VAPORESSO’s first-round PMTA applications were accepted by FDA
Shenzhen | August 2020
-On August 20, 2020, VAPORESSO received the acceptance letter for the first round of its PMTA applications from the FDA – only three days after submission. According to its U.S. scientific CRO agent, the application received positive comments from FDA on its overall preparation.
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. PMTA requires the applicant to provide scientific data that demonstrates the product is appropriate for the protection of public health. (See, FDA’s website)
On May 10, 2016, the US FDA finalized its “deeming” rule, subjecting additional products to scrutiny under the Federal Food, Drug, and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act. Although the entire application is a long process, the FDA does not leave much time for the preparation of application materials. After several times of modifications on timelines, it finalizes the deadline for submission on Sep 9th, 2020.
PMTA serves as the foundation of establishing long-term business locally due to its extremely high standards and complicated process. Besides the requirements the products must meet, a considerable investment of manpower, capital, and time are also necessary to a PMTA.
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 of 2020). As the founder of VAPORESSO, Mr. Simon Lai is a true visionary and veteran in the vaping industry, who call 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 was fully set to bring its innovative vaping products into the PMTA regulatory framework of FDA. 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 expertises, 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. Due to many years of SMOORE’s ODM/OEM experiences with international customers, VAPORESSO has been well known for its manufacturing excellence since the first day one which has led to a critical and fundamental element to the PMTA application.
Acceptance letter for the first round received!
On August 20, VAPORESSO’s first round of product applications were accepted by the FDA. It was a challenging moment when once upon the time there was still uncertainty on the regulation itself. However, a successful acceptance has boosted the confidence of SMOORE to keep investing in bringing more vaping products into PMTA in the future. Our commitment to vapers in U.S.A. remains the same: we will make vaping as easy as possible and we will consistently provide high-quality vaping experiences for vapers all over the world. So the first round of application accomplished by SMOORE is merely the start with more products to come.
As the world’s largest provider of vaping devices, SMOORE is the first company to achieve an IPO in vaping industry. SMOORE, with 11 years’ experience in the field, occupies the most cutting-edge vaping technology, and plays a significant role in the whole industry. Strong R&D capability, superior quality and excellent service have caused SMOORE to a global market share of over 16.5%.
Established in 2015, as one of SMOORE’s sub-brands, VAPORESSO has inherited SMOORE’s spirit and incorporated it into its own mission to be Beyond the Ordinary. with cutting-edge ingenuity, VAPORESSO is dedicated to satisfying its customers with high-quality vaping experience. VAPORESSO’s products cover the full range of open-system vapes and fulfill the various needs from the vapers.