District Vape Supply, LLC d/b/a VapeMasterz – FDA Warning Letter, Dec 13, 2023

The FDA Center for Tobacco Products reviewed vapemasterz.com and found that Electronic Nicotine Delivery System (ENDS) products were offered for sale to U.S. customers. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include nicotine from any source.

The FDA identified two specific ENDS products, EBDesign Lost Mary OS5000 Luster Disposable – Raspberry Lemonade and EBDesign TE6000 Disposable – Juicy Peach, as "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter also notes that imported products appearing adulterated or misbranded may be detained or refused admission.