On October 12, 2021, the U.S. Food and Drug Administration (“FDA”) issued orders granting R.J. Reynolds (RJR) Vapor Company approval to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo ENDS e-cigarette and accompanying tobacco-flavored pods. In issuing the orders, FDA found “that the marketing of these products is appropriate for the protection of public health.” However, FDA also stated that its orders do not mean “these products are safe or ‘FDA approved.’” See FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency | FDA.
Although ENDS products, such as e-cigarettes, have been on the market since the mid-2000s, this is the first time FDA has authorized the marketing of specific ENDS products through the Premarket Tobacco Product Application pathway.