Such Vapor, LLC – FDA Warning Letter, Jun 16, 2020

This FDA Warning Letter, dated May 22, 2020, addresses SuchVapor regarding e-liquid tobacco products advertised and sold on their website, https://suchvapor.com. The Center for Tobacco Products determined these products are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction. The primary violation identified is that the advertising for several e-liquid products, including SuchVapor Old Captain, Desert Ship, Cream, and Mango, fails to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). This omission renders the e-liquid products misbranded under two sections of the FD&C Act: section 903(a)(7)(B) for violating regulations prescribed under section 906(d) (specifically 21 C.F.R. Part 1143), and section 903(a)(7)(A) because the advertising is considered false or misleading by failing to reveal material facts about product consequences (section 201(n)). SuchVapor is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates of discontinuance of violative advertising/sales, and a plan for future compliance. Failure to comply may result in severe FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction, with imported products also subject to detention.