Summing Things Up: Bantam and the PMTA Process
As your trusted partner in vape, we value the relationship we share and strive to be transparent about what’s happening with our business. As you may have already heard, Bantam is preparing its Premarket Tobacco Product Application (PMTA) submission, but what you might not know is why. Allow us to explain…
What is the PMTA process?
Long story short, all ENDS or components, like e-liquids, must have a marketing order from the FDA in order to be sold in the U.S., even products like Bantam’s. The good news: Bantam can continue selling and marketing them, as long as we submit PMTAs for them by the FDA’s September 9, 2020 filing deadline. So, that’s just what we are doing!
To learn more, you can read the FDA’s overview of PMTAs here.
What is Bantam doing to prepare for submission?
In order to work toward receiving a marketing order (allowing Bantam to stay on shelves and enjoyed by adult consumers), we’ve fully committed ourselves to the PMTA process and are confident in the content and quality of materials we will submit with our application. We’ve been working with highly-qualified labs to conduct the necessary research and testing, and working with reputable, like-minded industry players to significantly improve efficiencies related to our respective PMTAs.
Preparing for PMTA submission is complex and resource intensive, but in the end, we believe PMTA will set a benchmark for all e-liquid manufacturers, which up until now, the industry lacked.
How long does the PMTA process take?
We don’t have a crystal ball, but what we do know is that once the FDA has accepted an application, they have 180 days to review. However, the time clock can start and stop, meaning the review process may be longer. And again, Bantam’s plan is to remain on the market during this time.
Will there be changes to Bantam’s products?
Like we mentioned, the PMTA process is complex. To help ensure the greatest chance of receiving a marketing order, we thought long and hard about what products would be submitted in our initial application. We considered a wide range of factors, with consumer preference being a top priority, and are here to help if you have questions. But don’t fret, we have the option of submitting additional PMTAs in the future.
Also, you may notice slight modifications to our packaging, labeling, flavors names, etc. We’re excited to share these improvements with you.
At the end of the day, we entered this process with our customers in mind and we are confident in our ability to continually deliver upon the qualities you enjoy about our brand. We look forward to providing you with updates on our PMTA journey. And, as always, feel free to reach out with questions.