FDA Withdraws Deeming Regulation

[papipeguy]

I just got this notice from the FDA. Very interesting development.
https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-27456.pdf

 

[swhipple]

Sounds like good news, I hope.

 

[deathmetal]

!!!

 

[pipesmokingtom]

Can anyone link to the "Final Rule" issued Aug 8th that this is referencing? This isn't a whole-hog withdrawal, doesn't look like, but I'm interested to see what part specifically is being rescinded.

 

[ssjones]

Wow, that is a step in the right direction! I would have guessed Federal employees, particularly directors would be looking for a place to hide.

 

[pagan]

 

[jackswilling]

Fantastic news. Hopefully the new rule will allow a prospective period so that further blends may be developed.

 

[pipesmokingtom]

Right! So this is in regards to the grounds by which the FDA can REFUSE to accept an application. Interesting.

 

[clickklick]

Holy Mother!

 

[papipeguy]

The official announcement will be released tomorrow so I'll post on that as soon as I read it. Keep fingers and toes crossed.

 

[pipesmokingtom]

Are we winning?!

 

[woodsroad]

This does not appear to be a withdrawal if the final rulemaking in it's entirety. But I can't be certain of what exactly it is withdrawing.

 

[hmhaines]

Let's not get to hopeful, but this sounds like it might be gooooood news!

 

[jefff]

Too soon to tell. But we can be hopeful.

 

[pipesmokingtom]

But I can't be certain of what exactly it is withdrawing.

I've been digging a little deeper on this. It looks like this is a withdrawal of the FDA's methodology on denying premarket applications. It looks like they've determined they made the door too narrow regarding new products coming to market and are reconsidering the process of accepting apps.
Looking forward to updates.

 

[tedswearingen]

From the document it seems that the FDA is withdrawing rule 81 FR 52371. Which reads "[t]he Food and Drug Administration (FDA) is issuing a proposed rule describing when FDA would refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the proposed rule, FDA would refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA would be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule."

 

[pipesmokingtom]

That's what I read as well, Ted. Thanks for posting.

 

[georged]

I just got this into the hands of Mike and Mary McNeil. They are extremely knowledgeable and connected regarding this stuff.

 

[cosmicfolklore]

OK, time to increase the number of pins in my FDA VooDoo doll. It's starting to show signs of working.

 

[papipeguy]

Thanks, Ted. It good to hear from someone in the industry. There is a lot of movement within the current administration to push certain things along as quickly as possible before the new group comes in and starts disassembling things. Crazy times ahead, folks.