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Federal judge gives tobacco manufacturers 10 months to comply with planned tighter FDA regulations

The Cromwell

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A federal judge agreed Friday to give the Food and Drug Administration a 10-month timeline for tobacco manufacturers to apply to meet planned enhanced regulations.

Judge Paul Grimm for the District of Maryland ruled that manufacturers have until May 11 to file pre-market applications for electronic cigarettes and cigars.

Products can remain in the marketplace for up to a year from the application submission date without being subject to FDA enforcement actions. The FDA can take enforcement actions against products that are not submitted for review.

More at link below.

https://www.journalnow.com/business...cle_c92efb06-de08-5fc0-bc91-a173f42f3295.html
 
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The Cromwell

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My read is that any vape product that has not had a PMTA application submitted by 5-11-2020 can be forbidden sale in the USA by the FDA.
Which will very likely be the vast majority of vape products currently being sold in the USA.

And on 5-11-2021 any vape product without an approved PMTA application will be pulled from the market.
Unless that product was sold in the USA prior to Feb 2007.
 
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JuicyLucy

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Several interesting nuggets in this article, especially one of the FDAs defense arguments:

According to the ruling, the FDA said a four-month timeline “would create massive administrative burdens at the agency that would ultimately be counterproductive.”

“It would threaten to abruptly clear the market of e-cigarette products, creating a ‘genuine risk’ that adult former smokers addicted to nicotine would ‘migrate’ from potentially less harmful (electronic nicotine delivery systems) products back to combustible tobacco products.”


Again, the scales of justice tilt towards where the real money is: BP and BT

The FDA timeline could have the effect of limiting competition from smaller e-cigarette makers by “protecting only those products backed by very deep-pocketed companies,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigs and health studies.
“Which means tobacco companies, and perhaps Juul and Njoy, can compete with cigarettes, but much of the threat vaping posed to Big Tobacco due to all the innovative start-ups has just been greatly diminished.”
 

The Cromwell

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“It would threaten to abruptly clear the market of e-cigarette products, creating a ‘genuine risk’ that adult former smokers addicted to nicotine would ‘migrate’ from potentially less harmful (electronic nicotine delivery systems) products back to combustible tobacco products.”
Yep interesting to hear the FDA finally admit that...

The possibility exists that this hurry up action is driven by a fear by some the the FDA might be leaning towards a more pro vaping stance?
And that cannot be allowed to happen?
 

The Cromwell

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I have to wonder about the vape market dynamics leading up to the May 2020 date...
Will there be sales or will the prices increase as demand increases fed by last minute vape preppers and decreasing vape stock in the USA?

Just curious as I do not need to buy any more vape hardware. However might if some very good clearance stuff comes up that interests me.
 

Countrypami

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I think the FDA is afraid to admit they were WRONG! It's gonna be a slow road, probably take years, but I do think eventually they will back off the stringent regulations.
 

The Cromwell

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I think the FDA is afraid to admit they were WRONG! It's gonna be a slow road, probably take years, but I do think eventually they will back off the stringent regulations.

I also lean in that direction.
But if vaping is pretty much banned they will not have much US data to go by.
The vape black market will not provide much data.
 

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I've been closely following this case. A bunch of self-righteous "health groups" like the American Heart Association and the American Lung Association among others, sued the FDA over the agency extending the PMTA submission deadline from August 2018 until August of 2022. The plaintiffs argued that this act exceeded the FDAs authority to do as a regulatory agency, claiming that once the FDA was charged with setting the original mandatory deadline and did so, postponing that date was only allowable if charged to do so by an authoritative government branch.
In his ruling, the judge agreed with the plaintiffs. The judge also blocked Amicus Curiae briefs even before they were submitted by attorneys representing vape product manufacturers as well as vaping advocacy groups, claiming that "if they wanted to be involved, they would have been involved from the beginning of this case."
The plaintiffs submitted a request that all vape product (they termed tobacco products. Sheesh) manufacturers have to have PMTAs on all existing devices and e-liquids currently available in a 4 month timeframe.
The FDA submitted a counter request brief asking for a 10 month timeframe, as the 4 month request, if granted, would not only cripple the FDA administratively, but would certainly destroy the vaping industry in the U.S. almost immediately.


The Wire Spider
 

The Cromwell

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n his ruling, the judge agreed with the plaintiffs. The judge also blocked Amicus Curiae briefs even before they were submitted by attorneys representing vape product manufacturers as well as vaping advocacy groups, claiming that "if they wanted to be involved, they would have been involved from the beginning of this case."

yeah it seems that our vaping industry/advocacy groups leave something to be desired.
 

VAPEROXX

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n his ruling, the judge agreed with the plaintiffs. The judge also blocked Amicus Curiae briefs even before they were submitted by attorneys representing vape product manufacturers as well as vaping advocacy groups, claiming that "if they wanted to be involved, they would have been involved from the beginning of this case."

yeah it seems that our vaping industry/advocacy groups leave something to be desired.
Yeah, they were a little late to the table on this one, considering the case has been ongoing for almost three years, and the first Amicus Curiae brief submission request was submitted about a month or so ago...

The Wire Spider
 

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I am becoming less and less apocalyptic about it overall. Some things will become more expensive and harder to get and we will be inconvenienced at every level but I do think it will survive. BT will try and push people to pods and closed systems but those already in the know and have experience will end up being champions for fighting that nonsense and helping pair people with the right products, sourcing them will become slightly more difficult and the second-hand market will explode.

I also believe forums and such will get a large uptick in folks as there will be more hand me down hardware, older hardware will become popular again and people will start spending more time with the stuff they have.
 

The Cromwell

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I also believe forums and such will get a large uptick in folks as there will be more hand me down hardware, older hardware will become popular again and people will start spending more time with the stuff they have.
Ahh but the vaping ad revenue...
 

The Cromwell

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China will keep advertising.
Not sure they can legally. Generally speaking advertising of illegal things is not allowed.
But then this site is located in Canada...
Will have to see how it all shakes out.

Importation of banned vape stuff is prohibited as well.

And yes I know it will still happen but maybe customs will seize it?
 
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Synphul

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I'm not too worried. Maybe some bumpy roads ahead, but let's look around. Bars all over the place, able to walk into any gas station or grocery store and snag beer by the case, bottles of liquor, wine coolers, shooters, margarita mix etc. Not bad after the government outright 'banned it' entirely, proactively enforced the ban and stormed backroom bars, chased bootleggers and prevented imports of alcohol during prohibition.

Let's also not forget the war on drugs. Apparently telling the hippies 'no more' worked out well. In spite of ongoing federal laws prohibiting it, states and cities are doing whatever the hell they want with no repercussions. Entire farms are being setup out in the open, they're giving it away to people at events, it's fine for recreational use.

So people think they're actually going to wipe vaping off the map? That's cute. It's worked so well in the past. If they treat the 'vaping epidemic' anything like the '****** epidemic' we won't even have to pay for mods, they'll be handing out pods and coils for free. lmao.
 

The Cromwell

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One thing most forget or never knew about prohibition.
Physicians could prescribe booze.
There were a few legal distilleries making legal booze for 'medicinal' purposes :)

ever wonder where the women wanting their daughters to grow up and marry a doctor came from?

so maybe in a few years we will have prescription ecigs so the medical industry can get their cut?
 

Synphul

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I don't know, it may seem like a bummer. But honestly to think an industry in this day and age wouldn't be regulated is kind of naive. I mean on one hand you have kids making lemonade getting shut down for not having a permit. Or people complaining they don't have any health inspection oversight. On the other you have people making things like ejuice and selling to thousands of people like 'wutt? you mean this juice I've been throwing together with nicotine and random food flavorings meant to be inhaled with no oversight or standards whatsoever - is going to be regulated at some point? awww man.'

A lot of ejuice companies do go out of their way to show how clean they are. They've got the lab rooms and cleanroom smocks, beard covers and all that good stuff. Which is great. But not mandatory. Not one of them can really say 'our labs meet standards' - because there are none. On the other end of the scale you've got Dr Crimmy whipping up lord knows what in the back room of their shed. I've heard people talk about the crap they do to 'house juice', adding water in the backroom, cutting it or adding alcohol or whatever else. The way gorilla bottles are shipped you pop a top on and it appears 'sealed', but what went into it in the meantime, before it got capped? We just hope that general public shame is what keeps companies aboveboard. The same people who wouldn't trust a food product without a tamper seal (maybe not a bad idea with all the asshole ice cream lickers lately) just buy juice from wherever.

It's easy to blow it off on a big tobacco conspiracy, I'm sure it plays a part. The FDA also seized documents from Juul though, so even BT backed vaping stuff isn't 'safe'. Matt at SMM had a pretty level headed view of things as they stand I think after watching his video. Without the classic 'sky is falling' b.s. He also made a good point, that newer vapers and regular consumers may be unaware. But for anyone in the industry, manufacturer, brand, shop owner etc that acted surprised by it needs to dig their head out of the sand and pay attention. It hasn't been a secret. People had warning this kind of oversight was coming 3yrs ago. It wasn't going to go away. They've had all kinds of time to prep, or at least attempt to even if they didn't know specifically what was needed. They have the insight to say 'hey that's child appealing, that's bad, that's hurting us' but then act like 'huh? you want information, about the product? Like what?'.
 

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