Vape123 was warned for offering electronic nicotine delivery system (ENDS) products for sale on its website without obtaining required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that these products, containing nicotine from any source, qualify as tobacco products subject to FDA jurisdiction and must comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires new tobacco products to have marketing authorization before being legally sold in the United States. The company failed to demonstrate that its ENDS products were either grandfathered in (commercially marketed before February 15, 2007) or had obtained the necessary premarket approval for modified or new tobacco products marketed after that date.