FDA WARNING_LETTER - Liquid Vapor Lounge, LLC - December 17, 2021

The FDA issued a Warning Letter to Liquid Vapor Lounge, LLC, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that the company's "Liquid Vapor Lounge Honey Suckle 6mg 30ml e-liquid 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 sale and distribution of this new tobacco product without the required premarket authorization order from the FDA, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the lack of required notice or information under section 905(j). Prohibited acts include selling adulterated/misbranded products (section 301(k)) and failing to provide required reports (section 301(p)).

The FDA noted that Liquid Vapor Lounge is a registered manufacturer with over 9,300 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 actions taken to address violations,