I guess some are going to Blame Trump even though He wasn't the one who Signed things into Law. Or who's 1st FDA Commissionaire did Extend the Deeming Dates.
Deeming Regulations have been released!!!!
- Thread starter Oliver
- Start date
- th_trl_thread_readers 0
I guess some are going to Blame Trump even though He wasn't the one who Signed things into Law. Or who's 1st FDA Commissionaire did Extend the Deeming Dates.
I had a Long Conversation with a Lawyer friend who deals in Regulatory Law after the APA lawsuit about doing an appeal of the Drop Dead Date.
Her position was that it would an Extremely Uphill Battle given that the FDA purposed the Date that the Court ruled with.
And that if the FDA wanted More time, and thought that they could Likely to get it on Appeal (Unlikely at best), that they would have been better to ask for a Pushed Out date and then have the court pull it back. Then Appeal that the lower court date was Unreasonable.
But that would be Dicey at Best. And that the FDA probably got More time then they could have on Appeal.
Her final word was... "They Asked for it. And they Got what they Asked for. And It's Hard to Appeal that."
But it’s still unclear what the rules are. Yes, it’s been clarified a bit better in the last year, but not enough to insure a complete application can even be produced.
I doubt that the the FDA can "change the rules" in any significant way at this point. There simply isn't sufficient time between now and May 11th to follow proper rule-making procedure, and the fact that they didn't follow proper procedure to extend the deadline was the basis for the APA suit. However there are two things they could do to soften the blow:
1) They could rubber-stamp "APPROVED" on any PMTAs for vapor products that are actually submitted.
2) They could be less than enthusiastic in their enforcement efforts, thereby making the remaining market for vapor products gray rather than black.
I don't have much hope for the former, but I think there's a good chance for the latter.
Last edited:
Unfortunately lax enforcement would still mean things legally can't be sold, so it would be a black market. Legitimate operators would close down or risk significant penalties.
Grey goods are legal, just non standard distribution channel. For instance if I buy a good camera from a Japan shop, I may not receive any US warranty support. Legal to buy, legal to import, but not the proper US distribution channel. This would be a grey market purchase.
Grey goods are legal, just non standard distribution channel. For instance if I buy a good camera from a Japan shop, I may not receive any US warranty support. Legal to buy, legal to import, but not the proper US distribution channel. This would be a grey market purchase.
In that case every vape shop in the country has been engaged in a "black market" for the past three years. By early 2017, just about every one of them was carrying and openly selling products that were introduced to the US market after the 8/8/16 deadline. These products cannot be "legally sold", yet they are being sold openly, with sales and other taxes being collected and paid, and do on. If a situation similar to the what we've had for the past three years is what we'll continue to have after 5/11/20, I'll take it, and whether we call it "gray" or "black" one really doesn't matter much, does it?
I look at it as ratcheting up the risk profile to be a shop, increased potential for disruption of channels and seizure of goods.
Business people rely on some degree of stability.
Business people rely on some degree of stability.
The FDA knew this was coming for years and they dragged their feet on creating a process for assessing applications because they knew they would get blamed whether they designed it to produce a total ban or not. The politicians wanted vaping to go away but they wanted the FDA to do the dirty work for them without giving them explicit instructions in public. Trump almost got involved but heard mixed signals from whoever he listens to so he dropped it like a hot potato. The politicians and bureaucrats are both happy to let the judges take the blame. The judges don't care about the real world consequences of their decisions because they are appointed for life. The corporations pass out bags of money and job offers behind closed doors. Campaign managers run focus groups and juggle numbers.
Politics as usual.
The more of this I see, the better anarchy sounds.
What's funny about so called anarchists is they have no idea what anarchy is and that they would be the first to go. I'm not saying you @Rossum.The more of this I see, the better anarchy sounds.
Actually, the best we can hope for, and is in place under the current court order moving things to Ma,y is for the FDA to rubber stamp all requests for extensions on producing a complete PMTA. They are supposed to give the waiver on a case by case basis, but if they're really fast with the stamping they could allow things to remain around far longer while the approval situation is sorted out.
It would also make sense for smaller manufacturers to then wait for any big boys who ante and file, then see what it took for an approval and whether an SE path is then a possibility.
Paul Blair is asking everyone to contact their Senators about Mitt Romney's flavor ban and tax bill. It's quick and easy.
,
,
Last edited:
Azim Chowdhury tweeted further information on their appeal of the May 2020 PMTA deadline, including a link to the actual motion.
,
,
What we need (and deserve) is a permanent extension.
(in the face of this inequitable, ham-handed and impossible "process".)
Good luck.
Yep. They're going after the cigs.
This is a viable method that should be available to current smokers, sure. The "danger" here is that eventually it will be the ONLY option.
I don't for second believe they'll smoke less. Unless they're dual-using NRT's or something.
Anarchy is really not that great, but neither is this. It's sort of hard to pick. I'm just... Well, it will be what it is.
Anna
Anna
I remember Years Ago reading an OP-Ed in the WSJ when Light Cigarettes was a Topic of Debate. The premise of it was that Light Cigarettes was exactly what BT/Governments needed.
Not because they posed a Significant Public Health Benefit. But because it was shown that Smokers, on Averaged, smoked more Light Cigarettes per day than Regular Cigarettes.
And since Governments received Taxes based on Packs not on mg's of Nicotine, that was a Win for State/Fed Tax Collectors. And Selling More Packs is a Win for BT no mater how you Slice It.
Similar threads
- Locked
