The agency’s announcement in July—while more philosophical than concrete—issued a definitive regulatory change with the extension of the product application deadlines for newly deemed products.
Under the original deeming rule, manufacturers had until May 8, 2018, to submit a substantial equivalence (SE) application and until Nov. 8, 2018, to submit a premarket tobacco application (PMTA); under the revised timelines announced in July, those deadlines were moved back to Aug. 8, 2021, for combustible product applications and Aug. 8, 2022, for noncombustible products.
It was a clear win for electronic nicotine delivery systems (ENDS): Beyond recognition from the FDA that these products potentially offer a lower-risk alternative, the extension also allows time for the industry to continue to invest in product development.
“The vape category now has a five-year grace period,” said Don Burke, senior vice president of Pittsburgh-based Management Science Associates Inc. “You’ll continue to see it innovate and grow.”