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FDA Extends Regulation Deadlines Until 2022

 

 

 

While the battle with the Food and Drug Administration to protect vapers' rights is far from over, huge news landed earlier today, and it's certainly a step in the right direction.


The FDA has just announced that, once again, it's extending the deadline for manufacturers of vape hardware and liquids that were on the market before August 8, 2016 to submit applications for FDA approval. This time instead of a few months' reprieve, as was announced late last year, the Administration has kicked the can a little further down the road – all the way to August 8, 2022!


This still doesn't necessarily say that devices or liquids introduced to the market after the 2016 deadline will be eventually granted legal status. And the FDA approval process is still long and prohibitively expensive – application cost estimates range from $100,000 to over $1 million. It's also still true that the only devices that can avoid having to petition for approval at all are ones that were on the market before 2007, which precludes virtually 100% of the product that's still on the market today.


With all of that said, this is still big news. The FDA acknowledges that companies waiting for a decision on their applications, or who are still in the process of preparing an application, will continue marketing their products. This essentially buys five years for vape suppliers across the country to keep selling their wares, either amassing enough capital to pay for the approval process or to find ways to reduce the cost.


It's also another five years to allow research on the effectiveness of vaping as a harm-reduction tool that can be a powerful aid in helping smokers to quit using tobacco. This could be another opportunity to petition for reduced regulatory burdens, as new FDA head Scott Gottlieb (who was part-owner of a chain of vape stores before his appointment) has said he'll give more consideration to scientific evidence than scaremongering or "what if" scenarios in considering how to regulate e-cigarettes going forward.


The announcement doesn't change the fact that the FDA still considers all vapor-related equipment, including batteries, glass clearomizers, computer chips in mod sets, and e-liquid that doesn't contain any nicotine (or contains lab-synthesized non-tobacco nicotine) to be "tobacco products." It does, however, go a bit further to distance vaping from actual tobacco use – while vapor products saw their application horizon expand into 2022, other newly-regulated tobacco products that actually contain tobacco, like cigars or hookah tobacco, only have until 2021 to submit their approval applications or stop selling.


That leaves us about where we started – in a state of confusion as to what the future will bring. Still, the fact that vape gear can continue to be sold, and that suppliers have continued to innovate and bring new products to market (without federal agents breaking down doors and raiding supplies), is indeed welcome news. As always, we'll continue to follow this story as it develops, hopefully with even more good news to report soon.


In the meantime, if you're curious here's a link to the full text of the FDA announcement.

acuity