FDA WARNING_LETTER - Smoke Tokes, LLC - February 18, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Raheel Lakhany after reviewing the website smoketokes.com, which advertises and sells e-liquid products. FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and fall under FDA jurisdiction per section 901(b) and 21 C.F.R. § 1100.2. The primary violation identified is that several e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act. This misbranding occurs because their advertising 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). The firm is responsible for ensuring all tobacco products, labeling, and advertising across all platforms comply with the FD&C Act and FDA regulations. The letter requires immediate corrective actions, including discontinuing violative advertising, and a written response within 15 working days detailing these actions and a compliance plan. Failure to comply could result in severe consequences, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, or refusal of import.