FDA WARNING_LETTER - Jayde's Vapor Lounge - December 09, 2021

The FDA issued a Warning Letter to Jayde’s Vapor Lounge, owned by Jayde Tran, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that Jayde’s Vapor Lounge Green Apple 6MG 60ML e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because required notice or information was not provided per section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The firm is a registered manufacturer with over 12,700 listed products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and/or injunction. The letter requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for maintaining compliance.