A US district court granted the US Food and Drug Administration’s (FDA) request for an extension of the submission deadline for certain deemed tobacco product premarket review applications. FDA requested the extension citing the “extraordinary circumstances” of the Covid-19 outbreak for the delay. The new deadline for applications for premarket review for deemed e-cigarettes, cigars, and other new tobacco products is September 9.
Under FDA’s plan instituted in 2017, the deadline for marketing applications for non-combusted products such as electronic nicotine delivery systems (ENDS) or e-cigarettes was August 8, 2022. However, the same US district court that is now extending the deadline, shocked the industry last year by summarily moving up the established end date significantly to May 12, 2020.
This latest 120-day extension, which FDA requested was attributed to the result of the pandemic and exceptional and unforeseen circumstances. It gives manufacturers more time to prepare marketing applications for relevant products.
FDA requested the extension after receiving feedback from the tobacco industry in which stakeholders expressed concern over meeting the May 2020 deadline in light of Covid-19 related laboratory disruptions, facility closures, and travel restrictions.
FDA also noted that a number of Center for Tobacco Products (CTP) employees have been deployed to assist with Covid-19 efforts as part of the Public Health Service, and thus the agency has fewer personnel available than usual for premarket application review.