Recently we’ve had the FDA ask for opinions regarding flavors. Then they put out an announcement that they are considering regulating e cigarettes as over the counter products.

Then they get sued by an anti-tobacco group.

Meanwhile over Easter, we see a raft of media outlets stating that vaping is toxic, due to the flavors… see this study, funded by the usual suspects.

What exactly is going on?

As we look into this, it is important to bear in mind the delayed PMTA until 2022. This could prove to be significant.

Let’s look at flavors first

Flavors are the easy target. By going after flavors, the FDA can show strength. They can show they are serious about protecting the nation’s health and come down hard.

Current estimates put the number of e-liquid flavors at around 8000.  Shaving several thousand off that number would be simple. Flavors are touted as an abomination that is akin to the child catcher. Flavors are seen as advertising to children with names such as ‘gummy bear’ and ‘cotton candy’. These then entice children to vape, that then allegedly lead them to smoking, despite a lack of proof.

Flavors are the low hanging fruit, so it is probably a foregone conclusion that flavors are going to be regulated in some way or another.

But how regulated could be down to us

The FDA have asked for opinions, and as such it is imperative that you put your few cents worth in, by making a comment on the FDA site stating how important flavors are to you. Remember tobacco flavor is a flavor.

Without any flavor, vaping is unpalatable.

The over the counter license is a slightly stranger fish…or is it?

The FDA wanted e cigarettes to be regulated as drug delivery devices back in 2010.

Could they do an about face on the deeming regulations and go for over the counter instead?

Yes. Probably very easily.

How many e-cigarette companies will be actively pursuing PMTAs in order to be ready by 2022?  They are prohibitively expensive, (think millions) there is no guarantee of success, and so wouldn’t it be more prudent to use the next 4 years to run their businesses as well as they can? 4 more possible years in business is better than none, and it gives time for business owners to explore other avenues.

Should the FDA then turn around in some amount of time and state they are changing the regulations, would it really mean that some e-cigarettes companies will have wasted millions?

It’s doubtful.

Then we get to the lawsuit

The lawsuit is an anti-tobacco group suing the FDA for not implementing the deeming regulations fast enough. They think delaying until 2022 is wrong and too far into the future. They want what is essentially a vaping ban to be enacted now.

Carl Phillips, (previously from CASAA) has an interesting take on this, and it ties in beautifully with the above.

He believes the lawsuit is essentially virtue signaling by anti-tobacco, making a bit of a noise and keeping e-cigarettes in the media, but, at the same time allowing the FDA to then say, “OK, we are being sued by both sides, anti-tobacco and pro-vaping so we have to make a compromise….

“As such this is what we (FDA) will do, (which is what they have always wanted to do…)

Reduce the flavors to under 10 and turn vaping into a treatment.

If you want to vape, you’ll have to go to a drug store. Bye bye vape shop, bye bye choice, and bye bye effective, fun devices.

“But hey! (this is the FDA speaking again) don’t panic peeps, we have vape gear (see, they are getting down with the kids and using the lingo…), it’s in the pipeline and due to be released in or around 2022 and made by… (insert the name of any Big P company of your choice)” 

The FDA then have complete control of the vaping market in the USA via their paymasters Big P’.  They have quelled the fears of anti-tobacco, they have saved the kids from vaping (no brainer what the teens will do instead of vaping…)  and all is well in the world. The disruptive technology is removed from the mainstream, tobacco carries on with its “reduced” nicotine cigarette.  Big P’ retain the medicinal NRT route.

Status Quo is returned.

Huge sigh of relief by the fat cats and the FDA.

Could we really end up here? 

This is where the bread trail seems to be going.

We have been watching the power struggle from the very beginning. The unfortunate fact for e-cigarettes is that they are successful. They have helped and continue to help people get away from smoking – and in the minds of those that are in control, this means a treatment, and it means money.

The only ones benefiting from vaping at the moment is you, the smoker that has switched, and us, the Vaping Industry that is doing our best to serve you.

Has the FDA been playing the long game?

So far, the ‘game’ has lasted eight years. It has involved a change of administration, a change of FDA commissioner, a few dabbles in regulations and now a pause, possibly until 2022.

We will eventually know if this was always the plan, Gottlieb or no Gottlieb, or if the FDA are merely speculating by seeing what the responses are to their announcements, and all will continue unchanged until 2022.

The FDA have had e-cigarettes in their sights from day one. In 2010 they wanted medical regulation, but Judge Leon said no. So, they waited and watched, and we currently have the deferred deeming regulations.

One would hope that the FDA would look at quality science during this pause, but we know from experience this is not always the case. Think antifreeze for confirmation on that.  We know their advisors can be of dubious quality. Think aged Professor and a ridiculous study that suggests 80 new smokers are produced for every 1 that switches fully to an e-cig. (Go check out twitter for that one.)

There is a game a foot, with the prize being e-cigarettes.  The goal posts have moved, or perhaps, with these announcements they have simply been moved back to their original place?

We understand that this might sound total tin foil hattery; what do you make of it?

Let us know your opinion, (let’s also make hay while the sun shines and enjoy vaping while we can!

And please don’t forget to also add your comment to the FDA website regarding flavors!