Investigating Vaping Safety

for Human Use and Consumption

Introduction

We are not salesmen, we are a group of credible qualified scientists who are establishing links with University and Hospital research functions to deliver to consumers and governments worldwide an awareness of vape safety, above and beyond what was required for regulation, making vape 99% safer than smoking.

95% is not statistically significant….

Since its regulation in 2017 by the EU commission, the vaping industry has experienced unprecedented growth and widespread adoption as a promising alternative to traditional smoking. The regulations released by the commission sought to establish safety standards for e-liquids and devices, aiming to ensure that vaping did not replicate the harmful levels of carcinogenic gases found in cigarettes. While these regulations were a crucial step towards consumer protection, the rapidly evolving landscape of vaping requires a more comprehensive examination of its safety.

In recent years, the vaping industry has faced increasing scrutiny from the public and governments, highlighting the need for thorough research to address the existing gaps in regulations. Public perception has shifted, prompting a demand for more transparent data on vaping safety to make informed choices. As responsible researchers, we acknowledge the urgency to bridge these knowledge gaps and explore vaping safety beyond the regulatory requirements.

Our research proposal endeavours to undertake a groundbreaking investigation into vaping safety for human use and consumption. We are committed to going above and beyond the existing regulations to provide evidence-based insights into the relative safety of vaping compared to smoking. Our approach encompasses three crucial areas: flavour toxicology on inhalation, new carrier technology, and clinical trials on dose response. Through rigorous scientific exploration, we aim to lay the foundation for a safer and healthier vaping industry.

The Urgency for Research: As vaping rapidly gains popularity, our responsibility to ensure consumer safety grows in tandem. While vaping may be a less harmful alternative to smoking, it is imperative to explore its long-term effects fully. By undertaking comprehensive research, we can furnish regulators with data that will enable them to make well-informed decisions, striking a balance between consumer freedom and health protection.

The Vision for Safer Vaping: Our vision is to contribute to the creation of a safer vaping landscape that inspires confidence in consumers, regulatory bodies, and the industry. We firmly believe that scientific evidence should be the cornerstone of industry practices and public policy. With a team of dedicated scientists, including one visionary who discontinued animal testing on vape products as early as 2013, we are committed to driving a paradigm shift in vaping safety research.

The Three Pillars of Research:

Flavour Toxicology on Inhalation: Through an exhaustive examination of inhaled flavours, we will surpass existing data limited to ingestion. By studying flavour compounds’ potential health risks when inhaled, we can identify and mitigate any adverse effects associated with flavouring agents, thereby promoting safer flavour profiles.
New Carrier Technology: Traditional carriers such as propylene glycol (PG) and vegetable glycerine (VG) have inherent limitations, and we are determined to explore alternative carriers with improved safety profiles. By assessing the biocompatibility of new carriers and their potential impact on vital organs, we will contribute to the development of safer vaping products.
Clinical Trials and Dose Response: Our comprehensive clinical trials, including longitudinal studies, will provide a holistic evaluation of vaping’s impact on human health. By comparing the dose response of vaping to smoking, we aim to furnish the industry with conclusive evidence on vaping’s safety and its potential to be a significantly safer alternative.

The Impetus for Industry Involvement: Your esteemed company’s support and involvement in this transformative research are pivotal. By joining us, you have the opportunity to be at the forefront of pioneering research that will redefine the vaping industry. Not only will your participation contribute to the betterment of public health, but you will also be recognized as a responsible industry leader, dedicated to consumer safety and promoting the highest standards in the vaping sector.

At the core of our initiative is the firm belief that scientific evidence should drive policymaking, consumer choices, and industry practices. By conducting thorough investigations into the safety of vaping, we seek to provide stakeholders with robust data that can lead to informed decisions. Through a multidisciplinary approach, we will explore three critical areas: flavour toxicology on inhalation, new carrier technology, and clinical trials on dose response. These interconnected research areas will shed light on the potential risks and benefits of vaping, paving the way for safer and more informed vaping practices.

Objectives

To comprehensively assess the toxicological impact of inhaled flavours, expanding beyond existing data limited to ingestion, and identifying potential risks associated with flavour compounds used in e-liquids. By understanding the effects of inhaling flavours, we can guide the development of safer flavour profiles and minimize potential health risks associated with vaping.
To explore and develop new carrier technology that reduces the accumulation of harmful compounds in the liver and kidneys, addressing the limitations of traditional propylene glycol (PG) and vegetable glycerine (VG). By investigating alternative carriers, we aim to mitigate potential long-term health effects and improve the overall safety profile of vaping products.
To conduct extensive clinical trials to determine the dose response of vaping and evaluate any potential adverse health effects compared to smoking. These trials will offer insights into the long-term health impact of vaping, enabling a comprehensive assessment of its safety relative to traditional smoking.

Methodology

1. Flavour Toxicology on Inhalation

Literature Review: We will conduct a far greater in-depth review of existing studies related to flavour toxicology on inhalation to identify knowledge gaps and build upon previous research findings. This review will serve as a foundation for our investigations.
In Vitro Testing: Utilizing advanced laboratory techniques, we will assess the impact of different flavour compounds on human lung cells, respiratory tissues, and other relevant biological systems. By simulating inhalation scenarios, we can identify potential cellular responses and toxicity levels.
In Vivo Studies: We will conduct living studies, with a focus on lung function, inflammation, and overall health, to gain insights into the effects of inhaling various flavours. This step will help establish correlations between animal models and potential health outcomes in humans.
Human Trials: To provide human-centric data, we will administer controlled vaping sessions to human participants using different flavours. By monitoring short-term and long-term health effects, we can determine any potential risks associated with flavour inhalation.

2. New Carrier Technology

Investigate Alternative Carriers: We will explore and test novel carrier compounds that do not exhibit the harmful osmotic properties found in PG/VG, aiming to minimize potential health risks associated with vaping. Identifying safer carriers will be pivotal in promoting responsible vaping practices.
Cellular and Tissue Studies: Assessing the biocompatibility of new carrier technologies with human cells and tissues, we will evaluate any inflammatory responses or cytotoxicity. These studies will be instrumental in determining the suitability of new carriers for vaping products.
Living Studies: Conducting controlled animal experiments, we will evaluate the safety and metabolism of these new carriers in living organisms. By focusing on organ toxicity and accumulation, we can ensure the carriers’ safety for human use.
Formulation Development: We will develop e-liquids with the new carriers, incorporating different flavours, and test their stability, usability, and safety in vaping devices. Creating safe and effective e-liquids will be crucial in advancing the vaping industry.

3. Clinical Trials and Dose Response

Participant Recruitment: To ensure a diverse study population, we will select both vapers and smokers to participate in clinical trials. This approach will enable a comprehensive evaluation of the health effects of vaping and smoking.
Monitoring and Data Collection: Implementing rigorous data collection methods, we will monitor participants’ vaping habits, smoking behaviours, and health parameters, such as respiratory function and cardiovascular health. These data will contribute to evidence-based conclusions.
Longitudinal Study: By conducting long-term follow-ups, we will assess the cumulative effects of vaping and smoking on participants’ health. This extended study will provide valuable insights into potential long-term safety concerns.
Meta-Analysis: Analysing the data obtained from clinical trials, we will compare the safety levels of vaping and smoking, enabling an accurate determination of whether vaping is 99% safer. A robust meta-analysis will be pivotal in drawing conclusive findings.

Budget Allocation

Flavour Toxicology on Inhalation – £25 million
New Carrier Technology – £40 million
Clinical Trials and Dose Response – £55 million

Impact and Benefits

The successful completion of this research will have far-reaching benefits for public health, regulatory bodies, and the vaping industry. The findings will empower policymakers to make informed decisions based on solid scientific evidence, leading to the formulation of more effective regulations. Additionally, companies participating in this research will not only be eligible to claim the donated amounts back through the UK R&D Tax Relief scheme but will also be recognized as pioneers in promoting consumer safety and responsible vaping practices.

Conclusion

Our research proposal sets the stage for an ambitious and impactful investigation into vaping safety for human use and consumption. The vaping industry’s exponential growth since its regulation in 2017 has sparked significant interest in its potential as a safer alternative to traditional smoking. However, lingering concerns about its long-term safety have driven us to take up this crucial research initiative.

Through our multidisciplinary approach, we aim to provide comprehensive and robust scientific evidence on the safety of vaping, going beyond the limitations of existing regulations. By delving into flavour toxicology on inhalation, developing new carrier technologies, and conducting extensive clinical trials, we will unravel the intricacies of vaping safety. Our vision is to empower consumers, regulators, and industry stakeholders with data-driven insights that will shape responsible vaping practices, regulatory policies, and product development.

With your valued company’s support, we will drive meaningful change and pave the way for a safer, healthier future. Your participation in this transformative research endeavour not only demonstrates your commitment to consumer safety but also positions your company as a trailblazer in advancing the vaping industry responsibly. As a token of our appreciation for your partnership, your company will be eligible to claim the donated amounts back through the UK R&D Tax Relief scheme, maximising the return on your investment in promoting the safest vaping practices.

In the spirit of innovation and dedication to public health, we extend a warm invitation to your esteemed company to join us on this transformative journey. Together, we will redefine the future of vaping, fostering a healthier and safer world for all.

We eagerly await the opportunity to discuss this research proposal further and sincerely hope to have your valued company’s invaluable support.