Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistKing Distribution LLC d/b/a Lava Vape USA was cited for offering electronic nicotine delivery system (ENDS) products for sale without required FDA premarket authorization. The company's products, listed on lavapods.com, were determined to be tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, as they contain nicotine from any source and are intended for human consumption. The FDA found the products to be marketed without the legally required premarket authorization order, rendering them both unapproved new tobacco products and in violation of compliance requirements under the Federal Food, Drug, and Cosmetic Act.