The last 18 months have again seen momentous change in the US tobacco control and legal and regulatory landscape. The tragic EVALI outbreak, which in the minds of many still appears to have been related to nicotine-containing e-cigarettes triggered a wave of hostile government action and tobacco control activism directed at the e-cigarette industry. The EVALI crisis developed concurrently with the release of the 2019 NYTS data, which reflected another dramatic rise in past 30-day e-cigarette use by both high school and middle school youth. Both events appeared to play a role in the former president Trump September 2019 announcement of a decision to remove all flavored e-cigarette products from the marketplace. Though that announcement was partially moderated in FDA’s early 2020 guidance that directed the removal of flavored “cartridge based” products only, there is increased uncertainty around the future of flavored e-cigarettes in the U.S. Now, all U.S. e-cigarette products have been required to enter the premarket tobacco product application (PMTA) process with the FDA – a process that could lead to the removal from the market of a significant number of current products, while potentially answering critical questions regarding product safety and the role of flavors for those products that are able to successfully obtain a PMTA.

As we look ahead to the next 12 months, it remains to be seen how the long-awaited PMTA deadline will impact the potential of tobacco harm reduction (THR). Critical questions include whether FDA product review will provide a measure of stability of this brand new category and whether it will improve the tenor of the U.S. tobacco control conversation. This year’s E-Cigarette Summit USA comes on the eve of a historical transition for the US e-cigarette industry and under the shadow of the Covid pandemic – where socio economic health disparities have been bought in to sharp focus.  As always, the Summit looks to provide an evidence based environment that encourages open and respectful dialogue on the key science and current public health topics, with a single aim of reducing smoking related death and disease.