FDA Regulation of Synthetic Nicotine May Be on the Horizon

[UncLeJunkLe]

Source

The Food and Drug Administration will get new powers to regulate synthetic nicotine, found in e-cigarettes popular among teenagers, as part of a government spending bill slated to pass in coming days, a lawmaker confirmed on Tuesday.

The language in the omnibus spending package, a yet-to-be unveiled bill to fund the government through September, would give the FDA the authority to regulate products that contain nicotine but aren’t derived from tobacco, such as synthetic nicotine, according to a document obtained by Bloomberg.
Sens. Richard Burr (R-N.C.), Dick Durbin (D-Ill.) and Patty Murray (D-Wash.), along with Rep. Frank Pallone (D-N.J.) led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions.

“This is an enormous win for public health and American consumers ,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”

The change will stop “bad actors attempting to evade FDA regulation and hook a new generation of young people into a lifetime of nicotine addiction,” Pallone said.

Public health groups have been warning that synthetic nicotine e-cigarettes such as Puff Bar have grown in popularity among teens while skirting FDA oversight. The FDA has authority to regulate natural tobacco products, but it’s unclear if that extends to lab-made nicotine.

More than a quarter of middle and high school e-cigarette users reported using Puff Bar as their usual brand, according to a survey from the Centers for Disease Control and Prevention. Puff Bar didn’t immediately respond to a request for comment.

The same survey found brands that use traditionally derived nicotine, such as those sold by Vuse, SMOK, and JUUL Labs Inc., are also popular among teens, even though people under age 21 can’t purchase them legally.

To contact the reporters on this story: Alex Ruoff in Washington at aruoff@bgov.com; Riley Griffin (Bloomberg) in New York at rgriffin42@bloomberg.net
To contact the editors responsible for this story: Robin Meszoly at rmeszoly@bgov.com; Anna Yukhananov at ayukhananov@bloombergindustry.com

 

[UncLeJunkLe]

Notice the virtue signalling quickly inserted right in the first paragraph.

 

[WorksForMe]

from @kristin at CASAA:

NATIONAL CALL TO ACTION!

Anti-vaping lawmakers have slipped language into the 2022 Omnibus Budget Bill that would be a near-immediate ban on the thousands of low risk e-liquids and smoke-free products that contain synthetic nicotine. TAKE ACTION NOW!

National Call To Action - Stop a Ban on Synthetic Nicotine


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[Bliss Doubt]

I overwrote the canned comments in the CASAA action. Here is what I wrote, in case it will help anybody else:

begin

I am writing to urge you to oppose the effort to include a ban on synthetic nicotine in the 2022 Omnibus Budget Bill.

The FDA is a hypocritical, unelected government bureaucracy that allows deadly pharmaceutical products on the market, while trying to defeat the only widely successful smoking cessation method ever known.

Vaping helped me quit cigarettes 9 years ago. I have not had a cigarette since then. A chronic ailment in my lungs cleared up right away after I stopped smoking.

Because of the fear of the term "nicotine", which is a mild stimulant like caffeine once it is separated from burning plant matter and dangerous additives, vapers like me are seeing continuous attempts to squash our ability to continue vaping.

Why don't you ban leaf blowers? That is something that really would make the air we breathe cleaner, safer and more healthy for children and everybody. There is so much hypocrisy in nanny government.

Thank you for considering my comments.

end

 

[ImperfectFuture]

from @kristin at CASAA:

NATIONAL CALL TO ACTION!

Anti-vaping lawmakers have slipped language into the 2022 Omnibus Budget Bill that would be a near-immediate ban on the thousands of low risk e-liquids and smoke-free products that contain synthetic nicotine. TAKE ACTION NOW!

National Call To Action - Stop a Ban on Synthetic Nicotine


.

Did, I have had contact with Patty Murray since 2003, so this might make a difference, but I don't know.

Focused on the populace, and their tendencies. Focused on my previous communications (which one's were listened to, and which one's led to only fund raising emails). hopefully, it will fall the way of online poker, but that is a long shot, and requires effort.

 

[zoiDman]

Two things that I am Not Surprised in this.

One is that Instead of doing things via Regular Order, once again a Unrelated Project is stuffed into a Must Pass Omnibus Spending Package. And Two, Dick Durbin is Front and Center of all of it.

What Isn't Clear to me is the Procedural Rule Making Requirements the FDA must fulfill if/when Congress amends the Federal Food, Drug, and Cosmetic Act changing the Statutory Definition of a "Tobacco Product"?

What Exactly is the Mechanics of a New or Amended Rule Promulgation and Related Guidance to Stakeholders?
Exm: Does the "Deeming" of TFN e-Liquids need to go thru a Public Comment Period?

 

[UncLeJunkLe]

Two things that I am Not Surprised in this.

One is that Instead of doing things via Regular Order, once again a Unrelated Project is stuffed into a Must Pass Omnibus Spending Package. And Two, Dick Durbin is Front and Center of all of it.

What Isn't Clear to me is the Procedural Rule Making Requirements the FDA must fulfill if/when Congress amends the Federal Food, Drug, and Cosmetic Act changing the Statutory Definition of a "Tobacco Product"?

What Exactly is the Mechanics of a New or Amended Rule Promulgation and Related Guidance to Stakeholders?
Exm: Does the "Deeming" of TFN e-Liquids need to go thru a Public Comment Period?

Some say this is just simply going to turn out to be a ban of synthetic nic. I didn't read all the theories and whatnot but I don't discount that.

 

[zoiDman]

Some say this is just simply going to turn out to be a ban of synthetic nic. I didn't read all the theories and whatnot but I don't discount that.

Oh I'm sure it will be a Ban also. That was the Intent of changing the Federal Food, Drug, and Cosmetic Act. Just like the Intent of Deeming e-Cigarettes was to Ban them. As has been shown.

My question is what does the FDA need to do Procedurally to Regulate (Wink) TFN e-Liquids?

 

[zoiDman]

BTW - Here is what I believe to be a Current Text as of 3-8-22.

https://rules.house.gov/sites/democrats.rules.house.gov/files/BILLS-117HR2471SA-RCP-117-35.pdf

It is searchable. So a Quick Search for "Nicotine" will bring up Subtitle B in Division P - Health Provisions.

 

[ImperfectFuture]

Two things that I am Not Surprised in this.

One is that Instead of doing things via Regular Order, once again a Unrelated Project is stuffed into a Must Pass Omnibus Spending Package. And Two, Dick Durbin is Front and Center of all of it.

What Isn't Clear to me is the Procedural Rule Making Requirements the FDA must fulfill if/when Congress amends the Federal Food, Drug, and Cosmetic Act changing the Statutory Definition of a "Tobacco Product"?

What Exactly is the Mechanics of a New or Amended Rule Promulgation and Related Guidance to Stakeholders?
Exm: Does the "Deeming" of TFN e-Liquids need to go thru a Public Comment Period?

No, not Dick Durbin, but an obscure representative mentioned on Grimmgreen's broadcast. (don't remember his name, but on reason magazine)

They will be required to pass the PMTA requirements they didn't pass before (too expensive for small startups). Now, it is somewhat their fault for thinking this would exempt them forever, and one company, Vapetasia, actually switched their products to TFN.

Again, the price for a variety of flavors, and each level of nic, is out of the reach for most companies. Who is behind, besides obscure representative (it passed the house first)? BT (Vuse, and states passing regulations for only FDA approved products, aka BT), Juul, and of course, two Pacs including the Bloomberg PAC.

 

[zoiDman]

No, not Dick Durbin, but an obscure representative mentioned on Grimmgreen's broadcast. (don't remember his name, but on reason magazine)

They will be required to pass the PMTA requirements they didn't pass before (too expensive for small startups). Now, it is somewhat their fault for thinking this would exempt them forever, and one company, Vapetasia, actually switched their products to TFN.

Again, the price for a variety of flavors, and each level of nic, is out of the reach for most companies. Who is behind, besides obscure representative (it passed the house first)? BT (Vuse, and states passing regulations for only FDA approved products, aka BT), Juul, and of course, two Pacs including the Bloomberg PAC.

Rep Mikie Sherrill is credited with introducing the Original Legislation in the House.

It is really just a Rehashing of what Durbin has been preaching in the Senate. But they wanted the Bill to Gain Traction 1st in the House. So Sherril took point on it.

Speaking of Dick Durbin...

Durbin, Senators To FDA Commissioner: Agency Is Six Months Past Court-Ordered Deadline To Regulate E-Cigarettes | U.S. Senator Dick Durbin of Illinois

 

[ImperfectFuture]

Rep Mikie Sherril is credited with introducing the Original Legislation in the House.

It is really just a Rehashing of what Durbin has been preaching in the Senate. But they wanted the Bill to Gain Traction 1st in the House. So Sherril took point on it.

Speaking of Dick Durbin...

Durbin, Senators To FDA Commissioner: Agency Is Six Months Past Court-Ordered Deadline To Regulate E-Cigarettes | U.S. Senator Dick Durbin of Illinois

Don't think that was the name mentioned on Grimm's channel today. Believe it was a Richard something, but I need to run an errand, no time to look up (time sensitive). He also likes AOC (interesting). Find I am more of a left leaning libertarian (62 yo) than flat out social thinker.

the problems in Congress are years, and blaming one particular soldier is non productive, and gives a feeling of helplessness when it comes to action, which I have done my part. There are several actors here, and again, it is partially the fault of vendors trying to circumvent the rules. it is what it is.

 

[zoiDman]

Rep. Sherrill Introduces Clarifying Authority Over Nicotine Act

 

[zoiDman]

...

the problems in Congress are years, and blaming one particular soldier is non productive, and gives a feeling of helplessness when it comes to action, which I have done my part. There are several actors here, and again, it is partially the fault of vendors trying to circumvent the rules. it is what it is.

Make Absolutely No Mistake over Tobacco Policy. Dick Durbin has done More in his Political Career to set back Tobacco Policy and THR than Any other Member of the House or the Senate. Probably More than Most Senators/House Members Combined.

He is Broken when it comes to Tobacco. Because his Father Died of Lung Cancer when Dick was young after being a Long Term 2 PAD Smoker.

The Chip on Durbin's Shoulder when it comes to Tobacco Use is the Size of Mt. Rushmore. And you are either a Tobacco User (aka a 2nd Class Citizen) and are a Blight to Society. Or you are 100% Tobacco/Nicotine Free.

There is No Middle Ground. Or concepts like THR with Dick. It's a Binary World as far as he is concerned.

 

[zoiDman]

So it's a Done Deal. Synthetic and or TFN Nicotine now falls under the FDA/Califf's dominion.

Nice of those who pushed for this Inclusion to give OEM's an adequate Time Period to put together PMTA's for these newly Deemed Products.

"The law will take effect 30 days after Biden signs it, which will probably happen early next week. Manufacturers then have 30 additional days to submit Premarket Tobacco Applications (PMTAs) for synthetic products already on the market. Those who submit applications must receive authorization from the FDA within 60 days or remove those products from the market (or be subject to enforcement)."

Also from the FTMF (Follow the Money File), consistent to see that Profits are once again the Primary Mover when it comes to driving THR Policy in the USA.

"As we explained earlier this week, the nicotine language was inserted in the bill by a bipartisan group of House and Senate members, representing the interests of both anti-vaping groups and the tobacco industry. Juul Labs and RJ Reynolds actively lobbied for the bill, claiming it closed a “loophole” that allowed bad actors to “target youth” and escape FDA regulation.

The real reason Reynolds and Juul supported the bill (and state-level bills to ban synthetic nicotine and create registries of FDA-authorized products) is to protect their profits. Disposables sold by manufacturers like synthetic nicotine bad boys Puff Bar are major convenience store competitors for Juul Labs and Reynolds’ Vuse brand. And open-system products sold in vape shops and online continue to make up a big chunk of the vaping market."

What Does the Synthetic Nicotine Law Mean for Vapers?

 

[UncLeJunkLe]

The real reason Reynolds and Juul supported the bill (and state-level bills to ban synthetic nicotine and create registries of FDA-authorized products) is to protect their profits. Disposables sold by manufacturers like synthetic nicotine bad boys Puff Bar are major convenience store competitors for Juul Labs and Reynolds’ Vuse brand. "

So...if ya can't join 'em, beat 'em. In a way, this tactic is like two children being mischievous but when one suddenly does the other one wrong, the wronged one goes and tells mom how bad the other one is being.

...

 

[zoiDman]

BT has Poured Hundreds and Hundreds (and Hundreds) of Millions of Dollars into ensuring that they will be the Dominant/Only Players in the US e-Cigarette Market. From getting the Marlboro Protection Act passed. To the Square Peg in the Round Hole PMTA process.

No Real Surprise that they would play an Active Role in the Regulatory Suppression of TFN.

 

[WorksForMe]

One is that Instead of doing things via Regular Order, once again a Unrelated Project is stuffed into a Must Pass Omnibus Spending Package. And Two, Dick Durbin is Front and Center of all of it.

I only see one good thing about this. The outrageous vape taxes that were in the failed Build Back Better Act did not get rolled over into the Omnibus spending bill. Of course, there may not be much left to tax pretty soon.


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[agateaqua]

from @kristin at CASAA:

NATIONAL CALL TO ACTION!

Anti-vaping lawmakers have slipped language into the 2022 Omnibus Budget Bill that would be a near-immediate ban on the thousands of low risk e-liquids and smoke-free products that contain synthetic nicotine. TAKE ACTION NOW!

National Call To Action - Stop a Ban on Synthetic Nicotine


.

Where do I sign or email, didn't really see that?

 

[UncLeJunkLe]

Where do I sign or email, didn't really see that?

The bill passed Senate and will be signed into law. Law takes effect 30 days after POTUS signs it.

National Call To Action - Stop a Ban on Synthetic Nicotine