Rave Salon Inc. d/b/a Joosie Vapes – FDA Warning Letter, Jul 16, 2021

The FDA issued a Warning Letter to Rave Salon Inc. d/b/a Joosie Vapes after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA regulation since August 8, 2016. The letter states that the firm is manufacturing and distributing RUSTY RAIL Vapor Co. RASPBERRY 3MG/ML 30ML e-liquid without the required premarket marketing authorization order, as it is considered a "new tobacco product" not commercially marketed before February 15, 2007. Consequently, this product is 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 under section 905(j). The manufacturing and distribution of such products constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. Rave Salon Inc. is a registered manufacturer with over 1,300 listed products and is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including dates of discontinued sales/distribution, and a plan for future compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction.