FDA FDA deeming regulation proposals

[Jman8]

Ok, thanks for your explanation of what you meant.

But it's not like the 'opening the door to science' is a reasonable proposition. Something we should be encouraged about. It is these type of 'data and research' studies that cost money. Money that some vendors don't have and some of whom have never heard of CASAA. It's a burden for them not only to submit these as 'comments,' but as I point out in the 'required' part of my post - they'll have to do it there as well, even if they don't do 'studies' for data gathering.

You can open a door, but if someone can't walk through, it's an empty gesture.

Agreed with last point. Though we respondents can link to studies, and I'm sure CASAA will suggest as much.

As I've said elsewhere, I think any response that is citing (legitimate) scientific data ought to go to a database in addition to FDA so it is made abundantly clear that (back) in 2014, FDA was given a substantial amount of commentary regarding available 'data' and 'research' regarding what they said they were seeking info on. Otherwise, it could be later in 2014, or sometime in 2016, or perhaps still in 2025 that FDA claims 'to date, we have not seen any evidence (whatsoever) that helps us understand the effects eCigs will have on the public health.' And they could tell bald faced lie of 'we asked for this in our comment period, but no one provided that' or what was provided was not legitimate.

I see science as on our side, and I think FDA knows this, but has been able to play a game of sorts of not acknowledging that for various reasons (namely, because ANTZ controls TCA narrative). This proposal does open the door, and I'm sure us CASAA types will provide that, but if we are all so distrusting of FDA come time of actual rules/enforcement, then I'm not sure why anyone would be trusting of FDA collection process of commentary. If I write response that cites 11 scientific studies and have a rambling philosophical message as well (no seriously, I sometimes ramble), then I'd just copy and paste the scientific portion and submit to this large database that shows that yes, I was one of the respondents, and here are the linked research items that I submitted to FDA.

 

[pamdis]

I also think that if people want to submit studies, they should not just link to them in their comments. They should download them, and then upload them as attachments to the comments.

 

[Danoman]

Oh do go on. "Obama doesn't want all this juicy tax money, what's his evil angle?" Try to stay on topic.

I promise, no offense meant. But, it's been a fact for over 50 years now, not a 'Party', an ideal. So, I promise nothing personal was meant.

Give me a few to put this all together...

 

[Roger_Lafayette]

Now what is to prevent Nude Nicotine or Wizard Lab to label their nicotine base "Insecticide" ?

I'm not joking--this is a serious question.

Any number of regulations could be evaded that way. The same game goes on w/ homeopathic/etc. "remedies" and so forth. I believe the legal standard is something like "intended or expected" for a given use.

This is how the FDA justifies siezing "pet milk" (i.e. raw [unpasteurized] milk). When I managed the Co-Op grocery here in town, I refused to have it on the shelves, because I wasn't going to mess with that possibility, even though our competitors did that. My successor has adopted the same policy. It's too risky otherwise.

Lots of people think they can get away with playing these "word games" w/ the gov't. Doesn't work. The gov't doesn't always nail them, but when it feels like it ... look out.

 

[Rossum]

This is how the FDA justifies siezing "pet milk" (i.e. raw [unpasteurized] milk).

Why do we, an ostensibly free people, put up with government telling us what we may or may not eat, drink, or inhale?

 

[Danoman]

Bottom line, it doesn't matter to me whether one is Democratic or Republican. I believe we each have 'drive' in a direction that we feel this country needs to travel. This is different, as it really has no "clear" way of how it's being driven. (which is a problem)

The Republicans did the same thing... so, i'm not singling out the Dems on this. There are some common denominators in this process in the last 15 years, I believe we can all agree on that, in full disclosure. But, yet... it IS and it's active as we speak.

Social issues are always a heated point in Washington... would we all agree...? Abortion, racism, Islamic freedoms, individual freedoms, taxes, Right Wing, Left Wing politics. Correct...? Thing is, EACH of these topics are centered on making one more focused on THAT than what the 'other' hand is doing. While our media is pressing these debates, they are doing things behind the backs of us and our media. <.... (which is supposed to expose everything going on, in Washington)

So, as they are doing all of these deceptions and swinging our attention to other things not important politically, they are doing things, literally in secret, as our news agencies are focused on other things, driven by RATINGS of their particular news organizations. Carter actually did some good things from what I've heard, Reagan did some too, Clinton did some too, Bush 1 did some, Bush 2 did some... THIS one is different, being the first Black president, he should have done TWICE what all the ones did before him by a standard that he was the FIRST black President in the United States. (Wow, what an HONOR it'd be for our country back in the 20's)

Here's what happened... (not racist, I promise... just facts)
Gas prices have soared, Executive orders are written at rates for 4 Presidents, the economy has tanked, (shown in numbers today, in fact) the dollar is worth less by 12% than it was when he came into office. Russia is starting a war to their South, North Korea is nearly at war with S. Korea, Japan is in danger of war with China, Iran now has been released of their bonds of sanctions... and this list can go on and on. (as we all know)

THIS is why I state, "This administration"... nothing more. I personally believe you have the RIGHT to your choosing of anything from your spouse to the way you live and what YOU believe, and it's your RIGHT under our Constitution, i'd support you to the very end for that right. It's how it's supposed to be BUT, here is the clause... Those rights can be taken away, from the very ones that WE, as a people elect. I support you, no doubt... but, the ones we as a people elect have other thoughts in mind, in which Obama is a part of. His policies are sketchy at best... and the underlying 'image' is that he's a Dictator, knowing the Law of the land seems to ignore. But, no one does anything about it... so far, anyway. My concern IS, THIS is how the vaping world will look like if we don't do something about it NOW. It has nothing at all with a preference to who's in power... it's the law of the land we adhere to, as spoken in our Constitution. We ALL have these rights to liberty and the PURSUIT of happiness... <...... leaving this part unended, as of yet.

I promise... i'm on topic. More than you might know... (respect for you, I give...)

 

[Danoman]

Any number of regulations could be evaded that way. The same game goes on w/ homeopathic/etc. "remedies" and so forth. I believe the legal standard is something like "intended or expected" for a given use.

This is how the FDA justifies siezing "pet milk" (i.e. raw [unpasteurized] milk). When I managed the Co-Op grocery here in town, I refused to have it on the shelves, because I wasn't going to mess with that possibility, even though our competitors did that. My successor has adopted the same policy. It's too risky otherwise.

Lots of people think they can get away with playing these "word games" w/ the gov't. Doesn't work. The gov't doesn't always nail them, but when it feels like it ... look out.

I firmly believe THEY will be the first to be hit... as they supply the nicotine, which is why this is going on in the first place.

 

[Roger_Lafayette]

They don't need to control hardware and I was surprised they seem to be trying to do just that. I have said for the last year that the Nic is the chokepoint. They get control of that they destroy vaping for the most part. After all what is the point of anything more than BT cigalikes if we have no liquid to use in our better devices.

Controlling hardware is 100% upside and 0% downside for the FDA. What's not to like (from their POV)?

It protects them from having vapers getting nic from an alternate source, such as: (1) combining "flavor vaping" with NRT use; (2) their freezers or the black market; (3) synthesizing it in some as-yet-unknown way; (4) paying a premium for non-tobacco-derived nic.

It also helps shut down non-cigAlike vaping (or prevent the conversion/cessation of new non-cigAlike vapers).

Vaping needs to become synonymous with "dual use" cigAlikes, in order to justify full "medicalization." - i.e. the eventual end of cigAlikes.

It protects BP's eventual monopoly once "medicalization" is in place.

No one is going to sue them.

It's all gain, and no pain (for the FDA).

 

[Danoman]

Controlling hardware is 100% upside and 0% downside for the FDA. What's not to like (from their POV)?

It protects vapers from people getting nic from an alternate source, such as: (1) combining "flavor vaping" with NRT use; (2) their freezers or the black market; (3) synthesizing it in some as-yet-unknown way; (4) paying a premium for non-tobacco-derived nic.

It also helps shut down non-cigAlike vaping (or prevent the conversion/cessation of new non-cigAlike vapers).

Vaping needs to become synonymous with "dual use" cigAlikes, in order to justify full "medicalization." - i.e. the eventual end of cigAlikes.

It protects BP's eventual monopoly once "medicalization" is in place.

No one is going to sue them.

It's all gain, and no pain.

Huh...? I've read you comment like 4 times now... ummmmm. It MUST be satire your speaking... because, it makes no sense other wise.

 

[Danoman]

*walk away tonight thinking... WOW, we're screwed...*
What really matters isn't being used or seen. WE have rights, guaranteed by our Constitution. What pisses me off is, WE are more powerful than them, by LAW. I'm afraid, this country is lost...

 

[Danoman]

THIS, isn't a joke to me... (I feel i'm loosing my country and ALL of my rights, as a Citizen of this once fine nation)

 

[KODIAK (TM)]

THIS, isn't a joke to me... (I feel i'm loosing my country and ALL of my rights, as a Citizen of this once fine nation)

My man, Dan-o-man. Cut back on that 36mg juice my friend.

We shall persevere. (And if not, Russia's just a boat ride away from yours truly. I'll save you a seat but you gotta row. )

 

[Danoman]

I've served this country militarily and given my life to this country. I've DONE my part to defend this country. I've been there, I know what it's like to be in "those" other countries. So, IF I wanted to start a business in MY nation, i'd have to go through all these hoops and unbelievable amounts of money to start a vaping or an E-juice business...? Are you kidding...? I'll do what I want to do after those imposed 'sanctions' go into place.

Speaking of... I think it's time to get a business going and link all of us together, as one. One FULL force, all in agreement is better than just one. We'll have flanking businesses as well.

A thought, IF we put this all together, as a group, could we all afford the cost, likely half of that proposed as a group...?

 

[Danoman]

My man, Dan-o-man. Cut back on that 36mg juice my friend.

We shall persevere. (And if not, Russia's just a boat ride away from yours truly. I'll save you a seat but you gotta row. )

Heading to 12mg my friend... (just in case) lol

 

[Danoman]

My man, Dan-o-man. Cut back on that 36mg juice my friend.

We shall persevere. (And if not, Russia's just a boat ride away from yours truly. I'll save you a seat but you gotta row. )

My friend, you and I both KNOW this isn't how it's supposed to be in our country... I agree in humor but, this one is unacceptable, by any means a normal and well adjusted individual, that knows the facts should respond... (I've been nice and respectable, on all fronts)

 

[Roger_Lafayette]

Roman numeral VIII is very close to a potential final form, the main reason that it doesn't look like that is that they have options, questions, and some discussion mixed in. There are lengthy quotations which are specifically intended as potential pieces of a final draft.

If/when this gets revised, presented to OMB for a final review, and presented to Congress, it will go into the Federal Register. FDA will then be free to publish additional guidance and clarifications in the Federal Register without having to go through the same lengthy process.

Or not. And by "or not," what I mean is that if they give no realistic or useful information about how a manufacturer of (say) a drip tip were to write an application, then there isn't a thing in the world that the manufacturer can do, other than to try to contact the FDA and hope for a response. They can't sue the FDA until the FDA specifically acts against them. Oversight by the executive or legislative branch would be their own (theoretical) option.

Reading again today I think my reply is going to go something like,

"It seems you really have no idea how to regulate the items you are deeming. Instead of going through answering your questions here is how I would regulate..."

Then go into the items that interest me and any points CASAA has I haven't picked up on, and tell them they can lobby congress for anything they need to have amended to make it work instead of trying to treat everything the same.

2 years? I don't think this proposal is anything close to being the final release, it's mostly asking how they can do it.

 

[Danoman]

Roman numeral VIII is very close to a potential final form, the main reason that it doesn't look like that is that they have options, questions, and some discussion mixed in. There are lengthy quotations which are specifically intended as potential pieces of a final draft.

If/when this gets revised, presented to OMB for a final review, and presented to Congress, it will go into the Federal Register. FDA will then be free to publish additional guidance and clarifications in the Federal Register without having to go through the same lengthy process.

Or not. And by "or not," what I mean is that if they give no realistic or useful information about how a manufacturer of (say) a drip tip were to write an application, then there isn't a thing in the world that the manufacturer can do, other than to try to contact the FDA and hope for a response. They can't sue the FDA until the FDA specifically acts against them. Oversight by the executive or legislative branch would be their own (theoretical) option.

State what your saying in laymen's terms, please...?

 

[Danoman]

Start with... the LAW says, I "

 

[Roger_Lafayette]

Huh...? I've read you comment like 4 times now... ummmmm. It MUST be satire your speaking... because, it makes no sense other wise.

The first sentence of the second para was garbled. Try it again.

 

[Roger_Lafayette]

State what your saying in laymen's terms, please...?

1) Take the quoted parts of proposed rules in part 8 and put them together. (In some cases, there are options, so pick one in each case. You know, like a menu in a Chinese restaurant where you get one appetizer, one main dish, etc.)

2) Now you have the outlines of a rule that will go into this thing called the Federal Register, once all is said and done.

3) It's not complete-as-is, but the FDA can then tweak it w/o going through this whole process all over again. Like adding flesh on bones.