FDA WARNING_LETTER - Vaporwave LLC - May 13, 2022

The FDA issued a Warning Letter to Vaporwave LLC for unlawfully manufacturing and distributing "Vaporwave The Mona Lisa e-liquid products" without the required premarket authorization. These e-liquid products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation. The FDA determined these are "new tobacco products" because they were not commercially marketed before February 15, 2007, and lack a marketing authorization order under section 910(c)(1)(A)(i) or an exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the failure to provide required notice under section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and the failure to provide a required report under section 905(j) is a prohibited act under section 301(p). Vaporwave LLC must submit a written response within 15 working days detailing actions to address these violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may lead to regulatory actions such as civil money penalties, seizure, or injunction.