Hundreds of millions of dollars needed for medical vape to be approved

The Global Nicotine Forum 2023 (GFN23) was held at the Warsaw Marriott Hotel in Warsaw, Poland, under the theme “Reducing Tobacco Harm – The Next Decade. The forum attracted senior practitioners, scientists and academics from international tobacco companies, leading international universities, non-profit organizations and research institutions. As the official partner media of GFN23, Two Supremacy participated in and covered the forum’s important agenda.


Medical e-cigarettes are increasingly becoming the focus of public attention. However, there is a complex and convoluted regulatory process to bring this innovative product into the medical field. Mark Dickinson, founder of Clarityse Ltd, a pharmaceutical marketing consultancy, and Ian Fearon, a member of the scientific advisory board of Qnovia, a US venture-backed pharmaceutical company, and chief scientific officer of McKinney Regulatory Science Advisors, spoke to two to the top about developments in this field.


The costly and time-consuming investment

According to them, the path to obtaining a medical license is not only scientifically challenging, but also requires a huge financial commitment and a strong commitment to the “common good.

Mark emphasized that the transition from traditional cigarettes to medical nicotine products required a shift in thinking and an adjustment in operational processes. Building a new supply chain while maintaining strict safety and quality standards is a huge challenge. However, he also believes that these challenges can be overcome by following the rules and innovating.


In comparing the differences between the U.K. and the U.S. in terms of obtaining licenses for the medical e-cigarette market, Ian believes the U.S. regulatory requirements are more stringent.


“The FDA data requirements are the same as any other new drug and are quite demanding, and you have to do a lot of preclinical studies.”


Although both the FDA and the U.S. Surgeon General know that nicotine does not cause cancer, “manufacturers are still required to conduct two-year cancer studies, which are costly and time-consuming.”


Ian told us, “In the UK, animal testing is not required and desk-based risk assessments can be carried out and supported by laboratory toxicity testing. As a result, there is a huge difference in testing requirements, despite identical results.”


On the financial side, the cost outlay to meet the regulatory requirements can be quite high.


In the UK, only about £3-4 million is required over a two-year timeframe, while in the US, a huge investment of hundreds of millions of dollars is required, which could take up to a decade.


“You have to raise external funding from investors to do all this research,” says Ian. This difference plays a crucial role in determining the company’s strategy and market choices.


High investment isn’t the only daunting aspect of the whole process; time is another important factor. The constant evolution of e-cigarette technology has meant that regular consumer-grade e-cigarette products have iterated over the long approval process for medical products.


Input from International Tobacco Companies

Ian shared two examples of products that have received medical licenses in the UK.


“The first case is Voke, which is a product that was developed by a company called Kind Consumer, and then later received investment from British American Tobacco (BAT). So in essence, Voke was a British American Tobacco product that had a marketing license in the UK. But for some reason, it did not make it to the market, so it is not available in pharmacies and cannot be prescribed by doctors. Technically, Voke is not an e-cigarette; it’s a gas-driven inhaler, similar to the inhalers people use to treat asthma.”


“Around the same time, another product called Evoke received a medical license, but failed to enter the market purely because it was a disposable cigarette-like product. It is one of those classic products that has the same shape as a cigarette and has a brown part that resembles a cigarette filter. It does not release nicotine to the user very well. By the time the product finished the licensing process, it was obsolete, as the industry as a whole had shifted to hookahs (Tank) and modular systems (MOD).”


But Ian emphasizes that there is still opportunity here, and that the first company to successfully address these challenges may pave the way for others to do so. This achievement could simplify the process for future manufacturers, which could have a ripple effect in the industry.


They believe medical e-cigarettes could be sold at a higher price point, which for U.S. consumers