Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistWolfe Trading Company LLC d/b/a East Coast Vapors manufactured and distributed e-liquid tobacco products without required premarket authorization as mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined the company's e-liquid products, which contain nicotine from any source, met the definition of tobacco products subject to FDA jurisdiction and compliance requirements under the Federal Food, Drug, and Cosmetic Act, but lacked the necessary premarket approval for legal marketing in the United States. The inspection and review identified that the company failed to obtain premarket authorization before offering these products for sale or distribution to customers.