any laws or agreements. That's why I'd be ok with having them classified as a nicotine delivery system and NOT a drug device. If they are regulated as a drug device by the FDA, then the FDA can decided (or be bribed) to say that they are not currently approved and should be banned pending further studies into their safety and efficacy -- and the studies would have to be paid for by these small garage/home businesses that we are buying our e-liquids from, so who knows how long that might take!
 

Vidi

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Big Tobacco bought off the government.

The Family Smoking Prevention and Tobacco Control Act, which was passed earlier this year was a smoke screen ( <--like that? Get it? ) It gives the FDA more power to regulate tobacco products ( hence the banning of the "light, ultralight" labels ) and reinforces that they have no power to actually ban tobacco products.

This is from an interesting article from before it passed, click it to read the whole article:


Allow FDA to require changes to tobacco products to protect the public health — FDA would be granted authority to require changes in current and future tobacco products, such as the reduction or elimination of harmful ingredients, additives and constituents, if it decided that these changes would protect public health. FDA would be granted authority to change nicotine yields; only Congress could ban nicotine from the product.

This is why if the FDA is going to regulate e cigs WE want them classified as a tobacco product, NOT a drug delivery device.
 

Hoosier

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floridamale

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In my opinion it's all about the money and who is losing out, right now it’s the big pharmaceutical and tobacco companies. Next down on the list is the tax loss to the government, if you stop to read what the cost are to smokers in health care and then look at the tax revenues the government takes in its staggering. I saw where if every smoker cut back 1 cigarette a day it would cost big tobacco companies 2 billion a year. Now if even 10% of current smokers switched to an e-cig what do you figure that would cost them. It’s all about the money
 

nerdygirl

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Cigarettes are regulated -- children, for example, can't purchase them. There are laws about how it can (and can't) be advertised, where they can be sold, Surgeon General's warnings on the packs, where people can and can't smoke, importation and exportation, and recently, banning of flavors like cloves, etc. They are also taxed very heavily at the federal and state level, as we all know. These are all forms of regulation. The fact that cigarettes are still sold at all is the result Big Tobacco's extremely powerful lobby and extremely deep pockets.
 

SimpleSins

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I still am not sure that I see the hand of Big Tobacco in this. If anything, I think they would have a vested interest in having the ecig industry either left alone or classified as a tobacco product. As someone pointed out above, new regulations could further tinker with the cigarette product itself. It would just stand to reason that Big Tobacco would have all the pieces in place to produce their own branded ecigarettes, having the tobacco, nicotine extraction capabilities, and name recognition. Producing a red ecigarette with prefilled cartridges would put the Phillip Morris in a perfect position to recoup some of the money it's lost to those who have managed to quit or are being forced by costs out of their brand.

It's just my opinion, but when I follow the money, my mental trail leads me to the government and Big Pharma as the big losers unless they find their way to choke off the ecig market.
 

Hoosier

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The FDA can do these things because the public has given them the power through their reps in congress. To say it has to make sense in a logical arguement is a misunderstanding of how regulators work.

Mattel imports lead tainted toys. Regulations are enacted. Who is exempt from 3rd party lead testing? Mattel is. Not the guy making wood blocks that have no finishing chemicals applied. See, people upset, power given, application is senseless. That's US goverenment in a nut shell.
 

IMWylde

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Im not worried about regulation Im worried about WHAT those regulations would be.

For example, its against the law to sell cigarettes that are "candy" flavored. Which means my Banana vape and Atomic cinnacide would be gone in a heartbeat.
Well actually no. I believe in the end unflavored nic juice is what we will end up with. But those flavorings will always be available. The entire world runs on those flavorings. You will mix your own. and you will like it.
 

quendelyn

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Thank you all for your input. A lot to think about. I've all ready signed petitions and I'm up to fight for this. E Cigs are nothing short of a miracle. As I posted somewhere else, I've already got 4 converts, hehe. If they FDA does try to ban them here, gonna make my own! Hopefully it won't come to that. Tobacco is big money, plus all the money that's made from lung cancer. Guess economically, there's just to much money to be lost with a viable alternative like e cigs around!
 

DC2

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Another thing I can't understand about the FDA is how they can say e-cigs cannot be advertised as a Stop Smoking Aid....
If anyone says they are a Stop Smoking Aid that makes them a drug delivery device.
Because then they are intended to treat and/or cure the disease of tobacco addition.

Any such claims fall under the medical umbrella, and then they have to be proven to be safe and effective under FDCA guidelines.
Effective means they have to undergo many very long and expensive clinical trials.
And safe means pretty much the same thing.
And all that costs a TON of money.

If a classification of drug delivery device happens, that means they will be pulled off the market.
At least until someone with huge money spends the time and effort to get them approved.

These are the things you want to be looking at if you are really interested in what is going on here...
http://www.e-cigarette-forum.com/fo...t-important-thing-every-vaper-needs-know.html
SE, NJoy vs FDA -- court dockets / updates
What is this Case all about, why do we need to watch it, and how to get up to speed on it.
 
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DC2

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I'm most likely wrong, but doesn't a different federal group control guns, alcohol and cigs? Why aren't they butting in?
I'm assuming you mean the Alcohol, Tobacco, and Fireams guys (ATF) which usually handles those things.
The reason they aren't involved (yet) is probably because electronic cigarettes are not "officially" classified as any of those things.

Yet.

And that is exactly what we need to stand together and stop.
All of us, every single one.
 

DC2

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ATF, yes thats what I was thinking of. But if we can get several of the fed groups fighting each other, and at the speed they move, it could be years before any thing is done on their level. And the ATF has better things to do with their time than look at e-cigs.
It's not the ATF we are worried about right now, it's the FDA at this point.
They want to declare these to be drug delivery devices, which puts electronic cigarettes under their purview.

If a classification of drug delivery device happens, that means they will be pulled off the market.
At least until someone with huge money spends the time and effort to get them approved.

These are the things you want to be looking at if you are really interested in what is going on here...
http://www.e-cigarette-forum.com/fo...t-important-thing-every-vaper-needs-know.html
SE, NJoy vs FDA -- court dockets / updates
What is this Case all about, why do we need to watch it, and how to get up to speed on it.
 

Sainted_S

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Of course the government is worried about a new industry where most of the users turn away from analogs to a better and more pleasant alternative for their habits, never to return to buying tobacco products. I personally believe the FDA will be able to do whatever it wants with the full support of Capitol Hill behind it. Imagine the billions in taxes that will be lost. The only thing we can possibly do is to grow the numbers of people using PV's and that will be a hard sell considering the first impression the majority of the public have with cheap, rip-off ecigs, not knowing of the wonderful alternatives.
 
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