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FDA Adopts the Anecdote as Official Policy Driver


  
Mark it down – September 12, 2018 – today is the day that the U.S. Food and Drug Administration officially abandoned data and science in favor of anecdote and hyperbole as the lodestar of their policy decision making.

Today, the FDA announced a “crackdown” on the “epidemic” of youth use of vapor products.  In a press announcement released this morning, the FDA issued a stridently worded justification of enforcement actions against retailers, websites, and manufacturers selling products to minors, or selling/marketing “youth-appealing” products.

As you all know, we at SFATA – and each of our members – pledges not to sell to minors, advertise to minors, or encourage or allow youth use of vapor products.  And we applaud some of these FDA actions to discourage lax age verification or deceptive marketing practices.

But FDA is also requiring the top 5 producers – Vuse, Blu, JUUL, MarkTen XL, and Logic – to come up with a plan to discourage youth use within 60 days. 

They are also re-considering the application extension that they granted for all new tobacco products to submit PMTAs.  So instead of August 2022, they could pull it back and make PMTAs due next year!

These are serious changes being contemplated by FDA and being applauded on the Hill.  And if you have a problem with them, you need to make your voice heard with those people who are right now asking for your vote!  Call your congressional representative and talk to them about this crazy set of proposals!

Most of all, here’s where I have a problem. 

In their announcement, the FDA says, “But in enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, EVEN IF IT MEANS PUTTING LIMITS IN PLACE THAT REDUCE ADULT UPTAKE OF THESE PRODUCTS.”

What?  Let’s unpack this a bit.  What do they mean by “we won’t allow the current trends in youth access and use to continue”?  Let’s look at the current trends:


So, use of any tobacco product is down, and smoking any combustible is way down. Smoking cigarettes – about half of the 2011 levels, and use of e-cigarettes is down 30% from the 2015 peak.  Is this what they are calling an “epidemic” and demanding they will not allow it to continue?  Really?

But they even go farther to say – “Even if it means putting limits in place that reduce adult uptake of these products.”  So they are insistent on stopping the decline in youth tobacco use, even if it means more adults will keep smoking?  Can you imagine anything more directly counterproductive to the very mission of the FDA?  It’s literally absurd.

I can’t get my head around why they would willfully ignore the real-world data and issue a set of directives based on nothing but fear and media hype. Someone (you and I) need to call them on this. 

NOW.  LOUDLY.  AND PUBLICLY.

But let’s look at what the likely impacts of this policy will be.  One impact is already apparent from the CNBC headline:

Tobacco stocks surge as FDA announces crackdown on e-cigarette companies over teen use.

  • Tobacco stocks surged after regulators threatened to pull e-cigarettes from shelves if manufacturers do not control "widespread" teen use.

 
But, other than protecting Big Tobacco, there are other impacts that will likely take place longer term.

In this announcement, Commissioner Gottlieb says he is considering pulling all “flavored” vapor products from the market. 

THIS.  IS.  REAL. 

I believe that FDA is using the media hype around Juul - and ignoring actual data on use – to take the major step that they have been trying to take since 2014… Banning all non-tobacco flavors.

That would suck. 

I am a flavor fan.  I have probably tried over 1,000 different vape flavors and have a large number of go-to liquids that keep me from wanting a cigarette.  NONE of them are tobacco flavored.

But the FDA’s insistence that flavors are the reason that minors try things is also completely devoid of evidence.  Minors have been rebelliously trying things that they are not supposed to have since time began. To suddenly say that Juul’s Crème Brulee is causing kids to go nuts is ridiculous on its face. 

After all, minors use alcohol at nearly 3 times the rate of youth vaping, and vodka comes in Cotton Candy flavor.  Where’s the outrage there? 

Or look at youth marijuana use – about double the rate of youth vaping – and THC comes not just in gummy bear flavorIT COMES IN ACTUAL GUMMY BEARS!  What does FDA say about this?  Crickets.

So, lots of hypocrisy here to justify what they have wanted to do all along.  And the impact will be to discourage the lowest risk alternatives to smoking – for both youth and adults – and the protection of the cigarette market.

What could we do?  I think we need to get ahead of this, with smarter policy moves to replace these dumb ideas.  Please give me your ideas.

We could advocate to make use of vapor products by minors illegal.  Right now, there is no prohibition against youth use – only sales and marketing.  If you want to stop a behavior so much, you may want to make it illegal, with penalties to minors and their parents.  This would possibly return some of the responsibility to the parents in this situation.

We could develop a “chain of custody” system, and with use of RFID labels, we could track products from manufacture to distro, to sale, and link the customer with the sale using their ID.  This way, we would be able to scan any product and know where the youth got it from.  If the kid’s big brother or parents purchased it legally, that would be documented at the point of sale.

Maybe we urge that vapor products only be sold in vape shops where everyone entering is ID’ed at the door, or online with delivery signature?

Yes, these are extraordinary suggestions in response to a fake “epidemic”.  But to get back the high ground politically and prove that we care about both helping people quit smoking and protecting against youth use, this may be what is required.  Such “youth protections” are also likely to be needed to pair with legislation that will create a legitimate path to market, and changes the application to a more rational, objective process.

Let me know what you think.  We’re on the defense here – big time.  And I think a strong offense is the best defense! 

We’ve got to turn this around – and FAST if we are going to save vaping.  Contact your members of Congress – they are the only ones who can correct the FDA’s actions here.

Thanks for fighting by my side.

Mike



Mike Hogan is our SFATA federal lobbyist.  You can read more about him at his firm's website, the Alpine Group

 

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