See below for the programme for ENDS 2017
Charles Hamshaw-Thomas | Head of Corporate and Legal Affairs – Europe and Board Member at UK Vaping Industry Association (UKVIA) of Nicopure Labs
Beryl Keeley | E-Cigarette Notification Scheme Lead of Medicines and Healthcare products Regulatory Agency (MHRA)
Dr. Dilip Bhuva | Chief Science and Compliance Officer of Xyfil
Tom Pruen | Chief Scientific Officer of Electronic Cigarette Industry Trade Association
Nele Zgavc | Programme Manager, Governance & Resilience - Healthcare of British Standards Institute (BSI)
Charles Ducker, Principal Chemist/Group Leader, Eurofins Medical Device Testing
Patricia Kovacevic, General Counsel and Chief Compliance Officer, Nicopure Labs
Tom Pruen, Chief Scientific Officer, Electronic Cigarette Industry Trade Association (ECITA)
Gregory Brown, General Counsel, Space Jam Juice
James Murphy, British American Tabaco (BAT)
David Dawit | Chief Scientific Officer of Eos Scientific
The electronic cigarette industry being new and rapidly evolving, analytical methods required for both quality control and regulatory submission tests are mostly in- house developed. The products were unregulated in Europe until very recently. The EU Directive commonly known as the Tobacco Product Directive (TPD II) was passed in 2014. Article 20 of this regulation requires electronic cigarettes product manufacturers to submit safety assessment test results and this came into force in May 2016 with a 6-month grace period. However, requirements for analytical methods to be used for identifying and quantifying substances of interest with regard to the new regulation were not included. This led to different interpretation of what to test for and what methods to use. The Medicines & Healthcare products Regulatory Agency (MHRA) guidelines and subsequently, the MHRA submission portal itself were useful indicators of the substances of interest to test for but lack of standard methods, validation acceptance criteria including detection limits are still not yet clear.
A good example signifying the need for standard methods and limits, is the huge controversy regarding diketones (Diacetyl, Acetyl Propionyl). Some producers claimed their products to be diketone free whereas at close investigation the method detection limits were as high as 0.1% (1000 ppm) making the claims inaccurate and perhaps dangerous. Another problem was what parameters to use for emission testing. It also meant with different devices and different settings of wattage, make of material average number of puffs per day for different strengths of nicotine, it was impossible to set parameters that can be used as a standard testing procedure. The additional problem of the sheer number of flavours, variation in Propylene Glycol, Vegetable Glycerin (PG_VG) ratio exacerbated the problem. The available literature is very limited and some were very specific to be used as a point of reference. As regulations in the UK and worldwide continue to evolve, the industry is looking to advanced instrumentation and analytical testing to comply with new quality standards. There are a few standards that are being studied and in some cases used as a reference by different analytical labs, for example the French standards (AFNOR), however, we feel industry-wide consultation and collaboration with guidance from the regulator is the only way forward.
It is understandable that setting safe limits for substances of concern may not be possible in the near future due to the relatively short period of the existence of electronic cigarette products. There is limited research, and the long term effects of constituents of e-liquid can only be understood clearly with time. Nevertheless, for some substances of concern such as metals, permissible exposure limits of the inhalation pathway set for drugs can be adopted in one way or another after consultation with all stakeholders. This will indirectly help set the methods and acceptance criteria for the analytical process.
Derek Mariner | CORESTA E-Vapour Subgroup of CORESTA
Ian Fearon | Principal Scientist and Head of Clinical Research of British American Tobacco
Willie McKinney | Vice President Regulatory Sciences of Altria Client Services (ALCS)
Panellists: To be announced!
Scott Fletcher | Director of Analytical Services of Hall Analytical
Richard Young, Principal Toxicologist and Pete Watts, Director of Toxicology, Bibra toxicology advice and consulting
Matthew Bland | Business Development Director of Eliquid Solutions
Glenn Myatt | Chief Scientific Officer of Leadscope
David McLaughlin | Director, Business Development of Elucid8
Jo Davis | Copy Advice Executive of Committee of Advertising Practice (CAP)
Daniel Merrill | Study Director of Eurofins Medical Device Testing
Dr. Daniel Norwood | Executive Partner of SCIO Analytical