Ahead of her participation at ENDS US 2017, we reached out to Patricia Kovacevic of Nicopure Labs to discuss the impact of FDA Regulations on the ENDS and E-cigarette industry.
What do you consider to be the biggest challenge in achieving and maintaining regulatory compliance in the ENDS and E-Cigarette industry?
In the United States the biggest challenge is the cost of compliance, coupled with lack of clarity with respect to the product dossier that needs to be submitted for newly regulated products by 2022 – the Premarket Tobacco Product Application. To date there are over 2 million products on the market, and the estimate costs that each of those products would incur based on the PMTA Draft Guidance information would be in the millions or tens of millions of dollars. FDA clearly vastly underestimated the costs and failed to conduct a cost benefit analysis before adopting the Deeming Rule in 2016.
What innovations or new technologies are being developed within the ENDS industry to develop safer products for the end user?
At present, innovative new technologies may only be marketed to consumers outside of the United States, since the Deeming Rule put a halt to innovation in the US as of August 8, 2016. This is possibly the most harmful consequence to public health that FDA will certainly have to reconsider, as safety and continuous improvements should be FDA’s foremost concerns.
From your perspective, how does the FDA’s new comprehensive regulatory plan for tobacco and nicotine regulation impact the ENDS industry?
The regulatory plan per se was only announced, but its elements are yet to be developed and communicated by the FDA. The only benefit of the July 28 announcement to the ENDS industry was a postponement of the deadline for submitting the PMTAs, from 2018 to 2022. We are hopeful that either a legislative change or a meaningful change of course at the FDA will allow the industry to remain diverse and innovative, when the elements of the announced comprehensive plan are actually communicated.
What are you most looking forward to at ENDS US 2017?
Hearing the inspiring presenters and engaging with the very diverse and sophisticated audience the conference is bound to attract.