Loading…
Kloc Vapor, LLC d/b/a The Vapor Edge, a manufacturer and distributor of e-liquid tobacco products, was cited for failing to obtain premarket authorization for "new tobacco products" as required under the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, deemed tobacco products effective August 8, 2016, were being manufactured and offered for sale in the United States without the legally mandated premarket approval. The FDA determined that these electronic nicotine delivery system products fell under federal tobacco regulation and were in violation of sections 201(rr) and 901(b) of the FD&C Act and applicable regulations at 21 C.F.R. § 1100.1.