Deeming Regulations have been released!!!!

[MacTechVpr]

Gottlieb, for cryin out loud, get it right. vaping is NOT tobacco. Most of us use an insignificantly minute amount of nicotine if any at times. Real vapers. Not 50mg podsters. Who invited them to the party anyway? So who the heck are you talking about Great Scott?!!! What part of this message is so hard to inhale?

Good luck.

 

[MacTechVpr]

So basically, they are trying to find a way to hand all nicotine over to the drug industry while removing nicotine from the tobacco companies products, all the while striving to obfuscate the fact that nicotine will be handed to Big Pharma interests on a golden platter. That is how it looks to me...

And reducing vaping to an OTC commodity will go a long way towards that.

[They always telegraph don't they?]

Good luck.

 

[zoiDman]

So basically, they are trying to find a way to hand all nicotine over to the drug industry while removing nicotine from the tobacco companies products, all the while striving to obfuscate the fact that nicotine will be handed to Big Pharma interests on a golden platter. That is how it looks to me...

I Don't know what they are Doing.

Because sometimes it is Hard to Separate the "For the Audience" Statements from the Realities of future policy.

I could See the FDA wanting to Open a Pathway via the OTC Market for OEM's who want to Sell/Market their e-Cigarettes as a Smoking Cessation Device.

But that Wouldn't work very well if next to some OTC, Expensive because of Approval, Device was a Plain Old, Inexpensive, e-Cigarette for the Recreational Use of Nicotine.

There would Also be the Issue of the Courts.

And the Influence BT has on Congress Members. Because BT aint gonna like a Mark 10 or Vuse having to go down an OTC Pathway.

Not sure where Gottlieb thinks all this can Go? Or if He is considering that He May/Might/Probably only be a 4 Year FDA Commissionaire?

 

[Mowgli]

Twirling his left fist saying "look at that!" so he can sucker punch with his right.

 

[Rossum]

This is interesting. Gottlieb wants to make e-cigs over-the-counter drugs like nicotine patches.

FDA may consider over-the-counter regulation for e-cigarettes

Let me guess, Big Pharma's sales of traditional NRTs have fallen off a cliff over the last 5 years or so, and they've made it clear to the FDA that they want some of that action back...?

 

[Sugar_and_Spice]

I Don't know what they are Doing.

Because sometimes it is Hard to Separate the "For the Audience" Statements from the Realities of future policy.

I could See the FDA wanting to Open a Pathway via the OTC Market for OEM's who want to Sell/Market their e-Cigarettes as a Smoking Cessation Device.

But that Wouldn't work very well if next to some OTC, Expensive because of Approval, Device was a Plain Old, Inexpensive, e-Cigarette for the Recreational Use of Nicotine.

There would Also be the Issue of the Courts.

And the Influence BT has on Congress Members. Because BT aint gonna like a Mark 10 or Vuse having to go down an OTC Pathway.

Not sure where Gottlieb thinks all this can Go? Or if He is considering that He May/Might/Probably only be a 4 Year FDA Commissionaire?

More blowing smoke.(pun intended). We don't know what they are trying to accomplish because THEY don't know what they are doing. Gottlieb says it all in the last paragraph you quoted. They do know that the marketing to children is a big talking point so they are blowing that up to be front and center and maybe appease those ANTZ for a while. But it is so clear that they rushed to try to control something they know absolutely nothing about. They figured if it walks like a duck, acts like a duck it must be a duck. Here is where they are gravely mistaken. Yes, vaping mimics smoking but its no duck.

And from the very beginning the FDA wanted vaping to be classified as a 'drug' so BP could control it and it would make the FDA's job so much simpler for it just to fall under guidelines already established under the drug laws. Clearly they recognize that there are pieces that aren't clearly defined and that are missing from their authority to put together a cohesive standard operating practice.

I don't think all hell has broken loose, at least not yet.

Just my 2 pennies.

 

[ENAUD]

I Don't know what they are Doing.

Because sometimes it is Hard to Separate the "For the Audience" Statements from the Realities of future policy.

I could See the FDA wanting to Open a Pathway via the OTC Market for OEM's who want to Sell/Market their e-Cigarettes as a Smoking Cessation Device.

But that Wouldn't work very well if next to some OTC, Expensive because of Approval, Device was a Plain Old, Inexpensive, e-Cigarette for the Recreational Use of Nicotine.

There would Also be the Issue of the Courts.

And the Influence BT has on Congress Members. Because BT aint gonna like a Mark 10 or Vuse having to go down an OTC Pathway.

Not sure where Gottlieb thinks all this can Go? Or if He is considering that He May/Might/Probably only be a 4 Year FDA Commissionaire?

None of us have a clue, wonder if the FDA even do? I'll watch what they DO, what they say is irrelevant. This whole thing needs to removed from the FDA's hands. Vaping is as much a tobacco product, as maple syrup is a lumber product. It's insanity to insult our intelligence like they are trying to do...

 

[440BB]

SCOTT GOTTLIEB: Well, I'm not going to address the specific litigation. But when we announced this plan earlier, late last year, the idea was to put nicotine at the center of our regulatory efforts

Restrict access to the nic and the whole game is up. Flavors, labeling, equipment, even the children become irrelevant.

This long and winding road the FDA has taken ends up at the back door of Big Pharma. We shouldn't be surprised.

 

[zoiDman]

More blowing smoke.(pun intended). We don't know what they are trying to accomplish because THEY don't know what they are doing. Gottlieb says it all in the last paragraph you quoted. They do know that the marketing to children is a big talking point so they are blowing that up to be front and center and maybe appease those ANTZ for a while. But it is so clear that they rushed to try to control something they know absolutely nothing about. They figured if it walks like a duck, acts like a duck it must be a duck. Here is where they are gravely mistaken. Yes, vaping mimics smoking but its no duck.

And from the very beginning the FDA wanted vaping to be classified as a 'drug' so BP could control it and it would make the FDA's job so much simpler for it just to fall under guidelines already established under the drug laws. Clearly they recognize that there are pieces that aren't clearly defined and that are missing from their authority to put together a cohesive standard operating practice.

I don't think all hell has broken loose, at least not yet.

Just my 2 pennies.

None of us have a clue, wonder if the FDA even do? I'll watch what they DO, what they say is irrelevant. This whole thing needs to removed from the FDA's hands. Vaping is as much a tobacco product, as maple syrup is a lumber product. It's insanity to insult our intelligence like they are trying to do...

I Agree that None of Use know what the FDA is Doing. Really Doing that is. But I Think they know what they are Doing.

What that is, like I said, you got me. Because making e-Cigarettes OTC sounds like it has FDA v. Brown & Williamson written all over it.

And I'm not sure How they would put the Toothpaste back in the Tube when we are this Far down the Deemed as a Tobacco Product road?

I think it is more Frosting for the ANTZ right now.

 

[MacTechVpr]

THEY don't know what they are doing.…They figured if it walks like a duck, acts like a duck it must be a duck.

I'll grant you that. A child can tell the difference between a leaf and a juice, combustion and steam but it seems to be beyond our determined Executive and Juciary. Yet they fancy themselves more capable at managing our risks. I'd say kids are better off without them. It might be laughable but for the hardship to us and the consequences for those yet coming in losing sight of this.

Good luck.

 

[Rossum]

I Agree that None of Use know what the FDA is Doing. Really Doing that is. But I Think they know what they are Doing.

Oh, I think they know what they would like to do, but that they aren't exactly sure what they can get away with; not just in the official court system, but also in the court of public opinion, specifically that part of the public that uses "tobacco products". Government found out around 100 years ago that it simply isn't practical to ban some things, even if they go so far as to amend the Constitution to do so.

What that is, like I said, you got me. Because making e-Cigarettes OTC sounds like it has FDA v. Brown & Williamson written all over it.

Yep, Brown, as well as Sottera have have (thankfully) made them somewhat more careful.

And I'm not sure How they would put the Toothpaste back in the Tube when we are this Far down the Deemed as a Tobacco Product road?

I doubt they intend to back-track very much on that. My guess: When the time comes, they will approve a few closed system PMTAs, most likely submitted by BT. However, BP doesn't wish to play on the same field as BT, after all "tobacco products" have such a bad name. Moreover, BP is on a far friendlier footing with the FDA than BT is. So why not create an alternative path for BP to compete with BT, where BP doesn't have to file any sort of "Tobacco Products" application? If I were a BP CEO, I'd insist on submitting products for OTC approval that made with synthetic nicotine, so that they're no way they can be labelled "tobacco".

 

[medleypat]

Just a quick google search, there are a lot more accidents with power tools than with Any type of vape mod.

Here are some statistics on the number of emergency room (ER) visits per year caused by individual types of tools (source: "The Most Dangerous Power Tools," Forbes.com, December 2009):

• Power nailers or nail guns: 37,000 emergency room visits/year
• John Deere-type Riding Lawn Mowers: 37,000 hospital visits a year
• Chain Saws: 36,000 ER visits/year
• Stationary Table Saws: 29,000 ER visits/year
• Snowblowers: 5,7000 ER Visits per year; 19 deaths recorded since 1992
• Circular or Rotary Saws: 10,600 ER cases/year
• Power Drills: 5,800
• Backhoes: Average of 38 construction fatalities a year
• Air Compression Devices: 2,400
• Wood Chippers: Average of 3 deaths a year
  
  Work Tools Accident Statistics | LegalMatch Law Library

I agree other power tools are way more dangerous but how many groups are trying to shut them down. Vapers must be more vigilant why do we keep giving them ammunition to use against us?

 

[zoiDman]

...

I doubt they intend to back-track very much on that. My guess: When the time comes, they will approve a few closed system PMTAs, most likely submitted by BT. However, BP doesn't wish to play on the same field as BT, after all "tobacco products" have such a bad name. Moreover, BP is on a far friendlier footing with the FDA than BT is. So why not create an alternative path for BP to compete with BT, where BP doesn't have to file any sort of "Tobacco Products" application? If I were a BP CEO, I'd insist on submitting products for OTC approval that made with synthetic nicotine, so that they're no way they can be labelled "tobacco".

I understand the Logic of a Dual Market/Same Product approach that from a PR Standpoint, would Definitely appeal to BP.

But what about the Time to Market, Cost of Approval, and End Point Price of an OTC e-Cigarette?

I mean sure, it would be Nice to be able to say that your OTC Cig-a-Like can Help you Quit Smoking. And that it is a Healthier Alternative to Smoking. But if your Product Costs More to the End User, do you think it would Do Well competing against a PMTA'ed e-Cigarette. Which is basically the same thing.

Because as I understand it, the OTC Approval process Isn't Exactly Cheap. And it Isn't a Time Friendly Process either.

A PMTA might cost Hundreds of Thousands of Dollars. But doesn't an OTC Approval cost Millions?

 

[Rossum]

I mean sure, it would be Nice to be able to say that your OTC Cig-a-Like can Help you Quit Smoking. And that it is a Healthier Alternative to Smoking. But if your Product Costs More to the End User, do you think it would Do Well competing against a PMTA'ed e-Cigarette. Which is basically the same thing.

Will people really perceive it that way though? One product will be marketed by the devil himself (e.g. Phillip Morris) while the other is from some BP company that's in the business of saving lives!

Because as I understand it, the OTC Approval process Isn't Exactly Cheap. And it Isn't a Time Friendly Process either.

A PMTA might cost Hundreds of Thousands of Dollars. But doesn't an OTC Approval cost Millions?

We don't really know what a successful PMTA for a vapor product will cost. AFAIK, there's only ever been one PMTA approved, and that was the one for Swedish Match Snus, right? I wonder how much they spent on it? And let's face it, 6 or 7 figure costs aren't more than a rounding error on the balance sheet of any BT or BP company.

 

[zoiDman]

Will people really perceive it that way though? One product will be marketed by the devil himself (e.g. Phillip Morris) while the other is from some BP company that's in the business of saving lives!


We don't really know what a successful PMTA for a vapor product will cost. AFAIK, there's only ever been one PMTA approved, and that was the one for Swedish Match Snus, right? I wonder how much they spent on it? And let's face it, 6 or 7 figure costs aren't more than a rounding error on the balance sheet of any BT or BP company.

Yeah... We're kinda in Uncharted Territory here.

I think the Whole OTC thing is Bizarre. Maybe Azar had been Drinking when he bought off on This One.

 

[Burnie]

PMTA approved, and that was the one for Swedish Match Snus

https://www.fda.gov/downloads/tobaccoproducts/labeling/tobaccoproductreviewevaluation/ucm472123.pdf

FYI from a Google search.

 

[Rossum]

https://www.fda.gov/downloads/tobaccoproducts/labeling/tobaccoproductreviewevaluation/ucm472123.pdf

FYI from a Google search.

Sure, we know that one was approved. The FDA announced it with some fanfare when they did so, as if to say, "See, submitting a PMTA application isn't totally hopeless".

But the questions are: How much did Swedish Match spend preparing it? And have any other PMTAs been approved?

 

[DPLongo22]

That is the real issue with stockpiling isn't it. It is funny though, most of us spent 15, 20, 30+ years smoking the same brand, same style cigarettes day in and day out, and our tastes never changed. We get into vaping and suddenly we want something different every month or two.

Not yet for me.

Well, some people do.

I found my happy place with vape-stuff several years ago and I made a conscious decision to stop chasing a "better" vape.

View attachment 731945

 

[Katdarling]

Is there some Strange Alignment of the Planets going on or Something?

Nothing happens for like 14 Months, then, in the Span of about 2 Weeks, All Hell Breaks Loose.

retrograde, Mercury.

Or Murphy.

Or both.

 

[stols001]

Oy, the more Gottlieb talks the more confused I get.

OTC vapes at pharmacies? What? That makes no sense whatsoever (other than yes, the FDA treats everything like a medication) and yes, some of the other possible Machiavellian motives, although at this point I'm so confused I really don't know what could be "good" other than to remove vaping from the FDA's purview. And, I don't think that's going to happen. I do think we're just going to have to hope the damage is "limited" to 4 years, not 8. The FDA knows full well they may only have 4 years to accomplish this, though.

Anna