FDA FDA deeming regulation proposals

[Myk]

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.

 

[Schwiggiddy]

Whoopeeeee! I've been saying this for a decade now. You wouldn't believe how many conversations I've had with Tea Partiers, conservatives on issues that we are 100% in agreement on - and I'm a "progressive". IMO the worst nightmare possible is that all of us remember that WE are not the enemy. I can guarentee you Wash. DC is terrified that we will figure this out.

This is one of those situations where WE THE PEOPLE should all be able to contact our congressional representatives and let our voices be heard. Imagine how awesome it would be if the one thing we could get Congress to agree on this year would be some sort of statement about how Congress recognizes that e-cigarettes pose substantially less risk than traditional tobacco cigarettes, and that Congress is willing to take a "wait-and-see" approach, and will not (for now) authorize any new FDA regulations of e-cigarettes under the TCA. This is something that, in theory, all civil libertarians should be willing to support. I'd love to see Harry Reid and Mitch McConnell with John Boehner and Nancy Pelosi all standing together supporting freedom and harm reduction.

 

[EddardinWinter]

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.

It's a hot mess. Badly written and meandering...painful to the eyes. It is astounding that it took four years to write this hog slop.

To think, my taxes have financed this abomination.

O judgment! thou art fled to brutish beasts,
And men have lost their reason. Bear with me;
My heart is in the coffin there with Caesar,
And I must pause till it come back to me.

Roaring thunderously via Tapatalk...

 

[Sirius]

"Vote Libertarian It Only Feels Kinky The First Time"

 

[Sirius]

This is one of those situations where WE THE PEOPLE should all be able to contact our congressional representatives and let our voices be heard. Imagine how awesome it would be if the one thing we could get Congress to agree on this year would be some sort of statement about how Congress recognizes that e-cigarettes pose substantially less risk than traditional tobacco cigarettes, and that Congress is willing to take a "wait-and-see" approach, and will not (for now) authorize any new FDA regulations of e-cigarettes under the TCA. This is something that, in theory, all civil libertarians should be willing to support. I'd love to see Harry Reid and Mitch McConnell with John Boehner and Nancy Pelosi all standing together supporting freedom and harm reduction.

I strongly agree ( in bold) But I doubt you will ever see them getting together across the isle on anything.

 

[Danoman]

"Vote Libertarian It Only Feels Kinky The First Time"

LOL... I do believe people are waking up and wondering what's happened in this country. There are SO many more important things this nation need to be focusing on than vaping and E-Cigs. Unbalanced to say the least. Oh, and it's OUR tax dollars at work here too... Smh

 

[Jman8]

Now how are we going to deal with it.

Taking the idealistic puritanical stance probably won't get very far. The fastest path from point A to E is to work within their own framework and hopefully turn it against them. Use studies they already approve, etc. The path of least resistance, choose your battles wisely, look for the blind spots, follow the fear, and all this is hypothetical anyway = meaningless. It's not an arguement we need right now. I apologize for getting into this.

I gotta run.

I still say a good counter measure is to ban cigalike that have the risk of renormalizing smoking for children. I don't expect that to go far, but I would expect a reaction that might be revealing to the public.

I don't like that last suggestion, as a cigalike user. But I see what you're saying.

I'd rather inundate them with false market applications. Knowing they'll get rejected, but that keeps everything on market longer. For how slow and bureaucratic they are, I could see submitting an application written entirely in "Lorem Ipsum" in say Oct. 2014, and hearing back in Feb. 2016, that this application has been rejected. You think I'm kidding?

Perhaps more realistically is to keep hammering away at the small business angle, for what is written into federal policy. I see this as one of the areas of legal challenge that will be pursued and as it is what us vaping enthusiasts keep hammering on, I think it behooves us to realize how that could be good angle to take in our response to the proposed regulations.

If the "little guy" doesn't succeed in a controlled/regulated way, I'm certain the little guy will succeed in an underground/unregulated way.

 

[Roger_Lafayette]

I've had eGos that have gone 2 years plus. A few spinners that didn't make it 6 months. but as always, ymmv. I also have no use for mods other than in the worst case scenario - I have a few "eGos" that take non-proprietary batts, which is nice. Love my reo-mini for a good bottom feeder box type mod. The only one I use other than eGos. I have an iTaste but it's going to classifieds.

You might like the one sticky I have

http://www.e-cigarette-forum.com/forum/ego-type-models/519902-types-joyetech-ego-batteries.html

I'm an "eGoist" in more ways than one

Wow I didn't know you were a battery expert. A man of many talents

But why acquire batteries now?

 

[Danoman]

I don't like that last suggestion, as a cigalike user. But I see what you're saying.

I'd rather inundate them with false market applications. Knowing they'll get rejected, but that keeps everything on market longer. For how slow and bureaucratic they are, I could see submitting an application written entirely in "Lorem Ipsum" in say Oct. 2014, and hearing back in Feb. 2016, that this application has been rejected. You think I'm kidding?

Perhaps more realistically is to keep hammering away at the small business angle, for what is written into federal policy. I see this as one of the areas of legal challenge that will be pursued and as it is what us vaping enthusiasts keep hammering on, I think it behooves us to realize how that could be good angle to take in our response to the proposed regulations.

If the "little guy" doesn't succeed in a controlled/regulated way, I'm certain the little guy will succeed in an underground/unregulated way.

Oh no...!!! Cigalike is the gateway into vaping... lol <.... joking, although possibly true.
I agree with you both though...

 

[Danoman]

I don't like that last suggestion, as a cigalike user. But I see what you're saying.

I'd rather inundate them with false market applications. Knowing they'll get rejected, but that keeps everything on market longer. For how slow and bureaucratic they are, I could see submitting an application written entirely in "Lorem Ipsum" in say Oct. 2014, and hearing back in Feb. 2016, that this application has been rejected. You think I'm kidding?

Perhaps more realistically is to keep hammering away at the small business angle, for what is written into federal policy. I see this as one of the areas of legal challenge that will be pursued and as it is what us vaping enthusiasts keep hammering on, I think it behooves us to realize how that could be good angle to take in our response to the proposed regulations.

If the "little guy" doesn't succeed in a controlled/regulated way, I'm certain the little guy will succeed in an underground/unregulated way.

Seriously, can we see ANY excuse for these applications to be any more than $100 per flavor...? Personally, I don't as they would have already been cleared (by then) of the manufactures of the ingredients involved, the rest would just be in flavorings and, in time those would have been cleared too.

 

[Kent C]

Wow I didn't know you were a battery expert. A man of many talents

But why acquire batteries now?

I expect all of 'this' to raise prices, esp. with eliquids but I've got that well covered. I've seen it in guns, ammo, reloading supplies, esp. the "lynchpin" - primers (hard to diy) and other stuff that have been targeted. Hell, oil... lol... If the threat goes away, prices come down but not always all the way. If it remains, prices stay high or go higher. All the batts I get come in at 40% charge - the perfect storage percentage and they'll last for many years. A by-product is our vendors get more money to perhaps pay for fda applications

 

[Jman8]

I don't understand what you mean by the bold part. The only place I see where the FDA is "asking" for scientific studies is in the required applications that manufacturers and importers/vendors would have to either conduct and present (quite costly) or refer to studies already made from other sources.

On p. 20 it says:

Given this initial data regarding the increased prevalence of flavored tobacco products following the 2009 flavored cigarette ban, FDA seeks comments, data, and research regarding the following

And lists 3 items that I believe 'data' and 'research' will be treated with higher value than comments.

On p. 61, it says:

If this deeming rule becomes final, FDA would have the authority to issue regulations to prevent youth access to e- cigarettes (such as the minimum age and identification provision, which is being proposed with this rule). FDA asks for comments, data, and research regarding the following

Listing 2 items.

On p. 94-94, it says:

In addition, we note that this requirement would apply to products that are derived from tobacco, and not just products that themselves contain tobacco, based on the definition of "tobacco product" in section 201(rr) of the FD&C Act. As a result, FDA recognizes that the use of the words "tobacco product" in the warning might be thought to have the potential to confuse consumers. Accordingly, FDA request comments, including supporting facts, research, and other evidence regarding the following questions

Listing 3 items.

Plus p. 122-123, does similar thing, and p.125, 126 and 127.

Plus all the stuff you cited. Plus some items I intentionally left out regarding "cigars."

I further believe CASAA will suggest our responses cite scientific data where FDA proposal is either requesting such data and research or where they make claims that evidence is lacking.

 

[Danoman]

Unless... there IS a deliberate drive to end something, say the value of something.

Let me explain... (in context of the nation as a whole)
If you could get more taxes from a multitude of millions switching to E-Cigs than you would from a very few business owners who can afford the FDA requirement, as high as it'd cost that individual business owner, why would you do it...? (keep common sense applied here)

It doesn't make any sense on the financial front. *pausing for a few minutes to get your thoughts...*

 

[Kent C]

On p. 20 it says:


And lists 3 items that I believe 'data' and 'research' will be treated with higher value than comments.
<snip>

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.

 

[Danoman]

There is no plausible reasoning in anything they are stating that makes ANY sense. But, as we all know, it's about the money. BUT, is it really...?
Because, to me the math doesn't add up... there is more behind this, I believe that can be proven and expose the true intent of what is happening. Obviously, there is a LOT more to this what's shown face value. Who are supporting those groups that are going against those that vape...? Non-smokers anonymous...? I SERIOUSLY doubt it. Just BT and PC...? I seriously doubt that too. (although, clearly each one of them I stated has a hand in all of this) There's more to this, and it's just under the radar of what we are able to see, I believe.

What we all need to find out is WHO has supported this drive for the FDA, beyond those we already know of. Who's supplied the financial means to get it up to the table and who will profit from it in the end. (It's NOT going to be the BT and PC... as it's be very easy for them to come out with something equal as WE do, on the same lines and machines we use) There is something very sinister going on here that's just behind the veal of what's being shown to us... don't you feel that...? Especially with THIS Administration in office currently.

Being that this country is SO far in debt...? Wouldn't the taxes from multitudes make sense more than taxing the few in an ultra hard way...? Something's not right here... politically.

 

[Myk]

I expect all of 'this' to raise prices, esp. with eliquids but I've got that well covered. I've seen it in guns, ammo, reloading supplies, esp. the "lynchpin" - primers (hard to diy) and other stuff that have been targeted. Hell, oil... lol... If the threat goes away, prices come down but not always all the way. If it remains, prices stay high or go higher. All the batts I get come in at 40% charge - the perfect storage percentage and they'll last for many years. A by-product is our vendors get more money to perhaps pay for fda applications

Liquid mixers had better be prepared to eat a lot of it like cigarette makers did with taxes considering they've had all these years of 1000% markup.

Of course I'm not talking about the higher estimates, for those I'd just expect them to all close up. I don't think there is any amount of liquid you could sell to make $10m per revision back on unless you were the last liquid mixer in the country.

 

[Thundernoggin]

There is something very sinister going on here that's just behind the veal of what's being shown to us... don't you feel that...?

We elect largely corrupt people who take money from anyone needing a favor to endlessly write laws that normally backfire. We do it over and again. The whole thing is crazy. Something sinister is surely going on. It's inevitable.

 

[Schwiggiddy]

Especially with THIS Administration in office currently.

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

 

[Roger_Lafayette]

Sirius,

As a liberal, I've had many occasions to dislike FOX. I think it's very telling that I am now defending and applauding them. The e-cig issues have definitely turned me against the Democrats. (Still a liberal, though; I suspect that's incurable for me).

It's not a partisan issue. When Fox is right, they're right. When Gov. Dayton (D-MN) is right, he's right. When Gov. Kasich (R-OH) is wrong, he's wrong. When St. Sen. Ray (R-UT) is wrong, he's wrong.

The national Dems get all the headlines. When Repubs go after vaping at the state level (or Dems defend vaping at the state level, like in NJ), no one on ECF emits a partisan peep.

When one takes information out of context, things look different. You know, like those 200 calls to poison control centers every month? Sounds like a lot. Until you realize that there are 20,000 annuallly about toothpaste. Same thing here. Context is everything.

 

[Myrany]

I am painfully independent when it comes to party.

My favorite saying is something along the line of "These days it doesn't seem to matter who's royal backside is warming the presidential throne, the same crap comes out every time."