FDA Any other News on Today's Court Arguments?
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I think that if it's a tamper proof disposable, it could be successfully argued that none of the regulations apply.
Isn't this why every thing for all intents and purposes is covered?
I have read no where of specific exemptions. A tank may contain juice with nicotine.
A wick and coil may atomize that juice. A battery is used to supply the power to the
coil. A integrated circuit may be used to regulate said power. This pretty much covers
the whole shabang.
I am going out on a limb here but, I think 90% or more of e-cigarettes products will be used
with nic'ed up juice. Ergo the FDA will reasonably assume with out any definitive way
to determine what 10% or less of these products may never contain nicotine they
have to 'reasonably' assume they all have the potential and all must be regulated.
Remember the FDA has stated they are the sole arbitrators of what their regulations
mean on a case by case basis. Why?, one might ask. Well the chillin' of course.
Regards
Mike
Yes, that is why it's all regulated, because it's all "intended" to be used with nic.Isn't this why every thing for all intents and purposes is covered?
I have read no where of specific exemptions. A tank may contain juice with nicotine.
A wick and coil may atomize that juice. A battery is used to supply the power to the
coil. A integrated circuit may be used to regulate said power. This pretty much covers
the whole shabang.
I am going out on a limb here but, I think 90% or more of e-cigarettes products will be used
with nic'ed up juice. Ergo the FDA will reasonably assume with out any definitive way
to determine what 10% or less of these products may never contain nicotine they
have to 'reasonably' assume they all have the potential and all must be regulated.
Remember the FDA has stated they are the sole arbitrators of what their regulations
mean on a case by case basis. Why?, one might ask. Well the chillin' of course.
Regards
Mike
Again, just specifically talking about the warning labels. Nothing else. Components, that are finished products labeled for sale directly to the consumer, that do not contain nicotine, or tobacco, do not IMO require a warning label of any kind.
Components, sold directly to consumers, will require PMTA approval.
The only products that require the "made from tobacco" warning are those that are actually made from tobacco but contain no nicotine, like a 0nic cigarette.
Intended use = anything that looks like smoking.
Forget all the FDA verbiage. It's all smoke and mirrors folks.
Forget all the FDA verbiage. It's all smoke and mirrors folks.
The FDA is doing this because they finally can do something, and empty pocket's will be feeding again. It's a win-win (or should I say win-win-win...) situation, just not for us, at all. I agree though, it is all smoke and mirrors.
So then they all do PTMA or not. Reasonable assumption and or intended use or,both.
regards
Mike
Recently we learn from a reputable health survey group at U of M that most kids who vape are avoiding nicotine (because what interests them is clouds and tricks). That means they can get their e liquid ingredients in the baking section of the grocery store. And mark my words, they will do that. So let's say the FDA requires the marketer of VG channeled to grocery stores is required to put on the label, derived from tobacco. That would not be so good for sales.
Now with the election, I am hearing about the slimy underhanded greedy lying network that these politicians have. It's so rigged and or dishonest from the start. There's a lot of verbage that no one really knows about but people are stunted way before they know it if they have a problem with BG. The system is already set up for the little man to lose without it looking crooked. I have no faith in any of them. It's a spider web of deceit. We see it first hand with the vaping. I guess most of you like me have never been concerned with politics and courts until some big people got an issue with vaping something along the lines of juice with nicotine added. Now we learn. They do need to be weeded out. Like drain the swamp.
I never had paid much attention to politics until I started vaping. What an eye opener it has been, now I see said the blind man.
I really shouldn't get excited, but...
The excerpt seems to be addressing nic fee e-liquid? Sounds like Judge Amy is scratching her head over this and the FDA's insistence that it's tobacco related (as she should).
Maybe she'll clue in on the fact the FDA is more interested in controlling behavior rather than examining the true harm/benefit of ingredients involved in that behavior.
0mg is at the Heart of the "Intended Use" issue. Something that, IMO, congress Did Not give the FDA Judgment/Authority over.
I felt from the beginning the 0mg was a Winnable. And I am Happy to see a Federal Judge take some issue with it.
But I would Really Like to see the Focus be on the PMTA Sham. I mean... PMTA Process Requirements.
BTW - What are the Requirements to submit a Successful PMTA?
I felt from the beginning the 0mg was a Winnable. And I am Happy to see a Federal Judge take some issue with it.
But I would Really Like to see the Focus be on the PMTA Sham. I mean... PMTA Process Requirements.
BTW - What are the Requirements to submit a Successful PMTA?
- Apr 2, 2009
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Given the two-year pre-market review compliance period, how would a challenge to the regulation of a nicotine-free e-liquid be adjudicated, if it is not ripe now?
I've read the above a dozen times now and still can't figure out what she's asking. Perhaps somebody whose neurons fire faster than mine could translate.
I've read the above a dozen times now and still can't figure out what she's asking. Perhaps somebody whose neurons fire faster than mine could translate.
- Apr 2, 2009
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"BTW - What are the Requirements to submit a Successful PMTA?"
The only requirement is to be an executive at Altria, Reynolds, Philip Morris International, British American Tobacco, Japan Tobacco, or Imperial Tobacco.
The only requirement is to be an executive at Altria, Reynolds, Philip Morris International, British American Tobacco, Japan Tobacco, or Imperial Tobacco.
Given the two-year pre-market review compliance period, how would a challenge to the regulation of a nicotine-free e-liquid be adjudicated, if it is not ripe now?
I've read the above a dozen times now and still can't figure out what she's asking. Perhaps somebody whose neurons fire faster than mine could translate.
The FDA argued that since no one was shut down for selling zero nic liquid yet, there is nothing to sue for yet. That is what is met by not yet ripe. If someone is shut down and they feel it was unjust, they obviously have the right to file. But what the judge is asking is, if a manufacturer thinks their zero nicotine eliquid does not qualify as a tobacco product under the deeming and then two years from now they get shut down, it's too late to file a PMTA; so, don't they need to sue now to find out what is really covered?
Given the two-year pre-market review compliance period, how would a challenge to the regulation of a nicotine-free e-liquid be adjudicated, if it is not ripe now?
I've read the above a dozen times now and still can't figure out what she's asking. Perhaps somebody whose neurons fire faster than mine could translate.
I believe what the Judge is asking is if it Is an Issue Now, then shouldn't it be Decided Now? Verses after a Company has spend Hundreds of Thousands of Dollars to do a PMTA.
And if 0mg are Not under the Congressional Granted Authority of FDA, then a company doesn't need to do a PMTA in the 1st Place. So shouldn't the Court Rule on this Today verses in 2018?
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