Substantial Equivalence and Premarket Question

[fireground_piper]

I did a search of the forum and didn't find any threads on it, but I was browsing around the FDA site on Substantial Equivalence and noticed a note at the top - Substantial Equivalence - https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/substantial-equivalence

On Jan. 19, 2021, the Premarket Tobacco Product Applications final rule and Substantial Equivalence final rule were displayed in the Federal Register, but did not publish. On Jan. 20, 2021 a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules have been withdrawn. The FDA will work closely with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.

Does that mean these parts of the Deeming regs are back to the drawing board? Or does it not really mean anything or have any impact?

 

[anotherbob]

I did a search of the forum and didn't find any threads on it, but I was browsing around the FDA site on Substantial Equivalence and noticed a note at the top - Substantial Equivalence - https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/substantial-equivalence



Does that mean these parts of the Deeming regs are back to the drawing board? Or does it not really mean anything or have any impact?

it means the law wasn't expressed clearly enough in a timely manner and has to go back to the drawing board.

 

[sablebrush52]

it means the law wasn't expressed clearly enough in a timely manner and has to go back to the drawing board.

Or that they will have to resubmit the standards that they had proposed. In any event it will represent a delay and it's anyone's guess how that affects a deeming process that is well underway.

 

[anotherbob]

Or that they will have to resubmit the standards that they had proposed. In any event it will represent a delay and it's anyone's guess how that affects a deeming process that is well underway.

and it is implied that it might have to be reworked.

 

[weezell]

it is implied that it might have to be reworked.

With the current political climate (ahem), that may not bode in our favor me thinks...

 

[anotherbob]

With the current political climate (ahem), that may not bode in our favor me thinks...

nah. Old farts like collecting taxes too much. And if anything all it might mean is pipe tobacco starts costing more and I hate to say this but I feel like we get way more then we pay for if I am being totally honest. Silver lining if the Gov is getting more of the pie they're less like to want to throw it in the trash.
Oh and this is funny but true. Might also mean it isn't happening because no one is willing to put the man power into it. Might also and I don't know at all about this but if the process was started under one head and there is a different one now, they might just let it die. I think that cause if it was important to them they'd have had it ready by their explicit deadline.

 

[Worknman]

I don't think anybody knows whats going on with any of this, including the FDA.

 

[telescopes]

If big tobacco and the growers were concerned, we’d see it via changes in size of tobacco being planted, dumping excess supplies, or something. Right now everything seems business as usual.

 

[craig61a]

C'mon, it's the Government we're talkin' about here... If you want any project to be galactically bungled, the Government's your man...

 

[kcghost]

If you trust the government to do any thing beyond defend the shores and delivering the mail you are SOL.

 

[pantsBoots]

delivering the mail

They've been doing a real swell job of that lately, eh?

 

[saltedplug]

I say we converge on FDA with about 2 dozen members and moon them.

 

[sablebrush52]

I say we converge on FDA with about 2 dozen members and moon them.

As I recall, That's what was done to the San Francisco City Council when they voted to outlaw public nudity in the Castro district. Didn't stop them from passing the ordinance.

 

[solideogloria86]

I say we converge on FDA with about 2 dozen members and moon them.

I say we all start mailing mm cobs and samples of great tobacco to fda headquarters. If you can't beat them, get the to join you!