CSP: FDA Guidance on Flavored Vape

In other words, they're reversing what they said in the original Deeming Regs, which quite clearly stated that manufacturers would have an additional year on the market after the PMTA deadline, provided they had filed a PMTA by the deadline. In fact, they're forcing stuff off the market prior to the actual deadline.

 

Does the Deeming Rule Set specifically say that there would be a 1 Year period to continue to sell products while under PMTA review?

 

Confusing...it also says this:
"Manufacturers need to file a PMTA for each ENDS product with the FDA by May 12, 2020, to keep their products on the market after May 12"

 

I'm not really inclined to re-read the whole depressing 499 pages again. My guess is it was couched in some words make it a matter of the FDA's "discretion".

 

I'm with you on the Not Re-Reading part. It kinda makes me want to Spit on my Monitor every time that I do.

But if I recall correctly, it said that a PMTA-ed product could remain on the market while under FDA Review. And or if the FDA requested Additional information or Data regarding the PMTA.

I Don't recall any Statuary Time Limits as to how long a PMTA-ed product under review could remain on the Market. And the 1 Year time frame I believe came from FDA Statements regarding How Long a successful PMTA would take to be Reviewed. Be that as it may.

There were also Statements by the FDA say'n that they predict that a Substantial Percentage of PMTA would be Summarily Dismissed due to "Incompleteness".

But that Isn't surprising. Seeing that the FDA has NEVER disclosed exactly what a "Complete PMTA" would look like.

 

I don't think they know themselves what one should look like.

I believe to date, three have been approved:
* The one for some Swedish Match snus.
* The one for IQOS
* The one for 21st Century's ultra-low nicotine cigs.

All three of these are totally different products, and of course, none are vapor products.

 

Yeah... If it Wasn't True, it would almost be Funny.

That the FDA alone can define what is a successful PMTA. But they are Unwilling or Unable to define what Exactly that is.

"You got to stem the evil tide
And keep it all on the inside
Mary you're nearly a treat
Mary you're nearly a treat
But you're Really a Cry"