Predicate Product Exists: Altria In Negotiations To Acquire

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aikanae1

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I'm not so sure if "any" improvements by the owner of a predicate product would prevent a new version from still being regarded (by the FDA) as substantially equivalent. Might depend on exactly what the changes were (more safety? less appeal to youngsters?) and... how "in" the company was with the powers-that-be at the FDA.

In over ten years of using CPAP machines for sleep apnea, I've looked (as an interested amateur) casually at quite a few applications for new machines that relied on being based on predicate devices when applying to FDA for permission to put them on the market. Granted, those are medical devices, but the applications did repeatedly mentioned the predicate machines they were based on. The changes/improvements were considerable, yet they sailed right through the approval process.

Interesting. I know Bill has posted results from applications for tobacco on here before. I seem to recall very confusing denials; changes in the number or change of cigarette rolling paper suplier, etc. There's no posted standards - an Atlantic magazine article went into detail on it. There was a backlog of over 3,000 applications and the FDA had only processed a few.

From what your saying, it sounds as if tobacco has a higher standard to meet than medical does.
 

Jman8

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We are going into campaign season. You can bet that ANY industry / organiztion without support will be considered low hanging fruit for the next 2 years. The reality is there are about 1,000 active donors funding 90% of political campaigns and that figure will probably increase on all fronts, local and national. Most those donors believe they can buy votes with enough money and marketing. So far, it looks like they have been right. They don't care when both parties are scrambling for dollars.

<snip>

I still say a national (loud) coordinated membership drive using shops and meets would go a long way. CASAA's membership should be 100's times higher than it is. I don't think vapers are apathetic but un-coordinated. Business's are getting their act together, we need to get ours together too. The more co-ordinated "we" vapers are, the tougher it'll be to cause harm to the industry. And it's not just about us. A large membership drive resulting is numbers would scare the pants off a lot of local / maybe federal politicians (reporters stil have to sell their stories). Obviously a sticker on the front door or banner on a home page isn't reaching vapers who are using non-BT ecigs.

IMO, the Boehner letter is our current best option going forward. It doesn't hold out promise or reassures me that everything will be perfect for the freedom loving vaper say 5 years from now.

But our other options strike me as fanciful and either many years away or not sure to what end they are working for. A coordinated membership drive will be great until the many (passionate) people start putting forth their various agendas. Who truly speaks for all vapers? I've not seen this group / leader. Post anyone of them here that you think ought to be considered, and except for CASAA, they'll get picked apart. Even CASAA will to some degree, but me and a few dozen others will defend them immediately. Others, within vaping family, not so much.

Congressional oversight that leads to change in FDA proposal is our best bet. That change might not be ideal, but when more than 50% of the politically aware vapers are claiming the sky is falling, then less than ideal is arguably reason to do cartwheels and make some noise about. Changing the grandfather date, as was proposed by the leader of the House Republicans, is easily the most significant item to occur politically since 4/24/14. I can't even think of an item that would be second to this, without considering it a distant second.

And I realize that the Boehner letter may be a fruitless path that will end up being a let down. But the whole politics of vaping right now is a huge let down unless one does entertain how very okay a black market could be. Take that out of the picture, and where is there reason to hope? The Boehner letter is reason to coordinate. The Boehner letter is reason to motivate and be motivated. It undoes all this predicate product nonsense, at least in the way it is currently being framed.

I can count on one hand the amount of times that politicians (at any level) have appeared reasonable on the topic of vaping. And almost all of of those times are from national Republicans who don't appear to be neglecting this issue nor in it just for the money. They'd stand a great chance of capturing a vast majority of voting vaping public by simply sticking to what they put forth in 2014, and a decent chance of capturing non-vaping public if they continue to show up modest/reasonable on this (and other) issues. In past election cycles, when an issue came up that had 'nothing to do with me,' I generally gravitated toward whatever candidate was most reasonable, not the one that had most donors willing to do most damage to an industry. I'm thinking I'm not alone in that approach but admittedly am not sure.
 

DC2

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I'm not so sure if "any" improvements by the owner of a predicate product would prevent a new version from still being regarded (by the FDA) as substantially equivalent. Might depend on exactly what the changes were (more safety? less appeal to youngsters?) and... how "in" the company was with the powers-that-be at the FDA.

In over ten years of using CPAP machines for sleep apnea, I've looked (as an interested amateur) casually at quite a few applications for new machines that relied on being based on predicate devices when applying to FDA for permission to put them on the market. Granted, those are medical devices, but the applications did repeatedly mentioned the predicate machines they were based on. The changes/improvements were considerable, yet they sailed right through the approval process.
Perhaps some things get treated with a lighter touch than other things.
But you sort of already said that.
;)
 

DC2

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Interesting. I know Bill has posted results from applications for tobacco on here before. I seem to recall very confusing denials; changes in the number or change of cigarette rolling paper suplier, etc. There's no posted standards - an Atlantic magazine article went into detail on it. There was a backlog of over 3,000 applications and the FDA had only processed a few.

From what your saying, it sounds as if tobacco has a higher standard to meet than medical does.
Below is the link to the thread that people who are interested in this topic should be reading...
http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html

I'm not sure it makes much sense to discuss this topic without having read that thread.
Which is to say that everyone reading this thread should also read that one.
:)

I'm not so sure if "any" improvements by the owner of a predicate product would prevent a new version from still being regarded (by the FDA) as substantially equivalent. Might depend on exactly what the changes were (more safety? less appeal to youngsters?) and... how "in" the company was with the powers-that-be at the FDA.

In over ten years of using CPAP machines for sleep apnea, I've looked (as an interested amateur) casually at quite a few applications for new machines that relied on being based on predicate devices when applying to FDA for permission to put them on the market. Granted, those are medical devices, but the applications did repeatedly mentioned the predicate machines they were based on. The changes/improvements were considerable, yet they sailed right through the approval process.
I have no problem imagining that some "people" might get a lighter touch from the FDA through these processes...
 

skoony

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i have been thinking this over a bit.
while i usually take the doom and gloom side of these
arguments i see a glimmer of light. all we need is another
party and,hopefully a third party to announce no,we have
the predicate product. there would have to be immediate
costly and lengthy legal mitigation to determine the rightful
owner of the predicate product. if indeed the ownership of
said product could perhaps obtain a distinct advantage
in the up coming regulations,how could the FDA issue
such reg.'s in the absence of a genuine predicate product
until the courts decided? even if the FDA does have a preicate
product in mind,if its not the product the party claims as theirs
could sue and keep things tied up in the courts until human
Mars Base 3 is full.
:2c:
regards
mike
 

aikanae1

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Your optimistic about voting. There's too many other issues for vaping to rate. That's not saying a single issue voting block doesn't have power because that's not true. Somewhere in the mix we need to be able to make sure they follow through with what they say. Our AG Horn (R) stuck up for voting rights and less than a month later (I think it was a week) signed off on the AG's letter demanding more regulations. He got a lot of press standing out, then he was one of a crowd doing the opposite.

Please understand, I don't want to bash any side. I'm just attempting to be objective. Context is critical in figuring out motives, intentions, bedfellows. That's where there is some difference in the parties. It doesn't mean much in the long run but that's where strategy comes in. Dems have a history of caving to shock and awe. Republicans have a public and a private face.

I hope your not serious about a leader. This is more of a crowd, grass roots movement and that's what it needs to be. A top down hierarchy is too easily torn down. Think of the way most "kids" (under 30) have been raised and the organizational system most infuential and it'll look more like a mesh, lateral organization / individual action. It does not fit within red vs. blue political systems. Vaping is not the only industry that's labeled "disruptive" before it has a chance to get off the ground and prove anything. I can read many of the same words, different faces and subjects in a number of different areas, and I sympathize because it narrows their futures down to a service industry, "don't think" position. Vaping is one more cog in the wheel.

We have time. I think we both know that in the back of many vapors' minds, the possiblity of having supplies cut off is real. I'm sure there are those day dreaming of how to deal with it such that if that ever were to happen, it'd get handled. But it's not there yet so we can't get lazy either.

This needs to be fought on all fronts, networked and moving together as one. That IMO is their worst fear.
 
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aikanae1

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Below is the link to the thread that people who are interested in this topic should be reading...
http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html

I'm not sure it makes much sense to discuss this topic without having read that thread.
Which is to say that everyone reading this thread should also read that one.
:)
I have no problem imagining that some "people" might get a lighter touch from the FDA through these processes...

Thanks for that refresher.

I also remember there were 2 different standards for nicotine use;

one was pharmaceutical in individual treatment for a specific disease which Zeller (and others) have said they could approve.

second was approving a known harmful substance for recreational use, which is how tobacco is viewed, and Zeller has stated that he has a moral conflict with that (the "public health" standard). I seem to recall similar statements coming from previous FDA directors.

I've always sorta wondered why cigarettes got a grandfather period and no other tobacco category got that.
 

Jman8

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Your optimistic about voting. There's too many other issues for vaping to rate. That's not saying a single issue voting block doesn't have power because that's not true. Somewhere in the mix we need to be able to make sure they follow through with what they say. Our AG Horn (R) stuck up for voting rights and less than a month later (I think it was a week) signed off on the AG's letter demanding more regulations. He got a lot of press standing out, then he was one of a crowd doing the opposite.

Please understand, I don't want to bash any side. I'm just attempting to be objective. Context is critical in figuring out motives, intentions, bedfellows. That's where there is some difference in the parties. It doesn't mean much in the long run but that's where strategy comes in. Dems have a history of caving to shock and awe. Republicans have a public and a private face.

You may be the first person to say I am optimistic about voting. I almost resent such a comment (as I am that pessimistic about voting). I think the letter is significant because it could open a debate up that is visible, just as the grandstanding by Dems last year was (made) visible. If anything were to occur in 2015, I'd want the letter to be pushed to point of debate on the (House) floor and have it so members are on record with what they really wish to put forth as public face on vaping. I'll be pleasantly surprised if there is one Dem (or more) that appears to be reasonable with vaping regulations moving forward. And I fully expect there to be some Pubs that are unreasonable when it comes to this matter, but do think Boehner a few others could raise a debate that would challenge people on predicate product stuff. Plus, there's a chance (albeit small) that it opens up debate on FSPTCA and remote possibility that someone, from somewhere claims eCigs ought to be exempt.

I hope your not serious about a leader. This is more of a crowd, grass roots movement and that's what it needs to be. A top down hierarchy is too easily torn down. Think of the way most "kids" (under 30) have been raised and the organizational system most infuential and it'll look more like a mesh, lateral organization / individual action. It does not fit within red vs. blue political systems. Vaping is not the only industry that's labeled "disruptive" before it has a chance to get off the ground and prove anything. I can read many of the same words, different faces and subjects in a number of different areas, and I sympathize because it narrows their futures down to a service industry, "don't think" position. Vaping is one more cog in the wheel.

I was serious about leadership. As far as it relates to coordinated efforts. Whoever takes on that responsibility will be looked at (by us and them) as some sort of leader. CASAA stands only chance that I see for making that happen. Everyone else could make it work to some degree, but would be ripped apart (by them mostly) in the process. And as we seem to have some of 'them' within our ranks, it would also appear like we don't think this person is a good coordinator. Probably doesn't even vape. Some of us will surely call that person ANTZ.

Grassroots is great. I'd prefer that as I'm okay with long term strategizing. I'm okay with black market where true grassroots people will NOT give up the fight.

IMHO, vaping is a really big deal politically as it encapsulates a few other (much bigger) issues. But because it is relegated to "just like smoking," it is easy to be dismissive about it unless you are politically aware vaper. I get why the general public is not all that aware of what vaping is, much less the politics involved. Seems 98% of society (worldwide) is entirely brainwashed on the smoking topic, so why (from that perspective) even be a little concerned about vaping. I count on vaping dangers to go up in what's reported. Predicted this back in 2011 and thus far I feel spot on. I think there is more to come and that if it does go like smoking has, it'll get a lot worse before it gets a little better. Therefore the Boehner letter is really our best chance for legitimate advancement given the troubled road ahead.

We have time. I think we both know that in the back of many vapors' minds, the possiblity of having supplies cut off is real. I'm sure there are those day dreaming of how to deal with it such that if that ever were to happen, it'd get handled. But it's not there yet so we can't get lazy either.

This needs to be fought on all fronts, networked and moving together as one. That IMO is their worst fear.

Grassroots makes it very challenging, if not impossible, to move together as one. There is much disagreement, I observe, on what is core to who we are. I see vaping as recreational alternative. Others are hung up on the THR claim as the core to what we are up to. I see that as okay and workable, but not what we ought to be hanging our hat on. It concedes way too much to opposition, telling them "you were absolutely right about smoking risks" and then attempts to argue "but you are absolutely wrong about vaping risks." As I said, the reports on 'vaping risks' will get worst and if recent issues are any indication on how things look going forward, we'll have many vapers (of the politically aware variety) who will be calling forth regulations based on these reports. I cite diketones as prime example of what I speak of. I bring all this up because 'moving together as one' strikes me as pipe dreaming. Makes me want to re-ask the question on leadership and if that is downplayed, then wondering how grassroots can all be on same page when it is plausible that we have ANTZ within us, within our ranks?
 

DC2

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I bring all this up because 'moving together as one' strikes me as pipe dreaming. Makes me want to re-ask the question on leadership and if that is downplayed, then wondering how grassroots can all be on same page when it is plausible that we have ANTZ within us, within our ranks?
I've been thinking about this a lot over the last few days...
Basically ever since I saw a post accusing many posters here of engaging in "Group Think" of some kind.

I don't think that I can cite a single poster here whom I agree with on all things vaping related.
Not even one.

But there has to be something we ALL agree on?
No, probably not.
 

DC2

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Oh yeah, and as far as the leadership thing, I'm thinking SFATA is a better choice than CASAA...
More experience, more money.

NOTE: This is in no way intended to downplay the importance of CASAA
NOTE: They have been, and hopefully will continue to be, a very important player in this "game"

I've always said that it's all about getting the vendors involved.
And I know I haven't had nearly the success doing that as I had hoped I would.
 
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Jman8

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I've been thinking about this a lot over the last few days...
Basically ever since I saw a post accusing many posters here of engaging in "Group Think" of some kind.

I don't think that I can cite a single poster here whom I agree with on all things vaping related.
Not even one.

But there has to be something we ALL agree on?
No, probably not.

I think there are many things we ALL agree on. I think where disagreement comes is from how important that item we all agree on actually is, and how we might push for it politically.

I think we all agree that vaping nicotine reduces cravings for smoking nicotine. I as dual user can attest to this. Perhaps there is vaper who's been vaping for all of 2 months who wishes to claim it has not reduced their cravings. But I think all long term vapers agree on this. Yet, I'm not going to get on board with some political action that says "vaping is clearly a smoking cessation product and we we ought to be pushing politicians into understanding this." In fact, I would be actively resisting such an action.
 

Jman8

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Oh yeah, and as far as the leadership thing, I'm thinking SFATA is a better choice than CASAA...
More experience, more money.

NOTE: This is in no way intended to downplay the importance of CASAA
NOTE: They have been, and hopefully will continue to be, a very important player in this "game"

I've always said that it's all about getting the vendors involved.
And I know I haven't had nearly the success doing that as I had hoped I would.

From vaping enthusiast perspective, I'd take CASAA over SFATA. Would be nice to see these two coordinated as one appears to speak directly to people and the other to businesses.
 

aikanae1

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We need both orgaizations. And we need AVA too. Two bills were recently introduced here. Last weekend was the first meeting of this state's SFATA chapter and I consider this to be an active area based on number of stores, meets, online activity, etc. Roughly about 50 business' (some with more than one shop) between 2 major cities. 6 business' showed up. A total of 20 people.

One reason some vapers may appear apathetic is there's no direction to channel their frustration. I can't tell you how often I feel like I care more about a buisness than the owner / employees do. I don't read the legislative section because I feel so helpless. That is a lot of energy that's being squandered. I'll say it again, a national membership drive has advantages on several fronts including the one it's intended for. Business would take more notice, education, .... This does not mean SFAFTA doesn't have a role - they do. That's the level that lobbyists are hired, testimoney, numbers, on and on. Getting involved is good business. AVA is essential. They've done a good job getting interviews, articles placed, responding to media. Needed them yesterday. If anyone of those lag behind, they drag the others down too.

We know the harms of smoking.
We know that vaping is less harmful.
We know that standard NRT therapies are inefectual and chantix kills.
What else do we need?
Arything else is BS.

2 more thouhghts:

"There is a danger that the precautionary principle is being used to deny smokers access to products which can save their lives." - Deborah Arnott, Chief Executive of Action on Smoking&Health UK (ASH)

"As science walks a dangerous line between persuasion and informing, we must be mindful of society stepping in and requiring individuals to accept norms regardless of their own beliefs. In the case of cigarettes and e-cigarettes, history will judge us harshly as to how we answer this billion person question. It may also look back in anger at policy-making amounting to institutionalized manslaughter". - Professor Julian Kinderlerer, President of the European Group on Ethics in Science and New Technologies (EGE)
 
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Kent C

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There is no independant science and tech agency (defunded during Bush years).

Not sure to what you're referring. No love lost here for Bush, but if he "defunded" something (and only congress can actually do that), then it was a government something, not likely "independent" as we have seen.
 

Kent C

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There's something about the Boehner letter that I don't think I'm understanding. It was basically a letter to the FDA urging them to consider moving the grandfather date, in regards to vaping products right? Isn't congress who set the grandfather date for cigarettes? Wouldn't it take congress, not the FDA, to change the grandfather dates for vaping products? Or am I missing something?

Zeller has said only congress could change the gf date.
 

Kent C

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The Boehner letter makes this all moot, IF he follows through. My gut says he will. There are many now in the majority in both Houses, that prefer not to regulate and some of them smoke and a few even vape, including Boehner on occasions.

I should note that I'm not in favor of a grandfather date as aikanae and others have said. Freezing tech at any date is just plain stupid. That said, I'd take the 2014/15/16/17 date over the 2007 date :) Just like I'd like to see no income tax, but if they dropped the rate to a flat 10% I'd not argue the point..... well, not right away anyway :lol:
 
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