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 2
Jul 26, 2017 | Published by Andrew Mooney
With confusion and uncertainty on all sides surrounding the FDA regulations, the ENDS industry came together once again for the Vape and the FDA conference in Washington last week.
The subtitle of the event was ‘Surviving and thriving in a new regime for vapor’ and the content on Day 1 covered two key areas coming from opposite sides of the argument. On the one hand the industry still has a strong appetite to fight the regulations and the event explained how working together via organisations such as the Vapor Technology Association (VTA) they could communicate this message effectively to US lawmakers. On the other there is a sense of realism that regulation is coming and PMTA preparation is required. Patricia Kovacevic, General Counsel at Nicopure Labs & David Graham from Reveritas Group gave concise presentations on the practicalities of a PMTA submission.
Day 2 of the event saw lobbying meetings on Capitol Hill with regional congressmen. I joined the California delegation and was impressed by their compassionate stories explaining how they entered the industry, often based on challenging personal experiences. It was reassuring to hear how these companies want to do the right thing and are not averse to industry regulation. What they are looking for is further clarity on what is required to comply and understanding that as it stands the associated cost to achieve compliance is prohibitive. They are therefore seeking a two-year delay in the current regulatory timelines.
With up to 7 legal cases to be heard challenging the FDA guidance as it stands, the industry was hit by the news on Friday that the first case brought by Nicopure Labs and the Right to be Smokefree coalition has been dismissed. The legal fight will go on and we can only hope that, whatever the outcome, the industry has the chance to survive in the US and save lives. Prominent scientific studies from the UK have shown that ENDS products are up to 95% safer than smoking tobacco.
As time draws ever closer to the (current) November 8th 2018 deadline for PMTA submissions, the industry is yearning for certainty to facilitate the correct business decisions. What we all now need is information in the coming weeks that provides that certainty to allow the industry to move forwards and the regulatory and analytical service industry to deliver what is required. There really is no time to lose.
At Broughton we have been supporting the ENDS industry since 2010. We are currently signing up US companies for PMTA projects and our analytical strategy is designed to optimise the likelihood of PMTA success while keeping costs under control.