FDA WARNING_LETTER - Bogart Enterprises LLC d/b/a The Vapor Shop - June 03, 2021

The FDA issued a Warning Letter to The Vapor Shop, identifying that their e-liquid products, specifically "vapor Smooth Tobacco 6 e-liquid," are tobacco products subject to FDA jurisdiction. The inspection and review of submissions revealed that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the manufacturing, sale, and/or distribution of this e-liquid product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The Vapor Shop, a registered manufacturer with over 600 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales and distribution, and a plan for maintaining compliance.