The Food and Drug Administration (FDA) said it would substantially extend deadlines imposed by the 2016 deeming rule on newly regulated combustible and non-combustible products as it reassesses its approach to tobacco regulation.

Makers of vaping devices and e-liquids will have until 8 August 2022 to submit applications to FDA for approval to continue marketing their products. Cigars, pipe and hookah tobacco were given an extension until 8 August 2021. In particular the vaping industry had complained that looming FDA deadlines and their associated costs would devastate the sector.
“This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive,” FDA said. “For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.”
FDA’s latest extensions followed three-month delays on imposing a variety of deadlines including submission of substantial equivalency and pre-market applications. Until the latest delay, most of them fell in 2018. FDA said it would issue additional rules to streamline the application process.
What in essence amounts to shifting the 2016 deeming rule into ‘park’ for several years would allow FDA time to formulate what it called a reassessment of its tobacco regulatory goals. The agency said it would shift its focus to the addictive qualities of nicotine and promised measures such as limiting nicotine content in cigarettes (see separate story). “The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes,” the agency said.