As manufacturers start submitting their applications, more and more are being accepted by the FDA for PMTA approval. Vaporesso has just gotten word that their first round of submissions has been accepted.
Vaporesso’s Application Is Accepted
Unless you’ve been lurking under a rock, you know that the Premarket Tobacco Product Application, or PMTA, submission deadline is looming. In essence, all Tobacco (and in this case vape related) companies need to submit an application to the Federal Food and Drug Administration of the United States for approval before being allowed to sell their products in the USA. This is bad news for vapers worldwide as the USA is the biggest consumer of Chinese vaping gear. No more US sales mean that Chinese manufacturers will turn to a new revenue stream, leaving us grasping at nothing. The industry would go bust in a matter of months.
To make matters worse, the whole process has been so convoluted that most manufacturers were caught off-guard, either not understanding the process or not having enough time to submit their applications. It needs to be noted that applications are on a “per product” basis and not for a brand as a whole, further complicating matters
Vaporesso has been hard at work preparing its application since the FDA finalized the application process in May 2020 with the help of industry experts.
“We have been engaging professional service providers and CROs from USA to work closely with our own disciplinary in-house team with various backgrounds and expertise, who are further supported by the strong R&D team from SMOORE’s leading laboratories and fundamental research institutes to secure a successful acceptance under a stringent timeline.”
On the 20th of August 2020, Vaporesso received their acceptance of their first round of applications and while it’s not yet known which products were submitted, it spells good news that there may actually be hope for e-cigarette users. Furthermore, Vaporesso has received positive feedback from the FDA, complimenting them on their overall presentation quality. PMTA regulations should also (hopefully) ensure that accepted products remain at a high standard and be socially responsible.
Not The End Of The Road
Acceptance allows these products to move on to the next stage of approval. This entails a scientific review of all submitted products to deem the product appropriate for the protection of public health. Until such a time comes where the FDA has finalized this stage (which may be months, even years from now) accepted products are sellable within the USA. Putting it simply, getting acceptance on your PMTA application gives you leeway to sell those products until the FDA gets their act together
Companies have until the 9th of September to submit their applications, after which the sale of that product will be disallowed if not accepted.