Juul filed its highly anticipated FDA applications late last month seeking the regulator’s permission to keep selling its device, as well as Virginia tobacco and menthol-flavored pods with 3% and 5% concentrations in the U.S. The agency will now review Juul’s submission to determine whether the products are appropriate for the protection of public health.
The company will “look forward to this next step as the FDA commences substantive review of the application,” Juul’s Chief Regulatory Officer Joe Murillo said in a statement.
Juul on Tuesday also announced it had promoted Bob Robbins to lead its global commercial organization upon the exit of Jared Fix, who had been serving as the e-cigarette maker’s chief commercial officer. It was the latest executive shuffle for the company as it retrenches amid intense public scrutiny, shrinking sales and the crucial regulatory review.
E-cigarette makers must submit applications to the FDA by Sept. 9. The review process could reshape the U.S. market.