FDA Common misconceptions about FDA regulations ( I hope CASAA will address at some point in the next few weeks)

[MD_Boater]

The OMB review is not published, and we have no idea why the first pass at deeming regulations were rejected.

Can CASAA make a FOIA request for this?

 

[Gato del Jugo]

Can CASAA make a FOIA request for this?

Honestly, I'd like to see everything that's e-cig related from the FDA, both internal & any/all "private" external communications...

 

[Kent C]

Honestly, I'd like to see everything that's e-cig related from the FDA, both internal & any/all "private" external communications...

Emails to BP, BT, bank accounts, money transfers, etc.

 

[Gato del Jugo]

Emails to BP, BT, bank accounts, money transfers, etc.

Of course, you'd have to get everything -- not just the stuff that they provide..


So what does that take? FBI? NSA? Hacker group? Congress? Insiders? Lawsuits?

 

[Kent C]

Of course, you'd have to get everything -- not just the stuff that they provide..


So what does that take? FBI? NSA? Hacker group? Congress? Insiders? Lawsuits?

NSA and Snowden probably know, Congress was likely the 'broker'.

 

[Roger_Lafayette]

Kent, you have not only put words in my mouth, but taken the point of my post completely out of context. I said nothing about making comments or anything other than whether a case could be successfully filed.

I was talking about the legal doctrine of Standing (law) - Wikipedia, the free encyclopedia

and the larger issue of http://en.wikipedia.org/wiki/Justiciability

And all I was saying is that a vendor might not have standing to sue in the federal courts until the FDA acted against it (no "case or controversy"), and that a group of customers might not ever have that "standing".

That means the case gets thrown out on purely procedural grounds (i.e. the court lacks jurisdiction), without a hearing on the merits.

If you think I'm wrong about the law, fair enough.

Good grief

I see you picked up a comment made earlier, I didn't respond but here I will 'elaborate'. One of the early cases for the Institute of Justice was against NJ in an attempt to take property though eminent domain. And this wasn't for a 'new post office' or gov't building. This was for a parking lot for Donald Trump's Taj Mahal casino.

So here was a case where Gov't acted with business and the effect was to deprive individuals in the neighborhood of their happiness and property. They liked where they lived. Result: IJ 1 Trump/NJ 0.

And here, re: us, You have Gov't acting [I]against[/I] business and the effect is the same - certain individuals could no longer have available stuff they want - iow, a violations of their rights even though it's an indirect effect, an effect that has the same result.

I actually agree that it is against vendors directly - users indirectly, but lets use your reasoning with regards to comments. I'm going to do a 'no no' ... put words in your mouth... but I do it openly and for the reason to show how a 'strict construction' of your 'it's only against vendors' could be applied.

Roger Lafayette advises all users of ecigs NOT to make any comments to the FDA because the actions of the FDA are only directed at vendors. Not only would your comments be totally irrelevant to the FDA.....

An aside:
I could see one of the 115 employees calling out (laughing) "Oh boy!, here's another (does air quotes) "I smoked for over 30 years..." laughs and throws the comments in the trash. I wished they would have listened to Roger on ECF - he told them it was ONLY about the vendors... (does a )

... back to Roger... And in fact, the more irrelevant comments made by users (remember it isn't about your 'rights') the more distractions there will be to legitimate comments from vendors.

Now, I know that isn't what you intended, but it follows from your premise - FDA vs. Vendors only.

There is a link (indirect) to individual rights. I might agree that vendors should send money to IJ since they will be affected directly and they, IJ, would argue on economic rights rather than what part of the business can they keep, iow, what regulations can we 'give' to the FDA in order to stay in business.

 

[Kent C]

Kent, you have not only put words in my mouth, but taken the point of my post completely out of context.

I was talking about the legal doctrine of Standing (law) - Wikipedia, the free encyclopedia

And all I was saying is that a vendor might not have standing to sue in the federal courts until the FDA acted against it, and that a group of customers might not ever have that standing.

That means the case gets thrown out, without a hearing on the merits.

If you think I'm wrong about the law, fair enough.

Good grief

Fact is Roger, you were right about what the deeming doc addresses - vendors, not consumers. My point still stands that on that alone, that it follows from you're position that consumers' comments should be irrelevant.

On the suing issue, I'll grant that, (although I still think there could be a case for consumers....they will be the effect of any 'bad' action taken... ), but I don't know if vendors would have to wait until they are 'exited' from the market. Some sort of injunction could take place to prevent that. That has a lot of precedent.

 

[Roger_Lafayette]

As I explained in one of my other posts, CASAA has a history of being able to oppose legislation at various levels of government. Some big cities have been lost of late, but so far no states have managed to pass anything dreadful during the current legislative season.

Let me turn it around.

You're in charge now. We await your orders.

{MODERATED}, what should we be doing?

Yes I have to agree how "groups" work hard the infiltrate real effort with tactics that simply and quietly slide everyone over the cliff into oblivion.

To that end I went directly to my western Pennsylvania Congress and Senate people.

Based on what I see here I foolishly thought I would be merely adding to a chorus of pro-vaping voices.



As to the underlined part and the above and my call, guess what?

Neither my two Senators nor Congressman had heard anything about this.

I spent a good hour between each office explaining how the FDA would A) force my wife back to smoking cigarettes after 3.5 years without and B) ruin our e-cig business ventures.

The poor office staffer literally gasped at the suggestion my wife would end up smoking again.

My point?

Community organizations and groups here seems hell-bent on sending vaping over the cliff as Kent C suggests.

Apparently no one has called the major metropolitan offices of these folks in my state to date.

Wow.

Regardless of what any of these folks ultimate do or not do the calls were well worth the effort:

Merely suggesting the FDA might cause someone to "go back to cigarettes" literally took people's breath away.

Now imagine the effect of an actual ad suggesting that these regulations might push people back to smoking.

(But I don't see any...)

And none of the staffers seemed the slightest bit surprised the FDA would attempt this.

I wonder how many other Senators and Congressmen don't know what's going on.

Good thing, as Roger_Lafayette points out, this will go back through Congress again - hopefully after a lot more calls by people like me.

 

[Roger_Lafayette]

Fact is Roger, you were right about what the deeming doc addresses - vendors, not consumers. My point still stands that on that alone, that it follows from you're position that consumers' comments should be irrelevant.

On the suing issue, I'll grant that, (although I still think there could be a case for consumers....they will be the effect of any 'bad' action taken... ), but I don't know if vendors would have to wait until they are 'exited' from the market. Some sort of injunction could take place to prevent that. That has a lot of precedent.

Oh c'mon Kent. Now you're just being silly. It only "follows" if you put words in my mouth and completely misread my post

Just because a court won't entertain a lawsuit based on a particular premise has never been an excuse for the absence of other types of action (and I'd include comments to the FDA). That's been true ever since the founding of the US, and long prior to that time.

Incidently, I believe the language of the APA (admin procedure act) allows comments from "stakeholders". Which is what we consumers/vapers are. That is not the same as having legal standing to sue.

 

[Kent C]

Oh c'mon Kent. It only "follows" if you put words in my mouth and completely misread my post

Just because a court won't entertain a lawsuit based on a particular premise has never been an excuse for the absence of other types of action (and I'd include comments to the FDA). That's been true ever since the founding of the US, and long prior to that time.

Do you agree that the deeming doc is aimed at vendor not consumers? Of course you do.

QED, my friend.

 

[DC2]

Can CASAA make a FOIA request for this?

That's one heck of a good question.

As far as I know, only Greg Conley (formerly of CASAA) had dug his feet into the pool of FOIA requests.
We saw some ugly emails from some of our enemies a few years back due to his efforts.

 

[DC2]

On the suing issue, I'll grant that, (although I still think there could be a case for consumers....they will be the effect of any 'bad' action taken... ), but I don't know if vendors would have to wait until they are 'exited' from the market. Some sort of injunction could take place to prevent that. That has a lot of precedent.

I'm pretty much sure you can't sue unless you can prove harm.

But can you show harm by claiming you "exited" the market due to burdensome regulation?
Don't know, but it sounds like a good thing to do if you can.

 

[Fitzie]

Anyone can file a FOIA request. But there are ways to get out of releasing the requested info (like statutory exemptions). Plus they can charge after the first 2 Hours of search time or 100 pages copied. It could get pretty expensive.

 

[Roger_Lafayette]

I edited my post while you were posting yours, to point out that the APA recognizes comments of "stakeholders." And I pointed out that consumers were included - but that this is not the same as standing to sue. The only thing you've proven is that you're being silly

This subthread is at an end as far as I'm concerned.

Do you agree that the deeming doc is aimed at vendor not consumers? Of course you do.

QED, my friend.

 

[Kent C]

I'm pretty much sure you can't sue unless you can prove harm.

But can you show harm by claiming you "exited" the market due to burdensome regulation?
Don't know, but it sounds like a good thing to do if you can.

An injunction is a court order requiring an individual to do or omit doing a specific action. It is an extraordinary remedy that courts utilize in special cases where preservation of the status quo or taking some specific action is required in order to prevent possible injustice. Injunctive relief is a discretionary power of the court in which the court, upon deciding that the plaintiff's rights are being violated, balances the irreparablility of injuries and inadequacy of damages if an injunction were not granted against the damages that granting an injunction would cause.

There is a balancing test that courts typically employ in determining whether to issue an injunction. The defendant's 5th Amendment due process rights are weighed (heavily) against the possibility of the defendant becoming judgment-proof, and the immediacy of the harm allegedly done to the plaintiff (i.e., how badly does the plaintiff need the injunction). When it is possible, the defendant must always be put on notice of the injunction hearing, and the duration of the injunction is typically as temporary as possible. Additionally, in many jurisdictions, plaintiffs demanding an injunction are required to post a bond.

http://www.law.cornell.edu/wex/injunction

In fifth amendment cases the injunction is against gov't action.

 

[Kent C]

I edited my post while you were posting yours, to point out that the APA recognizes comments of "stakeholders." And I pointed out that consumers were included - but that this is not the same as standing to sue.
This subthread is at an end as far as I'm concerned.

You might consider two more edits. 'Being silly' is directed at the person not what they say. Even with a smiley face. Saying something is silly, is directed at their comments. I'd drop it if I were you.

 

[Roger_Lafayette]

Yes, and there are good reasons to file for an injunction, even if there's little likelihood of success. Although deep pockets are needed to pony up the fees. For that, the plaintiff(s) might get some interesting info. from discovery, and some good publicity out of it.

For ex., I suspect this one went nowhere in the courts, but was probably useful to BT: Lorillard and R.J. Reynolds File Suit Against FDA to Prevent it from Relying Upon TPSAC Recommendations; Alleges Conflicts of Interest Among Panelists

An injunction is a court order requiring an individual to do or omit doing a specific action. It is an extraordinary remedy that courts utilize in special cases where preservation of the status quo or taking some specific action is required in order to prevent possible injustice. Injunctive relief is a discretionary power of the court in which the court, upon deciding that the plaintiff's rights are being violated, balances the irreparablility of injuries and inadequacy of damages if an injunction were not granted against the damages that granting an injunction would cause.

There is a balancing test that courts typically employ in determining whether to issue an injunction. The defendant's 5th Amendment due process rights are weighed (heavily) against the possibility of the defendant becoming judgment-proof, and the immediacy of the harm allegedly done to the plaintiff (i.e., how badly does the plaintiff need the injunction). When it is possible, the defendant must always be put on notice of the injunction hearing, and the duration of the injunction is typically as temporary as possible. Additionally, in many jurisdictions, plaintiffs demanding an injunction are required to post a bond.

In fifth amendment cases the injunction is against gov't action.

 

[Gato del Jugo]

That's one heck of a good question.

As far as I know, only Greg Conley (formerly of CASAA) had dug his feet into the pool of FOIA requests.
We saw some ugly emails from some of our enemies a few years back due to his efforts.

Okay, you can't just say that & not provide any links..

 

[Jman8]

For ex., I suspect this one went nowhere in the courts, but was probably useful to BT: Lorillard and R.J. Reynolds File Suit Against FDA to Prevent it from Relying Upon TPSAC Recommendations; Alleges Conflicts of Interest Among Panelists

After reading the link:

1 - It is challenging to understand a claim that FDA and BT are working together on behalf of BT

2 - That committee's lack of unbiased participating is something I'd love to exploit further with eCig proposed regulations, and thinking BT and Siegel wouldn't mind that occurring

3 - Either the integrity of science or integrity of FDA is seriously, and ultimately politically, in question

4 - Feeling very confident if shoe was on the other foot and 3 of the committee members were known supporters of BT, that regardless of objective scientific data they might put out, they'd be released from the committee in seconds flat

 

[DC2]

Okay, you can't just say that & not provide any links..

I hope you have a free weekend available...
Seattle - King County Health Department FOIA Results | Scribd
Tacoma-Pierce County Health Department FOIA Results collection
Madison County Health Depatment FOIA Results | Scribd
Kentucky Center for Smoke-free Policy FOIA Results | Scribd