FDA issues Brief Summary of “Not Substantially Equivalent” Determinations delineating why deeming reg would ban all e-cigs

[hlk]

Since the FDA already tried to make e-cigs "Medical Delivery devices" which would essentialy kill them, their intent already seems crysal clear.

I see no reason why they would NOT continue down this path using other means. They certainly have the power..

 

[Petrodus]

I think the reason the FDA speaks in such confusing jargon is that its worded in the greasy palm language
when you grease their palms they will tell you what it means

 

[DC2]

What's the anticipated timeline between proposal and final enactment?

Nobody can really answer that, as it can range from months to maybe even years.
And even after enactment, there may very well be lawsuits that might change things, or at least slow them down.

Once the regulations are proposed there will be a public comment period of AT LEAST 30 days.
And you can bet every last dollar the proposed regulations will be posted here within 30 seconds of being made public.

 

[AngiBe]

UGH this makes me sick. Guess I need a crash course on DIY.

 

[cookiebun]

UGH this makes me sick. Guess I need a crash course on DIY.

I started my "crash course" 2 years ago.

 

[Big Orange Country]

And you can bet every last dollar the proposed regulations will be posted here within 30 seconds of being made public.

That I have no doubt about.

 

[Talyon]

What the FDA is saying is Merry Christmas, go F yourself for taking us to court a few years back, oh and.... We have the RIGHT to kill u in several ways, just try us. This is for your own good, we care about you. Now just bend over and grab your ankles this won't hurt a but.

This is my humble, yet irate opinion.

 

[AngiBe]

I started my "crash course" 2 years ago.

Hhmm, Ohio is pretty close. I'll buy a bunch of stuff and then drive on by and u can teach me. Or I'll just pay you to do it for me

 

[supertrunker]

But i don't want a device that was on the market in 2007! they were all crap then!

T

 

[Steamix]

What the FDA is saying is Merry Christmas, go F yourself for taking us to court a few years back, oh and.... We have the RIGHT to kill u in several ways, just try us. This is for your own good, we care about you. Now just bend over and grab your ankles this won't hurt a but.

This is my humble, yet irate opinion.

Thanks for translating that legalese gubmintgibberish into a lingo I can unnerstand...

So nothing has changed in the world - a bunch carpetbagging shysters taking our money and screwing us over...

 

[Big Orange Country]

Hhmm, Ohio is pretty close. I'll buy a bunch of stuff and then drive on by and u can teach me. Or I'll just pay you to do it for me

It's not so bad, I actually enjoy it and I just started making my own two months ago.

 

[retired1]

Something everyone should be very worried about. Regardless of what is said about the product, the FDA is going to do exactly what it wants to do. Want an example? Here's one from yesterday.

Here we have the FDA going against its own panel's recommendations and doing the exact opposite of what it recommended. In other words, it approved a drug that it's own outside panel didn't give a stamp of approval.

We can already see that it's not the tobacco companies we have to worry about. It's the pharmaceuticals that are going to drive the end result. Regardless of the information that's out there saying how safe e-cigarettes are, I suspect the FDA is going to do everything it can to ensure the pharmacy companies continue to rake in their ill gotten gains.

 

[Talyon]

Something everyone should be very worried about. Regardless of what is said about the product, the FDA is going to do exactly what it wants to do. Want an example? Here's one from yesterday.

Here we have the FDA going against its own panel's recommendations and doing the exact opposite of what it recommended. In other words, it approved a drug that it's own outside panel didn't give a stamp of approval.

We can already see that it's not the tobacco companies we have to worry about. It's the pharmaceuticals that are going to drive the end result. Regardless of the information that's out there saying how safe e-cigarettes are, I suspect the FDA is going to do everything it can to ensure the pharmacy companies continue to rake in their ill gotten gains.

This exactly, here are the other 9 likes I want to give this post. Like,like,like,like,like,like,like,like,like,like.

 

[Uma]

+1 Retired1 & Talyon.
Here's more info about the FDA's bedfellows, oops, I mean bedside manners.
http://tobaccoanalysis.blogspot.com/2013/10/8th-national-conference-on-tobacco-or.html

 

[2coils]

We now have 6 B&M's in the state of N.J that I know of. I have been to five of them and have had LONG conversations with all. Not one of them have any concerns of the upcoming regulations. Some are already talking about their "work arounds". None of them have mentioned that they are actively participating in the fight in any way! This is what sucks! I would like to hear that they will fight, I just don't get that feeling from any of them. I truly hope I am reading them wrong!

 

[Talyon]

The post that was deleted for complaint about forum moderation, I'm also giving the fact it was deleted a Like. the option don't come up on deleted posts, shame.

But only one sorry.

2coils, I agree 100% and believe most vendors are not as worried about this as perhaps we are.

 

[Jman8]

We now have 6 B&M's in the state of N.J that I know of. I have been to five of them and have had LONG conversations with all. Not one of them have any concerns of the upcoming regulations. Some are already talking about their "work arounds". None of them have mentioned that they are actively participating in the fight in any way! This is what sucks! I would like to hear that they will fight, I just don't get that feeling from any of them. I truly hope I am reading them wrong!

If it comes to an actual reason to fight, they'll fight.

I wonder what the BT companies invested in eCigs think of NSE document.
I also wonder what those who favor the FDA position on NSE's have to say on this issue. I know what we think they would say, but I'm not talking about that. I'd be interested in hearing that other side minus the emotional rants from us who oppose the very idea of 'taking away my right to vape.'

Again, eCigs are currently in a gray market, and it seems reasonable to me that once such a market/industry starts making revenue in the neighborhood of a billion dollars a year, that TPTB are going to address that market. Furthermore, it seems reasonable to me that what was a gravy train of hardware and juice will likely be met with restrictions and, at worst, temporary bans.

Drawing a line in the sand with 2007 being the date that matters, and magically being able to escape all litigation from such a position would equal a defacto ban on eCigs. As I don't think any entity on this planet can escape all such litigation, I would call it a temporary ban at worst. How long that lasts is anyone's guess, but I'm fairly certain there'd be a whole bunch of people who would be on our side and wouldn't appear as silent as they currently do.

 

[Kandicat]

I could see them regulating NET tobacco juices due to real tobacco substances and not other juices that contain no tobacco products. Nicotine is a wild card.

 

[DC2]

I could see them regulating NET tobacco juices due to real tobacco substances and not other juices that contain no tobacco products. Nicotine is a wild card.

Anything that contains nicotine will be considered a tobacco product due to the FSPTCA definition of tobacco products.
The only exceptions are nicotine products that are approved drug/drug delivery devices.

In other words the patch, inhaler, gum, and lozenges produced by Big Pharma are exempt by definition.
And any "nicotine based" drugs they come up with in the near future will also be exempt.

 

[cookiebun]

Something everyone should be very worried about. Regardless of what is said about the product, the FDA is going to do exactly what it wants to do. Want an example? Here's one from yesterday.

Here we have the FDA going against its own panel's recommendations and doing the exact opposite of what it recommended. In other words, it approved a drug that it's own outside panel didn't give a stamp of approval.

We can already see that it's not the tobacco companies we have to worry about. It's the pharmaceuticals that are going to drive the end result. Regardless of the information that's out there saying how safe e-cigarettes are, I suspect the FDA is going to do everything it can to ensure the pharmacy companies continue to rake in their ill gotten gains.

I guess I'm never going to get my permanent prescription for Lortab-10