FDA Big news coming out of FDA

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zoiDman

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RIght, which would be trying to ignore/overstep the Judge Leon ruling.

Which could only be done by deeming Judge Leon's ruling to be no longer relevant.
Which could only be done by deeming tobacco use to be a disease.

Forget about all the Disease and Drug and Medical device stuff.

Just Focus on "tobacco Products". And the FDA's Legal Authority to Regulate "tobacco Products" after Deeming.
 
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Wow1420

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RIght, which would be trying to ignore/overstep the Judge Leon ruling.

Which could only be done by deeming Judge Leon's ruling to be no longer relevant.
Which could only be done by deeming tobacco use to be a disease.


Not only that, but the FDA could say that battery tubes with 510 connections ARE tobacco products, despite the manufacturer not specifying any intended use, just because they are sold in vape shops.
 
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DC2

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Like I said, I haven't seen Anything from the FDA with this type of Intended Use determination before. If you know of something, Please Post it. I would like to Read it.
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm173174.htm
What products are considered to be tobacco products as defined by the Tobacco Control Act?

The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. This includes, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
 

DC2

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How much does your link speak to Who and How the Intended use will be Determined?
I'm getting confused because you keep talking about hardware as now being included.
Whereas I always felt hardware WAS included.

I always thought you did too, based on many of your previous posts.

So I guess, trying again to summarize what you find to be different now...
You feel that "circumstantial evidence" now applies to hardware, not just electronic cigarettes in general?

I don't know that I see the difference.
I still think this is no different than what has always been the case.

The idea of "circumstantial evidence" coming into play is what Judge Leon shot down.
And it doesn't matter whether it's with respect to hardware or software.

I am failing to grasp what new concerns this presents other than an attempt to override Judge Leon.
In my opinion the attempted override applies to software (e-liquid) just as much as hardware.

And it's based on claiming that tobacco use is a disease, and in no way recreational as Judge Leon ruled.
 

zoiDman

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Not only that, but the FDA could say that battery tubes with 510 connections ARE tobacco products, despite the manufacturer not specifying any intended use, just because they are sold in vape shops.

Yeah... That is why I posted this about a Dozen Pages Back...

This is what I found Disturbing when I read this FDA Clarification.

And I foresee potential Problems with "including but not limited to the product’s labeling, promotional claims, and advertising" with regard to products that have a "510" Connection.
 
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zoiDman

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I'm getting confused because you keep talking about hardware as now being included.
Whereas I always felt hardware WAS included.

I always thought you did too, based on many of your previous posts.

So I guess, trying again to summarize what you find to be different now...
You feel that "circumstantial evidence" now applies to hardware, not just electronic cigarettes in general?

I don't know that I see the difference.
I still think this is no different than what has always been the case.

The idea of "circumstantial evidence" coming into play is what Judge Leon shot down.
And it doesn't matter whether it's with respect to hardware or software.

I am failing to grasp what new concerns this presents other than an attempt to override Judge Leon.
In my opinion the attempted override applies to software (e-liquid) just as much as hardware.

And it's based on claiming that tobacco use is a disease, and in no way recreational as Judge Leon ruled.

Maybe the PM I sent you will help.

BTW - Should the FDA be able to Regulate this Flashlight?


e-cigarette-im-torch-flashlight-head-adapter.jpg
 
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DC2

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I think we are in agreement, and yet still going around in circles.
:laugh:

I just think they always could regulate the flashlight above with the way the FSPTCA was written.
And you believe something has now changed based on the clarification.

Either way, clarification or not, we seem to agree that they can.
 

zoiDman

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...

I just think they always could regulate the flashlight above with the way the FSPTCA was written.
And you believe something has now changed based on the clarification.

...

I don't think the FSPTCA gave the FDA the Legal Authority to Regulate Flashlights. I don't think Anyone Does.

LOL
 

DC2

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I don't think the FSPTCA gave the FDA the Legal Authority to Regulate Flashlights. I don't think Anyone Does.

LOL
Okay, so part or accessory "used to mean" it was clearly and obviously part of an electronic cigarette?
And now the "intended use" will extend that to hardware like the flashlight?

I hope I finally understand where you're going with this.
:)

I believe it doesn't matter though.
Intended use was shot down by Judge Leon.

So this clarification does nothing unless it works.
And I don't see how it can work, because the FDA can't DEEM tobacco use to be a disease.

But maybe they can.
:shrug:

Regardless, hardware has never been a concern of mine.
If they kill free-roaming nicotine then hardware will dry up and blow away by itself.

I think the FDA knows this, and that the clarification is not aimed at hardware.
 
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YoursTruli

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I feel like it is a given that they are going to do what it takes to get to where they want to be with all of this in the end, one of the many reasons for all the foot dragging, and narrow it down to the easiest form(s) for regulation so it will be easy to enforce and there will be no room for confusion.
 

stevegmu

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I'm wondering, with all the trying to figure what all this proposal means, how much confusion is there going to be in the final deeming regs, and how long it will take to figure that out.

Years and years, but the end of Labor Day through Black Friday are slow for the vape industry, so these threads are needed...
 

Bad Ninja

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I Hope you are Right.

But I think there is a Little More going on here than what some might Perceive.

The FDA did this with vitamins and supplements.
It made labels more honest, and put the liability on the manufacturer to act right and not make untested- unproven promises

That's what's happening here.
 

DC2

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According to the FDA, only e-liquid will be regulated, as that is a tobacco product, at least the nicotine in it; that would be part of a tobacco product. Hardware will be left alone...
"part or accessory"

Having said that, I agree that hardware will be left alone.
No point in wasting time going after hardware.

But if they wanted to they could based on the "part or accessory" wording.
 
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