FDA Submission Date Moved to 8/8/2022

[Rathamar]

Did anyone else see this -
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

Looks like the application date is moved until August 2022.

The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

Good news for once!

 

[trying]

Now we are free to focus on the local regulations

 

[sofarsogood]

Now we are free to focus on the local regulations

The fda sees no clear and present danger. State and local government should also take a pause.

 

[Rossum]

Looks like the application date is moved until August 2022.

YUGE news.

 

[sofarsogood]

Imagine the celebrations in the vape shops and e liquid makers. If this sticks it's global news. The vape business should use this time to address standards and safety so the government has something to endorse instead of coming up with their own stuff.

 

[rwoodin]

This is the best news I've heard for the vapor industry and community since the deeming regs, ever!

 

[zoiDman]

Did anyone else see this -
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

Looks like the application date is moved until August 2022.

The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

Good news for once!

I always felt that if we could just Hold On Long Enough, that Reputable Science and Non-Rhetoric Policy thinking could prevail.

Extending out these Compliant Dates sorely helps to get us to a Place where THR can be Evaluated more Objectively.

 

[Kent C]

Not all 'good' but a rather new view from the new "FDA Commissioner Scott Gottlieb, M.D. "Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it's vital that we pursue this common ground."

 

[tj99959]

With the way the industry is, there probably isn't a product being sold today that will still be available in 2022. That alone will save the industry billions.

 

[Rossum]

With the way the industry is, there probably isn't a product being sold today that will still be available in 2022. That alone will save the industry billions.

Except that those aspects of the Deeming for which the deadlines have already passed are unaffected by this, meaning that in principle, any product introduced after August of 2016 still requires a PMTA before it can be sold.

The question of course is to what degree of enforcement we'll see regarding new products that are marketed without a PMTA...

 

[SteveS45]

We still need to advocate for our right to vape.

Sign the Petition

 

[Hulamoon]

Except that those aspects of the Deeming for which the deadlines have already passed are unaffected by this, meaning that in principle, any product introduced after August of 2016 still requires a PMTA before it can be sold.

The question of course is to what degree of enforcement we'll see regarding new products that are marketed without a PMTA...

When did the grandfather date move up to Aug 2016? That element is pretty important as the 2007 date was what was sticking in my craw.[/QUOTE]

 

[Bill Godshall]

FDA Commissioner Scott Gottlieb delays FDA’s vapor PMTA application deadline and vapor prohibition date from November 8, 2018 until August 8, 2022, vaguely endorses THR, calls for FDA to develop a new comprehensive plan for tobacco, nicotine, vapor and flavor product regulation
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
FDA's New Plan for Tobacco and Nicotine Regulation

Scott Gottlieb’s special announcement on tobacco/nicotine/vapor policy is at
Center For Tobacco Announcement

Gottlieb also said FDA CTP intends to:
- maintain Deeming Rule’s sales ban on all new vapor products since August 8, 2016,
- maintain Deeming Rule’s ban on truthful health claims by vapor manufacturers,
- reevaluate Deeming Rule’s policies on vapor products, cigars and OTP,
- promulgate regulations and final guidances for PMTA, MRTP and SE applications,
- promulgate rules on "kid-appealing" flavors in tobacco/vapor products (after FDA and its funding recipients falsely claimed, since 2009, that flavorings are marketed to youth),
- promulgate more rules and standards for ENDS (vapor products), and
- mandate low nicotine cigarettes (which would increase harms for many/most smokers, and would create an enormous black market for cigarettes).

News articles on FDA Commissioner Scott Gottlieb’s announcement are at
FDA unveils plan for major changes to tobacco product regulations
FDA aims to lower nicotine in cigarettes in bid to get smokers to quit
Tobacco Shares Plunge After FDA Proposes Cut to Cigarette Nicotine
FDA aims to cut nicotine in cigarettes, shift toward e-cigarettes
British American Tobacco not surprised by FDA move to cut nicotine

Altria responds to Scott Gottlieb’s announcement
Press Release

Clive Bates: Huge FDA announcement on future tobacco and nicotine strategy
Huge FDA announcement on future tobacco and nicotine strategy

 

[Akrotiri]

No you you didn't. In my thread which you hijacked some time ago(president trump just saved vaping) you were emphatic that the deeming laws were unavoidable and already codified into law.

I was 100% correct. I graciously tried to inform ECF members that the deeming regs were not yet codified due to lack of legislative days in the federal register and were in fact invalidated by trumps second executive order.

The thanks I got is that my IP address gets banned from ECF because of your trolling in my thread. I encourage everyone who reads this to read thru my thread "President Trump just saved vaping" to see how right I was and incorrect you were.

Also, the FDA is directly investigating ECF. For further information regarding the progress and reasons for the investigation I require ECF to unblock my IP and an apology from those who derailed my thread . That is all.

 

[cookiebun]

No you you didn't. In my thread which you hijacked some time ago(president trump just saved vaping) you were emphatic that the deeming laws were unavoidable and already codified into law.

I was 100% correct. I graciously tried to inform ECF members that the deeming regs were not yet codified due to lack of legislative days in the federal register and were in fact invalidated by trumps second executive order.

The thanks I got is that my IP address gets banned from ECF because of your trolling in my thread. I encourage everyone who reads this to read thru my thread "President Trump just saved vaping" to see how right I was and incorrect you were.

Also, the FDA is directly investigating ECF. For further information regarding the progress and reasons for the investigation I require ECF to unblock my IP and an apology from those who derailed my thread . That is all.

I'm all ears. Why would the FDA investigate ECF?

 

[Herrick]

So now all these vape companies have 5 years. How many of them will be able to afford the FDA hoop-jumping process in 2022?

 

[zoiDman]

So now all these vape companies have 5 years. How many of them will be able to afford the FDA hoop-jumping process in 2022?

If the FDA actually established Standards for PMTA, SE and MRTA approval, wouldn't this Substantially Reduce the cost of doing a successful PMTA, SE or MRTA?

Too Earlier to say how all this is going to Play Out. But I am Hopefully Optimistic by the Tone and Direction the FDA says it wants to move in regarding "Tobacco Products".

 

[JUDGMENT AFFIRMED]

No you you didn't. In my thread which you hijacked some time ago(president trump just saved vaping) you were emphatic that the deeming laws were unavoidable and already codified into law.

I was 100% correct. I graciously tried to inform ECF members that the deeming regs were not yet codified due to lack of legislative days in the federal register and were in fact invalidated by trumps second executive order.

The thanks I got is that my IP address gets banned from ECF because of your trolling in my thread. I encourage everyone who reads this to read thru my thread "President Trump just saved vaping" to see how right I was and incorrect you were.

Also, the FDA is directly investigating ECF. For further information regarding the progress and reasons for the investigation I require ECF to unblock my IP and an apology from those who derailed my thread . That is all.

I recall reading that thread and it does appear that you were right Akrotiri.

 

[zoiDman]

...

I was 100% correct. I graciously tried to inform ECF members that the deeming regs were not yet codified due to lack of legislative days in the federal register and were in fact invalidated by trumps second executive order.

...

I Hate to be the Big Black Fly in the Frosting Akrotiri. But Deeming is Still in Effect.

Yes, the PMTA Filing Date has been Extended. And there were Positive Remarks made about reviewing the PMTA, SE, MRTA processes, but Deeming hasn't gone anywhere just yet.

If you want someone to thank, Ironically that would probably be Judge Jackson.

And this Didn't Happen. Or wasn't even close.

We'll know in about 2 days if the anti-vaping deeming regs were completely struck down or if it is the regulations that have yet to take effect. Either way its a win-win because the harshest of the regulations are the ones in 2018. (Dated: Jan 23rd, 2017)

 

[sofarsogood]

There are a few items left to get for the stockpile (see below). Nothing announced today changes that plan. I probably won't delay the last purchases because I'd like to stop fretting about it.

The plan appears to be to take the nicotine out of cigarettes and encourage smokers to get their nic fix from something lower risk, including vaping. It might work.

The FDA is a revered institution around the world (deserved or not). All of a sudden vapers have the moral high ground, one of my favorite places.