We’ve known about it since 2016, but on the 9th of September, the Premarket Tobacco Application (PMTA) goes live.
This means any tobacco-related and vaping products being sold across the U.S. will only be those that have been approved for marketing by the FDA Centre for Tobacco Products.
The process tobacco-related products have to go through is called a Premarket Tobacco Application.
The purpose of this new legislation is to ensure all tobacco-related products are “appropriate for the protection of public health” among other things.
What is the PMTA and what does it mean for vapers?
Basically, a PMTA is an application manufacturers of tobacco-related products have to file to the FDA to be authorised to market and sell their products.
This legislation is set to impact the vaping market much harder than other tobacco products, such as cigarettes. In fact, cigarettes were already “grandfathered” in and remain on the market, it’s the new vaping products that are going to be scrutinised.
Manufacturers of vaping products are going to have to submit a separate application for every e-juice that has a different combination of flavours or nicotine levels. As well as accessories like atomisers and drip tips.
The reason why this legislation has come into effect is to ensure each and every new product is “appropriate for the protection of public health”.
There is no doubt that it’s beneficial for the end-user of vaping products. But at the same time, it’s believed a lot of companies are going to struggle with the added administrative costs.
The bar for passing a new tobacco-related product has been set very high. It’s too soon to say how it’s going to affect the companies and manufacturers making and marketing these products. It’s going to be interesting to see over the coming weeks, months, and years.
What do companies and manufacturers need to do to submit a PMTA?
The PMTA process is comprehensive and difficult to get through. So much so, that a lot of small companies think this is a deliberate move to push the smaller players out of business.
I won’t go into fine detail here, but the basics any company needs to demonstrate to bring a new product to market include:
Submitting all marketing materials – The FDA wants to see all product labels, packaging, and marketing materials. The primary reason being they want companies to be very clear with their advertising, and not target underage users.
The manufacturing process – A detailed report of exactly how the products are made is required.
Samples and scientific analyses – Samples are required so the FDA can perform their own tests. Along with a detailed scientific analysis into the possible health risks.
Intended uses – Explanations of exactly how the product is intended to be used.
This is just scratching the surface of what’s required. As you can see, the FDA requires a detailed breakdown of everything related to the product.
It’s estimated that each PMTA will cost in excess of $117,000. This barrier to entry alone is enough to force small manufacturers out of business.
How hard will the PMTA deadline hit the vaping industry?
The answer to this question is – very hard.
If you’re a vaper, don’t panic. It’s not the end of vaping and vape-related products as we know it. It may mean there are fewer products on the market, but this has some plus points as it does drawbacks.
