Chinese e-cigarette company Juwei JWEI announced today that they have successfully submitted a premarket tobacco application to the U.S. Food and Drug Administration using a device they manufacture that will focus on new innovations Technology that focuses on safety, reduces harm and aims to deter underage use.

As one of the world's leading manufacturers and innovators of electronic cigarette equipment, JWEI has more than 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS and ERP), and is committed to achieving Meaningful and responsible innovation contributes to the advancement of public health.

Juwei said that in early 2019, led by safety and efficacy studies, it developed a set of principles to guide every step of new product development. The design philosophy is the basis for designing, manufacturing, validating, validating and continuously improving and guiding innovative, responsible, reliable, high-quality products. The design philosophy was clearly established at the beginning of the development of the new product platform: to translate the smoking epidemic challenge into an opportunity to improve public health through meaningful and responsible innovation.

Second, JWEI assembled a dedicated multidisciplinary team of aerosol chemists, materials scientists, toxicologists, epidemiologists, clinicians, behavioral scientists, and other subject matter experts to harness creativity and innovation for meaningful and effective product development.

Third, JWEI upholds high standards from the beginning of the development of the new product platform to the whole process. They bring in domain experts, including biomedical engineers and clinical and regulatory experts with decades of experience in Class III medical devices. They prioritize safety, significantly reduce harm to users, and limit device-based access to stop teens from getting started.

Fourth, JWEI embeds comprehensive PMTA guidelines into a series of coherent standards for product development and research objectives. Thorough and systematic testing and research, including aerosol testing, stability Testing, E&L testing, in vitro toxicology testing, biomarker studies, in vivo pharmacokinetics, clinical studies, product perception and behavior studies, human factors studies, personal health assessments, actual use studies, population health modeling and environmental impact assessments .

The hand-in-hand interactive process between new product platform development and execution of the PMTA research modules efficiently and effectively yielded impressive results.

For example, the new product has been shown to reduce harmful and potentially harmful components (HPHC) by more than 99.9% compared to combustible cigarettes. This nicotine transfer effectiveness can enable nicotine consumption to be greatly reduced to meet the declining demand of users, innovative and pragmatic deterrent features greatly deter non-users, and are able to maintain switching to nicotine in actual use among the main source of users.

Last but not least, a mission-driven, motivated team spanning three continents (Asia, Europe and North America) worked tirelessly on the project day and night.

The limited-edition product debuted in the UK, and after several months of practical use, it has been overwhelmingly approved by users and business partners. High quality and innovative features resonate with users. Demographic data on actual age distribution also show that the vast majority of users are existing nicotine product users who have passed their young adult years. The totality of evidence provides a solid foundation for demonstrating that the new product and its platform offerings have enormous potential to have a profound impact on APPH (applicable to protecting public health).

More than 1,500 documents, hundreds of research reports and tens of thousands of pages in the final PMTA submission have been submitted to the FDA. The application will now be reviewed by the FDA before the agency decides to accept the submission, at which stage it will conduct an initial scientific review to ensure that the application contains all required items to allow the FDA to conduct a substantive review.

"JWEI has been a leader in the industry since the beginning, and this milestone reaffirms our commitment to the industry and to public health: ensuring our adult customers continue to have access to less harmful alternatives to traditional tobacco products, while developing new standards to prevent Contact with minors,” said Jason Yao, Vice President of JWEI Group.