Legal, Opinion, Politics

FDApocalypse FDA Tips its Hand

FDA LogoSo I’ve been going on about the FDA coming in and raining on our parade for years now.  And admittedly, I have been a bit of a downer on the subject.  But, some of what the agency has submitted to the OMB for approval has been revealed via leaked guidance documents.

My previous thoughts were that if enacted, the deeming regulations as proposed by the FDA would place a burden on small businesses requiring thousands of man hours and hundreds of thousands of dollars for each product they want to sell.  Well, it turns out I was wrong.

Based on the leaked guidance, companies that only had to shell out hundreds of thousands of dollars would be getting away cheap.  The reality is that the guidelines are so stringent, I’m not even sure Big Tobacco would bother with them.

I encourage you to read the post I linked to in the intro of the article for much more detail.  For this post, I’m just going to hit the highlights.

For starters, it looks like congressional Republicans weren’t able to get the grandfather date to budge from 2007.  That means anything that’s not the same as it was back in the infancy of the industry will have to submit to “pre-market authorization.”

To put what that means in perspective, I started this blog in 2011.  Back then the hot new things on the market were clearomizers and dual coil cartomizers (not tanks, cartomizers).  The ProVari was about the only variable voltage device around and cost as much as it does today.

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And of course don’t forget the e-liquid.  The requirement is still going to classify each individual flavor, VG ratio and nicotine strength as a different product requiring an authorization for each.

So what’s the problem with authorization?

I’m glad you asked, imaginary person I’m talking to.  You will need to submit to the FDA among other things, scientific and non-scientific evidence that the specific product provides a net benefit to public health.  Not just the public health, but also non-smokers too.

There’s also requirements that products prove they won’t appeal to kids. And remember studies = proof, not something anecdotal like old scotch flavor would never appeal to kids.  Guys with lab coats have to figure this crap out.

Keep in mind, the submitted material also has to include a study of existing science on the subject.  Remember all those shitty papers about the imaginary gateway theory?  Yep, those would be part of any kind of literature research.

Did I mention the studies have to include actual clinical trials? Don’t worry, those trials will be good, because they have to get a blessing as an investigational new drug.

Don’t worry, laboratory analysis of e-liquid is still included along with the requirement to prove the existence of unicorns.  There’s a little something in there for everyone.

I’ve only scratched the surface and already I’m too disgusted to go on.  Here’s the short story here.  These requirements are downright impossible.

Oh, but wait, here’s one more:  even if you somehow meet the criteria and prove beyond what even the staunchest prohibitionist can deny, there’s still one thing you can’t say.  e-Cigarettes can be used a cessation device.  Yes that’s right, despite the requirements pretty much demand you prove exactly that, you’re still not allowed to say it.

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So in some ways I was wrong.  I thought that this would allow Big Tobacco with their deep pockets to step in and corner the market. But, the new FDA regulations are so onerous, that I seriously doubt they’ll be bothered to go through the effort.

It’s not like people will quit smoking if vaping suddenly went away.  Well, at least those of us who didn’t turn to the black market.

Now would be a good time to mention you should get involved.  Contact your elected officials, be sure to check out CASAA for some tips on how to handle the slippery and crafty politicians in your life.  Join a group like CASAA.  Pressure your vendors into starting to give a shit if they don’t do that already.  And business owners, please look into trade groups and how to contact the OMB to put an end to this farce.

2 Comments

  1. If big tobacco are the only ones to have the resources to apply, then they simply won’t bother. They have bought in to give them leverage in the debate, looks like they are getting what they wanted, a return to burnt tobacco for millions. With FDA gatekeepers in position to prevent anything similar ever emerging, it’s game over.

  2. I really can’t understand the logic behind why an ecig can’t be advertised as a smoking cessation device, surely it would save congress more money if less people smoked?

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