FDA IF you were the FDA, what would your proposal be?

[Elizabeth Baldwin]

First, I'd not deem ecigs/vaping as a tobacco product. It's clearly not tobacco. Nicotine is found in a host of other things naturally.
Second, I'd do some unbiased, legitimate research to ensure the data I receive to make decisions for millions of people was based on verifiable data.
Third, I'd be cautious about imposing such strenuous regulations that may effect people's health negatively.
Fourth, I'd be fair and push the date to 2012. That would make the market fair.
Fifth, application fees would be based on gross sales. A percentage that wouldn't cripple the small businesses.

Of course, this is all imaginary and meaningless in the real world. I see none of this as something the FDA would even consider as they have hidden motives. Our only recourse is to fight in numbers and be educated about it.

 

[Elizabeth Baldwin]

BTW: you guys do realize any compromise to the current proposed regulations is saying you agree that ecigs are a tobacco product and basically opening a flood gate to future, more damning, regulations.

 

[zoiDman]

So far so good...



Devastate the DIY mixers, subject vapers to only flavors mixed by "experts"



A food prep standard, acceptable but a full pharmaceutical standard...not so much.



So vapers that need 3.0% - 4.8% to beat smoking can either quit or die. I vaped 3.6% for over a year to be able to lay down the smokes.



You realize that some oil based flavor is safer than some non-oil soluble. And a FDA food flavoring is not necessarily safe for vaping.



Will you be tearing down Costco also, they sell all sorts of things in very big packages.



Leaching to what degree, how many parts per billion? Any trace of anything whatsoever, or a FDA standard that allows a certain amount of bug parts in cereals?



To what end, saving electricity?



You realize a 510 cig-a-like with an atomizer and cartridge holds 0.5 mL and leaks much more than a much larger better built tank.



You realize larger batteries are safer than small under-powered ones. Engineers also design figuring in a "human numbskull factor", yet people still seem to be able to win "Darwin Awards"



They should definitely experience 5-10 years for destroying their health before they are allowed to vape.



Agreed, if they disclose all the data, how the subjects were selected, what vaping equipment was used, what nicotine level was used, etc...no bogus slanted studies need apply.

I think this Reply and the Original Post is a Good Example of how Difficult it is to Enact Regulations on e-Cigarettes/e-Liquids.

Since e-Cigarettes/e-Liquids are Truly a New Product, we are kinda Starting Out at Square One with Everything.

It is also a Good Example that No Matter what the Body of Regulations look like, Everyone is going to Take Exception too Much of it.

 

[Stosh]

I think this Reply and the Original Post is a Good Example of how Difficult it is to Enact Regulations on e-Cigarettes/e-Liquids.

Since e-Cigarettes/e-Liquids are Truly a New Product, we are kinda Starting Out at Square One with Everything.

It is also a Good Example that No Matter what the Body of Regulations look like, Everyone is going to Take Exception too Much of it.

No kinda about it, it's a wholly new area and basic science is being ignored and twisted depending on a point of view.

Bad regulations with the best intentions can kill millions. Banning DDT on questionable science has killed millions, and continues to kill people worldwide....

 

[zoiDman]

No kinda about it, it's a wholly new area and basic science is being ignored and twisted depending on a point of view.

...

Can you think of a way to Stop the FDA from Ignoring the basic science behind e-Cigarettes/e-Liquids?

 

[pamdis]

Can you think of a way to Stop the FDA from Ignoring the basic science behind e-Cigarettes/e-Liquids?

Probably can't at this point. I truly believe they think they can continue to ignore it with no consequences. At the very least we can embarrass them by:

1. Submit the basic science in our comments (through attachments, not links)
2. After final rule is submitted, submit copies of our comments to congressional committes
3. Request oversight hearings - first allow ANTZ to testify, next allow our experts to testify, then haul FDA up to justify why they are listening to the fearmongering from the ANTZ instead of the science

It's very interesting to read the final rules in the Federal Register (for prior rules they have made). They address specific comments received, and they respond with complete dismissal of each and every one that gives a good reason to oppose their rule. I think this is also something that should be studied before submitting our comments - how they have responded to comments in the past.

 

[aikanae1]

I'm beginning to think the way this could go is that there could be a renewed interest in developing synthetic nic. It might not be so expensive after all. ($75/5ml 100mg the single source I found). I have not saved a lot of money vaping, sure I could cut some of that out ... maybe. Idk, I think vape mail is part of the interest. By the time they get through with this, there will be so many taxes that it'll be cheaper to smoke. I'm trying to remember, but I think I saw somewhere that an actual pack of cigarettes costs just over a $1 in materials and labor.

If anyone wants to change any of this in a significant way, we will have to convince 60% of Congress it's the right thing to do. Complaining in here is preaching to the choir.

No, I don't agree with selling any addictive substance to minors. However if their parents want to supply them, then I don't think that's the business of anyone else, like it or not. So yea, there should be restrictions on selling to minors. I'm not really crazy about selling this stuff to non-smoking adults, but I wouldn't ban it unless someone figured out how to ban stupid, but then vaping wouldn't be in this situation if that were possible.

 

[Jman8]

After reading this entire thread, post #6 comes closest to my thoughts: "Abolish the FDA"

If I am FDA, and there is more than me in FDA, I'm becoming whistle blower that says this agency is not practicing independent science as is often implied. I'm blowing that whistle loud and calling for dismantling of FDA with hopes it can be re-organized into something legitimate. I'm making explicit point that BP has influenced the process in way that needs to be fully made transparent to American public, and that this perception of BP influence needs to be undone or curtailed greatly.

Assuming all this won't happen then for eCigs by FDA, my points are:

1 - creating an option 2 scenario where FDA seeks to exempt eCigs from regulation given the nature of the product and overriding perception that this is not a tobacco product, nor are the umpteen thousand accessories/components.

2 - letting everyone and anyone know that eCigs stand best chance we currently have available to us to overcome the American addiction to smoking and reliance of that industry (including excise taxes) to fixing things for the foreseeable future.

3 - enforcing no regulations for public safety until science has weighed in on the matter more. Citing that incidences of 'harm' from eCigs are far lower than hundreds of other legal products and that unless that changes, there is no reason for regulation.

4 - If a state doesn't want kids in its area buying eCigs, then they can pass that law. FDA is not ready to weigh in on that given what is said in #3.

5 - Putting ANTZ on notice. Your zealotry is not welcome at this time on eCigs. Stick to smokes and you are permitted to do as you please. Venture into eCigs territory and you will be exposed for all the pseudo science you are peddling that is contributing to perception that FDA engages in partisan scientific politics.

 

[DC2]

If I were the FDA, my proposal would be EXACTLY what they proposed.
In fact, I can't think of anything I would change.

It gives them the power to do whatever they want in the future.
It gives them what looks on the surface like something not so bad for vapers.

Only those willing to dig deep will see the harm this proposal will cause.
And only those with Big Money will cheer these regulations.

But it is a knife in the heart of vaping as we know it, while keeping those that don't know better quiet.

They don't want the vaping masses to get upset, just to keep them silent and docile.
They're clearly hoping to engender inaction on our parts.

And once it passes, it's going to be game over.

 

[Jman8]

If I were the FDA, my proposal would be EXACTLY what they proposed.

So, then you support the FDA proposed regulations?

 

[DC2]

So, then you support the FDA proposed regulations?

No, I oppose them vehemently.

 

[Stosh]

No, I oppose them vehemently.

read this one DC2..

http://www.washingtonpost.com/blogs...ted-paid-pro-government-shills-in-chat-rooms/

The Obama administration is reportedly proposing Cass Sunstein as a member of a panel to review the surveillance practices of the National Security Agency (NSA), among other former White House and intelligence staffers. Sunstein was the head of the White House’s Office of Information and Regulatory Affairs until last year, when he returned to teaching at Harvard Law School.

As one of our intrepid commenters pointed out yesterday, while at Harvard in 2008, Sunstein co-authored a working paper that suggests government agents or their allies "cognitively infiltrate" conspiracy theorist groups* by joining "chat rooms, online social networks or even real-space groups" and influencing the conversation.

Sunstein's paper defined a conspiracy theory* as "an effort to explain some event or practice by reference to the machinations of powerful people, who have also managed to conceal their role," and acknowledges that some conspiracy theories have turned out to be true. It also specifically notes that his plan of "cognitive infiltration" should only be used against false conspiracy theories that could be harmful to the government or society.

 

[DC2]

Yeah, I saw that, but I'm not prepared to get there yet.
But I'm getting closer and closer to doing so.

 

[Stosh]

Yeah, I saw that, but I'm not prepared to get there yet.
But I'm getting closer and closer to doing so.

Tweety convinced me.....

 

[Kent C]

Yeah, I saw that, but I'm not prepared to get there yet.
But I'm getting closer and closer to doing so.

All you need it a few more 'nudges'

 

[Kent C]

Tweety convinced me.....

Tweety can be convincing

 

[Jman8]

No, I oppose them vehemently.

Then I would think you would not do exactly as they proposed, if you actually were FDA.

 

[DC2]

Then I would think you would not do exactly as they proposed, if you actually were FDA.

Why not? It seems to me they nailed it perfectly.

 

[Katya]

Tweety convinced me.....

"Just because you're paranoid doesn't mean they aren't after you.”
-Joseph Heller

 

[chellemmm]

Yossarian