Products from SMOORE's First Batch Completed PMTA Filing Stage

2020.09.09

Exciting News from PMTA

On September 1, 2020, the local time in the U.S., according to the PMTA audit receipt provided by the U.S. Food and Drug Administration (hereinafter referred to as "FDA"), SMOORE International Holdings Co., Ltd. (hereinafter referred to as "SMOORE") own brand VAPORESSO has become the first vaping brand in the industry to complete the filing stage of PMTA review. The announcement indicates that VAPORESSO’s first batch products submitted to the FDA, with their high-quality, have quickly passed the first two rounds of rigorous review. Meanwhile, completing the filing stage also represents that products of VAPORESSO have entered the final stage of the PMTA application process.


Support by Professional Teams

Sufficient preparatory work is the key to pass the first two rounds of reviewing successfully. SMOORE has been actively preparing for the PMTA project as early as 2016 by setting up a professional team, and at the same time, united with top overseas consulting companies and laboratories, including hiring former FDA employees to assist our PMTA preparations. With the expert teams' professional guidance and the team members' well-cooperated, we have screened out the product portfolio that perfectly meets the US market and designed scientific experimental methods and the most rigorous test plan following PMTA requirements, laying the foundation for PMTA applications.

 

Escorting by the Core Tech

SMOORE is a well-deserved leader in vaping technology. VAPORESSO inherits the high-quality manufacturing and innovated technology of SMOORE and has a very high standard in safety assurance.

The fundamental research institution established by SMOORE, which qualified beyond the international level, has also been put into the relevant experiment process of PMTA. The analysis and testing labs have obtained CNAS and UL8139 certification and employ nearly 100 high-tech researchers with doctoral and master degrees. It is the only domestic company-owned laboratory that can independently complete the testing and analysis of all toxic and hazardous substances required by the PMTA guidelines and corresponding health and safety risk assessments.


Completing the second round of review is only the first step of SMOORE's long march in PMTA. SMOORE will continue to invest in the PMTA review process. What we will face down here must be more challenges and opportunities. SMOORE will not forget its original intention and make unremitting efforts to promote the development of the industry.