FDA GOD BLESS OUR NEW PRESIDENT TRUMP

[randyith]

I'm not sure I understand how freeing regulatory efforts helps us at this point. The FDA's Deeming doesn't need to be frozen. It needs to be rolled back.

The real teeth of the deeming regulations does not take effect until 2018. If those future stages are frozen our nightmare is over.

 

[randyith]

Never done business with RTS...and for sure won't now. Besides the fact that I'm a bleeding heart liberal, I prefer my ECF a little less political.

First off, I am non-partism. My statement was not meant to be political. If you owned a business and had to deal with all this FDA and state crap you would consider it a nightmare as I do. The first positive action from the federal government signals to me that the nightmare is over.

 

[Lessifer]

The real teeth of the deeming regulations does not take effect until 2018. If those future stages are frozen our nightmare is over.

So, we've been having this discussion in another thread. From what I've understood of everything that is happening, the "real teeth" don't take effect until 2018 for products that were already on the market as of 8/2016, if you were to release a new product today(or 8/9/2016) it would require an approved PMTA before it could be marketed. The entire rule is already in effect, there are just grace periods for certain provisions for products that were already on the market as of the date the rule took effect.

As for the applications that you've prepared, I think we're just all a little confused, are you talking about the detailed product/ingredient listing? As far as I know the only "application" is the Pre-Market tobacco Product Application.

 

[randyith]

So, we've been having this discussion in another thread. From what I've understood of everything that is happening, the "real teeth" don't take effect until 2018 for products that were already on the market as of 8/2016, if you were to release a new product today(or 8/9/2016) it would require an approved PMTA before it could be marketed. The entire rule is already in effect, there are just grace periods for certain provisions for products that were already on the market as of the date the rule took effect.

As for the applications that you've prepared, I think we're just all a little confused, are you talking about the detailed product/ingredient listing? As far as I know the only "application" is the Pre-Market tobacco Product Application.

December 30, 2016 used to be the deadline for a manufacturer and distributor to submit a list of all products that fall under the scope of the deeming regulations that were on the market prior to August 8, 2016. The applications are involved ( 12 to 18 pages each) with 2 pages being unique to each product. They want copies of advertisements placed, brochures and bottle labels. Completing these applications permits the company to continue selling these products until August 2017 at which time ingredient lists are required for each application.

The deadline was postponed to February 2017 in lieu of December 31, 2016.

 

[Lessifer]

December 30, 2016 used to be the deadline for a manufacturer and distributor to submit a list of all products that fall under the scope of the deeming regulations that were on the market prior to August 8, 2016. The applications are involved ( 12 to 18 pages each) with 2 pages being unique to each product. They want copies of advertisements placed, brochures and bottle labels. Completing these applications permits the company to continue selling these products until August 2017 at which time ingredient lists are required for each application.

The deadline was postponed to February 2017 in lieu of December 31, 2016.

So, yes, to my question? "As for the applications that you've prepared, I think we're just all a little confused, are you talking about the detailed product/ingredient listing?"

 

[randyith]

MODERATOR:

Please close down this thread since the discussion is being held in another older thread.

 

[randyith]

So, yes, to my question? "As for the applications that you've prepared, I think we're just all a little confused, are you talking about the detailed product/ingredient listing?"

No. The detailed ingredient list is not due until August 2017.

 

[classwife]

MODERATOR:

Please close down this thread since the discussion is being held in another older thread.

Closed