FDA delivers Final Deeming Rule to OIRA

[Racehorse]

and I don't know anybody here who would question Smokey Joe's sources, credentials or his judgement.

please don't put words in my mouth. Nobody "questioned SJ's credentials."


Everything deserves careful analysis. Esp. "leaked documents" and it was a completely VALID question.


I somehow doubt very much that SJ was at all offended by my asking.

Think about that for a moment.

 

[Kent C]

SJ on the post in Regulation:

"I should mention this here...

There's some very odd smoke and mirrors coming out of TVECA. I'm not sure what they're up to, but they've "released" an FDA industry guidance document which, on closer examination, is an old document from 2014.

I attempted to find the 2014 doc... while the deeming doc does have some of the same stuff, the 'industry guide for applications' is another one - there is one from 2011 but without the extensive handling of ENDS, so I think the leaked doc is new.

skoony posted this:

http://thehill.com/regulation/258465-e-cig-firms-steel-for-legal-battle

which includes these statements:

"
In a statement to The Hill Wednesday, FDA rep Michael Felberbaum said the FDA has not yet issued its final rule, so any documents are still in draft form.

“As a matter of policy, the FDA does not share draft documents with outside groups while they are under review and the FDA cannot provide any further comment,” he said.

Story said the FDA’s top regulator
has called, asking for him not to release the rest of the language, but said he
was trying to spur action among e-cigarette makers.

“If they know for sure they do not have a future ... they’ll get motivated, call the White House, go to OMB and get proactive in demanding reliable, responsible regulation rather than this kill order,” he said, referencing the Office of Management and Budget.

If that fails, Story said he’s prepared to challenge the final rules in court.

And the Cigar Rights group also implies a change from the original doc:

The TVECA isn’t alone. Industry-backed Cigar Rights of America said it would also fight the rules in court.

“We’d have to,” said the group’s executive director, J. Glynn Loope.

If the table of contents the TVECA leaked is accurate, he said, the cigar industry would be regulated the same way the FDA is regulating other tobacco products.

When the rules were first proposed in April 2014, the FDA was weighing whether to exempt premium cigars from the regulations. The agency defined premium cigars as any handmade cigar without a tip or filter that costs $10 or more.

Loope was lobbying for that exemption.

So.... I have to believe this is a draft (perhaps not the final draft) since I doubt someone went to the trouble of creating the doc just scare people. (although that's a possibility, but not a probability, imo).

 

[Jman8]

I would like to know where the "leaked" document came from. Mr. DmA posted it I think and noted "if this is for real......."

Yet,

It is interesting to me that nobody has even asked.

It is interesting to me that nobody has even set out to determine the veracity of this leaked document. Or where it came from.

Interesting because on this forum, we members will argue down a mean cornered bear over the slightest thing........yet, nobody even QUESTIONED where this document came from, first appeared, etc.

To me, that is sort of a shame.

yet it's intellectual dishonesty to post a photo of a blown up ecig because everyone WILL say it was photoshopped, etc.

Just sayin' *usually* there is some notion to verify things that are posted......verify the contents as well as verify where it came from.

There must've been 100+ responses to a popular vendor has test results posted on ejuice.....ripping it apart.

Yet.....total silence on this document. Hmmmm............nobody EVEN ASKED.

Even more interesting that in all you said here, not even you ASKED.

 

[Racehorse]

so I think the leaked doc is new.

<snip> I have to believe this is a draft (perhaps not the final draft) since I doubt someone went to the trouble of creating the doc just scare people. (although that's a possibility, but not a probability, imo).

Thanks Kent.

 

[Oliver]

I think it's fair to say that TVECA have something. Whether it's the final proposal or not is anyone's guess - and it was pointed out to me by Julie at CASAA that these documents are not static, but constantly evolving.

But, if they do indeed leak it (I don't believe they will), we'll have somewhat of a better understanding of the FDA's position than we've had previously.