FDA Who will survive the FDA Regs?

[EddardinWinter]

Totally disagree with this assertion simply because it makes too much sense. I'm convinced that vaping regulation is merely due to a cultural bias against smoking and anything that looks like smoking. Nothing to do with science or facts.

It's really that simple. Just look at Malaysia.

There could be both a cultural bias AND collusion.

Looking at how the regs are set up favors a collusion explanation in my mind. The preposterous choices of process, the inflexible requirements that EVERY juice combination requires separate application, etc. The regulations favor BT/BP with a clear bias, and they are currently clients of the FDA. Yeah, they are regulated industries, but they also pay the bills.

Who is ideally suited to dominate the market now?

Who benefits from the vape market decimation?

The fact they exist due to political/public will is probably a result of a cultural bias, so we agree there.

Sent from my XT1080 using Tapatalk

 

[seminolewind]

First off I think there's a money bias BT/FDA, a competition bias and a bias against small business.

 

[sofarsogood]

The number of applications for approval I expect is zero, none. That's what I hope it is. Nothing we use will get an application. We all hang together or we all hang separately. The only way to clarify things is if the FDA orders all the products off the market instead of just 99% of them.

 

[mcclintock]

The number of applications for approval I expect is zero, none. That's what I hope it is. Nothing we use will get an application. We all hang together or we all hang separately. The only way to clarify things is if the FDA orders all the products off the market instead of just 99% of them.

There's a huge amount of money to made if anyone can get through. So while I can understand that emotionally, it's not at all likely. Also some early apps may be "feelers".

I think that even if they had created a voluntary approval process, there would be some companies that would go through it because they'd gain a big market. Best of both worlds...

 

[retired1]

The PMTA process has been in place for years. There has been only one, just one product approved since the process has been put into place. And that product took YEARS to get approval.

So if people think that PMTAs are going to get approved, and approved quickly, dream on.

 

[sofarsogood]

There's a huge amount of money to made if anyone can get through. So while I can understand that emotionally, it's not at all likely. Also some early apps may be "feelers".

I think that even if they had created a voluntary approval process, there would be some companies that would go through it because they'd gain a big market. Best of both worlds...

The FDA's definition of a safe product is be a peice of crap that nobody uses because it is over priced and ineffective. That describes nicotine gum and patches. The FDA serves the interests of government first, the public's health second. The only solution to the ecig problem is to abolish them. The FDA is doing that without a hint of shame.

 

[Rossum]

The PMTA process has been in place for years. There has been only one, just one product approved since the process has been put into place. And that product took YEARS to get approval.

So if people think that PMTAs are going to get approved, and approved quickly, dream on.

The way things stand right now, no PMTAs getting approved would mean zero vaping products available come August of 2019; effectively a ban on an entire category of products, right?

I do not think the FDA wants to be perceived as having banned the entire category. IMO, they will approve a few, and they will do so with considerable fanfare to show that they're only regulating, not banning.

 

[retired1]

Wanna bet?

FDA’s snus PMTA approval — what it seems to mean

The FDA already knows (and has admitted) that 90% of the market will bail prior to 2018. And considering not a single e-cigarette product in use today was in existence prior to the cutoff of 2007, it ALL has to go through the PMTA process. This includes reams of studies and scientific evidence as to the safety of the product.

The FDA has no intention of approving anything. It's all a PR sham.

 

[Rossum]

I guess we will see. BT has invested an awful lot of money into closed, proprietary systems that appear to have been designed with advance knowledge of what the FDA wants to see in products it might approve (e.g. Vuse). Wall Street has also handed a lot of cash to smaller outfits to develop, market, and merchandise closed, proprietary systems that also appear to have been designed to meet the FDA's PMTA "specs" (e.g. Juul).

As for a wager, sure. What are you willing to put up? How about a liter of 100mg nic base?

 

[classwife]

...I edited the thread title and placed Regs for what was there.

 

[skoony]

@kodiak and @EddardinWinter I think there is truth in both your statements.
One could say collusion is the result in part of cultural bias.
One could also say the cultural bias is the result of prior collusion.
Neither is the sole reason but, both mixed with other reasons are
part of the whole.

Regards
Mike

 

[ENAUD]

Nice breadcrumb, I'd never heard of that movie.

 

[jwbnyc]

And here I thought you had it on Betamax, VHS, CD, Blu-ray, and MP4.

 

[seminolewind]

Totally disagree with this assertion simply because it makes too much sense. I'm convinced that vaping regulation is merely due to a cultural bias against smoking and anything that looks like smoking. Nothing to do with science or facts.

It's really that simple. Just look at Malaysia.

You have a very good point here. It's unfortunate that the phrase "electronic cigarette" ever came up.

However, Eddardinwinter has an equally good point. I think the unfortunate part is having BT as a competitor and their relationship with FDA doesn't make matters better. Corrupt and crooked. It's hard to win against that.

 

[seminolewind]

So would it be fair to say that all hangs in the balance in the hands of whether the judge is corrupt or not?

There are no restrictions in China where new and improved products are always coming from. And will continue to produce. If they need to be bought here black market.....oh well.

I'm not worried about not able to get products. I worry more about the BT and FDA winning using corruption . It's hard to beat cheaters when the judges are bought and paid for.
BT is caught in a situation they never ever expected-something created that people Will leave their cigarettes for. It's unheard of. And on top of that it grew so fast. I read somewhere that vaping products will outsell cigarettes in a few years. That is terrifying to BT. And the only way to win, so they think, is to squash the competition or slow it down to where they can catch up . Imagine, the FDA deeming that tobacco derived products include all the products that have NO nicotine in them. Even 0 nicotine e-liquid!

If they wanted to actually be more fair, they would be focusing on how to control nicotine. Not anything else. Nicotine is the only thing that cigarettes, vaping devices, gum, lozenges, and patches have in common. Nothing else.

 

[Painter_]

If they wanted to actually be more fair, they would be focusing on how to control nicotine. Not anything else. Nicotine is the only thing that cigarettes, vaping devices, gum, lozenges, and patches have in common. Nothing else.

Currently I can buy lab grade nicotine without any permission from our wonderfully bloated government. Is that nicotine going to change if the FDA regulates it? Do they even have the ability to regulate lab grade nicotine?

 

[retired1]

Currently I can buy lab grade nicotine without any permission from our wonderfully bloated government. Is that nicotine going to change if the FDA regulates it? Do they even have the ability to regulate lab grade nicotine?

That's most likely next on the hit parade. The FDA has already stated the rules will be "adapted" as necessary.

 

[seminolewind]

That's just it. The only thing in common with cigarettes is nicotine. And they haven't regulated nicotine because their Big Friend would have heart failure. Think about it. The nicotine is the dangerous part which they are ignoring, and instead regulating a bunch of stuff I can buy or have in my house with absolutely no restrictions. That really sounds corrupt to me. They will be making a real mess out of this, and they really have not discussed all the consequences. You can't tax the black market or control it. If push comes to shove I really can't be arrested for soaking cigarettes in PG or VG.

I even wonder if they'll find a way to close down forums about vaping. Oh wait, that's freedom of speech. Oh wait, it's the gov.. They can make it up as they go.

 

[KC33]

Unless all the information I've obtained is wrong there's nothing to worry about for another two years.

 

[retired1]

Unless all the information I've obtained is wrong there's nothing to worry about for another two years.

This is the type of attitude that got us into this mess to begin with.

Already the ramifications of the deeming regulations are being felt. How about that shiny new mod that's coming out of China? Ooops. So sorry. We can't ship it to the US because it came out after August 8th and it doesn't have FDA approval.

Or how about the eliquid company? Sorry customers, we'd love to make a new line based on your recommendations, but we're stuck with our formulations that were in use prior to August 8th and we can't change anything.

So yes, there's plenty to worry about and it's just going to get worse if the courts don't stop this nonsense.