FDA OP-ED piece. Why the delay?

[skoony]

I found this compelling.
FDA Deeming on Electronic Cigarettes - What’s the Hold-Up? - DIY E-liquid Supplies
Regards
mike

 

[Jman8]

From the Op-Ed:

If there is one aspect of the e-cigarette debate that is agreed on by virtually everyone, it is the fact that e-cigarettes are an adult consumer product. An FDA ruling to that effect would produce zero controversy.

I wonder what Jman8 would say about this (nonsense)?

 

[pennysmalls]

Really good article and one I agree with. The FDA knows it's facing a Gordian knot with vaping and attempting to simply cut the knot will open all kinds of cans of worms.

 

[EBates]

All I can say I 'Attaboy PHE'! They put a limp in the govment sponsored alphabet agencies march.

 

[Kent C]

Thought the Zeller/Frieden comparison was interesting....

Both idiots but Zeller was once burned by the courts.

 

[SeniorBoy]

Why the delay? The FDA is still shuffling paper so take a gander at this Federal Register pub which just broke today with a 60 day comment period.

Probably deserves it's own thread.

 

[skoony]

Why the delay? The FDA is still shuffling paper so take a gander at this Federal Register pub which just broke today with a 60 day comment period.

Probably deserves it's own thread.

does any one have an idea as how it relates to the deeming reg.s.
Regards
mike

 

[nicnik]

Why the delay? The FDA is still shuffling paper so take a gander at this Federal Register pub which just broke today with a 60 day comment period.

Probably deserves it's own thread.

The delay suppossedly, at least in part, has to do with OMB's mandatory review, but there's got to be a lot more to it than that.

BTW, there's a link on that page to public comments, showing 2 public comments. Those comments are from 2012.

 

[SeniorBoy]

Hopefully @Bill Godshall will chime in with his extensive wisdom. My guess with a little humor is that the Deming must obtain the blessings of OMB before a final rule. OMB looked at the deeming and said, not so fast Commander Zeller. We need more paper work and public input which embraces vaping if you hope to place vaping under the TCA etc. Note the heading on the linked document which reads (OMB Control Number 0910-0731)—Extension

So..no Final rule (if/when) till compliance with OMB and comment period expiration (11/16/15) and then more time to waste our money with FDA internal procedures. This pushes the publication (if/when) of the final rule in the Federal Registry into the first quarter of 2016 which makes my last predication wrong. /lol

All I can say is that vendors/manufact/etc must spend a hell of a lot of money before they meet with the FDA which is the focus of the linked document.

Just my best guesses and subject to the wisdom of "Uncle Bill"


Edited for clarity