FDA PMTA


PMTA

WHAT IS A PMTA?  A SIMPLE EXPLANATION OF HOW IT WILL AFFECT VAPERS

Even though you might not have to personally deal with it, most vapers have at least heard of a PMTA. But what actually is it? Even if you don’t run a vaping business, the question will become increasingly important in the next few months as the deadline for submission approaches.

 

In a nutshell, a PMTA is a “pre-market tobacco product application,” which basically means an application you have to file to the FDA to stay in business after the regulations come into effect. So for manufacturers, it’s a huge deal, but when you learn more about what it is and what it means for the industry, you’ll see that it’s a big deal for you as a consumer too.

 

Here’s what you need to know.

 

WHAT IS A PMTA?

 

A PMTA is a premarket tobacco application, or an application manufacturers have to make to the FDA to continue marketing and selling their products. Technically, if you had a product on the market (or something substantially similar) on the market in February 2007, then you could go through a much simpler process. However, as most people will know, there weren’t any vaping products on the market at this point. Other tobacco products – such as cigarettes – were “grandfathered” in under this rule and remain on the market. But vaping products are so new that you have to go through the whole process.

 

In short, 99% of all vaping products will have to go through this process. This includes importers of e-liquid and even vape stores that also make e-liquid on the side, if they intend to stay in business. It also includes other products you might not really have thought about: for instance, the FDA considers things like drip tips and atomizers to be components and so if they’re sold separately, they’d require a separate application. Not to mention every combination of flavor and nicotine level an e-juice company offers.

 

We’ll get into more of the details of what a PMTA actually includes in a minute, but the key part of the explanation is that you have to demonstrate that your new product is “appropriate for the protection of public health.” It shouldn’t come as much of a surprise that this is a pretty high bar, and smaller companies in particular will struggle to gather the required evidence and documentation.

 

WHAT YOU NEED TO SUBMIT WITH A PMTA

 

There is a lot of stuff you need to include with your PMTA, to the extent that we can’t really list everything here. If you’re a fellow vaping business, check out the FDA’s guidance document for the full explanation, but if you’re an interested vaper, the basics should be enough:

 

  • Product samples and labels: The FDA is requesting samples of products for testing, and manufacturers also have to send samples of labeling so they can be analyzed and scrutinized to see if they’re appropriate.
  • Scientific analyses: As well as the samples, manufacturers also have to send in results of testing they’ve conducted on their products and their health effects.
  • Manufacturing processes: Companies need to send in detailed descriptions of the manufacturing processes used for the product, including information about the facilities used.
  • Principles of operation: A description of how consumers use the product, what other products it could be used with and how customers could modify the product to adjust performance or ingredients.
  • Usage patterns: Essentially describing how customers use the product, including things like how often, whether they tend to use other tobacco products as well, and what the trends are in use over time.
  • Appeal and consumer perceptions: Basically how customers see your product and whether these perceptions affect how appealing the product is to youth
  • Chances for misuse: This includes other factors relating to real-world use, such as how it impacts people with normal use (i.e. do they quit smoking) or misuse (i.e. does your product serve as a gateway for non-nicotine users).

 

PMTA DEADLINE

 

The current deadline for PMTA is September 9th, 2020. This date has changed multiple times since the initial publication of the deeming regulations, with the original date of August 8th 2018 being pushed back four years to 2022, before being recently brought forward after a district court decision. For companies which submit applications, the product can remain on the market for up to one year or until a decision is made.

 

THE COST OF A PMTA

 

The PMTA process was never really intended to be easy. The goal, more than anything, was to make it difficult for tobacco companies to bring new products to market. The requirements listed above are challenging enough in terms of the required evidence and documentation (how, for example, do you argue your mod is “appropriate for the protection of public health”?), but when you translate it into estimated costs, the problems become unavoidable.

 

It’s estimated that each PMTA will cost $117,000 to $466,000. That is for every product you want to keep on the market, including different e-juice flavors and nicotine levels. For many businesses, this is an insurmountable hurdle and they will undoubtedly have to close up shop. The actual cost might also be even higher than this, depending on the amount of original research and analysis is needed to support the application.

 

HOW WILL IT AFFECT YOU AS A VAPER?

 

For vapers in general, there are some substantial changes on the horizon. The cost of submitting a PMTA undoubtedly means that the products on offer from your favorite companies will change very soon. It’s unlikely that many smaller businesses will even attempt to file the PMTAs for their products, but for the ones that do, large product catalogues are likely to be unfeasible and there is still no guarantee the applications that are submitted will be approved.

 

In practice, this will ironically mean that tobacco companies are among the best placed to deal with the requirements of the regulation. With so much infrastructure already built up and plenty of experience complying with regulations, they’re unlikely to be as hard-hit by the coming rules and many of the small and medium-sized independent businesses in the industry.

 

IT’S BAD NEWS, BUT VAPING WILL SURVIVE

 

But don’t get too down about the future of vaping. While there are tough times ahead, enough independent companies are going through the PMTA process that you will still be able to get quality vaping products. The FDA hasn’t thrown the industry many bones so far, but provided they’re fair when assessing the applications, the world of vaping may get smaller, but it won’t disappear entirely.