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Enta

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David after Trick or Treating last year. :blink:

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Lessifer

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So, the latest news is, as of yesterday the FDA submitted a "Final Rule" to OMB/OIRA for review. At this point this is not available for public view. OMB/OIRA review could/should take at least a couple months, and then it could be accepted, or sent back to the FDA with changes needed to be made, or anything really. CASAA expects to submit a comment to OMB/OIRA, but they do not expect to actually get to see the Final rule before they make their comment, gotta love government.

So there's news, not necessarily good or bad, and not anything that can really be disseminated.
 

FlamingoTutu

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So, the latest news is, as of yesterday the FDA submitted a "Final Rule" to OMB/OIRA for review. At this point this is not available for public view. OMB/OIRA review could/should take at least a couple months, and then it could be accepted, or sent back to the FDA with changes needed to be made, or anything really. CASAA expects to submit a comment to OMB/OIRA, but they do not expect to actually get to see the Final rule before they make their comment, gotta love government.

So there's news, not necessarily good or bad, and not anything that can really be disseminated.
Les, thank you for the update. For those of us with our brains stuck in geriatric mode, if approved, when would the new regulations go into effect?
Go Second Banana! :lol:

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He is happy. Actually, for him, that's downright excited.
 

DC2

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For those of us with our brains stuck in geriatric mode, if approved, when would the new regulations go into effect?
If approved by the OMB then Congress has an opportunity to stop it.
If Congress does nothing, then yes, they go into effect.
 

Lessifer

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Les, thank you for the update. For those of us with our brains stuck in geriatric mode, if approved, when would the new regulations go into effect?

Go Second Banana! :lol:

05-animals-461sp102308.jpg


He is happy. Actually, for him, that's downright excited.
I believe there will be an "effective date" written into the final rule. If they haven't changed it, there will be a 2 year grace period in which manufacturers can submit their applications, and continue selling until those applications are rejected.

If approved by the OMB then Congress has an opportunity to stop it.
If Congress does nothing, then yes, they go into effect.
I'm not sure how quickly a bill could be introduced and voted on to stop it, or how much support it would have at this point, but we have to hold out hope for something right?

AFAIK the Cole bill, changing the grandfather date, is still alive, but is awaiting more support.
 

FlamingoTutu

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If approved by the OMB then Congress has an opportunity to stop it.
If Congress does nothing, then yes, they go into effect.
Thanks DC2. Immediately?!

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I thought there was up to a year or two for it to take effect.

Oops, Lessifer snuck in there. My recollection is what Les said, hope that is the "correct" answer.
 

zoiDman

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I believe there will be an "effective date" written into the final rule. If they haven't changed it, there will be a 2 year grace period in which manufacturers can submit their applications, and continue selling until those applications are rejected.


...

Correct me if I'm Wrong. But this 2 Year proposed Grace period was for Hardware. And did not Include mention of e-liquids. Correct?

BTW - Here is a Chart of the 9 Step Rule Process.

http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

BTW2 - We are in Step #8.
 

Lessifer

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Correct me if I'm Wrong. But this 2 Year proposed Grace period was for Hardware. And did not Include mention of e-liquids. Correct?

BTW - Here is a Chart of the 9 Step Rule Process.

http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf
I don't recall there being a separate grace period, and it was never abundantly clear if hardware(that didn't already contain e-liquid) was part of the proposed rule, even though I believe it is.

I think the grace period is for all newly deemed tobacco products, for them to submit their PMTA, or if any plan to, an SE application.
 

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