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

The FDA issued a Warning Letter to Jayde’s Vapor Lounge on December 9, 2021, for manufacturing and distributing e-liquid products without required premarket authorization. The FDA determined that Jayde’s Vapor Lounge Banana 6mg 30ml e-liquid is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

Under sections 910(a) and 910(c)(1)(A)(i) of the FD&C Act, new tobacco products require a marketing authorization order or an exemption. Jayde’s Vapor Lounge's product lacks this authorization, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

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