FDA WARNING_LETTER - Southern Tobacco Company - April 14, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Rodney Masri of Sahara Smoke after reviewing saharasmoke.com, which advertises and sells waterpipe tobacco products in the U.S. These products are subject to FDA jurisdiction under the FD&C Act. The FDA determined that the advertising for several waterpipe tobacco products on the website is misbranded because it fails to include the required nicotine warning statement, as mandated by 21 CFR 1143.3(b). This deficiency leads to misbranding under two sections of the FD&C Act: 903(a)(7)(B) for violating prescribed regulations and 903(a)(7)(A) for false or misleading advertising due to the omission of material facts. Sahara Smoke is required to immediately correct these violations and ensure all tobacco products and related advertising across all platforms comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including dates of discontinuation of violative advertising/sales, and a compliance plan, must be submitted within 15 working days. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of import.