Chinese e-cigarette company JWEI announced today that they have successfully submitted a pre-market tobacco application (PMTA) to the United States based on innovative technology and products. This technology focuses on safety and harm reduction and aims to deter underage use.
JWEI has announced the submission of a pre-market tobacco product application (PMTA) prior to going public.
As one of the world's leading manufacturers and innovators in electronic cigarette product equipment, JWEI is committed to contributing to public health through meaningful and responsible innovation. The company holds over 3600 patents and several internationally recognized manufacturing and quality certifications including GMP, HACCP, ISO9001, ISO13485, EHS, and ERP.
Smoking is one of the greatest public health threats, causing over 7 million deaths worldwide every year. In the United States, approximately one-fifth of deaths each year are attributed to smoking. The illnesses related to tobacco use are long-term, but most mortality and morbidity rates can be prevented.
Tobacco can cause addiction mainly due to the presence of nicotine, although nicotine itself is not the direct cause of most smoking-related diseases. Many smokers who have attempted to quit, either on their own or with the help of a cessation program, have failed.
Products that contain nicotine carry ongoing risks, ranging from the most harmful combustible products such as cigarettes, to current, less harmful nicotine replacement therapies (NRTs). In recent years, attention has turned towards encouraging those who are unable or unwilling to quit smoking to reduce their cigarette consumption or switch to less harmful alternatives, such as e-cigarettes, as a potential end goal.
Efforts from regulatory agencies, manufacturers, entrepreneurs, academic researchers from the private sector, advocacy groups, and distributors are necessary in taking a comprehensive and multi-faceted approach to address the smoking epidemic, while avoiding another e-cigarette epidemic among young people and vulnerable groups.
First, under the leadership of JWEI's research team in early 2019, a set of principles was established to guide every step of new product development, putting safety and efficacy at the forefront. The design philosophy serves as the foundation for designing, manufacturing, testing, and constantly improving innovative, responsible, reliable, and high-quality products. From the outset of new product platform development, the design philosophy has been clearly established: to transform the smoking challenge into an opportunity to improve public health through meaningful and responsible innovation.
Secondly, JWEI has established a specialized multidisciplinary team, including aerosol chemists, material scientists, toxicologists, epidemiologists, clinical doctors, behavioral scientists, and other subject matter experts, to leverage creativity and innovation in achieving meaningful and effective product development.
Thirdly, JWEI has maintained high standards since the development of their new product platform. They have brought in experts in the field, including biomedical engineers and clinical and regulatory experts with decades of experience in third-class medical devices. They prioritize safety, significantly reducing the risk of harm to users and limiting device-based access to prevent unauthorized use by minors.
Fourthly, JWEI has incorporated a comprehensive PMTA guide into a coherent set of development and research objectives. Rigorous and systematic testing and research have been conducted across three continents (Asia, Europe, and North America) involving numerous certified third-party laboratories and renowned industry and academic researchers, including aerosol testing, stability testing, E&L testing, in vitro toxicology testing, biomarker research, in vivo pharmacokinetics, clinical studies, product perception and behavior research, human factors research, personal health assessment, actual use studies, population health modeling, and environmental impact assessment. The interactive process between the new product platform development and the execution of the PMTA research module has efficiently and effectively produced impressive results. For example, compared to combustible cigarettes, the new product has been proven to reduce more than 99.9% of harmful and potentially harmful constituents (HPHCs). The nicotine transfer effectiveness allows for lower nicotine consumption capability to meet users' needs, and the innovative and practical deterrence function greatly impedes non-users while maintaining the switch as the primary source of nicotine actually used by users.
Finally, but not least important, a task-driven team has been working around the clock on this project across three continents (Asia, Europe, and North America).
A limited product in the UK has garnered recognition from users and commercial partners after a few months of actual use. The high-quality and innovative features have resonated well with users, as shown by demographic data indicating that the majority of users are existing nicotine product users who are of legal age. The evidence provides a solid basis to suggest that the new product and its platform have the potential to make a significant impact on protecting public health.
In its PMTA application, JWEI has submitted over 1,500 documents, several hundred research reports, and tens of thousands of pages of data to the FDA. The FDA is currently reviewing the application and will then decide whether to accept it for preliminary scientific review, to ensure that all necessary items allowing for substantive FDA review are included in the application.
Jason Yao, Vice President of JWEI Group, stated that from the beginning, JWEI has been a leader in the industry. This milestone reiterates their commitment to the industry and public health, ensuring that adult customers have access to alternative products with less harm than traditional tobacco products, while also establishing new standards to prevent underage access.
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