Predicate Product Exists: Altria In Negotiations To Acquire

[aikanae1]

I think the Boehner letter was more for publicity than carried weight. Too many times I've seen causes supported one day and dumped the next. It's almost predictable. The only way to make it to a party platform is to make this a wider issue, i.e. Chamber of Commerce backing. It has to be on the party agenda to get all Republicans backing.

Dems tend to stray from party agenda frequently however there isn't much interest. Overall, the general public is apathetic about vaping since unlike smoking bans, this is a top down ban effort. There must be a much stronger call from the public to put a ..... in the wall of info - and the FDA / CDC need to be discredited. That's a tough one but it can be done. Right now all Dem's believe FDA / CDC as their source of authoritarian info. There is no independant science and tech agency (defunded during Bush years). Case: Wheeler and industry insider heading FCC recently went against teleco's and cable co's. That was a grass root movement. It didn't really buy much but hopefully will stop it from getting worse by ISP's. Dem's do a lot of compromises so no one feels like they've "won".

vaping just gets little interest from the public. That makes vaping low hanging fruit for funding.

 

[Jman8]

I think the Boehner letter was more for publicity than carried weight. Too many times I've seen causes supported one day and dumped the next. It's almost predictable.

If it is dumped, then that tells me vaping community rather play the reactionary game than the pro-active game.

I currently see nothing better than what this letter conveyed for the vaping community to get behind and push full steam ahead.

And if vaping community doesn't want to or doesn't think it is viable course, it has lost me as a concerned activist. All the other CASAA stuff strikes me as reactionary and playing from behind. I'll still likely to my duty, but realize that our golden opportunity was missed in 2015 and that are only real hope is in court battles or the black market. Both of which are highly reactionary.

 

[BlueSnake]

Just what do you think the vaping community can do? This is a private company. If another company or companies offer enough money it won't matter what the vaping community says or does. Unfortunately almost everyone has a price, and when it comes to business in this country, it's almost always about the money and nothing to do with what's good for the people, or even the country for that matter. Capitalism at it's best!

If it is dumped, then that tells me vaping community rather play the reactionary game than the pro-active game.

I currently see nothing better than what this letter conveyed for the vaping community to get behind and push full steam ahead.

And if vaping community doesn't want to or doesn't think it is viable course, it has lost me as a concerned activist. All the other CASAA stuff strikes me as reactionary and playing from behind. I'll still likely to my duty, but realize that our golden opportunity was missed in 2015 and that are only real hope is in court battles or the black market. Both of which are highly reactionary.

 

[aikanae1]

If it is dumped, then that tells me vaping community rather play the reactionary game than the pro-active game.

I currently see nothing better than what this letter conveyed for the vaping community to get behind and push full steam ahead.

And if vaping community doesn't want to or doesn't think it is viable course, it has lost me as a concerned activist. All the other CASAA stuff strikes me as reactionary and playing from behind. I'll still likely to my duty, but realize that our golden opportunity was missed in 2015 and that are only real hope is in court battles or the black market. Both of which are highly reactionary.

The vaping community is what it is. Yes, they could have gotten on the ball earlier when it comes to outreach, but as the same time it's important to remember that most activist don't do that for a living vs. public health lobbists who are paid to do what they do. The vaping community is also chock full of individualists, thinking out of the box, anti-conformists and unlikely to "join" or fall in step with ANY organized movement. It wouldn't be where it is today without such idealism and that just doesn't translate well to the mainstream. In fact most are frightened / terrorized by "wild, wild west" style of capitalism. The new cyber-security measures fear monger the internet as "wild, wild west" because large manufacturers are refusing to put in back doors that break security and ability to encrypt. People are afraid of the unknown. That translates well to the mainstream.

It would be just as wrong to force a private company to donate their predicate product (if it exists). They can choose to donate and if it's to a non-profit, I think there's some tax deduction benefit since value has been established. But it's not up to the vaping community nor should it be or should it reflect on the viability of the community at large since it's privatley owned. They own it.

I still say CASAA shouldn't feel like they are pandering to openly hold a national membership drive and ask for whatever they need. They limit their own support by not doing so. That's the harshest criticism I have for them and the work they do.

American Vaping Assoc. is the publicity arm of vaping and have been extremely successfull in getting well placed articles, answering questions for media and doing interviews. They also depend on donations. Funding these organizations is critical and that is something everyone can do. No one needs permission to do that.

 

[Cool_Breeze]

If a battle ensues, there should be no grandfather date.

 

[Lessifer]

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?

 

[Jman8]

The way I understand the Boehner letter is Congress (now run by Pubs) telling FDA to move the grandfather date (to circa 2014, or possibly date of final rule).

To me, it implied move it, or when this gets before us, we will move it.

Hence, I think it is worthwhile to make sure we (the vaping community) back it. I think we've already weighed in on this via CASAA, but need to keep that message known, or not lose sight of it. A thread like this ought to not be cause for concern if we are aware of politics and where we are wanting to make a push.

Will 100% of the vaping community stay on top of this? No, I don't think so or feel that is reasonable to expect it. But if us politically aware vapers stay on top of it, I see it as something that stands considerable chance of altering the playing field the FDA put forth, which is still in process of establishing final rule.

 

[aikanae1]

It woulld need party platform support and I haven't seen a lot of enthusiasm for it.

But yes, by all means, it deserves support and I didn't mean otherwise. Technically Congress can make changes. Reality is ....

Changing the grandfather date makes a lot of sense because the way it is now they are expecting to roll back almost a decade of advances. Who ever heard of doing that before to technology???

 

[Jman8]

I guess what I'm saying is that we, vaping enthusiasts, have to be (partly) responsible for party platform enthusiasm. I don't expect Congress to make vaping a top issue with the 2 year gift they've been handed politically. I don't see vaping as even a top 10 consideration when thinking about the scope of all current political issues on the table.

But do think that like Dems were able to grandstand and slide this issue in to their agenda, Pubs could do the same.

To me, being proactive means that instead of allowing Dems to say to Pubs, that you can have thus and so on your latest bill (dealing with a top 5 consideration) as long as you concede on the vaping thing, we instruct Pubs (acknowledgment by me that this is easier said than done) to give Dems some low hanging fruit item (that is top 20 issue on their agenda) but say to have this, you must also vote yes to moving vaping grandfather date. The only way I see this being opposed is if vaping is actually higher priority than we in this thread are suggesting. Perhaps for Dems, the vaping issue (like smoking) is actually top 10. For Pubs, I acknowledge that it is probably not even top 20, which if our little coalition of politically aware vapers were thinking strategically, it ought to be something that could be decided upon in next 2 years with almost no fanfare. Moving the grandfather date with barely any press going on. The public doesn't need to be made aware of how significant of a deal moving the grandfather date is. Why should we think they might care or should be made to care? I assume the general public doesn't care, even a little bit, when the grandfather date is established. If it were 2005 or 2020, I think the public will likely just expect some sort of oversight is occurring and that's as far as their concern goes.

 

[BlueSnake]

If I remember right I think Congress might have only passed ONE budget in the last 8 years. Since they can't even agree on important issues like money, why would anyone think they could or would even entertain any possible legislation on vaping? That is unless someone like Big Tobacco pays a lot of money and makes it very lucrative for them to do so.

I can't even remember the last time I saw any meaningful public demonstration.

 

[KODIAK (TM)]

To me, it implied move it, or when this gets before us, we will move it.

Well, color me confused. I thought these deeming regs will be enacted automatically without any further final/formal congressional approval (they already did that). So in essence, this won't even get to them unless they intervene with new legislation which will require a vote. (Not easily done).

Yes/no???

 

[WorksForMe]

Well, color me confused. I thought these deeming regs will be enacted automatically without any further final/formal congressional approval (they already did that). So in essence, this won't even get to them unless they intervene with new legislation which will require a vote. (Not easily done).

Yes/no???

After a rule is published, it is sent to Congress. If they do nothing, the rule becomes effective. In order to disapprove a rule, both houses of Congress have to pass a resolution and the President has to sign it. I'd guess that won't happen.

How is the Congress in involved in reviewing final rules?

Under the Small Business Regulatory Enforcement Fairness Act (also known as the
Congressional Review Act), new final rules must be sent to Congress and the Government
Accountability Office for review before they can take effect. “Major rules” (ones that are
economically significant and require OIRA review) must be made effective at least 60 days after
the date of publication in the Federal Register, allowing time for Congressional review. In
emergency situations, a major rule can be made effective before 60 days.

If the House and Senate pass a resolution of disapproval and the President signs it (or if both
houses override a presidential veto), the rule becomes void and cannot be republished by an
agency in the same form without Congressional approval. Since 1996, when this process
started, Congress has disapproved only one rule.

Congress may also exercise its oversight in other ways, by holding hearings and posing
questions to agency heads, by enacting new legislation, or by imposing funding restrictions.

 

[DC2]

I'm withholding judgement until anything concrete rises, but if true, here's what I'm thinking.

It means a company that is in no sense of the word strapped for cash would rather pay millions for an inferior predicate product, than face the future approval process.

If this is the right way to view it, that's quite scary.

When it comes to hedging your bets, this is most definitely the best way to do it.

 

[DC2]

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?

As far as I know that is an unknown.

The FDA has said that they don't think have the power to change the grandfather date.
That means they think only Congress can do it.

And yet it is Congress that sent the letter to the FDA urging them to change the grandfather date.

So something is amiss here.

 

[WorksForMe]

Past SE applications are an indication of what the FDA will do in the future. If a company that owns a predicate product makes any improvements to it, FDA won't consider it SE. Since very few people would buy an e-cig that was on the market in 2006, I don't understand how that company benefits greatly from owning the predicate. Even a Blu is much better than a predicate product.

 

[DC2]

Past SE applications are an indication of what the FDA will do in the future. If a company that owns a predicate product makes any improvements to it, FDA won't consider it SE. Since very few people would buy an e-cig that was on the market in 2006, I don't understand how that company benefits greatly from owning the predicate. Even a Blu is much better than a predicate product.

That's why Altria isn't willing to pay more than a token amount for this product.
Their offer sounds like pocket change.

 

[WorksForMe]

That's why Altria isn't willing to pay more than a token amount for this product.
Their offer sounds like pocket change.

I wouldn't mind having that kind of pocket change.

 

[aikanae1]

I guess what I'm saying is that we, vaping enthusiasts, have to be (partly) responsible for party platform enthusiasm. I don't expect Congress to make vaping a top issue with the 2 year gift they've been handed politically. I don't see vaping as even a top 10 consideration when thinking about the scope of all current political issues on the table.

But do think that like Dems were able to grandstand and slide this issue in to their agenda, Pubs could do the same.

To me, being proactive means that instead of allowing Dems to say to Pubs, that you can have thus and so on your latest bill (dealing with a top 5 consideration) as long as you concede on the vaping thing, we instruct Pubs (acknowledgment by me that this is easier said than done) to give Dems some low hanging fruit item (that is top 20 issue on their agenda) but say to have this, you must also vote yes to moving vaping grandfather date. The only way I see this being opposed is if vaping is actually higher priority than we in this thread are suggesting. Perhaps for Dems, the vaping issue (like smoking) is actually top 10. For Pubs, I acknowledge that it is probably not even top 20, which if our little coalition of politically aware vapers were thinking strategically, it ought to be something that could be decided upon in next 2 years with almost no fanfare. Moving the grandfather date with barely any press going on. The public doesn't need to be made aware of how significant of a deal moving the grandfather date is. Why should we think they might care or should be made to care? I assume the general public doesn't care, even a little bit, when the grandfather date is established. If it were 2005 or 2020, I think the public will likely just expect some sort of oversight is occurring and that's as far as their concern goes.

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.

I think of the first time Geo. Bush Sr. saw a grocery store scanner and was amazed at technology. The rest of us had been hating scanners for 10 years by then. They don't even go to the grocery store in their bubble. All the commuication and entertainment industries have VIP lists to give special service to politicians and the donor class - yet look at what happened with SOPA. In 24hrs, Congress went from passing it without objection to it failing. Also remember that in another 24 hours, the DOJ acted as if SOPA had passed and has been ever since. Those headlines never reach the person on the street. It's hard to believe that broadcasters and politicans can still get away with "it's too complicated" as a reason to refuse to report on IT issues 20+ years later! Same battles, different faces for tons of issues. The public can be bought.

That's not a no win. There are plenty of single issue voting blocks that have made a difference, even winning. Just have to be smart and coordinated. The vaping industry is just starting with networking.

CASAA has not been invited to many major policy meetings and that's NOT their fault. Congress / FDA calls in public health agencies, tobacco-free kids to represent the public. They use BT (TVEA or whatever) to represent business. They use AMA, FDA, CDC to represent science. Every single one of those are a joke. The independant vaping community has been iinvisiable in the past. That's getting harder to defend (yeah).

The regulations have to go through OMB one more time too. This time (I'm hoping) they'll have to use real figures and not just "guessimate" the number of products and financial impact.

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.

What cracks me up is every time a story mentions something about being met with a "passionate" group - like that's a bad thing? They have no idea ...

 

[LaraC]

Past SE applications are an indication of what the FDA will do in the future. If a company that owns a predicate product makes any improvements to it, FDA won't consider it SE.

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.

 

[Steamix]

Interesting .

But Altria isn't the only fish in the BT pond. And the competitors won't be twiddling their thumbs. And politicians - ever the opportunists - and the institutions - ever ehte opportunists - have been known to make an about-face when it suited - or benefited them - without so much missing a beat.

And they'll troop out their lawyers and lobbbyists, tryin to get the deeming regulation changed as some recommendations may not have been made 'in good fiath' and so and so forth.

Might - just might - work in favour of the vaping community : batallions of BT lawyers slugging it out in the courtooms, BT lobbyists quietly whispering in backrooms ...
could stall the whole shebang for a looooong time and deadlock any federal legislation. Still leaves the skirmishes with city councils and other governing bodies cooking up their own regs.