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Fantasia Distribution Inc. was warned for manufacturing and distributing electronic nicotine delivery systems (ENDS) products without required premarket authorization. The FDA determined that the company's ENDS products listed on its website were subject to FDA jurisdiction as deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act, but lacked the legally required marketing authorization order for new tobacco products. The company failed to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which mandates premarket approval before ENDS products can be legally marketed in the United States.