Deeming Regulations have been released!!!!

[Rossum]

I remember at the time (2007?) that FDA had just astronomically increased the tax on cigarettes and vaping products were introduced around the same time. I'll bet BT did not see them as ever coming the competition it is today. Now they're worried. Not only the US but cigarettes are sold world wide, and so are vaping products. Other countries do not have the battle we do with BT. They're countries don't make the money our Gov does on the sale of tobacco.

I'm probably nit-picking here, but the FDA does not have the power to tax anything.

 

[coldgin96]

I truly feel everyone's pain in here. I am spending a mint on gearing up and preparing for the worst. The money I have spent this year on ProVari's, endcap springs, 10% nic juice purged with N2, spare Kabuki glass, replacement air screws and Nautilus coils would make most people shake their heads and call me insane. Most of the people in here get it and I'm sure there are those who are going, and have went even further than me.

However,

It's not over until the fat lady sings and she's still putting on her jewelry.

 

[Kent C]

Thanks for posting that, Ken. I have no doubt that many of the anti vaping group say one thing publicly and mean another privately.

Altria has said publically it's against the deeming and for moving the grandfather date.

But like anything, I'll follow the money. These companies have not gotten where they are today by being "the good guys".

If you follow the biggest money, it's the tobacco companies paying MSA and the state gov'ts collecting. And the Federal gov't collecting the sin taxes on cigs.

They are a bunch of snakes in neck ties. Altria can play the boy scout but it could also be the sacrificial lamb. Altria is not a vaping product. It's a tobacco product.

Altria is a tobacco company that makes cigarettes and ecigs.

They are probably done with all the testing they have recommended and will not suffer the deeming requirements.

At this point there is no reason to believe that the FDA would accept any PMTAs even from those who could afford them.

I think in all fairness (what's that) that if Big Pharma and BT were part of the "dream team" in constructing the regulations, it is not right that our vaping community was not given an invite to be a part of that.

Perhaps CASAA should have tried harder or offered Altria assistance??

I remember at the time (2007?) that FDA had just astronomically increased the tax on cigarettes and vaping products were introduced around the same time.

The two biggest tax hikes in cigs was Clinton in 1997 $.24 to $.99, and Obama - On February 4, 2009, the Children's Health Insurance Program Reauthorization Act of 2009 was signed into law, which raised the federal tax rate for cigarettes on April 1, 2009 from $0.39 per pack to $1.01 per pack

I'll bet BT did not see them as ever coming the competition it is today. Now they're worried. Not only the US but cigarettes are sold world wide, and so are vaping products.

Altria and RJR don't appear "worried" - they want a bigger ecig market US and worldwide.

Other countries do not have the battle we do with BT. They're countries don't make the money our Gov does on the sale of tobacco.

They don't have MSA but they have plenty of luxury, excise taxes on tobacco.

And like I said in an earlier post,

Lawsuits mount against FDA regs on e-cigarettes

...one isn't going to stop the 'BT conspiracy' idea because it suits the narrative of people who hate business and love gov't OR who think that only big gov't can stop big business when in fact only the market can stop the bigness that gov't creates in business through 'crony fascism' - taxes and regulation that takes out competition against bigger companies.

 

[Kent C]

because the FDA would have had to show at least some credible reason to reject the PMTAs that were submitted by BT.

But in the final version of the Deeming, that's not how things work.

I see nothing in the final version that is different in the way of PMTA's from the original. And I don't think the FDA has to explain anything for rejecting them. They haven't so far on other products. The pocket veto has been used many times prior to the original deeming and since, according to Bill G. The only one passed was snus. (there were some SE products accepted but not PMTAs.)

 

[seminolewind]

I'm probably nit-picking here, but the FDA does not have the power to tax anything.

Yea it's nit-picking. Someone .gov is making lotsa money.

 

[Kent C]

I'm probably nit-picking here, but the FDA does not have the power to tax anything.

It's not nitpicking, just correcting errors in judgment.

 

[Rossum]

I see nothing in the final version that is different in the way of PMTA's from the original.

From the original proposal (23176 Federal Register /Vol. 79, No. 80 / Friday, April 25, 2014 / Proposed Rules):

FDA does not intend to initiate enforcement action against the product for failing to have an FDA marketing authorization unless and until FDA issues an order denying the PMTA under 910(c).

From the final rule (29011 Federal Register /Vol. 81, No. 90 /Tuesday, May 10, 2016 /Rules and Regulations)

PMTAs—36 months from the effective date of this final rule (12 months after the compliance period for submission of such requests). Once the continued compliance period ends, new tobacco products on the market without authorization will be subject to enforcement.

There definitely is a difference, and the previous couple of pages explain their supposed rationale for the change.

 

[Kent C]

From the original proposal (23176 Federal Register /Vol. 79, No. 80 / Friday, April 25, 2014 / Proposed Rules):

From the final rule (29011 Federal Register /Vol. 81, No. 90 /Tuesday, May 10, 2016 /Rules and Regulations)

There definitely is a difference, and the previous couple of pages explain their supposed rationale for the change.

Ok.... on the extension dates - agreed, but not on the actual determination on the PMTAs

 

[seminolewind]

I still don't buy Altria as someone trying to save the vaping community.

Altria Group Inc. Tries to Save the E-Cig Industry -- The Motley Fool

Follow the money. Not the "sacrifice" some BT is making. They are not.

Give Altria a hand? I have a finger to give them.
There are quite a few groups who could have sent a representive for the vaping community. CASAA, and possibly The American Vaping Association.

All I know is somewhere around 2009, the price of cigarettes rose dramatically and caused me to find vaping. Yes, my initial reasoning was to cut expenses.

I will bet that Altria had some head start with testing already. Probably about 10 years worth. I'll bet they can pass and sell legally now or soon like next year. They have been working hard in their Labs since 2007 or maybe before. All they have been looking for in this past 10 years is time to get it done first. Stalling us.

And they stole this whole vaping realm from us who were vaping to quit smoking. Why on earth didn't we patent everything, LOL? They will look like the heroes, not the bad guys. They do intend to wipe us out. I'm not touching any of their products.

 

[Rossum]

Ok.... on the extension dates - agreed, but not on the actual determination on the PMTAs

I'm not sure what you mean.

The way I read the difference is that in the original proposal, the FDA said (effectively): "Once you file a PMTA, you can keep selling your product until we make a determination, which may be never." Now we all know that the FDA doesn't exactly act quickly, so in all likelihood, this would have given BT (who definitely has the resources to file PMTAs) an ill-defined and potentially indefinite amount of time to keep selling their stuff while anyone who didn't have the resources to file one had to pull their stuff from the market.

Now, in the final rule, the FDA is saying effectively: "If you file a PMTA, you get one year more than anyone who doesn't, and if we don't get around to approving your PMTA within that year, too bad, you have to stop selling your product until we do, which may be never".

If I were an exec in charge of the vapor products division at a BT company, I would see that as a HUGE difference, and it would make me WANT a grandfather date change.

 

[Kent C]

I'm not sure what you mean.

The way I read the difference is that in the original proposal, the FDA said (effectively): "Once you file a PMTA, you can keep selling your product until we make a determination, which may be never." Now we all know that the FDA doesn't exactly act quickly, so in all likelihood, this would have given BT (who definitely has the resources to file PMTAs) an ill-defined and potentially indefinite amount of time to keep selling their stuff while anyone who didn't have the resources to file one had to pull their stuff from the market.

Now, in the final rule, the FDA is saying effectively: "If you file a PMTA, you get one year more than anyone who doesn't, and if we don't get around to approving your PMTA within that year, too bad, you have to stop selling your product until we do, which may be never".

If I were an exec in charge of the vapor products division at a BT company, I would see that as a HUGE difference, and it would make me WANT a grandfather date change.

I'm thinking more along the lines of what standards of determination on PMTA's. Either way, we don't really know and no indication from either version. Again, I agree the extension laid out in the final is more precise.

 

[Kent C]

Follow the money. Not the "sacrifice" some BT is making. They are not.

If you "follow the money" it goes to gov't in most cases or gov't protected businesses - iow, it makes more sense to say "follow gov't control" - only then can some businesses actually make money. No one said Altria was sacrificing anything. If you read Siegel, they simply think their chances of making money is better in a bigger market (hence their favoring Cole/Bishop) than in a smaller market where they are the only player or one of very few.

 

[Burnie]

The two biggest tax hikes in cigs was Clinton in 1997 $.24 to $.99, and Obama - On February 4, 2009, the Children's Health Insurance Program Reauthorization Act of 2009 was signed into law, which raised the federal tax rate for cigarettes on April 1, 2009 from $0.39 per pack to $1.01 per pack

@Kent C my math is a little rusty, but if Clinton raised it in 1997 from $.24 to $.99, How could Obama raise it from $0.39 per pack to $1.01 per pack? Was it not already at $.99 from 12 years earlier when Clinton raised it? Or did someone along the way lower it after Clinton to $.39 per pack? Am I missing something here? To me these numbers don't add up. But then again my math is a little rusty.

 

[seminolewind]

Smacks of Walmart in small towns.

I'm sure Altria is covering all the bases. I'm waiting to hear that they've finished all the requirements in testing their product. I know they were testing right after the vapes hit the market. So they will come in no matter what ahead of us all and gobble up the consumers.
The "tobacco" product of theirs will still require the high taxes and the gov won't have to look elsewhere to make up that 40+ billion dollars that they get from tobacco taxes.

 

[seminolewind]

@Kent C my math is a little rusty, but if Clinton raised it in 1997 from $.24 to $.99, How could Obama raise it from $0.39 per pack to $1.01 per pack? Was it not already at $.99 from 12 years earlier when Clinton raised it? Or did someone along the way lower it after Clinton to $.39 per pack? Am I missing something here? To me these numbers don't add up. But then again my math is a little rusty.

The price was raised substantially more than once.

 

[Kent C]

@Kent C my math is a little rusty, but if Clinton raised it in 1997 from $.24 to $.99, How could Obama raise it from $0.39 per pack to $1.01 per pack? Was it not already at $.99 from 12 years earlier when Clinton raised it? Or did someone along the way lower it after Clinton to $.39 per pack? Am I missing something here? To me these numbers don't add up. But then again my math is a little rusty.

The Clinton tax was reduced a few times. Clinton even supported the decrease at one point.

 

[coldgin96]

The Clinton tax was reduced a few times. Clinton even supported the decrease at one point.

I'm sure he did. He didn't want Monica to pay more for those cigars she was gifting him than she had to!

 

[seminolewind]

If you "follow the money" it goes to gov't in most cases or gov't protected businesses - iow, it makes more sense to say "follow gov't control" - only then can some businesses actually make money. No one said Altria was sacrificing anything. If you read Siegel, they simply think their chances of making money is better in a bigger market (hence their favoring Cole/Bishop) than in a smaller market where they are the only player or one of very few.

I prefer to follow the money.

The people I empathize most with are those who are "kept" smoking to supply every BT or .GOV with plenty of money. Approving junk that doesn't really work especially not a year after quitting smoking with lozenges, gums, or patches. But if something comes along that will capture at least 50% of the cigarette market in 3-4 years, expect a lot of rules, regulations, insisting on costly submission methods that small business owners can't afford.

Just like no one could stop Walmart from putting thousands of small businesses out of business, it will be BT closing us all up for the profit. I would hate to go from a tobacco smoking slave to a vaping slave. I will quit vaping if it means buying vaping product from BT.

Before this all started, I don't recall anyone (or very few) in our vaping community price gauging (sp?) . I have seen most of us being helpful and supportive. While small businesses opened up, yes, they were in it for profit. But when it came to information and support, they did not forget that they are still part of our community.

When I quit smoking for vaping, it became very important to me how smokers were taken advantage of, used as cash cows, were sent outside to our little corners, and how smoker reality really operated. I really don't mind if people want to continue smoking or don't want to do anything for their health. It's really not their fault, and it just makes me plain ole' crazy nuts to see what advantages there are for keeping people smoking. They prey on tobacco addicts. They are more guilty than people think. And no one can tell me that the gov. does not see any of this. If they don't they're a$$holes or choose not to see.
All of them can scream that they want to offer healthier products, or scream that they want people to quit smoking. But they really don't want them to-when you think of all the money made from those addicted to tobacco. Once BT takes most of the market, it won't be a cheaper way to quit and enjoy vaping. It's such a crime that they could not just leave us alone. If BT was not involved, there would not be all this deeming and expensive regulation.

Please don't pick and correct parts of this. It's not an argument.

 

[Bea-FL]

I prefer to follow the money.

The people I empathize most with are those who are "kept" smoking to supply every BT or .GOV with plenty of money. Approving junk that doesn't really work especially not a year after quitting smoking with lozenges, gums, or patches. But if something comes along that will capture at least 50% of the cigarette market in 3-4 years, expect a lot of rules, regulations, insisting on costly submission methods that small business owners can't afford.

Just like no one could stop Walmart from putting thousands of small businesses out of business, it will be BT closing us all up for the profit. I would hate to go from a tobacco smoking slave to a vaping slave. I will quit vaping if it means buying vaping product from BT.

Before this all started, I don't recall anyone (or very few) in our vaping community price gauging (sp?) . I have seen most of us being helpful and supportive. While small businesses opened up, yes, they were in it for profit. But when it came to information and support, they did not forget that they are still part of our community.

When I quit smoking for vaping, it became very important to me how smokers were taken advantage of, used as cash cows, were sent outside to our little corners, and how smoker reality really operated. I really don't mind if people want to continue smoking or don't want to do anything for their health. It's really not their fault, and it just makes me plain ole' crazy nuts to see what advantages there are for keeping people smoking. They prey on tobacco addicts. They are more guilty than people think. And no one can tell me that the gov. does not see any of this. If they don't they're a$$holes or choose not to see.
All of them can scream that they want to offer healthier products, or scream that they want people to quit smoking. But they really don't want them to-when you think of all the money made from those addicted to tobacco. Once BT takes most of the market, it won't be a cheaper way to quit and enjoy vaping. It's such a crime that they could not just leave us alone. If BT was not involved, there would not be all this deeming and expensive regulation.

Please don't pick and correct parts of this. It's not an argument.

No picking or corrections from me. I whole heartedly agree with you.

 

[zoiDman]

Well, that's your ( and Greg and Bonnie's ) interpretation. The question is did Greg know BT was actively lobbying Congress against the deeming regulations, when he made his analysis ?

In your opinion, is BT unwittingly acting against their own interests, or did Altria know the deeming regulations benefit them, and all this lobbying effort is a ruse, pretending to support legislation against the deeming to ensure it doesn't pass ?

...

I don't think knowledge of BT's Involvement in a perceived effort to effect the Predicate Date changes how people Evaluate BT's overall Strength in the Combined Cigarette/e-Cigarette market.

As was mentioned, those Individuals as well as Myself and Many Others feel that BT's Total Market Position is Stronger when the Predicate Date remains as it currently today.

It would be a Tough Case to make IMO that BT's involvement in HR2058 or Cole-Bishop in any way improves the chances of passage for either.

BT can write all the Letters it wants to the FDA saying what a Hardship the FDA's Deeming will be for them. Many see that as just BT playing the Victim Card. And wanting to look like a Friend to Vapers. Someone who is on Our Side.