On August 20, 2020, VAPORESSO received an acceptance letter from the FDA for its first round of PMTA applications — only three days after submission.
According to its U.S. scientific CRO agent, the application received positive comments from the FDA on its overall preparation.
With the September 9, 2020 PMTA deadline looming, major vaping manufacturers are beginning to submit their premarket tobacco product applications. Companies that submit a PMTA for their vapor product by the September 9, 2020 deadline will be allowed to remain on the market for up to a year while the FDA decides if the product meets its requirements for sale.
On August 20, 2020, VAPORESSO’s first round of product applications were accepted by the FDA. Which products they’ve submitted remains unclear, as they’ve declined to disclose this information due to “commercial confidentiality considerations”. From what I gather, Vaporesso does not want other vaping companies to know which products they’ve submitted.
This successful acceptance has boosted the confidence of SMOORE (Vaporesso’s parent company) to keep investing in submitting more PMTA applications for their other vaping products. SMOORE’s commitment to vapers in the U.S.A. remains the same: to make vaping as easy as possible and to consistently provide a high-quality vaping experience for vapers all over the world. This first round of applications accomplished by SMOORE is merely the start, with more products to come.
What Is a PMTA?
A PMTA is a Premarket Tobacco Product Application that all e-cigarette manufacturers have to submit to the FDA in order to continue marketing and selling their vaping products in the U.S. A PMTA requires the applicant to provide scientific data that demonstrates that the product is “appropriate for the protection of public health”.
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.
Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTAs for any new tobacco product before it can be sold in the U.S. But 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.
Then, in July of 2019, District Judge Paul Grimm of the U.S. District Court for the District of Maryland set a May 12, 2020 deadline for vaping companies to submit PMTAs to the FDA. Any company that did not submit a PMTA for their vapor product(s) by this deadline would no longer be legally allowed to sell them in the USA.
May 12, 2020 was the deadline for a while; but then the coronavius hit. The coronavirus pandemic closed laboratories both in the U.S and overseas which made it difficult for companies to complete their applications. Plus, FDA staff members were also pulled into the pandemic response. As a result, this deadline was once again postponed until September 9, 2020 to give vaping manufacturers the much needed time necessary to complete their applications.
Submitting a premarket tobacco application (PMTA) is expensive, with costs in the low to mid hundreds of thousands of dollars. In order to get their PMTA approved, the manufacturer must demonstrate to the FDA that “permitting the marketing of the new tobacco product would be appropriate for the protection of public health”. This guideline is unclear and vague which leaves many companies wondering exactly what they would have to prove in order to submit a successful application.
What has Vaporesso done for the PMTA?
Vaporesso was created in 2015 by its parent company SMOORE (founded in 2009, and publicly listed on the Stock Exchange of Hong Kong on July 10, 2020). As the founder of Vaporesso, Mr. Simon Lai calls for everyone in Vaporesso’s team to fight for a big dream: to make vaping as easy as possible for everyone.
Ever since the deeming rule was released in May 2016, Vaporesso has been fully set to bring its innovative vaping products into the PMTA regulatory framework of FDA. Vaporesso have been engaging professional service providers and CROs from the USA to work closely with their own disciplinary in-house team. This team consists of various backgrounds and expertises who are further supported by the R&D team from SMOORE’s leading laboratories and fundamental research institutes.
Due to many years of SMOORE’s ODM/OEM experiences with international customers, Vaporesso have been well known for their manufacturing excellence. This excellence has added a critical and fundamental element to their PMTA application.
As the world’s largest provider of vaping devices, SMOORE was the first vaping company to launch an IPO when they went public on the Hong Kong Stock Exchange earlier this year. SMOORE has 11 years of experience in the vaping sector and plays a significant role in the whole industry. Strong R&D capability, superior quality and excellent service have allowed SMOORE to attain a global vaping market share of over 16.5%.
Vaporesso surely won’t be the only major vaping company submitting PMTA applications. As the September 9, 2020 deadline approaches, expect to see other companies follow suit in the near future.