Loading…
E-Vaped Co manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products met the definition of newly deemed tobacco products subject to FDA jurisdiction as of August 8, 2016, and required a marketing authorization order under section 910 of the Federal Food, Drug, and Cosmetic Act before commercial distribution. The inspection revealed that E-Vaped Co failed to comply with these premarket submission requirements for their e-liquid products offered for sale in the United States.