FDA Today is August 8, 2018

[Rossum]

Something to think about:

According to the Deeming Regs that were finalized in May of 2016, this was the day that that was supposed to be the the deadline to file PMTAs, and no vapor product would have been legal to sell as of tomorrow unless a PMTA having been filed by today.

Moreover, according to the Deeming Regs, no new products were supposed to be introduced after August 8, 2016. For much of the fall of 2016, most everyone was afraid to introduce new products. Even some of the Chinese vendors wouldn't ship newly introduced products to US customers.

But somehow in 2017 the FDA had a change of heart. What Bill Godshall often referred to as "Obama's FDA" was no more. Instead, it became someone else's FDA, and that someone is not a big fan of regulations. As a result, the PMTA deadline was extended by four years, there's been no obvious enforcement of the "No new products" part of the Deeming that was already in effect, and tomorrow everyone will be doing business as usual instead of being out of business.

I wonder what the future holds?

 

[ENAUD]

We just don't know yet, what the long term effects of the Deeming will have upon the vapor product market.

 

[tearose50]

Yup. A lot is unknown -- yet what we do know is that there are several campaigns de-bunking vaping in many different forms and resulting prohibitions up the kazoo in many countries and states. Maybe they are all trying to "be the first" to "protect the children" .

 

[Myk]

"We just don't know" the effects of overregulating.
"It's the wild wild west" of regulations.

 

[stols001]

Well all I know is whatever happens, I am going to keep vaping. Etc. But I'm sure both good and bad things will happen and we will argue, I mean debate, all of them.

Man, I do remember how scary that date was when I showed up here and how desperate I was to build ONE rta that didn't suck.

That is one thing that came of the deeming regulation, I learned to build and wick an atomizer. So, I will forgive Obama's FDA 0.000001 percent.

Anna

 

[Opinionated]

it is pretty awesome!

 

[Bill Godshall]

As a result, the PMTA deadline was extended by four years, there's been no obvious enforcement of the "No new products" part of the Deeming that was already in effect, and tomorrow everyone will be doing business as usual instead of being out of business.

I wonder what the future holds?

Cigarette protecting vapor prohibitionists (CTFK, ACS, AHA, ALA, AAP, Legacy) that lobbied FDA to unlawfully ban e-cigs in 2009, lobbied FDA to ban them again (via the 2016 Deeming Rule), and then sued the FDA to prevent Gottlieb from delaying the 8/8/2018 vapor sales ban until 8/8/2022, urge FDA to crack down on the huge vapor black market (of vapor products that weren't on the market on 8/8/2016) that they lobbied to create.
https://www.tobaccofreekids.org/assets/content/press_office/2018/2018_08_07_new_ecig_products.pdf
https://www.tobaccofreekids.org/assets/images/content/2018_07_18_New_Ecigs_Post_Juul.pdf
Leading Health Groups Urge FDA to Stop Sales of New, Juul-Like E-Cigarettes Illegally Introduced Without Agency Review
Illegal JUUL copycats are flooding the e-cigarette market

Although the vapor prohibitionists correctly claim that many vapor products now being sold were NOT on the US market on 8/8/2016, they (and the FDA) don't seem to be aware that virtually ALL premium vaporizers made in China and many (perhaps most) e-liquids that are now sold in US vape shops and online were NOT on the US market on 2016.

These black market vapor products not only outsell Big Tobacco's cigalike e-cigs in the US, but I suspect they account for more than one-third of the $6-$7 Billion of annual vapor sales in the US.

This black market has grown so large that formerly law abiding vapor manufacturers (including BAT/Reynolds, Fontem Ventures and JUUL) also appear to be planning to introduce new vapor products (that weren't on the market on 8/8/2016).
Reynolds Vapor prepares national launch of new e-cig rival to Juul

Introducing Salt of the Earth: New Line of Nicotine Salt E-Liquids

JUUL Labs Will Make 3% Nicotine Pods Widely Available to Provide Existing Adult Smokers With Nicotine-Strength Options
Terms of Service Violation

 

[Rossum]

Leading Health Groups Urge FDA to Stop Sales of New, Juul-Like E-Cigarettes Illegally Introduced Without Agency Review
Illegal JUUL copycats are flooding the e-cigarette market

Why do I think Juul would not object at all to having the FDA stamp out their competitors?

 

[stols001]

To be frank, I'm not sure I would mind the idea of the FDA stamping out all my competitors, and I'm not even doing anything at the moment.

Well, the resulting carnage would be horrendous, I'd require the FDA to do it and all associated cleanup, while I'm asleep.

I would then ask the FDA to stamp itself out, because I'm pretty sure I could compete with them in the regulatory marketplace, and well so many problems solved.

It's a lonely world at times, but at least I wouldn't have to struggle not to move other people's shopping carts, or even maintain civility in my voice as I made my request five times in a row and ignored. So, lonely... but efficient. There's always that.

Anna

 

[ScottP]

...."Obama's FDA" was no more....
....someone else's FDA....
....I wonder what the future holds?

Well the future will very likely depend on whose FDA is is next. Remember to VOTE, and if you value vaping, vote for a candidate that isn't all about regulations.

 

[5cardstud]

What I don't understand is why the manufacturers didn't simply remove the kid friendly names and rename their flavors.

 

[zoiDman]

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

 

[Rossum]

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

Thanks. Active discussion over in the main Deeming Regulations thread.

 

[zoiDman]

Thanks. Active discussion over in the main Deeming Regulations thread.

Yeah... I just thought I would Pop it in here also because many Don't follow the Deeming Thread much anymore.

And it seemed like one of those "We are Turning a Corner" moments in the Grand Scheme of things.

 

[Rossum]

Honestly, I'm not surprised. I'm sure the FDA doesn't want to be seen as an agency that ignores and doesn't enforce its own regulations. So they'll make a show of taking some things that are most visible to the general public off the market. The general public sees this stuff in C-Stores, but has never set foot inside a vape shop.

 

[zoiDman]

Honestly, I'm not surprised. I'm sure the FDA doesn't want to be seen as an agency that ignores and doesn't enforce its own regulations. So they'll make a show of taking some things that are most visible to the general public off the market. The general public sees this stuff in C-Stores, but has never set foot inside a vape shop.

I'm with you. The Only surprise to me is How Long it went without the FDA Flexing it's Regulatory Muscles.

I kinda thought that there would be a 6 or 8 Month Grey Area where the FDA would Look the Other way to allow OEM's to get In-Pipeline products out. But by Q2 of 2017 there would be No More New Products.

 

[bnrkwest]

It's getting scary out there.

 

[Rossum]

It's getting scary out there.