Q. Can you provide a summary of what your presentation will cover at the ENDS Conference in London?
This presentation will look at some of the challenges that the industry is facing within the US. It will cover the difference between the specific laws relating to HPHC testing but also at what guidance is currently available. I will also be discussing the criticality of putting the right team together to take companies through HPHC testing and a PMTA, with some pointers on selecting the correct partners.
Q. Why is this topic important at the moment?
The ENDS market within the US is not only significantly large, but also very fragmented. Although some companies have already started to act on the HPHC reporting deadline, the majority have only just begun drawing up plans. Within the US there is a significant degree of uncertainty as to how to comply with specific laws around HPHC testing. To interpret the laws, FDA do issue guidance documents, however guidance documents are often issued too close to the deadlines. Even when guidance documents are issued, they still need a degree of interpretation. Companies have to choose between acting now to avoid leaving it too late to get HPHC testing completed within the specified timeframe vs waiting for clearer guidance from FDA.
Q. What are the main challenges that the industry is facing and how do you think that this conference can address them?
Aside from the immediate need to act on the upcoming HPHC reporting deadline, I would say the key concern within the US is the FDA’s overall stance on vaping and the challenges associated with completing a successful PMTA. We are very lucky within the UK that the government have taken a pragmatic stance and public bodies such as PHE recognise the relative safety of ENDS, however this is certainly not the case in the US. With this event having presentations around scientific topics such as HPHC and Extractable/Leachable testing, toxicology and regulatory updates, this is an excellent opportunity for companies to gain a deeper understanding of what’s required to enter or remain on the US market.
Q. Why would you recommend the summit to colleagues? Why do you think it’s an important meeting?
I would absolutely recommend this event to others within the industry. Rather than an opportunity for companies to ‘sell their products and services’ the event focuses on sharing information regarding the scientific, regulatory and political landscape with the aim of advancing a ‘smoke free future’.