JWEI Announces the Submission of a Premarket Tobacco Product Application (PMTA) for a New Technology Platform Product to the U.S. Food and Drug Administration Requesting Marketing Authorization

JWEI PMTA

SHENZHEN, ChinaJuly 21, 2022 JWEI, a global leader in the electronic cigarette industry, announces today that they have successfully submitted a Pre-Market Tobacco Application to the U.S. Food and Drug Administration for a device created with their new innovative technology, which is focusing on safety, harm reduction and designed to curb underage use.

As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, with over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP), JWEI is committed to contributing to the advancement of the public health with meaningful and responsible innovations.

Cigarette smoking is one of the biggest public health threats, killing over 7 million people in the world every year 1. About one in every five deaths in the US is caused by cigarette smoking annually 2. The litany of tobacco-related diseases is long. Sadly, most of the mortality and morbidity are preventable.

Tobacco is addictive, primarily due to the presence of nicotine, although nicotine itself is not the direct cause of most smoking-related diseases 3. Many smokers who try to quit, either on their own or with the help from cessation programs, fail in their attempt 4 5 6.

There is a continuum of risks for products that deliver nicotine, ranging from the most harmful combusted products (e.g. cigarettes) to currently least harmful medicinal nicotine products such as nicotine replacement therapy (NRT). In recent years, attention has turned to the possibility of encouraging those who are unable or unwilling to quit to either reduce their cigarette consumption or switch to a less harmful alternative such as e-cigarettes as a potential outcome goal 6 7.

It requires a comprehensive, multifaceted approach and efforts to tackle the cigarette smoking epidemic from regulators, manufacturers, entrepreneurs, researchers in academia or private sections, advocacy groups, and distributors while not creating another vaping epidemic in youth and vulnerable populations.

Firstly, JWEI developed a set of principles to guide through every step of the new product development, led by safety and effectiveness studies in early 2019. The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products. The design philosophy was clearly established at the very beginning of the new product platform development: Turning the smoking epidemic challenge into improving public health opportunities with meaningful and responsible innovations.

Secondly, JWEI formed a dedicated multidisciplinary team including aerosol chemists, material scientists, toxicologists, epidemiologists, clinicians, behavioral scientists, and other subject-matter experts to harness creativity and innovation towards the realization of meaningful and effective product development.

Thirdly, JWEI has held a high standard from the beginning of the new product platform development and throughout the whole process. They brought in domain experts, including biomedical engineers and clinical and regulatory experts with decades’ extensive experience in Class III medical devices. They prioritized safety with significant harm reductions for users and device-based access restrictions to deter youth initiation.

Fourthly, JWEI embedded the comprehensive PMTA guideline into a set of coherent criteria for product development and study objectives. The thorough and systematic testing and studies were conducted across three continents (AsiaEurope, and North America) with many certified third-party labs and reputable principal investigators and researchers from industry and academia, including aerosol testing, stability testing, E&L testing, in vitro toxicology testing, biomarker studies, in vivo pharmacokinetics, clinical studies, product perception and behavioral studies, human factors study, individual health assessment, actual use studies, population health modeling, and environmental impact assessment. The hand-in-hand interactive process between the new product platform development and executing PMTA study modules has yielded impressive results efficiently and effectively. For example, the new product has been shown to reduce>99.9% harmful and potentially harmful constituents (HPHC) compared to combustible cigarettes. This nicotine transfer effectiveness can enable the ability of much lower nicotine consumption to meet users’ needs to ramp down, innovative and pragmatic deterrence features that greatly discourage non-users, and the ability to sustain the switch as the primary source of nicotine in actual use among users.

Last but not least, the mission-driven motivated team across three continents (AsiaEurope, and North America) tirelessly worked on the project around the clock.

The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use. The high-quality and innovative features resonated well with users. The demographics of the actual use age distribution also showed the vast majority of users are existing nicotine product users who are well past young adulthood. The totality of the evidence builds a strong foundation demonstrating the new product and its platform products have a high potential to exert a profound impact on the APPH (appropriate for the protection of public health).

Over 1,500 documents, hundreds of study 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 a determination is made by the agency to accept the application for filing at which stage it will then undergo a preliminary scientific review to ensure the application contains all required items to permit a substantive review by the FDA.

“JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said Jason Yao, VP of JWEI Group.

References:

  1. WHO. Tobacco, <https://www.who.int/news-room/fact-sheets/detail/tobacco#:~:text=Key%20facts,exposed%20to%20second%2Dhand%20smoke.> (2022).
  2. CDC. Smoking & Tobacco Use, <https://www.cdc.gov/tobacco/data_statistics/fact_sheets/economics/econ_facts/index.htm> (2022).
  3. Apelberg, B. J. et al. Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United StatesN Engl J Med 378, 1725-1733, doi:10.1056/NEJMsr1714617 (2018).
  4. Giovino, G. A. Epidemiology of tobacco use in the United StatesOncogene 21, 7326-7340, doi:10.1038/sj.onc.1205808 (2002).
  5. Messer, K. et al. The California Tobacco Control Program’s effect on adult smokers: (1) Smoking cessation. Tob Control 16, 85-90, doi:10.1136/tc.2006.016873 (2007).
  6. Yong, H. H., Borland, R., Hyland, A. & Siahpush, M. How does a failed quit attempt among regular smokers affect their cigarette consumption? Findings from the International Tobacco Control Four-Country Survey (ITC-4). Nicotine Tob Res 10, 897-905, doi:10.1080/14622200802023841 (2008).
  7. Smith, T. T. et al. Whether to push or pull? Nicotine reduction and non-combusted alternatives – Two strategies for reducing smoking and improving public health. Prev Med 117, 8-14, doi:10.1016/j.ypmed.2018.03.021 (2018).

CONTACT: Fany Guo[email protected]

SOURCE Shenzhen JWEI Electronics Co., LTD.

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Author: joyce

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