FDA Relents, But are Vapers Safe?[Updated]

I posted this article a while back.  I wanted to add an update with details on the new deadlines for your favorite e-liquid makers to get their ingredient list to the FDA.   Fortunately, I don’t have to as VapeCraft has a pretty good writeup here.

Vapers around the world saw their news feeds blow up recently around the news that the FDA blinked in the battle of the vape.   The surprise announcement from the agency mostly garnered attention with its statement on requiring cigarette makers reduce the amount of nicotine in cigarettes.

Most vapers aren’t exactly huge fans of big tobacco, so the new restrictions aren’t what really captivated them with the release.  Buried a little further in the announcement, the FDA made a somewhat astounding admission:

And we must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution.  While there’s still much research to be done on these products and the risks that they may pose, they may also present benefits that we must consider.  FDA’s investment in regulatory science will eventually answer many of those benefit and risk questions.

Armed with the recognition of the risk continuum, and the reality that all roads lead back to cigarettes as the primary cause of the current problem, we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.

Yes, the FDA finally admits there’s different levels of harm from nicotine products, and that some products can deliver nicotine in a less harmful way.

Great day in the morning!

But, wait, it gets even better.  I’m sure you know all about the terrifying restrictions that are set to take effect within months.  You know, the ones that will drive most small businesses off the cliff.   Well, the big news is, of course, the reprieve announced in the statement.

To give ourselves time to implement this framework, including through notice and comment rulemaking, I’m directing CTP to reconsider the various compliance policies associated with the deeming regulation.  This includes the policies relating to the compliance periods for premarket submissions for products on the market at the time the deeming rule took effect and for FDA’s review of those submissions.  Specifically, CTP will consider the language in the preamble that set forth timelines for submissions and raised concerns about [vaping] products coming off the market before FDA had reached a decision.  Reconsideration of these policies is within FDA’s discretion, and we are exercising that discretion in a targeted way in order to lay the groundwork for a more strategic long-term approach to regulating tobacco products.

Ultimately, it’s looking like the dreaded deadline to submit the premarket application for non-vintage vaping devices is going to get pushed from 2018 to 2022!

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So, is it party time now?

Sort of.  A couple of details.  First, parts of the deeming regulations are going to kick in as planned.  This includes preventing sales to minors and registering ingredients with the FDA.

Both of these are good things.  Nobody wants sleazy people selling vaping stuff to kids.  And we all want to make sure there’s no special mystery ingredients in our e-liquid.  So far, so good.

Ok, so here’s where I start raising my eyebrow and actually start talking about the stuff I threatened in this article’s headline.

One of the key things the commissioner stated before talking about building a framework around the potential of e-cigarettes was preventing sales to minors.

I have real concerns about kids’ use of e-cigarettes, and I know many others share those concerns, especially those products marketed with obviously kid-appealing flavors.

Think about the children!

Those of you who have been around the block and who may have been following my previous writing know that “kid flavors” is hugely open to interpretation.  Most prohibitionists claim that anything that doesn’t taste like sorrow and dirt appeals to kids. How will the FDA determine what “obviously” appeals to kids?

Perhaps it will be something simple, like cracking down on those dirtbags who steal candy and cereal logos.  That I’m all for.  If you do that, we can’t be friends.  By stealing the copyrighted work of candy manufacturers, you are also stealing their marketing efforts that are geared towards… kids.  Knock it off, you’re giving us all a bad name.

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So let’s assume for now that the FDA figures out that grown-ups actually like things that taste delicious.  There’s still some other pitfalls here.

Things can change in four years

A four year reprieve is awesome.  But, things can always take an unexpected turn.  The whole point of the reprieve wasn’t to help small businesses necessarily.  The real point was to give the FDA time to figure out how to build a regulatory framework that understands vaping’s place.

That doesn’t mean vaping gets away clean.  That means there will likely be different regulations.  How will they look?

It’s also worth noting that the FDA is using their own discretion to put the brakes on things.  There are no laws that have been passed to force the FDA to do this.  They are doing it because the new people at the FDA decided things needed to be rebooted.

And finally, let’s not forget the FDA commissioner is a presidential appointment.  I’m going to stay far away from current politics here as best I can.  But let’s just say it’s not a given the current president will be re-elected (or serve his full term).  There’s a little bit of uncertainty there is all I’m saying.

Should the political winds blow, it’s entirely possible we could find ourselves with a less enlightened captain helming the FDA ship.

We can screw it all up

Ok, so I’m sort of a pessimist when it comes to humans.  We have an unlimited capacity to screw things up.

I’m not necessarily talking about the bad apples who could ruin it for everyone, though they certainly exist and still suck.

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What I’m talking about is us, the good vapers of the world who want change.  We fought hard.  The industry finally got its collective shit together after years of dipshittery to properly lobby.

Right, that’s what we did, so what’s the problem?

Thank you rhetorical me!  The problem is thinking that we’ve won.  Letting our guard down.  This sort of effort requires constant vigilance.  The truth is after a victory people sort of let go until the next crisis pops up.

I’m not even talking about vapers specifically.  This sort of thing happens with all sorts of things.  Remember the push to save net neutrality?  Lots of people participated, but what did they do to keep constant pressure up to avoid that problem from coming back?

The same thing can happen with vaping.  Just because we have some good news today doesn’t mean that we can forget all about it.  It sucks that everyone has to fight so hard to keep a life-saving consumer product available, but that’s the sad world we live in.  The fight ain’t over!

Celebrate anyway!

I’m not saying don’t celebrate.  Quite the contrary.

The FDA unexpectedly took its boot off the throat of the vaping industry and vapers in the US.  That’s a good thing.  We deserve to be happy about it.

But, we also need to remember that some things can change.  Until there are laws on the books protecting the industry and individuals, we must remain vigilant.

Make sure your favorite vape shop is a member of one or more reputable industry groups.  Sign up for a consumer advocacy group.  Keep contacting your elected officials.  Let them know you vape and you vote.

Steve K

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