Puff Bar: A Preview of the Post-PMTA Vaping Industry

[WorksForMe]

Jim McDonald(Vaping360) thinks the FDA won't be able to stop illegal vape products after September 9th. He's probably right. Most of the stuff on the market right now is technically illegal, but the FDA hasn't done much about it.

"The reason the FDA has not cracked down on the producers of Puff Bar and similar non-compliant manufacturers is probably that the agency simply can’t figure out who they are. If the FDA were to issue a warning letter, or two or three warning letters, to Puff Bar enterprises, and the products continued to be sold in every corner store, it would serve only to highlight the FDA’s regulatory impotence."

Puff Bar: A Preview of the Post-PMTA Vaping Industry

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[Rossum]

"In an era of internet commerce, cheap intercontinental shipping, and cryptocurrency, a plodding regulatory agency like the FDA has no chance of banning products that people want."

 

[zoiDman]

The FDA isn't the Only One who can put a Crimp in your Stride.

AG Maura Healey suing online vape company alleging it sold flavored tobacco products in Mass.

https://www.mass.gov/doc/puffbar-complaint/download

 

[cigarbabe]

The FDA isn't the Only One who can put a Crimp in your Stride.

AG Maura Healey suing online vape company alleging it sold flavored tobacco products in Mass.

https://www.mass.gov/doc/puffbar-complaint/download

I am damned sick of hearing about a dumb bint who has no clue apparently about us or this industry.
Forgive my poor language....
C.B.

 

[thanswr1]

I'm confused.

From the vaping 360 article: "Puff Bars—like all vaping products that were not on the market before Aug. 8, 2016—are illegal to sell, whether you’re the bonafide owner of the brand or not.

Does that mean all the products that were for sale before Aug. 8, 2016 are legal?

Call me a cynic, but I'm starting to believe no one in Washington, DC understands what the hell is going in the vape industry?

 

[zoiDman]

...

Does that mean all the products that were for sale before Aug. 8, 2016 are legal?

...

What it means is If you had a Tobacco Product that was offered for sale in a US Market prior to Aug 8th 2016, you can continue to sell it while you put together and file either a PMTA, or a SE, or a MRT Application with the FDA. Which are due on or before Sept 9th 2020.

After that time, you can continue to Sell your Product while the FDA evaluates your Application. Or your Application is Denied.

Any Tobacco Product Not offered for Sale before Aug 8th 2016 in a US Market is considered to be a "New Product". And can Not be Legally sold without an approved PMTA or a SE or MRT.

Puff-Bars were Not on the market prior to Aug 8th 2016. So they Can't Legally be sold until they obtain a PMTA or a SE or a MRT from the FDA.

But the Problem is Puff-Bars have been Severely Bootlegged. So the OEM can stop selling their product. But that Doesn't Stop all "Puff-Bars" from being Sold.

 

[thanswr1]

Thank you.

So I can assume the Aspire Nautilus tank would still be sold after September 9th? And products from all the online vape liquid vendors who sold their product before August 2016 could also still be sold?

Yanno, this thing is getting so convoluted as to be almost FUBAR.

 

[puffon]

Thank you.

So I can assume the Aspire Nautilus tank would still be sold after September 9th? And products from all the online vape liquid vendors who sold their product before August 2016 could also still be sold?

Yanno, this thing is getting so convoluted as to be almost FUBAR.

They can only sell it legally IF they have submitted a PMTA by Sept. 9 2020.

 

[zoiDman]

Thank you.

So I can assume the Aspire Nautilus tank would still be sold after September 9th? And products from all the online vape liquid vendors who sold their product before August 2016 could also still be sold?

Yanno, this thing is getting so convoluted as to be almost FUBAR.

It's really Pretty Simple. If your Product was on the Market before Aug 2016 than you're Legal. If Not, than it is Not. Where things got Convoluted is when the FDA Didn't enforce the August 2016 cut-off date.

Great for Vaper's. And we enjoyed continued New Products. But now those "New Products" are Entrench and are now the Norm.

I believe this was by Design. But the whole JUUl thing kinda threw a wrench into the works.

 

[Rossum]

It's really Pretty Simple. If your Product was on the Market before Aug 2016 than you're Legal.

Until September 9th. After that, you're only legal if you've submitted a PMTA.

I believe this was by Design.

How so? What did the FDA gain by allowing those products to become entrenched? After September 9th, it no longer matters whether a product was on the market prior to 8/8/16, the're all equally "misbranded" unless a PMTA has been filed.

But the whole JUUl thing kinda threw a wrench into the works.

I'm not sure I follow. Juul was on the market back in 2015.

 

[zoiDman]

...


How so? What did the FDA gain by allowing those products to become entrenched? After September 9th, it no longer matters whether a product was on the market prior to 8/8/16, the're all equally "misbranded" unless a PMTA has been filed.

---


I'm not sure I follow. Juul was on the market back in 2015.

Because I Don't think Gottlieb's plan was ever to do "Letter of the Regulation" enforcement of e-Cigarettes. He saw that e-Cigarette could be/are harm reduction over Smoking. So what would be the Sin of taking more of a "Look the Other Way" approach?

Much like the Previous President did with regards to what is now NORML to talk about here on the ECF.

---

Because JUUL became the Poster Child for under aged e-Cigarette use. Heck, it even has it's own Catch Phrase, "JUULing".

And BT's investment in JUUL just cemented the thought in Many Minds that JUUL had nothing to do with THR. It was all about Money and Facilitating Addiction.

If you Remove the Under Aged US Hysteria from the e-Cigarette narrative what do you have? A bunch of Adult Smokers who are improving their lives by using something that UK Heath says is Better than Smoking?

Not say'n that if JUUL had never been invented that we wouldn't be where were are today. And maybe if JUUL never came along the Catch Phrase would be NJOYing?

But it is Undeniable that JUUL has had the Most Devastating Effect on the e-Cigarette Market in the History of e-Cigarettes.

Be it Intentional. Unintentional. Or some melding of the Two.

 

[Rossum]

Because I Don't think Gottlieb's plan was ever to do "Letter of the Regulation" enforcement of e-Cigarettes. He saw that e-Cigarette could be/are harm reduction over Smoking. So what would be the Sin of taking more of a "Look the Other Way" approach?

Much like the Previous President did with regards to what is now NORML to talk about here on the ECF.

OK, that's entirely plausible. The regulations pre-dated Gottlieb's tenure, and were clearly not his creation. And I've been saying for quite some time that enforcement is the key question.

Because JUUL became the Poster Child for under aged e-Cigarette use. Heck, it even has it's own Catch Phrase, "JUULing".

And BT's investment in JUUL just cemented the thought in Many Minds that JUUL had nothing to do with THR. It was all about Money and Facilitating Addiction.

If you Remove the Under Aged US Hysteria from the e-Cigarette narrative what do you have? A bunch of Adult Smokers who are improving their lives by using something that UK Heath says is Better than Smoking?

Not say'n that if JUUL had never been invented that we wouldn't be where were are today. And maybe if JUUL never came along the Catch Phrase would be NJOYing?

But it is Undeniable that JUUL has had the Most Devastating Effect on the e-Cigarette Market in the History of e-Cigarettes.

Be it Intentional. Unintentional. Or some melding of the Two.

IMO, if Juul wasn't the product that caught on among the "youth", some other product likely would have, and would have ended up being similarly demonized.

 

[zoiDman]

...

IMO, if Juul wasn't the product that caught on among the "youth", some other product likely would have, and would have ended up being similarly demonized.

No arguments there. I think I mentioned it in the Portion you Quoted.

But what is Debatable is could our friend Scott have hung on if He was dealing with a More Receptive Company (without a BT Influence) that was the choice of Teen Vape?

It seemed that the FDA (and more importantly, the HHS) was caught Flat Footed when Altria was able to reach an Agreement for a Limited Ownership share in JUUL.

It Shouldn't have. Because it was Common Knowledge that Altria had be pursuing a Deal with JUUL for over a Year. And Altria's offering in the e-Cigarette market was Ho-Hum at best.

But it Did.

Which makes some Wonder just how Forthright Altria was with the FDA and Zeller? Because when the News broke, everyone at HHS/FDA/CTP all kinda looked like Rubes with Farm Fresh Egg on their Faces.

Remember... Just Prior to JUUL/Altria news, Scott had gotten up and Proudly Said that after Many Hours of discussion with Altria, that Altria had agreed to Voluntarily pull much of their e-Cigarette line (to Save the Children) until they received a PMTA.

Which made Scott look like some Idiot who got Flim-Flammed by BT smooth talk. Which played a Big Role in him Leaving/Having to Leave FDA.

So Yeah... I'm sure if some other Company had become the Hip thing for Teens to do, it would Not have been good. But it might not have been as Bad as the entire JUUL/Altria mess.

And Maybe Scott could have weathered the storm?

 

[zoiDman]

BTW - Interesting Reading if You (anyone) have not seen it until now...

FTC Sues to Unwind Altria’s $12.8 Billion Investment in Competitor JUUL

 

[Katya]

BTW - Interesting Reading if You (anyone) have not seen it until now...

FTC Sues to Unwind Altria’s $12.8 Billion Investment in Competitor JUUL

I haven't--thanks.