FDA WARNING_LETTER - ARDT Sales, LLC d/b/a Zenith E-Juice - June 04, 2019

The FDA issued a Warning Letter to Arlind Rexha of Zenith E-Juice, identifying violations related to the sale and advertising of e-liquid and smokeless tobacco products on zenithejuice.com. The FDA determined that Orion on Ice e-liquid was misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person under 18 years of age, violating 21 C.F.R. § 1140.14(b). Additionally, the smokeless tobacco product, Zenith Chewing Tobacco Orion (Raspberry Lemonade), was found to be misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because the website failed to include required health warning label statements for smokeless tobacco products, as mandated by the Comprehensive Smokeless Tobacco Health Education Act of 1986. The letter requires immediate corrective actions, including discontinuing violative sales and advertising, and submitting a written response within 15 working days detailing compliance plans. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.