Smoking is one of the most efficient and effective methods of delivering a drug to the lungs; which is one of the reasons smoking provides such efficient and quick drug delivery is the way that the...
Tar Wars - Episode 1
May 10, 2017 | Published by Andrew Mooney
A fascinating debate and discussion were order of the day once again at the latest E-Cig Summit. After the success of the UK events this was the inaugural US event held at the Marriott in Georgetown Washington.
Debate on the appropriateness of ENDS products with respect to delivering tobacco smoking cessation and harm reduction in the US is at near fever pitch levels. The two sides are split on the need for the FDA PMTA regulations, with the anti ENDS camp citing that the PMTA is required to prove that they deliver improved public health and the pro camp citing that all they will do is lead to 99% of products exiting the market.
The event started by evaluating the mass of current research data. An interesting contrast in the US to the approach being taken in the UK is the focus in the likelihood of youth vapers becoming addicted to nicotine (initiation). As Professor Ann McNeil from Kings College London commented, it is not that we don’t care for our children in the UK, however let’s consider the ‘bigger picture’ ie. the balance of quit rate vs youth initiation. This was backed up by Professor Kenneth E Warner from the University of Michigan who presented a study (currently underway) that predicts ENDS products could deliver a net saving of 1.25m life years in the US by 2050. Furthermore, 3m E-Cig users in the UK have stopped smoking tobacco. Pretty compelling evidence that the ‘bigger picture’ is good for public health!
The Summit then moved to the topic of tobacco control, industry and regulation. With continued uncertainty in industry and the recent announcement by the FDA that enforcement deadlines have been put back by 3 months, this section was eagerly anticipated by the audience.
FDA Defers enforcement of all future PMTA compliance dealines
The audience seemed in consensus that FDA regulations (PMTA) should be designed to deliver information on what is in a product (testing and characterisation), what is known about its effect on the population (research), the effect it has on consumers’ actions. The fundamental objective is to demonstrate that ENDS will lead to change for the protection of public health. Where there is no consensus is the level of detail and associated cost of a submission. David Graham (President and Managing Partner at Reveritas Group) gave an excellent presentation on addressing the challenges of ENDS regulation and covered the hot topic of bridging. The message is clear – ensure you undertake a detailed PMTA planning phase to optimise the process with respect to cost and effectiveness. Building your case, via clever design of experiment and statistical analysis, could lead to consolidated SKU testing opportunities. Broughton offers this service via its Analytical and Scientific services – the all-important Planning phase to deliver an effective testing strategy.
Next topic on the agenda was the Cole Bishop amendment. Deborah Arnott (Chief Executive of Action on Smoking – ASH) made the point that Grandfathering all current ENDS products, meaning that only ‘new to market’ products would require PMTA, would stifle innovation. She went on to suggest that Vaping devices have not yet been optimised for nicotine delivery which is leading to some smokers abandoning vaping and returning to tobacco as they cannot get the same pleasure from vaping – surely this needs to be addressed by further product development. She also covered the critical point that testing of these products is a pre-requisite to guarantee product quality and safety.
After a riveting day, with emotions running high (no need for lightsabers though – you had to be there to get that one!), the conclusion that I reached was that ENDS are good for public health and some level of regulation is a good thing for this industry and public health. As Eric N Lindblom stated in his presentation, effective regulation will:
- Ensure product safety
- Facilitate accurate product information
- Minimise harm (to users and the wider population)
- Ensure efficacy (confirm they do what they are designed to do ie. help people quit smoking).
So, let’s get on with it, finalise the regulatory pathway and start saving lives.
Broughton is an FDA inspected Analytical services laboratory that has been testing Nicotine containing products since 2007. Download our PMTA services datasheet to see how we can help with your PMTA.