On August 27th, U.S. time, VOOPOO of GR Technology officially submitted a pre-market tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA).
Since the FDA announced the first edition of PMTA regulations in 2017, VOOPOO has established a special team to conduct in-depth project research and analysis. The team members include toxicology experts, clinical medicine experts, PMTA project experts, product analysts, R&D experts, legal consultants, marketing personnel, etc.
The entire project process has spent 100 million yuan, and it took 20 months from preparation to application to complete the PMTA testing requirements such as product component analysis, manufacturing research, non-clinical and clinical human research.
According to the data and conclusions drawn by the cooperative laboratories, the various performance indicators of GR’s VOOPOO brand products in component analysis, toxicological research, design and manufacturing, and chemical tests are very excellent. This also makes the VOOPOO team feel good about PMTA. Project review is full of confidence.
In addition, VOOPOO has invested millions of dollars to upgrade the factory in an all-round way to achieve a higher standard of manufacturing environment and quality management system. At present, it has formed a modern manufacturing center integrating 100,000-level dust-free clean workshop, MES intelligent supply chain management system, automated production equipment and full-process traceable quality control, which fully guarantees design and development, product raw materials, manufacturing, product testing, Standardization and intelligent management of quality control and other processes provide world-class quality experience.
As the most stringent product listing standard in the global e-cigarette industry, the PMTA application process is quite complicated and the review is extremely rigorous and scientific. Relevant agencies speculate that the application of PMTA will take about two years from inception to approval.
This not only requires products with excellent quality and performance, but also requires the company’s own strong capital reserves and long-term preparation. It is precisely because of high costs and long preparations that have greatly increased the entry barrier for e-cigarette brands in the US market. Therefore, this is a protracted battle between capital and time, but also a life and death battle between quality and safety.
The application of PMTA also demonstrates VOOPOO’s fearless industry challenge and the spirit of a striving forward courageously. It also upholds the original intention of providing better and safer products to users around the world. Only those electronic atomization brands that truly possess the financial and technical strength, focus on product quality, and strictly guard against safety issues can pass the PMTA tests.
Through PMTA, it is of great significance to VOOPOO. Not only is the quality and safety of the product itself recognized by the world’s most stringent food and drug regulatory agency, it is also a strong demonstration of the company’s all-round strength.
In addition, the FDA requires the marketing of all products on the market to prevent young people from contacting and exposing them. For minors, this will greatly protect the physical and mental health of minors and fulfill the responsibility and responsibility of the entire industry to protect the growth of minors.
Everest, the founder and CEO of GR Technology and the VOOPOO brand, said that it will continue to deepen product innovation and standard control, and is committed to helping the global electronic atomization industry develop in a healthy and orderly manner with the most stringent product standards in the industry.
From the beginning of its establishment, VOOPOO has always insisted on putting product safety first, and resolutely assumed corporate responsibilities to the industry, users and society. The PMTA application is not an obstacle to the atomization industry, but a new starting point.
VOOPOO will continue to uphold the spirit of innovation and self-breakthrough, actively assume the responsibility of protecting minors, ensure the health and safety of global consumer users, promote the orderly and sound development of the industry, and lead the market development with product and technological innovation under the PMTA standard, bringing global users A better life experience.