Loading…
happyones.us was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without required FDA premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing tobacco products, including those containing nicotine from any source following the March 2022 legislation that expanded FDA jurisdiction. As "new tobacco products" not commercially marketed before February 15, 2007, the ENDS products required marketing authorization orders before being legally sold in the United States.