Deeming Regulations have been released!!!!

Spazmelda

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Wellll... At least one of the execs saw the writing on the wall....

"Mr. Parrish was one of the tobacco company executives who fought Dr. Kessler and the F.D.A.; indeed, as a senior vice president for Philip Morris, then, as now, the country’s biggest tobacco company, he pretty much led the charge, publicly denouncing Mr. Kessler as a “neo-prohibitionist.”

But even before the Supreme Court made its ruling, Mr. Parrish had come to the conclusion that the tobacco industry needed to be regulated, something he began to talk to Dr. Kessler about even before he went public. There has always been a great deal of skepticism about Philip Morris’ about-face "

"Rather, he said, it was his strong belief that federal regulation “could completely transform the industry.” In particular, Mr. Parrish believed that F.D.A. regulation could help push the industry to innovate — coming up with cigarettes, or cigarettelike products, that were less lethal. "

http://www.nytimes.com/2009/06/20/business/20nocera.html?pagewanted=2&_r=1

That is a riot. These regulations pretty much mandate that there will be no innovation. Why would a company try to make a safer cigarette when they have to navigate hectares of red tape. I have mentioned this on ECF before, but in grad school (late 90s) I had a professor who used to work at a major tobacco company. This would have been late-80s early 90s that the work was going on. They had come up with (what they were sure was) a safer cigarette, heat-not-burn, if I understood it correctly. They had to ditch the product because it would have been too difficult and expensive to get it approved. He actually had some of the cigarettes there in the class with him and I got to take a puff. It was rather an eye opening experience for me and I didn't quite understand the full irony of it at the time. I do remember wishing that the products had been brought to market because I was an inveterate smoker at the time.
 

wiredlove

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Yeah, I was just referring to the "less stringent" part. As of the time of the decision, the practical effects of the FSPTCA were unknown. The FDA hadn't yet received, and subsequently ignored, thousands of applications.


I believe they've completed much of the HPHC testing on their flavorings, and are working on their master files. Not sure about PMTA's, or if they plan to just continue as "raw material" vendors.

Either way, I believe we'd be in the same boat, just years in the past. If they had succeeded in 2009/10, BP would have bought the rights / companies that were most successful and we'd have a BP controlled, prescription, closed-system device that was pushed through as a FDA drug / cessation aid.

edited my post...

The comment was on the regulations, not the act.... mentioned a while back not worth looking for.

Yeah, I don't think they wrote the deeming regs, I think they knew some of the contents, certainly. They were also given more weight in their comments than we were - since they 'play ball' on things that are advantageous to the FDA's mindset of a closed-system market. I wonder if BT's possibly supporting amendments to move the grandfather dates has to do with something in the 499 pages that spooked them, perhaps they thought that the modified risk advertising sections would be less stringent than it is since e-cigs are less harmful - or it could be that they're just hedging their bets and playing both sides to see what shakes out in the US market. In the meantime, they'll just keep earning money in other areas of the world.

IMHO, the biggest enemy is BP, the Robert Wood Johnson Foundation and their current neo-ANTZ who suck on that pseudo-scientific research teat with a particularly hate for for having been 'tricked' by us evil vapers, who continue to use nicotine in a manner that is not approved by their money-swollen overlord, which all aligns well with their FDA regulatory agency who continues to nurse a hefty amount of butthurt about the 2010 smack-down delivered by Judge Leon.
 

Vandal

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That is a riot. These regulations pretty much mandate that there will be no innovation. Why would a company try to make a safer cigarette when they have to navigate hectares of red tape. I have mentioned this on ECF before, but in grad school (late 90s) I had a professor who used to work at a major tobacco company. This would have been late-80s early 90s that the work was going on. They had come up with (what they were sure was) a safer cigarette, heat-not-burn, if I understood it correctly. They had to ditch the product because it would have been too difficult and expensive to get it approved. He actually had some of the cigarettes there in the class with him and I got to take a puff. It was rather an eye opening experience for me and I didn't quite understand the full irony of it at the time. I do remember wishing that the products had been brought to market because I was an inveterate smoker at the time.
I just did a google search, and it looks like these heat-not-burn devices may still be in development. Perhaps not for the US market though- it appears there have been some launches in other countries. One thing I found that I didn't know was that Imperial Tobacco acquired the original e-cigarette patents from Hon Lik. In this article, they were pooh-poohing Phillip Morris' heat and burn device as less safe than electronic cigarettes.

Phillip Morris Smokeless Cigarette Not as Safe as E-Cigarettes, Big Tobacco Researcher Says | E-Cigarette Reviews and Rankings
 

Lessifer

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Either way, I believe we'd be in the same boat, just years in the past. If they had succeeded in 2009/10, BP would have bought the rights / companies that were most successful and we'd have a BP controlled, prescription, closed-system device that was pushed through as a FDA drug / cessation aid.



Yeah, I don't think they wrote the deeming regs, I think they knew some of the contents, certainly. They were also given more weight in their comments than we were - since they 'play ball' on things that are advantageous to the FDA's mindset of a closed-system market. I wonder if BT's possibly supporting amendments to move the grandfather dates has to do with something in the 499 pages that spooked them, perhaps they thought that the modified risk advertising sections would be less stringent than it is since e-cigs are less harmful - or it could be that they're just hedging their bets and playing both sides to see what shakes out in the US market. In the meantime, they'll just keep earning money in other areas of the world.

IMHO, the biggest enemy is BP, the Robert Wood Johnson Foundation and their current neo-ANTZ who suck on that pseudo-scientific research teat with a particularly hate for for having been 'tricked' by us evil vapers, who continue to use nicotine in a manner that is not approved by their money-swollen overlord, which all aligns well with their FDA regulatory agency who continues to nurse a hefty amount of butthurt about the 2010 smack-down delivered by Judge Leon.
Agreed, except I think they'd go for OTC like other NRT products. I still think we might see one or two from BP, once they figure out how to make it less effective, or maybe they'll just make long term use cost prohibitive.

ETA: I may have been one that said that BT had a hand in writing the FSPTCA, and by that I meant they had a big influence in having that grandfather date written in. Without that, they would have been in the same boat we are in now, though they'd have the money to at least give it a go, like they do now.
 
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crxess

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I can't see how FlavourArt has done much (if any) testing towards a PMTA application.

I'm thinking maybe you meant getting their Master File info worked out?
That would allow liquid manufacturers to continue to use their flavors for now.

I Believe and agree with @Mazinny, FlavourArt is well ahead of competition in Preparation for FDA PMTA. All of their Testing for Safe to Vape Flavored E-liquids is providing Valuable Data for required submission............1 step less to contend with.

Not that it Grants them any Advantage in a By Choice of FDA situation.

How they can continue to get away with non distinct regulatory requirements for approval is beyond me.:facepalm:

It is like they hand you a Square Peg and demand you fit it into a Round Hole of their choosing.:blink:
 

Lessifer

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Why would FlavorArt need to do a PMTA?

Do they sell a "Finished" or "Covered" Tobacco Product? I thought they just Sold Flavorings?
They do only sell flavorings, but they cater specifically to the vaping industry. If they sell flavorings, intended to be used with nicotine liquid, directly to consumers, are they not manufacturers of tobacco product components? Are those components not finished tobacco products?
 

beckdg

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Yes. I can just picture it now:

fda-raid-mucks.jpg
That's an old photo.

From the war on...

...

...

...

...

...

Milk. (No, that's not an acronym.)

Tapatyped
 

zoiDman

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They do only sell flavorings, but they cater specifically to the vaping industry. If they sell flavorings, intended to be used with nicotine liquid, directly to consumers, are they not manufacturers of tobacco product components? Are those components not finished tobacco products?

A lot will depend on how FlovorArt Markets/Advertises their Products.

I go to the LorAnn web site and I don't see any references to e-Cigarettes. Just a bunch of stuff say'n that you can make Yummy Cakes and Candies.

What's the Big Deal with Yummy Cakes and Candies? Nothin. Right?
 
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BuGlen

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A lot will depend on how FlovorArt Markets/Advertises their Products.

I go to the LorAnn web site and I don't see any references to e-Cigarettes. Just a bunch of stuff say'n that you can make Yummy Cakes and Candies.

What's the Big Deal with Yummy Cakes and Candies? Nothin. Right?

OMG! Now they're marketing candles to children!!!!! When will it end!!! Think of the poor children!!!

ETA: Maybe I could have used a few more exclamation points...
 

zoiDman

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OMG! Now they're marketing candles to children!!!!! When will it end!!! Think of the poor children!!!

ETA: Maybe I could have used a few more exclamation points...

Back in the Early 2000's, there was a Lot of Talk that the FDA should be Regulating Candy. That it was the Single Greatest cause of Tooth Decay in Children. And Racked up Millions in Dental Bills.

But the ADA (American Dental Association) lobbied hard to suppress any Candy Regulations. And it kinda died a Quite death.

;)
 

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