FDA WARNING_LETTER - BonZer BrandZ LLC d/b/a BonZer VapeZ, LLC - June 07, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Eric S. Lovins and Wendy A. Lovins regarding e-liquid products, including Cinnamon Sugar Cookie, Candy Cane, and Melon Ballz, sold on bonzervapez.com. The FDA determined these e-liquids are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. before February 15, 2007. The firm is manufacturing and offering these products for sale without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required marketing authorization and failure to provide necessary information under section 905(j). The letter emphasizes that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. The firm must submit a written response within 15 working days detailing corrective actions, including dates of discontinuance for violative activities and a plan for future compliance with the FD&C Act and its implementing regulations.