FDA WARNING_LETTER - Hakooh LLC - September 27, 2019

The FDA's Center for Tobacco Products issued a Warning Letter to HookahShisha.org after reviewing its website, https://www.hookahshisha.org, and determining that electronic nicotine delivery system (ENDS) and e-liquid products advertised and sold are tobacco products subject to FDA jurisdiction. The primary violation identified is that several ENDS and e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This misbranding stems from the failure of the website's advertising to include the required nicotine warning statement, specifically "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R § 1143.3(b). The letter cites examples of non-compliant products. The firm, as a manufacturer, packager, importer, distributor, or retailer, is required to immediately correct this violation and any similar deficiencies to bring all tobacco products and related advertising into compliance with the FD&C Act. A written response detailing corrective actions, including dates of discontinuance of violative activities and a plan for sustained compliance, is required within 15 working days. Failure to comply may lead to further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.