White House OMB scrapped FDA plan to ban flavors

[Bill Godshall]

The redlined version of FDA Deeming Regulation (showing changes the White House OMB/OIRA made to the Final Rule submitted by FDA in October, 2015) is at
Regulations.gov

Big Pharma funded CTFK’s Matt Myers issued a press release criticizing the White House OMB for deleting FDA’s November 2016 ban on newly deemed flavored tobacco products (even though the deeming rule still bans flavors for e-cigs by defining them as a component of a tobacco product).
Campaign for Tobacco-Free Kids

Even worse, the deeming rule bans the manufacturing of any new tobacco product after August 8, 2016. It appears that FDA is planning to begin banning vape shops from mixing (i.e. manufacturing) e-liquids containing nicotine and/or flavorings.

I suspect FDA won't begin banning factory sealed bottles of flavored nicotine e-liquids until August 8, 2018 (if the manufacture complies with all other provisions of the FDA deeming reg).

Although FDA now also considers nicotine-free flavored e-liquid to be a tobacco product "component" (because it could be mixed with nicotine and used in a vapor product), the FDA is likely to lose in court if challenged/sued by a nicotine-free flavored e-liquid manufacturer (because nothing in the product is derived from tobacco).

 

[dcdozer]

Just too much time on My hand I Guess.

He's a rebel and a runner
He's a signal turning green
He's a restless young romantic
Wants to run the big machine

There is never a bad time to quote Geddy Lee.

 

[Rickajho]

I'm just waiting for all those FDA police to show up at the door of every single tiny B&M across the country and destroy product, issue fines, toss people in jail, appear at Court hearings...

Oh yeah - no one ever talks about the unfunded mandate aspect of all this.

 

[Lessifer]

I'm just waiting for all those FDA police to show up at the door of every single tiny B&M across the country and destroy product, issue fines, toss people in jail, appear at Court hearings...

Oh yeah - no one ever talks about the unfunded mandate aspect of all this.

Wouldn't local enforcement fall to the Health Department?

 

[MacTechVpr]

Wouldn't local enforcement fall to the Health Department?

They're outsourcing to local PD's recruiting SWAT teams for the new vape Gestapo. Some welcome the federal subsidy. Thought I read that somewhere so maybe I'm wrong but don't bet your nic on it. Good luck.

 

[skoony]

I'm just waiting for all those FDA police to show up at the door of every single tiny B&M across the country and destroy product, issue fines, toss people in jail, appear at Court hearings...

Oh yeah - no one ever talks about the unfunded mandate aspect of all this.

The FDA through Health and Human Services in conjunction with the CDC is coordinating
efforts through state and local health departments.
Some one posted about this. Forgot who or where.

Here's an interesting google search.
The FDA through Health and Human Services in conjunction with the CDC is coordinating efforts through state and local health departments. - Google Search.
Regards
Mike

 

[MacTechVpr]

The FDA through Health and Human Services in conjunction with the CDC is coordinating
efforts through state and local health departments.
Some one posted about this. Forgot who or where.

Here's an interesting google search.
The FDA through Health and Human Services in conjunction with the CDC is coordinating efforts through state and local health departments. - Google Search.
Regards
Mike

The international financiers who adore US gov debt are big fans of the bureaucratic urge towards redundancy. They certainly do not mind gov leveraging the public assets to fuel that bubble.

"Congress has abdicated its constitutional role as the federal body that makes laws by allowing agencies like the EPA, FDA, USDA, and TSA to make their own laws through regulations and red tape. These agencies have assumed frightening new powers over the everyday lives of American citizens, giving these government entities free rein over you and me in ways unprecedented in our country's history." —Rand Paul

Web Extra: Read Sen. Rand Paul's New Book Intro - ABC News

Good luck all.

 

[Rossum]

Not Saying there will/can't be Legal Challenges.

And I would Hope that the Current/Pending Legal Challenges will be Positively Resolved before 2018. But having seen the speed that the Legal Wheels Turn, I'm not sure I would bet my Vaping Future on it.

Right, I wouldn't advise anyone to bet their personal vaping future on the success of legal challenges. IMO, to do so would be utterly foolish. I'm looking at such challenges more in terms of offering a glimmer of hope for a revival in the long term.

BTW - Do you the Possibility that the Purchasing by an Individual of Nicotine in Liquid Form will somehow be able to be successfully Legally Challenged.

Because Nicotine is the Key. And it Doesn't matter how many Atty's you have if you Don't have Liquid Nicotine to put in them.

Nope. I don't think there's much chance for a direct legal challenge with respect to nicotine. Virtually all the nicotine we currently use clearly IS a tobacco product because it's extracted from tobacco and thus clearly falls under the "authority" granted to the FDA to regulate tobacco products. My thoughts along these lines are that someone like Nicopure labs will be filing a PMTA for unflavored base, at say 24 mg, which if approved, would go a long way toward solving that problem, and if it's not approved, then the lack of approval would become basis for a new legal challenge.

 

[TUS172]

Well on the bright side... Since tobacco flavor looks to be the only one that will have any chance for PMTA approval (after a company has spent multiple millions)... We should have the best tobacco flavored liquids on the planet! Of course it will probably cost $90.00 per 30ml bottle at any strength after federal/state sin taxes and of course don't forget sales tax . This is all such a travesty!!!

 

[MacTechVpr]

Right, I wouldn't advise anyone to bet their personal vaping future on the success of legal challenges. IMO, to do so would be utterly foolish. I'm looking at such challenges more in terms of offering a glimmer of hope for a revival in the long term.


Nope. I don't think there's much chance for a direct legal challenge with respect to nicotine. Virtually all the nicotine we currently use clearly IS a tobacco product because it's extracted from tobacco and thus clearly falls under the "authority" granted to the FDA to regulate tobacco products. My thoughts along these lines are that someone like Nicopure labs will be filing a PMTA for unflavored base, at say 24 mg, which if approved, would go a long way toward solving that problem, and if it's not approved, then the lack of approval would become basis for a new legal challenge.

Hey Ros. Wrote you a thoughtful reply earlier. But blew it off somehow trying to save it. Tired you see. And though I'd likely be able to draw it from memory I'm running behind here. This particular discussion on nic really intrigues me as like zoid, I think it's central to our problem. However, this whole issue reminds me of a Forbes article I read some time ago…

“All commodities and products that are capable of being ingested by either human beings or animals”

executive order 13603
Obama's Plan To Seize Control Of Our Economy And Our Lives - Forbes

I'm going to refrain myself from going further OT to discuss the perils of the executive presidency.

Good luck all.

 

[MacTechVpr]

Getting back to this issue of nic @Rossum, noting the language of the rule as per the OP's .pdf, I fail to see with the OMB didn't redline this!

"The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law."

It is this extraordinarily vague and circular language of the FD&C, the irresponsible and unlawful delegation by Congress…an act of omission of a proper and differential definition for tobacco, combustion and nicotine…which enables the FDA's present extraordinarily contorted over-reach to deem flavorings used in vamping as tobacco (along with the kitchen sink you wash your gear in).

Of course, the OMB can't, lacking the power…but we can. Why I'm sitting here scratching my head wondering after three years vaping and decades looking at FDA's flagrant efforts to abolish tobacco by controlling it as a drug…

Why don't we?

If these indeed are the rotten roots, why does it seem we're doing everything but tearing them out?

Is it just me? Or am I missing some deep dark secret?

Good luck.

 

[Rossum]

Getting back to this issue of nic @Rossum, noting the language of the rule as per the OP's .pdf, I fail to see with the OMB didn't redline this!

"The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law."

It is this extraordinarily vague and circular language of the FD&C, an irresponsible and unlawful delegation by Congress…an act of omission of a proper and differential definition for tobacco, combustion and nicotine…which enables the FDA's present extraordinarily contorted over-reach to deem flavorings used in vamping as tobacco (along with the kitchen sink you wash your gear in).

Of course, the OMB can't, lacking the power…but we can. Why I'm sitting here scratching my head wondering after three years vaping and decades looking at FDA's flagrant efforts to abolish tobacco by controlling it as a drug…Why don't we?

If these indeed are the rotten roots, why does it seem we're doing everything but tearing them out?

Is it just me? Or am I missing some deep dark secret?

Good luck.

Oh, I think there's a good chance that the courts will toss out some of this over-reach regarding things that are clearly not tobacco products in any rational person's mind. However, I do not think it's very likely that they will do so with nicotine itself.

There is a school of thought that the FDA really doesn't wish to be bothered with tobacco at all; that they consider the entire mess beneath their dignity....

 

[MacTechVpr]

Here, as much as we may agree on details, I will differ but to ask just how many times have we seen law that entrenches corp monopoly reversed?

We may see some of FDA's exuberance mitigated by half-measures I'm certain. Saw the NRA play this game over decades. But it took the concerted pressure and external to one of the largest activist movements in the country to get concrete action in the courts. The popular support of many in various alternative activist streams accomplished it with the advantage of a hospitable court.

Don't think gov will prevail in the end because you simply cannot suppress knowledge. So I endorsed resistance when I resumed posting on the politics recently. It's inevitable and the only outcome practically possible if all we achieve is concession. We'll be allowed to keep a little something certainly that doesn't unsatisfactorily affect the inflows. And quite possibly that which we might consider a benefit in regulation only to cost us much more in right and capital than we had to begin with.

So I return to my premise that I don't see much benefit of getting in the ring if there is no intention of goring the bull. But with so many the matador competing for the job, we make the tailor a rich man.

Good luck.

 

[skoony]

The international financiers who adore US gov debt are big fans of the bureaucratic urge towards redundancy. They certainly do not mind gov leveraging the public assets to fuel that bubble.

"Congress has abdicated its constitutional role as the federal body that makes laws by allowing agencies like the EPA, FDA, USDA, and TSA to make their own laws through regulations and red tape. These agencies have assumed frightening new powers over the everyday lives of American citizens, giving these government entities free rein over you and me in ways unprecedented in our country's history." —Rand Paul

Web Extra: Read Sen. Rand Paul's New Book Intro - ABC News

Good luck all.

Minnesota's constitutional amendment allocating all lottery funds to education
and more so to protect the environment comes to mind. on the environmental side
this means limiting access to so called sensitive areas to those qualified to be
there,ie,tree huggers only. No handicapped access allowed.

regards
Mike

 

[MacTechVpr]

Minnesota's constitutional amendment allocating all lottery funds to education
and more so to protect the environment comes to mind. on the environmental side
this means limiting access to so called sensitive areas to those qualified to be
there,ie,tree huggers only. No handicapped access allowed.

regards
Mike

Florida's lottery "for the kids" (edIucaXon) comes to my mind as the perfect example of how to end-run state constitutional limitations on taxation. And that's what some consider over-the-top fiscal conservatism today. Laws don't matter. We just got to stop our addiction to electing klepto's that promise us stuff…no matter how charismatic. And they seem so normal, don't they?

Good luck.