FDA FDA deeming regulation proposals

[EddardinWinter]

In your indefatigable search for something positive, you omit three things:

1) Filing an application is incredibly burdensome. Many manufacturers will not bother. Some may not even register, and just hang up their hats when the regs become final. This will yield an immediate ripple effect on vape shops and distributors plus online sellers. We could even see a stampede out of the market.

2) FDA can refuse to accept an application. Bill G. says that they've done it before. I'm not sure on what grounds. I'm not sure if they're refused to accept registrations (but registrations have to be in at most six months after the rule becomes final, depending on the date of finalization).

3) Given how burdensome the application process is, FDA could easily filter out the applications that don't make a serious effort to comply with the requirements for all of those studies, etc. They are not mandated to process them in order of submission.

+1 for "indefatigable".



Roaring thunderously via Tapatalk...

 

[Myk]

Where is it written that you have to pay a lawyer to apply for you?

I already am anticipating your (or others') response to this, but why can't we go with "we don't know what will be required for submission" and so we don't know if this is accurate. Either that you'll need a lawyer/law degree to fill out the form, that it would take that much time/expertise, that it would cost this much.

I'd rather spend time constructing responses to FDA that deals with this hypothesis, based on past experiences with FDA, then thinking it automatically will happen this way and it is hopeless to think otherwise.



As written where?

I suppose you could be a lawyer who knows the system and apply for yourself.
We do know what is required (or estimated), it's in the proposal.

 

[Jman8]

So you think people will get away with inventing a Vamo V6, applying and selling while the application goes through and by the time it is looked at the product will be obsolete?

What do obsolete products have to do with what I wrote or is written in the proposal?

I'd rather focus on the lie, "we do not believe that we have the authority to amend it with respect to e-cigarettes or other products". If they actually wanted to change the date to when a product is brought under their control they can go to congress and have an amendment drawn up to say exactly what they want and have it rammed through. They're pretending they can't. Why are they lying?

So, just to be clear, we're not going to talk about what is written, but instead on accusations that don't really get us anywhere?

 

[mkbilbo]

Also these regulations favor one set of businesses over another.

That may not be sufficient. All regulation could be said to favor some forms of business over another. Outlawing "hit men" is showing favoritism in a way (well, it's a "business").

I do think the FDA has over reached (shocking, I know). Extracted nicotine is fairly clearly a tobacco product but it gets slippery after that. Such as, is a 18650 battery a "tobacco product" because I use them in my VTR? Well, no, it isn't. My VTR wasn't derived from tobacco either. Nor do I have to use nicotine in it. I can vape 0 nic juices. The FDA could end up in some very odd places.

Globally, jurisdictions don't seem to attempt to regulate hardware nor 0 nic. They go after the nicotine. That at least makes some sense in regulating "tobacco products". The FDA seems to think "e-cigs" are cigs and they can just move cig regs over and, ta da, regulatory structure. Well, no, that's not going to work.

There should be some room in there to at least gum up the works...

 

[Jman8]

In your indefatigable search for something positive, you omit three things:

1) Filing an application is incredibly burdensome. Many manufacturers will not bother. Some may not even register, and just hang up their hats when the regs become final. This will yield an immediate ripple effect on vape shops and distributors plus online sellers. We could even see a stampede out of the market.

Okay, so now it's not the FDA won't approve them, it's that all manufacturers/vendors (except BT of course) won't even apply cause it's burdensome. I see how this works. We're doomed! Doomed I tell you!

2) FDA can refuse to accept an application. Bill G. says that they've done it before. I'm not sure on what grounds. I'm not sure if they're refused to accept registrations (but registrations have to be in at most six months after the rule becomes final, depending on the date of finalization).

And so, we are to now believe that after those who decide to take on the burdensome task of doing an application, which will maybe be what, 3 companies, other than BT, that it'll then be rejected? Or maybe it'll be 200 companies, but we're pretty sure, they'll all be rejected, right? Okay, maybe not all of them, but 95%, yes?

Please cite where registrations for market application have to be in, at most 6 months after the rule becomes final.

3) Given how burdensome the application process is, FDA could easily filter out the applications that don't make a serious effort to comply with the requirements for all of those studies, etc. They are not mandated to process them in order of submission.

Hence, all of them, but BT are going to be filtered out as unacceptable for not making a serious effort to comply and this is precisely how the FDA will kill the eCig industry, yes?

I got it now. Makes sense. Not sure how I overlooked all this. Seems very knowledgeable.

 

[Jman8]

A new term to disparage those who disagree with your lofty perspective, and yet another clumsy misapplication.

No an old term referencing assertions that express fear, doubt or uncertainty that the products we all love will (not) be around for much longer due to FDA regulations.

Really not looking disparage anyone, anymore than someone who might write BCMV type language when involved in debate.

I see us on the same side, but not seeing how many comments here are constructive going forward. Feel free to cite those that you see as constructive. I may agree with you.

 

[Talyon]

Putting out a public wager doesn't make for idle speculation. Refusing to accept a wager based on speculation, and comments expressing FUD, is one's prerogative. It's actually "wishful thinking" of another kind. The kind that is counterproductive.

Yes wishful thinking would seem like someone's motive. Relax all is fine.


(Snip)

Is Mitch going to be alive forever? Is he going to head this regulatory body forever? Is his opinion and only his, the only one that matters when it comes to federal regulation of tobacco products?

Mitch could be long gone by time 2017 rolls around.

I'm sure if needed his predeseccor would have the same motivations, again wishful thinking.

 

[Jman8]

I suppose you could be a lawyer who knows the system and apply for yourself.
We do know what is required (or estimated), it's in the proposal.

Agreed that 5000 hours is estimated, per application response.

We also know that they are asking for comments that could change these estimates / requirements that are for new tobacco product applications. Whether or not they act on those, we don't know. But that they asked, we do know.

 

[mkbilbo]

The old court case may not be applicable to the current situation:

1) Everyone agrees that the FDA has jurisdiction over "[recreational consumer] tobacco products." The question is how it exercises that jurisdiction. The case you cite was clear about the fact that they could do so via making rules (and then publishing reg.s), that apply to such tobacco products. (Including components and parts, BTW: CASAA has just come out w/ a press release saying that FDA is asserting authority over "refillable devices" which presumably includes at least tank[O]s, hybrids, RDAs, and cart[O]s.)

2) Assuming that FDA exercises this jurisdiction by making rules and publishing regulations, they can't be taken to court until they actually act on those rules (which is what Greg Conley said in the conference call, and I believe that is true based on a legal doctrine known as "justiciability") That means they have to sieze something, or issue a cease and desist order before a court can get involved. Long before they do that, the effects of their activities will become manifest: local vape stores will close (and these are crucial to helping new vapers get up to speed), plus e-liquid and hardward manufacturers will leave the business, and distributors + online sellers will bail out too - unless they only want to sell approved cigAlikes.

Granted, it may be two years until the proposed rule becomes final (Bill Godshall) and the FDA is allowing another two years for enforcement. However the second two-year period assumes that all manufacturers register. Many will throw up their hands and leave, and some registrations may be rejected. (Assuming that a manufacturer registers, FDA does say that it will not remove a product until an application is rejected. But FDA can refuse to accept an application, according to Bill Godshall - who also says that filing an application is not easy).

All of this will occur long before the first "cease and desist" letter goes out, or the first shipment is siezed. And there will be no court action uintil then.

The question we should be asking ourselves is: who will be left in the market, by the time the FDA gets around to sending a "cease and desist" letter or siezing something, so a court can act - if these rules become final?

(And these are only the first step, says Mitch Z.)

Not a lawyer here but I could swear there have been court cases to stop regulation before it takes effect. The courts do recognize a government action can irreversibly damage an... industry (?) and allow stays while an issue is being fought over.

I should go agoogling, see why that's stuck in my head...

 

[Talyon]

No an old term referencing assertions that express fear, doubt or uncertainty that the products we all love will (not) be around for much longer due to FDA regulations.

Really not looking disparage anyone, anymore than someone who might write BCMV type language when involved in debate.

I see us on the same side, but not seeing how many comments here are constructive going forward. Feel free to cite those that you see as constructive. I may agree with you.

Agreed same side, but conveying opposing views. Some more productiive then others. All these words won't mean a thing down the road, but what will is a matter of time. Tick Tock.....

Have I mentioned I enjoy reading fairy tale stories? Love a Happy Ending.

 

[Jman8]

Yes wishful thinking would seem like someone's motive. Relax all is fine.

I'm sure this can't apply to the people in this thread offering up constructive comments about what we might write or talk about in response.

Doomed thinking seems be other's motives. Don't do anything in response, ecigs are dead/buried. BT took over. By design.

Or wait, we might respond, but only after Bill G. and CASAA have told us to. Until then, let's opine about just how horrible this is. Let's not quote from the proposal, but instead just what we think it is saying and FDA's track record and how regulation stinks. Can't get enough of that.

 

[sonicdsl]

The snarkiness and personal attacks need to stop now. If you can't play nice...

 

[Talyon]

I'm sure this can't apply to the people in this thread offering up constructive comments about what we might write or talk about in response.

Doomed thinking seems be other's motives. Don't do anything in response, ecigs are dead/buried. BT took over. By design.

Or wait, we might respond, but only after Bill G. and CASAA have told us to. Until then, let's opine about just how horrible this is. Let's not quote from the proposal, but instead just what we think it is saying and FDA's track record and how regulation stinks. Can't get enough of that.

So what u read is factual on the rules vs others are speculation, so what else would u like to debate/ argue about?

No one has said to NOT respond but it was suggested some wait for a more informative view of the rules by experts, a term not being grasped by some.

 

[Jman8]

So what u read is factual on the rules vs others are speculation, so what else would u like to debate/ argue about?

No one has said to NOT respond but it was suggested some wait for a more informative view of the rules by experts, a term not being grasped by some.

We'll just ignore the last part given desire to keep the thread open.

What I read is what I read in the proposal. I would prefer we discuss what is in the text of the proposal. If speculation is offered up, then just cite corresponding text and let the discussion continue, hopefully with constructive commentary that relates to how we might (someday soon) respond to the FDA proposal. I believe we can shape the things to come, and believe our side's experts will be conveying a similar sentiment, among other things.

 

[Elizabeth Baldwin]

On substantially equivalent... An eye opener!

http://www.tobacco.ucsf.edu/fda-pro...uivalent”-tobacco-prducts-keeps-public-dark

I see nothing intoduced to the market after 2007 being approved.

 

[Talyon]

We'll just ignore the last part given desire to keep the thread open.

What I read is what I read in the proposal. I would prefer we discuss what is in the text of the proposal. If speculation is offered up, then just cite corresponding text and let the discussion continue, hopefully with constructive commentary that relates to how we might (someday soon) respond to the FDA proposal. I believe we can shape the things to come, and believe our side's experts will be conveying a similar sentiment, among other things.

Pretty sure that's what I've been doing citing the proposals same as you have, Now let's move on and for me that is to wait until its time to pounce, I've every confidence I'll follow ( but not blindly) what CASAA will offer and not just a bunch of words form a forum thread.

All speculation will now stop?

 

[Myk]

What do obsolete products have to do with what I wrote or is written in the proposal?



So, just to be clear, we're not going to talk about what is written, but instead on accusations that don't really get us anywhere?

Why are you acting like the guy I blocked in the vaping in public thread?
If a product takes years to get approved it will be obsolete and it won't matter if it's approved or turned down. I thought maybe you had a recent incident with Bidis in mind when you brought that up.

I did talk about what was written. The FDA pretends they can't do anything. If they couldn't do exactly what they'd need to do to amend the law they wouldn't have been able to lobby to get tobacco in the first place.

That may not be sufficient. All regulation could be said to favor some forms of business over another. Outlawing "hit men" is showing favoritism in a way (well, it's a "business").

I do think the FDA has over reached (shocking, I know). Extracted nicotine is fairly clearly a tobacco product but it gets slippery after that. Such as, is a 18650 battery a "tobacco product" because I use them in my VTR? Well, no, it isn't. My VTR wasn't derived from tobacco either. Nor do I have to use nicotine in it. I can vape 0 nic juices. The FDA could end up in some very odd places.

Globally, jurisdictions don't seem to attempt to regulate hardware nor 0 nic. They go after the nicotine. That at least makes some sense in regulating "tobacco products". The FDA seems to think "e-cigs" are cigs and they can just move cig regs over and, ta da, regulatory structure. Well, no, that's not going to work.

There should be some room in there to at least gum up the works...

Outlawing hit men is not the same as making a law who's costs are only affordable to giant corporations. It violates equal protection. It possibly violates protectionism.

I agree. The regulations only on the nicotine liquid would make some sense. Expanding it to equipment is ridiculous (and the reason it's ridiculous is to had ecigs over to big tobacco). The equipment could easily be covered with GMP, issue a list of metals, plastics and wicks that are OK to use.

Agreed that 5000 hours is estimated, per application response.

We also know that they are asking for comments that could change these estimates / requirements that are for new tobacco product applications. Whether or not they act on those, we don't know. But that they asked, we do know.

I didn't see them asking for comments to change those estimates, but I was skimming that part since it was after the proposed rules and part of disclosure. It would seem to me they'd have to release the forms to ask for ways to streamline them.

 

[aikanae1]

We'll just ignore the last part given desire to keep the thread open.

What I read is what I read in the proposal. I would prefer we discuss what is in the text of the proposal. If speculation is offered up, then just cite corresponding text and let the discussion continue, hopefully with constructive commentary that relates to how we might (someday soon) respond to the FDA proposal. I believe we can shape the things to come, and believe our side's experts will be conveying a similar sentiment, among other things.

I think we do have to take in consideration the FDA's history. Ecigs are not the first to fall under the deeming process/ SE reguations or new product submissions.

How the FDA Is Keeping New Cigarettes Off the Market - Jacob Grier - The Atlantic

FDA Law Blog: Tobacco
Also http://www.fdalawblog.net/fda_law_b...review-of-tobacco-product-submissions-un.html
Also http://www.fdalawblog.net/fda_law_b...-the-substantial-equivalence-finish-line.html

U.S. GAO - New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process

 

[cmknight]

Do you seriously think the Chinese don't have a plan in place? My guess is ready and waiting to use it.

No, actually, They don't. Kanger doesn't care, nor does Vision, or any other Chinese company. Believe me, I have spoken to quite a few of them. As long as it doesn't affect their bottom-line right now, they have no position whatsoever on it.

 

[Myk]

FDA Needs to Set Time Frames for Its Review Process

It won't help. There needs to be personal penalties for those in charge or a removal of the law when it's violated.
IL's Firearms Owners ID has a 30 day limit. State Police are constantly dragging them out to 3 months and more. Since there is no penalty they don't care. State Police break the law, they get no penalty, they make law abiding people criminals and if caught they do pay the penalty.

Personally I think Congress needs to look at the FDA's performance and decide they can't (or won't) do the job and remove it from them. It's a failed experiment.