PMTAs - The Clock is Ticking

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In recent months, we’ve been eagerly watching the news as legislators have all but declared a war on vaping with what’s being referred to as a “flavor ban.” We know that this mass hysteria regarding vaping has been heavily manufactured by the media after the news picked up on a wave of respiratory illnesses that have been traced back to black-market THC vape cartridges, which, by the way, have nothing to do with commercial vaping products. Still, if there’s one thing that’s been made clear to vapers in the United States, it’s that our country wants to make it hard to obtain vaping products.

While one state after another has declared their stance on banning flavored vapes, another threat to the industry has been quietly looming, and that’s PMTAs. In reality, a lot of vapers themselves aren’t familiar with this phrase, despite the fact that it threatens their daily hobby more than anything else that’s going on in the vaping world at the moment. That’s right – the PMTAs have the potential to harm the industry more than the flavor ban that is grabbing all the headlines.

So, what exactly are the PMTAs, and how do they affect the vaping industry? Today, we’ll be discussing what they are in depth so that you can understand what the future of the vaping industry may have in store.

What are PMTAs?

A PMTA is a premarket tobacco product application, and the FDA requires that all tobacco products that wish to be distributed on the market submit one. Now, you may not know this, but essentially every vaping product is considered a tobacco product, according to FDA standards. This means that any vape manufacturer, whether it be an e-liquid brand or a hardware company, must submit a PMTA to the FDA before their items can be legally sold in the United States.

Now, this may sound simple enough, and you might even be thinking that some regulation within the industry is a good thing. And, of course it is. But, it seems like the FDA set up this process to make it more difficult for the vaping industry to thrive. Allow us to explain.

The PMTAs that are demanded have a lengthy list of requirements that manufacturers must complete. Essentially, vape companies must use third-party labs and other external sources to have their products tested and analyzed for a number of factors. Each manufacturer must be able to prove that their product is safe in terms of its ingredients and how it operates, and they also have to show that their products do not appeal to minors, among other things.

As you would imagine, this is a pretty expensive process. In fact, a vape company may end up spending more than half a million dollars just to provide PMTAs to the FDA. You can imagine the impact this has on up-and-coming vape companies, especially when you think about how new the industry is to begin with, and how it still struggles to compete with big tobacco.

The FDA initially implemented this in 2016, giving companies two years to submit their PMTAs. Then, the FDA pushed back the date, only to do so a few more times. Now, the official date is May 12, 2020, which has caught most vape companies by surprise as it allows for only a handful of months for each company to provide thorough analyses on their products. As you could imagine, the majority of the industry is now panicking to not only submit this information before the deadline but come up with the funding for the PMTAs to begin with. And, the FDA has made it clear that if a company fails to submit by the deadline, their products cannot be legally sold on the market.

How Does This Hurt the Vaping Industry?

It doesn’t take a lot of imagination to see that the FDA clearly doesn’t favor the vaping industry, and so it’s safe to argue that the PMTAs are somewhat deliberately trying to make it difficult for the industry to move forward. By pushing up the deadline to drastically decrease the chances of companies being able to submit their PMTAs in time, the FDA has sent a message that it won’t do the vaping industry any favors.

The core issue involving the PMTAs is that most vape companies don’t have those kinds of funds at the moment. They don’t have hundreds of thousands of dollars to devote to their products being approved according to the FDA’s standards. And, without a doubt, the FDA knows this, and isn’t doing anything to help them. The vaping industry, as we said, is very new, and most companies, whether it be hardware brands or e-juice manufacturers, are only just starting to see profits. They simply don’t have the resources required to submit PMTAs within a handful of months. So, many companies will inevitably fail to comply, which, according to the FDA, means that their business will effectively shut down as a result.

The other problem is that the FDA’s demands regarding PMTAs show that it does not believe in the vaping industry as a viable replacement for tobacco cigarettes. Otherwise, it wouldn’t scrutinize the industry so much, making it nearly impossible for companies’ products to be approved in order to be sold on the market. So, it’s clear that as time goes on, the FDA will likely continue to find ways to stifle the industry so that it struggles to sell products easily. It’s also important to point out that in many European countries, the vaping industry is heavily supported by legislation.

PMTA’s Will Change the Vaping Landscape

Arguably, the PMTAs are more dangerous to the vaping community than a ban on flavored cartridges. And, as time is running out, many vape manufacturers are beginning to panic, which is absolutely understandable. If you feel that the vaping industry is being wrongfully singled out by the FDA, it’s time to join a vaping advocacy group and contribute your effort to supporting the industry by whatever means possible.

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