There is considerable concern within the vaping industry as the PMTA deadline approaches. What is PMTA, and why is it of concern for the fast-growing vaping industry? We’ll explain the concerns below, but it’s worth considering why the overall value of the vaping industry is continuing to grow. Vaping has, for many people, replaced the far more dangerous habit of smoking tobacco. Furthermore, the legalization of cannabis in many states across the USA has added to the growth as vaping is one way to enjoy marijuana. Let’s have a look at PMTA and what it is all about.
What is PMTA?
PMTA stands for premarket tobacco application. Under the Family Smoking Prevention & Tobacco Control act, all tobacco products will require PMTA approval. This will mean longer lead times getting to market. As tobacco can be vaped, many vaping products will fall under the act and will also require PMTA approval. It is not just the product itself that will require authorization. Let’s consider a vape pen: the PMTA will look at the product, its packaging, manufacturing processes and more. Potentially, this could cost smaller vape product manufacturers vast amounts in getting approval.
They may have to change packaging and the way they product the products, or even alter the design of the product to meet PMTA approval. Many cannot afford this; hence large portions of the vaping industry are under imminent threat. When first proposed, then President Barack Obama was advised that implementing the PMTA rule quickly would have a disastrous effect on a growing industry. President Trump has also done his best to extend the deadline – originally slated for May 2020 but put back 9th September 2020 thanks to the covid-19 pandemic – but now it seems the deadline may be enforced.
However, it is to the COVID-19 pandemic that the vape industry has turned in a last-ditch attempt to extend the deadline further.
A group of small vaping manufacturers and trade organizations has requested that the FDA ask a federal court for permission to postpone the Sept. 9 PMTA deadline for 180 days. The companies say they have been prevented from complying with the process by the coronavirus pandemic. Vape4Ever and other vape companies are also appealing to e-cigarette users on social media to use a citizen petition to ask the FDA to delay implementation of the Deeming Rule, including the Premarket Tobacco Application (PMTA) deadline.
It is hoped that a further delay will give businesses that have been adversely affected by the covid-19 crisis further time to meet the approval requirements. They also contest the costs involved, with examples. Within the PMTA are several separate authorizations, each of which carries a fee. One area, for example, carries costs of at least $8.6million per product flavor or variation. Vape companies with many products face bills for potentially hundreds of millions of dollars that will simply render them unworkable.
Put simply, the PMTA regulations will directly affect some 14,000 businesses in the vape industry – all small to medium sized – across the USA. They will be forced to prove to the government that the products they make and sell are beneficial in protecting the public from smoking-related diseases. For many of them, this will be an impossible task in terms of costs.
There is litigation ongoing to extend the deadline by a further 180 days but with – at the time of writing – the deadline approaching in a few hours, it remains to be seen if this will be successful and, if it is, whether it will prevent the potential loss of thousands of so far successful small businesses.