FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery

[5150sick]

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

https://www.fda.gov/news-events/pre...ications-electronic-nicotine-delivery-systems

Let's have a fun exercise.

Read this document then think of three vape brands that could gather anywhere near the type of information they are asking for.

OK, Now name three that are NOT at least partially owned by Big Tobacco...

Don't feel bad, I can't name any either.

 

[Rossum]

I had somehow hoped that this administration's FDA would ease up on the guidance for PMTA submissions, but that doesn't seem to be the case. Preparing an application that meets these standards will not cost hundreds of thousands, but millions, possibly tens of millions.

There's only one line of vapor products that I'm confident will get a PMTA approved, and of course they are partially owned by BT now.

There are others that are wholly owned by BT, but I'm not at all sure their owners will bother to submit, due to them being such a flop in the marketplace. Why throw good money after bad?

As for the rest of the industry, this guidance clearly spells it out: No quarter will be given.

The only possible salvation is that they won't actually enforce, much like they haven't enforced the "No new products may be introduced after 2018-08-08" part of the regs. The trend I've been seeing of late is that every "smoke shop" around also sells vapor products. They will probably continue unless/until someone with a badge and a gun shows up and forces them to stop. There are many thousands of them. And of course, enforcing against direct, retail purchases from China, Inc is an even more difficult task.