FDA Submission Date Moved to 8/8/2022

[stols001]

I was gonna say, "Let's start a 'California' thread there. But Anna is kinda new to ECF. I don't think it would be fair to bring her into that dark, shadowy place. Probably best if she never goes there.

Now I want to go!!!!! Moooom! Rossum says I can't go OUTSIDE!


LOL, I think I will heed your advice for now, Rossum. Like I need more troubles....

Anna

 

[SeniorBoy]

FYI. May have been posted by others. Bolded by yours truly:

"President Donald Trump’s pick to head the U.S. Food and Drug Administration, Scott Gottlieb, will be in charge of implementing new rules governing the e-cigarette industry after serving for more than a year on the board of a company that sells vaping products. From March 2015 to May 2016, Gottlieb was a director of Kure Corp., a Charlotte, North Carolina-based firm that distributes e-juices and vaping pens in coffeehouse-style lounges known as vaporiums. He had a financial interest in the company as of March, according to financial and ethics disclosures, and promised to sell his stake if confirmed."

Article dated 4/19/17 - Source

EDIT: Disclosure by Dr. Gottlieb

 

[stols001]

Yes, I think I saw that elsewhere in a news article, including the fact that Dr. Gottleib had cancer.... It kind of makes me conclude that he may be a former-smoker, current-vaper, and if so, good for him. I wish he'd pulled out his vape during the speech he gave, and started demonstrating it's features.

I kid. This is all speculative, but it did make me think about that stuff. If e-cigging is going to be deemed by anyone, I'd be thrilled to have it be by someone who actually knows ANYTHING about vaping. Maybe why BT has been so... quiet-ish of late? (again, speculation).

Anna

 

[Rossum]

Yes, I think I saw that elsewhere in a news article, including the fact that Dr. Gottleib had cancer.... It kind of makes me conclude that he may be a former-smoker, current-vaper, and if so, good for him.

According to Wikipedia, he had Hodgkin's lymphoma. I'm not aware of any correlation between that and smoking.

 

[stols001]

Nope, me neither. Thanks for the lookup. I still think it might make him very aware of what cancer is like on a visceral level....

Anna

 

[Grego25]

I haven't been on ecf in a while & must have missed something. When was the date changed from 2007 to 2016? Last I saw the amendment was in the house


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[Rossum]

I haven't been on ecf in a while & must have missed something. When was the date changed from 2007 to 2016? Last I saw the amendment was in the house

It wasn't. The date that got changed was 2018 to 2022. That effectively allows products that were on the market prior to 8/8/2016 to remain on the market for an additional 4 years, but not in perpetuity, like Cole-Bishop would.

 

[Grego25]

Thanks


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[Verb]

I reason, the reason the FDA is not enforcing the 8/16 freeze on hardware sold without nicotine containing liquid, it opens them up to having to defend in court that zero nicotine vaping is tobacco use.

I could see them coming down on liquids first to test the waters.

 

[zoiDman]

I reason, the reason the FDA is not enforcing the 8/16 freeze on hardware sold without nicotine containing liquid, it opens them up to having to defend in court that zero nicotine vaping is tobacco use.

...

I'm not sure how Opened that Door is anymore? Now that Judge Jackson ruled that the FDA was within it's Authority to apply "Intended Use" if there was a "Reasonable Expectation" that a piece of Hardware was going to be used with Nicotine derived from Tobacco.

 

[Bill Godshall]

I don't think the changes that the new FDA Commissioner announced can be seen as any kind of negative for vaping in the U.S. but I am confused by one aspect.

The FDA has said that one of the reasons for the change to the deadline for the pmta applications is to encourage innovation in non combustibles yet they still freeze the market at 8/2016.
How can the vape industry innovate in the U.S.?

Under Gottlieb's four year delay, no new vapor products will be allowed to be lawfully marketed in the US unless/until FDA has approved a PMTA for them.
So that claim by Gottlieb was obviously false.

Ironically (or not), those who lobbied Congress to enact the TCA (from 2004-2009) also falsely claimed that the TCA would encourage the development of new low risk tobacco products (even though it banned all of them by imposing a grandfather date, and requiring FDA approval of a PMTA for any new product).

Similarly, those who lobbied FDA to impose the Deeming Regulation (as well as FDA's Mitch Zeller) falsely claimed that the Deeming Regulation would encourae the development of new low risk tobacco and vapor products (even though the Deeming Reg would have banned >99.9% of vapor products in 2018 had Gottlieb not extended the deadline four more years).

But Gottlieb's four year delay in the Deeming Regulation will encourage vapor manufacturers in other countries to develop new vapor products (that will be unlawfully sold in the US).

 

[zoiDman]

Under Gottlieb's four year delay, no new vapor products will be allowed to be lawfully marketed in the US unless/until FDA has approved a PMTA for them.
So that claim by Gottlieb was obviously false.

Ironically (or not), those who lobbied Congress to enact the TCA (from 2004-2009) also falsely claimed that the TCA would encourage the development of new low risk tobacco products (even though it banned all of them by imposing a grandfather date, and requiring FDA approval of a PMTA for any new product).

Similarly, those who lobbied FDA to impose the Deeming Regulation (as well as FDA's Mitch Zeller) falsely claimed that the Deeming Regulation would encourae the development of new low risk tobacco and vapor products (even though the Deeming Reg would have banned >99.9% of vapor products in 2018 had Gottlieb not extended the deadline four more years).

But Gottlieb's four year delay in the Deeming Regulation will encourage vapor manufacturers in other countries to develop new vapor products (that will be unlawfully sold in the US).

The TCA and the FDA's Deeming do many things. But encouraging the development of New low risk tobacco and vapor products is about the Last Thing that either do.

Hard to believe a Lobbyist (or anyone for that matter) could even say they would with a Straight Face.

 

[Verb]

I'm not sure how Opened that Door is anymore? Now that Judge Jackson ruled that the FDA was within it's Authority to apply "Intended Use" if there was a "Reasonable Expectation" that a piece of Hardware was going to be used with Nicotine derived from Tobacco.

But she also ruled the ability to argue for zero nicotine eLiquid and the equipment used to vape it has not been "made ripe" since no enforcement against it, for being sold as an unapproved tobacco product, has taken place.

As soon as they try to bring open system hardware into the fold, the argument becomes ripe for a court challenge. Using a "never to be used with tobacco or its derivatives" label would be a good idea before bringing a challenge.

I really wish a clear answer would have been provided to the judge when she rhetorically asked, what else would a person do with the device (other than consume a tobacco product).

 

[sky4it]

Kent:

A question for you here. Am I to understand that nicotine and flavorings that were for sale prior to Aug 2016 now will have an extended date until August 2022 for approval by FDA? You know nicotine that you mix with flavoring sold by all these vendors? And flavorings also?

If that is so this is a huge victory for vaping.

 

[Rossum]

Kent:

A question for you here. Am I to understand that nicotine and flavorings that were for sale prior to Aug 2016 now will have an extended date until August 2022 for approval by FDA? You know nicotine that you mix with flavoring sold by all these vendors? And flavorings also?

If that is so this is a huge victory for vaping.

I'm not Kent, but I'll throw two cents in anyway:

I don't think that's necessarily a sure thing. The FDA could propose additional rules at any time; stuff like restricting the nicotine concentrations in products sold to consumers, banning diketones in anything intended for vaping, etc, etc. However, I would suppose we'd have some warning because they'd have to go through the rule-making process, which generally takes a few months at an absolute minimum.

 

[Myrany]

Also remember many of the flavorings we use were never intended for vaping to begin with. THey are food flavoring so would likely stay on the market regardless if not sold by a vape shop.

Edit: I have always seen the nicotine as the real choke point the FDA could grab us by. PG, VG, Flavorings even batterys all have other uses non vaping related. Hardware can be improvised. Nicotine IS the sticker.

 

[Kent C]

Kent:

A question for you here. Am I to understand that nicotine and flavorings that were for sale prior to Aug 2016 now will have an extended date until August 2022 for approval by FDA? You know nicotine that you mix with flavoring sold by all these vendors? And flavorings also?

If that is so this is a huge victory for vaping.

I was commenting 'nice job' to zoidman's post, but you should also look at Bill G's reply here, that contains zoidman's quote:

Submission Date Moved to 8/8/2022

IOW, that 'extended date' is for suppliers to submit PMTA's for approval. Not a small task for many suppliers.


And thanks to Rossum for pinch hitting while I was away..... I agree with what he said as well.

 

[sky4it]

thanks Kent & Rossum.

Rossum but there are no proposed rules on the table, at least not that I could discern from glancing the stuff over. In addition, it would only seem reasonable if they were going to regulate nicotine, a window of just a few months would seem predatory.

The scope of this seems rather large, I would of thought the labs selling nicotine would have been out of business by august 2018 but now it seems to go on, which I think is huge news.

Im more concerned about my favorite flavorings, you cant store the stuff beyond a year or two.

Your the expert here Kent, you got an opinion? I will be just reading and listening.

 

[zoiDman]

Rossum but there are no proposed rules on the table, at least not that I could discern from glancing the stuff over. In addition, it would only seem reasonable if they were going to regulate nicotine, a window of just a few months would seem predatory.

...

I'm not Rossum.

But this is what a ANPRM (Advanced Notice of Proposed Rule Making) does.

 

[Rossum]

The scope of this seems rather large, I would of thought the labs selling nicotine would have been out of business by august 2018 but now it seems to go on, which I think is huge news.

The regs that were finalized last year left some room for doubt. The stated that the FDA wasn't planning on to enforce against anything that wasn't a finished product, and the most common 100mg/ml nic base isn't, because nobody would vape it straight.

Im more concerned about my favorite flavorings, you cant store the stuff beyond a year or two.

I guess it depends on what your favorite flavorings are, but flavorings in general were way down the worry list because they easily pass the "What else would someone do with this product?" test.