Vice-President of Vaporesso, Eve Wang, sat down with Matt from SMM to talk about Vaporesso’s approach to the PMTA process and the future of vaping in the U.S.
Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve a Pre-Market Tobacco Application (PMTA) for any new tobacco product before it can be sold in the U.S.
E-cigarettes and vapor products weren’t always classified as tobacco products. However, on August 8, 2016, the FDA’s Deeming Rule defined e-cigarettes and vaping products as tobacco products and thus required them to receive FDA approval to remain on the market.
Over the past few years, this deadline has been moved back and forth a number times until, on April 3rd 2020, Judge Paul Grimm of the United States District Court for the District of Maryland, finalized the deadline to September 9th, 2020.
A PMTA requires the applicant to provide scientific data that demonstrates that the product is “appropriate for the protection of public health”, a vague and unclear guideline.
A PMTA serves as the foundation for establishing a long-term vaping business in the U.S due to its extremely rigorous requirements and complicated application process. Aside from the stringent requirements that products must meet in order to be accepted, a considerable investment of manpower, capital, and time are also necessary to submit a PMTA.
In an interview with Matt from SMM, Vice-President of Vaporesso, Eve Wang, shed some light on what Vaporesso has been doing to comply with the PMTA process.
She explained that Vaporesso has been preparing for the PMTA for many years, since as early as 2016, and that they have been working full speed since 2018 to be ready for the deadline.
Vaporesso sees themselves as an innovative brand and as such, they have many different types of products: tanks and box mods, pod vapes, pod mods, etc… However, since there is only one guidance and process for Electronic Nicotine Delivery Systems (ENDS), the PMTA process was challenging for the brand.
She continued to say that the PMTA process has been especially challenging since many of their devices have variable settings like wattage adjustment and airflow adjustment, can use different coils, and are refillable which means that they can be used with many different eliquids.
Wang explained that since Vaporesso has been preparing for the PMTA since as early as 2016, their scientists have been able to conduct many studies and collect enough scientific data to establish a working model that proves to the FDA that their products are safe and “appropriate for the protection of public health”.
Vaporesso has several products that have been accepted by the FDA for review, one as early as August. Wang revealed that Vaporesso has submitted PMTAs for the following products:
Traditional Mods with Tanks
- Vaporesso Tarot Nano Kit
- Vaporesso Gen S Kit
- Vaporesso Zero
- Vaporesso XROS
- Vaporesso Luxe PM40
- Vaporesso Target PM80
When asked about what lies ahead, Wang stated that they are very confident in the future of Vaporesso and that they will continue to innovate. They will continue to invest in the PMTA review process and that in the future, more Vaporesso products will continue to have PMTAs submitted.
Wang stated that no matter what changes, Vaporesso’s commitment will remain the same: to continue to bring innovation and quality and to stay true to their commitment of helping vapers in the U.S. and around the world.
When asked about her opinion on whether these regulations are necessary, Wang said that Vaporesso’s position is that “it is what it is”. And she’s right; the vaping industry has had years to prepare and the regulations are here to stay. Whether or not it’s necessary is irrelevant at this point.
Wang continued on to say that Vaporesso welcomes regulations because they have always strived to provide a safe and reliable vaping solution to vapers and these regulations are one way to verify that their products are as safe and dependable as they say that they are.
The PMTA process is extremely expensive and time consuming and vaping companies will have to make up for this money somewhere. So will Vaporesso’s products become more expensive to compensate for the costs of their PMTAs?
When asked this question, Wang stated that Vaporesso has a team of more than 20 people working specifically on the PMTA process and so it’s true that it’s a huge investment. However, she continued to say that they are working on improving production efficiency and reducing internal costs to see how they can offset the cost of PMTA’s, rather than increasing prices to vapers.
The PMTA process is here to stay, and it appears that Vaporesso will be sticking around too.