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

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Talyon

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Anybody else ever get the impression that there are some here who, ever since 4/24, appear to be repeatedly attempting to make this FDA proposal out to be "no big deal," perhaps in hopes to detract others from any sort of organization, to sway others' opinions & to soften others' initial opposition to this proposal?

What sort of benefit could they potentially gain in doing so, should they be "successful"?

And do they have any sort of undisclosed affiliations which could also potentially gain to benefit from any such "success"?


Many unanswered questions, do arise...

People of whom u speak only serve to cause the rest of us true Vapers to be Stronger in our fight, I for one will not be laying down when push comes to shove.
 

Kent C

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In business I have found that perhaps the worst thing anyone can do when faced with adversity is A) rationalize why any solution will fail, B) ignoring opportunities to take any action, and C) wait for the "knight on the white horse" to show up.

My take:

In business I have found that perhaps the worst best thing anyone can do when faced with adversity is A) rationalize promote why any solution will fail, B) ignoring opportunities discourage others from taking any action, and C) wait for BE the "knight on the white horse" that shows up.

This is how consumer groups and community organizers put themselves in position of agreeing to some regulations and taxes (by being "reasonable") but stopping total bans. Then almost all consumers feel grateful. win-win :facepalm:

At this point, I think the best path is to not give an inch to the FDA, let them do what they need to do, then sue them in court with a group like the Institute for Justice on the grounds that they are violating individual rights of citizens to consume what they want to consume, while not harming others. Second hand vapor is less 'threatening' than a fart or bad expensive perfume. The possibility of a more objective judge or set of judges is much greater than the FDA. Not a certainty, but a much higher probability and less likely that whomever is judging is not in the pocket of BT, BP or BGov't.
 
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Jman8

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My take:

In business I have found that perhaps the worst best thing anyone can do when faced with adversity is A) rationalize promote why any solution will fail, B) ignoring opportunities discourage others from taking any action, and C) wait for BE the "knight on the white horse" that shows up.

Also excellent points.

At this point, I think the best path is to not give an inch to the FDA, let them do what they need to do, then sue them in court with a group like the Institute for Justice on the grounds that they are violating individual rights of citizens to consume what they want to consume, while not harming others. Second hand vapor is less 'threatening' than a fart or bad expensive perfume. The possibility of a more objective judge or set of judges is much greater than the FDA. Not a certainty, but a much higher probability and less likely that whomever is judging is not in the pocket of BT, BP or BGov't.

FDA is speaking to industry while states are doing what you are alluding to. I'd love to see Justice bring the states into court rooms for reason you stated.

But am okay that FDA will be sued as well for thinking it had a leg to stand on by trying to enforce any heavy handed pieces of regulation against ecig vendors/manufacturers.
 
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My take:

In business I have found that perhaps the worst best thing anyone can do when faced with adversity is A) rationalize promote why any solution will fail, B) ignoring opportunities discourage others from taking any action, and C) wait for BE the "knight on the white horse" that shows up.

This is how consumer groups and community organizers put themselves in position of agreeing to some regulations and taxes (by being "reasonable") but stopping total bans. Then almost all consumers feel grateful. win-win :facepalm:

At this point, I think the best path is to not give an inch to the FDA, let them do what they need to do, then sue them in court with a group like the Institute for Justice on the grounds that they are violating individual rights of citizens to consume what they want to consume, while not harming others. Second hand vapor is less 'threatening' than a fart or bad expensive perfume. The possibility of a more objective judge or set of judges is much greater than the FDA. Not a certainty, but a much higher probability and less likely that whomever is judging is not in the pocket of BT, BP or BGov't.

I'm not at all certain that the FDA could be sued by a group of citizens who were not vendors. After all the proposed rule only regulates vendors. Mind you, it's possible for a citizen to become a de facto vendor by mixing up e-liquid and handing it out at a party. A "mod building co-op" might also start to look a whole lot like a vendor (think: raw milk co-ops).

But until the FDA takes action against a specific vendor (or the equivalent of a vendor) by sending a C&D letter, or doing something else, I'm not sure there's a "Case or Controversy." For example I used to let people bum my injector-made (RYO) cigarettes. That was illegal. Could I have sued the FDA, claiming that I should be able to legally let people bum my smokes? Probably not - not without showing that there was any likelihood that the FDA was going to actually come after me, instead of looking the other way.

It seems that the FDA is going to carefully follow the APA steps: http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

That means that once the proposed final rule goes to OMB (which is the next step after the comments phase), we will have a chance to apply pressure. If OMB signs off on the proposed final fule, it will then go to Congress in the final step. That will also give us a chance to apply pressure via congress and the media. Hopefully we'll have some studies out there on people who have vaped for 2-5 years which could be compared to a control group of smokers who had continued to smoke. And more information on the behavior of minors, etc.

Could the FDA act against a vendor or (say) a mod-building club on the day after the proposed rule becomes final?

No, there is sitll an approx. 6-month registration window, see p.115 and following pages.

At that point, perhaps a "modding co-op" could send a registered letter to the FDA, announcing its intentions to meet and build puck mods at a particular time and location. If the FDA does nothing, I'm not sure it could be sued. But if the FDA sends a letter back, indicating that the co-op is not in compliance, then of course it's time to have the attorneys present, call the press, set up the cameras, etc. In a word, it's showtime.
 

toddkuen

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My take:

In business I have found that perhaps the worst best thing anyone can do when faced with adversity is A) rationalize promote why any solution will fail, B) ignoring opportunities discourage others from taking any action, and C) wait for BE the "knight on the white horse" that shows up.

This is how consumer groups and community organizers put themselves in position of agreeing to some regulations and taxes (by being "reasonable") but stopping total bans. Then almost all consumers feel grateful. win-win :facepalm:

...

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.

...

That means that once the proposed final rule goes to OMB (which is the next step after the comments phase), we will have a chance to apply pressure. If OMB signs off on the proposed final fule, it will then go to Congress in the final step. That will also give us a chance to apply pressure via congress and the media. Hopefully we'll have some studies out there on people who have vaped for 2-5 years which could be compared to a control group of smokers who had continued to smoke. And more information on the behavior of minors, etc.

...

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.
 

Kent C

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I'm not at all certain that the FDA could be sued by a group of citizens who were not vendors. After all the proposed rule only regulates vendors. <snip the relatively distractive co-op fantasizes - but yeah, that may become an issue later....>

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 :facepalm: )

... 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.
 
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toddkuen

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...

It seems that the FDA is going to carefully follow the APA steps: http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

That means that once the proposed final rule goes to OMB (which is the next step after the comments phase), we will have a chance to apply pressure. If OMB signs off on the proposed final fule, it will then go to Congress in the final step. That will also give us a chance to apply pressure via congress and the media. Hopefully we'll have some studies out there on people who have vaped for 2-5 years which could be compared to a control group of smokers who had continued to smoke. And more information on the behavior of minors, etc.

...

Exactly what step is all of this in your linked PDF regmap?

There seems like a lot of work under the "Specific Analysis for Steps Three and Seven that's not addressed, e.g., economic impact over $100 million dollars, etc.

When does all that kick in?
 

DC2

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toddkuen

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I've read through the CASAA stuff.

I was curious where the various Federal Register publications for Steps #2, the public comments for Step #3, and the Step #4 OMB review could be found?

Or are they somehow not required here...
 

DC2

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I was curious where the various Federal Register publications for Steps #2
I believe this is what you are looking for...
View Rule

the public comments for Step #3
Step 3 does not involve public comment.

and the Step #4 OMB review could be found?
The OMB review is not published, and we have no idea why the first pass at deeming regulations were rejected.
 

Jman8

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Exactly what step is all of this in your linked PDF regmap?

There seems like a lot of work under the "Specific Analysis for Steps Three and Seven that's not addressed, e.g., economic impact over $100 million dollars, etc.

When does all that kick in?

I believe answer to your first question is Step 9.

I believe the answer to the second question arose with Step 5.

As DC2 noted, the process is currently in Step 6.
 

DC2

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toddkuen

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So I found the view rule, and, at the top is a link to View EO 12866 meetings, which, if followed take me to a list of attendees from a "Cigar Rights of America" group that met with OMB people.

The view rule, by the way, clearly describes "electronic cigarettes" as one of its targets.

The attendees to the meeting were:

Bridget Dooling - OMB/OIRA
Paul DiNino - Cigar Rights of America
Mike Copperman - Cigar Rights of America
Glynn Loope - Cigar Rights of America
Bobby Newman - J.C. Newman Cigar Co.
Dominic Mancini - OMB/OIRA
Andrew Perraut - OMB/OIRA
Mary Fitzpatrick - OMB/OIRA
Scott Chesemore - HHS/FDA
Bryan Haynes - Troutman Sanders LLP
Kate Collins - HHS/FDA

Perraut, according to this link, "...review regulations from FDA and USDA relating to food safety, biotechnology, and nanotechnology. "

So Copperman was hired/became involved, according to the document linked, to "CRA federal effort to advance legislation that will exempt premium cigars from regulation by the U.S. Food & Drug Administration. "

This was October 12, 2011...

So these CRA (Cigar Rights of America) where lining their ducks up for what we as vapers face today in 2011.

I find this troubling...
 

Kent C

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So I found the view rule, and, at the top is a link to View EO 12866 meetings, which, if followed take me to a list of attendees from a "Cigar Rights of America" group that met with OMB people.

The view rule, by the way, clearly describes "electronic cigarettes" as one of its targets.

The attendees to the meeting were:

Bridget Dooling - OMB/OIRA
Paul DiNino - Cigar Rights of America
Mike Copperman - Cigar Rights of America
Glynn Loope - Cigar Rights of America
Bobby Newman - J.C. Newman Cigar Co.
Dominic Mancini - OMB/OIRA
Andrew Perraut - OMB/OIRA
Mary Fitzpatrick - OMB/OIRA
Scott Chesemore - HHS/FDA
Bryan Haynes - Troutman Sanders LLP
Kate Collins - HHS/FDA

Perraut, according to this link, "...review regulations from FDA and USDA relating to food safety, biotechnology, and nanotechnology. "

So Copperman was hired/became involved, according to the document linked, to "CRA federal effort to advance legislation that will exempt premium cigars from regulation by the U.S. Food & Drug Administration. "

This was October 12, 2011...

So these CRA (Cigar Rights of America) where lining their ducks up for what we as vapers face today in 2011.

I find this troubling...


While they just formed in 2008, they have some 'old ducks backing', and money from manufacturers.
 
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