FDA WARNING_LETTER - iSmoke, LLC d/b/a iSmoke Vapor Gallery - September 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to iSmoke, LLC d/b/a iSmoke Vapor Gallery for manufacturing and distributing e-liquid products, specifically "iSmoke Vapor Gallery Snozberries 6mg 30ml e-liquid product," without the required premarket marketing authorization. This product is classified as a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA authorization or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA emphasizes the firm's responsibility, as a registered manufacturer with over 300 listed products, to ensure compliance. iSmoke must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for maintaining compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.