Loading…
VapeOtine was warned for offering electronic nicotine delivery system (ENDS) products for sale through its website without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that VapeOtine's products qualified as tobacco products subject to FDA jurisdiction because they contained nicotine from any source, and therefore required compliance with premarket review requirements under section 910 of the FD&C Act. The company's products were being marketed without the legally required "new tobacco product" authorization orders that must be in effect before commercial distribution in the United States.