In 2016, the FDA had announced that as per the amended Family Smoking Prevention & Tobacco Control Act, all tobacco products, a term which includes safer nicotine alternatives that contain no tobacco, would need to apply for and obtain a PreMarket Tobacco Application Authorization (PMTA), in order to stay on the US market.
In these past years, the deadline for this application has been moved back and forth a number of times, until on April 3rd 2020, Judge Paul Grimm of the United States District Court for the District of Maryland, moved the final deadline to September 9th, 2020.
According to the Tobacco Act, all tobacco products need to be authorized for every aspect including adjustments in packaging, manufacturing processes, and product design. This makes obtaining the authorization very costly and time-consuming, leading many of the smaller vape businesses into bankruptcy or insurmountable debts.
Bantam is a manufacturer of artisanal flavours which are built from scratch using only high-quality ingredients. The brand is adamant about their quality and transparency standards, in fact they have employed a system: the SENTRISM track and trace system, where one can enter the batch number of an e-liquid bottle to check the content quality.
In an email interview with Bantam spokesperson Anthony Dillon, we sought to understand how the brand has approached and was affected by the PMTA process:
What is your opinion about the PMTA in general? Do you find it fair, doable, etc?
The PMTA process, though complex and resource intensive, provides a benchmark for all e-liquid manufacturers, something that the industry, up until now, was lacking. Like many others in the e-liquid category, we have invested significant resources to create the foundation of our PMTA submissions, and continue to invest resources in the PMTA process and post market surveillance. We are optimistic about the prospect of PMTA leveling the industry’s playing field; however, we are cognizant that additional transparency and enforcement by the FDA is still needed to optimize the intended purpose of the PMTA process.
How have you found the process itself? Is it manageable? Clear? Too costly and time consuming?
There is no doubt that the PMTA process is complex and resource intensive; however, we believe Bantam is well positioned for success. With any new process, there are kinks to be ironed out. The PMTA is no different, and we are committed to working with the FDA to streamline and improve the process, where possible.
When did you start filing PMTAs? And were you at all affected by all the changes in submission deadlines?
We have been anticipating and planning for potential regulations since entering the category, and our team worked diligently to conduct the necessary research and testing needed for our PMTA, and submitted the application prior to the deadline.
How has the PMTA process affected your company and your operations?
I think it is important to identify that the PMTA process has impacted the entire e-liquid industry – from the manufacturer to the retailer and the consumer. E-liquid companies undergoing the PMTA process must evolve, as needed, to remain on the market long term. Bantam is, and has always been, committed to developing and manufacturing high-quality, adult use e-liquid products consistent with FDA guidance and applicable laws. That goal has not changed.
Is making up for the cost of the PMTA process challenging? Will you have to increase the prices of your products to make up for the losses?
We have been anticipating and planning for potential regulations since entering the category. However, with any new process, there can be challenges. Currently, the biggest challenges we are experiencing are due to the lack of transparency on the process, and the need for enforcement to be taken against those who are not in compliance with FDA guidance and applicable laws.
Any other comments or important points you would like to share with our readers?
We are proud of and confident in the e-liquid products that are being taken through the PMTA process, and we look forward to Bantam’s products being enjoyed by adult consumers for years to come. To help ensure this, we remain committed to the PMTA process, and we intend to work closely with the FDA as the process moves forward.
The US FDA Finalizes Two Minimum Requirements For The PMTA