PMTA (Premarket Tobacco Application) means that after
February 15, 2007, the legal listing of any new
tobacco product requires FDA approval. The agency needs to consider whether this product is beneficial to
public health.
After project preparation and research, DRAGBAR submitted a PMTA to the FDA before September 9, 2020.
Our product testing conducts scientific research and analysis in product analysis and manufacturing research, non-clinical research, clinical human research and other compliance fields.
The HPHCs test is designed to analyze product components under high-intensity and non-high-intensity use conditions, including HPHCs and other toxicological analysis, to evaluate the toxicological and pharmacological properties of the product in detail, to ensure that the product components are harmless, and to ensure user safety.
In the process of supplier selection and raw material control, clear PMTA requirements on extracts and extracts to ensure supplier and raw material compliance. Meanwhile, the traceability of the whole process is realized, and the responsibility of each link is clarified to ensure the product quality and the safety of raw materials.
ANSI/CAN/UL 8139, Electrical Systems of Electronic Cigarettes and Vaping Devices, is recognized by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC), covering the electrical, heating, battery and charging systems of these products. The development of UL 8139 also addresses specific fire safety concerns raised by North American fire officials.
Provide world-class quality and safe products
It is equipped with a clean workshop environment with a cleanliness of 100000 class, which meets the requirements of ISO14644-2015 (International Standard for clean rooms and related control environment) and GB 50547-2019 (design standard for clean rooms in pharmaceutical industry).
MES (Manufacturing Execution System) is a collaborative supply chain management service system covering supplier management, order management, planning management, production management and delivery management. It can realize the whole life cycle management of orders, visual control of the whole supply chain and traceability of the whole process.
DRAGBAR digital factory introduces modern automatic equipment, simplify assembly procedures to improve production efficiency, and create a dedicated laboratory, strict product quality testing, and ensure product safety and reliability.
8 core processes are set up for quality control, and the whole process can be traceable through MES system management.
DRAGBAR has always put product safety at the top of its list, and is committed to taking responsibility for the
industry, users and society. And DRAGBAR has invested millions of dollars to prepare PMTA and will formally submit
PMTA application to FDA before September 9, 2020.
PMTA is not an obstacle to the atomization industry, but a new starting point. DRAGBAR will continue to uphold the
spirit of innovation, actively assume the responsibility of guardian of young adults, protect the health and
safety of global consumer users, and promote orderly and good development of the industry. DRAGBAR will lead the
market development with product and technology innovation in PMTA standards, and bring better life experience to
global users.
