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PMTAs - The Clock is Ticking

PMTAs - The Clock is Ticking

We’ve watched the recent news as legislators declared war on vaping with what’s been called a “flavor ban.” 

We know that the media have heavily manufactured this mass hysteria regarding vaping 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 made clear for all 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 its 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, even though 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 distributed on the market to submit one to function legally. 

Now, you may not know this, but virtually 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 will be sold legally 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 survive. Allow us to explain.

The PMTAs demanded to have, will also include a lengthy list of requirements that manufacturers must complete. Primarily, vape companies must use third-party labs and other external sources to have their products tested and analyzed for several 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. A vape company may end up spending more than half a million dollars 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. 

The FDA describes a PMTA as:

Before a new tobacco product can be legally marketed, FDA must issue an order permitting marketing of that product.
To issue a premarket tobacco product application (PMTA) marketing order, FDA must evaluate that product based on a public health standard that considers the risks and benefits of the product to the population as a whole, including tobacco product users as well as non-users.

The FDA does have draft guidance on filing PMTAs however the jargon is extremely convoluted and packed with wordy legalize but in a nutshell:

When you create a new tobacco product or modify a tobacco product in any way, you must obtain an order from FDA authorizing the marketing of the product before the product may be introduced or delivered for introduction into interstate commerce.
This includes “a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery, or form of nicotine, or any other additive or ingredient.

Don’t forget, any ‘new product’ means those on the market since February 2007!

Manufacturers will fail the PMTA process if:

  • You have not shown that the product is appropriate for the protection of the public health
  • The manufacturing methods, facilities, or controls do not conform to manufacturing regulations
  • The proposed labeling is false or misleading
  • Or You have not shown that the product complies with any tobacco product standard in effect

So this is really a lottery where you pay your money after gathering all the scientific evidence you can get to prove your vape products meets the FDA criteria. Fail at any stage and you’ve just lost nearly half a million dollars.

And don’t forget the cost! The FDA says:

…a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others.

It won’t cost you millions – that’s OK then. (source)

The industry is now trying to submit this information before the deadline but also to come up with funding for the PMTAs.

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 much imagination to see that the FDA doesn’t favor the vaping industry, and so it’s safe to argue that the PMTAs is 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 for approval 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, e-juice manufacturers, are only just starting to see profits. 

They 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 and continue to be selling 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 with ease.

It’s also important to point out that in many European countries, the vaping industry is being 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 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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