The US Food and Drug Administration (FDA) has published final guidance regarding Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS), detailing how they intend to prioritize...
The Flavours Conundrum
Dec 11, 2018 | Published by Andrew Mooney
Hot on the heels of the Next Generation Nicotine event in London, the ENDS US conference took place on the 5th through the 7th of December in Alexandria, Virginia. The theme of the event was on the current state of the ENDS US regulatory framework discussing flavors, youth initiation and clarifying recent FDA announcements.
World renowned toxicology specialists Cardno Chemrisk set the scene for the next two days with their pre-event workshop on product stewardship. In some respects, ahead of where industry currently sits, Amy and her team explained how product stewardship goes beyond regulations, covering activities that manufacturers should undertake during the whole lifetime of their products. The workshop culminated with a case study based on the tire industry which has surprising similarities to ENDS and could offer insights into the future direction of the ENDS industry. Crystal B Wersching from Altria gave a complementary presentation on how to control your supply chain.
The hot topic of flavors dominated day 1 of the event. It seems that the role they play in the ‘youth initiation vs helping adults quit’ debate is no nearer to reaching a conclusion with the FDA, the vape industry and those opposed to vaping unable to reach consensus. Following an ANPRM from the FDA and the submission of over 500k comments, we remain no nearer to reaching conclusion on whether flavors are a help or a hindrance to the FDA stated objective that these products must demonstrate that they protect public health for the population as a whole. It was, however, encouraging to note that a significant number of FDA employees were in the audience and hence hearing the powerful data backed flavor arguments from the ENDS industry.
With Premarket Tobacco Product Applications (PMTA) and Harmful and Potentially Harmful Constituents (HPHC) deadlines fast approaching, there were many presentations explaining the requirements for each data package required to meet the regulations. The first deadline, to submit quantities of HPHC’s by November 8, 2019, is now in sight with testing laboratories such as Broughton in demand and currently signing up clients. Choosing a laboratory that can help manufacturers determine the optimum product analysis strategy is a great way to ensure cost is kept under control.
In a change of regulatory pathway direction, Ian Fearon from Juul gave an excellent presentation on the UK medicinal product pathway, its benefits and the UK market drivers. Ian suggested benefits include giving medical professionals products that can be prescribed as cessation tools, reducing cost for low income smokers who want to use ENDS to quit and giving the opportunity to make health claims to improve public perception of ENDS products. It is also interesting to note that this is a lucrative industry with a current annual value of £140m.
Day 2 started with a number of startling revelations from Chris Russell of the Centre for Substance Use Research in Glasgow. Data, data, data was a recurring theme – "If you don’t have the data, it did not happen" is an often-cited statement in terms of regulatory submissions. As an expert in the field of behavioural studies, Chris shared with the audience results from a study his team ran for Juul. Referring back to the flavour debate, it was fascinating to see data backed evidence suggesting that certain flavors (mango and mint) have a greater impact on cessation rates. Could we be heading to the next stage of the debate where instead of banning all flavours, the FDA accept a restricted list of flavors? Time will tell.
Discussion moved on to innovation and the emergence of the CBD market. There is much confusion regarding the legality of such products and Keller and Heckman giving their assessment of the current situation. The announcement that Altria have invested $2.4bn in Cronos, the Canadian cannabis manufacturer, suggests that the CBD market could be the next to emerge in the next generation product space.
One thing is for sure – the ENDS industry is evolving fast and those that get it right commercially and from a regulatory perspective will be stewards of extremely successful businesses.