In a First, FDA Allows Marketing of Three New ENDS E-Cigarette Products

The FDA authorized the marketing of three new tobacco products, the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the FDA through the Premarket Tobacco Product Application pathway.

The FDA issued marketing granted orders to RJ Reynolds (RJR) Vapor Company for Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically:

  • Vuse Solo Power Unit
  • Vuse Replacement Cartridge Original 4.8% G1
  • Vuse Replacement Cartridge Original 4.8% G2

The FDA noted that the manufacturer’s data demonstrate its tobacco-flavored products could benefit addicted adult smokers who switch to these products, either completely or with a significant reduction in cigarette consumption, by reducing their exposure to harmful chemicals.

The FDA’s authorization imposes strict marketing restrictions on RJR, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products.

The FDA also issued 10 marketing denial orders for flavored ENDS products submitted under the Vuse Solo brand.