According to the Family Smoking Prevention and Tobacco Control Act of 2009, FDA must approve the PMTA of the newly certified tobacco products (including electronic cigarettes and steam products) before they are continued to be launched to the market.

In June 2019, the US Food and Drug Administration (FDA) formally issued the guiding paper corresponding to PMTA (Premarket Tobacco Application) of the Electronic Nicotine Delivery System (ENDS). The paper provides a clear channel for the manufacturers of new tobacco applications to enter the American market for sales.

YOUME Group formally launched the PMTA project in November 2019. Through the ceaseless struggle of the local and American PMTA teams, we have finished the test contents required by PMTA such as the “hazardous substance test”, “toxicological analysis”, “extraction test” and “clinical test” within 8 months. According to the data and conclusion gained from the lab, all kinds of performance indexes of multiple products of scoring brands of YOUME Group were very excellent. In August 2020, Suorin submitted more than 50000 pages of PMTA application materials to the US Food and Drug Administration (FDA).

Due to the complicated application process of PMTA, the requirement is strictly scientific. There should be products of high quality, and enterprises should have a higher cost of time and capital. YOUME Group has invested huge of manpower and material resources in product performance research, production quality process control and so on to apply for PMTA. The team members are relevant pathology experts, clinical research experts, professional researchers and legal consultant teams. It is estimated with an overall investment of more than 100 million yuan.

In August 2020, the PMTA of YOUME Group was officially accepted by the FDA. The application includes closed products and open products. The tens of thousands of pages of application materials submitted were just the tip of the iceberg that YOUME Group has been working hard for more than a year. YOUME Group improves all aspects from enterprise to products with the standards exceeding the PMTA requirement, from the R&D, and quality management to the production and manufacturing, so as to comprehensively upgrade to the high standards for tobacco, medical equipment and drugs.

For enterprises, passing PMTA certification means that they are qualified and capable to compete with the American market in the global electronic cigarette market; and they have gained authentication in product R&D, design, quality and safety from the strictest food and drug administration in the world. Besides, the potential effect of PMTA certification may exceed the American market itself, and it would be a benchmarking demonstration for other mainstream markets around the world. YOUME Group has spent so much to improve the enterprise with the PMTA, whose strategic goal would not only keep a leading status in the American market but also wish the consumers around the whole world could use the products with the highest standards in the world.