FDA Federal Judge Orders FDA to Begin Reviewing All E-Cigarettes in the U.S. Market

[zoiDman]

I'm not sure if this is good news or bad, but it's got to help.

FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes


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Thank you for Posting this WorksForMe.

https://www.fda.gov/media/127853/download

51 Pages of Excruciating Details of how to Jump Over a Bar. It just Doesn't say where the Bar is? Or How High it is either?

 

[MyMagicMist]

Thank you for Posting this WorksForMe.

https://www.fda.gov/media/127853/download

51 Pages of Excruciating Details of how to Jump Over a Bar. It just Doesn't say where the Bar is? Or How High it is either?

Definitely "the way to do it". Starting to get a creeping sense of tyranny with this being a piece of that coming into play. Consolidation & control over media, shutting down alternate media is another piece. If you smell gun oil from my direction, don't be alarmed. Only be alarmed if I start singing, "I don't want to set the world on fire". By then it is "too late".

 

[MyMagicMist]

Maybe the FDA should join ECF. Most of the reviews are already here for them...

What's saying they've not already?

How else do you think they know what vapers are doing but by infiltrating vaping communities? Lots of us don't simply and readily hand over information, or some might give false information.

Hard being a cop when the suspect you're tailing just might have cop training as well, but is probably better at being a cop than you because they lack being corrupted. Drat, did I just type that out loud? Guess my hand is blown and I ought to fold, eh? Pfft, "keep dreaming Alice, Wonderland is right around the corner".

 

[Bill Godshall]

I strongly suspect that just three manufacturers will be able to submit PMTAs to FDA (that the agency will officially review) for some of their closed system vapor products within the next year, while the other 99.9% of vapor manufacturers will not be able to do so (a defacto ban on the sale of open system nicotine vapor products and bottles of e-liquid).

Those three companies are BAT/Reynolds (Vuse), Imperial/Fontem (blu) and Altria/JUUL (JUUL).

For political reasons (i.e. the so-called JUUL teen vaping epidemic), FDA will be far more likely to first approve PMTAs submitted for Vuse and blu (before JUUL). That is also likely why BAT/Reynolds and Imperial/Fontem did NOT seek to intervene in the AAP v FDA lawsuit (as they'll likely be the lawsuit's chief beneficiaries if/when their PMTAs are the first ones FDA approves for vapor products), and why JUUL and SFATA sought to intervene in the case.

 

[ohioguy]

Somewhere in the fine print on VapeWilds web page; they mention they are consolidating some of their flavor options. They are doing so in anticipation of needing to register every flavor with the FDA. So it's too soon to tell but it looks like they plan on trying to get approval for e-liquid when it becomes necessary. I don't know if the e-liquid falls under the same regulations discussed above.

 

[Rossum]

Somewhere in the fine print on VapeWilds web page; they mention they are consolidating some of their flavor options. They are doing so in anticipation of needing to register every flavor with the FDA

Registration was supposed to happen quite some time ago. Originally in 2016, but the FDA punted it a few times, but I don't thing the registration deadline ever extended past 2017. Now just registering was a fairly straightforward process, one that bears almost no relationship to getting a PMTA approval.