Ahead of his presentation at this year's ENDS conference we spoke to Richard Young, Principal Toxicologist and MD at bibra toxicology advices and consulting, to get his opinion on future significant industry opportunities, the biggest stumbling blocks at the moment and more.
Q1. You will be presenting on ‘Toxicological assessment of emissions from e-cigarette devices and e-liquids?’ this June, could you give us a sneak peek of what you will be sharing?
When assessing the safety of ENDS products to the consumer, one of the major challenges faced by the manufacturer is the toxicological risk assessment (safety evaluation) of the emissions from the device. There are a significant number of variables and uncertainties that must be considered, addressed and documented, and these occur at various stages throughout the assessment process including the:
- particular device and device parameters (e.g. power, temperature), analytical methods (e.g. GC-MS, LC-UV-MS) and reporting thresholds used by the analytical laboratory (AET, LO, LOQ) when identifying and quantifying the emissions,
- consumer exposure scenario used (e.g. number of puffs per day, duration/volume of each puff, and interval between the puffs), and the
- weight of evidence of the existing toxicity data and ultimately how the critical inhalation Health Criteria Values (HCVs) are chosen and/or derived.
My presentation will expand on some of these issues, offer some possible solutions, and include a couple of illustrative case studies (e.g. the assessment of certain low-molecular weight carbonyls).
Q2. What do you think are the most significant future opportunities in this industry over the next 12-24 months?
There are many and it remains a fast-paced and exciting sector to be involved in. In the UK in particular, the healthcare authoritative bodies (notably MHRA, NICE and PHE) are openly supportive of the possibilities that ENDS products offer in assisting smokers to reduce/quit their reliance on combustible tobacco products. It will be interesting to see how this develops. Indeed, the MHRA are keen to encourage e-cigarette manufacturers to consider the medical marketing application option for certain of their ENDS products and have produced guidance on how to achieve this (which is an abridged application compared to say a novel pharmaceutical). If companies decide to go this route, and can achieve a medical license for a ENDS smoking cessation aid, they will be able to access a wider audience of smokers including through the inclusion of harm reduction marketing claims on their products. In addition, with regulator/government support (at least in the UK), and with key industry players collaborating (e.g. via trade associations), there will be the opportunity to hopefully better publicise to current smokers that switching to ENDS is a lower risk alternative to traditional tobacco use (a message that sadly seems to not currently be getting through).
Q3. What do you see as the biggest stumbling blocks for the industry at the moment?
This is a sector which is in the spotlight, with important public health considerations, and with wide general public and media interest. Unfortunately for those companies with high quality and safety standards, it is very much the sector as a whole that is tarnished when things go wrong (notably media coverage of battery failures and the issues surrounding diacetyl and the so-called popcorn lung). Indeed certain companies and individuals will continue to find work-arounds of the regulatory framework, for which changes to the regulatory text are slow to materialise. Short-fills are considered by many as such a workaround. However, just because these products contain zero-nicotine and are therefore considered outside of the remit of the Tobacco Products Directive (TPD), they still must comply with the General Product Safety Regulations (GPSR) and therefore high quality and safety standards are needed for these products also. As such, the industry as a whole must try to improve quality and safety standards across the sector, regardless of the regulations (medicine, TPD notification or GPSR) under which they are governed. Industry should also consider (further) assisting the regulators and enforcement authorities in the identification of poor-quality products and company practices. If poor quality products are used by consumers there is a strong possibility that they will switch back to smoking (e.g. low efficacy) or that we will start to see human health case reports and epidemiology data incriminating low-quality ENDS products in certain (e.g. respiratory) diseases, and of course battery malfunctions. It’s important that the industry as a whole continues to take precautions to ensure that their products are not aimed at or particularly attractive to young people, as this is another area of contention and public/media interest.
Q4. Why do you feel it is important for people to attend ENDS 2018?
It’s important for key players in the sector to meet regularly to discuss new and emerging issues, how best to move the sector forward to improve standards of quality and safety, to work more closely together and build better relationships between all stakeholders (including industry manufacturers/suppliers, device engineers, consultant risk assessors, analytical experts, and regulators), to work together to turn the tide of mis-information and poor scientific reporting in the media to more accurately reflect the reduced harm benefits of these products.
Q5. What are you most looking forward to at ENDS 2018?
I attended ENDS 2017 and it was certainly the most impressive science-focused conference in this sector that I have been involved in – so I’m looking forward to more of the same!
Richard will be presenting as part of the 'Characterisation, Analytics and Testing - Best Practice Stewardship' session next month. Other speakers in the session include Tanvir Walele of Fontem Ventures, Scott Fletcher of Hall Analytical and Shaun Wedgewood of EL-Science.
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